Pharmidea Carbetocin 100 microgramml solution for injection

Land: Malaysia

Sprache: Englisch

Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Wirkstoff:

CARBETOCIN

Verfügbar ab:

Eucogen Pharma Sdn. Bhd.

INN (Internationale Bezeichnung):

CARBETOCIN

Einheiten im Paket:

5 vials of 1 ml

Hergestellt von:

SIA PHARMIDEA

Fachinformation

The adverse effects in the table below are presented according to the
MedDRA System
Organ Class database and frequency convention.
System Organ Class
Very Common
Blood
and
lymphatic
system disorders
Nervous system disorders
Headache, tremor
Vascular disorders
H
yp
otension, flushing
Respiratory,
thoracic
and
mediastinal disorders
Gastrointestinal disorders
Nausea, abdominal pain
Skin
and
subcutaneous
Pruritus
tissue disorders
Musculoskeletal
and
connective tissue disorders
General
disorders
and
Feeling of warmth
administration
site
conditions
Sweating and tachycardia were reported as sporadic cases.
Reporting of suspected adverse reactions
Common
Anaemia
Dizziness
Chest pain, dyspnoea
Metallic taste, vomiting
Back pain
Chills, pain
Reporting suspected adverse reactions after authorisation of the
medicinal product is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal
product. Healthcare professionals are asked to report any suspected
adverse reactions.
_4. 9 Overdose_
Overdose of carbetocin may produce uterine h
yp
eractivity whether or not due to
h
yp
ersensitivity to this agent.
Hyperstimulation
with
strong
(h
yp
ertonic)
or
prolonged
(tetanic)
contractions
resulting
from
oxytocin
overdose
can
lead
to
uterine
rupture
or
postpa1tum
haemorrhage.
In
severe
cases,
overdose of oxytocin
may lead
to
h
yp
onatraemia
and
water
intoxication, especially when associated with excessive concomitant
fluid intake. As
carbetocin is an analogue of oxytocin, the possibility of a similar
event cannot be
excluded.
Treatment of overdose of carbetocin consists of symptomatic and
supportive therapy.
When signs or symptoms of overdose occur, oxygen should be given to
the mother.
In cases of water intoxication it is essential to restrict fluid
intake, promote diuresis,
correct electrolyte imbalance, and control convulsions that may
eventually occur.
5
PHARMACOLOGICAL PROPERTIES
_5.1 Pharmacodynamic properties _
Pharmacotherapeutic group: Oxytocin and analogues, ATC code: H01BB03
The pharmacological and