Pemetrexed PhaRes 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Land: Deutschland

Sprache: Deutsch

Quelle: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

Wirkstoff:

Pemetrexed-Dinatrium 2.5 H<2>O

Verfügbar ab:

Pharma Resources GmbH (8139312)

ATC-Code:

L01BA04

INN (Internationale Bezeichnung):

Pemetrexed Disodium 2.5 H<2>O

Darreichungsform:

Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Zusammensetzung:

Teil 1 - Pulver für ein Konzentrat zur Herstellung einer Infusionslösung; Pemetrexed-Dinatrium 2.5 H<2>O (41929) 606,9 Milligramm

Verabreichungsweg:

intravenöse Anwendung

Berechtigungsstatus:

verlängert

Berechtigungsdatum:

2016-08-20

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED VITANE 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED VITANE 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
pemetrexed
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pemetrexed Vitane is and what it is used for
2.
What you need to know before you use Pemetrexed Vitane
3.
How to use Pemetrexed Vitane
4.
Possible side effects
5.
How to store Pemetrexed Vitane
6.
Contents of the pack and other information
1.
WHAT PEMETREXED VITANE IS AND WHAT IT IS USED FOR
Pemetrexed Vitane is a medicine used in the treatment of cancer.
Pemetrexed Vitane 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 Vitane is also given in combination with cisplatin for the
initial treatment of patients with
advanced stage of lung cancer.
Pemetrexed Vitane 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 Vitane 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 YOU USE PEMETREXED VITANE
DO NOT USE PEMETREXED VITANE
-
if you are allergic to pemetrexed or any of the other ingredients of
this medicine (listed in section
6).
-
if you are breast-feeding; you must discontinue breast-feeding during
treatment with Pemetrexed
Vitane.
-
if you have recently rece

Fachinformation

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Vitane 100 mg Powder for Concentrate for Solution for
Infusion
Pemetrexed Vitane 500 mg Powder for Concentrate for Solution for
Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pemetrexed Vitane 100 mg powder for concentrate for solution for
infusion
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Excipients with known effect:
Each vial contains approximately 11 mg sodium.
Pemetrexed Vitane 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
Pemetrexed Vitane in combination with cisplatin is indicated for the
treatment of chemotherapy naive
patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Vitane 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 Vitane 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 Vitane is indicated as monotherapy for the second line
treatment of patients with locally
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advanced or m