Oxygen medicinal linde
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEDICAL OXYGEN Linde, gas
Oxygenium not less than 99.5%
Please read all of 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 consult your doctor, pharmacist or nurse.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
Table of contents:
- What Medical Oxygen Linde is and what it is used for
- Important information before using Medical Oxygen Linde
- How to use Medical Oxygen Linde
- Possible side effects
- How to store Medical Oxygen Linde
- Contents of the pack and other information
1. What Medical Oxygen Linde is and what it is used for
The indication for oxygen therapy includes all forms of hypoxia. Oxygen therapy is particularly beneficial in patients with normal oxygen consumption.
2. Important information before using Medical Oxygen Linde
Warnings and precautions
Before starting treatment with Medical Oxygen Linde, please discuss it with your doctor.
Medical Oxygen Linde and other medicines
Concurrent treatment with high concentrations of inhaled Medical Oxygen Linde and drugs that may cause pulmonary adverse effects, such as bleomycin (an anticancer drug), may increase the risk of adverse effects associated with Medical Oxygen Linde.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Driving and operating machinery
Not applicable.
3. How to use Medical Oxygen Linde
This medicine should always be used according to the doctor’s instructions. If in doubt, consult your doctor.
Medical Oxygen Linde is usually inhaled via nasal cannulae or a mask. The patient may either breathe spontaneously ("freely breathe") or receive oxygen via a respirator or ventilator.
Always read the instructions for use of the device carefully!
Use of higher than recommended dose of Medical Oxygen Linde
In specific situations, excessive amounts of Medical Oxygen Linde may affect respiratory function and, in exceptional cases, may lead to loss of consciousness or coma.
Prolonged administration of excessive amounts of Medical Oxygen Linde may cause pain, dry cough, and even respiratory arrest.
In case of accidental overdose, seek immediate medical advice from a doctor or hospital.
Safety instructions
- Medical Oxygen Linde is intended exclusively for medical use.
- The cylinder must only be connected to equipment fitted with a connection designed for medical oxygen.
- Medical Oxygen Linde (container and cylinder) must only be used in well-ventilated areas.
- Gas cylinders must not be exposed to high temperatures.
- Smoking or use of open flames is strictly prohibited in rooms where Medical Oxygen Linde is used, as this increases the risk of fire.
- Do not use toasters, hair dryers, or similar electrical appliances during oxygen therapy.
- Never place an oxygen mask or nasal cannula directly on clothing during treatment – fabrics saturated with Medical Oxygen Linde may become highly flammable. If this occurs, thoroughly shake and air out the clothing.
- When the device is not in use, turn it off.
- In case of fire, turn off the device immediately.
- In case of fire hazard, move gas cylinders to a safe location.
- Never use grease, oil, or similar substances to lubricate seizing threads. There is a risk of spontaneous ignition upon contact with high-pressure medical oxygen.
- Open the pressure regulator slowly and carefully.
- Handle the product with care and ensure the gas cylinder is protected from impact and dropping.
- Ensure the cylinder is clean and dry.
- During storage and transport, ensure the valve is closed and the protective cap and cover are in place.
4. Possible side effects
Like all medicines, this product can cause side effects, although not everybody will experience them.
Medical Oxygen Linde may cause adverse effects such as carbon dioxide narcosis with loss of consciousness or subsequent hypoxia caused by sudden administration of pure oxygen. In newborns (especially premature infants), retrolental fibroplasia may occur.
- Oxygen concentration in the incubator should not exceed 40%. When using medical oxygen at concentrations above 70%, oxygen toxicity (Paul Bert effect) may occur, the most characteristic symptom being generalized seizures. Other possible effects include: pulmonary interstitial edema, irritation of the larynx and trachea, nasal mucosa edema, periodic laryngeal pain, cough, bronchitis, ear pain, Eustachian tube blockage, mastoid pain, joint pain, loss of appetite, nausea, vomiting, reduced vital lung capacity, reduced visual field, myopia, cataract, hypersensitivity reactions, and psychological changes.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 improve the safety information available for this medicine.
5. How to store Medical Oxygen Linde
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label affixed to the packaging.
Storage and handling of cylinders
Store away from flammable materials and open flames.
Smoking is prohibited.
Do not expose to high temperatures. In case of fire risk, move to a safe location.
Protect valves from corrosive substances such as ammonia.
Ensure cylinders are not overturned or dropped.
Keep cylinders clean and dry. Do not use oils or greases. Avoid contact with oils and fats.
Store cylinders in areas designated for medical gases.
Store and transport with valves closed.
Store and use only in well-ventilated areas.
In case of leakage or cylinder damage, discontinue use and return to the supplier.
Contact with flammable materials may cause fire. Oxygen intensifies the rate of combustion.
Maintain a minimum residual pressure of 3 bar in the cylinder.
6. Contents of the package and other information
What T M Linde contains
- The active substance in the medicine is 99.5% medical oxygen (chemical symbol O₂).
- The medicine does not contain any other ingredients.
What T M Linde looks like and contents of the pack
T M Linde is a medical gas, compressed or liquefied, supplied in the following containers:
Steel cylinders with a capacity from 0.5 dm³ to 50 dm³;
Aluminium cylinders with a capacity from 2 dm³ to 10 dm³ for compressed gases;
Kevlar-reinforced aluminium cylinders with an "integrated" valve, capacity 4.7 dm³;
Bundles of steel cylinders – 12 cylinders per bundle (each cylinder in the bundle has its own valve, these valves are connected via a common manifold ending with a single gas withdrawal valve);
Cryogenic tanks from 50 kg to 100 tons;
Tanker trucks above 2 tons.
In the case of cylinders, both the cylindrical and hemispherical parts are white, indicating medical oxygen.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Linde Gaz Polska Sp. z o.o.
ul. prof. Michała Życzkowskiego 17
31-864 Kraków
Poland
Manufacturers:
Linde Gaz Polska Sp. z o.o.
ul. Kasprowicza 132
01-949 Warszawa
Poland
Linde Gaz Polska Sp. z o.o.
ul. Żwirowa 4
33-100 Tarnów
Poland
Linde Gaz Polska Sp. z o.o.
ul. Traktorowa 145
91-204 Łódź
Poland
Linde Gaz Polska Sp. z o.o.
ul. Przemysłowa 17
64-000 Kościan
Poland
Linde Gaz Polska Sp. z o.o.
ul. LG 2, Biskupice Podgórne
55-040 Kobierzyce
Poland
Linde Gaz Polska Sp. z o.o.
ul. prof. Michała Życzkowskiego 17
31-864 Kraków
Poland
Linde GmbH Geschaeftsbereich Linde Gas
EKO-Gelaende, Str. 70, Eisenhuettenstadt, Brandenburg, 15890
Germany
For more detailed information, please contact the marketing authorisation holder.
Other sources of information
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – www.urpl.gov.pl
October 2025