Strenzen 500/125 mg/g Powder for Use in Drinking Water for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

Amoxicillin, Clavulanic Acid

Available from:

Elanco Europe Ltd

INN (International Name):

Amoxicillin, Clavulanic Acid

Pharmaceutical form:

Powder for use in drinking water

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Expired

Authorization date:

2013-12-03

Summary of Product characteristics

                                Revised: November 2017
AN: 02002/2016
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
STRENZEN 500/125 mg/g powder for use in drinking water for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE
Amoxicillin
500 mg
(equivalent to 573.88 mg of Amoxicillin trihydrate)
Clavulanic acid
125 mg
(equivalent to 148.88 mg of Potassium clavulanate)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for use in drinking water.
Yellowish to yellow fine powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of clinical

respiratory tract infections caused by _Actinobacillus
pleuropneumoniae, _
_Pasteurella multocida, Streptococcus suis. _

gastrointestinal infections caused by _Clostridium perfringens,
Escherichia coli_
and _Salmonella _Typhimurium
where
the
causative
pathogens
are
beta-lactamase-producing
strains
of
bacteria
susceptible
to
amoxicillin
in
combination
with
clavulanic
acid
and
where
clinical
experience and/or susceptibility testing indicates the combination as
the drug of choice.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to penicillin or
other substances of
the beta-lactam group or to any of the excipients.
Do not use in rabbits, guinea pigs, hamsters, chinchillas, gerbils or
small herbivores.
Revised: November 2017
AN: 02002/2016
Page 2 of 7
Do not use in known cases of resistance to the combination of
amoxicillin and clavulanic
acid.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The uptake of medication by animals can be altered as a consequence of
illness. In
case of insufficient uptake of water animals should be treated
parenterally.
Use of the product should be based on susceptibility testing and
should take into
account official national and regional policies with respect to the
use of broad-spectrum
antibiotics. D
                                
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