Amoxinsol 100 w/w powder for oral solution

Introduction

Company name: Vétoquinol UK Ltd

Address: Vétoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

Telephone: 01280 814500

Fax: 01280 825460

Email: office@vetoquinol.co.uk

Website: www.vetoquinol.co.uk

Presentation

A white powder for oral solution containing Amoxicillin trihydrate 100% w/w

Uses

Treatment of infections in chickens, turkeys and ducks caused by bacteria susceptible to amoxicillin.

Not effective against beta-lactamase producing organisms.

Use of the product should be based on susceptibility testing and it should take into account official and local antimicrobial policies.

Dosage and administration

The product is administered in the drinking water. Prepare the solution with fresh tap water immediately before use. Once opened, use the contents of one sachet immediately. Any unused medicated water should be discarded after 12 hours.

In order to ensure consumption of the medicated water, animals should not have access to other water supplies whilst being treated.

The following formula may be used to calculate the amount of product required per day (in grams):

Number of birds x average live weight (kg)

50 (for 20 mg/kg) or 66 (for 15 mg/kg)

To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing. The uptake of medicated water depends on the clinical condition of the birds. In order to obtain the correct dosage the concentration of amoxicillin has to be adjusted taking into account water intake.

Chickens

The recommended dosage is 15 mg amoxicillin trihydrate per kg bodyweight.

The total period of treatment should be for 3 consecutive days or in severe cases for 5 consecutive days.

Ducks

Recommended dosage is 20 mg amoxicillin trihydrate/kg bodyweight for 3 consecutive days.

Turkeys

Recommended dosage is 15-20 mg amoxicillin trihydrate/kg bodyweight for 3 consecutive days or in severe cases for 5 consecutive days.

Contra-indications, warnings, etc

Amoxinsol 100 should not be administered to rabbits, hamsters, gerbils and guinea pigs.

Do not use in animals known to be hypersensitive to the active ingredient

Withdrawal Periods

Chickens (meat & offal): 1 day

Ducks (meat & offal): 9 days

Turkeys (meat & offal): 5 days

Not for use in laying birds producing eggs for human consumption.

Use during pregnancy, lactation or lay

Laboratory studies in rats have not produced any evidence of a teratogenic effect due to the administration of amoxicillin.

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

No problems with overdosage have been reported. Treatment should be symptomatic and no specific antidote is available.

Operator warning

Avoid inhalation of dust.

Wash hands after use.

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion and 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.

Pharmaceutical precautions

Shelf life of the veterinary medicinal product as packaged for sale - 18 months.

Shelf life after dilution or reconstitution according to directions - 12 hours.

Do not store above 25˚C.

Store in a dry place.

Any medicated water which is not consumed within 12 hours should be discarded.

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

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

Legal category

POM-V

Packaging Quantities

75g in foil/polythene sachets, 25 sachets per box

200g in foil/polythene sachets, 10 sachets per box

Not all pack sizes may be marketed

Further information

Amoxicillin is a bactericidal antibiotic belonging to the semi-synthetic penicillin group. It owes its activity to the inhibition of the development of the peptidoglycan network structure in the bacterial cell wall.

Pharmacodynamic properties: Amoxicillin is a semi-synthetic penicillin with a broad spectrum of activity against Gram positive and Gram negative bacteria.

Pharmacokinetic properties: Amoxicillin is well absorbed following oral administration and it is stable in the presence of gastric acids. Excretion of amoxicillin is mainly in the unchanged form via the kidneys to give high concentration in renal tissue and urine. Amoxicillin is well distributed in body fluids.

Studies in birds have indicated that amoxicillin is distributed and eliminated more rapidly than in mammals. Biotransformation appeared a more important route of elimination in birds than in mammals.

Marketing authorisation number

Vm 08007/4068.

Significant Changes

New product

 

Change to dosing regimen and indications

14/12/2012

 

Change to daily dosing of poultry and new indications

30/05/2013

GTIN (Global Trade Item No)

Amoxinsol 100 200g

03605874117549

Amoxinsol 100 75g

03605874117556