Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
pemetrexed, Quantity: 500 mg
Teva Pharma Australia Pty Ltd
Pemetrexed
Injection, powder for
Excipient Ingredients: mannitol; sodium hydroxide; hydrochloric acid; nitrogen
Intravenous
1 vial
(S4) Prescription Only Medicine
Malignant Pleural Mesothelioma Pemetrexed, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. Non-Small Cell lung Cancer Pemetrexed in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.
Visual Identification: PEMETREXED-TEVA powder for injection is available in sterile single-use vials containing 500mg pemetrexed.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-04-07
AUSTRALIAN PI –PEMETREXED-TEVA (PEMETREXED DISODIUM) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Pemetrexed disodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient in Pemetrexed-Teva powder for injection is pemetrexed disodium. Pemetrexed disodium has the chemical name L -glutamic acid, _ N_-[4-[2-(2-amino-4,7-dihydro-4-oxo-1_H_-pyrrolo[2,3- _d_]pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt, heptahydrate. It has an empirical formula of C 20 H 19 N 5 O 6 ●2Na●7H 2 O and a molecular weight of 597.49. Pemetrexed disodium is a white to almost white solid. Each 100 mg vial of Pemetrexed-Teva contains pemetrexed disodium equivalent to 100 mg pemetrexed. Each 500 mg vial of Pemetrexed-Teva contains pemetrexed disodium equivalent to 500 mg pemetrexed. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM The product is a white to either light yellow or green-yellow lyophilised solid. Pemetrexed-Teva is supplied as a powder for injection in 100mg vials and 500mg vials. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS MALIGNANT PLEURAL MESOTHELIOMA Pemetrexed, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. NON-SMALL CELL LUNG CANCER Pemetrexed in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy. 4.2 D OSE AND METHOD OF ADMINISTRATION Pemetrexed should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents Teva Pharma Australia Pty Limited Version 3.0 1 Pemetrexed in combination use with cisplatin: Adults - The recommended dose of pemetrexed is 500 mg/m 2 as body surface area (BSA) administe Прочитайте повний документ