Pemetrexed Teva 25 mg/ml, concentraat voor oplossing voor infusie

Maa: Alankomaat

Kieli: hollanti

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

Aktiivinen ainesosa:

PEMETREXED

Saatavilla:

Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM

ATC-koodi:

L01BA04

INN (Kansainvälinen yleisnimi):

PEMETREXED

Lääkemuoto:

Concentraat voor oplossing voor infusie

Koostumus:

CITROENZUUR 0-WATER (E 330) ; MANNITOL (D-) (E 421) ; STIKSTOF (HEAD SPACE) (E 941) ; TROMETAMOL ; WATER VOOR INJECTIE,

Antoreitti:

Intraveneus gebruik

Terapeuttinen alue:

Pemetrexed

Tuoteyhteenveto:

Hulpstoffen: CITROENZUUR 0-WATER (E 330); MANNITOL (D-) (E 421); STIKSTOF (HEAD SPACE) (E 941); TROMETAMOL; WATER VOOR INJECTIE;

Valtuutus päivämäärä:

2017-11-01

Pakkausseloste

Pemetrexed, DE/H/4630/001, 29.01.2021
update according to reference product Armisarte and amendments after
renewal of CP
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED TEVA 25 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE
pemetrexed
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
is a medicine used in the treatment of cancer.
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.
is also given in combination with cisplatin for the
initial treatment of patients with
advanced stage of lung cancer.
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.
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
DO NOT USE IF YOU
•
are allergic to pemetrexed or any of the other ingredients of this
medicine (listed in section 6).
•
are breast-feeding; you MUST discontinue breast-feeding during
treatment with (see Pregnan

Valmisteyhteenveto

Pemetrexed, DE/H/4630/001, 28.01.2021
update according to reference product Armisarte and amendments after
renewal of CP/RFI
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Teva 25 mg/ml, concentraat voor oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate contains 25 mg pemetrexed (as pemetrexed
diacid).
Each vial of 4 ml concentrate contains 100 mg of pemetrexed (as
pemetrexed diacid).
Each vial of 20 ml concentrate contains 500 mg of pemetrexed (as
pemetrexed diacid).
Each vial of 40 ml concentrate contains 1000 mg of pemetexed (as
pemetrexed diacid).
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Colourless to yellow or green yellow solution.
Free from visible particles.
pH of concentrate: 6.6 – 7.8
Osmolality: 260-320 mOsmol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
in combination with cisplatin is indicated for the
treatment of chemotherapy naïve
patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
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).
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).
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, DE/H/4630/001, 28.01.2021
update acco