Instructions for use
Yoks-teva 30ml spray instructions for use
Dosage form
Spray for topical application in the form of a transparent or slightly opalescent liquid of red-brown color, infinitely miscible with water.
Compound
in 1 bottle povidone-iodine 2.55 g, allantoin 30 mg, Excipients: levomenthol - 0.3 g, citric acid monohydrate - 0.06 g, sodium citrate dihydrate - 0.06 g, ethanol 96% - 6 g, propylene glycol - 9 g, purified water - up to 30 ml
Pharmacodynamics
A drug with antimicrobial and anti-inflammatory action for local use in diseases of the oral cavity and in ENT practice. On contact with skin, releases iodine. It has an antiseptic and anti-inflammatory effect. Possesses a wide spectrum of antimicrobial action. Active against bacteria, viruses, fungi, protozoa
Pharmacokinetics
Data on the pharmacokinetics of Jox® are not provided.
Side effects
In some cases: hypersensitivity reactions to the drug, local manifestations of an allergic reaction to iodine (itching, hyperemia), which may require discontinuation of the drug.
With prolonged use (more than 7-10 days), the phenomena of iodism are possible (including a metallic taste in the mouth, increased salivation, swelling of the eyes, larynx).
Selling features
Available without a prescription
Special conditions
The patient should be warned about the need to stop taking the drug and consult a doctor if signs of iodism appear.
The drug is not intended for oral administration and should not be inhaled or swallowed.
Indications
Infectious and inflammatory diseases of the oral cavity and pharynx, incl. tonsillitis, tonsillitis, tonsilopharyngitis, glossitis, stomatitis, aphthae;
For the treatment of the oral cavity and pharynx during surgical interventions on the respiratory tract and oral cavity and in the postoperative period;
For the treatment of infections of the mouth and throat that occur during chemotherapy;
With streptococcal tonsillitis, it is used as an additional agent in antibiotic treatment
Contraindications
Dysfunction of the thyroid gland (hyperthyroidism);
Heart failure;
Dühring's dermatitis herpetiformis;
Simultaneous use of radioactive iodine;
Children under the age of 8;
Pregnancy;
Lactation period of breastfeeding);
Hypersensitivity to iodine and other components of the drug
Drug interactions
It is inappropriate to use Jox® at the same time with other antiseptic agents for topical application in the oral cavity and pharynx, especially those containing hydrogen peroxide, due to inactivation of the drug.
Mode of application
Dosage
The drug is used 2-4 times / day, one injection to the right and left into the oral cavity and pharynx. If necessary, the drug can be used more often, every 4 hours.Before use, remove the protective cap and install the applicator. Press the applicator 2-3 times so that the solution enters the sprayer and sprays after pressing. After that, place the applicator tube 2-3 cm into the oral cavity, hold your breath and press the cap 2 times so that one irrigation is done to the right, and the second to the left. The applicator is washed with hot water before and after use.
Instructions
general characteristics
Transparent, slightly opalescent liquid of red-brown color, infinitely miscible with water.
Composition of the medicinal product
Each bottle of 30 ml contains: povidone-iodine 2.55 g, allantoin 0.03 g; excipients: levomenthol, citric acid monohydrate, sodium dihydrogen citrate, ethanol 96%, propylene glycol, purified water.
Pharmacotherapeutic group
Antiseptic. The codeATX: R02AA15.
Indications for use
Disinfection of the oral cavity and pharynx for inflammatory and infectious diseases: tonsillitis, pharyngitis, tonsillitis, tonsillopharyngitis, glossitis, stomatitis, aphthae; For preoperative processing and in the postoperative period during surgical interventions carried out on the upper respiratory tract and in the oral cavity; For the treatment of oral infections that occur with chemotherapy; With streptococcal tonsillitis, it is used as an additional agent in antibiotic treatment; For influenza conditions in the prodromal period.
Method of administration and dosage
Adults and children over 8 years old:
Usually it is applied 2-4 times a day, if necessary and more often (after 4 hours): 1-3 injections into the right and left sides of the oral cavity or directly to the affected area. The interval between individual applications of the medicinal product should be at least 4 hours. The drug can be used a maximum of 6 times per day. The dose of the drug is determined by the attending physician. Do not inhale or swallow the spray solution!
Cut the applicator bag with scissors and remove the applicator.
Remove the protective cap and install the applicator. Press the applicator 2-3 times so that the solution enters the sprayer and after pressing is sprayed. After that, place the applicator tube 2-3 cm into the oral cavity, hold your breath and press the cap twice so that one irrigation is carried out to the right and the second to the left. The applicator is rinsed with hot water before and after use.
Patient instructionovs on using the applicator
Dosage distribution of the drug from the vial is carried out With using a mechanical nebulizer and applicator (see fig.A1 or A2)
If the applicator is in a plastic bag, remove it from the bag using scissors or a similar tool (see figure B2). Check the integrity of the applicator. If the applicator is damaged, its use is prohibited. Remove the protective cap from the mechanical sprayer. Place the applicator on the bottle (see fig. B3). Press 2-3 times to force the solution through the nebulizer, after which the medication will begin to spray. Place the applicator tube 2-3 cm into the oral cavity, hold your breath and press the applicator 2 times, with the first press, spray the medication to the right side, and the second to the left.Hold bottle upright when spraying. Rinse applicators with hot water before use and always check that they are not damaged. Do not use a damaged applicator. It is recommended to use the drug Yoks spray 2-4 times a day. If necessary, the drug can be used more often, every 4 hours.
Side effect
The drug is well tolerated.
In some cases, hypersensitivity reactions to the drug are observed, a local manifestation of an allergic reaction to iodine (itching, hyperemia, urticaria) is possible, which requires discontinuation of the drug. Rarely, mainly in children, a short-term burning sensation or a feeling of dryness in the oral cavity appeared at the application site.
Prolonged use of the drug can cause the phenomenon of iodism (metallic taste, increased salivation, swelling of the eyes or larynx, etc.), upon the appearance of which, the use of the drug should be discontinued.
Contraindications
The drug is contraindicated in case of hypersensitivity to iodine or other components of the drug, with hyperfunction of the thyroid gland, with decompensated heart failure, with renal failure, it is contraindicated to use the drug for 2 weeks before and after studies or therapy with radioactive iodine.
The active substance penetrates the placental barrier and penetrates into breast milk, therefore, Jox spray is contraindicated during pregnancy and lactation.
Jox spray is contraindicated in children under 8 years of age.
Overdose
There is no experience of overdose with proper local application in the oral cavity or pharynx.
When using iodine solution inside, acute iodine poisoning is possible.
Symptoms: initially, patients report a metallic taste in the mouth, vomiting, pain in the stomach and upset stools. Within 1-2 days, anuria, edema of the glottis, leading to asphyxia, aspiration pneumonia or pulmonary edema appears. In some cases, vascular insufficiency was observed.
Treatment extremely symptomatic; first, standard measures are taken to stop absorption from the gastrointestinal tract. The victim is given milk and boiled starch. If the esophagus is not affected, then gastric lavage can be performed. Then activated carbon and 1% or 5% sodium thiosulfate solution is prescribed, which reduces iodine to iodide. The excretion of absorbed substances can be accelerated by osmotic diuresis. The experience of dialysis in such situations is not described in the literature.
Warnings
With laryngitis, the drug can be used only if absolutely necessary.
The drug is used with caution in patients with hepatic impairment.
In patients with hepatic impairment, the level of transaminases may increase, therefore it is necessary to monitor the level of these enzymes in the blood serum.
Pregnancy
There is no experience of topical application of povidone-iodine in the oral cavity of pregnant women. With vaginal administration of povidone iodine, or with local application on the skin during pregnancy or during childbirth, congenital hyperthyroidism or struma was found in newborns, therefore, the use of the drug Jox during pregnancy is not recommended.
Lactation
Iodine passes into breast milk. Several times more iodine was found in the blood and urine of newborns than in their mothers who used povidone iodine. High serum concentrations can cause hypothyroidism in neonates. For this reason, the drug Jox is contraindicated for use during lactation.
Influence on the ability to drive a car and other mechanisms
The drug Jox does not affect the ability to drive a car or other mechanisms.
The drug contains 19% ethanol.
In elderly patients and in patients with hepatic impairment, the dosage does not change.
Interaction with other medicinal products
It is inappropriate to use the drug Jox at the same time with other antiseptic agents intended for topical application in the oral cavity and pharynx, especially those containing hydrogen peroxide.
Jox's use leads to false-positive fecal occult blood test results. When examining the function of the thyroid gland, the values of protein-bound iodine may increase.
Conditions and shelf life
Store in a dark place at a temperature not exceeding 25 ° C. Do not use after the expiration date printed on the package.
Keep out of the reach of children.
Shelf life is 4 years.
Vacation conditions
Without recipe.
Package
A 30 ml plastic bottle, equipped with a mechanical spray, complete with an oral applicator in a plastic bag, placed in a cardboard box along with an enclosed leaflet.
Manufacturer (applicant) information
Teva Czech enterprises s.r.o., Czech Republic
st. Ostravska, 29, Opava-Komarov, 747 70.
P NO 14300/01Trade name of the drug: JOX ® (JOX ®)
International non-proprietary name or group name:
Povidone Iodine + Allantoin &
Dosage form:
topical solutionCompound:
Active substances:
Povidone-iodine 4.250 g and allantoin 0.050 g in 50 ml of solution. Povidone-iodine 8.500 g and allantoin 0.100 g in 100 ml of solution.
Excipients:
levomenthol, citric acid monohydrate, sodium citrate dihydrate, ethanol 96%, propylene glycol, purified water - to the required volume of the drug in the package.
Description
Transparent or slightly opalescent red-brown liquid, freely miscible with water.
Pharmacotherapeutic group:
antisepticATX code: A01AD; R02AA15
Pharmacological properties
Combined preparation for topical use in diseases of the oral cavity and ENT organs. Releases iodine on contact with skin or mucous membranes; has an antiseptic and anti-inflammatory effect.
The drug has a wide spectrum of antimicrobial action.
Active against bacteria, fungi, viruses, protozoa.
Indications for use
1. Infectious and inflammatory diseases of the oral cavity and pharynx: including tonsillitis, tonsillitis, tonsilopharyngitis, glossitis, stomatitis, aphthae;
2. For the treatment of the oral cavity and pharynx during surgical interventions on the respiratory tract and oral cavity and in the postoperative period;
3. For the treatment of infections of the mouth and throat arising from chemotherapy;
4. With streptococcal tonsillitis, it is used as an additional agent in the treatment of antibiotics.
Contraindications
Dilute the solution of the drug with water in a ratio of 1:20 - 1:40 (i.e. from 2.5 ml to 5 ml using the measuring cap included in the package or 1 / 2-1 teaspoon in 100 ml of water). Rinse the mouth or pharynx with a diluted solution.
It is recommended to use the drug Jox ® solution 2-4 times a day, if necessary, the drug can be used more often up to 6 times a day. The minimum interval between rinsing is 4 hours. Side effect
Yoks ® solution is generally well tolerated.
In some cases, hypersensitivity reactions to the drug and the manifestation of an allergic reaction to iodine (itching, hyperemia) are possible, which requires discontinuation of the drug.
Prolonged use of the drug can cause the phenomenon of iodism (including a metallic taste, increased salivation, swelling of the eyes or larynx), upon the appearance of which you should stop using the drug and consult a doctor. Interaction with other medicinal products
The simultaneous use of Yoks ® with other antiseptic agents intended for topical use in the oral cavity and pharynx, especially those containing hydrogen peroxide, is not recommended due to the inactivation of the drug. special instructions
Not intended for oral administration.
Do not inhale or swallow the drug.
The drug contains about 19% ethanol. Release form
Solution for topical use.
50 and 100 ml in dark glass vials with a screw-on propylene cap with a first opening control and a measuring cap. Each bottle, along with instructions for use, is placed in a cardboard box. Storage conditions
At a temperature of 10 ° C to 25 ° C in a dark place. Keep out of the reach of children. Best before date
5 years.
Do not use after the expiry date stated on the package! Vacation conditions
Without recipe. Manufacturer
Ivax Pharmaceuticals s.r.o., Czech Republic
Ostravska 29, 74770 Opava-Komarov
IVAX Pharmaceuticals s.r.o., Ostravska 29, 74770 Opava-Komarov, Czech Republic Address for receiving claims. 119049, Moscow, st. Shabolovka, 10, bldg. 2, Business Center "Concord"
YOKS ®
Tradename
International non-proprietary name
Dosage form
Topical spray 30 ml complete with applicator
Compound
1 ml of solution contains
active substances: povidone iodine 85 mg, allantoin 1 mg,
Excipients: levomenthol, citric acid monohydrate, sodium dihydrogen citrate, ethanol 96%, propylene glycol, purified water.
Description
Transparent liquid of red-brown color, slight opalescence is possible.
Farmakotherapeutic group
Drugs for the treatment of throat diseases. Antiseptics.
ATC code R 02 AA
Pharmacological properties
Pharmacokinetics
With local application of polyvidone-iodine to intact skin and mucous membranes, iodine absorption is minimal. Iodine in the body is converted to iodides, which accumulate mainly in the thyroid gland. Iodides that have not been captured by the thyroid gland are excreted mainly in the urine, a small amount in feces, saliva, sweat. They pass through the placental barrier and enter breast milk.
F armakodynamics
Povidone iodine, upon contact between the skin and mucosal membranes, releases organic iodine,which has a broad spectrum of antimicrobial actionin relation to bacteria, fungi, viruses, protozoa.The drug also contains allantoin, which has an anti-inflammatory effect.
The antimicrobial action of iodine is the result of its direct action on the proteinaceous microorganisms.
Indications for use
Angina, pharyngitis, tonsilopharengitis, tonsillitis, glossitis, aphthous stomatitis
When preparing a patient for surgical intervention and in the postoperative period on the respiratory tract and oral cavity
For the treatment of oral infections arising from chemotherapy,
In streptococcal sore throats, it is used as an additional treatment for antibiotic treatment.
Method of administration and dosage
Adults and children over 8 years old.
Remove the protective cap and install the applicator. Press the applicator 2 - 3 times so that the solution enters the sprayer and after pressing it is sprayed. After that, place the applicator tube 2–3 cm into the oral cavity, hold your breath and press the cap 1–3 times so that one irrigation is carried out to the right, and the second to the left. It is recommended to use the drug JOKS spray 2-4 times a day, one injection to the right and to the left of the oral cavity and pharynx. The interval between individual applications of the drug should be at least 4 hours. If necessary, the drug can be used more frequently. Do not inhale or swallow the sprayed preparation!
The drug can be used a maximum of 6 times per day.
The applicator is rinsed with hot water before use.
Side effects
Allergic reaction to iodine (itching, flushing, urticaria)
Rare: at the site of application, a burning sensation or a feeling of dryness in the mouth
The phenomenon of iodism (with prolonged use): metallic taste, increased salivation, swelling of the eyes or larynx, etc.
Contraindications
Hypersensitivity to iodine or other components of the drug
Hyperfunction of the thyroid gland
Decompensated heart failure
Pregnancy and lactation
Children under 8 years old
Simultaneous use of radioactive iodine
During's dermatitis herpetiformis.
Drug interactions
It is inappropriate to simultaneously use the drug Jox with other antiseptic agents intended for topical application in the oral cavity and pharynx.
special instructions
In case of laryngitis, the drug should be used only in case of urgent need. The drug is used with caution in patients with hepatic insufficiency.
The drug contains 18.6% ethanol.
Features of the use of the drug for the ability to drive vehicles or potentially dangerous mechanisms
Use the drug carefully because of the presence of ethyl alcohol in the composition.
Overdose
Symptoms:metallic taste in the mouth, vomiting, stomach pain and diarrhea. Within 1 - 2 days, the manifestation of anuria, edema of the voice gap, leading to asphyxia, aspiration pneumonia or pulmonary edema is possible. In some cases, vascular insufficiency may develop.
Treatment: carry out symptomatic therapy. There is no specific antidote.
Release form and packaging
30 ml of the drug in a plastic bottle equipped with a mechanical spray and a lid to protect the spray. Each bottle, together with an applicator and instructions for use in the state and Russian languages, are inserted into a carton box.
Storage conditions
Store in a protected from light place at temperatures from 10 0 C to 25 0 C Keep out of the reach of children!
Storage period
4 years
Do not use the drug after the expiration date indicated on the package has expired.
Vacation conditions
Without recipe
Manufacturer
Marketing Authorization Holder
Teva Czech Enterprises sro, Ostravska 29, 74779 Opava-Komarov, Czech Republic.
The address of the organization that receives claims from consumers on the territory of the Republic of Kazakhstan regarding the quality of products (goods)
Representative office of the company
« Teva Czech Industries sro. »VRK
050000 The Republic of Kazakhstan
Almaty city, Al-Farabi avenue 13,
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