Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
ROMIFIDINE
Boehringer Ingelheim Ltd
QN05CM93
ROMIFIDINE
10 Mg/Ml
Solution for Injection
VPO-Vet.Practitioner Only
Equine - Food
Romifidine
Neurological Preparations
Authorised
1996-03-29
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 ________________________________________________________________________________________________________________________ _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 Preberite celoten dokument