SEDATOR, 1.0 mg/ml, solution for injection for cats and dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Medetomidine hydrochloride

Available from:

Eurovet Animal Health B.V.

ATC code:

QN05CM91

INN (International Name):

Medetomidine hydrochloride

Dosage:

1.0 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

medetomidine

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2008-09-26

Summary of Product characteristics

Health Products Regulatory Authority
29 April 2019
CRN009165
Page 1 of 8
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).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
An appropriately graduated syringe must be used to allow accurate
administration of the required dose volume. Th