Nifencol

70 x 100 ml
Liquid for injection, solution
IM
SC

Active substance

  • Florfenicol : 300 mg/ml
  • Species

    Cattle and pigs.

    Indications

    Cattle:

    Metaphylaxis and treatment of respiratory tract infections in cattle due to Histophilus somni, Mannheimia haemolytica and Pasteurella multocida, susceptible to florfenicol.

    The presence of the disease in the herd should be established before the product is used.

    Pigs:

    Treatment of acute outbreaks of respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.

    Dose to be administered and administration route

    Cattle: Intramuscular or subcutaneous injection

    Pig: intramuscular injection


    Cattle:

    Treatment

    IM route: 20 mg florfenicol /kg bodyweight (1ml of the product/15kg) to be administered twice 48 hours apart using a 16 gauge needle.

    SC route: 40 mg florfenicol /kg bodyweight (2ml of the product/15kg) to be administered once only using a 16 gauge needle.

    Metaphylaxis

    SC route: 40 mg florfenicol/kg bodyweight (2ml of the product/15kg) to be administered once only using a 16 gauge needle.

    Pigs:

    15 mg florfenicol/kg bodyweight (1 ml of the product / 20 kg) by intramuscular injection twice at 48 hour intervals using a 16-gauge needle.

    The dose volume given at any one injection site should not exceed 10ml for both routes of administration (intramuscular and subcutaneous) in cattle and 3 ml in pigs. The injection should only be given in the neck in both target species.

    To ensure a correct dosage body weight of the animals should be determined as accurately as possible to avoid underdosing.

    It is recommended to treat animals in the early stages of disease and to evaluate the response to treatment within 48 hours after the second injection. If clinical signs of respiratory disease persist 48 hours after the last injection or if relapse occurs, treatment should be changed using another formulation or another antibiotic and continued until clinical signs have resolved.

    Swab septum before removing each dose. Use a dry sterile needle and syringe.

    Do not broach the stopper of vial more than 25 times.

    Adverse reactions

    In cattle, a decrease in food consumption and transient softening of the faeces may occur during the treatment period. The treated animals recover quickly and completely upon termination of treatment.

    Administration of the product by the intramuscular and subcutaneous routes may cause inflammatory lesions at injection site which persist for 14 days.

    On very rare occasions, anaphylactic reactions have been reported in cattle. In pigs, commonly observed adverse effects are transient diarrhoea and/or perianal and rectal erythema/oedema which may affect 50% of the animals. These effects can be observed for one week. Under field conditions approximately 30% of treated pigs presented with pyrexia (40°C) associated with either moderate depression or moderate dyspnea a week or more after administration of the second dose.

    Transient swelling lasting up to 5 days may be observed at the site of injection. Inflammatory lesions at the injection site may be seen up to 28 days.

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

    - very common (more than 1 in 10 animals treated displaying adverse reaction(s))

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

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

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

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

    EMA Categorisation

    C
    Pig
    Cattle
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    Art. Nr. 32509/4011
    PACKAGES
    Nifencol
    Bimeda Animal Health
    70 x 100 ml
    32509/4011

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