RELITREXED POWDER FOR SOLUTION FOR INFUSION 500MGVIAL

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

Pemetrexed disodium equivalent to Pemetrexed

Disponible desde:

WELLCHEM PHARMACEUTICALS PTE LTD

Código ATC:

L01BA04

formulario farmacéutico:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composición:

Pemetrexed disodium equivalent to Pemetrexed 500mg/vial

Vía de administración:

INTRAVENOUS

tipo de receta:

Prescription Only

Fabricado por:

Reliance Life Science Pvt. Ltd. (PLANT 6)

Estado de Autorización:

ACTIVE

Fecha de autorización:

2022-06-24

Ficha técnica

1. NAME OF THE MEDICINAL PRODUCT
_ReliTrexed_
_®_
100 mg powder for concentrate for solution for infusion
_ _
_ReliTrexed_
_®_
500 mg powder for concentrate for solution for infusion
_ _
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg lyophilized vial contains Pemetrexed Disodium equivalent
to Pemetrexed 100 mg
Each 500 mg lyophilized vial contains Pemetrexed Disodium equivalent
to Pemetrexed 500 mg
List of excipients: Mannitol, Sodium Hydroxide, Hydrochloric acid
Excipient with known effect
Each 100mg vial contains approximately 11 mg sodium.
Each 500mg vial contains approximately 54 mg 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 (MPM)
_ReliTrexed_
_®_
in combination with cisplatin is indicated for the treatment of
chemotherapy naïve
patients with unresectable malignant pleural mesothelioma or who
otherwise not candidates for
curative surgery.
Non-small cell lung cancer (NSCLC) (see sections 5.1):
_ReliTrexed_
_®_
in combination with cisplatin is indicated for the first line
treatment of patients with
locally advanced or metastatic non-squamous NSCLC.
_ReliTrexed_
_®_
i
n combination with pembrolizumab and platinum chemotherapy, is
indicated for the
first-line treatment of patients with metastatic non-squamous NSCLC,
with no EGFR or ALK genomic
tumor aberrations.
_ReliTrexed_
_® _
is indicated as monotherapy for the maintenance treatment of locally
advance or metastatic
non-squamous NSCLC in patients whose disease has not progressed
immediately following first-line
treatment with platinum-based chemotherapy.
_ReliTrexed_
_®_
is indicated as monotherapy for the second line treatment of patients
with locally
advanced or metastatic non-squamous NSCLC.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
_ReliTrexed_
_®_
must only be administered under the supervision of a physic