Nazivin 0.05% 10 ml nasal drops

The instruction for medical use

of NAZIVIN® medicine

the Trade name
of Nazivin®

the International unlicensed


name Oxymetazoline Dosage Form
of the Drop nasal 0.01%, 0.025% and 0.05%

Structure
of 1 ml of solution contains
active agent - oxymetazoline a hydrochloride of 0.1 mg, 0.25 mg and 0.5 mg,
excipients: citric acid monohydrate, sodium citrate a dihydrate, glitserol (85%), a benzalkoniya chloride (50% solution), the water purified.

The description
Almost transparent, from colourless till slightly yellowish color solution

Pharmacotherapeutic group
Drugs for treatment of diseases of a nose. Dekongenstanta and other drugs for topical administration. Sympathomimetics. Oxymetazoline
the ATX R01AA05 Code

the Pharmacological

Pharmacokinetics At properties topical intranasal administration drug does not possess systemic action. After instillation in a nose the effect of oxymetazoline comes quickly:
- for a form of 0.05% within several seconds (on average 20 seconds)
- for forms of 0.025% and 0.01% within several minutes
Duration of effect of drug till 12 o'clock. Elimination half-life of oxymetazoline at its intranasal introduction makes 35 h 2.1% of oxymetazoline also about 1.1% with a stake are removed with urine.
The pharmacodynamics
of Nazivin® has vasoconstrictive effect, is a sympathomimetic, with direct promoting effect on alfa2-adrenoceptors. At topical administration of drops for a nose there is a narrowing of blood vessels of a mucous membrane of a nose, hypostasis and hyperaemia of a mucous membrane of a nasopharynx is eliminated. Nasal breath in rhinitises is facilitated.
After removal of hypostasis of a mucous membrane the removing channels for aeration of adnexal bosoms of a nose, an acoustical pipe open and extend. It stimulates drainage function of nasal cavities and prevents development of bacterial complications. Antiviral, immunomodulatory and antioxidant effect of active agent is proved. Antiviral effect of oxymetazoline, is confirmed with researches with use of the cultivated cells infected with viruses (therapeutic approach). This cause and effect mechanism of action was shown by means of suppression of activity of the viruses causing cold and cold with use of the test of reduction of plaques, determination of residual infectivity of viruses (titration of viruses) and also the test of inhibition of virus cytopathic action (CPD/zpE)

Indications
- acute respiratory diseases with the phenomena of rhinitis (cold)
- allergic rhinitis
- vasomotorial rhinitis
- improvement of a drainage of secretion at inflammation of adnexal bosoms of a nasal cavity (sinusitis)
- the eustachitis associated by rhinitis
- elimination of hypostasis to a mucous membrane of a nasal cavity before the diagnostic

Route of administration procedures and doses
of Називин® 0.01%, 0.025% and 0.05% of a drop are intended for intranasal use.
Ìế󿡮 0.01% of a drop are applied to a nose at babies aged up to 4 weeks on 1 drop in each nasal course 2-3 times a day. From the 5th week of life to 1 year – on 1-2 drops in each nasal course 2-3 times a day.
For ensuring accuracy of a dosage the bottle of Називин® 0.01% of drops has the graduated pipette with marks of quantity of drops. For example, if 1 drop is appointed, then the pipette should be filled with solution to mark 1.
The efficiency as well following procedure is proved: depending on age 1-2 drops of 0.01% of solution apply on vatu and wipe the nasal courses.
Ìế󿡮 0.025% of a drop for a nose are appointed to children aged from 1 year up to 6 years on 1-2 drops in each nasal course 2-3 times a day.
Ìế󿡮 0.05% of a drop for a nose are appointed to adults and children 6 years on 1-2 drops in each nasal course 2-3 times a day
the Nasal drops containing oxymetazoline are more senior it is impossible to apply longer than 5-7 days if it is not appointed differently the attending physician. The period without treatment which is several days has to precede any repeated course of use of drug. Doses, above recommended, can be applied only under observation of the doctor.
The single dose of Називин® 0.01%, 0.025% and 0.05% cannot be applied more often than 3 times a day.

Side effects
Often (from ≥ 1% to & lt, 10%):
- burning sensation or xeromycteria
- sneezing, especially at sensitive patients.
Infrequently (from ≥ 0.1% to & lt, 1%):
- swelling and hypostasis of a mucous membrane (feeling of congestion of a nose) can become more intensive (reactive hyperemia), nasal bleeding
- hypersensitivity reactions (Quincke's disease, rash, an itching).
Seldom (from ≥ 0.01% to & lt, 0.1%):
- cardiopalmus, increase of pulse and increase in arterial blood pressure.
Very seldom & lt, 0.01% and isolated cases:
- the concern, insomnia, fatigue (drowsiness, sedative action), a headache, hallucinations (especially at children)
- arrhythmias
- an apnoea at babies and newborns
-

Contraindication spasms
- hypersensitivity to oxymetazoline or to any excipient
- atrophic rhinitis
- Називин® 0.025%, drops nasal should not be applied at children 1 years
- Називин® 0.05% are younger, drops nasal should not be applied at children up to 6 years
- it is impossible to apply after transsphenoidal hypophysectomy or other surgical interventions on a firm meninx

Medicinal interactions
the Combined (simultaneous) use of oxymetazoline and
- tricyclic antidepressants
- monoamine oxidase inhibitors of traniltsiprominovy type
- hypertensive means
can lead to increase in arterial blood pressure. Therefore, if perhaps, it is at the same time not desirable to use these drugs

the Special
instructions Treatment at newborns and babies it is necessary to carry out with extra care.
In the following cases this drug can be used only after careful assessment of a ratio of risk/advantage:
- the increased intraocular pressure, especially a narrow angle glaucoma
- a serious cardiovascular illness (for example, a coronary disease) and hypertensia
- a pheochromocytoma
- metabolic disorders (for example, a hyperthyroidism, diabetes)
- a prostate hyperplasia
- a porphyria
- the patients undergoing treatment by monoamine oxidase inhibitors (MAO inhibitors) and other drugs which have potential ability to increase arterial blood pressure

At prolonged use of nasal means from cold or at their overdose their efficiency can go down. The wrong use of nasal means from cold can cause:
- a reactive hyperemia (resuming of symptoms after drug withdrawal)
- chronic swelling / hypostasis of a mucous membrane of a nasal cavity (rhinitis medicamentosa)
- a mucosal atrophy.

Pregnancy and a lactation
At use during pregnancy or breastfeeding it is not necessary to exceed the recommended dosage. The data obtained at the limited number of the women receiving this drug during the first trimester of pregnancy did not show development of any adverse reactions owing to effect of oxymetazoline which could influence pregnancy or health of the fruit/newborn.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
After prolonged use of Nazivina®, in the dosages exceeding recommended it is impossible to exclude the general influence on a cardiovascular system and the central nervous system. In these cases the ability to run the vehicle or the equipment can decrease.

Overdose
Symptoms: when exceeding the recommended doses or accidental intake the following symptoms can appear: narrowing of pupils, nausea, vomiting, cyanosis, temperature increase, tachycardia, arrhythmia, collapse, oppression of warm activity, arterial hypertension, fluid lungs, respiratory disorders. Besides, there can be mental disorders and also the oppression of functions of the central nervous system which is followed by drowsiness, fall of temperature of a body, bradycardia, arterial hypotension, an apnoea and possible development of a coma.
Treatment: intake of activated carbon, gastric lavage, ventilation of the lungs by oxygen. For lowering of blood pressure – phentolamine of 5 mg in saline (physiological) solution slowly in/in or 100 mg orally. Use of angiotonic means is contraindicated. If it is necessary, to appoint means for decrease in symptoms of fever and anticonvulsant therapy.

A form of release and packing
On 5 ml of drug with a dosage of 0.01% in a bottle from dark glass with a cover pipette. On 10 ml of drug with a dosage of 0.025% and 0.05% in a bottle from dark glass with a cover pipette.
The bottle together with the instruction for medical use in the state and Russian languages is placed in a box cardboard.


To Store storage conditions at a temperature not above 25 °C.
To store out of children's reach!

A period of storage
3 years
the use Period after the first opening of 6 months.
Not to use after expiry date

Prescription status
Without prescription

the Producer
Merk of KGaA, Germany
of Frankfurter Strasse 250, D-64293 Darmstadt

the Owner of the registration certificate
of Merck Zelbstmedikation GmbH, Germany

the Name and the country of the organization packer
of Merck of KGaA, Germany
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office "Takeda Osteuropa Holding GmbH" (Austria) in Almaty, Shashkin St. 44 Phone number Kazakhstane050040 (727) 2444004 Fax number (727) 2444005
To Develop the e-mail address of DSO-KZ@takeda.com