《SCIENTIFIC DISCUSSION》.pdfVIP

SCIENTIFIC DISCUSSION This module reflects the initial scientific discussion for the approval of Tractocile. For information on changes after approval please refer to module 8. 1. Introduction Tractocile is indicated to delay imminent pre-term birth in pregnant 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% - age ≥ 18 years - 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 7.5 mg/ml solution for injection, immediately followed by a continuous high dose infusion loading infusion 300μg/min of Tractocile 7.5 mg/ml concentrate for solution for infusion during three hours, followed by a lower dose of Tractocile 7.5 mg/ml concentrate for solution for infusion subsequent infusion 100 μg/min up to 45 hours. The duration of the treatment should not exceed 48 hours. The total dose given during a full course of Tractocile therapy should preferably not exceed 330 mg of the active substance. Tractocile is a new medicinal product, developed by Ferring AB in collaboration with the R.W. Johnson Pharmaceuticals Research Institute. It contains atosiban, a synthetic peptide acting as an oxytocin antagonist. Tractocile is intended for the treatment of pre-term labour PTL . Pre-term birth i.e. birth before 37 weeks is a common obstetric condition, occurring in 10-15 percent of all births; it is associated with an increased risk of neonatal death and congenital neurological disability, including cerebral palsy. Although the common definition of pre-term birth includes all births before 37 weeks of