Xelaif

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT XeLife (XeLife)

Composition:

Active substance: xenon;

contains xenon not less than 99.999%.

Pharmaceutical form. Compressed medical gas.

Main physicochemical properties: colorless odorless gas; non-flammable, does not support combustion.

Pharmacotherapeutic group. Agents for inhalational general anesthesia. Xenon.

ATC code N01AX15.

Pharmacological Properties

Pharmacodynamics. An agent for inhalational general anesthesia. When used in combination with oxygen (in ratios of 60:40; 70:30; 80:20), it produces myorelaxant, analeptic, and anesthetic effects (more pronounced than those of nitrous oxide). The minimum alveolar concentration (MAC) for xenon is 71%, and for nitrous oxide is 105%. Within 2 minutes after inhalation, a stage of peripheral paresthesia and hypoalgesia develops; by the 3rd minute, a stage of psychomotor activity occurs; by the 4th minute, a stage of partial amnesia and analgesia; and by the 5th minute, a stage of anesthesia corresponding to the first level of surgical anesthesia stage according to Guedel. Hemodynamic parameters and gas exchange remain stable throughout anesthesia. Recovery from general anesthesia is rapid. Consciousness returns within 2–3 minutes after gas discontinuation, with full orientation in time and space. Analgesia is achieved by inhaling a 30–40% mixture with oxygen. Loss of consciousness occurs with inhalation of a 65–70% mixture with oxygen.

Pharmacokinetics. Rapidly absorbed upon inhalation; alveolar and arterial concentrations quickly equilibrate. Eliminated unchanged via the lungs within 4–5 minutes (final alveolar concentration reaches 5% after 2 minutes and 2% after 5 minutes). Complete elimination from the body occurs gradually over the subsequent 4 hours.

Clinical characteristics.

Indications.

For induction and maintenance of mask inhalation general anesthesia in adults when deep anesthesia and muscle relaxation are not required (in surgery, gynecological operations, dentistry, and during painful procedures). For enhancing the narcotic and analgesic effects of other anesthetics. For pain syndrome therapy.

Contraindications.

Individual hypersensitivity to the drug.

Conditions associated with hypoxia; surgical procedures on thoracic organs; cardiac surgery.

Interaction with other medicinal products and other forms of interaction.

Inhalation anesthetics, narcotic analgesics, tranquilizers, neuroleptics, and antihistamines enhance the effect of the drug.

Special precautions for use

During mask inhalation anesthesia, it is essential to ensure complete airtightness of the breathing circuit. After achieving the surgical stage of anesthesia, a laryngeal mask should be used.

When applying monocomponent mask general anesthesia with preserved spontaneous respiration, tranquilizers are the optimal choice for premedication. The use of opioid analgesics is less advisable due to the potential for respiratory depression.

Xenon is stored in cylinders in gaseous form under a pressure of 6.4 ± 0.05 MPa at a temperature of 20 °C.

Use with caution in patients with nervous system disorders or chronic alcoholism (excitation and hallucinations may occur).

The use of xenon may be limited in the presence of a non-airtight breathing circuit, as well as during surgery on the heart, lungs, trachea, or bronchi associated with pneumothorax, where there may be a need to use gas mixtures with oxygen concentrations exceeding 30 vol. %. Xenon anesthesia is not advisable in semi-open or semi-closed circuits without the use of scavenging systems (e.g., in dentistry, reconstructive surgery on the trachea and bronchi, or mask anesthesia with high or medium gas flow in open or semi-closed circuits), since accumulation of exhaled xenon in room air above the maximum allowable concentration (MAC) of 0.005 vol. % may cause lethargy, drowsiness, and motor incoordination in medical personnel.

Use during pregnancy or breastfeeding.

Do not use during pregnancy (except during labor) or breastfeeding.

Ability to affect reaction speed when driving vehicles or operating machinery.

The medicinal product is used exclusively in a medical facility setting.

Method of Administration and Dosage.

Administer by inhalation as xenon-oxygen mixtures, with a maximum alveolar concentration of xenon of 71 vol. %. The oxygen content in the inhaled mixture must be at least 20 vol. %. The respiratory gas mixture is prepared using an anaesthetic apparatus or specially designed devices. Prior to initiating xenon inhalation, a 5-minute denitrogenation with 100% oxygen at a gas flow rate of 10 L/min on a semi-open circuit is recommended, while maintaining the patient's spontaneous breathing. After denitrogenation, the required concentrations of xenon and oxygen are set depending on the type of surgery or procedure. To control pain, the inhaled mixture should contain 30–40 vol.% xenon. The duration of inhalation depends on the severity of the pain syndrome. For analgesia during surgical and painful procedures that do not require loss of consciousness, inhale a xenon-oxygen mixture containing 40–50 vol.% xenon. For deep general anesthesia or rapid induction of the required depth of general anesthesia (induction anesthesia), the xenon concentration should be 70–80 vol.%, with maintenance of general anesthesia at 50–70 vol.%. The technique of xenon monotherapy involves, after premedication and 3–5 minutes of denitrogenation, rapid saturation of the body with xenon using a high flow rate [1.5 FRC (functional residual capacity)] for 1.5 minutes, with monitoring of oxygen concentration using a gas analyzer. After reaching the surgical stage, a laryngeal or face mask is applied, and anesthesia is maintained with a minimal gas flow of xenon:oxygen (70:30). According to this method, the surgical stage of anesthesia is achieved within 3–4 minutes using the mask technique. To maintain anesthesia, xenon delivery ranges from 100 to 150 mL/min. The exhaled xenon must not enter the operating room but should be directed through a relief valve into a special adsorber capable of adsorbing up to 300 L of expired gas. The adsorber filled with exhaled xenon is replaced with a new one. Induction of anesthesia can also be performed using a simplified method similar to nitrous oxide anesthesia. According to this method, after 4–5 minutes of denitrogenation, a xenon:oxygen mixture in a 4:1 ratio is administered. In this case, the saturation phase is slightly prolonged, and the surgical stage of anesthesia is reached within 6–7 minutes, with a slightly higher xenon consumption.

Xenon may be used via mask or endotracheal techniques, either as a sole anesthetic agent or in combination with various intravenous sedatives, opioid and non-opioid analgesics, neuroleptics, and tranquilizers. After termination of general anesthesia, discontinue xenon administration and ventilate the patient's lungs for 4–5 minutes with an oxygen-air mixture to ensure reliable xenon elimination, using assisted ventilation if necessary. Extubation should be performed upon the first signs of consciousness and full restoration of spontaneous breathing.

Children.

Do not use in children.

Overdose.

Symptoms: Hypoxia.

Treatment: Oxygen therapy, artificial ventilation of the lungs.

Side effects.

Hoarseness, metallic taste in the mouth, hypoxia.

Shelf life.

2 years.

Storage conditions.

When stored in rooms, cylinders must be placed at a distance of not less than 1 m from heating devices and not less than 5 m from heat sources with open flame.

Store at temperature not exceeding 35 °C.

Keep out of reach of children.

Packaging.

Medical compressed gas, 2.196 ± 0.11 kg (corresponds to pressure of 6.4 ± 0.05 MPa at 20°C) in seamless aluminum cylinders with capacity of 2 L.

Supply category.

For specialized medical institutions only.

Manufacturer: LLC "INGAZ".

Manufacturer's location and address of business activity:

54B, Taganrogska Street, Mariupol, Donetsk region, 87522, Ukraine.