Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
doxorubicin hydrochloride, Quantity: 2 mg/mL
Accord Healthcare Pty Ltd
Doxorubicin hydrochloride
Injection, concentrated
Excipient Ingredients: sodium chloride; water for injections; hydrochloric acid
Intravenous Infusion, Intravesical
1
(S4) Prescription Only Medicine
Doxorubicin has been used successfully to produce regression in neoplastic conditions such as: acute leukaemia, Wilms' tumour, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, lymphomas of both Hodgkin's and non-Hodgkin's type, bronchogenic (lung) carcinoma, thyroid carcinoma, hepatomas, ovarian carcinoma, etc. The main antitumour activities are listed in Table 1 of the Product Information. Doxorubicin is also indicated by intravesical administration in the primary management of non-metastatic carcinoma of the bladder. (Tis, T1, T2).
Visual Identification: A clear red solution filled in clear glass vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2011-09-29
Version 4.0 Page 1 of 4 DOXORUBICIN ACCORD _Doxorubicin hydrochloride Concentrated Injection 10 mg/5 mL and 200 mg/100 mL _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE TREATMENT WITH DOXORUBICIN ACCORD. This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Doxorubicin Accord against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. PLEASE KEEP THIS LEAFLET. You may need to read it again. WHAT DOXORUBICIN ACCORD IS USED FOR Doxorubicin Accord is used to treat many types of cancer. Doxorubicin Accord works by stopping cancer cells from growing and multiplying. It contains the active ingredient doxorubicin hydrochloride. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DOXORUBICIN ACCORD HAS BEEN PRESCRIBED FOR YOU. Doxorubicin Accord is to be given only under the strict supervision of your doctor. Doxorubicin Accord is not addictive. BEFORE YOU ARE GIVEN IT _WHEN YOU MUST NOT BE GIVEN _ _DOXORUBICIN ACCORD _ DO NOT HAVE DOXORUBICIN ACCORD IF YOU ARE ALLERGIC TO DOXORUBICIN ACCORD OR HAVE HAD AN ALLERGIC REACTION TO ANY OTHER CANCER MEDICATION E.G. DAUNORUBICIN, EPIRUBICIN, MITOZANTRONE. Symptoms of an allergic reaction to Doxorubicin Accord 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 • light-headedness or back pain. DO NOT HAVE DOXORUBICIN ACCORD IF: • you have bone marrow suppression (reduced number of red or white blood cells or platelets) caused by previous treatment with other cancer medicines or radiation therapy, symptoms include tiredness, mouth ulcers or bleeding or bruising more easily than usual • you have a generalised infection • you have an irregula Prečítajte si celý dokument
Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION DOXORUBICIN ACCORD (DOXORUBICIN HYDROCHLORIDE) CONCENTRATED INJECTION 1 NAME OF THE MEDICINE Doxorubicin hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Doxorubicin hydrochloride concentrated injection is supplied as 10 mg/5 mL and 200 mg/100 mL glass vials (doxorubicin hydrochloride concentration 2 mg/mL). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Doxorubicin hydrochloride concentrated injection is a sterile, red coloured, clear solution of doxorubicin hydrochloride and sodium chloride in water for injections. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Doxorubicin has been used successfully to produce regression in neoplastic conditions such as: acute leukaemia, Wilms' tumour, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, lymphomas of both Hodgkin's and non-Hodgkin's type, bronchogenic (lung) carcinoma, thyroid carcinoma, hepatomas, ovarian carcinoma, etc. The main antitumour activities are listed in Table 1. Doxorubicin is also indicated by intravesical administration in the primary management of non- metastatic carcinoma of the bladder. (Tis, T1, T2). TABLE 1 DOXORUBICIN ANTITUMOUR ACTIVITY TUMOUR TYPE RESPONSE RATE (%) MEDIAN DURATION (MONTH) FIRST LINE CHEMOTHERAPY Established Activity Breast 35 3-6 √ Ovary 38 3-6 ? Lung 30 3 ? Sarcoma 30 4 √ Wilms' 66 4 √ Bladder 28 4-6 ? Neuroblastoma 41 4 √ Hodgkin's 36 4-6 ? Non-Hodgkin's Lymphoma 40 4-6 √ Acute Leukaemia 35 3 ? Hepatoma 32 4-6 √ Thyroid 30 6-10 √ Some Response Stomach 30 2-4 √? Cervix 32 2-6 ? Head & Neck 19 2-4 Testicle 20 3-6 Myeloma 33 3 Endometrial 36 4-6 √? Unresponsive Colorectal Pancreas Renal Page 2 of 17 TUMOUR TYPE RESPONSE RATE (%) MEDIAN DURATION (MONTH) FIRST LINE CHEMOTHERAPY Melanoma Brain 4.2 D OSE AND METHOD OF ADMINISTRATION GENERAL DIRECTIONS: The use of a Pharmacy Bulk Pack should be restricted to suitably qualified pharmacists operating in suitably equipped hospital pharmacies or compoun Prečítajte si celý dokument