Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
Paclitaxel
Baxter Healthcare Pty Ltd
Medicine Registered
Baxter Paclitaxel Injection CMI Aug_2008 1 BAXTER PACLITAXEL INJECTION Paclitaxel CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Paclitaxel 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 Paclitaxel injection 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 PACLITAXEL INJECTION IS USED FOR Paclitaxel Injection is used to treat cancer of the ovary, the breast and non small cell cancer of the lung. Paclitaxel Injection belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. Paclitaxel Injection works by stopping cancer cells from growing and multiplying. Your doctor may have prescribed Paclitaxel Injection for another reason. Ask your doctor if you have any questions about why Paclitaxel Injection has been prescribed for you. Paclitaxel Injection may be used in combination with other medicines to treat cancer. Paclitaxel Injection is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN PACLITAXEL INJECTION _ _ _WHEN YOU MUST NOT BE _ _GIVEN IT _ DO NOT HAVE PACLITAXEL INJECTION IF YOU HAVE AN ALLERGY TO PACLITAXEL OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction to Paclitaxel Injection may inc Lees het volledige document
1 BAXTER PACLITAXEL INJECTION PRODUCT INFORMATION Name of the medicine: Paclitaxel. [http://www.appco.com.au/appguide/drug.asp?drug_id=00097134] Description: Chemical name: (2S,5R,7S,10R,13S)- 10, 20-bis (acetoxy)-2-benzoyloxy- 1,7- dihydroxy-9-oxo-5,20-epoxytax- 11 –en-13-yl(3S)-3-benzoylamino-3-phenyl- D-lactate. Paclitaxel Injection contains paclitaxel, a natural product with antitumour activity. Paclitaxel is a white to off-white crystalline powder that is highly lipophilic and insoluble in water. Paclitaxel is the first of a new class of anticancer agents known as taxanes.The CAS number for paclitaxel is 33069- 62-4 (USAN). Molecular Formula: C 47 H 51 NO 14 Molecular Weight: 853.929 2 Pharmacology: Pharmacokinetics: The pharmacokinetics of paclitaxel have been evaluated over a wide range of doses, up to 300 mg/m 2 , and infusion schedules, ranging from 3 to 24 hours. Following intravenous administration, paclitaxel exhibits a biphasic decline in plasma concentrations. The initial rapid decline represents distribution to the peripheral compartment and elimination; the later phase is due, in part, to a relatively slow efflux of paclitaxel from the peripheral compartment. Maximum plasma concentrations are related to dose. In patients treated with doses of 135 and 175 mg/m 2 given as 3 and 24 hour infusions, mean terminal half-life has ranged from 3.0 to 52.7 hours, and total body clearance has ranged from 11.6 to 24.0 L/h/m 2 . Mean steady state volume of distribution following single dose infusion of 135 and 175 mg/m 2 has ranged from 198 to 688 L/m 2 , indicating extensive extravascular distribution and/or tissue binding. The volume of distribution is reduced in female subjects. Following 3 hour infusions of 175 mg/m 2 , Lees het volledige document