PHARMACEUTICAL FORM

An off-white oily suspension for injection

CLINICAL PARTICULARS

   Target species

         Cattle, sheep, pigs, cats and dogs.

    Indications for use, specifying the target species

The product is suitable for the control of infections, due to susceptible micro-organisms, in cattle, pigs, sheep, dogs and cats where a single injection giving prolonged antibiotic cover is required. It may also protect from secondary bacterial invasion in cases where bacteria are not the initial cause of the disease.

           Indications include infections of:

Alimentary tract, Respiratory tract, Skin and soft tissue

Urogenital tract and in prevention of post-operative infection (treat before surgery).

In vitro amoxicillin  is effective against  a wide range of Gram-positive and Gram-negative bacteria  which include:

Escherichia coli, Klebsiella pneumonia, Proteus spp., Salmonella spp. staphylococci and streptococci.

  Contra-indications

This product is not suitable for administration via intravenous or intrathecal routes.

Not to be administered to animals sensitive to penicillin.

Not to be used in rabbits, guinea pigs, hamsters, gerbils or in any other small herbivores.

Not effective against beta-lactamase producing organisms.

   Special warning for each target species

Not to be used in animals with previous sensitivity to penicillins.

   Special precautions for use

(i)    Special precautions for use in animals

         None

(ii)    Special precautions to be taken by the person administering the medicinal product to the          animals

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact.  Hypersensitivity to penicillins may cause 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.

            Wash hands after use.

   Adverse reactions (frequency and seriousness)

Occasional local tissue reaction may result from use of this product.

   Use during pregnancy, lactation or lay

No special precautions necessary.

   Interaction with other medicinal products and other forms of interaction

Amoxicillin exerts its bactericidal action by inhibition of bacterial cell wall synthesis during  multiplication.  It is therefore in principle not compatible with bacteriostatic antibiotics (tetracyclines, chloramphenicol) which inhibit multiplication.  Synergism occurs with ?-lactam antibiotics and aminoglycosides.