SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Suramox 1000 mg/g powder for use in drinking water for chickens, ducks, turkeys (AT, BE, DE, EL, FR, NL, PL)

Stabox 1000 mg/g powder for use in drinking water for chickens, ducks, turkeys (DK, ES, IT, PT, UK)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1.0 g powder contains:

Active substance:

Amoxicillin trihydrate 1000 mg (equivalent to 871.24 mg amoxicillin)

3. PHARMACEUTICAL FORM

Powder for use in drinking water

White or almost white, crystalline powder

4. CLINICAL PARTICULARS

4.1 Target species

Chicken, duck, turkey

4.2 Indications for use, specifying the target species

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

4.3 Contraindications

Do not use in ruminants and horses and lagomorphs and rodents such as rabbits, hamsters, gerbils and guinea pigs.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Do not use in animals with hypersensitivity to penicillins and other ß-lactam antibiotics.

Use of the product should be based on susceptibility testing and it should take into account official and local antimicrobial policies. Resistance against amoxicillin may vary. Therefore the use of the product should be based on culture and sensitivity of micro-organisms from diseased cases on farm or from recent previous experience on the farm.

Inappropriate use of the product may increase the prevalence of bacteria resistance to amoxicillin and may decrease its effectiveness.

Not effective against beta-lactamase producing organisms.

Avoid inhalation of dust and contact with skin.

When applying the product, wear gloves and a disposable half-mask respirator conforming to European Standard EN 140 with a filter to EN 143.

Penicillins may cause hypersensitivity (allergy) following 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.

Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations.

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.

Do not smoke, eat or drink while handling the product.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Penicillins and cephalosporins may cause hypersensitivity reactions following administration. Allergic reactions to these substances may occasionally be serious.

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 accordingly to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

The bactericidal effect of amoxicillin is neutralized by simultaneous use of pharmaceuticals with bacteriostatic mode of action.

Not to be used simultaneously with neomycin since it blocks the absorption of oral penicillins.

4.9 Amounts to be administered and administration route

The product is administered in the drinking water.

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)

1000/20 (for 20 mg/kg) or 1000/15 (for 15 mg/kg)

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.

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.

Prepare the solution with fresh tap water immediately before use.

Any unused medicated water should be discarded after 24 hours.

In order to ensure consumption of the medicated water, animals should not have access to other water supplies whilst being treated. The use of suitably calibrated weighing equipment for the administration of the calculated amount of the product is recommended.

Solubility in water varies depending on temperature and water quality as well as on time and intensity of stirring. Under worst case conditions (10°C and soft water) maximum solubility is approximately 1.0 g/l but increases by raising temperature. At 25°C and in hard water maximum solubility is increased to at least 2 g/l.

For stock solutions and for use of a proportioner: Take care not to exceed maximum solubility which can be achieved under the given conditions. Adjust flow rate settings of the dosing pump according to concentration of the stock solution and water intake of the animals treated. Moderate increase of temperature and constant stirring can help to raise solubility.

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

No side effects were observed after administration at 5 times the recommended dosage. Treatment should be symptomatic and no specific antidote is available.

4.11 Withdrawal period(s)

Chicken (meat & offal) 1 day

Duck (meat & offal) 9 days

Turkey (meat & offal) 5 days

The product is 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 semisynthetic penicillin group. It owes its activity to the inhibition of the development of the peptidoglycan network structure in the bacterial cell wall.

Amoxicillin is a semisynthetic penicillin with a broad spectrum of activity against Gram positive and Gram negative bacteria.

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.

For chickens, amoxicillin is quickly absorbed with Tmax (=1hr) and amoxicillin concentrations < 0.25 µg/ml after 6 hours after a dose of 10 mg/kg.

For turkeys, at a dose rate of 10 mg/kg, the Cmax was lower than seen in chickens.

For ducks, an oral dose of 20 mg/kg decreased to below a level of 0.25 µg/ml by 5 hours after administration.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

None.

6.2 Incompatibilities

In the absence of compatibility studies, this veterinary medicinal 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 first opening the immediate packaging: 3 months

Shelf-life after dilution or reconstitution according to directions: 24 hours

6.4 Special precautions for storage

After opening, do not store above 25ºC.

Keep the bag tightly closed after first opening in order to protect from moisture and light.

Any medicated water which has not been consumed within 24 hours, should be discarded.

6.5 Nature and composition of immediate packaging

100 g, 500 g, 1000 g and 5000 g in aluminum bags (PET – ALU – LDPE)

The 5000 g bag will be provided with a zip lock.

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 product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

VIRBAC

1ère avenue - 2065m – LID

Carros

06516

France

8. MARKETING AUTHORISATION NUMBER

Vm05653/4207

9. DATE OF FIRST AUTHORISATION

Date: 16December 2013

10. DATE OF REVISION OF THE TEXT

January 2016

Approved: 08 January 2016