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Medicinsk Oxygen Yara Praxair

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1. NAME OF THE MEDICINAL PRODUCT


Medicinal oxygen Yara Praxair100 %, medicinal gas, compressed


2. QUALITATIVE AND QUANTITATIVE COMPOSITION


Oxygen 100 % at a pressure of 200 bar (15°C).


3. PHARMACEUTICAL form


Medicinal gas, compressed

Colourless, odourless and tasteless


4. Clinical particulars


4.1 Therapeutic indications


Oxygen therapy

- For treatment or prevention of acute and chronic hypoxia irrespective of cause.

- As part of the fresh gas flow in anaesthesia or intensive care.

- As the propellant in nebuliser treatment.

- For treatment of an acute attack of cluster headache.


Hyperbaric oxygen therapy

For treatment of decompression sickness, air/gas emboli from other causes and carbon

monoxide poisoning. Treatment of patients who have been exposed to carbon monoxide is

especially indicated in pregnant patients or patients who are or have been unconscious, or

who have displayed neurological symptoms and/or cardiovascular effects or severe acidosis,

irrespective of the measured COHb value.


As adjunct treatment in:

severe osteoradionecrosis, clostridium myonecrosis (gas gangrene).


4.2 Posology and method of administration


Oxygen therapy

Oxygen is administered via the inspiratory air.


Oxygen can also be supplied through a so-called ‘oxygenator’ directly to the blood in cases

of, among other things, cardiac surgery with a heart-lung machine, and in other conditions

that require extracorporeal circulation.


Oxygen is administered by means of equipment intended for this purpose. With this

equipment, the oxygen is supplied to the inspiratory air, and, on expiration, the exhaled gas

with any excess of oxygen, passes from the patient and is mixed with the surrounding air

(non-rebreathing system). For treatment of cluster headache, oxygen is to be delivered by a

facemask, in a non re-breathing system.


For anaesthesia, special equipment is often used in which the exhaled gas recirculates and

can, in part, be re-inhaled (circular system with rebreathing).

There are a large number of devices intended for oxygen administration.


Low-flow system:

The simplest system, which mixes oxygen with the inhaled air, e.g. a system in which the

oxygen is dosed via a simple rotameter and a nasal catheter or face mask.


High-flow system:

System intended to supply a gas mixture corresponding to the patient’s breath. This system is

intended to produce a fixed oxygen concentration that is not affected or diluted by the

surrounding air, e.g. Venturimask with a constant oxygen flow in order to give a fixed oxygen

concentration in the inhaled air.


Hyperbaric oxygen therapy:

Hyperbaric oxygen therapy (HBO) is given in specially constructed pressurised chambers

intended for hyperbaric oxygen therapy, in which pressures up to the equivalent of

3 atmospheres (atm) can be maintained. HBO can also be given via a very tightly fitting

facemask, a hood that fits around the head, or through a tracheal tube.


Dosage

Oxygen therapy

The aim of treatment is to ensure, by adjusting the oxygen fraction in the inhaled air (FiO2),

that the oxygen partial pressure in arterial blood (PaO2) does not fall below 8.0 kPa

(60 mmHg) or that the oxygen saturation of haemoglobin in arterial blood does not fall below

90 %.


The dose (FiO2) must be adjusted according to each patient’s individual needs, taking into

account the risk of oxygen toxicity. A general recommendation is to use the lowest dose

(FiO2) necessary to achieve the desired result of treatment. In cases of pronounced hypoxia,

oxygen fractions that can involve a risk of oxygen toxicity may be indicated. (See section

4.9).


The treatment must be continuously evaluated and the effect measured by means of PaO2or

arterial oxygen saturation (SpO2).


In short-term treatment with oxygen, the oxygen concentration - the fraction in the inhaled gas

mixture (FiO2) (avoid >0.6 = 60 % O2in the inhaled gas mixture) - must be kept so that, with

or without positive end-expiratory pressure (PEEP) or continuous positive airway pressure

(CPAP), an arterial oxygen pressure (PaO2) > 8 kPa can be achieved.


Short-term treatment with oxygen must be monitored/followed with the aid of repeated

measurements of arterial oxygen pressure (PaO2) or pulse oximetry, which gives a numerical

value for haemoglobin oxygen saturation (SpO2). However, these are only indirect

measurements of the oxygen saturation in tissues. The effect of the treatment should also be

evaluated clinically.

In the emergency/acute setting the usual dose for adults to treat or prevent acute oxygen

deficiency is 3-4 litres per minute when using nasal prongs, or 5-15 litres per minute with a

mask.


In long-term treatment, the need for extra oxygen is guided by the result of arterial blood gas

measurements. For adjusting oxygen therapy in patients with hypercapnia, blood gases must

be monitored in order to avoid a marked increase in arterial carbon dioxide tension.


If the oxygen is mixed with other gases, the concentration of oxygen in the inhaled gas

mixture (FiO2) must not be lower than 21 % and may be up to 100 %.

Neonates may be given up to 100 % oxygen if required. However, treatment must be strictly

monitored, so that the oxygen concentration can be reduced rapidly when the patient´s

condition so allows. A general recommendation is to avoid oxygen concentrations that exceed

40 % in order to reduce the risk of damage to the ocular lens and the formation of atelectasis.


For treatment of cluster headache, oxygen is to be delivered by a facemask, in a non rebreathing

system. Oxygen therapy should be instituted early after onset of the attack and

should last for about 15 minutes or until the pain has disappeared. Usually a flow of 7 to 10

l/min is sufficient but a flow up to 15 l/min might be necessary to some patients to reach

efficacy. Oxygen should be discontinued if no effect occurs after 15 to 20 minutes.


Hyperbaric oxygen therapy

Hyperbaric oxygen therapy (HBO) involves administering 100 % oxygen at a pressure

exceeding 1.4 times atmospheric pressure at sea level (1 atmosphere = 101.3 kPa =

760 mmHg). For safety reasons the pressure in HBO should not exceed 3 atmospheres. The

duration of one treatment session with HBO at a pressure corresponding to 2 to 3 atm is

normally between 60 minutes and 4–6 hours, depending on the indication. Treatments may be

repeated 2–3 times daily if necessary, depending on the indication and the clinical condition.

Repeated treatments are most often necessary for the treatment of soft tissue infections and

ischaemic ulcers that do not respond to conventional therapy. HBO must be given by

personnel who are competent to do so. Increasing and reducing the pressure must be done

slowly in order to avoid the risk of pressure damage (barotrauma).


4.3 Contraindications


None known.


4.4 Special warnings and precautions for use


High oxygen concentrations should be given for the shortest possible time required to achieve

the desired result, and must be monitored with repeated checks of arterial gas pressure (PaO2)

or haemoglobin oxygen saturation (SpO2) and the inhaled oxygen concentration (FiO2).


There is evidence in the literature that the risk of oxygen toxicity can be considered negligible

if the treatment follows these guidelines:

• Oxygen in concentrations up to 100 % (FiO21.0) should not be given for more than 6

hours

• Oxygen in concentrations above 60–70 % (FiO20.6–0.7) should not be given for more

than 24 hours

• Oxygen in concentrations above 40–50 % (FiO20.4–0.5) should not be given during the

next 24 hours.

• Oxygen concentrations > 40 % (FiO2> 0.4) can potentially cause damage after 2 days.

These general guidelines are not applicable to premature infants on account of the risk of

retrolental fibroplasia, which has been described from the use of lower oxygen

concentrations.


Special care must be observed when treating neonates and premature infants. To minimise the

risk of ocular damage, retrolental fibrosis, and/or other negative effects, the aim must be to

keep the concentration to the absolute lowest that gives the desired result and avoid large

variations in the arterial oxygen pressure.


With high concentrations of oxygen in the inspiratory air/gas, the concentration/pressure of

nitrogen is reduced. As a result, the concentration of nitrogen in tissues and lungs (the alveoli)

falls. If oxygen is taken up from the alveoli into the blood more rapidly than it is supplied in

the inspiratory gas, alveolar collapse can occur (development of atelectasis). The development

of atelectatic sections of the lungs leads to a risk of poorer arterial blood oxygen saturation,

despite good perfusion, due to lack of gas exchange in the atelectatic sections of the lungs; the

ventilation/perfusion ratio worsens, leading to intrapulmonary shunt.


High concentrations of oxygen in vulnerable patients, with reduced sensitivity to the carbon

dioxide tension in arterial blood, can cause carbon dioxide retention, which in extreme cases

can lead to carbon dioxide narcosis.


In hyperbaric oxygen therapy, the pressure should be increased and reduced slowly in order to

avoid the risk of pressure damage (barotrauma).


4.5 Interaction with other medicinal products and other forms of interaction


Concomitant treatment with high concentrations of oxygen and drugs that cause pulmonary

toxicity, such as bleomycin, can exacerbate harmful effects caused by these drugs.


Fertility, pregnancy and lactation


Oxygen may be used during pregnancy and lactation.


4.7 Effects on ability to drive and use machines


Not relevant.


Undesirable effects


Oxygen therapy has only slight effects on pulmonary and cardiovascular functions.


Treatment with high oxygen concentrations results in reduced nitrogen pressure in the

inspiratory air/gas, thereby reducing the nitrogen concentration in tissues and lungs. This can

lead to resorption atelectasis caused by reduced alveolar volume in combination with oxygen induced effects on surfactant. This can lead to a worsening ventilation/perfusion ratio and thus poorer oxygen saturation (see section 4.4).


Heart rate and cardiac output decrease to some degree when 100 % oxygen is administered for

shorter periods and under normobaric conditions.


Early symptoms of oxygen toxicity are pleuritic pain and dry cough.


Vital capacity is reduced to some degree after treatment with 100 % oxygen for prolonged

periods (approx. 18 hours). In cases of continuous treatment with 100 % oxygen for more than

24–48 hours a condition of acute respiratory distress syndrome (ARDS) can develop.

Prolonged treatment with 100 % oxygen can also have toxic effects on other organs.


Toxic effects of high concentrations of oxygen are due to both the concentration of oxygen

and the duration of exposure. Clinical symptoms are not usually seen until after 6–12 hours.


Retrolental fibroplasia with fibroblast infiltration of the retina in neonates, which can cause

blindness, has been considered as possibly linked to treatment with high concentrations of

oxygen (> 40 %).


Other negative effects of long-term oxygen therapy with high oxygen concentrations

(FiO21.0) are haemolytic anaemia, pulmonary fibrosis, and effects on the heart, kidneys and

liver. These conditions can affect patients of all ages.


To reduce the risk of parenchymal damage, including in the lungs (bronchopulmonary

dysplasia), it is of the greatest importance to monitor arterial oxygen pressure (PaO2)

continually and to aim for the lowest oxygen concentration that produces the desired effect

(see section 4.4).


Side effects of HBO are usually mild and reversible. HBO treatment can cause rupture of the

eardrum, sinus pain, reversible muscle pain, and multifarious effects on the CNS ranging

from nausea, dizziness, anxiety, confusion and muscle twitching, to unconsciousness and

epileptic seizures. CNS symptoms can occur in HBO therapy when given at more than 2 atm

for more than a couple of hours. At higher pressures, symptoms may occur earlier. Competent

personnel must monitor the patient.


4.9 Overdose


Overdoses with oxygen do not occur outside treatment in intensive care, and the risks of these

are greater with hyperbaric oxygen therapy.


In oxygen intoxication, (symptoms of oxygen toxicity), the oxygen therapy should be reduced

or if possible stopped, and symptomatic treatment should be started in order to maintain vital

functions (e.g. artificial ventilation/assisted ventilation should be given if the patient shows

signs of failing respiration).


5. PHARMACOLOGICAL PROPERTIES


5.1 Pharmacodynamic properties


Pharmacotherapeutic group: Medicinal Gases, Oxygen, ATC code: V03AN01


Oxygen constitutes approx. 21 % of air. Oxygen is vital for human life and must be supplied

continually to all tissues in order to maintain the cells’ energy production. Oxygen is

transported in inhaled air via the airways to the lungs. In the pulmonary alveoli, as a result of

the difference in partial pressure, gas exchange takes place from the inhaled air/gas mixture to

the capillary blood. The oxygen is transported further in the systemic circulation, for the most

part bound to haemoglobin, to capillary beds in the various tissues of the body. The oxygen is

transported with the aid of the pressure gradient out to the various cells, its goal being the

mitochondria in the individual cells, where it takes part in an enzymatic chain reaction, which

creates energy. By increasing the oxygen fraction in the inhaled air/gas mixture, the partial

pressure gradient that controls the transport of oxygen to the cells increases.


Giving oxygen at a pressure higher than atmospheric pressure (HBO) considerably increases

the amount of oxygen that is transported with the blood to the peripheral tissues. Intermittent

hyperbaric oxygen therapy causes oxygen transport even within oedematous tissues and

tissues with inadequate perfusion, and in this way can maintain cellular energy production

and function.

In accordance with Boyle’s law, HBO reduces the volume of gas bubbles in tissues in relation

to the pressure with which it is given.


HBO counteracts the growth of anaerobic bacteria.



5.2 Pharmacokinetic properties


Inhaled oxygen is absorbed by a pressure-dependent gas exchange between alveolar gas and

the capillary blood that passes the alveoli.


Oxygen is transported by the systemic circulation to all tissues in the body, mainly bound

reversibly to haemoglobin. Only a very small proportion is freely dissolved in plasma. On

passage through tissue, partial pressure-dependent transport of the oxygen to the individual

cells takes place. Oxygen is a vital component in the intermediate metabolism of the cell. It is

critical to the cell’s metabolism, among other things, in order to create energy through the

aerobic ATP production in the mitochondria.


Oxygen accelerates the release of carbon monoxide that is bound to haemoglobin, myoglobin

and other iron-containing proteins, and thus counteracts the negative blocking effects caused

by carbon monoxide binding to iron.


Hyperbaric oxygen therapy further accelerates the release of carbon monoxide, compared

with 100 % oxygen under normal pressure.


Oxygen that is absorbed in the body is eliminated almost completely as carbon dioxide

formed in the intermediate metabolism.


5.3 Preclinical safety data


There are no preclinical data of relevance for safety assessment other than what have already

been considered in the summary of product characteristics.


6. PHARMACEUTICAL PARTICULARS


6.1 List of excipients


None


6.2 Incompatibilities


Not relevant


6.3 Shelf life


3 years


6.4 Special precautions for storage


Storage instructions relating to the medicinal product

Do not store above 45C. Store in a well ventilated room.


Storage instructions relating to gas containers and gases under pressure

Contact with combustible material may cause fire.

Keep away from combustible material.

No smoking.

Risk of explosion in cases of contact with oil and grease.

Must not be exposed to strong heat. If at risk of fire – move to a safe place.

Handle carefully. Ensure that the vessel is not dropped or exposed to knocks.

Keep the vessel clean and dry. Store in a ventilated place reserved for medicinal gases.

Store and transport with valves closed and, where used, with the protective cap and cover in

place.


Nature and contents of container


Container (incl. material) and valves:

Not all pack sizes may be marketed.



Cylinders/bundles filled to 200 bar delivers approx. X litre gas at atmospheric pressure and 15 °C according to the table below:


Cylinder size in litre

1

1.1

2

2.5

3

4

5

10

20

50

Litre of gas

200

220

400

500

600

800

1000

2000

4000

10 000

Bundle size in litre

9x50

12x50

Litre of gas

90 000

120 000

6.6 Special precautions for disposal


Instructions for use and handling


General

Medicinal gases must only be used for medicinal purposes.


Different gas types and gas qualities must be separated from each other. Full and empty

containers must be stored separately.


Never use oil or grease, even if the cylinder valve is stiff or if the regulator is difficult to

connect. Handle valves and devices to match with clean and grease-free (hand cream, etc.) hands.


Use only standard equipment that is intended for medicinal oxygen.


Check that the sylinders are sealed before they are taken into use.

Remaining pressure at return should be > 2 bar (200 kPa).


Preparation for use


Remove the seal from the valve before use.


Use only regulators intended for medicinal oxygen. Check that the automatic coupling or

regulator is clean and that the gaskets are in good condition.


Never use a tool on a stuck pressure/flow regulator intended to be connected manually,

as this can damage the coupling.


Open the cylinder valve slowly – at least half a turn.


Check for leakage in accordance with the instruction that accompanies the regulator. Do not

try to deal with leakage from the valve or device yourself other than by changing the gasket or

O-ring.


In the event of leakage, close the valve and uncouple the regulator. Label defective cylinders,

put them aside and return them to the supplier.


Using the gas cylinder


Smoking and open flames are absolutely forbidden in rooms where oxygen therapy is being

carried out.


Close down the equipment in the event of fire or if it is not being used.


Carry to safety in the event of fire.


Larger gas cylinders must be transported by means of a suitable type of cylinder trolley. Take

special care that connected devices are not inadvertently loosened.


When the cylinder is in use it must be fixed in a suitable support.


When a small amount of gas is left in the gas cylinder (approx. 2 bar), the cylinder valve must

be closed. It is important to leave a little pressure in the cylinder to protect it from

contamination.

After use, the cylinder valve must be closed hand-tight. Depressurise the regulator or

connection.


7. MARKETING AUTHORISATION HOLDER


Praxair Scandinavia Holding AS

P.O. Box 23, Haugenstua

N-0915 Oslo, Norway


8. MARKETING AUTHORISATION NUMBER(S)


24845



9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION


16 October 2007/10 February 2012


10. DATE OF REVISION OF THE TEXT


2016-08-19

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