Halothane-Vet 100% Inhalation Vapour, Liquid

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Halothane

Available from:

Merial Animal Health Limited

ATC code:

QN01AB01

INN (International Name):

Halothane

Pharmaceutical form:

Inhalation vapour, solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

All Animals, Horses

Therapeutic area:

Neurological Agent general anaesthetic

Authorization status:

Expired

Authorization date:

1988-10-04

Summary of Product characteristics

Revised: July 2008
AN: 00264/2008
Page 1 of 5
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Halothane-Vet 100% Inhalation vapour, liquid.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Halothane 100% w/w. (Includes Thymol 0.01% w/w as a preservative).
For full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation vapour, liquid.
A clear colourless volatile liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses, domestic animals, and non-domesticated mammals, birds and
reptiles.
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
The induction and maintenance of general anaesthesia.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS (FOR EACH TARGET SPECIES)
Malignant hyperthermia has been reported in the dog and horse but its
incidence is
rare.
4.5
SPECIAL PRECAUTIONS FOR USE, INCLUDING SPECIAL PRECAUTIONS TO BE TAKEN
BY THE
PERSON ADMINISTERING THE MEDICINAL PRODUCT TO THE ANIMALS
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
During the induction of anaesthesia, a moderate fall in blood pressure
commonly
occurs. The pressure tends to rise when the vapour concentration is
reduced to
maintenance levels, but it usually remains steady below the
pre-operative level.
(II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL
PRODUCT TO THE ANIMALS
Do not breathe vapour.
Avoid contact by mouth.
Pregnant and breast-feeding women should avoid exposure to the product
and
should avoid operating rooms and animal recovery areas.
Use with efficient scavenging equipment. To protect the environment,
the use of
Revised: July 2008
AN: 00264/2008
Page 2 of 5
charcoal filters with such equipment is to be encouraged to reduce the
amounts
discharged to the atmosphere.
Ensure that the operating room has an adequate active extraction
system.
Care should be taken when dispensing Halothane, with any spillage
removed
immediately using inert and absorbent material e.g. sawdust.
Use cuffed endotrachael intubation whenever possible for the
maintenance of
general anaesthesia with Halothane.
Where
possible,
vap