VALGANCICLOVIR HYDROCHLORIDE (Page 10 of 10)

Instructions for Use

Valganciclovir (val-gan-SYE-kloe-ver) Hydrochloride for Oral Solution

Be sure that you read, and that you understand and follow these instructions carefully to ensure proper dosing of the oral solution.

Important:

• Avoid contact with your skin or eyes. If you come in contact with the contents of the oral solution, wash your skin well with soap and water or rinse your eyes well with plain water.
• Do not use valganciclovir hydrochloride for oral solution after the discard date on the bottle.
• Always use the oral dispenser provided to give or take a dose of valganciclovir hydrochloride for oral solution.
• Call your pharmacist if your oral dispenser is lost or damaged, and they will tell you how to continue to give or take a dose of valganciclovir hydrochloride for oral solution.
• Ask your healthcare provider or pharmacist to show you how to measure your prescribed dose.

To take a dose of valganciclovir hydrochloride for oral solution, you will need the bottle of medicine and an oral dispenser provided with the medicine (see Figure 1). Your pharmacist inserts the bottle adapter in the valganciclovir hydrochloride for oral solution bottle.

Step 1: With the child-resistant cap on the bottle, shake the bottle well for about 5 seconds before each use.

Step 2: Open the bottle by pressing downward firmly on the child-resistant cap and turning it counterclockwise. Do not throw away the child-resistant cap.

Step 3: Check the dose in milliliters (mL) as prescribed by your healthcare provider. Find this number on the oral dispenser.

Step 4: Push the plunger down toward the tip of the oral dispenser.

Step 5: With the bottle in an upright position, insert the oral dispenser into the bottle adapter opening until firmly in place.

Step 6: Carefully turn the bottle upside down with the oral dispenser in place. Pull the plunger to withdraw the prescribed dose. If you see air bubbles in the ‌oral dispenser, fully push in the plunger so that the oral solution flows back into the bottle. Then withdraw your prescribed dose of valganciclovir hydrochloride for oral solution.

Step 7: Leave the oral dispenser in the bottle adapter and turn the bottle to an upright position. Slowly remove the oral dispenser from the bottle adapter.

Steps 8: Give or take the dose of valganciclovir hydrochloride for oral solution. Place the tip of the oral dispenser in the mouth. Slowly push down the oral dispenser plunger until the oral dispenser is empty.

Step 9: Put the child-resistant cap back on the bottle. Return the bottle back to the refrigerator.

Step 10: Rinse the oral dispenser with tap water after each use. Remove the plunger from the oral dispenser barrel by pulling the plunger all the way out of the barrel. Rinse the oral dispenser barrel and plunger with water and let them air dry. When the oral dispenser barrel and plunger are dry, put the plunger back into the oral dispenser barrel for the next use. Do not throw away the oral dispenser

How should I store valganciclovir hydrochloride for oral solution?

• Store solution in the refrigerator at 36°to 46°F (2°to 8°C) for no longer than 49 days.
• Do not freeze.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Brands listed are the trademarks of their respective owners.

Manufactured by: Manufactured for:

Granules Pharmaceuticals Inc. Somerset Therapeutics, LLC

Chantilly, VA 20151 Hollywood, FL 33024

Rev. 01/2022

For more information about valganciclovir hydrochloride, please contact Granules Pharmaceuticals Inc. at 1-877-770-3183.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALGANCICLOVIR HYDROCHLORIDE valganciclovir for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-810 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALGANCICLOVIR (VALGANCICLOVIR) VALGANCICLOVIR 50 mg in 1 mL

Inactive Ingredients Ingredient Name Strength MANNITOL SODIUM BENZOATE SUCRALOSE TARTARIC ACID

Product Characteristics Color WHITE (White to off-white) Score Shape Size Flavor TUTTI FRUTTI Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70069-810-01 100 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213306 01/15/2022

Labeler — Somerset Therapeutics, LLC (079947873)

Revised: 01/2022 Somerset Therapeutics, LLC