Dexdomitor
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
29-04-2021
Produktets egenskaber
(SPC)
29-04-2021
Offentlige vurderingsrapport
(PAR)
09-10-2012
Aktiv bestanddel:
Dexmedetomidine hydrochloride
Tilgængelig fra:
Orion Corporation
ATC-kode:
QN05CM18
INN (International Name):
dexmedetomidine
Terapeutisk gruppe:
Dogs; Cats
Terapeutisk område:
Psycholeptics
Terapeutiske indikationer:
Noninvasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.Premedication in cats before induction and maintenance of general anaesthesia with ketamine.Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.Premedication in dogs before induction and maintenance of general anaesthesia.
Produkt oversigt:
Revision: 20
Autorisation status:
Authorised
Autorisation dato:
2002-08-30
Indlægsseddel
29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET
DEXDOMITOR 0.1 mg/ml solution for injection
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND
OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE, IF DIFFERENT
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DEXDOMITOR 0.1 mg/ml solution for injection
dexmedetomidine hydrochloride
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Active substance:
One ml contains 0.1 mg dexmedetomidine hydrochloride
equivalent to 0.08 mg dexmedetomidine.
List of excipients:
Methyl parahydroxybenzoate (E 218) 2.0 mg/ml
Propyl parahydroxybenzoate (E 216)
0.2 mg/ml
4.
INDICATION(S)
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.
5.
CONTRAINDICATIONS
Do not use in animals with cardiovascular disorders.
Do not use in animals with severe systemic disease or in animals that
are moribund.
Do not use in case of known hypersensitivity to the active substance
or to any of the excipients.
6.
ADVERSE REACTIONS
By virtue of its
a
2
-adrenergic activity, dexmedetomidine causes decreases in heart rate
and body
temperature.
In some dogs and cats a decrease in respiratory rate may occur. Rare
instances of pulmonary oedema
have been reported. Blood pressure will increase initially and then
return to normal or below normal.
Due to peripheral vasoconstriction and venous desaturation in the
presence of normal arterial
oxygenation, the mucous membranes may appear pale and/or with a blue
tinge.
31
Vomiting may occur 5–10 minutes after injection.
Some dogs and cats may also vomit at the time of recovery.
Muscle tremors may occur during sedation.
When dexmedetomidine and ketamine are used sequentially, with a 10
minute
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DEXDOMITOR 0.1 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
One ml contains 0.1 mg dexmedetomidine hydrochloride
equivalent to 0.08 mg dexmedetomidine.
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218) 2.0 mg/ml
Propyl parahydroxybenzoate (E 216)
0.2 mg/ml
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.
Do not use in animals with severe systemic disease or in animals that
are moribund.
Do not use in case of known hypersensitivity to the active substance
or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The administration of dexmedetomidine to puppies younger than 16 weeks
and kittens younger than 12
weeks has not been studied.
The safety of dexmedetomidine has not been established in males
intended for breeding.
In cats, corneal opacities may occur during sedation. The eyes should
be protected by a suitable eye
lubricant.
3
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.
It is recommended that animals are fasted for 12 hours prior to
Dexdomitor administration. Water may
be given
_._
After treatment, the animal should not be given water or food before
it is able to swallow.
The eyes should be protected by a suitable lubricant.
To be used w
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