Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
etoposide, Quantity: 20 mg/mL
Pfizer Australia Pty Ltd
Injection, concentrated
Excipient Ingredients: macrogol 300; citric acid; polysorbate 80; ethanol absolute
Intravenous
1 x 1g/50mL multidose vial, 1 x 500mg/25mL multidose vial (hospital use only)
(S4) Prescription Only Medicine
INDICATIONS AS AT 3 April 1996: Etoposide Injection is indicated for the following: Small cell carcinoma of the lung. Acute monocytic and myelomonocytic leukaemia. Hodgkin's disease. Non-Hodgkin's lymphoma
Visual Identification: Clear, colourless to straw coloured solution, free from visible defects.; Container Type: Vial; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1995-08-02
ETOPOSIDE INJECTION _Etoposide_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Etoposide 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 taking Etoposide Injection against the benefits they expect it will have for you. This medicine is likely to be used while you are in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT ETOPOSIDE INJECTION IS USED FOR Etoposide belongs to a group of anticancer drugs known as epipodophyllotoxins. Etoposide is active against a number of cancers, including small cell carcinoma of the lung, as well as cancers of blood cells such as acute monocytic and myelomonocytic leukaemia, Hodgkin's disease, and Non- Hodgkin's lymphoma. It works by preventing the growth of cancer cells and eventually destroying them. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN ETOPOSIDE INJECTION _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT HAVE ETOPOSIDE INJECTION IF YOU HAVE AN ALLERGY TO: • any medicine containing etoposide • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT HAVE ETOPOSIDE INJECTION IF YOU HAVE ANY OF THE FOLLOWING MEDICAL CONDITIONS: • liver disease • severe bone marrow failure • severe infec Прочитать полный документ
Version: pfpetopi10422 Supersedes: pfpetopi11118 Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION – ETOPOSIDE (ETOPOSIDE) 1. NAME OF THE MEDICINE Etoposide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Etoposide Injection is a sterile solution containing etoposide 20 mg/mL in an organic solvent base. Excipients with known effect: Ethanol _ _ For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Concentrate for Solution for Infusion Etoposide is a white or almost white, crystalline powder, practically insoluble in water, sparingly soluble in methanol, slightly soluble in alcohol and in methylene chloride. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Small cell carcinoma of the lung. • Acute monocytic and myelomonocytic leukaemia. • Hodgkin’s disease. • Non-Hodgkin’s lymphoma. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The usual dose of etoposide must be based on the clinical and haematological response and tolerance of the patient. A repeat course of etoposide should not be administered until the patient’s haematological function is within acceptable limits. (See section 4.4 Special warnings and precautions for use). _ _ _ _ Version: pfpetopi10422 Supersedes: pfpetopi11118 Page 2 of 13 _ADULT _ The dosage for Etoposide Injection is 50-60 mg/m 2 /day intravenously for 5 consecutive days followed by a treatment free interval of 2-3 weeks. Total dose should not usually exceed 400 mg/m 2 per course. In any case, repeat courses should not be given until the hematological parameters have been checked for evidence of myelosuppression and found to be satisfactory. METHOD OF ADMINISTRATION Plastic devices made of acrylic or ABS (a polymer of acrylonitrile, butadiene and styrene) have been reported to crack or leak when used with undiluted Etoposide injection. Etoposide should only be given by slow intravenous infusion (see section 4.4 Special warnings and precautions for use, section 4.8 Adverse effects (undesirable effects)) Etoposide should not be administered Прочитать полный документ