Posology : מינונים

4.2.    Posology and method of administration

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

Atosiban Pharmidea is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Atosiban Pharmidea 6.75 mg/0.9ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 µg/min) of Atosiban Pharmidea 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of Atosiban Pharmidea 37.5 mg/5 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 Atosiban Pharmidea therapy should preferably not exceed 330.75 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 section “Pharmaceutical Particulars, instructions for use and handling”).
In the case of persistence of uterine contractions during treatment with Atosiban Pharmidea, alternative therapy should be considered.

The following table shows the full posology of the bolus injection followed by the infusion: Step Regimen                                   infusion rate              Atosiban Pharmidea dose 1        0.9 ml intravenous bolus injections Not applicable                6.75 mg given over 1 minute
2        3 hours intravenous loading infusion 24 ml/hour(300 µg/min)       54 mg
3        Up to 45 hours              subsequent 8 ml/hour(100 µg/min)      Up to 270 mg intravenous infusion

Re-treatment:
In case a re-treatment with Atosiban Pharmidea is needed, it should also commence with a bolus injection of Atosiban Pharmidea 6.75 mg/0.9 ml, solution for injection followed by infusion with Atosiban Pharmidea 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 atosiban 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.