País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Tramadol hydrochloride
Virbac S.A.
QN02AX02
Tramadol hydrochloride
50 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
tramadol
Authorised
2019-08-30
Health Products Regulatory Authority 11 September 2019 CRN008QD8 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Tramvetol 50 mg/ml solution for injection for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Tramadol (as hydrochloride) 43.9 mg Equivalent to 50 mg of tramadol hydrochloride EXCIPIENTS: For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. Clear and colourless solution, free from visible particles. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the reduction of mild postoperative pain. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not administer in conjunction with tricyclic antidepressants, monoamine oxidase inhibitors and serotonin reuptake inhibitors. Do not use in animals with epilepsy. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES 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 product failing to provide analgesia. Dogs should therefore be monitored regularly to ensure sufficient efficacy. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals 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 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 product. See also section 4.8. Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity t Llegiu el document complet