Treatment with Tractocile should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
Tractocile is administered IV in 3 successive stages: An initial bolus dose (6.75 mg), performed with Tractocile 7.5 mg/mL solution for slow IV infusion for 1 min, followed by a continuous high-dose infusion [loading infusion 300 mcg/min (or 18 mg/hr)] of Tractocile 7.5 mg/mL concentrate solution for infusion during 3 hrs, followed by a lower dose of Tractocile 7.5 mg/mL concentrate solution for infusion [subsequent infusion 100 mcg/min (6 mg/hr)] up to 45 hrs.
The duration of the treatment should not exceed 48 hrs. The total dose given during a full course of Tractocile therapy should preferably not exceed 330 mg of the active substance.
IV therapy using the initial bolus injection should be started as soon as possible after diagnosis of pre-term labour. Once the bolus has been injected, proceed with the infusion. In the case of persistence of uterine contractions during treatment with Tractocile, alternative therapy should be considered.
There is no data available regarding the need for dose adjustments in patients with renal or liver insufficiency.
The following table shows the full posology of the bolus injection followed by the infusion: See Table.
Click on icon to see table/diagram/image
Re-treatment: In case a re-treatment with Tractocile is needed, it should also commence with a bolus injection of Tractocile 7.5 mg/mL, solution for injection followed by infusion with Tractocile 7.5 mg/mL concentrate solution for infusion.
Preparation of Solutions: IV Injection:
Initially, withdraw 0.9 mL of a 0.9 mL labelled vial of Tractocile 7.5 mg/mL, solution for injection and administer slowly as an IV bolus dose over 1 min, under adequate medical supervision in an obstetric unit. The Tractocile 7.5 mg/mL solution for injection should be used immediately.
For IV infusion, following the bolus dose, Tractocile 7.5 mg/mL concentrate solution for infusion should be diluted in 1 of the following solutions: 0.9% w/v NaCl; Ringer's lactate solution; 5% w/v glucose solution.
Withdraw 10 mL solution from a 100-mL infusion bag and discard. Replace it by 10 mL Tractocile 7.5 mg/mL concentrate solution for infusion from two 5-mL vials to obtain a concentration of 75 mg atosiban in 100 mL. The loading infusion is given by infusing 24 mL/hr (ie, 18 mg/hr) of the previously prepared solution over the 3-hr period under adequate medical supervision in an obstetric unit. After 3 hrs, the infusion rate is reduced to 8 mL/hr.
Prepare new 100 mL bags in the same way as described to allow the infusion to be continued. If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation. To achieve accurate dosing, a controlled infusion device is recommended to adjust the rate of flow in drops/min. An IV microdrip chamber can provide a convenient range of infusion rates within the recommended dose levels for Tractocile.