Atipam 5.0 mg/ml, Solution for Injection for Cats and Dogs

Pays: Royaume-Uni

Langue: anglais

Source: VMD (Veterinary Medicines Directorate)

Ingrédients actifs:

Atipamezole Hydrochloride

Disponible depuis:

Eurovet Animal Health B.V.

Code ATC:

QV03AB90

DCI (Dénomination commune internationale):

Atipamezole Hydrochloride

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

POM-V - Prescription Only Medicine – Veterinarian

Groupe thérapeutique:

Cats, Dogs

Domaine thérapeutique:

Neurological Agent

Statut de autorisation:

Authorized

Date de l'autorisation:

2008-03-04

Résumé des caractéristiques du produit

Revised: June 2013
AN. 00690/2012
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Atipam, 5.0 mg/ml, solution for injection for cats and dogs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active ingredients
Atipamezole hydrochloride
5.0 mg
(equivalent to 4.27 mg atipamezole base)
Excipients
Methyl parahydroxybenzoate (E 218)
1.0 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless sterile aqueous solution.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Cats and dogs.
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Atipamezole hydrochloride is a selective α2-antagonist and is
indicated for reversal of
the sedative effects of medetomidine and dexmedetomidine in cats and
dogs.
4.3.
CONTRAINDICATIONS
The product should not be used in:
- Breeding animals
- Animals suffering from liver- or renal diseases
See also section 4.7.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Make sure the animal has regained a normal swallowing reflex before
any food or
drink is offered.
4.5.
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
After administration of the product, the animals should be allowed to
rest in a quiet
place. During recovery time animals should not be left unattended.
Due to different dosing recommendations caution should be taken if
using the
product off-label in animals other than the target species.
If sedatives other_ _than (dex)medetomidine are given, it must be kept
in mind that the
effects of those other agents may persist after reversal of
(dex)medetomidine.
Revised: June 2013
AN. 00690/2012
Page 2 of 5
Atipamezole does not reverse the effect of ketamine, which may cause
seizures in
dogs and elicit cramps in cats when used alone. Do not administer
atipamezole
within 30 – 40 minutes of prior administration of ketamine.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Due to the potent pharmacological activi