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Amoxicillin is a broad-spectrum semi-synthetic penicillin which is bactericidal in vitro against a wide range of Gram-positive and Gram-negative bacteria including the following:
Gram-positive
Actinomyces bovis, Bacillus anthracis, Clostridium spp., Erysipelothrix rhusiopathiae, Corynebacterium spp., Peptostreptococcus spp.
Staphylococcus spp. (non beta-lactamase producing strains), Streptococcus spp.
Gram-negative
Actinobacillus lignierisi, Actinobacillus pleuropneumoniae, Actinobacillus equili, Bacteroides spp., Bordetella bronchiseptica,
Campylobacter spp., Escherichia coli (non beta-lactamase producing strains), Fusobacterium necrophorum, Haemophilus spp.
Klebsiella spp., Pasteurella spp., Proteus mirabilis (non beta-lactamase producing strains).
Amoxicrid Retard Inj. is indicated for the control of infections caused by susceptible organisms in cattle, sheep, pigs, dogs and cats where prolonged activity from a single injection is required.
It may also be used to control secondary bacterial invasion in conditions where bacteria are not a primary cause of disease.
Indications for Amoxicrid Retard Inj:
1. Alimentary tract infections, including enteritis;
2. Respiratory tract infections including pneumonia in fattening veal;
3. Urogenital tract infections, including cystitis and metritis;
4. Skin and soft tissue infections, including wounds, abscesses, foot infections, joint and navel ill;
5. Prevention of post-operative infections by injection prior to surgery.
Amoxicillin (as amoxicillin trihydrate) 150 mg/ml
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
In common with all other penicillins, amoxicillin should not be used orally or parenterally in rabbits, guinea pigs, hamsters or gerbils. Caution is advised when used in other small herbivores. Do not administer by intravenous or intra-joints injection.
Use of the product may occasionally result in local tissue reaction.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Amoxicrid Retard Inj. is intended for use by intramuscular or subcutaneous routes.
Dosage rate: the recommended dosage rate is 15 mg amoxicillin/kg body weight, which is equivalent to 1 ml product/10 kg bodyweight. The dose may be repeated after 48 hours.
The following table gives examples of doses for the different species.
To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing. Shake well the vial before use. The product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Use dry and sterile syringes and needles. In cattle do not administer more than 20 ml in a single injection site.
Cattle (meat and offal): 92 days.
Sheep (meat and offal): 14 days.
Pig (meat and offal): 21 days.
Milk: 72 hours
Do not store above 250C.
Protect from light.
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 28 days.
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information about susceptibility of the target bacteria. Use of the product deviating from the instructions in the SPC may increase the risk of development and selection of resistant bacteria and decrease the effectiveness of treatment due to the potential for cross-resistance. Official, national and regional antimicrobial policies will be considered when using the product.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to amoxicillin should avoid contact with the veterinary medicinal product. Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion, or skin contact. Hypersensitivity to penicillins may be associated with cross-sensitivity to cephalosporins and vice versa. Occasionally, allergic reactions to these substances can be severe. Do not handle this product if you know you are sensitized, 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 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.
Use during pregnancy, lactation or lay
The product may be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Amoxicillin is of a very low order of acute toxicity and is well tolerated by the parenteral route. Occasional injection site reactions may occur with the recommended dose, but no other adverse side-effects are to be expected from accidental overdosing.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Vials of 50 ml, 100 ml, 250 ml and 500 ml.
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