Country: New Zealand
Lingwa: Ingliż
Sors: Medsafe (Medicines Safety Authority)
Doxorubicin hydrochloride 10mg
Pfizer New Zealand Limited
Doxorubicin hydrochloride 10 mg
10 mg
Powder for injection
Active: Doxorubicin hydrochloride 10mg Excipient: Lactose monohydrate
Vial, 10 mg
Prescription
Prescription
Microbiopharm Japan Co Ltd
Doxorubicin has produced significant therapeutic responses in a number of solid tumours and haematologic malignancies, and is commonly used in the treatment of the following tumours: · carcinoma of the breast · carcinoma of the lung · carcinoma of the ovary · transitional bladder cell cancer · neuroblastoma · Wilms' tumour · soft tissue sarcomas · osteosarcoma · acute lymphocytic - lymphoblastic leukaemia · acute myelogenous leukaemia · non-Hodgkin's lymphoma · Hodgkin's disease Doxorubicin has also shown antitumour activity in the following adult and paediatric malignancies: · carcinoma of the thyroid · carcinoma of the endometrium · carcinoma of the head and neck · carcinoma of the stomach · primary hepatocellular carcinoma · non-seminomatous carcinoma of the testis · carcinoma of the prostate · Ewing's sarcoma · rhabdomyosarcoma · multiple myeloma · chronic leukaemias
Package - Contents - Shelf Life: Vial, - 10 mg - 36 months from date of manufacture stored at or below 25°C
1991-06-27
Version pfddoxoa10219 Page 1 of 16 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ DBL™ Doxorubicin hydrochloride Injection Doxorubicin Hydrochloride (Hospira) for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL™ Doxorubicin hydrochloride Injection is supplied in solution form containing sodium chloride. Doxorubicin hydrochloride (Hospira) for Injection is supplied as a freeze dried product containing Lactose as an excipient. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM DBL™ Doxorubicin hydrochloride Injection is a solution for injection Doxorubicin Hydrochloride (Hospira) is a Powder for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Doxorubicin has produced significant therapeutic responses in a number of solid tumours and haematologic malignancies, and is commonly used in the treatment of the following tumours: carcinoma of the breast carcinoma of the lung carcinoma of the ovary transitional cell bladder cancer neuroblastoma Wilm's tumour soft tissue sarcomas osteosarcoma Version pfddoxoa10219 Page 2 of 16 acute lymphocytic - lymphoblastic leukaemia acute myelogenous leukaemia non-Hodgkin's lymphoma Hodgkin's disease Doxorubicin has also shown antitumour activity in the following adult and paediatric malignancies: carcinoma of the thyroid carcinoma of the endometrium carcinoma of the head and neck carcinoma of the stomach primary hepatocellular carcinoma non-seminomatous carcinoma of the testis carcinoma of the prostate Ewing's sarcoma rhabdomyosarcoma multiple myeloma chronic leukaemias 4.2 DOSE AND METHOD OF ADMINISTRATION Doxorubicin is a cytotoxic drug that is usually administered to cancer patients by the intravenous and, whenever appropriate, intravesical and intra-arterial routes. INTRAVENOUS (IV) ADMINISTRATION: Dosage is usually calculated on the basis of body surface area (mg/m 2 ). The doxorubicin dose-schedule to be delivered may differ depending on the t Aqra d-dokument sħiħ