Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PEGINTERFERON ALFA-2A (40KD)
DKSH MALAYSIA SDN BHD
PEGINTERFERON ALFA-2A (40KD)
1Units Units; 4Units Units
F. HOFFMANN-LA ROCHE LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ PEGASYS ® PRE-FILLED SYRINGE Peginterferon alfa-2a (135mcg/0.5ml, 180mcg/0.5ml) _________________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What PEGASYS is used for 2. How PEGASYS works 3. Before you use PEGASYS 4. How to use PEGASYS 5. While you are using PEGASYS 6. Side effects 7. Storage and disposal of PEGASYS 8. Product Description 9. Manufacturer and Product Registration Holder 1. WHAT PEGASYS IS USED FOR CHRONIC HEPATITIS B: In people with a condition where the liver is scarred but still able to perform important functions (compensated liver disease) and evidence of viral growth and liver inflammation. CHRONIC HEPATITIS C: As part of a combination regimen with other medicines used to treat hepatitis C virus (HCV), in people with compensated liver disease. 2. HOW PEGASYS WORKS PEGASYS belongs to a group of medicines called interferons. PEGASYS is a long-acting interferon. Interferons are proteins that modify the response of the body's immune system to help fight infections and severe diseases. 3. BEFORE YOU USE PEGASYS - _When you must not take it _ DO NOT USE PEGASYS IF: 1. You have had an allergic reaction to alfa interferons, E. coli-derived products, polyethylene glycol or any of the ingredients listed at the end of this leaflet. Some symptoms of an allergic reaction include: • hives or skin rash • swelling of the face, lips or tongue • wheezing or trouble breathing, • faintness 2. You have a condition where your immune system attacks your own liver and causes it to become inflamed. 3. You have decompensated cirrhosis (severe liver disease). 4. You previously have severe pre- existing heart problems. 5. You are pregnant. 6. You are breast-feeding or plan to breast-feed. It is not known whether PEGASYS passes into the breast milk. Your doctor will discuss the risks and benefits of using PEGASYS if you are breast-feeding. 7. You are also infected with HIV and have chronic l Belgenin tamamını okuyun
2211-390 Artwork Request: 131589 Printing Colours: PANTONE Black C Comp. Description: 11004157 LEAF 135_180MCG PEGASYS MY-DIV Comp. No. New: 11004157_MY_1 Comp. No. Old: n/a Format/Dimension: 370 x 1030 mm Tech. Drawing No.: NP9359 Pharma Code: n/a Min. Font Size Text (RA): 9 pt Font Type: OfficinaSansBoldITC Regular; OfficinaSansBookITC Regular; Times New Roman Bold, Bold Italic, Italic, Regular Proof No.: 1 05.12.2022 F. Maier ! PLEASE TURN OVERPRINTING ON ! PEGASYS® PEGASYS® PACK INSERT FOR MALAYSIA PEGASYS® Peginterferon alfa-2a 1. DESCRIPTION 1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG Immunostimulants/Interferons ATC code: L03A B11 1.2 TYPE OF DOSAGE FORM Pegasys is supplied as a sterile, ready-to-use liquid for subcutaneous (SC) injection as pre-filled syringes. The solution is clear and colourless to light yellow. • 180 mcg Pegasys Pre-Filled Syringe: each single use syringe contains 0.5 mL with 180 mcg _ _ peginterferon alfa-2a. • 135 mcg Pegasys Pre-Filled Syringe: each single use syringe contains 0.5 mL with 135 mcg peginterferon alfa-2a. 1.3 ROUTE OF ADMINISTRATION Subcutaneous injection 1.4 STERILE / RADIOACTIVE STATEMENT Not applicable 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient_ : peginterferon alfa-2a. _Other excipients_ : Sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, acetic acid, water for injections. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) CHRONIC HEPATITIS B: Pegasys is indicated for the treatment of both HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB) in non-cirrhotic and cirrhotic patients with compensated liver disease and evidence of viral replication and liver inflammation. CHRONIC HEPATITIS C: Pegasys, as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs, is indicated for the treatment of adults with chronic hepatitis C (CHC) with compensated liver disease. This includes patients with or without liver cirrhosis, treatment-naive patients, patients who have failed previous treatment and pa Belgenin tamamını okuyun