Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Pemetrexed disodium hemipentahydrate 604.05mg equivalent to Pemetrexed 500mg
Juno Pharmaceuticals NZ Limited
Pemetrexed disodium hemipentahydrate 604.05 mg (equivalent to Pemetrexed 500mg)
500 mg
Powder for infusion
Active: Pemetrexed disodium hemipentahydrate 604.05mg equivalent to Pemetrexed 500mg Excipient: Hydrochloric acid Mannitol Sodium hydroxide
Prescription
Gland Chemicals Private Limited
Pemetrexed, in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma.
Package - Contents - Shelf Life: Vial, 50 mL/20 mm USP Type 1 glass, Closure: 20mm rubber stopper & al flip off seals - 1 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze
2016-02-17
Pemetrexed Juno – Datasheet Page 1 of 26 PEMETREXED JUNO (pemetrexed disodium) 100 mg and 500 mg Powder for Injection _DATASHEET _ 1. PRODUCT NAME PEMETREXED JUNO contains pemetrexed as disodium hemipentahydrate. The active ingredient in PEMETREXED JUNO 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, hemipentahydrate. It has an empirical formula of C 20 H 19 N 5 O 6 2Na 2.5H2O and a molecular weight of 517.37. The structural formula is as follows: The CAS number for pemetrexed disodium (as hemipentahydrate) is 357166-30-4. Pemetrexed disodium is a white to almost white solid. PEMETREXED JUNO is supplied in as two strengths - 500 mg and 100 mg. Each 500 mg vial of PEMETREXED JUNO contains pemetrexed disodium hemipentahydrate equivalent to 500 mg pemetrexed. Each 100 mg vial of PEMETREXED JUNO contains pemetrexed disodium hemipentahydrate equivalent to 100 mg pemetrexed PEMETREXED JUNO is supplied as a sterile lyophilised powder for intravenous infusion available in single dose vials. The product is a white to either light yellow or green-yellow lyophilised solid. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 500 mg vial of PEMETREXED JUNO contains 604.05 mg pemetrexed disodium hemipentahydrate equivalent to 500 mg pemetrexed and 500 mg of mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH. Pemetrexed Juno – Datasheet Page 2 of 26 Each 100 mg vial of PEMETREXED JUNO contains 120.81 mg pemetrexed disodium hemipentahydrate equivalent to 100 mg pemetrexed and 106.0 mg of mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH 3. PHARMACEUTICAL FORM PEMETREXED JUNO is supplied as a sterile lyophilised powder for intravenous infusion available in single dose vials. The product is a white to either light yellow or green-yellow lyophilised solid. 4. CLINICAL PARTICULARS 4.1 THERAPE Les hele dokumentet