DOMOSEDAN GEL 7.6 mg/ml oromucosal gel

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

지금 구매하세요

제품 특성 요약 제품 특성 요약 (SPC)
12-06-2017
공공 평가 보고서 공공 평가 보고서 (PAR)
03-07-2019
DSU DSU (DSU)
31-10-2023

유효 성분:

Detomidine hydrochloride

제공처:

Orion Corporation

ATC 코드:

QN05CM90

INN (International Name):

Detomidine hydrochloride

복용량:

7.6 milligram(s)/millilitre

약제 형태:

Oromucosal gel

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 그룹:

Horses

치료 영역:

detomidine

치료 징후:

Neurological Preparations

승인 상태:

Authorised

승인 날짜:

2009-02-27

제품 특성 요약

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
DOMOSEDAN GEL 7.6 mg/ml oromucosal gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oromucosal gel
Even, translucent, blue gel
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horse
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Sedation to facilitate restraint for non-invasive veterinary
procedures (e.g. passage of naso-gastric tube, radiography,
rasping teeth) and minor husbandry procedures (e.g. clipping,
shoeing).
4.3 CONTRAINDICATIONS
Do not use in seriously ill animals with heart failure or impaired
liver or kidney function.
Do not use in conjunction with intravenous potentiated sulphonamides.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Unlike most other oral veterinary products, this product is not meant
to be swallowed. Instead, it must be placed under
the tongue of the horse. When the product is administered, the animal
should be allowed to rest in a quiet place. Before
any procedure is initiated, sedation should be allowed to fully
develop (approximately 30 min).
ACTIVE SUBSTANCE:
Detomidine
6.4
mg/ml
(equivalent to detomidine hydrochloride
7.6
mg/ml)
EXCIPIENTS:
Brilliant Blue FCF (E133)
0.032 mg/ml
For a full list of excipients, see section 6.1
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