SEMGLEE INSULIN VIAL
SEMGLEE and Insulin Glargine (insulin glargine-yfgn) are also available in a 10 mL vial 100 units/mL (U-100).
The
10 mL vial
A U-100 insulin syringe and needle. Needles are sold separately
Alcohol wipes
1 sharps disposal container for throwing away used
needles and syringes†
SUPPLIES NEEDED TO GIVE THE INJECTION:
BEFORE PREPARING YOUR SEMGLEE DOSE
DO
Wash
your hands with soap and water or clean them with rubbing alcohol.
Check the
SEMGLEE label to make sure you are taking the right type of insulin. This is especially
important if you use more than one type of insulin.
Always
use a syringe that is marked for U-100 insulin. If you use a syringe other
than a U-100 insulin syringe, you could be administering an incorrect dose.
Always
use a new syringe or needle for each injection. Do not reuse or share your syringes
or needles with other people. You may give other people a serious infection or get a
serious infection from them.
DON'T
Do
not use SEMGLEE if it is colored or cloudy or if you see particles in the
solution.
Do
not use SEMGLEE after the expiration date stamped on the label or 28 days
after you first use it.
Do
not reuse syringes.
Do
not share syringes or needles with other people, even if the needle
has been changed. You could give other people a serious infection or get a serious
infection yourself.
INSTRUCTIONS FOR USE SEMGLEE® (insulin glargine-yfgn) injection for subcutaneous
use 10 mL Vial 100 units/mL (U-100)
-
Step 1
-
If using a new vial, remove the protective cap. Do not remove the rubber stopper.
-
-
Step 2
-
Wipe the top of the vial with an alcohol wipe. You do not have to shake the vial before use.
-
-
Step 3
-
Draw air into the syringe equal to the insulin dose. Put the needle through the rubber top of the vial and push the plunger to inject the air into the vial.
-
-
Step 4
-
Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly in one hand. Make sure the tip of the needle is in the insulin. With your free hand, pull the plunger to withdraw the correct dose into the syringe.
-
-
Step 5
-
Before taking the needle out of the vial, check the syringe for air bubbles. If bubbles are in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw insulin back in until you have the correct dose.
-
-
Step 6
-
Remove the needle from the vial. Do not let the needle touch anything.
Administer the SEMGLEE injection:
- Inject insulin exactly as healthcare provider has discussed with you.
- Inject insulin under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
- Change (rotate) injection site within the area chosen for each dose to reduce risk of getting pits in the skin or thickened skin (lipodystrophy), and skin with lumps (localized cutaneous amyloidosis) at the injection sites.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
-
-
Step 7
-
Choose injection site. Wipe the skin with an alcohol wipe to clean the injection site. Let the injection site dry before injecting dose.
-
-
Step 8
- Pinch the skin.
- Insert the needle in the way your healthcare provider showed you.
- Release the skin.
- Slowly push in the plunger of the syringe all the way, making sure all the insulin has been injected.
- Leave the needle in the skin for about 10 seconds.
-
Step 9
-
Pull the needle straight out of skin. Gently press the injection site for several seconds. Do not rub the area. Do not recap the used needle since it can lead to a needlestick injury.
-
DISPOSING OF USED NEEDLES AND SYRINGES
- Put your used needles and syringes in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
- If you do not have an FDA-cleared sharps container, you may use a household
container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak resistant, and
- properly labeled to warn of hazardous waste inside the container.
- When the sharps disposal container is almost full, follow your community guidelines for the correct disposal of your sharps container. There may be state or local laws about how to throw away used needles and syringes.
- Do not dispose of a sharps container in a household trash unless community guidelines permit this. Do not recycle your used sharps disposal container.
- For more information about safe sharps disposal, and for specific information about
sharps disposal in the state that you live in, go to the FDA’s website at:
http://www.fda.gov/safesharpsdisposal.
SEMGLEE STORAGE
- Store unused
SEMGLEE vials in the refrigerator between 36° and 46°F (2° to 8°C) until the
expiration date. If the unopened SEMGLEE vial is stored at room temperature, up to 86°F
(30°C), it should be thrown away after 28 days.
Store
in-use (opened) SEMGLEE vials in a refrigerator or at room temperature up to 86°F
(30°C).- The SEMGLEE
vials should be thrown away after 28 days, even if it still has insulin left in it.
Do
not freeze SEMGLEE.
Keep SEMGLEE
out of direct heat and light. - If a vial has
been frozen or overheated, throw it away.
