wel (see Figure AA). Drink the full amount of the suspension right away, within 60 minutes of preparing it (see Figure BB).
Figure AA
Figure BB
Step 10: Refill the glass with the same amount of water (about 25 mL). Stir the contents with the same spoon and place the spoon back on the paper towel (see Figure CC). Drink the full amount right away so that you take any remaining medicine (see Figure DD).
Figure CC
Figure DD
If your total prescribed dose is more than 10 mg, repeat steps 4 through 10 to finish taking your dose.
Step 11: Wash the glass and the spoon thoroughly with water. Wipe the glass and spoon with a clean paper towel and store them in a dry and clean place until your next dose of AFINITOR DISPERZ (see Figure EE).
Figure EE
Step 12: Throw away the used paper towel and gloves in your household trash.
Step 13: Wash your hands.
How should I store AFINITOR DISPERZ?
•Store AFINITOR at room temperature, between 68°F to 77°F (20°C to 25°C).
•Keep AFINITOR DISPERZ in the pack it comes in.
•Open the blister pack just before taking AFINITOR DISPERZ.
•Keep AFINITOR DISPERZ dry and away from light.
•Do not use AFINITOR DISPERZ that is out of date or no longer needed.
Keep AFINITOR DISPERZ 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 by:
Novartis Pharma Stein AG
Stein, Switzerland
Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
T2012-157
August 2012
PRINCIPAL DISPLAY PANEL
Package Label – 2.5 mg
Rx Only NDC 0078-0594-51
Afinitor® (everolimus) Tablets
Each tablet contains
2.5 mg everolimus
28 Tablets
Carton contains 4 individual blister cards of 7 tablets.
PRINCIPAL DISPLAY PANEL
Package Label – 5 mg
Rx Only NDC 0078-0566-51
Afinitor® (everolimus) Tablets
Each tablet contains
5 mg everolimus
28 Tablets
Carton contains 4 individual blister cards of 7 tablets.
PRINCIPAL DISPLAY PANEL
Package Label – 7.5 mg
Rx Only NDC 0078-0620-51
Afinitor® (everolimus) Tablets
Each tablet contains
7.5 mg everolimus
28 Tablets
Carton contains 4 individual blister cards of 7 tablets.
PRINCIPAL DISPLAY PANEL
Package Label – 10 mg
Rx Only NDC 0078-0567-51
Afinitor® (everolimus) Tablets
Each tablet contains
10 mg everolimus
28 Tablets
Carton contains 4 individual blister cards of 7 tablets.
PRINCIPAL DISPLAY PANEL
Package Label – 2 mg
Rx Only NDC 0078-0626-51
Afinitor® DISPERZTM
(everolimus tablets for oral suspension)
TABLETS MUST BE DISPERSED IN WATER.
TABLETS MUST NOT BE SWALLOWED WHOLE, CHEWED OR CRUSHED.
28 Tablets for Oral Suspension
Carton contains 4 individual blister cards of 7 tablets.
PRINCIPAL DISPLAY PANEL
Package Label – 3 mg
Rx Only NDC 0 |
