Paracillin SP (Canada)

Company: Intervet/Schering-Plough

Amoxicillin trihydrate (Ph. Eur.) Soluble Powder

For Veterinary Use Only

DIN 02281376

Description

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

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 beta-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.

Susceptibility of poultry and swine target pathogens to amoxicillin

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% susceptible population)

Paracillin SP Indications

Paracillin^® SP is indicated for the treatment of infections caused by bacteria susceptible to amoxicillin, including:

Chickens:

- Colibacillosis, peritonitis caused by non-β-lactamase-producing E. 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 S. suis

- Secondary infections due to ear and tail-biting

Dosage and Administration

It is recommended to administer Paracillin^® SP once daily via the drinking water, using either a tank or water proportioner. A measure is provided in the packaging which, when level, will contain approximately 10 g of Paracillin^® SP.

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 Paracillin^® SP, 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 Paracillin^® SP required per day, the following formula may be used:

Tank Method:

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.

Make a stock solution, by scattering the calculated amount of Paracillin^® SP onto the surface of 5-10 Litres of water and stirring until completely dissolved. Dilute this stock solution by stirring into a tank of water sufficient to provide the volume of medicated drinking water that will be consumed in approximately two hours. The normal water supply should be resumed after this time.

Water Proportioner Method:

To calculate the amount of Paracillin^® SP required to medicate the total daily drinking water intake, the following is a guide:

Birds 0-4 weeks of age: 6-12 g Paracillin^® SP/100 Litres of water

Birds older than 4 weeks: 10-20 g Paracillin^® SP/100 Litres of water

Make a stock solution, by scattering the calculated amount of Paracillin^® SP onto the surface of 5-10 Litres of water and stirring. Dilute this stock solution by using a water proportioner calibrated to deliver medicated drinking water containing the appropriate concentration of Paracillin^® SP, sufficient to provide the volume of medicated drinking water that will be consumed in approximately two hours. The normal water supply should be resumed after this time.

Pigs:

The recommended dosage is 20 mg Paracillin^® SP, to provide 16 mg amoxicillin trihydrate, per kg body weight per day, equivalent to 1 g Paracillin® SP per 50 kg body weight per day, administered via the drinking water for a period of 3-5 consecutive days.

Tank Method:

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.

Make a stock solution, by scattering the calculated amount of Paracillin^® SP onto the surface of 5-10 Litres of water and stirring. Dilute this stock solution by stirring into a tank of water sufficient to provide the volume of medicated drinking water that will be consumed in approximately two hours. The normal water supply should be resumed after this time.

Water Proportioner Method:

To calculate the amount of Paracillin^® SP required to medicate the total daily drinking water intake, the following is a guide:

Pigs younger than 4 months: 20 g Paracillin^® SP/100 Litres of water

Pigs older than 4 months: 30 g Paracillin^® SP/100 Litres of water

Make a stock solution, by scattering the calculated amount of Paracillin® SP onto the surface of 5-10 Litres of water and stirring. Dilute this stock solution by using a water proportioner calibrated to deliver medicated drinking water containing the appropriate concentration of Paracillin^® SP, sufficient to provide the volume of medicated drinking water that will be consumed in approximately two 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.

Paracillin^® SP is not effective against β-lactamase producing organisms.

Paracillin^® SP 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.

Storage

Store below 25° C in a dry place.

Any unused medicated water should be discarded immediately after use.

Packaging:

Paracillin^® SP is available in containers of 250 or 1000 g.

Intervet Canada Corp., 16750, route Transcanadienne, Kirkland QC, H9H 4M7

For technical enquiries, call toll free 1 888 306-0069.

November, 2006

512665 INA570 010

EOSC 3379/002

CPN: 12082030