Pemirex powder for concentrate for solution for infusion 100mg

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

PEMETREXED DISODIUM 2.5 HYDRATE

Dostępny od:

Eucogen Pharma Sdn. Bhd.

INN (International Nazwa):

PEMETREXED DISODIUM 2.5 HYDRATE

Sztuk w opakowaniu:

1 Vials

Wyprodukowano przez:

Korea United Pharm. Inc.

Charakterystyka produktu

PEMIREX POWDER
FOR CONCENTRATE
FOR SOLUTION FOR INFUSION
Pemetrexed 100 mg
ROUTE OF ADMINISTRATION : For Intravenous use
COMPOSITION
Each vial contains
Pemetrexed Disodium 2.5 hydrate
‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
120.82 mg
(as Pemetrexed 100 mg)
Excipients with known effect: Each vial contains approximately 11mg
sodium
DESCRIPTION
White to either light yellow or green-yellow, freeze-dried powder in a
colorless vial.
After reconstitution, the solution is clear and ranges in color from
colorless to yellow or green-yellow
without adversely affecting product quality. The pH of the
reconstituted solution is between 6.6 and 7.8.
INDICATIONS
1) Pemetrexed in combination with cisplatin is indicated for the
treatment of chemotherapy naive
patients with unresectable malignant pleural mesothelioma.
2) Pemetrexed 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 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.
4) Pemetrexed 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
DOSAGE AND ADMINISTRATION
Pemetrexed must only be administered under the supervision of a
physician qualified in the use of anti-
cancer chemotherapy.
1. Combination use with cisplatin
The recommended dose of Pemetrexed is 500 mg/m
2
BSA administered as the completion of the
pemetrexed infusion on the first day of each 21-day cycle. The
recommended dose of cisplatin is 75
mg/m
2
infused over 2 hours beginning approximately 30 minutes after the
completion of pemetrexed
infusion on the first day of each 21-day cycle. Patients sh