Ketabel 100 mg/ml Solution for Injection

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

Ketamine

Disponibil de la:

Bela-Pharm GmbH & Co. KG

Codul ATC:

QN01AX03

INN (nume internaţional):

Ketamine

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

POM-V - Prescription Only Medicine – Veterinarian

Grupul Terapeutică:

Cats, Cattle, Dogs, Goats, Guinea Pig, Hamster, Horses, Mouse, Pigs, Rabbits, Rat, Sheep

Zonă Terapeutică:

Neurological Agent general anaesthetic

Statutul autorizaţiei:

Authorized

Data de autorizare:

2020-07-28

Caracteristicilor produsului

Unlimited Renewal: May 2024
AN: 00164/2024
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ketabel 100 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ketamine
100 mg
(equivalent to ketamine hydrochloride
115.34 mg)
EXCIPIENTS:
Chlorobutanol hemihydrate
5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs, cats, cattle, sheep, goats, horses, pigs, guinea pigs, hamsters,
rabbits, rats,
and mice.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product may be used in combination with a sedative for:
- Immobilisation
- Sedation
-General anaesthesia
4.3
CONTRAINDICATIONS
Do not use in animals presenting with:
- severe hypertension,
- cardio-respiratory deficiency,
- hepatic or renal dysfunction.
Do not use in animals with glaucoma.
Unlimited Renewal: May 2024
AN: 00164/2024
Page 2 of 10
Do not use in animals with eclampsia or pre-eclampsia.
Do not use in cases of hypersensitivity to the active substance or any
of the
excipients.
Do not use the product as a sole anaesthetic agent in any of the
target species.
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 ocular surgical interventions;
Do not use in animals undergoing a myelogram procedure.
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 inhalational
anaesthetics is indicated.
As muscle relaxation required for surgical procedures cannot be
achieved with
ketamine alone, additional muscle-relaxants should be used
concomitantly.
For improvement of anaesthesia or prolongation of effect, ketamine can
be combined
with
α2-receptor-agonists,
anaesthetic