Allergic Rhinitis / Allergic Rhinitis / Allergies/Hay Fever / Nasal Care

Nazarel 50 ug / dose of 120 doses of nasal spray

Brands: Teva (Czech Republic)

$28.40

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Nazarel 50 ug / dose of 120 doses of nasal spray quantity

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Brands:: Teva (Czech Republic)

Description

The instruction for medical use

of NAZAREL medicine
the Trade name
Nazarel

Mezhdunarodnoye the unlicensed

name Flutikazon Lekarstvennaya a form
Spray of nasal 50 mkg a dose on 60, 120 and 150 doses

Structure
One dose contains
active agent – a flutikazon of propionate of 50 mkg,
excipients: polysorbate 80, cellulose dispersed (Avicel RS 591), glucose anhydrous, a benzalkoniya chloride (50% solution), phenylethyl alcohol, the water purified.

The description
Opaque suspension of white or almost white color, thixotropic (ability of disperse systems to be diluted reversibly at intensive mechanical influences (hashing, stirring) and to harden (to lose fluidity) at stay in rest

Pharmacotherapeutic group
Nasal drugs. Antikongestanta and other nasal drugs for topical administration. Glucocorticosteroids
ATX R01AD08 Code

Pharmacological

Pharmacokinetics Absorption properties. After intranasal introduction of a flutikazon of propionate (200 mkg a day) the maximum concentration (Smakh) of this drug in blood plasma is not found in most of patients (i.e. it makes less than 0.01 ng/ml). The highest Smakh makes 0.017 ng/ml. Direct absorption on a mucous nasal cavity it is insignificant it is small because of low solubility of drug in water owing to what the most part of a dose, eventually, is swallowed. At oral administration, the flutikazona of propionate in blood is soaked up less than 1% of a dose owing to weak absorption and presystem metabolism. All this leads to the fact that total absorption in a nasal cavity and digestive tract (the swallowed drug) is extremely low.
Distribution. At achievement of equilibrium concentration in plasma of blood, a flutikazon propionate has the large volume of distribution (about 318 l). It has quite high ability to contact proteins of blood plasma (91%).
Metabolism. Flutikazona propionate is quickly brought from blood plasma, mainly as a result of metabolism in a liver to an inactive carboxyl metabolite under the influence of an isoenzyme of CYP3A4 of a system of P450 cytochrome. The propionate swallowed a flutikazona is exposed to intensive metabolism as a result of primary passing through a liver.
Elimination. The main way of elimination is removal of a flutikazon of propionate and its metabolites with bile.
A pharmacodynamics
Nazarel – a glucocorticosteroid for topical administration, the drug possessing strong anti-inflammatory and also antiedematous and antiallergic action. Anti-inflammatory action is implemented as a result of interaction of drug with receptors of glucocorticosteroids. Suppresses proliferation of mast cells, eosinophils, lymphocytes, macrophages, neutrophils. Flutikazon reduces development of mediators of inflammation, etc. biologically active agents (histamines, prostaglandins, leukotrienes, cytokines) during an early and late phase of allergic reaction. Restores reaction of the patient to action of bronkhodilyatator, allowing to reduce the frequency of their use. Has fast anti-inflammatory effect on a mucous membrane of a nose, and its antiallergenic effect is shown already in 2-4 h after the first use. Reduces sneezing, an itching of a nose, cold, congestion of a nose, unpleasant feelings in adnexal bosoms and feeling of pressure around a nose and eyes. Besides, facilitates the eye symptoms connected with allergic rhinitis. Reduction of expressiveness of symptomatology (especially congestions of a nose) remains during 24 h after single administration of spray in a dose of 200 mkg.
When using in the recommended doses it has no significant system activity and practically does not oppress gipotalamo – a hypophysial and adrenal system

Indications
– prevention and treatment of seasonal allergic rhinitises (including hay fever) and year-round rhinitises

the Route of administration and doses
to Adults and children are more senior than 12 years:
On 2 doses in each nasal course once a day (200 mkg),
if necessary – on 4 doses in each nasal course once a day (400 mkg),
a maintenance dose – 1 dose in each nasal course once a day
(100 mkg).
Children are from 4 to 12 years old:
On 1 dose (100 mkg) in each nasal course once a day.
Stir up a bottle and remove a cover of protection against dust. Carefully clean the nasal courses. Press a finger one nasal course and enter a spray tip into another. Slightly incline the head so that the bottle remained in vertical position. Slowly inhale through the open nasal course both at the same time and at the same time press a tip collar the strong movements of fingers down to receive an aerosol squirt. Exhale through a mouth. Repeat the necessary number of times corresponding to the quantity of doses appointed by the doctor. Carry out also the procedure on other nasal pass. After use of the applicator wipe it pure fabric and establish into place a cover of protection against dust.
Duration of a course of treatment is defined by the attending physician.

Side effects
– nasal bleedings
– dryness and irritation, an ulceration of a mucous nasopharynx
– perforation of a nasal partition (very seldom, at use after surgical intervention in a nasal cavity)
– reactions of hypersensitivity with manifestation of a bronchospasm, anaphylactic reaction, it is very rare – skin hypersensitivity or vascular hypostasis
– a headache, feeling of unpleasant smack and a smell
– very seldom glaucoma, the increased intraocular pressure, a cataract
– candidiasis of an oral cavity

of the Contraindication
– hypersensitivity to any component of drug
– the children’s age up to 4 years

Medicinal interactions
is not recommended Nazarel’s appointment to patients who at the same time take the medicine which is potential inhibitors of a system of P 450 3A4 cytochrome (for example, inhibitors of proteases, such as ritonavir). In researches on healthy faces on interaction of an intranasal flyutikazon of Dipropionas and ritonavir (high-probable inhibitor of a system of P 450 3A4 cytochrome) in a daily dose of 100 mkg Nazarel’s concentration in blood plasma increased in several hundreds of times that led to considerable decrease in level of cortisol in blood plasma. There are messages about Cushing’s syndrome and suppression of functions of adrenal glands. If the advantage considerably does not exceed the increased risk of side effects of system corticosteroids, then it is necessary to avoid such combination.
Other inhibitors of P 450 3A4 cytochrome cause insignificant (erythromycin) and weak (ketokonazol) increase in exposure of Nazarel without significant decrease in level of cortisol in blood plasma.

Special instructions
Before Nazarel’s use need to be carried out sanitation of the nasal courses though presence of local infections of the nasal courses is not a contraindication to drug use.
Nazarel is intended for long-term treatment, but not regular use of aerosol is very important for stopping of attacks and therefore.
When translating patients from system corticosteroids on the Nazarel drug treatment it is necessary to show care because of danger of development of adrenal insufficiency.
In most cases Nazarel controls seasonal allergic rhinitises, but in case of heavy allergic reaction the additional therapy can be necessary.
Nasal corticosteroids can cause system effects, especially at prolonged use high dosed
there Are messages that some nasal corticosteroids in high doses can cause a growth inhibition in children. It is regularly recommended to control growth of children, it is long accepting nasal corticosteroids. In case of identification of a growth inhibition, the pediatrician should reconsider treatment towards reduction of a dose of nasal corticosteroids.
It is necessary to consider a possibility of existence of residual dysfunction of bark of adrenal glands, at stressful situations (respiratory infections, operation, an injury, etc.) and to resolve an issue of need of additional purpose of glucocorticosteroids.
For prevention of risk of developing candidiasis of an oral cavity, after use of drug it is necessary to rinse a mouth.
Nazarel nasal spray is not intended for children 4 years are younger.
Pregnancy and the period of a lactation
to Pregnant women is appointed only when the expected advantage exceeds any possible risk for a fruit. In the period of a lactation it is appointed only when the expected advantage for mother exceeds any possible risk for the child.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects of drug it is necessary to be careful when driving or potentially dangerous mechanism.

The overdose
of Data on acute and chronic overdose of the drug “Nazarel” water nasal spray of 50 mkg is not available. Intranasal introduction of a flyutikazon of propionate in a dose of 2 mg twice a day to healthy volunteers within 7 days did not influence function of a gipotalamo-pituitary adrenal (GPA) system.
Inhalation or intake of high doses of corticosteroids during the long period can lead to suppression of the GPA function of a system.
The symptoms caused by action of high doses of Nazarel usually do not demand the emergency therapy as in most cases normal function of bark of adrenal glands is restored within several days.

The form of release and packing
place Drug in the bottle from dark glass supplied with the plastic spraying applicator on 6 ml (for 60 doses) or on 15 ml (for 120 and 150 doses).
The bottle together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard.

To Store storage conditions at a temperature not above 25ºС.
To store out of children’s reach!

A period of storage
2 years
After opening of a bottle – 3 months.
Not to apply after expiry date.

Prescription status
According to the prescription

“Teva Czech Enterprises of Neuter of the Lake.” Producer,
Ostravsk 29, 74779 Opava – Komarov, the Czech republic.

The owner of the registration certificate
“Teva Czech Enterprises of Neuter of the Lake.”,
Ostravska29, 74779 Opava – Komarov, the Czech republic

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):

050000 Republic of Kazakhstan Almaty, Al-Farabi Avenue 13,
Nurla Tau’s Business center of 1 V, office 305,
306 Phone number, fax (727) 311-10-66, 311-10-68
E-mail of teva@teva.co.il

to Develop representative office “Teva Czech Enterprises of Neuter of the Lake.”

Additional information