Dormostop 5 mg/ml Solution for Injection for Dogs and Cats

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Atipamezole Hydrochloride

Inapatikana kutoka:

Alfasan Nederland B.V.

ATC kanuni:

QV03AB90

INN (Jina la Kimataifa):

Atipamezole Hydrochloride

Dawa fomu:

Solution for injection

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Cats, Dogs

Eneo la matibabu:

Neurological Agent

Idhini hali ya:

Authorized

Idhini ya tarehe:

2023-07-26

Tabia za bidhaa

Issued: July 2023
AN: 00676/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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)
1.0mg
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.
Issued: July 2023
AN: 00676/2022
Page 2 of 6
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.
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 medicina