Tilmovet 250 Mg Oral Solution

    Tilmovet 250 Mg Oral Solution

    S4
    PDF Leaflet Revision Date: 08 August 2022


    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Treatment and prevention of respiratory infections in pigs and fowl.

    Dosage (summary)

    Pigs: 15-20 mg/kg for 5 days; Fowl: 15-20 mg/kg for 3 days.

    Onset of Action / Duration

    Onset: 6 hours, Duration: Not specified

    Pregnancy & Breastfeeding

    Safety not established; use based on risk/benefit assessment.

    Key Drug Interactions

    • Cross-resistance with other macrolides
    • Decreased activity of u03b2-lactam antibiotics
    • Avoid concurrent use with bacteriostatic agents

    Contraindications

    • Hypersensitivity to tilmicosin
    • Known resistance to tilmicosin
    • Access to drinking water by equines
    • Use in ruminants with active rumen function

    Common side effects

    • Irritation or sensitization through skin contact
    • Dehydration in pigs at high doses

    Counselling Points

    • Use only as directed and ensure proper dilution
    • Monitor for signs of disease improvement
    • Wash hands after handling

    Serious warnings

    • Keep out of reach of children
    • Withdrawal periods: 14 days for pigs, 12 days for fowl
    Important Disclaimer

    The Tilmovet 250 Mg Oral Solution professional information leaflet below is the property of Huvepharma South Africa 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 Therapeutic indications

    Pigs: For the treatment and prevention of respiratory infections associated with Mycoplasma hyopneumoniae, Pasteurella multocida and Actinobacillus pleuropneumoniae when the disease has been diagnosed at herd level.

    Fowl: For the treatment and control of respiratory infections in fowls associated with Mycoplasma gallisepticum, Mycoplasma synoviae and other organisms sensitive to tilmicosin.

    4.2 Posology and method of administration

    For oral use only. The product must be diluted in drinking water before administration.

    Pigs: 15 - 20 mg tilmicosin per kg bodyweight for 5 days, i.e., 6 - 8 ml of Tilmovet 250 mg/ml for 100 kg bodyweight corresponding to 80 ml of product per 100 litres of drinking water for 5 days.

    Fowl: 15-20 mg tilmicosin per kg bodyweight for 3 days, i.e., 6-8 ml of Tilmovet 250 mg/ml for 100 kg bodyweight corresponding to 30 ml of product per 100 litres of drinking water for 3 days.

    One 960 ml bottle is sufficient to medicate 1200 litres of drinking water for pigs or 3200 litres of drinking water for broilers, turkeys, and pullets.

    Drinking water containing Tilmovet 250 mg/ml should be freshly prepared every 24 hours, only using clean water. If signs of disease do not improve significantly within 3 - 5 days, the diagnosis should be re-evaluated, and treatment changed.

    4.3 Contraindications

    Do not use in cases of hypersensitivity to the active substance or in cases of known resistance to tilmicosin. Do not allow horses and other equines access to drinking water containing tilmicosin. Do not use in ruminants with active rumen function.

    4.4 Special warnings and precautions for use

    KEEP OUT OF REACH OF CHILDREN AND UNINFORMED PERSONS.

    • Water containing Tilmovet 250 mg/ml must be withdrawn from fowls 12 days prior to slaughter of fowls treated with Tilmovet 250 mg/ml.
    • Water containing Tilmovet 250 mg/ml must be withdrawn from swine 14 days prior to slaughter of swine treated with Tilmovet 250 mg/ml.
    • For oral use in swine and fowls only.
    • Do not administer undiluted.
    • Medicated drinking water must be freshly prepared every 24 hours and is stable when stored below 30u00b0C.
    • When mixing and handling Tilmovet 250 mg/ml, use a dust mask. Operators should wash contaminated parts of skin thoroughly with soap and water, should skin contact occur. If accidental eye contact occurs, immediately rinse thoroughly with clean water. If irritation persists, seek medical attention.
    • Tilmicosin should not be administered by injection to pigs. The product contains disodium edetate.
    • The uptake of medicated water can be altered because of illness. If the uptake is insufficient, alternative treatment may be required.

    4.6 Fertility, pregnancy and lactation

    The safety of Tilmovet 250 mg/ml has not been established during pregnancy and lactation. Use only in accordance with risk/benefit assessment by the responsible veterinarian.

    4.8 Undesirable effects

    Tilmovet 250 mg/ml is for oral use in swine and fowls only. Inappropriate use of Tilmovet 250 mg/ml may increase the prevalence of bacterial resistance to tilmicosin and may decrease the effectiveness of treatment with tilmicosin-related substances. Use of the Tilmovet 250 mg/ml should be based on susceptibility testing and official and local antimicrobial policies must be considered. Do not allow horses or other equines access to drinking water containing tilmicosin.

    People with known hypersensitivity to tilmicosin should avoid contact with the product. The veterinary medicinal product may cause irritation or sensitisation through skin contact. Avoid skin and eye contact. Wear protective gloves and protective clothing when handling the veterinary medicinal product. Wash hands after use. In case of contact with skin or eyes, rinse thoroughly with clean water. If irritation persists and in case of accidental ingestion, seek veterinary advice and notify the registration holder.

    4.9 Overdose

    Pigs drink less water when a dose of 300 to 400 mg/litre (1.5 to 2 times the recommended dose) is administered. While this will result in less intake of tilmicosin, it might lead to dehydration of the animals. Replace with untreated water when needed. No symptoms were observed in fowls treated at 375 mg/litre for 5 days. A dose of 75 mg/litre for 10 days resulted in less consistent faeces. No symptoms of overdose were noticed in turkeys treated at 375 mg/litre of drinking water for 3 days. No symptoms were observed at 75 mg/litre for 6 days.

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