Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
midazolam
Medical Valley Invest AB
N05CD08
midazolam
5 mg
Munhålelösning
midazolam 5 mg Aktiv substans
Receptbelagt
Förpacknings: Förfylld oral doseringsspruta, 2 st (1 ml); Förfylld oral doseringsspruta, 4 st (1 ml)
Godkänd
2020-12-16
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Midazolam Medical Valley 2.5 mg oromucosal solution Midazolam Medical Valley 5 mg oromucosal solution Midazolam Medical Valley 7.5 mg oromucosal solution Midazolam Medical Valley 10 mg oromucosal solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION2.5 mg oromucosal solution Each pre-filled oral syringe contains midazolam hydrochloride equivalent to 2.5 mg midazolam in 0.5 ml solution Läs hela dokumentet5 mg oromucosal solution Each pre-filled oral syringe contains midazolam hydrochloride equivalent to 5 mg midazolam in 1 ml solution 7.5 mg oromucosal solution Each pre-filled oral syringe contains midazolam hydrochloride equivalent to 7.5 mg midazolam in 1.5 ml solution 10 mg oromucosal solution Each pre-filled oral syringe contains midazolam hydrochloride equivalent to 10 mg midazolam in 2 ml solution For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oromucosal solution Clear solution pH 2.9 to 3.7 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to < 18 years). must only be used by parents/carers 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 4.2. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Standard doses are indicated below: AGE RANGE DOSE LABEL COLOUR 3 to 6 months hospital setting 2.5 mg Yellow > 6 months to < 1 year 2.5 mg Yellow 1 year to < 5 years 5 mg Blue 5 years to < 10 years 7.5 mg Purple 10 years to < 18 years 10 mg Orange Carers should only administer a single dose of midazolam. If the seizure has not stopped within 10 minutes after administration of midazolam, emergency medical assistance must be sought and the empty syringe given to the healthcare professi