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נאזונקס תרסיס לאף NASONEX NASAL SPRAY (MOMETASONE FUROATE)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

אפי : NASAL

צורת מינון:

תמיסה : SOLUTION

Posology : מינונים

Dosage and Administration:
After initial priming of the NASONEX® Aqueous Nasal pump (usually 10 actuations, until a uniform spray is observed), each actuation delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 µg mometasone furoate. If the spray pump has not been used for 14 days or longer, it should be reprimed with 2 actuations, until a uniform spray is observed, before next use.

Shake container well before each use.

The bottle should be discarded after 120 actuations or within 2 months of first use.
Adults (including geriatric patients) and children 12 years of age and older: The usual recommended dose for treatment is two sprays (50 µg/spray) in each nostril once daily (total dose 200 µg). Once symptoms are controlled, dose reduction to one spray in each nostril (total dose 100 mg) may be effective for maintenance.

If symptoms are inadequately controlled, the dose may be increased to four sprays in each nostril (total 400 µg).
Dose reduction is recommended following control of symptoms.

Children 3 to 11 years of age:
The usual recommended dose for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is 1 spray (50 µg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 100 µg).
Administration to young children should be aided by an adult.
Clinically significant onset of action occurs as early as 12 hours after the first dose.

Drug Interactions:
NASONEX® Aqueous Nasal Spray has been administered concomitantly with loratadine with no apparent effect on plasma concentrations of loratadine or its major metabolite. Mometasone furoate plasma concentrations were not detectable. The combination therapy was well tolerated.

Adverse Effects:
Treatment-related local adverse events reported in clinical studies include headache (8%), epistaxis (i.e., frank bleeding, blood-tinged mucous, and blood flecks) (8%), pharyngitis (4%), nasal burning (2%), nasal irritation (2%), Page 2 of 4
and nasal ulceration which are typically observed with use of a corticosteroid nasal spray. Epistaxis was generally self-limiting and mild in severity, and occurred at a higher incidence compared to placebo (5%), but at a comparable or lower incidence compared to the active control nasal corticoids studied (up to 15%). The incidence of all other effects was comparable with that of placebo.

In the pediatric population, the incidence of adverse effects, e.g., headache (3%), epistaxis (6%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.

Rarely, immediate hypersensitivity reactions (e.g. bronchospasm, dyspnea) may occur after intranasal administration of mometasone furoate monohydrate. Very rarely, anaphylaxis and angioedema have been reported.

Disturbances of test and smell have been reported very rarely.

שימוש לפי פנקס קופ''ח כללית 1994 לא צוין
תאריך הכללה מקורי בסל לא צוין
הגבלות לא צוין

רישום

109 85 29277 00

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0 ₪

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