OXYGEN MEDICINAL GASEOUS

INSTRUCTIONS
for medical use of medicinal product

MEDICAL OXYGEN GAS
(OXYGEN GAS MEDICAL)

Composition:

active substance: oxygen;

contains not less than 99.5% oxygen.

Pharmaceutical form. Gas.

Main physico-chemical properties: colorless, odorless and tasteless gas; supports combustion more actively than air; strong oxidizing agent.

Pharmacotherapeutic group.

Medical gases.

ATC Code V03A N01.

Pharmacological properties.

Pharmacodynamics.

Oxygen belongs to the group of anti-hypoxants and antioxidants. It is capable of binding with blood hemoglobin in the lungs and being transported as a complex compound with heme to the body's cells. Oxygen is a strong oxidizing agent and an essential element in metabolic transformations of carbohydrates, proteins, and fats into energy substrates necessary to sustain vital functions of the organism.

Pharmacokinetics.

In the human body, oxygen diffuses through lung tissue into the blood, binding to hemoglobin in erythrocytes and partially dissolving in plasma. Oxygen is then transported to body tissues, where it diffuses into the interstitial fluid. The final stage of respiration is the utilization of oxygen in biological oxidation processes, resulting in energy production within cells; subsequently, after a series of transformations, it is exhaled by the lungs in the form of carbon dioxide (CO2).

Clinical characteristics.

Indications.

Diseases associated with hypoxia:

respiratory system:

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

cardiovascular system:

• heart failure;
• coronary insufficiency.

Poisonings:

• carbon monoxide;
• hydrogen cyanide;
• asphyxiating gases.

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

Used 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 paranasal sinuses, presence of lung cavities, bronchopleural fistulas, severe forms of arterial hypertension, neoplasms, and increased individual sensitivity to oxygen.

Interaction with other medicinal products and other forms of interactions.

Nitrates, beta-blockers, calcium channel antagonists, and nootropics promote more efficient tissue utilization of oxygen, thereby reducing hypoxia and increasing the body's resistance to oxygen deficiency.

Special precautions.

For women during menstruation, oxygen should be used only when necessary in severe cases of respiratory failure, under hemoglobin level monitoring.

Use with humidifiers is recommended.

Use during pregnancy or breastfeeding.

Do not use during pregnancy beyond 5 months.

During the use of this medicinal product, breastfeeding should be discontinued.

Ability to influence reaction rate when driving or operating machinery.

Due to possible dizziness, patients should refrain from driving or performing tasks requiring high attention and rapid reaction.

Method of administration and dosage.

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

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

For hyperbaric oxygenation, i.e., oxygen delivery under increased pressure, special ventilated chambers, so-called hyperbaric chambers, are used, where oxygen is delivered via inhalation as well as through mucous membranes and skin.

Most frequently, oxygen is 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 administered humidified.

During hyperbaric oxygenation, oxygen is delivered at 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.

In case of overdose, nausea, vomiting, and convulsions may occur.

Treatment is symptomatic.

Side effects.

In some patients, individual hypersensitivity to oxygen and its mixtures, dizziness, nausea, increased dryness of mucous membranes, their irritation, coughing may occur.

If any adverse events occur, consult a physician.

Reporting of suspected side effects.

Reporting of adverse reactions after drug registration is of great importance. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

18 months.

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

Storage conditions.

Store gaseous medical oxygen in cylinders, cylinder bundles and megapacs in special storage rooms or under shelters. During storage, ensure that the cylinder surface temperature does not exceed +50 °C.

Store gaseous medical oxygen from cryogenic vaporizers in the oxygen pipeline within an appropriate container, in accordance with current legislation.

Do not allow contact with oils, open flames and sources of heat, except when they are oxygen-compatible.

Packaging.

Gas in cylinders of 1 L, 2 L, 3 L, 5 L, 6 L, 8 L, 10 L, 20 L, 40 L, 50 L; in cylinder bundles of 480 L (40 L × 12), 600 L (50 L × 12), 640 L (40 L × 16), 720 L (40 L × 18), 800 L (50 L × 16), 800 L (40 L × 20), 840 L (40 L × 21), 1050 L (50 L × 21); in megapacs C4 (4 × 150 L), C6 (6 × 150 L), and from cryogenic vaporizers.

Prescription status.

Prescription only.

Manufacturer.

Subsidiary enterprise "Messer Ukraine".

Manufacturer's address and place of business.

22K Dniprostaievska Street, Dnipro, Dnipropetrovsk Oblast, 49051, Ukraine.