PEMETREXED ACCORD pemetrexed (as disodium) 500 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

29-05-2020

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

pemetrexed disodium, Quantity: 551.45 mg (Equivalent: pemetrexed, Qty 500 mg)

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

pemetrexed disodium

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: hydrochloric acid; mannitol; sodium hydroxide

Administration route:

Intravenous

Units in package:

1 vial per carton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Malignant Pleural Mesothelioma,Pemetrexed, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.,Non-Small Cell lung Cancer,Pemetrexed 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.,Pemetrexed 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.

Product summary:

Visual Identification: A white to either light yellow or greenish yellow lyophilized solid in a clear glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-05-28

Patient Information leaflet

v 2.0
1
PEMETREXED ACCORD POWDER FOR INJECTION
pemetrexed (as disodium)
CONSUMER MEDICINES INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pemetrexed Accord.
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. The updated leaflet
may contain important information
about Pemetrexed Accord and its use
that you should be aware of.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking Pemetrexed Accord
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 PEMETREXED
ACCORD IS USED FOR
Pemetrexed Accord 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.
Pemetrexed Accord may be used in
combination with other chemotherapy
drugs.
BEFORE YOU ARE GIVEN
PEMETREXED ACCORD
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT TAKE PEMETREXED ACCORD IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
pemetrexed disodium
•
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 o

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Summary of Product characteristics

Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
PEMETREXED ACCORD (PEMETREXED) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Pemetrexed disodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 100 mg, 500 mg or 1000 mg of pemetrexed.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Pemetrexed Accord pemetrexed (as disodium) powder for Injection.
Pemetrexed Accord is supplied as a sterile lyophilised powder for
intravenous infusion available in
single dose clear glass vials. The product is a white to either light
yellow or green-yellow lyophilised
solid.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
MALIGNANT PLEURAL MESOTHELIOMA
Pemetrexed, in combination with cisplatin, is indicated for the
treatment of patients with malignant
pleural mesothelioma.
NON-SMALL CELL LUNG CANCER
Pemetrexed 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.
Pemetrexed 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
D
OSE AND METHOD OF ADMINISTRATION
Pemetrexed Accord should be administered under the supervision of a
qualified physician experienced
in the use of antineoplastic agents.
PEMETREXED ACCORD IN COMBINATION USE WITH CISPLATIN
ADULTS -
The recommended dose of Pemetrexed Accord is 500 mg/m
2
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/m
2
BSA infused over 2 hours approximately 30 minutes
after completion of the Pemetrexed Accord infusion on the first day of
each 21-day cycle. Patients must
receive adequate anti-emetic treatment and appropriate hydration prior
to and/or after receiving
cisplatin. See cisplatin Product Information document for specific
dosin

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