Humalog Mix 50, 5 pcs., 3 ml, 100 IU/ml, suspension for subcutaneous administration

Instructions for use HUMALOG

Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in potency, brand (manufacturer), type (regular, NPH, lente, etc.), species (animal, human, human insulin analog) and/or production method (DNA recombinant insulin or animal insulin) may lead to the need to change the dose. When using short-acting insulins in patients also receiving basal insulin, it is necessary to adjust the dose of both insulins to achieve optimal blood glucose levels throughout the day, especially at night or on an empty stomach.

Conditions in which early warning symptoms of hypoglycemia may be nonspecific and less severe include long-term diabetes mellitus, intensive insulin therapy, nervous system disease associated with diabetes mellitus, or use of medications such as beta-blockers.

In some patients with hypoglycemic reactions after switching from animal insulin to human insulin, early symptoms of hypoglycemia may be less severe or different from those they experienced with the previous insulin. Uncorrected hypo- or hyperglycemic reactions may cause loss of consciousness, coma, or death.

Use in inadequate doses or discontinuation of treatment, especially in insulin-dependent diabetes mellitus, can lead to hyperglycemia and diabetic ketoacidosis, conditions that are potentially life-threatening to the patient.

Insulin requirements may be reduced in the presence of renal failure.

Insulin requirements may be reduced in patients with impaired liver function as a result of decreased gluconeogenesis and insulin metabolism, but in patients with chronic liver failure, increased insulin resistance may lead to increased insulin requirements.

The need for insulin may increase with illness or emotional stress.

Dose adjustment may also be required if the patient increases physical activity or changes their usual diet. Exercise immediately after eating increases the risk of hypoglycemia. A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycemia occurs, it may occur sooner after injection than with injection of soluble human insulin.

The patient should be warned that if the doctor has prescribed an insulin drug with a concentration of 40 IU/ml in a vial, then insulin should not be drawn from a cartridge with an insulin concentration of 100 IU/ml using a syringe for administering insulin with a concentration of 40 IU/ml.

The use of Humalog in children is preferable to the use of soluble human insulin only in cases where the rapid action of insulin is an advantage. For example, in the timing of injections relative to meals.

Combination of Humalog with pioglitazone:

Cases of heart failure have been reported when pioglitazone is used in combination with insulin, especially in patients with risk factors for its development. This should be taken into account when prescribing treatment with a combination of pioglitazone and Humalog. When using this combination, patients should be monitored for signs and symptoms of heart failure, weight gain, and edema. Pioglitazone should be discontinued if any symptoms of worsening cardiac function are noticed.

Effect on the ability to drive a car and other mechanical means

With hypoglycemia, the ability to concentrate and the speed of psychomotor reactions may be impaired. This can become a risk factor when these abilities are of particular importance (including when driving vehicles or working with machinery).

Patients should be advised to take precautions to avoid hypoglycemia while driving, this is especially important for patients who have reduced or absent awareness of the warning signs of hypoglycemia, or who experience frequent episodes of hypoglycemia. In these circumstances, it is necessary to evaluate the advisability of driving a vehicle.

Humalog®

Dosage regimen

The dose of Humalog® is determined by the doctor individually depending on the concentration of glucose in the blood. The insulin administration regimen is individual.

Humalog® can be administered shortly before meals. If necessary, Humalog® can be administered shortly after meals.

When administered subcutaneously, Humalog® begins to act quickly and has a shorter duration of action (from 2 to 5 hours) compared to soluble human insulin. The rapid onset of action allows Humalog® to be administered close to a meal. The time course of action of any insulin can vary significantly between patients or at different times within the same patient. The faster onset of action compared to soluble human insulin is maintained regardless of injection site. The duration of action of Humalog® depends on the dose, injection site, blood supply, temperature and physical activity.

The drug Humalog®, on the recommendation of a doctor, can be used in combination with longer-acting insulin.

The drug Humalog® 100 IU/ml in the KwikPen® syringe pen and the drug Humalog® 200 IU/ml in the KwikPen® syringe pen

Humalog® in the KwikPen® syringe pen is available in 2 concentrations: Humalog® 100 IU/ml and Humalog® 200 IU/ml. Both prefilled pens, Humalog® 100 IU/ml and Humalog® 200 IU/ml, allow you to administer from 1 to 60 IU in 1 IU increments per injection. When transferring a patient from one drug concentration to another, dose recalculation is not required.

The number of collected MEs for both concentrations of the drug is indicated in the dose indicator window of the KwikPen® syringe pen.

The drug Humalog® 200 IU/ml in the KwikPen® syringe pen should be used for the treatment of patients with diabetes mellitus who require a daily dose of short-acting insulin of more than 20 IU. A cartridge with a solution of insulin lispro with a concentration of 200 IU/ml cannot be removed from a syringe pen (KwikPen®) or mixed with other insulins.

Special patient groups

Kidney failure

In renal failure, the need for insulin may be reduced.

Liver failure

In patients with liver failure, insulin requirements may be reduced as a result of decreased gluconeogenesis and insulin metabolism; however, in patients with chronic liver failure, increased insulin resistance may lead to increased insulin requirements.

Mode of application

Humalog® 200 IU/ml should be administered subcutaneously.

Subcutaneous injections should be given in the upper arm, thigh, buttock or abdomen. Injection sites must be alternated so that the same site is used no more than approximately once a month.

When administering Humalog® subcutaneously, care must be taken to avoid the drug entering a blood vessel. After the injection, do not massage the injection site. Patients should be taught proper injection technique.

Humalog® 200 IU/ml in the KwikPen® syringe pen is not intended for administration using an insulin pump.

The drug Humalog® 200 IU/ml in the KwikPen® syringe pen is not intended for intravenous administration.

INSTRUCTIONS FOR USE OF THE QUIKPEN® PEN

UMALOG® QUIKPEN® 200 IU/ml, 3 ml

PLEASE READ THIS MANUAL BEFORE USING

USE ONLY IN THIS PEN TO AVOID SEVERE OVERDOSE

Read the QuickPen® Instructions for Use before using Humalog®, 200 IU/ml. Read the manual each time you start using your new KwikPen® Humalog® 200 IU/ml as there may be new information. The information contained in the QuickPen® manual is not intended to replace consultation with a physician regarding your medical condition or treatment.

Humalog® QuickPen®, 200 IU/mL (“pen”) is a single-use, prefilled pen that contains 3 mL (600 units, 200 units/mL) of Humalog®. With one pen you can inject several doses of insulin. The dose of the drug can be set with an accuracy of 1 unit. In one injection you can inject from 1 to 60 units. If your dose is more than 60 units, you will need to give more than one injection. With each injection, the piston moves only slightly, and you may not notice a change in its position. The plunger will only reach the bottom of the cartridge when you have used up all 600 units contained in the pen.

This pen is designed to deliver larger doses than other pens you may have previously used. Set your usual dose as directed by your doctor.

Humalog® QuickPen® is available in two dosages: 100 IU/ml and 200 IU/ml. Administer Humalog® 200 IU/ml using your pen ONLY. DO NOT transfer insulin from your pen to another insulin delivery device. Syringes will not provide an accurate dose of 200 IU/ml insulin. This may cause a severe overdose, which will result in very low blood glucose concentrations and may be life-threatening.

The syringe pen cannot be shared with other people, even when using a new needle. Do not reuse needles. Do not share needles with other people. The needle can transmit infection, which can lead to infection.

The pen is not recommended for use by patients with low vision or complete loss of vision without the assistance of people trained in the proper use of the pen.

How to recognize the drug Humalog® 200 IU/ml in the KwikPen® syringe pen

To perform the injection it is necessary

— Humalog®, 200 IU/ml, in a KwikPen® syringe pen;

— A needle compatible with the KwikPen® syringe pen (it is recommended to use needles manufactured by BD [Becton, Dickinson and Company]);

- Alcohol wipe.

Needles and alcohol wipes are not included.

Preparing a syringe pen for insulin injection

— Wash your hands with soap.

— Check your pen to make sure it contains the type of insulin you need. This is especially important if you are using more than one type of insulin.

— Do not use pens that have expired, which is indicated on the label. Do not use the pen for more than 28 days from the date of use.

— Use a new needle with each injection to prevent infection and to avoid needle clogging.

Checking the syringe pen for drug intake

This check should be carried out before each injection.

— Checking the syringe pen for the supply of the drug is carried out to remove air from the needle and cartridge, which may accumulate during normal storage, and to ensure the proper operation of the syringe pen.

- If you do not do this check before each injection, you may give either too low or too high a dose of insulin.

Dose selection

This pen has been designed to deliver the dose indicated in the window

dose indicator. Set your usual dose as directed by your doctor.

- You can administer from 1 to 60 units per injection.

- If your dose is greater than 60 units, you will need to take more than one

injections.

— If you need help with how to divide the dose correctly, contact your doctor.

— For each injection, use a new needle and repeat the procedure

checking the syringe pen for the supply of the drug.

— If there is less insulin left in the syringe pen than you need, you will not be able to administer the dose you need using this syringe pen.

— If you need a dose that exceeds the number of units remaining in the pen, you can:

— inject the amount remaining in your pen and then use a new pen to administer the rest of the dose, or

- take a new syringe pen and inject the full dose.

— There may be a small amount of insulin left in the pen that you cannot inject. Do not transfer this insulin to another syringe. This can lead to a significant overdose.

Carrying out the injection

— Carry out the insulin injection strictly in accordance with what your doctor has shown.

- Change (alternate) injection sites with each injection.

- Do not try to change the dose during the injection.

With each injection, the piston moves only slightly, and you may not notice a change in its position.

If you notice a drop of blood after removing the needle from the skin, gently press a clean gauze pad onto the injection site. Do not rub this area.

After the injection

Disposal of syringe pens and needles

Place used needles in a sharps container or hard plastic container with a tight-fitting lid. Do not dispose of needles in areas designated for household waste.

The used syringe pen can be disposed of as household waste after the needle is removed.

Ask your healthcare professional about how to dispose of your sharps container.

The needle disposal guidelines provided in this manual do not replace the rules, regulations, or policies of each healthcare facility.

Storing a syringe pen

Unused syringe pens

— Store unused pens in the refrigerator at a temperature between 2°C and 8°C.

— Do not freeze the insulin you use. If it has been frozen, do not use it.

— Unused pens can be stored until the expiration date stated on the label if stored in the refrigerator.

Used syringe pen

— Do not store the pen you are currently using in the refrigerator. A syringe pen in use should be stored at a temperature not exceeding 30°C in a place protected from heat and light.

— You should throw away a pen that has been in use for more than 28 days, even if there is insulin left in it.

General information about the safe and effective use of pen syringes

— Keep the pen and needles out of the reach of children.

— Do not use the pen if any part of it appears broken or damaged.

— Always carry a spare pen with you in case your pen gets lost or broken.

Troubleshooting

— If you cannot remove the cap from the syringe pen, carefully twist it back and forth, and then pull the cap.

— If the dose dial button is difficult to press:

— Press the dose dial button more slowly. By slowly pressing the dose dial button it is easier to inject.

— The needle may be blocked. Put on a new needle and check the syringe pen for drug delivery.

— Dust, food or other substances may have gotten inside the syringe pen. Throw away this syringe pen and get a new one.

— Do not transfer insulin from a pen to another syringe. This can lead to severe overdose.

If you have any questions or problems regarding the use of the drug Humalog® 200 IU/ml in the KwikPen® syringe pen, contact your doctor for help or contact the Representative Office of Eli Lilly Vostok S.A. in Moscow.

Humalog® and Humalog® QuickPen® are trademarks.

Humalog overdose, symptoms and treatment

Leads to the development of hypoglycemia, which is manifested by lethargy, apathy, impaired consciousness, tremor, sweating, tachycardia, vomiting and headache. Hypoglycemia can develop as a result of an overdose of insulin lispro relative to the amount of food taken, increased energy expenditure, or both. Hypoglycemia can usually be corrected by oral glucose. Dose, diet, or exercise adjustments may be necessary. More severe episodes of hypoglycemia attacks, which are accompanied by coma, convulsions or other neurological disorders, are stopped by intramuscular or subcutaneous administration of glucagon or intravenous administration of concentrated glucose solution. Carbohydrate maintenance and medical monitoring may be necessary as hypoglycemia may recur after apparent clinical improvement.

Humalog drug interactions

The need for insulin may increase with the simultaneous use of drugs with hyperglycemic effects, such as oral contraceptives, corticosteroids or thyroid hormone preparations. Insulin requirements may be reduced when taking medications that have a hypoglycemic effect, such as oral hypoglycemic drugs, salicylates (for example, acetylsalicylic acid), sulfonamides and some antidepressants (MAO inhibitors). In patients with type II diabetes mellitus, with combination therapy with a sulfonylurea and insulin lispro, the level of glycosylated hemoglobin decreases more significantly than with monotherapy with a sulfonylurea.

Side effects of Humalog

Possible allergic reactions, reactions at the injection site, lipodystrophy, itching, rash, hypoglycemia. Hypoglycemia is the most common side effect of insulin therapy in patients with diabetes. Severe hypoglycemia can lead to loss of consciousness and, in exceptional cases, death. Patients may develop allergic reactions in the form of hyperemia, swelling or itching at the injection site. These reactions usually disappear within a few days or weeks. In some cases, these reactions may be caused by reasons not directly related to the administration of insulin (for example, skin irritation after treatment with an antiseptic or incorrect injection technique). Systemic allergic reactions caused by insulin occur much less frequently, but are potentially more dangerous. Generalized allergic reactions to insulin administration may include itching all over the body, difficulty breathing, shortness of breath, decreased blood pressure, tachycardia, or sweating. Severe cases of generalized allergic reactions can be life-threatening. The development of an acute allergic reaction requires emergency desensitizing therapy and drug replacement.

Humalog Mix 50, 5 pcs., 3 ml, 100 IU/ml, suspension for subcutaneous administration

PC

, in the area of ​​the shoulder, thigh, buttock or abdomen. Injection sites should be alternated so that the same site is used no more than approximately once a month. When administering Humalog® Mix 50 subcutaneously, care must be taken to avoid the drug entering a blood vessel. After the injection, do not massage the injection site.

The temperature of the administered drug should be at room temperature.

The doctor determines the dose of Humalog® Mix 50 individually, depending on the level of glucose in the blood. The insulin administration regimen is individual.

IV administration of Humalog® Mix 50 is unacceptable.

When installing the cartridge into the device and attaching the needle, you should strictly follow the manufacturer's instructions for administering insulin.

Rules for administering Humalog® Mix 50

Preparing for the introduction.

For insulin suspensions only: Gently roll the pen 10 times between your palms and turn the pen over 10 times. Stirring is important to ensure you get the correct dose. The insulin should appear uniformly mixed. Do not shake vigorously as this may cause foam to appear, which may prevent the dose from being delivered correctly. To facilitate mixing, the cartridge contains a small glass ball. The drug should not be used if it contains flakes after mixing.

Before performing an injection, you must read the Instructions for Use of the KwikPen™ syringe pen.

Instructions for using the KwikPen™ syringe pen

The KwikPen™ syringe pen is easy to use. It is a device for administering insulin (“insulin syringe pen”) containing 3 ml (300 units) of an insulin preparation with an activity of 100 IU/ml. You can administer from 1 to 60 units of insulin per injection. You can set the dose with an accuracy of one unit. If too many units are set, the dose can be adjusted without losing insulin. The QuickPen™ syringe pen is recommended for use with needles manufactured by Becton, Dickinson and Company (BD)

for syringe pens. Before using the pen, you must ensure that the needle is completely attached to the pen.

In the future, the following rules should be followed.

1. Follow the rules of asepsis and antisepsis recommended by the attending physician.

2. Wash your hands.

3. Select the injection site.

4. Wipe the skin at the injection site.

5. Rotate injection sites so that the same site is used no more than approximately once a month.

Preparation of the KwikPen™ syringe pen and administration

1. Pull the pen cap to remove it. Do not rotate the cap. Do not remove the label from the syringe pen. Make sure the insulin is checked for insulin type; expiration date; appearance.

2. Take a new needle. Remove the paper sticker from the outer needle cap. Use an alcohol swab to wipe the rubber disc at the end of the cartridge holder. Place the needle in the cap straight along the axis onto the syringe pen. Screw the needle until completely connected.

3. Remove the outer cap from the needle. Don't throw it away. Remove the inner needle cap and discard it.

4. Check the KwikPen™ syringe pen for insulin supply. You should check your insulin supply every time. Checking the delivery of insulin from the pen should be performed before each injection until a stream of insulin appears to ensure that the pen is ready to administer a dose.

If you do not check your insulin before the trickle appears, you may receive too little or too much insulin.

5. Fix the skin by stretching it or gathering it into a large fold. Insert the needle subcutaneously using the injection technique recommended by the attending physician. Turn the dose button to the number of units needed for the injection. Insert the needle subcutaneously using the injection technique recommended by the attending physician. Place your thumb on the dose button and press firmly until it stops completely. To administer a full dose, hold the dose button and slowly count to 5.

6. Remove the needle and gently press the injection site with a cotton swab for a few seconds. Do not rub the injection site. If insulin drips from the needle, the patient most likely did not hold the needle under the skin long enough. It is normal to have a drop of insulin at the tip of the needle and will not affect your dose. Carefully place the outer cap on the needle. The needle should be removed after each injection to prevent air bubbles from entering the cartridge. Do not store a pen with a needle attached to it.

7. Using the needle protective cap, unscrew the needle and dispose of it in accordance with the instructions of the attending physician.

Even numbers are printed in the dose indicator window as numbers, odd numbers are printed as straight lines between even numbers.

If the dose required to deliver exceeds the number of units remaining in the cartridge, you can inject the remaining amount of insulin in the pen and then use a new pen to complete the required dose, or administer the entire dose required using a new pen.

Do not attempt to inject insulin by rotating the dose button. The patient will not receive insulin if he rotates the dose button. It is necessary to press the dose button along a straight axis in order to receive a dose of insulin.

Do not try to change the insulin dose during the injection.

Note.

The pen will not allow the patient to set an insulin dose greater than the number of units remaining in the pen. If you are not sure that the full dose has been administered, do not administer another one. You should read and follow the instructions contained in the instructions for use of the drug. The label on the pen should be checked before each injection to ensure that the drug has not expired and that the patient is using the correct type of insulin; Do not remove the label from the syringe pen.

The color of the dose button of the QuickPen™ syringe pen corresponds to the color of the stripe on the label of the syringe pen and depends on the type of insulin. In this manual, the dose button is shown in gray. The blue color of the body of the QuickPen™ syringe pen indicates that it is intended for use with the Humalog® line of drugs.

Storage and disposal

The syringe pen cannot be used if it has been out of the refrigerator for more than the time specified in the instructions for use.

Do not store a pen with a needle attached to it. If the needle is left attached, insulin may leak out of the pen, the insulin may dry out inside the needle, causing the needle to become clogged, or air bubbles may form inside the cartridge.

Syringe pens that are not in use should be stored in the refrigerator at a temperature of 2 to 8 °C. Do not use the pen if it has been frozen.

The currently used syringe pen should be stored at a temperature not exceeding 30 °C, protected from heat and light, and out of the reach of children.

Dispose of used needles in a puncture-resistant, lockable container (such as a biohazard or waste container), or as directed by your healthcare provider.

The needle must be removed after each injection.

Dispose of used pens without needles attached as directed by your healthcare provider and in accordance with local medical waste disposal regulations.

Do not recycle a filled sharps container.

FAQ

Pressing the button to administer a dose may become difficult if foreign matter (dirt, dust, food, insulin or any liquids) gets inside the pen. Do not allow foreign matter to get inside the syringe pen.

— Why does insulin leak from the needle after the patient has finished administering his dose?

The patient probably removed the needle from the skin too quickly. You must make sure that the dose indicator window contains the number “0”.

To administer the next dose, press and hold the dose button and slowly count to 5 before the needle is removed.

— What should an insulin preparation look like?

Some insulin preparations are cloudy suspensions, while others are clear solutions; It is imperative to read the description of insulin in the attached instructions for use.

— What should a patient do if the dose prescribed to him is higher than 60 units?

If the prescribed dose is higher than 60 units, the patient will require a repeat injection or may contact their physician regarding this issue.

— Why is it necessary to use a new needle for each injection?

If needles are reused, the patient may receive the wrong dose of insulin, the needle may become clogged, the pen may become jammed, or infection may occur due to poor sterility.

— What to do if the patient is not sure how much insulin is left in the cartridge?

You should take the pen so that the tip of the needle points down. The scale on the transparent cartridge holder shows the approximate number of units of insulin remaining. These numbers should not be used to set the dose.

— What should be done if the patient cannot remove the cap from the syringe pen?

To remove the cap, you need to pull it. If the patient has difficulty removing the cap, the cap should be carefully rotated clockwise and counterclockwise to release it, then pull to remove the cap.

Pharmacological properties of the drug Humalog

Insulin lispro is similar in molecular composition to human insulin, has a faster onset of action, an earlier peak of action, and has a shorter duration of hypoglycemic action compared to regular human insulin. The earlier onset of action of insulin lispro (approximately 15 minutes after administration) is directly related to its higher rate of absorption. This allows insulin lispro to be administered before meals (within 15 minutes) as opposed to regular insulin (30–45 minutes before meals). The maximum effect develops after 30–70 minutes. Insulin lispro has a rapid onset of action and a shorter duration (2–5 hours). The rate of insulin absorption and, accordingly, the onset of its action may vary depending on the injection site, its blood supply, body temperature, physical activity, drug dose, and other reasons. The primary action of insulin, including insulin lispro, is to regulate glucose metabolism. In addition, all insulins have anabolic and anti-catabolic effects on various tissues of the body. In muscle and other tissues (with the exception of the brain), insulin promotes rapid intracellular transport of glucose and amino acids, accelerates anabolic processes and inhibits protein catabolism. In the liver, insulin increases the uptake of glucose and its storage in the form of glycogen, inhibits gluconeogenesis and accelerates the conversion of excess glucose into fats. A faster onset of action and shorter duration of action compared to regular human insulin were observed in patients with renal and hepatic insufficiency. Studies with human insulin have shown that circulating insulin levels are elevated in patients with renal and/or hepatic impairment. In this case, regular monitoring of glycemia and appropriate adjustment of the dose of insulin, including insulin lispro, is required.