Sedastop 5 mg/ml solution for injection for cats and dogs

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Atipamezole hydrochloride

Mevcut itibaren:

Le Vet BV

ATC kodu:

QV03AB90

INN (International Adı):

Atipamezole hydrochloride

Doz:

5 milligram(s)/millilitre

Farmasötik formu:

Solution for injection

Reçete türü:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapötik grubu:

Cats, Dogs

Terapötik alanı:

atipamezole

Terapötik endikasyonlar:

Neurological Preparations

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2010-05-28

Ürün özellikleri

Health Products Regulatory Authority
25 June 2019
CRN0094HY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Sedastop 5 mg/ml solution for injection for cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
_Active substance: _
Atipamezole hydrochloride 5.0 mg
(Equivalent to 4.27 mg of atipamezole)
_Excipients:_
Methyl parahydroxybenzoate (E 218) 1.0 mg
For the 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 after use of alpha-2-
agonists like medetomidine and dexmedetomidine in dogs and cats.
4.3 CONTRAINDICATIONS
Do not use in:
- Breeding animals
- Animals suffering from liver-, renal or cardiac 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.
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
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.
Health Products Regulatory Authority
25 June 2019
CRN0094HY
Page 2 of 5
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETER