Medicinal Products

ATOSIBAN SUN 37.5 mg / 5 mL

Generic drug of Tractocile
Therapeutic class: Gynecology
active ingredients: Atosiban
laboratory: Sun Pharma Indus Eur BV

Solution for solution for IV infusion
Box of 1 bottle of 5 ml
All forms

Indication

Atosiban is indicated to delay delivery when there is a threat of preterm birth in adult pregnant women:

- having regular uterine contractions lasting at least 30 seconds and occurring at least 4 times in 30 minutes, - having a cervical dilation of 1 to 3 cm (0-3 in nulliparas) and an erasure ≥ 50%, - having a gestational age of 24 weeks to 33 complete weeks included, - presenting a normal fetal heart rate.

Against indications

Atosiban should not be used under the following conditions:
- gestational age less than 24 weeks or greater than 33 full weeks;

- Premature rupture of membranes beyond 30 weeks of gestation;

- abnormal fetal heart rate;

- Ante-partum uterine hemorrhage requiring immediate delivery;

- Eclampsia and severe pre-eclampsia requiring childbirth;

- Fetal death in utero;

- suspicion of uterine infection;

- Placenta praevia;

- Retroplacental hematoma;

- Any other factor, in the mother or the fetus, making continuation of the pregnancy dangerous;

Hypersensitivity to the active substance or to any of the excipients listed under Composition.

Atosiban Sun side effects

The potential adverse effects of atosiban have been reported in atosiban - treated mothers in clinical trials. A total of 48% of patients treated with atosiban experienced adverse events during clinical trials. The adverse effects observed were generally moderate. Nausea is the most commonly reported adverse reaction in the mother (14%).


In the neonate, clinical trials have not revealed any specific adverse effects of atosiban. Adverse events observed in infants are within normal range and are comparable to placebo and betamimetic.


The frequency of adverse reactions listed below is defined according to the following convention: Very common (≥ 1/10); Frequent (≥ 1/100 to <1/10); Uncommon (≥ 1/1000 to <1/100); Rare (≥ 1/10 000 to <1/1000). Within each frequency group, adverse effects are presented in descending order of severity.

MedDRA Organ System Class

Very common

Frequent

Little

frequent

Rare

System conditions

Allergic reaction

immune

Metabolism and

hyperglycemia

nutrition

Psychiatric disorders

Insomnia

Nervous system disorders

Headache, vertigo

Heart conditions

tachycardia

Vascular disorders

Hypotension, hot flashes

Gastrointestinal disorders

nausea

vomiting

Affections of the skin and

pruritus,

subcutaneous tissue

rash

Disorders of organs of

Uterine hemorrhage,

reproduction and breast

uterine atony

General disorders and

Reaction at the level

Fever

site anomalies

injection site

administration


Post-marketing experience


Respiratory events including dyspnea and pulmonary edema, particularly when co-administered with other drugs with tocolytic activity such as calcium antagonists and beetamimetics, and / or in women with multiple pregnancy, have been reported after the placing on the market.

Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

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