All the Active Ingredient Drugs
Tocolytic Agent. Atosiban 7.5 mg/ml. Sol. FOR INJECT: 1
CONC. FOR INFUSION: 1
To start as soon as possible aft. diagn.
of preterm labour in 3 successive
stages: initial bolus dose (6.75 mg)
with 7.5 mg/ml sol. for inject., immed.
foll. by continuous high dose infus.
(300 μg/min) during 3 hrs. foll. by
lower dose (100 μg/min) for up to 45
hrs. Infus. to be performed with 7.5
mg/ml conc. sol. for infus. Tmt. not to
exceed 48 hrs. Total dose not to exceed
330 mg active substance.
To delay imminent pre-term birth in
pregn. women with reg. uterine
contracts. of at least 30 secs. durat. at
rate of ≥ 4/30 mins., cervical dilat. of 1-3
cm (multiparas: 0-3), effacement of ≥
50%; age ≥ 18 yrs., gestat. age: 24-33
completed wks; normal fetal heart rate.
C/I: Gestat. age below 24 or over 33
completed wks., prem. rupture
membranes > 30 wks gestat.,
intrauterine growth retard, abnorm.
fetal heart rate, antepartum uterine
hemorrh. req. immed. delivery,
eclampsia and severe pre-eclampsia
req. delivery, intrauterine fetal death,
suspect. intrauterine infect., placenta previa, abruptio placenta, any other cond. of mother and fetus which is
hazardous, known hypersens. to excips.
