FPO 128: 12982100
`
`12982100
`
`Rapamune®
`(sirolimus) Tablets
`0.5 mg
`
`Unit Dose - 100 Tablets
`(10 Blister Cards of 10 Tablets Each)
`
`ALWAYS DISPENSE WITH MEDICATION GUIDE
`
`NDC 0008-1040-10
`
`Rapamune®
`(sirolimus) Tablets
`0.5 mg
`
`Rapamune®
`(sirolimus) Tablets
`0.5 mg
`
`Rapamune®
`(sirolimus) Tablets
`0.5 mg
`
`DOSAGE AND USE: See accompanying prescribing information.
`
`Store at room temperature, 20°C to 25°C (68°F to 77°F).
`[See USP Controlled Room Temperature.] Protect from light.
`This unit-dose package is not child-resistant. If dispensed for
`outpatient use, a child-resistant container should be utilized.
`Keep out of reach of children.
`
`Distributed by
`Wyeth Pharmaceuticals Inc
`A subsidiary of Pfizer Inc
`Philadelphia, PA 19101
`
`MADE IN SWITZERLAND
`
`FPO
`
`For oral use only.
`
`Unit Dose - 100 Tablets
`(10 Blister Cards of 10 Tablets Each)
`
`Unit Dose - 100 Tablets
`(10 Blister Cards of 10 Tablets Each)
`
`Rx only
`
`Unit Dose - 100 Tablets
`(10 Blister Cards of 10 Tablets Each)
`
`0008-1040-10
`
`1
`
`3N
`
`12982100
`
`12982100
`
`FPO 128: 12982100
`
`Reference ID: 3316582
`
`

`

`12112101
`
`N 3 0008-1040-05 7
`
`FPO128 (80% x 5.5mm)
`
`ALWAYS DISPENSE WITH MEDICATION GUIDE
`NDC 0008-1040-05
`
`Rapamune
`®
`(sirolimus) Tablets
`0.5 mg
`
`For oral use only.
`
`100 Tablets
`
`Rx only
`
`DOSAGE AND USE: See
`accompanying prescribing
`information.
`Store at room temperature,
`20°C to 25°C (68°F to 77°F).
`[See USP Controlled Room
`Temperature.] Dispense in
`tight (USP), light-resistant
`(USP), and child-resistant
`containers.
`Distributed by
`Wyeth Pharmaceuticals Inc
`A subsidiary of Pfizer Inc
`Philadelphia, PA 19101
`MADE IN SWITZERLAND
`
`Reference ID: 3316582
`
`

`

`FPO 128: 12982200
`
`12982200
`
`Rapamune®
`(sirolimus) Tablets
`1 mg
`
`Unit Dose - 100 Tablets
`(10 Blister Cards of 10 Tablets Each)
`
`ALWAYS DISPENSE WITH MEDICATION GUIDE
`
`NDC 0008-1041-10
`
`Rapamune®
`(sirolimus) Tablets
`1 mg
`
`Rapamune®
`(sirolimus) Tablets
`1 mg
`
`Rapamune®
`(sirolimus) Tablets
`1 mg
`
`For oral use only.
`
`DOSAGE AND USE: See accompanying prescribing information.
`
`Store at room temperature, 20°C to 25°C (68°F to 77°F).
`[See USP Controlled Room Temperature.] Protect from light.
`This unit-dose package is not child-resistant. If dispensed for
`outpatient use, a child-resistant container should be utilized.
`Keep out of reach of children.
`
`Distributed by
`Wyeth Pharmaceuticals Inc
`A subsidiary of Pfizer Inc
`Philadelphia, PA 19101
`
`MADE IN SWITZERLAND
`
`FPO
`
`Unit Dose - 100 Tablets
`(10 Blister Cards of 10 Tablets Each)
`
`Unit Dose - 100 Tablets
`(10 Blister Cards of 10 Tablets Each)
`
`Rx only
`
`Unit Dose - 100 Tablets
`(10 Blister Cards of 10 Tablets Each)
`
`0008-1041-10
`
`8
`
`3N
`
`12982200
`
`12982200
`
`FPO 128: 12982200
`
`Reference ID: 3316582
`
`

`

`12112401
`
`N 3 0008-1041-05 4
`
`FPO128 (80% x 5.5mm)
`
`ALWAYS DISPENSE WITH MEDICATION GUIDE
`NDC 0008-1041-05
`
`Rapamune
`®
`(sirolimus) Tablets
`1 mg
`
`For oral use only.
`
`100 Tablets
`
`Rx only
`
`DOSAGE AND USE: See
`accompanying prescribing
`information.
`Store at room temperature,
`20°C to 25°C (68°F to 77°F).
`[See USP Controlled Room
`Temperature.] Dispense in
`tight (USP), light-resistant
`(USP), and child-resistant
`containers.
`Distributed by
`Wyeth Pharmaceuticals Inc
`A subsidiary of Pfizer Inc
`Philadelphia, PA 19101
`MADE IN SWITZERLAND
`
`Reference ID: 3316582
`
`

`

`12112601
`
`N 3 0008-1042-05 1
`
`FPO128 (80% x 5.5mm)
`
`ALWAYS DISPENSE WITH MEDICATION GUIDE
`NDC 0008-1042-05
`
`Rapamune
`®
`(sirolimus) Tablets
`2 mg
`
`For oral use only.
`
`100 Tablets
`
`Rx only
`
`DOSAGE AND USE: See
`accompanying prescribing
`information.
`Store at room temperature,
`20°C to 25°C (68°F to 77°F).
`[See USP Controlled Room
`Temperature.] Dispense in
`tight (USP), light-resistant
`(USP), and child-resistant
`containers.
`Distributed by
`Wyeth Pharmaceuticals Inc
`A subsidiary of Pfizer Inc
`Philadelphia, PA 19101
`MADE IN SWITZERLAND
`
`Reference ID: 3316582
`
`

`

`FPO – 128 10 mil
`13123001
`
`AREA
`IMPRINT
`
`MFG
`EXP
`LOT
`
`ALWAYS DISPENSE WITH MEDICATION GUIDE
`
`NDC 0008-1030-04
`
`Rapamune®
`(sirolimus)
`Oral Solution
`1 mg/mL
`
`Rapamune®
`(sirolimus)
`Oral Solution
`1 mg/mL
`
`Rapamune®
`(sirolimus)
`Oral Solution
`1 mg/mL
`
`DOSAGE AND USE:
`See accompanying prescribing
`information.
`
`Keep out of reach of children.
`
`Store refrigerated at 2° to 8°C
`(36° to 46°F).
`
`PROTECT FROM LIGHT.
`
`Use contents of bottle within
`1 month after opening.
`
`MADE IN JAPAN
`
`FPO – UPC
`
`For oral use only.
`Each mL of RAPAMUNE contains 1 mg
`sirolimus.
`1.5%-2.5% ethanol
`Also contains a mixture of propylene
`glycol and phosphatidylcholine derived
`from soy lecithin (and other
`components) and polysorbate 80.
`
`60 mL bottle
`
`60 mL bottle
`
`Rx only
`
`60 mL bottle
`
`Distributed by
`Wyeth Pharmaceuticals Inc
`A subsidiary of Pfizer Inc
`Philadelphia, PA 19101
`
`13123001
`
`FPO – 128 10 mil
`13123001
`
`Reference ID: 3316582
`
`090177e184019172\Approved\Approved On: 07-Mar-2013 16:33
`
`

`

`YYYYYYYYYY
`13122901
`
`ZZZ
`EXP.
`YYY
`LOT
`XXX
`
`Use contents within 1 month after opening.
`Store refrigerated at 2° to 8°C (36° to 46°F). Protect from light.
`
`ALWAYS DISPENSE WITH MEDICATION GUIDE
`NDC 0008-1030-04
`
`Rapamune®
`(sirolimus)
`Oral Solution
`1 mg/mL
`
`For oral use only.
`Each mL of RAPAMUNE contains 1 mg sirolimus.
`1.5%-2.5% ethanol
`Also contains a mixture of propylene glycol and
`phosphatidylcholine derived from soy lecithin
`(and other components) and polysorbate 80.
`Rx only
`60 mL
`
`MADE IN JAPAN
`
`FPO
`
`
`
`
`
`DOSAGE AND USE: See accompanying prescribing information.
`Keep out of reach of children.
`Distributed by
`Wyeth Pharmaceuticals Inc
`A subsidiary of Pfizer Inc
`Philadelphia, PA 19101
`
`
`
` FnL1 03 0076 01 BVd5ZXRoBVd5ZXRoAE2tmr4CMTAEMTAw 02 JQEwC1JTUyBMaW1pdGVkDjAwMzAwMDgx 03 MDMwMDQxAA==
`
`(01)00300081030041
`
`Reference ID: 3316582
`
`

`

`FPO: 128
`12965902
`
`1 mg/mL
`Oral Solution
`(sirolimus)
`Rapamune®
`
`12965902
`
`Instructions for Use for RAPAMUNE® (sirolimus) Oral Solution
`1
`2
`3
`
`4
`
`Open the solution bottle. Remove the safety cap
`by squeezing the tabs on the cap and twisting
`counterclockwise.
`
`The first time you use a bottle of Rapamune Oral
`Solution, insert the oral syringe adapter (plastic
`tube with stopper) tightly into the bottle until it is
`even with the top of the bottle. Do not remove the
`oral syringe adapter from the bottle once inserted.
`
`Use a new disposable amber oral syringe for each
`dose of Rapamune Oral Solution. Fully push down
`(depress) on the plunger of the disposable amber
`oral syringe. Then, tightly insert the oral syringe
`into the opening in the adapter.
`
`5
`
`6
`
`7
`
`If your doctor tells you to carry your medicine with
`you: If you need to carry your Rapamune Oral
`Solution in a filled syringe, place a cap securely
`on the syringe. The cap should snap into place.
`
`Place the capped syringe in the enclosed
`carrying case.
`
`Taking a dose of Rapamune Oral Solution: Empty the
`syringe into a glass or plastic cup containing at least
`2 ounces (1/4 cup; 60 mL) of water or orange juice,
`stir vigorously for 1 minute and drink right away.
`Refill the container with at least 4 ounces (1/2 cup;
`120 mL) of water or orange juice, stir vigorously
`again and drink the rinse solution. Do not mix
`Rapamune Oral Solution with apple juice, grapefruit
`juice, or other liquids. Only glass or plastic cups
`should be used to mix Rapamune Oral Solution. The
`syringe and cap should be used only one time and
`then thrown away.
`
`LOT
`EXP.
`
`Distributed by
`Wyeth Pharmaceuticals Inc
`A subsidiary of Pfizer Inc
`Philadelphia, PA 19101
`
`Withdraw the prescribed amount of Rapamune
`Oral Solution. Gently pull back the plunger of the
`syringe until the bottom of the black line of the
`plunger is even with the appropriate mark on the
`syringe. Always keep the bottle in an upright
`position. If bubbles form in the syringe, empty the
`syringe into the bottle and repeat steps 3 and 4.
`
`8
`
`Always store the bottles of medication in the
`refrigerator.
`You may store RAPAMUNE Oral Solution that
`is in a syringe at room temperature up to
`77°F (25°C) or in the refrigerator at 36°F to
`46°F (2°C to 8°C) for up to 24 hours. See
`“How should I store RAPAMUNE?” at the end
`of Instructions for Use provided in the
`package insert.
`
`60 mL Patient Kit
`
`Rapamune®
`(sirolimus)
`Oral Solution
`1 mg/mL
`
`DOSAGE AND USE:
`See accompanying prescribing
`information.
`Refer to back of box for
`Instructions for Use for
`RAPAMUNE (sirolimus)
`Oral Solution
`Keep out of reach of children.
`
`ALWAYS DISPENSE WITH MEDICATION GUIDE
`NDC 0008-1030-06
`
`Rapamune®
`(sirolimus)
`Oral Solution
`1 mg/mL
`
`For oral use only.
`Each mL of RAPAMUNE contains 1 mg sirolimus.
`1.5%-2.5% ethanol
`Also contains a mixture of propylene glycol and
`phosphatidylcholine derived from soy lecithin (and other
`components) and polysorbate 80.
`
`60 mL Patient Kit
`
`Rx only
`
`Each Rapamune Oral Solution carton contains:
`a) A 2 oz. (60 mL fill) amber glass bottle of sirolimus
`(concentration of 1 mg/mL)
`b) 1 oral syringe adapter for fitting into the neck of the
`bottle
`c) 30 amber oral syringes and 30 caps for daily dosing
`d) 1 carrying case
`Also contains: Package Insert and Medication Guide
`You will also need:
`• glass or plastic cup
`• 6 oz. of water or orange juice only
`
`d
`
`a
`
`b
`
`c
`
`60 mL Patient Kit
`
`Rapamune®
`(sirolimus)
`Oral Solution
`1 mg/mL
`
`Store refrigerated at
`2° to 8°C (36° to 46°F).
`PROTECT FROM LIGHT
`Use contents of bottle
`within 1 month after
`opening.
`MADE IN JAPAN
`
`FPO: UPC
`
`Reference ID: 3316582
`
`090177e1840179c5\Approved\Approved On: 07-Mar-2013 16:29
`
`

`

`Rapamune - For Oral Use Only
`
`Made in Denmark
`
`½t
`
`sp
`
`tsp
`¼
`
`3
`
`mL
`2.5
`
`mL
`2
`
`mL
`1.5
`
`mL
`1
`
`mL
`0.5
`
`Reference ID: 3316582
`
`