Huvamox (Canada)

Company: Huvepharma Canada

AMOXICILLIN FOR ORAL SOLUTION

DIN 02554062

VETERINARY USE ONLY

ANTIBIOTIC, ATCvet code QJ01CA04

FOR ORAL SOLUTION

CHICKENS • SWINE

Description

Huvamox is a soluble powder containing 800 mg/g amoxicillin trihydrate (equivalent to 697 mg amoxicillin) specially formulated to promote rapid and complete dissolution. Huvamox will not block nipple drinkers or water lines. The maximum solubility of Huvamox is 3 g/Litre, although solubility may be increased by use of a water conditioner.

Huvamox Indications

Huvamox is indicated for the treatment of infections caused by bacteria susceptible to amoxicillin, including:

Chickens:

● Colibacillosis, peritonitis caused by non-β-lactamase-producing Escherichia coli

● Salmonellosis caused by non-β-lactamase-producing Salmonella enterica subsp. enterica

● Respiratory tract infections caused by non-β-lactamase-producing E. coli

Swine:

● Respiratory infections caused by Actinobacillus pleuropneumoniae

● Arthritis and meningitis caused by Streptococcus suis

● Secondary infections due to ear and tail-biting

Directions For Use

To reduce the development of antimicrobial resistance and maintain effectiveness, use this antibiotic prudently and for the shortest duration required to achieve the desired clinical outcome. It is recommended to administer Huvamox once daily via the drinking water, using either a tank or water proportioner. It is advisable to restrict drinking water for approximately 2 hours (less in hot weather) prior to medication.

Chickens: The recommended dosage is 10-20 mg Huvamox, to provide 8-16 mg amoxicillin trihydrate, per kg body weight per day, for a period of 3-5 consecutive days. The higher dosage is advised when treating severe infections. To calculate the amount of Huvamox required per day, the following formula may be used:

Ensure there is no access to unmedicated water while medicated water is being offered. Any unused medicated water should be discarded immediately after the treatment period.

Tank Method: Make a stock solution, by scattering the calculated amount of Huvamox onto the surface of a small volume of water (for example, 5-10 Litres) and stirring until the powder is completely dissolved. Add this stock solution into a tank of water sufficient to provide the volume of medicated drinking water that will be consumed in approximately two (2) hours. The normal water supply should be resumed after this time.

Water proportioner method: Make a stock solution, by scattering the calculated amount of Huvamox onto the surface of the required volume of water and stirring until the powder is completely dissolved. Dilute this stock solution by using a water proportioner calibrated to deliver medicated drinking water containing the appropriate concentration of Huvamox, sufficient to provide the volume of medicated drinking water that will be consumed in approximately two (2) hours. The normal water supply should be resumed after this time.

Swine: The recommended dosage is 20 mg Huvamox, to provide 16 mg amoxicillin trihydrate, per kg body weight, per day. This is equivalent to 1 g Huvamox per 50 kg body weight per day, for a period of 3-5 consecutive days. Ensure there is no access to unmedicated water while medicated water is being offered. Any unused medicated water should be discarded immediately after the treatment period.

Tank method: Make a stock solution, by scattering the calculated amount of Huvamox onto the surface of a small volume of water (for example 5-10 Litres) and stirring until the powder is completely dissolved. Add this stock solution into a tank of water sufficient to provide the volume of medicated drinking water that will be consumed in approximately two (2) hours. The normal water supply should be resumed after this time.

Water proportioner method: Make a stock solution, by scattering the calculated amount of Huvamox onto the surface of the required volume of water and stirring until the powder is completely dissolved. Dilute this stock solution by using a water proportioner calibrated to deliver medicated drinking water containing the appropriate concentration of Huvamox, sufficient to provide the volume of medicated drinking water that will be consumed in approximately two (2) hours. The normal water supply should be resumed after this time.

Contraindications

Amoxicillin exerts its bactericidal action by inhibition of bacterial cell wall synthesis during multiplication. It is therefore, in principle, not compatible with bacteriostatic antibiotics, for example tetracyclines which inhibit multiplication. Synergism may occur with other β-lactam antibiotics and aminoglycosides.

Cautions

● Use of the product should be based on susceptibility testing because of reported resistance (up to 50%) in E. coli and Salmonella spp. from chickens.

● Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin and may decrease its effectiveness.

● Huvamox is not effective against β-lactamase producing organisms.

● Huvamox should not be administered to animals sensitive to penicillins.

● As with other penicillin-containing preparations, this product should not be given orally or parenterally to small herbivores such as guinea pigs, hamsters and rabbits.

Warnings

● Treated chickens must not be slaughtered for use in food for at least two (2) days following the latest treatment with this drug.

● Treated pigs must not be slaughtered for use in food for at least three (3) days following the latest treatment with this drug.

● Do not use in laying birds.

● Persons who are allergic to penicillins and cephalosporins should avoid direct contact with the product.

● To limit the development of antimicrobial resistance, the choice of this drug as the most appropriate treatment should be confirmed by clinical experience supported, where possible, by pathogen culture and drug susceptibility testing.

● Keep out of reach of children.

Pharmacology

Amoxicillin is rapidly absorbed after oral administration. It demonstrates a low capacity for protein-binding and is widely distributed in various tissues after absorption. Amoxicillin is primarily excreted via the kidneys into the urine and circulated via the liver into the bile. Amoxicillin, like all β-lactam antibiotics, prevents the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. Amoxicillin inhibits the activity of the transpeptidase and other peptidoglycan-active enzymes which catalyse the cross-linkage of the glycopeptide polymer units. This leads to rupture of the cytoplasmic membrane through the weakened section and formation of a spheroplast. The drug exerts its bactericidal action only in growing cells, that is, cells with an undergoing cell wall synthesis.

¹ MIC = minimal inhibitory concentration; MIC₅₀ and MIC₉₀ are drug concentrations which inhibit 50% and 90% of the isolates, respectively.

² MIC₅₀ was calculated by including the susceptible population only. The resistance breakpoint R of amoxicillin against Enterobacteriaceae is R ≥ 32 µg/mL (CLSI document M 31-A 2). According to the resistance breakpoint, the MIC₅₀ of 4 µg/mL represents the value for 49 susceptible isolates out of 104 broiler E. coli isolates tested (equals 47% of susceptible population)

Storage

Store in a cool, dry place between 15°C and 30°C. Use within 6 months of first open. Reconstituted solution should be used within 24 hours and stored at room temperature (15- 30°C). Dispose of unused reconstituted solution after 24 hours.

Rev: Dec 2024

HUVEPHARMA EOOD, 3A, Nikolay Haytov Street, Sofia 1113, Bulgaria

Imported and distributed by:

HUVEPHARMA CANADA CORPORATION INC., PO BOX 301 STN B, Ottawa, ON K1P 6C4

CPN: 1299031.0