Epistatus 7,5 mg Munhålelösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

midazolammaleat

Tillgänglig från:

SERB S.A.

ATC-kod:

N05CD08

INN (International namn):

midazolammaleat

Dos:

7,5 mg

Läkemedelsform:

Munhålelösning

Sammansättning:

etanol, vattenfri Hjälpämne; midazolammaleat 10,2 mg Aktiv substans; maltitol, flytande Hjälpämne; glycerol Hjälpämne

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Förfylld oral doseringsspruta, 1 st (0,75 ml)

Bemyndigande status:

Godkänd

Tillstånd datum:

2022-01-05

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Epistatus 2.5 mg oromucosal solution
Epistatus 5 mg oromucosal solution
Epistatus 7.5 mg oromucosal solution
Epistatus 10 mg oromucosal solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.5 mg oromucosal solution
Each pre-filled oral syringe (0.25 ml) contains midazolam maleate
corresponding to 2.5 mg
midazolam.
5 mg oromucosal solution
Each pre-filled oral syringe (0.5 ml) contains midazolam maleate
corresponding to 5 mg
midazolam.
7.5 mg oromucosal solution
Each pre-filled oral syringe (0.75 ml) contains midazolam maleate
corresponding to 7.5 mg
midazolam.
10 mg oromucosal solution
Each pre-filled oral syringe (1 ml) contains midazolam maleate
corresponding to 10 mg
midazolam.
Excipients with known effect
2.5 mg oromucosal solution
Ethanol 49 mg/dose.
Maltitol, liquid 169 mg/dose.
5 mg oromucosal solution
Ethanol 99 mg/dose.
Maltitol, liquid 338 mg/dose.
7.5 mg oromucosal solution
Ethanol 148 mg/dose.
Maltitol, liquid 506 mg/dose.
10 mg oromucosal solution
Ethanol 197 mg/dose.
Maltitol, liquid 675 mg/dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal solution.
Clear colourless to pale yellow solution, practically free from
visible particles.
pH 4.8 - 5.6
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
is indicated for the treatment of prolonged, acute,
convulsive seizures in
infants, toddlers, children and adolescents aged from 3 months to less
than 18 years.
must only be used by parents / caregivers where the
patient has been
diagnosed to have epilepsy.
For infants between 3-6 months of age treatment should be in a
hospital setting where
monitoring is possible and resuscitation equipment is available. See
section 4.4.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Standard doses are indicated below:
Age range
Dose
Labelled packaging colo