Runarorn 500 mg Pulver till koncentrat till infusionsvätska, lösning

Χώρα: Σουηδία

Γλώσσα: Σουηδικά

Πηγή: Läkemedelsverket (Medical Products Agency)

Δραστική ουσία:

pemetrexeddinatrium (vattenfri)

Διαθέσιμο από:

Sigillata Limited

Φαρμακολογική κατηγορία (ATC):

L01BA04

INN (Διεθνής Όνομα):

pemetrexeddinatrium (anhydrous)

Δοσολογία:

500 mg

Φαρμακοτεχνική μορφή:

Pulver till koncentrat till infusionsvätska, lösning

Σύνθεση:

pemetrexeddinatrium (vattenfri) 551,5 mg Aktiv substans

Τρόπος διάθεσης:

Receptbelagt

Περίληψη προϊόντος:

Förpacknings: Injektionsflaska, 1 st (500 mg)

Καθεστώς αδειοδότησης:

Avregistrerad

Ημερομηνία της άδειας:

2016-08-18

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
RUNARORN 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
RUNARORN 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
RUNARORN 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 Runarorn is and what it is used for
2.
What you need to know before you use Runarorn
3.
How to use Runarorn
4.
Possible side effects
5.
How to store Runarorn
6.
Contents of the pack and other information
1.
WHAT RUNARORN IS AND WHAT IT IS USED FOR
Runarorn 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.
Runarorn 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.
Runarorn is also given in combination with cisplatin for the initial
treatment of patients with advanced
stage of lung cancer.
Runarorn 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.
Runarorn 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 RUNARORN
DO NOT USE RUNARORN
-
if you are allergic to pemetrexed or any of the other ingredients of
this medicine (li

Αρχείο Π.Χ.Π.

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Runarorn 100 mg powder for concentrate for solution for infusion
Runarorn 500 mg powder for concentrate for solution for infusion
Runarorn 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
5.1).
4.2
POSOLOGY AND METHOD OF AD