Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
INTERFERON ALFA-2A
Roche Products Limited
INTERFERON ALFA-2A
6miu/ml %v/v
Solution for Injection
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
1 Roferon- pil-clean-1405-3-4.5-6-9MIU-pfs PACKAGE LEAFLET: INFORMATION FOR THE USER ROFERON ® -A 3 MILLION INTERNATIONAL UNITS (IU) 4.5 MILLION INTERNATIONAL UNITS (IU) 6 MILLION INTERNATIONAL UNITS (IU) 9 MILLION INTERNATIONAL UNITS (IU) SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Interferon alfa-2a 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 or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Roferon-A is and what it is used for 2. What you need to know before you use Roferon-A 3. How to use Roferon-A 4. Possible side effects 5. How to store Roferon-A 6. Contents of the pack and other information 7. How to inject Roferon-A 1. WHAT ROFERON-A IS AND WHAT IT IS USED FOR Roferon-A contains an antiviral agent called interferon alfa-2a which is similar to a natural substance produced by the body to protect against viral infections, tumors and foreign substances that may invade the body. Once Roferon-A has detected and attacked a foreign substance, it alters it by slowing, blocking, or changing its growth or function. Roferon-A is used to treat the following: ● Viral infections, such as chronic hepatitis B and C. Cancers of the blood (cutaneous T-cell lymphoma, hairy cell leukaemia and chronic myelogenous leukaemia). Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Roferon-A 6 million international units (IU) solution for injection in pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 6 million International Units interferon alfa-2a* per 0.5 millilitres** (6 million IU/0.5ml). *produced in Escherichia coli by recombinant DNA technology. **Contains volume overages. For the full list of excipients, see section 6.1. Excipients recognised to have a known effect: Benzyl alcohol (10mg/1ml) 3 PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. Solution is clear and colourless to light yellow. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Roferon-A is indicated for the treatment of: - Hairy cell leukemia. - AIDS patients with progressive, asymptomatic Kaposi's sarcoma who have a CD4 count > 250/mm 3 . - Chronic phase Philadelphia-chromosome positive chronic myelogenous leukemia. Roferon-A is not an alternative treatment for CML patients who have an HLA-identical relative and for whom allogeneic bone marrow transplantation is planned or possible in the immediate future. It is still unknown whether Roferon-A can be considered as a treatment with a curative potential in this indication. - Cutaneous T-cell lymphoma. Interferon alfa-2a (Roferon-A ) may be active in patients who have progressive disease and who are refractory to, or unsuitable for, conventional therapy. - Adult patients with histologically proven chronic hepatitis B who have markers for viral replication, i.e., those who are positive for HBV DNA or HBeAg. - Adult patients with histologically proven chronic hepatitis C who are positive for HCV antibodies or HCV RNA and have elevated serum alanine aminotransferase (ALT) without liver decompensation. The efficacy of interfe Read the complete document