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

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: VMD (Veterinary Medicines Directorate)

सक्रिय संघटक:

Ketamine

थमां उपलब्ध:

Zoetis UK Limited

ए.टी.सी कोड:

.QN01AX0

INN (इंटरनेशनल नाम):

Ketamine

फार्मास्यूटिकल फॉर्म:

Solution for injection

प्रिस्क्रिप्शन प्रकार:

POM-V - Prescription Only Medicine – Veterinarian

चिकित्सीय समूह:

Cats, Dogs, Horses

चिकित्सीय क्षेत्र:

Neurological Agent general anaesthetic

प्राधिकरण का दर्जा:

Authorized

प्राधिकरण की तारीख:

2015-03-18

उत्पाद विशेषताएं

Revised: May 2020
AN: 01887/2019
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ketavet 100 mg/ml solution for injection for dogs, cats and horses.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ketamine:
100 mg
(Equivalent to ketamine hydrochloride)
115.35 mg
EXCIPIENT(S):
Benzethonium chloride:
0.10 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution, 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 the benefit/risk assessment performed by the veterinarian the
product may
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 pre-existing hepatic or renal pathology.
Do not use in animals with severe cardiac de-compensation or with
apparent high blood
pressure or glaucoma.
Do not reverse ketamine combinations in dogs with atipamezole.
Do not use ketamine as a sole agent in dogs or horses.
Revised: May 2020
AN: 01887/2019
Page 2 of 14
Do not use in animals with eclampsia or pre-eclampsia.
Do not use for surgical intervention on pharynx, larynx, trachea or
bronchial tree, if
sufficient relaxation is not ensured by administration of a muscle
relaxant (intubation
obligatory).
Do not use in cases of hypersensitivity to the active substance or to
the excipient.
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
i