APRAVET 100 G/KG PREMIX FOR MEDICATED FEEDING STUFF FOR PIGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

APRAMYCIN SULFATE

Available from:

Huvepharma NV

ATC code:

QJ01GB

INN (International Name):

APRAMYCIN SULFATE

Dosage:

100 Per Cent

Pharmaceutical form:

Premix for Med.Feedstuffs

Prescription type:

POM

Therapeutic group:

Porcine

Therapeutic area:

Other aminoglycosides

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2013-08-29

Summary of Product characteristics

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
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 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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/08/2013_
_CRN 7012879_
_page number: 1_
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
Wash hands carefully with soap