Sedastart 1 mg/ml Solution for Injection for Cats and Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Medetomidine Hydrochloride

Available from:

Le Vet B.V.

ATC code:

QN05CM91

INN (International Name):

Medetomidine Hydrochloride

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Neurological Agent sedative

Authorization status:

Authorized

Authorization date:

2010-06-04

Summary of Product characteristics

Revised: September 2015
AN. 01179/2014
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sedastart 1 mg/ml solution for injection for cats and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
_Active substance:_
Medetomidine hydrochloride
1.0 mg
(equivalent to 0.85 mg medetomidine)
_Excipients:_
Methyl parahydroxybenzoate (E 218)
1.0 mg
Propyl parahydroxybenzoate
0.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear colourless, sterile aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog and Cat
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_In dogs and cats:_
Sedation to facilitate handling. Premedication prior to general
anaesthesia.
_In cats:_
In combination with ketamine for general anaesthesia for minor
surgical
procedures of short duration.
4.3
CONTRAINDICATIONS
Do not use in animals with:
-
severe cardiovascular disease or respiratory diseases or impaired
liver
or kidney
function.
-
mechanical disturbances of the gastrointestinal tract (torsio
ventriculi,
incarcerations, oesophagal obstructions).
-
pregnancy.
-
diabetes mellitus.
-
state of shock, emaciation or serious debilitation.
Revised: September 2015
AN. 01179/2014
Page 2 of 8
Do not use concomitantly with sympathomimetic amines.
Do not use in cases of known hypersensitivity to the active substance
or to
any other excipients.
Do not use in animals with ocular problems where an increase in
intraocular
pressure would be detrimental.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Medetomidine may not provide analgesia throughout the entire period of
sedation,
therefore
consideration
should
be
given
to
providing
additional
analgesia for painful procedures.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
A clinical examination should be carried out in all animals before the
use of
veterinary medicinal products for sedation and/or general anaesthesia.
Higher doses of medetomidine