Cevaxel-RTU

1 x 100 ml

Suspension for injection

Active substance

Ceftiofur (Ceftiofur hydrochloride) : 50 mg/ml

ATC code

QJ01DD90 Ceftiofur

QJ01DD Third-generation cephalosporins

QJ01D Other beta-lactam antibacterials

QJ01 Antibacterials for systemic use

QJ Antiinfectives for systemic use

Species

Cattle and pigs.

Indications

Infections associated with bacteria sensitive to ceftiofur.

In cattle:

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

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 after calving associated with Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum: : this indication is restricted to cases where treatment with another antimicrobial has failed.

In pigs:

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

Dose to be administered and administration route

Cattle: Subcutaneous use

- Respiratory disease: 1 mg ceftiofur (as hydrochloride)/kg /day for 3 to 5 days, i.e. 1 ml/50 kg at each injection.

- Acute interdigital necrobacillosis: 1 mg ceftiofur (as hydrochloride)/kg /day for 3 days, i.e. 1 ml/50 kg at each injection.

- Acute post-partum metritis within 10 days after calving: 1 mg ceftiofur (as hydrochloride)/kg /day for 5 consecutive days, i.e. 1 ml/50 kg at each injection.

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

Pigs: Intramuscular use

3 mg ceftiofur (as hydrochloride)/kg /day for 3 days, i.e. 1 ml/16 kg at each injection.

Shake the bottle well before use to bring the product back into suspension.

To ensure a correct dosage, body weight should be determined as accurately as possible in order to avoid under-dosing. Subsequent injections must be given at different sites. As the vial cannot be broached more than 50 times, the user should choose the more appropriate vial size.

Adverse reactions

Hypersensitivity reactions (e.g. skin reactions, anaphylaxia) have been reported in very rare cases. In case of the occurrence of hypersensitivity reaction the treatment should be withdrawn.

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

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

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).