Country: Израел
Језик: Енглески
Извор: Ministry of Health
PEMETREXED AS DISODIUM
NOVARTIS ISRAEL LTD
L01BA04
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
PEMETREXED AS DISODIUM 1000 MG/VIAL
I.V
Required
GLAND PHARMA LIMITED , INDIA
PEMETREXED
Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. Pemetrexed Sandoz in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Sandoz is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed Sandoz is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.
2018-04-22
Novartis Israel Ltd 36 Shaham St., Kiryat Matalon, Petach-Tikva P.O.B 7759, Petach Tikva 4951729, Israel Tel: 972-3-9201111 Fax: 972-3-9229244 .מ"עב לארשי סיטרבונ 'חר םחש 36 חתפ ןולטמ תיירק - הוקת .ד.ת 7759 חתפ - הוקת 4951729 :ןופלט 03-9201111 :סקפ 03-9229244 אפור / ה , חקור / ת דבכנ / ה , :ןודנה אפורל ןולע ןוכדע לע העדוה PEMETREXED SANDOZ ® 100MG, 500MG, 1000MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ונא םישקבמ עידוהל ך יכ ולעה אפורל ן לש רישכתה םי ןודנבש ילויב ןכדוע 2018 . ® Pemetrexed Sandoz ל הוותמ תויצקידניא תואבה : MALIGNANT PLEURAL MESOTHELIOMA Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. NON-SMALL CELL LUNG CANCER Pemetrexed Sandoz in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Sandoz is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Sandoz is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. ביכרמ ליעפ : pemetrexed disodium ידומעב םיאבה ם יתועמשמ יוניש וא הרמחה הווהמ רשא יוניש השענ םהב םיפיעס םינייוצמ . עב ןייעל שי ,ףסונ עדימל ןול אפורל ףרוצמה יפכ רשואש לע ידי דרשמ תואירבה . ןולעה חלשנ ןכדועמה םוסרפל ר Прочитајте комплетан документ
1. NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz ® 100 mg powder for concentrate for solution for infusion Pemetrexed Sandoz ® 500 mg powder for concentrate for solution for infusion Pemetrexed Sandoz ® 1000 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium). Excipient with known effect Each vial contains approximately 11 mg sodium. Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium). Excipient with known effect Each vial contains approximately 54 mg sodium. Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium). Excipient with known effect Each vial contains approximately 108 mg sodium. After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white or pale yellow lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. Non-small cell lung cancer Pemetrexed Sandoz in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1). Pemetrexed Sandoz is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chem Прочитајте комплетан документ