Isothesia 1000 mg/g inhalation vapour, liquid

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Isoflurane

Available from:

Piramal Critical Care B.V.

ATC code:

QN01AB06

INN (International Name):

Isoflurane

Dosage:

1000 milligram(s)/gram

Pharmaceutical form:

Inhalation vapour, liquid

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

isoflurane

Authorization status:

Authorised

Authorization date:

2020-04-09

Summary of Product characteristics

Health Products Regulatory Authority
18 December 2020
CRN009YVW
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Isothesia 1000 mg/g inhalation vapour, liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Isoflurane 1000 mg
3 PHARMACEUTICAL FORM
Inhalation vapour, liquid.
Clear, colourless, mobile, heavy 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 cases of known susceptibility to malignant hyperthermia.
Do not use in cases of known hypersensitivity to isoflurane or to
other halogenated agents/ halogenated inhalation
anaesthetics.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The ease and rapidity of alteration of the depth of anaesthesia with
isoflurane and its low metabolism, may be considered
advantageous for its use in special groups of patients such as the old
or young, and those with impaired hepatic, renal or
cardiac function.
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 is important to monitor breathing and pulse for the frequency and
its features. Respiratory arrest should be treated by
assisted ventilation. It is important to maintain airways free and
properly oxygenate tissues during the maintenance of
anaesthesia. In the case of cardiac arrest, perform a complete cardio
pulmonary resuscitation.
The metabolism of isoflurane in birds and small mammals, can be
affected by decreases in body temperature, that ma