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Synulox Palatable Tablets 50 mg

Information leaflet

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© Pfizer Ltd                                                                                      UK


                         SUMMARY OF PRODUCT CHARACTERISTICS


1.    NAME OF THE VETERINARY MEDICINAL PRODUCT

      SYNULOX PALATABLE TABLETS 50mg

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

      Active ingredients:                                     mg per tablet
      Amoxicillin                                                     40.0
      (as Amoxicillin Trihydrate)                                     45.0
      Clavulanic acid                                                 10.0
      (as Potassium Clavulanate)                                      11.9
      Erythrosine Lake (E127)                                         3.50

      For the full list of all other excipients see section 6.1.

3.    PHARMACEUTICAL FORM

      Tablet.
      (Circular pink scored tablets).

4.    CLINICAL PARTICULARS

4.1   Target species

      Cats and dogs.

4.2   Indications for use, specifying the target species

      The product has been shown to be effective in treating a wide range of diseases of cats
      and dogs including: Skin disease (including deep and superficial pyodermas); soft tissue
      infections (abscesses and anal sacculitis); dental infections (e.g. gingivitis); urinary tract
      infections; respiratory disease (involving upper and lower respiratory tract); enteritis.

4.3   Contraindications

      The product should not be given to rabbits, guinea pigs, hamsters or gerbils. Caution is
      advised in their use in any other very small herbivores.

4.4   Special warnings for each target species

      None.




                                                                                         16th May 2007
Revised SPC                          Synulox Palatable Tablets 50mg
Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!
© Pfizer Ltd                                                                                      UK

4.5   Special precautions for use
      Special precautions for use in animals

      None.

      Special precautions to be taken by the person administering the veterinary
      medicinal product to animals

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

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

4.6   Adverse reactions (frequency and seriousness)

      None known.

4.7   Use during pregnancy, lactation or lay

      The product can be safely used in pregnant and lactating animals.

4.8   Interaction with other medicinal products and other forms of interaction

      None known.

4.9   Amounts to be administered and administration route

      Administration : by the oral route.
      Dosage rate: 12.5 mg/kg bodyweight.
      Dosage frequency : The following table is intended as a guide to dispensing at the
      standard dose rate of 12.5 mg/kg, twice daily.




                                                                                         16th May 2007
Revised SPC                          Synulox Palatable Tablets 50mg
Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!
© Pfizer Ltd                                                                                      UK

         Bodyweight         Number of tablets per
            (kg)              dose, twice daily
                             50 mg         250 mg
         1-2                   ½              -
         3-5                   1              -
         6-9                   2              -
         10 - 13               3              -
         14 - 18               4              -
         19 - 25               -              1
         26 - 35               -             1½
         36 - 49               -              2
         50                    -              3


      For the majority of infections including those of the skin, urinary tract and
      gastrointestinal tract, the above dosage regime is effective. Refractory cases however
      particularly of the respiratory tract, have shown improved cure rates by doubling the
      dose to 25mg/kg bodyweight twice daily.
      Duration of therapy:
      Routine cases involving all indications:
      The majority of these cases respond to between 5 and 7 days therapy.

      Chronic or refractory cases:
      In these cases, where there is considerable tissue damage, a longer course of therapy
      maybe required in that it allows sufficient time for damaged tissue to repair. Based on
      clinical trials, the following durations are suggested as guidelines:

        Chronic skin disease 10 – 12 days
        Chronic cystitis            10 – 28 days
        Respiratory disease   8 – 10 days

      The product is effective against Klebsiella infections found in veterinary practice, but it
      is not indicated for cases involving Pseudomonas species.
      Tablets are often accepted from the hand, even by sick dogs and cats. Alternatively, the
      tablets may be crumbled and added to a little food.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

      The product is of low order toxicity to the target species. No adverse side effects are to
      be expected from accidental overdose.

4.11 Withdrawal period(s)

      Not applicable.




                                                                                         16th May 2007
Revised SPC                          Synulox Palatable Tablets 50mg
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