Antisedan 5 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atipamezole hydrochloride

Available from:

Orion Corporation

ATC code:

QV03AB90

INN (International Name):

Atipamezole hydrochloride

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

atipamezole

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2010-02-26

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Antisedan 5 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains:
Active substance:
Atipamezole (as atipamezole hydrochloride)
5 mg
Excipients:
Methyl parahydroxybenzoate (E 218)
1 mg
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
Elimination of the sedative and other effects of medetomidine or
dexmedetomidine in dogs and cats.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in pregnant animals (see section 4.7).
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.
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4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
This veterinary medicinal product must not be administered earlier
than 30 to 40 minutes if used in patients administered ketamine
with medetomidine or dexmedetomidine. If the effect of the alpha-2
agonist is eliminated earlier, the residual effect of ketamine may
cause convulsio