Ceftisol 100 ml

50 mg/ml solution for injection for cattle and pigs.

Marketing Authorization Holder:

S.C. CRIDA PHARM S.R.L.

Str. Intrarea Vagonetului, Nr. 2, Bloc 101, Ap. 47, Parter, Sector 6, Bucharest, Romania.

Tel.:/Fax: +4021 430 4399, E-mail: office@cridapharm.ro

Manufacturer:

S.C. CRIDA PHARM S.R.L, Str. Stadionului, Nr. 1, Oltenița, Jud. Calarasi, Romania.

Tel./Fax: +4024 251 5005, E-mail: office@cridapharm.ro

Composition:

1 ml of injection solution contains:

Active substance: Ceftiofur (as ceftiofur hydrochloride)...50 mg

Indications:

Respiratory tract infections in cattle and pigs caused by bacteria sensitive to ceftiofur.

Acute inter-hoof necrobacteriosis (panaricium, hoof rot) and post-weaning metritis in cattle. It is indicated for metritis in cases where treatment with other antimicrobial drugs has been ineffective.

Active against the following bacteria:

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

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

Contraindications: Do not use in animals with hypersensitivity to ceftiofur or other beta-lactam antibiotics. Do not administer intravenously. Do not use in cases of resistance to other cephalosporins or beta-lactam antibiotics. Do not use in poultry.

Adverse reactions: Hypersensitivity reactions may occur, which are not dose-related. Allergic reactions (skin reactions, anaphylaxis) have been reported very rarely (1 in 10,000 animals, including isolated reports).

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

In cattle, mild inflammatory reactions have been observed at the injection site, such as tissue swelling and discoloration of the subcutaneous tissue and/or superficial fascia of the muscle. This resolves in most animals within 10 days of injection, although slight tissue discoloration may persist for 28 days or more.

Mild to moderate localised chronic inflammation is most commonly seen within 42 days of injection. This has been observed in very rare cases.

Target animals: Cattle and pigs.

Dosage for each species, route and method of administration:

To ensure the correct dosage, accurate determination of body weight is necessary to avoid overdosing.

Pigs: Ceftiofur 3 mg/kg body weight intramuscularly for 3 days (1 ml Ceftisol/16 kg body weight). A maximum of 4 ml may be administered at one injection site.

Cattle:

Respiratory diseases: Ceftiofur 1 mg/kg body weight/day, subcutaneously for 3-5 days (1 ml Ceftisol/50 kg body weight).

Acute necrobacteriosis of the hoof: 1 mg/kg body weight/day, subcutaneously for 3 days (1 ml Ceftisol/50 kg body weight).

Acute postpartum metritis within 10 days of parturition: 1 mg/kg body weight daily for 5 days subcutaneously (1 ml of ceftisol/50 kg body weight). A maximum of 13 ml may be administered at one injection site.

Advice on correct use:

Shake the bottle vigorously for a maximum of 60 seconds before use or until the product is homogeneous. Each subsequent injection should be made at a different site.

The vial can be punctured a maximum of 50 times.

For acute postpartum metritis, additional supportive therapy may be required in some cases.

Withdrawal period:

Swine (meat and offal): 2 days.

Cattle (meat and offal): 6 days.

Milk: 0 (zero) days.

Special precautions for storage:

Keep out of reach of children. Do not store above 25°C. Store in the original packaging. Protect from direct sunlight. Do not use this veterinary medicinal product after the expiry date stated on the label. Shelf life after opening: 28 days.

Special precautions for use in animals:

Ceftisol should be used in cases that are not amenable to first-line treatment. This applies to very severe cases where treatment must be started without bacteriological examination. Frequent use of the product or failure to follow the recommended dosage regimen may lead to the development of resistance. Ceftisol should be used only on the basis of susceptibility testing. Do not use the product for the prophylaxis of disease, including in cases of placental abruption.

Special precautions to be observed by the person providing the medicinal product

Interaction with other medicinal products and other forms of interaction:

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

Aminoglycosides may have an enhancing effect on cephalosporins.

Overdose: Low toxicity of ceftiofur was observed in pigs when a dose exceeding 8 times the recommended daily dose of ceftiofur was administered intramuscularly for 15 consecutive days. No systemic toxicity was observed in cattle after a significant overdose of the parenteral dose.

Incompatibilities: This veterinary medicinal product must not be mixed with other veterinary medicinal products.

Special precautions for disposal of unused products or waste materials derived from the use of such products.

Do not dispose of medical products via sewage system or household waste.

Pharmacotherapeutic group: Antibacterials for systemic use, third generation cephalosporins.

ATC Vet Code: QJ01DD90.

Packaging:

100 ml polypropylene vials, closed with a bromobutyl rubber stopper and an aluminium cap, placed in an individual cardboard box with a leaflet.