POSILAC- sometribove suspension
Union Agener Inc
----------
DESCRIPTION: Sterile, prolonged-release injectable formulation of a recombinant DNA-derived bovine somatotropin analog in single-dose syringes each containing 500 mg of sometribove zinc.
CAUTION: Federal law prohibits extra-label use of this drug to enhance food and/or fiber production in animals.
DOSAGE: Inject one syringe of Posilac every 14 days. Start during the 9th or 10th week (57-70 days) after calving and continue until the end of lactation.
INJECTION TECHNIQUE: Inject Posilac subcutaneously (under the skin). Recommended injection sites are neck area, behind the shoulder or in the depression on either side of the tailhead (see diagrams below). Alternate between the cow's left and right side on consecutive injections. Remove surface dirt from the injection site area before injecting. Inject entire contents of the syringe subcutaneously. Do not reuse syringes.
Inject directly into the deepest depressions on either side of the tailhead (marked "Yes"). Avoid the bone, muscles, tendons and ligaments of the tail and the rectal and anal muscles. Do NOT inject into the caudal fold (marked "No") because this may invalidate USDA tuberculosis testing. Locate the caudal fold by raising the tail.
USER SAFETY WARNINGS: Not for use in humans, Keep out of reach of children, Avoid prolonged or repeated contact with Posilac with eyes and skin, Posilac is a protein. Frequent skin contact with proteins may produce an allergic reaction in some people. Always wash hands and skin exposed to Posilac with soap and water after handling. Clothing soiled with the product should be laundered before reuse.
STORAGE: Store under refrigeration (2° to 8° C; 36° to 46° F). DO NOT FREEZE. Allow syringes to warm to room temperature (15° to 30° C; 59° to 86° F) before use. Avoid prolonged exposure to excessively high temperature and sunlight. Expiration dates are stated on syringes and box labeling.
ENVIRONMENTAL SAFETY: Dispose of used syringes in a leak-resistant, puncture-resistant container in accordance with applicable Federal, state, and local regulations.
Contact Union Agener, Inc. at +1 844-952-0330. To report side effects, contact Union Agener, Inc. at +1 844-952-0330. For additional information about reporting side effects for animal drugs, contact FDA at + 1 1-888-FDA-VETS or http://www.fda.gov/reportanimalae
Approved by FDA under NADA # 140-872
Manufactured by
Union Agener, Inc.
1788 Lovers Lane, Augusta, Georgia 30901, U.S.A.
4024774
Posilac (sometribova suspensión de zinc)
Mantener en refrigeración (2 °C a 8 °C; 36° F a 46 °F). NO CONGELAR. Permita que las jeringas alcancen la temperatura ambiente
(15 °C a 30 °C; 59 ° a 86 °F) antes de usar. Evite la exposición prolongada a temperaturas excesivamente altas y a la luz solar.
Elaborado por
Union Agener, Inc.
1788 Lovers Lane, Augusta, Georgia 30901, EUA
¿PREGUNTAS/COMENTARIOS?
Conctate a Union Agener, Inc. al +1 844-952-0330. Para reportar efectos secundarios, conctate Union Agener, Inc.: +1 844-952-0330. Para obtener informaciones
adicionales sobre cómo reportar efectos secundarios de medicamentos para animales, conctate FDA +1 1-888-FDA-VETS o http://www.fda.gov/reportanimalae
Aprobado por la FDA bajo número NADA # 140-872
POSILAC
sometribove suspension |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
Labeler - Union Agener Inc (116587901) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Union Agener Inc. | 116587901 | ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK |