OXYGEN MEDICINAL GASEOUS

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MEDICAL GASEOUS OXYGEN (OXYGEN MEDICAL GAS)

Composition:

Active substance: oxygen not less than 99.5%.

Pharmaceutical form. Gas.

Main physicochemical properties: colorless, odorless, tasteless gas. Slightly soluble in water (approximately 1:43).

Pharmacotherapeutic group.

Medical gases. ATC code V03AN01.

Pharmacological properties.

Pharmacodynamics. Oxygen belongs to the group of drugs known as anti-hypoxants and antioxidants. It has the ability to bind with blood hemoglobin in the lungs and, in a complex compound with heme, is transported to the body's cells. It is a strong oxidizing agent and an essential element in the metabolic transformations of carbohydrates, proteins, and fats into energy required to sustain vital functions of the organism.

Pharmacokinetics. In the human body, oxygen diffuses through lung tissue into the blood, where it binds to hemoglobin in erythrocytes and partially dissolves in plasma. It is then transported to body tissues, where it diffuses into the tissue interstitial fluid. The final stage of respiration is the utilization of oxygen in biological oxidation processes to generate energy within cells; subsequently, after a series of transformations, it is eliminated via the lungs in the form of carbon dioxide (CO₂).

Clinical characteristics.

Indications.

Conditions associated with hypoxia:

Respiratory diseases:

• pneumonia;
• pulmonary edema;
• bronchial asthma;
• pneumosclerosis.

Cardiovascular diseases:

• heart failure;
• coronary insufficiency.

Poisonings:

• carbon monoxide;
• cyanide;
• suffocating gases.

Also used during general anesthesia in combination with inhalation anesthetics; in the postoperative period.

For preparation of oxygen cocktails and foams.

Contraindications.

For hyperbaric oxygenation, contraindications include acute respiratory diseases, history of epileptiform seizures, impaired patency of auditory tubes and canals connecting the nasal sinuses with the external environment, presence of lung cavities or bronchopleural fistulas, severe forms of arterial hypertension, neoplasms, increased individual sensitivity to oxygen. Menstrual period, pregnancy over 5 months.

Interaction with other medicinal products and other types of interactions.

Nitrates, beta-blockers, calcium ion antagonists, and nootropic agents promote more efficient tissue utilization of oxygen, improve its utilization, and thereby reduce hypoxia and increase the body's resistance to oxygen deficiency.

Special precautions for use.

Do not use in women during menstruation.

Recommended to use with lubricants.

Use during pregnancy or breastfeeding.

Do not use during pregnancy for longer than 5 months.

Breastfeeding should be discontinued for the duration of treatment with this medicinal product.

Ability to affect reaction speed when driving or operating machinery.

Due to possible dizziness, avoid driving or performing tasks that require heightened attention and quick reactions.

Administration and Dosage

In hospital settings, oxygen is most commonly administered via inhalation through special rubber or plastic masks connected directly to steel oxygen cylinders.

In outpatient practice and at home, special rubber or plastic containers (bags) filled with oxygen or its mixtures are more frequently used.

For hyperbaric oxygenation, i.e., oxygen delivery under increased pressure, special ventilated chambers, so-called hyperbaric chambers (barochambers), are used, where oxygen is administered both by inhalation and through mucous membranes and skin.

Oxygen is most commonly administered by inhalation as a mixture with air at a concentration of 40–60%, at a flow rate of 4–5 liters per minute. A mixture called "carbogen," consisting of 95% oxygen and 5% carbon dioxide, is also used. The mixture is usually humidified before administration.

During hyperbaric oxygenation, oxygen is delivered under a pressure of 1.2–2 atm. Therapeutically, 8–10 sessions are typically conducted.

Preparation of oxygen cocktails and foams: oxygen is mixed with food products, juices, or herbal infusions.

Children.

The medicinal product is used in pediatric practice.

Overdose.

Symptoms: nausea, vomiting, and convulsions may occur in case of overdose.

Treatment: symptomatic therapy.

Side effects.

In individual patients, individual increased sensitivity to oxygen and its mixtures, dizziness, nausea, increased dryness of mucous membranes, their irritation, cough may be possible.

If any adverse events occur, consult a physician!

Reporting of suspected adverse reactions: healthcare professionals should report any suspected adverse reactions through the national pharmacovigilance system.

Shelf life.

18 months.

The medicinal product must not be used after the expiry date stated on the packaging.

Storage conditions.

Store in a place protected from direct sunlight, at a temperature not exceeding +50 °C. Avoid contact with open flame and sources of heat. Avoid contact with oils. Do not drop.

Packaging.

Compressed gas at a pressure of 14.7 ± 0.5 MPa in 40 L (dm³) steel cylinders. Cylinders are painted blue or dark blue with the black inscription "Medical Oxygen". Each cylinder bears a label indicating composition, batch/lot number, and date of manufacture.

Prescription category. Prescription only.

Manufacturer.

Joint Stock Company "National Atomic Energy Generating Company "Energoatom".

Manufacturer's address and place of business.

City of Varash, Rivne Oblast, 34400, Ukraine