Pemetrexed Actavis Pdr/Conc/Soln for Infus 500mg

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

PEMETREXED

Tilgængelig fra:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC-kode:

L01BA04

INN (International Name):

PEMETREXED 500 mg

Lægemiddelform:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Sammensætning:

PEMETREXED 500 mg

Recept type:

POM

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Autorisation status:

Withdrawn

Autorisation dato:

2016-04-04

Indlægsseddel

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED ACTAVIS 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED ACTAVIS 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED ACTAVIS 1000 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
pemetrexed
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If you get any side effects, talk to your doctor or nurse or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Pemetrexed Actavis is and what it is used for
2.
What you need to know before you use Pemetrexed Actavis
3.
How to use Pemetrexed Actavis
4.
Possible side effects
5.
How to store Pemetrexed Actavis
6.
Contents of the pack and other information
1.
WHAT PEMETREXED ACTAVIS IS AND WHAT IT IS USED FOR
Pemetrexed Actavis is a medicine used in the treatment of cancer. It
contains the active substance
pemetrexed. Pemetrexed belongs to a group of medicines known as folic
acid analogues and
disrupts processes that are essential for cell replication.
Pemetrexed Actavis is given in combination with cisplatin, another
anti-cancer medicine, as
treatment for malignant pleural mesothelioma, a form of cancer that
affects the lining of the lung, to
patients who have not received prior chemotherapy.
Pemetrexed Actavis is also given in combination with cisplatin for the
initial treatment of patients
with advanced stage of lung cancer.
Pemetrexed Actavis can be prescribed to you if you have lung cancer at
an advanced stage if your
disease has responded to treatment or it remains largely unchanged
after initial chemotherapy.
Pemetrexed Actavis is also a treatment for patients with advanced
stage of lung cancer whose
disease has progressed after other initial chemotherapy has been used.
2.
WHAT YOU NEED TO KNOW BEFORE YO

Produktets egenskaber

Page 1 of 22
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Actavis 100 mg powder for concentrate for solution for
infusion
Pemetrexed Actavis 500 mg powder for concentrate for solution for
infusion
Pemetrexed Actavis 1000 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium
hemipentahydrate).
Each vial contains 500 mg of pemetrexed (as pemetrexed disodium
hemipentahydrate).
Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium
hemipentahydrate).
After reconstitution (see section 6.6), each vial contains 25 mg/ml of
pemetrexed.
Excipient with known effect:
Each 100 mg vial contains approximately 11.29 mg sodium.
Each 500 mg vial contains approximately 53.77 mg sodium.
Each 1000 mg vial contains approximately 107.54 mg sodium.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to yellow or greenish-yellow lyophilisate powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleuralmesothelioma
Pemetrexed in combination with cisplatin is indicated for the
treatment of chemotherapy naïve
patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
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 (see section 5.1).
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 (see section
5.1).
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
(see section 5.1).
Page 2 of 22
4.2
POSOLOGY