Tizin Alerji ref. called dosage. 50 mcg / dose, vial 10 ml (100 doses)

Release form, composition and packaging

Nasal spray dosed 50 mcg / dose, in the form of a homogeneous suspension of white color.

1 ml

levocabastine hydrochloride 0.54 mg,

- which corresponds to the content of levocabastine 0.5 mg

propylene glycol - 48.26 Ојl, sodium hydrogen phosphate - 8.66 mg, sodium hydrogen phosphate monohydrate - 5.38 mg, hypromellose (2910 5 mPa.s) - 2.5 mg, polysorbate 80 - 1 mg, benzalkonium chloride - 0.15 mg (in the form of a 50% solution - 0.03 ml ), disodium edetate - 0.15 mg, water for injection - up to 1 ml.

10 ml (100 doses) - bottles made of high density polyethylene (1) with a spray and a protective cap made of low density polyethylene - cardboard packs.

pharmachologic effect

Levocabastine is a long-acting selective histamine H1 receptor blocker.

After intranasal use, TizinAlergy eliminates the symptoms of allergic rhinitis: nasal discharge, sneezing, itching in the nasal cavity.

The local effect occurs in 5 minutes.

The action lasts until 12 noon.

Pharmacokinetics

Absorption and distribution

With each intranasal administration at the rate of 50 Ојg / dose, approximately 30-40 Ојg of levocabastine is absorbed.

Cmax of levocabastine in blood plasma is reached approximately 3 hours after nasal administration.

Levocabastine binds to blood plasma proteins by approximately 55%.

Metabolism and excretion

The main metabolite of levocabastine, acylglucuronide, is formed by glucuronidation, which is the main metabolic pathway.

T1 / 2 of levocabastine is about 35-40 hours. Levocabastine is excreted mainly in the urine unchanged (about 70% of the absorbed amount).

Indications for use

- symptomatic therapy of seasonal and perennial allergic rhinitis.

Contraindications for use

- children under 6 years old

- hypersensitivity to drug components.

The drug should be prescribed with caution in patients with impaired renal function and in elderly patients.

Dosage regimen

Intranasally administered to adults and children over 6 years of age, 2 doses (100 Ојg) into each nasal passage 2 times / day.

The use of the drug should be continued until the symptoms are eliminated.

For more severe symptoms, the drug can be used 3-4 times / day.

The patient should be warned about the need to clear the nasal passages before using the spray and inhale through the nose during administration.

Before the first use, remove the protective cap and press the spray nozzle several times until a cloud of fog" appears.

The bottle is ready for further use.

Inhale the drug through the nose.

Shake the bottle before each use.

Overdose

There have been no reports of levocabastine overdose.

Symptoms: in case of accidental ingestion, a decrease in blood pressure, tachycardia, sedation is possible.

Treatment: in case of oral administration, the patient should drink a large amount of liquid to accelerate the excretion of levocabastine by the kidneys.

Side effect

Determination of the frequency of adverse reactions: very often (> 1/10), often (> 1/100, < 1/10), infrequently (> 1/1000, < 1/100), rarely (> 1/10 000, < 1 / 1000), very rare (< 1/10 000, including individual messages), frequency unknown (incidence cannot be estimated from the available data).

Adverse events observed in patients during clinical trials

From the digestive system: often - nausea.

Infectious and parasitic diseases: often - sinusitis.

From the nervous system: very often - headache

often - drowsiness, dizziness.

From the respiratory system: often - pain in the pharynx and larynx, epistaxis

infrequently - shortness of breath, nasal congestion

rarely - swelling of the nasal mucosa

frequency unknown - bronchospasm, cough.

On the part of the cardiovascular system: infrequently - a feeling of palpitations

Name ENG

TYZINE ALERGY

Clinical and pharmacological group

Antiallergic drug - histamine H1 receptor blocker

ATX code

Levocabastine

Dosage

50mcg / dose x 10ml

Structure

1 ml: levocabastine hydrochloride 540 mcg,

the content of levocabastine 500 mcg.

Excipients: propylene glycol - 48.26 Ојl, sodium hydrogen phosphate - 8.66 mg, sodium hydrogen phosphate monohydrate - 5.38 mg, hypromellose (2910 5 mPa.s) - 2.5 mg, polysorbate 80 - 1 mg, benzalkonium chloride - 150 Ојg (in the form of a 50% solution - 30 Ојl), disodium edetate - 150 Ојg, water for injection - up to 1 ml.

Indications

Allergic rhinitis, hay fever.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

INN / Active ingredient

Levocabastine

Contraindications

children under 6 years old

hypersensitivity to the components of the drug Tizin Alerji.

The drug should be prescribed with caution in patients with impaired renal function and in elderly patients.

Specifications

Category

Allergy

Scope of the drug

General

Release form

Spray

Manufacturer country

Belgium

Package quantity, pcs

one

Scope of application

Allergology

Minimum age from

6 years

Way of introduction

Intranasally

Vacation conditions

Without recipe

Volume, ml.

10 ml

Brand name

Tizine

The amount of the dosage form in the primary package

10 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Anatomical and therapeutic characteristics

R01AC02 Levocabastine

Dosage form

Dosed nasal spray

Expiration date in days

730

The target audience

Children

Package weight, g

thirty

Mode of application

:

Intranasally administered to adults and children over 6 years of age, 2 doses (100 Ојg) into each nasal passage 2 times / day.

The use of the drug should be continued until the symptoms are eliminated.

With more pronounced symptoms, the drug Tizin Alerji can be used 3-4 times / day.

The patient should be warned about the need to clear the nasal cavity before using the spray and inhale through the nose during administration.

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

Information on technical characteristics, delivery set, country of manufacture "