OXYGEN MEDICINAL GASEOUS

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

Composition:

active substance: oxygen with a volume fraction of not less than 99.5%.

Pharmaceutical form. Gas.

Main physicochemical properties: colorless odorless gas, supports combustion more vigorously than air.

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, as a complex compound with heme, is transported to the body's cells. Oxygen 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 the 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 and the generation of energy within cells; subsequently, through a series of transformations, it is excreted by the lungs in the form of carbon dioxide (CO₂).

Clinical characteristics.

Indications.

Diseases accompanied by hypoxia:

respiratory organs:

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

cardiovascular system:

• heart failure;
• coronary insufficiency.

Poisonings:

• carbon monoxide;
• cyanic acid;
• suffocating gases.

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

For preparation of oxygen cocktails, foams.

Contraindications. For hyperbaric oxygenation, contraindications include acute respiratory diseases, history of epileptiform seizures, impaired patency of auditory tubes and canals connecting the paranasal sinuses, presence of cavities in the lungs, 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, adrenoblockers, calcium ion antagonists, and nootropic agents promote more economical utilization of oxygen by tissues, improve its utilization, and thereby reduce hypoxia and increase the body's resistance to oxygen deficiency.

Special precautions for use.

It is recommended to use with moisturizers.

Do not use during menstrual period.

Use during pregnancy or breastfeeding.
Do not use if pregnancy term is more than 5 months.

Breastfeeding should be discontinued for the duration of drug use.

Ability to affect reaction speed when driving or operating machinery.
Due to possible dizziness, avoid driving vehicles or performing tasks requiring heightened attention and quick reactions.

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 frequently used.

For hyperbaric oxygenation, i.e., delivery of oxygen under increased pressure, special ventilated devices, so-called hyperbaric chambers, 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 can be used in pediatric practice.

Overdose. In case of overdose, nausea, vomiting, and seizures may occur. Treatment is symptomatic.

Adverse Reactions.

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

In case of any adverse reactions, consult a physician.

Reporting of adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical personnel, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy through 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.

Oxygen-filled cylinders and cryogenic gasifiers must be stored in special warehouse premises or on open platforms under a canopy, protected from atmospheric precipitation and direct sunlight. To prevent explosion, contact with oils must be avoided. Prevent falling, impact against each other, and damage.

Gaseous medical oxygen must be stored at a temperature not exceeding 50 °C.

Packaging. In steel cylinders with a capacity of 1 L, or 2 L, or 3 L, or 4 L, or 5 L, or 10 L, or 12 L, or 40 L, or 50 L, or in cryogenic gasifiers.

Prescription status. Prescription only.

Manufacturer. DIP AIR GAS LLC

Manufacturer's location and address of business activity. 1/154 Promyslova Street, Zhytomyr, 10025, Ukraine