Medical Oxygen/Carbon Dioxide mixtures

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxygen; Carbon dioxide

Available from:

BOC Gases Ireland Ltd

ATC code:

V03AN; V03AN01; V03AN02

INN (International Name):

Oxygen; Carbon dioxide

Dosage:

percent

Pharmaceutical form:

Medicinal gas, compressed

Prescription type:

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

Therapeutic area:

Medical gases; oxygen; carbon dioxide

Authorization status:

Marketed

Authorization date:

1985-09-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEDICAL OXYGEN/CARBON DIOXIDE MIXTURES
OXYGEN, CARBON DIOXIDE,
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).
-
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 heathcare professional immediately.
THIS LEAFLET GIVES YOU INFORMATION ABOUT:
1.
What are Medical Oxygen/Carbon Dioxide Mixtures and what are they used
for
2.
Things to consider before use
3.
How to use Medical Oxygen/Carbon Dioxide Mixtures
4.
Possible side effects
5.
How to store
6.
Further Information
1.
WHAT ARE MEDICAL OXYGEN/CARBON DIOXIDE MIXTURES AND WHAT
ARE THEY USED FOR
Medical Oxygen/Carbon Dioxide Mixtures are medicinal gas mixtures,
supplied in cylinders
filled to a high pressure.
These medicinal gas mixtures are used in blood analysis and bypass
circulation
2.
THINGS TO CONSIDER BEFORE USE
These medicinal gas mixtures are only given to you in a hospital or
clinic under the supervision
of a healthcare professional. Ensure that your healthcare professional
is aware of any medical
conditions that you may have.
TAKE SPECIAL CARE WHEN USING IF:
you have accidentally taken Paraquat (a type of weed killer), advise
your healthcare professional
before using the medicinal gas mixtures, as there is a possibility of
toxic effects to the lungs
TAKING OTHER MEDICINES
These medicinal gas mixtures should not be used with adrenaline or
similar drugs.
If you have been taking or prescribed Bleomycin (to treat cancer),
Amiodarone (to treat
an irregular heartbeat) or Nitrofurantoin and similar antibiotics (to
treat infection),
advise your healthcare professional before using these medicinal gas
mixtures, as th

Summary of Product characteristics

Health Products Regulatory Authority
21 February 2020
CRN009HPR
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medical Oxygen/Carbon Dioxide mixtures
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Medical Oxygen/ Carbon Dioxide Mixtures cylinders
are supplied to the following specifications:
Chemical Composition: Oxygen 95.0% +/- 0.5%
Carbon Dioxide 5.0% +/-0.5%
The specification above is the most commonly used mixture.
There are various other mixtures as follows:
Oxygen 98% Carbon Dioxide 2%
Oxygen 97% Carbon Dioxide 3%
Oxygen 90% Carbon Dioxide 10%
Oxygen 80% Carbon Dioxide 20%
The Medical Oxygen specification complies with the current European
Pharmacopoeia monograph (0417) and the Carbon
Dioxide specification complies with the current European Pharmacopoeia
monograph (0375)
3 PHARMACEUTICAL FORM
Medicinal gas, compressed.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. In blood gas analysis.
2. For use in the oxygenator during extracorporeal circulation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As appropriate.
_Paediatric population_
Currently available data are described in section 4.8 but no
recommendation on posology can be made.
Method of administration
As appropriate.
4.3 CONTRAINDICATIONS
Not applicable.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The product should be used under the direction of appropriately
trained personnel.
Health Products Regulatory Authority
21 February 2020
CRN009HPR
Page 2 of 5
Where the patient has been exposed to agents which are toxic to the
lungs, such as Paraquat, the use of additional oxygen
such as within Medical Oxygen/Carbon Dioxide mixtures should be
avoided.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
The use of higher levels of oxygen can increase the risk of pulmonary
toxicity in patients who have been administered
Bleomycin, Amiodarone and Nitrofurantoin or similar antibiotics. In
these cases Medical Oxygen/Carbon dioxide mixtures
should be administered with caution and at levels kept a