Narcostop 5 mg/ml, solution for injection for cats and dogs
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
22-03-2012
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Active ingredient:
atipamezole hydrochloride 5 mg/ml
Available from:
Le Vet B.V
ATC code:
QV03AB90
Pharmaceutical form:
Solution for injection
Therapeutic group:
atipamezole
Therapeutic area:
Cats, Dogs
Authorization date:
2011-03-30
Summary of Product characteristics
PART I B
SUMMARY OF PRODUCT CHARACTERISTICS, LABEL AND PACK AGE INSERT
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Narcostop 5 mg/ml – Solution for Injection for Cats and Dogs
(NL, AT, BE, CZ, EL, FR, HU, IS, IE, LU, PL, SK)
Sedastop 5 mg/ml – Solution for Injection for Cats and Dogs
(SE, NO, DK, ES, PT, IT, UK, FI)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
_ _
_Active substance: _
Atipamezole (as hydrochloride) 4.27 mg
Equivalent to 5.0 mg of atipamezole hydrochloride
_ _
_ _
_Excipients: _
Methyl parahydroxybenzoate (E 218) 1.0 mg
_ _
For a 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
on circulation
after use of alpha-2- agonists like medetomidine
and dexmedetomidine in dogs and cats.
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
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