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Medicinal Oxygen Air Liquide Sante
oxygen

12/15

authorised

no

Medicinal


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.

    Medicinal product no longer authorised

  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 be maintained at more than 50 %.


  10. WITHDRAWAL PERIOD


    Zero days.


  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the reach and sight of children.


    Cylinders should be stored in a locked, clean and ventilated area reserved for the storage of medical gases, protected from weather and with no inflammable materials. Full and empty cylinders should be stored separately. Cylinders should be protected from falling, from being hit, from sources of heat or ignition, from temperatures of more than 50 °C and from combustible materials. Cylinders must be kept vertical.


    Do not use after {Month/Year}.


  12. SPECIAL WARNING(S)


    Pregnancy and lactation

    Medicinal Oxygen Air Liquide Santé can be used during pregnancy and lactation.


    Incompatibilities

    Medicinal Oxygen Air Liquide Santé has no known incompatibilities with other products likely to be administered concomitantly


    Overdose

    Due to the high partial pressure of oxygen inhaled by animals during the administration of the veterinary medicinal product, oxygen toxicity may be seen in animals after extended periods of use. The first signs of oxygen toxicity include dyspnoea and cyanosis, but should only be suspected after at least 12 hours of 100 % oxygen administration or 18 hours of 80 % oxygen administration under normobaric conditions. In cases where oxygen toxicity is suspected, the fresh gas flow rate should be maintained, but the oxygen concentration of the inspired gas should be reduced to approximately 50 % or less if adequate oxygenation can be maintained. Oxygenation can be assessed using pulse oximetry or arterial blood gas analysis. The oxygen concentration can be reduced to 50 % by including 50 % nitrogen or approximately 60 % medical air. This is best monitored with an in-circuit oxygen monitor. Alternatively, supplementary oxygen can be given to an animal breathing air, and the flow rate adjusted to provide the appropriate inspired concentration.

    Medicinal product no longer authorised

    Special precautions for use in animals

    Oxygen in concentration up to 100 % (FiO2 1.0) should not exceed 12 hours. Oxygen in concentration over 80 % (FiO2 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.


    Precautions to be taken by the person administering the veterinary medicinal product to animals Medicinal Oxygen Air Liquide Santé 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.


    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.


  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    Unwanted partially full, or empty, Medicinal Oxygen Air Liquide Santé cylinders should be returned to the manufacturer or their authorised distributor.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED


    20.12.2006


    Detailed information on this product is available on the website of the European Medicines Agency (EMEA) https://www.emea.europa.eu


  15. OTHER INFORMATION


Pack sizes


15 l cylinders filled at 200 bar, containing 3.2 m³ oxygen under a pressure of 1 bar at 15 ºC. 50 l cylinders filled at 200 bar, containing 10.6 m³ oxygen under a pressure of 1 bar at 15 ºC.


Lot number


Lot {Number}