AMOXIDEM 10% PREMIX

Medicated premix

AMOXIDEM 10% PREMIX, 100 mg/g, premix for medicated feed for pigs and poultry.

1. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
AMOXIDEM 10% PREMIX is a white-yellowish powder that contains per 1 gram:
Amoxicillin trihydrate …………….… 100 mg (equivalent to 87 mg amoxicillin as base)
Excipient (corn starch) up to.………………………. 1 g

2. 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

3. 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.

4. 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).

5. TARGET SPECIES
Pigs and poultry.

6. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
AMOXIDEM 10% PREMIX is administered via feed in the following dosages:
In poultry: mix with feed to ensure a dosage of 230 mg AMOXIDEM 10 % premix/kg bw/day and administer for 5 consecutive days.
In pigs: mix with feed to ensure a dosage of 230 mg AMOXIDEM 10 % premix/kg bw/day and administer 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 10% PREMIX should be calculated according to the following formula:

mg AMOXIDEM 10% PREMIX / kg body weight/day x mean body weight of animals to be treated

=

mg AMOXIDEM 10% premix / kg feed

Mean daily feed consumption (kg) / animal

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

7. 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.

8. WITHDRAWAL PERIOD
Pigs, poultry: 28 days after cessation of oral medication.
Not permitted for use in laying birds producing eggs for human consumption.

9. SPECIAL PRECAUTIONS FOR STORAGE
Keep away from reach and sight of children!
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Keep in original packaging, at temperature below 25oC, protected from direct sunlight and moisture.
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.