Mycophenolate Mofetil (Page 10 of 10)

INSTRUCTIONS FOR USE

Mycophenolate Mofetil (mye” koe fen’ oh late moe’ fe til)

for Oral Suspension

Be sure that you read, understand and follow these instructions carefully to ensure proper dosing of mycophenolate mofetil for oral suspension.

Important:

  • Always use the oral dispenser provided with mycophenolate mofetil for oral suspension to make sure you measure the right amount of medicine.
  • Call your pharmacist if your oral dispenser is lost or damaged.
  • Your pharmacist will write the expiration date on your mycophenolate mofetil for oral suspension bottle label. Do not use after the expiration date.
  • Ask your doctor or pharmacist if you have any questions or are unsure about how to take your dose of medicine.

To take a dose of mycophenolate mofetil for oral suspension, you will need the bottle of medicine and an oral dispenser provided with the medicine (See Figure 1). Your pharmacist will insert the bottle adapter in the mycophenolate mofetil for oral suspension bottle.

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Figure 1

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 down on the child-resistant bottle cap and turning it counter-clockwise (to the left). Do not throw away the child-resistant bottle cap.

Step 3: Before inserting the tip of the oral dispenser into the bottle adapter, push the plunger completely down toward the tip of the oral dispenser. Insert the tip firmly into the opening of the bottle adapter.

Step 4: Carefully turn the bottle upside down with the oral dispenser in place. Slowly pull the plunger down to withdraw your prescribed dose. Do not pull the plunger out of the oral dispenser (See Figure 2).

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Figure 2

Step 5: Leave the oral dispenser in the bottle and turn the bottle to an upright position.

Slowly remove the oral dispenser from the bottle.

Step 6: Place the tip of the oral dispenser in the patient’s mouth and slowly push the plunger down until the oral dispenser is empty. The mycophenolate mofetil oral suspension that is in the oral dispenser should not be mixed with any type of liquids before taking the dose.

Step 7: Put the child-resistant bottle cap back on the bottle after each use.

Step 8: Rinse the oral dispenser under running tap water after each use:

  • Remove the plunger from the oral dispenser.
  • Rinse the oral dispenser and plunger with water and let them air dry.
  • When the oral dispenser and plunger are dry, put the plunger back in the oral dispenser for the next use.

Important:

  • Do not let mycophenolate mofetil for oral suspension come in contact with the skin. If this happens, wash the skin well with soap and water.
  • If you spill any oral suspension, wipe it up using paper towels wet with water. Put the child-resistant bottle cap back on the bottle and wipe the outside of the bottle with wet paper towels.

How should I store mycophenolate mofetil for oral suspension?

  • Store the mycophenolate mofetil for oral suspension at room temperature between 59°F to 86°F (15°C to 30°C), for up to 60 days. You can also store mycophenolate mofetil for oral suspension in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze.

Keep mycophenolate mofetil for oral suspension and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured In Croatia By:
Pliva Hrvatska d.o.o.

Manufactured For:
Teva Pharmaceuticals
Parsippany, NJ 07054

Iss. 11/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-1175-22
Mycophenolate Mofetil for Oral Suspension, USP
200 mg/mL
Each mL contains 200 mg mycophenolate mofetil, USP after constitution.
PHARMACIST: Dispense the enclosed Medication Guide to each patient.Rx only

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MYCOPHENOLATE MOFETIL mycophenolate mofetil powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-1175
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MYCOPHENOLATE MOFETIL (MYCOPHENOLIC ACID) MYCOPHENOLATE MOFETIL 200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
ANHYDROUS CITRIC ACID
SILICON DIOXIDE
CORN SYRUP
MALTODEXTRIN
METHYLPARABEN
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
ANHYDROUS TRISODIUM CITRATE
SORBITOL
LECITHIN, SOYBEAN
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor FRUIT (mixed-fruit) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-1175-22 1 BOTTLE in 1 CARTON contains a BOTTLE
1 225 mL in 1 BOTTLE This package is contained within the CARTON (0480-1175-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211272 06/02/2022
Labeler — Teva Pharmaceuticals, Inc. (022629579)

Revised: 11/2021 Teva Pharmaceuticals, Inc.

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