Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
midazolam
Neuraxpharm Pharmaceuticals S.L.
N05CD08
midazolam
Psycholeptics
Epilepsy
Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from three months to less than 18 years).Buccolam must only be used by parents / carers where the patient has been diagnosed to have epilepsy.For infants between three and six months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.
Revision: 18
Authorised
2011-09-04
52 B. PACKAGE LEAFLET 53 PACKAGE LEAFLET: INFORMATION FOR THE USER BUCCOLAM 2.5 MG OROMUCOSAL SOLUTION FOR CHILDREN AGED 3 MONTHS TO LESS THAN 1 YEAR BUCCOLAM 5 MG OROMUCOSAL SOLUTION FOR CHILDREN AGED 1 YEAR TO LESS THAN 5 YEARS BUCCOLAM 7.5 MG OROMUCOSAL SOLUTION FOR CHILDREN AGED 5 YEARS TO LESS THAN 10 YEARS BUCCOLAM 10 MG OROMUCOSAL SOLUTION FOR CHILDREN AGED 10 YEARS TO LESS THAN 18 YEARS 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 BUCCOLAM is and what it is used for 2. What you need to know before you give BUCCOLAM 3. How to give BUCCOLAM 4. Possible side effects 5. How to store BUCCOLAM 6. Contents of the pack and other information 1. WHAT BUCCOLAM IS AND WHAT IT IS USED FOR BUCCOLAM contains a medicine called midazolam. Midazolam belongs to a group of medicines known as benzodiazepines. BUCCOLAM is used to stop a sudden, prolonged, convulsive, seizure in infants, toddlers, children and adolescents (from 3 months to less than 18 years of age). In infants from 3 months to less than 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 BUCCOLAM DO NOT GIVE BUCCOLAM IF THE PATIENT HAS: • An allergy to midazolam, benzodiazepines (such as diazepam) or any of the other ingredients of this medicine (l Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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. 3 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 b Прочетете целия документ