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Lantus: Package Insert and Label Information (Page 7 of 7)

LANTUS® SOLOSTAR® (insulin glargine [rDNA origin] injection)

Instruction Leaflet

Your healthcare professional has decided that SoloStar® is right for you. Talk with your healthcare professional about proper injection technique before using SoloStar®.

Read these instructions carefully before using your SoloStar®. If you are not able to follow all the instructions completely on your own, use SoloStar® only if you have help from a person who is able to follow the instructions.

Follow these instructions completely each time you use SoloStar® to ensure that you get an accurate dose. If you do not follow these instructions you may get too much or too little insulin, which may affect your blood glucose.

SoloStar® is a disposable pen for the injection of insulin. Each SoloStar® contains in total 300 units of insulin. You can set doses from 1 to 80 units in steps of 1 unit.

Keep this leaflet for future reference.

If you have any questions about Solostar® or about diabetes, ask your healthcare professional, go to www.lantus.com or call sanofi aventis at 1-800-633-1610.

Figure
(click image for full-size original)

Important information for use of SoloStar®:

  • Always attach a new needle before each use.

    BD Ultra-Fine needles are compatible with SoloStar®. These are sold separately and manufactured by BD. Contact your healthcare professional for further information.

  • Always perform the safety test before each injection.
  • This pen is only for your use. Do not share it with anyone else.
  • If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
  • Never use SoloStar® if it is damaged or if you are not sure that it is working properly.
  • Always have a spare SoloStar® in case your SoloStar® is lost or damaged.

Storage Instructions

Please check the leaflet for the insulin for complete instructions on how to store SoloStar®.

If your SoloStar® is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject.

Keep SoloStar® out of the reach and sight of children.

Keep your SoloStar® in cool storage (36°F – 46°F [2°C – 8°C]) until first use. Do not allow it to freeze. Do not put it next to the freezer compartment of your refrigerator, or next to a freezer pack.

Once you take your SoloStar® out of cool storage, for use or as a spare, you can use it for up to 28 days. During this time it can be safely kept at room temperature up to 86°F (30°C). Do not use it after this time. SoloStar® in use must not be stored in a refrigerator.

Do not use SoloStar® after the expiration date printed on the label of the pen or on the carton.

Protect SoloStar® from light.

Discard your used SoloStar® as required by your local authorities.

Maintenance

Protect your SoloStar® from dust and dirt.

You can clean the outside of your SoloStar® by wiping it with a damp cloth.

Do not soak, wash or lubricate the pen as this may damage it.

Your SoloStar® is designed to work accurately and safely. It should be handled with care. Avoid situations where SoloStar® might be damaged. If you are concerned that your SoloStar® may be damaged, use a new one.

Step 1. Check the insulin

A.
Check the label on your SoloStar® to make sure you have the correct insulin. The Lantus® SoloStar® is grey with a purple injection button.
B.
Take off the pen cap.
C.
Check the appearance of your insulin. Lantus® is a clear insulin. Do not use this SoloStar® if the insulin is cloudy, colored or has particles.

Step 2. Attach the needle

Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.

A.
Wipe the Rubber Seal with alcohol.
B.
Remove the protective seal from a new needle.
C.
Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).

Figure

  • If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.

    Figure

Step 3. Perform a Safety test

Always perform the Safety test before each injection.Performing the safety test ensures that you get an accurate dose by:

  • ensuring that pen and needle work properly
  • removing air bubbles
A.
Select a dose of 2 units by turning the dosage selector.

Figure

B.
Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it.

Figure

C.
Hold the pen with the needle pointing upwards.
D.
Tap the insulin reservoir so that any air bubbles rise up towards the needle.
E.
Press the injection button all the way in. Check if insulin comes out of the needle tip.

Figure

You may have to perform the safety test several times before insulin is seen.

  • If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
  • If still no insulin comes out, the needle may be blocked. Change the needle and try again.
  • If no insulin comes out after changing the needle, your SoloStar® may be damaged. Do not use this SoloStar®.

Step 4. Select the dose

You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.

A.
Check that the dose window shows “0″ following the safety test.
B.
Select your required dose (in the example below, the selected dose is 30 units). If you turn past your dose, you can turn back down.

Figure

  • Do not push the injection button while turning, as insulin will come out.
  • You cannot turn the dosage selector past the number of units left in the pen. Do not force the dosage selector to turn. In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar® or use a new SoloStar® for your full dose.

Step 5. Inject the dose

A.
Use the injection method as instructed by your healthcare professional.
B.
Insert the needle into the skin.

Figure
(click image for full-size original)

C.
Deliver the dose by pressing the injection button in all the way. The number in the dose window will return to “0″ as you inject.

Figure

D.
Keep the injection button pressed all the way in. Slowly count to 10 before you withdraw the needle from the skin. This ensures that the full dose will be delivered.

Step 6. Remove and discard the needle

Always remove the needle after each injection and store SoloStar® without a needle attached. This helps prevent:

  • Contamination and/or infection
  • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
A.
Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injury, never replace the inner needle cap.
  • If your injection is given by another person, special caution must be taken by this person when removing and disposing the needle. Follow recommended safety measures for removal and disposal of needles (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
B.
Dispose of the needle safely. Used needles should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.
If you are giving an injection to a third person, you should remove the needle in an approved manner to avoid needle-stick injuries.
C.
Always put the pen cap back on the pen, then store the pen until your next injection.

sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

Country of Origin: Germany

Date of revision:
March 2007

©2007 sanofi-aventis U.S. LLC

PRINCIPAL DISPLAY PANEL — 10 mL-1 Count Vial

NDC 55045-3685-01
(click image for full-size original)

NDC 55045-3685-01Rx ONLY

Lantus®

insulin glargine (rDNA origin) injection

100 units/mL (U-100)

FOR SUBCUTANEOUS INJECTION ONLY

DO NOT MIX WITH OTHER INSULINS

STORE REFRIGERATED – DO NOT FREEZE

One 10mL Vial

LANTUS insulin glargine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55045-3685(NDC:0088-2220)
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
insulin glargine (insulin glargine) insulin glargine 100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
zinc 30 ug in 1 mL
METACRESOL 2.7 mg in 1 mL
glycerin 20 mg in 1 mL
water
hydrochloric acid
sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55045-3685-1 10 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021081 09/23/2009
Labeler — Dispensing Solutions, Inc. (066070785)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 relabel, repack

Revised: 09/2011 Dispensing Solutions, Inc.

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