Ketavet 100 mg/ml solution for injection for dogs, cats and horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ketamine

Available from:

Zoetis Belgium S.A.

ATC code:

QN01AX03

INN (International Name):

Ketamine

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs, Horses

Therapeutic area:

ketamine

Therapeutic indications:

Anaesthetic/Analgesic

Authorization status:

Authorised

Authorization date:

2015-03-20

Summary of Product characteristics

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ketaset 100 mg/ml solution for injection for dogs, cats and horses
(AT, DE, ES, PT)
Ketavet 100 mg/ml solution for injection for dogs, cats and horses
(UK(NI), CY, EL, IE)
Ketastesic Vet 100 mg/ml solution for injection for dogs, cats and
horses
(IT)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ketamine
100 mg
(Equivalent to ketamine hydrochloride)
115.35 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt
Benzethonium chloride
0.10 mg
Water for injections
Solution for injection.
Clear, colourless solution, free from visible evidence of
contamination.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs, cats and horses.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
The product may be used to induce anaesthesia:
a) in conjunction with butorphanol and medetomidine in the dog and
cat,
b) in conjunction with xylazine in the dog, cat and horse,
c) in conjunction with detomidine in the horse,
d) in conjunction with romifidine in the horse.
Based on the benefit/risk assessment performed by the veterinarian the
product may be used as a sole
agent for restraint and minor surgical procedures where muscle
relaxation is not required in the
domestic cat.
3.3
CONTRAINDICATIONS
Do not use in animals with pre-existing hepatic or renal pathology.
Do not use in animals with severe cardiac de-compensation or with
apparent high blood pressure or
glaucoma.
Do not reverse ketamine combinations in dogs with atipamezole.
3
Do not use ketamine as a sole agent in dogs or horses.
Do not use in animals with eclampsia or pre-eclampsia.
Do not use for surgical intervention on pharynx, larynx, trachea or
bronchial tree, if sufficient
relaxation is not ensured by administration of a muscle relaxant
(intubation obligatory).
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL