DURATOCIN RTS SOLUTION FOR INJECTION 100 MCGML

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

Carbetocin

Commercializzato da:

FERRING PHARMACEUTICALS PRIVATE LIMITED

Codice ATC:

H01BB03

Forma farmaceutica:

INJECTION, SOLUTION

Composizione:

Carbetocin 100 mcg/ml

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

Prescription Only

Prodotto da:

Ferring GmbH

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2017-02-08

Scheda tecnica

30(RTS)-I-SG,MM-02.01
1.
NAME OF THE MEDICINAL PRODUCT
DURATOCIN
®
RTS Solution for Injection 100 mcg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbetocin 100 mcg/mL.
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
DURATOCIN
®
RTS
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 DURATOCIN
®
RTS containing 100 micrograms
carbetocin and administer only by intravenous injection, under
adequate
medical supervision in a hospital.
_ _
_Vaginal delivery: _
Withdraw 1 ml of DURATOCIN
®
RTS 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, and
as
soon as possible after delivery, preferably before the delivery of the
placenta.
For intravenous administration carbetocin must be administered slowly,
over 1 minute.
DURATOCIN
®
RTS 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
Pregnancy and labour before delivery of the infant.
Induction of labour.
Serious cardiovascular disorders.
Hypersensitivity to carbetocin or oxytocin or to any of the excipients
listed in
section 6.1.
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 all times