Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
oxaliplatin
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
Oxaliplatin
Registered
CMI for Oxaliplatin Kabi PFI March 2011 OxaPFICMI090311 OXALIPLATIN KABI PFI Oxaliplatin Kabi PFI powder for injection (50 mg, 100 mg and 150 mg) 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 OXALIPLATIN KABI PFI. 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 OXALIPLATIN KABI PFI 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 OXALIPLATIN KABI PFI IS USED FOR OXALIPLATIN KABI PFI is used to treat cancer of the large intestine and rectum (colorectal cancer). OXALIPLATIN KABI PFI is used in combination with two other anti-cancer drugs, fluorouracil (FU), and folinic acid. The active ingredient in OXALIPLATIN KABI PFI 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 OXALIPLATIN KABI PFI because they believe that the benefit of OXALIPLATIN KABI PFI treatment will be greater than the unwanted effects. Many of the side effects from anticancer 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. OXALIPLATIN KABI PFI is only available on a prescription from your doctor. BEFORE YOU ARE GIVEN OXALIPLATIN KABI PFI _WHEN YOU MUST NOT RECEIVE IT _ YOU SHOULD NOT BE GIVEN OXALIPLATIN KABI PFI 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 OX Baca dokumen lengkap
Filename:OxaPFI030211 Page 1 of 20 - 1 - PRODUCT INFORMATION NAME OF THE MEDICINE Oxaliplatin Kabi PFI Powder for Injection CHEMICAL STRUCTURE Oxaliplatin has the following chemical structure: CAS Number: 61 825-94-3. DESCRIPTION Oxaliplatin is designated chemically as [S_P_-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 is a white to off-white crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and practically insoluble in ethanol. Oxaliplatin Kabi PFI 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-l-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. Filename:OxaPFI030211 Page 2 of 20 - 2 - 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 ox Baca dokumen lengkap