Active substanceInsulin-isophane [human genetic engineering]Insulin-isophane [human genetic engineering]
Similar drugsTo uncover
  • Biosulin® H
    suspension PC 
  • Vozulim-30/70
    suspension PC 
    Vokhard Ltd     India
  • Vozulim-H
    suspension PC 
    Vokhard Ltd     India
  • Gensulin N
    suspension PC 
    BIOTEK MFPDK, CJSC     Russia
  • Insuman® Bazal GT
    suspension PC 
  • Insuran NPH
    suspension PC 
  • Protamine-insulin ES
    suspension PC 
    VIAL, LLC     Russia
  • Protafan® HM
    suspension PC 
    Novo Nordisk A / S     Denmark
  • Protafan® HM Penfill®
    suspension PC 
    Novo Nordisk A / S     Denmark
  • Rinsulin® NPH
    suspension PC 
    GEROPHARM-BIO, JSC     Russia
  • Rinsulin® NPH
    suspension PC 
    GEROPHARM-BIO, JSC     Russia
  • Rosinsulin ะก
    suspension PC 
  • Humodar® B 100 Rivers
    suspension PC 
  • Humulin® NPH
    suspension PC 
    Eli Lilly East SA     Switzerland
  • Dosage form: & nbspsubcutaneous suspension
    Composition:

    1 ml of the preparation contains:

    active substance: human insulin 100 ME;

    Excipients: protamine sulfate 0.34 mg, glycerol 16 mg, phenol crystalline 0.65 mg, meta-cresol 1.6 mg, sodium hydrogen phosphate dihydrate 2.25 mg, water for injection up to 1 ml.

    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 - medium-duration insulin
    ATX: & nbsp

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

    Pharmacodynamics:

    Rinsulin® NPH is a human insulin obtained using technology of recombinant DNA. Insulin of average duration of action. It interacts with a specific receptor of the external cytoplasmic cell membrane and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, etc.).

    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 in both different people and the same person .

    On average, after subcutaneous administration Rinsulin® NPH begins to act after 1.5 hours, the maximum effect develops between 4 and 12 hours, the duration of action is up to 24 hours.

    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, 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. It is excreted by the kidneys (30-80%).

    Indications:- Type 1 diabetes mellitus;
    - Type 2 diabetes mellitus: the stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (when combinedtreatment), intercurrent diseases;
    - fromdiabetes mellitus type 2 in pregnant women.
    Contraindications:

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

    - hypoglycemia.

    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:

    The drug 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 ranges from 0.5 to 1 IU / kg body weight (depends on the individual characteristics of the patient and the concentration of glucose in the blood).

    Elderly patients who use any insulin, including Rinsulin® NPH, are at increased risk of hypoglycemia due to the presence of concomitant pathology and simultaneous production of several drugs. The ego can cause the need to adjust the dose of insulin.

    Patients with impaired renal and hepatic function are at increased risk of hypoglycemia and may need a more frequent adjustment of insulin dose and rapid monitoring of blood glucose.

    Contraindicated intravenous drug Rinsulin® NPH.

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

    The drug is usually administered subcutaneously in the thigh. Injections can also be made in the anterior abdominal wall, buttock or in the shoulder region in the projection of the deltoid muscle. It is necessary to change injection sites within the anatomical region, to prevent the development of lipodystrophy.

    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.

    Rinsulin® NPH cartridges should be rolled between the palms horizontally 10 times before use and shaken to resuspend insulin until it becomes a homogeneous cloudy liquid or milk. Do not allow the appearance of foam, which may interfere with the correct dose set. Cartridges should be carefully checked. Do not use insulin if it has flakes after mixing, if solid white particles adhere to the bottom or walls of the cartridge, giving it a frozen look.

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

    When using cartridges with a reusable syringe pen, follow the manufacturer's instructions for refilling the cartridge in the syringe and attaching the needle. The drug should be administered in accordance with the manufacturer's instructions for the syringe pen.

    After the introduction, it is necessary to unscrew the needle using the outer cap of the needle and immediately destroy it safely. Removing the needle immediately after injection provides sterility, prevents leakage, air ingress and possible clogging of the needle. Then put the cap on the handle.

    When using multi-dose disposable syringes, stir Rinsulin® NPX suspension in a syringe pen immediately before use. The correctly mixed suspension must be uniformly white and cloudy.

    Rinsulin® NPH in the syringe pen can not be used if it has been frozen.

    When using a multidose disposable prefilled injection pens need for multiple injections before first use to remove the pen from the refrigerator and allow the drug to reach room temperature. It is necessary to follow the exact instructions of the instructions for using the syringe-pen supplied with the drug.

    Rinsulin® NPH in the syringe pen and needle are for individual use only. Do not refill the cartridge sprisc-pens.

    Needles should not be reused.

    To protect from light, the syringe pen should be closed with a cap.

    Do not store the used syringe pen in the refrigerator,

    Rinsulin® NPH may be administered alone or in combination with short-acting insulin (Rinsulin® P).

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

    Side effects:

    Due to the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitations, tremors, chills, hunger, agitation, paresthesia mucous membrane of the mouth, weakness, headache, dizziness, decreased visual acuity). Pronounced hypoglycemia can lead to the development of hypoglycemic coma.

    Allergic reactions: skin rash, angioedema, anaphylactic shock.

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

    Other: swelling, transient visual acuity reduction (usually at the beginning of therapy).
    Overdose:In case of overdose, hypoglycemia may develop (symptoms - see "Possible side effects"actions ").

    Treatment: the patient can eliminate mild hypoglycemia himself by taking sugar 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 (glucose); intramuscularly, subcutaneously, intravenously - glucagon. After restoration of consciousness, the patient is recommended to take a food rich in carbohydrates to prevent the re-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 glucagon, somatropin, estrogens, oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, thiazide diuretics, loop diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, epinephrine, blockers H1-gistaminovyh receptors, blockers of "slow" calcium channels, diazoxide, morphine, phenytoin, nicotine.

    Under the influence of reserpine and salicylates, it is possible to weaken, hack and increase the effect of the drug.

    The drug reduces tolerance to alcohol.

    Special instructions:

    Do not apply the drug if after stirring the suspension does not turn white and evenly cloudy.

    On the background of insulin therapy, a constant control of the concentration of glucose in the blood 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 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, liver and kidney dysfunction and diabetes mellitus in persons over 65 years of age.

    In view of the increased risk of cardiac and cerebral complications of hypoglycemia, it is necessary to use the drug with caution in patients with severe stenosis of the coronary and cerebral arteries.

    The drug should be used with caution in patients with proliferative retinopathy, especially those who do not receive photocoagulation (laser coagulation) because of the risk of amaurosis (complete blindness).

    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.

    Transfer of the patient to a new type of insulin or an insulin preparation of another manufacturer must be carried out under the supervision of a doctor.

    When using insulin preparations in combination with preparations of the thiazolidinedione group in patients with type 2 diabetes mellitus, fluid retention in the body may occur, which increases the risk of developing and progressing chronic heart failure, especially in patients with cardiovascular disease and the presence of risk factors for chronic heart failure. Patients receiving this therapy should be screened regularly for signs of heart failure. When heart failure occurs, her therapy is carried out in accordance with current treatment standards. It is necessary to consider the possibility of removing thiazolidinedione or reducing its dose.

    Using cartridges using reusable syringes

    Cartridges with Rinsulin® NPH can be used with an Autopen Classic 3ml 1 Unit (1-21 units) AN3810, Autopen Classic 3ml 2 Unit (2-42 units) AN3800) manufactured by Owen Mumford Ltd. , United Kingdom.

    Carefully follow the instructions for using the Autopen Classic pen for insulin administration.

    INSTRUCTION FOR THE USE OF THE SYNDROME-HANDLE RINASTER

    (single-dose multidose for multiple injections)

    Provision of aseptic injection

    Wash your hands with soap and water and choose a place for injection. Wipe the skin at the injection site with an alcoholic napkin only after the insulin dose has been set in the syringe pen. Before injection, allow the alcohol to dry at the injection site.

    Syringe pen - see Fig. 1.

    Attention: The syringe pen should be rolled between the palms horizontally 10 times and shaken to resuspend insulin until it becomes a homogeneous cloudy liquid or milk.

    Assembly

    A) Hold the syringe handle with one hand and remove the Cap by pulling the other with your other hand. Wipe the rubber membrane (Partition) with an alcohol cloth (see Figure A).

    Note: The use of alcohol wipes helps to minimize the risk of infection.

    B) Select the needle from the kit. Remove the Protective Sticker from the new Needle (see Figure B).

    AT) Using the Outer nozzle, place the needle directly on the cartridge holder. Tighten securely (see Figure B).

    Attention: Always use a new needle for the syringe pen.

    D) Slightly pulling, remove the outer nozzle. Save the outer nozzle for the subsequent removal of the used Needle (see Figure D).

    Preparation

    E) Carefully remove the inner nozzle and discard. Hold the Syringe handle with the needle up. Lightly tap your finger on the cartridge to help air bubbles rise up. Small bubbles may remain, but this is permissible (see Figure E).

    Note: The needle becomes visible (exposed) as the inner nozzle is removed.

    Checking the suitability of the syringe pen before injection It is necessary to remove air from the needle.

    Attention: Check the suitability of the syringe-pen before each injection.

    E) Scroll the Dosing selector and set the dose to 2 units so that the number 2 coincides in the Dosage window with a pointer.When typing each unit, you will hear a click (see Figure E).

    Note: If the Dose selector has skipped the required dose, simply reverse it in order to adjust the dose.

    Attention: Do not press the Start button during dose setting.

    G) Holding the syringe handle with the needle pointing upwards, press the Start button all the way. The dose selector will click when it reaches zero (see Figure F).

    Check that a drop of liquid leaves the needle. If this does not happen, repeat steps E and F, but no more than 6 times. If the drop still does not come out, remove the Needle (see step A) and repeat your actions from step B (with the selection of a new needle).

    Attention: In order for the dose to be complete, before every dose administration, it is always necessary to check the outlet of the liquid drop from the needle.

    A small "loss" of insulin is allowed

    Attention: Have you checked the Syringe Pen with a dose set to 2 units to remove air from the needle? If not, go back to "E".

    Dose setting

    H) Scroll the Dosage selector until the desired dose matches the pointer in the Dosage window (see Figure 3).

    For example, if you need a dose of 40 units, scroll the Dose Selector to 40 (as shown in the figure).

    Attention: You can not select a dose that exceeds the number of units remaining in the cartridge. In the event that the Dosing selector does not scroll, this means that there is not enough of the drug in the Syringe Pen. Discard the syringe pen or enter the remaining dose units and use a new syringe pen to complete the required dose.

    Dosing Introduction

    AND) Make sure you get the required dose.

    Wipe the skin with an alcoholic wipe at the injection site. Pinch the skin in the right place and insert the needle under the skin with one continuous movement (see Figure I).

    To avoid accidental injury from a needle stick:

    - CLICK at least 2.5 cm of leather;

    - DO NOT insert the needle at an angle in the direction of the fingers.

    TO) Press the Start button until the value "0" matches the pointer in the Dosage window. Hold the button depressed, and the Syringe handle at the injection site for 10 seconds after the click stops (see Figure K).

    Attention: Failure to follow these steps can lead to an incorrect dose.

    If you do not hold the Syringe handle at the injection site for a full 10 seconds, you may not receive the required dose of the medication.

    If the insulin continues to flow out of the needle after the injection, hold the needle in the skin for longer injections.

    Disposing of the needle and storage of the syringe pen

    L) Carefully put the outer nozzle on the needle until it stops. Unscrew the needle and discard it with the Outer nozzle (see Figure A).

    M) Wear the cap of the syringe pen and store the syringe pen until the next use (see Figure M).

    Care of the Syringe handle and recycling

    - Keep the syringe-pen away from direct sunlight.

    - The syringe pen is designed for individual use and can not be used by several persons.

    - Do not attempt to repair the Syringe pen by yourself. Report on the occurrence of the problem to the Organization accepting the claims specified in the Instruction for Medical Use.

    An empty syringe pen should not be reused and must be destroyed.

    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 disrupt the ability to drive vehicles or various mechanisms,as well as engage in other potentially hazardous activities that require increased attention and speed of response.

    Form release / dosage:

    Suspension for subcutaneous administration, 100 IU / ml.

    Packaging:

    By 3 ml of the drug in glass cartridges with rubber rubber plugs, rolled with combined caps of aluminum with rubber discs.

    A glass bead with a polished surface is embedded in each cartridge.

    1) 5 cartridges per contour cell packaging made of polyvinylchloride film and aluminum foil printed lacquered. 1 contour pack with instructions for use is placed in a pack of cardboard.

    2) Cartridge, mounted in a plastic multi-dose disposable syringe pen for repeated injections of Rinastra. Five pre-filled multi-dose disposable syringe pens for multiple injections of Rinastra with instructions for use and instructions for the use of the syringe-pen Rinastra are placed in a pack of cardboard.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001560
    Date of registration:02.03.2012
    Date of cancellation:2017-03-02
    The owner of the registration certificate:GEROPHARM-BIO, JSC GEROPHARM-BIO, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp31.10.2015
    Illustrated instructions
    Instructions
    Up