Cydectin Oral Drench for Sheep

Boehringer Ingelheim Vetmedica, Inc.

CYDECTIN Oral Drench for Sheep

FULL PRESCRIBING INFORMATION: CONTENTS*

• PRODUCT CYDECTIN ORAL DRENCH FOR SHEEP DESCRIPTION:
• INDICATIONS:
• ADMINISTRATION:
• DOSAGE:
• HUMAN WARNINGS:
• RESIDUE WARNINGS:
• ENVIRONMENTAL WARNINGS:
• ANIMAL SAFETY WARNINGS:
• ANIMAL SAFETY:
• STORAGE:
• DISPOSAL:
• Container Label, Front, 1 L
• Container Label, Back, 1 L

FULL PRESCRIBING INFORMATION

NADA 141-247, Approved by FDA

Contains 1 mg moxidectin/mL

For Treatment and Control of Infections Due to Internal Parasites of Sheep.

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

PRODUCT DESCRIPTION:

CYDECTIN Oral Drench for Sheep is a ready-to-use solution containing 0.1% moxidectin. Moxidectin is an endectocide in the milbemycin chemical class which shares the distinctive mode of action characteristic of macrocyclic lactones. Moxidectin acts by interfering with chloride channel-mediated neurotransmission in the parasite. This results in paralysis and elimination of the parasite.

INDICATIONS:

CYDECTIN Oral Drench for Sheep, when administered at the recommended dose level of 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight, is effective in the treatment and control of adult and larval (L₄) stages of the following internal parasites of sheep:

Parasites

Haemonchus contortus - Adult and L₄

Teladorsagia circumcincta - Adult and L₄

Teladorsagia trifurcata - Adult and L₄

Trichostrongylus axei - Adult and L₄

Trichostrongylus colubriformis - Adult and L₄

Trichostrongylus vitrinus - Adult and L₄

Cooperia curticei – Adult and L₄

Cooperia oncophora - Adult and L₄

Oesophagostomum columbianum - Adult and L₄

Oesophagostomum venulosum -Adult and L₄

Nematodirus battus - Adult and L₄

Nematodirus filicollis - Adult and L₄

Nematodirus spathiger - Adult and L₄

ADMINISTRATION:

CYDECTIN Oral Drench is ready-to-use. Administer 1 mL per 11 lb (1 mL per 5 kg) body weight into the mouth of the sheep, using any standard drenching equipment. Check dose rates and equipment before drenching. Do not overdose. Do not mix with any other products before administration. Avoid contaminating the drench solution.

DOSAGE:

The recommended rate of administration for CYDECTIN Oral Drench for Sheep is 1 mL per 11 lb (5 kg) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight. The table below will assist in the calculation of the appropriate volume of drench in 1.0 mL increments and it must be administered based on the weight of animal being treated.

HUMAN WARNINGS:

Not for use in humans. Keep this and all drugs out of the reach of children. To obtain a copy of the material safety data sheet (MSDS) which provides more detailed occupational safety information or to report adverse reactions attributable to exposure to this product, call 1-866-638-2226.

RESIDUE WARNINGS:

Sheep must not be slaughtered for human consumption within 7 days of treatment. Because a withholding time in milk has not been established for this product, do not use in female sheep providing milk for human consumption.

ENVIRONMENTAL WARNINGS:

Studies indicate that when moxidectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive. Free moxidectin may adversely affect fish and certain aquatic organisms. Do not contaminate water by direct application or by improper disposal of drug containers.

ANIMAL SAFETY WARNINGS:

CYDECTIN Oral Drench for Sheep has been formulated specifically for oral use in sheep and should not be given by any other route of administration. Do not use in sick, debilitated, or underweight animals. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

ANIMAL SAFETY:

A well-controlled U.S. study has demonstrated an adequate margin of safety to allow treatment of sheep four months of age and older with CYDECTIN Oral Drench. In this study no signs of toxicity were seen in sheep given up to 5 times the recommended dose. Reproductive safety studies evaluating the use of CYDECTIN Oral Drench in breeding ewes and rams have not been conducted in the U.S.

STORAGE:

Store product at or below 77°F (25°C). Protect from light.

DISPOSAL:

Do not contaminate water by direct application or by improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.

© 2013 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.

CYDECTIN is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.

Restricted Drug (CA) – Use Only As Directed

Manufactured for:
Boehringer Ingelheim Vetmedica, Inc.
St. Joseph, MO 64506 U.S.A.

Container Label, Front, 1 L