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Package Leaflet: Information for the User

Medical Oxygen

Oxygenium
99.5% (V/V),gas

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be taken as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you need advice or more information.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

Table of Contents of the Leaflet:

• 1. What is Medical Oxygen and what is it used for
• 2. Important information before using Medical Oxygen
• 3. How to use Medical Oxygen
• 4. Possible side effects
• 5. How to store Medical Oxygen
• 6. Contents of the pack and other information

1. WHAT IS MEDICAL OXYGEN AND WHAT IS IT USED FOR

Medical Oxygen is a compressed gas with an oxygen content of not less than 99.5%
by volume (V/V). Medical Oxygen is indicated in all forms of hypoxia.
Oxygen therapy is particularly beneficial for patients with normal oxygen consumption, in whom
a 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

Oxygen under pressure greater than atmospheric pressure (hyperbaric oxygen therapy)
should not be used in cases of untreated pneumothorax. Pneumothorax is
caused by the accumulation of air in the thoracic cavity between the two pleural membranes.
If the patient has ever had pneumothorax, the doctor should be informed.

Warnings and precautions

Before using Medical Oxygen, talk to your doctor or pharmacist.
Before starting oxygen therapy, you should know that:

• oxygen at higher concentrationscan have harmful effects. It can cause lung damage (atelectasis), leading to impaired gas exchange with the blood;
• caution should be exercised in the case of newborns and premature babiesto avoid adverse events, such as vision damage. If the baby requires oxygen therapy, they should be given the amount of Medical Oxygen prescribed by the doctor.

Hyperbaric oxygen therapy requires precautions in the case of:

• chronic obstructive pulmonary disease(COPD);
• pulmonary emphysema: lung disorders caused by loss of lung tissue elasticity, accompanied by (severe) shortness of breath;
• upper respiratory tract infections;
• ineffectively treated asthma;
• recently performed middle ear surgery;
• recently performed chest surgery;
• uncontrolled high fever;
history of seizures or convulsions;claustrophobia(fear of enclosed spaces);pneumothorax, i.e. the presence of air or gas in the pleural cavity;
• heart disorders.

Information on increased fire risk in an oxygen atmosphere

• Oxygen is an oxidizing agent that supports combustion. In rooms where Medical Oxygen is used, open flames (e.g. pilot lights, oven, gas stove, sparks, candles...) should not be used, as this increases the risk of fire.
• Smoking or using e-cigarettes should not be allowed during oxygen therapy.
• During oxygen therapy, toasters, dryers, and similar electrical appliances should not be used.
• Fatty substances should not be applied to surfaces in contact with Medical Oxygen (e.g. oils, creams, ointments). Only water-based products can be used on hands, face, or inside the nose.
• The pressure regulator valve should be opened slowly and carefully to avoid ignition. There have been cases of burns due to accidental fires in the presence of oxygen.

Instructions for users:

• The cylinder should be handled with care. The cylinder should not be exposed to drops or impacts.
• Damage to the valve can cause difficulties with gas flow and/or incorrect readings on the pressure gauge regarding the remaining oxygen content and flow rate, leading to a lack or insufficient supply of oxygen.
• Oxygen liquefies at a temperature of -183°C. At such a low temperature, there is a risk of frostbite. Gloves and safety glasses should always be worn when working with liquid oxygen for medical purposes.

Children

In premature babies and newborns, oxygen therapy can cause eye damage
(retinopathy of prematurity). The doctor may reduce the risk of eye damage by selecting the appropriate oxygen concentration.

Medical Oxygen and other medicines

Tell your doctor or pharmacist about all other medicines you are taking or have recently taken.
In the case of the patient taking or being prescribed bleomycin (cancer treatment), amiodarone (coronary heart disease), nitrofurantoin, or other antibiotics (infections), or nitric oxide (pulmonary hypertension), consult your doctor before using oxygen, as there is a risk of pulmonary toxicity.
Lung damage caused by the herbicide paraquat may worsen during oxygen therapy. In the case of paraquat poisoning, oxygen should be avoided if possible.

Pregnancy, breastfeeding, and fertility

Medical Oxygen can be used during pregnancy when necessary.
Medical Oxygen can be used during breastfeeding.
Always inform your doctor about pregnancy or suspected pregnancy.
Pregnant, breastfeeding, suspected, or planning women should consult their doctor or pharmacist before using Medical Oxygen .

Driving and using machines

During Medical Oxygen therapy, you can drive vehicles and operate machines if your doctor considers you able to do so.

3. HOW TO USE MEDICAL OXYGEN

Using a higher dose of Medical Oxygen than recommended

In some cases, too much Medical Oxygen may negatively affect breathing, and in exceptional cases, may cause unfavorable neurological effects, which in extreme cases can lead to loss of consciousness.
Prolonged use of too much Medical Oxygen can cause breathing difficulties, dry cough, or even shortness of breath. If symptoms of overdose occur, contact your doctor or the nearest medical facility.

If the cylinder has a built-in pressure regulator, use:

• a hose clamped on a special connector with a closing safety device, connected to the dosing valve;
• a flowmeter equipped with a closing safety device.

Before connection:

• check the identity of the medicinal product and the filling indicator (5).

Connectors:

• adjustable flow connector for connecting a flexible hose (3);
• standard quick connector (4).

Opening the cylinder:

• unscrew the shut-off valve (1);
• adjust the flow: use the knob (2), if the connector (3) is used.

After each use:

• set the flow to 0 l/min using the knob (2);
• disconnect the hose or quick connector if necessary;
• close the cylinder by screwing the shut-off valve (1).

Note: The supply of medical gas through the connector is cut off if the flow knob (2) is set between two flow values

Valve maintenance:

• the valve requires regular inspections, performed by trained personnel authorized by the valve manufacturer;

Valve cleaning and disinfection:

• the user can only clean the collar and pressure gauge (glass) that are accessible;
• the valve should be cleaned with the cylinder closed (full or empty) using a lightly damp cloth; do not use abrasive powders, pure alcohol, acetone, or other flammable solvents;
• the valve can be disinfected (after cleaning) with a cloth moistened with a water-alcohol solution; Personnel handling oxygen cylinders should be properly trained and aware of the hazards resulting from the physicochemical properties of the product.

Medical Oxygen is administered in concentrations from 21% to 100%. Oxygen should be administered continuously. Separate devices should be used for administering oxygen in high and low concentrations. High-concentration oxygen can be administered using nasal catheters or face masks to patients who are not apneic.

Using a higher dose of Medical Oxygen than recommended

The oxygen concentration should be reduced immediately or oxygen therapy should be discontinued.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects usually occur with prolonged use of high concentrations.

Very common (more than 1 in 10 patients)

In newborns undergoing oxygen therapy in high concentrations: vision damage leading to vision disorders.
In hyperbaric therapy: eye pain, myopia, barotrauma (physical damage to body tissues or organs caused by pressure differences)

Common (may affect up to 1 in 10 people)

In hyperbaric therapy: seizures.
Uncommon (may affect up to 1 in 100 people): lung collapse.
In hyperbaric therapy: eardrum rupture.

Rare (may affect up to 1 in 1,000 people):

In hyperbaric therapy: shortness of breath, abnormally low blood sugar levels in diabetic patients.

Frequency not known (cannot be estimated from the available data)

Side effects:lung disorders, dryness of mucous membranes, burns.
In hyperbaric therapy: breathing difficulties, involuntary muscle spasms, dizziness, hearing loss, acute serous otitis media, nausea, behavioral disorders, peripheral vision disorders, cataract (lens clouding).
Tissue damage due to frostbite caused by liquid oxygen.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181 C,
02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. HOW TO STORE MEDICAL OXYGEN

Store in well-ventilated areas, away from heat sources. Do not allow contact with flammable materials, fats, and oils. Protect from overheating.
Store in a place out of sight and reach of children.
Do not use oxygen after the expiry date stated on the packaging.
Oxygen is stored exclusively in steel or aluminum cylinders, cylinder bundles, cryogenic containers, cryogenic tanks, or tankers that meet the requirements of the Office of Technical Inspection.
Cylinders should be stored upright and secured against falling.
The warehouse organization should allow for the separation of different types of medical gases, as well as empty and full cylinders, cylinder bundles, cryogenic containers, cryogenic tanks to prevent the incorrect use of gases. Valves and reducers should be strictly protected against contamination with fats or lubricants.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Medical Oxygen contains

Medical Oxygen is a colorless, odorless gas with an oxygen content of at least 99.5% (V/V).

What Medical Oxygen looks like and what the pack contains

Available packs:
Steel cylinders with a capacity of 1 l to 50 l with an RPV valve or an integrated G2 valve.
Aluminum cylinders with a capacity of 0.1 l to 50 l with an integrated Compact G2 valve (with or without the TIPI function).
Cylinder bundles of 8-16 cylinders with a capacity of 400 l - 800 l at a filling pressure of 200 bar with an oxygen valve with the RPV function.
Cryogenic containers with a capacity of 1 l to 1000 l.
Tankers with a capacity of over 800 kg.
Cryogenic tanks with a capacity of 2 t to 2356 t.
Steel and aluminum cylinders contain compressed gas with an oxygen content of not less than 99.5% (V/V)at a filling pressure of 150 or 200 bar.
Cryogenic containers, tanks, and tankers contain liquid oxygen with an oxygen content of not less than 99.5% (V/V).

Marketing authorization holder

Air Liquide Polska Sp. z o.o.
Jasnogórska Street 9
31-358 Kraków
Phone: 12 627 93 00
[email protected]

Manufacturer

ALKAT Sp. z o.o.
Piłsudskiego Avenue 92
41-308 Dąbrowa Górnicza
Phone: 32 790 81 11
[email protected]
Date of last revision of the leaflet:19.04.2023