Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Procaine benzylpenicillin; Dihydrostreptomycin
Norbrook Laboratories Limited
QJ01RA01
Procaine benzylpenicillin; Dihydrostreptomycin
200, 200 milligram(s)/millilitre
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
penicillins, combinations with other antibacterials
Authorised
1987-10-01
Health Products Regulatory Authority 15 November 2018 CRN008Q6S Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Pen & Strep Suspension for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substances Procaine Benzylpenicillin 200 mg Dihydrostreptomycin Sulphate equivalent to Dihydrostreptomycin 200 mg Excipients Methyl, ethyl, and propyl parahydroxybenzoates as sodium salts (as preservative) 1.5 mg Sodium formaldehyde sulfoxylate (as antioxidant) 1.25 mg 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, Sheep, Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of systemic infections caused by or associated with organisms sensitive to penicillin and/or streptomycin including: _Corynebacterium pyogenes_ _Erysipelothrix rhusiopathiae_ _Klebsiella pneumoniae_ _Listeria spp_ _Pasteurella haemolytica_ _Pasteurella multocida_ Health Products Regulatory Authority 15 November 2018 CRN008Q6S Page 2 of 5 _Staphylococcus spp_. (non-penicillinase producing) _Streptococccus spp._ Pen & Strep 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; listeriosis, meningitis; septicaemia; toxaemia associated with mastitis; urogenital tract infections; enteritis and the control of secondary bacterial invaders in diseases of primary viral origin. 4.3 CONTRAINDICATIONS Not for intravenous administration. Not for use in sheep producing milk for human consumption. Contra-indicated in known cases of hypersensitivity to penicillins. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Occasionally in sucking and fattening pigs, administration of Pen & Strep may cause transient pyrexia, vomiting, shivering, listlessness and inco-ordination. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL Прочетете целия документ