Tractocil, 7.5 mg/ml, 0.9 ml

Tractocil is used in the threat of preterm labor in pregnant women in the following cases:

• regular uterine contractions of at least 30 s and a frequency of more than 4 for 30 minutes;
• opening of the cervix from 1 to 3 cm (0-3 cm for non-pregnant women);
• age over 18 years old;
• gestational age 24 to 33 full weeks;
• normal fetal heart rate.

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Indications

Tractocil is used for the threat of premature birth in pregnant women in the following cases:
regular uterine contractions lasting at least 30 seconds and frequency more than 4 within 30 minutes;
cervical dilatation from 1 to 3 cm (0–3 cm for nulliparous women);
age over 18 years;
gestational age from 24 to 33 completed weeks;
normal fetal heart rate.

Pharmacological effect

Pharmacological action

Special instructions

If there is no decrease in the contractile activity of the uterus during the administration of Tractocil, uterine contractions should be monitored, as well as the fetal heart rate. The use of other medications should also be considered.
There is no experience with the use of atosiban in patients with impaired liver and kidney function.

Active ingredient

Atosiban

Composition

active substance:
atosiban acetate (in terms of atosiban)
7.5 mg
excipients: mannitol – 50 mg; hydrochloric acid – up to pH 4.5; water for injection – up to 1 ml

Pregnancy

Tractocil should only be used in cases of diagnosed preterm labor between 24 and 33 completed weeks of pregnancy.

Contraindications

The gestational age is less than 24 or more than 33 completed weeks;
premature rupture of membranes during pregnancy more than 30 weeks;
intrauterine growth retardation;
abnormal fetal heart rate;
uterine bleeding requiring immediate delivery;
eclampsia and severe preeclampsia requiring immediate delivery;
intrauterine fetal death;
suspicion of intrauterine infection;
placenta previa;
placental abruption;
any conditions of the mother and fetus in which the continuation of pregnancy is dangerous;
breast-feeding;
hypersensitivity to atosiban or to one of the components of the drug.
With caution: if premature rupture of the membranes is suspected, the use of Tractocil to prolong labor should be weighed against the potential risk of developing chorioamnionitis. Use Tractocil with caution during multiple pregnancies, as well as during pregnancy 24–27 weeks (due to the lack of sufficient clinical experience).

Side Effects

From the gastrointestinal tract: very often (>1/10) – nausea, less often – vomiting.

Interaction

Interaction with other drugs

Overdose

There are several known cases of overdose. There are no specific symptoms or signs.

Storage conditions

The drug should be stored out of the reach of children in its original packaging at a temperature of 2-8°C.

Shelf life

4 years.

Manufacturer

Ferring GmbH, Switzerland