Страна: Израел
Език: английски
Източник: Ministry of Health
PEMETREXED
TARO INTERNATIONAL LTD, ISRAEL
L01BA04
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
PEMETREXED 100 MG/VIAL
I.V
Required
TARO INTERNATIONAL LTD, ISRAEL
PEMETREXED
1.Pemetrexed Taro 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. 2.Pemetrexed Taro 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. 3.Pemetrexed Taro 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.4.Pemetrexed Taro 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.
2020-01-16
Page 1 of 8 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only PEMETREXED TARO 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION PEMETREXED TARO 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION PEMETREXED TARO 1000 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ACTIVE INGREDIENT: pemetrexed. PEMETREXED TARO 100 MG: Each vial contains 100 mg pemetrexed (as pemetrexed disodium heptahydrate) PEMETREXED TARO 500 MG: Each vial contains 500 mg pemetrexed (as pemetrexed disodium heptahydrate) PEMETREXED TARO 1000 MG: Each vial contains 1000 mg pemetrexed (as pemetrexed disodium heptahydrate). After reconstitution, the solution contains 25 mg/ml of pemetrexed. Further dilution by a healthcare provider is required prior to administration. Inactive ingredients and allergens: see section 2 under “Important information about some of this medicine’s ingredients” and section 6 “Additional information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please contact 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? PEMETREXED TARO is a medicine used to treat cancer. PEMETREXED TARO 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 curative surgery. PEMETREXED TARO 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 TARO is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic Прочетете целия документ
Page 1 of 19 1. NAME OF THE MEDICINAL PRODUCT PEMETREXED TARO 100 MG powder for concentrate for solution for infusion PEMETREXED TARO 500 MG powder for concentrate for solution for infusion PEMETREXED TARO 1000 MG powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed Taro 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium heptahydrate). Excipients with known effect: Each vial contains approximately 11 mg sodium. Pemetrexed Taro 500 mg powder for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium heptahydrate). Excipients with known effect: Each vial contains approximately 54 mg sodium. Pemetrexed Taro 1000 mg powder for solution for infusion Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium heptahydrate). Excipients 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 either light yellow or green yellow lyophilized powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma Pemetrexed Taro 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 curatable surgery. Non-small cell lung cancer: Pemetrexed Taro 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 Taro is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell Page 2 of 19 histology in patients whose disease has not progressed immediately follow Прочетете целия документ