Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
olaparib, Quantity: 50 mg
AstraZeneca Pty Ltd
olaparib
Capsule
Excipient Ingredients: gellan gum; hypromellose; titanium dioxide; potassium acetate; lauroyl macrogolglycerides; iron oxide black; Shellac
Oral
4 x 112
(S4) Prescription Only Medicine
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.
Visual Identification: White opaque hard capsules marked with "OLAPARIB 50 mg" and the AstraZeneca logo printed in black ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure
Registered
2016-01-07
LYNPARZA ® CAPSULES _olaparib_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LYNPARZA capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has 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 CAPSULES ARE 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. PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage. These specific cancer cells can be identified by looking for faulty DNA repair genes, such as BRCA (BReast CAncer) genes. 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 TAKE LYNPARZA CAPSULES _WHEN YOU MUST NOT TAKE 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 read_full_document
LYNPARZA Capsules Product Information 1 AUSTRALIAN PRODUCT INFORMATION LYNPARZA ® olaparib capsules 1 NAME OF THE MEDICINE Olaparib 2 QUALITATIVE AND QUANTITATIVE COMPOSITION LYNPARZA capsules consist of 50 mg olaparib drug substance suspended in the semi-solid lipidic excipient lauroyl macrogolglycerides, within a hypromellose capsule shell which also contains gellan gum, titanium dioxide and potassium acetate . The printing ink used contains shellac and iron oxide black. 3 PHARMACEUTICAL FORM LYNPARZA capsules are white and are marked with “OLAPARIB 50 mg” and the AstraZeneca logo printed in black ink. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS LYNPARZA 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 D OSE AND METHOD OF ADMINISTRATION Treatment with LYNPARZA should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. IMPORTANT ADMINISTRATION INFORMATION LYNPARZA is also available as a 100mg and 150 mg tablet. DO NOT substitute LYNPARZA capsules (50 mg) with LYNPARZA 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 full prescribing information for LYNPARZA tablets for specific tablet dosing. Patients must have confirmation of a breast cancer susceptibility gene ( _BRCA_ ) mutation (germline or tumour) before LYNPARZA treatment is initiated. _BRCA_ mutation status should be determined by an experienced laboratory using a validated test method. LYNPARZA Capsules Product Information 2 DOSAGE IN ADULTS The recommended dose of LYNPARZA is 400 mg (eight 50 mg capsules) taken twice daily, equivalent to a total d read_full_document