দেশ: সুইডেন
ভাষা: সুইডিশ
সূত্র: Läkemedelsverket (Medical Products Agency)
zolmitriptan
Orifarm AB
N02CC03
zolmitriptan
5 mg/dos
Nässpray, lösning
zolmitriptan 5 mg Aktiv substans
Apotek
Vissa förpackningar receptbelagda
Zolmitriptan
Avregistrerad
2011-12-16
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zomig Nasal 5 mg/dose, nasal spray, solution Zomig Nasal 2.5 mg/dose, nasal spray, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zomig Nasal 5 mg/dose nasal spray contains zolmitriptan 50 mg/ml corresponding to 5 mg zolmitriptan per dose. Zomig Nasal 2.5 mg/dose nasal spray contains zolmitriptan 25 mg/ml corresponding to 2.5 mg zolmitriptan per dose. The solution is buffered to pH 5.0. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, solution. A clear, colourless to yellow liquid. In glass vials in a single unit dose nasal spray device. The device is intended for a single use only. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zomig Nasal is indicated in adults and adolescents aged 12 years and older for the acute treatment of migraine headache with or without aura and in adults for the acute treatment of cluster headache. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Treatment of migraine_ _Adults_ The recommended dose of Zomig Nasal to treat a migraine attack is 2.5 mg or 5 mg. For those patients that do not achieve satisfactory effect with 2.5 mg a dose of 5 mg may be effective at subsequent attacks. It is advisable that Zomig Nasal is taken as early as possible after the onset of migraine headache but it is also effective if taken at a later stage. _Adolescents (from the age of 12 years)_ The recommended dose of Zomig Nasal to treat a migraine attack is 2.5 mg or 5 mg. For those patients that do not achieve satisfactory effect with 2.5 mg, a dose of 5 mg may be effective at subsequent 2 attacks. It is advisable that Zomig Nasal is taken as early as possible after the onset of migraine headache but it is also effective if taken at a later stage. If symptoms of migraine should recur within 24 hours following an initial response, a second dose may be taken. If a second dose is required, it should not be taken within 2 hours of the initial dose. If a patient does not respond to the first d সম্পূর্ণ নথি পড়ুন