Oxygen medicinal gaseous

Ukraine
Brand name Oxygen medicinal gaseous
Form gas
Active substance / Dosage
oxygen · not less than 99.5 percent
Prescription type prescription only
ATC code
Registration number UA/17076/01/01
Oxygen medicinal gaseous gas

INSTRUCTION
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 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 has the ability to bind with blood hemoglobin in the lungs and be transported as a complex compound with heme to the body's cells. It is a strong oxidizing agent and an essential element in metabolic transformations of carbohydrates, proteins, and fats into energy material necessary to sustain life functions of the organism.

Pharmacokinetics.

In the human body, oxygen diffuses through lung tissue into the blood, binding with hemoglobin in erythrocytes and partially dissolving in plasma. Then, oxygen is transported to body tissues, where it diffuses into the interstitial fluid of tissues. The final stage of respiration is utilization of oxygen in biological oxidation and formation of energy within cells, followed by its elimination via the lungs in the bound form as carbon dioxide (CO2).

Clinical characteristics.

Indications.

Diseases accompanied by hypoxia:

respiratory system:

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

cardiovascular system:

  • heart failure;
  • coronary insufficiency.

Poisonings:

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

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

Used for preparation of oxygen cocktails and foams.

Contraindications.

Contraindications for hyperbaric oxygenation include acute respiratory diseases, history of epileptic seizures, impaired patency of auditory tubes and channels 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 ion antagonists, and nootropics promote more economical use of oxygen by tissues, improve its utilization, and thereby reduce hypoxia and increase 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, refrain from driving or performing tasks requiring high attention and quick 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 administered via inhalation as well as through mucous membranes and skin.

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 administered humidified.

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

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

Children.

The medicinal product is used in pediatric practice.

Overdose.

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

Adverse reactions.

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

If any adverse events occur, consult a physician.

Reporting of adverse reactions.

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous 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 Pharmacovigilance Information System 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 in a place protected from direct sunlight, at a temperature from –50 °С to
+50 °С. Avoid contact with open flame and sources of heat. Do not allow contact with oils. Do not drop or throw.

Packaging.

40 L, 10 L, 5 L, 4 L, 3 L, 2 L, 1.5 L, 1 L in steel cylinders.

Prescription status.

Prescription only.

Manufacturer.

Commandite partnership "TOV Zaporizhzhia Autogenous Plant and Company".

Manufacturer's address.

20 Ivanova Street, Zaporizhzhia, Zaporizhzhia Oblast, 69068, Ukraine.