Tralieve 20 mg Chewable Tablets for Dogs

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Tramadol hydrochloride

Tilgængelig fra:

Le Vet Beheer B.V.

ATC-kode:

QN02AX02

INN (International Name):

Tramadol hydrochloride

Lægemiddelform:

Chewable tablet

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Dogs

Terapeutisk område:

Neurological Agent analgesic

Autorisation status:

Authorized

Autorisation dato:

2018-07-09

Produktets egenskaber

Revised: April 2022
AN: 02906/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tralieve 20 mg chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
20 mg tablet:
1 tablet contains:
ACTIVE SUBSTANCE:
Tramadol hydrochloride
20 mg
equivalent to 17.6 mg tramadol
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
20 mg tablet: Light brown with brown spots, round and convex flavoured
7 mm tablet
with a cross-shaped break line on one side.
Tablets can be divided into 2 or 4 equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
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
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
Revised: April 2022
AN: 02906/2021
Page 2 of 6
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 and therefore in dogs with renal
impai