Oxygen medical compressed siad

Poland
Brand name Oxygen medical compressed siad
Form gas, compressed medical
Active substance / Dosage
Oxygen · 99.5 %
Prescription type Hospital use only
ATC code
V03AN01
Registration number 100347717
Manufacturer SIAD Czech s.r.o.
Oxygen medical compressed siad gas, compressed medical

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

Compressed Medical Oxygen SIAD, 99.5% v/v, compressed medical gas
Oxygenium
Please read carefully the entire leaflet 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 questions, please consult your doctor or pharmacist.
  • This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Leaflet Contents

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

Compressed Medical Oxygen SIAD contains at least 99.5% v/v oxygen (Oxygenium).
Compressed Medical Oxygen SIAD 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 with impaired blood circulation,
  • 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 Compressed Medical Oxygen SIAD

Compressed medical oxygen is prescribed exclusively by a healthcare professional.
Ensure that the healthcare provider is aware of any medical conditions or health-related factors 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.
  • when medical oxygen has been administered in a hyperbaric chamber operating at a working pressure exceeding 3 bar, the dose should be limited to 3 hours.

Compressed Medical Oxygen SIAD and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
The pharmacokinetic effect of compressed medical oxygen is modified by changes in arterial partial pressure of carbon dioxide, but without clinically significant consequences. High concentrations of oxygen may worsen lung injury caused by toxic agents such as bleomycin and nitrofurantoin. High concentrations of oxygen may also react, for example, with NO, forming NO and other nitrogen oxides (NOx).
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 where continuous oxygen therapy is required, the ability to drive or operate machinery must be confirmed by a physician.

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 oxygen dose is appropriate for the individual patient and that
the equipment has been correctly set up to deliver the required amount of oxygen.
To inhale oxygen, 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 at the back of the neck for comfort. A face mask
or nasal cannula is connected via tubing to the provided oxygen delivery system.
Always use compressed medical oxygen devices exactly as demonstrated by a healthcare professional
and at the prescribed flow rate. If in doubt, consult a healthcare professional.
DO NOT SMOKE CIGARETTES OR BE NEAR AN OPEN FLAME DURING OXYGEN THERAPY.
OXYGEN WILL SIGNIFICANTLY INCREASE THE INTENSITY OF FLAMES.
WHEN USING OXYGEN EQUIPMENT, NEVER USE OIL-BASED MOISTURISING CREAMS.
Use of a higher than recommended dose of Compressed Medical Oxygen SIAD
If the patient follows the healthcare professional's instructions, overdose is unlikely in most cases.
If experiencing discomfort or having concerns about having received too much medical oxygen,
or if there are any questions regarding the proper use of oxygen, consult a healthcare professional.

4. Possible adverse reactions

Like all medicinal products, compressed medical oxygen SIAD may cause adverse reactions, although
not everyone experiences them.
Exceptionally, after several hours of exposure to medical oxygen at pressures above 3 bar, the following
adverse reactions may occur:
Very rare (affects less than 1 in 10,000 people):

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

Uncommon (affects less than 1 in 1,000 people):

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

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions
at 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]. Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to enhance the safety information regarding the use of this medicinal product.

5. How to store Compressed Medical Oxygen SIAD

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the term
"Expiry date". The expiry date refers to the last day of the specified month.
All instructions regarding handling of gas cylinders must be observed.
Gas cylinders must be stored in adequately ventilated areas, protected from rain and direct sunlight.
Gas cylinders must be protected from impacts, falls, flammable substances and petroleum products (oil, grease, etc.),
moisture, and sources of heat or ignition. Store at temperatures between -30°C and +50°C.
Store in rooms designated for the storage of medicinal gases. Full and empty gas cylinders must be stored separately.
Transport of compressed gas cylinders
Gas cylinders must be transported using appropriate materials that protect them from hazardous shocks and falls, and keep them in an upright position.
The gas cylinder must be securely closed. Do not completely empty the cylinder to prevent contamination or to allow gas identification. Maintain a residual pressure in the cylinder of 3 to 5 bar.
Keep the cylinder and regulator clean, and never use any oils or greases, as they may cause spontaneous ignition.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the package and other information

What Tlen medyczny sprężony SIAD contains
The active substance is oxygen, min. 99.5% vol.
The medicine does not contain any other excipients.
What Tlen medyczny sprężony SIAD looks like and contents of the pack
Oxygen is a colourless and odourless gas.
Gas volume in cylinders of various sizes filled at a pressure of 200 bar:

Water capacity
of cylinder in liters		Gas volume
in liters (at
temperature
15 °C and pressure
1.013 bar)		Material of
the cylinder		Type of
closing valve		Material of
the valve
2 l430SteelStandard +) with
threaded side
connection W 21.8
x 1/14''		Chromed brass
2 l430SteelRPV with
threaded side
connection W 21.8
x 1/14''		Chromed brass
2 l430SteelStandard +) with
threaded side
connection G
3/4''		Chromed brass
2 l430SteelRPV with
threaded side
connection G
3/4''		Chromed brass
2 l430AluminiumIntegrated with
check valve and
built-in pressure
and flow rate
regulator		Nickel-plated brass
3 l675SteelStandard +) withChromed
threaded side
connection W 21.8
x 1/14''		brass
3 l675SteelRPV with
threaded side
connection W 21.8
x 1/14''		Chromed brass
3 l675SteelStandard +) with
threaded side
connection G
3/4''		Chromed brass
3 l675SteelRPV with
threaded side
connection G
3/4''		Chromed brass
5 l1 080SteelStandard +) with
threaded side
connection W 21.8
x 1/14''		Chromed brass
5 l1 080SteelRPV with
threaded side
connection W 21.8
x 1/14''		Chromed brass
5 l1 080SteelStandard +) with
threaded side
connection G
3/4''		Chromed brass
5 l1 080SteelRPV with
threaded side
connection G
3/4''		Chromed brass
10 l2 160SteelStandard +) with
threaded side
connection W 21.8
x 1/14''		Chromed brass
10 l2 160SteelRPV with
threaded side
connection W 21.8
x 1/14''		Chromed brass
10 l2 160SteelStandard +) with
threaded side
connection G
3/4''		Chromed brass
10 l2 160SteelRPV with
threaded side
connection G
3/4''		Chromed brass
10 l2 160SteelIntegrated with
check valve and
built-in pressure
and flow rate
regulator		Nickel-plated brass
20 l4 320SteelStandard +) with
threaded side
connection W 21.8
x 1/14''		Chromed brass
20 l4 320SteelRPV with
threaded side
connection W 21.8
x 1/14''		Chromed brass
20 l4 320SteelStandard +) with
threaded side
connection G
3/4''		Chromed brass
20 l4 320SteelRPV with
threaded side
connection G
3/4''		Chromed brass
40 l8 640SteelStandard +) with
threaded side
connection W
21.8 x 1/14''		Chromed brass
40 l8 640SteelRPV with
threaded side
connection W
21.8 x 1/14''		Chromed brass
40 l8 640SteelStandard +) with
threaded side
connection G
3/4''		Chromed brass
40 l8 640SteelRPV with
threaded side
connection G
3/4''		Chromed brass
50 l10 800SteelStandard +) with
threaded		Chromed brass
side connection W
21.8 x 1/14''
50 l10 800SteelRPV with
threaded side
connection W
21.8 x 1/14''		Chromed brass
50 l10 800SteelStandard +) with
threaded side
connection G
3/4''		Chromed brass
50 l10 800SteelRPV with
threaded side
connection G
3/4''		Chromed brass
16 x 50 l
(cylinder bundle)		172 800Steel (cylinder
connection–stainless
steel)		Standard +) with
threaded side
connection W 21.8
x 1/14''		Chromed brass
16 x 50 l
(cylinder bundle)		172 800Steel (cylinder
connection–stainless
steel)		Standard +) with
threaded side
connection G
3/4''		Chromed brass

Note:
+) The standard closure valve is a valve without a non-return valve
Gas volume in cylinders of various sizes filled at a pressure of 150 bar:

Water capacity
of cylinder in liters		Gas volume
in liters (at
15 °C and
1.013 bar pressure)		Material of
cylinder construction		Type of closure
valve		Material of
valve construction
2 l320SteelStandard+) with side
connection thread G 3/4´´		Chromed brass
2 l320SteelRPV with side
connection thread
G 3/4´´		Chromed brass
2 l320SteelStandard+) with side
connection thread
W 21.8 x 1/14''		Chromed brass
2 l320SteelRPV with side
connection thread
W 21.8 x 1/14''		Chromed brass
2 l320AluminiumIntegrated with check
valve and built-in
pressure and flow rate
regulator		Nickel-plated brass
3 l500SteelStandard+) with side
connection thread G 3/4´´		Chromed brass
3 l500SteelRPV with side
connection thread
G 3/4´´		Chromed brass
3 l500SteelStandard+) with side
connection thread
W 21.8 x 1/14''		Chromed brass
3 l500SteelRPV with side
connection thread
W 21.8 x 1/14''		Chromed brass
5 l810SteelStandard+) with side
connection thread G 3/4´´		Chromed brass
5 l810SteelRPV with side
connection thread
G 3/4´´		Chromed brass
5 l810SteelStandard+) with side
connection thread
W 21.8 x 1/14''		Chromed brass
5 l810SteelRPV with side
connection thread
W 21.8 x 1/14''		Chromed brass
10 l1 620SteelStandard+) with side
connection thread G 3/4´´		Chromed brass
10 l1 620SteelRPV with side
connection thread
G 3/4´´		Chromed brass
10 l1 620SteelStandard+) with side
connection thread
W 21.8 x 1/14''		Chromed brass
10 l1 620SteelRPV with side
connection thread
W 21.8 x 1/14''		Chromed brass
10 l1 620SteelIntegrated with check
valve and built-in
pressure and flow rate
regulator		Nickel-plated brass
20 l3 240SteelStandard+) withChromed
side connection thread
G 3/4´´		brass
20 l3 240SteelRPV with side
connection thread
G 3/4´´		Chromed brass
20 l3 240SteelStandard+) with side
connection thread
W 21.8 x 1/14''		Chromed brass
20 l3 240SteelRPV with side
connection thread
W 21.8 x 1/14''		Chromed brass
40 l6 480SteelStandard+) with side
connection thread G 3/4´´		Chromed brass
40 l6 480SteelRPV with side
connection thread
G 3/4´´		Chromed brass
40 l6 480SteelStandard+) with side
connection thread
W 21.8 x 1/14''		Chromed brass
40 l6 480SteelRPV with side
connection thread
W 21.8 x 1/14''		Chromed brass
50 l8 100SteelStandard+) with side
connection thread G 3/4´´		Chromed brass
50 l8 100SteelRPV with side
connection thread
G 3/4´´		Chromed brass
50 l8 100SteelStandard+) with side
connection thread
W 21.8 x 1/14''		Chromed brass
50 l8 100SteelRPV with side
connection thread
G 3/4´´		Chromed brass
16 x 50 l
(cylinder bundle)		129 600Steel
(cylinder connection–stainless steel)		Standard+) with side
connection thread G 3/4´´		Chromed brass
16 x 50 l
(cylinder bundle)		129 600Steel
(cylinder connection–stainless steel)		Standard+) with side
connection thread
W 21.8 x 1/14''		Chromed brass

Note:
+) The standard closing valve is a valve without a non-return valve.
Gas cylinder colour coding:
The rounded upper part of the cylinder is white with two black letters "N" placed opposite each other; the cylindrical part of the cylinder is white.
Not all package sizes may be marketed.
Marketing Authorisation 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.
K Hájům 2606/2b
Praha 5 - Stodůlky
155 00
Czech Republic
Tel.: +420 235 097 520
Fax: +420 235 097 525
Other sources of information:
For information on the medicinal product Tlen medyczny sprężony SIAD, 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