ALIMTA

Pays: Indonésie

Langue: indonésien

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingrédients actifs:

PEMETREXED DISODIUM HEPTAHYDRATE

Disponible depuis:

PYRIDAM FARMA TBK - Indonesia

DCI (Dénomination commune internationale):

PEMETREXED DISODIUM HEPTAHYDRATE

Dosage:

713 MG

forme pharmaceutique:

SERBUK INFUS

Unités en paquet:

DUS, 1 VIAL @ 500 MG

Fabriqué par:

VIANEX S.A. - PLANT C - Greece

Date de l'autorisation:

2021-09-11

Résumé des caractéristiques du produit

Alimta 500 mg_ID_RAPT 220855 _leaflet for doctor_Proposed TC_V1
Company Confidential – Eli Lilly and Company
Page 1 of 21
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Proposed truth_v1_
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Internal reviewer_YC__
Medical reviewer_________
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Internal creator_DS_
Approval for Submission
Marketing reviewer_______
Date ____________
ALIMTA
PEMETREXED
1.
NAME OF THE MEDICINAL PRODUCT
ALIMTA 500 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALIMTA 500 mg powder for concentrate for solution for infusion
Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
_Excipients with known effect _
Each vial contains approximately 54 mg sodium.
After reconstitution (see section 6.6), each vial contains 25 mg/mL of
pemetrexed.
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: _
ALIMTA in combination with cisplatin is indicated for the treatment of
chemotherapy naive patients with
unresectable malignant pleural mesothelioma.
_Non-small cell lung cancer: _
ALIMTA 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).
ALIMTA 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. First line
treatment should be a platinum based with other
cytotoxics chemotherapy (see section 5.1).
DISETUJUI OLEH BPOM : 18/08/2021
ID : EREG100366VR12000081
Alimta 500 mg_ID_RAPT 220855 _leaflet for doctor_Proposed TC_V1
Company Confidential – Eli Lilly and Company Page 2 of 21
_ _
ALIMTA is indicated as a single-agent for the treatment of patients
with loc