Oxygen medicinal gaseous

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

Composition:

Active substance: oxygen;

oxygen volumetric fraction 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 V03A N01.

Pharmacological properties.

Pharmacodynamics.

Oxygen belongs to the group of anti-hypoxia agents and antioxidants. It has the ability to bind to blood hemoglobin in the lungs and be 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 substances necessary 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. Subsequently, oxygen is 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 and the generation of energy within cells; the oxygen is then subsequently released from the body via the lungs in the form of carbon dioxide (CO₂) after a series of transformations.

Clinical characteristics.

Indications.

Diseases accompanied by hypoxia:

respiratory diseases:

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

cardiovascular diseases:

• heart failure;
• coronary insufficiency.

Poisonings:

• carbon monoxide;
• cyanide;
• suffocating gases.

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 the 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 efficient tissue utilization of oxygen, thereby reducing hypoxia and increasing the body's resistance to oxygen deficiency.

Special precautions for use

Do not use in women during menstruation.

The use of lubricants is recommended.

Use during pregnancy or breastfeeding

Do not use during pregnancy after 5 months gestation.

Breastfeeding should be discontinued for the duration of drug use.

Ability to affect reaction speed when driving or operating machinery

Due to possible dizziness, it is advisable to avoid driving vehicles and performing tasks requiring increased 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 frequently used.

For hyperbaric oxygenation, i.e., oxygen delivery under increased pressure, special ventilated so-called hyperbaric chambers are used, where oxygen is administered not only via the inhalation route but also 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 administered humidified.

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

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

Children.

The drug is used in pediatric practice.

Overdose.

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

Treatment is symptomatic.

Side effects.

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

If any adverse reactions occur, consult a doctor immediately!

Shelf life. 18 months.

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

Storage conditions.

Store in special warehouse premises or on open platforms under a canopy that protects cylinders from atmospheric precipitation and direct sunlight. To prevent explosion, avoid contact with oils. Prevent dropping, impacts, and damage to cylinders. Store medicinal gaseous oxygen at a temperature not exceeding 40 °C.

Packaging.

In steel cylinders with a capacity of 2 L, 3 L, 5 L, 10 L, 20 L, 33 L, 40 L, 50 L; in cylinder groups with a total capacity of 600 L (50 L × 12); in aluminum cylinders with a capacity of 2 L, 5 L, 10 L.

Prescription status. Prescription only.

Manufacturer.

Kyiv branch of Private Joint-Stock Company “Linde Gas Ukraine”

Manufacturer's location and address of business activity.

3b Lebedynska Street, Kyiv, 04209, Ukraine

INSTRUCTION

for medical use of the medicinal product

MEDICINAL GASEOUS OXYGEN

(OXYGENUM MEDICINALIS GASEOUS)

Composition:

Active substance: oxygen;

oxygen volume fraction not less than 99.5%.

Pharmaceutical form. Gas.

Main physico-chemical properties: colorless, odorless and tasteless gas; slightly soluble in water (approximately 1 : 43).

Pharmacotherapeutic group. Medical gases. ATC Code V03A N01.

Pharmacological properties.

Pharmacodynamics.

Oxygen belongs to the group of anti-hypoxia agents 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 metabolic transformations of carbohydrates, proteins, and fats into energy substances 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. Subsequently, oxygen is 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; the resulting byproducts are then excreted via the lungs as carbon dioxide (CO₂) after a series of transformations.

Clinical characteristics.

Indications.

Conditions associated with hypoxia:

respiratory diseases:

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

cardiovascular diseases:

• heart failure;
• coronary insufficiency.

Poisonings:

• carbon monoxide;
• hydrocyanic acid;
• choking 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, adrenergic blockers, calcium ion antagonists, and nootropic agents promote more efficient tissue utilization of oxygen, thereby reducing hypoxia and increasing the body's resistance to oxygen deficiency.

Special precautions for use.

Do not use in women during menstruation.

The use with lubricants is recommended.

Use during pregnancy or breastfeeding.

Do not use during pregnancy for more than 5 months.

Breastfeeding should be discontinued for the duration of treatment with the drug.

Ability to influence reaction speed when driving or operating machinery.

Due to possible dizziness, avoid driving vehicles and performing tasks that require increased 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., oxygen delivery under increased pressure, special ventilated so-called hyperbaric chambers are used, where oxygen is delivered not only via inhalation but also through mucous membranes and the 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 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 a pressure of 1.2–2 atm. For therapeutic purposes, typically 8–10 sessions are conducted.

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

Children.

The drug is used in pediatric practice.

Overdose.

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

Treatment is symptomatic.

Side effects.

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

If any adverse reactions occur, consult a physician immediately!

Shelf life. 18 months.

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

Storage conditions.

Store in special warehouse premises or on open platforms under a canopy protecting cylinders from atmospheric precipitation and direct sunlight. To avoid explosion, contact with oils must be avoided. Prevent dropping, impacts, and damage to cylinders. Gaseous medical oxygen must be stored at temperatures not exceeding 40 °C.

Packaging.

In steel cylinders with a capacity of 2 l, 3 l, 5 l, 10 l, 20 l, 33 l, 40 l, 50 l; in cylinder groups with a total capacity of 600 l (50 l × 12), and in aluminum cylinders with a capacity of 2 l, 5 l, 10 l.

Prescription status. By prescription only.

Manufacturer.

Private Joint-Stock Company “Linde Gas Ukraine”.

Manufacturer’s location and address of business activity.

1 Kyisneva Street, Industrialnyi District, Dnipro, Dnipropetrovsk Oblast, 49074, Ukraine.