Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Procaine Benzylpenicillin
Laboratorios SYVA S.A.U
QJ01CE09
Procaine Benzylpenicillin
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Pigs
Antimicrobial
Authorized
2019-03-26
Unlimited Renewal: September 2023 AN: 01792/2023 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Procactive 300 mg/ml suspension for injection for cattle and pigs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Benzylpenicillin procaine monohydrate…………………..300 mg (corresponding to 170 mg benzylpenicillin) EXCIPIENTS: Sodium methyl parahydroxybenzoate (E219)……… 1.25 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. White suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs (weighing more than 25 kg). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of systemic infections in cattle and pigs (weighing more than 25 kg) caused by bacteria sensitive to penicillin. 4.3 CONTRAINDICATIONS Do not inject intravenously. Do not use in known cases of hypersensitivity to penicillins, cephalosporins, procaine or to any of the excipients. Do not use in case of severe renal dysfunction with anuria and oliguria. Do not use in the presence of β-lactamase producing pathogens. Do not use in very small herbivores such as guinea pigs, gerbils and hamsters. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None Unlimited Renewal: September 2023 AN: 01792/2023 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The product is not to be used in pigs weighing less than 25 kg bodyweight. Administer by deep injection only. The 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 benzylpenicillin and may Read the complete document