Excenel Flow is a suspension for injection, containing 50 mg/ml ceftiofur (as hydrochloride).

Excenel contains ceftiofur which is a b-lactamase resistant, broad spectrum, bactericidal cephalosporin antibiotic and is effective in the treatment of infections associated with bacteria sensitive to ceftiofur. The product is indicated for:

For the treatment of bacterial respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.

For the treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with Fusobacterium necrophorum and Bacteroides melaninogenicus (Porphyromonas asaccharolytica).

For treatment of the bacterial component of acute post-partum (puerperal) metritis within 10 days of calving, associated with Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum, sensitive to ceftiofur, where treatment with another antimicrobial has failed.

For the treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida and Streptococcus suis.

Before use, shake the bottle vigorously for a maximum of 60 seconds or until the product appears adequately resuspended.

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

For the treatment of respiratory disease: 1 mg/kg bwt/day subcutaneously for 3 to 5 days, i.e. 1 ml/50 kg bwt at each injection.

For the treatment of acute interdigital necrobacillosis: 1 mg/kg bwt/day subcutaneously for 3 days, i.e. 1 ml/50 kg bwt at each injection.

For the treatment of acute post-partum metritis: 1 mg/kg bwt/day subcutaneously for 5 consecutive days, i.e. 1 ml/50 kg bwt at each injection. Subsequent injections must be given at different sites.

3 mg ceftiofur/kg bwt (i.e. 1 ml/16 kg bwt) intramuscularly once daily at 24 hour intervals for 3 days in total.

Do not administer to an animal previously found to be hypersensitive to ceftiofur and other b-lactam antibiotics. Do not inject intravenously.

Do not use in cases where resistance to other cephalosporins or beta-lactam antibiotics has occurred.

Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans.

Even though studies in laboratory animals show no evidence of teratogenesis, abortion or influence on reproduction, the reproductive safety of ceftiofur has not been specifically investigated in pregnant sows or cows. Use only according to a benefit/risk assessment by the attending veterinary surgeon.

Hypersensitivity reactions unrelated to dose can occur. Allergic reactions (e.g. skin reactions, anaphylaxia) have been reported in very rare cases (less than 1 animal in 10,000 animals, including isolated reports).

In case of the occurrence of an allergic reaction the treatment should be withdrawn.

Excenel Flow selects for resistant strains such as bacteria carrying extended spectrum betalactamases (ESBL) which may constitute a risk to human health if these strains disseminate to humans e.g. via food. For this reason, Excenel Flow should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly (refers to very acute cases when treatment must be initiated without bacteriological diagnosis), to more narrow spectrum antimicrobials first line treatment. Official, national and regional antimicrobial policies should be taken into account when the product is used. Increased use, including use of the product deviating from the instructions given in the SPC, may increase the prevalence of such resistance bacteria resistant to Excenel Flow. Whenever possible, Excenel Flow should only be used based on susceptibility testing.

Do not use as prophylaxis in case of retained placenta.

Excenel Flow is intended for treatment of individual animals. Do not use for disease prevention or as a part of herd health programmes. Treatment of groups of animals should be strictly limited to ongoing disease outbreaks according to the approved conditions of use.

In cattle, firmness and swelling were observed at the injection site after SC injection of Excenel Flow. Mild to moderate local chronic inflammation was observed in most animals until 42 days post injection. Injection site reactions have been reported from the field in very rare cases. In cattle, no signs of systemic toxicity have been observed following substantial parenteral overdosages.

In pigs, mild reactions at the injection site such as discolouration of the fascia or fat have been observed in very rare cases for up to 20 days after injection.

The low toxicity of ceftiofur has been demonstrated in swine using ceftiofur sodium at doses in excess of 8 times the recommended daily dose of ceftiofur administered intramuscularly for 15 consecutive days.

Cattle: meat and offal: 6 days.

Milk: zero hours.

Pigs: meat and offal: 2 days.

Penicillins and cephalosporins may cause hypersensitivity (allergy) 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.

Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.

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 and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.

Wash hands after use.

Do not store above 25°C. Following withdrawal of the first dose, use the product within 28 days.

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

Keep out of the sight and reach of children.

For animal treatment only.

Excenel Flow is supplied in 50, 100 or 250 ml vials. Not all pack sizes may be marketed.

In case of acute post-partum metritis, additional supportive therapy might be required in some cases.

50 and 100 ml vials can be broached a maximum of 50 times. 250 ml vials can be broached a maximum of 33 times. Otherwise, the use of a multiple-dose syringe is recommended.