Tlen medihni Linde

LEAFLET ATTACHED TO THE PACKAGING: INFORMATION FOR THE PATIENT

MEDICAL OXYGEN Linde, gas
Oxygen not less than 99.5%

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is T M Linde medicine and what is it used for
• 2. Important information before using T M Linde medicine
• 3. How to use T M Linde medicine
• 4. Possible adverse reactions
• 5. How to store T M Linde medicine
• 6. Contents of the packaging and other information

1. What is TLEN MEDYCZNY Linde medicine and what is it used for

Indications for oxygen therapy are all forms of hypoxia. Oxygen therapy is particularly beneficial for patients with normal oxygen consumption.

2. Important information before using TLEN MEDYCZNY Linde medicine

Warnings and precautions

Before starting to use T M Linde medicine, you should discuss it with your doctor.

TLEN MEDYCZNY Linde medicine and other medicines

Concomitant treatment with high concentrations of T M Linde medical gas and medicines that may cause adverse reactions in the lungs, such as bleomycin (cancer medicine), may enhance the adverse reactions of T M Linde.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.

Driving and using machines

This is not applicable.

3. How to use TLEN MEDYCZNY Linde medicine

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult your doctor.
T M Linde is usually inhaled through nasal tubes or a mask. You should either inhale the medicine on your own - "breathing freely" or with the help of a respirator or ventilator.
You should carefully read the instructions for the device being used!

Using a higher dose of TLEN MEDYCZNY Linde medicine than recommended

In specific situations, too much T M Linde may affect the functioning of the respiratory system, and in exceptional cases, may cause loss of consciousness or coma.
Using T M Linde in excessive quantities for a long time may cause pain, dry cough, and even respiratory arrest.
In case of overdose, you should always consult a doctor or hospital.

Safety instructions

• T M Linde is intended exclusively for medical use.
• The cylinder should only be connected to a device equipped with a connection intended for medical oxygen.
• T M Linde (cylinder and bottle) can only be used in well-ventilated rooms.
• Gas cylinders must not be exposed to high temperatures.
• In rooms where T M Linde is used, smoking or using open fire is prohibited, as it increases the risk of fire.
• You should not use toasters, hair dryers, or similar electrical appliances while taking T M Linde.
• While taking the medicine, you should never place the oxygen mask or nasal tubes directly on clothing - materials soaked with T M Linde can become highly flammable. If this happens, you should thoroughly shake and ventilate your clothes.
• When the device is not in use, it should be turned off.
• In case of a fire - the device should be turned off.
• In case of a fire hazard, gas cylinders should be moved to a safe place.
• You should never use grease, oil, or similar substances to lubricate jammed threads. There is a risk of self-ignition when in contact with medical oxygen under high pressure.
• The pressure regulator should be opened slowly and carefully.
• You should handle the medicine with care and ensure that the gas cylinder is not exposed to impacts and drops.
• You should ensure that the cylinder is clean and dry.
• When storing and transporting, you should ensure that the valve is closed and the protective cap and cover are in place.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
T M Linde may cause adverse reactions such as carbon dioxide narcosis with loss of consciousness or hypoxia (oxygen deficiency) caused by the sudden administration of pure oxygen. In newborns (especially premature babies), retinopathy of prematurity may occur

• the oxygen concentration in the incubator should not exceed 40%. When using medical oxygen with a concentration above 70%, oxygen poisoning (Paul Bert effect) may occur, and the most characteristic symptom is generalized convulsions. Additionally, the following may occur: pulmonary atelectasis, irritation of the larynx and trachea, swelling of the nasal mucosa, periodic laryngeal pain, cough, bronchitis, ear pain, blockage of the Eustachian tube, costal pain, joint pain, loss of appetite, nausea, vomiting, decreased lung vital capacity, decreased visual field, myopia, cataract, hypersensitivity, and psychological changes.

Reporting adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions 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:
Jerozolimskie Avenue 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 can help gather more information on the safety of the medicine.

5. How to store TLEN MEDYCZNY Linde medicine

The medicine should be stored out of sight and out of reach of children.
You should not use this medicine after the expiry date stated on the label attached to the packaging.

Storage and handling of cylinders

Store away from flammable materials and open fire.
Smoking is prohibited.
Do not expose to high temperatures. If there is a risk of fire, move to a safe place.
Protect valves from corrosion-causing substances, such as ammonia.
Ensure that the cylinder is not overturned or dropped.
Keep the cylinder clean and dry, do not use oils and greases. Do not allow contact with greases and fats.
Cylinders should be stored in a place designated for medical gases.
Store and transport with closed valves.
Store and use only in well-ventilated rooms.
In case of leakage or cylinder damage, set aside and return to the supplier.
Contact with flammable materials can cause a fire. It increases the burning rate.
Leave a minimum pressure of 3 bar in the cylinder.

6. Contents of the packaging and other information

What T M Linde medicine contains

• The active substance of the medicine is 99.5% medical oxygen (chemical symbol O)
• The medicine does not contain any other ingredients.

What T M Linde medicine looks like and what the packaging contains

T M Linde is a medical gas, compressed or liquid, in packaging:
Steel cylinders with a capacity of 0.5 dm to 50 dm;
Aluminum cylinders with a capacity of 2 dm to 10 dm for compressed gases;
Aluminum cylinders reinforced with kevlar with an "integrated" valve with a capacity of 4.7 dm;
Bundles of steel cylinders - 12 cylinders in a bundle (each cylinder in the bundle has its own valve, and the valves are connected to a common collector with one gas intake valve);
Cryogenic containers from 50 kg to 100 tons;
Tankers over 2 tons.
In the case of cylinders, both the cylindrical and spherical parts are white, which indicates medical oxygen.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Linde Gaz Polska Sp. z o. o.
ul. prof. Michała Życzkowskiego 17
31-864 Kraków

Manufacturer:

Linde Gaz Polska Sp. z o. o.
ul. Kasprowicza 132
01-949 Warszawa
Linde Gaz Polska Sp. z o. o.
ul. Żwirowa 4
33-100 Tarnów
Linde Gaz Polska Sp. z o. o.
ul. Traktorowa 145
91-204 Łódź
Linde Gaz Polska Sp. z o. o.
ul. Przemysłowa 17
64-000 Kościan
Linde Gaz Polska Sp. z o. o.
ul. LG 2, Biskupice Podgórne
55-040 Kobierzyce
Linde Gaz Polska Sp. z o.o.
Al. Jerozolimskie 142B
02-305 Warszawa
Linde Gaz Polska Sp. z o. o.
ul. prof. Michała Życzkowskiego 17
31-864 Kraków
Linde GmbH Geschaeftsbereich Linde Gas
EKO-Gelaende, Str. 70, Eisenhuettenstadt, Brandenburg, 15890
Germany
To obtain more detailed information, you should contact the marketing authorization holder.

Other sources of information

Detailed information about this medicine can be found on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products - www.urpl.gov.pl

Date of the last update of the leaflet:

December 2021