Sedadex

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Dexmedetomidine hydrochloride

Saatavilla:

Le Vet Beheer B.V.

ATC-koodi:

QN05CM18

INN (Kansainvälinen yleisnimi):

dexmedetomidine

Terapeuttinen alue:

Psycholeptics, Hypnotics and sedatives

Käyttöaiheet:

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.

Tuoteyhteenveto:

Revision: 5

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2016-08-12

Pakkausseloste

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET
Sedadex 0.1 mg/ml solution for injection for dogs and cats
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Le Vet Beheer B.V.
Wilgenweg 7
3421 TV Oudewater
The Netherlands
Manufacturer responsible for batch release:
Produlab Pharma B.V.
Forellenweg 16
4941 SJ Raamsdonksveer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sedadex 0.1 mg/ml solution for injection for dogs and cats
dexmedetomidine hydrochloride
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
1 ml contains:
ACTIVE SUBSTANCE:
Dexmedetomidine hydrochloride
0.1 mg
(equivalent to dexmedetomidine
0.08 mg)
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218)
2.0 mg
Propyl parahydroxybenzoate
0.2 mg
Clear, colourless solution for injection.
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.
31
Do not use in case of known hypersensitivity to the active substance
or to any of the excipients.
6.
ADVERSE REACTIONS
Adverse reactions in dogs and cats
Pulmonary oedema has been reported rarely.
Corneal opacities during sedation may occur (see also section 4.5).
By virtue of its α2-adrenergic activity, dexmedetomidine causes a
decrease in heart rate and body
temperature, which has been reported very rarely in spontaneous
reports.
Bradypnoea has been reported very rarely in spontaneous reports.
Blood pressure will increase initially and then return to normal or
below normal.
Due to peripheral vasoconstriction and venou

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sedadex 0.1 mg/ml solution for injection for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Dexmedetomidine hydrochloride
0.1 mg
(equivalent to dexmedetomidine
0.08 mg)
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218)
2.0 mg
Propyl parahydroxybenzoate
0.2 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.
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.
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
Sedadex administration. Water may be
given.
After treatment, the animal should not be given water or food before
it is able to swallow.
Corneal opacities may occur during sedation. The eyes should be
protected by a suitable eye lubricant.
To be used with precaution in elderly animals.
The safety of dexmedetomidine has not been established in males
intended for breeding.
Nervous, aggressive or excited a