PROTECT HERD PERFORMANCE

Transcription

1 (eprinomectin) 99.9% Effective against the major species and stages of parasites ZERO days meat withdrawal ZERO milk discard SAME active ingredient and dosing regimen as Eprinex (eprinomectin) PROTECT HERD PERFORMANCE FROM 39 PARASITE SPECIES IMPORTANT SAFETY INFORMATION: No meat or milk withdrawal is required when used according to label. Do not use in calves intended for veal or unapproved animal species as severe adverse reactions, including fatalities in dogs, may result.

2 (eprinomectin) Eprizero Pour-On for treatment and control of 39 species and stages of parasites. Eprizero (eprinomectin) Pour-On contains the same active ingredient as Eprinex (eprinomectin) Pour-On, utilizing identical dosing regimens. Eprizero Pour-On provides excellent broad-spectrum treatment and control against internal and external parasites, and return on investment, in a convenient pour-on formulation. DRIVE RETURN ON INVESTMENT Research confirms treatment for parasites with eprinomectin can increase milk yield by 2.07 lbs per cow per day. 1 BROAD-SPECTRUM TREATMENT 99.9% effective against the major species and stages of parasites SHORTER CALVING INTERVAL Following treatment for parasites with eprinomectin, both heifers and dairy cows show improved fertility, i.e. 58% v 38% conception rate at first service. 2 ZERO MILK DISCARD ZERO MEAT WITHDRAWL WEATHERPROOF FORMULATION

3 STOPS PARASITES AT THEIR SOURCE FOR LONGER CONTROL AND SAFETY Studies have shown eprinomectin kept eff icacy levels higher than 90% from 2 up to 28 days 3 versus competitive pour-on parasite treatments. Put Eprizero Pour-On to Work Today Additionally, research shows that the active ingredient in Eprizero Pour-On outperformed Cydectin (moxidectin), Ivomec (ivermectin) and Dectomax (doramectin) in head-to-head university studies. 3 Adult worms produce eggs Burrows into internal tissue/glands causing damage Parasite Life Cycle Eggs excreted by cattle Grazed by cattle Worm larvae on grass INTERNAL PARASITES Brown stomach worm Ostertagia ostertagi Brown stomach worm (inhibited) Barbers pole worm Haemonchus placei Black scour worm Trichostrongylus colubriformis Thread-necked intestinal worm Nematodirus helvetianus Intestinal threadworm Strongyloides papillosus Nodular worm Oesophagostomum radiatum Whipworm Trichuris spp Lungworm Dictyocaulus viviparus Small intestinal worm Cooperia oncophora Small intestinal worm C. punctata Small intestinal worm C. surnabada Hairworm T. axei A=ADULT STAGE L4=LARVAL STAGE Black scour worm T. longispicularis Hookworm Bunostomum phlebotomum LICE L4 EXTERNAL PARASITES Biting louse Damalinia bovis Short-nosed cattle louse Haematopinus eurysternus Long-nosed cattle louse Linognathus vituli Small blue louse Solenopotes capillatus A GRUBS Northern cattle grub 1/2/3 instar Hypoderma bovis A Common cattle grub 1/2/3 instar Hypoderma lineatum HORN FLIES Horn flies Haematobia irritans MANGE Mange mite Sarcoptes scabiei Mange mite Chorioptes bovis (tailhead mange) A Rain is not an issue Where rain is an issue after treatment, the active ingredient in Eprizero Pour-On was 99% effective against adults and immature larvae (L4) of the most economically significant internal parasites (worms) and nematodes found in cattle. 4 Eprizero Pour-On - A Higher Level of Convenience and Safety Kills 39 species and stages of internal/ external parasites Weatherproof formulation that works in rain, cold or heat Zero milk discard Zero days meat withdrawl Safe for any age animal including pregnant cows, calves and bulls Nonflammable for improved safety and storage

4 Norbrook offers Eprizero Pour-On in convenient 1 Liter, 2.5 Liter, 5 Liter and 20 Liter sizes for economical per-dose application. Convenient Packaging to Fit YOUR Needs Know Your Enemy External parasites such as lice, flies, ticks, grubs and mites limit dairy production and animal welfare. External parasites: Feed on body tissues such as blood, skin and hair Produce wounds and skin irritation Transmit diseases from infected animals to healthy ones Cause depressed appetite and subsequent weight loss, reduced milk production and general weakness Create sites for secondary invasion of disease organisms Internal parasites are the most economically damaging parasites and are particularly detrimental in mature dairy cows at calving and during lactation resulting in serious economic losses. Internal parasites: Loss of milk yield Reduced feed intake and dramatically lowered live weight gain Reduced body condition

5 DOSING GUIDE Body Weight Dose Volume Number of doses per pack 1 L 2.5 L 5 L 20 L 220 lbs (100 kg) 10 ml lbs (150 kg) 15 ml lbs (200 kg) 20 ml lbs (250 kg) 25 ml lbs (300 kg) 30 ml lbs (400 kg) 40 ml lbs (450 kg) 45 ml lbs (500 kg) 50 ml TREATMENT REGIMEN Administer Eprizero Pour-On only by topical application at the dose rate of 1 ml per 10 kg (22 lb) of body weight, corresponding to the recommended dose rate of 0.5 mg eprinomectin per kg of body weight. The product should be applied topically by pouring along the backline in a narrow strip extending from the withers to the tailhead. Rainfall at any time before or after treatment will not affect the efficacy of the product. To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device (dosing cup or dosing gun delivery system) should be checked. For best results use as part of a program to control both internal and external parasites of cattle based on the epidemiology of these parasites.

6 ANADA , Approved by FDA (eprinomectin) POUR-ON for Beef and Dairy Cattle Parasiticide Contains 5 mg eprinomectin/ml Not for use in calves to be processed for veal. INTRODUCTION Eprizero Pour-On delivers effective internal and external parasite control in one application. Eprizero Pour-On contains eprinomectin, a unique avermectin. Its broad-spectrum efficacy in a weatherproof formulation, margin of safety, zero slaughter withdrawal and zero milk discard, make it a convenient product for parasite control in beef and dairy cattle, including lactating dairy cattle. MODE OF ACTION Eprinomectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier. INDICATIONS 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 Persistent Activity Eprizero (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 Eprizero Pour-On. Management Considerations for Treatment of External Parasites For best results Eprizero 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 Eprizero 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 Eprizero 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. 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. ADMINISTRATION Squeeze-Measure-Pour System (33.8 fl oz/1 liter pack with dispensing cap) The dispensing cap is graduated in 5 ml increments. Each 5 ml will treat 110 lbs body weight. When body weight is between markings, use the next higher increment. Attach the dispensing cap to the container. Select the correct dose rate by rotating the adjuster top in either direction to position the dose indicator to the appropriate level. Hold the container upright and gently squeeze it to deliver a slight excess of the required dose as indicated by the calibration lines. By releasing the pressure, the dose automatically adjusts to the correct level. Tilt the container to deliver the dose. The closed-off-shut position will close the system between dosing. If the animal being treated weighs more that 550 lbs (250 kg), refill the dispensing cap to the additional amount required to provide the total dose for that animal and apply as directed.

7 Container (84.5 fl oz/2.5 liter pack; 169 fl oz/5 liter pack) The applicator gun from Simcro Tech, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage. Remove the shipping cap from the backpack container and replace with the vent cap provided. Attach the hose from the automatic dosing equipment to the outlet from the vent cap. Follow the applicator gun manufacturer s directions for priming the gun, adjusting the dose, and care of the applicator gun following use. Container (676 fl oz/20 liter container with draw-off device) The draw-off device and applicator gun from Simcro Tech, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage. Screw Feedlot pack cap and dip tube onto the 20 liter drum ensuring a tight fit. Connect the long 3m feed tube at one end to the spigot on the Feedlot pack cap and the other end to the applicator gun. Then follow the applicator gun manufacturer s directions for priming the gun, adjusting the dose, and care of the applicator gun following use. When the interval between use of the applicator gun is expected to exceed 12 hours, disconnect the gun, draw off tubing and dip tube and cap from the product container, empty the product from the gun and tubing back into the container and replace the shipping cap. 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 ANIMAL SAFETY Tolerance and toxicity studies have demonstrated the margin of safety for eprinomectin in cattle. In toxicity studies, application of 3 times the recommended dose had no adverse effects on neonatal calves, and application of up to 5 times the recommended dose 3 times at 7 day intervals had no adverse effects on 8 week old calves. In the tolerance study, one of 6 cattle treated once at 10 times the recommended dose showed clinical signs of mydriasis. Application of 3 times the recommended dose had no adverse effect on breeding performance of cows or bulls. 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 Eprizero (eprinomectin) Pour-On 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. 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 report adverse effects, obtain an SDS or for assistance, contact Norbrook at PRECAUTIONS This product is for topical application only. Do not administer orally or by injection. Do not apply to areas of the backline covered with mud or manure. Eprizero Pour-On is not recommended for use in species other than cattle. Severe adverse reactions have been reported in other species treated with products containing compounds of this class. When to Treat Cattle with Grubs Eprizero Pour-On is effective against all stages of cattle grubs. However, proper timing of treatment is important. For the most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. While this is not peculiar to eprinomectin, destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions. Killing Hypoderma lineatum when it is in the esophageal tissues may cause bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. Cattle should be treated either before or after these stages of grub development. Cattle treated with Eprizero Pour-On at the end of the fly season may be re-treated with Eprizero Pour-On during the winter without danger of grub-related reactions. For further information and advice on a planned parasite control program, consult your veterinarian. ENVIRONMENTAL SAFETY Studies indicate that when eprinomectin comes in contact with soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin/eprinomectin may adversely affect fish and certain aquatic organisms. Do not permit cattle to enter lakes, streams or ponds for at least 6 hours after treatment. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration. As with other avermectins, eprinomectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects. ADVERSE REACTIONS No adverse reactions were observed during clinical trials. STORAGE CONDITIONS Store container in the carton to protect from light and at temperatures up to 86 F/30 C. Storage at temperatures up to 104 F/40 C is permitted for a short period of time, however, such exposure should be minimized. HOW SUPPLIED Eprizero (eprinomectin) Pour-On for Beef and Dairy Cattle is available in 1 L/33.8 fl oz container with a squeeze-measure-pour system, or in a 2.5 L/84.5 fl oz or 5 L/169 fl oz container or 20 L/676 fl oz container intended for use with appropriate automatic dosing equipment. Restricted Drug (California) - Use Only as Directed. Made in the UK. Manufactured by: Norbrook Laboratories Limited Newry, BT35 6PU, Co. Down, Northern Ireland. Eprizero is a registered trademark of Norbrook Laboratories Limited I02

8 ANADA , Approved by FDA (eprinomectin) POUR-ON for Beef and Dairy Cattle Parasiticide Contains 5 mg eprinomectin/ml Not for use in calves to be processed for veal. INTRODUCTION Eprizero Pour-On delivers effective internal and external parasite control in one application. Eprizero Pour-On contains eprinomectin, a unique avermectin. Its broad-spectrum efficacy in a weatherproof formulation, margin of safety, zero slaughter withdrawal and zero milk discard, make it a convenient product for parasite control in beef and dairy cattle, including lactating dairy cattle. MODE OF ACTION Eprinomectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier. INDICATIONS 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 Persistent Activity Eprizero (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 Eprizero Pour-On. Management Considerations for Treatment of External Parasites For best results Eprizero 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 Eprizero 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 Eprizero 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. 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. ADMINISTRATION Squeeze-Measure-Pour System (33.8 fl oz/1 liter pack with dispensing cap) The dispensing cap is graduated in 5 ml increments. Each 5 ml will treat 110 lbs body weight. When body weight is between markings, use the next higher increment. Attach the dispensing cap to the container. Select the correct dose rate by rotating the adjuster top in either direction to position the dose indicator to the appropriate level. Hold the container upright and gently squeeze it to deliver a slight excess of the required dose as indicated by the calibration lines. By releasing the pressure, the dose automatically adjusts to the correct level. Tilt the container to deliver the dose. The closed-off-shut position will close the system between dosing. If the animal being treated weighs more that 550 lbs (250 kg), refill the dispensing cap to the additional amount required to provide the total dose for that animal and apply as directed. Container (84.5 fl oz/2.5 liter pack; 169 fl oz/5 liter pack) The applicator gun from Simcro Tech, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage. Remove the shipping cap from the backpack container and replace with the vent cap provided. Attach the hose from the automatic dosing equipment to the outlet from the vent cap. Follow the applicator gun manufacturer s directions for priming the gun, adjusting the dose, and care of the applicator gun following use. Container (676 fl oz/20 liter container with draw-off device) The draw-off device and applicator gun from Simcro Tech, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage. Screw Feedlot pack cap and dip tube onto the 20 liter drum ensuring a tight fit. Connect the long 3m feed tube at one end to the spigot on the Feedlot pack cap and the other end to the applicator gun. Then follow the applicator gun manufacturer s directions for priming the gun, adjusting the dose, and care of the applicator gun following use. When the interval between use of the applicator gun is expected to exceed 12 hours, disconnect the gun, draw off tubing and dip tube and cap from the product container, empty the product from the gun and tubing back into the container and replace the shipping cap. 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 ANIMAL SAFETY Tolerance and toxicity studies have demonstrated the margin of safety for eprinomectin in cattle. In toxicity studies, application of 3 times the recommended dose had no adverse effects on neonatal calves, and application of up to 5 times the recommended dose 3 times at 7 day intervals had no adverse effects on 8 week old calves. In the tolerance study, one of 6 cattle treated once at 10 times the recommended dose showed clinical signs of mydriasis. Application of 3 times the recommended dose had no adverse effect on breeding performance of cows or bulls. 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 Eprizero (eprinomectin) Pour-On 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. 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 report adverse effects, obtain an SDS or for assistance, contact Norbrook at PRECAUTIONS This product is for topical application only. Do not administer orally or by injection. Do not apply to areas of the backline covered with mud or manure. Eprizero Pour-On is not recommended for use in species other than cattle. Severe adverse reactions have been reported in other species treated with products containing compounds of this class. When to Treat Cattle with Grubs Eprizero Pour-On is effective against all stages of cattle grubs. However, proper timing of treatment is important. For the most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. While this is not peculiar to eprinomectin, destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions. Killing Hypoderma lineatum when it is in the esophageal tissues may cause bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. Cattle should be treated either before or after these stages of grub development. Cattle treated with Eprizero Pour-On at the end of the fly season may be re-treated with Eprizero Pour-On during the winter without danger of grub-related reactions. For further information and advice on a planned parasite control program, consult your veterinarian. ENVIRONMENTAL SAFETY Studies indicate that when eprinomectin comes in contact with soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin/eprinomectin may adversely affect fish and certain aquatic organisms. Do not permit cattle to enter lakes, streams or ponds for at least 6 hours after treatment. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration. As with other avermectins, eprinomectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects. ADVERSE REACTIONS No adverse reactions were observed during clinical trials. STORAGE CONDITIONS Store container in the carton to protect from light and at temperatures up to 86 F/30 C. Storage at temperatures up to 104 F/40 C is permitted for a short period of time, however, such exposure should be minimized. HOW SUPPLIED Eprizero (eprinomectin) Pour-On for Beef and Dairy Cattle is available in 1 L/33.8 fl oz container with a squeeze-measure-pour system, or in a 2.5 L/84.5 fl oz or 5 L/169 fl oz container or 20 L/676 fl oz container intended for use with appropriate automatic dosing equipment. Restricted Drug (California) - Use Only as Directed. Made in the UK. Manufactured by: Norbrook Laboratories Limited Newry, BT35 6PU, Co. Down, Northern Ireland. Eprizero is a registered trademark of Norbrook Laboratories Limited I02 Norbrook logos and Eprizero are registered trademarks of Norbrook Laboratories Limited. Eprinex and Ivomec are registered trademarks of Merial. Cydectin is a registered trademark of Boehringer Ingelheim. Dectomax is a registered trademark of Zoetis. 1 Nodtvedt A, et al. Increase in milk yield following eprinomectin treatment at calving in pastured dairy cattle. Vet Parasitol. 2002;105: McPherson WB, et. al. The impact of eprinomectin treatment on dairy cattle reproductive performance. Proceedings, 44th Annual Meeting American Association of Veterinary Pathologists. 1999; Paul A, Hutchens D, Hart D, Maciel AE, Robertson C, Gross SJ. Comparison of Eprinomectin with other macrocyclic lactones in cattle. Proceedings, 45th Annual Meeting of the American Association of Veterinary Parasitologists, Salt Lake City, Utah Cruthers L, Sloan R. Comparative efficacy of commercial pour-on parasiticides applied to wet cattle. Proceedings, 44th Annual Meeting of the American Association of Veterinary Pathologists, 1999, I02A

9 Eprizero Pour On for Beef and Dairy Cattle Safety Data Sheet According To Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules And Regulations Revision Date: 03/08/2016 Date of issue: 03/08/2016 Version: 1.0 SECTION 1: IDENTIFICATION 1.1. Product Identifier Product Form: Mixture Product Name: Eprizero Pour On for Beef and Dairy Cattle Product Code: ANADA Intended Use of the Product Use of the substance/mixture: Eprizero 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 Name, Address, and Telephone of the Responsible Party Supplier Norbrook, Inc Indian Creek Parkway Ste. 680 Overland Park, KS Phone: Fax: Emergency Telephone Number Emergency Number : SECTION 2: HAZARDS IDENTIFICATION 2.1. Classification of the Substance or Mixture GHS-US classification Repr. 2 H361 Lact. H362 Aquatic Acute 3 H402 Aquatic Chronic 3 H412 Full text of hazard classes and H-statements : see section Label Elements GHS-US Labeling Hazard Pictograms (GHS-US) : Manufacturer Norbrook Laboratories Ltd, Station Works, Newry, Co.Down, N.Ireland, BT35 6JP. Telephone No. +44 (0) Fax No. +44 (0) enquiries@norbrook.co.uk Signal Word (GHS-US) Hazard Statements (GHS-US) Precautionary Statements (GHS-US) 2.3. Other Hazards Exposure may aggravate those with pre-existing eye, skin, or respiratory conditions Unknown Acute Toxicity (GHS-US) No data available GHS08 : Warning : H361 - Suspected of damaging fertility or the unborn child. H362 - May cause harm to breast-fed children. H402 - Harmful to aquatic life. H412 - Harmful to aquatic life with long lasting effects. : P201 - Obtain special instructions before use. P202 - Do not handle until all safety precautions have been read and understood. P260 - Do not breathe vapors, mist, or spray. P263 - Avoid contact during pregnancy/while nursing. P264 - Wash hands, forearms, and other exposed areas thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P273 - Avoid release to the environment. P280 - Wear protective gloves, protective clothing, and eye protection. P308+P313 - If exposed or concerned: Get medical advice/attention. P405 - Store locked up. P501 - Dispose of contents/container in accordance with local, regional, national, and international regulations. 03/08/2016 EN (English US) 1/6

10 Eprizero Pour On for Beef and Dairy Cattle Safety Data Sheet According to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS 3.1. Substance Not applicable 3.2. Mixture Name Product Identifier % GHS-US classification 1,2-Propylene glycol (CAS No) Proprietary Not classified Eprinomectin (CAS No) Proprietary Acute Tox. 3 (Oral), H301 Lact., H362 Repr. 2, H361 STOT RE 2, H373 Aquatic Acute 1, H400 Aquatic Chronic 1, H410 2,6-Di-tert-butyl-p-cresol (CAS No) Proprietary Aquatic Acute 1, H400 Aquatic Chronic 1, H410 The specific chemical identity and/or exact percentage of composition have been withheld as a trade secret [29 CFR ]. Full text of H-phrases: see section 16 SECTION 4: FIRST AID MEASURES 4.1. Description of First Aid Measures First-aid Measures General: Never give anything by mouth to an unconscious person. If you feel unwell, seek medical advice (show the label if possible). First-aid Measures After Inhalation: Remove to fresh air and keep at rest in a position comfortable for breathing. Obtain medical attention if breathing difficulty persists. First-aid Measures After Skin Contact: Remove contaminated clothing. Gently wash with plenty of soap and water followed by rinsing with water for at least 15 minutes. Call a POISON CENTER or doctor/physician if you feel unwell. Wash contaminated clothing before reuse. First-aid Measures After Eye Contact: Rinse cautiously with water for at least 15 minutes. Remove contact lenses, if present and easy to do so. Continue rinsing. Obtain medical attention if irritation persists. First-aid Measures After Ingestion: Do NOT induce vomiting. Rinse mouth. Immediately call a POISON CENTER or doctor/physician Most important symptoms and effects, both acute and delayed Symptoms/Injuries: Suspected of damaging fertility or the unborn child. May cause harm to breast-fed children. Please refer to the package insert for more detailed information. Symptoms/Injuries After Inhalation: May cause drowsiness or dizziness. Symptoms/Injuries After Skin Contact: May cause skin irritation. Symptoms/Injuries After Eye Contact: May cause eye irritation. Symptoms/Injuries After Ingestion: Ingestion is likely to be harmful or have adverse effects. Chronic Symptoms: Suspected of damaging fertility or the unborn child. May cause harm to breast-fed children Indication of Any Immediate Medical Attention and Special Treatment Needed If you feel unwell, seek medical advice (show the label where possible). SECTION 5: FIRE-FIGHTING MEASURES 5.1. Extinguishing Media Suitable Extinguishing Media: Use extinguishing media appropriate for surrounding fire. Unsuitable Extinguishing Media: None known Special Hazards Arising From the Substance or Mixture Fire Hazard: Not flammable. Explosion Hazard: Product is not explosive. Reactivity: Hazardous reactions will not occur under normal conditions Advice for Firefighters Precautionary Measures Fire: Exercise caution when fighting any chemical fire. Under fire conditions, hazardous fumes will be present. Firefighting Instructions: Use water spray or fog for cooling exposed containers. Prevent fire-fighting water from entering environment. Protection During Firefighting: Do not enter fire area without proper protective equipment, including respiratory protection. 03/08/2016 EN (English US) 2/6

11 Eprizero Pour On for Beef and Dairy Cattle Safety Data Sheet According to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations SECTION 6: ACCIDENTAL RELEASE MEASURES 6.1. Personal Precautions, Protective Equipment and Emergency Procedures General Measures: Use only as directed. Avoid all contact with skin, eyes, or clothing. Avoid breathing vapor, mist, or spray For Non-emergency Personnel Protective Equipment: Use appropriate personal protection equipment (PPE). Emergency Procedures: Evacuate unnecessary personnel For Emergency Responders Protective Equipment: Equip cleanup crew with proper protection. Emergency Procedures: Upon arrival at the scene, a first responder is expected to recognize the presence of dangerous goods, protect oneself and the public, secure the area, and call for the assistance of trained personnel as soon as conditions permit Environmental Precautions Avoid release to the environment Methods and Material for Containment and Cleaning Up For Containment: Contain any spills with dikes or absorbents to prevent migration and entry into sewers or streams. Methods for Cleaning Up: Clean up spills immediately and dispose of waste safely. Absorb and/or contain spill with inert material, then place in suitable container. Use only non-sparking tools. Do not take up in combustible material such as: saw dust or cellulosic material Reference to Other Sections See Heading 8. Exposure controls and personal protection. For further information refer to section 13. SECTION 7: HANDLING AND STORAGE 7.1. Precautions for Safe Handling Precautions for Safe Handling: Obtain special instructions before use. Do not handle until all safety precautions have been read and understood. Hygiene Measures: Handle in accordance with good industrial hygiene and safety procedures. Wash hands and other exposed areas with mild soap and water before eating, drinking, or smoking and again when leaving work Conditions for Safe Storage, Including Any Incompatibilities Technical Measures: Comply with applicable regulations. Storage Conditions: Store in a dry, cool and well-ventilated place. Store locked up. Keep container closed when not in use. Keep/Store away from direct sunlight, extremely high or low temperatures and incompatible materials. Incompatible Products: Strong acids, strong bases, strong oxidizers. Storage Temperature: 30 C Max 7.3. Specific End Use(s) Eprizero 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. SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1. Control Parameters For substances listed in section 3 that are not listed here, there are no established exposure limits from the manufacturer, supplier, importer, or the appropriate advisory agency including: ACGIH (TLV), AIHA (WEEL), NIOSH (REL), or OSHA (PEL). 2,6-Di-tert-butyl-p-cresol ( ) USA ACGIH ACGIH TWA (mg/m³) 2 mg/m³ (inhalable fraction and vapor) USA ACGIH ACGIH chemical category Not Classifiable as a Human Carcinogen USA NIOSH NIOSH REL (TWA) (mg/m³) 10 mg/m³ 1,2-Propylene glycol ( ) USA AIHA WEEL TWA (mg/m³) 10 mg/m³ 8.2. Exposure Controls Appropriate Engineering Controls Personal Protective Equipment : Ensure adequate ventilation, especially in confined areas. Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure. Ensure all national/local regulations are observed. : Avoid all unnecessary exposure. Gloves. Protective clothing. Protective goggles. Insufficient ventilation: wear respiratory protection. 03/08/2016 EN (English US) 3/6

12 Eprizero Pour On for Beef and Dairy Cattle Safety Data Sheet According to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations Materials for Protective Clothing Hand Protection Eye Protection Skin and Body Protection Respiratory Protection SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES 9.1. Information on Basic Physical and Chemical Properties Physical State : Liquid Appearance Odor Odor Threshold ph Evaporation Rate Melting Point Freezing Point Boiling Point Flash Point Auto-ignition Temperature Decomposition Temperature Flammability (solid, gas) Vapor Pressure Relative Vapor Density at 20 C Relative Density Solubility Partition Coefficient: N-Octanol/Water Viscosity : Chemically resistant materials and fabrics. : Wear chemically resistant protective gloves. : Chemical safety goggles. : Wear suitable protective clothing. Wash contaminated clothing before reuse. : In case of inadequate ventilation, oxygen deficient atmosphere, or where exposure levels are not known wear approved respiratory protection. : Clear solution 9.2. Other Information No additional information available SECTION 10: STABILITY AND REACTIVITY Reactivity: Hazardous reactions will not occur under normal conditions Chemical Stability: Stable at standard temperature and pressure Possibility of Hazardous Reactions: Hazardous polymerization will not occur Conditions to Avoid: Direct sunlight, extremely high or low temperatures, and incompatible materials Incompatible Materials: Strong acids, strong bases, strong oxidizers Hazardous Decomposition Products: Thermal decomposition generates: Carbon oxides (CO, CO 2 ). Nitrogen oxides. SECTION 11: TOXICOLOGICAL INFORMATION Information On Toxicological Effects Acute Toxicity: Not classified Eprinomectin ( ) LD50 Oral Rat 2,6-Di-tert-butyl-p-cresol ( ) LD50 Oral Rat LD50 Dermal Rat 1,2-Propylene glycol ( ) LD50 Oral Rat LD50 Dermal Rabbit Skin Corrosion/Irritation: Not classified Serious Eye Damage/Irritation: Not classified Respiratory or Skin Sensitization: Not classified Germ Cell Mutagenicity: Not classified Carcinogenicity: Not classified 55 mg/kg > 2930 mg/kg (Species: Sprague-Dawley) > 2000 mg/kg 20 g/kg mg/kg 03/08/2016 EN (English US) 4/6

13 Eprizero Pour On for Beef and Dairy Cattle Safety Data Sheet According to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations 2,6-Di-tert-butyl-p-cresol ( ) IARC group 3 Reproductive Toxicity: Suspected of damaging fertility or the unborn child. May cause harm to breast-fed children. Specific Target Organ Toxicity (Single Exposure): Not classified Specific Target Organ Toxicity (Repeated Exposure): Not classified Aspiration Hazard: Not classified Symptoms/Injuries After Inhalation: May cause drowsiness or dizziness. Symptoms/Injuries After Skin Contact: May cause skin irritation. Symptoms/Injuries After Eye Contact: May cause eye irritation. Symptoms/Injuries After Ingestion: Ingestion is likely to be harmful or have adverse effects. Chronic Symptoms: Suspected of damaging fertility or the unborn child. May cause harm to breast-fed children. SECTION 12: ECOLOGICAL INFORMATION Toxicity Ecology - General 2,6-Di-tert-butyl-p-cresol ( ) EC50 Other Aquatic Organisms 2 : Harmful to aquatic life. Harmful to aquatic life with long lasting effects mg/l (Exposure time: 72 h - Species: Desmodesmus subspicatus) 1,2-Propylene glycol ( ) LC50 Fish mg/l (Exposure time: 96 h - Species: Oncorhynchus mykiss [static]) EC50 Daphnia mg/l (Exposure time: 24 h - Species: Daphnia magna) LC 50 Fish ml/l (Exposure time: 96 h - Species: Oncorhynchus mykiss [static]) EC50 Daphnia mg/l (Exposure time: 48 h - Species: Daphnia magna [Static]) Persistence and Degradability No additional information available Bioaccumulative Potential 2,6-Di-tert-butyl-p-cresol ( ) BCF fish Log Pow ,2-Propylene glycol ( ) BCF fish 1 < 1 Log Pow Mobility in Soil No additional information available Other Adverse Effects Other Information : Avoid release to the environment. SECTION 13: DISPOSAL CONSIDERATIONS Waste treatment methods Sewage Disposal Recommendations: This material is hazardous to the aquatic environment. Keep out of sewers and waterways. Waste Disposal Recommendations: Dispose of waste material in accordance with all local, regional, national, and international regulations. Additional Information: Contaminated sharps should be handled with care and discarded immediately or as soon as possible in containers that are closable, puncture-resistant, leak proof on sides and bottoms, and appropriately labeled. Contact your local health department for referral to a syringe disposal program. In hospital and workplace settings, contaminated sharps are to be handled in accordance with EC Directive 2010/32/EU. SECTION 14: TRANSPORT INFORMATION In Accordance with DOT Not regulated for transport In Accordance with IMDG Not regulated for transport In Accordance with IATA Not regulated for transport SECTION 15: REGULATORY INFORMATION 15.1 US Federal Regulations Eprizero Pour On for Beef and Dairy Cattle SARA Section 311/312 Hazard Classes Delayed (chronic) health hazard 2,6-Di-tert-butyl-p-cresol ( ) Listed on the United States TSCA (Toxic Substances Control Act) inventory 1,2-Propylene glycol ( ) Listed on the United States TSCA (Toxic Substances Control Act) inventory 03/08/2016 EN (English US) 5/6

14 Eprizero Pour On for Beef and Dairy Cattle Safety Data Sheet According to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations EPA TSCA Regulatory Flag 15.2 US State Regulations 2,6-Di-tert-butyl-p-cresol ( ) U.S. - Massachusetts - Right To Know List U.S. - New Jersey - Right to Know Hazardous Substance List U.S. - Pennsylvania - RTK (Right to Know) List 1,2-Propylene glycol ( ) U.S. - New Jersey - Right to Know Hazardous Substance List U.S. - Pennsylvania - RTK (Right to Know) List Y2 - Y2 - indicates an exempt polymer that is a polyester and is made only from reactants included in a specified list of low concern reactants that comprises one of the eligibility criteria for the exemption rule SECTION 16: OTHER INFORMATION, INCLUDING DATE OF PREPARATION OR LAST REVISION Revision Date : 03/08/2016 Other Information : This document has been prepared in accordance with the SDS requirements of the OSHA Hazard Communication Standard 29 CFR GHS Full Text Phrases: Acute Tox. 3 (Oral) Acute toxicity (oral) Category Aquatic Acute 1 Hazardous to the aquatic environment - Acute Hazard Category Aquatic Acute 3 Hazardous to the aquatic environment - Acute Hazard Category Aquatic Chronic 1 Hazardous to the aquatic environment - Chronic Hazard Category Aquatic Chronic 3 Hazardous to the aquatic environment - Chronic Hazard Category Lact. Reproductive toxicity (Lact.) Repr. 2 Reproductive toxicity Category STOT RE 2 Specific target organ toxicity (repeated exposure) Category H301 Toxic if swallowed H361 Suspected of damaging fertility or the unborn child H362 May cause harm to breast-fed children H373 May cause damage to organs through prolonged or repeated exposure H400 Very toxic to aquatic life H402 Harmful to aquatic life H410 Very toxic to aquatic life with long lasting effects H412 Harmful to aquatic life with long lasting effects This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental requirements only. It should not therefore be construed as guaranteeing any specific property of the product. SDS US (GHS HazCom) 03/08/2016 EN (English US) 6/6