NovoMix® 30 Penfill® (NovoMix® 30 Penfill®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceInsulin aspart biphasicInsulin aspart biphasic
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  • NovoMix® 30 Penfill®
    suspension PC 
    Novo Nordisk A / S     Denmark
  • NovoMix® 30 FlexPen®
    suspension PC 
    Novo Nordisk A / S     Denmark
  • NovoMix® 50 FlexPen®
    suspension PC 
    Novo Nordisk A / S     Denmark
  • NovoMix® 70 FlexPen®
    suspension PC 
    Novo Nordisk A / S     Denmark
    • Dosage form: & nbspsubcutaneous suspension
    Composition:

    In 1 ml of the drug is contained:

    active substance: insulin aspart (soluble insulin aspart (30%) and insulin crystals of aspart protamine (70%)) 100 units (3.5 mg);

    Excipients: glycerol 16.0 mg, phenol 1.50 mg, metacresol 1.72 mg, zinc 19.6 μg (in the form of zinc chloride), sodium chloride 0,877 mg, sodium hydrogen phosphate dihydrate 1.25 mg, protamine sulfate about 0.32 mg , sodium hydroxide about 2.2 mg, hydrochloric acid about 1.7 mg, water for injection up to 1.0 ml.

    1 cartridge (3 ml) contains 300 units.

    Description:

    Homogenous suspension of white color, not containing lumps. Flakes may appear in the sample. When standing, the suspension stratifies to form a white precipitate and a colorless or almost colorless supernatant. While stirring the contents of the cartridge according to the procedure described in the Instruction for medical use, a homogeneous suspension should be formed.

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

    A.10.A.D.05   Insulin aspart

    Pharmacodynamics:

    NovoMiks® Penfill® 30 represents a biphasic suspension of mixtures of insulin analogs: soluble insulin aspart (30% short-acting insulin analogue) and insulin aspart protamine crystals (70% of the analogue intermediate-acting insulin).

    Active substance NovoMix® 30 Penfill® is insulin aspart, produced by biotechnology of recombinant DNA using a strain Saccharomyces cerevisiae.

    Insulin aspart is an equipotential soluble human insulin based on the molarity index.

    Reduction of blood glucose level occurs due to the increase of its intracellular transport after binding of insulin aspart with insulin receptors of muscle and fat tissues and simultaneous inhibition of glucose production by the liver.

    After subcutaneous administration of NovoMix® 30 Penfill®, the effect develops within 10-20 minutes. The maximum effect is observed in the range from 1 to 4 hours after the injection.The duration of the drug reaches 24 hours.

    In a three-month comparative clinical trial involving patients with type 1 and type 2 diabetes mellitus who received NovoMix® 30 Penfill® and biphasic human insulin 30 twice daily before breakfast and dinner, NovoMix® 30 Penfill® was shown to decrease postprandial levels more strongly blood glucose (after breakfast and dinner). A meta-analysis of data from nine clinical trials involving patients with type 1 and type 2 diabetes showed that NovoMix® 30 Penfill®, when administered before breakfast and dinner, provides better control of postprandial blood glucose (mean increase in prandial glucose levels after breakfast, lunch and dinner), compared to human biphasic insulin 30. Although fasting glucose in patients using NovoMix® 30 Penfill® was higher, in general NovoMix® 30 Penfill® had the same effect and the concentration of glycated hemoglobin (HbA1c), as well as biphasic human insulin 30.

    In a clinical study involving 341 patients with type 2 diabetes mellitus, patients were randomized to treatment groups only NovoMix® 30 Penfill®,NovoMix® 30 Penfill® in combination with metformin and metformin in combination with the sulfonylurea derivative.

    Concentration HbA1c after 16 weeks of treatment did not differ in patients who received NovoMix® 30 Penfill® in combination with metformin and in patients who received metformin in combination with a sulfonylurea compound. In this study, in 57% of patients the baseline concentration HbA1c was above 9%; In these patients, therapy with NovoMix® 30 Penfill® in combination with metformin resulted in a significantly lower concentration HbA1c, than in patients who received metformin in combination with a sulfonylurea compound.

    In another study, patients with type 2 diabetes mellitus with unsatisfactory control glycemia, who took oral hypoglycemic drugs, were randomized into the following groups: those receiving NovoMix® 30 twice a day (117 patients) and receiving insulin glargine once a day (116 patients). After 28 weeks of use, the average decrease in HbA1c in the NovoMix® 30 Penfill® group was 2.8% (the initial mean was 9.7%).In 66% and 42% of patients who used NovoMix® 30 Penfill®, at the end of the study, HbA1c were below 7% and 6.5% respectively. The mean fasting plasma glucose decreased by about 7 mmol / l (from 14.0 mmol / L at the beginning of the study to 7.1 mmol / L). The results of a meta-analysis of data from clinical trials involving patients with type 2 diabetes mellitus demonstrated a reduction in the total number of episodes of nocturnal hypoglycemia and severe hypoglycemia with NovoMix® 30 Penfill® compared to biphasic human insulin 30. However, day hypoglycemia in patients treated with NovoMix® 30 Penfill® was higher.

    Children and teens:

    A 16-week clinical trial comparing blood glucose after meals with NovoMix® 30 (before meals), human insulin / biphasic human insulin 30 (before meals), and isofan-insulin (administered at bedtime) was performed. The study involved 167 patients aged 10 to 18 years. Mean values HbA1c in both groups remained close to the initial values ​​throughout the study.Also, when NovoMix® 30 Penfill® or biphasic human insulin 30 was used, there was no difference in the incidence of hypoglycemia.

    A double-blind, cross-sectional study was conducted in the population of patients aged 6 to 12 years (54 patients in total, 12 weeks for each type of treatment). The incidence of hypoglycemia and the increase in post-prandial glucose in the group of patients using NovoMix® 30 Penfill® were significantly lower than those in the group of patients using biphasic human insulin 30. Values HbA1c at the end of the study, the use of biphasic human insulin 30 was significantly lower than in the group of patients using NovoMix® 30 Penfill®.

    Elderly patients:

    Pharmacodynamics of NovoMix® 30 Penfill® in elderly and senile patients has not been studied. However, in a randomized, double-blind, cross-over study, 19 patients with type 2 diabetes aged 65-83 years (mean age 70 years) compared the pharmacodynamics and pharmacokinetics of insulin aspart and soluble human insulin.Relative differences in the values ​​of pharmacodynamics (the maximum rate of glucose infusion - GIRmax and the area under the curve of its infusion rate within 120 minutes after the administration of insulin preparations - AUCgir, 0-120 min) between insulin aspart and human insulin in elderly patients were similar to those in healthy volunteers and in younger patients with diabetes mellitus.

    Pharmacokinetics:

    In insulin aspart, the replacement of the amino acid proline in position B28 with aspartic acid reduces the tendency of the molecules to form hexamers in the soluble fraction Novomix® 30 Penfill®, which is observed in soluble human insulin. Concerning insulin aspart (30%) is absorbed from the subcutaneous fat faster than soluble insulin, contained in a two-phase human insulin. The remaining 70% is attributable to the crystalline form protamine-insulin aspart, the rate of absorption of which is the same as that of human NPH insulin.

    The maximum serum insulin concentration after administration of NovoMix® 30 Penfill® is 50% higher than that of biphasic human insulin 30, and the time to achieve it is half as long as compared with biphasic human insulin 30.

    In healthy volunteers, after subcutaneous administration of NovoMix® 30 at the rate of 0.20 U / kg body weight, the maximum serum insulin concentration in blood serum was reached after 60 minutes and was 140 ± 32 pmol / L. Duration of half life (T1/2) of NovoMix® 30, which reflects the rate of absorption of the protamine-related fraction, was 8-9 hours. The insulin level in the serum returned to the baseline 15-18 hours after subcutaneous administration of the drug. In patients with type 2 diabetes, the maximum concentration was reached 95 minutes after administration and remained above the original at least 14 hours.

    Patients of elderly and senile age:

    The study of the pharmacokinetics of NovoMix® 30 in elderly and senile patients was not carried out. However, the relative differences in pharmacokinetics between insulin aspart and human soluble insulin in elderly patients with type 2 diabetes (age 65-83 years, mean age 70 years) were similar to those in healthy volunteers and in younger patients with diabetes mellitus. In elderly patients there was a decrease in the rate of absorption, which led to a slowdown tmax (82 minutes (interquartile range: 60-120 minutes)), while the average maximum concentration of CmOh was similar to that observed in younger patients with type 2 diabetes, and slightly less than in patients with type 1 diabetes.

    Patients with impaired renal and hepatic function:

    The pharmacokinetics of NovoMix® 30 Penfill® in patients with impaired renal and hepatic function was not studied. Nevertheless, with an increase in the dose of the drug in patients with varying degrees of renal and hepatic impairment, there was no change in the pharmacokinetics of soluble insulin aspart.

    Children and teens:

    The pharmacokinetic properties of NovoMix® 30 Penfill® in children and adolescents have not been studied. However, the pharmacokinetic and pharmacodynamic properties of soluble insulin aspart have been studied in children (6-12 years old) and in adolescents (13-17 years old) with type 1 diabetes mellitus.

    In patients of both age groups insulin aspart characterized by rapid absorption and values tmax, similar to those of adults. However, the values ​​of CmOh in two age groups were different, which indicates the importance of individual selection of insulin aspart doses.

    Preclinical safety data

    Pre-clinical studies have not identified any hazard to humans, based on data from generally accepted pharmacological safety studies, re-use toxicity, genotoxicity, and reproductive toxicity.

    In the tests in vitro, including binding to insulin and IGF-1 receptors and effects on cell growth, it was shown that the properties of insulin aspart are similar to those of human insulin. The results of the studies also showed that the dissociation of the binding of insulin aspart with insulin receptors is equivalent to that of human insulin.

    Indications:

    Diabetes.

    Contraindications:

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

    It is not recommended for use in children under 6 years of age. clinical trials of NovoMix® 30 Penfill® have not been performed.

    Pregnancy and lactation:

    Clinical experience with NovoMix® 30 Penfill® during pregnancy is limited.

    Studies on the use of NovoMix® 30 Penfill® in pregnant women have not been conducted. Nevertheless, data from two randomized controlled clinical trials (157 and 14 pregnant women, respectively insulin aspart in the basal-bolus regimen), no adverse effects of insulin aspart during pregnancy or fetus / newborn health were compared with soluble human insulin.

    In addition, in a clinical randomized study involving 27 women with gestational diabetes who received insulin aspart and soluble human insulin (insulin aspart received 14 women, human insulin - 13), similar safety profiles were demonstrated for both types of insulin.

    In the period of possible pregnancy and throughout its term, it is necessary to carefully monitor the status of patients with diabetes mellitus and monitor the concentration of glucose in the blood. The need for insulin, as a rule, decreases in the first trimester and gradually rises in the II and III trimesters of pregnancy. Shortly after birth, the need for insulin quickly returns to the level that was before pregnancy.

    During breastfeeding, NovoMix® 30 Penfill® can be used without restrictions. The introduction of insulin to a nursing mother does not pose a threat to the child.However, it may be necessary to adjust the dose of NovoMix® 30 Penfill®.

    Dosing and Administration:

    NovoMix® 30 Penfill® is intended for subcutaneous administration. Do not inject NovoMix® 30 Penfill® intravenously, as this can lead to severe hypoglycemia. You should also avoid intramuscular injection of NovoMix® 30 Penfill®. Do not use NovoMix® 30 Penfill® for subcutaneous insulin infusions (PPII) in insulin pumps.

    The dose of NovoMix® 30 Penfill® is determined by the doctor individually in each case, in accordance with the patient's needs. To achieve the optimal level of glycemia, it is recommended to monitor the concentration of glucose in the blood and correct the dose of the drug.

    Patients with type 2 diabetes Novomix® 30 Penfill® can be prescribed both in monotherapy and in combination with oral hypoglycemic drugs in those cases where the blood glucose level is not adequately regulated by oral hypoglycemic drugs alone.

    Initiation of therapy

    For patients with type 2 diabetes mellitus, who have been prescribed insulin for the first time, the recommended initial dose of NovoMix® 30 Penfill® is 6 units before breakfast and 6 units before dinner.It is also possible to administer 12 units of NovoMix® 30 Penfill® once a day in the evening (before dinner).

    Transfer of the patient from other insulin preparations

    When transferring a patient from biphasic human insulin to NovoMix® 30 Penfill® should be started with the same dose and administration regimen. Then adjust the dose according to the individual needs of the patient (see the recommendations for titrating the dose of the drug below). As always when transferring a patient to a new type of insulin, strict medical control is necessary during the patient's transfer and in the first weeks of using the new drug.

    Intensification of therapy

    Strengthen the therapy NovoMix® 30 Penfill® can be done by switching from a single daily dose to a double. It is recommended that after taking a dose of 30 units of the drug, switch to NovoMix® 30 Penfill® twice a day, dividing the dose into two equal parts - morning and evening (before breakfast and dinner). The transition to the application of NovoMix® 30 Penfill® three times a day is possible by dividing the morning dose into two equal parts and introducing these two parts in the morning and at lunch (three times the daily dose).

    Correction of dose

    To adjust the dose of NovoMix® 30 Penfill®, the lowest fasting glucose concentration obtained in the last three days is used.

    To assess the adequacy of the previous dose, use the blood glucose value before the next meal.

    Dose adjustment can be performed once a week until the target value is reached HbA1c.

    Do not increase the dose of the drug, if this period was observed hypoglycemia.

    Dose adjustment may be necessary if the patient's physical activity is increased, his usual diet changes, or if there is a concomitant disease.

    To correct the dose of NovoMix® 30 Penfill® it is recommended to use the following recommendations for dose titration:

    The concentration of glucose in the blood before ingestion

    Adjustment

    doses

    NovoMix® 30

    <4.4 mmol / l

    <80 mg / dL

    -2ED

    4.4-6.1 mmol / l

    80-110 mg / dL

    0 (not required)

    6.2-7.8 mmol / l

    111-140 mg / dL

    + 2ED

    7.9-10 mmol / L

    141-180 mg / dL

    + 4ED

    > 10 mmol / l

    > 180 mg / dL

    + 6ED

    Special patient groups

    As always when using insulin preparations, patients of special groups should more closely monitor the concentration of glucose in the blood and adjust the dose of insulin aspart individually.

    Patients of elderly and senile age

    NovoMix® 30 Penfill® can be used in elderly patients, but experience with oral hypoglycemic agents in patients older than 75 years is limited.

    Patients with kidney and liver failure:

    In patients with renal or hepatic insufficiency, the need for insulin can be reduced.

    Children and adolescents:

    NovoMix® 30 Penfill® can be used to treat children and adolescents over 10 years of age when pre-mixed insulin is preferred. There are limited clinical data for children aged 6-9 years (see section "Pharmacodynamic properties").

    NovoMix® 30 Penfill® should be injected subcutaneously into the thigh or anterior abdominal wall. If desired, the drug can be injected into the shoulder or buttock area.

    It is necessary to change the injection site within the anatomical area to prevent the development of lipodystrophy. As with any other form of insulin, the duration of NovoMix® 30 Penfill® depends on the dose, site of administration, intensity of blood flow, temperature and level of physical activity.

    Compared with the two-phase human insulin NovoMix® 30 Penfill® starts to act more quickly, so it should be administered immediately before meals. If necessary, NovoMix® 30 Penfill® can be administered shortly after meals.

    Side effects:

    All of the side effects presented below, based on data from clinical trials, are grouped according to the frequency of development according to MedDRA and organ systems. The incidence of side effects is defined as: very often (≥ 1/10); often (≥ 1/100 to <1/10); infrequently (≥1 / 1,000 to <1/100); rarely (≥1 / 10,000 to <1 / 1,000), very rarely (<1 / 10,000) and unknown (impossible to estimate based on available data).

    Immune system disorders

    Infrequent - hives, skin rashes, skin rashes

    Very rarely - anaphylactic reactions *

    Disorders from the metabolism and nutrition

    Very often - hypoglycemia *

    Disturbances from the nervous system

    Rarely - peripheral neuropathy ("acute pain neuropathy")

    Infringements from organ of vision

    Infrequent refractive disorders

    Infrequently - diabetic retinopathy

    Disturbances from the skin and subcutaneous tissues

    Infrequent - lipodystrophy *

    General disorders and violations at the site of administration

    Infrequently - reactions in places of administration

    Infrequent - swelling

    *Cm. "Description of individual adverse reactions"

    Description of individual adverse reactions:

    Anaphylactic reactions

    Very rare reactions of generalized hypersensitivity were noted (including generalized skin rash, itching, increased sweating, gastrointestinal disorders, angioedema, difficulty breathing, rapid heartbeat, decrease in blood pressure), which are potentially life-threatening.

    Hypoglycaemia

    Hypoglycemia is the most common side effect. It can develop if the dose of insulin is too high in relation to the need for insulin. Severe hypoglycemia can lead to loss of consciousness and / or convulsions, temporary or irreversible impairment of brain function up to a lethal outcome. Symptoms of hypoglycemia, as a rule, develop suddenly. They may include cold sweats, pale skin, increased fatigue, nervousness or tremor, anxiety, unusual fatigue or weakness, disorientation, decreased concentration, drowsiness, severe hunger, visual impairment, headache, nausea and heart palpitations .

    Clinical studies have shown that the incidence of hypoglycemia varies depending on the patient population, dosing regimen, and glycemic control. In the course of clinical there was no difference in the overall incidence of episodes of hypoglycemia between patients receiving insulin aspart therapy and patients using human insulin preparations.

    Lipodystrophy

    There were reports of infrequent cases of development of lipodystrophy. Lipodystrophy can develop at the site of injection.

    Overdose:

    A certain dose required for an insulin overdose has not been established, but hypoglycemia can develop gradually if too high doses of insulin are administered relative to the patient's need.

    - Light hypoglycemia the patient can eliminate himself by taking glucose inside or sugar-containing foods. therefore patients with diabetes are encouraged to constantly carry with them sugar-containing foods.

    - In case of severe hypoglycemia, when the patient is unconscious, should be administered from 0.5 mg to 1 mg glucagon intramuscularly or subcutaneously (can be administered by a trained person) or intravenously glucose solution (dextrose) (may be administered only by a medical professional).It is also necessary to introduce intravenous dextrose in the case if the patient does not regain consciousness 10-15 minutes after the introduction of glucagon. After restoration of consciousness, the patient is recommended to take a carbohydrate-rich food to prevent the recurrence 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, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, salicylates.

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

    Beta-blockers can mask symptoms of hypoglycemia.Octreotide / lanreotide can both increase and decrease the body's need for insulin.

    Alcohol can increase or decrease the hypoglycemic effect of insulin.

    Incompatibility

    Since compatibility studies have not been conducted, NovoMix® 30 Penfill® should not be mixed with other drugs.

    Special instructions:

    Before a long trip associated with the change of time zones, the patient should consult with his attending physician, as changing the time zone means that the patient must take food and inject insulin at another time.

    Hyperglycaemia

    Insufficient dose of the drug or discontinuation of treatment, especially in type 1 diabetes, can lead to the development of hyperglycemia or diabetic ketoacidosis. Typically, the first symptoms of hyperglycemia appear gradually over several hours or days. Symptoms of hyperglycemia are thirst, frequent urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, and the smell of acetone in the exhaled air. Without proper treatment, hyperglycemia in patients with diabetes mellitus I type can lead to diabetic ketoacidosis - a condition that is potentially lethal.

    Hypogluandchemium

    Skipping meals or unplanned intense exercise can lead to hypoglycemia. Hypoglycemia can also develop if the insulin dose is too high in relation to the patient's need (see "Side effect "and" Overdose ").

    Compared with a two-phase human insulin NovoMix® 30 Penfill® has a more pronounced hypoglycemic effect within 6 hours after administration. In this regard, in In some cases, it may be necessary to adjust the insulin dose and / or the nature of the diet.

    After the compensation of carbohydrate metabolism, for example, with intensified insulin therapy, the symptoms typical for them-precursors of hypoglycemia may change in patients, which patients should be informed about. Common symptoms-precursors can disappear with prolonged course of diabetes.

    Stricter glycemic control in patients may increase the risk of developing hypoglycemia, so increasing the dose of NovoMix® 30 Penfill® should be done under strict medical supervision, as described in the section on "Method of administration and dose".

    Since Novomix® 30 Penfill® should be used in direct connection with food intake, it is necessary to take into account the high rate of onset of the drug effect in the treatment of patients who have comorbid diseases or who take medications that slow food intake. Concomitant diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin. Correction of the dose of the drug may also be required if the patient has concomitant diseases of the kidneys, liver, adrenal, pituitary or thyroid gland disorders.

    When transferring the patient to other types of insulin, early symptoms-precursors of hypoglycemia may change or become less pronounced compared to those observed with the application of the previous type of insulin.

    Transfer of a patient from other insulin preparations

    Transfer of the patient to a new type of insulin or an insulin preparation of another manufacturer must be carried out under strict medical supervision. If the concentration, type, producer and species (human insulin, human insulin analog) of insulin preparations and / or production method changes, a dose change may be required.Patients switching from other insulin preparations to NovoMix® 30 Penfill® may need an increase in injection frequency or dose change compared to the doses of previously used insulin preparations. If it is necessary to adjust the dose, it can be done already at the first injection of the drug or during the first weeks or months of treatment.

    Reactions at the site of administration

    As with other insulin preparations, reactions at the injection site may develop, which is manifested by pain, redness, hives, inflammation, bruising, swelling and itching. Regular change of injection site in the same anatomical area reduces the risk of these reactions. Reactions usually disappear for a few days to several weeks. In rare cases, it may be necessary to cancel NovoMix® 30 Penfill® because of reactions at the injection site.

    The simultaneous use of drugs of the thiazolidinedione group and insulin preparations

    There have been reports of chronic heart failure in the treatment of patients thiazolidinediones in combination with insulin preparations, especially if such patients have risk factors for developing chronic heart failure.This fact should be taken into account when appointing patients combination therapy with thiazolidinediones and insulin preparations. In the appointment of such combination therapy, it is necessary to conduct medical examinations of patients to identify signs and symptoms of chronic heart failure, increase in body weight and the presence of edema. If the symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued.

    Antibodies to insulin

    With the use of insulin, the formation of antibodies is possible. In rare cases, the formation of antibodies may require a dose adjustment of insulin to prevent cases of hyperglycemia or hypoglycemia.

    Precautions for use:

    NovoMix® 30 Penfill® and needles are for personal use only.

    Do not refill the Penfill® cartridge.

    NovoMix® 30 Penfill® can not be used if it does not become uniformly white and cloudy after mixing.

    It should be emphasized to the patient that the Novomix® 30 Penfill® suspension must be stirred immediately before use.

    Do not use NovoMix® 30 Penfill® if it has been frozen. Patients should be warned about the need to throw out the needle after each injection.

    Instructions for storage, use and disposal

    The package contains a sheet with instructions for use and storage. It is necessary to emphasize the importance of mixing the NovoMix 30 suspension immediately before use. Properly mixed liquid must be uniformly white and cloudy.

    Instructions for patients on the use of NovoMix® 30 Penfill®

    Do not use NovoMix® 30 Penfill®:

    - If you are allergic (hypersensitive) to insulin aspart or any of the components that make up Novomix® 30 Penfill® (see Composition).

    - If you feel the approach of hypoglycemia (low blood sugar) (see section Hypoglycemia).

    - For subcutaneous insulin infusions (PPII) in insulin pumps.

    - If the cartridge or insertion device with the cartridge installed is dropped, or the cartridge is damaged or crushed.

    - If the storage conditions of the drug have been violated or it has been frozen.

    - If insulin does not become uniformly white and cloudy after mixing.

    - If in the preparation after mixing left white lumps or if white particles stick to the bottom or walls of the cartridge.

    Before using NovoMix® 30 Penfill®:

    - Check the label to make sure that the correct type of insulin is selected.

    - Always check the cartridge, including the rubber piston. Do not use the cartridge if it has visible damage, or if there is a gap between the piston and the white strip on the cartridge. For further instructions, refer to the instructions for using the insulin delivery system.

    - Always use a new needle for each injection to prevent infection.

    - NovoMix® 30 Penfill® and needles are for personal use only. NovoMix® 30 is intended for subcutaneous injections. Never administer this insulin intravenously or intramuscularly.

    Each time, change the injection site within the anatomical area. This will help reduce the risk of seals and ulcers at the injection site. The best places for injections are: anterior abdominal wall, buttocks, anterior thigh or shoulder. Insulin will act faster if it is injected into the anterior abdominal wall.Regularly monitor blood glucose.

    Procedure for mixing insulin

    Before placing the cartridge in the injection system for insulin administration, hold it at room temperature, and then mix, as described below:

    - When using NovoMix® 30 Penfill® for the first time, roll the cartridge between the palms 10 times - it is important that the cartridge is in a horizontal position (see Figure A). Then lift and lower the cartridge 10 times up and down between positions a and b, as shown in Figure B, so that the glass ball inside the cartridge moves from one end of the cartridge to the other. Repeat these manipulations (see Figures A and B) until the liquid becomes uniformly white and cloudy. The mixing procedure will become easier if by this time insulin has reached room temperature. Immediately make an injection.

    - Before each next injection, shake the insertion device with the cartridge inside it between positions a and b (see Figure B) until the liquid becomes uniformly white and cloudy, but at least 10 times. Immediately make an injection.

    Check that there are at least 12 units of insulin remaining in the cartridge to ensure even mixing. If less than 12 units are left, use the new NovoMix® 30 Penfill®.

    How to inject insulin

    - Insulin should be injected under the skin.

    Use the injection technique recommended by your doctor or nurse, follow the instructions for administering insulin described in the manual for the insulin delivery device.

    - Hold the needle under the skin for at least 6 seconds. Hold the start button down until the needle is removed from under the skin. This will ensure the introduction of a full dose of insulin and prevent the ingress of blood into the needle or into the cartridge with insulin.

    - After each injection, always remove and discard the needle; Never store NovoMix® 30 Penfill® with attached needle. Otherwise, it is possible to leak the liquid from the cartridge, which can lead to an incorrect dosage of insulin.

    Do not refill the cartridge with insulin.

    NovoMix® 30 Penfill® is designed for use with Novo Nordisk insulin injection systems and NovoFine® or NovoTvist® needles.

    If both Novomix® 30 Penfill® and other insulin in the Penfill® cartridge are used simultaneously for treatment, two separate insulin delivery systems, one for each type of insulin, should be used.

    As a precaution, always carry a spare insulin with you in case you lose or damage your NovoMix® 30 Penfill®.

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

    The patient's ability to concentrate and the reaction rate can be violated during hypoglycemia that may constitute a danger in situations where these capabilities are especially needed (e.g., when driving or operating machinery).

    Patients should be advised to take measures to prevent the development of hypoglycemia in the management of vehicles or work with mechanisms. This is especially important for patients with a lack or decline in symptomatic signs of developing hypoglycemia or suffering from frequent episodes of hypoglycemia. In these cases, the expediency of driving vehicles and performing such work should be considered.

    Form release / dosage:

    Suspension for subcutaneous administration, 100 U / ml.

    Packaging:

    3 ml of the drug in cartridges of glass I hydrolytic class, ukuporennye stoppers from brombutyl rubber / polyisoprene on one side and pistons of bromobutyl rubber on the other side.A glass bead is placed in the cartridge, making it easier stirring the slurry.

    For 5 cartridges in a blister pack together with instructions for use in a cardboard box.

    Storage conditions:

    Store at a temperature of 2 to 8 ° C (in the refrigerator), but not next to the freezer. Do not freeze.

    For opened cartridges:

    Do not store in the refrigerator. Store at a temperature not exceeding 30 ° C. Use within 4 weeks.

    Store the cartridges in a cardboard box to protect them from light.

    NovoMix® 30 Penfill® should be protected from excessive heat and light.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015291 / 01
    Date of registration:08.10.2008
    The owner of the registration certificate:Novo Nordisk A / SNovo Nordisk A / S Denmark
    Manufacturer: & nbsp
    Representation: & nbspNOVO NORDISK TOVNOVO NORDISK TOVDenmark
    Information update date: & nbsp23.10.2015
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