País: Israel
Língua: inglês
Origem: Ministry of Health
OLAPARIB
ASTRAZENECA (ISRAEL) LTD
L01XX46
FILM COATED TABLETS
OLAPARIB 100 MG
PER OS
Not required
ASTRA ZENECA UK LIMITED
OLAPARIB
Ovarian cancer:Lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • Maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.First-line Maintenance Treatment of Advanced Ovarian Cancer in Combination with BevacizumabLynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:• a deleterious or suspected deleterious BRCA mutation, and/or• genomic instability Breast cancer:Germline BRCA-mutated HER2-negative Metastatic Breast CancerLynparza is indicated in patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.Adjuvant Treatment of Germline BRCA-mutated HER2-negative High Risk Early Breast Cancer Lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Adenocarcinoma of the pancreas:First-line Maintenance Treatment of Germline BRCA-mutated Metastatic Pancreatic AdenocarcinomaLynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.Prostate cancer:germline or somatic BRCA1/2 or ATM- mutated metastatic castration-resistant prostate cancerLynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA1/2 or ATM- mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.
2019-01-21
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only Lynparza ® 100 mg Film-coated tablets Composition: Each tablet contains: Olaparib 100 mg Lynparza ® 150 mg Film-coated tablets Composition: Each tablet contains: Olaparib 150 mg For inactive ingredients, please see section 6 – “Further Information”. Please see also section 2 – "Important information regarding some of the medicine ingredients". Read this leaflet carefully in its entirety before using the medicine. Keep this leaflet. You may need it again. This leaflet contains concise information about the medicine. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed to treat your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. 1. WHAT THE MEDICINE INTENDED FOR? Lynparza is intended for: Ovarian cancer: • Monotherapy, maintenance treatment of adult patients with advanced BRCA1/2-mutated (germline or somatic) high-grade epithelial ovarian (fallopian tube or primary peritoneal) cancer who are in response (complete or partial) to first-line platinum-based chemotherapy. • Maintenance treatment of patients with platinum-sensitive relapsed high- grade epithelial ovarian (or fallopian tube, or primary peritoneal) cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. • For the maintenance treatment, in combination with bevacizumab, of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: - a deleterious or suspected deleterious BRCA mutation, and/or - genomic instability Breast cancer: • For the treatment of metastatic breast cancer in patients with mutati Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lynparza 100 mg film-coated tablets Each film-coated tablet contains 100 mg olaparib. Lynparza 150 mg film-coated tablets Each film-coated tablet contains 150 mg olaparib. Excipient with known effect : This medicinal product contains 0.24 mg sodium per 100 mg tablet and 0.35 mg sodium per 150 mg tablet, i.e. essentially “sodium - free”. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Lynparza 100 mg film-coated tablets Yellow to dark yellow, oval, bi- convex tablet, debossed with ‘OP100’ on one side and plai n on the other side. Lynparza 150 mg film-coated tablets Green to green/grey, oval, bi- convex tablet, debossed with ‘OP150’ on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OVARIAN CANCER Lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (FIGO stages III and IV) _BRCA1/2_- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • Maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. First-line Maintenance Treatment of Advanced Ovarian Cancer in Combination with Bevacizumab Lynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status def Leia o documento completo