CEFTISOL

COMPOSITION

Ceftiofur (as hydrochloride) 50 mg/mL

TARGET SPECIES

Cattle and pigs

INDICATIONS

In cattle and pigs, for the treatment of respiratory diseases caused by microorganisms susceptible to ceftiofur. In cattle, for the treatment of interdigital necrobacillosis and postpartum metritis. The recommendation is limited to those cases of metritis where the treatment with another anti-microbial substance has not proven effective. It is effective against the following bacteria:

Cattle - Pasteurella haemolytica, P. multocida, Haemophylus somnus, Fusobacterium necrophorum, Bacteroides melaninogenicus

Pigs - Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, Streptococcus suis

CONTRAINDICATIONS

Do not use in animals that have previously exhibited sensitivity to ceftiofur and β-lactam antibiotics. Do not inject it intravenously. It cannot be used in case of resistance to other cephalosporins or to β-lactam antibiotics. Do not use in poultry (including egg-laying ones) because of the risk of occurrence of antimicrobial resistance in humans.

ADVERSE REACTIONS: 

Hypersensitivity may occur regardless of the dose used. Very rare (less than 1 animal in 10,000 treated animals, including isolated cases), allergic reactions may occur (e.g., skin reactions, anaphylaxis).

Cattle - A slight reaction, a temporary inflammation may occur at the injection site, and then discoloration of the connective tissue and fascia, which generally occurs within 10 days. A slight discoloration of the tissue can last even more than 28 days. In most animals, mild or moderate inflammation was reported, 42 days after treatment. Very rare reactions have been reported from the field, which occurred at the administration site. 

Pigs - A slight discoloration may occur at the injection site, in the fascia and in the fat tissue within at least 20 days after administration.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

Cattle - In the case of respiratory infections: 1 mg ceftiofur/kg of live body weight (1 mL CEFTISOL/50 kg live body weight) given subcutaneously once daily, for 3-5 consecutive days. For the treatment of acute interdigital necrobacillosis: 1 mg ceftiofur/kg of live body weight (1 mL CEFTISOL/50 kg live body weight) given subcutaneously once daily, for 5 consecutive days. In the case of acute postpartum metritis, within 10 days after calving, 1 mg ceftiofur/kg live weight (1 mL CEFTISOL/50 kg live weight) given subcutaneously once daily, for 5 consecutive days. Do not administer more than 13 mL at the injection site.

Pigs - 3 mg ceftiofur/kg of body weight (1 mL CEFTISOL/16 kg live body weight) given intramuscularly once daily, for 3 consecutive days. Do not administer more than 4 mL at the injection site.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

Before use, shake the vial well for at least 60 seconds or until the product looks homogeneous. Subsequent administrations must be applied in different places. 50mL and 100mL vials will be punctured 50 times at most. 250mL vials will be punctured 33 times at most. In other cases, it is recommended to use a multidose syringe. In some cases, complementary therapy may be required in the treatment of acute postpartum metritis.

WITHDRAWAL PERIOD(S)

Pigs (meat and offal): 2 days
Cattle (meat and offal): 6 days
Milk 0 days

SPECIAL PRECAUTIONS FOR STORAGE

Do not store above 25 °C. Keep away from light. Do not refrigerate.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

CEFTISOL selects resistant strains, such as bacteria that secrete extended spectrum beta-lactamases (ESBL) and could pose a risk to human health if these strains would spread to humans, for example, through food. For this reason, CEFTISOL should be reserved for the treatment of clinical conditions that have inadequate response or are expected to respond poorly (it refers to very acute cases when treatment should be initiated without bacteriological diagnosis) to first-line treatment. Official, national and regional policies on antimicrobial drugs shall be observed when using the product. Increased use, including use of the product deviating from the instructions provided in the SmPC, may increase the prevalence of this resistance. Wherever possible, CEFTISOL should only be used based on susceptibility testing. CEFTISOL is intended for the treatment of individual animals. Do not use for prophylaxis of diseases or in health programs for herds. Treatment of animal groups should be strictly limited to outbreaks of current disease according to approved conditions for use. Do not use for prophylactic purposes in case of retained placenta.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Penicillins and cephalosporins can cause hypersensitivity (allergy) after self-injection, inhalation, ingestion, or after skin contact. Persons experiencing hypersensitivity to penicillin may also be hypersensitive to cephalosporin and vice versa. Allergic reactions triggered by these active substances may be serious, on a case-by-case basis. Those with known hypersensitivity to penicillin or cephalosporin are advised to avoid direct contact with this preparation. In order to avoid direct contact with the product, all precautions must be observed. If symptoms are experienced after contact with product, such as skin irritation, you should contact your doctor immediately and show the instructions for use or the product label. Swelling of the face, lips, eyes or difficulty breathing are serious symptoms and require immediate medical attention.

USE DURING PREGNANCY AND LACTATION 

Use during gestation: laboratory studies in animals (rats, rabbits) did not indicate any teratogenic, embryotoxic or other maternal toxic effects of ceftiofur. The safety of the product in target species during gestation and lactation has not been demonstrated. Use during lactation: the safety of the product in piglets and calves was demonstrated when the product was used in lactating sows and cows. Use only in accordance with the benefit/risk ratio evaluation performed by a competent veterinarian.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

The bactericidal effect of β-lactam antibiotics is neutralized by bacteriostatic antibiotics (macrolides, sulphonamides and tetracyclines) administered simultaneously. The effect of cephalosporin may be potentiated by aminoglycosides

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

For pigs, reduced ceftiofur toxicity has been demonstrated by taking a dose of 8 times the recommended dose of ceftiofur for 15 days. No symptoms of systemic toxicity could be shown in the case of cattle even after overdoses administered parenterally. 

INCOMPATIBILITIES

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

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Medicines should not be disposed of via waste water or household waste.

PRESENTATION/PACKAGE

50 mL, 100 mL, 250 mL and 500 mL polypropylene vials sealed with bromobutyl rubber stopper and aluminium cap.