NIMATEK 100 MG/ML, SOLUTION FOR INJECTION FOR DOGS
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
07-05-2024
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Virkt innihaldsefni:
KETAMINE HYDROCHLORIDE
Fáanlegur frá:
Eurovet Animal Health B.V.
ATC númer:
QN01AX03
INN (Alþjóðlegt nafn):
KETAMINE HYDROCHLORIDE
Skammtar:
100 Mg/Ml
Lyfjaform:
Solution for Injection
Gerð lyfseðils:
VPO-Vet.Practitioner Only
Meðferðarhópur:
Canine, Equine - Food, Feline
Lækningarsvæði:
Ketamine
Ábendingar:
Neurological Preparations
Leyfisstaða:
Authorised
Leyfisdagur:
2014-05-09
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
NIMATEK 100 mg/ml, Solution for injection for dogs, cats and horses.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains:
ACTIVE SUBSTANCE:
Ketamine
100 mg
(corresponding to ketamine hydrochloride 115.4 mg)
EXCIPIENT(S):
Chlorocresol (preservative) 1 mg
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
Dogs, cats and horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE 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 a benefit/risk assessment performed by the veterinarian the 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.
4.3 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 any of the excipients.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 09/05/2014_
_CRN 7015018_
_page number: 1_
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 a
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