البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
BENZYLPENICILLIN
Schering Plough Limited
QJ01CE01
95.7 %w/w
Pdr for Soln for Injection
Antibacterial
Equine - Food
1997-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Crystapen 5 Mega 95.7% w/w Powder for Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM A white powder for solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and control of systemic infections caused by or associated with organisms sensitive to penicillin including: Gram-positive bacteria _Arcanobacterium pyogenes_ _Erysipelothrix rhusiopathiae_ _Listeria _spp. _Rhodococcus equi_ _Staphylococcus aureus_ _Streptococcus zooepidemicus_ Gram-negative bacteria _Klebsiella pneumoniae_ _Mannheimia haemolytica_ _Pasteurella multocida_ _Proteus _spp. _Pseudomonas aeruginosa_ Some _Salmonella _spp. 4.3 CONTRAINDICATIONS Do not use in known cases of hypersensitivity to penicillins. Each vial contains ACTIVE SUBSTANCE Benzylpenicillin 3g* (as Benzylpenicillin Sodium Ph. Eur. 95.7 % w/w) *equivalent to 5 mega-units of benzylpenicillin IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 09/12/2010_ _CRN 7009860_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES No special warnings are considered necessary. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The usual aseptic precautions should be followed when administering the product. 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. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL اقرأ الوثيقة كاملة