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 Histophilus somni, Mannheimia haemolytica and Pasteurella multocida.

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, Trueperella 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.

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

Cattle:

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Hypersensitivity reaction¹, Allergic skin reaction¹, Anaphylaxis¹

Rare

(1 to 10 animals / 10,000 animals treated):

Injection site reaction² (e.g. inflammation, oedema, thickening³, discoloration⁴)

¹In case of the occurrence of allergic reaction the treatment should be withdrawn. ²Clinical resolution is reached in most animals by 10 days after injection although slight tissue discoloration may persist for 28 days or more.

³Of connective tissue

⁴Of the subcutaneous tissue and/or fascial surface of the muscle

Pigs

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Hypersensitivity reaction¹, Allergic skin reaction¹, Anaphylaxis¹

Undetermined frequency (cannot be estimated from the available data)

Injection site reaction (e.g. discoloration) ²

¹In case of the occurrence of allergic reaction the treatment should be withdrawn.

² Of the fascia or fat, mild, observed in some animals for up to 20 days after injection.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.