Humalog - instructions for use, doses, side effects, contraindications

Active substanceInsulin LysproInsulin Lyspro

Similar drugsTo uncover

Insulin Lyspro

solution in / in PC

ENDODZHENIKS, LLC Russia

Humalog®

solution in / in PC

Eli Lilly East SA Switzerland

Dosage form: & nbspsolution for intravenous and subcutaneous administration

Composition:

In 1 ml contains:

active substance: insulin lyspro 100 ME;

Excipients: glycerol (glycerol) 16 mg, metacresol 3.15 mg, zinc oxide q.s. for content Zn⁺⁺ 0.0197 mg, sodium hydrogen phosphate heptahydrate 1.88 mg, hydrochloric acid 10% solution and / or sodium hydroxide solution 10% q.s. up to pH 7.0-8.0, water for injection q.s. up to 1 ml.

Description:

A clear, colorless solution.

Pharmacotherapeutic group:hypoglycemic agent - short-acting insulin analog

ATX: & nbsp

A.10.A.D.04 Insulin LizPro

Pharmacodynamics:

Humalog® is a DNA-recombinant analog of human insulin. It differs from human insulin by an inverse amino acid sequence at positions 28 and 29 of the B chain of insulin.

The main effect of insulin lispro is the regulation of glucose metabolism. In addition, it has anabolic and anti-catabolic effect on various tissues of the body. In muscle tissue, the content of glycogen, fatty acids, glycerol increases, protein synthesis increases and amino acid consumption increases, but glycogenolysis, gluconeogenesis, ketogenesis, lipolysis,protein catabolism and amino acid release.

Shown, that insulin lyspro is equimolar to human insulin, but its action occurs more quickly and lasts a shorter period of time.

Insulin lispro is characterized by a rapid onset of action (about 15 minutes), since it has a high rate of absorption, and this allows you to inject it immediately before meals (0-15 minutes before meals), unlike usual short-acting insulin (for 30-45 minutes before meals). Insulin Lyspro quickly exerts its effect and has a shorter duration of action (2 to 5 hours) compared to conventional human insulin.

In patients with type 1 and type 2 diabetes, hyperglycemia that occurs after ingestion decreases more significantly with the use of lyspro, compared to soluble human insulin. For patients receiving short-acting and basal insulin, it is necessary to select a dose of both insulin to achieve the optimal blood glucose concentration throughout the day.

As with all insulin preparations, the duration of action of insulin lispro can vary in different patients or at different times in the same patient and depends on the dose, the injection site, the blood supply,body temperature and physical activity. Pharmacodynamic characteristics of insulin lizpro in children and adolescents is similar to that observed in adults.

In patients with type 2 diabetes mellitus receiving maximum doses of sulfonylurea derivatives, the addition of insulin lispro leads to a significant decrease glycosylated hemoglobin in this category of patients.

Treatment with insulin lispro for patients with type 1 and type 2 diabetes is accompanied by a decrease in the number of episodes of nocturnal hypoglycemia.

The glucodynamic response to insulin lyspro does not depend on the functional deficiency of the kidneys or liver.

Pharmacokinetics:

After subcutaneous administration insulin lyspro quickly absorbed and reaches a maximum concentration in the blood after 30-70 minutes.

The volume of distribution of insulin lyspro is identical to the volume of distribution of normal human insulin and is in the range of 0.26-0.36 l / kg.

With subcutaneous injection, the half-life of insulin lispro is about 1 hour.

In patients with renal and hepatic insufficiency, a higher rate of absorption of insulin lispro is maintained compared to conventional human insulin.

Indications:

Diabetes mellitus in adults and children requiring insulin therapy to maintain normal blood glucose levels.

Contraindications:

Hypersensitivity to insulin lizpro or to any auxiliary substance.

Hypoglycemia.

Pregnancy and lactation:

At the moment, there is no undesirable effect of insulin lispro on pregnancy or on the health of the fetus / newborn. To date, no relevant epidemiological studies have been conducted.

During pregnancy, the main is maintaining good glycemic control in patients with diabetes who are receiving insulin treatment. The need for insulin usually decreases during the I trimester and increases during II and III trimesters. During and immediately after delivery, the need for insulin can dramatically decrease. Patients with diabetes should consult a doctor in case of onset or planning of pregnancy. In the case of pregnancy in patients with diabetes the main thing is careful monitoring of glucose, as well as general health.

For patients with diabetes during breastfeeding, it may be necessary to choose a dose of insulin, a diet, or both.

Dosing and Administration:

The dose of Humalog® is determined by the doctor individually depending on the concentration of glucose in the blood. Mode of insulin administration is individual. The drug Humalog® can be administered shortly before meals. If necessary, Humalog® can be administered shortly after eating. The temperature of the drug should be at room temperature.

The drug Humalog® should be administered in the form of subcutaneous injections or prolonged subcutaneous infusion with an insulin pump. If necessary (ketoacidosis, acute diseases, the period between operations or the post-operation period) the preparation Humalog® can also be administered intravenously.

Subcutaneously should be administered to the shoulder, hips, buttocks or abdomen. The injection sites should be alternated in such a way that the same place is used no more often than 1 time per month.

When subcutaneous administration of the preparation Humalog®, care must be taken to avoid getting the drug into the blood vessel. After injection, do not massage the injection site.The patient should be trained in the correct technique of injection.

Instructions for the administration of Humalog®

a) Preparation for introduction

The solution of the drug Humalog must be clear and colorless. Do not apply a solution of Humalog® if it turns out to be cloudy, thickened, slightly colored or visually detecting solid particles.

When installing the cartridge in the syringe pen, attaching the needle and performing insulin injection, follow the manufacturer's instructions that are attached to each syringe pen.

b) Introduction

1. Wash your hands.

2. Choose a place for injection.

3. Wipe the skin at the injection site.

4. Remove the cap from the needle.

5. Fix the skin, pulling it or collecting it in a large crease. Insert the needle according to the instructions for using the syringe pen.

6. Click the button.

7. Remove the needle and gently squeeze the injection site with a cotton swab for a few seconds. Do not rub the injection site.

8. Using the protective cap of the needle, unscrew the needle and dispose of it.

9. Place alternate places so that the same place is used no more often than once a month.

For the preparation Humalog® in the pen-handle KvikPen™

Before administering insulin, it is necessary to read the Manual on the use of the syringe pen QuickKenny™.

c) Intravenous insulin administration

Intravenous injections of Humalog® should be carried out in accordance with routine clinical practice of intravenous injection, for example, intravenous bolus administration or using an infusion system. It is often necessary to monitor the concentration of glucose in the blood.

Infusion systems with concentrations of 0.1 IU / ml and up to 1.0 IU / ml of insulin lyspro in a 0.9% solution of sodium chloride or 5% dextrose are stable at room temperature for 48 hours.

d) Subcutaneous insulin infusion with an insulin pump

For infusion of Humalog®, pumps can be used Minimed and Disetronic for infusion of insulin. It is necessary to strictly follow the instructions attached to the pump. The system for infusion is changed every 48 hours. When connecting the system for infusion, observe aseptic rules. In the case of a hypoglycemic episode, the infusion is stopped until the episode is resolved. If there is a very low concentration of glucose in the blood, then this should be reported to the doctor and provide for a reduction or termination of insulin infusion.

A pump malfunction or a clogged system for infusion can lead to a rapid rise in glucose concentration. If you suspect a violation of the supply of insulin, follow the instructions and, if necessary, inform the doctor. When applying the pump Humalog® should not be mixed with other insulins.

Side effects:

Hypoglycaemia is the most common undesirable side effect in the treatment of insulin in patients with diabetes mellitus. Severe hypoglycemia can lead to loss of consciousness (hypoglycemic coma) and, in exceptional cases, death.

Patients may be observed local allergic reactions in the form of redness, swelling, or itching at the injection site. Usually these symptoms disappear within a few days or weeks. More rarely arise generalized allergic reactions, which can cause itching all over the body, urticaria, angioedema, fever, dyspnea, lowering blood pressure, tachycardia, increased sweating. Severe cases of generalized allergic reactions can be life threatening.

At the injection site, lipodystrophy.

Spontaneous messages

Cases of development edema, mainly with fast normalization of blood glucose concentration against intensive insulin therapy with initially poor glycemic control (see section "Special instructions").

Overdose:

Overdose is accompanied by the development of symptoms of hypoglycemia: lethargy, increased sweating, hunger, tremor, tachycardia, headache, dizziness, blurred vision, vomiting, confusion.

Light hypoglycemic episodes are stopped by ingestion of glucose or other sugar, or products containing sugar (it is recommended to always have at least 20 grams of glucose). About transferred hypoglycemia it is necessary to inform the attending physician.

Correction moderately severe hypoglycemia can be performed by intramuscular or subcutaneous administration of glucagon followed by ingestion of carbohydrates after stabilization of the patient's condition. Patients who do not respond to glucagon, intravenously injected with a solution of dextrose (glucose).

If the patient is in a coma, then glucagon should be administered intramuscularly or subcutaneously.In the absence of glucagon or if there is no reaction to its administration, it is necessary to inject intravenously a solution of dextrose. Immediately after recovery - consciousness, the patient needs to give food rich in carbohydrates. It may be necessary to continue to maintain the intake of carbohydrates and monitor the patient, as it may cause a relapse of hypoglycemia.

About the transferred hypoglycemia it is necessary to inform the attending physician.

Interaction:

The severity of hypoglycemic effect is reduced when co-administered with the following drugs: oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, danazol, beta₂-adrenomimetics (for example, ritodrin, salbutamol, terbutaline), tricyclic antidepressants, thiazide diuretics, chloroprotoxen, diazoxide, isoniazid, lithium carbonate, a nicotinic acid, phenothiazine derivatives.

The severity of hypoglycemic action increases when co-administered with the following medications: beta-blockers, ethanol and ethanol containing drugs, anabolic steroids, fenfluramine, guanethidine, tetracyclines,oral hypoglycemic drugs, salicylates (for example, acetylsalicylic acid), sulfonamide antibiotics, some antidepressants (monoamine oxidase inhibitors), inhibitors of angiotensin-converting enzymes (captopril, enapril), octreotide, angiotensin II receptor antagonists. The preparation Humalog® should not be mixed with preparations of animal insulin.

When taking other medications in conjunction with the preparation Humalog® it is necessary to consult a doctor.

On the recommendation of a doctor, Humalog® can be used in combination with a longer-acting human insulin or in combination with sulfonylureas for oral administration.

If you need to use other drugs in addition to insulin, you should consult your doctor (see section "Special instructions").

Special instructions:

Transfer of the patient to another type or other brand of insulin should be carried out under strict medical supervision. Change in activity, brand (manufacturer), type (Regular, NPH, etc.), species (animal, human,analogue of human insulin) and / or production method (DNA-recombinant insulin or insulin of animal origin) may lead to the need for dose changes.

Conditions in which the early predictive symptoms of hypoglycemia may be nonspecific and less pronounced include the long existence of diabetes mellitus, intensive insulin therapy, diseases of the nervous system in diabetes mellitus, or the administration of medications, such as beta-adrenoblockers.

In patients with hypoglycemic reactions after switching from animal insulin to human insulin, the early symptoms of hypoglycemia may be less pronounced or different from those they experienced when treated with their previous insulin. Unadjusted hypoglycemic or hyperglycemic reactions can cause loss of consciousness, to whom or death. The use of inadequate doses or discontinuation of treatment, especially in patients with type I diabetes, can lead to hyperglycemia and diabetic ketoacidosis - conditions potentially life-threatening to the patient.

The need for insulin can decrease in the case of renal failure, as well as in patients with hepatic insufficiency as a result of a decrease in the processes of gluconeogenesis and insulin metabolism. However, in patients with chronic hepatic insufficiency, increased insulin resistance may lead to an increased need for insulin. The need for insulin can increase during an infectious disease, with emotional stress, with an increase in the amount of carbohydrates in food.

Dose adjustment may be required if the patient's physical activity increases or the usual diet changes. Physical exercises immediately after eating can increase the risk of hypoglycemia. A consequence of the pharmacodynamics of fast acting analogues of human insulin is that if hypoglycemia develops, it can develop after injection earlier than when injected with soluble human insulin.

If a 40 IU / ml insulin preparation is prescribed in a vial, then insulin should not be taken from a 100 IU / ml insulin cartridge using an insulin syringe with a concentration of 40 IU / ml.

When using insulin preparations in combination with drugs of the thiazolidinedione group, the risk of edema and chronic heart failure increases, especially in patients with cardiovascular disease and the presence of risk factors for chronic heart failure.

GUIDE FOR USING THE SYRINGE-HANDLE QuickKenny ™

Humalog® QuickPan ™, Humalog® Mix 25 QuickPan ™, Humalog® Mix 50 QuickPan ™

100 IU / ml, 3 ml

SPRIC-HANDLE FOR INSULIN INTRODUCTION

See Fig. 1

PLEASE READ THESE INSTRUCTIONS BEFORE APPLICATION

Introduction

The QuickK pen is easy to use. It is a device for the introduction of insulin (an "insulin syringe pen") containing 3 ml (300 units) of an insulin preparation with an activity of 100 IU / ml. You can administer 1 to 60 units of insulin per injection. You can set the dose to within one unit. If you have set too many units. You can correct the dose without losing insulin.

Before using the QuickKP pen, read this manual completely and follow its instructions carefully. If you do not fully comply with these instructions, then you can get either too low,or too high a dose of insulin.

Your syringe Penkin Pen for insulin administration should only be used for your injections. Do not pass the syringe pen or needle to others, as this can lead to transmission of the infection. For each injection, use a new needle.

DO NOT USE a syringe pen if any of its parts is damaged or broken. Always have a spare syringe-pen in case you lose a syringe pen or it will be damaged.

It is not recommended to use a syringe pen for patients with complete loss of sight or with impaired vision without the help of well-seeing people trained in the use of a syringe pen.

Preparing the QuickK pen

Important notes:

- Read and follow the instructions for use described in the Instruction for Use.

- Check the label on the syringe pen before each injection to make sure the drug has not expired and you are using the right type of insulin; Do not remove the label from the syringe pen.

Note: The color of the dose button of the QUIKPEN pen syringe corresponds to the color of the strip on the label of the pen syringe and depends on the type of insulin.In this manual, the dose button is grayed out. The blue color of the body of the QuickK pen syringe indicates that it is intended for use with the products of the Humalog line.

Color marking of the dose introduction button - see Fig. 2.

- Your doctor wrote you the most suitable type of insulin. Any changes in insulin therapy should be performed only under the supervision of the attending physician.

- It is recommended to use the KvikPen syringe pen with needles from Becton, Dickinson and Company (BD) for pen syringes.

- Before using the syringe pen, make sure that the needle is fully attached to the syringe handle.

- Follow the instructions given below.

Frequently Asked Questions about preparing a QUIKPEN pen syringe for use

- What should my insulin look like? Some insulin preparations are cloudy suspensions, while others are clear solutions; be sure to read the description of insulin in the enclosed Instruction for Use.

- What should I do if the dose prescribed to me is more than 60 units? If your dose is more than 60 units, you will need a second injection, or you can contact the doctor in charge.

- Why should I use a new needle for each injection? If the needles are reused, you may receive an incorrect dose of insulin, the needle may become clogged, or the syringe pen will start to seize, or you may infect the infection due to a sterility violation.

- What should I do if I'm not sure how much insulin is left in my cartridge? Take the handle so that the tip of the needle is pointing down. The scale on the transparent cartridge holder shows the approximate number of remaining insulin units. These numbers MUST NOT be used to set the dose.

- What should I do if I can not remove the cap from the syringe pen? In order to remove the cap, pull it. If you are having difficulty removing the cap, gently turn the cap clockwise and counterclockwise to release it, then pull it off, remove the cap.

Checking the QUIKPEN syringe pen for insulin delivery

Important notes:

- Check insulin intake every time. Checking the intake of insulin from the syringe-pen should be performed before each injection before the emergence of a trickle of insulin to make sure that the syringe pen is ready for the dose.

- If you do not check the insulin intake before the trickle, you can get too little or too much insulin.

Frequently asked questions about insulin intake check

- Why should I check the insulin intake before each injection?

1. This ensures that the syringe pen is ready for the dose.

2. This confirms that the trickle of insulin exits the needle when you press the dose button.

3. This removes air that can collect in the needle or in the cartridge with insulin during normal use.

- What should I do if I can not fully press the dose entry button while checking QuickPen on insulin delivery?

1. Attach a new needle.

2. Inspect the insulin intake from the syringe pen.

- What should I do if I see air bubbles in the cartridge?

You must check the insulin intake from the syringe pen. Remember that you can not store a syringe pen with a needle attached to it, as this can lead to the formation of air bubbles in the cartridge with insulin. A small air bubble does not affect the dose, and you can enter your dose as usual.

Administration of the required dose

Important notes:

- Observe the rules of asepsis and antiseptics, recommended by the attending physician.

- Make sure that you have entered the desired dose by pressing and holding the dose button, and slowly count to 5 before removing the needle. If the insulin drips from the needle, most likely, you did not hold the needle under the skin long enough.

- The presence of a drop of insulin at the tip of the needle - this is normal. This will not affect your dose.

- The syringe pen will not allow you to dial a dose exceeding the number of units of insulin left in the cartridge.

- If you doubt that you have taken the full dose, do not administer another dose. Call the Lilly office or ask your doctor for help.

- If your dose exceeds the number of units left in the cartridge, you can enter the remaining amount of insulin in this syringe pen and then use a new pen to complete the required dose, OR EVERYTHING the necessary dose using a new syringe pen.

- Do not attempt to inject insulin by turning the dose button. You will NOT get insulin if you turn the dose button.You must PUT on the dose button on a straight axis in order to get a dose of insulin.

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

- The used needle should be disposed of in accordance with local medical waste disposal requirements.

- Remove the needle after each injection.

Frequently Asked Questions for Dose Administration

- Why is it difficult to press the dose button, the cord I try to inject?

1. Your needle may be clogged. Attempt to attach a new needle. Once you do this, you can see how the insulin exits the needle. Then, check the syringe pen for insulin.

2. A quick push of a dose button can make pressing a button tight. A slower depression of the dose button may make pressing easier.

3. Using a larger diameter needle will make it easier to press the dose button during the injection.

Consult your doctor to determine the size of the needle you are most likely to use.

4. If pressing the button when the dose is administered remains tight after all the above items have been completed, the syringe pen must be replaced.

- What should I do if the Quickkien pen gets stuck when used?

Your syringe stickles up if it is difficult to inject or set a dose. In order for the syringe pen to not seize:

1. Attach a new needle. Once you do this, you can see how the insulin exits the needle.

2. Inspect the insulin intake.

3. Set the desired dose and perform the injection.

Do not attempt to lubricate the syringe handle, as this may damage the mechanism of the syringe handle.

Pressing the button to enter the dose can become taut if foreign impurities (dirt, dust, food, insulin or any liquids) get inside the syringe pen. Do not allow foreign matter to enter the syringe handle.

- Why does insulin leak out of the needle after I have finished administering my dose?

You probably took the needle out of the skin too quickly.

1. Make sure that you see the number "0" in the dose indicator window.

2. For the next dose, press and hold the dose button and slowly count to 5 before removing the needle.

- What should I do if my dose is set, and the dose button accidentally found to be drowned in without a needle attached to the syringe pen?

1. Turn the dose button back to zero.

2. Attach a new needle.

3.Inspect your insulin intake.

4. Set the dose and perform the injection.

- What should I do if I have set the wrong dose (too low or too high)? Turn the dose button back or forward to correct the dose.

- What should I do if I see insulin flows from needle pen during selection or dose adjustment? Do not administer a dose, as you may not receive your full dose. Set the pen on the number zero and check again insulin receipt of the pen (see "Checking the pen KvikPen for admission insulin"). Set the dose and inject.

- What should I do if my full dose can not be established? The syringe pen will not allow you to set a dose that exceeds the number of units of insulin left in the cartridge. For example, if you need 31 units and in the cartridge is only 25 units, you will not be able to go through when setting number 25. Do not try to set a dose, going through this figure. If the partial dose is left in the syringe pen, then you can either:

1. Enter the partial dose and then enter the remaining dose using a new syringe-pen, or

2.Enter the full dose from the new pen.

- Why can not I set a dose to use the small amount of insulin that is left in my cartridge? The syringe pen is designed to provide at least 300 insulin units. The device of the syringe-pen protects the cartridge from complete emptying, since the small amount of insulin that remains in the cartridge can not be entered with the necessary accuracy.

Storage and disposal

Important notes:

- The syringe pen can not be used if it is outside the refrigerator for more than the time specified in the Instruction for Use.

- Do not store the syringe pen with the needle attached to it. If the needle is left attached, insulin can leak out of the pen syringe, or insulin may dry up inside the needle, causing clogging of the needle, 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 ° C to 8 ° C. Do not use a syringe pen if it has been frozen.

- The syringe pen you are currently using should be stored at a temperature not exceeding 30 ° C and in a place protected from heat and light.

- Refer to the instructions for use to fully understand the storage conditions of the syringe pen.

- Keep the syringe pen out of the reach of children.

- Dispose of used needles in puncture-resistant, closed containers (for example, in biohazard containers or waste containers), or as recommended by your doctor.

- Dispose used disposable syringes without needles attached to them and in accordance with the recommendations of your doctor.

- Do not re-use the filled container for sharp objects.

- Ask your doctor about possible ways to dispose of filled sharps containers that are available in your area.

- Recommendations for handling needles do not replace local rules for disposal, rules recommended by the doctor in charge or departmental requirements.

Humalog®, Humalog® in the KvikPen ™ syringe handle, Humalog® Mix 50 in the KvikPen ™ syringe handle, Humalog® Mix 25 in the KvikPen ™ pen syringe are trademarks of Eli Lilly and Company.

Date of approval:

The QUIKPEN ™ syringe pen meets the requirements of precise dosing and the functional requirements of ISO 11608 1: 2000

Preparation

Make sure you have the following components:

□ Syringe handle

□ New needle for syringe pen

□ A swab moistened with alcohol

Components of the pen-handle QUIKPEN and needles * (* sold separately); parts of the syringe-pen - see Fig. 3.

Color marking of the dose introduction button - see Fig. 2.

Common use of the syringe pen

Follow these instructions to complete each injection.

1.Preparation of pen syringes

Pull the cap of the syringe pen to remove it. Do not rotate the cap. Do not remove the label from the syringe pen.

Be sure that you have checked your insulin on:

- Type of insulin

- Expiration date

- Appearance

Attention: Always read the text on the label of the syringe pen to make sure that you are using the right type of insulin.

Only for insulin suspensions:

Carefully roll the syringe handle 10 times between the palms

and

Turn the syringe handle 10 times.

Stirring is important in order to be sure of getting the right dose. Insulin should look uniformly mixed.

AT.

Take a new needle.

Remove the paper sticker from the outer needle cap.

Use a tampon moistened with alcohol to wipe the rubber disc on the end of the cartridge holder.

Put the needle in the cap, straight on the axis on the syringe-pen.

Screw the needle until the connection is complete.

2. Checking the QUIKPEN syringe pen for insulin delivery

Caution: If you do not check insulin intake before each injection, you can get either too low or too high a dose of insulin.

Remove the outer needle cap. Do not throw it away.

Remove the inner needle cap and discard it.

Set 2 units by rotating the dose introduction button.

AT.

Point the syringe up.

Tap on the cartridge holder to let the air

top part.

- With the needle pointing up, press the dose button until it stops and the number of "0" appears in the dose indicator window.

- Keep the dose button in the recessed position and count slowly until 5.

- Insulin intake check is considered to be performed when an insulin stream appears on the end of the needle.

- If the trickle of insulin does not appear at the end of the needle, then repeat the steps of checking insulin intake four times, starting at point 2B and ending at point 2G.

Note: If you do not see the emergence from the needle of a trickle of insulin, and the dose setting becomes difficult, then replace the needle and repeat the insulin intake from the syringe pen.

3. Dosing Introduction

Turn the dose button until the number of units you need for injection.

If you accidentally set too many units, you can correct the dose by rotating the dose button in the opposite direction.

Insert the needle under the skin using the injection technique recommended by your doctor.

Put your thumb on the dose introduction button and firmly press the dose introduction button until it stops completely.

To enter the full dose, hold the dose button and slowly count to 5.

Remove the needle from under the skin.

Note: Check and make sure that you see the number "0" in the dose indicator window, in order to confirm that you have entered the full dose.

AT.

Carefully place the outer cap on the needle.

Note: Remove the needle after each injection to prevent air bubbles from entering the cartridge.

Do not store a syringe pen with a needle attached to it.

Unscrew the needle with the outer cap on it and dispose of it according to the instructions of the attending physician.

Put the cap on the syringe-pen, combining the cap of the cap with the dose indicator, pushing the cap straight on the axis to the syringe-pen.

Example:

Shows 15 units (see Fig. 4).

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

Note: The syringe pen will not allow you to set the number of units greater than the number of units left in the syringe pen.

If you are not sure that you have entered the full dose, do not enter another dose.

Effect on the ability to drive transp. cf. and fur:

The patient's ability to concentrate and the reaction rate may be compromised by hypoglycemia or Hyperglycemia associated with improper dosing regimens. This may pose a risk in situations in which these capabilities are of particular importance (for example, driving or working with machinery).

Patients should be careful to avoid hypoglycemia during the management of a motor vehicle. This is especially important for those patients who have a reduced or absent sensation of premonitory symptoms of hypoglycemia or in which episodes of hypoglycemia are observed frequently.In these circumstances, it is necessary to assess the appropriateness of driving a vehicle.

Form release / dosage:Solution for intravenous and subcutaneous administration, 100 IU / ml.

Packaging:

Cartridges:

3 ml of the drug in the cartridge. Five cartridges per blister. One blister with instructions for use in a cardboard package.

KvikPen ™ pen syringe:

3 ml of the drug in the cartridge, integrated in the pen-handle KvikPen ™. Five of the QuickKenny ™ syringe pens together with the instructions for use and the QuickKnPM ™ pen-handle guide in a cardboard box.

Storage conditions:

Store in refrigerator at 2-8 ° C.

In-use drug in the cartridge / syringe pen should be stored at room temperature not higher than 30 ° C, not more than 28 days.

Protect from direct sunlight and heat. Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N 015490/01

Date of registration:09.02.2009

The owner of the registration certificate:Eli Lilly East SAEli Lilly East SA Switzerland