Lincomix Soluble Powder (Canada)

Company: Zoetis

lincomycin hydrochloride soluble powder mfr. std.

Veterinary Use Only

Antibiotic

DIN 00813761

Medicinal Ingredient

Each g of LINCOMIX soluble powder contains 400 mg lincomycin base (as lincomycin hydrochloride).

Lincomix Soluble Powder Indications

Chickens: For the treatment of necrotic enteritis in broiler chickens.

Swine: For the treatment of swine dysentery (bloody scours) associated with Serpulina (Treponema) hyodysenteriae.

Honey Bees: For the control of American foulbrood associated with Paenibacillus larvae in honey bees.

Lincomix Soluble Powder Dosage And Administration

To reduce the development of antimicrobial resistance and maintain effectiveness, use this antibiotic prudently.

Chickens: At the first sign of disease, administer medication at the following dosage as the sole source of drinking water for 7 consecutive days.

80 g of LINCOMIX soluble powder will medicate 2000 liters of drinking water or 1 level scoop (4.7 g) per 120 liters of drinking water (providing 16 mg antibiotic activity per liter).

To prepare a stock solution, dissolve 80 g in 8 liters (1 level scoop in 470 mL) of water in a clean glass or plastic container, mix, and dispense 1 liter of stock solution per 250 liters of drinking water.

Automatic Proportioner Calibrated In Metric Units

Dissolve 80 g in water to make 8 liters of stock solution and set medicator to deliver 4.0 mL of stock solution per liter of drinking water.

Automatic Proportioner Calibrated In U.s. Units

Dissolve 80 g in water to make 2 U.S. gallons of stock solution and set medicator to deliver 0.45 U.S. fluid ounce of stock solution per U.S. gallon of drinking water.

Swine: At the first sign of disease, administer medication at the following dosage as the sole source of drinking water and continue use until 5 days after the disappearance of bloody stools, up to a maximum of 10 consecutive days.

An amount of 80 g of LINCOMIX soluble powder will medicate 960 liters of drinking water or 1 level scoop (4.7 g) per 55 liters of drinking water (providing 33 mg antibiotic activity per liter). To prepare a stock solution, dissolve 80g in 80 liters (1 level scoop in 470 mL) of water in a clean glass or plastic container, mix and dispense as shown in the following table.

Automatic Proportioner Calibrated In Metric Units

Dissolve 80 g in water to make 8 liters of stock solution and set medicator to deliver 8.0 mL of stock solution per liter of drinking water.

Automatic Proportioner Calibrated In U.s. Units

Dissolve 80 g in water to make 2 U.S. gallons of stock solution and set medicator to deliver 1 U.S. fluid ounce of stock solution per U.S. gallon of drinking water.

IMPORTANT: Fresh medicated drinking water should be provided daily. Store stock solution in closed glass containers in a cool place and discard after 7 days.

Honey Bees:

Dosage: Administer 100 mg to 200 mg of lincomycin hydrochloride (active ingredient) per hive.

Treatment period: The drug should be administered to the hive weekly for 3 weeks.

Administration: Mix 250 mg or 500 mg LINCOMIX with 20 g confectioner’s powdered sugar and dust over the top bars of the brood chamber.

CAUTIONS:

● Not for use in layers and breeder chickens.

● Not for use in breeding swine.

● Treated pigs may develop some stool softening or mild diarrhea within 18 to 36 hours. Signs of mild irritation and swelling of the anus and/or vulva may be associated with the stool changes. These side effects are transient and are self-correcting by the fifth to seventh day of treatment. Should these reactions be more severe than described above, discontinue use of the drug.

● If no improvement in disease condition is noted after 3 to 5 days of treatment, re-determine the diagnosis.

● Do not allow rabbits, hamsters, guinea pigs, horses, dairy cattle or other ruminants access to feeds and/or drinking water containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects or metabolic disorders (i.e., ketosis in dairy cattle).

Warnings

Chickens: No drug withdrawal period is required when chickens are treated at the recommended dose (16 mg/liter of drinking water).

Swine: No drug withdrawal period is required when swine are treated at the recommended dose (33 mg per liter of drinking water).

Honey Bees: The drug should be fed early in the spring or late in the fall and consumed by the bees before the main honey flow begins, to avoid contamination of production honey. Complete treatments at least 4 weeks prior to main honey flow.

When handling the product, avoid inhalation, oral exposure and direct contact with skin or eyes.

KEEP OUT OF REACH OF CHILDREN

Safety And Efficacy In Honey Bees

Safety: A US margin-of-safety study was conducted on 20 healthy colonies to determine the toxicity of lincomycin hydrochloride to immature and adult honey bees. Groups of 4 colonies received one of the following treatments weekly for 9 weeks:

1. None (no sugar; no drug)

2. Sugar only (no drug)

3. 200 mg lincomycin hydrochloride (in 20 g confectioner’s sugar)

4. 600 mg lincomycin hydrochloride (in 20 g confectioner’s sugar)

5. 1000 mg lincomycin hydrochloride (in 20 g confectioner’s sugar)

Adult bee mortality, the presence of sealed brood (healthy larvae), and queen health were observed during the study. The statistical analysis did not show any significant differences due to dose group or observation day. No mortality or other adverse health effects were seen that could be associated with the drug product. These results demonstrate that lincomycin hydrochloride is safe when administered to honey bee colonies up to 10 times the recommended doses of 100 mg per hive once weekly for 3 weeks.

Efficacy: A US dose-confirmation study was conducted on 30 honey bee colonies experimentally infected with Paenibacillus larvae to determine the efficacy of lincomycin hydrochloride for the control of American foulbrood (AFB).

Six (6) days after the colonies were rated for presence and severity of AFB, each treatment group (10 colonies per group) received one of the following treatments on Study Day 58:

1. Sugar-treated control (no drug)

2. 100 mg lincomycin hydrochloride (in 20 g confectioner’s sugar)

3. 200 mg lincomycin hydrochloride (in 20 g confectioner’s sugar)

All treatment groups had comparable mean AFB severity ratings pre-treatment. By the end of the study, AFB in the untreated group had increased considerably and the colony scores in the untreated control colonies had raised to a mean treatment group score of 0.738 (see Table I below). By comparison, no colonies in the either the 100 mg or the 200 mg lincomycin-treated groups had active disease.

Table I: Average colony scores of AFB infected honey bee colonies by treatment

(n =10 colonies/group)

Based on the results of this study, lincomycin hydrochloride is effective in controlling American foulbrood (Paenibacillus larvae) when applied at a rate of 100 mg or 200 mg per hive per treatment as a dust in confectioners’ sugar, one week apart for 3 treatments.

Storage

Store between 15-25°C.

PRESENTATION

LINCOMIX soluble powder is available in 80 and 1500 gram bottles.

Zoetis^® and Lincomix are registered trademarks of Zoetis or its licensors.

Zoetis Canada Inc., Kirkland QC H9H 4M7

CONTAINS ANTIMICROBIAL

USE RESPONSIBLY

1599-11-3

507674/40034952

CPN: 1198293.7