País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
docetaxel, Quantity: 80 mg
Dr Reddys Laboratories Australia Pty Ltd
Docetaxel
Injection, concentrated
Excipient Ingredients: ethanol absolute; polysorbate 80; citric acid
Intravenous Infusion
1 vial
(S4) Prescription Only Medicine
Breast Cancer,Metastatic Breast Cancer,DOCETAXEL-RZ is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed.,DOCETAXEL-RZ 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-RZ 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-RZ 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-RZ in combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2,DOCETAXEL-RZ in c
Visual Identification: Sterile pale yellow to brownish yellow solution in 5 ml tubular glass vial stoppered with chlorobutyl rubberstopper and sealed with flip off seal.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-12-22
DOCETAXEL-DRLA DOCETAXEL-RZ DOCETERE DOTAX _Contains the active ingredient docetaxel _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some of the common questions about docetaxel. It does not contain all the information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking this medicine against the benefits they expect it will 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 THIS MEDICINE IS USED FOR The name of your medicine is Docetaxel-DRLA Docetaxel-RZ Docetere Dotax. It contains the active ingredient docetaxel. Docetaxel is used to treat breast cancer, ovarian cancer, some types of lung cancer, head and neck cancer and prostate cancer. Docetaxel works by stopping cells from growing and multiplying. Docetaxel 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 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 docetaxel. Docetaxel may be used alone or in combination with other medicines to treat cancer. This medicine is only available with a doctor's prescription. Docetaxel is not addictive. Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information. Rosuvastatin is not addictive. _USE IN CHILDREN _ Docetaxel is not recommended for use in children. BEFORE YOU GIVEN THIS MEDICINE _WHEN YOU MUST NOT BE GIVEN _ _IT _ DO NOT RECEIVE DOCETAXEL IF YOU HAVE AN ALLERGY TO D Llegiu el document complet
Product Information (v2, update 13/1/15) DOCETAXEL-DRLA DOCETAXEL-RZ DOCETERE DOTAX CONCENTRATED INJECTION NAME OF THE MEDICINE Docetaxel Chemical Name: 5β,20-Epoxy-1,7β,10β-trihydroxy-9-oxotax-11-ene-2α,4, 13α-triyl 4-acetate 2- benzoate 13-[(2R,3S)-3-[[(l,1-dimethylethoxy)carbonyl] amino]-2-hydroxy-3- phenylpropanoate]. Structural Formula: CAS Number: 114977-28-5 Molecular Formula: C 43 H 53 NO 14 Molecular Weight: 808 DESCRIPTION Docetaxel is white or almost white, crystalline, hygroscopic powder. Practically insoluble in water. Freely soluble in anhydrous ethanol, soluble in methylene chloride. Single-dose vials of Docetaxel-DRLA Docetaxel-RZ Docetere Dotax concentrated injection containing 20 or 80 mg of docetaxel per 1.0 or 4.0 mL, respectively, in 50% (v/v) mixture of polysorbate 80 (0.54 g or 2.16 g) and absolute ethanol (0.395 g or 1.58 g), citric acid anhydrous (0.003 g or 0.012 g). The sterile pyrogen-free viscous solution contains 20 mg/mL docetaxel (anhydrous). PHARMACOLOGY 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 schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human gra Llegiu el document complet