ANTIBIOTIC

Amoxidem 10%

100 mg/g, amoxicillin trihydrate, premix for medicated feed for pigs and poultry.

Formula

-premix is a white to off-white powder containing 1 gram per gram:
Active substance:
Amoxicillin trihydrate 100 mg

Excipient (corn starch) qs.ad. 1 g

Target species

Pigs and poultry.

Indications

In pigs : AMOXIDEM 10% PREMIX is used for treatment and control of infections produced by susceptible bacteria from genera: Staphylococcus, Streptococcus, Corynebacterium, Clostridium, Salmonella, Escherichia coli, Klebsiella, Pasteurella, Erysipelothrix rhusiopatiae, Haemophilus, Brucella, Fusobacterium, Bacillus, Serpulina (Brachispira) hyodisenteriae and Leptospira.

In poultry: for treatment and control of infections produced by susceptible bacteria from genera: Staphylococcus, Streptococcus, Corynebacterium, Clostridium, Salmonella, Escherichia coli, Klebsiella, Pasteurella, Haemophilus, Erysipelothrix rhusiopatiae, Fusobacterium, Bacillus and Borellia

Administration

AMOXIDEM 10% PREMIX is administered via feed in the following dosages:

In poultry: mix with feed to ensure a dosage of 230 mg Amoxicilina 10 % premix/kg bw/day and administer for 5 consecutive days.

In pigs: mix with feed to ensure a dosage of 230 mg Amoxicilina 10 % premix/kg bw/day and administer for 5 consecutive days.

For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.

Contraindications

Do not administer to animals with known hypersensitivity to penicillins, beta-lactams and cephalosporins.

The product must not be administered in small rodents such as hamsters, Guinea pigs, rabbits, chinchillas. The amoxicillin is altering the intestinal microflora of these animals leading to lethal enterocolitis.

Side effects

A common side effect of antibiotics is diarrhea, which may be caused by the elimination of beneficial bacteria normally found in the colon.

Rarely, some animals may develop hypersensitivity reactions. In such cases, remove the medicated feed or water and treat the animals by administering of anti-allergic medications (antihistamines, adrenaline, corticosteroids).

Special precautions for storage

Keep away from reach and sight of children! The product should be stored in original packaging at temperature bellow 25°C, protected from direct sunlight and moisture. Protect from freezing. Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after dilution in drinking water, according to directions: 24 hours. Shelf-life after first opening of package: 28 days. Close tight the recipient after every use. Do not use after expiry date which is stated on the label.

Advice on correct administration

During treatment, the animals should eat only medicated feed. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

The use of suitable calibrating weighing equipment is recommended if part packs are used. The product should be well mixed with the feed to be homogenous.

Withdrawal period

Pigs, poultry: 28 days after cessation of oral medication.

Not permitted for use in laying birds producing eggs for human consumption.

Special warnings

People with known hypersensitivity to any of the product ingredients should avoid contact with the veterinary medicinal product. To prevent any unpleasant effects, personal protective equipment consisting in rubber gloves, goggles and dust masks should be worn when administering the product. Wash hands and exposed skin after use.

In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. Serious symptoms such as face swelling, lips or eye lids, accompanied by breath difficulties, are life-threatening symptoms and need immediate medical attention.

Due to variability (time, geographical) in susceptibility of bacteria for amoxicillin, bacteriological sampling and susceptibility testing of microorganisms from diseased animals on farm are highly recommended.

As eradication of the target pathogens may not be achieved, medication should therefore be combined with good management practices, e.g. good hygiene, proper ventilation, no overstocking.

Special precautions for the disposal of unused product or waste materials

For the environmental protection, medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal prod- ucts should be disposed of in accordance with local requirements.

Other information

Thermo-sealed PET bags with aluminum insertion, containing 10g, 25g, 50g, 100g, 500g, 1000g, 5kg, 10kg and PET sacks with aluminum insert of 25kg, 50kg.
Not all pack sizes may be marketed.