Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Oxaliplatin
Sanofi-Aventis Australia Pty Ltd
Oxaliplatin
WINTHROP ® OXALIPLATIN _Oxaliplatin powder for injection_ CONSUMER MEDICINE INFORMATION PLEASE READ THIS LEAFLET BEFORE YOU ARE GIVEN THIS MEDICINE. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Winthrop Oxaliplatin 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 benefits and risks. Your doctor has weighed the risks of using Winthrop Oxaliplatin against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. WHAT WINTHROP OXALIPLATIN IS USED FOR Winthrop Oxaliplatin is used to treat cancer of the oesophagus/stomach, large intestine and rectum (colorectal cancer). Winthrop Oxaliplatin is used in combination with other anti-cancer drugs; capecitabine, bevacizumab, epirubicin, fluorouracil (FU), and/or folinic acid. The active ingredient in Winthrop Oxaliplatin is called oxaliplatin. Cancer cells are normal cells which have changed so that they grow in an uncontrolled way. Oxaliplatin works by interfering with cancer cell growth. Because of the similarities between cancer cells and normal cells, anti cancer drugs often have unwanted effects on the body. Your doctors have decided to treat you with Winthrop Oxaliplatin because they believe that the benefit of Winthrop Oxaliplatin treatment will be greater than the unwanted effects. Many of the side effects from anti cancer drugs are predictable and can be prevented or lessened. Your doctor and other staff will take all of the precautions needed to reduce the unwanted effects of treatment. Winthrop Oxaliplatin is only available on a prescription from your doctor. BEFORE YOU ARE GIVEN WINTHROP OXALIPLATIN _WHEN YOU MUST NOT RECEIVE_ _IT_ YOU SHOULD NOT BE GIVEN WINTHROP OXALIPLATIN IF YOU ARE ALLERGIC TO THE ACTIVE INGREDIENT 'OXALIPLATIN'. If you have had an allergic reaction to oxaliplatin before, you should not receive it again. YOU MUST NOT RECEIVE WINTHROP OXALIPLATI Read the complete document
Winthrop-oxaliplatin-powd- ccdsv13-piv4-30jun15_ _ _ _ Page 1 of 30_ _ PRODUCT INFORMATION WINTHROP OXALIPLATIN NAME OF DRUG WINTHROP OXALIPLATIN ® Oxaliplatin powder for injection DESCRIPTION Oxaliplatin is designated chemically as [_SP_-4-2]-(1_R_,2_R_)-(cyclohexane-1,2-diamine-k 2 _N,N_´(oxalato(2- )-k 2 _O_ 1 ,_O_ 2 ]platinum (II) The empirical formula of oxaliplatin is C 8 H 14 N 2 O 4 Pt and its molecular weight is 397.3. Oxaliplatin has the following chemical structure: CAS Number: 61 825-94-3 Oxaliplatin is a white to off-white crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and practically insoluble in ethanol. Winthrop Oxaliplatin powder for injection contains oxaliplatin and lactose. PHARMACOLOGY PHARMACODYNAMICS Oxaliplatin is an antineoplastic drug belonging to a new class of platinum based compounds in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and an oxalate group. Oxaliplatin is a single enantiomer, the Cis-[oxalato(trans- λ -1,2-DACH) platinum]. Oxaliplatin exhibits a wide spectrum of both _ in vitro_ cytotoxicity and _ in vivo_ antitumour activity in a variety of tumour model systems, including human colorectal cancer models. Oxaliplatin also demonstrates _in vitro _and_ in vivo_ activity in various cisplatin resistant models. A synergistic cytotoxic action has been observed in combination with fluorouracil both _in vitro_ and _in _ _vivo_. Studies on the mechanism of action of oxaliplatin, although not completely elucidated, show that the aqua-derivatives resulting from the biotransformation of oxaliplatin interact with DNA to form both inter- and intra-strand cross links, resulting in the disruption of DNA synthesis leading to cytotoxic and antitumour effects. PHARMACOKINETICS The pharmacokinetics of individual active compounds have not been determined. The pharmacokinetics of ultrafiltrable platinum, representing a mixture of all unbound, active and inactive platinum species, following a two hour infusion of oxaliplatin at Read the complete document