CYDECTIN ORAL DRENCH FOR SHEEP - moxidectin liquid
Boehringer Ingelheim Vetmedica, Inc.

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CYDECTIN®
(moxidectin)
Oral Drench for Sheep
Antiparasitic

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

Cooperia oncophora - Adult and L4

Teladorsagia circumcincta - Adult and L4

Oesophagostomum columbianum - Adult and L4

Teladorsagia trifurcata - Adult and L4

Oesophagostomum venulosum -Adult and L4

Trichostrongylus axei - Adult and L4

Nematodirus battus - Adult and L4

Trichostrongylus colubriformis - Adult and L4

Nematodirus filicollis - Adult and L4

Trichostrongylus vitrinus - Adult and L4

Nematodirus spathiger - Adult and L4

Cooperia curticei - 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.

Body Weight		Dose	Body Weight		Dose
11 lb	5 kg	1 mL	99 lb	45 kg	9 mL
22 lb	10 kg	2 mL	110 lb	50 kg	10 mL
33 lb	15 kg	3 mL	121 lb	55 kg	11 mL
44 lb	20 kg	4 mL	132 lb	60 kg	12 mL
55 lb	25 kg	5 mL	143 lb	65 kg	13 mL
66 lb	30 kg	6 mL	154 lb	70 kg	14 mL
77 lb	35 kg	7 mL	165 lb	75 kg	15 mL
88 lb	40 kg	8 mL

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.

U.S. Patent No. 4,916,154 - used under license.

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

Manufactured by:

Boehringer Ingelheim Vetmedica, Inc.

St. Joseph, MO 64506 U.S.A.

1 Liter - Front Label

1 Liter - Back Label

4 Liter - Front Label

4 Liter - Back label

CYDECTIN ORAL DRENCH FOR SHEEP
moxidectin liquid

Product Information
Product Type	OTC ANIMAL DRUG	NDC Product Code (Source)	0010-3840
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MOXIDECTIN (MOXIDECTIN)	MOXIDECTIN	1 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0010-3840-01	1000 mL In 1 BOTTLE, PLASTIC	None
2	0010-3840-02	4000 mL In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141247	11/30/2005

Labeler - Boehringer Ingelheim Vetmedica, Inc. (007134091)

Revised: 11/2010Boehringer Ingelheim Vetmedica, Inc.