ALIMTA pemetrexed (as disodium) 100 mg powder for injection vial

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

pemetrexed disodium heptahydrate, Quantity: 151.7 mg

थमां उपलब्ध:

Eli Lilly Australia Pty Ltd

INN (इंटरनेशनल नाम):

Pemetrexed disodium heptahydrate

फार्मास्यूटिकल फॉर्म:

Injection, powder for

रचना:

Excipient Ingredients: hydrochloric acid; mannitol; water for injections; sodium hydroxide

प्रशासन का मार्ग:

Intravenous

पैकेज में यूनिट:

1 vial

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

Malignant Pleural Mesothelioma. ALIMTA, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. 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 the treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

उत्पाद समीक्षा:

Visual Identification: White to either light yellowish or green-yellowish lyophilized solid.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2007-11-08

सूचना पत्रक

ALIMTA
®
_pemetrexed disodium heptahydrate_
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 other
chemotherapy drugs.
BEFORE YOU ARE GIVEN
ALIMTA
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT TAKE ALIMTA IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
pemetrexed disodium
heptahydrate
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swell

उत्पाद विशेषताएं

vA15_Nov2019
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION – ALIMTA
® (PEMETREXED
DISODIUM HEPTAHYDRATE) POWDER FOR SOLUTION FOR INFUSION
1.
NAME OF THE MEDICINE
pemetrexed disodium heptahydrate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALIMTA is supplied in 500 mg and 100 mg vials.
Each 500 mg vial of ALIMTA contains pemetrexed disodium heptahydrate
equivalent to 500
mg pemetrexed. Each 100 mg vial of ALIMTA contains pemetrexed disodium
heptahydrate
equivalent to 100 mg pemetrexed.
For the full list of excipients, see section 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,
in
combination
with
cisplatin,
is
indicated
for
the
treatment
of
patients
with
malignant pleural mesothelioma.
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 the treatment of patients with
locally advanced or
metastatic non-small cell lung cancer other than predominantly
squamous cell histology after
prior platinum-based chemotherapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
ALIMTA should be administered under the supervision of a qualified
physician experienced
in the use of antineoplastic agents.
vA15_Nov2019
Page 2 of 26
ALIMTA in combination use with cisplatin:
Adults - The recommended dose of ALIMTA is 500 mg/m2 as 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 infused over 2 hours
approximately 30
minutes after completion of the ALIMTA infusion on the first day of
each 21 day cycle.
Patients must receive adequate anti-emetic treatm