ATIPAM VETERINARY

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

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Produktets egenskaber Produktets egenskaber (SPC)
26-10-2017

Aktiv bestanddel:

ATIPAMEZOLE HYDROCHLORIDE

Tilgængelig fra:

ABIC VETERINARY PRODUCTS LTD

Lægemiddelform:

SOLUTION FOR INJECTION

Sammensætning:

ATIPAMEZOLE HYDROCHLORIDE 5 MG/ML

Indgivelsesvej:

I.M

Recept type:

Required

Fremstillet af:

EUROVET ANIMAL HEALTH B.V., NETHERLANDS

Terapeutiske indikationer:

Atipamezole hydrochloride is a selective α2-antagonist that reverses the sedative effect of medetomidine and dexmedetomidine in dogs and cats.

Autorisation dato:

2018-10-31

Produktets egenskaber

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The format of this leaflet was determined by the Ministry of Health,
and its content was checked and
approved by the Ministry of Health.
PACKAGE LEAFLET
ATIPAM VETERINARY 5.0 MG/ML, SOLUTION FOR INJECTION FOR CATS AND DOGS
1.
NAME AND ADDRESS OF THE MANUFACTURER
Eurovet Animal Health BV
Handelsweg 25, 5531 AE Bladel, the Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Atipam Veterinary, 5.0 mg/ml, solution for injection for cats and
dogs.
Atipamezole hydrochloride
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER
INGREDIENT(S)
1 ml clear and colourless aqueous solution for injection contains:
ACTIVE SUBSTANCES:
Atipamezole hydrochloride
5.0 mg
(equivalent to 4.27 mg atipamezole base)
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218)
1.0 mg
4.
INDICATION(S)
Atipamezole hydrochloride is a selective α2-antagonist and indicated
for reversal of the
sedative effects of medetomidine and dexmedetomidine in cats and dogs.
5.
CONTRAINDICATIONS
The product should not be used in:
- Breeding animals
- Animals suffering from liver- or renal diseases.
See also section 12.
6.
ADVERSE REACTIONS
A transient hypotensive effect has been observed during the first 10
minutes post-injection of
atipamezole
hydrochloride.
In
rare
cases
hyperactivity,
tachycardia,
salivation,
atypical
vocalisation, muscle tremor, vomiting, increased respiratory rate,
uncontrolled urination and
uncontrolled defecation may occur. In very rare cases recurrence of
sedation may occur or the
recovery time may not be shortened after administration of
atipamezole.
In cats, when using low doses to partially reverse the effects of
medetomidine or
dexmedetomidine, the possibility of hypothermia (even when aroused
from sedation) should
be guarded against.
If you notice any serious effects or other effects not mentioned in
this leaflet, please inform
your veterinary surgeon or pharmacist.
7.
TARGET SPECIES
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Cats and dogs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF
ADMINISTRATION
For single intramuscular injection in cats and dogs. U
                                
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