Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Imiglucerase
Genzyme Therapeutics Ltd
A16AB02
Imiglucerase
400unit
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 09080100; GTIN: 5030045000197
Cerezyme should not be given as a mixture with other medicinal products in the same infusion (drip). PREGNANCY AND BREAST-FEEDING If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Cautious use of Cerezyme during pregnancy and breastfeeding is recommended. CEREZYME CONTAINS SODIUM This medicine contains sodium and is administered in 0.9% sodium chloride intravenous solution. To be taken into consideration by patients on a controlled sodium diet. 3. HOW CEREZYME IS GIVEN Instructions for proper use Cerezyme is given through a drip into a vein (by intravenous infusion). It is supplied as a powder which will be mixed with sterile water before it is given. Cerezyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Gaucher disease. Your doctor may advise that you can be treated at home provided you meet certain criteria. Please contact your doctor if you would like to be treated at home. Your dose will be specific to you. Your doctor will work out your dose based on how severe your symptoms are, and other factors. The recommended dose is 60 units/kg body weight given once every 2 weeks. Your doctor will keep a close check on your response to your treatment, and may change your dose (up or down) until he/she finds the best dose to control your symptoms. Once this dose is found your doctor will still keep a check on your responses to make sure you are using the right dose. This might be every 6 to 12 months. There is no information on the effect of Cerezyme on brain- based symptoms of patients with chronic neuronopathic Gaucher disease. Therefore no special dosage regimen can be recommended. The ICGG Gaucher Registry You can ask your doctor to register your patient information into the “ICGG Gaucher Registry”. The aims of this Registry are to increase the understanding of Gaucher disease and to check how well enzyme replacement therapy, like Cerezyme, works. This s Прочитать полный документ
OBJECT 1 CEREZYME 400 U POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 17-Aug-2016 | Genzyme Therapeutics 1. Name of the medicinal product Cerezyme 400 U Powder for concentrate for solution for infusion 2. Qualitative and quantitative composition Each vial contains 400 units* of imiglucerase**. After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (400 U/10 ml). * An enzyme unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl β-D-glucopyranoside (pNP-Glc) per minute at 37°C. ** Imiglucerase is a modified form of human acid β-glucosidase and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture, with mannose modification for targeting macrophages. Excipients: For the full list of excipients, see section 6.1. This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6). After reconstitution, the solution contains 1.24 mmol sodium (400 U/10 mL). To be taken into consideration by patients on a controlled sodium diet. 3. Pharmaceutical form Powder for concentrate for solution for infusion. Cerezyme is a white to off-white powder. 4. Clinical particulars 4.1 Therapeutic indications Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease. The non-neurological manifestations of Gaucher disease include one or more of the following conditions: • anaemia after exclusion of other causes, such as iron deficiency • thrombocytopenia • bone disease after exclusion of other causes such as Vitamin D deficiency • hepatomegaly or splenomegaly 4.2 Posology and method of administration Disease management should be directed Прочитать полный документ