Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
5-aminolevulinic acid hydrochloride
Photonamic GmbH & Co. KG
L01XD04
5-aminolevulinic acid hydrochloride
Antineoplastic agents
Glioma
Gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (World Health Organization grade III and IV).
Revision: 8
Authorised
2007-09-07
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE USER GLIOLAN 30 MG/ML POWDER FOR ORAL SOLUTION 5-aminolevulinic acid hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. • If you get 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 Gliolan is and what it is used for 2. What you need to know before you take Gliolan 3. How to take Gliolan 4. Possible side effects 5. How to store Gliolan 6. Contents of the pack and other information 1. WHAT GLIOLAN IS AND WHAT IT IS USED FOR Gliolan is used for the visualisation of certain brain tumours (called malignant glioma) during tumour surgery. Gliolan contains a substance called aminolevulinic acid (5-ALA). 5-ALA accumulates preferably in tumour cells where it is transformed into another similar substance. If the tumour is then exposed to blue light, this new substance emits a red-violet light which helps to better see what is normal tissue and what is tumour tissue. This helps the surgeon to remove the tumour while sparing healthy tissue. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLIOLAN DO NOT TAKE GLIOLAN • if you are allergic to 5-ALA or porphyrins. • in case of known or suspected acute or chronic types of porphyria (i.e. inherited or acquired disorders of certain enzymes in the synthesis pathway of red blood pigment). • in case of known or suspected pregnancy. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Gliolan. • For 24 hours after administration of this medicine, PROTECT YOUR EYES AND SKIN FROM STRONG LIGHT (for example direct sunlight or brightly focused indoor light). • If you have a HEART DISEASE or had heart disease in the past, you should tell your doctor. In this case, this medicine shou Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Gliolan 30 mg/ml powder for oral solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl. 3. PHARMACEUTICAL FORM Powder for oral solution. The powder is a white to off-white cake. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gliolan is indicated in adults for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should only be used by experienced neurosurgeons conversant with surgery of malignant gliomas and in-depth knowledge of functional brain anatomy who have completed a training course in fluorescence-guided surgery. Posology The recommended dose is 20 mg 5-ALA HCl per kilogram body weight. The total number of bottles needed to achieve the intended dose for the individual patient can be determined according to the equation below (rounded up to the nearest whole bottle): _ _ _Patient body weight (kg) _ _Number of bottles = _ _——————————————_ _ _ _ _ _75 kg/bottle _ The administration volume needed to achieve the intended dose for the individual patient can be calculated according to the equation below: _ _ _Patient body weight (kg) x 20 mg/kg _ _Administration volume (ml) = _ _———————————————————_ _ _ _ _ _30 mg/ml _ _Renal or hepatic impairment _ No trials have been performed in patients with clinically relevant hepatic or renal impairment. Therefore, this medicinal product should be used with caution in such patients. _ _ _Elderly_ There are no special instructions for use in elderly patients with regular organ function. 3 _Paediatric population _ The safety and efficacy of Gliolan in children and adolescents aged 0 to 18 years ha Læs hele dokumentet