Anesketin 100 mg/ml Solution for Injection for Dogs, Cats and Horses

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

유효 성분:

Ketamine

제공처:

Eurovet Animal Health B.V.

ATC 코드:

QN01AX03

INN (국제 이름):

Ketamine

약제 형태:

Solution for injection

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Cats, Dogs, Horses

치료 영역:

Neurological Agent general anaesthetic

승인 상태:

Authorized

승인 날짜:

2013-07-10

제품 특성 요약

Revised: June 2018
AN: 01506/2017
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ANESKETIN 100 mg/ml solution for injection for dogs, cats and horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Active substance:
Ketamine
100 mg
(corresponding to ketamine hydrochloride 115.4 mg)
Excipient:
Chlorocresol
1 mg
For the 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 and horse.
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 butorphanol and medetomidine in the dog and cat,
b)
in combination with xylazine in the horse, dog and cat,
c)in combination with detomidine in the horse,
d)
in combination with romifidine in the horse.
4.3
CONTRAINDICATIONS
Do not use:
•
in animals with hepatic or renal failure.
•
ketamine as a sole agent in the horse or the dog.
•
in animals with severe cardiac de-compensation, suspected pulmonary
disease, apparent high blood pressure or cerebrovascular insults.
•
in animals with 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).
•
in animals undergoing a myelogram procedure.
Revised: June 2018
AN: 01506/2017
Page 2 of 13
Do not use in known cases of hypersensitivity to the active substance
or any of the
excipients.
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 surgical procedures cannot b