Antisedan 5 mg/ml solution for injection

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Atipamezole hydrochloride

זמין מ:

Orion Corporation

קוד ATC:

QV03AB90

INN (שם בינלאומי):

Atipamezole hydrochloride

כמות:

5 milligram(s)/millilitre

טופס פרצבטיות:

Solution for injection

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Cats, Dogs

איזור תרפויטי:

atipamezole

סממני תרפויטית:

Neurological Preparations

מצב אישור:

Authorised

תאריך אישור:

2010-02-26

מאפייני מוצר

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