SEDIVET 10 MG/ML SOLUTION FOR INJECTION FOR HORSES
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
ROMIFIDINE
Available from:
Boehringer Ingelheim Ltd
ATC code:
QN05CM93
INN (International Name):
ROMIFIDINE
Dosage:
10 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
VPO-Vet.Practitioner Only
Therapeutic group:
Equine - Food
Therapeutic area:
Romifidine
Therapeutic indications:
Neurological Preparations
Authorization status:
Authorised
Authorization date:
1996-03-29
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Sedivet 10 mg/ml Solution for Injection for horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Romifidine hydrochloride
10 mg
equivalent to 8.76 mg romifidine
EXCIPIENTS:
Chlorocresol
2 mg
For a full list of excipients, please see 6.1
3 PHARMACEUTICAL FORM
Solution for injection
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Sedative to facilitate handling, examination, minor surgical interventions and manipulations.
Sedivet may be used as a premedication agent with ketamine or thiopentone for short duration anaesthesia, or used with
ketamine or thiopentone prior to halothane inhalation or ‘topping up’ with ketamine or thiopentone for prolonged
procedures.
Sedivet has also been used with synthetic opiates (eg. butorphanol) to provide profound sedation/analgesia.
4.3 CONTRAINDICATIONS
The product should not be used in horses in the last month of pregnancy.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 29/08/2014_
_CRN 7016608_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In common with other sedatives of this class, defensive movements, ie kicking, may occur even in apparently well
sedated animals. These occurrences may be reduced by the use of opiates, eg. butorphanol.
When used as a pre-anaesthetic agent, sedation should be apparent before the induction of anaesthesia.
When the product is used as part of the anaesthetic procedure, care should be taken during the recovery phase to ensure
that the hor
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