Amoxiclav-VMD 50 mg
Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
10-11-2013
Summary of Product characteristics
(SPC)
10-11-2013
Active ingredient:
amoxicillin 40 mg, clavulanic acid 10 mg
Available from:
V.M.D.
ATC code:
QJ01CR02
Pharmaceutical form:
Tablet
Therapeutic group:
amoxicillin and enzyme inhibitor
Therapeutic area:
Cats, Dogs
Authorization date:
2011-09-20
Patient Information leaflet
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amoxiclav-VMD 50 mg (BE, NL)
Clavucill 40 mg/10 mg (DE, DK, ES, FR, PL, PT, RO, SE)
Tablets for dogs and cats.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet (180 mg) contains:
- Active substances:
Amoxicillin (as amoxicillin trihydrate) 40 mg/tablet
Clavulanic acid (as potassium clavulanate) 10 mg/tablet
- Excipients:
Erythrosine (E127) 0.05 mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Pale pink, rounded, one side scored, uncoated tablet with a diameter of 8 mm.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs and cats:
Treatment of infections caused by micro-organisms sensitive for the combination amoxicillin/clavulanic
acid, especially:
- dermatitis (superficial and deep pyodermatitis) caused by _Staphylococcus intermedius_.
- urinary tract infections caused by _E. coli_.
- respiratory tract infections caused by _Streptococcus_ spp.
- enteritis caused by _E. coli_.
4.3
CONTRAINDICATIONS
- Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam
group.
- Do not use in case of serious dysfunction of the kidneys accompanied by anuria and oliguria.
- Do not use in rabbits, guinea pigs, hamsters, chinchillas or gerbils.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5
SPECIAL PRECAUTIONS FOR USE
_i) Special precautions for use in animals _
-
Do not use in case of known resistance to the combination.
-
Officia
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amoxiclav-VMD 50 mg (BE, NL)
Clavucill 40 mg/10 mg (DE, DK, ES, FR, PL, PT, RO, SE)
Tablets for dogs and cats.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet (180 mg) contains:
- Active substances:
Amoxicillin (as amoxicillin trihydrate) 40 mg/tablet
Clavulanic acid (as potassium clavulanate) 10 mg/tablet
- Excipients:
Erythrosine (E127) 0.05 mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Pale pink, rounded, one side scored, uncoated tablet with a diameter of 8 mm.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs and cats:
Treatment of infections caused by micro-organisms sensitive for the combination amoxicillin/clavulanic
acid, especially:
- dermatitis (superficial and deep pyodermatitis) caused by _Staphylococcus intermedius_.
- urinary tract infections caused by _E. coli_.
- respiratory tract infections caused by _Streptococcus_ spp.
- enteritis caused by _E. coli_.
4.3
CONTRAINDICATIONS
- Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam
group.
- Do not use in case of serious dysfunction of the kidneys accompanied by anuria and oliguria.
- Do not use in rabbits, guinea pigs, hamsters, chinchillas or gerbils.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5
SPECIAL PRECAUTIONS FOR USE
_i) Special precautions for use in animals _
-
Do not use in case of known resistance to the combination.
-
Officia
Read the complete document
