国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
propranolol hydrochloride
Pierre Fabre Medicament
C07AA05
propranolol
Beta blocking agents
Hemangioma
Hemangiol is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy: , Life- or function-threatening haemangioma,, Ulcerated haemangioma with pain and/or lack of response to simple wound care measures,, Haemangioma with a risk of permanent scars or disfigurement. , It is to be initiated in infants aged 5 weeks to 5 months.,
Revision: 6
Authorised
2014-04-23
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE USER HEMANGIOL 3.75 MG/ML ORAL SOLUTION propranolol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS RECEIVING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, or pharmacist or nurse. • This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s. • If your child get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What HEMANGIOL is and what it is used for 2. What you need to know before your child receives HEMANGIOL 3. How to give HEMANGIOL to your child 4. Possible side effects 5. How to store HEMANGIOL 6. Contents of the pack and other information 1 WHAT HEMANGIOL IS AND WHAT IT IS USED FOR WHAT HEMANGIOL IS The name of your medicine is HEMANGIOL. The active ingredient is propranolol. Propranolol belongs to a group of medicines known as beta-blockers. WHAT IT IS USED FOR This medicine is used to treat a disease called haemangioma. A haemangioma is a collection of extra blood vessels that have formed a lump in or under the skin. Haemangioma can be superficial or deep. It is sometimes called ‘strawberry mark’ because the surface of a haemangioma looks a bit like a strawberry. Hemangiol is started in infants aged 5 weeks to 5 months, when: - the localisation and/or extend of the lesions are life- or function threatening (might impair vital organs or senses such as vision or hearing); - the haemangioma is ulcerated (i.e. with sore on the skin which fails to heal) and painful, and/or does not respond to simple wound care measures; - there is a risk of permanent scars or disfigurement. 2 WHAT YOU NEED TO KNOW BEFORE YOUR CHILD RECEIVES HEMANGIOL _ _ DO NOT GIVE HEMANGIOL If your child: • is born p 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1 NAME OF THE MEDICINAL PRODUCT HEMANGIOL 3.75 mg/mL oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 4.28 mg of propranolol hydrochloride equivalent to 3.75 mg of propranolol base. Excipients with known effect: 1 ml of solution contains Propylene glycol………………………………………………….2.60 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. Clear, colourless to slightly yellow oral solution, with a fruity odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HEMANGIOL is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy: • Life- or function-threatening haemangioma, • Ulcerated haemangioma with pain and/or lack of response to simple wound care measures, • Haemangioma with a risk of permanent scars or disfigurement. It is to be initiated in infants aged 5 weeks to 5 months (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Treatment with HEMANGIOL should be initiated by physicians who have expertise in the diagnosis, treatment and management of infantile haemangioma, in a controlled clinical setting where adequate facilities for handling of adverse reactions, including those requiring urgent measures, are available. _ _ Posology The posology is expressed in propranolol base. The recommended starting dose is 1 mg/kg/day which is divided into two separate doses of 0.5 mg/kg. It is recommended to increase the dose up to the therapeutic dose under medical supervision as follows: 1 mg/kg/day for 1 week, then 2 mg/kg/day for 1 week and then 3 mg/kg/day as a maintenance dose. The therapeutic dose is 3 mg/kg/day, which is to be administered into 2 separate doses of 1.5 mg/kg, one in the morning and one in late afternoon, with a time interval of at least 9 hours between two intakes. HEMANGIOL is to be given during or right after a feed to avoid the risk of hypoglycaemia. If the child is not eating enough or is vomi 完全なドキュメントを読む