Kelaflo 300 Mg Solution

    Kelaflo 300 Mg Solution

    S4
    PDF Leaflet Revision Date: 01 April 2025


    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Treatment of respiratory disease in cattle and pigs.

    Dosage (summary)

    Cattle: 20 mg/kg IM, 2 doses 48 hours apart. Pigs: 15 mg/kg IM, 2 doses 48 hours apart.

    Onset of Action / Duration

    Onset: 24 hours, Duration: Not specified

    Pregnancy & Breastfeeding

    Safety during pregnancy and lactation not demonstrated.

    Key Drug Interactions

    • Unknown effect with simultaneous administration of other products

    Contraindications

    • Do not use in lactating cows
    • Do not use in breeding bulls and boars

    Common side effects

    • Lowered food consumption
    • Diarrhoea in swine
    • Minor swelling at injection site

    Counselling Points

    • Administer in the neck only
    • Do not exceed 10 mL per injection site
    • Use within 28 days after first dose

    Serious warnings

    • Do not slaughter cattle within 34 days after treatment
    • Do not slaughter pigs within 20 days after treatment
    Important Disclaimer

    The Kelaflo 300 Mg Solution professional information leaflet below is the property of Lebasi Pharmaceuticals and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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    Clinical Particulars

    Section 4 of the official insert — extracted exactly as issued, no alterations

    4.1 Indications

    Cattle: Treatment of respiratory disease, also called shipping fever or transit fever, associated with microorganisms sensitive to florfenicol, including Mannheimia haemolytica, Mycoplasma bovis and Pasteurella multocida, and for treatment of interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Prevotella melaninogenica. Metaphylaxis: for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Mycoplasma bovis, Pasteurella multocida and Histophilus somni.

    Pigs: Treatment of infections associated with microorganisms sensitive to florfenicol and for the treatment of respiratory diseases caused by Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae.

    4.2 Contraindications

    Do not use in cows producing milk for human consumption. Do not use in bulls and boars intended for breeding purposes.

    4.3 Warnings

    WITHDRAWAL PERIOD
    Cattle: Do not slaughter animals for human consumption within 34 days after the last intramuscular treatment. Do not use in cows producing milk intended for human consumption.
    Pigs: Do not slaughter animals for human consumption within 20 days after last treatment.

    4.4 Pregnancy, lactation or lay

    Safety during pregnancy and lactation in cows and sows has not been demonstrated.

    4.5 Dosage and directions for use

    Cattle: The recommended dose is 20 mg/kg body mass (1 mL/15 kg) by intramuscular injection. Administer a total of 2 injections 48 hours apart using a 18 G needle. Do not administer more than 10 mL at each injection site. The injection should only be given in the neck. A clinical response was noticeable in most treated animals within 24 hours after initiation of therapy.
    Pigs: The recommended dose is 15 mg/kg body mass (1 mL/20 kg) by intramuscular injection into the neck muscle. Administer a total of 2 injections 48 hours apart using a 18 G needle. The volume administered per site of injection should not exceed 10 mL.

    4.6 Side effects and special precautions

    • Lowering of food consumption has been observed.
    • The effect of simultaneous administration with other products is unknown.
    • Microsomal enzyme inhibition may occur.
    • In swine, diarrhoea and/or peri-anal erythema/oedema may occur transiently following treatment. A transient reaction may occasionally occur with minor swelling at the injection site. These swellings disappear completely within 21 days.

    4.7 Known signs of overdose and particulars of its treatment

    A large overdose may cause anorexia, pyrexia, vomiting, diarrhoea and slight ataxia which resolves within 2 weeks. Treatment is symptomatic and supportive.

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