Target species
Dairy cattle (dry cow)
Indications for use, specifying the target species
For the treatment of subclinical mastitis at drying-off and the prevention of new bacterial infections of the udder during the non-lactating period of cows caused by Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, Trueperella pyogenes, Escherichia coli and Klebsiella spp. susceptible to cefalonium.
Contraindications
Do not use in animals with known hypersensitivity to cephalosporins, other β-lactam antibiotics or to any of the excipients. Please refer to section, Use during pregnancy, lactation or lay
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
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.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to cefalonium and may decrease the effectiveness of treatment with other beta lactams.
The efficacy of the product is only established against the pathogens mentioned in section, Indications for use, specifying the target species of the SPC. Consequently, serious acute mastitis (potentially fatal) due to other pathogen species, particularly Pseudomonas aeruginosa, can occur after drying off. Good hygienic practices should be thoroughly respected in order to reduce this risk.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use.
Penicillin and cephalosporins may cause sensitisation (allergy) following injection, inhalation, ingestion or skin contact. Sensitivity to penicillin may lead to cross-sensitivity to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious.
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
Handle this product with great care to avoid exposure, taking all recommended precautions.
If you develop symptoms following exposure such as a skin rash you should seek medical advice and show the doctor this warning. Swellings of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.
The cleaning towels provided with the intramammary product contain isopropyl alcohol. Wear protective gloves if skin irritation due to isopropyl alcohol is known or suspected. Avoid contact with eyes because isopropyl alcohol can cause eye irritation.
Adverse reactions (frequency and seriousness)
In very rare cases immediate hypersensitivity reactions were observed in some animals (restlessness, tremors, swelling of mammary gland, eyelids and lips). These reactions can lead to death.
The frequency of adverse reactions is defined using the following convention:
•very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
•common (more than 1 but less than 10 animals in 100 animals)
•uncommon (more than 1 but less than 10 animals in 1,000 animals )
•rare (more than 1 but less than 10 animals in 10,000 animals)
•very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
Intended for use during the last trimester of pregnancy once the lactating cow has been dried off. There is no adverse treatment effect on the foetus.
Not to be used in cows that are lactating.
Interaction with other medicinal products and other forms of interaction
Cephalosporins should not be administered concurrently with bacteriostatic antimicrobials. Concomitant use of cephalosporins and nephrotoxic drugs may increase renal toxicity.
Amounts to be administered and administration route
For intramammary use.
The contents of one syringe should be infused into the teat canal of each quarter immediately after the last milking of the lactation. Avoid contamination of the nozzle after removing the cap. Before infusion, thoroughly clean and disinfect the end of the teat with the cleaning towel provided.
Option 1: For short nozzle intramammary administration hold the barrel of the syringe and the base of the cap in one hand and twist off the small upper part of the cap above the indent mark (the base portion of the cap remains on the syringe). Take care not to contaminate the short exposed part of the nozzle.
Option 2: For full nozzle intramammary administration remove the cap fully by holding the barrel of the syringe firmly in one hand and with the thumb push up and along the length of the cap until the cap clicks off. Take care not to contaminate the nozzle.
Insert the nozzle into the teat canal and apply steady pressure on the syringe plunger until the full dose has been delivered. Holding the end of the teat with one hand, gently massage upwards with the other to aid dispersion of the antibiotic into the quarter.
After infusion it is advisable to dip the teats in an antiseptic preparation specifically designed for this purpose.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Repeated doses in cattle on three consecutive days did not demonstrate or produce any adverse effects.
Withdrawal period(s)
Meat and offal: 21 days
Milk: 96 hours after calving if the dry period is longer than 54 days. 58 days following treatment if the dry period is less than or equal to 54 days.