Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Oxaliplatin 5 mg/mL
sanofi-aventis new zealand limited
Oxaliplatin 5 mg/mL
5 mg/mL
Concentrate for infusion
Active: Oxaliplatin 5 mg/mL Excipient: Water for injection
Vial, glass, single dose, Type 1 clear glass, 50mg in 10mL pack, 10 mL
Prescription
Prescription
Johnson Matthey Pharmaceutical Materials
Oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of the primary tumour.
Package - Contents - Shelf Life: Vial, glass, single dose, Type 1 clear glass, 50mg in 10mL pack - 10 mL - 36 months from date of manufacture stored at or below 25°C. Do not freeze. - Vial, glass, single dose, Type 1 clear glass, 100mg in 20mL pack - 20 mL - 36 months from date of manufacture stored at or below 25°C. Do not freeze. - Vial, glass, single dose, Type 1 clear glass, 200mg in 40mL pack - 40 mL - 36 months from date of manufacture stored at or below 25°C. Do not freeze
2004-06-14
ELOXATIN Page 1 of 4 _ _ ELOXATIN ® _Oxaliplatin concentrated solution 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 Eloxatin 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 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 THIS MEDICINE. You may need to read it again. WHAT ELOXATIN IS USED FOR Eloxatin is used to treat cancer of the large intestine and rectum (colorectal cancer). Eloxatin is used with two other anti-cancer drugs, fluorouracil (FU), and folinic acid. The active ingredient in Eloxatin 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 Eloxatin because they believe that the benefit of Eloxatin 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. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor’s prescription. BEFORE YOU ARE GIVEN IT _WHEN YOU MUST NOT BE _ _GIVEN IT _ YOU SHOULD NOT BE GIVEN ELOXATIN IF YOU ARE ALLERGIC TO THE ACTIVE INGREDIENT OXALIPLATIN. If you have had an allergic reaction to oxaliplatin before Soma hati kamili
Page | 1 eloxatin-conc-ccdsv15-dsv7-18jun20 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Eloxatin 5mg/mL concentrated solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eloxatin concentrate for injection is available in the following strengths: • Oxaliplatin 50 mg • Oxaliplatin 100 mg • Oxaliplatin 200 mg For the full list of excipients, see section 6.1. 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. 3 PHARMACEUTICAL FORM Powder for injection: White to off-white freeze-dried powder in a clear glass vial Concentrated solution for injection: A liquid contained in a clear glass vial 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for: • Adjuvant treatment of stage III (Duke’s C) colon cancer after complete resection of the primary tumour • Treatment of advanced colorectal cancer Page | 2 eloxatin-conc-ccdsv15-dsv7-18jun20 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE In combination with fluorouracil and folinic acid the recommended dose for the treatment of advanced colorectal cancer is 85 mg/m 2 intravenously repeated every two weeks, or 130mg/m 2 repeated every three weeks. In combination with fluorouracil and folinic acid the recommended dose for adjuvant treatment is 85 mg/m 2 intravenously repeated every two weeks for 12 cycles (6 months). DOSAGE MODIFICATION Prior to each treatment cycle, patients should be evaluated for toxicity and the dose of oxaliplatin adjusted accordingly. Neurological toxicity If acute neurological reactions occur eg acute pharyngolaryngeal dysaesthesia, increase the oxaliplatin infusion time from 2 hours to 6 hours. This decreases C max by 30% and may lessen acute toxicities. If sensory loss or paraesthesia persists longer than 7 days or interferes with function (grade 2 toxicity), reduce oxaliplatin dose by 25%. If sensory loss or paraesthesia interferes with activities of dail Soma hati kamili