Tralieve 80 mg chewable tablets for dogs

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Tramadol hydrochloride

제공처:

Le Vet Beheer B.V.

ATC 코드:

QN02AX02

INN (국제 이름):

Tramadol hydrochloride

복용량:

80 mg/tablet

약제 형태:

Chewable tablet

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 영역:

tramadol

승인 상태:

Authorised

승인 날짜:

2018-07-06

제품 특성 요약

Health Products Regulatory Authority
10 July 2018
CRN000V6W
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tralieve 80 mg chewable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
80 mg tablet:
​
1 tablet contains:
​
​
ACTIVE SUBSTANCE:
​
​
Tramadol hydrochloride
​
80 mg
​
equivalent to 70.3 mg tramadol
​
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
80 mg tablet: Light brown with brown spots, round and convex flavoured
11 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.
Health Products Regulatory Authority
10 July 2018
CRN000V6W
Page 2 of 7
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. 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