Pemetrexed APOTEX pemetrexed 500 mg (as disodium) powder for injection vial

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

pemetrexed disodium hemipentahydrate, Quantity: 604 mg (Equivalent: pemetrexed, Qty 500 mg)

Verfügbar ab:

Arrotex Pharmaceuticals Pty Ltd

INN (Internationale Bezeichnung):

pemetrexed disodium hemipentahydrate

Darreichungsform:

Injection, powder for

Zusammensetzung:

Excipient Ingredients: mannitol; hydrochloric acid; sodium hydroxide

Verabreichungsweg:

Intravenous Infusion

Einheiten im Paket:

1

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Malignant Pleural Mesothelioma,Pemetrexed, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.,Non-Small Cell Lung Cancer (NSCLC),Pemetrexed, in combination with cisplatin, is indicated for initial treatment of patients with locally advanced or metastatic NSCLC other than predominantly squamous cell histology.,Pemetrexed, as monotherapy, is indicated for the treatment of patients with locally advanced or metastatic NSCLC other than predominantly squamous cell histology after prior platinum-based chemotherapy.

Produktbesonderheiten:

Visual Identification: White to either light yellow or green-yellow powder.; Container Type: Vial; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2014-09-04

Gebrauchsinformation

PEMETREXED APOTEX
POWDER FOR INJECTION
_Contains the active ingredient pemetrexed (as disodium)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Pemetrexed APOTEX Powder for
Injection, which is given as an
intravenous infusion. It contains the
active ingredient pemetrexed, as the
disodium salt.
Pemetrexed 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.
Pemetrexed 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.
Pemetrexed may be used in
combination with other
chemotherapy drugs.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
This medicine should not be used in
children under the age of 18.
BEFORE YOU ARE GIVEN
THIS MEDICINE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
pemetrexed
•
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 diffi

Fachinformation

1
AUSTRALIAN PRODUCT INFORMATION
PEMETREXED APOTEX (PEMETREXED DISODIUM
HEMIPENTAHYDRATE) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Pemetrexed disodium hemipentahydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 500 mg vial contains pemetrexed disodium, equivalent to 500 mg
pemetrexed, and 500 mg
mannitol. Hydrochloric acid and/or sodium hydroxide may have been
added to adjust pH.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
500 MG:
White to either light yellow or green-yellow powder.
4
CLINICAL PARTICULARS
4.1
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 (NSCLC) other than
predominantly squamous
cell histology.
Pemetrexed, as monotherapy, is indicated for the treatment of patients
with locally advanced or
metastatic NSCLC other than predominantly squamous cell histology
after prior platinum-based
chemotherapy.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Pemetrexed APOTEX powder for injection is intended for intravenous
infusion.
Pemetrexed should be administered under the supervision of a qualified
physician experienced in
the use of antineoplastic agents.
PEMETREXED IN COMBINATION USE WITH CISPLATIN
Adults – the recommended dose of pemetrexed 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 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. Refer to cisplatin Product Information document
for specific dosing advice.
SINGLE A