Novomix 30 Flekspen suspension for injection 100E for ml syringe pen 3ml N5
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Active ingredients
Insulin aspart biphasic
Release form
Suspension
Composition
Active ingredient: Insulin aspart two-phase Concentration of active substance (unit): 100
Pharmacological effect
Analogue of human insulin of average duration of action with a rapid onset of action. NovoMix 30 FlexPen is a two-phase suspension consisting of soluble insulin aspart (30% of the analog of insulin of short action) and insulin crystals of aspart of protamine (70% of insulin analog of the average duration of action). Insulin aspart of insulin is obtained by recombinant DNA biotechnology using the Saccharomyces cerevisiae strain. Insulin aspart is an equipotential soluble human insulin based on the molyapnosti.Snizhenie her blood glucose concentration occurs by enhancing its intracellular transport of insulin aspart after binding to insulin receptors of muscle and adipose tissue and the simultaneous inhibition of glucose production pechenyu.Posle s / c injection NovoMiks 30 FleksPen effect develops in 10-20 min. The maximum effect is observed 1-4 hours after injection. The duration of the drug reaches 24 hours. In a three-month comparative clinical study involving patients with type 1 and type 2 diabetes who received Novomix 30 Flex Pen and biphasic human insulin 30 2 times / day before breakfast and dinner, Novomix 30 FlexPen was shown postprandial concentration of glucose in the blood more severely (after breakfast and dinner). Meta-analysis of data obtained in 9 clinical studies involving patients with type 1 and 2 diabetes showed that Novomix 30 FlexPen p When administered before breakfast and dinner, it provides better control of postprandial glucose concentration in the blood (average increase in prandial glucose concentration after breakfast, lunch and dinner), compared with human biphasic insulin 30. Although the concentration of fasting glucose in patients receiving Novo Mix 30 FlexPen, was higher, in general Novomix 30 FlexPen has the same effect on glycated hemoglobin concentration (HbA1C) as biphasic human insulin 30. In a clinical study with the participation of patients In patients with type 2 diabetes mellitus (n = 341), patients were randomized to treatment groups only with NovoMix 30 FlexPen, NovoMix 30 FlexPen in combination with metformin and metformin with a sulfonylurea derivative.The concentration of HbA1C after 16 weeks of treatment did not differ in patients who received Novomix 30 FlexPen in combination with metformin and in patients who received Metformin in combination with a sulfonylurea derivative. In this study, in 57% of patients, the baseline concentration of HbA1C was higher than 9%; in these patients, Novomix 30 FlexPen therapy in combination with metformin resulted in a more significant decrease in HbA1C concentration than in patients who received Metformin in combination with a sulfonylurea derivative. were randomized to the following groups: Novomix 30 FlexPen was administered 2 times / day (117 patients) and insulin glargine was administered 1 time / day (116 patients). After 28 weeks of use, the average decrease in HbA1C in the Novomix 30 FlexPen group was 2.8% (the initial average value was 9.7%). 66% and 42% of patients using Novomix 30 FlexPen at the end of the study had HbA1C values below 7% and 6.5%, respectively. The average value of fasting plasma glucose decreased 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 obtained during clinical studies involving patients with type 2 diabetes showed a decrease total number of episodes of nocturnal hypoglycemia and severe hypoglycemia when using Novomix 30 FlexPen, compared with biphasic human insulin 30. At the same time, the overall risk of daytime hypoglycemia in patients receiving Novomix 30 FlexPen was higher .In children and adolescents, a 16-week clinical study was conducted that compared blood glucose after a meal with NovoMix 30 FlexPen (before meals), human insulin / two-phase human insulin 30 (before meals), and insulin isophane (administered before bedtime). The study involved 167 patients aged 10 to 18 years. The mean HbA1C values in both groups remained close to the initial values throughout the study. Also, when Novomix 30 FlexPen or biphasic human insulin 30 was used, there were no differences in the incidence of hypoglycemia.A double-blind, cross-sectional study was also conducted in a population of patients aged from 6 to 12 years (a total of 54 patients, 12 weeks for each type of treatment). The incidence of hypoglycemia and elevated postprandial glucose in the Novomix 30 group FlexPen was significantly lower compared to the values in the biphasic human insulin 30 group. used Novomix 30 FlexPen. The pharmacodynamics Novomix 30 FlexPen in patients of elderly and old age has not been studied. However, in a randomized, double-blind, cross-sectional study conducted on 19 patients with type 2 diabetes mellitus aged 65–83 years (mean age 70 years), compared the pharmacodynamics and pharmacokinetics of insulin aspart and soluble human insulin. The relative differences in pharmacodynamic indices (maximum glucose infusion rate — GIRmax and the area under the infusion rate curve for 120 minutes after administration of insulin preparations — AUCGIR, 0-120 min) between aspart insulin and human insulin in elderly patients were similar to those of healthy volunteers and in younger patients with diabetes.
Pharmacokinetics
Absorption In insulin aspart, replacing the amino acid proline in position B28 with aspartic acid reduces the tendency of molecules to form hexamers in the soluble fraction of Novomix 30 FlexPen, which is observed in soluble human insulin. In this regard, insulin aspart (30%) is absorbed from subcutaneous fatty tissue faster than soluble insulin contained in two-phase human insulin. The remaining 70% comes from the crystalline form of protamine insulin aspart, the absorption rate of which is the same as that of human NPH insulin. When NovoMix 30 FleksPen Cmax insulin in serum is used on average 50% higher than when using two-phase human insulin 30; while the time to reach Cmax is on average 2 times less. When s / c administration of the drug to healthy volunteers at a dose of 0.2 U / kg body weight, the average Cmax of insulin aspart was 140 ± 32 pmol / l and was reached after 60 minutes. In patients with type 2 diabetes, Cmax is achieved 95 minutes after the administration and remains above baseline for at least 14 hours. Serum insulin concentration returns to baseline 15–18 hours after s / c injection. Excretion is T1 / 2,reflecting the rate of absorption of the fraction associated with protamine, is 8-9 hours. Pharmacokinetics in special clinical situations. The pharmacokinetics of the NovoMix 30 FlexPen preparation was not studied in elderly and old patients. However, the relative differences in pharmacokinetic indices between insulin aspart and human soluble insulin in elderly patients with type 2 diabetes (aged 65–83 years, mean age 70 years) were similar to those in healthy volunteers and in younger patients with diabetes mellitus. In elderly patients, a decrease in absorption rate was observed, which resulted in a slower Tmax (82 min (interquartile range: 60-120 min)), whereas the average Cmax was similar to that observed in younger patients with type 2 diabetes and than in patients with type 1 diabetes. A study of the pharmacokinetics of NovoMix 30 FlexPen was not conducted in patients with impaired renal and hepatic function. However, with increasing doses of the drug in patients with varying degrees of renal and liver dysfunction, no changes in the pharmacokinetics of soluble insulin aspart were observed. The pharmacokinetic properties of Novomix 30 FlexPen in children and adolescents were not studied. However, the pharmacokinetic and pharmacodynamic properties of soluble insulin aspart were studied in children (from 6 to 12 years old) and adolescents (from 13 to 17 years old) with type 1 diabetes. In patients of both age groups, insulin aspart was characterized by rapid absorption and Tmax values, similar to those in adults. However, Cmax values in the two age groups were different, which indicates the importance of individual selection of insulin aspart doses.
Indications
- diabetes mellitus type 1 (insulin-dependent); - diabetes mellitus type 2 (insulin-independent): stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (when conducting combination therapy), intercurrent diseases.
Contraindications
- increased individual sensitivity to insulin aspart or other components of the drug; - hypoglycemia. It is not recommended to use the drug in children and adolescents under the age of 18 years, because clinical studies on the use of Novomix 30 FlexPen in patients of this age group have not been conducted.
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
Clinical experience with Novomix 30 FlexPen in pregnancy is limited. Studies on the use of Novomix 30 FlexPen in pregnant women have not been conducted. However, data from two randomized controlled clinical trials (157 and 14 pregnant women, respectively, who received insulin aspart in the basis-bolus therapy regimen) did not reveal any adverse effect of insulin aspart on pregnancy or fetal / 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, human insulin 13) similar safety profiles for both types of insulin were demonstrated. During the onset and during the entire period of pregnancy, it is necessary to carefully monitor the condition of patients with diabetes mellitus and monitor plasma glucose concentration. The need for insulin, as a rule, decreases in the first trimester and gradually increases in the second and third trimesters of pregnancy. Shortly after giving birth, the need for insulin quickly returns to the level that was before pregnancy. During breastfeeding, the drug can be used without restrictions. The introduction of insulin nursing mother does not pose a threat to the child. However, it may be necessary to adjust the dose of NovoMix 30 FlexPen.
Dosage and administration
The drug is intended for s / c administration. The drug Novomix 30 FlexPen can not be administered in / in! Dose set individually on the basis of indicators of glucose in the blood. The average daily dose ranges from 0. 5 to 1 U / kg body weight. With insulin resistance (for example, in patients with obesity), the daily need for insulin can be increased, and in patients with residual endogenous insulin secretion - reduced. Novomix 30 FleksPen should be entered immediately before a meal; if necessary, immediately after a meal. The temperature of the drug should be at room temperature. An injection is performed sc in the region of the thigh or anterior abdominal wall; if desired, in the area of the shoulder or buttocks.It is necessary to change the injection sites within the anatomical region in order to prevent the development of lipodystrophies. As with any other insulin preparations, the duration of action of NovoMix 30 FlexPen depends on the dose, site of administration, blood flow intensity, temperature, and level of physical activity. The dependence of the absorption Novomix 30 FlexPen on the injection site has not been studied.
Side effects
Adverse reactions associated with effects on carbohydrate metabolism: often - hypoglycemia, the symptoms of which may include pallor of the skin, cold sweat, nervousness, tremor, anxiety, unusual tiredness or weakness, loss of orientation in space, decreased concentration, dizziness, pronounced feeling hunger, temporary visual impairment, headache, nausea, tachycardia. Severe hypoglycemia can lead to loss of consciousness, temporary or irreversible disruption of the brain and death. Allergic reactions: local reactions - redness, swelling, itching at the injection site; generalized - skin rash, pruritus, increased sweating, disorders of the gastrointestinal tract, angioedema, difficulty breathing, tachycardia, a decrease in blood pressure. Other: edema, impaired refraction (usually temporary and observed at the beginning of insulin treatment), the development of lipodystrophy at the injection site.
Overdose
The specific dose required for insulin overdose has not been established, but hypoglycemia can develop gradually if too high doses of insulin are administered in relation to the patient’s needs. Treatment: the patient can eliminate slight hypoglycemia by ingesting glucose or sugar-containing foods. Therefore, patients with diabetes are advised to constantly carry with them sugar-containing products. In the case of severe hypoglycemia, when the patient is unconscious, from 0.5 mg to 1 mg of glucagon should be injected in m or s / c (a trained person can enter) or in / in glucose solution (dextrose) (can only enter a medical professional). It is also necessary to introduce dextrose in / in the case if the patient does not regain consciousness 10-15 minutes after the introduction of glucagon. After the recovery of consciousness, the patient is recommended to take carbohydrate-rich food to prevent the recurrence of hypoglycemia.
Interaction with other drugs
There are a number of drugs that affect the need for insulin. Hypoglycemic effect of the drug is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-adrenoblockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, white-colored, and non-selective, non-selective, non-selective beta-cramps, bromocriptine, sulfanilamides, anabolic steroids, tetracyclines, non-selective color , theophylline, cyclophosphamide, fenfluramine, lithium preparations, salicylates. The hypoglycemic effect of the drug is weakened by oral contraceptives, GCS, thyroid go mones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatropin, danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine. Beta-adrenergic blockers can mask the symptoms of hypoglycemia. of the body in insulin. Ethanol may enhance or decrease the hypoglycemic effect of insulin. Incompatibility Since compatibility studies have not been conducted, Novomix 30 FlexPen cannot be mixed with other drugs. Atami.
special instructions
Before a long trip associated with changing time zones, the patient should consult with your doctor, because changing the time zone means that the patient must eat and inject insulin at another time. Hyperglycemia Insufficient dose of the drug or discontinuation of treatment, especially for type 1 diabetes, may lead to the development of hyperglycemia or diabetic ketoacidosis. As a rule, the first symptoms of hyperglycemia appear gradually, over several hours or days. Symptoms of hyperglycemia include thirst, increased urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, and the smell of acetone in exhaled air . Without appropriate treatment, hyperglycemia in patients with type 1 diabetes 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 insulin dose is too high relative to the patient's needs. Compared with two-phase human insulin, NovoMix 30 FlexPen has a more pronounced hypoglycemic effect within 6 hours after administration.In this regard, in some cases, insulin dosage and / or nutrition may need to be adjusted. After compensating for carbohydrate metabolism, for example, in case of intensified insulin therapy, patients may experience typical symptoms of precursors of hypoglycemia, which patients should be informed about. The usual symptoms of precursors may disappear with long-term diabetes mellitus. More strict control of the glycemia level in patients may increase the risk of hypoglycemia, therefore, increasing the dose of Novomix 30 FlexPen should be carried out under strict medical control. Because Novomix 30 FlexPen should be used in direct connection with the reception food, you should consider the high rate of onset of the effect of the drug in the treatment of patients with concomitant diseases or taking drugs means of slowing down the absorption of food. Concomitant diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin. Correction of the drug dose may also be needed if the patient has concomitant diseases of the kidneys, liver, dysfunction of the adrenal glands, pituitary gland or thyroid gland. When transferring a patient For other types of insulin, early symptoms — precursors of hypoglycemia — may change or become less pronounced compared to those observed with insulina.Perevod preceding one type of patient with other drugs the patient insulinaPerevod a new type of insulin or insulin drug from another manufacturer must be carried out under strict medical supervision. If you change the concentration, type, manufacturer and type (human insulin, human insulin analogue) of insulin preparations and / or production method, you may need to change the dose. Patients switching from other insulin preparations to treatment with NovoMix 30 FlexPen may require an increase in the frequency of injections or a change in dose compared to doses of previously used insulin preparations. If necessary, dose adjustment, it can be made already at the first injection of the drug or during the first weeks or months of treatment. Reactions at the injection site As with other insulin preparations, reactions can develop at the injection site, which manifests as pain, redness, hives, inflammation , hematomas, swelling and itching.Regularly changing the injection site in the same anatomical area can reduce symptoms or prevent the development of these reactions. Reactions usually disappear within a few days to a few weeks. In rare cases, it may be necessary to discontinue NovoMix 30 FlexPen due to reactions at the injection site. Simultaneous use of thiazolidinedione group drugs and insulin drugs development of chronic heart failure. This fact should be taken into account when prescribing thiazolidinediones and insulin combination therapy to patients. When prescribing such a combination therapy, it is necessary to conduct medical examinations of patients in order to identify their signs and symptoms of chronic heart failure, weight gain and the presence of edema. If the symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued. Insulin antibody If antibodies are used, insulin may be formed. In rare cases, antibodies may require insulin dosage adjustment to prevent cases of hyperglycemia or hypoglycemia. Effect on ability to drive vehicles and mechanisms Patients' ability to concentrate and reaction rate may be impaired during hypoglycemia, which is dangerous in situations where these abilities are necessary (for example, when driving or working with machinery). Patients should be advised to take action I warning of hypoglycaemia when driving or operating machinery. This is especially important for patients with the absence 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 expediency of driving and carrying out such work. Pre-clinical safety data During the preclinical studies, there was no danger to peoplebased on data from generally accepted pharmacological safety studies, re-use toxicity, genotoxicity and reproductive toxicity. In vitro tests that involved binding to insulin and IGF-1 receptors and the effect on cell growth showed that the properties of insulin aspart are similar to those of human insulin . Research results also showed that dissociation of insulin aspart binding to insulin receptors is equivalent to that of human insulin.