Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
oxaliplatin, Quantity: 200 mg
Sun Pharma ANZ Pty Ltd
Oxaliplatin
Injection, solution
Excipient Ingredients: lactose monohydrate; water for injections
Intravenous
One vial packed in an outer carton
(S4) Prescription Only Medicine
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
Visual Identification: Clear and colourless solution free from visible particulates; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2011-06-28
Oxaliplatin SUN 1 OXALIPLATIN SUN CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING OXALIPLATIN SUN? Oxaliplatin SUN contains the active ingredient oxaliplatin. Oxaliplatin SUN is used to treat cancer of the large intestine and rectum (colorectal cancer). For more information, see Section 1. Why am I using Oxaliplatin SUN in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE OXALIPLATIN SUN? Do not use if you have ever had an allergic reaction to Oxaliplatin SUN or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Oxaliplatin SUN in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Oxaliplatin SUN and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE OXALIPLATIN SUN? • Oxaliplatin SUN will be given to you as an infusion into one of your veins (this is called an intravenous infusion). The infusion will be given over 2-6 hours. • The usual dose is 85mg/m2 every two weeks. Your doctor may change the dose in some circumstances. • Each course of treatment is called a cycle; your doctor will tell you how many cycles you will receive. More instructions can be found in Section 4. How do I use [medicine name]? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING OXALIPLATIN SUN? THINGS YOU SHOULD DO • You must tell your doctor if: □ you have had a reaction to any other platinum compound □ you have severe kidney disease, nerve damage (neuropathy) or any other medical condition □ you are taking any other medicines, includi Lees het volledige document
Oxaliplatin SUN PI v04_12 Apr 2021 Page 1 of 25 AUSTRALIAN PRODUCT INFORMATION – OXALIPLATIN SUN (OXALIPLATIN) CONCENTRATED SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Oxaliplatin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 concentrated solution for injection also contains lactose monohydrate and water for injections. 3 PHARMACEUTICAL FORM Concentrated solution for injection 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE In combination with fluorouracil and folinic acid the recommended dose for the treatment of advanced colorectal cancer is 85mg/m 2 intravenously repeated every two weeks. In combination with fluorouracil and folinic acid the recommended dose for adjuvant treatment is 85mg/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 e.g. 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. Oxaliplatin SUN PI v04_12 Apr 2021 Page 2 of 25 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 daily living (grade 3 toxicity), oxaliplatin should be discontinued. Haematological Toxicity If haematological toxicity (neutrophils <1.5 x 10 9 /L or platelets <75 x 10 9 /L) is present before star Lees het volledige document