AMOXIDEM 50%

Water Soluble Powders

500 mg/g, water-soluble powder for pigs and poultry.

NAME AND ADRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER, IF DIFFERENT MANUFACTURING AUTHORIZATION HOLDER

S.C. Delos Impex ’96 S.R.L. 81, Horia, Closca si Crisan Street, Otopeni, Ilfov District, Romania, Tel. +0040-372 714 433

NAME OF THE VETERINARY MEDICINAL PRODUCT

AMOXIDEM 50%, 500 mg/g, water-soluble powder for pigs and poultry.

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

AMOXIDEM 50% is a white water-soluble powder that contains per 1 gram:

Amoxicillin trihydrate …………….… 500 mg (equivalent to 434,78 mg amoxicillin as base)

Excipient (lactose monohydrate) up to.………………………. 1 g

INDICATIONS: In pigs : Amoxidem 50% 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

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.

ADVERSE REACTIONS

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).

TARGET SPECIES: Pigs and poultry.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Amoxidem 50% is administered via drinking water and/or feed in the following dosages:

Pigs: the therapeutically dosage is 20-25 mg amoxicillin /kg b.w./day (23 mg – 28 mg amoxicillin trihydrate/kg b.w./day, aproximatively 46 – 56 mg Amoxidem 50% /kg b.w./day), for 5 consecutive days.

Poultry: the therapeutically dosage is 20-25 mg amoxicillin /kg b.w./day (23 mg – 28 mg amoxicillin trihydrate/kg b.w./day, aproximatively 46 – 56 mg Amoxidem 50% /kg b.w./day), for 5 consecutive days. Based on the recommended doses and the number and weight of the animals to be treated, the exact daily amount of Amoxidem 50% should be calculated according to the following formula:

In drinking water:

Amoxidem 50 APA

In feed:

Amoxidem furaj

The uptake of medicated water is dependent on the clinical condition of animals. In order to obtain the correct dosage, the concentration in feed or drinking water may have to be adjusted. The use of suitable calibrating weighing equipment is recommended if part packs are used.

ADVICE ON CORRECT ADMINISTRATION

During treatment, the animals should eat only medicated feed and drink only medicated water. 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

Poultry: edible tissues: 28 days after cessation of oral medication.

Pigs: edible tissues: 6 days after cessation of oral medication.

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

SPECIAL PRECAUTIONS FOR STORAGE

Keep away from reach and sight of children! Store in original packaging, at room temperature (15–25°C), protected from moisture and direct sunlight.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after dilution in drinking water, according to directions: 6 hours. After opening the package the product should be used entirely.

Shelf life after incorporation into meal: 7 days. Do not use after expiry date which is stated on the label.

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, IF ANY

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 products should be disposed of in accordance with local requirements.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

February 2012

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