One ml contains:

Ceftiofur (as crystalline free acid) 200mg.

Suspension for injection.

Opaque white to light brown suspension.

Treatment of acute interdigital necrobacillosis, also known as Panaritium or foot rot.

Treatment of acute post-partum (puerperal) metritis, in cases where treatment with another antimicrobial has failed.

Single subcutaneous injection of 6.6 mg ceftiofur/kg bodyweight (equivalent to 1 ml of the veterinary medicinal product per 30 kg bodyweight) administered at the base of the ear.

To ensure a correct dosage, bodyweight should be accurately determined as accurately as possible.

It is recommended to limit injection volumes to a maximum of 30 ml per injection site.

Shake the bottle vigorously for 30 seconds, or until all visual settlement has been resuspended.

Base of the ear administration:

If clinical signs have not improved 48 hours after treatment, the diagnosis and treatment of the condition should be re-evaluated.

Do not use in cases of hypersensitivity to ceftiofur or other beta-lactam antibiotics, or to any of the excipients.

Do not use as prophylaxis in cases of retained placenta.

For systemically administered broad spectrum cephalosporins (3rd and 4th generation, such as ceftiofur), it should be reflected that these are to be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other antimicrobials. Increased use, including use of the product deviating from the instructions given in the SPC/datasheet, may increase the prevalence of bacteria resistant to ceftiofur. Official, national and regional antimicrobial policies should be taken into account when the product is used.

Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing. When considering the treatment strategy, it is appropriate to consider improvement of the herd management practice and use supporting treatment with suitable local products (e.g. disinfectants).

Cattle:

1Visible two days after injection in about two thirds of treated animals and resolving within a maximum of 23 days.

2Mild to moderate in the initial days following injection.

3Following accidental intra-vascular administration or anaphylaxis.

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.

In cattle, although the veterinary medicinal product has not been specifically tested for overdoses, no signs of systemic toxicity related to ceftiofur have been observed following 55 mg/kg parenteral daily overdoses of ceftiofur sodium for five days.

Penicillins and cephalosporins such as ceftiofur may cause hypersensitivity in people and in animals following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

People with known hypersensitivity to penicillins and cephalosporins should avoid contact with this veterinary medicinal product.

Avoid contact with skin or eyes. In the event of contact, wash with clean water. If you develop symptoms following exposure such as a skin rash or persistent eye irritation, you should seek medical advice and show the package leaflet or label to the physician. Swelling of the face, lips or eyes or difficulty with breathing are serious reactions and require urgent medical attention.

Meat and offal: 9 days.

Milk: zero days.

It is essential that the veterinary medicinal product is only administered subcutaneously at the base of ear location in non-edible tissue, as described in the Dosage & Administration section, in order to comply with the meat withdrawal period.

Do not store above 25 °C.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first broaching the vial: 28 days.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Medicines should not be disposed of via wastewater.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

For animal treatment only.

Keep out of the reach and sight of children.

Cardboard box with one type I glass vial of 100 ml with a chlorobutyl-isoprene rubber stopper and an aluminium cap.

Laboratory studies in mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Laboratory studies in rats have shown no evidence of teratogenic effects but maternotoxic (soft faeces) and foetotoxic (reduced foetal weight) effects were observed. No effects on the reproductive performance were observed.

This veterinary medicinal product can be used during lactation. No specific studies have been conducted in pregnant cows or breeding cattle. Use only according to the benefit/risk assessment performed by the responsible veterinarian.

UK(GB): Vm 42058/5041