Detogesic 10mg/ml Solution for Injection for Horses
Țară: Țările de Jos
Limbă: engleză
Sursă: HMA (Heads of Medicines Agencies)
Caracteristicilor produsului
(SPC)
30-08-2013
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Trimite cerere.
Ingredient activ:
detomidine hydrochloride 10 mg/ml
Disponibil de la:
Vetcare Limited
Codul ATC:
QN05CM90
Forma farmaceutică:
Solution for injection
Grupul Terapeutică:
Detomidine
Zonă Terapeutică:
Horses
Data de autorizare:
2012-02-16
Caracteristicilor produsului
Revised: August 2013
AN: 00202/2012
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DETOGESIC 10 mg/ml Solution for Injection for
Horses
BE, BG, CY, CZ, DE,
EL, ES, FR, IE, IT, LU,
NL, PL, PT, RO, SI,
SK, UK
EQUISEDAN vet 10 mg/ml Solution for Injection for
Horses
FI, NO, SE
EQUISEDAN 10mg/ml Solution for Injection for
Horses
DK, LT. LV
EQUIDOR 10mg/ml Solution for Injection for Horses
AT, HU
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Detomidine hydrochloride 10 mg/ml (Detomidine 8.36 mg/ml)
EXCIPIENT(S):
Preservative
Methyl parahydroxybenzoate (E218)
1 mg/ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection.
Clear, almost colourless solution for intravenous injection.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horse
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the sedation and slight analgesia of horses, to facilitate physical
examinations and treatments, such as minor surgical interventions.
The product can be used for:
Medical examinations
(e.g. endoscopic, rectal and gynaecological
examinations, X-rays).
Minor surgical procedures (e.g. treatment of wounds, dental treatment,
tendon treatment, excision of skin tumours, teat treatment).
Before treatment and medication (e.g. stomach tube, horse shoeing).
For pre-medication prior to administration of injection or inhalation anaesthetics.
See section 4.5 before use.
Revised: August 2013
AN: 00202/2012
Page 2 of 7
4.3 CONTRAINDICATIONS
Do not use in
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