Excenel Flow

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

Pigs and cattle.

Indications

Infections associated with bacteria sensitive to ceftiofur:

In pigs:

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

In cattle:

For the treatment of bacterial respiratory disease associated with Mannheimia haemolytica (former Pasteurella haemolytica), Pasteurella multocida and Histophilus somni (former Haemophilus somnus).

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, sensitive to ceftiofur, were treatment with another antimicrobial has failed.

Dose to be administered and administration route

Before use, shake the bottle vigorously for a maximum of 60 seconds or until the product appears adequately resuspended.

To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

Pigs:

3 mg ceftiofur /kg bw/day for 3 days via intramuscular route, i.e. 1 ml/16 kg bw at each injection.

Not more than 4 ml should be administered per injection site.

Cattle:

Respiratory disease: 1 mg ceftiofur /kg bw/day for 3 to 5 days by subcutaneous injection, i.e. 1 ml/50 kg bw at each injection.

Acute interdigital necrobacillosis: 1 mg/kg bw/day for 3 days by subcutaneous injection, i.e.

1 ml/50 kg bw at each injection.

Acute post-partum metritis within 10 days after calving: 1 mg/kg bw/day for 5 consecutive days by subcutaneous injection, i.e. 1 ml/50 kg bw at each injection. Not more than 13 ml should be administered per injection site.

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

Subsequent injections must be given at different sites.

50 ml and 100 ml vials can be broached a maximum of 50 times. 250 ml vials can be broached a maximum of 33 times. Otherwise, the use of a multiple-dose syringe is recommended.

Adverse reactions

Pigs:

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

Hypersensitivity reaction (e.g. allergic skin reaction, anaphylaxis), Injection site reaction (e.g. discolouration of fascia or fat)¹

¹Mild, observed for up to 20 days.

Cattle:

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

Hypersensitivity reaction (e.g. allergic skin reaction, anaphylaxis), Injection site induration, Injection site swelling, Injection site inflammation¹

¹Mild to moderate, observed until 42 days post 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.