SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

AMOXICILLIN GLOBAL VET HEALTH 500 mg/g, powder for use in drinking water for chickens, turkeys, ducks and pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram contains:

Active substance:

Amoxicillin (equivalent to 500 mg amoxicillin trihidrate)………. 436 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Powder for use in drinking water

A white powder.

Clear and colourless liquid when in solution.

4. CLINICAL PARTICULARS

4.1 Target species

Chickens, turkeys, ducks and pigs.

4.2 Indications for use, specifying the target species

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

Pigs: For the treatment of salmonellosis and pasteurellosis.

4.3 Contraindications

Do not administer 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 the excipient.

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

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

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 using a suitable injectable product prescribed by the veterinarian.

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.

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.

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 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 EN143.

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.

4.6 Adverse reactions (frequency and seriousness)

Penicillins and cephalosporins may cause hypersensitivity reactions which may occasionally be serious.Rarely, gastro-intestinal tract signs associated with alteration of the intestinal flora (for example, loose stools, diarrhoea) may occur.

4.7 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.

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

4.8 Interaction with other medicinal products and other forms of interaction

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

4.9 Amounts to be administered and administration route

Chickens, turkeys and ducks

For administration in drinking water.

Prepare the solution with fresh potable water immediately before use.

. Any medicated water which is not consumed within 24 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 amount of product required per day (in grams):

Numberofbirds x averageliveweight (kg)

25 (for20 mg/kg)or33 (for15 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 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

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

Turkeys

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

Pigs

For the medication of pigs, the product may be administered via the drinking water or administered by addition to liquid feeds produced with commercial feed. It may not be used in dry feeds.

1. Administration in drinking water

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

Prepare the solution by carefully mixing the product in the requisite quantity of fresh potable water immediately before use. The dose should be administered at approximately 24 hourly intervals for up to 5 days.

Any medicated water which is not consumed within 24 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 on treatment

2. Administration in liquid feed

Administer in liquid feed to give 20 mg amoxicillin trihydrate per kg bodyweight (corresponding to 40 mg product/kg bodyweight/day) daily for up to 5 days.

Medicated feed should be freshly prepared on at least 3 occasions per day over the treatment period. The daily dose should be calculated based on the number of animals and average weight and then divided by the number of feed lots prepared in the day.

Medicated liquid feed should be prepared with fresh potable water.

Dissolve the required amount of product in water at a rate of 25g/L before addition to the feed.

After adding the product to some or all of the water needed to make the liquid feed, ensure the product is fully dissolved. Dissolution of the product can take up to 10 minutes. This medicated water can then be mixed with the dry complete meal and if appropriate, the remaining water. The system used should ensure that the medicated water is evenly distributed into the feed. Once prepared the final medicated liquid feed should be fed to the pigs immediately.

The medicated liquid feed should not be fermented and should not be stored.

Stability of amoxicillin in all commercial feeds has not been established. In order to ensure that any loss of amoxicillin activity is minimized, the quantity of medicated liquid feed prepared should not exceed the amount of feed which will be consumed within 4 hours.

Any medicated liquid feed which is not consumed within 4 hours should be discarded

Although restricted access to other water supplies would help ensure medicated liquid feed is consumed, separate clean potable water should remain available at all times for welfare reasons.

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.

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

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

4.11 Withdrawal period(s)

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.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic Group: Beta-lactam antibiotic, penicillins

ATCvet Code: QJ01CA04

5.1 Pharmacodynamic properties

Amoxicillin is a bactericidal antibiotic belonging to the group of semi-synthetic 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.

5.2 Pharmacokinetic particulars

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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Citric acid, anhydrous

6.2 Incompatibilities

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

6.3 Shelf life

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

Shelf life after dilution or reconstitution in water according to directions: 24 hours.

Shelf life after incorporation into liquid feed: 4 hours.

Shelf-life after first opening the immediate packaging: use immediately

6.4. Special precautions for storage

Do not store above 25º C. Store in a dry place.

Keep the bags tightly closed.

Protect from light.

6.5 Nature and composition of immediate packaging

The veterinary medicinal product is packed in thermo-sealed bags of 200 g and 1 kg.

Bags are made of polypropylene, aluminium and polyethylene complex.

Not all pack sizes may be marketed.

6.6 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.

7. MARKETING AUTHORISATION HOLDER

GLOBAL VET HEALTH SL

C/Capçanes, nº12-baixos.

Polígon Agro-Reus.

REUS 43206

SPAIN

8. MARKETING AUTHORISATION NUMBER

Vm 36167/4004

9. DATE OF FIRST AUTHORISATION

December 2015

10. DATE OF REVISION OF THE TEXT

December 2015

Approved: 01 December 2015