NIMATEK 100 mg/ml, Solution for injection for dogs, cats and horses

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Ketamine hydrochloride

MAH:

Eurovet Animal Health B.V.

ATC_code:

QN01AX03

INN:

Ketamine hydrochloride

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_indication:

Neurological Preparations

authorization_status:

Authorised

authorization_date:

2014-05-09

SPC

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NIMATEK
100 mg/ml, Solution for injection for dogs, cats and horses (AT, IE,
IT, PL, PT, UK(NI)).
Nimatek vet 100 mg/ml, Solution for injection for dogs, cats and
horses (FI, SE).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
100 mg ketamine equivalent to 115.4 mg ketamine hydrochloride
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
Chlorocresol
1 mg
Sodium hydroxide
Hydrochloric acid
Water for injections
Clear, colourless liquid 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 veterinary medicinal 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 a benefit/risk assessment performed by the veterinarian the
veterinary medicinal product
may also 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 hepatic or renal failure.
Do not use ketamine as a sole agent in the horse or the dog.
Do not use in animals with severe cardiac de-compensation, apparent
high blood pressure or
glaucoma.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
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
surgical procedures cannot be achieved with ketamine alone, additional
muscle-relaxants should be
used concomitantly. For improvement of anaesthesia