DURATOCIN INJECTION 100 mcgml

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

Carbetocin

Tilgjengelig fra:

FERRING PHARMACEUTICALS PRIVATE LIMITED

ATC-kode:

H01BB03

Dosering :

100 mcg

Legemiddelform:

INJECTION

Sammensetning:

Carbetocin 100 mcg/ml

Administreringsrute:

INTRAVENOUS

Resept typen:

Prescription Only

Produsert av:

Ferring GmbH

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2003-08-25

Informasjon til brukeren

DURATOCIN
®
(Carbetocin Injection) 
1 mL ampoule - 100µg/mL Injection 
For Intravenous Use Only 
THERAPEUTIC CLASSIFICATION 
Uterotonic Agent 
ACTION AND CLINICAL PHARMACOLOGY 
DURATOCIN
®
 (carbetocin injection) is a long-acting synthetic nonapeptide analogue 
of oxytocin with agonist properties. It can  be administered intravenously as a single 
dose  immediately  following  delivery  by  cesarean  section  under  epidural  or  spinal 
anesthesia, to prevent uterine atony and postpartum hemorrhage. 
The  clinical  and  pharmacological  properties  of  carbetocin  are  similar  to  those  of 
naturally  occurring  oxytocin,  another  post erior  pituitary  hormone.  Like  oxytocin, 
carbetocin  binds  to  oxytocin  receptors  present  on  the  smooth  musculature  of  the 
uterus,  resulting  in  rhythmic   contractions  of  the  uterus,  increased  frequency  of 
existing contractions, and increased uterine  tone. The oxytocin receptor content of the 
uterus  is  very  low  in  the  non-pregnant  state,  and  in creases  during  pregnancy, 
reaching  a  peak  at  the  time  of  delivery.  Therefore  carbetocin  has  no  effect  on  the 
non-pregnant  uterus,  and  ha s  a  potent  uterotonic  effect  on  the  pregnant  and 
immediate postpartum uterus. 
The  onset  of  uterine  contraction  following  carbetocin  administration  by  either  the 
intravenous  or  intramuscular  route  is  rapid,   with  a  firm  contraction  being  obtained 
within  2  minutes.  The  total  duration  of  action  of  a  single  intravenous  injection  of 
carbetocin on uterine activity is about on e hour suggesting that carbetocin may act 
long enough to prevent postpartum hemorrhage in the 

Preparatomtale

DURATOCIN
®
(Carbetocin Injection)
1 mL ampoule - 100µg/mL Injection
For Intravenous Use Only
THERAPEUTIC CLASSIFICATION
Uterotonic Agent
ACTION AND CLINICAL PHARMACOLOGY
DURATOCIN
®
(carbetocin injection) is a long-acting synthetic nonapeptide analogue
of oxytocin with agonist properties. It can
be administered intravenously as a single
dose immediately following delivery by cesarean section under epidural
or spinal
anesthesia, to prevent uterine atony and postpartum hemorrhage.
The clinical and pharmacological properties of carbetocin are similar
to those of
naturally occurring oxytocin, another post erior pituitary hormone.
Like oxytocin,
ca
rbetocin binds to oxytocin receptors present on the smooth musculature
of the
uterus, resulting in rhythmic contractions of the uterus, increased
frequency of
existing contractions, and increased uterine tone. The oxytocin
receptor content of the
uterus is very low in the
non-pregnant state, and in creases during pregnancy,
reaching a peak at the time of delivery. Therefore carbetocin has no
effect on the
non-pregnant
uterus,
and
has
a
potent
uterotonic
effect
on
the
pregnant
and
immediate postpartum uterus.
The onset of uterine contraction following carbetocin administ
ration by either the
intravenous or intramuscular route is rapid, with a firm contraction
being obtained
within 2 minutes. The total duration of action of a single intravenous
injection of
carbetocin on uterine activity is about on e hour suggesting that
carbetocin may act
long enough to prevent postpartum hemorrhage in the immediate
postpartum period.
In comparison to oxytocin, carbetocin induces a prolonged uterine
response when
administered postpartum, in terms of both amplitude and frequency of
contractions.
Carbetocin, when administered immediately
postpartum as a single intravenous bolus
injection of 100µg to women delivered by
cesarean section under epidural or spinal
anesthesia, was found to be significantly more effective than placebo
in preventing
uterine atony and minimizing uterine bleeding.