Medicinal Oxygen Air Liquide Sante - patient leaflet, side effects, dosage

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Active substance:

4.1 Target species

4.2 Indications for use, specifying the target species

4.3 Contraindications

Special precautions to be taken by the person administering the veterinary medicinal product to animals

4.7 Use during pregnancy, lactation or lay

4.8 Interaction with other medicinal products and other forms of in

on

4.9 Amounts to be administered and administration r

rawal period(s)

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Medical Gases, ATCvet code: QV03AN01.

• 5.1 Pharmacody­namic properties

Oxygen is an essential element for living organisms. It is involved in cellular metab catabolism and permits production of energy in the form of adenosine triphosphate ( variation of the partial pressure of oxygen in the blood affects the cardiovascular syste respiratory system, cellular metabolism, and the central nervous system. Deprivatio resulting in tissue hypoxia, results in a rapid deterioration of myocardial and ce Intervention with oxygen therapy is essential for the resolution of adequate tissu

5.2 Pharmacokinetic particulars

Oxygen administered by inhalation is absorbed by alveolar-capillary exch

plasma in the solution and is transported by erythrocytes in the form of oxyhaemoglobin­. Oxygen

released at tissue level by oxyhaemoglobin is then used in mitochondri Following these catalytic reactions it reappears in the form of CO2 and excess, unmetabolised oxygen are eliminated from the body during exh

• 6. PHARMACEUTICAL PARTICULARS

  6.1 List of excipients

  
  

None.

Shelf-life of the veterinary medicinal 5 years.

6.4. Special precautions for storage

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.

osition of immediate packaging

Special precautions for the disposal of unused veterinary medicinal product or waste ls derived from the use of such products

7. MARKETING AUTHORISATION HOLDER

AIR LIQUIDE Santé INTERNATIONAL

10, rue Cognacq-Jay

75341 Paris Cedex 07

FRANCE

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/06/067/001

EU/2/06/067/002

20.12.2006

10 DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA)

CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION

WITH REGARD TO SAFE AND EFFECTIVE USE

• A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATC RELEASE

Name and address of the manufacturer responsible for batch release

Air Liquide Santé France

Zone Industrielle Est

BP 34

F-54181 Heillecourt

France

• B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUT REGARDING SUPPLY OR USE

To be supplied only on veterinary prescription.

Information to appear on a durable plastic label appended directly to the cylinder

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

3. PHARMACEUTICAL FORM

Read the package leaflet before use.

8. WITHDRA

Withdrawal period: zero days

9. SPECIAL WARNING(S), IF NECESSARY

Keep away from naked flames. Do not lubricate.

ing.

10. EXPIRY DATE

11. SPECIAL STORAGE CONDITIONS

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSE WASTE MATERIALS, IF ANY

14. THE WORDS “KEEP OUT OF THE

15. NAME AND ADDRESS OF T

16. MARKETING A

RISATION NUMBER(S)

PACKAGE LEAFLET

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

2.  NAME OF THE VETERINARY MEDICINAL P

3.  STATEMENT OF THE

4. INDICATION(S)

(S) AND OTHER INGREDIENT(S)

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATIO

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 status of the animal and the anaesthetic equipment and agents being used. The animal must b monitored closely, preferably by means of a pulse oximeter, and the flow rate adapted du 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 %.

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.

can be used during pregnancy and lactation.

Incompatibilities

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

essure of oxygen inhaled by animals during the administration of the roduct, oxygen toxicity may be seen in animals after extended periods of use. ygen toxicity include dyspnoea and cyanosis, but should only be suspected after at 0 % oxygen administration or 18 hours of 80 % oxygen administration un­der

onditions. In cases where oxygen toxicity is suspected, the fresh gas flow rate should be ut the oxygen concentration of the inspired gas should be reduced to approximately 50 % uate oxygenation can be maintained. Oxygenation can be assessed using pulse oximetry ood gas analysis. The oxygen concentration can be reduced to 50 % by including 50 % r approximately 60 % medical air. This is best monitored with an in-circuit oxygen monitor. ively, supplementary oxygen can be given to an animal breathing air, and the flow rate usted to provide the appropriate inspired concentration.

Special precautions for use in animals

Oxygen in concentration up to 100 % (FiO2 1.0) should not exceed 12 hours. Oxygen in concentrati over 80 % (FiO2 0.8) should not exceed 18 hours.

Animals with pre-existing oxygen radical damage to the lung may have this damage exacerb oxygen therapy e.g. in the treatment of paraquat poisoning.

Precautions to be taken by the person administering the veterinary medicinal product to

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 avo sources of ignition for at least 15 minutes.

13. SPECIAL PRECAUTIONS FOR THE DISPOS 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

LET WAS LAST APPROVED

15.

Pack sizes 15 l cylinders filled at 20 ontaining 3.2 m3 oxygen under a pressure of 1 bar at 15 °C.

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

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