Tlen medihni Messer

Leaflet attached to the packaging: patient information

MEDICAL OXYGEN MESSER, not less than 99.5% (V/V),

medical liquid gas, compressed medical gas
Oxygenium

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Medical Oxygen Messer and what is it used for

Medical Oxygen Messer (chemical formula: O) is a colorless and odorless gas. Indication for oxygen therapy is most 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 Messer

When not to use Medical Oxygen Messer

• if the patient's carbon dioxide partial pressure (CO) in arterial blood exceeds 9.3 kPa (more than 75% above normal), as this may lead to carbon dioxide narcosis with loss of consciousness, and subsequently to death;
• if the patient is using or has used the following medicines:
• adriamycin (a medicine used in chemotherapy for cancer);
• disulfiram (a medicine used to treat alcoholism);
• cisplatin (a medicine used in chemotherapy for cancer);
• sulfamylon (a medicine used to treat wound infections in patients with severe burns).

Warnings and precautions

Before starting treatment with Medical Oxygen Messer, consult a doctor or nurse.

• The doctor should exercise particular caution when using oxygen at concentrations above 60% (in newborns above 40%) and in hyperbaric therapy (a method of treating various diseases and injuries by breathing pure oxygen under increased pressure).

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• Oxygen therapy causes a significant enrichment of the air with oxygen and increases the risk of fire. The use of open flames or other ignition sources is strictly prohibited during this time. Medical personnel must exercise particular caution in cases of paraquat poisoning (a highly toxic chemical plant protection agent), as high oxygen concentrations can exacerbate lung damage.

Medical Oxygen Messer and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• Do not use Medical Oxygen Messer with the medicines listed in the section "When not to use Medical Oxygen Messer".
• Using high concentrations of oxygen during treatment with bleomycin (a medicine used to treat cancer, from the group of medicines called cytostatics) can increase the side effects of bleomycin (pulmonary fibrosis).

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, consult a doctor before using this medicine. The decision to use the medicine during pregnancy and breastfeeding is made by the doctor.

Driving and operating machinery

After oxygen therapy, do not drive vehicles or operate machinery.

3. How to use Medical Oxygen Messer

Medical Oxygen Messer is always administered by trained personnel who are familiar with this form of the medicine. During administration of Medical Oxygen Messer, both the patient and the administration of the medicine should be monitored to ensure safe use. Medical Oxygen Messer should always be used in accordance with the doctor's recommendations. The doctor should explain to the patient what the use of Medical Oxygen Messer involves, how it works, and what its effects are.

• Medical Oxygen Messer is used by inhalation - the patient inhales the gas through a nasal catheter or face mask.
• Medical Oxygen Messer is used in concentrations from 21% to 100%. The dose and duration of use are determined by the doctor.
• Oxygen should be administered continuously. Interrupted oxygen administration is particularly dangerous, as the increase in carbon dioxide partial pressure (CO) in the alveoli can cause further reduction of oxygen concentration when the patient breathes air.

Using a higher dose of Medical Oxygen Messer than recommended

Overdose can lead to side effects, mainly from the respiratory, central nervous, and cardiovascular systems (decreased heart efficiency, hemolysis), and in premature infants, it can cause retinopathy of prematurity (a disease of the retina of the eye) and blindness. If an overdose is suspected, medical personnel must immediately reduce the concentration of oxygen being administered or its flow rate.

4. Possible side effects

Like all medicines, Medical Oxygen Messer can cause side effects, although not everybody gets them.

• Oxygen can cause side effects such as carbon dioxide narcosis with loss of consciousness and (or) subsequent hypoxia caused by the administration of pure oxygen.
• In newborns (especially premature infants), retinopathy of prematurity (a disease of the retina of the eye) may occur - the oxygen concentration in the incubator should not exceed 40%.
• When using Medical Oxygen Messer at concentrations above 70%, oxygen toxicity (Paul Bert effect) may occur.
• Additionally, the following may occur:
• atelectasis (collapse of the alveoli) - its symptoms may include mild cough, chest pain, difficulty breathing, rapid heartbeat;
• bronchitis;
• costal pain (pain and pressure in the chest);
• joint pain;
• loss of appetite;
• nausea, vomiting;
• decreased vital capacity of the lungs (the amount of air that can be introduced into the lungs after maximum exhalation);
• decreased visual field;
• hypersensitivity (excessive sensitivity to various stimuli);
• psychic changes.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or nurse. 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 181C, 02-222 Warsaw, e-mail: ndl@urpl.gov.pl. By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Medical Oxygen Messer

Medical Oxygen Messer should be stored in a place inaccessible to children. Do not use Medical Oxygen Messer after the expiry date stated on the label after "Expiry date". Personnel handling oxygen cylinders and bottles should be properly trained and aware of the hazards associated with the physical and chemical properties of the product.

6. Package contents and other information

What Medical Oxygen Messer contains

• The active substance is oxygen. Oxygen content is not less than 99.5% by volume.
• The medicine does not contain other ingredients.

What Medical Oxygen Messer looks like and what the package contains

Medical Oxygen Messer is available as:

• medical liquid gas - in cryogenic containers containing from 50 kg to 70,000 kg of oxygen
• compressed medical gas - in steel, aluminum, and composite cylinders with a capacity of less than 10 liters, 10 liters, 20 liters, 40 liters, 50 liters, and in bundles of seamless steel cylinders with a capacity of 600 liters (12 cylinders with a capacity of 50 liters). Medical Oxygen Messer is a colorless, odorless gas.

Responsible entity:

Messer Polska Sp. z o.o., ul. Maciejkowicka 30, 41-503 Chorzów

Manufacturer:

Messer Polska Sp. z o.o., ul. Maciejkowicka 30, 41-503 Chorzów, MG Odra Gas spol. s r.o., Na Popinci 1088, 739 32 Vratimov, Czech Republic, Eloros Sp. z o.o., ul. Strefowa 22, 44-207 Rybnik. For more detailed information, please contact the representative of the responsible entity. Messer Polska Sp. z o.o., ul. Maciejkowicka 30, 41-503 Chorzów, tel. (32) 77 26 000, fax. (32) 77 26 115

Date of last update of the leaflet:

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INFORMATION INTENDED EXCLUSIVELY FOR MEDICAL PROFESSIONALS:

MEDICAL OXYGEN MESSER, not less than 99.5% (V/V), medical liquid gas, compressed medical gas

Special warnings and precautions for use

Close monitoring of treatment with Medical Oxygen Messer is necessary. Oxygen should be administered in such a way as to reduce hypoxia, but not to suppress the respiratory center. Oxygen therapy should always be used when there is a risk of hypoxia in patients with chronic lung disease. Before starting oxygen therapy, the arterial carbon dioxide partial pressure should be assessed by blood gas analysis or the rebreathing method. If the carbon dioxide partial pressure exceeds 6.6 kPa, 25% oxygen should be administered and its concentration gradually increased if there is no respiratory depression. Medical Oxygen Messer should be administered continuously. Interrupted oxygen administration is particularly dangerous, as the increase in carbon dioxide partial pressure in the alveoli can cause further reduction of oxygen concentration when the patient breathes air. Particular caution should be exercised when administering oxygen at concentrations above 60% (in newborns above 40%) and in hyperbaric therapy.

Instructions for preparing the medicinal product for use and disposing of its remnants:

• 1. Before use, the cylinder should be stored at a temperature of 20°C for at least 6 hours.
• 2. Before screwing the threaded connector of the reducer onto the cylinder, the valve should be opened briefly to remove any possible dust particles.
• 3. Before mounting the reducer on the cylinder, check the seal ring of the threaded connector.
• 4. Mount the reducer on the cylinder. Slowly open the cylinder valve.
• 5. Check the manometer to see if there is enough gas in the cylinder.
• 6. Set the flow rate, using the flow meter, as specified by medical personnel.

Special precautions for storage of cylinders:

Medical Oxygen Messer, ≥99.5% compressed medical gas, may only be stored in cylinders that meet the requirements of the Technical Supervision Authority.

• Cylinders with oxygen should be stored in a ventilated area, away from heat sources and flammable gases and other flammable substances.
• Cylinders should be stored and transported at a temperature below 50°C.
• Cylinders secured against tipping should be stored in an upright position.
• The warehouse organization should allow for the separation of different types of gases, as well as empty and full cylinders.
• A cylinder should be considered empty when the pressure in the cylinder at room temperature drops to 2 bar.

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