Tlen medihni Tzf

Package Leaflet: Information for the Patient

Medical Oxygen TZF, 99.5%, Compressed Medical Gas

Oxygenium

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

• Keep this package 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 the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

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

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

Medical Oxygen TZF is a colorless and odorless gas.
The 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 TZF

When not to use Medical Oxygen TZF

• if the patient's carbon dioxide tension (CO) in arterial blood exceeds 9.3 kPa, as this may lead to carbon dioxide narcosis with loss of consciousness, and subsequently to the patient's death;
• if the patient is using or has used the following medicines: adriamycin, disulfiram, cisplatin, or sulfamylon (see subsection "Medical Oxygen TZF and other medicines").

Warnings and precautions

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

• Medical staff should exercise particular caution when using oxygen at concentrations above 60% (above 40% in newborns) and in hyperbaric therapy (a method of treating various diseases and injuries by breathing pure oxygen under increased pressure). See also section 4 "Possible side effects".
• Oxygen therapy causes 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.
• Oxygen should be administered continuously. Interrupted oxygen administration is particularly dangerous, as it may lead to further reduction of oxygen concentration when the patient breathes air.
• Patients with signs of paraquat poisoning

The use of high oxygen concentrations in cases of paraquat poisoning may worsen lung tissue damage (see subsection "Medical Oxygen TZF and other medicines").

Medical Oxygen TZF 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 TZF at the same time as the following medicines:
• adriamycin (a medicine used to treat cancer);
• disulfiram (a medicine used to treat alcoholism);
• cisplatin (a medicine used to treat cancer);
• sulfamylon (a medicine used to treat wound infections in patients with severe burns).
• Using high oxygen concentrations during treatment with bleomycin (a medicine from the group of medicines called cytostatics used to treat cancer) enhances the side effects of bleomycin (pulmonary fibrosis).
• Medical staff must exercise particular caution in cases of paraquat poisoning (a highly toxic chemical plant protection agent), as high oxygen concentrations may exacerbate lung tissue damage in patients with pre-existing lung damage caused by oxygen treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
During pregnancy and breastfeeding, it is recommended to avoid using Medical Oxygen TZF. The decision to use the medicine during pregnancy and breastfeeding is made by the doctor.

Driving and using machines

After oxygen therapy, do not drive vehicles or operate machines. Side effects may affect the patient's psychophysical fitness (see section 4 "Possible side effects").

3. How to use Medical Oxygen TZF

Medical Oxygen TZF is always administered by medical staff familiar with this form of the medicine.
During administration of Medical Oxygen TZF, medical staff must closely monitorboth the patient's condition and the administration of the medicine to ensure safe use.
Medical Oxygen TZF should be used in accordance with the doctor's recommendations. In case of doubts, consult a doctor. The doctor should explain to the patient what the use of Medical Oxygen TZF involves, how the medicine works, and what its effects are.

• Medical Oxygen TZF is used by inhalation - the patient inhales the gas through a nasal catheter or face mask.
• Medical Oxygen TZF is used at a concentration of 21% to 100%. The dose and duration of use are determined by medical staff.
• Oxygen should be administered continuously. Interrupted oxygen administration is particularly dangerous, as it may lead to further reduction of oxygen concentration when the patient breathes air.

Using a higher dose of Medical Oxygen TZF than recommended

Overdose leads to the occurrence of side effects, mainly from the respiratory system, central nervous system, and cardiovascular system (decreased heart efficiency, red blood cell breakdown), and in premature infants, it causes retinopathy of prematurity (a disease of the retina of the eye) and blindness.
In case of suspected overdose, medical staff must immediately reduce the oxygen concentration or flow rate.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Oxygen may 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%.
• During the use of oxygen at concentrations above 70%, oxygen poisoning (Paul Bert effect) may occur - the most characteristic symptom is generalized convulsions.

The following side effects may also occur:

• atelectasis (collapse of the lungs) - symptoms may include mild cough, chest pain, difficulty breathing, rapid heartbeat;
• irritation of the larynx and trachea, swelling of the nasal mucosa, periodic laryngeal pain, cough;
• bronchitis;
• ear pain, Eustachian tube blockage;
• costosternal 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; myopia, cataract;
• hypersensitivity (excessive sensitivity to various stimuli);
• psychic changes.

Reporting side effects

If any side effects occur, including any not listed in this package leaflet, inform 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
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 to gather more information on the safety of the medicine.

5. How to store Medical Oxygen TZF

Cylinders should be stored at a temperature below 50°C.
Medical Oxygen TZF should be stored in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cylinder.
Personnel handling oxygen cylinders should be properly trained and aware of the hazards resulting from the physicochemical properties of the product.

6. Contents of the package and other information

What Medical Oxygen TZF contains

• The active substance is oxygen, 99.5%.
• The medicine does not contain any other ingredients.

What Medical Oxygen TZF looks like and what the package contains

Medical Oxygen TZF is a compressed medical gas.
Medical Oxygen TZF is a colorless, odorless gas.
The cylinder has a standard valve and an integrated valve. The valves of the cylinder are protected with heat-shrinkable foil after filling.
1 x 2 L; 1 x 3 L, 1 x 5 L; 1 x 10 L; 1 x 40 L; 1 x 50 L
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: (22) 811-18-14
To obtain more detailed information, please contact the representative of the marketing authorization holder.
Manufacturer
SPAWMET Spółka z o.o.
ul. Zakładowa 8
89-600 Chojnice

Date of the last update of the package leaflet:

INFORMATION INTENDED EXCLUSIVELY FOR MEDICAL PROFESSIONALS:

Medical Oxygen TZF, 99.5%, Compressed Medical Gas

Oxygenium

Special warnings and precautions for use

It is necessary to carefully monitor the treatment with Medical Oxygen TZF. Oxygen should be administered in such a way as to reduce hypoxia, but not to inhibit 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 CO tension should be assessed by blood gas analysis or the rebreathing method. If the CO tension is above 6.6 kPa, 25% oxygen should be administered and its concentration gradually increased if there is no inhibition of breathing.
Medical Oxygen TZF should be administered continuously. Interrupted oxygen administration is particularly dangerous, as it may lead to further reduction of oxygen concentration when the patient breathes air.
Particular caution should be exercised when administering oxygen at concentrations above 60% (above 40% in newborns) and in hyperbaric therapy.

Instructions for preparation of the medicinal product for use and disposal of its residues:

• 1. Before use, the cylinder should be stored at a temperature of 15-20°C for at least 6 hours.
• 2. Before screwing the threaded connector of the reducer onto the cylinder, briefly open the valve to remove any 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 staff.

Special precautions for storage:

Medical Oxygen TZF, 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 and oxidizing substances.
• Protect cylinders from overheating. Do not use open flames. Protect valves and connections from oil and grease.
• Cylinders should be stored and transported at a temperature below 50°C.
• Cylinders, protected against tipping, should be stored in an upright position.
• The warehouse organization should allow for the separation of empty and full cylinders.
• A cylinder should be considered empty when the pressure in the cylinder at room temperature drops to 2 bar.