Pemetrexed W&H 500 mg powder for concentrate for solution for infusion

Ország: Málta

Nyelv: angol

Forrás: Malta Medicines Authority

Aktív összetevők:

PEMETREXED

Beszerezhető a:

Williams & Halls ehf Reykjavikurvegur 62, 220 Hafnarfjörður, , Iceland

ATC-kód:

L01BA04

INN (nemzetközi neve):

PEMETREXED 500 mg

Gyógyszerészeti forma:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Összetétel:

PEMETREXED 500 mg

Recept típusa:

POM

Terápiás terület:

ANTINEOPLASTIC AGENTS

Termék összefoglaló:

Licence number in the source country: NOT APPLICAPABLE

Engedélyezési státusz:

Authorised

Engedély dátuma:

2020-07-21

Betegtájékoztató

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED W&H 500 MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
pemetrexed (as pemetrexed disodium)
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 or pharmacist or
nurse.
-
If you get any side effects, talk to your doctor or 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 W&H is and what it is used for
2.
What you need to know before you use Pemetrexed W&H
3.
How to use Pemetrexed W&H
4.
Possible side effects
5.
How to store Pemetrexed W&H
6.
Contents of the pack and other information
1.
WHAT PEMETREXED W&H IS AND WHAT IT IS USED FOR
Pemetrexed W&H is a medicine used in the treatment of cancer.
Pemetrexed W&H 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 W&H is also given in combination with cisplatin for the
initial treatment of patients
with advanced stage of lung cancer.
Pemetrexed W&H 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 W&H 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 W&H
DO NOT USE PEMETREXED W&H
-
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 W&H.
-
if you have recently received or are about to receive a vaccine
against yellow fever.
WARNI

Termékjellemzők

1
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed W&H 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.
Excipients with known effect:
Each vial contains approximately 2.4 mmol (or 54 mg) 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 cake or
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed W&H in combination with cisplatin is indicated for the
treatment of chemotherapy naïve
patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed W&H 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 W&H 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 W&H 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 W&H must only be administered under the supervision of a
physician qualified in the use
of anti-cancer chemotherapy.
Pemetrexed W&H in combination with cisplatin
The recommended dose of Pemetrexed W&H is 500 mg/m
2
of body surface area (BSA) administered
as an intravenous infusion over 10 minutes on the first day of each
21-day cycle. The recommended
2
dose of cisplatin is 75 mg/m
2
BSA