PEMETREXED

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

PEMETREXED DISODIUM

متاح من:

Generics (UK) Limited

ATC رمز:

L01B

INN (الاسم الدولي):

PEMETREXED DISODIUM

جرعة:

500 Milligram

الشكل الصيدلاني:

Pdr/Conc/Soln for Infus

نوع الوصفة الطبية :

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

المجال العلاجي:

ANTIMETABOLITES

الوضع إذن:

Not Marketed

تاريخ الترخيص:

2016-02-05

نشرة المعلومات

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED 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 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
If you

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pemetrexed 500mg Powder for Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg of pemetrexed (as pemetrexed disodium 2.5
hydrate).
After reconstitution (see section 6.6), each vial contains 25 mg/ml of
pemetrexed.
Excipient(s) with known effect:
Each vial contains approximately 54 mg sodium (2.35 mmol).
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 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
histology (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Pemetrexed must only be administered under the supervision of a
physician qualified in the use of anti-cancer
chemotherapy.
Pemetrexed in combination with cisplatin
The recommended dose of Pemetrexed is 500 mg/m² of body surface area
(BSA) administered as an intravenous
infusion over 10 minutes on the first day of each 21-day cycle. The
recommended dose of cisplatin is 75 mg/m² BSA
in