Ketaset 100 mg/ml Solution for Injection

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Ketamine

Tilgængelig fra:

Zoetis UK Limited

ATC-kode:

QN01AX03

INN (International Name):

Ketamine

Lægemiddelform:

Solution for injection

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cats, Dogs, Horses, Sub Human Primates

Terapeutisk område:

Neurological Agent general anaesthetic

Autorisation status:

Authorized

Autorisation dato:

1990-04-20

Produktets egenskaber

Revised: August 2020
AN: 00685/2020
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ketaset
100 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Ketamine
100mg/ml.
(Equivalent to ketamine hydrochloride 115.36 mg/ml)
EXCIPIENT(S):
Benzethonium chloride (preservative)
0.01%
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless liquid free from visible evidence of contamination.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog, cat, horse and sub-human primates.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Ketaset is a dissociative anaesthetic agent for use by intramuscular,
subcutaneous or intravenous injection.
Ketaset may be used as a sole agent for restraint and minor surgical
procedures where muscle relaxation is not required in the domestic cat
and sub-human primates.
Ketaset may also be used to induce anaesthesia:
a)
In conjunction with butorphanol (Torbugesic Injection) 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.
Revised: August 2020
AN: 00685/2020
Page 2 of 15
4.3
CONTRAINDICATIONS
•
Do not use in animals with hepatic or renal failure.
•
Xylazine
and
detomidine
must
not
be
used
in
late
stages
of
pregnancy.
•
Medetomidine must not be used in pregnant cats.
•
Do not use Ketaset Injection as a sole agent in the horse.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
A small proportion of animals have been reported to be unresponsive
to Ketaset as an anaesthetic agent at normal dosages. Use of
premedicants should be followed by a suitable reduction in dosage.
Care should be taken when using Ketaset-halothane combinations
since the half-life of ketamine is prolonged.
When used in combination with other products, consult the contra-
in