Sedator 1.0 mg/ml Solution for Injection for Cats and Dogs

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

Medetomidine Hydrochloride

Disponibil de la:

Eurovet Animal Health B.V.

Codul ATC:

QN05CM91

INN (nume internaţional):

Medetomidine Hydrochloride

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

POM-V - Prescription Only Medicine – Veterinarian

Grupul Terapeutică:

Cats, Dogs

Zonă Terapeutică:

Neurological Agent sedative

Statutul autorizaţiei:

Authorized

Data de autorizare:

2007-03-21

Caracteristicilor produsului

Revised: April 2019
AN: 01582/2018
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SEDATOR, 1.0 mg/ml, solution for injection for cats and dogs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Active substance
Medetomidine hydrochloride
1.0 mg
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.
Clear and colourless solution
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Dogs, cats.
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_Dogs_: for restraint, sedation and analgesia associated with clinical
examinations and procedures, minor surgery, pre-anaesthesia and as a
premedication before thiopentone-halothane general anaesthesia and as
a
premedicant before general anaesthesia with propofol. In combination
with
butorphanol for sedation, analgesia and as a premedicant to
thiopentone
anaesthesia.
_Cats_: for restraint and sedation. In combination with ketamine for
induction of
general anaesthesia prior to surgical procedures in the cat. In
combination
with butorphanol for sedation and analgesia, and combined with both
butorphanol and ketamine for general anaesthesia. As a premedication
before
alphaxalone/alphadolone for general anaesthesia.
4.3.
CONTRAINDICATIONS
Do not use in conjunction with sympathomimetic amines. Care should be
taken with the use of medetomidine in animals with cardiovascular
disease or
in poor general health.
Before using any combinations consult the contraindications and
warnings that
appear on the other products’ data sheet.
Medetomidine should not be used with thiopentone or propofol in
animals with
cardiac or respiratory disease (see also section 4.10).
Revised: April 2019
AN: 01582/2018
Page 2 of 10
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
An appropriately graduated syringe must be used to allow accurate
administration of the required dose volume. This is particularly
important when
injecting sm