AMOXIVET 15% LA (long-acting suspension for injection)

An oily white suspension which may separate on storage.

1 ml of the product contains:

- amoxicillin (as amoxicillin trihydrate) – 150,0 mg

Excipients: butylhydroxytoluene (E321), sodium carboxymethylcellulose, chlorobutanol hemihydrate, polysorbate 80, benzyl alcohol, medium-chain triglycerides (Miglyol 812 N), water for injections.

ATC vet classification code QJ01 – antibacterial veterinary medicinal products for systemic use. QJ01CA04 – Amoxicillin.

Amoxicillin belongs to the group of β-lactam antibiotics. It blocks the synthesis of bacterial cell walls, inhibits the activity of transpeptidase and carboxypeptidase enzymes, and causes disruption of the osmotic balance, leading to the death of microorganisms at the development stage.

Amoxicillin is active against Gram-positive (Actinomyces spp., Bacillus anthracis, Clostridium spp., Corynebacterium spp., Erysipelothrix rhusiopathiae, Streptococcus spp., Listeria monocytogenes) and Gram-negative (Actinobacillus spp., Bordetella bronchiseptica, Fusobacterium spp., Haemophilus spp., Moraxella spp., Pasteurella spp., Proteus mirabilis, Salmonella spp.) microorganisms. The following microorganisms are insensitive to amoxicillin: Pseudomonas aeruginosa, Serratia spp., indole-positive Proteus (except Proteus mirabilis), Enterobacter spp., Citrobacter spp. and Acinetobacter spp.

After intramuscular administration, amoxicillin is rapidly absorbed into the blood from the injection site and distributed to most tissues and body fluids, maintaining a therapeutic concentration for a long time (48–72 hours), ensuring prolonged therapeutic concentrations in tissues. The maximum plasma concentration of amoxicillin is reached within 2–3 hours after administration and remains at a therapeutic level for 48 hours. The rapid distribution of amoxicillin in tissues is promoted by its low degree of binding to plasma proteins. In inflammation of the meninges, the concentration of amoxicillin in cerebrospinal fluid may reach 30–60% of its concentration in blood serum. The elimination half-life of amoxicillin in ruminants is 90 minutes.

Amoxicillin is excreted mainly by the kidneys unchanged through tubular secretion, but a small portion is metabolised by hydrolysis to inactive penicillic acid and excreted in the urine.

Treatment of cattle and pigs with diseases of the digestive tract (gastritis, enteritis, peritonitis), respiratory organs (tonsillitis, tracheitis, pneumonia, bronchitis, rhinitis, sinusitis, bronchopneumonia), urogenital system (cystitis, metritis, mastitis), and skin (dermatitis) caused by microorganisms sensitive to amoxicillin.

Intramuscularly at the following doses:

- cattle – 1,0 ml of the product per 10 kg body weight (15 mg of amoxicillin per 1 kg body weight);

- pigs – 1,0 ml of the product per 10 kg body weight (15 mg of amoxicillin per 1 kg body weight).

If necessary, the injection may be repeated after 48 hours. Shake thoroughly before use. If the injection dose exceeds 20 ml, divide it and administer into different sites of the body.

Hypersensitivity to penicillins or other β-lactam medicinal products.

Do not use in rabbits, guinea pigs, hamsters or small herbivorous animals.

Do not use in animals with impaired renal function.

Do not use simultaneously with cephalosporin, tetracycline or macrolide antibiotics.

Do not administer intravenously!

Local swelling at the injection site may occur, which resolves after discontinuation of treatment.

In isolated cases, allergic reactions are possible (skin rash, pruritus and oedema, thrombocytopenia, leukopenia, anaemia, anaphylactic shock).

Use of the product should be based on determination of the susceptibility of pathogens to amoxicillin. In the absence of data on the susceptibility of the pathogen/pathogens to amoxicillin, the use of the product should be based on the regional epizootic situation regarding antimicrobial susceptibility.

Prolonged use of the product may lead to the emergence of microbial strains resistant to β-lactam antibiotics.

Shake the vial thoroughly before use. Use only dry, sterile syringes and needles.

Studies in laboratory animals did not reveal any teratogenic, embryotoxic or maternotoxic effect of amoxicillin on the maternal organism or foetus.

However, the safety of amoxicillin in target animal species during pregnancy has not been studied. Use of the product in pregnant animals should depend on the veterinarian’s assessment of the benefit/risk ratio.

Slaughter of animals for meat is permitted 28 days (cattle) and 20 days (pigs) after the last administration of the product. Milk for human consumption is permitted 3 days after the last administration of the product. Meat and milk obtained before the specified period shall be disposed of or fed to non-productive animals, depending on the conclusion of a veterinary medicine doctor.

Type I neutral glass vials (NS-1, NS-2, USP-1), closed with rubber stoppers and aluminium caps, of 10, 20, 50 and 100 ml. Secondary packaging: cardboard box.

Store in a dry, dark place out of the reach of children at a temperature from 10 to 25 °C.

2 years.

After first withdrawal from the vial, the product must be used within 28 days when stored in a dark place at a temperature from 0 to 5 °C.