Pemetrexed Teva 25 mg/ml Concentrate for Solution for Infusion

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Pemetrexed

Mevcut itibaren:

Teva B.V.

ATC kodu:

L01BA; L01BA04

INN (International Adı):

Pemetrexed

Doz:

25 milligram(s)/millilitre

Farmasötik formu:

Concentrate for solution for infusion

Reçete türü:

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

Terapötik alanı:

Folic acid analogues; pemetrexed

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

2017-06-23

Bilgilendirme broşürü

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED TEVA 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 TEVA IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PEMETREXED TEVA
3.
HOW TO USE PEMETREXED TEVA
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PEMETREXED TEVA
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT PEMETREXED TEVA IS AND WHAT IT IS USED FOR
Pemetrexed Teva is a medicine used in the treatment of cancer.
Pemetrexed Teva 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 Teva is also given in combination with cisplatin for the
initial treatment of patients with advanced
stage of lung cancer.
Pemetrexed Teva 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 Teva 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 TEVA
DO NOT USE PEMETREXED TEVA 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 Pemetrexed Teva (see
Pregnancy, breast-feeding and fertility).

have recently received or are about to receive a vaccine against
yellow fever.
WARNIN

Ürün özellikleri

Health Products Regulatory Authority
07 April 2021
CRN00C1KJ
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pemetrexed Teva 25 mg/ml Concentrate for Solution for Infusion
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
Pemetrexed Teva in combination with cisplatin is indicated for the
treatment of chemotherapy naïve patients with unresectable
malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Teva 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 Teva 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 Teva 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 Teva must only be administered under the supervision of a
physician qualified in the use of anti-c