Ketamidor
Country: Austria
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
15-02-2013
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Active ingredient:
ketamine hydrochloride 100 mg/ml
Available from:
Richter Pharma AG
ATC code:
QN01AX03
Pharmaceutical form:
Solution for injection
Therapeutic group:
ketamine
Therapeutic area:
Cats, Cattle Food, Dogs, Horses Food, Pigs Food
Authorization date:
2012-11-21
Summary of Product characteristics
21. November 2012
1
_[Version 8, 10/2012] _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AT, BE, EL, ES, FR, HU, IE, NL, PT, UK:
Ketamidor 100 mg/ml solution for injection
DK, IS, SE, FI:
Ketador vet. 100 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE :
Ketamine (as hydrochloride)
100 mg
EXCIPIENT:
Benzethonium chloride
0.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to nearly colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horse, cattle, pig, dog, cat.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To be used as a sole agent for restraint and minor surgical procedures in the cat, where muscle
relaxation is not required.
To be used to induce anaesthesia:
a) in combination with detomidine in the horse.
b) in combination with xylazine in the horse, in cattle, dog and in the cat.
c) in combination with azaperone in the pig.
d) in combination with medetomidine in the dog and cat.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in
animals with severe cardiac de-compensation, apparent high blood pressure, cerebrovascular insults
and disorders in liver- and kidney function.
Do not use in eclampsia, pre-eclampsia, glaucoma and seizure disorders (e.g. epilepsy). Not
recommended for surgical intervention on pharynx, larynx, trachea or bronchial tree, if
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