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Pharmacological properties

NovOmix 30 flexpen is a two-phase suspension consisting of a mixture of insulin analogues: insulin aspart (an analog of human short-acting insulin) and protamine insulin aspart (an analog of medium-duration human insulin). a decrease in blood glucose under the influence of insulin aspart occurs after its binding to insulin receptors, which contributes to the uptake of glucose by muscle and fat cells and simultaneously inhibits the release of glucose from the liver. Novomix 30 flexpen is a two-phase suspension containing 30% soluble aspart insulin. this provides a faster onset of action than soluble human insulin, which allows the drug to be administered immediately before meals (from 0 to 10 minutes). the crystalline phase (70%) consists of protamine-insulin aspart, whose activity profile is the same as that of the human neutral protamine-insulin hagedorn (npc).

NovoMix 30 Flexpen begins to act 10–20 minutes after sc injection. The maximum effect is achieved 1–4 hours after administration. Duration of action is up to 24 hours.

The level of glycosylated hemoglobin in patients with type I and type II diabetes who were injected with NovoMix 30 FlexPen for 3 months is the same as when administering biphasic human insulin. With the introduction of the same molar doses, insulin aspart is equipotential to human insulin.

In a clinical study, patients with type II diabetes mellitus (341 people), divided into groups according to a randomized principle, received only NovoMix 30 FlexPen or NovoMix 30 FlexPen in combination with metformin, or metformin in combination with sulfonylurea. After 16 weeks of treatment, the values ​​of HbA1c concentration in patients receiving NovoMix 30 FlexPen in combination with metformin or metformin in combination with sulfonylurea were the same. In this study, 57% of patients had a HbA1c level of 9%. In these patients, combined treatment with NovoMix 30 FlexPen and metformin resulted in a more pronounced decrease in HbA1c compared with a combination of metformin and sulfonylurea.

In a study of patients with type II diabetes mellitus, in which glycemic control with only oral hypoglycemic drugs turned out to be ineffective, NovoMix 30 FlexPen was administered 2 times a day (117 patients) or insulin glargine 1 time per day (116 patients). After 28 weeks of treatment with NovoMix 30 FlexPen, accompanied by dose selection, the level of HbA1c decreased by 2.8% (the average value of HbA1c when included in the study was 9.7%). During treatment with NovoMix 30 FlexPen, HbA1c levels of 7% reached 66% of patients, and 6.5% - 42% of patients; at the same time, the concentration of glucose in fasting plasma decreased by about 7 mmol / L (from 14.0 mmol / L before treatment to 7.1 mmol / L).

In a meta-analysis performed in patients with type II diabetes mellitus, there was a decrease in the risk of episodes of hypoglycemia at night and severe hypoglycemia in the treatment of NovoMix 30 FlexPen compared with biphasic human insulin. At the same time, the risk of daytime hypoglycemia episodes was higher in patients who received NovoMix 30 FlexPen.

Period of pregnancy. Novomix 30 was not investigated in pregnant women. However, in clinical studies comparing the safety and efficacy of insulin aspart and soluble human insulin in the treatment of pregnant women with type I diabetes (322 pregnant women, insulin aspart - 157 people, soluble human insulin - 165 people), side effects of aspart insulin on the fetus or a newborn.

In addition, in a clinical study involving 27 women with gestational diabetes who received insulin aspart (14 individuals) or soluble human insulin (13 individuals), there were no discrepancies in treatment safety between the two drugs.

Children and teens.In a 16-week study involving 167 patients aged 10–18 years, the efficacy of maintaining postprandial glycemic control by administering NovoMix 30 FlexPen when eating with human insulin / biphasic human insulin 30 when eating with NPH-insulin injections before bedtime was compared. Throughout the study period in both groups, the concentration of HbA1c remained at the level that was when included in the study; there were no discrepancies in the incidence of episodes of hypoglycemia.

In a double-blind cross-sectional study (12 weeks per treatment course) conducted with a relatively small group of children (54 people) aged 6–12 years, an increase in the number of episodes of hypoglycemia and an increase in glucose concentration were statistically significantly lower with treatment with NovoMix 30 Flexpen compared with biphasic human insulin 30. The level of HbA1c at the end of the course of treatment was significantly lower in the group that received biphasic human insulin 30 than in the group that took NovoMix 30 Flex en.

The elderly. The pharmacodynamics of NovoMix 30 FlexPen have not been studied in elderly and senile patients. However, a randomized double-blind crossover study was conducted that compared the pharmacokinetics and pharmacodynamics of aspart insulin and soluble human insulin in 19 patients with type 2 diabetes mellitus at the age of 65 years - 83 years. Relative differences in pharmacodynamics (GIRmaxAUCgir0-120 min) after administration of insulin aspart or human insulin in these patients were the same as in healthy individuals or young patients with diabetes mellitus.

Pharmacokinetics In insulin aspart, the amino acid proline at position 28 of the B chain of the insulin molecule is replaced by aspartic acid, which reduces the formation of hexamers formed in soluble human insulin preparations. In the soluble phase of NovoMix 30 FlexPen, the proportion of insulin aspart is 30% of all insulin. It is absorbed into the blood from subcutaneous tissue faster than soluble insulin of biphasic human insulin. The remaining 70% is the fraction of the crystalline form of protamine-insulin aspart, the longer absorption rate of which is the same as that of human NPH-insulin.

Cmax the serum insulin after administration of NovoMix 30 FlexPen is 50% higher, and its achievement time is half as short as that of biphasic human insulin 30. In healthy volunteers, after sc administration of NovoMix 30 FlexPen at a rate of 0.20 U / kg body Cmax serum insulin aspart was achieved after 60 minutes and was 140 ± 32 pmol / L. T1/2 NovoMix 30 FlexPen, which reflects the rate of absorption of the protamine fraction, was approximately 8–9 hours. The level of insulin in the blood serum returned to the original 15–18 hours after s / c administration. In patients with type II diabetes mellitusmax was achieved 95 min after administration and remained above the initial concentration for at least 14 hours

Children and teens

The pharmacokinetics of NovoMix 30 FlexPen in children and adolescents has not been investigated. However, the pharmacokinetics and pharmacodynamics of soluble aspart insulin were studied in children (6–12 years old) and adolescents (13–17 years old) with type I diabetes. It was rapidly absorbed in patients from both groups, with tmax were the same as in adults. At the same time, the values ​​of Cmax in different groups they differed significantly, which indicates the importance of individual selection of doses of insulin aspart.

The elderly. The pharmacokinetics of NovoMix 30 FlexPen has not been studied in elderly patients. However, the relative discrepancies in the values ​​of pharmacodynamics after the administration of aspart or human insulin insulin diabetes mellitus type II of the elderly and senile age (65 years old - 83 years old, average age - 70 years old) were the same as in healthy individuals or patients with diabetes mellitus more young age. In elderly and senile patients, the absorption rate decreases, as evidenced by a longer time to reach Cmax blood insulin (tmax) (82 min with an interquartile range of 60–120 min). The value of Cmax was the same as in younger patients with type II diabetes, and slightly lower than in patients with type I diabetes.

The pharmacokinetics of NovoMix 30 FlexPen has not been studied in patients with impaired renal or hepatic function.

Indications

Diabetes treatment.

Application

The dosage of insulin is individual and determined by the doctor in accordance with the needs of the patient. since the effect of the drug Novomix 30 flexpen occurs faster compared to biphasic human insulin, it should be administered immediately before meals. if necessary, novOmix 30 flexpen can be administered after a short period of time after a meal. on average, the patients need for insulin, depending on body weight, is from 0.5 to 1.0 units / kg / day. it can be fully or partially provided by the introduction of the drug Novomix 30 flexpen. the daily need for insulin may increase in patients with resistance to it (for example, with obesity) and decrease in patients with preserved residual production of endogenous insulin.

NovoMix 30 FlexPen is usually administered sc to the thigh area. Injections can also be made to the anterior abdominal wall, buttocks or deltoid muscle of the shoulder. In order to avoid lipodystrophy, the injection site should be changed even within the same area of ​​the body.

Similar to other insulin preparations, the duration of action may vary depending on the dose, injection site, blood flow velocity, body temperature and level of physical activity. The dependence of the absorption rate on the injection site has not been investigated.

NovoMix 30 FlexPen can be prescribed to patients with type II diabetes mellitus both in the form of monotherapy and in combination with oral hypoglycemic agents in cases where the glucose level in the blood cannot be effectively controlled using only hypoglycemic drugs.

For patients with type II diabetes mellitus, the recommended initial dose of NovoMix 30 FlexPen is 6 units before breakfast and 6 units before dinner. You can start its administration with a dose of 12 units before dinner. After reaching a dose of 30 units, it is usually recommended to switch from a single injection to 2 injections per day for 15 units before breakfast and dinner. Then you can safely switch to 3 injections per day and enter half the morning dose before breakfast and lunch.

When selecting doses, it is recommended to be guided by the table below:

Blood glucose levels before meals Selection of a dose of the drug NovoMix 30 Flexpen
4.4 mmol / l 80 mg / 100 ml –2 units
4.4-6.1 mmol / L 80–110 mg / 100 ml 0
6.2–7.8 mmol / L 111-140 mg / 100 ml +2 units
7.9-10 mmol / L 141-180 mg / 100 ml +4 units
10 mmol / l 180 mg / 100 ml +6 units

You should focus on the lowest glucose concentration over the last 3 days. If episodes of hypoglycemia occur during this period, the dose of insulin is not increased. Dose selection is performed once a week until the target level of HbA1c is reached. The values ​​of glucose concentration before meals assess the adequacy of the previous dose.

Impaired liver or kidney function may reduce the patients need for insulin.

NovoMix 30 Flexpen can be used in children and adolescents over the age of 10 years, when the introduction of a mixture of insulin is preferred. Clinical studies on the use of the drug in children aged 6–9 years are limited. Studies involving children under the age of 6 years have not been conducted.

NovoMix 30 Flexpen can be used in elderly patients; nevertheless, experience with its use in combination with hypoglycemic drugs in people over the age of 75 is limited.

In no case can NovoMix 30 FlexPen be administered iv.

Instructions for use of the drug NovoMix 30 Flexpen for the patient

Thoroughly mix the suspension of insulin before use. After mixing, the suspension should be uniformly white and cloudy.

NovoMix 30 FlexPen is intended for individual use only.

Do not fill NovoMix 30 FlexPen again.

NovoMix 30 FlexPen is used with short needles NovoFayn S.

Before using NovoMix 30 Flexpen

Check the label for the correct type of insulin used.

Always use a new needle for each injection to avoid infection.

Do not use NovoMix 30 Flexpen:

  • in insulin pumps;
  • if the FlexPen syringe pen has been dropped, if it is damaged or deformed, as in these cases insulin leaks may occur;
  • if the syringe pen was stored incorrectly or was frozen;
  • if after stirring the suspension does not become uniformly white and cloudy;
  • if white clots or solid white particles appear in the preparation, adhering to the bottom or walls of the cartridge, giving it the appearance of a frozen one.

NovoMix 30 Flexpen is designed for SC injection.

The drug can not be entered in / in or directly into the muscle.

To avoid the formation of infiltrates, the injection site should be constantly changed. The best places for administration are the anterior abdominal wall, buttocks, anterior surface of the thigh or shoulder. The action of insulin occurs faster when it is injected in the waist.

Instructions for use of the NovoMix 30 FlexPen syringe pen

NovoMix 30 FlexPen is a unique insulin syringe pen with a dose selector. It allows you to set the dose of insulin from 1 to 60 units in increments of 1 unit. NovoMix 30 FlexPen is used with NovoFayn S needles 8 mm long or shorter. Pay attention to marker S on the needle packaging. S is the designation of short needles. It is always necessary to carry a spare syringe pen in case of damage or loss of the FlexPen syringe pen.

Preparing NovoMix 30 Flexpen for injection

Check on the label that the NovoMix 30 FlexPen syringe contains the right type of insulin. At the first use of NovoMix 30 FlexPen, it is necessary to mix the insulin, which is in the syringe pen:

1. Mixing is best if the liquid in the cartridge is at room temperature. Remove the cap of the syringe pen.

2. Roll NovoMix 30 FlexPen between the palms 10 times, it is important that the cartridge remains in a horizontal position.

3. After this, at least 10 times re-start

Tags: Insulin asparagine