Pemetrexed Zentiva 100 mg, poeder voor concentraat voor oplossing voor infusie

Land: Niederlande

Sprache: Niederländisch

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

Wirkstoff:

PEMETREXED DINATRIUM 2,5-WATER 120,8 mg/flacon SAMENSTELLING overeenkomend met ; PEMETREXED 100 mg/flacon

Verfügbar ab:

Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)

ATC-Code:

L01BA04

INN (Internationale Bezeichnung):

PEMETREXED DINATRIUM 2,5-WATER 120,8 mg/flacon SAMENSTELLING overeenkomend met ; PEMETREXED 100 mg/flacon

Darreichungsform:

Poeder voor concentraat voor oplossing voor infusie

Zusammensetzung:

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

Verabreichungsweg:

Intraveneus gebruik

Therapiebereich:

Pemetrexed

Produktbesonderheiten:

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

Berechtigungsdatum:

2015-12-14

Gebrauchsinformation

PEMETREXED_100
mg_500
mg_1000
mg_powder
for
concentrate
for
solution
for infusion_EN_NL-H-3329-001-003_EPAR 11/2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Zentiva 100 mg poeder voor concentraat voor oplossing voor
infusie
Pemetrexed Zentiva 500 mg poeder voor concentraat voor oplossing voor
infusie
Pemetrexed Zentiva 1000 mg poeder voor concentraat voor oplossing voor
infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
vial
contains
100,
500
or
1,000
mg
pemetrexed
(as
pemetrexed
disodium
hemipentahydrate).
After reconstitution (see section 6.6), each vial contains 25 mg/ml
pemetrexed.
Excipients 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 1,000 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
Pemetrexed
Zentiva
in
combination
with
cisplatin
is
indicated
for
the
treatment
of
chemotherapy naïve patients with unresectable malignant pleural
mesothelioma.
PEMETREXED_100
mg_500
mg_1000
mg_powder
for
concentrate
for
solution
for infusion_EN_NL-H-3329-001-003_EPAR 11/2020
Non-small cell lung cancer
Pemetrexed Zentiva 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 Zentiva 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 Zentiva is indicated as monotherapy for the second line
treatment of patients with
locally adva

Fachinformation

PEMETREXED_100 mg_500 mg_1000 mg_powder for concentrate for solution
for infusion_NL_NL-H-3329-001-003_06/2022 EPAR+QRD
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Pemetrexed Zentiva 100 mg poeder voor concentraat voor oplossing voor
infusie
Pemetrexed Zentiva 500 mg poeder voor concentraat voor oplossing voor
infusie
Pemetrexed Zentiva 1000 mg poeder voor concentraat voor oplossing voor
infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100, 500 or 1,000 mg pemetrexed (as pemetrexed
disodium
hemipentahydrate).
After reconstitution (see section 6.6), each vial contains 25 mg/ml
pemetrexed.
Excipients 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 1,000 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
Pemetrexed Zentiva in combination with cisplatin is indicated for the
treatment of
chemotherapy naïve patients with unresectable malignant pleural
mesothelioma.
Non-small cell lung cancer
Pemetrexed Zentiva 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 Zentiva 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_100 mg_500 mg_1000 mg_powder for concentrate for solution
for infusion_NL_NL-H-3329-001-003_06/2022 EPAR+QRD
Pemetrexed Zentiva is indicated as monotherapy for the second line
treatment of patients with
locally