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ADMELOG- insulin lispro injection, solution


  1. Patient Information
  2. Do Not Use Admelog If You:
  3. Your Dose Of Admelog May Need To Change Because Of:
  4. While Using Admelog Do Not:
  5. Admelog May Cause Serious Side Effects That Can Lead To Death, Including:
  6. Serious Allergic Reactions (whole Body Reaction). Get Medical Help Right Away, If You Have Any Of These Signs Or Symptoms Of A Severe Allergic Reaction:
  7. Treatment With Tzds And Admelog May Need To Be Adjusted Or Stopped By Your Healthcare Provider If You Have New Or Worse Heart Failure.get Emergency Medical Help If You Have:
  8. The Most Common Side Effects Of Admelog Include:
  9. Active Ingredient:
  10. Inactive Ingredients:
  11. Manufactured By:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Never Share an ADMELOG SoloStar Prefilled Pen or Syringe Between Patients

Advise patients that they must never share an ADMELOG SoloStar pen with another person, even if the needle is changed. Advise patients using ADMELOG vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

Hypoglycemia

Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of ADMELOG therapy. Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct patients on the management of hypoglycemia.

Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery[

  • ADMELOG is a man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.
  • It is not known if ADMELOG is safe and effective in children younger than 3 years of age or when used to treat children with type 2 diabetes mellitus.

Do Not Use Admelog If You: 

  • are having an episode of low blood sugar (hypoglycemia).
  • have an allergy to ADMELOG or any of the ingredients in ADMELOG.
    • Read the detailedInstructions for Usethat come with your ADMELOG.
    • Use ADMELOG exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much ADMELOG to use and when to use it.
    • Know the amount of ADMELOG you use.Do notchange the amount of ADMELOG you use unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take a different type of insulin.
    • Check your insulin label each time you give your injection to make sure you are using the correct insulin.
    • ADMELOG comes in a vial or in a SoloStar disposable prefilled pen.
      Do notreuse needles. Always use a new needle for each injection. Reuse of needles increases your risk of having blocked needles, which may cause you to get the wrong dose of ADMELOG. Using a new needle for each injection also lowers your risk of getting an infection. If your needle is blocked, follow the instructions in Step 3 of the Instructions for Use of your pen.
    • ADMELOG is a rapid-acting insulin. Take ADMELOG within15 minutesbefore eating or right after eating a meal.
    • ADMELOG is injected under your skin (subcutaneously).
    • Change (rotate) your injection site with each dose.
    • Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.
    Keep ADMELOG and all medicines out of the reach of children.

Your Dose Of Admelog May Need To Change Because Of: 

  • a change in physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

While Using Admelog Do Not: 

  • drive or operate heavy machinery, until you know how ADMELOG affects you.
  • drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

Admelog May Cause Serious Side Effects That Can Lead To Death, Including: 

  • low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
    • dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood changes, hunger.

Serious Allergic Reactions (whole Body Reaction). Get Medical Help Right Away, If You Have Any Of These Signs Or Symptoms Of A Severe Allergic Reaction: 

  • a rash over your whole body, trouble breathing, a fast heartbeat, feel faint, or sweating.
  • low potassium in your blood (hypokalemia).
  • heart failure.Taking certain diabetes pills called TZDs (thiazolidinediones) with ADMELOG may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with ADMELOG. Your healthcare provider should monitor you closely while you are taking TZDs with ADMELOG. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
    • shortness of breath, swelling of your ankles or feet, sudden weight gain.
  • Treatment With Tzds And Admelog May Need To Be Adjusted Or Stopped By Your Healthcare Provider If You Have New Or Worse Heart Failure.get Emergency Medical Help If You Have: 

    • trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

    The Most Common Side Effects Of Admelog Include: 

    • low blood sugar (hypoglycemia), allergic reactions, including reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, and rash.

    These are not all the possible side effects of ADMELOG.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    General information about the safe and effective use of ADMELOG
    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.Do notuse ADMELOG for a condition for which it was not prescribed.Do notgive ADMELOG to other people, even if they have the same symptoms that you have. It may harm them.
    You can ask your pharmacist or healthcare provider for information about ADMELOG that is written for health professionals. For more information, go to www.sanofi.com or call 1-800-633-1610.

    Active Ingredient: 

    insulin lispro

    Inactive Ingredients: 

    glycerin, dibasic sodium phosphate, metacresol, zinc oxide (zinc ion), and Water for Injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

    Manufactured By: 

    sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, A SANOFI COMPANYADMELOG and SoloStar are registered trademarks of sanofi-aventis U.S. LLC.

    Instructions for Use
    ADMELOG
    (ad-mah-log)
    (insulin lispro injection) for subcutaneous use
    10 mL or 3 mL Vial (100 Units/mL, U-100)

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

    Do not share your ADMELOG syringes with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

    Supplies needed to give your injection

    • an ADMELOG 10 mL or 3 mL vial
    • a U-100 insulin syringe and needle
    • 2 alcohol swabs
    • 1 sharps container for throwing away used needles and syringes.

      Unopened (not in-use) ADMELOG vials

      • Store unused ADMELOG vials in the refrigerator from 36 F to 46 F (2 C to 8 C).
      • Do notfreeze ADMELOG.
      • Keep ADMELOG away from direct heat and light.
      • If a vial has been frozen or overheated, throw it away.
      • Unopened vials can be used until the expiration date on the carton and label if they have been stored in the refrigerator.
      • Unopened vials should be thrown away after 28 days if they are stored at room temperature.

      After ADMELOG vials have been opened (in-use)

      • Store in-use (opened) ADMELOG vials in a refrigerator from 36 F to 46 F (2 C to 8 C) or at room temperature below 86 F (30 C) for up to28 days.
      • Do notfreeze ADMELOG.
      • Keep ADMELOG out of direct heat and light.
      • If a vial has been frozen, throw it away.
      • The ADMELOG vial you are using should be thrown away after28days, even if it still has insulin left in it.

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

      sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, A SANOFI COMPANY

      ADMELOG is a registered trademark of sanofi-aventis U.S. LLC.

      Revised: October 2018



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