The effect of NovoRapid FlexPen occurs earlier than with the introduction of soluble human insulin, while the blood glucose level becomes lower during the first 4 hours after a meal. When administered subcutaneously, the duration of action of NovoRapid FlexPen is shorter than that of soluble human insulin and occurs 10–20 minutes after injection. The maximum effect develops between 1 and 3 hours after injection. The duration of action is 3-5 hours.
The results of clinical studies of patients with type I diabetes mellitus have shown that with the introduction of NovoRapid FlexPen, the glucose level after a meal is lower than with the introduction of human insulin.
Children and adolescents. In children, when treated with NovoRapid FlexPen, the effectiveness of long-term control of blood glucose is the same as in treatment with soluble human insulin. A clinical study of 26 children aged 2–6 years compared the effectiveness of glycemic control with the administration of soluble human insulin before meals and insulin aspart administered after meals, and also determined the parameters of pharmacokinetics and pharmacodynamics in children aged 6–12 years and adolescents 13– 17 years. The pharmacodynamic profile of insulin aspart in children and adults was the same. The results of clinical studies of patients with type I diabetes mellitus have shown that when using insulin aspart, the risk of hypoglycemia at night is lower compared to soluble human insulin; with regard to the incidence of hypoglycemia during the day, there were no significant differences. When calculating the dose (in moles), insulin aspart is quipotent to soluble human insulin. The substitution of aspartic acid for the amino acid proline in position B-28 of the insulin molecule in NovoRapid FlexPen leads to a decrease in the formation of hexamers, which is observed with the introduction of soluble human insulin. Therefore, NovoRapid FlexPen is more rapidly absorbed into the bloodstream from the subcutaneous fatty tissue in comparison with soluble human insulin. The time to reach the maximum concentration of insulin in the blood is, on average, half that of an injection of soluble human insulin. The maximum concentration of insulin in the blood of patients with type I diabetes mellitus 492 ± 256 pmol / l is achieved 30–40 minutes after the SC administration of NovoRapid FlexPen at the rate of 0.15 U / kg of body weight. Insulin levels return to baseline 4–6 hours after administration. The intensity of absorption is somewhat lower in patients with type II diabetes mellitus. Therefore, the maximum insulin concentration in such patients is somewhat lower - 352 ± 240 pmol / l and is reached later - on average after 60 minutes (50–90) minutes. With the administration of NovoRapid FlexPen, the variability in the time to reach the maximum concentration in the same patient is significantly less, and the variability in the level of maximum concentration is greater than with the administration of human soluble insulin.
In elderly patients or with impaired liver or kidney function, the pharmacokinetics of NovoRapid FlexPen have not been studied. The pharmacokinetics and pharmacodynamics of NovoRapid FlexPen were studied in children (6–12 years old) and adolescents (13–17 years old) with type I diabetes mellitus. Insulin aspart was rapidly absorbed in both age groups under study, while the time to reach the maximum concentration in the blood was the same as in adults. However, the level of maximum concentration is different in children of different ages, which indicates the importance of individual selection of doses of NovoRapid FlexPen.
Novorapid - indications for use
diabetes treatmentContraindications
hypoglycemia; hypersensitivity to insulin aspart or any ingredient in the drug.Cautions for use
inadequate dosage or discontinuation of treatment (especially in type 1 diabetes mellitus) can lead to hyperglycemia and diabetic ketoacidosis, which are potentially fatal. Patients who have significantly improved blood glucose control, for example, thanks to intensive care, may notice a change in the usual symptoms - precursors of hypoglycemia, about which patients should be warned in advance. A consequence of the peculiarities of the pharmacodynamics of fast-acting insulin analogs is the possible faster development of hypoglycemia in comparison with soluble human insulin. NovoRapid FlexPen should be administered immediately before meals. The rapid onset of its action should be taken into account when treating patients with concomitant diseases or taking drugs that slow down the absorption of food in the gastrointestinal tract.Concomitant diseases, especially infections and fevers, usually increase the patient's need for insulin.
Transfer of patients to a new type or type of insulin should be carried out under strict medical supervision. If the concentration, type, type, origin of the insulin preparation (animal, human, analog of human insulin) and / or the method of its production changes, it may be necessary to adjust the dose. Patients taking NovoRapid FlexPen may need to increase the number of injections or change the dose compared to the usually used insulin. The need for dose selection may arise both at the first introduction of a new drug, and during the first few weeks or months of its use.
Skipping meals or unexpected strenuous exercise can lead to hypoglycemia. Exercise immediately after a meal increases the risk of hypoglycemia. NovoRapid FlexPen contains metacresol, which in rare cases can cause allergic reactions.
Use during pregnancy and lactation. The experience of using NovoRapid FlexPen during pregnancy is limited. The results of animal studies have shown that insulin aspart, like human insulin, does not have embryotoxic and teratogenic effects. It is recommended to strengthen control in the treatment of pregnant women with diabetes mellitus during the entire period of pregnancy, as well as if pregnancy is suspected. The need for insulin usually decreases in the first trimester of pregnancy and increases significantly in the second and third trimesters. There are no restrictions on the treatment of diabetes mellitus with NovoRapid FlexPen during breastfeeding. Treatment during pregnancy does not pose a risk to the baby. However, during this period, the mother may need to adjust the dose.
Influence on the ability to drive vehicles and mechanisms. The patient's response and ability to concentrate can be impaired in hypoglycemia. This can become a risk factor in situations where increased attention is required (for example, when driving a car or operating machinery). Patients should be advised to take measures to prevent hypoglycemia before driving. This is especially important for patients who have weakened or no symptoms - harbingers of hypoglycemia or episodes of hypoglycemia occur frequently. In such circumstances, the advisability of driving should be weighed.
Drug interactions
a number of medicinal substances affect glucose metabolism.Drugs that can reduce the need for insulin: oral hypoglycemic agents, octreotide, MAO inhibitors, non-selective β-adrenoreceptor blockers, ACE inhibitors, salicylates, alcohol, anabolic steroids, sulfonamides.
Drugs that may increase the need for insulin: oral contraceptives, thiazides, GCS, thyroid hormones, sympathomimetics, danazol.
Β-adrenergic receptor blockers can mask the symptoms of hypoglycemia.
Alcohol can enhance and prolong the hypoglycemic effect of insulin.
Incompatibility. Adding some drugs to insulin can cause it to inactivate, such as drugs containing thiols or sulfites.
Novorapid - method of administration and dosage
dosage of NovoRapid FlexPen is individual and determined by the doctor in accordance with the characteristics and needs of the patient. Usually NovoRapid FlexPen is used in combination with medium-duration or long-acting insulin preparations, which are administered at least once a day.The individual need for insulin is usually 0.5-1.0 U / kg / day. With a frequency of use in accordance with food intake, 50–70% of the insulin requirement is satisfied by NovoRapid FlexPen, and the rest is satisfied with insulins of medium duration or long-acting.
The method of administration of NovoRapid FlexPen is characterized by a faster onset and a shorter duration of action compared to soluble human insulin. Due to the faster onset of action, NovoRapid FlexPen, as a rule, should be administered immediately before meals. If necessary, the specified drug can be administered shortly after meals.
NovoRapid is injected under the skin of the anterior abdominal wall, thigh, in the area of the deltoid muscle of the shoulder or buttocks. The injection sites should be changed even within the same area of the body. With subcutaneous injections in the area of the anterior abdominal wall, the effect of the drug begins in 10–20 minutes. The maximum effect is between 1 and 3 hours after injection. The duration of action is 3-5 hours. As with all insulins, subcutaneous injection into the anterior abdominal wall provides faster absorption than when administered to other sites. Nevertheless, the faster onset of action of NovoRapid FlexPen compared to soluble human insulin is maintained regardless of the injection site. If necessary, NovoRapid FlexPen can be administered intravenously, these injections can be performed only under the supervision of a physician. NovoRapid can be used for continuous SC administration using appropriate infusion pumps. Continuous subcutaneous injection is carried out into the anterior abdominal wall, the injection site should be periodically changed. When used in infusion pumps, NovoRapid should not be mixed with any other insulin preparations. Patients using infusion pumps should receive detailed instructions on the use of these systems and use appropriate containers and tubing. The infusion set (tubes and cannulas) should be changed in accordance with the requirements of the attached instructions. Patients using NovoRapid in the pumping system should have insulin in case of failure. Abnormal liver and kidney function can reduce the patient's need for insulin. Instead of soluble human insulin, NovoRapid FlexPen should be administered to children in cases where it is desirable to obtain a quick action of insulin, for example, before meals. NovoRapid FlexPen is a pre-filled syringe pen designed for use with NovoFine® short cap needles. Packaging with NovoFine® needles is marked with the S symbol. FlexPen allows you to inject from 1 to 60 U of the drug with an accuracy of 1 U. It is necessary to follow the instructions for medical use of the drug, which is in the package. NovoRapid FlexPen is intended for individual use only, it cannot be reused.
Instructions for use of the drug NovoRapid FlexPen
NovoRapid is intended for subcutaneous injection or continuous administration using infusion pumps. NovoRapid can also be administered intravenously under the strict supervision of a physician.
Use in infusion pumps
For infusion pumps, tubes are used, the inner surface of which is made of polyethylene or polyolefin. Some insulin is initially absorbed on the inside of the infusion bottle.
Use for IV administration
Infusion systems with NovoRapid 100 U / ml at an insulin aspart concentration of 0.05 to 1.0 U / ml in an infusion solution containing 0.9% sodium chloride, 5 or 10% dextrose and 40 mmol / L chloride potassium, are in polypropylene infusion containers, are stable at room temperature for 24 hours. During the insulin infusion, it is necessary to monitor the concentration of glucose in the blood.
Side effects
adverse reactions observed in patients using NovoRapid FlexPen are mainly associated with the size of the administered dose of the drug and are a manifestation of the pharmacological action of insulin. The most commonly reported side effect of insulin therapy is hypoglycemia. It can develop if the dose significantly exceeds the patient's need for insulin. Severe hypoglycemia can lead to loss of consciousness and / or seizures, followed by temporary or permanent impairment of brain function and even death.According to the results of clinical studies, as well as data registered after the release of the drug on the market, the incidence of severe hypoglycemia varies in different patient groups and with different dosing regimens; the incidence of severe hypoglycemia in patients receiving insulin aspart is the same as in those receiving human insulin. Below is the frequency of adverse reactions that, according to clinical studies, may be associated with the administration of NovoRapid. According to the frequency of occurrence, these reactions are divided into those that occur sometimes (> 1/1000, 1/10 000,
From the immune system
Sometimes: urticaria, itching, skin rashes.
Very rare: anaphylactic reactions. Generalized hypersensitivity reactions may include skin rashes, itching, sweating, gastrointestinal disturbances, angioedema, shortness of breath, palpitations, and decreased blood pressure. These reactions are potentially life-threatening.
From the nervous system
Rare: peripheral neuropathy. Rapid improvement in blood glucose control can result in acute painful neuropathy, usually of a transient nature.
Visual impairment
Sometimes: refractive errors. Refractive errors of a transient nature may occur at the beginning of insulin therapy; diabetic retinopathy.
Long-term maintenance of glycemic control reduces the risk of diabetic retinopathy progression. However, intensifying insulin therapy to rapidly improve glycemic control may cause a temporary exacerbation of diabetic retinopathy.
On the part of the skin and subcutaneous tissue
Sometimes: lipodystrophy can occur at the injection sites as a result of non-compliance with the recommendation to change the injection site within the same area; local hypersensitivity.
With the introduction of insulin, reactions at the injection sites are sometimes noted as manifestations of local hypersensitivity (redness, swelling and itching). Swelling of the tissues at the injection site may develop at the beginning of insulin therapy. These reactions are usually transient and stop with continued treatment.
Overdose
for insulin, a specific definition of an overdose has not been formulated, but after its administration, hypoglycemia may develop.In case of mild hypoglycemia, it is necessary to ingest glucose or sugary foods. Therefore, patients with diabetes are advised to constantly have a few pieces of sugar or sweets with them.
In severe hypoglycemia, when the patient is unconscious, it is necessary to inject glucagon (0.5–1 mg) intramuscularly or subcutaneously, which can be given by persons who have received appropriate instructions. A healthcare professional can give the patient IV glucose. Glucose should be administered intravenously also if the patient does not respond to glucagon administration within 10-15 minutes. After the patient regains consciousness, he should take carbohydrates orally to prevent recurrence of hypoglycemia.
Storage conditions
shelf life - 2.5 years. The used syringe pen with NovoRapid FlexPen should not be stored in the refrigerator. A syringe pen, which is used or carried with you as a spare, should be stored for no more than 4 weeks (at a temperature not exceeding 30 ° C). An unused pen with NovoRapid FlexPen should be stored in the refrigerator at a temperature of 2–8 ° C (away from the freezer). Do not freeze. To protect from light, store the pen with the cap on.Manufacturer: Novo Nordisk (Denmark), Novo Nordisk
Name: Novorapid ® (insulin aspart), NovoRapid ®
Composition: 1 ml of Novorapid ® contains: active substance: insulin aspart 100 U, produced by recombinant DNA biotechnology in the Saccharomyces cerevisiae strain.
Pharmachologic effect: NovoRapid is a short-acting human insulin analog produced by recombinant DNA biotechnology using the Saccharomyces cerevisiae strain, in which the amino acid proline at position B28 is substituted for aspartic acid.
It interacts with a specific receptor of the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthetase, etc.). A decrease in blood glucose is due to an increase in its intracellular transport, an increase in tissue uptake, stimulation of lipogenesis, glycogenogenesis, a decrease in the rate of glucose production by the liver, etc. in a solution of ordinary insulin. In this regard, NovoRapid is absorbed much faster from the subcutaneous fat and begins to act much faster than soluble human insulin. NovoRapid ® lowers blood glucose more strongly in the first 4 hours after a meal than soluble human insulin. In patients with type 1 diabetes mellitus, a lower postprandial blood glucose level is revealed when NovoRapid is administered, compared with soluble human insulin.
The duration of action of Novorapid® after subcutaneous administration is shorter than that of soluble human insulin.
After subcutaneous administration, the effect of the drug begins within 10-20 minutes after administration.
The maximum effect is observed 1-3 hours after injection. The duration of action of the drug is 3-5 hours.
When using Novorapid ® in patients with type 1 diabetes mellitus, there is a decrease in the risk of nocturnal hypoglycemia compared to soluble human insulin. There was no significant increase in the risk of daytime hypoglycemia. NovoRapid® is equipotential to soluble human insulin based on molarity values.
Indications for use:
- Diabetes mellitus type 1.
- Diabetes mellitus type 2.
Mode of application: Novorapid ® is injected subcutaneously into the anterior abdominal wall, thigh, shoulder, buttocks. When injected subcutaneously into the anterior abdominal wall, the action begins 10-20 minutes after injection. The maximum effect of the drug is achieved between 1 and 3 hours after injection. The duration of action is from 3 to 5 hours. Studies of the drug in children under 6 years of age have not been conducted.
NovoRapid® has a faster onset and shorter duration of action than soluble human insulin. Can be administered just before meals. If necessary, NovoRapid1 can be administered immediately after a meal.
Side effects: Hypoglycemia is usually the most common side effect.
Contraindications: Hypoglycemia, hypersensitivity to insulin aspart or excipients.
Drug interactions: There are a number of medications that affect your insulin requirement.
The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, monoamine oxidase inhibitors, angiotensin-converting enzyme inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, cetracycline tetracycline , preparations containing ethanol. The hypoglycemic effect of insulin is weakened by oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, blockers of "slow" calcium channels, diazoxide, morphine, phenytoin.
Under the influence of reserpine and salicylates, both a weakening and an increase in the effect of the drug are possible.
Pregnancy and lactation: Currently, there are limited data on the clinical use of NovoRapid® in pregnant women. There are no restrictions on the use of NovoRapid ® during breastfeeding. Impact on driving and working with mechanisms: The ability of patients to concentrate and reaction speed can be impaired during hypoglycemia, which can be dangerous in situations where these abilities are especially needed (for example, when driving or working with machines and mechanisms).
Storage conditions:
- Store unused NovoRapid FlexPen between 2 ° C and 8 ° C (in the refrigerator), but not near the freezer. Do not freeze.
- To protect from light, store NovoRapid FlexPen with the protective cap put on.
- Used NovoRapid FlexPen is not recommended to be stored in the refrigerator. Store at a temperature not exceeding 30 ° C for 4 weeks.
- Keep out of the reach of children
Additionally: NovoRapid is intended for subcutaneous injections or continuous infusions in the insulin pumping system (IPII). NovoRapid can also be administered intravenously under the strict supervision of a physician. Injection sites should always be changed to avoid the formation of lipodystrophies. The best sites for injection are: the anterior abdominal wall; buttocks; the front of the thigh or shoulder. Insulin will act faster if it is injected into the anterior abdominal wall.
The drug NovoRapid is a new generation drug that allows you to compensate for the deficiency of human insulin. It has a number of advantages over other similar drugs, is easily and quickly absorbed, instantly normalizes blood sugar, can be used regardless of food intake, since it is an ultra-short insulin.
NovoRapid is produced in 2 types: ready-made FlexPen pens, replacement Penfill cartridges. The composition of the medication in both cases is the same - a transparent liquid for injection, one ml contains 100 IU of the active substance. The cartridge, like the pen, contains 3 ml of insulin.
The price of 5 NovoRapid Penfill insulin cartridges will average about 1,800 rubles, FlexPen costs about 2,000 rubles. One package contains 5 syringe pens.
Features of the drug
The main active ingredient of the drug is insulin aspart, it has a powerful hypoglycemic effect, is an analogue of short insulin that is produced in the human body. This substance is obtained through the use of recombinant DNA technology.
The drug enters into contact with the outer cytoplasmic membranes of amino acids, forms a complex of insulin endings, and starts the processes taking place inside the cells. After lowering blood sugar, it is noted:
- increased intracellular transport;
- an increase in the digestibility of tissues;
- activation of lipogenesis, glycogenesis.
Additionally, it is possible to achieve a decrease in the rate of glucose production by the liver.
NovoRapid is better absorbed by subcutaneous fat than soluble human insulin, but the duration of the effect is much shorter. The action of the agent occurs within 10-20 minutes after the injection, and its duration is 3-5 hours, the maximum concentration of insulin is noted after 1-3 hours.
Medical studies of patients with type 1 diabetes mellitus have shown that the systematic use of NovoRapid reduces the likelihood of nighttime by several times. In addition, there is evidence of a significant decrease in postprandial hypoglycemia.
- excessive sensitivity of the body to the components of the product;
- children under 6 years of age.
The drug is allowed to be used for the treatment of intercurrent diseases.
Instructions for use of the drug
Sugar level
For optimal results, this hormone must be combined with long-acting and intermediate-acting insulins. To control the level of glycemia, a systematic measurement of blood sugar is shown, and the dose of the drug is adjusted if necessary.
Often, the daily dose of insulin for a diabetic fluctuates in the range of 0.5-1 U per kilogram of weight. One injection of the hormone provides the patient's daily need for insulin by about 50-70%, the rest is long-acting insulin.
- increase;
- changes in his diet;
- progression of concomitant diseases.
Insulin NovoRapid Flekspen, unlike the soluble human hormone, acts quickly, but short-term. It is shown to use the drug before meals, but it is allowed to do this immediately after meals, if necessary.
Due to the fact that the drug acts on the body for a short time, the likelihood of developing nocturnal hypoglycemia is significantly reduced. If the drug is used to treat an elderly diabetic, with hepatic or renal failure, blood sugar control should be performed more often, the volume of insulin should be selected individually.
It is necessary to inject insulin into the anterior region of the abdomen, buttocks, brachial, deltoid muscles. To prevent lipodystrophy, it is necessary to change the area into which the drug is injected. But you should know that the introduction into the anterior abdominal region ensures the fastest absorption of the drug, when compared with injections in other parts of the body.
The duration of the effect of insulin is directly influenced by:
- dosage;
- injection site;
- the patient's activity level;
- the degree of blood flow;
- Body temperature.
For some diabetics, long-term subcutaneous infusions are recommended, which can be carried out using a special pump. The introduction of the hormone is shown in the anterior abdominal wall, but, as in the previous case, the places must be changed.
When using an insulin pump, you must not mix the drug with other insulins. Patients who receive funds using such a system should have a spare dose of the drug with them in the event of a device breakdown. NovoRapid is suitable for intravenous administration, but such an injection should only be given by a physician.
During treatment, it is required to regularly donate blood for testing for glucose concentration.
How to calculate the correct dosage
To accurately calculate the amount of the drug, you need to know that the hormone insulin is ultrashort, short, medium, prolonged and combined. A combination drug helps to bring blood sugar back to normal; it is administered on an empty stomach for type 1 or type 2 diabetes mellitus.
If only prolonged insulin is shown to some patients, then to others, if necessary, to prevent sudden changes in sugar surges, only NovoRapid is shown. To treat hyperglycemia, you can use short and long insulins at the same time, but at different times. Sometimes only a combination insulin preparation is suitable to achieve the intended result.
When choosing a treatment, the doctor takes into account some aspects, for example, thanks to only the action of long insulin, it is possible to retain glucose and do without an injection of a short-acting drug.
The choice of a prolonged-release agent is required to be carried out in this way:
- blood sugar is measured before breakfast;
- 3 hours after the second breakfast, another measurement is taken.
Further, the study must be carried out every hour. On the first day of the selection of the dosage, it is imperative to skip lunch, but have dinner. On the second day, sugar measurements are taken every hour, including at night. On the third day, measurements are taken by itself, food is not limited, but short insulin is not injected. Ideal morning results: first day - 5 mmol / l; the second day - 8 mmol / l; third day - 12 mmol / l.
It should be remembered that NovoRapid reduces the concentration of blood sugar one and a half times stronger than its counterparts. Therefore, you need to inject 0.4 doses of short insulin. The dosage can only be determined more accurately through experimentation, taking into account the severity of diabetes. Otherwise, an overdose develops, which will cause a number of unpleasant complications.
The main rules for determining the volume of insulin for a diabetic:
- early stage of type 1 diabetes - 0.5 U / kg;
- if diabetes has been observed for more than a year - 0.6 U / kg;
- complicated diabetes - 0.7 U / kg;
- decompensated diabetes - 0.8 U / kg;
- diabetes on the background of ketoacidosis - 0.9 U / kg.
Pregnant women in the third trimester are shown to administer 1 U / kg of insulin. To find out a single dose of a substance, it is necessary to multiply the body weight by the daily dose, and then divide by two. The result is rounded.
NovoRapid FlexPen
The introduction of the drug is carried out using a syringe pen, it has a dispenser, color coding. The volume of insulin can be from 1 to 60 units, the step in the syringe is 1 unit. The NovoRapid tool uses a needle 8 mm Novofine, Novotvist.
Using a pen syringe to inject the hormone, you need to remove the sticker from the needle, screw it to the handle. A new needle is used for the injection each time, this helps to prevent the growth of bacteria. It is forbidden to damage the needle, bend, transfer to other patients.
The pen syringe may contain a small amount of air inside so that oxygen does not accumulate, the dose was injected accurately, it is shown to observe the following rules:
- dial 2 UNITS by turning the dosage selector;
- place the syringe pen with the needle up, tap the cartridge a little with your finger;
- press the start button all the way down (the selector will return to the 0 mark).
If a drop of insulin does not appear on the needle, the procedure is repeated (no more than 6 times). If the solution does not flow, this means that the syringe pen is not suitable for use.
Before setting the dosage, the selector must be in position 0. After that, the required amount of the drug is collected, adjusting the selector in both directions.
It is forbidden to set the rate above the prescribed one; use the scale to determine the dosage of the agent. When injecting the hormone under the skin, be sure to follow the technique recommended by the doctor. To make an injection, press the start button, do not release it until the selector is at 0.
The usual rotation of the dosage indicator will not start the drug delivery; after the injection, the needle must be held under the skin for another 6 seconds, while holding down the trigger. This will allow you to enter NovoRapid completely, as prescribed by the doctor.
The needle must be removed after each injection; it must not be stored with the syringe, otherwise the drug will leak out.
Unwanted effects
NovoRapid insulin in some cases can provoke a number of side reactions of the body, it can be hypoglycemia, its symptoms:
- pallor of the skin;
- excessive sweating;
- tremor of the limbs;
- unreasonable anxiety;
- muscle weakness;
- tachycardia;
- bouts of nausea.
Other manifestations of hypoglycemia will be disorientation, decreased concentration, vision problems, and hunger. Changes in blood glucose can cause seizures, loss of consciousness, severe brain damage, and death.
Rarely are allergic reactions, in particular urticaria, as well as disruption of the digestive tract, angioedema, shortness of breath, tachycardia. Local reactions should be called discomfort in the injection area:
- edema;
- redness;
Symptoms of lipodystrophy, refractive errors are not excluded. Doctors say that such manifestations are purely temporary in nature, manifest in dose-dependent patients, and are caused by the action of insulin.
Analogues, patient reviews
If it happened that insulin NovoRapid Penfill for some reason did not suit the patient, the doctor recommends him to use analogs. The most popular are the funds Apidra, Gensulin N, Humalog, Novomiks, Ryzodeg. Their cost is about the same.
Many patients have already evaluated the drug NovoRapid, they note that the effect occurs quickly, side reactions are rare. The drug is excellent for the treatment of type 1 and type 2 diabetes mellitus. The majority of diabetics believe that the product is quite convenient, especially pen-type syringes, they eliminate the need to purchase syringes.
In practice, insulin is used against the background of a long course of insulin, it helps to keep blood glucose at an optimal level during the day, and to reduce glucose after meals. For some patients, NovoRapid is indicated exclusively at the very beginning of the disease.
The disadvantage of the remedy is a sharp drop in glucose in children, as a result, patients may feel bad. To prevent such problems, it is necessary to switch to long-term insulin.
Diabetics also note that if the dosage is incorrectly selected, the symptoms of hypoglycemia develop, and the state of health worsens. The video in this article will continue the topic of Novorapid insulin.
Insulin Novorapid is a new generation drug that makes it possible to compensate for the lack of a hormone in the body. It has many advantages: it is easily and quickly absorbed, normalizes blood sugar levels, and can be used regardless of meals. Belongs to the category of ultra-short-acting insulin.
Composition
The diabetic agent Novorapid is a colorless liquid for injection. Available in replaceable cartridges and 3 ml syringe pens. The active ingredient of the drug, insulin aspart, has a powerful hypoglycemic effect and is analogous to the human hormone. The substance is extracted by recombinant DNA biotechnology and is 100 IU, or 3.5 g of the total solution.
Additional components are glycerol, phenol, metacresol, zinc chloride, sodium chloride, sodium hydrogen phosphate dihydrate, sodium hydroxide, hydrochloric acid and water.
Indications and contraindications
Novorapid is prescribed for type 1 and type 2 diabetes. In non-insulin dependent diabetics, the drug should be administered when diagnosing resistance to hypoglycemic formulations intended for oral administration.
Can be taken by children from 2 years of age. However, this composition has not passed clinical trials, therefore, the drug can be administered only after 6 years of age. The indication for the appointment is the difficulty in observing the child's intervals between injections and meals.
Of the contraindications, individual sensitivity to the components of the drug should be noted. Use with extreme caution in elderly people with hepatic or renal impairment.
Method of administration and dosage
Novorapid is intended for subcutaneous and intravenous administration. The dose of the hormone is selected individually, taking into account the characteristics of the organism and the severity of the course of the disease. The drug is recommended to be used in combination with long- or medium-acting insulins, which are administered once a day. To avoid surges in glucose levels, blood sugar should be checked before the administration of Novoropid and the dose should be adjusted depending on the indicators.
The recommended daily dose of the drug for adults and children ranges from 0.5-1 IU per 1 kg of body weight. Novorapid can be administered just before meals. In this case, insulin will cover about 60–70% of the diabetic's needs. The rest of the amount will be compensated by long-acting insulins. The introduction of the composition after a meal is also permissible.
It is necessary to adjust the dose of the hormone:
- when changing the usual diet;
- with intercurrent diseases;
- with unplanned or excessive physical exertion;
- during surgical interventions.
The dosage of short-acting insulin is usually adjusted after measuring the sugar level for a week. Based on these indicators, the specialist will draw up an individual admission scheme. For example, if jumps in blood glucose levels are observed in the evening, Novorapid is administered 1 time per day before dinner. If sugar rises after each snack, injections should be injected before meals.
The areas of the thighs, shoulders, buttocks, and the anterior abdominal wall should be selected for insulin administration. To reduce the risk of lipodystrophy, the injection zones must be alternated.
The duration of the hormone depends on many factors: dosage, injection site, blood flow, physical activity, etc. If necessary, it is possible to administer the drug using an insulin pump. However, this method should only be used with the necessary skills and available tools (reservoir, catheter and tubing). Intravenous administration is permissible only under the watchful supervision of a specialist. For infusion, a solution of insulin with sodium chloride or dextrose is used.
Novorapid Flekspen
Most often, the drug is administered using a syringe pen. Insulin Novorapid Flekspen is color-coded and dispensed. One step of the syringe contains 1 IU of the substance. Before using the hormone, you must carefully read the instructions for use. Check the manufacturing date and expiration date. Then remove the cap from the syringe and remove the sticker from the needle. Screw the needle onto the handle. Remember: a sterile needle must be used for every injection.
The manufacturer warns that the pen syringe may contain a small amount of air inside. To avoid the accumulation of oxygen bubbles and to correctly administer the drug, follow certain rules. Draw 2 U of hormone, lift the syringe with the needle up and gently tap the cartridge with your fingertip. This will move the air bubbles upward. Now press the start button and wait for the dosage selector to return to position "0". With a working syringe, a drop of the composition will appear on the needle. If it doesn't, try again a few more times. The lack of insulin in the needle indicates a malfunction of the syringe.
After confirming that the device is functioning properly, set the syringe dosage selector to the "0" position. Draw up the required amount of the drug. Be careful when setting the dose. Accidental pressing can cause premature release of the hormone. Do not set the rate more than prescribed by the manufacturer. Inject insulin following the technique and advice of your healthcare professional. Leave your finger on the trigger within 6 seconds of injection to achieve a full dose.
Remove the needle and guide it into the outer cap. After it enters there, unscrew and discard. Cap the syringe and store it in storage. Detailed information on injection and disposal of used needles can be found in the instructions for use.
The use of the drug Novorapid Flexpen is prohibited in certain cases.
- Allergic reactions to insulin aspart or other components of the drug.
- Early hypoglycemia (always measure sugar before hormone administration).
- The pen is damaged, crushed, or dropped to the floor.
- The liquid in the syringe has a cloudy color, foreign particles float in it or a precipitate is visible.
- The storage conditions of the medicinal product have been violated or the substance has been frozen.
The surface of the pen can be treated with an alcohol wipe. It is forbidden to immerse Novorapid Flekspen in liquid, wash or lubricate. Otherwise, the mechanism of the device may fail.
Novorapid during pregnancy
Like other insulins, Novorapid is approved for use during pregnancy and lactation. Many special studies have confirmed that the drug does not have an adverse effect on the fetus. However, the expectant mother should carefully monitor blood glucose levels, since hypo- and hyperglycemia are dangerous to the health of both the woman and the baby.
The dosage of short-acting insulin must be adjusted depending on the length of the pregnancy. At the beginning of the 1st trimester, the need for insulin will be much less than by the end of the 2nd and early 3rd trimesters. Immediately after childbirth, blood glucose levels return to normal, but in rare cases, minor adjustments may still be necessary.
Side effects and overdose
Most often, undesirable reactions occur to the hormone itself and are manifested in the form of hypoglycemia, which is accompanied by:
- excessive sweating
- pallor of the skin
- nervousness
- unreasonable feeling of anxiety,
- tremor of the limbs,
- weakness in the body
- disorientation and decreased concentration.
Often, an excessive drop in blood sugar can cause:
- dizziness,
- hunger,
- vision problems
- nausea
- headache,
- tachycardia.
Severe glycemia can lead to loss of consciousness, seizures, cerebrovascular accident and death.
If the drug is used incorrectly, local and allergic reactions are possible: urticaria, itching, redness and swelling. Most often, these symptoms occur at the beginning of the use of the hormone and after a while they disappear on their own. However, some diabetics also noted other allergic reactions, accompanied by gastrointestinal upset, angioedema, difficult breathing, heart palpitations and low blood pressure.
Excessive use of insulin Novorapid can lead to overdose, which is accompanied by hypoglycemia. A slight degree of overdose is easy to eliminate on your own. To do this, you need to eat foods that contain sugar. Moderate and severe forms of glycemia, accompanied by loss of consciousness, should be treated in a hospital setting.
Analogs
If, for some reason, Novorapid did not fit the patient, the endocrinologist can choose its analogues. The most common among them are Apidra, Novomix, Aktrapid, Humalog, Gensulin N, Protafan and Ryzodeg. All of these drugs are short-acting insulins, suitable for the treatment of type 1 and type 2 diabetes, and are easy to use.
Storage rules
The drug should be stored in a refrigerator at a temperature of +2 ... +8 ° C. It is unacceptable to freeze the drug and expose it to direct sunlight. If necessary, it is possible to store the hormone at a temperature of +30 ° C, but in this case, its shelf life is reduced to 4 weeks.
When using the drug, certain nuances should be taken into account.
- When using a pen, remember that it can get lost or damaged, so always have a spare injection system with you.
- The drug is most often recommended at the beginning of the diagnosis of diabetes and is prescribed against the background of a course of long-acting insulin.
- An analogue of a human hormone can cause a sharp drop in glucose in children, therefore, Novorapid should be prescribed with caution at a young age.
- Transfer from another insulin-containing drug to Novorapid should be carried out under medical supervision.
- The hormone is used in direct connection with food intake. Therefore, it is important to consider its fast action in the treatment of diabetics who suffer from concomitant diseases or take drugs that slow down the absorption of food.
Insulin Novorapid is a mild and high-quality drug that effectively lowers blood glucose levels even in type 1 diabetes. Using the drug with long-acting insulin helps maintain post-meal sugar levels and allows for off-hour snacking. However, an incorrectly selected dosage often causes hypoglycemia and negatively affects well-being. To avoid side effects, taking the drug should be agreed with your doctor.
5
5 (1 rating)INSTRUCTIONS
on the medical use of the drug
Registration number:
P N016171 / 01Tradename: NovoRapid® FlexPen®
INN: Insulin aspart
Dosage form:
Solution for subcutaneous and intravenous administrationComposition:
1 ml of the drug contains:active substance: insulin aspart 100 U (3.5 mg);
Excipients: glycerol 16 mg, phenol 1.5 mg, metacresol 1.72 mg, zinc chloride 19.6 μg, sodium chloride 0.58 mg, sodium hydrogen phosphate dihydrate 1.25 mg, sodium hydroxide 2M about 2.2 mg, hydrochloric acid 2M about 1.7 mg, water for injection up to 1 ml.
One syringe pen contains 3 ml of solution equivalent to 300 U.
Description
Transparent, colorless solution.
Pharmacotherapeutic group:
A hypoglycemic agent, a short-acting analogue of human insulin.ATX code- А10АВ05.
Pharmacological properties:
Pharmacodynamics.Insulin aspart is a short-acting human insulin analogue produced by recombinant DNA biotechnology using the Saccharomyces cerevisiae strain, in which the amino acid proline at position B28 is substituted for aspartic acid.
It interacts with a specific receptor of the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, etc.). A decrease in the content of glucose in the blood is due to an increase in its intracellular transport, increased absorption by tissues, stimulation of lipogenesis, glycogenogenesis, a decrease in the rate of glucose production by the liver, etc.
Substitution of the amino acid proline at position B28 for aspartic acid in insulin aspart reduces the tendency of molecules to form hexamers, which is observed in conventional insulin solutions. In this regard, insulin aspart is absorbed much faster from the subcutaneous fat and begins to act faster than soluble human insulin. Insulin aspart lowers blood glucose more strongly in the first 4 hours after a meal than soluble human insulin. The duration of action of insulin aspart after subcutaneous administration is shorter than that of soluble human insulin. After subcutaneous administration, the effect of the drug begins within 10-20 minutes after administration. The maximum effect is observed 1-3 hours after injection. The duration of action of the drug is 3-5 hours.
Clinical studies in patients with type 1 diabetes mellitus have shown a reduction in the risk of nocturnal hypoglycemia with insulin aspart compared to soluble human insulin. The risk of daytime hypoglycemia was not significantly increased.
Insulin aspart is equipotential to soluble human insulin in terms of molarity.
Adults. Clinical studies in patients with type 1 diabetes mellitus demonstrate a lower postprandial blood glucose concentration with the administration of insulin aspart compared to soluble human insulin.
Elderly: A randomized, double-blind, crossover study of the pharmacokinetics and pharmacodynamics (PK / PD) of insulin aspart and soluble human insulin was conducted in elderly patients with type 2 diabetes mellitus (19 patients aged 65-83 years, mean age 70 years). The relative differences in pharmacodynamic properties between insulin aspart and soluble human insulin in elderly patients were similar to those in healthy volunteers and in younger diabetic patients.
Children and adolescents. The use of insulin aspart in children has shown similar long-term glycemic control results when compared to soluble human insulin.
A clinical study using soluble human insulin before meals and insulin aspart after meals was conducted in young children (26 patients aged 2 to 6 years); and a PK / PD study using a single dose was conducted in children (6-12 years old) and adolescents (13-17 years old). The pharmacodynamic profile of insulin aspart in children was similar to that in adult patients.
Pregnancy: Clinical studies of the comparative safety and efficacy of insulin aspart and human insulin in the treatment of pregnant women with type 1 diabetes mellitus (322 examined pregnant women, of whom 157 received insulin aspart, 165 - human insulin) did not reveal any negative effects of insulin aspart on the course of pregnancy or fetal health / newborn.
Additional clinical studies in 27 women with gestational diabetes who received insulin aspart and human insulin (14 women received insulin aspart, 13 women received human insulin) showed comparable safety profiles along with significant improvements in postprandial glucose control with insulin aspart treatment.
Pharmacokinetics.
After subcutaneous administration of insulin aspart, the time to reach the maximum concentration (t max) in the blood plasma is on average 2 times less than after the administration of soluble human insulin. The maximum concentration in blood plasma (Cmax) averages 492 ± 256 pmol / l and is reached 40 minutes after subcutaneous administration of a dose of 0.15 U / kg body weight to patients with type 1 diabetes mellitus. The insulin concentration returns to the initial level 4-6 hours after the administration of the drug. The absorption rate is slightly lower in patients with type 2 diabetes, which leads to a lower maximum concentration (352 ± 240 pmol / L) and a later t max (60 minutes).
The intra-individual variability in t max is significantly lower with insulin aspart compared to soluble human insulin, while the indicated variability in C max for insulin aspart is greater.
Pharmacokinetics in children (6-12 years old) and adolescents (13-17 years old) with type 1 diabetes mellitus. The absorption of insulin aspart is rapid in both age groups with a t max similar to that of adults. However, there are differences in C max in the two age groups, which emphasizes the importance of individual dosage of the drug. Elderly: The relative differences in pharmacokinetics between insulin aspart and soluble human insulin in elderly patients (65-83 years, mean age 70 years) with type 2 diabetes mellitus were similar to those in healthy volunteers and younger patients with diabetes mellitus. In elderly patients, a decrease in the absorption rate was observed, which led to a slowdown in t max (82 (variability: 60-120) minutes), while C max was the same as that observed in younger patients with type 2 diabetes mellitus and slightly less than in patients with type 1 diabetes mellitus. Insufficiency of liver function: A pharmacokinetic study was conducted with the introduction of a single dose of insulin aspart in 24 patients whose liver function is in the range from normal to severe form of impairment. In individuals with impaired liver function, the rate of absorption of insulin aspart was reduced and more variable, resulting in a slowdown in t max from about 50 minutes in those with normal liver function to about 85 minutes in those with moderate to severe hepatic impairment. The area under the concentration-time curve, maximum plasma concentration and total drug clearance (AUC, C max and CL / F) were similar to streets with reduced and normal liver function. Insufficient renal function: The pharmacokinetics of insulin aspart was studied in 18 patients whose renal function ranged from normal to severe. There was no clear effect of creatinine clearance on AUC, C max, t max of insulin aspart. The data were limited to those for persons with moderate and severe renal impairment. Individuals with renal failure requiring dialysis were excluded from the study.
Non-clinical safety data:
Preclinical studies have not identified any hazard to humans based on generally accepted safety pharmacology, re-use toxicity, genotoxicity and reproductive toxicity data. In in vitro tests, including binding to receptors for insulin and insulin-like growth factor-1, as well as effects on cell growth, the behavior of insulin aspart is very similar to that of human insulin. The research results also showed that the dissociation of the binding of insulin aspart to the insulin receptor is equivalent to that of human insulin.
Indications for use:
Diabetes mellitus in adults, adolescents and children over 2 years of age.Contraindications:
Application during pregnancy and during breastfeeding
NovoRapid® FlexPen® can be prescribed during pregnancy. Data from two randomized controlled clinical trials (157 + 14 pregnant women examined) did not reveal any adverse effects of insulin aspart on pregnancy or fetal / neonatal health compared with human insulin (see section “
Pharmacological properties:
"). Careful monitoring of blood glucose levels and monitoring of pregnant women with diabetes mellitus (type 1 diabetes, type 2 diabetes, or gestational diabetes) are recommended throughout pregnancy and during possible pregnancy. The need for insulin, as a rule, decreases in the first trimester and gradually increases in the second and third trimesters of pregnancy. Soon after giving birth, the need for insulin quickly returns to pre-pregnancy levels.During breastfeeding NovoRapid® FlexPen® can be used, because the introduction of insulin to a woman during breastfeeding does not pose a threat to the baby. However, it may be necessary to adjust the dose of the drug.
Method of administration and dosage:
NovoRapid® FlexPen® is a fast-acting insulin analogue. The dose of NovoRapid® FlexPen® is determined by the doctor individually in accordance with the patient's needs. Typically, the drug is used in combination with medium-duration or long-acting insulin preparations, which are administered at least once a day.To achieve optimal glycemic control, it is recommended that you regularly measure your blood glucose concentration and adjust your insulin dose.
Usually, the individual daily need for insulin in adults and children is from 0.5 to 1 U / kg of body weight. When the drug is administered before a meal, the need for insulin can be provided by NovoRapid® FlexPen® by 50-70%, the remaining need for insulin is provided by prolonged-action insulin.
An increase in the patient's physical activity, a change in the habitual diet or concomitant diseases may lead to the need for dose adjustment.
NovoRapid® FlexPen® has a faster onset and shorter duration of action than soluble human insulin. Due to its faster onset of action, NovoRapid® FlexPen® should be administered, as a rule, immediately before a meal, if necessary, it can be administered shortly after a meal. Due to the shorter duration of action compared to human insulin, the risk of developing nocturnal hypoglycemia in patients receiving NovoRapid® FlexPen® is lower.
Special patient groups
As with the use of other insulins, in elderly patients and patients with renal or hepatic insufficiency, the blood glucose concentration should be more closely monitored and the dose of insulin aspart should be adjusted individually.
Children and adolescents
It is preferable to use NovoRapid® FlexPen® instead of soluble human insulin in children when a rapid onset of action of the drug is required, for example, when it is difficult for a child to observe the required time interval between an injection and a meal.
Transfer from other insulin preparations
When transferring a patient from other insulin preparations to NovoRapid® FlexPen®, a dose adjustment of NovoRapid® FlexPen® and basal insulin may be required.
NovoRapid® FlexPen® is injected subcutaneously into the anterior abdominal wall, thigh, shoulder, deltoid or gluteal region. Injection sites within the same area of the body should be changed regularly to reduce the risk of developing lipodystrophy. As with all insulin preparations, subcutaneous injection into the anterior abdominal wall provides faster absorption compared to administration elsewhere. The duration of action depends on the dose, site of administration, blood flow intensity, temperature and level of physical activity. However, the faster onset of action compared to soluble human insulin is maintained regardless of the injection site location.
NovoRapid® can be used for continuous subcutaneous insulin infusions (PSII) in insulin pumps designed for insulin infusions. PPII should be performed in the anterior abdominal wall. Infusion sites should be changed periodically.
When using an insulin pump for infusion, NovoRapid® should not be mixed with other types of insulins.
Patients using PPII should be fully trained in the use of the pump, the appropriate reservoir, and pump tubing. The infusion set (tube and catheter) should be replaced according to the user manual that came with the infusion set.
Patients receiving NovoRapid® with PPII should have additional insulin available in case of breakdown of the infusion system.
Intravenous administration
If necessary, NovoRapid® can be administered intravenously, but only by qualified medical personnel.
For intravenous administration, infusion systems with NovoRapid® 100 U / ml with a concentration of 0.05 U / ml to 1 U / ml of insulin aspart in 0.9% sodium chloride solution are used; 5% dextrose solution or 10% dextrose solution containing 40 mmol / L potassium chloride using polypropylene infusion containers. These solutions are stable at room temperature for 24 hours. Despite being stable over time, a certain amount of insulin is initially absorbed into the material of the infusion system. During insulin infusions, it is necessary to constantly monitor the concentration of blood glucose.
Side effect:
Adverse reactions observed in patients using NovoRapid® FlexPen® are mainly due to the pharmacological effect of insulin.The most common adverse reaction is hypoglycemia. The incidence of side effects varies depending on the patient population, dosing regimen and glycemic control (see section below).
At the initial stage of insulin therapy, refractive errors, edema and reactions at the injection sites (pain, redness, urticaria, inflammation, hematoma, swelling and itching at the injection site) may occur. These symptoms are usually transient. Rapid improvement in glycemic control can lead to a condition of "acute painful neuropathy", which is usually reversible. Intensification of insulin therapy with a sharp improvement in the control of carbohydrate metabolism can lead to a temporary worsening of the state of diabetic retinopathy, at the same time, a long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy.
The list of adverse reactions is presented in the table.
|
Immune system disorders | Uncommon - Hives, skin rashes, skin rashes |
| Very rare - Anaphylactic reactions * | |
| Metabolic and nutritional disorders | Very common - hypoglycemia * |
| Nervous system disorders | Rarely, peripheral neuropathy ("acute painful neuropathy") |
|
Violations of the organ of vision | Uncommon - refractive errors |
| Uncommon - diabetic retinopathy | |
| Skin and subcutaneous tissue disorders | Uncommon - lipodystrophy * |
|
General disorders and disorders at the injection site | Uncommon - injection site reactions |
| Uncommon - edema |
*Cm. "Description of selected adverse reactions"
All of the adverse reactions presented below, based on data obtained from clinical trials, are divided into groups according to the frequency of development in accordance with MedDRA and organ systems. The incidence of adverse reactions is defined as: very often (≥ 1/10); often (≥ 1/100 to<1/10); нечасто (≥1/1,000 до <1/100); редко (≥1/10,000 до <1/1,000), очень редко (<1/10,000) и неизвестно (невозможно оценить на основании имеющихся данных).
Description of selected adverse reactions:
Anaphylactic reactions
There have been very rare reactions of generalized hypersensitivity (including generalized skin rash, itching, increased sweating, gastrointestinal disorders, angioedema, difficulty breathing, rapid heart rate, decreased blood pressure), which are potentially life-threatening.
Hypoglycemia
Hypoglycemia is the most common side effect. It can develop if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycemia can lead to loss of consciousness and / or seizures, temporary or irreversible dysfunction of the brain, or even death. Symptoms of hypoglycemia usually develop suddenly. These may include cold sweats, pallor of the skin, increased fatigue, nervousness or tremors, anxiety, unusual tiredness or weakness, disorientation, decreased concentration, drowsiness, extreme hunger, visual impairment, headache, nausea, and heart palpitations. ... Clinical studies have shown that the incidence of hypoglycemia varies depending on the patient population, dosing regimen and glycemic control. In clinical trials, there was no difference in the overall incidence of episodes of hypoglycemia between patients receiving insulin aspart therapy and patients using human insulin preparations.
Lipodystrophy
Infrequent cases of lipodystrophy have been reported. Lipodystrophy can develop at the injection site.
Overdose:
The definite dose required for an insulin overdose has not been established, however, hypoglycemia can develop gradually if too high doses are administered in relation to the patient's needs.The patient can eliminate mild hypoglycemia himself by ingesting glucose or sugar-containing foods. Therefore, patients with diabetes mellitus are advised to constantly carry sugar-containing foods with them.
- In the case of severe hypoglycemia, when the patient is unconscious, 0.5 mg to 1 mg of glucagon should be administered intramuscularly or subcutaneously (can be administered by a trained person), or intravenous glucose (dextrose) solution (can only be administered by a healthcare professional). It is also necessary to inject dextrose intravenously if the patient does not regain consciousness 10-15 minutes after the administration of glucagon. After regaining consciousness, the patient is advised to eat carbohydrate-rich foods to prevent recurrence of hypoglycemia.
Interaction with other medicinal products
There are a number of medications that affect your insulin requirement.The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, monoamine oxidase inhibitors, angiotensin-converting enzyme inhibitors, carbonic anhydrase inhibitors, nonselective beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibolamidolate ...
The hypoglycemic effect of insulin is weakened by oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatropin, danazol, clonidine, blockers of "slow" nicotine channels, diazoxidine, morphine. Beta-adrenoblockers can mask the symptoms of hypoglycemia. Octreotide / lanreotide can both increase and decrease insulin requirements.
Alcohol can both increase and decrease the hypoglycemic effect of insulin.
Incompatibility
Some drugs, for example, those containing thiol or sulfite groups, when added to NovoRapid® FlexPen®, can cause the destruction of insulin aspart. NovoRapid® FlexPen® should not be mixed with other drugs. The exception is insulin isophane and infusion solutions described in the section "
Method of administration and dosage:
».special instructions
Before a long trip involving a change of time zone, the patient should consult with their doctor, as the change of the time zone means that the patient must eat and administer insulin at a different time.Hyperglycemia
An insufficient dose of the drug or discontinuation of treatment, especially in type 1 diabetes mellitus, can lead to the development of hyperglycemia and diabetic ketoacidosis. Typically, symptoms of hyperglycemia appear gradually, over several hours or days. Symptoms of hyperglycemia are nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, increased urine output, thirst and loss of appetite, and the odor of acetone in the exhaled air. Hyperglycemia can be fatal if left untreated.
Hypoglycemia
Skipping meals, unplanned increased physical activity or too high in relation to the patient's dose of insulin can lead to hypoglycemia.
After compensation of carbohydrate metabolism, for example, with intensified insulin therapy, patients may change their typical symptoms, precursors of hypoglycemia, about which patients should be informed.
The usual precursor symptoms can disappear with prolonged diabetes mellitus.
A consequence of the pharmacodynamic features of short-acting insulin analogues is that the development of hypoglycemia with their use can begin earlier than with the use of soluble human insulin.
Since NovoRapid® FlexPen® should be used in direct connection with food intake, the high rate of onset of the drug's effect should be taken into account when treating patients with concomitant diseases or taking medications that slow down the absorption of food.
Concomitant diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin. Correction of the dose of the drug may also be required if the patient has concomitant diseases of the kidneys, liver, dysfunction of the adrenal glands, pituitary gland or thyroid gland.
When the patient is switched to other types of insulin, the early warning signs of hypoglycemia may become less pronounced compared to those with the previous type of insulin.
Transfer of the patient from other insulin preparations
Transfer of a patient to a new type of insulin or insulin preparation from another manufacturer must be carried out under strict medical supervision. If the concentration, type, manufacturer and type (human insulin, animal insulin, human insulin analogue) of insulin preparations and / or manufacturing method changes, it may be necessary to change the dose or increase the frequency of injections compared to previously used insulin preparations. If it is necessary to adjust the dose, it can be made already at the first administration of the drug or during the first weeks or months of treatment.
Injection site reactions
As with other insulin drugs, reactions at the injection site can develop, which is manifested by pain, redness, hives, inflammation, bruising, swelling and itching. Regularly changing the injection site in the same anatomical region can reduce symptoms or prevent reactions from developing. In very rare cases, it may be necessary to cancel NovoRapid® FlexPen®.
Simultaneous use of drugs of the thiazolidinedione group and insulin drugs
Cases of chronic heart failure have been reported when patients are treated with thiazolidinediones in combination with insulin preparations, especially if such patients have risk factors for the development of chronic heart failure. This fact should be taken into account when prescribing combination therapy with thiazolidinediones and insulin preparations for patients. When prescribing such a combination therapy, it is necessary to conduct medical examinations of patients in order to detect signs and symptoms of chronic heart failure, weight gain and the presence of edema. In case of worsening symptoms of heart failure in patients, treatment with thiazolidinediones should be discontinued.
Influence on the ability to drive vehicles and work with mechanisms
The ability of patients to concentrate and reaction speed can be impaired during hypoglycemia, which can be dangerous in situations where these abilities are especially needed (for example, when driving or working with machines and mechanisms). Patients should be advised to take measures to prevent the development of hypoglycemia when driving and operating machinery. This is especially important for patients with no or decreased severity of symptoms, precursors of developing hypoglycemia or suffering from frequent episodes of hypoglycemia.
Release form:
Solution for subcutaneous and intravenous administration of 100 U / ml.3 ml of the drug in cartridges made of glass of 1 hydrolytic class with bromobutyl rubber pistons, sealed with bromobutyl rubber / polyisoprene discs on one side and sealed in plastic multi-dose disposable syringe pens for multiple injections on the other.
5 plastic multi-dose disposable syringe pens for multiple injections, together with instructions for use, are placed in a cardboard box.
Storage conditions:
Store between 2 ° C and 8 ° C (in the refrigerator), but not near the freezer. Do not freeze.To protect from light, store the pen with the cap on.
NovoRapid® FlexPen® should be protected from excessive heat and light.
Do not store the syringe pen with the drug used or carried as a spare in the refrigerator. Store at a temperature not exceeding 30 ° C. Use within 4 weeks.
Keep out of the reach of children.
Shelf life:
30 months. Do not use after the expiration date indicated on the pen label and packaging.Terms of dispensing from pharmacies:
On prescription.Manufacturer:
Novo Nordisk A / SNovo Alla
DK-2880 Bagsvaerd, Denmark
Representation
Novo Nordisk A / S
119330, Moscow, Lomonosovsky prospect, 38, office 11
Precautions for use
NovoRapid® FlexPen® and needles are intended for individual use only. Refilling of the cartridge of the pen is not allowed.
NovoRapid® FlexPen® should not be used if it has ceased to be transparent and colorless, or if it has been frozen. Inform the patient to discard the needle after each injection.
NovoRapid® can be used in insulin pumps (see "
Method of administration and dosage:
"). Tubes with an inner surface made of polyethylene or polyolefin have been inspected and found to be suitable for use in pumps.In urgent cases (hospitalization, malfunction of the insulin delivery device) NovoRapid® can be removed from FlexPen® for administration to the patient using the U100 insulin syringe.
Instructions for patients on the use of NovoRapid® FlexPen®
Do not use NovoRapid® FlexPen®
Before using NovoRapid® FlexPen®
Mode of application
NovoRapid® is intended for subcutaneous injections or continuous infusions in the insulin pumping system (IPII). NovoRapid® can also be administered intravenously under strict medical supervision. Never give an insulin preparation intramuscularly.
Change the injection site within the anatomical region each time. This will help reduce the risk of lumps and ulceration at the insertion site. It is best to inject the drug into the anterior abdominal wall, shoulder, or front of the thigh. Insulin will act faster if it is injected into the anterior abdominal wall. Measure your blood glucose concentration regularly.
How to use NovoRapid® FlexPen®
Carefully read the attached Patient Instruction for the use of NovoRapid® FlexPen®. Use your pen in strict accordance with this instruction.
Instructions for patients on the use of NovoRapid® FlexPen®
NovoRapid® FlexPen® is a unique color-coded insulin syringe pen with a dispenser. The administered dose of insulin, in the range from 1 to 60 units, can be changed in 1 unit steps. NovoRapid® FlexPen® is designed for use with NovoFine® and NovoTvist® disposable needles up to 8 mm long. As a precaution, always carry a spare insulin delivery system with you in case your NovoRapid® FlexPen® is lost or damaged.
Getting started
Check the label to make sure NovoRapid® FlexPen® contains the correct type of insulin.
Use a new needle for each injection to prevent infection.
Be careful not to bend or damage the needle before use.
To avoid accidental pricking, never put the inner cap back on the needle.
Checking insulin intake
Even with proper use of the pen, a small amount of air may accumulate in the cartridge before each injection.
To prevent the ingress of an air bubble and to ensure that the correct dose is administered:
E. Dial 2 UNITS of the drug by turning the dosage selector. |
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F. While holding NovoRapid® FlexPen® with the needle up, lightly tap the cartridge several times with your fingertip to move air bubbles to the top of the cartridge. |
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G. While holding NovoRapid® FlexPen® with the needle up, press the trigger until it stops. The dosage selector will return to zero. |  |
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Dose setting
Make sure the dosage selector is in the "O" position.
Do not use the residue scale to measure the insulin dose.
Storage and care
NovoRapid® FlexPen® is designed for effective and safe use and requires careful handling. In the event of a fall or strong mechanical impact, the pen may be damaged and insulin may leak.
The surface of NovoRapid® FlexPen® can be cleaned with a cotton swab moistened with alcohol. Do not immerse the pen in liquid, wash or lubricate it, as this could damage the mechanism.
Refilling of NovoRapid® FlexPen® is not allowed.
Insulin injection
Insert the needle under your skin. Use the injection technique recommended by your doctor.
|
I. To inject, press the start button all the way until “0” appears opposite the dosage indicator. Be careful: when injecting the drug, press only the start button. |  |
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J. Hold down the trigger fully while removing the needle from under your skin. |  |
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K. Guide the needle into the outer needle cap without touching the needle cap. When the needle enters, put on the cap and unscrew the needle. |  |
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Remove the needle after each injection and never store NovoRapid® FlexPen® with a needle attached. Otherwise, liquid may leak from NovoRapid® FlexPen®, which may lead to incorrect dosage.
Caregivers must be careful when removing and discarding needles to avoid the risk of accidental needle sticking.
Throw away the used NovoRapid® FlexPen® with the disconnected needle.
Needles and NovoRapid® FlexPen® are intended for individual use only.
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