Alzane 5 mg/ml, Solution for Injection for Dogs and Cats

Země: Velká Británie

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktivní složka:

Atipamezole Hydrochloride

Dostupné s:

Laboratorios SYVA S.A.U

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:

2010-05-20

Charakteristika produktu

Revised: June 2015
AN: 00904/2014
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Alzane 5 mg/ml, solution for injection for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Atipamezole hydrochloride
5.0 mg
(equivalent to 4.27 mg atipamezole base)
Excipients
Methyl parahydroxybenzoate (E 218)
1.0 mg
For the 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
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Atipamezole hydrochloride is a selective α2-antagonist and indicated
for reversal of
the sedative effects of medetomidine and dexmedetomidine in dogs and
cats.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substance or to any of
the excipients.
Do not use in breeding animals or animals suffering from hepatic,
renal or cardiac
diseases.
See also section 4.7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Revised: June 2015
AN: 00904/2014
Page 2 of 6
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 animals should not be left unattended.
Make sure the animal has regained a normal swallowing reflex before
any food or
drink is offered.
Due to different dosing recommendations caution should be taken using
the product
off label in animals other than the target species.
If sedatives other_ _than medetomidine or dexmedetomidine are given,
it must be kept
in mind that the effects of those other agents may persist after the
reversal of the
effect of the α2-agonist.
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