ATIPAM, 5.0 MG/ML SOLUTION FOR INJECTION FOR CATS AND DOGS
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
10-05-2024
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Virkt innihaldsefni:
ATIPAMEZOLE HYDROCHLORIDE
Fáanlegur frá:
Eurovet Animal Health B.V.
ATC númer:
QV03AB90
INN (Alþjóðlegt nafn):
ATIPAMEZOLE HYDROCHLORIDE
Skammtar:
5.0 Mg/Ml
Lyfjaform:
Solution for Injection
Gerð lyfseðils:
POM
Meðferðarhópur:
Canine, Feline
Lækningarsvæði:
Atipamezole
Ábendingar:
Neurological Preparations
Leyfisstaða:
Authorised
Leyfisdagur:
2008-05-23
Vara einkenni
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
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 2-antagonist and 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.
Each ml contains:
Active ingredients
Atipamezole hydrochloride (equivalent to 4.27 mg atipamezole base) 5.0 mg
Excipients
Methyl parahydroxybenzoate (E 218)
1.0 mg
For a full list of excipients, see section 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 07/06/2013_
_CRN 7013323_
_page number: 1_
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.
Atipamezole does not reverse the effect of ketamine, which m
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