Medical Oxygen 100% Medicinal gas, compressed

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxygen

Available from:

SOL S.p.A.

ATC code:

V03AN; V03AN01

INN (International Name):

Oxygen

Dosage:

100 percent volume/volume

Pharmaceutical form:

Medicinal gas, compressed

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Medical gases; oxygen

Authorization status:

Marketed

Authorization date:

2018-05-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEDICAL OXYGEN 100% MEDICINAL GAS, COMPRESSED
LIQUID MEDICAL OXYGEN 100% MEDICINAL GAS, CRYOGENIC
LIQUID MEDICAL OXYGEN 100 % MEDICINAL GAS, CRYOGENIC
OXYGEN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
other. It may harm them, even if their
signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What medicinal oxygen is and what it is used for
2.
What you need to know before you use medicinal oxygen
3.
How to use medicinal oxygen
4.
Possible side effects
5.
How to store medicinal oxygen
6.
Contents of the pack and other information
The full name of this medicine is Medical Oxygen 100 % medicinal gas,
compressed and Liquid Medical Oxygen
100 % medicinal gas, cryogenic. For ease of reference it will be
referred to as medicinal oxygen throughout the
leaflet.
1.
WHAT MEDICINAL OXYGEN IS AND WHAT IT IS USED FOR
Medicinal
oxygen contains oxygen, a gas that is essential for life. Treatment
with oxygen can take place under
normal pressure and under high pressure.
OXYGEN THERAPY AT NORMAL PRESSURE
(normobaric oxygen therapy)
Oxygen therapy at normal pressure can be used to treat:
•
LOW
OXYGEN CONCENTRATION OF THE BLOOD OR OF A SPECIFIC ORGAN
, or to prevent this from happening
•
CLUSTER HEADACHES
(a specific headache with short and very severe attacks on one side of
the head)
OXYGEN THERAPY AT HIGH PRESSURE
(hyperbaric oxygen therapy)
Oxygen therapy at high pressure should only be administered by
qualified healthcare professionals in order to
avoid the risk of injury due to strong fluctuations in pressure.
Oxygen therapy at high pressure can be used:
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Summary of Product characteristics

Health Products Regulatory Authority
02 October 2023
CRN00DL8R
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medical Oxygen 100% Medicinal gas, compressed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxygen (O
2
) 100 % v/v
(150 bar, 200 bar or 300 bar, 15°C)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicinal gas, compressed.
Oxygen is a colourless, odourless and tasteless gas.
In liquid state it has a blue colour
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Normobaric oxygen therapy:
·
Treatment or prevention of acute or chronic hypoxia.
·
Treatment of cluster headache.
Hyperbaric oxygen therapy
·
Treatment of serious carbon monoxide poisoning. (In the case of carbon
monoxide poisoning, hyperbaric oxygen
therapy is considered essential for patients who have lost
consciousness; neurological symptoms, cardiovascular
failure or serious acidosis; or pregnant patients (all of these
indications irrespective of COHb content)).
·
Treatment of decompression sickness, or of air/gas embolism of a
different origin.
·
As supporting treatment in cases of osteoradionecrosis.
·
As supporting treatment in cases of clostridial myonecrosis (gas
gangrene).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The concentration, flow and duration of the treatment will be
determined by a physician, according to the characteristics of
each pathology.
Hypoxemia refers to a condition where the arterial partial pressure of
oxygen (PaO
2
) is lower than 10 kPa (<70 mmHg). An
oxygen pressure level of 8 kPa (55 / 60 mmHg) will result in
respiratory insufficiency.
Hypoxemia is treated by enriching the patient’s inhalation air with
extra oxygen. The decision to introduce oxygen therapy
depends on the degree of hypoxemia and the patient’s individual
tolerance level.
In all cases, the objective of the oxygen therapy is to maintain a PaO
2
> 60 mm Hg (7,96 kPa) or oxygen saturation in the
arterial blood ≥ 90%.
If oxygen is administered diluted in another gas, the oxyg