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Instructions for Use - Figure 1
Important information
Store TEGSEDI in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original container.
Do not freeze.
TEGSEDI prefilled syringes can also be kept at room temperature that is no higher than 86°F (30°C) in the original container for up to 6 weeks.
Do not let TEGSEDI reach temperatures above 86°F (30°C).
If you do not use TEGSEDI kept at room temperature within the 6 weeks, throw it away.
Protect from light.
Keep TEGSEDI and all medicines out of reach of children.
Each TEGSEDI prefilled syringe contains 1 dose of TEGSEDI and is for 1-time use only.
Warnings
Do not remove needle cap until you have reached Step 6 of the Injection phase of these instructions and are ready to inject TEGSEDI
Do not share your syringe with another person or re-use your syringe
Do not use if dropped onto a hard surface or damaged
Do not shake or freeze the prefilled syringe
Do not use if the expiration date on the side of the syringe body has passed
If any of the above happens, throw away the prefilled syringe in a puncture-resistant (sharps) container and use a new prefilled syringe.
Preparation
Step 1. Gather supplies
Instructions for Use - Figure 2
1 TEGSEDI prefilled syringe from the refrigerator
1 Alcohol wipe (not supplied)
1 Gauze pad or cotton ball (not supplied)
1 Puncture-resistant (sharps) container (not supplied)
Do not perform the injection without all the supplies listed.
Step 2. Prepare to use your TEGSEDI prefilled syringe
Remove the TEGSEDI tray from the carton and check the expiration date. Do not use if the expiration date has passed.
Let TEGSEDI warm up at room temperature 68°F to 77°F (20°C to 25°C) for 30 minutes before giving the injection.
Do not warm the syringe in any other way. For example, do not warm in a microwave or hot water, or near other heat sources.
Remove the syringe from the tray by holding onto the syringe body.
Do not move the plunger
Do not remove the syringe from the tray by holding onto the needle cap or plunger.
Instructions for Use - Figure 3
Step 3. Check medicine in the syringe
Instructions for Use - Figure 4
Look in the inspection area to check that the TEGSEDI solution is clear and colorless or pale yellow in color. It is normal to see air bubbles in the solution. You do not need to do anything about it.
Do not use if the solution looks cloudy, discolored, or has particles. Throw the prefilled syringe away in a puncture resistant (sharps) container, and use a new prefilled syringe.
Step 4. Choose the injection site
Instructions for Use - Figure 5
Choose an injection site on your abdomen or the front of your thigh.
Do not inject into the same site each time.
Do not inject into the 2 inch area around the belly-button (naval).
Do not inject where skin is bruised, tender, red, or hard.
Do not inject into areas of the skin with scars or tattoos.
Do not inject through clothing.
Step 5. Clean the injection site
Instructions for Use - Figure 6
Wash your hands with soap and water.
Clean the injection site with an alcohol wipe in a circular motion. Let the skin air dry.
Do not touch the area again before injecting.
Injection
Step 6. Remove the needle cap
Instructions for Use - Figure 7
Hold the syringe by the body, with the needle facing away from you.
Remove needle cap by pulling it straight off. Do not to twist it off.
You may see a drop of liquid at the end of the needle. This is normal.
Keep your hands away fro |
