Tlen medihni Air Products

1. What is medical oxygen and what is it used for

Medical oxygen is a colorless, odorless gas with very strong oxidizing properties.
Indications for oxygen therapy are all forms of hypoxia. Oxygen therapy is
particularly beneficial for patients with normal oxygen consumption, in whom decreased oxygen tension is found in mixed venous blood during breathing of atmospheric air.

2. Important information before using medical oxygen

When not to use medical oxygen

Do not use in patients with arterial blood PCO of 9.3 kPa, as it may lead to carbon dioxide narcosis with loss of consciousness, and subsequently death of the patient.

Warnings and precautions

Exercise particular caution when using medical oxygen:
when administering the drug in concentrations above 60% (above 40% in newborns)
and in hyperbaric therapy.
Oxygen therapy causes significant enrichment of the air with oxygen and increases the risk of fire. The use of open fire or other ignition sources is prohibited during this time.

Medical oxygen and other medicines

Using high concentrations of oxygen during concurrent bleomycin therapy enhances the adverse effects of this cytostatic (pulmonary fibrosis).
During oxygen therapy for the treatment of paraquat poisoning, lung tissue damage may worsen in patients with pre-existing lung damage caused by oxygen therapy.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.

Driving and using machines

It is not recommended to drive vehicles or operate machines after oxygen therapy.
Adverse effects may affect the patient's psychophysical fitness (see section 4 Possible side effects).

3. How to use medical oxygen

Medical oxygen is used for inhalation in concentrations from 21% to 100%. The dosage and method of administration are determined by medical personnel.
Oxygen therapy requires specialized devices for administering oxygen at high and low concentrations. High concentrations can be administered using nasal catheters or face masks.
Oxygen must be administered continuously. Discontinuation of oxygen administration is particularly dangerous, as the increase in CO pressure in the pulmonary alveoli can cause further reduction of oxygen concentration when the patient breathes air.

In case of administration of a higher dose of medical oxygen than recommended:

The administered oxygen concentration or flow rate should be reduced immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare: carbon dioxide narcosis with loss of consciousness, subsequent hypoxia (hypoxia) caused by sudden administration of pure oxygen, retrolental fibroplasia in newborns (especially premature babies) - the oxygen concentration in the incubator should not exceed 40%, oxygen toxicity (Paul Bert effect) - may occur when using oxygen at concentrations above 70%, and the most characteristic symptom is generalized convulsions, pulmonary alveolar hypoplasia, irritation of the larynx and trachea, swelling of the nasal mucosa, periodic laryngeal pain, cough, bronchitis, ear pain, Eustachian tube blockage, costal pain, joint pain, loss of appetite, nausea, vomiting, decreased visual field, myopia, cataract, decreased lung vital capacity, hypersensitivity, mental disorders.

Reporting side effects.

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
al. Jerozolimskie 181 C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store medical oxygen

Store in a place inaccessible and invisible to children.
Do not use the medical oxygen after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Before use, the cylinder must be stored at a temperature of 20°C for at least 6 hours.
Oxygen cylinders should be stored vertically, in a cool, dry, and well-ventilated place, away from heat sources and flammable gases and other combustible and oxidizing substances. The medicinal product should be protected from overheating.
Storage conditions: from -20°C to +50°C. Do not use open fire. Protect from oil and grease contamination.

6. Package contents and other information

What medical oxygen contains

• Active substanceof the medicine is oxygen (oxygenium)

What medical oxygen looks like and what the package contains

Medical oxygen compressed steel and aluminum seamless cylinders of capacities: 0.5; 1; 2; 2.7; 3; 5; 8; 10; 40; 50 liters equipped with a standard valve with a residual pressure valve or a valve with an integrated pressure regulator
Medical oxygen liquefied cryogenic containers with a capacity of 0.1 to 60 tons.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Air Products Sp. z o.o. ul. Komitetu Obrony Robotników 48, 02-146 Warsaw
Tel. +48 (22) 440 32 00
Fax +48 (22) 440 32 05

Manufacturers:

Air Products Sp. z o.o. ul. Kielecka 30, 42-470 Siewierz
Air Products Sp. z o.o. ul. Sienkiewicza 29, 56-120 Brzeg Dolny
Air Products Sp. z o.o. ul. Bukowiecka 71, 03-893 Warsaw
Date of leaflet approval: 01.11.2019