SUMMARY OF PRODUCT CHARACTERISTICS

MAXYL 500 mg/g POWDER FOR USE IN DRINKING WATER FOR CHICKENS, TURKEYS, DUCKS AND PIGS[AT, BG, CY, DE, DK, HU, IE, IT, NL, PL, PT, UK]

Maxyl vet 500 mg/g powder for use in drinking water for chickens, turkeys, ducks and pigs[SE]

BETAMAXYL 500 mg/g POWDER FOR USE IN DRINKING WATER FOR CHICKENS, TURKEYS, DUCKS AND PIGS[ES]

Each gram contains:

Active substance:

Amoxicillin (equivalent to 500 mg amoxicillin trihydrate) 436 mg

For a full list of excipients, see section 6.1.

Powder for use in drinking water.

A white powder. Clear and colourless liquid when in solution.

Chickens, turkeys, ducks and pigs.

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

Pigs: For the treatment of pasteurellosis.

This product should not be administered to rabbits, guinea pigs, hamsters, gerbils or any other small herbivore.

Do not use in animals with known hypersensitivity to penicillins or other ß-lactam antibiotics or to any of the excipients.

Do not administer to animals with renal disease including anuria or oliguria.

None

Not effective against beta-lactamase producing organisms.

Pigs: The uptake of medication by animals may be altered as a consequence of illness. In case of insufficient water uptake, animals should be treated parenterally instead.

Official, national and regional antimicrobial policies should be taken into account when the product is used.

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 (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the amoxicillin and may decrease the effectiveness of the treatment.

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.

People with known hypersensitivity the active substance or if you have been advised not to work with such preparations should avoid contact with the veterinary medicinal product.

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.

Avoid inhalation of dust. Wear either a disposable half-mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 with a filter to ENl43.

Wear gloves during preparation and administration of medicated water or liquid feed.

Wash any exposed skin after handling the product or medicated water or feed. Wash hands after use.

Penicillins and cephalosporins may cause hypersensitivity reactions which may occasionally be serious.

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

Use only according to the benefit/risk assessment of the responsible veterinarian.

Do not use in birds producing eggs for human consumption or within 3 weeks of onset of laying.

The product should not be administered with antibiotics that have a bacteriostatic mode of action, such as tetracyclines, macrolides, sulphonamides.

In drinking water use.

Prepare the solution with fresh potable water immediately before use. Any medicated water which is not consumed within 12 hours should be discarded and the medicated drinking water replenished.

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 required concentration of product (in milligrams of product per litre of drinking water):

x mg product per kg bodyweight per day	X	mean bodyweight (kg) of animals to be treated	= x mg product per litre drinking water
mean daily water consumption (l) per animal

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 animal. 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 per day (corresponding to 30 mg product/kg·bodyweight/day).

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

Ducks

Recommended dosage is 20 mg amoxicillin trihydrate/kg bodyweight per day (corresponding to 40 mg product/kg bodyweight/day) for 3 consecutive days.

Turkeys

Recommended dosage is 15-20 mg amoxicillin trihydrate/kg bodyweight per day (corresponding to 30-40 mg product/kg·bodyweight/day) for 3 days or in severe cases for 5 days.

Pigs

Administer in the drinking water to give 20 mg amoxicillin trihydrate/kg bodyweight (corresponding to 40 mg product/kg·bodyweight) daily for up to 5 days.

After the end of the medication period the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.

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

Meat and offal:

Chickens 1 day

Ducks 9 days

Turkeys 5 days

Pigs 2 days

Not authorised for use in laying birds producing eggs for human consumption and within 3 weeks of onset of laying.

Pharmacotherapeutic group:Beta-lactam antibiotic, penicillins

ATCVet code:QJ01CA04

Amoxicillin is a bactericidal antibiotic belonging to the group of semisynthetic penicillinswith a broad spectrum of activity against Gram positive and Gram negative bacteria. It owes its activity to the inhibition of the development of the peptidoglycan network structure in the bacterial cell wall.

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.

Anhydrous citric acid

In the absence of compatibility studies, this veterinary product must not be mixed with other veterinary medicinal products.

Shelf life of the veterinary medicinal product as packaged for sale: 21 months

Shelf life after first opening the immediate packaging: 3 months

Shelf life after dilution or reconstitution according to directions: 12 hours

Do not store above 30ºC.

Keep the bags tightly closed.

Thermosealed bags made of polyester, aluminium and polyethylene complex.

Pack sizes:

400g bag

1kg bag

Box with 15 bags of 1kg.

Not all pack sizes may be marketed.

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

Vetpharma Animal Health, S.L.

Les Corts, 23

08028 Barcelona

Spain

Vm32509/4019

Date:08 October 2014

Date:October 2014

PROHIBITION OF SALE, SUPPLY AND/OR USE

For animal treatment only.

To be supplied only on veterinary prescription

Approved: 08/10/2014