Diprofol Edta emulsion for infusions 10 mg/ml. 20 ml. ampoules №5

Description

Diprofol Edta Storage:

active substance: рropofol;

1 ml of emulsion contains 10 mg of propofol;

Diprofol Edta Excipients: soybean oil, egg phospholipid, glycerin, sodium hydroxide, disodium edetate, water for injections.

Diprofol Edta Dosage form.

Emulsion for infusions.

Main physical and chemical properties: white or almost white homogeneous emulsion, practically free of solid particles and large oil droplets. During prolonged settling, a slight stratification of the emulsion is possible.

Pharmacotherapeutic group. Means for general anesthesia. ATX code N01A X10.

Pharmacological properties.

Pharmacodynamics.

Mechanism of action.

Propofol (2,6-diisopropylphenol) is a general short-acting anesthetic with a rapid onset of effect for approximately 30 seconds. Recovery from anesthesia is usually rapid. The mechanism of action, as for other drugs for general anesthesia, is insufficiently studied. However, it is believed that propofol has sedative and narcotic effects by a positive effect on the inhibitory function of the neurotransmitter GABA by facilitating the interaction of the latter with ligand-activated GABA receptors.

Pharmacodynamic properties

Usually when propofol 1% is used to induce and maintain anesthesia, there is a decrease in mean blood pressure and slight changes in heart rate. However, hemodynamic parameters under normal conditions remain relatively stable during maintenance of anesthesia, and the number of cases of adverse hemodynamic reactions is small.

Although respiratory depression may develop after administration of 1% propofol, any reactions are qualitatively similar to those with other intravenous anesthetic agents and are easily corrected in clinical practice.

Propofol 1% reduces cerebral circulation, intracranial pressure and brain metabolism. The decrease in intracranial pressure is more pronounced in patients with initial elevated intracranial pressure.

Clinical safety and efficacy

Recovery from anesthesia is usually rapid and is characterized by rapid recovery of cognitive function with a small number of cases of headache and postoperative nausea and vomiting.

In general, the use of propofol 1% postoperative nausea and vomiting are less common than when using means for inhalation anesthesia. There is evidence that this may be due to the reduced emetogenic potential of propofol.

Propofol 1% does not inhibit the synthesis of hormones of the adrenal cortex in clinically applicable concentrations.

Pediatric population

Limited data from propofol anesthesia studies in children indicate that safety and efficacy are maintained for up to 4 hours of anesthesia. According to published data, the drug can be used in children during long procedures without changing the safety or effectiveness of the latter.

Indication.

As a means of general short-term anesthesia, the drug is administered intravenously for:

· Induction and maintenance of general anesthesia in adults and children> 1 month of age;

· Sedation during diagnostic and surgical procedures, alone or in combination with drugs for local or general anesthesia, in adults and children aged> 1 month;

· Sedation of patients> 16 years of age undergoing artificial lung ventilation in the intensive care unit (ICU).

Contraindication.

Hypersensitivity to the active substance or to any of the excipients.

Children up to 1 month (for induction and maintenance of general anesthesia).

Diprofol® EDTA 1% contains soybean oil and is not intended for use in patients with hypersensitivity to peanuts or soybeans.

Diprofol® EDTA 1% should not be used for sedation in patients ≤ 16 years of age who are in the intensive care unit (see section “Special instructions”).

Interaction with other medicinal products and other forms of interaction.

Propofol 1% was used in combination with drugs for spinal and epidural anesthesia, as well as commonly used premedication drugs, muscle relaxants, inhalation anesthetics and analgesics; cases of pharmacological incompatibility were not observed. When general anesthesia is used in combination with local anesthetics, lower doses of Diprofol® EDTA 1% may be prescribed. Cases of severe hypertension have been reported with propofol in patients receiving rifampicin.

Concomitant use with other CNS depressants, such as premedication drugs, inhalation anesthetics, and analgesics, may increase the sedative, analgesic, and depressant effects of Diprofol® EDTA 1% on cardiovascular and respiratory function. systems (see section “Features of application”).