Tizin Alerji nasal spray 50mcg / dose, 10 ml
Expiration Date: 05/2027
Russian Pharmacy name:
Тизин Алерджи спрей назальный 50мкг/доза, 10 мл
Symptomatic therapy of seasonal and perennial allergic rhinitis.
Intranasal for adults and children over 6 years of age, 2 doses (100 mcg) each
nasal passage 2 times a day.
The use of the drug should be continued until the symptoms are eliminated.
In case of severity of symptoms, it can be used 3-4 times a day.
Patients 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 several times
spray nozzle until a cloud of 'fog' appears.
The bottle is ready for further use.
Shake the bottle before each use. Inhale the drug through the nose.
1 ml of the drug contains:
active substance:
levocabastine hydrochloride (0.54 mg) in terms of levocabastine 0.5 mg;
Excipients:
propylene glycol 48.26 ?l, sodium hydrogen phosphate 8.66 mg, sodium hydrogen phosphate
monohydrate 5.38 mg, hypromellose (2910 5 mPa.s) 2.50 mg, polysorbate 80 1.00 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 1.0 ml.
Hypersensitivity to any component of the drug.
Children under 6 years of age.
CAREFULLY
Patients with impaired renal function and the elderly.
Trade name: TizinЃ Allergy
International non-proprietary name: levocabastine.
Dosage form: dosed nasal spray.
Composition:
1 ml of the drug contains:
active substance:
levocabastine hydrochloride (0.54 mg) in terms of levocabastine 0.5 mg;
Excipients:
propylene glycol 48.26 ?l, sodium hydrogen phosphate 8.66 mg, sodium hydrogen phosphate
monohydrate 5.38 mg, hypromellose (2910 5 mPa.s) 2.50 mg, polysorbate 80 1.00 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 1.0 ml.
Description: white homogeneous suspension.
Pharmacotherapeutic group: antiallergic agent - H1-
a histamine receptor blocker.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Levocabastine is a selective blocker of H1-histamine receptors with
long-term action. The local effect occurs in 5 minutes, and
the action lasts for 12 hours. After intranasal administration
nasal spray 'TizinЃ Allergy' eliminates the symptoms of allergic
rhinitis: nasal discharge, sneezing, itching in the nasal cavity.
Pharmacokinetics
With each intranasal administration at the rate of 50 ?g / dose is absorbed
about 30-40 mcg of levocabastine, maximum concentration of levocabastine
in blood plasma is reached approximately 3 hours after nasal administration.
Levocabastine binds to blood plasma proteins by approximately
55%.
The main metabolite of levocabastine, acylglucuronide, is formed when
glucuronidation, which is the main metabolic pathway.
Levocabastine is excreted mainly in the urine unchanged
(about 70% of the absorbed amount). Half-life
levocabastine is about 35-40 hours.
INDICATIONS FOR USE
Symptomatic therapy of seasonal and perennial allergic rhinitis.
CONTRAINDICATIONS
Hypersensitivity to any component of the drug.
Children under 6 years of age.
CAREFULLY
Patients with impaired renal function and the elderly.
APPLICATION DURING PREGNANCY AND LACTATION
Reliable data on the use of the nasal spray 'TizinЃ Allergy' in
pregnant women are absent. Therefore, the nasal spray 'TizinЃ Allergy'
should not be used during pregnancy unless
when the intended benefit to the mother justifies the potential risk to
fetus.
Based on the determination of the concentration of levocabastine in saliva and chest
milk of lactating women who received a single oral dose of 0.5 mg
levocabastine, expected to be approximately 0.6% of the total intranasal dose
levocabastine can be passed on to the baby during breastfeeding.
Due to the limited number of clinical and experimental data
caution is advised when using the nasal spray
'TizinЃ Alergy' in lactating women. If necessary, appointments
the drug during lactation should stop breastfeeding.
DOSAGE AND APPLICATION
Intranasal for adults and children over 6 years of age, 2 doses (100 mcg) each
nasal passage 2 times a day.
The use of the drug should be continued until the symptoms are eliminated.
In case of severity of symptoms, it can be used 3-4 times a day.
Patients 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 several times
spray nozzle until a cloud of 'fog' appears.
The bottle is ready for further use.
Shake the bottle before each use. Inhale the drug through the nose.
SIDE EFFECT
Very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely
(> 1/10000, <1/1000), very rare (<1/10000, including individual messages),
frequency unknown (incidence cannot be estimated from
available data).
Adverse events that were observed in patients during clinical
research
Disturbances from the gastrointestinal tract: nausea (often).
General disorders and disorders at the injection site: fatigue, pain at the site
injection (often), irritation at the injection site, pain at the injection site, dryness
at the injection site, anxiety (infrequently), burning at the injection site, discomfort
at the injection site (rarely).
Infectious and parasitic diseases: sinusitis (often).
Nervous system disorders: headache (very common),
drowsiness, dizziness (often).
Disturbances from the respiratory system, chest organs and
mediastinum: pain in the pharynx and larynx, epistaxis (often), shortness of breath,
nasal congestion (uncommon), swelling of the nasal mucosa (rare),
bronchospasm, cough (frequency unknown).
Heart disorders: Palpitations (infrequent), tachycardia
(seldom).
Disturbances from the organ of vision: edema of the eyelids (frequency unknown).
Immune system disorders: hypersensitivity (infrequent),
anaphylactic reactions (frequency unknown).
Post-registration data
Heart disorders: palpitations, tachycardia (very
seldom).
Disturbances from the organ of vision: edema of the eyelids (very rare).
General disorders and disorders at the injection site: malaise (infrequently).
Immune system disorders: anaphylactic reactions,
hypersensitivity (very rare).
Disturbances from the respiratory system, chest organs and
mediastinum: bronchospasm, shortness of breath, swelling of the nasal mucosa (very
seldom).
OVERDOSE
Symptoms
There have been no reports of levocabastine overdose. When
accidental ingestion may lower blood pressure,
tachycardia, slight sedation.
Treatment
If taken orally, the patient should drink a large amount
fluids to accelerate the excretion of levocabastine through the kidneys.
INTERACTION WITH OTHER DRUGS
Interactions with alcohol have not been observed in clinical studies. Also
there was no increase in the effect of alcohol or diazepam when used
the usual dosages of the TizinЃ Allergy nasal spray.
Concomitant use of ketoconazole CYP3A4 isoenzyme inhibitors
or erythromycin did not affect the pharmacokinetics of levocabastine when administered nasally
administered.
Possible local interactions with other nasal medications
insufficiently studied, with the exception of interaction with oxymetazoline,
which can transiently reduce the absorption of levocabastine with nasal
administered.
SPECIAL INSTRUCTIONS
If the medicinal product has become unusable or the expiration date has expired, do not
throw it into wastewater or outside! Place the medicinal
the product in a bag and put in the trash can. These measures will help protect
environment!
INFLUENCE ON THE ABILITY TO DRIVE A VEHICLE AND
USE OF TECHNOLOGY
TizinЃ Allergy Nasal Spray in the recommended dose is usually not
has a clinically pronounced sedative effect and does not reduce the speed
reactions compared to placebo. If drowsiness occurs, do not
engage in potentially hazardous activities that require
increased attention and speed of psychomotor reactions.
RELEASE FORM
Dosed nasal spray 50 mcg / dose.
10 ml (100 doses) of the drug in a high density polyethylene bottle with
spray and low density polyethylene protective cap.
1 bottle with instructions for use in a cardboard box.
STORAGE CONDITIONS
Store at a temperature not exceeding 25 ? C.
Keep out of the reach of children.
SHELF LIFE
2 years.
Do not use the drug after the expiry date indicated on the package.
TERMS OF RELEASE FROM PHARMACIES
Without recipe.
MANUFACTURER
Janssen Pharmaceuticals N.V., Belgium.
Legal address: Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340,
Beerse, Belgium / Janssen Pharmaceuticals N.V., Turnhoutseweg 30, 2340 Beerse,
Belgium.
Organization accepting claims: Johnson & Johnson LLC, Russia,
121614, Moscow, st. Krylatskaya, 17, bldg. 2, tel. (495) 726-55-55.