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

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

pemetrexed disodium

Dostupné z:

Sandoz Pty Ltd

INN (Medzinárodný Name):

pemetrexed disodium

Stav Autorizácia:

Registered

Príbalový leták

PEMETREXED
SANDOZ
®
_pemetrexed disodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pemetrexed
Sandoz
®
. 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 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
SANDOZ
® IS USED FOR
This medicine 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 Sandoz
®
may be used in
combination with other
chemotherapy drugs.
BEFORE YOU ARE GIVEN
PEMETREXED SANDOZ
®
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT TAKE THIS MEDICINE IS 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 or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN THIS MEDICINE, TALK
TO YOUR DOCTOR.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
kidney problems
TELL YOUR DOCTOR IF YOU ARE
PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE

Súhrn charakteristických

_Product Information _
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_Pemetrexed Sandoz 500mg powder for injection _
_03/2015 _
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PPRODUCT INFORMATION
PEMETREXED SANDOZ
® 500MG POWDER FOR INJECTION
NAME OF THE MEDICINE
pemetrexed disodium
N-[4-[2-(2-Amino-4, 7-dihydro-4-oxo-1H-pyrrolo [2,3d] pyrimidin-5-yl)
ethyl] benzoyl]-
L-glutamic acid disodium salt 2.5 hydrate
Disodium
(2S)-2-[[4-[2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo-[2,3-d]pyrimidin-5-yl)
ethyl]benzoyl]amin]pentanedioate 2.5 hydrate
CAS [357166-30-4 (2.5 hydrate)]
Empirical formula: C
20
H
19
N
5
Na
2
O
6
2.5 H
2
O MW: 516.42
DESCRIPTION
Pemetrexed disodium is a white to almost white solid.
Pemetrexed Sandoz is supplied as a sterile lyophilised powder for
intravenous infusion available
in single dose vials. The product is a white or off-white lyophilised
solid. Pemetrexed Sandoz is
supplied in 500 mg vials. Each 500 mg vial of Pemetrexted Sandoz
contains pemetrexed
disodium equivalent to 515 mg pemetrexed and 515 mg of mannitol.
Hydrochloric acid and/or
sodium hydroxide may have been added to adjust pH.
Pemetrexed is freely soluble in water and in 0.1 mol/L sodium
hydroxide; sparingly soluble in
methanol; very slightly soluble in 0.1 mol/L hydrochloric acid,
practically insoluble or insoluble
in N,N-dimethylformamide, in ethyl acetate, in alcohol and in acetone
and pKa of: ≤ 3.5, 6.24,
7.61 and > 13.
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PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pemetrexed is an antifolate antineoplastic agent. _ In vitro_ studies
have shown that pemetrexed
behaves as a multitargeted 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 reduce