NAM PHUC THINH TRADING CO., LTD

RHEMOX 500

Powder for use in drinking wáter

Amoxicillin trihydrate
COMPOSITION
1 g contains:
Amoxicillin trihydrate ........ 500 mg (equivalent to 435.6 mg of amoxicillin base)
PHARMACEUTICAL FORM
Powder for use in drinking water.
Target species
Pigs and poultry (broilers, duck broilers and turkeys for meat production).
Indications for use, specifying the target species
Pigs: Treatment of infections caused by Streptococcus suis sensitive to amoxicillin.
Broilers, duck broilers and turkeys for meat production: Treatment of pasteurellosis and colibacillosis caused by strains of Pasteurella spp. And Escherichia coli sensitive to amoxicillin.

Contraindications
Do not use in case of hypersensitivity to penicillins, to other beta- lactams or to the excipient. Do not use in horses, rabbits, guinea pigs, hamsters or other small herbivores, given that amoxicillin, as for all aminopenicillins, has deleterious effects on caecal bacteria. Do not use orally in animals with a functional rumen.
Do not use in animals with renal disease, including anuria and oliguria.
Adverse reactions (frequency and seriousness)
Hypersensitivity reactions may occur, the severity varying from skin rash to anaphylactic shock.
Gastrointestinal symptoms (vomiting, diarrhoea).
Secondary infections from non-sensitive microorganisms after prolonged use.
Amounts to be administered and administration route
Oral use in drinking water.
Pigs: 20 mg of amoxicillin trihydrate/kg of body weight every 24 hours (equivalent to 40 mg of product/kg body weight/day) for 4 days.
Broilers: 15 mg of amoxicillin trihydrate/kg of body weight every 24 hours (equivalent to 30 mg of product/kg body weight/day) for 5 days.
Duck broilers: 20 mg of amoxicillin trihydrate/kg of body weight every 24 hours (equivalent to 40 mg of product/kg body weight/day) for 3 days.
Turkeys for meat production: 15-20 mg of amoxicillin trihydrate/kg of body weight every 24 hours (equivalent to 30-40 mg of product/kg body weight/day) for 5 days.

The uptake of medicated water depends on the clinical condition of the animals, the environment, the age, and the kind of feed provided. In order to obtain the correct dosage, the concentration of active substance has to be adjusted accordingly.
Use the following formula in order to calculate the quantity of the product (g) that should be incorporated in the drinking water tank:
Number of animals x Mean body weight of animals (kg) x Dose (mg amx.trih./kg b.w./day)
Total water consumption of the house (L) the previous day x 500
Renew medicated water every 24 hours. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Prepare the solution with fresh tap water immediately before use.
Water uptake should be monitored at frequent intervals during medication. In order to ensure consumption of the medicated water, animals should not have access to other water supplies whilst being treated.
After the end of the medication period, the water supply system should be cleaned appropriately to avoid intake of subtherapeutic amounts of the active substance.
Withdrawal periods
Meat: Pigs: 6 days
Broilers: 1 day
Duck broilers: 7 days
Turkeys for meat production: 5 days
Not for use in birds producing or intended to produce eggs for human consumption. Do not use within 4 weeks of the start of the laying period.

Special precautions for storage
Store in a dry place protected from light.
Store below 25 ºC.

Special precautions:

Special warnings for each target species
The use of the product should be combined with good management practices, i.e. good hygiene, proper ventilation, no overstocking.

Special precautions for use
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the bacteria isolated from the animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillins and cephalosporins cause hypersensitivity reactions (allergy) following injection, inhalation, ingestion or contact with the skin. Cross hypersensitivity reactions are observed between cephalosporins and penicillins.
- Do not handle the product if you are allergic to penicillins and/or cephalosporins.
- Handle the product with care to avoid inhaling the powder, and contact with the skin and eyes while adding it to water, taking special precautions:
o Take the necessary actions to prevent the powder from spreading while the product is being added to the drinking water;
o Wear either a disposable half-mask respirator, gloves, overalls and approved goggles;
o Avoid contact with the skin and eyes. In case of contact, rinse with plenty of clean water;
o Do not smoke, eat or drink while handling the product;
o Wash hands after use.

If symptoms appear following exposure, such as a skin rash, 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)
Hypersensitivity reactions may occur, the severity varying from skin rash to anaphylactic shock.
Gastrointestinal symptoms (vomiting, diarrhoea).
Secondary infections from non-sensitive microorganisms after prolonged use.
Use during pregnancy, lactation or lay
Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic, maternotoxic effects. The safety of the veterinary medicinal product has not been established during pregnancy or lactation in sows. Use only accordingly to the benefit-risk assessment by the responsable veterinarian.
Not for use in birds producing or intended to produce eggs for human consumption. Do not use within 4 weeks of the start of the laying period.
Interaction with other medicinal products and other forms of interaction
Do not use simultaneously with neomycin since it blocks the absorption of oral penicillins.
Do not use together with bacteriostatic antibiotics as they can antagonise the bactericidal effect of penicillins.

Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose no other adverse reactions are known than those mentioned in section 4.6.

Special precautions for the disposal of unused veterinary medicinal
products 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.

Presentations:

Sachets of 100 g, 300 g, 400 g and 1 kg

Shelf life:
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: For immediate use.
Shelf life after dissolution or reconstitution according to directions: 24 hours.

MARKETING AUTHORISATION HOLDER
Industrial Veterinaria, S.A.
Esmeralda, 19
08950 Esplugues de Llobregat (Barcelona) Spain

MANUFACTURER:

aniMedica Herstellungs GmbH

Pappelstrasse, 7  72160 Horb a. N. Germany