Tramvetol 50 mg/ml solution for injection for dogs

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Tramadol hydrochloride

Sẵn có từ:

Virbac S.A.

Mã ATC:

QN02AX02

INN (Tên quốc tế):

Tramadol hydrochloride

Liều dùng:

50 milligram(s)/millilitre

Dạng dược phẩm:

Solution for injection

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Khu trị liệu:

tramadol

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2019-08-30

Đặc tính sản phẩm

Health Products Regulatory Authority
11 September 2019
CRN008QD8
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tramvetol 50 mg/ml solution for injection for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
​
Tramadol (as hydrochloride)
43.9 mg
Equivalent to 50 mg of tramadol hydrochloride
EXCIPIENTS:
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution, free from visible particles.
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 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 t