Label: SYNOVEX PRIMER- trenbolone acetate and estradiol benzoate implant
- NDC Code(s): 54771-6870-1
- Packager: Zoetis Inc.
- Category: OTC ANIMAL DRUG LABEL
Drug Label Information
Updated April 8, 2024
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- SPL UNCLASSIFIED SECTION
- DESCRIPTION
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WITHDRAWAL PERIODS AND RESIDUE WARNINGS
No withdrawal period is required when used according to labeling.
Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.
Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.
Implant pellets subcutaneously in ear only. Any other location is a violation of Federal law. Do not attempt salvage of implanted site for human or animal food. - USER SAFETY WARNINGS
- ANIMAL SAFETY WARNINGS
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DIRECTIONS
Administer one SYNOVEX® PRIMER™ implant (two pellets), containing 50 mg of trenbolone acetate and 7 mg of estradiol benzoate, to each steer or heifer by subcutaneous implantation in the middle-third of the ear.
Use only a SYNOVEX applicator. Approved implantation technique is fully described in the fold-out carton section. Never sacrifice careful, clean technique for speed of implantation. -
STORAGE
Store unopened product at controlled room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat and humidity. Use product before the expiration date on the label.
Once the pouch is opened, unused product may be stored in the end-folded pouch (away from light) for up to six months under refrigerated conditions 2°-8°C (36°-47°F) or at room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F) for up to one month. - DISPOSAL
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INDICATIONS FOR USE
• For increased rate of weight gain in growing beef steers and heifers in a dry lot.
• Other than as described on the labeling, this implant is not approved for repeated implantation (reimplantation) with any other cattle ear implant in growing beef steers and heifers in a dry lot as safety and effectiveness have not been evaluated.
Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established.
Do not use in animals intended for subsequent breeding, or in dairy cows. - QUESTIONS/COMMENTS?
- SPL UNCLASSIFIED SECTION
- IMPORTANT
- SPL UNCLASSIFIED SECTION
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HOW TO IMPLANT
HOW TO IMPLANT
For use with a SYNOVEX Applicator
Study the following instructions carefully, then proceed step by step, until the technique becomes routine. Many head can be implanted per hour by an experienced team, one member of which should be assigned to do nothing but the implantation.
Care should be taken to insure the hands of the person administering the implant are clean and only sanitary instruments are used.f
- PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton
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INGREDIENTS AND APPEARANCE
SYNOVEX PRIMER
trenbolone acetate and estradiol benzoate implantProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:54771-6870 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRENBOLONE ACETATE (UNII: RUD5Y4SV0S) (TRENBOLONE - UNII:P53R4420TR) TRENBOLONE ACETATE 50 mg ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL BENZOATE 7 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-6870-1 1 in 1 BOX 1 10 in 1 POUCH 1 10 in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141043 07/01/2024 Labeler - Zoetis Inc. (828851555)