Vetflurane 1000 mg/g Inhalation vapour, liquid

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Isoflurane

MAH:

Virbac S.A.

ATC_code:

QN01AB06

INN:

Isoflurane

dosage:

1000 milligram(s)/gram

pharmaceutical_form:

Inhalation vapour, liquid

prescription_type:

POM: Prescription Only Medicine 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_indication:

Neurological Preparations

authorization_status:

Authorised

authorization_date:

2010-09-24

SPC

Health Products Regulatory Authority
25 June 2019
CRN0094HZ
Page 1 of 8
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 import