Betamox Palatable Drops Powder for Oral Suspension 50 mg/ml

Composition

Each bottle contains:

Active Substance: mg

Amoxicillin…………………………………………750

(as Amoxicillin Trihydrate)

When reconstituted with 12 ml water gives a 15 ml suspension containing amoxicillin at a concentration of 50 mg/ml.

Excipients:

Erythrosin E127 …………………………………..2.34

For a full list of excipients, see section 6.1

6.1 List of excipients

Erythrosine (E127)

Trusil Strawberry Select Flavour H9922

Lactose Monohydrate

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Pharmaceutical form

Powder for oral suspension

A pale red powder

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Pharmacological properties

Pharmacotherapeutic group: Antibacterial

ATC Vet Code: QJ01CA04

5.1 Pharmacodynamic properties

Amoxycillin is a broad-spectrum semi-synthetic penicillin. Amoxycillin predominately inhibits cell wall synthesis in susceptible bacteria. Amoxycillin has a mode of action which directly and irreversibly disrupts cell wall peptidoglycan. Amoxicillin is absorbed well after oral administration, giving high plasma and tissue levels. Excretion takes place in both bile and urine.

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Target species

Dogs

Cats

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Indications

For the control of infections in dogs and cats, including infections of the alimentary tract, respiratory tract and urogenital tract, eye and ear infections, and skin and wound infections. In vitro, amoxycillin is effective against a wide range of Gram-positive and Gram-negative bacteria, including:

Bacillus cereus

Bordetella bronchiseptica

Corynebacterium spp

Citrobacter freundii

Chromobacter spp

Escherichia coli

Flavobacter spp

Pasteurella spp (including P. multocida)

Proteus mirabilis

Salmonella spp

Staphylococci (penicillin sensitive stains)

Streptococci

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Dosage

Reconstitution: Add 12 ml water to the powder and shake vigorously. This will make 15 ml of the suspension, containing amoxycillin at a concentration of 50 mg/ml.

Administration and Dosage: Recommended dosage rate is 10 mg/kg bodyweight amoxycillin twice daily for up to 7 days. The drops are given orally using a graduated pipette provided. The dosage rate of 10 mg/kg is achieved by administering 1 ml of reconstituted product per 5 kg bodyweight.

Shake well before use

To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid under dosing.

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Contraindications

Not to be used in animals known to be hypersensitive to penicillin.

Not to be used orally or parenterally in rabbits, guinea pigs, hamsters or gerbils.

Caution is advised when used in any other small herbivores.

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Adverse reactions

No known undesirable effects

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Warnings

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.

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.

Wash hands after use.

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Use during pregnancy, lactation or lay

No known contraindication exists for the use of Betamox Palatable Drops during pregnancy.

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Interactions

None known.

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Overdose

Penicillins have a high margin of safety and clinical signs are unlikely even in accidental overdose.

No treatment specified.

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Special warnings

No special warnings

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Withdrawal period

Not applicable

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Incompatibilities

None known

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Immediate packaging

White polyethylene / polypropylene bottle with white, wadded polypropylene cap (screw-fit), with a graduated natural polyethylene pipette with white polypropylene screw-on cap and natural rubber bulb as a dosing device.

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Storage

Do not store above 25ºC.

Do not store reconstituted product above 25ºC.

Any reconstituted product remaining 7 days after preparation should be discarded

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after dilution or reconstitution according to direction: 7 days

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Disposal of unused product

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

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Additional information

Vm: 02000/4101

9 DATE OF FIRST AUTHORISATION

25th February 1988

10 DATE OF REVISION OF THE TEXT

December 2008

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Registration holder

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

Northern Ireland

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