Eprinomectin

Beef and Dairy Cattle

The drug is used in beef and dairy cattle for treatment and control of gastrointestinal roundworms (Haemonchus placei (adult and L4), Ostertagia ostertagi (adult and L4, including inhibited L4), Trichostrongylus axei (adult and L4), T. colubriformis (adult and L4), T. longispicularis (adult), Cooperia oncophora (adult and L4), C. punctate (adult and L4), C. surnabada (adult and L4), Nematodirus helvetianus (adult and L4), Bunostomum phlebotomum (adult and L4), Oesophagostomum radiatum (adult and L4), Strongyloides papillosus (adults), Trichuris species (adults)); lungworms (Dictyocaulus viviparous, adult and L4); cattle grubs (all parasitic stages Hypoderma lineatum, H. bovis); lice (Damalinia bovis, Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mange mites (Chorioptes bovis, Sarcoptes scabiei); and horn flies (Haematobia irritans). Controls and protects from reinfection of D. viviparous for 21 days after treatment and H. irritans for 7 days after treatment.

Apply topically along backbone from withers to tailhead. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not use in calves to be processed for veal.

Eprinex®

Cattle (On Pasture)

Persistent Activity LONGRANGE® (eprinomectin) has been proven to effectively protect cattle from reinfection with the following parasites for the indicated amounts of time following treatment:Parasites Duration of Persistent Effectiveness Gastrointestinal Roundworms Bunostomum phlebotomum 150 daysCooperia oncophora 100 days Cooperia punctata 100 days Haemonchus placei 120 days Oesophagostomum radiatum 120 days Ostertagia lyrata 120 days Ostertagia ostertagi 120 days Trichostrongylus axei 100 days Lungworms Dictyocaulus viviparous 150 days

Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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. Do not use in calves to be processed for veal. Not for use in breeding bulls, or in calves less than 3 months of age. Not for use in cattle managed in feedlots or under intensive rotational grazing.

Longrange®

Cattle (On Pasture)

For the treatment and control of the following parasites: Gastrointestinal Roundworms Bunostomum phlebotomum: Adults and L4 Cooperia oncophora : Adults and L4 Cooperia punctata : Adults and L4 Cooperia surnabada : Adults and L4 Haemonchus placei : Adults Oesophagostomum radiatum : Adults Ostertagia lyrata : Adults Ostertagia ostertagi : Adults, L4, and inhibited L4 Trichostrongylus axei : Adults and L4 Trichostrongylus colubriformis : Adults Lungworms Dictyocaulus viviparus : Adults Grubs Hypoderma bovis Mites Sarcoptes scabiei var. bovis

Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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. Do not use in calves to be processed for veal.Not for use in breeding bulls, or in calves less than 3 months of age. Not for use in cattle managed in feedlots or under intensive rotational grazing.

Longrange®

Beef and dairy cattle, including lactating dairy cattle

For the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle. Applied at the recommended dose volume of 1 mL/10 kg (22 lb) body weight, to achieve a dose level of 500 mcg eprinomectin/kg body weight, Eprimectin™ Pour-On is indicated for the effective treatment and control of the following parasites: Gastrointestinal Roundworms Haemonchus placei (adults and L4) Ostertagia ostertagi (adults and L4) (including inhibited L4) Trichostrongylus axei (adults and L4) Trichostrongylus colubriformis (adults and L4) Trichostrongylus longispicularis (adults only) Cooperia oncophora (adults and L4) Cooperia punctata (adults and L4) Cooperia surnabada (adults and L4) Nematodirus helvetianus (adults and L4) Oesophagostomum radiatum (adults and L4) Bunostomum phlebotomum (adults and L4) Strongyloides papillosus (adults only) Trichuris spp. (adults only) Lungworms Dictyocaulus viviparus (adults and L4) Cattle Grubs (all parasitic stages) Hypoderma lineatum Hypoderma bovis Lice Damalinia bovis Linognathus vituli Haematopinus eurysternus Solenopotes capillatus Mange Mites Chorioptes bovis Sarcoptes scabiei Horn Flies Haematobia irritans Persistent Activity Eprinomectin pour-on for beef and dairy cattle has been proved to effectively control infections and to protect cattle from re-infection with Dictyocaulus viviparus for 21 days after treatment and Haematobia irritans for 7 days after treatment.

Eprimectin™ Pour-On

Beef and dairy cattle, including lactating dairy cattle

For the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle. Eprizero™ Pour-On is indicated for the effective treatment and control of the following parasites: Gastrointestinal Roundworms Haemonchus placei (adults and L4) Ostertagia ostertagi (adults and L4) (including inhibited L4) Trichostrongylus axei (adults and L4) Trichostrongylus colubriformis (adults and L4) Trichostrongylus longispicularis (adults only) Cooperia onchophora (adults and L4) Cooperia punctata (adults and L4) Cooperia surnabada (adults and L4) Nematodirus helvetianus (adults and L4) Oesophagostomum radiatum (adults and L4) Bunostomum phlebotomum (adults and L4) Strongyloides papillosus (adults only) Trichuris spp. (adults only) Lungworms Dictyocaulus viviparus (adults and L4) Cattle Grubs (all parasitic stages) Hypoderma lineatum Hypoderma bovis Lice Damalinia bovis Linognathus vituli Haematopinus eurysternus Solenopotes capillatus Mange Mites Chorioptes bovis Sarcoptes scabiei Horn Flies Haematobia irritans

Eprizero®

Beef and Dairy Cattle, including Lactating Dairy Cattle

For the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle. Applied at the recommended dose volume of 1 mL/10 kg (22 lb) body weight, to achieve a dose level of 500 mcg eprinomectin/kg body weight, it is indicated for the effective treatment and control of the following parasites: Gastrointestinal Roundworms Haemonchus placei (adults and L4) Ostertagia ostertagi (adults and L4) (including inhibited L4) Trichostrongylus axei (adults and L4) Trichostrongylus colubriformis (adults and L4) Trichostrongylus longispicularis (adults only) Cooperia oncophora (adults and L4) Cooperia punctata (adults and L4) Cooperia surnabada (adults and L4) Nematodirus helvetianus (adults and L4) Oesophagostomum radiatum (adults and L4) Bunostomum phlebotomum (adults and L4) Strongyloides papillosus (adults only) Trichuris spp. (adults only) Lungworms Dictyocaulus viviparus (adults and L4) Cattle Grubs (all parasitic stages) Hypoderma lineatum Hypoderma bovis Lice Damalinia bovis Linognathus vituli Haematopinus eurysternus Solenopotes capillatus Mange Mites Chorioptes bovis Sarcoptes scabiei Horn Flies Haematobia irritans Persistent Activity EpriGard™ (eprinomectin) Pour-On for Beef and Dairy Cattle has been proved to effectively control infections and to protect cattle from re-infection with Dictyocaulus viviparus for 21 days after treatment and Haematobia irritans for 7 days after treatment.

EpriGard®

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (fourth stage larval and adult Toxocara cati), hookworm (fourth stage larval and adult Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworm (Dipylidium caninum) infections. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations and the treatment and control of Ixodes scapularis (black-legged tick) and Amblyomma americanum (lone star tick) infestations for one month in cats and kittens 8 weeks of age and older, and weighing 1.8 lbs or greater.

NexGard® COMBO

For the prevention of heartworm disease caused by Dirofilaria immitis, and for the treatment and control of roundworms (adult and fourth stage larval Toxocara cati), hookworms (adult and fourth stage larval Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworms (adult Dipylidium caninum and Echinococcus multilocularis), in cats and kittens 7 weeks of age and older and 1.8 lbs or greater.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Centragard®

INDICATIONS Eprimectin Pour-On (eprinomectin) is indicated for the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle. Applied at the recommended dose volume of 1 mL/10 kg (22 lb) body weight, to achieve a dose level of 500 mcg eprinomectin/kg body weight, Eprimectin Pour-On is indicated for the effective treatment and control of the following parasites: Gastrointestinal Roundworms Haemonchus placei (adults and L4) Ostertagia ostertagi (adults and L4) (including inhibited L4) Trichostrongylus axei (adults and L4) Trichostrongylus colubriformis (adults and L4) Trichostrongylus longispicularis (adults only) Cooperia oncophora (adults and L4) Cooperia punctata (adults and L4) Cooperia surnabada (adults and L4) Nematodirus helvetianus (adults and L4) Oesophagostomum radiatum (adults and L4) Bunostomum phlebotomum (adults and L4) Strongyloides papillosus (adults only) Trichuris spp. (adults only) Lungworms Dictyocaulus viviparus (adults and L4) Cattle Grubs (all parasitic stages) Hypoderma lineatum Hypoderma bovis Lice Damalinia bovis Linognathus vituli Haematopinus eurysternus Solenopotes capillatus Mange Mites Chorioptes bovis Sarcoptes scabiei Horn Flies Haematobia irritans Persistent Activity Eprinomectin pour-on for beef and dairy cattle has been proved to effectively control infections and to protect cattle from re-infection with Dictyocaulus viviparus for 21 days after treatment and Haematobia irritans for 7 days after treatment. Use Conditions Varying weather conditions, including rainfall, do not affect the efficacy of Eprinomectin pour-on. Management Considerations for Treatment of External Parasites For best results Eprimectin Pour-On should be applied to all cattle in the herd. Cattle introduced to the herd later should be treated prior to introduction. Consult your veterinarian or an entomologist for the most effective timing of applications for the control of external parasites. Chorioptic Mange: In clinical studies evaluating the efficacy of eprinomectin pour-on against chorioptic mange mites, mites were not recovered from skin scrapings taken 8 weeks after treatment; however, chronic skin lesions were still present on some animals. Horn flies: For optimal control of horn flies, as Eprimectin Pour-On provides 7 days of persistent activity against horn flies, the product should be used as part of an integrated control program utilizing other control methods to provide extended control.

EprimectinTM Pour-On(eprinomectin)

Eprizero (eprinomectin) Pour-On is indicated for the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle. Applied at the recommended dose volume of 1 mL/10 kg (22 lb) body weight, to achieve a dose level of 500 mcg eprinomectin/kg body weight, Eprizero Pour-On is indicated for the effective treatment and control of the following parasites. Gastrointestinal Roundworms Haemonchus placei (adults and L4) Ostertagia ostertagi (adults and L4) (including inhibited L4) Trichostrongylus axei (adults and L4) Trichostrongylus colubriformis (adults and L4) Trichostrongylus longispicularis (adults only) Cooperia oncophora (adults and L4) Cooperia punctata (adults and L4) Cooperia surnabada (adults and L4) Nematodirus helvetianus (adults and L4) Oesophagostomum radiatum (adults and L4) Bunostomum phlebotomum (adults and L4) Strongyloides papillosus (adults only) Trichuris spp. (adults only) Lungworms Dictyocaulus viviparus (adults and L4) Cattle Grubs (all parasitic stages) Hypoderma lineatum, Hypoderma bovis Lice Damalinia bovis, Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus Mange Mites Chorioptes bovis, Sarcoptes scabiei Horn Flies Haematobia irritans

FDA application 200-563

LONGRANGE, when administered at the recommended dose volume of 1 mL per 110 lb (50 kg) body weight, is effective in the treatment and control of the following internal and external parasites of cattle: Gastrointestinal Roundworms Lungworms Bunostomum phlebotomum – Adults and L4 Dictyocaulus viviparus – Adults Cooperia oncophora – Adults and L4 Cooperia punctata – Adults and L4 Cooperia surnabada – Adults and L4 Grubs Haemonchus placei – Adults Hypoderma bovis Oesophagostomum radiatum – Adults Ostertagia lyrata – Adults Mites Ostertagia ostertagi – Adults, L4, and inhibited L4 Sarcoptes scabiei var. bovis Trichostrongylus axei – Adults and L4 Trichostrongylus colubriformis – Adults

LONGRANGE® (eprinomectin)

NexGard® COMBO is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (fourth stage larval and adult Toxocara cati), hookworm (fourth stage larval and adult Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworm (Dipylidium caninum) infections. NexGard® COMBO kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations and the treatment and control of Ixodes scapularis (black-legged tick) and Amblyomma americanum (lone star tick) infestations for one month in cats and kittens 8 weeks of age and older, and weighing 1.8 lbs or greater.

NexGard® COMBO (esafoxalaner, eprinomectin, and praziquantel topical solution)

5% Sterile Solution Extended-Release Injectable For Subcutaneous Use Parasiticide for Cattle on Pasture For the Treatment and Control of Internal and External Parasites of Cattle on Pasture with Persistent Effectiveness Not for use in female dairy cattle 20 months of age or older, including dry dairy cows. Not for use in calves to be processed for veal. Not for use in breeding bulls, or in calves less than 3 months of age. Not for use in cattle managed in feedlots or under intensive rotational grazing. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

LONGRANGE® (eprinomectin)

Due to its unique formulation characteristics, when LONGRANGE is injected subcutaneously in the shoulder area of cattle, a polymeric PLGA matrix is formed. The biodegradable matrix solidifies in vivo to form an in situ forming gel, which allows a gradual release of eprinomectin from the formulation. The rate-limiting step is diffusion of the drug through the gel matrix. Because of its mechanism of release, absorption characteristics can be highly dependent upon the injection technique used and the corresponding surface to volume ratio of the gel. Clinical efficacy of avermectins and milbemycins is closely related to their pharmacokinetic behavior, and the time of parasite exposure to active drug concentrations is relevant to obtain optimal and persistent antiparasitic activity (Lanusse et al., 1997; Lifschitz et al., 1999; Lifschitz et al., 2004; Shoop et al., 1996). Lifschitz et al. (1999) indicated that plasma concentrations between 0.5 and 1 ng/mL would represent the minimal drug level required for optimal nematocidal activity, while others have suggested minimum levels of 1 to 2 ng/mL. Pharmacokinetic studies of LONGRANGE in cattle indicate that effective plasma levels remain for an extended period of time (at least 100 days). Mean Eprinomectin B1a Plasma Concentration Versus Time Following a Single Subcutaneous Injection of LONGRANGE at a Dose Rate of 1 mg Eprinomectin per kg Body Weight in Beef Cattle

LONGRANGE® (eprinomectin)

There are no known contraindications for the use of NexGard® COMBO.

NexGard® COMBO (esafoxalaner, eprinomectin, and praziquantel topical solution)

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.

EpriGard® (eprinomectin) Pour-On

WARNING: Keep this and all drugs out of the reach of children. NOT FOR USE IN HUMANS. As with any topical medication intended for treatment of animals, skin contact should be avoided. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To obtain a Safety Data Sheet(s), contact Bimeda, Inc. at 1-888-524-6332. CONTACT INFORMATION Contact Bimeda, Inc. at 1-888-524-6332. To report suspected adverse drug experiences, contact Bimeda, Inc. at 1-888-524-6332. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS, or www.fda.gov/reportanimalae

EprimectinTM Pour-On(eprinomectin)

Keep this and all drugs out of the reach of children. NOT FOR USE IN HUMANS. As with any topical medication intended for treatment of animals, skin contact should be avoided. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance, or to obtain a copy of the SDS, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. 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.

Eprinex® (eprinomectin) Pour-On

Keep this and all drugs out of the reach of children. NOT FOR USE IN HUMANS. As with any topical medication intended for treatment of animals, skin contact should be avoided. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water. The safety data sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Norbrook at 1-866-591-5777. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

FDA application 200-563

Keep this and all drugs out of the reach of children. NOT FOR USE IN HUMANS. As with any topical medication intended for treatment of animals, skin contact should be avoided. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug experiences, for technical assistance, or to obtain a copy of the SDS, contact Aurora Pharmaceutical at 1-888-215-1256. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

EpriGard® (eprinomectin) Pour-On

Not for Use in Humans. Keep this and all drugs out of the reach of children. Reproductive and developmental toxicities have been reported in laboratory animals following high, repeated exposures to N-methyl-2- pyrrolidone (NMP). Pregnant women should wear gloves and exercise caution or avoid handling this product. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse effects, to obtain an SDS, or for assistance, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

LONGRANGE® (eprinomectin)

Not for human use. Keep this and all drugs out of sight and reach of children. Avoid direct contact with application site for 4 hours or until visibly dry. This product may act as a mild to moderate eye irritant. Keep product in the original packaging until use. Wash hands after product administration. If the product accidentally gets into the eyes, rinse thoroughly with water. If wearing contact lenses, flush the eyes first with water and then remove the lenses and continue to flush thoroughly with water. In case of accidental ingestion, or if skin or eye irritation occurs, contact a poison control center or physician for treatment advice.

NexGard® COMBO (esafoxalaner, eprinomectin, and praziquantel topical solution)

Withdrawal Periods and Residue Warnings Animals intended for human consumption must not be slaughtered within 48 days of the last 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 pre-ruminating calves. Do not use in calves to be processed for veal.

LONGRANGE® (eprinomectin)

RESIDUE WARNINGS: When used according to label directions, neither a pre-slaughter drug withdrawal period nor a milk discard time is required, therefore, meat and milk from cattle treated with Eprimectin Pour-On (eprinomectin) may be used for human consumption at any time following treatment. A withdrawal period has not been established for pre-ruminating calves. Do not use in calves to be processed for veal.

EprimectinTM Pour-On(eprinomectin)

In a field safety and effectiveness study, which included a total of 201 households and 380 treated cats (244 cats treated with NexGard® COMBO, 136 cats treated with an active control), the safety of NexGard® COMBO was evaluated over a 90-day period through in-clinic physical examinations or through reporting of abnormalities by the owner. The most frequently reported reactions in the NexGard® COMBO and active control groups are presented in the following table. Adverse Reactions by Treatment Group EVENT Treatment Group NEXGARD® COMBO Active Control n1 % (n=244) n2 % (n=136) Vomiting 16 6.56 8 5.88 Application Site Hair Change 9 3.69 0 0.00 Anorexia 7 2.87 4 2.94 Lethargy 6 2.46 5 3.68 Bacterial skin infection 4 1.64 1 0.74 Itching 4 1.64 0 0.00 Sneezing 4 1.64 5 3.68 Skin Peeling 3 1.23 2 1.47 Diarrhea 3 1.23 3 2.21 Epiphora 3 1.23 1 0.74 Hypersalivation 3 1.23 0 0.00 Hyperthermia 3 1.23 0 0.00 Alopecia 2 0.82 0 0.00 Dermal thickening 2 0.82 0 0.00 Ear Pruritus 2 0.82 1 0.74 Application Site Redness 2 0.82 0 0.00 Conjunctivitis 1 0.41 1 0.74 1Number of cats treated with NexGard® COMBO with the identified abnormality. 2Number of cats treated with Active Control with the identified abnormality.

NexGard® COMBO (esafoxalaner, eprinomectin, and praziquantel topical solution)

ADVERSE REACTIONS No adverse reactions were observed during clinical trials.

EprimectinTM Pour-On(eprinomectin)

No adverse reactions were observed during clinical trials.

FDA application 200-563

Beef and Dairy Cattle

One milliliter (5 milligrams) per 10 kilograms (22 Lbs) of body weight

Topical

Apply topically along backbone from withers to tailhead. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not use in calves to be processed for veal.

Eprinex®

Cattle (On Pasture)

Administer 1 mg eprinomectin per kg body weight (1 mL/110 lb body weight).

Subcutaneous

Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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. Do not use in calves to be processed for veal. Not for use in breeding bulls, or in calves less than 3 months of age. Not for use in cattle managed in feedlots or under intensive rotational grazing.

Longrange®

Beef and dairy cattle, including lactating dairy cattle

The dose rate is 1 mL/10 kg (22 lb) of body weight. The product should be applied topically along the backline in a narrow strip extending from the withers to the tail head.

Topical

Eprimectin™ Pour-On

Beef and dairy cattle, including lactating dairy cattle

1 mL/10 kg (22 lb) body weight, to achieve a dose level of 500 mcg eprinomectin/kg body weight.

Topical

Eprizero®

Beef and Dairy Cattle, including Lactating Dairy Cattle

The dose rate is 1 mL/10 kg (22 lb) of body weight. The product should be applied topically along the backline in a narrow strip extending from the withers to the tailhead.

Topical

EpriGard®

Administer the entire contents of a provided unit applicator topically once a month at a minimum dose of 0.055 mL/lb (0.12 mL/kg), which delivers a minimum dose of 0.65 mg/lb (1.44 mg/kg) esafoxolaner, 0.22 mg/lb (0.48 mg/kg) eprinomectin, and 4.53 mg/lb (9.98 mg/kg) praziquantel.

Topical

NexGard® COMBO

Centragard™ is dosed at a minimum of 0.055 mL/lb (0.12 mL/kg), which delivers a minimum dose of 0.23 mg/lb eprinomectin and 4.55 mg/lb praziquantel.

Transdermal

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Centragard®

NexGard® COMBO is dosed at a minimum of 0.055 mL/lb (0.12 mL/kg), which delivers a minimum dose of 0.65 mg/lb (1.44 mg/kg) esafoxolaner, 0.22 mg/lb (0.48 mg/kg) eprinomectin, and 4.53 mg/lb (9.98 mg/kg) praziquantel. For heartworm disease prevention, apply once monthly for at least three months after last exposure to mosquitoes (see Effectiveness). Administer the entire contents of a NexGard® COMBO unit applicator topically once a month as specified in the following table: Dosing Schedule Cat Weight (lb) Volume (mL) Esafoxolaner (mg) Eprinomectin (mg) Praziquantel (mg) 1.8- 5.5 0.3 3.6 1.2 24.9 5.6-16.5 0.9 10.8 3.6 74.7 16.6-22 0.3 + 0.9 14.4 4.8 99.6 22.1-33 0.9 + 0.9 21.6 7.2 149.4 A veterinarian or veterinary technician should demonstrate or instruct the pet owner regarding the appropriate technique for applying NexGard® COMBO topically to cats and kittens prior to first use. Keep product in original packaging until ready to use. 1.Use scissors to cut the blister along the dotted line. 2.Then pull the lid away. 3.Remove the applicator from the package and hold it upright. Pull back the plunger slightly. 4.Twist and pull off the cap. 5.Part the hair on the midline of the neck, between the base of the skull and the shoulder blades until the skin is visible. Place the tip of the applicator on the skin and apply the entire contents directly onto the skin in one spot. The product should be applied to dry skin on an area where the cat cannot lick it off. If the weight of the cat requires a second application, apply the contents in the same manner as described above in the same location. 6.Wash hands after use with soap and water. Heartworm Prevention: For the prevention of heartworm disease, NexGard® COMBO should be administered once a month year-round. At a minimum, administration of NexGard® COMBO should start at least 1 month before the cat’s first expected exposure to mosquitoes and monthly thereafter until at least 3 months after the cat’s last seasonal exposure to mosquitoes (see Effectiveness). If a dose is missed and a 30-day interval between doses is exceeded, administer NexGard® COMBO immediately and resume the monthly dosing schedule. Treatment with fewer than 3 monthly doses may not provide complete heartworm prevention. When replacing another monthly heartworm preventive product in a heartworm prevention program, the first treatment with NexGard® COMBO should be given within one month of the last dose of the former medication. At the discretion of the veterinarian, cats older than 6 months of age may be tested to determine the presence of existing heartworm infection before treatment with NexGard® COMBO. Cats already infected with adult heartworms can be given NexGard® COMBO monthly to prevent further infections. Flea Treatment and Prevention: For the treatment and prevention of flea infestations, the use of NexGard® COMBO may begin at any time of year. NexGard® COMBO should be administered year-round at monthly intervals or begin at least one month before fleas become active. However, an environmental infestation may persist for a short time after beginning treatment with NexGard® COMBO because of the development of adult fleas from eggs that were laid prior to the initiation of treatment. Tick Treatment and Control: For the treatment and control of infestations with Ixodes scapularis and Amblyomma americanum, the use of NexGard® COMBO may begin at any time of year. NexGard® COMBO should be administered year-round at monthly intervals or begin at least one month before the ticks become active. Treatment and Control of Roundworms, Hookworms, and Tapeworms: NexGard® COMBO provides treatment and control of roundworms (adult and fourth stage larval Toxocara cati), hookworms (adult and fourth stage larval Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworms (Dipylidium caninum). For the treatment of hookworm, roundworms and tapeworm infections, NexGard® COMBO should be administered once as a single dose. Monthly use of NexGard® COMBO will control any subsequent infections. Cats may be exposed to and can become infected with roundworms, hookworms, and tapeworms throughout the year, regardless of season or climate.

TOPICAL

NexGard® COMBO (esafoxalaner, eprinomectin, and praziquantel topical solution)

Metering Cup with Measure-Squeeze-Pour System 1 Liter (33.8 fl oz) Container with 25 mL Metering Cup This pack contains 1 Metering Cup and 1 dip tube Insert the dip tube into base of the Metering Cup. Leave the “slotted end” of the dip tube exposed in the bottom of the container. Unscrew shipping cap from container top. Screw the Metering Cup onto container top Measure: To select the correct dose rate, rotate the adjuster cap (top) in either direction to position the dose indicator to the weight of the animal you want to treat. When body weight is between markings, use the higher setting. Squeeze the container gently to fill the Metering Cup to the required dose. Release your grip and any excess will return to the container. Pour: Apply the full dose by tipping and pouring along the backline of the animal until the Metering Cup is empty. Storage: The Metering Cup should not remain attached to the container when not in use. Detach the Metering Cup after each use and replace the shipping cap to close the container top. If the animal being treated weighs more than 550 lbs (250 kg), refill the Metering Cup to the additional amount required to provide the total dose for that animal and apply as directed. Collapsible Pack (2.5 L/84.5 fl oz and 5 L/169 fl oz Packs) Connect the dosing applicator and draw-off tubing to the collapsible pack as follows: Attach the open end of the draw-off tubing to an appropriate dosing applicator. Attach the draw-off tubing to the cap with the stem that is included in the pack. Replace the shipping cap with the cap having the draw-off tubing. Gently prime the dosing applicator, checking for leaks. Follow the dosing applicator manufacturer's directions for adjusting the dose and proper use and maintenance of the dosing applicator and draw-off tubing. 20 Liter Pack (20 L/676 fl oz Pack) Connect the dosing applicator and draw-off tubing to the container as follows: Attach the open end of the draw-off tubing to an appropriate dosing applicator. Attach draw-off tubing to the cap with the stem. Replace the shipping cap with the cap having the draw-off tubing. Gently prime the dosing applicator, checking for leaks. Follow the dosing applicator manufacturer's directions for adjusting the dose and proper use and maintenance of the dosing applicator and draw-off tubing. Weight Dose 220 lb (100 kg) 10 mL 330 lb (150 kg) 15 mL 440 lb (200 kg) 20 mL 550 lb (250 kg) 25 mL 660 lb (300 kg) 30 mL 770 lb (350 kg) 35 mL 880 lb (400 kg) 40 mL 990 lb (450 kg) 45 mL 1100 lb (500 kg) 50 mL

TOPICAL

FDA application 200-563

Metering Cup with Measure-Squeeze-Pour System 250 mL (8.5 fl oz) Container with 25 mL Metering Cup This pack contains 1 Metering Cup and 1 dip tube 1. Insert the dip tube into base of the Metering Cup. Leave the "slotted end" of the dip tube exposed in the bottom of the container. 2. Unscrew shipping cap from container top. 3. Screw the Metering Cup onto container top. 4. Measure: To select the correct dose rate, rotate the adjuster cap (top) in either direction to position the dose indicator to the weight of the animal you want to treat. When body weight is between markings, use the higher setting. 5. Squeeze the container gently to fill the Metering Cup to the required dose. Release your grip and any excess will return to the container. 6. Pour: Apply the full dose by tipping and pouring along the backline of the animal until the Metering Cup is empty. 7. Storage: The Metering Cup should not remain attached to the container when not in use. Detach the Metering Cup after each use and replace the shipping cap to close the container top. Squeeze-Measure-Pour Bottle (1 L/33.8 fl oz) 1. Unscrew cap from the dosing chamber and remove the seal.If the dosing chamber closure is not removed, liquid will not flow into the dosing chamber when squeezing the main chamber. 2. Squeeze the main chamber gently until the desired level of solution is present in the dosing chamber. Release pressure on the main chamber to avoid further filling. 3. Measure: Fill the dosing chamber to the weight of the animal you want to treat. When body weight is between markings, use the higher volume. 4. Pour: With the dosing chamber positioned above the capped main chamber, apply the full dose by tipping and pouring along the backline of the animal until the dosing chamber is empty. 5. Storage: After use, replace the dosing chamber cap. Backpack (1 L/33.8 fl oz, 2.5 L/84.5 fl oz, and 5 L/169 fl oz), or 5L/169 fl oz or 10 L/338 fl oz Pack Connect the dosing applicator and draw-off tubing to the backpack as follows: Attach the open end of the draw-off tubing to an appropriate dosing applicator. Attach draw-off tubing to the cap with the stem that is included in the pack. Replace the shipping cap with the cap having the draw-off tubing. Gently prime the dosing applicator, checking for leaks. Follow the dosing applicator manufacturer's directions for adjusting the dose and proper use and maintenance of the dosing applicator and draw-off tubing.

TOPICAL

EpriGard® (eprinomectin) Pour-On

LONGRANGE (eprinomectin) should be given only by subcutaneous injection in front of the shoulder at the recommended dosage level of 1 mg eprinomectin per kg body weight (1 mL per 110 lb body weight). Each mL of LONGRANGE contains 50 mg of eprinomectin, sufficient to treat 110 lb (50 kg) body weight. Divide doses greater than 10 mL between two injection sites to reduce occasional discomfort or site reaction. 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. Body Weight (lb) Dose Volume (mL) 110 1 220 2 330 3 440 4 550 5 660 6 770 7 880 8 990 9 1100 10 LONGRANGE is to be given subcutaneously only. Animals should be appropriately restrained to achieve the proper route of administration. Inject under the loose skin in front of the shoulder (see illustration) using a 16 or 18 gauge, ½ to ¾ inch needle. Sanitize the injection site by applying a suitable disinfectant. Clean, properly disinfected needles should be used to reduce the potential for injection site infections.

SUBCUTANEOUS

LONGRANGE® (eprinomectin)

Metering Cup with Measure-Squeeze-Pour System 250 mL Container with 25 mL Metering Cup 1 Liter Container with 60 mL Metering Cup This pack contains 1 Metering Cup and 1 dip tube 1.Insert the dip tube into base of the Metering Cup. Leave the "slotted end" of the dip tube exposed in the bottom of the container. 2.Unscrew shipping cap from container top. 3.Screw the Metering Cup onto container top. 4. Measure: To select the correct dose rate, rotate the adjuster cap (top) in either direction to position the dose indicator to the weight of the animal you want to treat. When body weight is between markings, use the higher setting. 5. Squeeze the container gently to fill the Metering Cup to the required dose. Release your grip and any excess will return to the container. 6. Pour: Apply the full dose by tipping and pouring along the backline of the animal until the Metering Cup is empty. 7. Storage: The Metering Cup should not remain attached to the container when not in use. Detach the Metering Cup after each use and replace the shipping cap to close the container top.

TOPICAL

Eprinex® (eprinomectin) Pour-On

DOSAGE The product is formulated only for external application to beef and dairy cattle. The dose rate is 1 mL/10 kg (22 lb) of body weight. The product should be applied topically along the backline in a narrow strip extending from the withers to the tailhead. 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 Backpack (2.5 L and 5 L Packs); 10 L Container Connect the dosing applicator and draw-off tubing to the pack as follows: Attach the open end of the draw-off tubing to an appropriate dosing applicator. Attach draw-off tubing to the cap with the stem that is included in the pack. Replace the shipping cap with the cap having the draw-off tubing. Gently prime the dosing applicator, checking for leaks. Follow the dosing applicator manufacturer's directions for adjusting the dose and proper use and maintenance of the dosing applicator and draw-off tubing.

TOPICAL

EprimectinTM Pour-On(eprinomectin)

The product is formulated only for external application to beef and dairy cattle. The dose rate is 1 mL/10 kg (22 lb) of body weight. The product should be applied topically along the backline in a narrow strip extending from the withers to the tailhead. 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.

TOPICAL

Eprinex® (eprinomectin) Pour-On