CYDECTIN ORAL DRENCH FOR SHEEP- moxidectin liquid

Cydectin by

Drug Labeling and Warnings

Cydectin by is a Animal medication manufactured, distributed, or labeled by Bayer HealthCare, LLC Animal Health Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 141-247

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.

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

Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

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 1-800-422-9874.

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.

OTHER WARNINGS:

• Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.
• Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance.
• Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).
• A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.
• Macrocyclic lactones provide prolonged drug exposure that may increase selection pressure for resistant parasites. This effect may be more pronounced in extended-release formulations.

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.

SPL UNCLASSIFIED SECTION

Restricted Drug (CA) – Use Only As Directed

Bayer HealthCare LLC, Animal Health Division
Shawnee Mission, KS 66201

Made in Italy

Bayer, the Bayer Cross and Cydectin are registered trademarks of Bayer
© 2019 Bayer

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

CYDECTIN®

(moxidectin)

Oral Drench for Sheep

Antiparasitic

Contents 1 L

INGREDIENTS AND APPEARANCE

CYDECTIN  ORAL DRENCH FOR SHEEP
moxidectin liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 0859-2413
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MOXIDECTIN (UNII: NGU5H31YO9) (MOXIDECTIN - UNII:NGU5H31YO9)	MOXIDECTIN	1 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0859-2413-01	1000 mL in 1 BOTTLE
2	NDC: 0859-2413-02	4000 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141247	07/01/2017

Labeler - Bayer HealthCare, LLC Animal Health Division (152266193)