TRACTOCILE Solution for injection Ref.[6331] Active ingredients: Atosiban

Posology

Treatment with Tractocile should be initiated and maintained by a physician experienced in the treatment of pre-term labour.

Tractocile is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Tractocile 6.75 mg/0.9 ml solution for injection, 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 Tractocile therapy should preferably not exceed 330.75 mg of atosiban.

Intravenous 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 (See Summary of Product Characteristics of Tractocile 37.5 mg/5 ml, concentrate for solution for infusion). In the case of persistence of uterine contractions during treatment with Tractocile, alternative therapy should be considered.

The following table shows the full posology of the bolus injection followed by the infusion:

Re-treatment

In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of Tractocile 6.75 mg/0.9 ml, solution for injection followed by infusion with Tractocile 37.5 mg/5 ml, concentrate for solution for infusion.

Patients with renal or hepatic impairment

There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys. Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine. In patients with impaired hepatic function, atosiban should be used with caution.

Paediatric population

The safety and efficacy of Tractocile in pregnant women aged less than 18 years have not been established.

No data are available.

Method of administration

For instructions on preparation of the medicinal product before administration, see section 6.6.

Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms. There is no known specific treatment in case of an overdose.

Shelf life: 4 years.

Once the vial has been opened, the product must be used immediately.

Store in a refrigerator (2°C-8°C).

Store in the original package in order to protect from light.

For storage conditions after first opening of the medicinal product, see section 6.3.

One vial of solution for injection contains 0.9 ml solution, corresponding to 6.75 mg atosiban.

Colourless glass vials, clear borosilicated (type I) sealed with grey siliconised bromo-butyl rubber stopper, type I, and flip-off cap of polypropylene and aluminium.

The vials should be inspected visually for particulate matter and discoloration prior to administration.

Preparation of the initial intravenous injection: Withdraw 0.9 ml of a 0.9 ml labelled vial of Tractocile 6.75 mg/0.9 ml, solution for injection and administer slowly as an intravenous bolus dose over one minute, under adequate medical supervision in an obstetric unit. The Tractocile 6.75 mg/0.9 ml, solution for injection should be used immediately.