Sileo gel oromucosal

Nchi: Armenia

Lugha: Kiingereza

Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Viambatanisho vya kazi:

dexmedetomidine (dexmedetomidine hydrochloride)

Inapatikana kutoka:

Orion Corporation

ATC kanuni:

QN05CM18

INN (Jina la Kimataifa):

dexmedetomidine (dexmedetomidine hydrochloride)

Kipimo:

0,1mg/ml

Dawa fomu:

gel oromucosal

Vitengo katika mfuko:

(1) pre-filled syringe 3ml

Dawa ya aina:

OTC

Idhini hali ya:

Registered

Idhini ya tarehe:

2021-07-05

Tabia za bidhaa

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