Medicinal Oxygen Air Liquide Sante

Основна информация

  • Търговско наименование:
  • Medicinal Oxygen Air Liquide Sante
  • Активна съставка:
  • oxygen
  • INN (Международно Name):
  • oxygen
  • Използвай за:
  • Животни
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Medicinal Oxygen Air Liquide Sante
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Horses, Dogs, Cats
  • Терапевтична област:
  • ALL OTHER THERAPEUTIC PRODUCTS
  • Терапевтични показания:
  • For oxygen supplementation and as a carrier gas during inhalation anaesthesia.For oxygen supplementation during recovery.

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Withdrawn
  • Номер на разрешението:
  • EMEA/V/C/000111
  • Дата Оторизация:
  • 19-12-2006
  • EMEA код:
  • EMEA/V/C/000111
  • Последна актуализация:
  • 31-03-2019

Доклад обществена оценка

Medicinal product no longer authorised

European Medicines Agency

Veterinary Medicines

7 Westferry Circus, Canary Wharf, London E14 4HB, UK

Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47

E-mail: mail@emea.europa.eu http://www.emea.europa.eu

EMEA

2006

Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged

EMEA/V/C/111

EMEA/CVMP/431314/2006

EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)

MEDICINAL OXYGEN AIR LIQUIDE SANTÉ

EPAR summary for the public

This document is a summary of the European Public Assessment Report. Its purpose is to explain

how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP)

on the basis of the documentation provided, led to the recommendations on the conditions of use.

This document cannot replace a face-to-face discussion with your veterinarian. If you need more

information about your animal’s medical condition or treatment, contact your veterinarian. If you

want more information on the basis of the CVMP recommendations, read the Scientific

Discussion (also part of the EPAR).

What is Medicinal Oxygen Air Liquide Santé?

Medicinal Oxygen contains oxygen extracted as a free gas from the atmosphere (the air we

breathe). It is presented as 15- or 50-litre steel cylinders containing compressed oxygen gas.

What is Medicinal Oxygen Air Liquide Santé used for?

Medicinal Oxygen

is used to provide oxygen in dogs, cats and horses who have been

anaesthetised and are not breathing naturally. It is also given after anaesthesia to help

recovery. It can also be used as a carrier gas for other gases used to anaesthetise the animal.

How does Medicinal Oxygen Air Liquide Santé work?

Oxygen is an essential element for living organisms. It is absorbed from the air into the blood

through the lungs (respiration). Intervention with oxygen therapy is therefore important in

certain cases to ensure adequate tissue oxygenation

.

How has Medicinal Oxygen Air Liquide Santé been studied?

Oxygen is a well-established medical gas that has been in use for many years, and the

company

used

information

from

published

literature.

They

provided

satisfactory

information on the quality, the safety of the medicine in dogs, cats and horses and its safety in

humans (people in contact with the product) and the environment.

Further

information

provided

benefits

oxygen

supplementation

during

anaesthesia and recovery.

Medicinal product no longer authorised

Page 2/2

EMEA 2006

What benefit has Medicinal Oxygen Air Liquide Santé shown during the studies?

The literature provided by the Applicant supported the recommendations in the SPC for

oxygen supplementation during anaesthesia and recovery in dogs, cats and horses.

What is the risk associated with Medicinal Oxygen Air Liquide Santé?

Medicinal Oxygen has no side effects.

The principal risks associated with the use of this medicine are the inadvertent release of

pressurised gas following incorrect use and the increased fire risks associated with localised

increased oxygen concentrations.

What are the precautions for the person who gives the medicine or comes into contact with the

animal?

This product should only be used by persons who are trained in the use of compressed gas and

associated equipment.

Why has Medicinal Oxygen Air Liquide Santé been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the

benefits of oxygen supplementation during anaesthesia and recovery in dogs, cats and horses

exceed the risks associated with its use. However, it is noted that the rate of oxygen

supplementation required by an animal varies depending on a variety of factors, and that the

appropriate oxygen ‘dose’ to use during anaesthesia for a given animal must be established by

the attending veterinarian, and continually monitored during anaesthesia.

Other information about Medicinal Oxygen Air Liquide Santé:

The European Commission granted a marketing authorisation valid throughout the European

Union, for Medicinal Oxygen

Air Liquide Santé

to Air Liquide Santé International on

20.12.2006. Information on the prescription status of this product may be found on the

label/outer package.

This summary was last updated on 20.12.2006.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

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 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.

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Medicinal product no longer authorised

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Special precautions for use in animals

Oxygen in concentration up to 100 % (FiO

1.0) should not exceed 12 hours. Oxygen in concentration

over 80 % (FiO

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) http://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}