- SPL UNCLASSIFIED SECTION
- ACTIVE DRUG INGREDIENT
- INERT INGREDIENTS
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CATTLE
Dairy and Beef Cattle
FOR THE REMOVAL AND CONTROL OF:
Lungworms: (Dictyocaulus viviparus).
Stomach worms: Barberpole worms (Haemonchus contortus), brown stomach worms (Ostertagia ostertagi), small stomach worms (Trichostrongylus axei).
Intestinal worms: Hookworms (Bunostomum phlebotomum), threadnecked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata & C. oncophora).
Bankrupt worms: (Trichostrongylus colubriformis).
Nodular worms: (Oesophagostomum radiatum).
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DOSAGE REGIMEN
5 mg fenbendazole per kg body weight in a one (1) day treatment (2.27 mg fenbendazole per pound).
EXAMPLE OF MIXING AND FEEDING RATES FOR SAFE-GUARD® 20% TYPE A MEDICATED ARTICLE
For a one (1) day treatment, mix the following quantities of SAFE-GUARD® 20% Type A Medicated Article into the daily ration according to body weight and number of cattle per pen.
Amount of SAFE-GUARD® 20% Type A Medicated Article for: Body Weight 10 Cattle 20 Cattle 100 Cattle lbs. kg g lbs. g lbs. g lbs. 200 90.7 23 0.05 46 0.10 230 0.5 400 181.4 46 0.10 92 0.20 460 1.0 600 272.2 69 0.15 138 0.30 690 1.5 800 362.9 92 0.20 184 0.40 920 2.0 1000 453.6 114 0.25 228 0.50 1140 2.5 1400 635.0 160 0.35 320 0.70 1600 3.5 Feed as the sole ration for one (1) day. No prior withdrawal of feed or water necessary. When feed containing SAFE-GUARD® has been fed for 1 day and blended according to the above rates based on weight and number of cattle treated, a total intake of 2.27 mg fenbendazole per pound of body weight is assured. Cattle feed containing SAFE-GUARD® can be fed pelleted or as meal.
FREE-CHOICE FEEDS
Free-choice feed must be formulated to provide a total of 5 mg per kg body weight over 3 to 6 days. (Only a licensed medicated feed mill may manufacture the dry or liquid free choice feeds following the approved formulas.)
Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks.
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GENERAL USE DIRECTIONS
It is recommended that SAFE-GUARD® 20% Type A Medicated Article be diluted before addition to the feed. A dilution of one part of SAFE-GUARD® 20% Type A Medicated Article and nine parts of grain carrier is the suggested working premix. The working premix is then blended with the complete feed mixture. Thoroughly mix both working premix and complete feed to ensure complete and uniform distribution of the SAFE-GUARD® 20% Type A Medicated Article.
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CAUTION
Due to the possible variation in animal feeding behavior, underdosing may occur in individual animals. Underdosing may encourage the development of parasite resistance. It is recommended that parasite resistance be monitored following the use of any anthelmintic with the use of a fecal egg count reduction test program.
- WARNING
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SWINE
Growing pigs, gilts, pregnant sows, and boars
FOR THE REMOVAL AND CONTROL OF:
Lungworms: (Metastrongylus apri, Metastrongylus pudendotectus).
Gastrointestinal worms: Adult and larvae (L3, L4 stages, liver, lung, intestinal forms) large roundworms (Ascaris suum); nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); small stomach worms (Hyostrongylus rubidus); whipworms, adult and larvae (L2, L3, L4 stages - intestinal mucosal forms) (Trichuris suis).
Kidney worms: Adult and larvae (Stephanurus dentatus).
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DOSAGE REGIMEN
9 mg fenbendazole per kg body weight (4.08 mg fenbendazole per pound) to be fed as the sole ration over a period of 3 to 12 days.
EXAMPLE OF MIXING AND FEEDING RATES FOR SAFE-GUARD® 20% TYPE A MEDICATED ARTICLE
Average daily feed consumption Amount of SAFE-GUARD® 20% Type A Medicated Article added to each ton of swine feed based on weight and average feed consumption Treatment Period Pig Wt. (lbs.) lbs. of Feed 3 Days 6 Days 12 Days lbs. Grams lbs. Grams lbs. Grams 30 2.25 0.40 182 0.20 91 0.10 46 50 3.20 0.47 213 0.24 107 0.12 54 75 4.25 0.53 241 0.27 121 0.14 61 100 5.30 0.57 258 0.29 129 0.15 65 150 6.80 0.66 301 0.33 151 0.17 76 200 8.00 0.75 341 0.38 171 0.19 86 Feed as the sole ration for three (3) to twelve (12) consecutive days. No prior withdrawal of feed or water necessary. When feed containing SAFE-GUARD® has been blended according to the above rates based on pig weight and average daily feed consumption, and is then fed for 3-12 days, a total intake of 9 mg fenbendazole per kilogram body weight (4.08 mg fenbendazole per pound) is assured. Swine feeds containing SAFE-GUARD® can be fed pelleted or as meal.
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GENERAL USE DIRECTIONS
It is recommended that SAFE-GUARD® 20%Type A Medicated Article be diluted before addition to the feed. A dilution of one part of SAFE-GUARD® 20%Type A Medicated Article and nine parts of grain carrier is the suggested working premix. The working premix is then blended with the complete feed mixture. Thoroughly mix both working premix and complete feed to ensure complete and uniform distribution of the SAFE-GUARD® 20%Type A Medicated Article.
- WARNING
- HORSES
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DOSAGE REGIMEN
For the control of large strongyles, small strongyles, and pinworms the recommended dose is 5 mg fenbendazole per kg body weight (2.27 mg fenbendazole per pound) in a ONE (1) DAY treatment. For the control of ascarids the recommended dose is 10 mg fenbendazole per kg body weight (4.54 mg fenbendazole per pound) in a ONE (1) DAY treatment.
All horses must be eating normally to ensure that each animal consumes an adequate amount of the medicated feed.
EXAMPLE OF MIXING AND FEEDING RATES FOR SAFE-GUARD® 20% TYPE A MEDICATED ARTICLE
For a ONE (1) DAY treatment, mix the following quantities of SAFE-GUARD® 20% Type A Medicated Article into the daily ration according to body weight and dose.
Amount of SAFE-GUARD® 20% Type A Medicated Article Body Weight For dose of 2.27 mg fenbendazole/lb body weight For dose of 4.54 mg fenbendazole/lb body weight lbs. grams grams 200 2.27 4.54 400 4.54 9.08 600 6.81 13.62 800 9.08 18.16 1000 11.35 22.70 1200 13.62 27.24 Feed for ONE (1) DAY as above. No prior withdrawal of feed or water is necessary. Horse feed containing SAFE-GUARD® 20% can be fed pelleted or as a meal.
Regular deworming at intervals of 6 to 8 weeks may be required due to the possibility of reinfection.
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GENERAL USE DIRECTIONS
It is recommended that SAFE-GUARD® 20% Type A Medicated Article be diluted before addition to the feed. A dilution of one part of SAFE-GUARD® 20% Type A Medicated Article and nine parts of grain carrier is the suggested working premix. The working premix is then blended with the complete feed mixture. Thoroughly mix both working premix and complete feed to ensure complete and uniform distribution of the SAFE-GUARD® 20% Type A Medicated Article.
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ANIMAL SAFETY
There are no known contraindications for the use of fenbendazole in horses. Side effects associated with SAFE-GUARD® 20% (fenbendazole) could not be established in well-controlled safety studies in horses with single doses as high as 454 mg/lb (1,000 mg/kg) and 15 consecutive daily doses of 22.7 mg/lb (50 mg/kg).
SAFE-GUARD® 20% (fenbendazole) has been evaluated for safety in pregnant mares during all stages of gestation with doses as high as 11.4 mg/lb (25 mg/kg) and in stallions with doses as high as 11.4 mg/lb (25 mg/kg). No adverse effects on reproduction were detected.
- WARNING
- Zoo and Wildlife Animals
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DOSE/DOSAGE REGIMENS
Host Animal Recommended Treatment for mg Fenbendazole/kg
Body Wt./Day
× Days of TreatmentBighorn Sheep (Ovis canadensis canadensis) lungworms: (Protostrongylus spp.) 10 mg × 3 Feral Swine
(Sus scrofa)kidney worms: (Stephanurus dentatus),
roundworms: (Ascaris suum),
nodular worms: (Oesophagostomum dentatum)3 mg × 3 Ruminants - subfamily
antilopinae:
Persian gazelles
(Gazella subgutturosa
subgutturosa)
Addra gazelle
(Gazella dama ruficollis)
Slendorhorn Gazelle
(Gazella leptoceros)
Kenya impala
(Aepyceros melampus rendilis)
Roosevelt's gazelle
(Gazella granti roosevelti)
Indian blackbuck
(Antilope cervicapra)
Mhorr gazelle (Gazella dama mhorr)
Thomson's gazelles
(Gazella thomsoni thomsoni)
small stomach worms:
(Trichostrongylus spp.),
thread-necked intestinal worms:
(Nematodirus spp.),
barberpole worms:
(Haemonchus spp.),
whipworms:
(Trichuris spp.)
2.5 mg × 3Ruminants - subfamily
hippotraginae:
Addax (Addax nasomasculatus)
Angolan roan antelope
(Hippotragus equinus cottoni)
Fringed-ear oryx (Oryx gazella callotis)
Arabian oryx (Oryx leucoryx)Ruminants - subfamily
caprinae:
Armenian mouflon (Ovis orientalis gmelini)
Russian saiga (Saiga tatarica)It is recommended that the user exercise judgmental expertise as needed for retreatment within six (6) weeks. This would depend upon the conditions of continued exposure to parasites, condition of treated animals, and ambient temperatures.
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GENERAL USE DIRECTIONS
SAFE-GUARD® 20% Type A Medicated Article must be mixed according to directions and at correct concentrations based upon the species to be treated. It is recommended that SAFE-GUARD® 20% Type A Medicated Article be diluted before addition to the feed. The correct proportions of premix and feed ingredients should be established for blending into the complete feed. This premix and feed ingredient combination should be thoroughly and uniformly mixed with the complete feed.
SAFE-GUARD® 20% Type A Medicated Article can be fed to adult and young animals either in a mash or pelleted feed. No prior withdrawal of feed or water is necessary.
- WARNING
- ANIMAL SAFETY
- RESIDUE WARNING
- Growing Turkeys
- DOSAGE REGIMEN
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GENERAL USE DIRECTIONS
It is recommended that SAFE-GUARD® 20% Type A Medicated Article be diluted before addition to the feed. A dilution of one part of SAFE-GUARD® 20% Type A Medicated Article and nine parts of grain carrier is the suggested working premix. The working premix is then blended with the complete feed mixture. Thoroughly mix both working premix and complete feed to ensure complete and uniform distribution of the SAFE-GUARD® 20% Type A Medicated Article.
- FEEDING DIRECTIONS
- WARNING
- SPL UNCLASSIFIED SECTION
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 11.34 kg Bag
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INGREDIENTS AND APPEARANCE
SAFE-GUARD
fenbendazole powderProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:57926-090 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36) Fenbendazole 200 g in 1 kg Inactive Ingredients Ingredient Name Strength Mineral Oil (UNII: T5L8T28FGP) Calcium Carbonate (UNII: H0G9379FGK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57926-090-25 1 in 1 BAG 1 11.34 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA131675 01/31/1984 Labeler - Schering Corporation (001317601) Establishment Name Address ID/FEI Business Operations ADM Alliance Nutrition, Inc. 834721284 MANUFACTURE Establishment Name Address ID/FEI Business Operations Intervet Mexico S.A. de C.V. 588215863 API MANUFACTURE