Posilac (sometribove zinc suspension)

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.

USE: To increase production of marketable milk in healthy lactating dairy cows.

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.

ADMINISTRATION: Allow syringes to warm to room temperature (15° to 30° C, 59° to 86° F) before use.

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.

INJECTION SITES:

Tailhead Depression	Neck & Behind The Shoulder
	Gather skin and inject between skin and muscle layers.
WITHDRAWAL PERIODS:
No milk discard time and no withdrawal period is required when used according to labeling.

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.

• Use in lactating dairy cows only.
• Safety to replacement bulls born in dairy cows injected with Posilac has not been established.
• Avoid injecting within 2 weeks of slaughter to minimize injection site blemishes on carcass.

• Milk production response during each 14-day injection period is cyclic and will be greatest during the middle of each period.

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.

HOW SUPPLIED: Single-dose syringes in 25 or 100 count boxes.

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