Apravet 100 g/kg Premix for Medicated Feeding Stuff for Pigs

Summary of Product characteristics

                                Revised: July 2018
AN: 01636/2017
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Apravet 100 g/kg premix for medicated feeding stuff for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each kg contains:
ACTIVE SUBSTANCE:
Apramycin sulfate 100 g (corresponds to apramycin 100.000.000 IU)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Premix for medicated feeding stuff
Light brown granules
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and metaphylaxis of bacterial enteritis caused by
micro-organisms
susceptible to apramycin such as _Escherichia coli._
4.3
CONTRAINDICATIONS
Do not use in the cases of hypersensitivity to apramycin or any of the
excipients.
Do not use in animals suffering from kidney disorders.
Do not use in cats.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The uptake of medication by animals can be altered as a consequence of
illness. In
case of insufficient uptake of feed animals should be treated
parenterally.
The use of the product should be combined with good management
practices e.g.
good hygiene, proper ventilation, no overstocking.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the veterinary medicinal product should be based on
susceptibility testing of
the bacteria isolated from the animal. If this is not possible,
therapy should be based
on local (regional, farm level) epidemiological information about
susceptibility of the
target bacteria.
Official, national and regional antimicrobial policies should be taken
into account
Revised: July 2018
AN: 01636/2017
Page 2 of 5
when the veterinary medicinal product is used.
Use of the veterinary medicinal product deviating from the
instructions given in the
Summary of Product Characteristics may increase the prevalence of
bacteria
resistant to the apramycin and may decrease the effectiveness of
treatment with
aminoglycosides due to the potential for cross-resistance.
SPECIAL PRECAUTIO
                                
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