Sedastop 5 mg/ml Solution for Injection for Cats and Dogs

Země: Velká Británie

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktivní složka:

Atipamezole Hydrochloride

Dostupné s:

Le Vet B.V.

ATC kód:

QV03AB90

INN (Mezinárodní Name):

Atipamezole Hydrochloride

Léková forma:

Solution for injection

Druh předpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Cats, Dogs

Terapeutické oblasti:

Neurological Agent

Stav Autorizace:

Authorized

Datum autorizace:

2010-06-04

Charakteristika produktu

Revised: August 2015
AN.01180/2014
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sedastop 5 mg/ml solution for injection for cats and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
_Active substance: _
Atipamezole hydrochloride 5.0 mg
(Equivalent to 4.27 mg of atipamezole)
_Excipients:_
Methyl parahydroxybenzoate (E 218) 1.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear colourless, sterile aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Atipamezole hydrochloride is indicated for reversal of the sedative
effects and
cardiovascular effects after use of alpha-2- agonists like
medetomidine and
dexmedetomidine in dogs and cats.
4.3
CONTRAINDICATIONS
Do not use in:
- Breeding animals
- Animals suffering from liver-, renal or cardiac diseases
See also section 4.7
Revised: August 2015
AN.01180/2014
Page 2 of 6
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 other sedatives than medetomidine are given it must be kept in mind
that the
effects of those other agents may persist after reversal of
(dex)medetomidine.
Atipamezole does not reverse the effect of ketamine, which may cause
seizures in
dogs and elicit cramps in cats when used alone. Do not use
atipamezole earlier than
30-40 minutes after concomitant administration of
ketamine.
SPECIAL
PRECAUTIONS
TO
BE
TAKEN
BY
THE
PERSON
ADMINISTERING
THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Due to the po