Cobactan® LC

Summary of product characteristics.

  1. NAME of the Veterinary Medicinal Product

    Cobactan® LC (in UK: Cephaguard® Milking Cow)

  2. QUALITATIVE AND QUANTITATIVE COMPOSITION

    Composition of Cobactan LC
    Compositionper 8g syringe
    Active ingredient:Cefquinome
    (as cefquinome sulphate)
    75.0-mg

  3. PHARMACEUTICAL FORM

    Intramammary ointment in prefilled syringes.

  4. PHARMACOLOGICAL PROPERTIES

    Pharmaceutic group: Cephalosporins and related substances
    ATCvet code: QJ51DA92.
    Cefquinome is an antibacterial drug of the cephalosporin group which acts by inhibition of cell wall synthesis. It is characterised by its broad therapeutic spectrum of activity and a high stability against beta-lactamases.

    • Pharmacodynamic properties

      In vitro, Cefquinome has antibiotic activity against common Gram negative and Gram positive bacteria including Escherichia coli, Staphylococcus aureus, Streptococcus dysgalactiae, Streptococcus agalactiaeand Streptococcus uberis.

    • Pharmacokinetic properties

      After intramammary administration, a mean concentration of 19 mcg/ml in milk is observed 12 hours post last infusion. The highest MIC 90 value was found for Staphylococcus aureus. This pathogen has a MIC 90 in the range of 1 µg/ml.
      At the second milking following the last infusion the mean concentration is still approximately 2.5 mcg/ml and then falls to 0.75 mcg/ml at the third milking post last infusion.

      Resorption of cefquinome from the udder is insignificant.

  • CLINICAL PARTICULARS
    1. Target species

      Lactating cows

    2. Indications for Use

      For the treatment of clinical mastitis in the lactating dairy cow caused by the following cefquinome-sensitive organisms : Streptococcus uberis, Streptococcus dysgalactiae, Staphylococcus aureus and Escherichia coli.

    3. Contra-indications

      Not to be administered to animals which are known to be hypersensitive to cephalosporin antibiotics and other β-lactam antibiotics.
      Do not use the cleaning towel on lesioned teat.

    4. Undesirable effects (frequency and seriousness)

      None known

    5. Special precautions for use

      None

    6. Use during pregnancy and lactation

      Cephaguard® Milking Cow is intended for use during lactation. There is no available information indicating reproductive toxicity (inc. teratogenicity) in cattle. In reproductive toxicity studies in laboratory animals cefquinome did not reveal any effect on reproduction or teratogenic potential.

    7. Interaction with other medicaments and other forms of interaction

      It is known that a cross sensitivity to cephalosporins exits for bacteria sensitive to the cephalosporin group.

    8. Posology and method of administration

      The content of one syringe should be infused gently into the teat of the infected quarter every 12 hours after each of three successive milkings.
      Milk out the affected quarter(s). After thoroughly cleaning and disinfecting the teat and teat orifice with the cleaning towel provided, gently infuse the contents of one syringe into each affected quarter. Disperse the product by gentle massage of the teat and udder of the affected animal.

    9. Overdose

      No symptoms expected or emergency procedures required.

    10. Special warnings for each target species

      None.

    11. Withdrawal periods

      Meat = 4 days
      Milk = 5 days

    12. Special precautions to be taken by the person administering the product to animals

      Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious.

      • Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
      • Handle this product with great care to avoid exposure, taking all recommended precautions.
      • If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the Doctor this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.

      Wash hands after using the wipes and wear protective gloves if skin irritation due to Isopropyl alcohol is known or suspected.

      The syringe must only be used once. Part used syringes should be discarded.

  • PHARMACEUTICAL PARTICULARS
    1. Major Incompatibilities

      None known

    2. Shelf-life

      30 months

    3. Special precautions for storage

      Do not store above 30°C.

    4. Nature and contents of container

      White opaque polyethylene syringes and cleaning towels in paper aluminium copolymer laminate sachet.
      Packs of 3, 15, 20 and 24 syringes and cleaning towels.
      Not all pack sizes may be marketed.

    5. Special precautions for the disposal of unused product or waste material

      Any unused product or waste material should be disposed of in accordance with national requirements.

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    Cobactan LC