Pemetrexed Seacross 100 mg powder for concentrate for solution for infusion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Pemetrexed

Verfügbar ab:

Seacross Pharma (Europe) Limited

ATC-Code:

L01BA; L01BA04

INN (Internationale Bezeichnung):

Pemetrexed

Dosierung:

100 milligram(s)

Darreichungsform:

Powder for concentrate for solution for infusion

Therapiebereich:

Folic acid analogues; pemetrexed

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2017-05-26

Gebrauchsinformation

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED SEACROSS 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED SEACROSS 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
pemetrexed
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Pemetrexed Seacross is and what it is used for
2.
What you need to know before you use Pemetrexed Seacross
3.
How to use Pemetrexed Seacross
4.
Possible side effects
5.
How to store Pemetrexed Seacross
6.
Contents of the pack and other information
1.
WHAT PEMETREXED SEACROSS IS AND WHAT IT IS USED FOR
Pemetrexed Seacross is a medicine used in the treatment of cancer.
This medicine 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.
It is also given in combination with cisplatin for the initial
treatment of patients with advanced
stage of lung cancer.
Pemetrexed Seacross 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.
This medicine 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 SEACROSS
DO NOT USE PEMETREXED SEACROSS
-
if you are allergic (hypersensitive) to pemetrexed or any of the other
ingredients of this
medicine (listed in section 6).
-
if you are breast-feeding; you must discontinue breast-feed

Fachinformation

Health Products Regulatory Authority
09 September 2022
CRN00D3FD
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pemetrexed Seacross 100 mg powder for concentrate for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
After reconstitution (see section 6.6), each vial contains 25 mg/ml of
pemetrexed.
Excipients with known effect:
Each 100 mg vial contains less than 1 mmol (11 mg) of sodium.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to either light yellow or green-yellow lyophilised powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Seacross in combination with cisplatin is indicated for the
treatment of chemotherapy naïve patients with
unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Seacross 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 Seacross 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 Seacross 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 Seacross must only be administered under the supervision of
a physician qualified in the use of anti-cancer
chemotherapy.
Pemetrexed Seacross incombination withcisplatin
The recommended dose of Pemetrexed Seacross is 500 mg/m
2
of body surface area (BSA) administe