Oxygen medicinal liquefied siad

PACKAGE LEAFLET: INFORMATION FOR THE USER

SIAD Medical Liquid Oxygen, 99.5% v/v, liquefied medicinal gas
Oxygenium
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 or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Contents of the leaflet

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

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

SIAD Medical Liquid Oxygen is a gas liquefied at very low temperatures and
containing at least 99.5% v/v oxygen (Oxygenium).
SIAD Medical Liquid Oxygen is used as a supplementary source of oxygen in the treatment of the following conditions:
As part of anaesthesia (general anaesthesia) and intensive care, such as:

• pre- and post-operative care,
• treatment of acute cardiac and respiratory arrest due to trauma or drug overdose,
• resuscitation of critically ill patients when blood circulation is impaired,
• neonatal resuscitation.

In many cases during treatment of hypoxia, such as:

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

2. Important information before using Medical Liquid Oxygen SIAD

Medical Liquid Oxygen SIAD is prescribed solely by a healthcare professional.
Ensure that the healthcare provider is aware of any medical conditions or health-related issues 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;
• when medical oxygen has been administered in a hyperbaric chamber at an operating pressure exceeding 3 bar, the dose should be limited to 3 hours.

Medical Liquid Oxygen SIAD and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to take.
The pharmacokinetic action of Medical Liquid Oxygen SIAD is modified by changes in partial carbon dioxide pressure in blood, but without clinically significant consequences. High oxygen concentration may worsen lung damage caused by toxic agents such as bleomycin, nitrofurantoin. High concentrations of oxygen may also react, for example, with NO, forming NO and other nitrogen oxides (NO ).
Pregnancy, breastfeeding and fertility
Women who are pregnant or breastfeeding may also use medical oxygen.
Driving and operating machinery
The use of medical oxygen does not impair the ability to drive or operate machinery. However, in cases requiring continuous oxygen administration, the ability to drive or operate machinery must be confirmed by a physician.
3. How to use Medical Liquid Oxygen SIAD
Medical Liquid Oxygen SIAD is administered only after being converted into Compressed Medical Oxygen SIAD at room temperature.
In a hospital or clinic, Medical Liquid Oxygen SIAD is administered by a healthcare professional after confirming that the therapeutic dose of liquid medical oxygen is appropriate for the patient and that the equipment has been correctly set up to deliver the required amount of oxygen.
For oxygen inhalation, a mask or nasal cannula is used. The ends of the cannula are inserted into the nostrils, the tubing is placed over the ears and adjusted under the chin for comfort. The face mask or nasal cannula is connected via tubing to the provided oxygen set.
Always use medical liquid oxygen devices as instructed by a healthcare professional and at the prescribed flow rate. In case of doubt, consult a healthcare professional.
During oxygen therapy, DO NOT SMOKE or be near open flames. Oxygen will greatly increase flame intensity.
When using oxygen equipment, NEVER use oil-based moisturizing creams.
Use of more than the recommended dose of Medical Liquid Oxygen SIAD
If the patient follows the healthcare professional's instructions, overdose is unlikely in most cases. If experiencing discomfort or if concerned about having used too much medical oxygen, or if there are any questions regarding proper use of oxygen, consult a healthcare professional.

4. Possible adverse reactions

Like all medicines, Tlen medyczny skroplony SIAD may cause adverse reactions, although they do not occur in
everyone.
Exceptionally, after several hours of exposure to medical oxygen above 3 bar, the following adverse reactions may occur:
Very rare (affects fewer than 1 person in 10,000)

• in newborns exposed to high oxygen concentrations, retinal damage may occur, possibly leading to subsequent retinal detachment and blindness,
• muscle spasms, loss of consciousness,
• disorientation,
• chest pain associated with cough and breathing difficulties,
• pain in body cavities,
• nausea.

Not very common (affects fewer than 1 person in 1,000)

• painful and unpleasant feeling of pressure in the ears,
• pleuritis,
• sensation of lack of air in the lungs.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department for 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, e-
mail: [email protected]. Reporting adverse reactions allows more information to be collected on the safety of the medicine.
Adverse reactions can also be reported to the responsible entity.

5. How to store Tlen medyczny skroplony SIAD

The medicinal product should be stored out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the container label or in the quality certificate of the tank, or in the special Certificate 2.3 according to EN 10204, following the designation "Expiry date". The expiry date refers to the last day of the stated month.

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

Storage of portable cryogenic containers
Store portable cryogenic containers in a well-ventilated area designated for storage of medicinal gases.
Store portable cryogenic containers under cover, in a dry and clean condition. Protect them from flammable materials and store at temperatures between
-30°C and +50°C.

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

Transport of portable cryogenic containers
During transport by trucks, containers must be secured with straps to prevent falling.

Do not dispose of medicinal products via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the packaging and other information

What Tlen medyczny skroplony SIAD contains
The active substance is oxygen, min. 99.5% v/v.
The product does not contain any other ingredients.
What Tlen medyczny skroplony SIAD looks like and contents of the packaging
Oxygen is a colourless and odourless gas; in liquid form it is pale blue.
Tlen medyczny skroplony SIAD is supplied as a liquid product in bulk in tankers or in portable cryogenic vessels.
The tanker is made of stainless steel, thermally insulated, designed for storage and transport of the contents in liquid form, equipped with valves made of steel and brass.
The portable cryogenic vessel is made of austenitic steel, thermally insulated, designed for transport and storage of the contents in liquid form, equipped with valves made of brass.
Dimensions of the vessels used:

Warning: 1 kg of liquid oxygen yields 748 L of gas when vaporized at a temperature of 15°C and at a pressure of 1013 hPa.
Not all package sizes may be marketed.
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
For information on the medicinal product Tlen medyczny skroplony 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