Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Benzylpenicillin procaine monohydrate
WDT - Wirtschaftsgenossenschaft deutscher Tierarzte eG,
QJ51CE09
Benzylpenicillin procaine monohydrate
3 gram(s)
Intramammary suspension
POM: Prescription Only Medicine as defined in relevant national legislation
procaine benzylpenicillin
Authorised
2020-07-24
Health Products Regulatory Authority 20 January 2022 CRN00CMNT Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Taneven LC 3 g intramammary suspension for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 intramammary syringe (20 g) contains: ACTIVE SUBSTANCE: Benzylpenicillin (procaine) monohydrate 3 g (equivalent to 1.7 g benzylpenicillin) EXCIPIENTS: Procaine hydrochloride 0.20 g Sodium metabisulfite 0.02 g For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Intramammary suspension White to off-white homogenous suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (lactating cows) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of clinical mastitis caused by benzylpenicillin-susceptible streptococci and staphylococci in lactating cows. 4.3 CONTRAINDICATIONS Do not use in cases of - infections with ß-lactamase producing pathogens - hypersensitivity to penicillins, other beta-lactam antibiotics or to any of the excipients. - severe renal dysfunction with anuria or oliguria 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In case of mastitis with systemic clinical signs, additionally an appropriate parenteral antimicrobial should be administered. Particular attention should be paid to _Staphylococcus aureus _udder infections, which require to distinguish between acute and chronic udder infections prior treatment. Culling of animals which have been identified to suffer from chronic _Staphylococcus _ _aureus _udder infections might be preferred over treatment. 4.5 SPECIAL PRECAUTIONS FOR USE 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 produ Lue koko asiakirja