Antisedan 5 mg/ml Solution for Injection

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Atipamezole Hydrochloride

Fáanlegur frá:

Orion Corporation

ATC númer:

QV03AB90

INN (Alþjóðlegt nafn):

Atipamezole Hydrochloride

Lyfjaform:

Solution for injection

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Cats, Dogs

Lækningarsvæði:

Neurological Agent

Leyfisstaða:

Authorized

Leyfisdagur:

1989-09-26

Vara einkenni

Revised: September 2019
AN: 01288/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Antisedan 5 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Atipamezole hydrochloride
5 mg/ml
EXCIPIENT:
Methyl parahydroxybenzoate (E 218)
1 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Atipamezole is indicated for the reversal of the sedative & analgesic
effects of
medetomidine or dexmedetomidine in dogs and cats. It also reverses all
other effects
of medetomidine or dexmedetomidine, such as cardiovascular and
respiratory
effects.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
After administration of this veterinary medicinal product, the animals
should be
allowed to rest in a maximally quiet place.
When any combination of butorphanol or medetomidine or dexmedetomidine
and
ketamine have been used, atipamezole should not be used to reverse the
effect in
dogs.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
With the exception of those drugs mentioned within the SPC, the
concurrent use of
drugs affecting the CNS is not recommended.
Revised: September 2019
AN: 01288/2018
Page 2 of 5
Antisedan should not be administered within 30-40 minutes of the
administration of
ketamine in cats. If the effect of the alpha-2 agonist is eliminated
earlier, the residual
effect of ketamine may cause convulsions.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Due to the potent pharmacological activity of atipamezole, contact
with skin or
mucosal membranes should be avoided and impervious gloves should be
worn
during administration. Care should be taken to avoid accidental
self-inj