Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Neomycin sulfate; Lincomycin hydrochloride
Huvepharma NV
QJ51RF03; QJ51RG01
Neomycin sulfate; Lincomycin hydrochloride
330/100 mg/syringe
Intramammary solution
POM: Prescription Only Medicine as defined in relevant national legislation
lincomycin, combinations with other antibacterials; neomycin, combinations with other antibacterials
Authorised
2021-10-29
Health Products Regulatory Authority 20 January 2022 CRN00CQ2Z Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Huvebiotic 330 mg/100 mg Intramammary solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES Each 10 ml syringe contains: Lincomycin (as hydrochloride) 330 mg Neomycin (as sulphate) 100 mg EXCIPIENTS Disodium edetate 5 mg For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Intramammary solution. Clear colourless to slightly yellow liquid. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (lactating cows). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of mastitis in cattle during the lactation period caused by: Staphylococcus species (both penicillinase and non-penicillinase producers) including _Staphylococcus aureus_ susceptible to lincomycin and/or neomycin_,_ Streptococcus species including _Streptococcus agalactiae_, _Streptococcus dysgalactiae_ and _Streptococcus uberis _ susceptible to lincomycin and/or neomycin, Coliform bacteria including _Escherichia coli _susceptible to neomycin. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Use of the 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 when the product is used. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to lincomycin and neomycin and may decrease the effectiveness of treatment with other liconsamides, macrolides, streptogramin Health Products Regulatory Authority 20 January 2022 CRN00CQ2Z Page 2 of 4 B and aminoglycosides, due to the potential for cross-resistance. The feeding to Přečtěte si celý dokument