The need to update instructions on the use of appropriate drugs has been identified.
In the civil turnover of the Russian Federation there are 10 medicinal products, the active substance of which is propofol, in the form of a dosage form - an emulsion for intravenous administration, information about which in the part of application during pregnancy, during the period of breastfeeding, and in obstetric practice differs among different manufacturers, and besides does not correspond to the current information on the experience of clinical use of propofol.
In connection with the foregoing, we consider it advisable to give instructions on the use of propofol medicines in terms of their use in pregnancy, during breastfeeding, and in obstetric practice, in accordance with current information.
- In the "Contraindications" section, indicate "Pregnancy, as well as the use of the Breastfeeding Period in obstetric practice, with the exception of the termination of pregnancy (see the section on" Application during pregnancy and during breastfeeding ").
- In the section "Use during pregnancy and during breastfeeding" indicate:
"Application in pregnancy
The safety of propofol during pregnancy is not established. Propofol should not be used during pregnancy. But, propofol can be used in the conduct of induced abortion (in the first trimester).
Obstetrics
Propofol penetrates the placental barrier and can exert a depressing effect on the fetus. Do not use in obstetrics as an anesthetic.
Breastfeeding period
A small amount of propofol enters the breast milk. In this regard, it is not recommended to breast-feed for 24 hours after the administration of propofol. Milk, secreted during this period, should not be used for feeding. "