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Effects and efficacy:
Atosiban is suitable for pregnant women with the following conditions to delay impending premature birth. Regular uterine contractions of at least 30 seconds each time, ≥4 times every 30 minutes. Cervical dilation 1~3cm (0-3cm for nulliparous women) and uterine softening/thinning ≥50%. Age ≥18 years. Gestation 24 to 33 weeks. Normal fetal heart rate.
Usage and Dosage:
The dosage and usage of different dosage forms and specifications of atosiban may vary. Please read and take the medicine according to the doctor’s instructions. Generally, atosiban must be used by doctors with experience in treating premature birth. Intravenous atosiban is given in three sequential steps: an initial single-dose bolus of 6.75 mg of atosiban acetate injection in a strength of 0.9 ml: 6.75 mg, followed by a continuous infusion of a high-dose diluted atosiban acetate injection in a strength of 5 ml: 37.5 mg for 3 hours (300 μg/min), followed by a low-dose diluted atosiban acetate injection in a strength of 5 ml: 37.5 mg for 45 hours (100 μg/min). Treatment should not exceed 48 hours, and the total dose of atosiban administered in a complete course of atosiban should preferably not exceed 330 mg. Once preterm labor is diagnosed, treatment with the first single-dose intravenous bolus should be started as soon as possible, followed by intravenous drip therapy. If uterine contractions persist during atosiban treatment, other treatments should be considered. There are no data on dose adjustments for patients with renal or hepatic impairment. Repeated treatment If repeated treatment with atosiban is required, a single bolus of 0.9 ml:6.75 mg atosiban acetate injection should also be used initially, followed by an intravenous drip of 5 ml:37.5 mg atosiban acetate injection. Use and operating procedures Before administration, check the vial for particulate matter and discoloration. Preparation of infusion After intravenous administration of 0.9 ml:6.75 mg atosiban acetate injection, prepare the infusion with 5 ml:37.5 mg atosiban acetate injection using one of the following diluents: 0.9% (w/v) sodium chloride solution. Sodium lactate Ringer’s injection. 5% (w/v) glucose solution. Preparation method: Draw 10 ml of solvent from the infusion bag (or infusion bottle) (100 ml/bag or 100 ml bottle) containing the above diluent and discard it. Use two bottles of 5m:37.5mg atosiban acetate injection to add it to the infusion bag (or infusion bottle) to prepare 75mg/100ml atosiban infusion. When intravenously infused, the infusion rate should first be 24ml/h (18mg/h), and the loading dose should be given for 3 hours (the administration should be carried out in the obstetrics department of the hospital and under the close supervision of medical staff). After 3 hours of administration, the infusion rate is reduced to 8ml/h. If one bag (or bottle) of infusion is not enough, repeat the above preparation method to prepare another bag (or bottle) of 100ml infusion and continue to use it. If the volume of the infusion bag (or infusion bottle) is not 100ml, the amount of atosiban acetate injection with a specification of 5m:37.5mg should be accurately converted, and then the infusion of the same concentration should be prepared. In order to achieve accurate dosing, it is recommended to use an adjustable infusion set, and the adjustment unit is calculated in “drops/minute”. Using an intravenous micropump, an appropriate range of infusion speed can be set within the recommended dose. Due to the lack of incompatibility information, this drug should not be mixed with other drugs. If other drugs need to be given intravenously when using this product, they must be given in other parts of the body, so that the administration rate of this product can be guaranteed. Once the bottle is opened, this product should be diluted quickly. The diluted solution should be used within 24 hours after preparation.
Adverse reactions:
Maternal adverse reactions to atosiban are generally mild, and 48% of patients in clinical trials have adverse reactions. For newborns, clinical trials have not shown any special adverse reactions to atosiban. Adverse events in infancy are within the normal variation range, and the incidence of adverse events is similar to that of placebo and beta-receptor agonists. Maternal adverse reactions are as follows. Very common (>10%) nausea. Common (1~10%) central and peripheral nervous system: headache, dizziness. Gastrointestinal system: vomiting. Systemic adverse reactions: hot flashes. Cardiovascular: tachycardia, hypotension. Local: injection site reactions. Metabolism and nutrition: hyperglycemia. Uncommon (0.1~1%) systemic adverse reactions: fever. Psychiatric: insomnia. Skin and its appendages: itching, rash. Rare (<0.1%) reports of unexpected cases of uterine bleeding and uterine atony. The incidence in clinical trials was no higher than that in the control group. There was a report of an allergic reaction that was believed to be related to atosiban.
Drug contraindications:
This product is contraindicated if allergic to it
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