RenuTend

1 x 1 dose
Suspension for injection
IL

Active substance

  • tpMSCs : 1 doser
  • Species

    Horses

    Indications

    To restore fibre alignment in horses with superficial digital flexor tendon or suspensory ligament fibre disruption

    Dose to be administered and administration route

    Route of administration:

    Intra-lesional use.

    Dosage:

    A single intra-lesional injection of 1 ml per animal on one occasion.

    Preparation of the suspension for injection:

    The veterinary medicinal product must be administered intra-lesionally by a licensed veterinarian taking special precautions to ensure sterility of the injection process. The veterinary medicinal product should be handled and injected using sterile techniques and in a clean environment.

    The veterinary medicinal product is required to be administered immediately after thawing in order to maintain cell viability.

    Using appropriate gloves, remove the vial from the freezer/liquid nitrogen and thaw immediately at 25 °C–37 °C, e.g. in a water bath, until the content is completely thawed (approximately 5 minutes).

    If any cell clusters are visible after thawing, gently invert the vial until the suspension is clear and colourless.

    Remove the cap of the vial and aspirate the suspension into a sterile syringe for injection.

    Administer using a needle with a diameter greater than or equal to 22G in order to prevent cell damage.

    Administer intra-lesionally under ultrasound guidance with chemical or physical restraint as needed according to good veterinary practice to facilitate a safe intralesional injection. After insertion of the needle into the tendon or ligament, redirect the needle, if necessary, until the lesion is reached. Slowly inject the suspension. In case of a larger lesion the needle can be slowly retracted during injection to facilitate dispersion of the cells throughout the lesion.

    Adverse reactions

    Mild injection site reactions, such as increased heat, pain at palpation, limb swelling and increased limb circumference occurred very commonly during the first 10 days after administration.

    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).

    References

    Leaflet is unavailable
    Horse
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    Art. Nr. 04491/5064
    EAN (01)04064951002502
    PACKAGES
    RenuTend
    Boehringer Ingelheim Animal Health
    1 x 1 dose
    04491/5064
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