Target species
Pig.
Indications for use, specifying the target species
Local anaesthesia during and following castration of piglets, and provision of castration wound antisepsis.
Contraindications
Do not administer in cases of hypersensitivity to any of the active substances or to any of the excipients.
Special warnings for each target species
For use in piglets up to 7 days of age.
The veterinary medicinal product will provide local anaesthesia within 30 seconds of application, with a duration of effect of approximately 1 hour. Additional analgesia or anaesthesia should be considered, according to recognised veterinary practice. No data are available on concurrent use with other products (see also Interactions).
Special precautions for use in animals
In the clinical field trial, the product was not tested on piglets less than 3 days of age or weighing less than 1 kg. Use only according to the benefit-risk assessment by the responsible veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Contact with skin or eyes can cause irritation and repetitive exposure can lead to allergic reactions. Pharmacological effects (i.e. local anaesthesia) are likely to occur in case of contact with the product.
Lidocaine and bupivacaine can form a metabolite (2,6-xylidine) in humans, which can induce carcinogenic effects at high doses in long-term toxicology studies in rats.
Avoid skin, eye or oral contact with the product. Wear disposable impermeable gloves when handling the product and treating animals.
In case of accidental spillage onto skin, wash off immediately with soap and water.
Avoid ingestion of and do not smoke or eat while handling the veterinary medicinal product.
In case of accidental ingestion, seek medical advice and show the package insert to the physician.
People with known hypersensitivity to any of the active substances or to any of the excipients (e.g., sodium metabisulfite) should administer the product with caution.
Exposure to this product whilst using another medicinal product which also contains a locally acting amide anaesthetic may cause cross sensitivity.
Wash hands thoroughly after use.
Adverse reactions (frequency and seriousness)
Mild, transient (5-11 days duration) application site inflammation was the most commonly reported adverse reaction in the clinical field trial. There was an isolated report of anaphylaxis in one piglet.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
Not applicable
Interaction with other medicinal products and other forms of interaction
As no data are available on interactions, it is recommended not to apply other products to the castration site when using this product.
Amounts to be administered and administration route
For cutaneous use only.
<2 kg bw = 1 ml per piglet
2-4 kg bw = 2 ml per piglet
Assemble the applicator as directed below. Set the dose at 0.5 ml. Incise the scrotum and exteriorise the testis, exposing the spermatic cord. Instil 1 or 2 doses (depending on the bodyweight) of 0.5 ml to the opened scrotal sac, to fully coat the spermatic cord and the cut skin edge, then repeat for the other testicle. Wait 30 seconds before severing the spermatic cords.
Use of Applicator:
Connect the long nozzle to the dosing applicator. Connect the dosing applicator and draw-off tubing to the container as follows: Attach the tubing to the dosing applicator. Attach draw-off tubing to the spigot cap. Remove the screw cap and seal, replace with the spigot cap and draw-off tubing and check that they are firmly attached. Follow the dosing applicator manufacturer's directions for priming the application and for proper use and maintenance of the dosing applicator and draw-off tubing. The dosing applicator should be removed at the end of each day’s use of the product. Remove the spigot cap and replace with screw cap, checking it is firmly attached. When the dosing gun is removed, expel any remaining product in it and clean according to the manufacturer’s directions, before storage.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In a laboratory safety study in piglets, transient application site inflammation was seen following 3-fold and 5-fold overdose, but this was similar to that seen at the normal dose (see Adverse reactions). No other clinically relevant findings were seen after a five-fold overdose of Tri-Solfen was applied to the castration site.
Withdrawal period(s)
Zero days.