Medical Oxygen

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxygen

Available from:

BOC Gases Ireland Ltd

ATC code:

V03AN; V03AN01

INN (International Name):

Oxygen

Dosage:

99.5 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:

1980-04-01

Patient Information leaflet

Medical Oxygen
Medicinal gas, compressed
Package leaflet: Information for the user
Compressed Medical Oxygen
Oxygen 99.5%
Medicinal gas, compressed
Read all of this leaflet carefully before you start
using this medicine.
•
Keep this leaflet as you may need to read it
again.
•
If you have further questions, ask your
healthcare professional (doctor, nurse or
pharmacist) or homecare provider.
•
This medicine has been prescribed for you.
•
Do not pass it on to others as it may harm them,
even if their symptoms are the same as yours.
•
If any of the side effects become serious, or
if you notice any side effects not listed in this
leaflet, please tell your healthcare professional
or homecare provider immediately.
This leaflet gives you information about:
1. What Medical Oxygen is and what it is used for
2. What you need to know before you use
Medical Oxygen
3. How to use Medical Oxygen
4. Possible side effects
5. How to store Medical Oxygen cylinders
6. Contents of the pack and other information
1. WHAT MEDICAL OXYGEN IS AND WHAT IT
IS USED FOR?
Medical Oxygen is a medicinal gas, supplied in
cylinders filled to a high pressure.
Medical Oxygen is used:
•
during anaesthesia and for recovery following
surgery
•
to treat or prevent oxygen deficiency in the
body in many different situations such as:
•
surgery or major trauma such as a road traffic
accident
•
heart attacks
•
severe blood loss
•
carbon monoxide poisoning
•
severe lung and heart conditions
•
very high fevers
•
for resuscitation of adults, children and babies
•
for treatment of cluster headaches.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE MEDICAL OXYGEN
Medical Oxygen is only prescribed to you by a
healthcare professional.
Ensure that your healthcare professional is aware of
any medical conditions that you may have.
BOC: Living healthcare
02
Medical Oxygen medicinal gas, compressed package leaflet: Information
for the user
Take special care when using Medical Oxygen if:
•
your baby requires extra oxygen and is
premature. Only give t

Summary of Product characteristics

Health Products Regulatory Authority
24 May 2022
CRN00CQ3K
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medical Oxygen
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Compressed Medical Oxygen cylinders are supplied to the following
specification:
Compressed Medical Oxygen Purity 99.5%(min)
The Compressed Medical Oxygen cylinder specification complies with the
current European Pharmacopoeia monograph (0417).
3 PHARMACEUTICAL FORM
Medicinal gas, compressed.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Medical Oxygen is widely used in clinical practice to:
§ provide a basis for most modern anaesthetic techniques including
pre and postoperative management.
§ restore the tissue oxygen tension towards normal by improving
oxygen availability in a wide range of conditions such as:
• cyanosis of recent origin as a result of cardio-pulmonary disease
• surgical trauma, chest wounds and rib fracture
• carbon monoxide poisoning
• hyperpyrexia
• major trauma, i.e. road traffic accidents and gunshot wounds
• in the management of sudden cardiac and respiratory arrest,
whether drug induced or traumatic
§ aid in the resuscitation of the critically ill, when the
circulation is impaired
§ aid in neo-natal resuscitation
§ treat acute severe headache in adults diagnosed with cluster
headache
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Medical Oxygen is administered by inhalation through the lungs. The
major exception is when a metered supply is fed into the
oxygenator of an extracorporeal circulation of a cardio-pulmonary
by-pass system.
For cluster headache, oxygen should be administered as soon as
possible after the onset of the attack, via a non-rebreathing
facemask at a flow of 6 to 12 l/min for approximately 15 minutes.
4.3 CONTRAINDICATIONS
There are no absolute contra-indications in the use of oxygen but the
inspired concentration should be limited in the case of
premature infants and those patients with chronic bronchitis and
emphysema.
Health Products Regulatory Authority
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