Atosiban injection for adults

Who can administer

Who can administer: May be administered by competent doctor or nurse/midwife

Atosiban must be initiated and maintained by a physician experienced in the treatment of pre-term labour

Tractocile 6.75mg in 0.9ml vial
Tractocile 37.5mg in 5ml vial

Already in solution
Dilute the 37.5mg per 5ml injection further prior to infusion

Sodium chloride 0.9% or Glucose 5%

Bolus intravenous injection (initial dose only)

Draw up 0.9ml from vial containing 6.75mg/0.9ml and administer as a bolus injection over one minute, followed by intravenous infusion as outlined below

Intermittent intravenous infusion

Remove and discard 10ml fluid from 100ml infusion solution
Add contents of two vials of 37.5mg/5ml (total 75mg in 10ml) to the bag to give a solution of approximately 75mg per 100ml (0.75mg/ml)
Prepare new 100ml bags in the same way to allow the infusion to be continued

Initial bolus dose

Intravenous infusion

Using a solution as outlined above (75mg in 100ml)
Give 24ml per hour for three hours (equivalent to 18mg per hour)
Followed by 8ml per hour for up to a further 45 hours (equivalent to 6mg per hour)
The duration of treatment should not exceed 48 hours (total dose during a full course of treatment should not exceed 330.75mg atosiban)

Retreatment

In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of 6.75mg, followed by an infusion as outlined above
There is only limited clinical experience available with multiple re-treatments (up to 3 re-treatments)

Renal impairment

Hepatic impairment

Monitor uterine contractions and foetal heart rate
In case of persistance of uterine contractions during treatment with atosiban, alternative treatment should be considered

Store between 2 and 8⁰C

SPC March 2022

Oxytocin receptor antagonist