Oxygen medicinalis tzf

Package leaflet: Information for the patient

Medical Oxygen TZF, 99.5%, compressed medical gas
Oxygenium
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Contents of the leaflet

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

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

Medical Oxygen TZF is a colourless and odourless gas.
The indication for oxygen therapy is most forms of hypoxia. Oxygen therapy is particularly beneficial in patients with normal oxygen consumption in whom decreased partial pressure of oxygen in mixed venous blood is observed during breathing of ambient air.

2. Important information before using Tlen medyczny TZF

When not to use Tlen medyczny TZF

• if the patient's arterial carbon dioxide tension (CO₂) exceeds 9.3 kPa, as this may lead to carbon dioxide narcosis with loss of consciousness, followed by death;
• if the patient is currently using or has recently used the following medicines: adriamycin, disulfiram, cisplatin, or sulfamylon (see section "Tlen medyczny TZF and other medicines").

Warnings and precautions
Before starting treatment with Tlen medyczny TZF, consult a doctor or nurse.

• Medical personnel should exercise particular caution when administering oxygen at concentrations above 60% (above 40% in newborns) and during hyperbaric therapy (a treatment method for various diseases and injuries involving breathing pure oxygen under increased pressure). See also section 4 "Possible side effects".
• Oxygen therapy significantly enriches the air with oxygen and increases the risk of fire. Open flames or other sources of ignition must be strictly avoided during oxygen therapy.
• Oxygen should be administered continuously. Interrupted oxygen supply is especially dangerous (see section 3 "How to use Tlen medyczny TZF").
• Patients with symptoms of paraquat poisoning

Use of high oxygen concentrations in cases of paraquat poisoning may worsen lung tissue damage (see section "Tlen medyczny TZF and other medicines").

Tlen medyczny TZF and other medicines
Inform the doctor about all medicines currently used or recently used by the patient, as well as any medicines the patient plans to use.

• Do not use Tlen medyczny TZF together with the following medicines:
  • adriamycin (a medicine used in cancer treatment);
  • disulfiram (a medicine used in the treatment of alcoholism);
  • cisplatin (a medicine used in cancer treatment);
  • sulfamylon (a medicine used to treat wound infections in patients with severe burns).
• Use of high oxygen concentrations during treatment with bleomycin (a cytostatic agent used in cancer treatment) may intensify bleomycin-related side effects (pulmonary fibrosis).
• Medical personnel must exercise special caution in cases of paraquat poisoning (a highly toxic agricultural chemical), as high oxygen concentrations may exacerbate lung tissue damage in patients with pre-existing lung injury caused by oxygen therapy.

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 doctor before using this medicine.
The use of Tlen medyczny TZF is not recommended during pregnancy and breastfeeding. The decision to use this medicine during pregnancy or breastfeeding must be made by a physician.

Driving and operating machinery
After oxygen therapy, patients should not drive or operate machinery. Side effects may affect the patient's psycho-physical performance (see section 4 "Possible side effects").

3. How to use Tlen medyczny TZF

Tlen medyczny TZF is always administered by medical personnel familiar with this
medicinal product.
During administration of Tlen medyczny TZF, medical personnel must carefully monitor
both the patient's condition and the administration of the medicinal product to ensure safe use.
Tlen medyczny TZF should always be used in accordance with the doctor's instructions. In case of doubts,
consult the doctor. The doctor should explain to the patient the nature of treatment with Tlen medyczny TZF,
how the medicinal product works, and what effects may be expected.

• Tlen medyczny TZF is administered by inhalation – the patient inhales the gas through a nasal cannula or a facial mask.
• Tlen medyczny TZF is administered at concentrations ranging from 21% to 100%. The dosage and duration of administration are determined by medical personnel.
• Oxygen should be administered continuously. Intermittent oxygen administration is particularly dangerous because increased partial pressure of carbon dioxide (CO ) in lung alveoli may lead to further reduction in oxygen concentration at the moment when the patient breathes ambient air.

Use of a higher than recommended dose of Tlen medyczny TZF
Overdosage leads to adverse effects mainly affecting the respiratory system, central nervous system, and cardiovascular system (reduced cardiac output, hemolysis), and in premature infants may cause bronchopulmonary dysplasia
(retinopathy of prematurity causing retinal damage) and blindness.
If administration of an excessive dose is observed, medical personnel must immediately reduce the concentration of administered oxygen or its flow rate.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

• Oxygen may cause adverse reactions such as: carbon dioxide narcosis with loss of consciousness and (or) secondary hypoxia caused by administration of pure oxygen.
• In newborns (especially premature infants), bronchopulmonary dysplasia (retrolental fibroplasia – retinal damage known as retinopathy of prematurity) may occur. The oxygen concentration in the incubator should not exceed 40%.
• When administering oxygen at concentrations above 70%, oxygen toxicity (Paul Bert effect) may occur – the most characteristic symptom being generalized seizures.

Additionally, the following adverse reactions may occur:

• Atelectasis (collapse of the lung alveoli) – symptoms may include mild cough, chest pain, difficulty breathing, rapid heartbeat;
• Irritation of the larynx and trachea, nasal mucosal swelling, periodic laryngeal pain, cough;
• Bronchitis;
• Ear pain, Eustachian tube blockage;
• Retrosternal pain (chest pain and pressure);
• Joint pain;
• Loss of appetite;
• Nausea, vomiting;
• Decreased vital capacity of the lungs (the amount of air that can be inhaled into the lungs after maximal exhalation);
• Reduced visual field; myopia, cataract;
• Hyperesthesia (increased sensitivity to various stimuli);
• Mental changes.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Tlen medyczny TZF

Cylinders should be stored at temperatures below 50°C.
Tlen medyczny TZF should be stored out of sight and out of reach of children.
Do not use this medicinal product after the expiry date stated on the cylinder.
Persons handling oxygen cylinders should be adequately trained and aware of the hazards arising from the physicochemical properties of the product.

6. Contents of the packaging and other information

What Tlen medyczny TZF contains

• The active substance is oxygen, 99.5%.
• The medicine contains no other ingredients.

What Tlen medyczny TZF looks like and contents of the pack
Tlen medyczny TZF is a compressed medical gas.
Tlen medyczny TZF is a colourless, odourless gas.
Cylinder with a standard closing valve and an integrated valve. Cylinder valves after filling
are protected with heat-shrink foil.
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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
ul. A. Fleminga 2
03-176 Warsaw
Telephone number: (22) 811-18-14
For further information, please contact the representative of the Marketing Authorisation Holder.

Manufacturer
SPAWMET Sp. z o.o.
ul. Zakładowa 8
89-600 Chojnice

INFORMATION INTENDED EXCLUSIVELY FOR MEDICAL PROFESSIONALS:

Medical Oxygen TZF, 99.5%, compressed medical gas
Oxygenium

Special warnings and precautions for use
Careful monitoring of treatment with Medical Oxygen TZF is essential. Oxygen should be administered in such a way as to alleviate hypoxia, but without causing respiratory center depression. Oxygen therapy should always be used whenever there is a risk of hypoxia in patients with chronic lung disease. Before initiating oxygen therapy, arterial CO\ pressure should be assessed via blood gas analysis or by the method of reverse breathing. If the CO\ pressure exceeds 6.6 kPa, 25% oxygen should be administered and its concentration gradually increased, provided that no respiratory depression occurs.

Medical Oxygen TZF should be administered continuously. Intermittent oxygen administration is particularly dangerous, as an increase in alveolar CO\ pressure may further reduce oxygen concentration at the moment when the patient breathes ambient air.

Extreme caution must be exercised when administering oxygen at concentrations above 60% (above 40% in neonates) and during hyperbaric therapy.

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

1. Prior to use, the cylinder should be placed at a temperature of 15–20°C for at least 6 hours.
2. Before attaching the threaded connector of the regulator, briefly open the valve to remove any dust particles.
3. Before mounting the regulator on the cylinder, check the sealing ring of the threaded connector.
4. Mount the regulator onto the cylinder. Slowly open the cylinder valve.
5. Check the manometer to confirm sufficient gas volume remains in the cylinder.
6. Set the flow rate as prescribed by medical personnel using the flowmeter.

Special precautions related to storage: Medical Oxygen TZF, 99.5%, compressed medical gas, may be stored only in cylinders meeting Technical Supervision requirements.

• Oxygen cylinders must be stored in a well-ventilated area, away from sources of heat, flammable gases, and other combustible and oxidizing substances.
• Cylinders must be protected from heating. Open flames must not be used. Valves and connections must be protected from oil and grease.
• Cylinders must be stored and transported at temperatures below 50°C.
• Cylinders secured against overturning must be stored in an upright position.
• Warehouse organization should allow for separation of empty and full cylinders.
• A cylinder should be considered empty when the internal pressure at room temperature drops to 2 bar.