Rosinsulin R - instructions for use, dose, side effects, contraindications

Rosinsulin P - human insulin, obtained using recombinant DNA technology. It is a short-acting insulin preparation. Interacts with a specific receptor cytoplasmic outer cell membrane to form insulin-receptor complex stimulates intracellular processes, in m. H. Synthesis of some key enzymes (hexokinase, pyruvate kinase, glycogen and others.).

Reduction of glucose in the blood due to an increase of intracellular transport, absorption and assimilation tissue enhancement, stimulation of lipogenesis, glikogenogeneza decreased hepatic glucose rate and other products.

The duration of action of insulin preparations is mainly due to the rate of absorption, which depends on several factors (for example, on the dose, method and site of administration), and therefore the profile of insulin activity is subject to significant fluctuations, both in different people and in the same rights.

The action profile for subcutaneous injection (approximate figures): the onset of action after 30 minutes, the maximum effect - in the interval between 2 and 4 hours, the duration of the action - 6-8 hours.

Pharmacokinetics:Completeness of absorption and the beginning of the effect of insulin depends on the mode of administration (subcutaneously, intramuscularly), the place of administration (abdomen, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the preparation, etc. Distributed in tissues unevenly; does not penetrate the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and kidneys. The half-life is a few minutes. It is excreted by the kidneys (30-80%).

Indications:

- Diabetes;

- Mr.Emergency conditions in patients with diabetes mellitus, accompanied by decompensation of carbohydrate metabolism.

Contraindications:

- Increased individual sensitivity to insulin or any of the components of the drug;

- ghypoglycaemia.

Pregnancy and lactation:

There are no restrictions on the treatment of diabetes mellitus with insulin, since insulin does not penetrate the placental barrier. When planning pregnancy and during it, it is necessary to intensify the treatment of diabetes.The need for insulin usually decreases in the first trimester of pregnancy and gradually rises in the II and III trimesters. During and immediately after delivery, the need for insulin can dramatically decrease. Shortly after birth, the need for insulin quickly returns to the level that was before pregnancy.

There are no restrictions on the treatment of diabetes mellitus with insulin during breastfeeding, as treatment of the mother with insulin is safe for the child. However, it may be necessary to reduce the dose of insulin, so careful monitoring is necessary before stabilizing the need for insulin.

Dosing and Administration:

Rosinsulin R is intended for subcutaneous, intravenous and intramuscular administration. The dose and route of administration of the drug is determined by the physician individually in each case based on the level of glucose in the blood.

On average, the daily dose of the drug ranges from 0.5 IU / kg to 1 IU / kg body weight (depending on the individual characteristics of the patient and blood glucose level).

The drug is administered 30 minutes before a meal or a light snack containing carbohydrates.

The temperature of the insulin should be appropriate at room temperature.

When monotherapy with the drug, the frequency of administration is 3 times a day (if necessary, 5-6 times a day). At a daily dose exceeding 0.6 IU / kg, it is necessary to inject 2 or more injections into different areas of the body.

Rosinsulin P is usually injected subcutaneously into the anterior abdominal wall. Injections can also be done in the thigh, buttock, or the area of the deltoid muscle of the shoulder. It is necessary to change the injection site within the anatomical area to prevent the development of lipodystrophy.

Intramuscularly and intravenously, Rosinsulin P can be administered only under the supervision of a physician.

Rosinsulin P - short-acting insulin and is usually used in combination with insulin of medium duration (Rosinsulin C).

When using pre-filled disposable multi-dose syringe pens for multiple injections, before using for the first time, remove the syringe pen from the refrigerator and allow the drug to reach room temperature. The preparation Rosinsulin P in a disposable syringe pen can not be used if it has been frozen. Follow the instructions in the manual for the use of the syringe pen supplied with the drug.

Side effects:

Due to the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitation, tremor, hunger, excitement, paresthesia in the mouth, headache). Pronounced hypoglycemia can lead to the development of hypoglycemic coma.

Allergic reactions: rarely - skin rash, angioedema; extremely rare - anaphylactic shock.

Local Reactions: hyperemia, puffiness and itching at the injection site; with prolonged use - lipodystrophy at the injection site.

Other: edema, transient refractive disorders (usually at the beginning of therapy).

Overdose:

Overdose may develop hypoglycemia.

Treatment: an easy hypoglycemia patient can eliminate himself by taking sugar inside or carbohydrate-rich foods. Therefore, patients with diabetes are encouraged to always carry sugar, sweets, cookies or sweet fruit juice.

In severe cases, if the patient lost consciousness, intravenously injected 40% solution of dextrose; intramuscularly, subcutaneously, intravenously - glucagon. After restoration of consciousness the patient is recommended to take food rich in carbohydrates, to prevent the repeated development of hypoglycemia.

Interaction:

There are a number of drugs that affect the need for insulin.

Hypoglycemic action of insulin enhances oral hypoglycemic agents, monoamine oxidase inhibitors, angiotensin converting enzyme inhibitors, carbonic anhydrase inhibitors, nonselective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, preparations containing ethanol.

Hypoglycemic action of insulin weakens oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Under the influence of reserpine and salicylates, both weakening and enhancement of the action of the drug are possible.

Special instructions:

Do not use Rosinsulin P if it becomes cloudy, colored, or if solid particles are detected.

On the background of insulin therapy, continuous monitoring of blood glucose levels is necessary.

Causes hypoglycemia In addition to an overdose of insulin, there may be: drug substitution, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (liver and kidney dysfunction, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), injection site change, and interaction with other drugs.

Incorrect dosing or breaks in the administration of insulin, especially in patients with type 1 diabetes, can lead to hyperglycemia. Usually the first symptoms of hyperglycemia develop gradually, over a period of several hours or days. They include the appearance of thirst, increased urination, nausea, vomiting, dizziness, redness and dryness of the skin, dry mouth, loss of appetite, odor of acetone in the exhaled air. If not treated, hyperglycemia in type 1 diabetes can lead to the development of life-threatening diabetic ketoacidosis.

The dose of insulin must be corrected in case of thyroid dysfunction, Addison's disease, hypopituitarism, violations of liver and kidney function, and diabetes of streets older than 65 years.

Correction of the dose of insulin may also be required if the patient increases the intensity of physical activity or changes the habitual diet. Concomitant diseases, especially infections and conditions accompanied by fever, increase the need for insulin.

The transition from one type of insulin to another should be carried out under the control of blood glucose.

The drug lowers tolerance to alcohol.

Due to the possibility of precipitation in some catheters, the use of the drug in insulin pumps is not recommended.

Manual on the use of a pre-filled disposable syringe pen Autopen Classic (Autopen Classic 1-Unit)

Syringe pen Autopen Classic is an easy-to-use disposable multi-dose disposable syringe pen for repeated injections designed to introduce insulin Rosinsulin with an activity of 100 IU / ml in a cartridge) 3.0 ml. Compatible with any needles for syringe pens. Please see the step-by-step instruction for the use of syringe pens.

Failure to follow instructions can lead to a set of an inaccurate dose of insulin.

Composition pre-filled syringe-bundles disposable

1. A cap

2. The piston

3. Shutter release button

4.Dose selector

5. Housing

6. Cartridge holder

7. The cartridge

8. Trigger Adapter

9. Dose selector adapter

(see the figure "Composition of a prefilled syringe-injector")

Preparation for use

Pull the cap of the pre-filled disposable syringe to remove it. Do not remove the label from the pre-filled disposable syringe pen.

Remove the protective film from the new needle (needles are not included). Screw the needle directly to the cartridge holder (Figure 1). Remove the outer protective cap and the needle cap.

Follow steps 2-3 before each injection.

It is important to prepare a pre-filled disposable syringe pen to use to remove all air that may be inside the needle.

Before use, set 8 units on the dose selector (Figure 2A / 2B).

Hold the pre-filled syringe pen with the disposable needle up. Press and hold the start button until the arrow icon on the pen syringe body returns to the start line on the dose selector.

Collect and lower 2 units until a drop of insulin appears on the end of the needle (Figure 3A / 3B).Now the pre-filled disposable syringe pen is ready for use.

If the cartridge contains long-acting insulin, turn the pre-filled syringe handle up and down one-time at least 10 times, as indicated in the cartridge instructions. Then put the needle on the cartridge holder.

If, during step 3, the dose selector does not return to the starting line position and insulin does not appear at the tip of the needle, it is possible that the used needle of the pre-filled disposable syringe is impassable. In this case, remove the old needle and replace it with a new one. Then repeat steps 2-3.

Dosing Introduction

Ensure that the ► arrow on the body of the pre-filled syringe pen is a one-time sign that points to the start line on the dose selector. Dial the required number of units. Do not turn the dose selector in the opposite direction, which can lead to a breakage of the pre-filled disposable syringe pen and, as a result, to an incorrect dose set.

If you have gained more than the necessary dose of insulin, we recommend completely draining the wrong dose and re-typing the required amount.

Before injection, make sure that the ► arrow points to the desired number of units on the dose selector. For example, Figures 4A and 4B show the correct position for the introduction of 20 units of insulin.

Insert the needle using the injection technique recommended by your doctor. Press the release button towards the needle and hold until the start line on the dose selector returns to the pointer ► on the body of the pre-filled disposable syringe pen (Figure 5). Count to 10 and pull the needle out of the skin.

If the dose selector stops before the start line is aligned with the ► arrow, it means that you did not receive the required dose of insulin. The dose selector indicates the number of units that must be entered for the full dose of insulin.

Removing the needle

Disconnect the outer protective cap of the needle and unscrew the needle from the pre-filled disposable syringe pen. Always check that the needle is disconnected. Put the cap of the pre-filled disposable syringe in place (Figure 6). Disposal of used needles should be carried out in accordance with the recommendations of health workers and sanitary and epidemiological standards.

Precautionary measures

- The pre-filled disposable syringe pen should only be used after consultation with your health care provider.

- Before each injection, make sure that the pre-filled disposable syringe pen contains the type of insulin you need, prescribed by your health care provider.

- Read and follow the instructions for the medical use of insulin. Always make sure that the pre-filled disposable syringe pen is ready for use in accordance with the guidelines and paragraphs 2-3. Violation of the procedure for preparing a pre-filled syringe pen is disposable to use may lead to the introduction of an inaccurate dose of insulin.

- Use a new needle for each injection. Immediately after the injection, the needle should be removed and disposed of in a safe way. If the needle remains on the syringe pen, it can lead to clogging and affect the accuracy of the dose.

- If you find an insulin leak after disconnecting the needle from the syringe pen, you may not have entered the required amount of insulin completely. Do not try to make up a missed dose of insulin with a second injection (you risk dramatically reducing blood sugar).As a precautionary measure, we recommend that you regularly check blood sugar levels at regular intervals, read the instructions for the medical use of insulin, or contact a healthcare professional.

- Check with your doctor if you find an unusual level of sugar in your blood.

Storage and disposal

- Pre-filled syringe disposable pen should always be stored with the needle removed and in the cap.

- The pre-filled disposable syringe pen can not be used if it was outside the refrigerator for more than the time specified in the medical instructions.

- Pre-filled disposable syringe pen that you are currently using should be stored at room temperature 15-25 ° C for no longer than 28 days, protected from direct sunlight and heat.

- Clean the syringe handle with a damp cloth. Do not immerse the syringe handle in water.

- Pre-filled disposable syringes that are not in use should be stored in the refrigerator at a temperature between 2 and 8 ° C.

- Store pre-filled disposable syringes in places inaccessible to children.

- Dispose of used needles in their protective piercing caps, or as recommended by your doctor.

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

Syringe pen Autopen Classic has been thoroughly tested and meets the requirements of ISO 11608-1 for the accuracy of the dose.

Manual on the use of pre-filled syringe-pen disposable production LLC "Plant Medsintez"

The syringe pen is intended for administration of insulin Rosinsulin with an activity of 100 IU / ml in cartridges of 3.0 ml. Compatible with any needles for syringe pens. Please see the step-by-step instruction for the use of syringe pens.

Failure to follow instructions can lead to a set of an inaccurate dose of insulin.

The composition of a pre-filled disposable syringe pen manufactured by LLC "Medsintez Plant"

see Fig. 7.

1. Preparation for use

A. Pull the cap of the pre-filled disposable syringe pen to remove it. Do not remove the label from the pre-filled disposable syringe pen.

B. Remove the protective film from the new needle (needles are not included) (Figure 8).

Screw the needle directly to the cartridge holder (Figure 9).

Remove the outer protective cap and the needle cap (figure 10).

Do not dispose of the outer cap.

C. It is important to prepare a pre-filled disposable syringe pen to use to remove all air that may be inside the needle. Before use, set 2 units on the dose selector. Hold the pre-filled syringe pen with the disposable needle up. Press and hold the shutter release button until the arrow icon on the pen syringe body returns to the start line on the dose selector.

Collect and lower 2 units until a drop of insulin appears on the end of the needle (Figure 11, 12).

Now the pre-filled disposable syringe pen is ready for use.

If the dose selector does not return to the starting line position and insulin does not appear at the tip of the needle, repeat step 1B of the preparation procedure for using the syringe pen.If insulin does not appear at the tip of the needle, it is possible that the used needle of the pre-filled disposable syringe is impassable. In this case, remove the old needle and replace it with a new one. Then repeat step 1B.

2. Dosing Introduction

A. Ensure that the ► arrow on the body of the pre-filled disposable syringe indicates a zero mark on the dose selector. Dial the required number of units.

A set of insulin dose in a syringe-pen manufactured by LLC "Medsintez Plant" can be changed by rotating the dose dial selector in any direction.

Before injection, make sure that the ► arrow points to the desired number of units on the dose selector.

B. Insert the needle using the injection technique recommended by your doctor. Press the release button towards the needle and hold until the start line on the dose selector returns to the pointer ► on the body of the pre-filled disposable syringe pen. Count to 10 and pull the needle out of the skin (Figure 13).

If the dose selector stops before the start line is aligned with the ► arrow, it means that you did not receive the required dose of insulin.The dose selector indicates the number of units that must be entered for the full dose of insulin.

3. Removing the needle

Carefully place the outer protective cap on the needle and unscrew the needle together with the cap from the pre-filled disposable syringe pen (Figure 14).

Always check that the needle is disconnected. Put the cap of the pre-filled disposable syringe in place. Disposal of used needles should be carried out in accordance with the recommendations of health workers and sanitary and epidemiological standards.

Precautionary measures

- The pre-filled disposable syringe should only be used after consultation with your health care provider.

- To prevent infection, a pre-filled disposable syringe pen should be used only by one patient and not transferred to another person.

- If there is a suspicion that the used specimen of the pre-filled disposable syringe pen is damaged, a new pre-filled disposable syringe pen should be used.

- Before each injection,that a pre-filled disposable syringe contains the type of insulin you need, prescribed by your health care provider.

- Read and follow the instructions for the medical use of insulin. Always make sure that the pre-filled disposable syringe pen is prepared for use in accordance with the manual. Violation of the procedure for preparing a pre-filled syringe pen is disposable to use may lead to the introduction of an inaccurate dose of insulin.

- If you find an insulin leak after disconnecting the needle from the syringe pen, you may not have entered the required amount of insulin completely. Do not try to make up a missed dose of insulin with a second injection (you risk dramatically reducing blood sugar). As a precautionary measure, we advise you to regularly check the blood sugar level at regular intervals,read the instructions for the medical use of insulin or contact a healthcare professional.

- Check with your doctor if you find an unusual level of sugar in your blood.

Storage and disposal

- The pre-filled disposable syringe should always be stored with the needle removed and in the cap.

- The pre-filled disposable syringe pen can not be used if it was outside the refrigerator for more than the time specified in the medical instructions.

- Pre-filled disposable syringe pen that you are currently using should be stored at room temperature 15-25 ° C for no longer than 28 days, protected from direct sunlight and heat.

- Clean the syringe handle with a damp cloth. Do not immerse the syringe handle in water.

- Pre-filled disposable syringes that are not in use should be stored in the refrigerator at a temperature between 2 and 8 ° C.

- Store pre-filled disposable syringes in places inaccessible to children.

- Dispose of used needles in their protective piercing caps, or as recommended by your doctor.

Empty syringe-pens should not be reused. Dispose of used syringes without needles attached to them and in accordance with the advice of your doctor.

Instructions to be given to the patient

The technique of injection with the use of insulin in vials

If the patient uses only one type of insulin

1. Disinfect the rubber membrane on the vial.

2. Insert the air in the syringe in the amount corresponding to the required dose of insulin. Insert air into the vial with insulin.

3. Turn the bottle with the syringe upside down and type the desired dose of insulin into the syringe.

Remove the needle from the vial and remove air from the syringe. Check the correctness of the dose of insulin.

4. Immediately inject.

If the patient needs to mix two types of insulin

1. Disinfect the rubber membranes on the vials.

2. Directly before typing, roll a vial of long-acting insulin ("cloudy") between the palms until the insulin becomes evenly white and cloudy.

3. Draw in the syringe air in an amount corresponding to the dose of "cloudy" insulin.

Enter the air into the bottle with a "cloudy" insulin and remove the needle from the bottle.

4.Type in the syringe air in an amount corresponding to a dose of insulin of short action ("transparent"). Insert air into the bottle with "transparent" insulin.

Turn the bottle with the syringe upside down and type the desired dose of transparent "insulin." Remove the needle and remove air from the syringe.

5. Insert the needle into the bottle with a "cloudy" insulin, flip the bottle with the syringe upside down and type the desired dose of insulin. Remove air from the syringe and check the correctness of the dialed dose. Immediately inject the dialed mixture of insulin.

6. Always take the insulin in the same sequence described above.

The technique of injection with the use of insulin in cartridges

The cartridge with the preparation Rosinsulin R is intended for use with a multi-use pen. Autopen Classic (Autopen Classic 1-Unit, Autopen Classic 2-Unit ) produced by Owen Mumford Ltd., United Kingdom.

The patient should be warned about the need to carefully follow the instructions in the instructions for using the syringe pen for insulin administration.

Before use, make sure that there is no damage (for example, cracks) on the Rosinsulin P cartridge. Do not use the cartridge if there are any visible damage.After the cartridge is inserted into the syringe pen, a colored strip should be visible through the cartridge holder window.

After the injection, the needle should remain under the skin for a minimum of 6 seconds. Keep the button depressed until the needle is completely removed from the skin, thus ensuring the correct dose administration and limiting the possibility of blood or lymph flow into the needle or the insulin cartridge.

The cartridge with the preparation Rosinsulin R is intended only for individual use and can not be refilled.

Injection procedure

- With two fingers, take the fold of the skin, insert the needle into the base of the fold at an angle of about 45 ° and insert insulin under the skin.

- After the injection, the needle should remain under the skin for at least 6 seconds, in order to ensure that the insulin is injected completely. If blood is removed from the needle after the needle is removed, gently press the injection site with your finger.

- It is necessary to change the injection site.

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

In connection with the primary purpose of insulin, a change in its type or in the presence of significant physical or mental stress, it is possible to reduce the ability to drive a car or to manage variousmechanisms, and also employment by other potentially dangerous kinds of activity demanding increased attention and speed of mental and motor reactions.

Form release / dosage:

Solution for injection, 100 IU / ml.

Packaging:

For 5, 10 ml in glass bottles. For 5 vials (5 ml) in a planar cell package. 1 circuit cell pack or 1 bottle (10 ml) together with the instruction for use is placed in a pack of cardboard.

3 ml in glass cartridges.

The cartridge is placed in a syringe-pen Autopen Classic (Autopen Classic 1-Unit) manufactured by Owen Mumford Ltd., UK or in a syringe pen manufactured by Medsintez Plant, Russia (pre-filled disposable syringe pen).

Five pre-filled disposable syringes, together with the instruction for use and guidance on the use of a pre-filled disposable syringe pen, are placed in a pack of cardboard.

5 cartridges in a contour acheive box. 1 circuit cell pack together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of 2 to 8 ° C. Do not freeze.

The drug in use Store at room temperature 15-25 ° C for no more than 28 days, protect from direct sunlight and heating.

Keep out of the reach of children.

Shelf life:

3 of the year.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002479/09

Date of registration:27.03.2009

The owner of the registration certificate:MEDSINTEZ FACTORY, LTD. MEDSINTEZ FACTORY, LTD. Russia