Tlen medihni spremzhoni Siad

INFORMATION LEAFLET: INFORMATION FOR THE USER

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

Oxygen

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 tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Compressed Medical Oxygen SIAD contains at least 99.5% v/v of oxygen (Oxygen).
Compressed Medical Oxygen 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 arrest due to injury or after taking medications,
• resuscitation of critically ill patients when blood circulation is impaired,
• resuscitation of newborns.

In many cases, when treating hypoxia, such as:

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

2. Important information before using Compressed Medical Oxygen SIAD

Medical oxygen is prescribed exclusively by a healthcare professional.
Please ensure that this person is aware of any diseases or health conditions that the patient may have.

Warnings and precautions:

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

Compressed Medical Oxygen SIAD and other medicines

Please tell your doctor or pharmacist about all medicines that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take.
The pharmacokinetic action of compressed medical oxygen is modified by changes in the partial pressure of carbon dioxide in the blood, but without significant clinical significance. High
concentrations of oxygen may worsen lung damage caused by toxic factors such as bleomycin, nitrofurantoin. Oxygen at high concentrations can also react, e.g., 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 Compressed Medical Oxygen SIAD

In a hospital or clinic, compressed medical oxygen is administered by a healthcare professional after ensuring that the therapeutic dose of medical oxygen is suitable for the patient and that the equipment has been 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 by tubes.
Always use compressed medical oxygen devices as instructed by a healthcare professional and with the set flow rate. In case of doubts, consult a healthcare professional.

During oxygen therapy, DO NOT SMOKE or be near an open flame. Oxygen will cause a significant increase in flame intensity.

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

Using a higher dose of Compressed Medical Oxygen SIAD than recommended

If the patient follows the instructions of the healthcare professional, in most cases, it is unlikely that an overdose will occur. If the patient feels unwell and is concerned that they have used too much medical oxygen or has any questions about the proper use of medical oxygen, they should consult a healthcare professional.

4. Possible side effects

Like all medicines, Compressed Medical Oxygen SIAD can cause side effects, although not everybody gets them.
Exceptionally, after several hours of exposure to medical oxygen above 3 bar, 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 difficulty breathing,
• body aches,
• nausea.

Uncommon (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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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. Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Compressed Medical Oxygen 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 packaging after the term "Expiry Date". The expiry date refers to the last day of the month stated.
Please follow all recommendations for handling gas cylinders.
Gas cylinders should be stored in well-ventilated areas, protected from rain and direct sunlight. Gas cylinders should be protected from impacts, falls, flammable substances, and petroleum products (oil, grease, etc.), moisture, and heat or ignition sources. Store at a temperature between -30°C and +50°C.
Store in areas designated for storing medical gases. Full and empty gas cylinders must be stored separately.
Transport of gas cylinders
Gas cylinders should be transported using suitable materials that will protect them from hazardous impacts and falls and keep them in a vertical position.
The gas cylinder must be properly closed. Do not completely empty the cylinder to prevent contamination or to identify the gas in the cylinder. A residual pressure of 3 to 5 bar should be maintained in the cylinder.
Keep the cylinder and regulator clean and never use any oils or greases, as they may cause self-ignition.
Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Compressed Medical Oxygen SIAD contains

The active substance of the medicine is oxygen, min. 99.5% v/v.
The medicine does not contain any other excipients.

What Compressed Medical Oxygen SIAD looks like and what the pack contains

Oxygen is a colorless and odorless gas.
The volume of gas in different cylinder sizes filled at a pressure of 200 bar:

Note:
+) The standard valve is a valve without a check valve
The volume of gas in different cylinder sizes filled at a pressure of 150 bar:

Note:
+) The standard valve is a valve without a check valve

Color coding of gas cylinders:

The rounded top of the cylinder is white with two black letters "N" facing each other, the cylindrical part of the cylinder is white.
Not all pack sizes may be marketed.

Marketing authorization holder:

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

Manufacturer:

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

Other sources of information:

To obtain information about Compressed Medical Oxygen SIAD, please contact:

SIAD Czech spol. s r.o.
K Hájům 2606/2b
Praha 5 - Stodůlky
155 00
Czech Republic
Phone: +420 235 097 520
Fax: +420 235 097 525
Date of last revision of the leaflet:December 2021