Apravet 100g/kg Premix for Medicated Feeding Stuff for Pigs
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
24-08-2013
Summary of Product characteristics
(SPC)
24-08-2013
Active ingredient:
apramycin sulfate 100 g/kg
Available from:
Huvepharma N.V.
ATC code:
QJ01GB90
Pharmaceutical form:
Premix for medicated feed
Therapeutic group:
apramycin
Therapeutic area:
Pigs
Authorization date:
2013-05-29
Patient Information leaflet
1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Apravet 100 g/kg premix for medicated feeding stuff for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each kg contains:
Apramycin sulfate 100 g, equivalent to apramycin 100.000.000 IU
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Premix for medicated feeding stuff
Granular powder
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment 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
Do not use in cats
4.4
SPECIAL WARNINGS
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 product should be based on susceptibility testing and should take into account official
national and regional policies.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of
bacteria resistant to the apramycin and may decrease the effectiveness of treatment with
aminoglycosides due to the potential for crossresistance
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL
PRODUCT TO ANIMALS
3
Wash h
Read the complete document
Summary of Product characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Apravet 100 g/kg premix for medicated feeding stuff for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each kg contains:
Apramycin sulfate 100 g, equivalent to apramycin 100.000.000 IU
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Premix for medicated feeding stuff
Granular powder
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment 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
Do not use in cats
4.4
SPECIAL WARNINGS
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 product should be based on susceptibility testing and should take into account official
national and regional policies.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of
bacteria resistant to the apramycin and may decrease the effectiveness of treatment with
aminoglycosides due to the potential for crossresistance
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL
PRODUCT TO ANIMALS
3
Wash h
Read the complete document
