Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Interferon alfa-2a
Roche Products Pty Ltd
Interferon alfa-2a
Registered
ROFERON-A 170927 1 ROFERON ® -A _PRE FILLED SYRINGES _ _contains the active ingredient interferon alfa-2a (rbe) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Roferon-A pre-filled syringes. 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 Roferon-A against the benefits they expect it will have 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 ROFERON-A IS USED FOR Roferon-A contains the active ingredient interferon alfa-2a. Roferon-A belongs to a group of medicines called interferons. Roferon-A is a similar form of interferon to one of the interferons made naturally by your own immune system as a defence against viruses and tumours. Roferon-A works by slowing the growth of certain tumour cells and viruses and also by boosting the effects of your own immune system to fight these. Roferon-A is used in the treatment of viral infections of the liver (chronic active hepatitis B and chronic hepatitis C). Roferon-A treatment will not prevent a hepatitis B or C infected person from giving another person hepatitis B or C. Roferon-A may be used in combination with ribavirin for the treatment of chronic hepatitis C in patients who have relapsed to previous interferon monotherapy treatment. Roferon-A is also used in the treatment of various types of cancer such as, kidney cancer (renal cell carcinoma), cancer of the lymph glands (cutaneous T-cell lymphoma), blood cancer (hairy cell leukaemia, chronic myelogenous leukaemia (CML) and other bone marrow conditions causing platelet disorders), AIDS-related cancer (Kaposi's sarcoma), and low-grade non-Hodgkin's lymphoma. Roferon-A may be used in combination with AVASTIN for the treatment of kidney cancer. Your doctor, however, may have prescribed Roferon-A Læs hele dokumentet
Roferon-A ® 170908 1 NAME OF THE MEDICINE ROFERON-A _interferon alfa-2a _ CAS-76543-88-9 _ _ DESCRIPTION Roferon-A (interferon alfa-2a) is a sterile protein product for use by injection. ROFERON-A is produced biosynthetically using recombinant DNA technology, and is the product of a cloned human leucocyte interferon gene inserted into and expressed in _E.coli_ . Interferon alfa-2a is a highly purified protein containing 165 amino acids. It has an approximate molecular weight of 19 kD. Roferon-A solution for injection is supplied as pre-filled syringes containing interferon alfa-2a, sodium chloride, ammonium acetate, benzyl alcohol, polysorbate 80, glacial acetic acid, sodium hydroxide and water for injections. Fermentation is carried out in a defined nutrient medium containing the antibiotic tetracycline hydrochloride, 5 mg/L. However, the presence of the antibiotic is not detectable in the final product. Each pre-filled syringe of Roferon-A solution for injection contains 3 or 9 million international units (MIU) of interferon alfa-2a. The specific activity of interferon alfa-2a is approximately 270 MIU/mg protein. Roferon-A should be administered by subcutaneous injection. PHARMACOLOGY PHARMACODYNAMICS _Mechanism of action: _ The mechanism by which interferon alfa-2a, or any other interferon, exerts anti- tumour activity is not clearly understood. However, it is believed that direct anti-proliferative action against tumour cells and modulation of the host immune response play important roles in the anti- tumour activity. Roferon-A exerts its antiviral effects by inducing a state of resistance to viral infections in cells and by modulating the effector arm of the immune system to neutralise viruses or eliminate virus- infected cells. Roferon-A ® 170908 2 The biological activities of interferon alfa-2a are species-restricted, i.e. they are expressed in a very limited number of species other than humans. As a consequence, preclinical evaluation of interferon alfa-2a has involved _in vitro_ experiments with hu Læs hele dokumentet