Kromogeksal - instructions for use, dose, side effects, contraindications

Excipients: benzalkonium chloride, sodium chloride, disodium edetate, sorbitol liquid, non-crystallized, sodium dihydrogen phosphate dihydrate, disodium hydrophosphate dodecahydrate, water for injection.

Description:Transparent colorless to slightly yellowish solution without mechanical inclusions.

Pharmacotherapeutic group:Antiallergic agent - stabilizer of membranes of mast cells

ATX: & nbsp

S.01.G.X.01 Cromoglycic acid

R.03.B.C.01 Cromoglycic acid

Pharmacodynamics:

Antiallergic, has a membrane-stabilizing effect, blocks the entry of calcium ions into the mast cell, preventing its degranulation and release of histamine, bradykinin, prostaglandins, leukotrienes (including slow reacting substances) and other biologically active substances. The drug is most effective as a means of prevention. A noticeable clinical effect occurs in a few days or weeks of admission.

Pharmacokinetics:

At intranasal administration, less than 7% is absorbed into the systemic blood stream. Relationship with plasma proteins - 65%. It is not metabolized, excreted by the kidneys and through the intestines in unchanged form (approximately in equal amounts within 24 hours after application). Half-life is 1.5 hours. Part of the active substance is swallowed (about 1%) and released through the gastrointestinal tract without significant absorption.

Indications:

Prevention and treatment:

- pollinosis

- allergic rhinitis (including seasonal and / or year-round).

Contraindications:

component of the drug

- children under 5 years old

- pregnancy and lactation

Carefully:With caution should take the drug in patients with renal and / or liver failure, with polyps nasal cavity.

Pregnancy and lactation:contraindicated

Dosing and Administration:

Intranasally.

Adults and children older than 5 years are recommended to inject in each nasal passage of 1 aerosol dose (2.8 mg of sodium cromoglycate) 4 times a day.

If necessary, one aerosol dosage can be used up to 6 times (maximum - 16.8 mg) per day in each nasal passage.

After achieving the therapeutic effect, the frequency of application of the drug can be reduced and used Cromohexal only in contact with allergens (house dust, spores of fungi, pollen).

The course of treatment is 4 weeks. Cancellation should be carried out gradually within 1 week.

To administer the drug, remove the protective cap, insert the nebulizer into the nostril and press the spray mechanism hard.When using the vial for the first time, press the spray mechanism several times until the droplets of liquid appear.

Side effects:

On the part of the respiratory system: irritation or burning sensation of the nasal mucosa, frequent sneezing, cough, rhinorrhea, rarely - nosebleeds. Allergic reactions: urticaria, skin itching, skin rash, swelling of the face, lips or eyelids, shortness of breath, difficulty swallowing.

Other: unpleasant taste sensations, headache.

Overdose:DannaThere is no overdose of the drug.

Interaction:Cromoglycic acid can increase the effectiveness of H1-histamin blockers.

Special instructions:

If irritation or burning of the mucous membrane of the nasal cavity does not go away or is worse, treatment should be stopped.

Effect on the ability to drive transp. cf. and fur:not described

Form release / dosage:

Spray nasal dosed 2.8 mg / dose

For 15 ml (not less than 85 doses) or 30 ml (at least 170 doses) in polyethylene bottles with a dispensing device, closed with a polyethylene lid. 1 bottle with instructions for use in a cardboard box.

Packaging:polyethylene bottles with dosing device (1) -package cardboard

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date indicated on the package. Open vials can be used within 6 weeks.

Terms of leave from pharmacies:On prescription

Registration number:П N012390 / 02

Date of registration:11.08.2008 / 21.07.2014

Expiration Date:Unlimited

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

HEXAL AG Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp21.07.2014

Illustrated instructions

Instructions

Cromohexal (Cromohexal)