Trixid 1000 mg, poeder voor concentraat voor oplossing voor infusie

Χώρα: Ολλανδία

Γλώσσα: Ολλανδικά

Πηγή: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Δραστική ουσία:

PEMETREXED DINATRIUM 2,5-WATER SAMENSTELLING overeenkomend met ; PEMETREXED

Διαθέσιμο από:

Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)

Φαρμακολογική κατηγορία (ATC):

L01BA04

INN (Διεθνής Όνομα):

PEMETREXED DISODIUM 2,5-WATER COMPOSITION corresponding to ; PEMETREXED

Φαρμακοτεχνική μορφή:

Poeder voor concentraat voor oplossing voor infusie

Σύνθεση:

MANNITOL (D-) (E 421) ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; ZOUTZUUR (E 507),

Οδός χορήγησης:

Intraveneus gebruik

Θεραπευτική περιοχή:

Pemetrexed

Περίληψη προϊόντος:

Hulpstoffen: MANNITOL (D-) (E 421); NATRIUMHYDROXIDE (E 524); STIKSTOF (HEAD SPACE) (E 941); ZOUTZUUR (E 507);

Ημερομηνία της άδειας:

2016-02-10

Φύλλο οδηγιών χρήσης

Common Technical Document
Pemetrexed
lyophilized powder for concentrate for solution for infusion
Page 1 of 9
1.3.1
Package leaflet - Core
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIXID 100 MG, POEDER VOOR CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE
TRIXID 500 MG, POEDER VOOR CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE
TRIXID 1000 MG, POEDER VOOR CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE
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 Trixid is and what it is used for
2.
What you need to know before you use Trixid
3.
How to use Trixid
4.
Possible side effects
5.
How to store Trixid
6.
Contents of the pack and other information
1
WHAT TRIXID IS AND WHAT IT IS USED FOR
Trixid is a medicine used in the treatment of cancer.
Trixid 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.
Trixid is also given in combination with cisplatin for the initial
treatment of patients with advanced
stage of lung cancer.
Trixid 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.
Trixid 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 TRIXID
DO NOT USE TRIXID
Common Technical Document
Pemetrexed
lyophilized powder for concentrate for solution for infusion
Page 2 of 9
•
if you are allergic to pemetrexed or any of the other ingred

Αρχείο Π.Χ.Π.

Common Technical Document
Pemetrexed
lyophilized powder for concentrate for solution for infusion
Page 1 of 20
1.3.1. Summary of product characteristics - Core
1.
NAME OF THE MEDICINAL PRODUCT
Trixid 100 mg, poeder voor concentraat voor oplossing voor infusie
Trixid 500 mg, poeder voor concentraat voor oplossing voor infusie
Trixid 1000 mg, poeder voor concentraat voor oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100, 500 or 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 mg sodium (<1 mmol).
Each 500 mg vial contains approximately 54 mg sodium (2.35 mmol).
Each 1000 mg vial contains approximately 108 mg sodium (4.70 mmol).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to light yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Trixid in combination with cisplatin is indicated for the treatment of
chemotherapy naïve patients with
unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Trixid 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).
Trixid 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).
Trixid 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).
Common Technical Document
Pemetrexed
lyophilized powder for concentrate