Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
zidovudine, Quantity: 10 mg/mL
ViiV Healthcare Pty Ltd
Oral Liquid, solution
Excipient Ingredients: citric acid; glycerol; maltitol solution; purified water; sodium benzoate; saccharin sodium; Flavour
Oral
200mL
(S4) Prescription Only Medicine
(1) Treatment of adult patients with severe symptomatic human immunodeficiency virus infection (AIDS or advanced AIDS related complex). (2) Treatment of other HIV-positive adult patients with less than 500 CD4 cells/mm3. New indications as at 11 May 1994: Retrovir is indicated for: . Treatment of adult patients with severe symptomatic human immunodeficiency virus infection (AIDS or advanced AIDS related complex); . Treatment of other HIV-positive adult patients with less than 500 CD4 cells/mm3. Notes: (1) The limited available data currently support the extended use of Retrovir (indication 2 above). (2) The optimal dosage for these indications has not been established . Combination therapy in advanced HIV infection: The addition of HIVID (zalcitabine) may be considered for the management of adult patients with advanced HIV infection and CD4 + cell counts less than or equal to 200/mm3, who have received Retrovir monotherapy for less than 12 months. Retrovir monotherapy is still indicated as initial therapy f
Visual Identification: A clear, pale yellow syrup.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1992-12-11
RETROVIR _CAPSULES AND SYRUP_ _zidovudine_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you start RETROVIR. This leaflet answers some common questions about RETROVIR. It does not contain all of 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 taking RETROVIR against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT RETROVIR IS USED FOR RETROVIR contains zidovudine which belongs to a group of medicines called antiretrovirals. RETROVIR is used, alone or with other antiretrovirals, to slow down the progression of human immuno- deficiency virus (HIV) infection, which can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (e.g. AIDS- related Complex or ARC). RETROVIR does not cure AIDS or HIV infection, but slows production of human immunodeficiency virus. In this way it stops ongoing damage to the body's immune system, which fights infection. You will still be able to pass on the HIV virus by sexual activity or by passing on blood or bodily secretions, which carry the HIV virus, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people. While taking RETROVIR and/or any other therapy for HIV disease, you may continue to develop other infections and other complications of HIV infection. You should keep in regular contact with your doctor. RETROVIR has been extensively studied but for limited periods of time. The long-term risks and benefits of taking RETROVIR are not known; especially in patients without symptoms of HIV infection, or with early HIV disease. Your doctor may have prescribed RETROVIR for another reason. Ask your doctor if you have any questions about why RE Đọc toàn bộ tài liệu
1 AUSTRALIAN PRODUCT INFORMATION RETROVIR (ZIDOVUDINE) CAPSULES AND SYRUP 1 NAME OF THE MEDICINE Zidovudine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zidovudine is a white to off-white, odourless crystalline solid. RETROVIR Capsules 100 mg: Each capsule contains zidovudine 100 mg. RETROVIR Capsules 250 mg: Each capsule contains zidovudine 250 mg. RETROVIR Syrup: Each 5 mL contains zidovudine 50 mg, sodium benzoate, saccharin sodium, maltitol solution. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM RETROVIR Capsules 100 mg: Opaque white cap and body coded GSYJU. RETROVIR Capsules 250 mg: Opaque blue cap and opaque white body coded GSJV2. RETROVIR Syrup: Pale yellow, strawberry flavoured. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RETROVIR (zidovudine) is indicated for use in the treatment of HIV infection, alone and in combination with other antiretroviral therapies. The optimal dosage for this indication has not been established. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS WEIGHING AT LEAST 30 KG A broad range of dosage regimens has been employed; a daily dose of 500-600 mg in two to five divided doses has been used commonly world wide. DOSAGE IN COMBINATION THERAPY RETROVIR may be administered separately or with other antiretroviral therapies (see Section 5.1 PHARMACODYNAMIC PROPERTIES - Clinical trials - Combination therapy). MONITORING OF PATIENTS Haematologic toxicities appear to be related to pretreatment bone marrow reserve and to dose and duration of therapy. In patients with poor bone marrow reserve, particularly in patients with advanced symptomatic HIV disease, frequent monitoring of haematologic 2 indices is recommended to detect serious anaemia or granulocytopenia (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). In patients who experience haematologic toxicity, reduction in haemoglobin may occur as early as 2 to 4 weeks, and granulocytopenia usually occurs after 6 to 8 weeks. DOSE ADJUSTMENT Significant anaemia (haemoglobin of < 7.5 g/dL Đọc toàn bộ tài liệu