Medicinal Oxygen Air Liquide Sante
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
12-01-2007
Summary of Product characteristics
(SPC)
12-01-2007
Public Assessment Report
(PAR)
12-01-2007
Active ingredient:
oxygen
Available from:
Air Liquide Santé International
ATC code:
QV03AN01
INN (International Name):
oxygen
Therapeutic group:
Horses; Dogs; Cats
Therapeutic area:
All other therapeutic products
Therapeutic indications:
For oxygen supplementation and as a carrier gas during inhalation anaesthesia.For oxygen supplementation during recovery.
Authorization status:
Withdrawn
Authorization date:
2006-12-20
Patient Information leaflet
Medicinal product no longer authorised
B. PACKAGE LEAFLET
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Medicinal product no longer authorised
PACKAGE LEAFLET
Medicinal Oxygen Air Liquide Santé 100 % inhalation gas for dogs,
cats and horses.
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
:
AIR LIQUIDE Santé INTERNATIONAL
10, rue Cognacq-Jay
75341 Paris Cedex 07
FRANCE
Manufacturer for the batch release
:
AIR LIQUIDE Santé FRANCE
ZI Est, BP 34
54181 Heillecourt Cedex
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Medicinal Oxygen Air Liquide Santé 100 % inhalation gas for dogs,
cats and horses.
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Medicinal Oxygen Air Liquide Santé is an inhalation gas consisting of
100 % oxygen.
4.
INDICATION(S)
Medicinal Oxygen Air Liquide Santé can be used for oxygen
supplementation and as a carrier gas
during inhalation anaesthesia.
The veterinary medicinal product can also be used for oxygen
supplementation during recovery.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
None.
7.
TARGET SPECIES
Dogs, cats and horses.
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8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
The precise fresh gas flow rate required by an animal during
anaesthesia and recovery should be
determined by a suitably experienced veterinarian, taking into
consideration the bodyweight and health
status of the animal and the anaesthetic equipment and agents being
used. The animal must be
monitored closely, preferably by means of a pulse oximeter, and the
flow rate adapted during
anaesthesia to meet their individual requirements.
9.
ADVICE ON CORRECT ADMINISTRATION
In-circuit oxygen meters can be used to measure the inspired oxygen
fraction and depending on the
individual animal, a level of 50 – 100 % of the veterinary medicinal
product may be required. As a
rule, and if oxygen tension cannot be measured, the inspired oxygen
fraction should
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Summary of Product characteristics
Medicinal product no longer authorised
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Medicinal Oxygen Air Liquide Santé 100 % inhalation gas for dogs,
cats and horses.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
100 % oxygen.
3.
PHARMACEUTICAL FORM
Inhalation gas.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs, cats and horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For oxygen supplementation and as a carrier gas during inhalation
anaesthesia.
For oxygen supplementation during recovery.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Oxygen in concentration up to 100 % (FiO
2
1.0) should not exceed 12 hours. Oxygen in concentration
over 80 % (FiO
2
0.8) should not exceed 18 hours.
Animals with pre-existing oxygen radical damage to the lung may have
this damage exacerbated by
oxygen therapy e.g. in the treatment of paraquat poisoning.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
This veterinary medicinal product should only be used by persons who
have been fully trained to use
pressure regulators and associated equipment.
Whilst oxygen is non-flammable, it strongly supports combustion and no
naked flames should be
allowed near the container. Since even the smallest spark can cause
violent ignition, electrical
equipment capable of sparking should not be used in the vicinity of
patients receiving oxygen.
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Cylinder valves and associated equipment must not be lubricated and
must be kept entirely free from
carbon-based oils and grease because otherwise there is a risk of
spontaneous combustion and a
violent explosion may occur.
If you have been working in an oxygen-enriched atmosphere avoid
smoking, open flames or other
sources of ignition for at least 15 minutes
.
4.6
ADVERSE REACTIONS (FREQUENCY
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