Nazivin 0.05% 10 ml nasal spray
- $6.10
The instruction for medical use
of NAZIVIN® medicine
the Trade name
of Nazivin®
the International unlicensed
name Oxymetazoline Dosage Form Spray of Nasal 0.05% Structure of 1 Ml of Solution contains
active agent - oxymetazoline a hydrochloride of 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 to slightly zheltovato colors 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 injection in a nose effect of oxymetazoline comes quickly (within several minutes). Duration of action of Nazivina® till 12 o'clock.
Elimination half-life makes 1.5 days. The main part of drug eliminirutsya by kidneys, other with excrements.
The pharmacodynamics
Active agent of the drug Nazivin® – oxymetazoline is a sympathomimetic, with direct promoting effect on alfa2-adrenoceptors. At topical administration of spray 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)
At topical intranasal administration drug does not possess systemic action.
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 nose (sinusitis)
- the eustachitis associated by rhinitis
- elimination of hypostasis
and doses
of Називин® 0.05% spray is intended to a mucous membrane of a nasal cavity before the diagnostic Route of administration procedures for intranasal use.
Ìế󿡮 0.05% spray are appointed to adults and children of school age
(from 6 years and is more senior) on 1 injection in each nasal course 2-3 times a day.
Spray the nasal, containing oxymetazoline, 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.
The single dose of Називина® 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)
- 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:
- concern, insomnia, fatigue (drowsiness, sedative action), a headache, hallucinations (especially at children)
-
Contraindication arrhythmias
- hypersensitivity or to any excipient
- Називин® 0.05% spray should not be applied to oxymetazoline at children up to 6 years
the Medicinal interactions
do not apply along with inhibitors of the mono-amino-oxidase (MAO) and tricyclic antidepressants the increase in arterial blood pressure is possible.
Joint prescribing of other vasoconstrictive drugs increases risk of development of side effects.
Special instructions
It is necessary to avoid long use and overdose of drug.
Long or frequent use of vasoconstrictive drugs leads to reduction of efficiency of drug, also misuse them can cause an atrophy and hypostasis of mucous membranes of a nose.
When prescribing oxymetazoline, in order to avoid risk of a mucosal atrophy of a nose, it is necessary to apply to treatment of chronic rhinitis only under observation of the doctor
At frequent use of high dosages of derivatives of imidazoline can result (congestion) of nasal passes in reactive stagnation. Therefore drug is used no more than 5-7 days after an initiation of treatment.
In the following cases drug can be used only after careful assessment of risk and advantage of its use:
- the patients undergoing treatment by monoamine oxidase inhibitors (MAO inhibitors) and other drugs which have potential ability to increase blood pressure
- the increased intraocular pressure, especially closed-angle glaucoma
- a serious cardiovascular illness (for example a coronary disease, hypertensia)
- a pheochromocytoma
- metabolic disorders (for example, a hyperthyroidism, diabetes)
Pregnancy and a lactation
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. At use during pregnancy or breastfeeding it is not necessary to exceed the recommended dosage.
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: 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 10 ml in a bottle from white polyethylene with the spray, corked by the screw-on cover from white polyethylene. 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 12 months.
Not to use after expiry date.
Prescription status
Without prescription
the Producer/packer
Merk of KGaA, Germany
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
the e-mail address of DSO-KZ@takeda.com
of NAZIVIN® medicine
the Trade name
of Nazivin®
the International unlicensed
name Oxymetazoline Dosage Form Spray of Nasal 0.05% Structure of 1 Ml of Solution contains
active agent - oxymetazoline a hydrochloride of 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 to slightly zheltovato colors 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 injection in a nose effect of oxymetazoline comes quickly (within several minutes). Duration of action of Nazivina® till 12 o'clock.
Elimination half-life makes 1.5 days. The main part of drug eliminirutsya by kidneys, other with excrements.
The pharmacodynamics
Active agent of the drug Nazivin® – oxymetazoline is a sympathomimetic, with direct promoting effect on alfa2-adrenoceptors. At topical administration of spray 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)
At topical intranasal administration drug does not possess systemic action.
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 nose (sinusitis)
- the eustachitis associated by rhinitis
- elimination of hypostasis
and doses
of Називин® 0.05% spray is intended to a mucous membrane of a nasal cavity before the diagnostic Route of administration procedures for intranasal use.
Ìế󿡮 0.05% spray are appointed to adults and children of school age
(from 6 years and is more senior) on 1 injection in each nasal course 2-3 times a day.
Spray the nasal, containing oxymetazoline, 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.
The single dose of Називина® 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)
- 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:
- concern, insomnia, fatigue (drowsiness, sedative action), a headache, hallucinations (especially at children)
-
Contraindication arrhythmias
- hypersensitivity or to any excipient
- Називин® 0.05% spray should not be applied to oxymetazoline at children up to 6 years
the Medicinal interactions
do not apply along with inhibitors of the mono-amino-oxidase (MAO) and tricyclic antidepressants the increase in arterial blood pressure is possible.
Joint prescribing of other vasoconstrictive drugs increases risk of development of side effects.
Special instructions
It is necessary to avoid long use and overdose of drug.
Long or frequent use of vasoconstrictive drugs leads to reduction of efficiency of drug, also misuse them can cause an atrophy and hypostasis of mucous membranes of a nose.
When prescribing oxymetazoline, in order to avoid risk of a mucosal atrophy of a nose, it is necessary to apply to treatment of chronic rhinitis only under observation of the doctor
At frequent use of high dosages of derivatives of imidazoline can result (congestion) of nasal passes in reactive stagnation. Therefore drug is used no more than 5-7 days after an initiation of treatment.
In the following cases drug can be used only after careful assessment of risk and advantage of its use:
- the patients undergoing treatment by monoamine oxidase inhibitors (MAO inhibitors) and other drugs which have potential ability to increase blood pressure
- the increased intraocular pressure, especially closed-angle glaucoma
- a serious cardiovascular illness (for example a coronary disease, hypertensia)
- a pheochromocytoma
- metabolic disorders (for example, a hyperthyroidism, diabetes)
Pregnancy and a lactation
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. At use during pregnancy or breastfeeding it is not necessary to exceed the recommended dosage.
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: 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 10 ml in a bottle from white polyethylene with the spray, corked by the screw-on cover from white polyethylene. 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 12 months.
Not to use after expiry date.
Prescription status
Without prescription
the Producer/packer
Merk of KGaA, Germany
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
the e-mail address of DSO-KZ@takeda.com
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