Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Procaine benzylpenicillin
Norbrook Laboratories (Ireland) Limited
QJ01CE09
Procaine benzylpenicillin
300 milligram(s)/millilitre
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
procaine benzylpenicillin
Authorised
1997-12-12
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ultrapen LA 300 mg/ml Suspension for Injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Procaine Benzylpenicillin 300 mg/ml EXCIPIENTS: Butylhydroxyanisole (E320) 0.1 mg/ml Butylhydroxytoluene (E321) 0.1 mg/ml For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suspension for Injection. A white to off white suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Ultrapen LA is specifically formulated to provide sustained antibacterial activity following a single administration. Ultrapen LA is indicated for use in cattle and pigs in the treatment and control of a wide range of common systemic, respiratory, urinary and local infections caused by or associated with organisms sensitive to penicillin, including _Corynebacterium _ _pyogenes_ , _Erysipelothrix _ _rhusiopathiae_ , _Pasteurella _ _haemolytica_ , _Pasteurella _ _multocida_ , _Staphylococcus_ spp (non-penicillinase producing) and _Streptococcus_ spp. Ultrapen LA will therefore be effective in the treatment of infections, caused by susceptible organisms including: Erysipelas; navel/joint-ill; respiratory tract infections, including pneumonia and atrophic rhinitis; meningitis; septicaemia; toxaemia associated with mastitis; urogenital tract infections and the control of secondary bacterial invaders in diseases primarily of viral origin. 4.3 CONTRAINDICATIONS Do not administer by the intravenous route. Do not use on very small herbivores such as guinea pigs, gerbils or hamsters. Do not use in animals with known hypersensitivity to the active ingredient. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhal Przeczytaj cały dokument