ATOSIBAN PHARMIDEA

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

ATOSIBAN AS ACETATE

Disponible desde:

A.L. MEDI-MARKET LTD.

Código ATC:

G02CX01

formulario farmacéutico:

SOLUTION FOR INJECTION/ CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

ATOSIBAN AS ACETATE 7.5 MG/ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricado por:

SIA "PHARMIDEA", LATVIA

Área terapéutica:

ATOSIBAN

indicaciones terapéuticas:

Atosiban 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 or more per 30 minutes- a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of 50 % or more - age: 18 years and above - a gestational age from 24 until 33 completed weeks - a normal foetal heart rate.

Fecha de autorización:

2021-03-03

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ATOSIBAN PHARMIDEA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 7.5 mg atosiban free base in the form of
atosiban acetate.
Solution for injection:
Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate).
Concentrate for solution for infusion:
Each vial of 5 ml concentrate contains 37.5 mg atosiban (as acetate).
After dilution according to the instructions (see section 6.6
“Pharmaceutical Particulars, Instructions for use and handling”),
the concentration
of Atosiban is 0.75 mg/ml.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection or concentrate for solution for infusion.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
Atosiban Pharmidea 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
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.