Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Midazolam
Rowa Pharmaceuticals Limited
N05CD08
Midazolam
Oromucosal solution
midazolam
Not marketed
2021-01-29
PACKAGE LEAFLET: INFORMATION FOR THE USER MIDAZOLAM ROWA 2.5 MG OROMUCOSAL SOLUTION MIDAZOLAM ROWA 5 MG OROMUCOSAL SOLUTION MIDAZOLAM ROWA 7.5 MG OROMUCOSAL SOLUTION MIDAZOLAM ROWA 10 MG OROMUCOSAL SOLUTION midazolam READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU START GIVING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their signs of illness are the same as those of the child for whom this medicine has been prescribed. • If you see any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Midazolam Rowa is and what it is used for 2. What you need to know before you give Midazolam Rowa 3. How to give Midazolam Rowa 4. Possible side effects 5. How to store Midazolam Rowa 6. Contents of the pack and other information 1. WHAT MIDAZOLAM ROWA IS AND WHAT IT IS USED FOR Midazolam Rowa is an oromucosal solution, containing midazolam. Midazolam belongs to a group of medicines known as benzodiazepines. Midazolam Rowa is used to stop a prolonged, acute convulsive- seizure in infants, toddlers, children and adolescents (from 3 months to less than 18 years of age). In infants from 3 to 6 months it should only be used in a hospital setting where monitoring is possible and resuscitation equipment is available. This medicine must only be used by parents/carers where the child has been diagnosed to have epilepsy. 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE MIDAZOLAM ROWA DO NOT GIVE MIDAZOLAM ROWA IF THE PATIENT HAS: • An allergy to midazolam, benzodiazepines (such as diazepam) or any of the other ingredients of this medicine (listed in section 6) • A disease of the nerves and muscles causing muscle weakness (myasthenia gravis) • Severe difficulty breathing at rest M Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 21 March 2024 CRN00DZ9V Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Midazolam Rowa 2.5 mg oromucosal solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Midazolam Rowa 2.5 mg oromucosal solution Each pre-filled oral syringe contains midazolam hydrochloride equivalent to 2.5 mg midazolam in 0.5 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). Midazolam Rowa 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. 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 professional to provide information on the dose received by the patient. A second or repeat dose when seizures re-occur after an initial response should not be given without prior medical advice (see section 5.2). Special populations _Paediatric population_ The safety and efficacy of midazolam in children aged 0 to 3 months has not been established. No data are available. _Renal impairment_ Health Products Regulatory Authority 21 March 2024 CRN00DZ9V Page 2 of 12 No dose adjustment is required, however, Midazolam Rowa should be used with caution in patien Διαβάστε το πλήρες έγγραφο