ANTIBIOTICS

Amoxidem 50%

Amoxicillin trihydrate 500 mg/g.
Water-soluble powder for pigs and chickens

Formula

Each gram of product contains:

Amoxicillin trihydrate (active substance): 500 mg

Target species

Pigs and chickens

Indications

For treatment of primary or secondary gastrointestinal, respiratory, urogenital, skin and mucous membrane infections caused by bacteria susceptible to amoxicillin in pigs and chickens.

In pigs: for the treatment of colibacillosis, salmonellosis, dysentery with Serpulina spp., swine erysipelas, primary or secondary bronchopneumonia, atrophic rhinitis, metritis-mastitis-agalaxia syndrome in sows, urinary infections, omphalophlebitis caused by bacteria susceptible to amoxicillin.

In chickens: for treatment of pasteurellosis, colibacillosis, salmonellosis, spirochetosis, staphylococci, dermatitis and other diseases caused by bacteria susceptible to amoxicillin.

Administration

Amoxidem 50% is administered via drinking water in the following dosages:

Pigs: the therapeutically dosage is 16 – 22 mg Amoxidem 50% /kg b.w./day), for 5 consecutive days.

Chickens: 300 -400 g Amoxidem 50%/1000 liters of drinking water, administered for 5 consecutive days.

For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorization Holder.

Contraindications

Do not administer to animals with known hypersensitivity to active substance or excipient.

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

Rarely, hypersensitivity reactions may occur in some animals. In such situations, the medicated water is removed, and the animals are treated by administering antiallergic veterinary medicinal products (antihistamines, adrenaline, glucocorticoids).

Advice on correct administration

The uptake of medicated water is dependant 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 daily dose is incorporated in drinking water, so that the entire amount is consumed within 6 hours. A new amount of medicated water must be freshly prepared every 6 hours.

To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

Special precautions for storage

Keep out of sight and reach of children.

Store in original packaging, at temperature bellow 25oC, protected from moisture and direct sunlight.

Shelf life after dilution in drinking water, according to directions: 6 hours.

Shelf-life after first opening of primary package: 7 days.

Do not use after expiry date which is stated on the label.

Withdrawal period

Meat and offal:

Pigs: 6 days.

Chickens: 28 days.

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

Special warnings

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. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Use of the product deviating from the instructions given by the SPC may increase the prevalence of bacteria resistant to amoxicillin and may decrease the effectiveness of treatment with other penicillines due to the potential for cross resistance. Official, national and regional antimicrobial policies should be taken into account when the product is used.

Penicillins can cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins can lead to cross-hypersensitivity to cephalosporins and vice versa. Occasionally, allergic reactions to these substances can be severe. People with known hypersensitivity to amoxicillin should avoid contact with the veterinary medicinal product.

Handle product carefully to avoid exposure, taking all recommended precautions. Avoid product contact with skin and eyes, as irritation may occur. In case of contact with skin or eyes, rinse with plenty of water. After using the product, wash your hands. During the preparation and administration of medicated drinking water, skin contact with the product and inhalation of powder particles should be avoided. When mixing and handling the veterinary medicinal product, appropriate personal protective equipment consisting of gloves and a respirator (either a disposable mask in accordance with European Standard EN149 or a respirator in accordance with European Standard EN140 with a filter in accordance with the European Standard EN 143).

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.

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 products should be disposed of in accordance with local requirements.

Other information

Bags 10g, 25g, 50g, 100g, 500g, 1000g, 5kg, 10kg and 25kg.
Not all pack sizes may be marketed.

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