Do not use in horses in horses in the last month of pregnancy.
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
In common with other sedatives of this class, defensive movements, i.e. kicking may occur even in apparently well sedated animals. These occurrences may be reduced by the use of opiates, e.g. 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 horse is kept in a warm and quiet environment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the case of accidental ingestion or self-injection, seek medical advice immediately and show the package leaflet or the label to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.
Avoid skin, eye or mucosal contact.
Immediately after exposure, wash the exposed skin with large amounts of fresh water. Remove contaminated clothes that are in direct contact with skin.
In the case of accidental contact of the veterinary medicinal product with eyes, rinse with large amounts of fresh water. If symptoms occur, seek the advice of a doctor.
If pregnant women handle the veterinary medicinal product, special caution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.
To the physician:
Romifidine is an alpha2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia. Ventricular arrhythmias have also been reported. Respiratory and haemodynamic symptoms should be treated symptomatically.
Adverse events
Horses:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Bradycardia1; Heart block 2nd degree1; Hypotension1 Ataxia Sudation Hyperglycaemia2 Frequent micturition2 Hypersensitivity |
1 Observed with the alpha-2 agonists. Effects may be prevented by the administration of 0.01mg/kg atropine 5 minutes prior to administration of the sedative. These effects are usually well-tolerated but care should be taken in patients with cardiovascular disease.
2May accompany sedation.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Do not use in horses in the last month of pregnancy.
Interaction with other medicinal products and other forms of interaction
The sedative effect of the product may be potentiated by other psychoactive compounds, such as tranquillisers, other sedatives or morphine-like analgesics, therefore reducing the required dose of subsequent anaesthetic agents.
The concurrent i.v. use of potentiated sulphonamides with alpha2-agonists has been reported to cause cardiac arrhythmias which may be fatal. Whilst no such effects have been reported with the veterinary medicinal product, it is recommended that i.v. administration of TMP/S containing products should not be undertaken when horses have been sedated with the veterinary medicinal product.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Dosages upto 5 times the highest recommended dose caused transient adverse reactions, such as sweating, bradycardia, second degree atrio-ventricular heart blocks, hypotension, ataxia, hyperglycaemia and diuresis.
In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more frequent.
In such cases, symptomatic treatment should be initiated; an alpha-2 adrenergic antagonist may be useful in reducing such effects.
Withdrawal period
Meat and offal: 6 days.
When used in combination with other veterinary medicinal products, consult the product literature of those products and apply whichever is the longer. However, if any of these products is contra-indicated for human consumption, then treated animals must not be slaughtered for human consumption.
Not authorised for use in animals producing milk for human consumption.