Cattle.

Recommended for routine dry cow therapy to treat existing sub-clinical infections and to prevent new infections which occur during the dry period.

Not for use in the lactating cow.

Not intended for use within 54 days of calving.

No special warnings are considered necessary.

Use of the product should be based on susceptibility testing of the bacteria isolated from milk samples 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.

Dry cow therapy protocols should take local and national policies on antimicrobial use into consideration, and undergo regular veterinary review.

The feeding to calves of milk containing residues of cefalonium that could select for antimicrobial-resistant bacteria (e.g. production of beta-lactamases) should be avoided up to the end of the milk withdrawal period, except during the colostral phase.

The efficacy of the product has only been established against pathogens sensitive to the active substance. Consequently, serious acute mastitis (potentially fatal) due to other pathogen species, particularly Pseudomonas aeruginosa, can occur after drying off. Good hygiene practices should be thoroughly respected in order to reduce this risk.

Do not bend the nozzle.

Do not contaminate the nozzle

If calving occurs before 54 days after treatment, the absence of antibiotic should be confirmed by testing before the milk is used for human consumption. Milk for human consumption may be taken after 54 days plus 96 hours after treatment.

In cows suffering from hypocalcaemia it may be necessary to discard milk for a longer period.

If the product is used in heifers during their first pregnancy the same precautions should be observed as in cows, i.e. infusions should be given not less than 54 days before calving and milk discarded for the statutory four days after calving.

Summer Mastitis - It is unlikely that antibiotic treatment alone will control Summer Mastitis and therefore other measures should be implemented as part of routine management. These measures include:

- Practising some form of fly control on the farm.

- Avoiding pasturing cattle on wet or wooded fields which are known to be associated with Summer Mastitis.

- Post-infusion teat dipping of cows and heifers receiving prophylactic intramammary infusions for the disease.

- Prompt attention to teat injuries or sores as these rapidly attract flies.

- Farms with an intractable problem should consider changing the calving pattern to avoid having animals at risk during the summer months.

Penicillin and cefalosporins may cause sensitisation (allergy) following injection, inhalation, ingestion or skin contact. Sensitivity to penicillin may lead to cross-sensitivity to cefalosporin 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. Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.

Wash hands after use.

None known

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.

There are no known interactions.

For intramammary infusion.

The contents of one syringe should be infused into the teat canal of each quarter immediately after the last milking of the lactation. Before infusion, the teat should be thoroughly cleaned and disinfected. Avoid contamination of the nozzle after removing the cap. After infusion it is advisable to dip the teats in an antiseptic preparation specifically designed for this purpose.

After milking is complete 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 and 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.

Finally immerse the teats in a teat dip.

Repeated doses in cattle on three consecutive days did not demonstrate or produce any adverse effects.

Milk for human consumption may only be taken 96 hours after calving.

If calving occurs before 54 days after treatment, milk for human consumption may be taken after 54 days plus 96 hours after treatment, ensuring that the milk from at least 7 complete milking is discarded.

The absence of antibiotic should be confirmed by testing before its milk is used for human consumption. This is advisable because of variation in the milking cows ability to excrete antibiotic from dry cow products. In cows suffering from hypocalcaemia, it may be necessary to discard milk for a longer period.

Animals for human consumption should not be slaughtered until 21 days after last treatment.