Insulin Vial

SEMGLEE® and Insulin Glargine (insulin glargine-yfgn) injection are available as a 10 mL Vial (100 units/mL, U-100)

The following instructions are provided to patients for use. Click here for Instructions for Use.

Supplies needed for injection:

  • A SEMGLEE 10 mL vial
  • A U-100 insulin syringe and needle.
  • Alcohol wipes.
  • 1 sharps container for throwing away used needles and syringes.
Do not share syringes with other people even if the needle has been changed. Doing so could give other people a serious infection, or get a serious infection from them.

Preparing the dose:

  • Wash hands with soap and water or with alcohol.
  • Check the vial label to make sure taking the right type of insulin. This is especially important if using more than 1 type of insulin.
  • Check the insulin to make sure it is clear and colorless. Do not use SEMGLEE if it is colored or cloudy, or if particles are visible in the solution.
  • Do not use SEMGLEE after the expiration date stamped on the label or 28 days after first use.
  • Always use a syringe that is marked for U-100 insulin. Using a syringe other than a U-100 insulin syringe, patient may get the wrong dose of insulin.
  • Always use a new syringe or needle for each injection. Do not reuse or share syringes or needles with other people. Doing so may give other people a serious infection or get a serious infection from them.

Step 1:
If using a new vial, remove the protective cap. Do not remove the rubber stopper.

Removing Protective Cap from Vial

Step 2:
Wipe the top of the vial with an alcohol wipe. Do not shake the vial of SEMGLEE before use.

Cleaning Top of Vial with Alcohol Wipe

Step 3:
Draw air into the syringe equal to your insulin dose. Put the needle through the rubber top of the vial and push the plunger to inject the air into the vial.

Drawing Air into Syringe and Pushing Plunger to Inject Air into the Vial Once Needle is Through Rubber Top

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 free hand, pull the plunger to withdraw the correct dose into the syringe.

Vial is Upside Down with Inserted Syringe, Pulling the Plunger to Correct Dose

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 patient has the correct dose.

Tapping Syringe Before Removing Syringe From Vial

Step 6:
Remove the needle from the vial. Do not let the needle touch anything. Ready to inject.

Giving SEMGLEE injection:

  • -  Inject insulin exactly as healthcare provider has discussed.
  • -  Inject insulin under the skin (subcutaneously) of thigh, buttocks, 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.

Wiping Injection Site with Alcohol Wipe

Step 8:

  • - Pinch the skin.
  • - Insert the needle in the way the healthcare provider showed.
  • - 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.
Injecting Needle into Body in Area of Pinched Skin

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. Recapping the needle can lead to a needle stick injury.
     Disposing of used needles and syringes:
  • - Put used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not
      throw away (dispose of) loose needles and syringes in household trash.

  • - If you do not have a FDA-cleared sharps container, use a household container that is:
    1. - made of a heavy-duty plastic,
    2. - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    3. - upright and stable during use,
    4. - leak resistant, and
    5. - properly labeled to warn of hazardous waste inside the container.

  • - When sharps disposal container is almost full, follow community guidelines for the right way to dispose of
      sharps disposal container. There may be state or local laws about how to throw away used needles
      and syringes. 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.

  • - Do not dispose of used sharps disposal container in household trash unless community guidelines permit
      this. Do not recycle used sharps disposal container.
     How to store SEMGLEE?
  • - Store unused SEMGLEE vials in the refrigerator at 36° to 46°F (2° to 8°C).
      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.

References:

  • SEMGLEE® (insulin glargine-yfgn) injection. Prescribing Information. 2023. Biocon Biologics Inc. Cambridge, MA.  
  • SEMGLEE® (insulin glargine-yfgn) injection. Instructions for use. Biocon Biologics Inc. Cambridge, MA.