Atipam (5.0 mg/ml solution for injection for Cats and Dogs - atipamezole hydrochloride
Country: Slovenia
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
06-07-2013
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Active ingredient:
atipamezole hydrochloride 5 mg
Available from:
Eurovet Animal Health
ATC code:
QV03AB90
Pharmaceutical form:
Solution for injection
Therapeutic group:
atipamezole
Therapeutic area:
Cats, Dogs
Authorization date:
2008-12-02
Summary of Product characteristics
Revised: June 2013
AN. 00690/2012
Page 1 of 5
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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.
Revised: June 2013
AN. 00690/2012
Page 2 of 5
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If sedatives other_ _than (dex)medetomidine are given, it must be kept in mind that the
effects of thos
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