MWI/VetOneBimeda, Inc.Bimeda-MTC Animal HealthMoxiSolvMoxidectinMOXIDECTINMOXIDECTINMoxiSolvTM Injection (moxidectin)Injectable Solution for Beef and Nonlactating Dairy CattleAntiparasiticContains 10 mg moxidectin/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 CattleConsult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.PRODUCT DESCRIPTION MoxiSolv Injection (moxidectin) 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. MoxiSolv Injection 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 MoxiSolv Injection, 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 L4Cattle Grubs Hypoderma bovis Hypoderma lineatum Mites Psoroptes ovis (Psoroptes communis var. bovis) Lice Linognathus vituli Solenopotes capillatusPersistent Activity Moxidectin 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, MoxiSolv Injection (moxidectin) 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 MoxiSolv Injection in your location to effectively control external parasites.DOSAGE The recommended rate of administration for MoxiSolv Injection 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 MoxiSolv Injection 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 MoxiSolv.Figure 1. Sites for administration of MoxiSolv Injectionimage descriptionHUMAN WARNINGS Not For Use in Humans. Keep this and all drugs out of the reach of childrenCONTACT 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/reportanimalaeRESIDUE 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 WARNINGSParasite 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 MoxiSolv 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.MoxiSolv Injection is effective against the migrating stage of cattle grubs (Hypoderma larvae). Treatment with MoxiSolv 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 MoxiSolv 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 MoxiSolv 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 MoxiSolv Injection is available in 500 mL plastic, multi-dose bottles.Restricted Drug (CA) - Use Only As Directed.Approved by FDA under ANADA # 200-788Distributed by: MWI Boise, ID 83705 www.VetOne.net Made in CanadaMoxiSolvTM is a trademark of Bimeda, Inc. Iss. 06/2024image description