Moxidectin Injection (moxidectin)

Figure 1. Sites for administration of Moxidectin Injection

Human Warnings

Not For Use in Humans. Keep this and all drugs out of the reach of children.

CONTACT INFORMATION

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae

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.

Precautions

Moxidectin Injection (moxidectin) 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.

Moxidectin Injection is effective against the migrating stage of cattle grubs (Hypoderma larvae). Treatment with Moxidectin Injection (moxidectin) 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 Moxidectin Injection 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 Moxidectin Injection.

Animal Safety

U.S. tolerance and toxicity studies have demonstrated that moxidectin 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 moxidectin 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 at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F). Use within 28 days of first puncture and puncture a maximum of 30 times with a needle or 5 times with a dosage delivery device. When using a draw-off spike or needle larger than 4-gauge, discard any remaining product immediately after use.

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

Moxidectin Injection is available in 500 mL plastic, multi-dose bottles.

Read accompanying package insert carefully before use.

Restricted Drug (CA) - Use Only As Directed.

Approved by FDA under ANADA # 200-788

Manufactured for

Durvet, Inc., Blue Springs, MO 64014

www.durvet.com

Made in Canada

8MOX042 Rev. 07 /24

CPN: 1084451.0