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

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Atipamezole hydrochloride

Mevcut itibaren:

Alfasan Nederland B.V

ATC kodu:

QV03AB90

INN (International Adı):

Atipamezole hydrochloride

Farmasötik formu:

Solution for injection

Reçete türü:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapötik alanı:

atipamezole

Yetkilendirme tarihi:

2023-08-18

Ürün özellikleri

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dormostop 5 mg/ml solution for injection for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Atipamezole
4.27 mg
(equivalent to 5.0 mg atipamezole hydrochloride)
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
Methyl parahydroxybenzoate (E218)
1.0
mg
Sodium chloride
Hydrochloric acid, diluted (for pH-
adjustment)
Sodium hydroxide (for pH-adjustment)
Water for injections
Clear colourless, practically free from particles solution.
3. CLINICAL INFORMATION
3.1
TARGET SPECIES
Dog, cat
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Reversal of the sedative effects of medetomidine and dexmedetomidine.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in animals suffering from hepatic or renal diseases.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species
After administration of the veterinary medicinal product, the animals
should be allowed to rest in a
quiet place.
Atipamezole reverses all effects of (dex)medetomidine, thus the
sedative, analgesic and cardiovascular
effects which may lead to a transient increase in heart rate.
2
If sedatives other than (dex)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 administer atipamezole within
30 – 40 minutes of prior
administration of ketamine.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
The veterinary medicinal product may cause irritation to the skin,
eyes and mucous membranes.
Dermal and ocular exposure should therefore be avo