Pemetrexed Mylan 25 mg/ml concentrate for solution for infusion

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Pemetrexed

Beschikbaar vanaf:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC-code:

L01BA; L01BA04

INN (Algemene Internationale Benaming):

Pemetrexed

Dosering:

25 milligram(s)/millilitre

farmaceutische vorm:

Concentrate for solution for infusion

Therapeutisch gebied:

Folic acid analogues; pemetrexed

Autorisatie-status:

Not marketed

Autorisatie datum:

2017-12-22

Bijsluiter

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you use Pemerexed Mylan
3.
How to use Pemetrexed Mylan
4.
Possible side effects
5.
How to store Pemetrexed Mylan
6.
Contents of the pack and other information
1
WHAT PEMETREXED MYLAN IS AND WHAT IT IS USED FOR
Pemetrexed Mylan is a medicine used in the treatment of cancer.
Pemetrexed Mylan 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 Mylan is also given in combination with cisplatin for the
initial treatment of patients with
advanced stage of lung cancer.
Pemetrexed Mylan 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 Mylan 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 MYLAN
DO NOT USE PEMETREXED MYLAN
•
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 Mylan.
•
if you have recently received or are about to receive a vaccine
against yellow fever.
Page 2 of 10
WAR

Productkenmerken

Health Products Regulatory Authority
12 December 2022
CRN00D5J7
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pemetrexed Mylan 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 4 ml vial which
is equivalent to 35 mg/ml.
This medicine contains 1400 mg propylene glycol in each 4 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 Mylan in combination with cisplatin is indicated for the
treatment of chemotherapy naïve patients with
unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Mylan 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 Mylan 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 Mylan is indicated as monotherapy for the second line
treatment of patients with locall