SYNTOCINON INJECTION 10 iuml

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

OXYTOCIN

Disponible des:

MYLAN PHARMACEUTICALS PTE. LTD.

Codi ATC:

H01BB02

Dosis:

10 iu/ml

formulario farmacéutico:

INJECTION

Composición:

OXYTOCIN 10 IU/ml

Vía de administración:

INTRAVENOUS, INTRAMUSCULAR

tipo de receta:

Prescription Only

Fabricat per:

Steriscience Sp. z o.o.

Estat d'Autorització:

ACTIVE

Data d'autorització:

1989-03-14

Informació per a l'usuari

SYNTOCINON
 

Posterior pituitary lobe hormones 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM(S) 
Concentrate for solution for infusion; Solution for injection (in
1 mL ampoule) containing 5 
IU/mL. 
Concentrate
for solution for infusion; Solution for injection (in
1 mL ampoule) containing 10 
IU/mL. 
ACTIVE SUBSTANCE  
The active substance is synthetic oxytocin. One ampoule contains
1mL solution. 
Certain dosage strengths and dosage forms may not
be available in all countries. 
EXCIPIENTS 
Sodium acetate trihydrate, acetic acid glacial, chlorobutanol,
ethanol 94% w/w, water for 
injections. 
Pharmaceutical formulations may vary between countries. 
INDICATIONS 
ANTEPARTUM 
  Induction of labor for medical reasons, e.g. in cases
of post-term gestation, premature 
rupture of the membranes, pregnancy-induced
hypertension associated with significant 
protein in the urine (pre-eclampsia). 
  Enhancement of labor in selected cases of uterine
inertia. 
  Syntocinon may also be indicated in early stage
of pregnancy, as adjunctive therapy for 
management of incomplete, inevitable or missed abortion. 
POSTPARTUM 
  During caesarean section, but after the delivery of
the child. 
  Prevention and treatment of postpartum hemorrhage
associated with uterine atony. 
Novartis   Page 
2 
Country Specific Package Leaflet (Singapore)04 May 2012 
Syntocinon solution for infusion 

DOSAGE AND ADMINISTRATION 
DOSAGE 
GENERAL TARGET POPULATION 
INDUCTION OR ENHANCEMENT OF LABOR 
Syntocinon should be administered as an intravenous (i.v.) drip
infusion or, preferably, by 
means of a variable-speed infusion pump. For drip infusion it
is recommended that 10 IU of 
Syntocinon be added to 1000 mL of
a physiological electrolyte solution (such as sodium 
chloride 0.9%). For patients in whom infusion of
sodium chloride must be avoided, 5% 
dex

Fitxa tècnica

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Singapore
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Comp. Description:
Syntocinon PI
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Date:
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SYNTOCINON
®
Posterior pituitary lobe hormones
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
Concentrate for solution for infusion; Solution for injection (in 1
mL ampoule) containing 5 IU/mL.
Concentrate for solution for infusion; Solution for injection (in 1
mL ampoule) containing 10 IU/mL.
ACTIVE SUBSTANCE
The active substance is synthetic oxytocin. Each ampoule
contains 1mL solution. Certain dosage strengths and dosage
forms may not be available in all countries.
EXCIPIENTS
Sodium acetate trihydrate, acetic acid glacial, chlorobutanol,
ethanol 94% w/w, water for injections.
Pharmaceutical formulations may vary between countries.
INDICATIONS
ANTEPARTUM
•
Induction of labor for medical reasons, e.g. in cases of
post-term gestation, premature rupture of the membranes,
pregnancy-induced hypertension associated with significant
protein in the urine (pre-eclampsia).
•
Enhancement of labor in selected cases of uterine inertia.
•
Syntocinon may also be indicated in early stage of
pregnancy, as adjunctive therapy for management of
incomplete, inevitable or missed abortion.
POSTPARTUM
•
During cesarean section, but after the delivery of the child.
•
Prevention and treatment of postpartum hemorrhage
associated with uterine atony.
DOSAGE AND ADMINISTRATION
DOSAGE
GENERAL TARGET POPULATION
INDUCTION OR ENHANCEMENT OF LABOR
Syntocinon should be administered as an intravenous (i.v.) drip
infusion or, preferably, by means of a variable-speed infusion
pump. For drip infusion it is recommended that 10 IU of
Syntocinon be added to 1000 mL of a physiological electrolyte
solution (such a