País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Tramadol hydrochloride
Virbac S.A.
QN02AX02
Tramadol hydrochloride
50 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
tramadol
Authorised
2019-08-30
Health Products Regulatory Authority 06 September 2019 CRN008QD7 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Tramvetol 50 mg tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: ACTIVE SUBSTANCE(S): 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 Tablets White to almost white tablets with brown dots with a break line on one side, flat, with rounded edges and a characteristic smell of meat. Tablets can be divided into 2 equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs weighing more than 6.25 kg. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the reduction of acute and chronic mild soft tissue and musculoskeletal pain. 4.3 CONTRAINDICATIONS Do not administer in conjunction with tricyclic antidepressants, monoamine oxidase inhibitors and serotonin reuptake inhibitors. Do not use in cases of hypersensitivity to tramadol or to any of the excipients. 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. For chronic pain, multimodal analgesia should be considered. Dogs should be monitored regularly by a veterinarian to ensure adequate pain relief. In case of recurrence of pain or insufficient analgesia the analgesic protocol may need to be reconsidered. 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 Leia o documento completo