Pemetrexed Fresenius Kabi

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

pemetrexed

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

L01BA04

INN (International Name):

pemetrexed

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Carcinoma, Non-Small-Cell Lung; Mesothelioma

Therapeutic indications:

Malignant pleural mesotheliomaPemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Fresenius Kabi 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.Pemetrexed Fresenius Kabi 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. Pemetrexed Fresenius Kabi 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.

Product summary:

Revision: 13

Authorization status:

Authorised

Authorization date:

2016-07-22

Patient Information leaflet

75
B.
PACKAGE LEAFLET
76
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED FRESENIUS KABI 100 MG POWDER FOR CONCENTRATE FOR SOLUTION
FOR INFUSION
PEMETREXED FRESENIUS KABI 500 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 pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pemetrexed Fresenius Kabi is and what it is used for
2.
What you need to know before you use Pemetrexed Fresenius Kabi
3.
How to use Pemetrexed Fresenius Kabi
4.
Possible side effects
5.
How to store Pemetrexed Fresenius Kabi
6.
Contents of the pack and other information
1.
WHAT PEMETREXED FRESENIUS KABI IS AND WHAT IT IS USED FOR
Pemetrexed Fresenius Kabi is a medicine used in the treatment of
cancer.
Pemetrexed Fresenius Kabi 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 Fresenius Kabi is also given in combination with cisplatin
for the initial treatment of
patients with advanced stage of lung cancer.
Pemetrexed Fresenius Kabi 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 Fresenius Kabi 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 FRESENIUS KABI
DO NOT USE PEMETREXED FRESENIUS KABI
-
if you are allergic to pemetrexed or any of the other ingredients of
this medicine (listed in
sectio

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution
for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 100 mg of pemetrexed (as pemetrexed
diacid).
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 off-white lyophilised powder or solid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Fresenius Kabi in combination with cisplatin is indicated
for the treatment of
chemotherapy naïve patients with unresectable malignant pleural
mesothelioma.
Non-small cell lung cancer
Pemetrexed Fresenius Kabi 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 Fresenius Kabi 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 Fresenius Kabi 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
Pemetrexed Fresenius Kabi must only be administered under the
supervision of a physician
qualified in the use of anti-cancer chemotherapy.
Posology
_Pemetrexed Fresenius Kabi in combination with cisplatin_
The recommended dose of Pemetrexed Fresenius Kabi is 500 mg/m
2
of body surface area (BSA)
administered as an intravenous infusion over 10 minutes on the first
day of each 21-day cycle.
3
The recommended dose of