البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
NIRAPARIB AS TOSYLATE MONOHYDRATE
MEDISON PHARMA LTD
L01XX54
HARD CAPSULE
NIRAPARIB AS TOSYLATE MONOHYDRATE 100 MG
PER OS
Required
TESARO UK LTD, UK
NIRAPARIB
Zejula is indicated:• as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.• As monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
2019-09-01
ZEJULA-PIL-0223-V2 Page 1 of 7 Zejula-PIL-ENG-D30-F PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only ZEJULA 100 MG HARD CAPSULES NAME AND QUANTITY OF ACTIVE INGREDIENT: Each capsule contains niraparib 100 mg. For a list of inactive ingredients and allergens in this medicine, see section 6 ‘ADDITIONAL INFORMATION’. See also section 2 under 'IMPORTANT INFORMATION ABOUT SOME OF THIS MEDICINE’S INGREDIENTS’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? WHAT ZEJULA IS USED FOR? Zejula is used as a single maintenance treatment in adult patients with: - advanced high-grade epithelial ovarian cancer (FIGO Stages III and IV), cancer of the fallopian tubes, or primary peritoneal cancer after full or partial response to first- line platinum-based chemotherapy has been achieved. - high-grade recurrent epithelial ovarian cancer that is sensitive to platinum, cancer of the fallopian tubes (part of the female reproductive system that connects the ovaries to the uterus), or primary peritoneal (the membrane lining the abdomen) cancer that has responded (fully or partially) to previous treatment with platinum-based chemotherapy. WHAT ZEJULA IS AND HOW IT WORKS? Zejula contains the active substance niraparib. Niraparib is a type of anti-cancer medicine called a PARP inhibitor. PARP inhibitors block an enzyme called poly [adenosine diphosphate-ribose] polymerase (PARP). PARP helps cells repair damaged DNA so blocking it means that the DNA of cancer cells cannot be repaired. This results in death of tumor cells, which helps to control the cancer. THERAPEUTIC GROUP: an اقرأ الوثيقة كاملة
1 PHYSICIAN’S PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Zejula 100 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg niraparib. Excipients with known effect Each hard capsule contains 254.5 mg of lactose monohydrate (see section 4.4). Each hard capsule shell also contains the colouring agent tartrazine (E 102) [0.0172 mg]. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Hard capsule of approximately 22 mm × 8 mm; white body with “100 mg” printed in black ink and purple cap with “Niraparib” printed in white ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zejula is indicated: • As monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. _ _ • As monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Zejula should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Posology First-line ovarian cancer maintenance treatment The recommended starting dose of Zejula is 200 mg (two 100-mg capsules), taken once daily. However, for those patients who weigh ≥ 77 kg and have baseline platelet count ≥ 150,000/μL, the recommended starting dose of Zejula is 300 mg (three 100-mg capsules), taken once daily. (see section 4.4 and 4.8). Recurrent Ovarian Cancer _maintenance treatment_ The dose is three 100 mg hard capsules once daily, equivalent to a total daily dose of 300 mg. 2 Patients should be encouraged to take their dose at approximately the sa اقرأ الوثيقة كاملة