Tramadog 50 mg/ml solution for injection for dogs

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Tramadol hydrochloride

Saadav alates:

Domes Pharma SC

ATC kood:

QN02AX02

INN (Rahvusvaheline Nimetus):

Tramadol hydrochloride

Annus:

50 milligram(s)/millilitre

Ravimvorm:

Solution for injection

Retsepti tüüp:

VPO: Veterinary Practitioner Only as defined in relevant national legislation

Terapeutiline rühm:

Dogs

Terapeutiline ala:

tramadol

Näidustused:

Anaesthetic/Analgesic

Volitamisolek:

Authorised

Loa andmise kuupäev:

2018-04-13

Toote omadused

Health Products Regulatory Authority
24 March 2021
CRN00C59Y
Page 1 of 4
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.
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 to tramadol or any of the
excipien