ALIMTA 100 MG

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

PEMETREXED

Διαθέσιμο από:

ELI LILLY ISRAEL LTD, ISRAEL

Φαρμακολογική κατηγορία (ATC):

L01BA04

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION FOR INFUSION

Σύνθεση:

PEMETREXED 100 MG/VIAL

Οδός χορήγησης:

I.V

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

LILLY FRANCE S.A.S., FRANCE

Θεραπευτική ομάδα:

PEMETREXED

Θεραπευτική περιοχή:

PEMETREXED

Θεραπευτικές ενδείξεις:

Alimta in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. Alimta 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. Alimta 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.Alimta 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.

Ημερομηνία της άδειας:

2018-08-31

Φύλλο οδηγιών χρήσης

I ALIMVL F 05
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PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
ALIMTA
100 MG
POWDER FOR SOLUTION FOR INFUSION
COMPOSITION:
Each vial contains:
100 milligrams pemetrexed (as pemetrexed disodium)
After reconstitution, the solution contains 25 mg/ml of pemetrexed.
Further dilution by a
healthcare provider is required prior to administration.
FOR INFORMATION ON INACTIVE INGREDIENTS AND ALLERGENS - see section 2
“Important information
about some of the ingredients of this medicine” and section 6
“Additional information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have any further
questions, please contact your
doctor or pharmacist
.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others.
It may harm them, even if it seems to you that their illness is
similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
ALIMTA is a medicine used in the treatment of cancer.
ALIMTA in combination with cisplatin, is indicated for the treatment
of patients with malignant
pleural mesothelioma, whose disease is unresectable or who are
otherwise not candidates for
curatible surgery.
ALIMTA 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.
ALIMTA 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.
ALIMTA 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.
THERAPEUTIC GROUP: folic acid analogues.
2. BEFORE

Αρχείο Π.Χ.Π.

X ALIMVL F 16
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1.
NAME OF THE MEDICINAL PRODUCT
ALIMTA 100 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALIMTA 100 mg powder for solution for infusion
Each vial contains 100
mg
of pemetrexed (as pemetrexed disodium).
_Excipient with known effect _
Each vial contains approximately 11
mg sodium.
After reconstitution (see section 6.6), each vial contains 25 mg/ml of
pemetrexed.
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
ALIMTA in combination with cisplatin is indicated for the treatment of
patients with malignant pleural
mesothelioma whose disease is unresectable or who are otherwise not
candidates for curatible surgery.
Non-small cell lung cancer
:
ALIMTA 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).
ALIMTA 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).
ALIMTA 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
ALIMTA must only be administered under the supervision of a physician
qualified in the use of
anti-cancer chemotherapy.
_ALIMTA in combination with cisplatin _
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The recommended dose of ALIMTA 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
c