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.

Basic physical and 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 material necessary to sustain life.

Pharmacokinetics.

In the human body, oxygen diffuses through lung tissue into the blood, binding with hemoglobin in erythrocytes and partially dissolving in plasma. It is then transported to body tissues, where it diffuses into interstitial tissue fluid. The final stage of respiration is utilization of oxygen in biological oxidation and energy production within cells, followed by its elimination via 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.

Poisoning:

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

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

Used for preparation of oxygen cocktails and foams.

Contraindications.

Contraindications for hyperbaric oxygenation include acute respiratory diseases, history of epileptiform seizures, impaired patency of auditory tubes and channels connecting paranasal sinuses, presence of lung cavities or bronchopleural fistulas, severe forms of arterial hypertension, neoplasms, and increased individual sensitivity to oxygen.

Interaction with other medicinal products and other types of interactions.

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

Special precautions.

Use with humidifiers is recommended.

Do not use during menstruation.

Use during pregnancy or breastfeeding.

Do not use during pregnancy beyond 5 months.

During treatment with 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 concentration 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., delivery of oxygen under increased pressure, special ventilated chambers, so-called hyperbaric chambers, are used, where oxygen is administered 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 known as "carbogen," consisting of 95 % oxygen and 5 % carbon dioxide, is also used. The mixture is usually administered humidified.

During hyperbaric oxygenation, oxygen is delivered under 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, and 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.

Adverse reactions.

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

If any adverse effects occur, medical advice should be sought.

Shelf life.

1.5 years.

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 temperature not exceeding 50 °C. Avoid contact with open flame and sources of heat. Do not allow contact with lubricants. Do not drop.

Packaging.

40 L in cylinders.

Prescription status.

By prescription only.

Manufacturer.

Sumy Machine-Building Scientific-Production Association Ltd.

Manufacturer's address and place of business.

58 Gorky Street, Kovpakivskyi District, Sumy, Sumy Region, 40004, Ukraine.