Target Species
Cattle, horses, sheep, pigs, dogs and cats.
Indications for use
The veterinary medicinal product is indicated for the treatment of infections caused by bacteria sensitive to penicillin.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in rabbits, guinea pigs, hamsters or gerbils. Caution is advised in its use in any other small herbivores.
Not effective against beta-lactamase producing organisms.
Special warnings for each target species
Occasionally in sucking and fattening pigs, administration of products containing procaine penicillin may cause a transient pyrexia, vomiting, shivering, listlessness and incoordination. Additionally in pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported.
After absorption, benzylpenicillin poorly penetrates biological membranes (e.g., blood-brain barrier) since it is ionised and poorly lipid soluble. Use of the product for treatment of meningitis or CNS infections due to e.g., Streptococcus suis or Listeria monocytogenes may not be efficacious. Furthermore, benzylpenicillin penetrates mammalian cells poorly and hence this product may have little effect in treating intracellular pathogens e.g., Listeria monocytogenes.
Elevated MIC values or bi-modal distribution profiles suggesting acquired resistance have been reported for the following bacteria:
- Glaesserella parasuis, Staphylococcus spp. causing MMA/PPDS, Streptococcus spp. and S. suis in pigs;
- Fusobacterium necrophorum causing metritis and Mannheimia haemolytica (only in some member states), as well as Bacteroides spp., Staphylococcus chromogenes, Actinobacillus lignieresii and Trueperella pyogenes in cattle;
- S. aureus, coagulase negative Staphylococci and Enterococcus spp. in dogs;
- Staphylococcus aureus and Staphylococcus felis in cats.
Use of the veterinary medicinal product may result in a lack of clinical efficacy when treating infections caused by these bacteria.
Special precautions for use
Not recommended for intravenous or intrathecal administration
Operator warnings
Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances are occasionally serious.
1. Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations.
2. Handle this product with great care to avoid exposure, taking all recommended precautions.
3. If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
Adverse Reactions
Cattle, horses, sheep, dogs, cats:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction, Anaphylaxis1; Injection site reaction (e.g.,swelling, pain) |
Pigs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction, Anaphylaxis1; Vomiting2; Injection site reaction (e.g. swelling, pain) |
1 May be life-threatening. Potentially fatal reactions associated with the administration of procaine penicillin in horses have been observed. If such reactions occur appropriate treatment is recommended.
2 In sucking and fattening pigs.
Systemic toxic effects have been observed in young piglets, which are transient but can be potentially lethal, especially at higher doses.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation
No special precautions necessary
Interactions
Antagonism between the product and bacteriostatic preparations may occur.
Resistant bacteria, particularly gram-negative, that show a cross-resistance with other beta-lactam antibiotics might occur.
Amounts to be administered and administration route
Horses and cattle 12 mg/kg bodyweight, sheep and pigs 15 mg/kg. Intramuscular use.
Dogs and cats 30 mg/kg (1 ml per 10 kg bodyweight). Subcutaneous use.
Suggested doses are:
Cattle | 500 kg | 20 ml |
Horses | 500 kg | 20 ml |
Sheep | 50 kg | 2.5 ml |
Pigs | 50 kg | 2.5 ml |
Dogs | 10 kg | 1 ml |
Cats | 5 kg | 0.5 ml |
Clean the area of the injection site and swab with spirit. Shake well before use.
The treatment duration is 3 to 7 days and should be repeated at 24 hour intervals.
Do not use the same injection site more than once during a course of treatment.
Do not inject more than 20 ml per injection site in cattle.
Do not inject more than 5 ml per injection site in pigs and sheep.
Overdose
Penicillin is a compound with a very high therapeutic ratio. It is very unlikely that an overdose of the product will have adverse effects on the treated animal.
Withdrawal periods
Meat and offal:
Cattle, pigs, sheep:
5 days for the treatment duration 3-5 days
7 days for the treatment duration 6-7 days
Horses: Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.
Milk:
Cattle: 264 hours (11 days)
Sheep, horses: Not authorised for use in animals producing milk for human consumption.