Pemetrexed Sigillata 500 mg Pulver till koncentrat till infusionsvätska, lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

pemetrexeddinatrium (vattenfri)

Tillgänglig från:

Sigillata Limited

ATC-kod:

L01BA04

INN (International namn):

pemetrexeddinatrium (anhydrous)

Dos:

500 mg

Läkemedelsform:

Pulver till koncentrat till infusionsvätska, lösning

Sammansättning:

pemetrexeddinatrium (vattenfri) 551,5 mg Aktiv substans; mannitol Hjälpämne

Receptbelagda typ:

Receptbelagt

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2016-08-18

Bipacksedel

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED SIGILLATA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED SIGILLATA 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED SIGILLATA 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 Sigillata is and what it is used for
2.
What you need to know before you use Pemetrexed Sigillata
3.
How to use Pemetrexed Sigillata
4.
Possible side effects
5.
How to store Pemetrexed Sigillata
6.
Contents of the pack and other information
1.
WHAT PEMETREXED SIGILLATA IS AND WHAT IT IS USED FOR
Pemetrexed Sigillata 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 Sigillata 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 Sigillata is also given in combination with cisplatin for
the initial treatment of patients
with advanced stage of lung cancer.
Pemetrexed Sigillata 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 Sigillata is also a treatment for patients with advanced
stage of lung cancer whose disease
has progressed after other initial chemotherapy has been used.
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Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Sigillata 100 mg powder for concentrate for solution for
infusion
Pemetrexed Sigillata 500 mg powder for concentrate for solution for
infusion
Pemetrexed Sigillata 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 pleural mesothelioma
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