Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Olaparib 50mg
AstraZeneca Limited
Olaparib 50 mg
50 mg
Capsule
Active: Olaparib 50mg Excipient: Gellan gum Hypromellose Lauroyl macrogol-32 glycerides Iron oxide black Potassium acetate Shellac Titanium dioxide
Prescription
Lonza AG
LYNPARZA is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) after platinum-based chemotherapy. Prior treatment must have included at least 2 courses of platinum-based regimens.
Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle with PP CRC, 4 bottles x 112 capsules - 448 capsules - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 months opened stored at or below 25°C
2016-06-08
Lynparza ® Capsules CMI 041120 Copyright 1(6) LYNPARZA ® CAPSULES OLAPARIB 50 MG CAPSULE. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about LYNPARZA. It does not contain all the information that is known about LYNPARZA CAPSULES. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking LYNPARZA CAPSULES 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 LYNPARZA IS USED FOR You will have been prescribed LYNPARZA CAPSULES if you have ovarian cancer and it has responded to treatment with platinum-based chemotherapy and you have a mutation of the BRCA gene. BRCA stands for “BReast CAncer" gene. A genetic test will be done to determine if you have the BRCA gene mutation. LYNPARZA is a PARP (Poly (ADP-Ribose) Polymerase enzymes) inhibitor. It works by destroying cancer cells when both copies of the BRCA gene, are faulty (mutated). Carriers of a mutated BRCA gene have a higher risk of developing certain cancers, including ovarian cancer. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. BEFORE YOU USE LYNPARZA _WHEN YOU MUST NOT USE IT _ Do not take LYNPARZA CAPSULES if you have an allergy to: any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath wheezing or difficulty breathing swelling of the face, lips, tongue or other parts of the body rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. It may affect your developing baby if you take it during pregnancy. DO NOT BREA Les hele dokumentet
L YNPARZA Data Sheet 240122 Copyright 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME L YNPARZA ® 50 mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 mg of olaparib For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule White, opaque, size 0 hard capsule, marked with “OLAPARIB 50 mg” and the AstraZeneca logo in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Olaparib is indicated as monotherapy for the maintenance treatment of patients with platinum-sensitive relapsed _BRCA-_mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) after platinum-based chemotherapy. Prior treatment must have included at least 2 courses of platinum-based regimens. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment with L YNPARZA should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. IMPORTANT ADMINISTRATION INFORMATION L YNPARZA is also available as a 100mg and 150 mg tablet. DO NOT substitute L YNPARZA capsules (50 mg) with L YNPARZA tablets (100 mg and 150 mg) on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation. Refer to the Data Sheet for L YNPARZA tablets for specific tablet dosing. Patients must have confirmation of a breast cancer susceptibility gene (_BRCA_) mutation (germline or tumour) before L YNPARZA treatment is initiated. _BRCA_ mutation status should be determined by an experienced laboratory using a validated test method. DOSAGE IN ADULTS The recommended dose of L YNPARZA is 400 mg (eight 50 mg capsules) taken twice daily, equivalent to a total daily dose of 800 mg. L YNPARZA Data Sheet 240122 Copyright 2 L YNPARZA should be taken on an empty stomach (at least 1 hour after a meal). The capsules should not be opened. Once L YNPARZA is taken, refrain from eating for 2 hours. It is recommended that treatment be continued until progress Les hele dokumentet