ROSINSULIN M mix 30/70 - instructions for use, dose, side effects, contraindications

Active substances:
Human recombinant insulin	- 100 ME
Excipients:
Protamine sulfate	- 0.12-0.20 mg
Sodium hydrogen phosphate dihydrate	- 2.08 mg
Sodium dihydrogen phosphate dihydrate	- 0.26 mg
Phenol crystalline	- 0.65 mg
Metacresol	- 1.5 mg
Glycerol (glycerol)	- 16 mg
Water for injections	- up to 1 ml

1 ml of the preparation contains 30 ME neutral solution of insulin [human genetic engineering] and 70 ME suspension of insulin-isophane [human genetic engineering].

Description:

A suspension of white color. When standing, the slurry settles. The liquid above the precipitate is clear, colorless or almost colorless. 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:

ROSINSULIN M mix 30/70 - a preparation of insulin of average duration of action. The composition of the drug includes insulin soluble (30%) and insulin-isophane (70%).

Insulin interacts with a specific receptor of the outer cytoplasmic cell membrane and forms an insulin-receptor complex. Through activation of cAMP biosynthesis (in fat cells and liver cells) or directly penetrating into the cell (muscles), the insulin-receptor complex stimulates intracellular processes, incl. synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, etc.).

Reduction of blood glucose is due to increased intracellular transport, increased absorption and assimilation by tissues, lipogenesis stimulation, glycogenogenesis, protein synthesis, a decrease in the rate of glucose production by the liver, etc.

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

On average, after subcutaneous administration, ROSINSULIN M mix 30/70 starts to act after 0.5 hours, the maximum effect develops in the interval from 4 to 12 hours, the duration of the action is up to 24 hours.

Pharmacokinetics:

Completeness of absorption and the beginning of the effect of insulin depends on the mode of administration (subcutaneously), 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 in breast milk. It is destroyed by insulinase mainly in the liver and kidneys. It is excreted by the kidneys (30-80%).

Indications:

Diabetes mellitus type 1 in adults.

Diabetes mellitus type 2: the stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (with combined therapy), intercurrent diseases.

Contraindications:

Hypoglycemia.

Increased individual sensitivity to insulin or any of the components of the drug.

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. However, it may require a reduced dose of insulin, so careful observation for several months to stabilize insulin requirements.

Dosing and Administration:

ROSINSULIN M mix 30/70 is intended for subcutaneous administration. The dose of the drug is determined by the doctor individually in each case, based on the concentration of glucose in the blood. On average, the daily dose of the drug varies from 0.5 to 1 IU / kg of body weight, depending on the individual characteristics of the patient and the concentration of glucose in the blood.

The temperature of the insulin should be appropriate at room temperature. Before use, the suspension carefully stir until reaching homogeneity.

ROSINSULIN M mix 30/70 is usually injected subcutaneously into the thigh. Injections can also be done in the anterior abdominal wall, buttock or shoulder in the projection of the deltoid muscle.

It is necessary to change the injection site within the anatomical area to prevent the development of lipodystrophy.

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.

Mix the suspension of the drug ROSINSULIN M mix 30/70 in a disposable syringe pen immediately before use. The correctly mixed suspension must be uniformly white and cloudy. The drug ROSINSULIN M mix 30/70 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, agitation, 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 administered 40% solution of dextrose (glucose); 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 increases oral hypoglycemic drugs, 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, blockers of "slow" calcium channels, diazoxide, morphine, phenytoin, nicotine, sulfinpyrazone, epinephrine, blockers H₁-gistaminovyh receptors.

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

Special instructions:

Before use, carefully check the appearance of the contents of the vial and DO NOT use DOSINSULIN M mix 30/70,if after mixing the suspension contains flakes or particles when white stuck to the bottom or walls of the bottle, creating the effect of frost.

You can not use ROSINSULIN M Mix 30/70 if after shaking the suspension becomes uniformly white and cloudy.

On the background of insulin therapy, a constant control of the concentration of glucose in the blood is necessary.

The causes of hypoglycemia than insulin overdose may be: replacement drug, skipping meals, vomiting, diarrhea, physical stress, disease, reducing the need for insulin (human liver and kidneys, hypofunction of the adrenal cortex, pituitary, or thyroid), the change of the injection site, and also 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 mellitus 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, liver and kidney dysfunction and diabetes mellitus in persons over 65 years of age.

Correction of the dose of insulin may also be required if the patient increases the level of physical activity or changes the habitual diet.

Concomitant diseases, especially infections and conditions accompanied by fever, increase the need for insulin.

Correction of the dose and the transition from one type of insulin to another should be done under the supervision of a doctor and monitoring the concentration of glucose in the blood.

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 pen-syringe for multiple injections,designed to introduce insulin Rosinsulin with an activity of 100 IU / ml in the 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. Cap

2. Piston

3. Shutter release button

4. Dose selector

5. Housing

6. Cartridge Holder

7. Cartridge

8. Shutter Release 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 (Fig.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

- A 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 contains the type of insulin that your prescribing physician prescribes.

- 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.

- For each injection, use a new needle. 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 advise you to regularly check the blood sugar level at regular intervals, read the instructions on the medical use insulin or contact a healthcare professional.

- Consult 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.

- A 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 not more than 28 days, protect 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 of 2 to 8 ° C.

- Store pre-filled disposable syringes in places out of the reach of children.

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

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

Syringe-pen Autopen Classic has been thoroughly tested and meets the requirements of the standard 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 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).

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, 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 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.

- 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

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

- Pre-filled A disposable syringe pen can not be used if it is outside the refrigerator for more than the time specified in the medical instructions.

- Pre-filled The disposable syringe 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 of 2 to 8 ° C.

- Store in advance 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

1. Disinfect the rubber membrane of the vial;

2. Put the air in the syringe in the volume corresponding to the required dose of insulin. Insert air into the vial of 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 insulin dose set;

4. Immediately inject.

The technique of injection with the use of insulin in cartridges

The cartridge with the drug ROSINSULIN M mix 30/70 is intended for use with a multi-use syringe 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 cartridge with the drug ROSINSULIN M mix 30/70.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.

Before placing the cartridge in the syringe pen, turn the cartridge up and down so that the glass ball moves from end to end of the cartridge. This procedure should be repeated at least 10 times, until all the liquid becomes white and evenly turbid. Immediately after this, an injection must be made.

If the cartridge is already inside the pen syringe, turn it with the cartridge inside up and down at least 10 times. This procedure must be repeated before each injection.

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 drug ROSINSULIN M mix 30/70 is intended only for individual use and can not be refilled.

Injection procedure

With two fingers, assemble the skin fold, 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 to ensure that insulin is injected completely.

If, after removing the needle, blood appears on the site of the injection, gently press the injection site with a swab dipped in a disinfectant solution.

It is necessary to change the injection site.

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

In connection with the primary appointment 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 various mechanisms, as well as engaging in other potentially dangerous activities requiring increased attention and speed of mental and motor reactions.

Form release / dosage:

Suspension for subcutaneous administration, 100 IU / ml.

Packaging:

For 5, 10 ml of the drug into neutral glass bottles, sealed with imported rubber stoppers and coated with aluminum caps or caps with a detachable plastic overlay Flip Off Seal.

5 vials (5 ml) are placed in a contour mesh box made of polyvinyl chloride film and aluminum foil lacquered or without it. 1 circuit cell pack or 1 bottle (10 ml) together with the instruction for use is placed in a pack of chromium-ersatz cardboard or boxed or lacquered imported.

By 3 ml of the drug in cartridges with rubber plugs made of bromobutyl rubber and coated with aluminum caps with a rubber disc. A ball with a diameter of 2.5 ± 0.05 mm made of borosilicate glass with a polished surface is inserted into the cartridge. 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).

5 pre-filled disposable syringes, together with instructions for use and guidelines for the use of pre-filled disposable syringes, are placed in a pack of cardboard.

Or 5 cartridges packed in a contour mesh box made of polyvinyl chloride film and aluminum foil lacquered or without it,together with the instructions for use are placed in a pack of cardboard chrome-ersatz or boxed or lacquered imported.

Storage conditions:

In a dry, dark place at a temperature of 2 to 8 ° C. 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:LP-000645

Date of registration:28.09.2011

Date of cancellation:2016-09-28

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

Manufacturer: & nbsp