Instruction for use: NovoRapid Penfill

Active substance Insulin aspart biphasic

ATX codeA10AD05 Insulin aspart

Pharmacological group of substance Calcitonin

A hypoglycemic agent, a combination of insulin analogues of medium duration or long and short action [Insulins]

Nosological classification (ICD-10)

E10 Insulin-dependent diabetes mellitus

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

E11 Non-insulin-dependent diabetes mellitus

Acetonuric diabetes, Decompensation of carbohydrate metabolism, Diabetes insulin-independent sugar, Diabetes sugar type 2, Type 2 Diabetes, Non-insulin-dependent diabetes, Non-insulin dependent diabetes mellitus, Non-insulin-dependent diabetes mellitus, Insulin resistance, Insulin resistant diabetes mellitus, Coma lactobacillus diabetic, Violation of carbohydrate metabolism, Type 2 diabetes mellitus, Diabetes mellitus type II, Diabetes mellitus in adulthood, Diabetes mellitus in old age, Diabetes insulin-independent, Diabetes mellitus type 2, Sugar insulin-independent diabetes type II

Composition

NovoMix® 30 Penfill®

Suspension for subcutaneous administration 1 ml

active substance:

Insulin aspart - soluble insulin aspart (30%) and insulin crystals of aspart protamine (70%) 100 units (3.5 mg)

Auxiliary substances: glycerol - 16 mg; Phenol - 1.5 mg; Meta-cresol - 1.72 mg; Zinc (in the form of zinc chloride) - 19.6 μg; 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 ml

1 cartridge (3 ml) contains 300 units

NovoMix® 30 FlexPen®

Suspension for subcutaneous administration 1 ml

active substance:

Insulin aspart - soluble insulin aspart (30%) and insulin crystals of aspart protamine (70%) 100 units (3.5 mg)

Auxiliary substances: glycerol - 16 mg; Phenol - 1.5 mg; Meta-cresol - 1.72 mg; Zinc (in the form of zinc chloride) - 19.6 μg; 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 ml

1 pre-filled syringe pen (3 ml) contains 300 units

Description of dosage form

Homogenous suspension of white color, not containing lumps. Flakes may appear in the sample.

Upon standing, the suspension is stratified to form a white precipitate and a colorless or almost colorless supernatant.

When the precipitate is stirred, a homogeneous suspension should be formed according to the procedure described in the medical instructions.

pharmachologic effect

Pharmacological action - hypoglycemic.

Pharmacodynamics

NovoMix® 30 Penfill® / FlexPen® is a two-phase suspension consisting of soluble insulin aspart (30% short-acting insulin analog) and insulin crystals of aspart protamine (70% insulin analog of average duration of action). Active substance NovoMix® 30 Penfill® / FlexPen® is insulin aspart produced by the method of biotechnology of recombinant DNA using the strain of Saccharomyces cerevisiae.

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

Reduction of blood glucose level occurs due to 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 the introduction of NovoMix® 30 Penfill® / FlexPen® 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® / FlexPen® and biphasic human insulin 30, 2 times a day, before breakfast and dinner, it was shown that NovoMix® 30 Penfill ® / FlexPen ® strongly reduces postprandial blood glucose level (after breakfast and dinner).

Meta-analysis of data from 9 clinical trials involving patients with type 1 and type 2 diabetes showed that NovoMix® 30 Penfill® / FlexPen®, 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® / FlexPan® was higher, in general NovoMix® 30 Penfill® / FlexPen® Having rendered There is the same effect on the concentration of glycosylated hemoglobin (HbA1c), as well as biphasic human insulin 30.

In a clinical study involving 341 patients with type 2 diabetes, patients were randomized to only NovoMix® 30 Penfill® / FlexPan®, NovoMix® 30 Penfill® / FlexPen® in combination with metformin and metformin in combination with the sulfonyl urea derivative. The HbA1c concentration after 16 weeks of treatment was not different in patients treated with NovoMix® 30 Penfill® / FlexPin® in combination with metformin and in patients receiving metformin in combination with the sulfonyl urea derivative. In this study, in 57% of patients the baseline HbA1c concentration was above 9%; In these patients, therapy with NovoMix® 30 Penfill® / FlexPen® in combination with metformin resulted in a more significant decrease in HLA1c concentration than in patients receiving metformin in combination with the sulfonyl urea derivative.

In another study, patients with type 2 diabetes mellitus with unsatisfactory glycemic control taking oral hypoglycemic drugs were randomized to 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 application, the average decrease in HbA1c concentration in the NovoMix® 30 Penfill® / FlexPan® group was 2.8% (the initial mean was 9.7%). In 66% and 42% of patients using NovoMix® 30 Penfill® / FlexPen®, the HbA1c values were below 7 and 6.5%, respectively, at the end of the study. The average fasting plasma glucose was reduced by about 7 mmol / l (from 14 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® / FlexPen® compared with the two-phase human insulin 30. In this case The overall risk of daytime hypoglycaemia in patients treated with NovoMix® 30 Penfill® / FlexPan® was higher.

Children and teenagers. 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 of HbA1c in both groups remained close to the initial values throughout the study. Also, when NovoMix® 30 Penfill® / FlexPen® or two-phase 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 (total 54 patients, 12 weeks for each type of treatment). The incidence of hypoglycemia and increased post-prandial glucose in the group of patients using NovoMix® 30 Penfill® / FlexPen® were significantly lower than those in the group of patients using biphasic human insulin 30. The values of HbA1c at the end of the study in the biphasic group Of human insulin 30 were significantly lower than in the group of patients using NovoMix® 30 Penfill® / FlexPen®.

Elderly patients. Pharmacodynamics NovoMix® 30 Penfill® / FlexPen® in patients of elderly and senile age has not been studied. However, in a randomized double-blind cross-over study in 19 patients with type 2 diabetes mellitus aged 65-83 years (mean age 70 years), pharmacodynamics and pharmacokinetics of insulin aspart and soluble human insulin were compared. The relative differences in pharmacodynamics (the maximum glucose infusion rate - GIRmax and the area under the curve of its infusion rate within 120 min 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.

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 in vitro tests, which included 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.

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® / FlexPen®, which is observed in soluble human insulin. In this regard, insulin aspart (30%) is absorbed from the subcutaneous fat faster than soluble insulin contained in biphasic human insulin. The remaining 70% is attributed to the crystalline form of protamine-insulin aspart, the rate of absorption of which is the same as that of human NPH insulin.

Cmax insulin in the blood serum after the administration of NovoMix® 30 Penfill® / FlexPen® is 50% higher than in the two-phase human insulin 30, and Tmax is half as long as compared with the two-phase human insulin 30.

In healthy volunteers, after the administration of Novomix® 30 at a rate of 0.2 U / kg Cmax insulin aspart in the blood serum was achieved after 60 min and was (140 ± 32) pmol / l. The duration of T1 / 2 of NovoMix® 30, which reflects the rate of absorption of the protamine-related fraction, was 8-9 hours. The serum insulin level returned to the baseline 15-18 hours after the administration of the drug. In patients with type 2 diabetes mellitus, Cmax was achieved 95 minutes after administration and remained above the baseline at least 14 hours.

Patients of elderly and senile age. The study of 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 type 2 diabetes mellitus (aged 65-83 years, mean age 70) were similar to those in healthy volunteers and younger patients with diabetes mellitus. In elderly patients, a decrease in the rate of absorption was observed, which led to a slowing down of T1 / 2 (82 minutes interquartile range - 60-120 min), while the average Cmax was similar to that observed in younger patients with type 2 diabetes mellitus, and slightly less than Of patients with type 1 diabetes mellitus.

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

Children and teenagers. The pharmacokinetic properties of NovoMix® 30 Penfill® / FlexPen® in children and adolescents have not been studied. However, the pharmacokinetic and pharmacodynamic properties of soluble insulin aspart have been studied in children (6 to 12 years) and adolescents (13 to 17 years) with type 1 diabetes mellitus. In both age groups, insulin aspart was characterized by rapid absorption and Tmax values similar to those In adults. However, the values of Cmax in the two age groups were different, which indicates the importance of individual selection of insulin aspart doses.

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 studies on the use of NovoMix® 30 Penfill® / FlexPen® have not been performed.

pregnancy and lactation

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

Studies on the use of NovoMix® 30 Penfill® in pregnant women have not been conducted.

However, the data from two randomized controlled clinical trials (157 and 14 pregnant women receiving insulin aspart in the basal bolus regimen) showed no adverse effects of insulin aspart during pregnancy or fetus / newborn health compared to soluble human insulin. In addition, in a clinical randomized trial involving 27 women with gestational diabetes, who received insulin aspart and soluble human insulin (14 women received insulin aspart, 13 human insulin), similar safety profiles for both types of insulin were demonstrated.

In the period of possible pregnancy and throughout its term, it is necessary to carefully monitor the condition of patients with diabetes mellitus and monitor the concentration of glucose in the blood. The need for insulin, as a rule, decreases in the I 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 the breastfeeding period, NovoMix® 30 Penfill® / FlexPen® 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® / FlexPen®.

Side effects

Adverse reactions observed in patients using Novomix® 30 are mainly due to the pharmacological effect of insulin. The most common undesirable phenomenon in the use of insulin is hypoglycemia. The incidence of side effects on the background of NovoMix® 30 varies depending on the patient population, the dosage regimen of the drug and the control of glycemia.

At the initial stage of insulin therapy, refractive disorders, edema and reactions at the injection site (including pain, redness, urticaria, inflammation, hematomas, swelling and itching at the injection site) may occur. These symptoms are usually temporary. Rapid improvement in glycemic control can lead to a state of acute pain neuropathy, which is usually reversible. Intensification of insulin therapy with a dramatic improvement in the control of carbohydrate metabolism may lead to a temporary deterioration in the state of diabetic retinopathy, while a prolonged improvement in glycemic control reduces the risk of progression of diabetic retinopathy.

Descriptions of selected adverse reactions

Anaphylactic reactions. Very rare reactions of generalized hypersensitivity (including generalized skin rash, itching, increased sweating, gastrointestinal disorders, angioedema, difficulty breathing, heart palpitations, decreased blood pressure), which are potentially life-threatening, have been noted.

Hypoglycemia. 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 disruption of brain function up to a lethal outcome. Symptoms of hypoglycemia tend to develop suddenly. They may include cold sweats, pale skin, increased fatigue, nervousness or tremor, feelings of anxiety, unusual fatigue or weakness, impaired orientation, 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. Clinical studies showed no difference in the overall incidence of episodes of hypoglycemia in patients receiving insulin aspart therapy and patients using human insulin preparations.

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

Interaction

There are a number of drugs that affect the need for insulin. Hypoglycemic action of insulin increases oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, nonselective beta adrenoblockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, salicylates.

The hypoglycemic effect of insulin is weakened by oral contraceptives, GCS, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatropin, danazol, clonidine, BCC, 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 carried out, NovoMix® 30 Penfill® / FlexPen® should not be mixed with other drugs.

Dosing and Administration

NovoMix® 30 Penfill® / FlexPen® is intended for use in the wax. Do not inject NovoMix® 30 Penfill® / FlexPen® IV. This can lead to severe hypoglycemia. You should also avoid the / m introduction of NovoMix® 30 Penfill® / FlexPen®. Do not use NovoMix® 30 Penfill® / FlexPen® for insulin infusions (PPII) in insulin pumps.

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

Patients with type 2 diabetes mellitus NovoMix® 30 Penfill® / FlexPen® can be prescribed both in monotherapy and in combination with oral hypoglycemic medications 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, who have been prescribed insulin for the first time, the recommended initial dose of NovoMix® 30 Penfill® / FlexPen® is 6 units before breakfast and 6 units before dinner. It is also possible to administer 12 units of NovoMix® 30 Penfill® / FlexPen® 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® / FlexPen®, the same dose and administration regimen should be started. 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

To strengthen NovoMix® 30 Penfill® / FlexPen® therapy is possible by switching from a single daily dose to a double dose. It is recommended that after reaching a dose of 30 units of the drug, switch to NovoMix® 30 Penfill® / FlexPen® 2 times a day, dividing the dose into two equal parts-morning and evening (before breakfast and dinner).

The transition to NovoMix® 30 Penfill® / FlexPen® 3 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 the dose

To adjust the dose of NovoMix® 30 Penfill® / FleksPen®, 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 done once a week until the target HbA1c is reached. Do not increase the dose of the drug, if during this period, hypoglycemia was observed.

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

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

NovoMix® 30 Penfill® / FlexPen® should be injected 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 insulin preparation, the duration of NovoMix® 30 Penfill® / FlexPen® depends on the dose, site of administration, blood flow intensity, temperature and level of physical activity.

Compared to the two-phase human insulin, NovoMix® 30 Penfill® / FlexPen® starts to act more quickly, so it should be injected immediately before taking on the baby. If necessary, you can enter NovoMix® 30 Penfill® / FlexPen® shortly after receiving a niche.

Overdose

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

Treatment. Easy patient hypoglycemia can eliminate itself, taking in glucose 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, you should enter from 0.5 mg to 1 mg of glucagon IM or SC (may be administered by a trained person) or IV glucose (dextrose) solution (can only be administered by a medical professional ). It is also necessary to inject IV dextrose in the case if the patient does not regain consciousness 10-15 minutes after the introduction of glucagon. After recovery of consciousness, the patient is recommended to take a carbohydrate-rich food to prevent the recurrence of hypoglycemia.

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 should take food and inject insulin at another time.

Hyperglycemia. 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 within a few 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 type 1 diabetes mellitus can lead to diabetic ketoacidosis, a condition that is potentially lethal.

Hypoglycemia. Skipping meals or unplanned intense exercise can lead to hypoglycemia. Hypoglycemia can also develop if the dose of insulin is too high in relation to the patient's need (see "Side effects" and "Overdose"). Compared to biphasic human insulin, NovoMix® 30 Penfill® / FlexPen® has a more pronounced hypoglycemic effect within 6 hours after administration. In this regard, in some cases, you may need to adjust the dose of insulin and / or the nature of nutrition.

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® / FlexPan® should be done under strict medical supervision, as described in the section on "Method of administration and dose". Since Novomix® 30 Penfill® / FlexPan® should be used in direct connection with food intake, the high rate of onset of the drug effect should be considered in the treatment of patients who have comorbidities or who take drugs 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 the 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® / FlexPan® may require 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 administration 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 can 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 over a period of several days to several weeks. In rare cases, it may be necessary to cancel NovoMix® 30 Penfill® / FlexPen® because of reactions at the site of administration.

Simultaneous use of the preparations of the thiazolidinedione group and insulin preparations. Cases of CHF in the treatment of patients with thiazolidinediones in combination with insulin preparations have been reported, especially if such patients have risk factors for CHF. This fact should be taken into account when appointing patients combination therapy with thiazolidinediones and insulin preparations. When this combination therapy is prescribed, it is necessary to conduct medical examinations of patients to identify signs and symptoms of CHF, weight gain and edema. In case of worsening of symptoms of heart failure in patients, treatment with thiazolidinediones should be stopped.

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

Influence on the ability to drive vehicles and work with machinery. The ability of patients to focus and respond to the reaction may be impaired during hypoglycemia, which can be dangerous in situations where these abilities are particularly needed (for example, when driving vehicles or working with mechanisms). Patients should be advised to take measures to prevent hypoglycemia when driving vehicles or working with mechanisms. This is especially important for patients with a lack or decrease in the severity of symptoms-precursors of developing hypoglycemia or suffering from frequent episodes of hypoglycemia. In these cases, consideration should be given to the desirability of driving vehicles and performing such work.

Form of issue

NovoMix® 30 Penfill®

Suspension for subcutaneous administration, 100 U / ml. For 3 ml of the drug in the cartridges of glass I of the hydrolytic class, sealed with bromobutyl rubber / polyisoprene stoppers on one side and the pistons of bromobutyl rubber on the other side. A glass ball is placed in the cartridge, which facilitates the mixing of the suspension. The cartridge is sealed in a plastic multi-dose disposable syringe pen for multiple injections. 5 multi-dose disposable syringes are placed in a cardboard box.

NovoMix® 30 FlexPen®

Suspension for subcutaneous administration, 100 U / ml. For 3 ml of the drug in the cartridges of glass I of the hydrolytic class, sealed with bromobutyl rubber / polyisoprene stoppers on one side and the pistons of bromobutyl rubber on the other side. A glass ball is placed in the cartridge, which facilitates the mixing of the suspension. The cartridge is sealed in a plastic multi-dose disposable syringe pen for multiple injections. 5 multi-dose disposable syringes are placed in a cardboard box.

Terms of leave from pharmacies

On prescription.

Storage conditions

At a temperature of 2-8 ° 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. The drug should be protected from exposure to excessive heat and light.

Keep out of the reach of children.

Shelf life

2 years.

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