Tralieve 50 mg/ml Solution for Injection for Dogs

The analgesic effects of tramadol hydrochloride may be variable. This is thought to
be due to individual differences in the metabolism of the drug to the primary active
metabolite O-desmethyltramadol. In some dogs (non-responders) this may result in
the veterinary medicinal product failing to provide analgesia. Dogs should therefore
be monitored regularly to ensure sufficient efficacy.

Special precautions for safe use in the target species:
Use with caution in dogs with renal or hepatic impairment. In dogs with hepatic
impairment the metabolism of tramadol to the active metabolites may be decreased
which may reduce the efficacy of the veterinary medicinal product. One of the active
metabolites of tramadol is renally excreted and therefore in dogs with renal
impairment the dosing regimen used may need to be adjusted. Renal and hepatic
function should be monitored when using this veterinary medicinal product. See also
section 3.8.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
People with known hypersensitivity to tramadol or any of the excipients should avoid
contact with the veterinary medicinal product.
The veterinary medicinal product may cause skin and eye-irritation. Avoid contact
with the skin and eyes. Wash hands after use. In case of accidental eye exposure,
rinse with clean water.
There is inadequate evidence available on the safety of tramadol in human
pregnancy. Pregnant women and women of childbearing age should therefore take
great care when handling this veterinary medicinal product and, in the event of
exposure, seek medical advice immediately.
Tramadol may cause nausea and dizziness following accidental self-injection. If you
develop symptoms following accidental exposure, seek medical advice and show the
package leaflet or the label to the physician. However, DO NOT DRIVE as sedation
may occur.
Special precautions for the protection of the environment:
Not applicable.