AMOXIVET 500 (powder for oral use)

White to yellowish-brown powder with an odour characteristic of the ingredients.

1 g of the product contains active substance:

- amoxicillin trihydrate – 500,0 mg.

Excipients: disodium edetate (Trilon B), sodium carbonate, sodium citrate.

ATCvet code: QJ01 - Antibacterials for systemic use. QJ01CA04 - Amoxicillin.

Amoxicillin is a semi-synthetic antibiotic of the aminopenicillin group. It has a bactericidal effect, blocking the synthesis of the bacterial cell wall, inhibiting the activity of the enzymes transpeptidase and carboxypeptidase, and causing disruption of osmotic balance, which leads to the death of microorganisms at the stage of growth. Amoxicillin is ineffective against strains producing β-lactamase.

Amoxicillin is active against Gram-positive (Bacillus anthracis, Clostridium spp., Corynebacterium spp., Erysipelothrix rhusiopathiae, Streptococcus spp., Staphylococcus spp., Leptospira spp., Listeria monocytogenes) and Gram-negative (Actinobacillus spp., Bordetella bronchiseptica, Fusobacterium spp., Haemophilus spp., Moraxella spp., Pasteurella spp., Proteus mirabilis, Salmonella spp.) microorganisms.

After oral administration, amoxicillin is rapidly distributed throughout many organs, including the liver, lungs and tissues, and it is also found in bile, ascitic, pleural and synovial fluids. In inflammation of the meninges, the concentration of amoxicillin in the cerebrospinal fluid may reach 30–60% of its concentration in blood serum.

The half-life of amoxicillin in calves after oral administration is 2,15 ± 0,20 hours. Bioavailability in calves is 27%.

Amoxicillin is resistant to the action of gastric juice and intestinal contents. It is rapidly absorbed in the intestine and distributed in most tissues and body fluids, except the brain and cerebrospinal fluid, into which amoxicillin penetrates only in the case of meningitis. After oral administration of the product to pigs with drinking water at a dose of 30 mg of amoxicillin per 1 kg of body weight, its pharmacokinetic parameters were: Cmax = 5,29 ± 2,24 µg/ml, Tmax = 0,80 ± 0,21 h and T1/2e = 0,72 ± 0,23 h.

After oral administration to poultry, amoxicillin is rapidly absorbed from the gastrointestinal tract. Bioavailability in poultry is 63,00 ± 4,58%. Tmax is 1,00 ± 0,06 h. The maximum concentration of amoxicillin in blood plasma is 160,40 ± 4,67 µg/ml, and mean concentrations of amoxicillin > 15 µg/ml are maintained for 24 hours. In poultry, the half-life and mean residence time of amoxicillin in plasma are 9,16 ± 0,60 and 12,26 ± 0,81 hours after oral administration.

Most of the amoxicillin is excreted unchanged in the urine, and to a lesser extent in bile.

Calves aged from 6 weeks to 3 months: treatment of animals suffering from pasteurellosis, salmonellosis, as well as diseases of the gastrointestinal tract, respiratory and urogenital systems caused by microorganisms sensitive to amoxicillin.

Pigs: treatment of animals suffering from pasteurellosis, salmonellosis and colibacillosis, as well as diseases of the gastrointestinal tract, respiratory and urogenital systems caused by microorganisms sensitive to amoxicillin.

Poultry (broiler chickens, replacement pullets, turkeys, ducks, geese): treatment of birds suffering from necrotic enteritis, as well as diseases of the gastrointestinal tract and respiratory organs caused by microorganisms sensitive to amoxicillin.

Orally with drinking water or feed at the following doses:

- calves aged from 6 weeks to 3 months – 2,0–4,0 g of the product per 100 kg of body weight twice daily (10–20 mg of amoxicillin per 1 kg of body weight) for 5 days;

- pigs – 4,0 g of the product per 100 kg of body weight twice daily (20 mg of amoxicillin per 1 kg of body weight) with drinking water for 5 days;

- poultry (broiler chickens, replacement pullets, turkeys, ducks, geese) – 0,3–0,4 g per 10 kg of body weight per day (15–20 mg of amoxicillin per 1 kg of body weight) or 100 g of the product per 300 l of drinking water daily. The course of treatment is 3–5 days.

The required amount of the product per 1 l of water is calculated by the formula:

where 0,04 is the dose of the product (g/kg of bird body weight),

m is the concentration of the product in drinking water (g/l),

M is the total body weight of the treated bird flock (kg),

V is the total daily water consumption by the flock (l).

When used with drinking water, a solution of the product is prepared based on the daily dose for half of the daily requirement for drinking water according to the water consumption standards for individual age categories of animals. First, drinking water with the daily dose of the product is given for the first 12 hours, and then for the next 12 hours drinking water without the product is given.

Hypersensitivity to penicillins or other medicinal products of the β-lactam group.

Do not administer to rabbits, guinea pigs, hamsters, chinchillas and small herbivorous animals.

Do not administer to laying hens whose eggs are used for human consumption, as well as to animals with severe renal dysfunction.

Do not administer simultaneously with chloramphenicol, lincosamides, tetracyclines, macrolides and sulfonamides.

Do not administer to ruminants with functionally developed forestomachs.

Do not administer in cases of detection of pathogenic bacterial strains resistant to penicillins.

In rare cases, allergic reactions may occur (skin rash, pruritus and oedema, thrombocytopenia, leukopenia, anaemia, anaphylactic shock). If they occur, administration of the product should be discontinued and desensitising therapy should be prescribed.

High doses or prolonged use of the product may cause a neurotoxic effect (for example, ataxia).

Amoxicillin has no hepatotoxic effect, but cases of increased liver enzyme levels are known.

Before using the product, it is recommended to perform bacteriological confirmation of the diagnosis and a susceptibility test of the pathogens to amoxicillin.

Do not administer to laying hens whose eggs are used for human consumption.

Use during pregnancy and lactation is allowed only after a risk/benefit assessment by a veterinarian.

Do not administer simultaneously with chloramphenicol, lincosamides, tetracyclines, macrolides and sulfonamides.

Do not administer simultaneously with bacteriostatic antibiotics, as this reduces the antibacterial effect.

The slaughter of animals and poultry for meat is allowed 7 days (calves, pigs) and 3 days (poultry) after the last administration of the product. Meat obtained before the specified period is disposed of or fed to non-productive animals, depending on the opinion of the veterinarian.

Bags made of polyethylene film of 1, 2, 3, 5, 10, 50, 100, 500 g and 1 kg.

Bags of 5, 20 and 25 kg.

Polymer containers of 100, 500 g and 1 kg.

Store in a dry, dark place inaccessible to children at a temperature from 5 °C to 25 °C.

2 years.

The shelf life after first opening of the container, provided it is stored in a dry, dark place at a temperature from 5 to 25 °C and the package with the product is subsequently tightly closed, is 28 days.

Shelf life when mixed with feed is 24–36 hours; when dissolved in water – 12 hours.