Lilly HUMALOG 4 Mix75/25 Pen User Manual

3 ml disposable insulin delivery device

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75% INSULIN LISPRO PROTAMINE SUSPENSION AND
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THIS LILLY HUMAN INSULIN ANALOG MIXTURE IS DIFFERENT FROM
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OTHER INSULIN MIXTURES IN THAT ITS ONSET OF ACTION IS VERY
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QUICK. THE QUICK ONSET OF ACTION MEANS THAT YOU SHOULD
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TAKE YOUR DOSE OF HUMALOG
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PROTAMINE SUSPENSION AND 25% INSULIN LISPRO INJECTION, [rDNA
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ORIGIN]) WITHIN 15 MINUTES BEFORE YOU EAT.
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ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY
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UNDER MEDICAL SUPERVISION. CHANGES IN STRENGTH,
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MANUFACTURER, TYPE (E.G., REGULAR, NPH, ANALOG), SPECIES (BEEF,
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PORK, BEEF-PORK, HUMAN), OR METHOD OF MANUFACTURE (rDNA
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VERSUS ANIMAL-SOURCE INSULIN) MAY RESULT IN THE NEED FOR A
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CHANGE IN THE TIMING OR DOSAGE OF HUMALOG Mix75/25.
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PATIENTS TAKING HUMALOG Mix75/25 MAY REQUIRE A CHANGE IN
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DOSAGE FROM THAT USED WITH OTHER INSULINS. IF AN ADJUSTMENT
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IS NEEDED, IT MAY OCCUR WITH THE FIRST DOSE OR DURING THE
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FIRST SEVERAL WEEKS OR MONTHS.
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TO OBTAIN AN ACCURATE DOSE, CAREFULLY READ AND FOLLOW
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THE "DISPOSABLE INSULIN DELIVERY DEVICE USER MANUAL" AND
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THIS "INFORMATION FOR THE PATIENT" INSERT BEFORE USING THIS
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PRODUCT.
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BEFORE EACH INJECTION, YOU SHOULD PRIME THE PEN, A
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NECESSARY STEP TO MAKE SURE THE PEN IS READY TO DOSE.
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PRIMING THE PEN IS IMPORTANT TO CONFIRM THAT INSULIN COMES
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OUT WHEN YOU PUSH THE INJECTION BUTTON AND TO REMOVE AIR
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THAT MAY COLLECT IN THE INSULIN CARTRIDGE DURING NORMAL
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USE. IF YOU DO NOT PRIME, YOU MAY RECEIVE TOO MUCH OR TOO
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LITTLE INSULIN (see also INSTRUCTIONS FOR INSULIN PEN USE section).
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Insulin is a hormone produced by the pancreas, a large gland that lies near the stomach. This
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hormone is necessary for the body's correct use of food, especially sugar. Diabetes occurs when
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the pancreas does not make enough insulin to meet your body's needs.
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To control your diabetes, your doctor has prescribed injections of insulin products to keep your
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blood glucose at a near-normal level. You have been instructed to test your blood and/or urine
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regularly for glucose. Studies have shown that some chronic complications of diabetes such as
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eye disease, kidney disease, and nerve disease can be significantly reduced if the blood sugar is
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maintained as close to normal as possible. The American Diabetes Association recommends that
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if your pre-meal glucose levels are consistently above 130 mg/dL, bedtime glucose levels are
INFORMATION FOR THE PATIENT
3 ML DISPOSABLE INSULIN DELIVERY DEVICE
®
HUMALOG
Mix75/25™ Pen
25% INSULIN LISPRO INJECTION
(rDNA ORIGIN)
100 UNITS PER ML (U-100)
WARNINGS
®
Mix75/25™ (75% INSULIN LISPRO
DIABETES
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5.01 PA 9235 FSAMP

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Summary of Contents for Lilly HUMALOG 4 Mix75/25 Pen

  • Page 1 25% INSULIN LISPRO INJECTION (rDNA ORIGIN) 100 UNITS PER ML (U-100) WARNINGS THIS LILLY HUMAN INSULIN ANALOG MIXTURE IS DIFFERENT FROM OTHER INSULIN MIXTURES IN THAT ITS ONSET OF ACTION IS VERY QUICK. THE QUICK ONSET OF ACTION MEANS THAT YOU SHOULD ®...
  • Page 2 (rDNA origin) injection (rDNA origin), by Eli Lilly and Company, has the trademark Humalog. Humalog products are available in two formulations — Humalog and Humalog Mix75/25. Your doctor has prescribed the type of insulin that he/she believes is best for you.
  • Page 3 be examined frequently. Do not use if the insulin substance (the white material) remains visibly separated from the liquid after mixing. Do not use a Humalog Mix75/25 Pen if there are clumps in the insulin after mixing. Do not use a Humalog Mix75/25 Pen if solid white particles stick to the bottom or wall of the cartridge, giving a frosted appearance.
  • Page 4 6. After injecting a dose, pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area. 7. Immediately after an injection, remove the needle from the Humalog Mix75/25 Pen. Doing so will guard against contamination, and prevent leakage of Humalog Mix75/25, reentry of air, and needle clogs.
  • Page 5 7. Interactions with other drugs that lower blood glucose, such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, and certain antidepressants. 8. Consumption of alcoholic beverages. Symptoms of mild to moderate hypoglycemia may occur suddenly and can include: •...
  • Page 6 The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979). Literature revised XXX, 2004 Manufactured by Lilly France S.A.S. F-67640 Fegersheim, France For Eli Lilly and Company Indianapolis, IN 46285, USA Copyright © 1999, 2004, Eli Lilly and Company. All rights reserved. 5.01 PA 9235 FSAMP...
  • Page 7 5.01 PA 9115 FSAMP Lilly Disposable Insulin Delivery Device User Manual Instructions for Use Read and follow all of these instructions carefully. If you do not follow these instructions completely, you may get too much or too little insulin. Every time you inject: •...
  • Page 8: Table Of Contents

    Table of Contents _______________________________________________________________ Pen Parts......................3 Important Notes....................4 Preparing the Pen ....................6 Attaching the Needle ..................8 Priming the Pen....................10 Setting a Dose....................14 Injecting a Dose....................16 Following an Injection..................18 Questions and Answers ................... 20 _______________________________________________________________...
  • Page 9: Pen Parts

    Pen Parts Injection Button Dose Knob Raised Notch Raised Notch Dose Window Label Pen Cap Insulin Cartridge Clear Cartridge Holder Rubber Seal Paper Needle Inner Needle Shield Outer Needle Shield...
  • Page 10: Important Notes

    Important Notes • Read and follow all of these instructions carefully. If you do not follow these instructions completely, you may get too much or too little insulin. • Use a new needle for each injection. • Be sure a needle is completely attached to the Pen before priming, setting the dose and injecting your insulin.
  • Page 11 Important Notes (Continued) • After a Pen is used for the first time, it should NOT be refrigerated but should be kept at room temperature [below 86°F (30°C)] and away from direct heat and light. • An unrefrigerated Pen should be discarded according to the time specified in the Information for the Patient insert, even if it still contains insulin.
  • Page 12: Preparing The Pen

    I. Preparing the Pen 1. Before proceeding, refer to the INFORMATION FOR THE PATIENT insert for instructions on checking the appearance of your insulin. 2. Check the label on the Pen to be sure the Pen contains the type of insulin that has been prescribed for you.
  • Page 13 I. Preparing the Pen (Continued) 5. If your insulin is a suspension (cloudy): a. Roll the Pen back and forth 10 times then perform step b. b. Gently turn the Pen up and down 10 times until the insulin is evenly mixed.
  • Page 14: Attaching The Needle

    II. Attaching the Needle This device is suitable for use with Becton Dickinson and Company’s insulin pen needles. 1. Always use a new needle for each injection. Do not push injection button without a needle attached. Storing the Pen with the needle attached may allow insulin to leak from the Pen and air bubbles to form in the cartridge.
  • Page 15 II. Attaching the Needle (Continued) 4. Hold the Pen with the needle pointing up and remove the outer needle shield. Keep it to use during needle removal. 5. Remove the inner needle shield and discard.
  • Page 16: Priming The Pen

    III. Priming the Pen • The Pen must be primed before each injection to make sure the Pen is ready to dose. Performing the priming step is important to confirm that insulin comes out when you push the injection button, and to remove air that may collect in the insulin cartridge during normal use.
  • Page 17 III. Priming the Pen (Continued) 3. With the arrow in the center of the dose window, pull the dose knob out in the direction of the arrow until a “0” is seen in the dose window. 4. Turn the dose knob clockwise until the number “2”...
  • Page 18 III. Priming the Pen (Continued) 5. Hold your Pen with the needle pointing up. Tap the clear cartridge holder gently with your finger so any air bubbles collect near the top. Using your thumb, if possible, push in the injection button completely. Keep pressing and continue to hold the injection button firmly while counting slowly to 5.
  • Page 19 III. Priming the Pen (Continued) 6. At the completion of the priming step, a diamond (♦) must be seen in the center of the dose window. If a diamond (♦) is not seen in the center of the dose window, continue pushing on the injection button until you see a diamond (♦) in the center of the dose window.
  • Page 20: Setting A Dose

    IV. Setting a Dose • Always use a new needle for each injection. Storing the Pen with the needle attached may allow insulin to leak from the Pen and air bubbles to form in the cartridge. • Caution: Do not push in the injection button while setting your dose. Failure to follow these instructions carefully may result in getting too much or too little insulin.
  • Page 21 IV. Setting a Dose (Continued) 3. With the arrow (→) in the center of the dose window, pull the dose knob out in the direction of the arrow until a “0” is seen in the dose window. A dose cannot be dialed until the dose knob is pulled out.
  • Page 22: Injecting A Dose

    V. Injecting a Dose • Always use a new needle for each injection. Storing the Pen with the needle attached may allow insulin to leak from the Pen and air bubbles to form in the cartridge. • Caution: Do not attempt to change the dose after you begin to push in the injection button.
  • Page 23 V. Injecting a Dose (Continued) 1. Wash hands. Prepare the skin and use the injection technique recommended by your Health Care Professional. 2. Insert the needle into your skin. Inject the insulin by using your thumb, if possible, to push in the injection button completely. 3.
  • Page 24: Following An Injection

    VI. Following an Injection 1. Make sure you got your full dose by checking that the injection button has been completely pushed in and you can see a diamond (♦) or arrow (→) in the center of the dose window. If you do not see the diamond (♦) or arrow (→) in the center of the dose window, you have not received your full dose.
  • Page 25 VI. Following an Injection (Continued) 3. Remove the capped needle by turning it counterclockwise. Place the used needle in a puncture-resistant disposable container and properly throw it away as directed by your Health Care Professional. 4. Replace the cap on the Pen. 5.
  • Page 26: Questions And Answers

    Questions and Answers Problem Action 1. Dose dialed and injection To obtain an accurate dose you must: button pushed in without a 1) Attach a new needle. needle attached. 2) Push in the injection button completely (even if a “0” is seen in the window) until a diamond (♦) or arrow (→) is seen in the center of the dose window.
  • Page 27 Questions and Answers (Continued) Problem Action 3. Wrong dose (too high or If you have not pushed in the injection too low) dialed. button, simply turn the dose knob backward or forward to correct the dose. 4. Not sure how much insulin Hold the Pen with the needle end pointing remains in the cartridge.
  • Page 28 Questions and Answers (Continued) Problem Action 5. Full dose cannot be dialed. The Pen will not allow you to dial a dose greater than the number of insulin units remaining in the cartridge. For example, if you need 31 units and only 25 units remain in the Pen you will not be able to dial past 25.
  • Page 29 Questions and Answers (Continued) Problem Action 7. Cannot completely push in the Needle is not attached or is injection button when priming clogged. the Pen or injecting a dose. a. Attach a new needle. b. Push in the injection button completely (even if a “0”...
  • Page 30 For additional information call, 1-800-LILLY-RX (1-800-545-5979) Revised XX, 2004 Manufactured by Lilly France S.A.S. F-67640 Fegersheim, France for Eli Lilly and Company Indianapolis, IN 46285, USA PA 9115 FSAMP...

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