Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RECOMBINANT HUMAN INTERFERON BETA
MERCK SDN. BHD.
RECOMBINANT HUMAN INTERFERON BETA
12Units Units; 3Units Units; 1Units Units; 3 Pieces Pieces; 1 Pieces Pieces; 12 Pieces Pieces
Merck Serono S.p.A.
Consumer Medication Information Leaflet (RiMUP) 1 REBIF ® SOLUTION FOR INJECTION Interferon Beta-1a (22mcg, 44mcg per 0.5ml) What is in this leaflet 1. What Rebif is used for 2. How Rebif works 3. Before you use Rebif 4. How to use Rebif 5. While you are using Rebif 6. Side Effects 7. Storage and Disposal of Rebif 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision What Rebif is used for R ebif is used in ambulatory people who have relapsing forms of multiple sclerosis (MS). It is also approved for use in those who have experienced a single clinical event likely to be a first sign of multiple sclerosis. How Rebif works Rebif belongs to a class of medicine known as interferons. The active substance of Rebif is interferon beta- 1a, a recombinant human interferon beta produced in Chinese hamster ovary cells. Rebif has been shown to reduce the number of attacks that occur, decrease the severity of attacks and increase the time between attacks. Treatment with Rebif also delays the progression in disability and lowers the number of times people need to be hospitalised because of attacks. Before you use Rebif - When you must not use it Do not use if you have an allergy to: interferon beta any of the other ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath wheezing or difficulty breathing swelling of the face, lips, tongue or other parts of the body rash, itching or hives on the skin. Do not use Rebif if: you are feeling depressed (feeling of severe sadness and unworthiness) or have thoughts of suicide. you are pregnant or intend to become pregnant as there may be an increased risk of spontaneous abortion. Rebif may be considered during pregnancy if clinically needed. you want to have children; you should discuss this matter with your doctor. after the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is Lestu allt skjalið
1 NAME OF THE MEDICINAL PRODUCT Rebif 22mcg/0.5ml solution for injection Rebif 44mcg/0.5ml solution for injection QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe or prefilled pen (0.5 ml) contains 22 mcg (6 MIU*) or 44mcg (12 MIU*) of interferon beta-1a**. Each cartridge (1.5ml) contains 66mcg (18 MIU*) or 132mcg (36 MIU*) of interferon beta-1a** * Million International Units, measured by cytopathic effect (CPE) bioassay against the in -house IFN beta- 1a standard which is calibrated against the current international NIH standard (GB -23 -902- 531). ** produced in Chinese hamster ovary Cells (CHO -K1) by recombinant DNA technology. Excipient: 2.5 mg/0.5ml benzyl alcohol For a full list of excipients, please see section List of excipients. PHARMACEUTICAL FORM Solution for injection in pre -filled syringe or pre-filled pen. Clear to opalescent solution, with pH 3.5 to 4.5 and osmolarity 250 to 450 mOsm/l. Solution for injection in cartridge Clear to opalescent solution, with pH 3.7 to 4.1 and osmolarity 250 to 450 mOsm/l. CLINICAL PARTICULARS Therapeuti c indications Rebif is indicated for the treatment of • patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis. • patients with relapsing multiple sclerosis. In clinical trials, this was characterised by two or more acute exacerbations in the previous two years. Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity. Posology and method of administration Treatment should be initiated under supervision of physician experienced in the treatment of the disease. Rebif is available in two strengths: 22 mcg and 44 mcg. Posology When first starting treatment with Rebif, in order to allow tachyphylaxis to develop thus reducing adverse reactions, it is recommended that 8.8 mcg (0.1 ml of the 44 mcg strength or 0.2 ml o Lestu allt skjalið