TRACTOCILE 7.5MG/ML I.V. CONC. VIAL 5 ML

Tractocile is indicated to delay imminent pre-term birth in pregnant adult women with: - regular uterine contractions of at least 30 seconds duration at a rate of = 4 per 30 minutes - a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of = 50% - a gestational age from 24 until 33 completed weeks - a normal foetal heart rate. Tractocile is administered intravenously in three successive stages: an initial bolus dose (6.75 mg) performed with Tractocile 6.75 mg/0.9 ml immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Tractocile 37.5 mg/5 ml concentrate for solution for infusion during three hours followed by a lower dose of Tractocile 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours. The duration of the treatment should not exceed 48 hours. The total dose given during a full course of therapy should preferably not exceed 330.75 mg of atosiban.