Alimta
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
13-05-2013
Summary of Product characteristics
(SPC)
24-11-2020
Active ingredient:
Pemetrexed disodium 151.7mg (as the heptahydrate, equivalent to pemetrexed free acid 100mg)
Available from:
Eli Lilly and Company (NZ) Limited
INN (International Name):
Pemetrexed disodium 151.7 mg (as the heptahydrate, equivalent to pemetrexed free acid 100mg)
Dosage:
100 mg
Pharmaceutical form:
Powder for infusion
Composition:
Active: Pemetrexed disodium 151.7mg (as the heptahydrate, equivalent to pemetrexed free acid 100mg) Excipient: Hydrochloric acid Mannitol Sodium hydroxide Water for injection
Units in package:
Vial, glass, 10 mL Type I clear glass vial with bromobutyl rubber stopper, 100 mg
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Eli Lilly SA
Therapeutic indications:
· ALIMTA in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. · ALIMTA as monotherapy is indicated for treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.
Product summary:
Package - Contents - Shelf Life: Vial, glass, 10 mL Type I clear glass vial with bromobutyl rubber stopper - 100 mg - 36 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
Authorization date:
2007-10-23
Patient Information leaflet
ALIMTA
®
CMI v4.0 May 2013
1
ALIMTA
®
_pemetrexed disodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALIMTA. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date shown on the
final page. More recent information
on this medicine may be available.
Make sure you speak to your
pharmacist, nurse or doctor to obtain
the most up to date information on
this medicine. You can also
download the most up to date leaflet
from www.lilly.com.au. The updated
leaflet may contain important
information about ALIMTA and its
use that you should be aware of.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ALIMTA
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ALIMTA IS USED
FOR
ALIMTA is used to treat:
mesothelioma, a rare cancer of
the lungs often related to
exposure to asbestos
non-small cell lung cancer, a type
of lung cancer.
It belongs to a group of medicines
called cytotoxic or antineoplastic
agents. They may also be called
chemotherapy medicines.
It affects enzymes within cancer cells
to kill cancer cells or prevent them
growing and multiplying.
Your doctor may have prescribed it
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
ALIMTA may be used in
combination with oth
Read the complete document
Summary of Product characteristics
NEW ZEALAND DATASHEET
vD15.1_Nov2019
SUPERSEDES: vA15-0_17May2019
Page 1 of 26
1.
PRODUCT NAME
ALIMTA
®
100mg powder for infusion
ALIMTA
®
500mg powder for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg vial contains pemetrexed disodium heptahydrate equivalent
to 100 mg
pemetrexed. Each 100 mg vial must be reconstituted with 4.2 mL of 0.9
% Sodium Chloride
Injection (preservative free). The reconstituted ALIMTA solution
contains 25 mg/mL of
pemetrexed.
The 500 mg vial contains 500 mg of pemetrexed as pemetrexed disodium
heptahydrate. Each
500 mg vial must be reconstituted with 20 mL of 0.9 % Sodium Chloride
Injection
(preservative free). The reconstituted ALIMTA solution contains 25
mg/mL of pemetrexed.
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
ALIMTA is supplied as a sterile lyophilised powder for intravenous
infusion available in
single dose vials. The product is a white to either light yellow or
green-yellow lyophilised
solid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MALIGNANT PLEURAL MESOTHELIOMA
ALIMTA is indicated for the treatment of patients with malignant
pleural mesothelioma in
combination with cisplatin.
NON-SMALL CELL LUNG CANCER
ALIMTA in combination with cisplatin is indicated for initial
treatment of patients with
locally advanced or metastatic non-small cell lung cancer other than
predominantly
squamous cell histology.
ALIMTA as monotherapy is indicated for treatment of patients with
locally advanced or
metastatic non-small cell lung cancer other than predominantly
squamous cell histology after
prior platinum-based chemotherapy.
NEW ZEALAND DATASHEET
vD15.1_Nov2019
SUPERSEDES: vA15-0_17May2019
Page 2 of 26
4.2
DOSE AND METHOD OF ADMINISTRATION
ALIMTA should only be administered under the supervision of a
physician qualified in the
use of anticancer chemotherapy. The ALIMTA solution must be prepared
according to the
instructions provided (see 4.2 DOSE AND METHOD OF ADMINISTRATION-
INSTRUCTIONS FOR USE
AND HANDLING).
Combinatio
Read the complete document
