Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
midazolammaleat
SERB S.A.
N05CD08
midazolammaleat
5 mg
Munhålelösning
midazolammaleat 6,8 mg Aktiv substans; maltitol, flytande Hjälpämne; etanol, vattenfri Hjälpämne; glycerol Hjälpämne
Receptbelagt
Förpacknings: Förfylld oral doseringsspruta, 1 st (0,5 ml)
Godkänd
2022-01-05
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 COMPOSITION2.5 mg oromucosal solution Each pre-filled oral syringe (0.25 ml) contains midazolam maleate corresponding to 2.5 mg midazolam. Läs hela dokumentet5 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