Pemetrexed Reig Jofre 500 mg Pulver till koncentrat till infusionsvätska, lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

pemetrexeddinatrium-2,5-hydrat

Tillgänglig från:

Laboratorio Reig Jofre S.A.

ATC-kod:

L01BA04

INN (International namn):

pemetrexeddinatrium-2,5-hydrat

Dos:

500 mg

Läkemedelsform:

Pulver till koncentrat till infusionsvätska, lösning

Sammansättning:

mannitol Hjälpämne; pemetrexeddinatrium-2,5-hydrat 616,2 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Injektionsflaska, 1 st (500 mg)

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2015-12-04

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED REIG JOFRE 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED REIG JOFRE 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 further questions, please 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 Reig Jofre is and what it is used for
2.
What you need to know before you use Pemetrexed Reig Jofre
3.
How to use Pemetrexed Reig Jofre
4.
Possible side effects
5.
How to store Pemetrexed Reig Jofre
6.
Contents of the pack and other information
1.
WHAT PEMETREXED REIG JOFRE IS AND WHAT IT IS USED FOR
Pemetrexed Reig Jofre is a medicine used in the treatment of cancer.
Pemetrexed Reig Jofre 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 Reig Jofre is also given in combination with cisplatin for
the initial treatment of patients
with
advanced stage of lung cancer.
Pemetrexed Reig Jofre 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 Reig Jofre 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 REIG JOFRE
DO NOT USE PEMETREXED REIG JOFRE
-
if you are allergic (hypersensitive) to pemetrexed or any of the other
ingredients of this
medicine (listed in section 6).
-
if
you
are
breast-feeding;
you
must
discontinue
b

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Reig Jofre 500 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg of pemetrexed (as pemetrexed disodium 2.5 H
2
O).
Excipient with known effect:
Each vial contains 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 faint
yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Reig Jofre in combination with cisplatin is indicated for
the treatment of chemotherapy naïve
patients
with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Reig Jofre 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 Reig Jofre 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 Reig Jofre 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
Posology
Pemetrexed Reig Jofre must only be administered under the supervision
of a physician qualified in the
use of
anti-cancer chemotherapy.
_Pemetrexed Reig Jofre in combination with cisplatin_
The
recommended
dose
of
Pemetrexed
Reig
Jofre
is
500
mg/m
2
of
body
surface
area
(BSA)
2
administered as an
intravenous infusion over 10 minutes on the first day of each 21-day
cycle. The
recommended dos