Cydectin Injectable (500 mL)

BAYER HEALTHCARE LLC
Animal Health Division (acquired by Elanco US, Inc.)
Distributed by ELANCO US, INC.
P.O. BOX 390, SHAWNEE MISSION, KS, 66201-0390
Customer Service Tel.: 800-633-3796
Customer Service Fax: 800-344-4219
THIS SERVICE AND DATA ARE PROVIDED "AS IS". DVMetrics assumes no liability, and each user assumes full risk, responsibility, and liability, related to its use of the DVMetrics service and data. See the Terms of Use for further details.
CYDECTIN®

Bayer Animal Health

moxidectin

Injectable Solution for Beef and Nonlactating Dairy Cattle

Antiparasitic

Sterile

Contains 10mg moxidectin/mL (5,000 mg/500 mL)

Not for use in female dairy cattle 20 months of age or older (including dry dairy cows), veal calves, and calves less than 8 weeks of age.

For Treatment of Infections and Infestations Due to Internal and External Parasites of Cattle.

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

PRODUCT DESCRIPTION

CYDECTIN Injectable Solution is a ready-to-use, sterile solution containing 1% moxidectin. Moxidectin is an endectocide in the milbemycin chemical class which shares the distinctive mode of action characteristic of macrocyclic lactones. CYDECTIN Injectable is specially formulated to allow moxidectin to be absorbed from the site of injection and distributed internally to the areas of the body affected by endo- and/or ectoparasitism. Moxidectin binds selectively and with high affinity to glutamate-gated chloride ion channels which are critical to the function of invertebrate nerve and muscle cells. This interferes with neurotransmission resulting in paralysis and elimination of the parasite.

INDICATIONS

CYDECTIN Injectable, when administered at the recommended dose level of 0.2 mg/2.2 lb (0.2 mg/kg) body weight, is effective in the treatment and control of the following internal and external parasites of cattle:

Gastrointestinal Roundworms

Ostertagia ostertagi - Adults and L4 (including inhibited Larvae)

Haemonchus placei - Adults

Trichostrongylus axei - Adults and L4

Trichostrongylus colubriformis - Adults and L4

Cooperia oncophora - Adults

Cooperia pectinata - Adults

Cooperia punctata - Adults and L4

Cooperia spatulata - Adults

Cooperia surnabada - Adults and L4

Nematodirus helvetianus - Adults

Oesophagostomum radiatum - Adults and L4

Trichuris spp. - Adults

Lungworms

Dictyocaulus viviparus - Adults and L4

Cattle Grubs

Hypoderma bovis

Hypoderma lineatum

Mites

Psoroptes ovis (Psoroptes communis var. bovis)

Lice

Linognathus vituli

Solenopotes capillatus

Persistent Activity: CYDECTIN Injectable has been proven to effectively protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 42 days after treatment, Haemonchus placei for 35 days after treatment, and Ostertagia ostertagi and Trichostrongylus axei for 14 days after treatment.

Management Considerations for External Parasites: For most effective external parasite control, CYDECTIN Injectable should be administered to all cattle in the herd. Cattle entering the herd following this administration should be treated prior to introduction. Consult your veterinarian or a livestock entomologist for the most appropriate time to administer CYDECTIN Injectable in your location to effectively control external parasites.

DOSAGE

The recommended rate of administration for CYDECTIN Injectable is 1 mL for each 110 lb (50 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 injectable which must be administered based on the weight of animal being treated. Be careful not to overdose animals; estimate animal’s body weight as closely as possible or weigh animals individually.

Weight (lb)

165

220

330

440

550

660

770

880

990

1100

Weight (kg)

75

100

150

200

250

300

350

400

450

500

Dose (mL)

1.5

2.0

3.0

4.0

5.0

6.0

7.0

8.0

9.0

10.0

• 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.

ADMINISTRATION

CYDECTIN Injectable should be administered by subcutaneous injection under the loose skin in front of or behind the shoulder (Figure 1). Needles 1/2 to 3/4 inch in length and 16 to 18 gauge are recommended for subcutaneous injections. Use sterile, dry equipment and aseptic procedures when withdrawing and administering CYDECTIN.


Figure 1. Sites for administration of CYDECTIN Injectable

HUMAN WARNINGS

Not For Use in Humans. Keep this and all drugs out of the reach of children. For customer service or to obtain product information, including Safety Data Sheet (SDS), call 1-800-633-3796. For medical emergencies or to report adverse reactions, call 1-800-422-9874.


RESIDUE WARNINGS

Cattle must not be slaughtered for human consumption within 21 days of treatment. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for preruminating calves. Do not use in calves to be processed for veal.


ANIMAL SAFETY WARNINGS

Do not use in sick, debilitated, or underweight animals. In foreign countries there have been reports of adverse effects, including death. This product should not be used in calves less than 8 weeks of age because safety testing has not been done in the U.S. in calves less than 8 weeks of age.

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.

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.

PRECAUTIONS

CYDECTIN Injectable has been formulated specifically for subcutaneous injection in cattle and should not be given by other routes of administration. Subcutaneous injection can cause transient local tissue reaction that may result in trim loss of edible tissue at slaughter if animals are slaughtered within 35 days after treatment. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

CYDECTIN Injectable is effective against the migrating stage of cattle grubs (Hypoderma larvae). Treatment with CYDECTIN Injectable during the period when grubs are migrating through vital areas may cause undesirable host-parasite reactions. Killing H. lineatum when they are located in peri-esophageal tissues may cause bloat. Killing H. bovis when they are in the vertebral canal may cause staggering or hindlimb paralysis. Cattle should be treated as soon as possible after heel fly (warble fly) season to avoid this potential problem. Cattle treated with CYDECTIN Injectable at the end of fly season can be retreated during the winter without danger of grub-related reactions. Consult your veterinarian for more information regarding these secondary grub reactions and the correct time to treat with CYDECTIN Injectable.

ANIMAL SAFETY

U.S. tolerance and toxicity studies have demonstrated that CYDECTIN Injectable has an adequate margin of safety for use in cattle 8 weeks of age and older. No toxic signs were seen in growing cattle given up to 5 times the recommended dose. Calves as young as 8 weeks of age showed no toxic signs when treated with up to 3 times the recommended dose while nursing from cows concurrently treated with the recommended dose level of CYDECTIN Injectable. Mild, transient ataxia was noted in growing cattle receiving 10 times the recommended dose and in bulls treated at 4.5 times the recommended dose. In breeding animals (bulls and cows in estrous and during early, mid and late pregnancy), treatment with at least 3 times the recommended dose had no effect on breeding performance.

Signs of toxicity include ataxia, excessive salivation, depression, and mydriasis. These signs usually occur within 12 to 48 hours post-treatment.

STORAGE

Store product at or below 77°F (25°C). Protect from light. Use contents within 12 months of first puncture.

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.

PACKAGE INFORMATION

CYDECTIN Injectable is available in 500 mL amber glass bottles.

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

U.S. Patent No. 5,965,603

Bayer, the Bayer Cross and Cydectin are registered trademarks of Bayer.

© 2019 Bayer

Restricted Drug (CA) - Use Only As Directed

Approved by FDA under NADA # 141-220

May, 2019

LV1905

CPN: 1040178.2

COLORADO SERUM COMPANY4950 YORK STREET, P.O. BOX 16428, DENVER, CO, 80216-0428Telephone: 303-295-7527Order Desk: 800-525-2065Fax: 303-295-1923Website: www.colorado-serum.comEmail: colorado-serum@colorado-serum.comTHIS SERVICE AND DATA ARE PROVIDED "AS IS". DVMetrics assumes no liability, and each user assumes full risk, responsibility, and liability, related to its use of the DVMetrics service and data. See the Terms of Use for further details.

TETANUS TOXOID-CONCENTRATED

Colorado Serum

Adjuvanted

GENERAL INFORMATION: This product has been shown to be effective for the vaccination of healthy horses, cattle, sheep, goats, and swine against tetanus. This product was licensed prior to the requirement to establish a minimum age for use. The duration of immunity is unknown. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

Safety in pregnant animals is unknown.

Tetanus Toxoid is prepared by detoxifying tetanus toxin in such a manner as to allow the antigenic properties to remain intact. Product is purified, concentrated and adjuvanted to provide a low dose effective immunizing agent.

Each serial is tested for purity, safety, and potency in accordance with USDA requirements.

Tetanus is caused by a neurotoxin produced by growth of Clostridium tetani, an anaerobic (lives without air) micro-organism, in necrotic tissue. Affected animals become stiff, have difficulty swallowing, and have an increased pulse rate. Breathing is labored. Spasmodic contractions of the muscular system occur, such as contracting muscles of the jaw.

Spasmodic contractions of the muscular system occur, such as contracting muscles of the jaw. Thus, the term “lockjaw” is often used. Legs and tail are often stiff with abdominal muscles contracted. Tetanus stricken animals may be unusually sensitive to light and heat. Temperature of the animal generally remains normal, elevating only shortly before death.

Protective antibody levels usually occur about two weeks after the second injection of the primary immunization series. In contrast, administration of Tetanus Antitoxin is recommended for immediate, emergency, passive treatment of exposed animals with unknown vaccination history or with signs of tetanus infection.

DIRECTIONS: Do not vaccinate within 21 days before slaughter. Store at 2-8° C. Do not freeze. Do not mix with other products. Shake well before use. Use entire contents when first opened.

PRECAUTIONS: A transitory local reaction may occur at injection site. Anaphylactoid reaction may occur following administration of products of this nature. If noted, administer adrenalin or equivalent. In case of human exposure, consult a physician.

DOSAGE & ADMINISTRATION: For primary immunization, two doses should be administered subcutaneously or intramuscularly approximately 30 days apart. Use intramuscularly for horses as local reactions are more likely to occur if injected subcutaneously.

Horses: 1 ml IM

Cattle: 1 ml SC or IM

Sheep, Goats, Swine: 0.5 ml SC or IM

Historically, annual single dose revaccination has been recommended. Contact veterinarian for advice.

OTHER INFORMATION: Contains thimerosal and formalin as preservatives. Tetanus Toxoid Concentrate is available in single dose size packaged 10 vials to the carton, and in 10 dose vials.

THE PEAK OF QUALITY SINCE 1923

VLN: 188 / PCN: 8601.00

COLORADO SERUM COMPANY, 4950 York Street, Denver, Colorado 80216

303-295-752

www.colorado-serum.com

Contact us for information on other Colorado Serum Company products. Fine Veterinary Products since 1923.

FOR VETERINARY USE ONLY

Order #

10 - 1 ml vials

10 - 1 dose vials

11411

10 ml

10 doses

11415

CPN: 1101033.3