Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
MIDAZOLAM AS HYDROCHLORIDE
NEOPHARM CURE (2005) LTD
N05CD08
OROMUCOSAL SOLUTION
MIDAZOLAM AS HYDROCHLORIDE 5 MG
BUCCAL
Required
SHIRE SERVICES BVBA, BELGIUM
MIDAZOLAM
Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to < 18 years). Buccolam 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.
2018-04-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The dispensing of this medicine requires a physician’s prescription only BUCCOLAM 2.5 MG BUCCOLAM 5 MG BUCCOLAM 7.5 MG BUCCOLAM 10 MG OROMUCOSAL SOLUTION COMPOSITION: Each pre-filled syringe contains: Active ingredient: Midazolam (as hydrochloride): 5 mg/ml For the list of excipients - see section 6 "Further Information". READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE. This insert contains concise information about the medicine. In case you have any additional questions, please refer to the physician or the pharmacist. This medicine has been prescribed for the treatment of your child/patient. Do not pass it on to others. It may harm them, even though it may seem to you that they have a similar medical state. This medicine is intended for use in children and adolescents aged 3 months and older, but younger than 18 years of age. IF THE SEIZURE DOES NOT STOP WITHIN 10 MINUTES OF GIVING BUCCOLAM: - YOU MUST TELEPHONE FOR AN AMBULANCE IMMEDIATELY. - YOU MUST KEEP THE EMPTY ORAL SYRINGE AND GIVE IT TO THE AMBULANCE STAFF SO THAT THEY KNOW HOW MUCH BUCCOLAM HAS BEEN GIVEN TO THE PATIENT. - DO NOT GIVE THE PATIENT ANOTHER DOSE OF BUCCOLAM! Taking this medicine with other opioids or other medications which suppress the central nervous system (including narcotics) or alcohol, may result in profound sedation, breathing difficulties (respiratory depression), coma and death. 1. WHAT IS THIS MEDICINE USED FOR? This medicine is used for the treatment of prolonged, acute, convulsive, epileptic seizures in infants, toddlers, children and adolescents (from 3 months to less than 18 years of age). This medicine must only be used by parents/carers where the child/patient has been diagnosed to have epilepsy. IN INFANTS FROM 3 MONTHS TO LESS THAN 6 MONTHS IT SHOULD ONLY BE USED IN A HOSPITAL SETTING WHERE MONITORING OF THE INFANT’S CONDITION IS POSSIBLE AND RESUSCITATION EQUIPMENT IS AVAILABLE. THERAPEUTIC G Citiți documentul complet
1 THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH AND ITS CONTENT WAS CHECKED AND APPROVED SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BUCCOLAM 2.5 mg oromucosal solution BUCCOLAM 5 mg oromucosal solution BUCCOLAM 7.5 mg oromucosal solution BUCCOLAM 10 mg oromucosal solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BUCCOLAM 2.5 mg oromucosal solution Each pre-filled oral syringe contains 2.5 mg midazolam (as hydrochloride) in 0.5 ml solution BUCCOLAM 5 mg oromucosal solution Each pre-filled oral syringe contains 5 mg midazolam (as hydrochloride) in 1 ml solution BUCCOLAM 7.5 mg oromucosal solution Each pre-filled oral syringe contains 7.5 mg midazolam (as hydrochloride) in 1.5 ml solution BUCCOLAM 10 mg oromucosal solution Each pre-filled oral syringe contains 10 mg midazolam (as hydrochloride) in 2 ml solution For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oromucosal solution Clear colourless 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). BUCCOLAM 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. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death [see section 4.5]. • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Standard doses are indicated below: AGE RANGE DOSE LABEL COLOUR 3 _ _ to 6 months hospita Citiți documentul complet