Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Peginterferon alfa-2a 270 µg/mL
Roche Products (NZ) Ltd
Peginterferon alfa-2a 270 µg/mL
135 mcg/0.5mL
Solution for injection
Active: Peginterferon alfa-2a 270 µg/mL Excipient: Acetic acid Benzyl alcohol Glacial acetic acid Sodium acetate soln 10% Polysorbate 80 Sodium acetate trihydrate Sodium chloride Water for injection
Syringe, glass, 4 prefilled syringes, 2 mL
Prescription
Prescription
Roche Diagnostics GmbH
Latest Regulatory Activity
Package - Contents - Shelf Life: Syringe, glass, 4 prefilled syringes - 2 mL - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2001-02-15
Pegasys ® 220530-1.00 1 CONSUMER MEDICINE INFORMATION PEGASYS ® PEGINTERFERON ALFA-2A 180 MCG IN 0.5 ML SOLUTION FOR INJECTION IN PREFILLED SYRINGES WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pegasys solution for injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Pegasys against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PEGASYS IS USED FOR Pegasys contains the active ingredient peginterferon alfa-2a. Pegasys belongs to a group of medicines called interferons. Pegasys is a long-acting interferon. Interferons are proteins that change how the body’s immune system fights infections and severe disease. Pegasys is used to treat chronic hepatitis B and chronic hepatitis C, which are viral infections of the liver. If these viral infections are not managed, in some people, the liver becomes badly damaged and scarred. This is called cirrhosis. Cirrhosis can cause the liver to stop working. Cirrhosis can also be caused by caused by things other than viral infections such as long-term alcoholism. It is not known if Pegasys can prevent liver failure or liver cancer that is caused by hepatitis infection. People who get hepatitis B or hepatitis C will usually carry the virus in their blood for the rest of their lives, unless successfully treated. Most will end up with some liver damage, but not all will feel sick in the earlier stages of the disease. In some people, the liver becomes badly damaged and scarred. This is called cirrhosis. Cirrhosis can cause the liver to stop working properly. Pegasys ® 220530-1.00 2 CHRONIC HEPATITIS B: Pegasys is usually used alone. CHRONIC HEPATITIS C: Pegasys is best used for this treatment in combination with ribavirin tablets. IF YOU RECEIVE THE COMBINA Pročitajte cijeli dokument
Pegasys 220530 -1.00 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Pegasys (peginterferon alfa-2a) 180mcg/0.5mLsolution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pegasys 180 micrograms solution for injection in pre-filled syringe. Each syringe of 0.5mL solution contains 180 micrograms of peginterferon alfa-2a. Excipients with known effect Benzyl alcohol (10 mg/ 1 ml) For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. The solution is clear and colourless to light yellow, practically free of particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chronic hepatitis B (CHB) Pegasys is indicated for the treatment of both HBeAg-positive and HBeAg-negative CHB in non-cirrhotic and cirrhotic patients with compensated liver disease and evidence of viral replication and liver inflammation. Chronic hepatitis C (CHC) Pegasys alone or in combination with ribavirin is indicated for the treatment of CHC in non- cirrhotic and cirrhotic patients with compensated liver disease. 4.2 DOSE AND METHOD OF ADMINISTRATION Before beginning Pegasys, standard haematological and biochemical laboratory tests are recommended for all patients (see section 4.4 Special warnings and precautions for use). Dose Chronic hepatitis B The recommended dosage of Pegasys for both HBeAg-positive and HBeAg-negative CHB is 180 mcg once weekly by subcutaneous administration in the abdomen or thigh. The recommended duration of therapy is 48 weeks. Chronic hepatitis C: treatment-naïve, prior treatment non-responder and relapser patients The recommended dosage of Pegasys, alone or in combination with ribavirin, is 180 mcg once a week by subcutaneous administration in the abdomen or thigh. Ribavirin should be administered in divided doses (morning and evening) with food. The recommended duration of Pegasys monotherapy is 48 weeks. The duration of combination therapy and the daily dose of ribavirin given in combination with Pegasys should be individualised based on the patient’s v Pročitajte cijeli dokument