SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Rhemox Forte, 1000mg/g Powder for use in Drinking Water for chickens, ducks, turkeys (AT, BE, DE, EL, HU, IT, NL, PL, PT, RO, UK)

Amox Vet., 1000mg/g Powder for use in Drinking Water for chickens, ducks, turkeys (DK)

Rhemox Forte, 871,24 mg/g Powder for use in Drinking Water for chickens, ducks, turkeys (FR)

Robucina, 1000mg/g Powder for use in Drinking Water for chickens, ducks, turkeys (ES)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1g powder contains:

Active substance:

Amoxicillin trihydrate 1000 mg

(equivalent to amoxicillin 871.24 mg)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Powder for use in Drinking Water. White to off-white powder.

4. CLINICAL PARTICULARS

4.1 Target species

Chickens, ducks, turkeys

4.2 Indications for use, specifying the target species

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

4.3 Contraindications

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

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

Special precautions for use in animals

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.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

• 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 impervious gloves during preparation and administration of medicated water.

• Wash any exposed skin after handling the product or medicated water.

• 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.

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. If suspected adverse reactions do occur, treatment should be discontinued immediately.

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 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

Dosage:

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.

Suitably calibrated weighing equipment should be used for dispensing the calculated amount of the product.

Solubility in water varies depending on temperature and water quality as well as on time and intensity of stirring. Under worst case conditions (4°C and soft water) maximum solubility is approximately 1.0 g/l but increases by raising temperature. At 20°C and in hard water maximum solubility is increased to at least 2.1 g/l. Complete dissolution of the powder should be ensured.

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.

Chickens

Recommended dosage is 15 mg amoxicillin trihydrate/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.

Administration route:

The product is administered in the drinking water. 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.

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)

Chickens (meat & offal): 1 day

Ducks (meat & offal): 9 days

Turkeys (meat & offal): 5 days

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

Do not use within 3 weeks of onset of laying.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Beta-Lactam antibiotic, Penicillins with extended spectrum.

ATCvet code: QJ01CA04.

5.1 Pharmacodynamic properties

Amoxicillin is a time-dependent bactericidal antibiotic which acts by inhibiting the synthesis of bacterial cell walls during bacterial replication. It inhibits the formation of bridges between the chains of linear polymers constituting the peptidoglycan cell wall of Gram positive bacteria.

Amoxicillin is a broad-spectrum penicillin. It is also active against a limited range of Gram negative bacteria on which the outer layer of the bacterial cell wall is composed of lipolysaccharide and proteins.

There are three main mechanisms of resistance to beta-lactams: beta-lactamase production, altered expression and/or modification of penicillin binding proteins (PBP), and decreased penetration of the outer membrane. One of the most important is the inactivation of penicillin by beta-lactamase enzymes produced by certain bacteria. These enzymes are capable of cleaving the beta-lactam ring of penicillins, making them inactive. The beta-lactamase could be encoded in chromosomal or plasmidic genes.

Cross-resistance is observed between amoxicillin and other penicillins, particularly with aminopenicillins.

The use of extended spectrum beta-lactam drugs (e.g. aminopenicillins) might lead to the selection of multi-resistant bacterial phenotypes (e.g. those producing extended spectrum beta-lactamases(ESBLs)).

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 T_max(=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 C_maxwas 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: 2 years

100g, 200g, 500g:

Shelf life after first opening the immediate packaging: 3 months

1kg, 5kg:

Shelf life after first opening the immediate packaging: 6 months

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

6.4 Special precautions for storage

Store in a dry place.

This veterinary medicinal product does not require any special temperature storage conditions.

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

Any medicated water which is not consumed within 24 hours should be discarded.

6.5 Nature and composition of immediate packaging

100g, 200g, 0.5 kg, 1 kg, 5 kg PET/ALU/PE sachets

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

aniMedica Espaňa

Esmeralda 19

08950 Esplugues de Llobregat

Barcelona

Spain

8. MARKETING AUTHORISATION NUMBER

Vm 43173/4001

9. DATE OF FIRST AUTHORISATION

14 June 2016

10. DATE OF REVISION OF THE TEXT

July 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Veterinary prescription only.

Approved: 28 July 2016