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Tizin 0.05% 10 ml nasal spray metered (for children)

$8.60

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Description

The instruction for medical use

of Tizin® medicine
the Trade name
of Tizin®

the International unlicensed

name Xylomethazolinum Dosage Form Spray the nasal dosed

Structure
of 1 ml of solution contains
active agent – xylomethazolinum a hydrochloride of 0.5 mg (0.05%) or 1.0 mg (0.1%), amount of active component in one dose for 0.05% – 0.035 mg of xylomethazolinum of a hydrochloride, for 0.1% – 0.14 mg of xylomethazolinum of a hydrochloride
excipients: a benzalkoniya chloride, sorbitol of 70%, sodium chloride, dihydrophosphate sodium a dihydrate, hydrophosphate dinatrium a dihydrate, dinatrium edetat, the water purified.

The description
flavourless Transparent colourless solution or with a slight characteristic smell.

Pharmacotherapeutic group
of Antikongestanta other nasal drugs for topical administration.
Sympathomimetics. Xylomethazolinum.
The ATX R01AA07 code

the Pharmacological

Pharmacokinetics At properties topical administration is practically not absorbed, concentration in plasma are so small that they cannot be determined by modern analytical methods.
A pharmacodynamics
Xylomethazolinum (derivative an imidazole) – the sympathomimetic drug having alpha and adrenergic activity. It has vasoconstrictive effect and reduces puffiness of a mucous membrane.
Action usually begins within 5-10 min. Drug facilitates nasal breath due to reduction of puffiness and hyperaemia of a mucous membrane and also improves an otkhozhdeniye of discharges.

Indications
– for reduction of hypostasis of a mucous membrane of a nasopharynx and discharges in acute allergic rhinitis, ORZ with the rhinitis phenomena, sinusitis, a pollinosis, average otitis.
– training of the patient for diagnostic manipulations in the nasal courses.

Route of administration and
Intranazalno’s doses.
0.05% spray for children from 2 to 6 years: on 1 injection in each nasal course of 1 – 2 time a day.
0.1% spray for adults and children are more senior than 6 years: on 1 injection in each nasal course 2-3 times a day.
The dose depends on individual sensitivity of the patient and clinical effect. It is not necessary to apply more than 3 times a day.
Drug is used within no more than 5-7 days.
After completion of therapy it is possible to appoint drug repeatedly only in several days.

The general recommendations about introduction
to Remove a protective cap. Before the first use several times to press a raspylitelny nozzle (fig. 1) before emergence of a uniform cloudlet of fog. The bottle is ready to further use. At use to press once (fig. 2). To inhale drug through a nose. Whenever possible to hold a bottle spray vertically. Not to spray horizontally or down. After the use to close a bottle a cap.

Side effects
Often
– at frequent or prolonged use the irritation or dryness mucous a nose, an artrofiya mucous a nose, burning, sneezing, dependence, hypersecretion, chronic rhinitis
Infrequently
– heartbeat, disturbance of a warm rhythm, increase in arterial
blood pressure
– nausea, vomiting
– allergic reaction
Very seldom

the Contraindication headache
– hypersensitivity to drug components
– a concomitant use of inhibitors of a monoaminooxidase (MAO), or other drugs capable to cause increase in arterial blood pressure
– arterial hypertension
– tachycardia
– the profound atherosclerosis
– glaucoma
– atrophic rhinitis
– surgical interventions on a meninx (in the anamnesis)
– children’s age up to 2 years (ТИЗИН® for a dosage of 0.05%)
– children’s age up to 6 years (ТИЗИН® for a dosage of 0.1%)
With care is possible:
– Ischemic heart disease (stenocardia), prostate hyperplasia, thyrotoxicosis, diabetes, pheochromocytoma.

Simultaneous use of MAO inhibitors of type of Tranylcyprominum or tricyclic antidepressants can lead medicinal interactions to increase in arterial blood pressure owing to cardiovascular effects of these substances.

Prolonged use and overdose of the sympathomimetics having dekongestivny effect can lead special instructions to a reactive hyperemia of a mucous membrane of a nose.
The phenomenon of return can cause obstruction of airways which leads to the fact that the patient begins to use drug repeatedly or is even constant. It can result in chronic puffiness (medicamentous rhinitis), and as a result even to a nose mucosal atrophy (ozena).
In case of chronic rhinitis drug ТИЗИН® 0.05 of % and 0.1% can be applied only under control of the doctor, considering risk of a mucosal atrophy of a nose.
ТИЗИН® chloride which is a part of drug as preservative should not apply with hypersensitivity to a benzalkoniya.
Pregnancy and the period of lactation
ТИЗИН® should not be applied during pregnancy as effects of this drug on a fruit in adequate researches were not studied. Drug should not be used during feeding by a breast as it is unknown whether active agent with breast milk is removed or not.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
At long-term treatment or use of the drug TIZIN® in higher doses cannot exclude a possibility of its systemic action on a cardiovascular system that can worsen ability to driving and use of the equipment.

Overdose
Symptoms: The overdose or accidental administration of drug inside can lead to the following symptoms: expansion of pupils, nausea, vomiting, cyanosis, fever, spasms, tachycardia, cardiac arrhythmias, collapse, cardiac arrest, hypertension, fluid lungs, breath disturbance, mental disturbances.
Besides, the following symptoms can be observed: suppression of function of the central nervous system which is followed by drowsiness, decrease in body temperature, bradycardia, shocklike hypotonia, apnoea and coma.
Treatment: symptomatic.

A form of release and packing
On 10 ml of drug in a bottle of brown hydrolytic glass (class III) with the portioning device and the polyethylene screwed cover like pull-off.
On 1 bottle together with the instruction for use in the state and Russian languages put in a cardboard pack.
Quantity of doses in a bottle: for 0.05% not less than 140 doses, for 0.1% dosed

Storage conditions
to Store not less than 70 at a temperature not above 30 °C.
To store out of children’s reach.

3 years
not to apply a period of storage after expiry date.

Prescription status
Without prescription

Famar Orlean Producer, 5 avenue de Consir, 45071 Orléans Sedex 2, France

the Name and the country of the owner of the registration certificate
of LLC Johnson & Johnson,
Russia, 121614, Moscow, Krylatskaya St., 17, building 2,
ph. (495) 726-55-55

The name and the country
of the Famar Orlean organization packer, 5 avenue de Consir, 45071 Orléans Sedex 2, France
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Branch of Johnson & Johnson limited liability company in Republic of Kazakhstan, Almaty, 050040, Timiryazev St. 42, pavilion 23 – ATel: (727) 245-88-10, fax: (727) 245-88-15Электр address: safetyru@its.jnj.com

Additional information

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