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

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

유효 성분:

Tramadol hydrochloride

제공처:

Domes Pharma SC

ATC 코드:

QN02AX02

INN (국제 이름):

Tramadol hydrochloride

약제 형태:

Solution for injection

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Dogs

치료 영역:

Neurological Agent analgesic

승인 상태:

Authorized

승인 날짜:

2018-05-21

제품 특성 요약

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