Pemetrexed Genthon 25 mg/ml concentrate for solution for infusion

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Pemetrexed

Disponible desde:

Genthon B.V.

Código ATC:

L01BA; L01BA04

Designación común internacional (DCI):

Pemetrexed

Dosis:

25 milligram(s)/millilitre

formulario farmacéutico:

Concentrate for solution for infusion

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Folic acid analogues; pemetrexed

Estado de Autorización:

Not marketed

Fecha de autorización:

2017-12-22

Información para el usuario

M1.3.1_03.PXD.inj.001.07.IE.3923.01
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED GENTHON 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
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 Pemetrexed Genthon is and what it is used for
2.
What you need to know before you use Pemetrexed Genthon
3.
How to use Pemetrexed Genthon
4.
Possible side effects
5.
How to store Pemetrexed Genthon
6.
Contents of the pack and other information
1
WHAT PEMETREXED IS AND WHAT IT IS USED FOR
Pemetrexed Genthon is a medicine used in the treatment of cancer.
Pemetrexed Genthon 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 Genthon is also given in combination with cisplatin for the
initial treatment of
patients with advanced stage of lung cancer.
Pemetrexed Genthon 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 Genthon 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 PEMETREXED GENTHON
DO NOT USE PEMETREXED
GENTHON

if you are
ALLERGIC TO PEMETREXED OR ANY OF THE OTHER INGREDIENTS
of this medicine (listed in
section 6).

if you are
BREAST-FEEDING
; you must discontinue breast-feeding during treatment with
Pemetrexed.

if you have recently received or are about to receive a
VACCINE A

Ficha técnica

Health Products Regulatory Authority
27 May 2019
CRN008TT5
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pemetrexed Genthon 25 mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate contains 25 mg pemetrexed (as pemetrexed
diarginine)
One vial of 4 ml concentrate contains 100 mg pemetrexed (as pemetrexed
diarginine).
One vial of 20 ml concentrate contains 500 mg pemetrexed (as
pemetrexed diarginine).
One vial of 40 ml concentrate contains 1000 mg pemetrexed (as
pemetrexed diarginine).
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to slightly yellow to brown, brown yellow or green
yellow solution.
The pH of the concentrate is between 8.3 and 9.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Genthon in combination with cisplatin is indicated for the
treatment of chemotherapy naïve patients with
unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Genthon 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 Genthon 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 Genthon 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 Genthon must only be administered under the supervision of
a physician qualified in the use of anti-cancer
chemotherapy.
Pemetrexed Gent