Sileo
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
11-01-2021
Valmisteyhteenveto
(SPC)
11-01-2021
Julkisesta arviointikertomuksesta
(PAR)
07-07-2015
Aktiivinen ainesosa:
Dexmedetomidine hydrochloride
Saatavilla:
Orion Corporation
ATC-koodi:
QN05CM18
INN (Kansainvälinen yleisnimi):
dexmedetomidine
Terapeuttinen ryhmä:
Dogs
Terapeuttinen alue:
Nervous system, Other hypnotics and sedatives
Käyttöaiheet:
Alleviation of acute anxiety and fear associated with noise in dogs.
Tuoteyhteenveto:
Revision: 8
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2015-06-10
Pakkausseloste
20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET:
SILEO 0.1 MG/ML OROMUCOSAL GEL FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND
OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE, IF DIFFERENT
Orion Corporation
Orionintie 1
FI-02200 Espoo
FINLAND
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sileo 0.1 mg/ml oromucosal gel for dogs
dexmedetomidine hydrochloride
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
ACTIVE SUBSTANCE:
Dexmedetomidine hydrochloride 0.1 mg/ml
(equivalent to 0.09 mg/ml dexmedetomidine).
Other ingredients: Brilliant blue (E133) and tartrazine (E102).
Sileo is a translucent, green oromucosal gel.
4.
INDICATION(S)
For the alleviation of acute anxiety and fear associated with noise in
dogs.
5.
CONTRAINDICATIONS
Your dog should not be given Sileo if it:
- has severe liver, kidney or heart disease.
- is hypersensitive to the active substance or to any of the
excipients.
- is drowsy due to previous medication.
6.
ADVERSE REACTIONS
Sileo may cause the following adverse reactions.
Common reactions:
- paleness of the mucous membranes at the application site
- tiredness (sedation)
- vomiting
- uncontrolled urination.
Uncommon reactions:
- distress
22
- swelling around the eyes
- drowsiness
- loose stools.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 animals in 10,000 animals
treated)
- very rare (less than 1 animal in 10,000 animals treated, including
isolated reports).
If you notice any side effects, even those not already listed in this
package leaflet or you think that the
medicine has not worked, please inform your veterinary surgeon.
7.
TARGET SPECIES
Dogs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Oromucosal gel.
Sileo is administere
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sileo 0.1 mg/ml oromucosal gel for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the oromucosal gel contains:
ACTIVE SUBSTANCE:
Dexmedetomidine hydrochloride 0.1 mg
(equivalent to 0.09 mg dexmedetomidine).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal gel.
Translucent, green gel.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alleviation of acute anxiety and fear associated with noise in dogs.
4.3
CONTRAINDICATIONS
Do not use in dogs with severe cardiovascular disorders.
Do not use in dogs with severe systemic disease (graded as ASA III-IV)
e.g. end stage renal or liver
failure.
Do not use in known cases of hypersensitivity to the active substance
or to any of the excipients.
Do not use in dogs obviously sedated from previous dosing.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
If the oromucosal gel is swallowed it will become ineffective.
Therefore feeding the dog or giving it
treats within 15 minutes after administration of the gel should be
avoided. In case the gel is swallowed
the dog can be given another dose if necessary 2 hours after the
previous dose.
In extremely nervous, excited or agitated animals, the levels of
endogenous catecholamines are often
high. The pharmacological response elicited by alpha-2 agonists (e.g.
dexmedetomidine) in such animals
may be reduced.
3
The safety of administering dexmedetomidine to puppies younger than 16
weeks and dogs over 17 years
of age has not been studied.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
In case of accidental ingestion or prolonged mucosal contact, seek
medical advice immediately and show
the package leaflet or the label to the physician. Do not drive as
sedation and changes in blood pressure
may occur.
Avoid skin, eye or mu
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