CEFTISOL 50 mg/ml

50 mg /ml, injectable suspension for cattle and pigs

Indications

In cattle and pigs for treatment of respiratory infections associated with bacteria sensitive to ceftiofur.

In cattle for the treatment of acute interdigital necrobacillosis (panaritium, foot rot), and post-partum (puerperal) metritis. The indication is restricted to cases of metritis where treatment with another antimicrobial has failed.

It is active against following bacteria:

Cattle: Pasteurella haemolytica, P. multocida, Haemophilus somnus, Fusobacterium necrophorum, Bacteroides melaninogenicus.

Pigs: Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, Streptococcus suis.

COMPOSITION

Ceftiofur (as ceftiofur hydrochloride)    50 mg/ml

 

CONTRAINDICATIONS

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.

 

ADVERSE REACTIONS

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

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

In cattle, mild inflammatory reactions at the injection site, such as tissue oedema and discoloration of the subcutaneous tissue and/or fascial surface of the muscle may be observed. Clinical resolution is reached in most animals by 10 days after injection although slight tissue discoloration may persist for 28 days or more.

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.

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

 

DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION

To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid overdosing.

Pigs

3 mg ceftiofur /kg bw/day for 3 days via intramuscular route, (1 ml Ceftisol/16 kg bw). Not more than 4 ml should be administered per injection site.

Cattle

Respiratory diseases: 1 mg ceftiofur /kg bw/day for 3 to 5 days by subcutaneous injection, (1 ml Ceftisol /50 kg bw).

Acute interdigital necrobacillosis: 1 mg/kg bw/day for 3 days by subcutaneous injection, (1 ml Ceftisol /50 kg bw).

Acute post-partum metritis within 10 days after calving: 1 mg/kg bw/day for 5 consecutive days by subcutaneous injection, (1 ml Ceftisol /50 kg bw). Not more than 13 ml should be administered per injection site.

 

ADVICE ON CORRECT ADMINISTRATION

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

Subsequent injections must be given at different sites.

50 ml 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.

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

WITHDRAWAL PERIODS

Pig (meat and offal): 2 days

Cattle (meat and offal): 6 days

Milk: 0 (zero) days.

 

SPECIAL STORAGE PRECAUTIONS

Do not store above 25oC.

 

SHELF-LIFE

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

Shelf-life after first opening the immediate packaging: 28 days.

 

SPECIAL WARNINGS

Special precautions for use in animals

Ceftisol selects for resistant strains such as bacteria carrying extended spectrum betalactamases (ESBL) and may constitute a risk to human health if these strains disseminate to humans e.g. via food. For this reason, Ceftisol 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 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 SPC, may increase the prevalence of resistance. Whenever possible, Ceftisol should only be used based on susceptibility testing. Ceftisol is intended for treatment of individual animals. Do not use for disease prevention or as a part of herd health programs. Treatment of groups of animals should be strictly restricted to ongoing disease outbreaks according to the approved conditions of use.

Do not use as prophylaxis in case of retained placenta.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

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.

People with known hypersensitivity to penicillin or cephalosporins should avoid contact with the veterinary medicinal product. 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 the package leaflet or the label. Swelling of the face, lips, or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.

Use during pregnancy, lactation or lay

Studies in laboratory species have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the veterinary medicinal product has not been established during pregnancy. Use only according to the benefit/risk assessment by the responsible veterinarian.

Interaction with other medicinal products and other forms of interaction

The bactericidal properties of Beta-lactams are neutralized by simultaneous use of bacteriostatic antibiotics (macrolides, sulfonamides and tetracyclines).

Aminoglycosides may have a potentiating effect on cephalosporins.

Overdose

The low toxicity of ceftiofur has been demonstrated in pigs using ceftiofur at doses in excess of 8 times the recommended daily dose of ceftiofur intramuscularly administered for 15 consecutive days. In cattle, no signs of systemic toxicity have been observed following substantial parenteral overdosages.

Incompatibilities

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

 

PRESENTATION/PACKAGE

Vials of 50 ml, 100 ml, 250 ml and 500 ml.


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