Pemetrexed Teva Pdr/Conc/Soln for Infus 500mg

מדינה: מלטה

שפה: אנגלית

מקור: Malta Medicines Authority

מרכיב פעיל:

PEMETREXED

זמין מ:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

קוד ATC:

L01BA04

INN (שם בינלאומי):

PEMETREXED 500 mg

טופס פרצבטיות:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

הרכב:

PEMETREXED 500 mg

סוג מרשם:

POM

איזור תרפויטי:

ANTINEOPLASTIC AGENTS

מצב אישור:

Withdrawn

תאריך אישור:

2016-02-16

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED TEVA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED TEVA 500 MG POWDER FOR 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).

hav

מאפייני מוצר

Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Teva 500 mg Powder for Concentrate for Solution for
Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
After reconstitution (see section 6.6), each vial contains 25 mg/ml of
pemetrexed.
Excipient with known effect:
Each vial contains approximately 2.3 mmol sodium (approximately 54
mg).
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 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-cancer chemotherapy.
Pemetrexed Teva in combination with cisplatin
Page 2 of 23
The recommended dose of Pemetrexed Teva is 500 mg/m
2
of body surface area (BSA) administered
as an intravenous infusion over 10 minutes on the first day of each
2