Domosedan 10 mg/ml Solution for Injection

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktívna zložka:

Detomidine Hydrochloride

Dostupné z:

Orion Corporation

ATC kód:

QN05CM90

INN (Medzinárodný Name):

Detomidine Hydrochloride

Forma lieku:

Solution for injection

Typ predpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Horses

Terapeutické oblasti:

Neurological Agent sedative

Stav Autorizácia:

Authorized

Dátum Autorizácia:

1985-02-13

Súhrn charakteristických

Revised: June 2020
AN: 02164/2019
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DOMOSEDAN 10 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT:
Detomidine hydrochloride
10 mg/ml
EXCIPIENTS:
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
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
A sedative with analgesic properties used to facilitate handling of
horses for
examination, minor surgical interventions and other manipulations._ It
can be _
_used with or without butorphanol._
The product is also indicated for use with ketamine for short duration
general
anaesthesia to carry out surgical procedures such as castration.
4.3
CONTRAINDICATIONS
1.
Do
not
use
in
conjunction
with
sympathomimetic
amines
or
with
intravenous potentiated sulphonamides.
2.
Do not administer simultaneously with ketamine in the same syringe
(see
sections 4.8 and 4.9).
_3._
_Do not use the butorphanol combination in horses suffering from
colic._
4.
Do not use in seriously ill animals with heart failure or impaired
liver or
kidney function.
Revised: June 2020
AN: 02164/2019
Page 2 of 7
5.
Do not use in case of hypersensitivity to the active substance or to
any of
the excipients.
6.
Do not administer to horses in the last month of pregnancy
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
The product should not be used in horses with pre-existing AV blocks,
with severe cardiac insufficiency, respiratory disease or chronic
renal
failure.
Careful consideration should be given prior to administration to
animals
in shock and to animals with liver or kidney disease.
Intravenous administration should be slow.
It is recommended that feed should be withheld for at least 12 hours
prior to anaesthesia.
The horse should not be