Ketamidor 100 mg/ml Solution for Injection

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Ketamine

Dostępny od:

VetViva Richter GmbH

Kod ATC:

QN01AX03

INN (International Nazwa):

Ketamine

Forma farmaceutyczna:

Solution for injection

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Cats, Cattle, Dogs, Horses, Pigs

Dziedzina terapeutyczna:

Neurological Agent general anaesthetic

Status autoryzacji:

Authorized

Data autoryzacji:

2013-02-07

Charakterystyka produktu

Revised: January 2023
AN: 02966/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ketamidor 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 almost 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.
e)
in combination with diazepam in the dog.
4.3
CONTRAINDICATIONS
Do not use:

in animals with severe cardiac de-compensation, suspected pulmonary
disease,
apparent high blood pressure, or cerebrovascular insults.

in animals with pre-existing liver and kidney pathology.

in eclampsia, pre-eclampsia, glaucoma and seizure disorders (e.g.
epilepsy).

for surgical intervention on pharynx, larynx, trachea or bronchial
tree, if sufficient
relaxation is not ensured by administration of a muscle relaxant
(intubation
obligatory).
Revised: January 2023
AN: 02966/2022
Page 2 of 8

in animals undergoing a myelogram procedure.
Do not use in cases of hypersensitivity to the active substance or to
the excipient.
Do not use the product as a sole anaesthetic agent in any other
species apart from
the cat.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
For very painful and major surgical interventions, as well as for
maintenance of
anaesthesia, a combination with injectable- or inhalation-anaesthetics
is necessary.
As muscle relaxation required for surgica