SPC, UK: Tractocile 7.5 mg/ml Solution for injection (2005)

Therapeutic indications

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 fetal heart rate

Posology and method of administration

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 7.5 mg/ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/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 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 mg of the active substance.

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 7.5 mg/ml, concentrate for solution for 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:

StepRegimenInjection/infusion rateAtosiban dose
10.9 ml intravenous bolusover 1 minute6.75 mg
23 hours intravenous loading infusion24 ml/hour18 mg/hour
3subsequent intravenous infusion8 ml/hour6 mg/hour

Re-treatment

In case a re-treatment with atosiban 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 for solution for infusion.

Overdose

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

2 years.

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

Special precautions for storage

Store in a refrigerator (2°C – 8°C).

Store in the original package.

Nature and contents of container

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.

Special precautions for disposal and other handling

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 7.5 mg/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 7.5 mg/ml, solution for injection should be used immediately.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products (see section 6.2).