Posology : מינונים

4.2     Posology and method of administration
Posology
Treatment with Atosiban EVER Pharma should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
Atosiban EVER Pharma is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Atosiban EVER Pharma 75 mg/10 ml (or 2 vials of 37.5 mg/5 ml) concentrate for solution for infusion during three hours, followed by a lower dose of Atosiban EVER Pharma 75 mg/10 ml (or 2 vials of 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 Atosiban EVER Pharma therapy should preferably not exceed 330 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 Section 6.6 “Special precautions for disposal and other handling”). In the case of persistence of uterine contractions during treatment with Atosiban EVER Pharma, 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 close 1      0.9 ml intravenous bolus injection Not applicable                    6.75 mg given over 1 minute
2      3 hours intravenous loading       24 ml/hour (300 µg/min)            54mg infusion
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 is needed, it should also commence with a bolus injection of Atosiban EVER Pharma 6.75 mg/0.9 ml solution for injection followed by infusion with Atosiban EVER Pharma 37.5 mg/5 ml (or Atosiban EVER Pharma 75 mg/10 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 EVER Pharma 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.