DEXMOPET 0.5 mg/ml solution for injection for dogs and cats

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Dexmedetomidine hydrochloride

Disponibbli minn:

Vetpharma Animal Health, S.L.

Kodiċi ATC:

QN05CM18

INN (Isem Internazzjonali):

Dexmedetomidine hydrochloride

Dożaġġ:

0.5 milligram(s)/millilitre

Għamla farmaċewtika:

Solution for injection

Tip ta 'preskrizzjoni:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupp terapewtiku:

Cats, Dogs

Żona terapewtika:

dexmedetomidine

Indikazzjonijiet terapewtiċi:

Neurological Preparations

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2016-08-26

Karatteristiċi tal-prodott

Health Products Regulatory Authority
14 February 2022
CRN00CSG8
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
DEXMOPET 0.5 mg/ml solution for injection for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
ACTIVE SUBSTANCE:
​
​
Dexmedetomidine
​
0.42 mg
​
(equivalent to 0.5 mg of dexmedetomidine hydrochloride)
​
​
​
​
EXCIPIENTS:
​
​
Methyl parahydroxybenzoate (E 218)
​
1.60 mg
​
Propyl parahydroxybenzoate
​
0.20 mg
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
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Non-invasive, mildly to moderately painful, procedures and
examinations which require restraint, sedation and analgesia in
dogs and cats.
Deep sedation and analgesia in dogs in concomitant use with
butorphanol for medical and minor surgical procedures.
Premedication in dogs and cats before induction and maintenance of
general anaesthesia.
4.3 CONTRAINDICATIONS
Do not use in animals with cardiovascular disorders, severe systemic
disease or impaired liver or kidney function.
Do not use in animals with mechanical disturbances or the
gastrointestinal tract (torsio ventriculi, incarcerations, oesophageal
obstructions).
Do not use in pregnant animals (see also section 4.7)
Do not use in animals with diabetes mellitus
Do not use in cases of state of shock, emaciation or serious
debilitation.
Do not use concomitantly with sympathomimetic amines.
Do not use in cases of known hypersensitivity to the active substance
or to any of the 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
None
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Treated animals should be kept warm and at a constant temperature,
both during the procedure and recovery.
Health Pro