Pemetrexed Viatris 25 mg/ml concentrate for solution for infusion(20ml)

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Disponible desde:

Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Código ATC:

L01BA04

Designación común internacional (DCI):

PEMETREXED 25 mg/ml

formulario farmacéutico:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

PEMETREXED 25 mg/ml

tipo de receta:

POM

Área terapéutica:

ANTINEOPLASTIC AGENTS

Estado de Autorización:

Authorised

Fecha de autorización:

2023-12-15

Información para el usuario

_Page 1 of 9 _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED VIATRIS 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
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 is and what it is used for
2.
What you need to know before you use Pemetrexed
3.
How to use Pemetrexed
4.
Possible side effects
5.
How to store Pemetrexed
6.
Contents of the pack and other information
1.
WHAT PEMETREXED IS AND WHAT IT IS USED FOR
Pemetrexed is a medicine used in the treatment of cancer.
Pemetrexed 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 is also given in combination with cisplatin for the initial
treatment of patients
with advanced stage of lung cancer.
Pemetrexed 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 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
DO NOT USE PEMETREXED
-
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
against yellow fever.
WARNINGS AND PRECAUTIONS
Talk to your doctor or hospital pharmacist before receiving
Pemetrexed.
_Page 2

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Viatris 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).
Excipient with known effect:
This medicine contains 140 mg propylene glycol in each 4 ml vial which
is equivalent to 35 mg/ml.
This medicine contains 700 mg propylene glycol in each 20 ml vial
which is equivalent to 35 mg/ml.
This medicine contains 1400 mg propylene glycol in each 40 ml vial
which is equivalent to 35 mg/ml.
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 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 h