Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
oxygen
Air Liquide Santé International
QV03AN01
oxygen
Horses; Dogs; Cats
All other therapeutic products
For oxygen supplementation and as a carrier gas during inhalation anaesthesia.For oxygen supplementation during recovery.
Withdrawn
2006-12-20
Medicinal product no longer authorised B. PACKAGE LEAFLET 12/15 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. 13/15 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 Leggi il documento completo
Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/15 Medicinal product no longer authorised 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 WARNINGSNone. 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. 2/15 Medicinal product no longer authorised 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 Leggi il documento completo