Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
docetaxel, Quantity: 160 mg
Wockhardt Bio Pty Ltd
Injection, concentrated
Excipient Ingredients: citric acid monohydrate; polysorbate 80; ethanol absolute
Intravenous Infusion
One vial
(S4) Prescription Only Medicine
Docetaxel concentrate for solution for infusion is indicated for;,Breast Cancer -,Metastatic Breast Cancer : Docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. ,Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. ,Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. ,Adjuvant Treatment of Breast Cancer : Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. ,Doxorubicin and cyclophosphamide followed by Docetaxel in combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2. ,Docetaxel in combination with carboplatin and trastuzumab (TCH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2. ,Docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of ? 1cm and < 7cm. ,Non Small Cell Lung Cancer -,Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, including those who have failed platinum-based chemotherapy. ,Ovarian Cancer - Docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. ,Prostate Cancer -,Docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. ,Head and Neck Cancer -,Docetaxel, in combination with cisplatin and fluorouracil is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.
Visual Identification: Clear viscous, colourless to yellowish or greenish-yellow sterile solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2017-12-04
DOCETAXEL WKT 1 DOCETAXEL WKT ( _Docetaxel_ ) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Docetaxel WKT It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. The information in this leaflet was last updated on the date shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist, nurse or doctor to obtain the most up to date information on this medicine. All medicines have risks and benefits. Your doctor has weighed the risks of you being given this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DOCETAXEL WKT IS USED FOR DOCETAXEL WKT is used to treat breast cancer, ovarian cancer, some types of lung cancer, head and neck cancer and prostate cancer. DOCETAXEL WKT works by stopping cells from growing and multiplying. DOCETAXEL WKT belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. Your doctor, however, may prescribe DOCETAXEL WKT for another purpose. ASK YOUR DOCTOR, NURSE OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. You may have probably taken another medicine to treat your breast, ovarian, lung, head and neck or prostate cancer. However, your doctor has now decided to treat you with D O C E T A X E L WKT may be used alone or in combination with other medicines to treat cancer. This medicine is only available with a doctor's prescription. D O C E T A X E L WKT is not addictive. BEFORE YOU ARE GIVEN IT _WHEN YOU MUST NOT BE GIVEN IT _ DOCETAXEL WKT is not recommended for use in children. DO NOT RECEIVE DOCETAXEL WKT IF YOU HAVE AN ALLERGY TO DOCETAXEL OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEA Läs hela dokumentet
DOCETAXEL WKT Version 1.1 Page 1 PRODUCT INFORMATION DOCETAXEL WKT AUSTRALIAN APPROVED NAME Docetaxel CHEMICAL STRUCTURE Molecular Formula: C 43 H 53 NO 14 Molecular Weight: 807.88 Chemical Name: (2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butyl ester, 13-ester with 5β, 20 epoxy 1, 2α , 4, 7β, 10β, 13α -hexahydroxytax-11-en-9-one 4-acetate 2- benzoate CAS REGISTRY NUMBER 114977-28-5 DOCETAXEL WKT Version 1.1 Page 2 DESCRIPTION DOCETAXEL Docetaxel is a white to almost white powder. It is highly lipophilic and practically insoluble in water. Single-dose vials of DOCETAXEL WKT concentrated injection containing 20 or 80 or 160mg of docetaxel per 1.0 or 4.0 or 8.0mL. In each DOCETAXEL WKT 20mg/1mL concentrate vial, contains 2 mg citric acid, 457 mg of absolute ethanol (96%) and 450 mg of polysorbate 80. In each DOCETAXEL WKT 80mg/4mL concentrate vial, contains 8mg citric acid, 1828 mg of absolute ethanol (96%) and 1800 mg of polysorbate 80. In each DOCETAXEL WKT 160mg/8mL concentrate vial, contains 16 mg citric acid, 3656 mg of absolute ethanol (96%) and 3600 mg of polysorbate 80. PHARMACOLOGY CLASS Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin. The binding of docetaxel to microtubules does not alter the number of protofilaments. PHARMACODYNAMICS MECHANISM OF ACTION Docetaxel has been shown in vitro to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions. _PRECLINICAL DATA _ Docetaxel was found to be cytotoxic _in vitro _ against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays. Docetaxel achieves high intracellular concentrations with a long cell residence time. In addition, docetaxel was found to be active on some, but not all, cell lines overexpressing the p-glycoprotein which is encoded by the multidrug resistance gene. In vivo, docetaxel is schedu Läs hela dokumentet