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OXYVIN-DF

nasal drops for newborn 0.01%, 10 ml

Dispensing conditions: NO PRESCRIPTION 

 

Category: Nasal preparations

THERAPEUTIC INDICATIONS:

  • acute, allergic vasomotor rhinitis;

  • rhinosinusitis;

  • eustachyitis associated with rhinitis;

  • elimination of nasal cavity mucous membrane edema before diagnostic procedures.

dwldDownload instructions for use

Composition

1 ml of the product contains:

  • active substance - oxymetazoline hydrochloride - 0.1 mg;
  • excipients: benzalkonium chloride (as 10% solution), sodium chloride, sodium dihydrophosphate dihydrate, dodecahydrate phosphate dihydrate, water for injection.

Pharmaceutical form

Nasal drops 0.01%, 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;
  • conditions after transsphenoidal pituitaryectomy or other surgical interventions on the dura mater;
  • thyrotoxicosis, hyperthyroidism;
  • closed angle glaucoma;
  • severe eye diseases;
  • pheochromacytoma;
  • porphyria.

Posology and method of administration

Intranasally.

Unscrew and remove the cap, and slightly press on the body of the bottle.

0.01% nasal drops:

  • for newborns in the first 4 weeks of life - 1 drop in each nasal passage 2-3 times a day;
  • for children from the 5th week to 1 year of life - 1-2 drops in each nasal passage 2-3 times a day.

The following procedure is possible: depending on the age, 1-2 drops of 0.01% solution are put on absorbent cotton and wipe the nasal passages.

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);
  • nasal bleeding;
  • reactive hyperemia;
  • atrophy of the mucous membrane;
  • allergic reactions (Quincke's edema, urticaria, itching).

Very rare:

  • increased pulse rate;
  • arterial hypertension;
  • tachycardia;
  • tachyphylaxis;
  • arrhythmias;
  • apnea in infants and newborns;
  • convulsions.

Overdose

Symptoms: if the recommended doses are exceeded or accidental ingestion, the following symptoms may occur: 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.

Use during pregnancy or breastfeeding

None.

Pediatric population

Approved for children from birth.

Special warnings

Prolonged use and overdose of Oxyvin-DF® should be avoided. Prolonged or frequent use of vasoconstrictors leads to decreased effectiveness of the product, also their improper use can cause atrophy and swelling of nasal mucous membranes. When Oxyvin-DF® is prescribed for the treatment of chronic rhinitis, to avoid the risk of nasal mucosal atrophy, it may be used only under the supervision of a physician.

Imidazoline derivatives can lead to reactive nasal congestion (blockage) if high doses are used frequently. Therefore, 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 dropper bottles, sealed with tamper-proof caps, or in 10 ml plastic dropper bottles, sealed with caps. 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.

The period of use of the product after opening the bottle is 28 days.

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.

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