Sirolimus (Page 12 of 12)

INSTRUCTIONS FOR USE

Sirolimus (sir oh li mus) Oral Solution

Be sure that you read and understand the following instructions for the correct way to dilute and take sirolimus oral solution. Ask your pharmacist or doctor if you are not sure.

Important:

  • Always keep the bottle in an upright position.
  • You may store sirolimus 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 sirolimus oral solution?” at the end of this Instructions for Use.
  • Sirolimus oral solution can develop a slight haze when it is refrigerated. If this happens, bring the sirolimus oral solution to room temperature and then gently shake the bottle until the haze goes away.
  • Only use a glass or plastic cup to dilute sirolimus oral solution.
  • If you are a caregiver, do not let sirolimus oral solution come in contact with your skin or eyes. If you get the oral solution on your skin, wash the area well with soap and water. If you get the oral solution in your eyes, rinse with plain water.
  • If you spill sirolimus oral solution, dry the area with a dry paper towel and then wipe the area with a wet paper towel. Throw away the paper towels in the trash and wash your hands well with soap and water.

Each sirolimus oral solution carton contains:

instruction-01

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) enough disposable amber oral syringes and caps for daily dosing

d) 1 carrying case

You will also need:

  • glass or plastic cup
  • 6 oz. of water or orange juice only
  • Figure 1: Opening the bottle instruction-02

    1.Open the solution bottle.

    • Remove the safety cap by pressing down the cap (arrow 1) and twisting counterclockwise (arrow 2)(Figure 1).

    Figure 2: Inserting adapter instruction-03

    2. The first time you use a bottle of sirolimus oral solution

    • Insert the oral syringe adapter (stopper) tightly into the bottle until it is even with the top of the bottle (Figure 2).
    • Do not remove the oral syringe adapter from the bottle once inserted.
    Figure 3: Inserting syringe

    instruction-04
    (click image for full-size original)

    3. Use a new disposable amber oral syringe for each dose of sirolimus 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 (Figure 3).

    Figure 4: Withdrawing solution

    intsruction-05
    (click image for full-size original)

    4. Withdraw the prescribed amount of sirolimus oral solution

    • Invert the bottle and gently pull back the plunger of the syringe until the level of the oral solution is even with the marking on the syringe for your prescribed dose.
    • If bubbles form within the oral solution in the syringe, empty the syringe into the bottle and repeat step 4 (Figure 4).
    • You may need to repeat step 4 more than once to draw up your prescribed dose.

    Figure 5: Capping syringe

    instruction-06

    5.If your doctor tells you to carry your medicine with you

    • Each dose of sirolimus oral solution should be placed in an oral syringe. Place a cap securely on each syringe. The cap should snap into place (Figure 5).
    • Place the capped syringe in the Figure enclosed carrying case (Figure 6). If you need more than 1 carrying case, talk with your doctor or pharmacist.
    • See ‘How should I store Sirolimus oral solution’ for storage instructions.

    Figure 6: Placing syringe in carrying case Figure

    instruction-07

    Figure 7: Emptying syringe into glass

    instrution-08
    6. Taking a dose of sirolimus oral solution:
    • Choose a clean flat work surface. Place a clean paper towel on the work surface. Wash and dry your hands.
    • 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 (Figure 7).
    • If more than 1 syringe is needed for your prescribed dose, empty the oral solution from each syringe into the same glass or plastic cup of water or orange juice.
    • 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 sirolimus oral solution with apple juice, grapefruit juice, or other liquids. Only glass or plastic cups should be used to mix sirolimus oral solution.
    • The syringe and cap should be used only one time and then thrown away.
    • Throw away the paper towel and clean the work surface. Wash your hands.
    7. Always store the bottles of medication in the refrigerator.

How should I store sirolimus oral solution?

  • Store bottles of sirolimus oral solution in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Protect from light.
  • Store sirolimus 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.
  • If necessary, bottles of sirolimus oral solution can be stored at room temperature up to 77°F (25°C) for up to 15 days.
  • When a bottle of sirolimus oral solution is opened, it should be used within 1 month.
  • Use any diluted sirolimus oral solution right away.

Keep sirolimus oral solution and all medicines out of the reach of children.

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

torrent-logo-2-

Manufactured by:

Cambrex Whippany, NJ 07981

Manufactured For: TORRENT PHARMA INC.,Levittown, PA 19057 Issued: January 2022

PRINCIPAL DISPLAY PANEL — 60 mL Bottle Label

Bottle

bottle
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 mL Bottle Carton

Carton

carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mg/mL Oral Solution Bottle Carton Kit

Carton kit

kit
(click image for full-size original)
SIROLIMUS sirolimus solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-658
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIROLIMUS (SIROLIMUS) SIROLIMUS 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-658-87 1 CARTON in 1 KIT contains a CARTON
1 1 BOTTLE, GLASS in 1 CARTON This package is contained within the KIT (13668-658-87) and contains a BOTTLE, GLASS (13668-658-13)
1 NDC:13668-658-13 60 mL in 1 BOTTLE, GLASS This package is contained within a CARTON and a KIT (13668-658-87)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215016 12/27/2021
Labeler — Torrent pharmaceuticals limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Cambrex Pharmaceutical 829609168 manufacture (13668-658), analysis (13668-658)

Revised: 01/2022 Torrent pharmaceuticals limited

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