Mirosiban concentrate for infusions 37.5 mg/5 ml. 5 ml. vial №1

Description

Mirosiban composition
active substance: atosiban acetate;
1 vial (5 ml of concentrate for solution for infusion) contains 37.5 mg of atosiban (as acetate);
Excipients: mannitol (E 421), 1 M hydrochloric acid solution, water for injections.

Dosage form
Concentrate for solution for infusion.

Pharmacological properties
It is a competitive antagonist of the human hormone oxytocin. Acts at the receptor level. Reduces the frequency of uterine contractions, the tone of the myometrium, suppressing the activity of the uterus. In addition, by binding to vasopressin receptors, it suppresses its effects.

Indications
Mirosiban is used to prevent premature birth if the following conditions are met:

• regular uterine contractions lasting at least 30 seconds, with a frequency of 4 or more for 30 minutes;
• gestational age 24-33 complete weeks;
• dilation of the cervix 1-3 cm (for primiparous women), smoothing of the cervix more than 50%;
• the patient’s age from 18 years;
• normal fetal heart rate.

Contraindications:

• with intolerance to the components;
• with premature rupture of the amniotic fluid with a gestational age of more than 30 weeks;
• in violation of the fetal heart rate;
• with a gestational age of less than 24 or more than 33 complete weeks;
• with prenatal uterine bleeding requiring immediate delivery;
• with eclampsia, severe preeclampsia, which requires immediate delivery;
• with intrauterine death of the fetus;
• with intrauterine growth retardation, abnormal fetal heart rate;
• if you suspect an intrauterine infection;
  with placenta previa;
• with placental abruption;
• in any condition affecting both the mother and the fetus, when the continuation of pregnancy poses a danger to health or life.

Children
It is not used in pediatric practice.

Application during pregnancy and lactation
The drug is used only in cases of diagnosed premature birth in gestational periods from 24 to 33 complete weeks.
If a pregnant woman is lactating (after a previously born child), breastfeeding should be discontinued, as this increases the contractility of the uterus.

Method of administration and dosage
Mirosiban is used parenterally (intravenously).
The drug should be used by a physician experienced in the treatment of preterm labor.
The solution is introduced in three consecutive stages:

• the initial dose is administered as a bolus (concentrate for injection 6.75 mg / 0.9);
• then immediately carry out a long-term infusion (infusion concentrate 37.5 mg / 5 ml) in a high dose (300 μg / minute) for three hours;
• then infusion is carried out in lower doses (100 μg / minute) with an infusion concentrate (37.5 mg / 5 ml) for a period of up to 45 hours.

The total duration of therapy should not exceed 48 hours.
The maximum total dose is 330.75 mg.

Overdose
Several cases of overdose development have been described, which proceeded without specific symptoms.
A therapy appropriate to the clinical situation is carried out.

Side effects:

• Immune disorders: anaphylactic, anaphylactoid reactions.
• Metabolic disorders: hyperglycemia.
• Mental disorders: insomnia.
• Neurological disorders: dizziness, headache.
• Cardiovascular disorders: arterial hypotension, tachycardia, hot flashes.
• Digestive disorders: nausea, vomiting.
• Dermatological disorders: exanthema, itching.
• Sexual disorders: uterine atony, uterine bleeding.
• General: hyperthermia, reactions at the injection site.

Storage conditions and periods
Store Mirosiban for no more than three years at temperatures from +2 to +8 ° C.
It is forbidden to use a macroscopically altered or expired concentrate.