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DailyMed – TIROSINT SOL TIROSINT SOL


Instructions for Use

TIROSINT

®-SOL (tee-row-sent-sōl)

(levothyroxine sodium)

oral solution

Read this Instructions for Use before you start taking TIROSINT-SOL and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important Information:

  • TIROSINT-SOL is for oral use only.

    Do not inhale, inject, or place TIROSINT-SOL in the eyes.

  • TIROSINT-SOL can be taken:
    • by diluting or mixing in water first or
    • by directly squeezing into the mouth or onto a spoon.
  • Do not dilute or mix TIROSINT-SOL with any liquid other than water.

  • Open the ampule and prepare the solution right before you take TIROSINT-SOL.
  • After you have diluted or mixed TIROSINT-SOL it must be taken or thrown away.

Step 1. Open the aluminum pouch by tearing the edge along the dotted line

(See

Figure A)

.

                Figure A

Step 2. Remove 1 ampule from the strip to be used right away

(See

Figure B)

. Return the unused ampules back into the pouch before storing.

Figure B

                Figure B

Step 3. Hold the TIROSINT-SOL ampule upright (cap on top) between the first finger and thumb without squeezing the ampule. Open the ampule by twisting off the top

(See

Figure C)

.

Figure C

                Figure C

Step 4.

Taking TIROSINT-SOL by diluting or mixing:

Figure D

                Figure D

Taking TIROSINT-SOL directly into the mouth or by spoon:

Figure E

                Figure E

Step 5. Throw away (discard) the empty ampule.

How should I store TIROSINT-SOL?

  • Store TIROSINT-SOL at room temperature between 68°F to 77°F (20°C to 25°C).
  • Use TIROSINT-SOL within three (3) months after opening the pouch. Keep TIROSINT-SOL in the original closed pouch until you are ready to use it as important information may be lost (i.e., manufacturer/distributor names and distributor contact phone number.
  • Do not store the diluted or mixed TIROSINT-SOL solution.

Keep TIROSINT-SOL and all medicines out of the reach of children.

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

Manufacturer: IBSA Institut Biochimique SA, 6915 Pambio-Noranco, Switzerland

Marketed and Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054 USA

Issued: January 2021



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