Target species
Cattle (lactating cows).
Indications for use
Treatment of clinical mastitis in lactating dairy cows caused by Staphylococcus aureus, coagulase negative staphylococci, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis and Escherichia coli sensitive to cefapirin.
Contraindications
Do not use in cases of hypersensitivity to cephalosporins, other β‑lactam antibiotics or to any of the excipients.
Special warnings for each target species
None.
Special precautions for use
Do not use the cleaning towels on teats with open wounds.
Use of the product should be based on identification and susceptibility testing of the target pathogens. If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.
Use of the product should be in accordance with official, national and regional antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
The feeding of waste milk containing residues of cefapirin to calves should be avoided up to the end of the milk withdrawal period (except during the colostral phase), because it could select antimicrobial-resistant bacteria within the intestinal microbiota of the calf and increase the faecal shedding of these bacteria.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the cefapirin and may decrease the effectiveness of the treatment.
Operator warnings
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious.
People with known hypersensitivity to cephalosporins, penicillins or prednisolone should avoid contact with the veterinary medicinal product.
Handle this product with care to avoid exposure, taking all recommended precautions.
If you develop symptoms following exposure, such as a skin rash, you should seek medical advice immediately and show the package leaflet or the label to the physician. Swellings of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.
Wash hands after using the cleaning towels and wear protective gloves if skin irritation due to isopropyl alcohol is known or suspected.
Adverse reactions
Cattle (Lactating cows):
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction |
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 also “Contact details” of the package leaflet.
Use during pregnancy or lactation
The veterinary medicinal product is intended for use during lactation.
Laboratory studies in mice, rats, rabbits, and hamster have not produced any evidence of a teratogenic, foetotoxic, maternotoxic effects.
Because no specific studies have been performed in the target animal species, use only according to the benefit/risk assessment by the responsible veterinarian during pregnancy and in breeding animals.
Interactions
The concurrent use with bacteriostatic antibiotics may cause antagonistic effects.
The concurrent use of parenteral aminoglycosides or other nephrotoxic drugs is not recommended.
Amounts to be administered and administration route
For intramammary use:
The contents of one syringe should be infused into each affected quarter via the teat canal, immediately after milking, at 12 hour intervals for four consecutive milkings. Each syringe contains 300 mg cefapirin and 20 mg prednisolone. The syringe must only be used once for one teat.
Before infusion, the udder should be milked out completely. The teat and its orifice should be thoroughly cleaned and disinfected with the cleaning towel provided (A). Care should be taken to avoid contamination of the syringe nozzle. Break the top of cap and gently insert either about 5 mm (B) or remove whole cap and gently insert the total length of the nozzle (C) into the teat canal. Infuse the total content of the syringe into the quarter.
Disperse the product by gentle massage of the teat and the udder of the affected cow.
Overdose
None known.
Withdrawal periods
Meat and offal: 4 days (96 hours)
Milk: 5.5 days (132 hours).