Target species
Horses
Indications for use for each target species
Sedative to facilitate handling, examination, minor surgical interventions and minor procedures.
For premedication prior to administration of injectable or inhalation anaesthetics.
Romifidine can also be used with synthetic opiates (e.g. butorphanol) to provide deeper sedation/analgesia
Contraindications
Do not use in horses in the last month of pregnancy.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use Trimethoprim-Sulfonamide-containing products intravenously when horses have been sedated with romifidine.
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
Sedation with α2 agonist drugs, such as romifidine may increase the sensitivity of the hind legs to tactile stimuli. Occasionally, defensive reactions, i.e. kicking, may occur even in apparently well sedated animals.
The veterinary medicinal product should be used with caution in animals suffering from cardiovascular or respiratory diseases, hepatic or renal insufficiency and in animals in shock.
When used as a pre-anaesthetic agent, sedation should be apparent before the induction of anaesthesia.
When the veterinary medicinal 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 to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.
Avoid skin, eye or mucosal contact.
Wash the exposed skin immediately after exposure with large amounts of 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 thoroughly with fresh water. If symptoms occur, seek the advice of a physician.
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.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Horses:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Colic (mild)a Hypersensitivity reaction Ataxiab, increased sensitivityc |
Undetermined frequency (cannot be estimated from the available data): | Bradycardiad, arrhythmia (heart block 2nd degree, sino-atrial block)e, hypotensionf, hypertensionf Increased sweating Increased salivation Hyperglycaemia Polyuria Penile prolapse (partial)g |
a As the intestinal motility is temporarily inhibited.
b Incoordination of the limbs.
c Of the hind legs (defensive movements).
d May be profound.
e Benign, reversible.
f Short period of hypertension, followed by hypotension.
g Reversible.
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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Do not use during the last month of pregnancy.
Interaction with other medicinal products and other forms of interaction
The sedative effect of the veterinary medicinal 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 intravenous use of potentiated sulphonamides with alpha2-agonists has been reported to cause cardiac arrhythmias which may be fatal. Intravenous administration of TMP/S containing veterinary medicinal products is therefore contra-indicated when horses have been sedated with romifidine.
The concomitant use of romifidine and phenothiazines (e.g. acepromazine) can result in severe hypotension.
The veterinary medicinal product should not be used in association with other substances belonging to the same pharmacological class (sympathicomimetic amines, including alpha-2-agonist, such as xylazine, detomidine..).
Administration routes and dosage
Intravenous use.
A dose range of 0.04 – 0.12 mg romifidine HCl/kg bodyweight (0.4 – 1.2 ml veterinary medicinal product per 100 kg bodyweight) gives a dose-related response.
Onset of action, which is independent of dose, is 1 – 2 minutes. Maximum sedation is achieved after 5 – 10 minutes. Please see the Table below.
Recommended dose:
Sedation:
Dose | Depth of Sedation | Duration of Sedation |
0.04 mg romifidine HCl/kg body weight (i.e. 0.4 ml product/100 kg body weight) | Light | 0.5-1 hour |
0.08 mg romifidine HCl/kg body weight (i.e. 0.8 ml product/100 kg body weight) | Deep | 0.5–1.5 hours |
0.12 mg romifidine HCl/kg body weight (i.e. 1.2 ml product/100 kg body weight) Table wide | Deep sedation of prolonged duration | At this dose residual sedation may persist for up to 3 hours |
When romifidine is used in combination with butorphanol for deeper sedation and analgesia, a dose of 0.04 mg – 0.12 mg romifidine HCl/kg bw (0.4 – 1.2 ml veterinary medicinal product per 100 kg bw) should be used followed by butorphanol.
Premedication
Premedication with ketamine for induction
When romifidine is used as premedication prior to ketamine induced anaesthesia, a dose of 0.1 mg romifidine HCl/ kg bw (1 ml veterinary medicinal product per 100 kg bw) should be used followed by ketamine after 5 – 10 minutes.
Premedication with other agents for induction
When romifidine is used as premedication in combination with other agents such as injectable or inhalation anaesthetics, a dose of 0.04 mg – 0.08 mg romifidine HCl/kg bw (0.4 – 0.8 ml veterinary medicinal product per 100 kg bw) should be used followed by induction of anaesthesia after 5 – 10 minutes.
Maintenance of anaesthesia
To maintain or deepen surgical anaesthesia with romifidine/ketamine, when facilities for gaseous anaesthesia are not available, romifidine can be administered at a dose of 0.025 mg/kg romifidine HCl (0.25 ml veterinary medicinal product per 100 kg bodyweight) followed immediately by ketamine intravenously (50 % of the initial ketamine premedication dose). Administer the romifidine/ketamine top-up dose immediately prior to commencement of surgical incision or when signs of returning consciousness appear.
The stopper should not be punctured more than 40 times
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Dosages up to 5 times the highest recommended dose caused transient adverse events, such as sweating, bradycardia, second degree atrio-ventricular heart blocks, hypotension, ataxia, hyperglycaemia and diuresis.
In case of overdose, adverse events, as listed in section 3.6 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.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Meat and offal: 6 days.
Not authorised for use in animals producing milk for human consumption.