Zomig Nasal 5 mg/dos Nässpray, lösning

Země: Švédsko

Jazyk: švédština

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktivní složka:

zolmitriptan

Dostupné s:

2care4 ApS

ATC kód:

N02CC03

INN (Mezinárodní Name):

zolmitriptan

Dávkování:

5 mg/dos

Léková forma:

Nässpray, lösning

Složení:

zolmitriptan 5 mg Aktiv substans

Třída:

Apotek

Druh předpisu:

Receptbelagt

Terapeutické oblasti:

Zolmitriptan

Stav Autorizace:

Avregistrerad

Datum autorizace:

2013-12-18

Charakteristika produktu

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