Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
velaglucerase alfa
Takeda Pharmaceuticals International AG Ireland Branch
A16AB10
velaglucerase alfa
Other alimentary tract and metabolism products,
Gaucher Disease
Vpriv is indicated for long-term enzyme-replacement therapy (ERT) in patients with type-1 Gaucher disease.
Revision: 20
Authorised
2010-08-26
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE USER VPRIV 400 UNITS POWDER FOR SOLUTION FOR INFUSION velaglucerase alfa READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet (see section 4). WHAT IS IN THIS LEAFLET 1. What VPRIV is and what it is used for 2. What you need to know before VPRIV is used 3. How VPRIV is used 4. Possible side effects 5. How to store VPRIV 6. Contents of the pack and other information 1. WHAT VPRIV IS AND WHAT IT IS USED FOR VPRIV is a long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease. Gaucher disease is a genetic disorder caused by a missing or defective enzyme named glucocerebrosidase. When this enzyme is missing or does not work properly, a substance called glucocerebroside builds up inside cells in the body. The build-up of this material causes the signs and symptoms found in Gaucher disease. VPRIV contains a substance called velaglucerase alfa which is designed to replace the missing or defective enzyme, glucocerebrosidase, in patients with Gaucher disease. 2. WHAT YOU NEED TO KNOW BEFORE VPRIV IS USED DO NOT USE VPRIV - if you are severely allergic to velaglucerase alfa or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before VPRIV is used - If you are treated with VPRIV, you may experience side effects during or following the infusion (see section 4, possible side effects). These are called infusion related reactions and might appear as a hypersensitivity reaction with symptoms like nausea, rash, difficulty in breathing, back pain, chest discomfort (chest tightness), hives, joint pain or headache. - Apart from symptoms of hypersensitivity reactions infusion-related reactions m Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT VPRIV 400 Units powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 400 Units* of velaglucerase alfa**. After reconstitution, one ml of the solution contains 100 Units of velaglucerase alfa. *An enzyme unit is defined as the amount of enzyme that is required to convert one micromole of p-nitrophenyl β-D-glucopyranoside to p-nitrophenol per minute at 37 ºC. **produced in an HT-1080 human fibroblast cell line by recombinant DNA technology. Excipient with known effect Each vial contains 12.15 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. White to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VPRIV is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION VPRIV treatment should be supervised by a physician experienced in the management of patients with Gaucher disease. Posology The recommended dose is 60 Units/kg administered every other week. Dose adjustments can be made on an individual basis based on achievement and maintenance of therapeutic goals. Clinical studies have evaluated doses ranging from 15 to 60 Units/kg every other week. Doses higher than 60 Units/kg have not been studied. Patients currently treated with imiglucerase enzyme replacement therapy for type 1 Gaucher disease may be switched to VPRIV, using the same dose and frequency. Special populations _Elderly (≥ 65 years old) _ Elderly patients may be treated within the same dose range (15 to 60 Units/kg) as other adult patients (see section 5.1). 3 Renal impairment No dosing adjustment is recommended in patients with renal impairment based on current knowledge of the pharmacokinetics and pharmacodynamics of velaglucerase alfa (see section 5.2). Hepatic impairment No dosing adjustment is recommended in patients with hepatic impairment based on curr Lestu allt skjalið