Active substanceInsulin biphasic [human genetic engineering]Insulin biphasic [human genetic engineering]
Dosage form: & nbspsubcutaneous suspension
Composition:

In 1 ml contains:

active substance: human insulin 100 ME;

Excipients: metacresol 1.6 mg, glycerol 16 mg, phenol liquid 0.65 mg, protamine sulfate 0.244 mg, sodium hydrogen phosphate 3.78 mg, zinc oxide 0.011 mg, water for injection up to 1 ml, 10% hydrochloric acid solution - qs to pH 6.9-7.8.10% solution of sodium hydroxide - qs to a pH of 6.9-7.8.

Description:

A white suspension that exfoliates to form a white precipitate and a clear, colorless or almost colorless supernatant. The precipitate is easily resuspended by gentle shaking.

Pharmacotherapeutic group:hypoglycemic agent - a combination of insulin of short and medium duration of action
ATX: & nbsp

A.10.A.C   Insulins and their analogues of average duration of action

Pharmacodynamics:

Humulin® M3 is a DNA-recombinant human insulin. It is a two-phase injection suspension containing 30% Humulin® Regular and 70% Humulin® NPH.

The main effect of insulin is the regulation of glucose metabolism. In addition, it has an 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 decrease.

Humulin® M3 is a medium-duration insulin preparation. The beginning of the drug - 30 minutes after the introduction, the maximum effect of the action - between 1 and 8.5 hours, the duration of the action - 14-15 hours. Individual differences in insulin activity depend on such factors as dose, choice of injection site, physical activity of the patient, etc.

Pharmacokinetics:

Completeness of absorption and the beginning of the effect of insulin depends on the place of administration (abdomen, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the preparation,It is distributed unevenly in tissues; does not penetrate the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and in the kidneys. It is excreted by the kidneys (30-80%).

Indications:

- Diabetes mellitus, requiring insulin therapy.

- Diabetes mellitus during pregnancy.

Contraindications:

- Hypersensitivity to insulin or to one of the components of the drug.

- Hypoglycemia.

Pregnancy and lactation:

During pregnancy it is especially important to maintain good glycemic control in patients receiving insulin therapy. The need for insulin usually decreases during the first trimester and increases during the II and III trimesters. During and immediately after delivery, the need for insulin can dramatically decrease. Patients with diabetes are advised to inform the doctor about pregnancy or about pregnancy planning.

Patients with diabetes during breastfeeding may need to adjust their dose of insulin, diet, or both.

Dosing and Administration:

The dose of Humulin ® M3 is determined by the doctor individually depending on the concentration of glucose in the blood. The drug should be administered subcutaneously.Intramuscular administration is allowed.

Intravenous injection of Humulin® M3 is contraindicated.

The temperature of the drug should be at room temperature.

Subcutaneous injections should be done in the area of ​​the shoulder, hips, buttocks or abdomen. The injection sites need to be alternated so that the same place is used no more often than once a month. With subcutaneous administration of insulin, care must be taken so that when injected do not enter the blood vessel. After injection, do not massage the injection site. Patients should be trained in the correct use of the insulin delivery device.

Humulin® M3 is a ready-made mixture with a certain content of Humulin® Regular and Humulin® NPH, prepared in order to avoid the need to mix insulin preparations by the patients themselves. Mode of insulin administration is individual.

Preparation for introduction

For the drug Humulin® M3 in vials

Immediately before use, the Humulin® M3 flasks must be rolled several times between the palms until complete resuspension of insulin until it becomes a homogeneous cloudy liquid or milk.Do not shake vigorously, as this can lead to the appearance of foam, which may interfere with the correct dose set.

Do not use insulin if there are flakes after mixing. Do not use insulin if solid white particles stick to the bottom or walls of the vial, creating the effect of a frosty pattern. Use an insulin syringe that matches the concentration of insulin administered.

For Humulin® M3 in cartridges

Immediately before use, Humulin® M3 cartridges should be rolled between the palms ten times and shaken, turning 180 degrees also ten times until complete resuspension of insulin until it becomes a homogeneous cloudy liquid or milk. Do not shake vigorously, as this can lead to the appearance of foam, which may interfere with the correct dose set. Inside each cartridge there is a small glass ball, which facilitates the mixing of insulin. Do not use insulin if there are flakes after mixing.

The device of cartridges does not allow to mix their contents with other insulins directly in the cartridge. Cartridges are not intended for refilling.

Before the injection, it is necessary to read the manufacturer's instructions for the use of a syringe-pen for the introduction of insulin.

For the drug Humulin® M3 in the QuickK pen syringe

Before carrying out the injection, it is necessary to read the manual for the use of the QUIKPEN ™ syringe pen.

Side effects:

Hypoglycaemia It is the most a frequent side effect, arising upon introduction insulin preparations, including Humulin ® M3. Severe hypoglycemia can lead to loss of consciousness and, in exceptional cases, death.

Allergic reactions: patients may have local aAllergic reactions in the form of hyperemia, edema or itching at the injection site. These reactions usually cease during the period from several days to several weeks. In some cases, these reactions may be caused by causes not associated with insulin, for example, skin irritation with a cleansing agent or incorrect injection.

Systemic allergic reactions, caused by insulin, appear less often, but are more serious. They may manifest as generalized pruritus, difficulty breathing, shortness of breath, lower blood pressure, increased heart rate, increased sweating. Severe cases of systemic allergic reactions can be life threatening. In rare cases, a severe allergy to Humulin ® M3 is required immediate treatment. You may need to change your insulin, or desensitization.

Spontaneous messages:

There were cases of edema development, mainly with rapid normalization of blood glucose concentration against intensive insulin therapy with initially poor glycemic control (see section "Special instructions").
Overdose:

An overdose of insulin causes hypoglycemia, followed by the following symptoms: lethargy, excessive sweating, tachycardia, pale skin, headache, trembling, vomiting, confusion. Under certain conditions, for example, with a long duration or with intensive control of diabetes mellitus, the symptoms-precursors of hypoglycemia may change.

Light states of hypoglycemia can usually be suppressed by ingesting glucose or sugar. You may need to adjust the dose of insulin, diet or physical activity.

Correction of moderate hypoglycemia can be carried out by intramuscular or subcutaneous administration of glucagon, followed by ingestion of carbohydrates. Severe conditions of hypoglycemia, accompanied by coma, convulsions or neurological disorders, are stopped by intramuscular / subcutaneous administration of glucagon or by intravenous administration of a concentrated 40% dextrose (glucose) solution. After the restoration of consciousness, the patient needs to give food rich in carbohydrates, in order to avoid the re-development of hypoglycemia.

It may be necessary to take further carbohydrates and monitor the patient, as it may develop a relapse of hypoglycemia.

Interaction:

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

An increase in the dose of insulin may be required for the administration of drugs that increase the concentration of glucose in the blood, such as: oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, danazol, beta2-adrenomimetics (for example, ritodrin, salbutamol, terbutaline), thiazide diuretics, chloroprotoxen, diazoxide, isoniazid, lithium carbonate, a nicotinic acid, phenothiazine derivatives.

Reducing the dose of insulin may be required for the administration of drugs that reduce the concentration of glucose in the blood, such as: 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), angiotensin-converting enzyme inhibitors (captopril, enalapril), octreotide, angiotensin II receptor antagonists.

Beta-adrenoblockers, clonidine, reserpine can mask the manifestation of symptoms of hypoglycemia.

Incompatibility

The effects of mixing human insulin with animal insulin or human insulin produced by other manufacturers have not been studied.

Special instructions:

Transfer of a patient to another type or preparation of insulin with a different trade name should be under strict medical supervision. Change of activity, trade mark (animal, human, human insulin analogues) and / or production method (DNA-recombinant insulin or insulin of animal origin) may lead to the need for dose adjustment.

For some patients, when switching from animal insulin to human insulin, it may be necessary to adjust the dose. This can happen even with the first injection of a human insulin preparation or gradually for several weeks or months after the transfer.

Symptoms-precursors of hypoglycemia against the background of the introduction of human insulin in some patients may be less pronounced or different from those that were observed in them against the background of the introduction of insulin of animal origin. When normalizing the blood glucose, for example, as a result of intensive insulin therapy, all or some of the symptoms-precursors of hypoglycemia may disappear, which patients should be informed about. Symptoms-precursors of hypoglycemia may change or be less pronounced with prolonged course of diabetes mellitus, diabetic neuropathy or treatment with such drugs as beta-blockers.

The use of inadequate doses or discontinuation of treatment, especially in patients with type 1 diabetes, can lead to hyperglycemia and diabetic ketoacidosis (potentially potentially life-threatening conditions).

The need for insulin may decrease if adrenal, pituitary or thyroid gland function is insufficient, with renal or hepatic insufficiency. With some diseases or with emotional overstrain, the need for insulin can increase. Correction of the dose of insulin may also be required with an increase in physical activity or with a change in the usual diet.

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.

GUIDELINES FOR USING THE QUIKPEN ™ SYRINGE-HANDLE

Humulin® Regular KvikPen ™, Humulin ® NPK QuickPhen ™, Humulin® M3 QuickPhen ™

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.

The syringe pen QuickKen for insulin administration should only be used by you. 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 vision or vision impairment withouthelp 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 beige color of the PenK pen pen-pen indicates that it is intended for use with the Humulin 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 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 that the insulin is flowing out of the needle of the syringe pen during the selection or correction of the dose? Do not administer a dose, as you may not receive your full dose. Set the syringe pen to the number zero and again check the insulin intake from the syringe pen (see "Checking the QUIKPEN syringe pen for insulin delivery").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 only 25 units remain in the cartridge, you can not go through the figure at the time of installation. Do not try to set the dose by going through this figure. If the partial dose is left in the syringe pen, then you can either:

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

2. Enter the full dose from the new pen-syringe.

- 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.

Humulin® and Humulin® in the KvikPen ™ pen syringe are trademarks of Eli Lilly and Company.

Copyright © 2006, yyyy Eli Lilly and Company. All rights reserved.

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

A.

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,that you are using the right type of insulin.

B.

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.

G.

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.

A.

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

Remove the inner needle cap and discard it.

B.

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.

G.

- 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

A.

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.

B.

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.

G.

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:

Showing 10 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:

During hypoglycemia, the patient's concentration and speed of psychomotor reactions may decrease.This can be dangerous in situations in which these abilities are particularly necessary (for example, driving or driving mechanisms).

It should be recommended that patients take precautions to avoid hypoglycemia while driving vehicles. This is especially important for patients with mild or absent symptoms-precursors of hypoglycemia or with frequent development of hypoglycemia. In such cases, the doctor should evaluate the appropriateness of driving the patient by motor transport.

Form release / dosage:

Suspension for subcutaneous administration, 100 IU / ml.

Packaging:

For 10 ml of the drug in bottles of neutral glass. On 1 bottle together with the instruction on application of a preparation place in a pack a cardboard.

3 ml per cartridge of neutral glass. Five cartridges are placed in a blister. One blister, together with the instruction for use, is placed in a cardboard pack.

Or a cartridge is built in a pen syringe QuickKentm.

Five syringe pens along with the instructions for use and a manual on the use of the syringe-pen are placed in a pack of cardboard.

Storage conditions:

Store at a temperature of 2-8 ° C in places inaccessible to children, in a place protected from light.Do not freeze.

The drug should be stored at room temperature 15-25 ° C for no longer than 28 days.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription
Registration number:П N013713 / 01
Date of registration:25.05.2011
The owner of the registration certificate:Eli Lilly East SAEli Lilly East SA Switzerland
Manufacturer: & nbsp
Representation: & nbspELI LILLY EAST SA ELI LILLY EAST SA Switzerland
Information update date: & nbsp25.10.2015
Illustrated instructions
Instructions
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