Revertor 5 mg/ml Solution for Injection for Dogs and Cats

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Atipamezole hydrochloride

Tilgjengelig fra:

CP-Pharma Handelsgesellschaft mbH

ATC-kode:

QV03AB90

INN (International Name):

Atipamezole hydrochloride

Dosering :

5 milligram(s)/millilitre

Legemiddelform:

Solution for injection

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cats, Dogs

Terapeutisk område:

atipamezole

Indikasjoner:

Neurological Preparations

Autorisasjon status:

Authorised

Autorisasjon dato:

2008-04-25

Preparatomtale

Health Products Regulatory Authority
02 July 2019
CRN0095H5
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Revertor 5 mg/ml Solution for Injection for Dogs and Cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
ACTIVE SUBSTANCE:
Atipamezole hydrochloride 5.0 mg
(equivalent to 4.27 mg atipamezole)
EXCIPIENT(S):
Methyl parahydroxybenzoate 1.0 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear colourless 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 a2-Antagonist and indicated
for reversal of the sedative effects of medetomidine and
dexmedetomidine in dogs and cats.
4.3 CONTRAINDICATIONS
Do not use in:
- Breeding animals.
- Animals suffering from liver- or renal diseases.
See also section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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. Make sure that the animal has regained a
normal swallowing reflex before any food or drink is offered.
Due to different dosing recommendations caution should be taken if
using the product off-label in animals other than the
target species. If other sedatives than 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 may cause
Health Products Regulatory Authority
02 July 2019
CRN0095H5
Page 2 of 4
seizures in dogs and elicit cramps in cats when used alone. Do not use
atipamezole earlier than 30-40 minutes after
concomitant administration of ketamine.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Due to the poten