CEFTIOFUR-VS® (suspension for injection)

White to yellowish oily suspension.

Each 1 ml of the product contains the active substance:

- сeftiofur (as hydrochloride) — 50,0 mg

Excipients: lecithin, sorbitan monooleate, cottonseed oil.

ATC vet classification code QJ01 — antibacterial veterinary medicinal products for systemic use. QJ01DD90 — Ceftiofur.

Ceftiofur is a semi-synthetic third-generation cephalosporin antibiotic. It is characterised by a broad spectrum of bactericidal activity against Gram-positive (Streptococcus zooepidemicus, Streptococcus suis, Staphylococcus spp., Bacillus spp., Trueperella pyogenes (formerly Arcanobacterium pyogenes)) and Gram-negative (Pasteurella (Mannheimia) haemolytica, Pasteurella multocida, Haemophilus somnus, Haemophilus parasuis, Actinobacillus pleuropneumoniae, Escherichia coli, Salmonella cholerasuis, Salmonella typhimurium, Fusobacterium necrophorum, Bacteroides melaninogenicus, Klebsiella spp., Citrobacter spp., Proteus spp., Porphyromonas asaccharolytica) bacteria, including β-lactamase-producing strains. Ceftiofur inhibits bacterial cell wall synthesis, thereby exerting a bactericidal effect.

Following a single intramuscular administration to pigs at a dose of 3 mg ceftiofur per 1 kg body weight, the maximum plasma concentration (Cmax) of approximately 9 µg/ml is reached within approximately 1 hour. The terminal elimination half-life (t½) of desfuroylceftiofur is 23 hours. No accumulation of desfuroylceftiofur was observed following administration at a dose of 3 mg ceftiofur per 1 kg body weight per day for 3 days. In pigs, ceftiofur is excreted predominantly via urine (more than 70%), with 12–15% excreted via faeces.

Following a single subcutaneous administration to cattle at a dose of 1 mg ceftiofur per 1 kg body weight, the maximum plasma concentration (Cmax) of 2 µg/ml is reached within 2,5 hours. Following parenteral administration, the half-life (t½) of ceftiofur in cattle is approximately 18 hours. In some cases, an increase in Cmax to 2,25 µg/ml was observed, reached approximately 5 hours after a single administration of ceftiofur. Ceftiofur is excreted in cattle predominantly via urine (more than 55%) and via faeces (31%).

Following subcutaneous injection in dogs, the absolute bioavailability of ceftiofur was 93,7%, the maximum plasma concentration (Cmax) of ceftiofur (10,50 µg/ml) was reached at 3,2 hours, and the absorption half-life (t½ka) was 45 ± 15 minutes.

Cattle: treatment of respiratory tract diseases caused by Pasteurella haemolytica, Pasteurella multocida, and Haemophilus somnus; treatment of acute necrobacteriosis caused by Fusobacterium necrophorum and Bacteroides melaninogenicus (Porphyromonas asaccharolytica); and treatment of acute postpartum metritis within 10 days of calving caused by Escherichia coli, Trueperella pyogenes (formerly Arcanobacterium pyogenes), and Fusobacterium necrophorum susceptible to ceftiofur.

Pigs: treatment of respiratory tract diseases caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, and Streptococcus suis susceptible to ceftiofur.

Dogs: treatment of respiratory tract diseases, urogenital tract diseases, and skin conditions (pyoderma) caused by microorganisms susceptible to ceftiofur.

Cattle: subcutaneous administration:

- respiratory tract diseases: 1 ml of the product per 50 kg body weight once daily for 3–5 days (1 mg ceftiofur per 1 kg body weight).

- fcute necrobacteriosis: 1 ml of the product per 50 kg body weight once daily for 3 days (1 mg ceftiofur per 1 kg body weight once daily).

- acute postpartum metritis: 1 ml of the product per 50 kg body weight once daily for 5 days (1 mg ceftiofur per 1 kg body weight once daily).

Pigs: intramuscular administration at a dose of 1 ml of the product per 16 kg body weight (3 mg ceftiofur per 1 kg body weight) once daily for 3 days.

Dogs: intramuscular or subcutaneous administration at a dose of 1,0 ml of the product per 10–20 kg body weight (equivalent to 2,5–5 mg ceftiofur per 1 kg body weight) once daily for 5–10 days.

In cases of acute postpartum metritis, additional supportive therapy may be required.

Shake well before use.

The maximum volume of product administered at a single injection site must not exceed 10 ml for cattle, 5 ml for pigs, and 2,5 ml for dogs.

Do not use in cases of hypersensitivity to the active substance, to other β-lactam antibiotics, or to any of the excipients.

Do not use concomitantly with bacteriostatic antibiotics (macrolides, sulphonamides, and tetracyclines).

Do not administer intravenously.

Do not use in animals with renal insufficiency.

Do not use as a prophylactic agent in cases of retained placenta.

Hypersensitivity reactions, independent of dose, may occur. Allergic reactions, including cutaneous manifestations and anaphylaxis, may occasionally arise.

In pigs, minor local reactions at the injection site are occasionally observed — for example, transient discolouration of connective tissue or fat, which may persist for up to 20 days following injection.

In cattle, mild inflammatory reactions at the injection site may occur, namely tissue oedema and discolouration of the subcutaneous tissue or fascial surface of the muscles. In most animals, clinical recovery occurs within 10 days following injection, although minor tissue discolouration may persist for up to 28 days or longer.

Reversible thrombocytopaenia and anaemia have occasionally been observed in dogs receiving ceftiofur over prolonged periods. Accordingly, the use of this product is contraindicated in animals presenting with existing signs of these conditions.

The product is recommended for use only after susceptibility testing of the causative microorganisms to ceftiofur has been performed.

Ceftiofur may promote the development of resistant microbial strains, including extended-spectrum beta-lactamase-producing bacteria, which may pose a risk to human health through the potential spread of such strains. The product should be used solely for the treatment of clinical conditions that respond poorly to first-line antibiotic therapy (i.e., peracute cases in which treatment is initiated without bacteriological diagnosis).

Recommendations regarding the prudent use of antimicrobial agents must be observed when using this product. Irrational use of the product, including its use in a manner deviating from the recommendations stated in the Summary of Product Characteristics, may contribute to the emergence of ceftiofur-resistant microbial strains.

The product is intended for individual animal treatment. Do not use the product for disease prevention or as part of a whole-herd health programme. Treatment of groups of animals must be strictly limited to active disease outbreaks, in accordance with the approved conditions of use.

Do not use as a prophylactic agent in cases of retained placenta.

Studies in laboratory animals have revealed no evidence of teratogenic, foetotoxic, or maternotoxic effects. The safety of the product in target animal species during pregnancy and lactation has not been established. In such cases, the product should be used exclusively following a benefit/risk assessment by the responsible veterinary surgeon.

Slaughter of animals for human consumption is permitted 8 days (cattle) and 5 days (pigs) after the last administration of the product. Consumption of milk for human use is permitted without restriction. Meat obtained prior to the stated withdrawal period must be disposed of or fed to non-productive animals, subject to the decision of the responsible veterinary surgeon.

Vials of neutral glass (Type I or equivalent, grades NS-1, NS-2, USP-1), sealed with rubber stoppers and aluminium crimp caps, in volumes of 10, 20, 50, 100, and 200 ml. Secondary packaging: cardboard box.

Store in a dry, dark place, out of the reach of children, at a temperature of 10–25 °C.

2 years.

Shelf life after first opening the immediate packaging: 28 days, provided it is stored in a dark place at a temperature of 0–8 °C.