Oxygen medical air products
PolandTable of Contents
Package leaflet: Information for the user
MEDICAL OXYGEN AIR PRODUCTS
99.5%, inhalation gas
Oxygenium
Please read this leaflet carefully before using this medicine, because it
contains important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, please ask your doctor or nurse.
- If the patient experiences any adverse reactions, including any not listed in this leaflet, please inform your doctor or nurse. See section 4.
Contents of the leaflet:
- What medical oxygen is and what it is used for
- Important information before using medical oxygen
- How to use medical oxygen
- Possible side effects
- How to store medical oxygen
- Contents of the pack and other information
1. What medical oxygen is and what it is used for
Medical oxygen is a colourless, odourless gas with very strong oxidising properties.
Oxygen therapy is indicated in all forms of hypoxia. Oxygen therapy is particularly beneficial in patients with normal oxygen consumption in whom reduced partial pressure of oxygen in mixed venous blood is observed during breathing of atmospheric air.
2. Important information before using medicinal oxygen
When not to use medicinal oxygen
Do not use in patients with arterial PCO₂ of 9.3 kPa, as it may lead to carbon dioxide narcosis with loss of consciousness, followed by patient death.
Warnings and precautions
Exercise particular caution when using medicinal oxygen:
during administration at concentrations above 60% (above 40% in newborns) and during hyperbaric therapy.
Oxygen therapy significantly enriches the surrounding air with oxygen and increases the risk of fire. The use of open flames or other ignition sources is strictly prohibited during oxygen therapy.
Medicinal oxygen and other medicines
The use of high oxygen concentrations during concomitant therapy with bleomycin intensifies the adverse effects of this cytostatic agent (pulmonary fibrosis).
During oxygen therapy for paraquat poisoning, lung tissue damage may worsen in patients with pre-existing lung injury caused by prior oxygen treatment.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a physician before using this medicine.
Driving and operating machinery
Driving and operating machinery are not recommended after oxygen therapy. Adverse reactions may affect the patient's psychophysical performance (see section 4 Possible adverse reactions).
3. How to use medicinal oxygen
Medicinal oxygen is administered by inhalation in concentrations ranging from 21% to 100%. Dosage and method of administration are determined by medical personnel.
Oxygen therapy requires specialized devices for delivering oxygen at high and low concentrations. High concentrations may be delivered via nasal cannulas or facial masks.
Oxygen must be administered continuously. Interrupting oxygen delivery is particularly dangerous, as increased partial pressure of CO in the lung alveoli may lead to further reduction in oxygen concentration at the moment when the patient breathes air.
If a higher dose of medicinal oxygen than recommended has been administered:
The oxygen concentration or flow rate should be immediately reduced.
4. Possible adverse reactions
Like all medicines, this product may cause adverse reactions, although not everybody will
experience them.
Very rare occurrences include: carbon dioxide narcosis with loss of consciousness, secondary
hypoxia caused by sudden administration of pure oxygen, retrolental fibroplasia in newborns
(particularly premature infants) – oxygen concentration in the incubator should not exceed
40%, oxygen toxicity (Paul Bert effect) – may occur when using oxygen at concentrations
above 70%, with generalized seizures being the most characteristic symptom, pulmonary
edema, sensation of larynx and trachea irritation, nasal mucosa edema, periodic laryngeal
pain, cough, bronchitis, ear pain, Eustachian tube blockage, retrosternal pain, joint pain, loss
of appetite, nausea, vomiting, reduced visual field, myopia, cataract, decreased vital lung
capacity, hypersensitivity, psychiatric disorders.
Reporting of adverse reactions.
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform
your doctor or pharmacist. Adverse reactions can be reported directly to the Department of
Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal
Products, Medical Devices and Biocidal Products
al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Email: [email protected]
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of using this
medicine.
5. How to store medicinal oxygen
Keep the medicinal oxygen out of the reach and sight of children.
Do not use medicinal oxygen after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month. Before use, the cylinder must be kept at a temperature of 20°C for at least 6 hours.
Oxygen cylinders must be stored vertically in a cool, dry and well-ventilated place, away from heat sources, flammable gases and other combustible and oxidizing substances. Protect the medicinal product from heating.
Storage conditions: from -20°C to +50°C. Do not use open flames. Protect from contamination with oils and greases.
6. Contents of the packaging and other information
What the medicinal product contains
- The active substance in the medicinal product is oxygen (oxygenium)
What the medicinal product looks like and contents of the packaging
Compressed medical oxygen in seamless steel and aluminium cylinders with capacities of: 0.5; 1; 2; 2.7; 3; 5; 8; 10; 40; 50 litres, equipped with a standard valve with residual pressure valve or with a valve with integrated pressure regulator.
Liquefied medical oxygen in cryogenic vessels with capacities from 0.1 to 60 tonnes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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