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 10mg

equivalent to 8.76 mg romifidine Excipients:

Qualitative composition of excipients and other constituents	Quantitative composition if that information is essential for proper administration of the veterinary medicinal product
Chlorocresol	2 mg
Sodium Chloride
Water for Injections

Clear, colourless solution.

3. CLINICAL INFORMATION

3.1 Target species

Horses.

3.2 Indications for use for each target species

Sedative to facilitate handling, examination, minor surgical interventions and manipulations.

The veterinary medicinal product 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.

The veterinary medicinal product has also been used with synthetic opiates (eg.

butorphenol) to provide profound sedation/analgesia. 3.3 Contraindications

Do not use in horses in the last month of pregnancy.

3.4 Special warnings

None.

3.5 Special precautions for use

Special precautions for safe use in the target species:

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 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.

Special precautions for the protection of the environment:

Not applicable.

3.6 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.

3.7 Use during pregnancy, lactation or lay

Do not use in horses in the last month of pregnancy.

3.8 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.

3.9 Administration routes and dosage

For intravenous use only. A dose range of 0.4 – 1.2 ml of the veterinary medicinal product/100 kg bodyweight (equivalent to 40 to 120 micrograms romifidine HCl/kg) 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 Chart below

Recommended dose Sedation

Dose	Depth of Sedation	Duration of Sedation
0.4 ml Sedivet/100 kg bodyweight (ie. 40 micrograms romifidine/kg bodyweight).	Light	0.5 – 1 hour
0.8 ml Sedivet/100 kg bodyweight (ie. 80 micrograms romifidine/kg bodyweight).	Deep	0.5 – 1.5 hours

1.2 ml Sedivet/100 kg Deep sedation At this dose

bodyweight of prolonged residual sedation (ie. 120 micrograms duration may persist for up romifidine/kg bodyweight). to 3 hours

To reduce the possibility of unexpected defensive movements such as kicking, a dose of

0.4 – 1.2 ml per 100 kg bodyweight (equivalent to 40 – 120 micrograms romifidine HCl /kg) followed by 0.2ml Torbugesic per 100kg bodyweight (equivalent to 20 micrograms butorphanol/kg) should be administered intravenously. (An average dose of 0.6 ml Sedivet and 0.2 ml Torbugesic has been found to be effective in the majority of horses, although this may vary between individuals).

Premedication

Premedication with ketamine for induction

When used prior to ketamine induced anaesthesia, with or without halothane, a dose rate of 1 ml/100 kg (equivalent to 100 micrograms romifidine HCl/kg bodyweight) should be used followed by 2.2 mg/kg ketamine after 5 to 10 minutes.

Premedication with other agents for induction

When used with other anaesthetic agents, a dose of 0.4 – 0.8 ml per 100 kg bodyweight has been found to be most suitable. This corresponds to 40 to 80 micrograms romifidine HCl/kg bodyweight. Anaesthesia should be induced after maximum sedation is achieved (5 – 10 minutes).

Maintenance of anaesthesia

Anaesthesia may be maintained using halothane in oxygen by inhalation. Should maintenance of surgical anaesthesia be required when facilities for gaseous anaesthesia are not available, this can be achieved by ‘topping up’ doses of romifidine/ketamine or thiopentone.

Ketamine

To maintain or deepen surgical anaesthesia with romifidine/ketamine, administer the product intravenously at a dose of 0.25ml/100 kg bodyweight (25 micrograms/kg romifidine) followed immediately by ketamine intravenously at a dose of 1.1mg/kg (Vetalar 1.1ml/100 kg). Administer the romifidine/ketamine top-up dose immediately prior to commencement of surgical incision or when signs of returning consciousness appear.

Thiopentone

Thiopentone may be used after romifidine/ketamine or romifidine/thiopentone induction at a dose of 0.25g/100 kg bodyweight. This should be administered when signs of returning consciousness appear. This can be repeated upto 3 times after the induction dose.

3.10 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.

3.11 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.

3.12 Withdrawal periods

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.

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QN05CM93

4.2 Pharmacodynamics

Romifidine exerts sedative and analgesic effects. Its sedative effect is induced by stimulation of alpha-2-adrenoreceptors in the central nervous system. The substance possesses a strong specific affinity for these receptors.

4.3 Pharmacokinetics

Absorption

Since the veterinary medicinal product is recommended to be administered intravenously, its active ingredient is completely bioavailable.

Distribution:

Approximately 20% of romifidine is bound to plasma proteins. The highest drug concentrations are to be found in the liver and kidney.

Metabolism:

Romifidine is found predominantly in kidney and muscle, whereas liver contains only traces of the parent compound. The major metabolites present in urine and tissues are SHT 2130, STH 2337 and ESR 1235, which have been shown to be pharmacologically inactive.

Elimination:

Romifidine is rapidly eliminated: approximately 80% of the administered dose is via urine and the remainder via faeces.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

5.2 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening the immediate packaging: 28 days.

5.3 Special precautions for storage

Do not store above 25 °C.

5.4 Nature and composition of immediate packaging

20 ml clear Type I Ph.Eur glass vial with grey bromobutyl stopper.

5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Animal Health UK Limited

7. MARKETING AUTHORISATION NUMBER

Vm 08327/5064

8. DATE OF FIRST AUTHORISATION

15 October 1991

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

September 2026

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 28 September 2026