Clavudale 40 mg/10 mg tablets for cats and dogs

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Amoxicillin trihydrate; potassium clavulanate

Sẵn có từ:

Dechra Regulatory B.V.

Mã ATC:

QJ01CR02

INN (Tên quốc tế):

Amoxicillin trihydrate; potassium clavulanate

Liều dùng:

40, 10 mg/tablet

Dạng dược phẩm:

Tablet

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Khu trị liệu:

amoxicillin and enzyme inhibitor

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2011-10-28

Đặc tính sản phẩm

Health Products Regulatory Authority
17 July 2020
CRN009SMX
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavudale 40 mg/10 mg tablets for cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
Active substances:
Amoxicillin (as amoxicillin trihydrate) 40 mg
Clavulanic acid (as potassium clavulanate) 10 mg
Excipient:
Erythrosine (E127) 0.75 mg
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Pink, oblong, scored, meat flavoured tablets.
The tablet can be divided into halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats and dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of bacterial infections susceptible to amoxicillin
in combination with clavulanic acid where clinical experience
and/or sensitivity testing indicates the product as the drug of
choice.
Uses include:
Skin infections (including deep and superficial pyodermas) associated
with _Staphylococcus _spp. and _Streptococcus _spp.;
Infections of the oral cavity (mucous membrane) associated with
_Clostridium _spp., _Corynebacterium _spp., _Staphylococcus _spp.,
_Streptococcus _spp., _Bacteroides_s pp. and _Pasteurella _spp.;
Urinary tract infections associated with _Staphylococcus _spp.,
_Streptococcus _spp., _Escherichia coli _and _Proteus mirabilis_;
Respiratory tract infections associated with _Staphylococcus _spp.,
_Streptococcus _spp., and _Pasteurella _spp.
Gastrointestinal infections associated with _Escherichia coli_and
_Proteusmirabilis._
4.3 CONTRAINDICATIONS
Do not use in rabbits, guinea pigs, hamsters and gerbils.
Do not use in animals with known hypersensitivity to penicillin or
substances of the ß-lactam group or any of the excipients.
Do not use in animals with either oliguria or anuria associated with
renal dysfunction.
Do not use in cases of known resistance to the combination of
amoxicillin and clavulanic acid.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
Health Products Regulatory Authority
17 July 202