Pemetrexed Seacross 100 mg powder for concentrate for solution for infusion

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Pemetrexed

Disponible desde:

Seacross Pharmaceuticals Limited

Código ATC:

L01BA; L01BA04

Designación común internacional (DCI):

Pemetrexed

Dosis:

100 milligram(s)

formulario farmacéutico:

Pdr/Conc/Soln for Infus

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Folic acid analogues; pemetrexed

Estado de Autorización:

Authorised

Fecha de autorización:

2017-05-26

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pemetrexed Seacross 100 mg powder for concentrate for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
After reconstitution (see section 6.6), each vial contains 25 mg/ml of
pemetrexed.
Excipients with known effect:
Each 100 mg vial contains less than 1 mmol (11 mg) of sodium.
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 lyophilised powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Seacross in combination with cisplatin is indicated for the
treatment of chemotherapy naïve patients with
unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Seacross 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 Seacross 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 (see section 5.1).
Pemetrexed Seacross 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 (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Pemetrexed Seacross must only be administered under the supervision of
a physician qualified in the use of anti-cancer
chemotherapy.
Pemetrexed Seacrossin combination with cisplatin
The recommended dose of Pemetrexed Seacross is 500 mg/m2 of body
surface area (BSA) administered as an
intravenous infusion over 10 minutes on the first day of each 21-da