Tlen medihni skroploni Siad

INFORMATION LEAFLET: INFORMATION FOR THE USER

Medical Oxygen Liquid SIAD, 99.5% v/v, Medical Gas Liquid

Oxygenium

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

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Medical Oxygen Liquid SIAD and what is it used for

Medical Oxygen Liquid SIAD is a liquid gas at very low temperatures and contains at least 99.5% oxygen by volume (Oxygenium).
Medical Oxygen Liquid SIAD is used as a supplementary source of oxygen in the treatment of the following conditions:
As part of anesthesia (general anesthesia) and intensive care, such as:

• pre- and post-operative care,
• treatment of sudden cardiac and respiratory arrests due to injuries or medication overdose,
• resuscitation of critically ill patients with impaired blood circulation,
• resuscitation of newborns.

In many cases, when treating hypoxia, such as:

• severe heart and lung diseases,
• shock, severe bleeding,
• blockage of coronary vessels,
• carbon monoxide poisoning,
• high fever (40-41°C).

2. Important information before using Medical Oxygen Liquid SIAD

Medical Oxygen Liquid SIAD is prescribed exclusively by a healthcare professional.
Please ensure that the healthcare professional is aware of any diseases or health conditions the patient may have.

Warnings and precautions:

• in premature infants and elderly patients with chronic bronchitis, when it is necessary to control the flow rate of medical oxygen,
• in cases where medical oxygen is used in a hyperbaric chamber at a working pressure above 3 bars, the dose should be limited to 3 hours.

Medical Oxygen Liquid SIAD and other medicines

Please inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The pharmacokinetic action of Medical Oxygen Liquid SIAD is modified by changes in the partial pressure of carbon dioxide in the blood, but without significant clinical significance. High concentrations of oxygen can worsen lung damage caused by toxic factors such as bleomycin, nitrofurantoin. Oxygen at high concentrations can also react with NO, resulting in the formation of NO and other nitrogen oxides (NO).

Pregnancy, breastfeeding, and fertility

Pregnant or breastfeeding women can also use medical oxygen.

Driving and using machines

Using medical oxygen does not limit the ability to drive vehicles or operate machinery.
In cases where continuous oxygen supply is required, the ability to drive vehicles or operate machinery must be confirmed by a doctor.

3. How to use Medical Oxygen Liquid SIAD

Medical Oxygen Liquid SIAD is administered only after it has been converted to Medical Oxygen Compressed SIAD at room temperature.
In a hospital or clinic, Medical Oxygen Liquid SIAD is administered by a healthcare professional after ensuring that the therapeutic dose of medical oxygen is suitable for the patient and that the equipment is properly set up to deliver the correct amount of oxygen.
To inhale oxygen, a mask or nasal catheter is used. The catheter tips are inserted into the nostrils, the tubes are placed over the ears, and adjusted under the neck for comfort. The face mask or nasal catheter is connected to the oxygen supply system using tubes. Always use medical oxygen equipment as instructed by the healthcare professional and with the set flow rate. In case of doubts, consult a healthcare professional.

During oxygen therapy, DO NOT SMOKE or stay near an open flame. Oxygen will significantly increase the intensity of the flame.

When using equipment, NEVER use oil-based moisturizing creams.

Using a higher dose of Medical Oxygen Liquid SIAD than recommended

If the patient follows the healthcare professional's instructions, it is unlikely that an overdose will occur. In case of discomfort and resulting concerns that too much medical oxygen has been used, or if there are any questions about the proper use of medical oxygen, consult a healthcare professional.

4. Possible side effects

Like all medicines, Medical Oxygen Liquid SIAD can cause side effects, although they may not occur in everyone.
Exceptionally, after several hours of exposure to medical oxygen above 3 bars, the following side effects may occur:
Very rare (occurs in less than 1 in 10,000 people)

• in newborns exposed to high concentrations of oxygen, retinal damage may occur with possible later retinal detachment and blindness,
• muscle spasms, loss of consciousness,
• disorientation,
• chest pain associated with coughing and breathing difficulties,
• body aches,
• nausea.

Not very common (occurs in less than 1 in 1,000 people)

• painful and unpleasant feeling of pressure in the ears,
• pleurisy,
• feeling of shortness of breath in the lungs.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, please inform your doctor or pharmacist 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, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl. By reporting side effects, more information can be gathered on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Medical Oxygen Liquid SIAD

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label on the tank or in the certificate of quality of the tank, special Certificate 2.3 in accordance with EN 10204, after the term "Expiry Date". The expiry date refers to the last day of the specified month.

Storage of tanks

Do not expose the tank to temperatures below -30°C and above +50°C.
Store away from flammable materials. Protect from static electricity, oils, greases, and other organic and flammable substances. During the operation of the tank, it should be at least 5 meters away from open flame sources.

Storage of portable cryogenic containers

Store the portable cryogenic container in a well-ventilated area designated for the storage of medicinal gases.
Portable cryogenic containers should be stored in a covered area, the containers should be dry and clean, and protected from flammable materials, stored at a temperature between -30°C and +50°C.

• between -30°C and +50°C.

Protect from static electricity, greases, oils, and other organic and flammable materials.
Measures should be taken to prevent shocks and falls.

Transport of portable cryogenic containers

During transport by truck, the containers should be secured with straps to protect against falling.
Medicines should not be disposed of via wastewater or household waste containers. Please ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Medical Oxygen Liquid SIAD contains

The active substance is oxygen, min. 99.5% v/v.
The product does not contain any other ingredients.

What Medical Oxygen Liquid SIAD looks like and what the packaging contains

Oxygen is a colorless and odorless gas; in a liquid state, it is light blue.
Medical Oxygen Liquid SIAD is supplied as a liquid product in bulk in tanks or portable cryogenic containers.
The tank is made of stainless steel, thermally insulated, designed for storage and transport of the contents in a liquid state, equipped with valves made of steel and brass.
The portable cryogenic container is made of austenitic steel, thermally insulated, designed for transport and storage of the contents in a liquid state, equipped with valves made of brass.
Dimensions of the containers used:

Note: 1 kg of liquid oxygen gives 748 liters of gas at 15°C and 1013 bar pressure.
Not all packaging sizes may be available.

Marketing authorization holder:

SIAD Czech spol. s r.o.
K Hájům 2606/2b
Praha 5 - Stodůlky
155 00
Czech Republic
Tel.: +420 235 097 520
Fax: +420 235 097 525

Manufacturer:

SIAD Czech spol. s r.o.
U Sýpky 417
664 61 Rajhradice
Czech Republic

Other sources of information

To obtain information about the medicine Medical Oxygen Liquid SIAD, please contact:

SIAD Czech spol. s r.o.
K Hájům 2606/2b
Praha 5 - Stodůlky
155 00
Czech Republic
Tel.: +420 235 097 520
Fax: +420 235 097 525
Date of last update of the leaflet:04/2023