Medine.co.uk

Clamoxyl Palatable Tablets 200 Mg

Revised: June 2014

AN: 00245/2014

SUMMARY OF PRODUCT CHARACTERISTICS


NAME OF THE VETERINARY MEDICINAL PRODUCT


CLAMOXYL Palatable Tablets 200 mg


QUALITATIVE AND QUANTITATIVE COMPOSITION


The 200 mg tablet has the following composition:


Active ingredients
Amoxicillin as amoxicillin trihydrate - 200 mg/tablet


For the full list of all other excipients see section 6.1


PHARMACEUTICAL FORM


Tablet.

Speckled, off-white circular tablets with a break line on one side, for oral dosing.


CLINICAL PARTICULARS


Target species


Dogs and cats.


Indications for use, specifying the target species


Amoxicillin is a broad spectrum semi-synthetic penicillin which is bactericidal against a wide range of Gram-positive and Gram-negative bacteria found in dogs and including the following:
Haemophilusspp., Pasteurellaspp., Proteus mirabilis, Salmonellaspp., Staphylococci (penicillin-sensitive strains), Leptospiraspp., Streptococci and Escherichia coli.

When susceptible organisms are present, the product may be effective in the following indications: localised infections, alimentary tract infections, respiratory infections, urogenital tract infections, secondary bacterial infections and generalised infections.


Contraindications


In common with all penicillins do not administer to penicillin-sensitive animals.

Not to be used orallyor parenterally in rabbits, guinea pigs, hamsters or gerbils. Caution is advised in its use in any other very small herbivores.


Special warnings for each target species


None.


Special precautions for use


Special precautions for use in animals

Not to be used in cases of known hypersensitivity.

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


Penicillinsand 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.

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 a skin rash, you should seek medical advice and show the doctor this warning.

Swelling of the face, lips or eyes, or difficulty breathing are more serious symptoms and require urgent medical attention. Wash hands after use.


Adverse reactions (frequency and seriousness)


See section 4.10 (Overdose).


Use during pregnancy, lactation or lay


May be used safely in pregnant or lactating animals.


Interaction with other medicinal products and other forms of interaction


Do not use concurrently with bacteriostatic antimicrobials.


Amounts to be administered and administration route


Dosage Rate:
An oral dose rate of 4 to 10 mg/kg twice daily is recommended (½ to 1 tablet per 20 kg bodyweight
twice daily). In severe or acute conditions, these levels may be increased and/or repeated at more frequent intervals.

Dosage Guide:

Per 10 kg ¼ to ½ x 200 mg tablet, twice daily

Per 20 kg half or one x 200 mg tablet, twice daily

The tablets are often accepted from the hand, even by sick animals. Alternatively, the tablets may be crushed and added to a little food.

Because of the high blood levels rapidly achieved after oral dosing, parenteral antibiotic treatment has generally been found to be unnecessary even in the presence of systemic infection. However, where parenteral treatment is required, the tablets may be useful as follow-up therapy.


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


Amoxicillin is of a low order of toxicity to the target species and is well tolerated by the oral route. Apart from occasional instances of diarrhoea, which have been reported with the recommended dose, no adverse side effects are to be expected from accidental overdose.


Withdrawal period


Not applicable.


PHARMACOLOGICAL PROPERTIES


Bactericidalagainst a wide range of Gram-negative and Gram-positive bacterial pathogens found in dogs and cats including the following:
Haemophilusspp.
Pasteurellaspp.
Proteus mirabilis
Salmonellaspp.
Staphylococci (penicillin-sensitive strains)
Leptospiraspp.
Streptococci
Escherichia coli.


The following features are important:

Oral absorption is particularly good.

After absorption amoxicillin is widely distributed throughout the tissue with especially high levels in the kidney, urine, liver and bile.

Amoxicillin shares with other penicillins the virtual absence of toxicity problems even at very high dose levels.


ATCVet Code:QJ01CA04


PHARMACEUTICAL PARTICULARS


List of excipients


Magnesium Stearate

Silica Colloidal Anhydrous

Yeast

Methyl Cellulose

Microcrystalline Cellulose


Incompatibilities


None known.


Shelf-life


Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.


Special precautions for storage


Store in a dry place.
Do not store above 25
oC.


Nature and composition of immediate packaging


Polypropylene securitainers containing 250 x 200 mg tablets.

Aluminium canister with screw-fit cap containing 250 x 200 mg tablets.

Not all pack sizes may be marketed.


Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate


Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.


MARKETING AUTHORISATION HOLDER


Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE


MARKETING AUTHORISATION NUMBER


Vm:42058/4014


DATE OF THE FIRST AUTHORISATION


Date:30 January 1990


DATE OF REVISION OF THE TEXT


Date:June 2014


26 June 2014

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