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NAPHAZOLINE-DF

nasal drops 0.05%, 0.1%, 10 ml

Dispensing conditions: NO PRESCRIPTION 

Фарм.группа: Nasal preparations

THERAPEUTIC INDICATIONS:

  • acute rhinitis;

  • inflammation of the nasal sinuses;

  • to reduce swelling during diagnostic and therapeutic procedures..

dwldDownload instructions for use

Composition

1 ml of the solution contains:

  • active substance - naphazoline nitrate - 0.5 mg (0.05% solution) or 1 mg (0.1% solution);
  • excipients - boric acid, purified water.

Pharmaceutical form

Nasal drops 0.05% and 0.1%, 10 ml

Pharmacotherapeutic group

Nasal preparations. Anticongestants and other nasal medications for topical use. Sympathomimetics. Naphazoline.

ATC code R01AA08

Indications

  • acute rhinitis;
  • inflammation of the nasal sinuses;
  • to reduce swelling during diagnostic and therapeutic procedures.

Contraindications

  • hypersensitivity to the components of the product;
  • dry inflammation of the nasal mucosa;
  • children under 3 years of age for 0.05% solution;
  • children under 15 years of age for 0.1% solution;
  • hyperthyroidism;
  • thyrotoxicosis;
  • chronic rhinitis;
  • diabetes mellitus;
  • arterial hypertension;
  • coronary heart disease;
  • pheochromocytoma;
  • tachycardia;
  • pronounced atherosclerosis;
  • closed angle glaucoma;
  • concomitant use of MAO inhibitors and up to 14 days after the end of their use.

Posology and method of administration

Naphazoline-DF is injected into each nasal passage with the head slightly tilted back and tilted to the right when instilling into the left nostril and to the left when instilling into the right nostril.

For treatment:

  • adults and children over 15 years of age - 1 to 3 drops of 0.1% solution in each nasal passage;
  • children of 3 to 6 years of age use a 0.05% solution - 1 drop, children of 6 to 15 years of age - 2 drops in each nasal passage.

Naphazoline-DF is used 2-3 times a day, but not more often than 4-6 hours.

Naphazoline-DF should not be used more than 5 days for adults and more than 3 days for children.

For diagnostic purposes, to reduce swelling - after clearing the nasal cavity, instill 3-4 drops of the 0.05% solution into each nasal passage or insert a swab soaked in 0.05% solution for 1-2 minutes.

Adverse reactions

Burning sensation and dryness in the nasal cavity, reactive hyperemia; with prolonged use - nasal mucous membrane swelling; allergic reactions, very rare - Quincke's edema.

If used for more than 1 week, it can be addictive.

Overdose

Overdose or accidental ingestion of the product may manifest as symptoms of systemic effects of the product: increased blood pressure, tachycardia, headache, tremor, irritability, increased sweating, palpitations, impaired consciousness. Cyanosis, nausea, cardiac arrest, pulmonary edema, mental disorders, increase in body temperature may occur. The depressing effect on the central nervous system is manifested by the following symptoms: drowsiness, bradycardia, decreased body temperature, shock, apnea, coma.
In case of an accidental overdose, stop using the product and consult a doctor immediately.
Symptomatic treatment.
The risk of overdose is higher in children, as they are more susceptible to adverse effects than adults.

Use during pregnancy or breastfeeding

Use of the product during pregnancy and lactation is possible only if the expected benefits to the mother exceed the risk to the fetus and the baby.

Pediatric population

Approved for children over 3 years of age.

Special warnings

Prolonged use of the product can lead to chronic nasal congestion and mucosal atrophy.

With prolonged use the vasoconstrictor effect gradually decreases (tachyphylaxis phenomenon), therefore it is recommended to use the product for not more than 5 days.

The product should be used very carefully in people with severe cardiovascular disease, with bronchial asthma. Caution should be exercised during general anesthesia with anesthetics that increase myocardial sensitivity to sympathomimetics (e.g., halothane) in patients with bronchial asthma.

Prolonged use and overdose should be avoided. Prolonged use of medicines designed to relieve mucosal edema can lead to swelling and subsequent atrophy of the nasal mucosa.

Presentation and package

10 ml of the product in plastic dropper bottles, sealed with tamper-proof caps, or in plastic dropper bottles, sealed with caps. Bottles with instructions for use in the state and Russian languages are placed in a group container.

Storage conditions

In a place protected from light, at a temperature of 180С to 250С.

Keep out of the reach of children.

Shelf life

3 years
Do not use after expiration date.

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: Адрес электронной почты защищен от спам-ботов. Для просмотра адреса в вашем браузере должен быть включен Javascript.

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