Instruction for use: Humalog Mix 50

ATX Code A10AD04 Insulin Lyspro

Active substance Insulin lispro biphasic

Pharmacological group

Hypoglycemic agent - an insulin analogue of human long-acting [Insulin]

Nosological classification (ICD-10)Z31.1 Artificial insemination

E10 Insulin-dependent diabetes mellitus

Decompensation of carbohydrate metabolism, Diabetes mellitus, Diabetes insulin sugar, Diabetes mellitus type 1, Diabetic ketoacidosis, Insulin-dependent diabetes, Insulin-dependent diabetes mellitus, Coma hyperosmolar non-ketoacidotic, Labile form of diabetes mellitus, Violation of carbohydrate metabolism, Type 1 diabetes mellitus, Type I diabetes mellitus, Insulin-dependent diabetes mellitus, Type 1 diabetes mellitus

Composition

Suspension for subcutaneous administration 1 ml

active substance:

Insulin lyspro 100 ME

Auxiliary substances: metacresol - 1,76 mg; Phenol liquid - 0.8 mg (in terms of 89% phenol - 0.715 mg); Glycerol (glycerol) - 16 mg; Protamine sulfate - 0.28 mg; Sodium hydrophosphate - 3.78 mg; Zinc oxide - q.s. (To obtain zinc ions not more than 25 μg), hydrochloric acid solution of 10% and / or sodium hydroxide solution of 10% - q.s. To establish a pH of 7.0-7.8; Water for injection - up to 1 ml

pharmachologic effect

Pharmacological action - hypoglycemic.

Dosing and Administration

F / k, in the area of the shoulder, hips, buttocks or abdomen. The injection sites should be alternated in such a way that one and the same place is used no more than once a month. When n / to the preparation Humalog® Mix 25 should be careful to avoid getting the drug into the blood vessel. After injection, do not massage the injection site.

The temperature of the drug should be at room temperature.

The dose of Humalog® Mix 25 is determined by the doctor individually, depending on the level of glucose in the blood. Mode of insulin administration is individual.

In / in the introduction of the preparation Humalog® Mix 25 is unacceptable.

When installing the cartridge in the device and attaching the needle, the instructions of the manufacturer of the insulin delivery device must be strictly observed.

Rules for the administration of Humalog® Mix 25

Preparation for the introduction. Immediately before use, the Humalog® Mix 25 cartridge should be rolled between the palms 10 times and shaken, turning 180 ° also 10 times to resuspend insulin until it looks like a homogeneous cloudy liquid or milk. Do not shake vigorously. This can lead to the appearance of foam, which may interfere with the correct dose set. To facilitate mixing, the cartridge contains a small glass bead. The drug is not to be used if it has flakes after mixing.

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

The rules for the administration of Humalog® Mix 25 in the QuickKenny ™ syringe pen

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

The following rules should be followed in the future.

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

2. Wash your hands.

3. Choose a site for injection.

4. Wipe the skin at the injection site.

5. Place the injection sites in such a way that the same place is used no more often than once a month.

Preparation of the QuickKenny ™ syringe pen and introduction

1. Pull the cap of the syringe handle to remove it. Do not rotate the cap. Do not remove the label from the syringe handle. Make sure that insulin is inspected for type of insulin; Expiration date; appearance. Only for insulin suspension: gently roll the syringe pen 10 times between the palms and turn 10 times

2. 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 directly on the axis on the syringe handle. Screw the needle until it is fully attached.

3. Remove the cap from the needle.

4. Check the QUIKPEN ™ syringe pen for insulin delivery. Each time, you should check your insulin intake. 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.

5. Fix the skin by pulling it or putting it in a large crease. Rotate the dose button until the number of units that is needed for injection. Introduce the needle sc, using the technique of performing the injection, recommended by the attending physician. Put your thumb on the dose button and firmly press until it stops. For the introduction of a full dose, keep the dose button and slowly count to 5.

6. Remove the needle and put the protective cap on the needle, 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, it is likely that the patient 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, it will not affect the dose.

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

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

If the dose required for administration is greater than the number of units remaining in the cartridge, you can enter the remaining amount of insulin in that syringe pen and then use a new pen to complete the required dose, or enter the entire required dose using a new syringe pen.

Do not try to inject insulin by turning the dose button. The patient will not receive insulin if the dose button is rotated. It is necessary to press the button of introduction of a dose on a direct axis, in order to receive a dose of insulin.

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

Note. The syringe pen will not allow the patient to set a dose of insulin that exceeds the number of units left in the syringe pen. If there is no certainty that a full dose is administered, you should not enter another one. Read and follow the instructions in the instructions for use. It is necessary to check the label on the syringe pen before each injection to make sure that the drug has not expired and the patient uses the correct type of insulin; Do not remove the label from the syringe pen.

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

Important notes

Storage and disposal

The syringe pen can not be used if it is outside the refrigerator for more time specified in the instructions for use.

Do not store a syringe pen with a 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 to 8 ° C. Do not use a syringe pen if it has been frozen.

The currently used syringe pen should be stored at a temperature not exceeding 30 ° C in a place protected from the source of heat and light, in places inaccessible to children.

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

It is necessary to remove the needle after each injection.

Dispose used used syringes without needles attached to them in accordance with the recommendations of the doctor in accordance with local requirements for the disposal of medical waste.

Do not recycle the filled container for sharp objects.

Frequently asked Questions

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 pen.

- Why does insulin leak from the needle after the patient has completed the administration of his dose?

Probably, the patient too quickly extracted the needle from the skin. It is necessary to make sure that there was a number "0" in the dose indicator window.

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

- What should 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 instructions for use.

- What should the patient do if the dose prescribed to him is above 60 units?

If the prescribed dose is greater than 60 units, the patient will need a second injection, or he can contact the attending physician on this matter.

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

If the needles are reused, the patient may receive an incorrect dose of insulin, the needle may become clogged, or the syringe pen may start to seize, or an infection may be caused due to a sterility disorder.

- What if the patient is not sure how much insulin is left in the cartridge?

You should take the handle in such a way that the tip of the needle is pointing down. The scale on the transparent cartridge holder shows the approximate number of remaining insulin dosage units. These figures should not be used to set the dose.

- What should I do if the patient can not remove the cap from the syringe pen?

In order to remove the cap, it is necessary to pull for it. If the patient is having difficulty removing the cap, then gently to turn the cap clockwise and counterclockwise in order to release it, then pulling it to remove the cap.

Form of issue

Suspension for subcutaneous administration, 100 IU / ml. 3 ml in a neutral glass cartridge. 5 cartridges are placed in a blister. To 1 bl. Put in a pack of cardboard. Or, the cartridge is inserted into the QuickKenny ™ syringe pen. On 5 syringes-handles place in a pack a cardboard.

Terms of leave from pharmacies

On prescription.

Storage conditions

At a temperature of 2-8 ° C (do not freeze). Protect from direct sunlight and heat

Keep out of the reach of children.

Shelf life

Suspension for subcutaneous administration of 100 IU / ml - 3 years. After opening the package - at a temperature of no higher than 30 ° C for 28 days.

Do not use after the expiry date printed on the package.