Tramadog, 50 mg/ml, Solution for Injection for Dogs

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Tramadol hydrochloride

Commercializzato da:

Domes Pharma SC

Codice ATC:

QN02AX02

INN (Nome Internazionale):

Tramadol hydrochloride

Forma farmaceutica:

Solution for injection

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Dogs

Area terapeutica:

Neurological Agent analgesic

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

2018-05-21

Scheda tecnica

Revised: March 2021
AN: 01865/2020 & 01743/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TRAMADOG, 50 mg/ml, solution for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml vial of solution contains:
ACTIVE SUBSTANCE:
Tramadol hydrochloride ......................... 50.0 mg
(equivalent to 43.9 mg of tramadol base)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless liquid.
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 tramadol or to any of the
excipients.
Do not use in dogs receiving concomitant treatment with tricyclic
antidepressants,
MAO inhibitors or 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.
Revised: March 2021
AN: 01865/2020 & 01743/2020
Page 2 of 6
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 animal