DBL PEMETREXED pemetrexed (as disodium) 1000 mg powder for injection vial

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

pemetrexed disodium hemipentahydrate

Beschikbaar vanaf:

Pfizer Australia Pty Ltd

INN (Algemene Internationale Benaming):

pemetrexed disodium

Autorisatie-status:

Registered

Bijsluiter

DBL™ Pemetrexed (as disodium) powder for injection
1
DBL™ PEMETREXED (AS DISODIUM)
POWDER FOR INJECTION
_ _
_pemetrexed disodium (pem-e-TREX-ed dye-SOE-dee-um) _
CONSUMER MEDICINE INFORMATION
_Date of Dispensing_
_Consumer Name _
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_Pharmacist Name _
_Consumer Address _
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_Pharmacist Address _
_Consumer Address _
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WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL™
Pemetrexed (as disodium) powder
for injection.
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 DBL™
Pemetrexed (as disodium) powder
for injection 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 DBL™
PEMETREXED (AS
DISODIUM) POWDER FOR
INJECTION IS USED FOR
DBL™ Pemetrexed (as disodium)
powder for injection is used to treat:

malignant pleural
mesothelioma, a rare cancer of
the lungs often related to
exposure to asbestos

non small cell lung cancer, a
type of lung cancer
This medicine belongs to a group of
medicines called antineoplastic or
cytotoxic medicines. You may also
hear of these being called
chemotherapy medicines.
DBL™ Pemetrexed (as disodium)
powder for injection affects
enzymes within cancer cells, killing
cancer cells or stopping them from
growing and multiplying.
This medicine may be used in
combination with other medicines
used to treat cancer.
Your doctor may have prescribed
this medicine for another reason.
Ask your doctor if you have any
questions about why DBL™
Pemetrexed (as disodium) powder
for injection has been prescribed
for you.
This medicine is available only with
a doctor’s prescription.
DBL™ Pemetrexed (as disodium)
powder for injection is not
recommended for use in children
under the age of 18, as ther

Productkenmerken

V5.0, Page 1
DBL™ PEMETREXED (AS DISODIUM) POWDER FOR
INJECTION
NAME OF THE MEDICINE
DBL™ Pemetrexed (as disodium) powder for injection
The active ingredient in DBL™ Pemetrexed (as disodium) powder for
injection is
pemetrexed (present as disodium hemipentahydrate). Pemetrexed disodium
hemipentahydrate
has the chemical name
_N_
-[4-[2-(2-amino-4,7-dihydro-4-oxo-1
_H_
-pyrrolo[2,3-
_d_
]pyrimidin-5-
yl)ethyl]benzoyl]-, L-glutamic acid disodium salt, hemipentahydrate.
It has an empirical
formula of C
20
H
19
N
5
Na
2
O
6
•2.5H
2
O and a molecular weight of 516.42. The structural
formula is as follows:
The CAS number for pemetrexed disodium is 150399-23-8 (Anhydrous).
DESCRIPTION
DBL™ Pemetrexed (as disodium) powder for injection 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. DBL™ Pemetrexed (as
disodium) powder for
injection is supplied in 1000 mg, 500 mg and 100 mg vials. Each 1000
mg vial contains
pemetrexed disodium hemipentahydrate equivalent to 1000 mg pemetrexed
and 980.40 mg of
mannitol. Each 500 mg vial contains pemetrexed disodium
hemipentahydrate equivalent to
500 mg pemetrexed and 490.20 mg of mannitol. Each 100 mg vial contains
pemetrexed
disodium hemipentahydrate equivalent to 100 mg pemetrexed and 98.04 mg
of mannitol.
Hydrochloric acid and/or sodium hydroxide may have been added to
adjust pH.
N
H
O
O
-
Na
+
O
O
-
Na
+
O
HN
H
N
N
O
H
2
N
2.5 H
2
O
V5.0, Page 2
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pemetrexed is an antifolate antineoplastic agent
_. In vitro _
studies have shown that pemetrexed
behaves as a multi-targeted antifolate by inhibiting thymidylate
synthase (TS), dihydrofolate
reductase (DHFR) and glycinamide ribonucleotide formyltransferase
(GARFT), which are
key folate-dependent enzymes for the de novo biosynthesis of thymidine
and purine
nucleotides that are essential for cell replication. Both the reduced
folate carrier and
membrane folate bin