Medicinal Products

ATOSIBAN PANPHARMA 675 mg / 09 ml

Generic drug of the therapeutic class: Gynecology
active ingredients: Atosiban
laboratory: Panpharma

Injectable solution
box of 1 bottle of 2 ml
All forms

Indication

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

· With regular uterine contractions lasting at least 30 seconds and occurring at least 4 times in 30 minutes;

· With cervical dilatation of 1 to 3 cm (0-3 in nulliparas) and an effacement ≥ 50%;

· Having a gestational age of 24 weeks to 33 complete weeks included;

· With normal fetal heart rate.

Dosage ATOSIBAN PANPHARMA 675 mg / 09 ml solution for injection 1 vial of 2 ml

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

· With regular uterine contractions lasting at least 30 seconds and occurring at least 4 times in 30 minutes;

· With cervical dilatation of 1 to 3 cm (0-3 in nulliparas) and an effacement ≥ 50%;

· Having a gestational age of 24 weeks to 33 complete weeks included;

· With 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 previa;

· 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 .

Adverse effects Atosiban Panpharma

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)

at <1/1000). Within each frequency group, adverse effects are presented in descending order of severity.

Class of organ system

MedDRA

Very

frequent

Frequent

Rare

Rare

System conditions

immune

Allergic reaction

Metabolism and

nutrition

hyperglycemia

Psychiatric disorders

Insomnia

Nervous system disorders

Headache, vertigo

Heart conditions

tachycardia

Vascular disorders

hypotension,

hot flushes

Gastrointestinal disorders

nausea

vomiting

Affections of the skin and

subcutaneous tissue

Pruritus, rash

Disorders of organs of

reproduction and breast

Uterine hemorrhage,

uterine atony

General disorders and

site anomalies

administration

Reaction at the level

injection site

Fever

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 betamimetics, and / or in women with multiple pregnancies, 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 declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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