PABAL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CARBETOCIN

Available from:

FERRING PHARMACEUTICALS LTD

ATC code:

H01BB03

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

CARBETOCIN 100 MCG/ML

Administration route:

I.V, I.M

Prescription type:

Required

Manufactured by:

FERRING GmbH ,GERMANY

Therapeutic area:

CARBETOCIN

Therapeutic indications:

PABAL is indicated for the prevention of postpartum haemorrhage due to uterine atony

Authorization date:

2023-02-28

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
PABAL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbetocin 100 micrograms/ml.
Oxytocic activity: approximately 50 IU of oxytocin/vial
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PABAL
is indicated for the prevention of postpartum haemorrhage due to
uterine atony.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_Caesarean section under epidural or spinal anaesthesia:_
Withdraw 1 ml of PABAL containing 100 micrograms carbetocin and
administer only by intravenous
injection, under adequate medical supervision in a hospital.
_ _
_Vaginal delivery:_
Withdraw 1 ml of PABAL containing 100 micrograms carbetocin and
administer by intravenous injection or
intramuscular injection, under adequate medical supervision in a
hospital.
Method of administration
For intravenous or intramuscular administration.
Carbetocin must only be administered after delivery of the infant,
preferably before removal of the placenta.
For intravenous administration carbetocin must be administered slowly,
over 1 minute. PABAL is intended
for single use only. No further doses of carbetocin should be
administered.
_Paediatric population_
There is no relevant use of carbetocin in children below 12 years of
age.
The safety and efficacy of carbetocin in adolescents has not yet been
established.
Currently available data are described in section 5.1 but no
recommendation on a posology can be made.
4.3
CONTRAINDICATIONS
•
During pregnancy and labour before delivery of the infant.
•
Carbetocin must not be used for the induction of labour.
•
Hypersensitivity to carbetocin, oxytocin or to any of the excipients
listed in section 6.1.
•
Hepatic or renal disease.
•
Serious cardiovascular disorders.
•
Epilepsy.
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Carbetocin is intended for use only at well equipped specialist
obstetrics units with experienced and
qualified staff available at