THERAPEUTIC INDICATIONS:
-
acute, allergic vasomotor rhinitis;
-
rhinosinusitis;
-
eustachyitis associated with rhinitis;
-
elimination of nasal cavity mucous membrane edema before diagnostic procedures.
Download instructions for use
Composition
1 ml of the product contains:
- active substance - oxymetazoline hydrochloride - 0.25 mg or 0.5 mg;
- excipients: benzalkonium chloride (as 10% solution), sodium chloride, sodium dihydrophosphate dihydrate, dodecahydrate phosphate dihydrate, purified water.
Pharmaceutical form
Nasal spray 0.025%, 0.05%, 10 ml.
Pharmacotherapeutic group
Respiratory system. Nasal preparations. Anticongestants and other nasal medications for topical use. Simple sympathomimetics. Oxymetazoline.
ATC code R01AA05
Indications
- acute, allergic vasomotor rhinitis;
- rhinosinusitis;
- eustachyitis associated with rhinitis;
- elimination of nasal cavity mucous membrane edema before diagnostic procedures.
Contraindications
- hypersensitivity to the components of the product;
- atrophic rhinitis;
- pronounced atherosclerosis;
- chronic heart failure;
- arrhythmias;
- arterial hypertension;
- chronic renal failure;
- prostatic hyperplasia;
- concomitant use of monoamine oxidase inhibitors and a period of up to 14 days after the end of their use;
- diabetes mellitus;
- thyrotoxicosis, hyperthyroidism;
- closed angle glaucoma;
- severe eye diseases;
- pheochromacytoma;
- porphyria
- children under 1 year of age (for Oxyvin-DF® 0.025%);
- children under 6 years of age (for Oxyvin-DF 0.05%).
Posology and method of administration
Intranasally.
In order to inject correctly, remove the protective cap, gently press the plastic spray tip 1 - 2 times so that the solution enters the atomizer and sprays. Then the nozzle of the bottle should be placed in the nasal passage, quickly and sharply press once on the atomizer and take out the nozzle without unclenching the atomizer.
- 0.025% nasal spray for children of 1 to 6 years of age: 1 injection into each nasal passage 2-3 times a day.
- 0.05% nasal spray for children over 6 years of age: 1 injection into each nasal passage 2-3 times a day.
The course of treatment is not more than 5-7 days.
Adverse reactions
Common:
- burning and dryness of the nasal mucosa;
- dry mouth and throat;
- sneezing.
Uncommon:
- dizziness, headache;
- insomnia;
- tiredness (fatigue);
- nausea;
- swelling and edema of the mucous membrane (nasal congestion);
- reactive hyperemia;
- atrophy of the mucous membrane;
- allergic reactions (Quincke's edema, urticaria, itching).
Very rare:
- increased pulse rate;
- arterial hypertension;
- tachycardia;
- tachyphylaxis.
Overdose
Symptoms: constriction of the pupils, nausea, vomiting, cyanosis, fever, tachycardia, arrhythmia, collapse, cardiac depression, arterial hypertension, pulmonary edema, respiratory distress.
Treatment: immediately administer activated charcoal (absorbent), sodium sulfate (laxative) or gastric lavage. Non-selective alpha-adrenoblockers (phentolamine 5 mg in saline (physiological) solution slowly v/v or 100 mg orally) are prescribed to decrease blood pressure.
Use during pregnancy or breastfeeding
Use of the product during pregnancy and lactation is possible only when the estimated benefit to the mother exceeds the potential risk to the child and fetus.
Pediatric population
For children
- 1 to 6 years of age - Oxyvin-DF® 0.025%.
- over 6 years of age - Oxyvin-DF® 0.05%.
Special warnings
Prolonged use of Oxyvin-DF® should be avoided as it may lead to a decrease of its therapeutic effect.
You should not independently exceed the recommended doses and use the product for more than 5-7 days.
Use with caution in coronary heart disease (CHD).
Presentation and package
10 ml of the product in plastic brown bottles with a pump dispensing device, including an aluminum flap with a dip tube and a plastic spray tip with a protective cap. Each bottle has a label. One bottle is with instruction for use in the state and Russian language are placed in a carton pack.
Storage conditions
Store in a place protected from light, at a temperature below 250С.
Keep out of the reach of children.
Shelf life
3 years
Manufacturer
"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan, tel.: (727) 253-03-88.
Marketing authorization holder
"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan.
Name, address, contact information of the organization accepting claims (proposals) against quality of products from consumers in the territory of the Republic of Kazakhstan, which is responsible for post-authorization safety surveillance of the medicine:
"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan,
Tel./Fax: (727) 253-07-07, 253-03-88, e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.