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

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Medetomidine hydrochloride

Διαθέσιμο από:

Eurovet Animal Health B.V.

Φαρμακολογική κατηγορία (ATC):

QN05CM91

INN (Διεθνής Όνομα):

Medetomidine hydrochloride

Δοσολογία:

1.0 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Cats, Dogs

Θεραπευτική περιοχή:

medetomidine

Θεραπευτικές ενδείξεις:

Neurological Preparations

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2008-09-26

Αρχείο Π.Χ.Π.

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