Vetflurane 1000 mg/g Inhalation vapour, liquid

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Isoflurane
Available from:
Virbac S.A.
ATC code:
QN01AB06
INN (International Name):
Isoflurane
Dosage:
1000 milligram(s)/gram
Pharmaceutical form:
Inhalation vapour, liquid
Prescription type:
VPO: Veterinary Practitioner Only as defined in relevant national legislation
Therapeutic group:
Cats, Dogs, Ferrets, Gerbils, Guinea pigs, Hamsters, Horses, Non Food Animals, Other Birds, Reptiles
Therapeutic area:
isoflurane
Therapeutic indications:
Neurological Preparations
Authorization status:
Authorised
Authorization number:
VPA10988/085/001
Authorization date:
2010-09-24

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Health Products Regulatory Authority

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Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Vetflurane 1000 mg/g Inhalation vapour, liquid

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each millilitre contains:

Active substance:

Isoflurane 1000 mg/g.

The veterinary medicinal product contains no excipients.

3 PHARMACEUTICAL FORM

Inhalation vapour, liquid.

Clear, colourless liquid.

4 CLINICAL PARTICULARS

4.1 Target Species

Horses, dogs, cats, ornamental birds, reptiles, rats, mice, hamsters, chinchillas, gerbils, guinea pigs and ferrets.

4.2 Indications for use, specifying the target species

Induction and maintenance of general anaesthesia.

4.3 Contraindications

Do not use in case of known susceptibility to malignant hyperthermia.

Do not use in cases of known hypersensitivity to isoflurane or to other halogenated agents.

4.4 Special warnings for each target species

The metabolism of birds, and to an extent small mammals, is affected more profoundly by decreases in body temperature, due

to high surface area to body weight ratio. Drug metabolism in reptiles is slow and highly dependent upon environmental

temperature.

The absorption, distribution and elimination of isoflurane are rapid, and it is eliminated largely unchanged via the lungs. These

characteristics may make it suitable for groups of patients including the young or old, or those with impaired hepatic, renal or

cardiac function, however anaesthetic protocols should be decided on a case by case basis.

4.5 Special precautions for use

Special precautions for use in animals

Isoflurane has little or no analgesic properties. Adequate analgesia should always be given before surgery. The analgesic

requirements of the patient should be considered before general anaesthesia is ended.

The use of the product in patients with cardiac disease should be considered only after a risk/ benefit assessment by the

veterinarian.

It’s important to monitor breathing and pulse for the frequency and its features. It’s important to maintain airways free and

properly oxygenate tissues during the maintenance of anaesthesia.

When using isoflurane to anaesthetise an animal with a head injury, consideration should be given as to whether artificial

ventilation is appropriate to maintain normal CO

levels, so that cerebral blood flow does not increase.

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As isoflurane is a respiratory depressant, it could be advised to monitor the respiratory rate and depth during anaesthesia.

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

In case of a known hypersensitivity to isoflurane, the professional must not handle this product.

Do not breathe the vapour.

Users should consult their National Authority for advice on Occupational Exposure Standards for isoflurane.

Operating rooms and recovery areas should be provided with adequate ventilation or scavenging systems to prevent the

accumulation of anaesthetic vapour. All scavenging/ extraction systems must be adequately maintained.

Pregnant and breast feeding women should not have any contact with the product and should avoid operating rooms and

animal recovery areas.

Avoid using masking procedures for prolonged induction and maintenance of general anaesthesia.

Use cuffed endotracheal intubation when possible for the administration of this product during maintenance of general

anaesthesia.

To protect the environment, it is considered good practice to use charcoal filters with scavenging equipment.

Care should be taken when dispensing isoflurane, with any spillage removed immediately using an inert and absorbent

material e.g. sawdust.

Wash any splashes from skin and eyes, and avoid contact with the mouth. If severe accidental exposure occurs remove the

operator from the source of exposure, seek urgent medical assistance and show this label.

Halogenated anaesthetic agents may induce liver damage. In case of isoflurane this is an idiosyncratic response very rarely

seen after repeated exposure.

Advice to Doctors: Ensure a patent airway and give symptomatic and supportive treatment. Note that adrenaline and

catecholamines may cause cardiac dysrhythmias.

4.6 Adverse reactions (frequency and seriousness)

Isoflurane produces hypotension and respiratory depression in a dose-related manner. Cardiac arrhythmias and transient

bradycardia have been reported only rarely.

Malignant hyperthermia has been reported very rarely in susceptible animals.

Respiratory arrest should be treated by assisted ventilation.

In the case of cardiac arrest, perform a complete cardio pulmonary resuscitation.

4.7 Use during pregnancy, lactation or lay

Pregnancy:

Use only according to the benefit/risk assessment by the responsible veterinarian. Isoflurane has been safely used for

anaesthesia during caesarean section in the dog and cat.

Lactation:

Use only according to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interactions

Concurrent inhalation of nitrous oxide enhances the effect of isoflurane in man and similar potentiation might be expected in

animals.

The concurrent use of sedative or analgesic drugs is likely to reduce the level of isoflurane required to induce and maintain

anaesthesia.

In horses, detomidine and xylazine have been reported to reduce MAC for isoflurane.

In dogs, morphine, oxymorphone, acepromazine, medetomidine plus midazolam have been reported to reduce the MAC for

isoflurane. The concomitant administration of midazolam/ketamine during isoflurane anaesthesia may result in marked

cardiovascular effects, particularly arterial hypotension. The depressant effects of propanolol on myocardial contractility are

reduced during isoflurane anaesthesia, indicating a moderate degree of β-receptor activity.

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In cats, intravenous administration of midazolam-butorphanol has been reported to alter several cardio-respiratory parameters

in isoflurane-induced cats as has epidural fentanyl and medetomidine. Isoflurane has been shown to reduce the sensitivity of

the heart to adrenaline (epinephrine).

In cockatoos, butorphanol has been reported to reduce the MAC for isoflurane.

In pigeons, midazolam has been reported to reduce the MAC for isoflurane.

For reptiles and small mammals, there are no data available.

Isoflurane has a weaker sensitising action on the myocardium, to the effects of circulating dysrhythmogenic catecholamines,

than halothane.

Isoflurane may be degraded to carbon monoxide by dried carbon dioxide absorbents.

4.9 Amounts to be administered and administration route

Isoflurane should be administered using an accurately calibrated vaporiser in an appropriate anaesthetic circuit, since levels of

anaesthesia may be altered rapidly and easily.

Isoflurane may be administered in oxygen or oxygen/nitrous oxide mixtures.

The MAC (minimal alveolar concentration in oxygen) or effective dose ED

values and suggested concentrations given below

for the target species should be used as a guide or starting point only. The actual concentrations required in practice will

depend on many variables, including the concomitant use of other drugs during the anaesthetic procedure and the clinical

status of the patient.

Isoflurane may be used in conjunction with other drugs commonly used in veterinary anaesthetic regimes for premedication,

induction and analgesia. Some specific examples are given in the individual species information.

Recovery from isoflurane anaesthesia is usually smooth and rapid. The analgesic requirements of the patient should be

considered before the termination of general anaesthesia.

The concurrent use of sedative or analgesic drugs is likely to reduce the level of isoflurane required to produce and maintain

anaesthesia.

HORSE

The MAC for isoflurane in the horse is approximately 1.31 %

Premedication

Isoflurane may be used with other drugs commonly used in veterinary anaesthetic regimes. The following drugs have been

found to be compatible with isoflurane: acepromazine, butorphanol, detomidine, diazepam, dobutamine, dopamine,

guaiphenesin, ketamine, morphine, pethidine, thiamylal, thiopentone and xylazine. Drugs used for premedication should be

selected for the individual patient. However, the potential interactions below should be noted.

Interactions

See section 4.8.

Induction

As it is not normally practicable to induce anaesthesia in adult horses using isoflurane, induction should be by the use of a

short acting barbiturate such as thiopentone sodium, ketamine or guaiphenesin. Concentrations of 3 to 5 % isoflurane may

then be used to achieve the desired depth of anaesthesia in 5 to 10 minutes.

Isoflurane at a concentration of 3 to 5 % in a high flow oxygen may be used for induction in foals.

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Maintenance

Anaesthesia may be maintained using 1.5 % to 2.5 % isoflurane.

Recovery

Recovery is usually smooth and rapid.

DOG

The MAC for isoflurane in the dog is approximately 1.28 %.

Premedication

Isoflurane may be used with other drugs commonly used in veterinary anaesthetic regimes. The following drugs have been

found to be compatible with isoflurane: acepromazine, atropine, butorphanol, buprenorphine, bupivacaine, diazepam,

dobutamine, ephedrine, epinephrine, glycopyrrolate, ketamine, medetomidine, midazolam, methoxamine, oxymorphone,

propofol, thiamylal, thiopentone and xylazine. Drugs used for premedication should be selected for the individual patient.

However, the potential interactions below should be noted.

Interactions

See section 4.8.

Induction

Induction is possible by face mask using up to 5 % isoflurane, with or without premedication.

Maintenance

Anaesthesia may be maintained using 1.5 % to 2.5 % isoflurane.

Recovery

Recovery is usually smooth and rapid.

CAT

The MAC for isoflurane in the cat is approximately 1.63 %.

Premedication

Isoflurane may be used with other drugs commonly used in veterinary anaesthetic regimes. The following drugs have been

found to be compatible with isoflurane: acepromazine, atropine, diazepam, ketamine, and oxymorphone. Drugs used for

premedication should be selected for the individual patient. However, the potential interactions below should be noted.

Interactions

See section 4.8.

Induction

Induction is possible by face mask using up to 4 % isoflurane, with or without premedication.

Maintenance

Anaesthesia may be maintained using 1.5 % to 3 % isoflurane.

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Recovery

Recovery is usually smooth and rapid.

ORNAMENTAL BIRDS

Few MAC/ED

values have been recorded. Examples are 1.34 % for the Sandhill crane, 1.45 % for the racing pigeon, reduced to

0.89 % by the administration of midazolam, and 1.44 % for cockatoos, reduced to 1.08 % by the administration of butorphanol

analgesic.

The use of isoflurane anaesthesia has been reported for many species, from small birds such as zebra finches, to large birds

such as vultures, eagles and swans.

Drug interactions/compatibilities

Propofol has been demonstrated in the literature to be compatible with isoflurane anaesthesia in swans.

Interactions

See section 4.8.

Induction

Induction with 3 to 5 % isoflurane is normally rapid. Induction of anaesthesia with propofol, followed by isoflurane

maintenance, has been reported for swans.

Maintenance

The maintenance dose depends on the species and individual. Generally, 2 to 3 % is suitable and safe.

Only 0.6 to 1 % may be needed for some stork and heron species.

Up to 4 to 5 % may be needed for some vultures and eagles.

3.5 to 4 % may be needed for some ducks and geese.

Generally, birds respond very rapidly to changes in concentration of isoflurane.

Recovery

Recovery is usually smooth and rapid.

REPTILES

The literature records isoflurane’s use on a wide variety of reptiles (e.g. various species of lizard, tortoise, iguanas, chameleon

and snakes).

The ED

was determined in the desert iguana to be 3.14 % at 35 °C and 2.83 % at 20 °C.

Drug interactions/ compatibilities

See section 4.8.

Induction

Induction is usually rapid at 2 to 4 % isoflurane.

Maintenance

1 to 3 % is a useful concentration

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Recovery

Recovery is usually smooth and rapid

RATS, MICE, HAMSTERS, CHINCHILLAS, GERBILS, GUINEA PIGS AND FERRETS

The MAC for mice has been cited as 1.34 %, and for the rat as 1.38 %, 1.46 % and 2.4 %.

Drug interactions/ compatibilities

See section 4.8.

Induction

Isoflurane concentration 2 to 3 %.

Maintenance

Isoflurane concentration 0.25 to 2 %.

Recovery

Recovery is usually smooth and rapid.

Species

MAC (%)

Induction (%)

Maintenance (%)

Recovery

Horse

1.31

3.0 – 5.0 (foals)

1.5 – 2.5

Smooth and rapid

1.28

Up to 5.0

1.5 – 2.5

Smooth and rapid

1.63

Up to 4.0

1.5 – 3.0

Smooth and rapid

Ornamental birds

See posology

3.0 – 5.0

See posology

Smooth and rapid

Reptiles

See posology

2.0 – 4.0

1.0 – 3.0

Smooth and rapid

Rats, mice, hamsters, chinchillas, gerbils, guinea pigs

and ferrets

1.34 (mouse)

1.38/1.46/2.40 (rat)

2.0 – 3.0

0.25 – 2.0

Smooth and rapid

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Isoflurane overdose may result in profound respiratory depression. Therefore, respiration must be monitored closely and

supported when necessary with supplementary oxygen and/ or assisted ventilation.

In cases of severe cardiopulmonary depression, administration of isoflurane should be discontinued, the breathing circuit

should be flushed with oxygen, the existence of a patent airway ensured, and assisted or controlled ventilation with pure

oxygen initiated. Cardiovascular depression should be treated with plasma expanders, pressor agents, antiarrhythmic agents or

other appropriate techniques.

4.11 Withdrawal period(s)

Horse: withdrawal period for meat and offal: 2 days.

The product should not be used for the treatment of mares producing milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anaesthetic, general - halogenated hydrocarbons

ATCvet code: QN01AB06

5.1 Pharmacodynamic properties

Isoflurane produces unconsciousness by its action on the central nervous system. It has little or no analgesic properties.

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Like other inhalation anaesthetics of this type, isoflurane depresses the respiratory and cardiovascular systems.

5.2 Pharmacokinetic particulars

Isoflurane is absorbed on inhalation and is rapidly distributed via the bloodstream to other tissues, including the brain. Its

blood/gas partition coefficient at 37 °C is 1.4. The absorption and distribution of isoflurane and the elimination of

non-metabolised isoflurane by the lungs are all rapid, with the clinical consequences of rapid induction and recovery and easy

and rapid control of the depth of anaesthesia.

Metabolism of isoflurane is minimal (about 0.2 %, mainly to inorganic fluoride) and almost all of the administered isoflurane is

excreted unchanged by the lungs.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

None

6.2 Major incompatibilities

Isoflurane has been reported to interact with dry carbon dioxide absorbents to form carbon monoxide. In order to minimise

the risk of formation of carbon monoxide in rebreathing circuits and the possibility of elevated carboxyhaemoglobin levels,

carbon dioxide absorbents should not be allowed to dry out.

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

6.4 Special precautions for storage

Do not store above 25 °C.

Protect from direct sunlight and heat.

Store in tightly closed original container.

6.5 Nature and composition of immediate packaging

The product is packaged in a cardboard box containing 100 ml or 250 ml amber coloured glass bottles (Type III) with low

density polyethylene-lined caps.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the

use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be

disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Virbac S.A.

1ère avenue

2065 M LID

06516 Carros

France

8 MARKETING AUTHORISATION NUMBER(S)

VPA10988/085/001

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9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 24 September 2010

Date of last renewal: 23 September 2015

10 DATE OF REVISION OF THE TEXT

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