国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Interferon alfa-2a
Roche Products Ltd
L03AB04
Interferon alfa-2a
12mega unit/1ml
Solution for injection
Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08020400; GTIN: 5000471004472
1 uk-pl-roferon-clean-180420-3-4.5-6-9 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). Some other forms of cancer (renal cell carcinoma, follicular non-Hodgkin’s lymphoma and malignant melanoma). If you are not sure why you have been prescribed Roferon-A, you should discuss your illness and its treatment with your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ROFERON-A DO NOT USE ROFERON-A: if 完全なドキュメントを読む
OBJECT 1 ROFERON-A 6 MILLION INTERNATIONAL UNITS (IU) SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Summary of Product Characteristics Updated 04-Jun-2018 | Roche Products Limited 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/0.5 ml). * produced in Escherichia coli by recombinant DNA technology **Contains volume overages For the full list of excipients, see section 6.1. Excipients recognized to have a known effect: Benzyl alcohol (10 mg/1 ml) 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. - 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 interferon alfa-2a in the treatment of hepatitis C is enhanced when combined with ribavirin. Roferon-A should be given alone mainly in case of intolerance or contraindication to riba 完全なドキュメントを読む