Tralieve 50 mg/ml solution for injection for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tramadol hydrochloride

Available from:

Le Vet Beheer B.V.

ATC code:

QN02AX02

INN (International Name):

Tramadol hydrochloride

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

tramadol

Therapeutic indications:

Anaesthetic/Analgesic

Authorization status:

Authorised

Authorization date:

2018-03-16

Summary of Product characteristics

Health Products Regulatory Authority
20 March 2018
CRN000V2D
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tralieve 50 mg/ml solution for injection for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
​
​
ACTIVE SUBSTANCE:
​
​
Tramadol hydrochloride
50 mg
​
(equivalent to 43.9 mg tramadol)
​
​
EXCIPIENT(S):
​
​
Benzyl alcohol (E1519)
​10 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear and colourless solution
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
Health Products Regulatory Authority
20 March 2018
CRN000V2D
Page 2 of 6
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