资料单张
DURATOCIN
®
INJECTION
_Carbetocin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Duratocin.
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 having Duratocin
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DURATOCIN IS
USED FOR
Duratocin contains carbetocin, a
substance which is an oxytocic agent
and causes the womb (uterus) to
contract.
Duratocin is used to minimise post
delivery bleeding in women who
have delivered their baby by elective
caesarean section under local
anaesthetic around the spinal cord
(epidural).
_HOW IT WORKS_
In some women, following delivery
by caesarean section, the womb fails
to contract quickly enough which
increases the risk of bleeding. Drugs
that act directly on the womb to
make it contract are used to minimise
post delivery bleeding and are
sometimes called oxytocic agents
because they act in a similar manner
to oxytocin.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Duratocin is available only with a
doctor's prescription. It is not
addictive.
BEFORE YOU ARE GIVEN
DURATOCIN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DURATOCIN MUST NOT BE GIVEN IF YOU
HAVE AN ALLERGY TO:
•
carbetocin, the active ingredient,
or to any of the ingredients listed
at the end of this leaflet
•
any medicines containing
oxytocin.
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.
YOU MUST NOT BE GIVEN DURATOCIN
DURING PREGNANCY OR ANY TIME
BEFORE DELIVERY OF THE BABY.
YOU MUST NOT BE GIVEN DURATOCIN IF
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产品特点
PRODUCT INFORMATION
#15449-v8A
DURATOCIN
(CARBETOCIN INJECTION)
NAME OF THE DRUG
Carbetocin
SYNONYMS:
2,1-Desamino-4, 1-desthio-O4, 2-Methyl
1 [1-homocysteine] oxytocin
1-desamino-1-monocarba-2-(0-methyl)-tyrosine-oxytocin
(2-0-methyltyrosine)-1-deaminocarba-1-oxytocin
(6,1-
deaminocystathionine, 2-0-methyl-tyrosine)-oxytocin
[Tyr(Me)
2
]-desamino-1-carba-oxytocin
CAS: 37025-55-1
STRUCTURE:
O
C
Tyr
Ile
Glu
Asp
Cys
Pro
Leu
Gly
NH
2
Me
NH
2
NH
2
CH
2
CH
2
CH
2
MOLECULAR FORMULA: C
45
H
69
N
11
O
12
S
MOLECULAR WEIGHT: 988.1
DESCRIPTION
Carbetocin is a white, fluffy lyophilized powder, soluble in water, ethanol, methanol and acetic acid.
Carbetocin is insoluble in ether and petroleum ether.
Each ampoule contains 100μg of carbetocin, 9 mg sodium chloride, acetic acid – glacial to pH 3.8 and
water for injections to 1 mL.
PHARMACOLOGY
DURATOCIN (carbetocin injection) is a long-acting synthetic octapeptide analogue of oxytocin with
agonist properties. It can be administered intravenously as a single dose immediately following delivery
by caesarean section under epidural or spinal anaesthesia, to prevent uterine atony and postpartum
haemorrhage.
The clinical and pharmacological properties of carbetocin are similar to those of naturally occurring
oxytocin, another posterior pituitary hormone. In in vitro studies, carbetocin was shown to bind to the
oxytocin receptor with similar affinity as the natural peptide. Carbetocin elicited similar uteronic and
galactogogic effects to oxytocin in animals and in vitro. Carbetocin was less potent than oxytocin, but its
action was more prolonged.
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