Novomix 30 flexpen suspension for injection 100 U/ml cartridge 3 ml inserted into syringe pen No. 5

Pharmacological properties

Pharmacodynamics. NovoMix 30 FlexPen is a biphasic suspension consisting of a mixture of insulin analogues: insulin aspart (a short-acting human insulin analogue) and protamine-insulin aspart (an intermediate-acting human insulin analogue). The reduction in blood glucose levels under the influence of insulin aspart occurs after its binding to insulin receptors, which promotes glucose uptake by muscle and fat cells and simultaneously inhibits glucose release from the liver. NovoMix 30 FlexPen is a biphasic suspension containing 30% soluble insulin aspart. This provides a faster onset of action compared to soluble human insulin, which allows the drug to be administered immediately before meals (from 0 to 10 min). The crystalline phase (70%) consists of protamine insulin aspart, which has the same activity profile as human neutral protamine insulin Hagedorn (nph).

NovoMix 30 FlexPen begins to act 10-20 minutes after subcutaneous injection. The maximum effect is achieved 1-4 hours after administration. The duration of action is up to 24 hours.

The level of glycosylated hemoglobin in patients with type I and type II diabetes mellitus who were administered NovoMix 30 FlexPen for 3 months was the same as that after the administration of biphasic human insulin. When administered at the same molar doses, insulin aspart is equipotent to human insulin.

In a clinical study, patients with type 2 diabetes (341 people) were randomized to receive NovoMix 30 FlexPen alone, NovoMix 30 FlexPen in combination with metformin, or metformin in combination with a sulfonylurea. After 16 weeks of treatment, HbA1c levels were similar in patients receiving NovoMix 30 FlexPen in combination with metformin or metformin in combination with a sulfonylurea. In this study, 57% of patients had an HbA1c level of 9%. In these patients, combined treatment with NovoMix 30 FlexPen and metformin resulted in a greater reduction in HbA1c than with the combination of metformin and a sulfonylurea.

In a study, patients with type 2 diabetes mellitus who were not adequately controlled with oral antidiabetic drugs alone were given NovoMix 30 FlexPen twice daily (117 patients) or insulin glargine once daily (116 patients). After 28 weeks of dose-titrated treatment with NovoMix 30 FlexPen, HbA1c levels decreased by 2.8% (mean HbA1c at baseline was 9.7%). With NovoMix 30 FlexPen, HbA1c levels of 7% were achieved in 66% of patients and 6.5% in 42% of patients; fasting plasma glucose levels decreased by approximately 7 mmol/L (from 14.0 mmol/L before treatment to 7.1 mmol/L).

A meta-analysis in patients with type 2 diabetes showed a reduced risk of nocturnal hypoglycaemic episodes and severe hypoglycaemia with NovoMix 30 FlexPen compared with biphasic human insulin. However, the risk of daytime hypoglycaemic episodes was higher in patients treated with NovoMix 30 FlexPen.

Pregnancy. NovoMix 30 has not been studied 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 1 diabetes mellitus (a total of 322 pregnant women, insulin aspart - 157 people, soluble human insulin - 165 people), no adverse effects of insulin aspart on the fetus or newborn were identified.

In addition, a clinical study involving 27 women with gestational diabetes who received insulin aspart (14 people) or soluble human insulin (13 people) found no differences in the safety indicators of treatment with both drugs.

Children and adolescents. A 16-week study in 167 patients aged 10-18 years compared the efficacy of NovoMix 30 FlexPen with meals to maintain postprandial glycemic control with human insulin/biphasic human insulin 30 with meals and NPH insulin injections at bedtime. HbA1c levels remained at baseline in both groups throughout the study period, and there was no difference in the incidence of hypoglycemic episodes.

In a double-blind crossover study (12 weeks for each treatment course) conducted in a relatively small group of children (54 people) aged 6-12 years, the increase in the number of episodes of hypoglycemia and the increase in glucose concentration were statistically significantly lower when treated with NovoMix 30 FlexPen compared with biphasic human insulin 30. The HbA1C level at the end of the treatment course was significantly lower in the group receiving biphasic human insulin 30 than in the group receiving NovoMix 30 FlexPen.

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 that are formed in soluble human insulin preparations. In the soluble phase of the NovoMix 30 FlexPen, the proportion of insulin aspart is 30% of the total insulin. It is absorbed into the blood from the subcutaneous tissue faster than the soluble insulin of biphasic human insulin. The remaining 70% is the proportion of the crystalline form of protamine-insulin aspart, the longer absorption intensity of which is the same as that of human NPH insulin.

C max of insulin in the blood serum after the administration of NovoMix 30 FlexPen is 50% higher, and the time to achieve it is half as short compared to biphasic human insulin 30. In healthy volunteers, after s / c administration of NovoMix 30 FlexPen at the rate of 0.20 U / kg body weight, C max of insulin aspart in the blood serum was reached after 60 min and was 140 ± 32 pmol / l. T 1/2 NovoMix 30 FlexPen, which reflects the rate of absorption of the protamine fraction, was approximately 8-9 h. The level of insulin in the blood serum returned to the initial level 15-18 h after s / c administration. In patients with type II diabetes mellitus, C max was reached 95 min after administration and remained above the initial concentration for at least 14 h.

Children and adolescents

The pharmacokinetics of NovoMix 30 FlexPen in children and adolescents have not been studied. However, the pharmacokinetics and pharmacodynamics of soluble insulin aspart have been studied in children (6-12 years) and adolescents (13-17 years) with type 1 diabetes. It is rapidly absorbed in patients from both groups, with t max values being similar to those in adults. At the same time, the C max values in the different groups differed significantly, indicating the importance of individual selection of doses of insulin aspart.

Elderly. The pharmacokinetics of NovoMix 30 FlexPen have not been studied in elderly patients. However, the relative differences in the values of pharmacodynamic parameters after administration of insulin aspart or human insulin to elderly and senile type II diabetes patients (65 years - 83 years, mean age - 70 years) were the same as in practically healthy individuals or younger diabetic patients. In elderly and senile patients, the absorption rate is reduced, as evidenced by a longer time to reach C max of insulin in the blood (t max) (82 min with an interquartile range of 60-120 min). At the same time, the C max value was the same as in younger type II diabetes patients and slightly lower than in type I diabetes patients.

The pharmacokinetics of NovoMix 30 FlexPen have not been studied in patients with renal or hepatic impairment.

Indication

Diabetes treatment.

Application

The insulin dosage is individual and determined by the doctor in accordance with the patient's needs. Since the effect of NovoMix 30 FlexPen occurs faster than with biphasic human insulin, it should be administered immediately before meals. If necessary, NovoMix 30 FlexPen can be administered shortly after meals. On average, the patient's insulin requirement, depending on body weight, is 0.5 to 1.0 units/kg/day. It can be fully or partially provided by the administration of NovoMix 30 FlexPen. The daily insulin requirement may increase in patients with insulin resistance (e.g., obesity) and decrease in patients with residual endogenous insulin production.

NovoMix 30 FlexPen is usually injected subcutaneously into the thigh. Injections can also be given into the anterior abdominal wall, buttocks or deltoid muscle of the shoulder. To avoid lipodystrophy, the injection site should be rotated, even within the same area of the body.

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

NovoMix 30 FlexPen can be prescribed to patients with type 2 diabetes mellitus as monotherapy or in combination with oral hypoglycemic agents in cases where blood glucose levels cannot be effectively controlled with hypoglycemic agents alone.

For patients with type 2 diabetes, the initial dose of NovoMix 30 FlexPen is 6 units before breakfast and 6 units before dinner. You can start 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 of 15 units before breakfast and dinner. Then you can safely switch to 3 injections per day and inject half the morning dose before breakfast and dinner.

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

It is necessary to focus on the lowest values of glucose concentration for the last 3 days. If during this period there were episodes of hypoglycemia, the insulin dose is not increased. The dose is selected once a week until the target HbA1c level is reached. The adequacy of the previous dose is assessed by the values of glucose concentration before meals.

Impaired liver or kidney function may reduce the patient's insulin requirement.

NovoMix 30 FlexPen can be used in children and adolescents aged 10 years and older, when premixed insulin is most appropriate. Clinical trial data in children aged 6-9 years are limited. No studies have been conducted in children under 6 years of age.

NovoMix 30 FlexPen can be used in elderly patients; however, experience with its use in combination with glucose-lowering drugs in people over 75 years of age is limited.

NovoMix 30 FlexPen should never be administered intravenously.

Instructions for the patient on how to use NovoMix 30 FlexPen

The insulin suspension should be thoroughly mixed before use. After mixing, the suspension should be uniformly white and cloudy.

NovoMix 30 FlexPen is intended for individual use only.

Do not refill NovoMix 30 FlexPen.

NovoMix 30 FlexPen is used with short NovoFine S needles.

Before using NovoMix 30 FlexPen

Check the label to make sure the type of insulin used is correct.

You should always use a new needle for each injection to avoid infection.

Do not use NovoMix 30 FlexPen:

NovoMix 30 FlexPen is intended for subcutaneous injections.

The drug should not be administered intravenously or directly into a muscle.

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

Instructions for using the NovoMix 30 FlexPen syringe pen

NovoMix 30 FlexPen is a unique insulin pen with a dose selector. It allows you to set the insulin dose from 1 to 60 U in steps of 1 U. NovoMix 30 FlexPen is used with NovoFine S needles of 8 mm or shorter. You should pay attention to the S marker on the needle packaging. S is the designation of short needles. It is always necessary to have a spare pen with you in case your FlexPen is damaged or lost.

Preparing NovoMix 30 FlexPen for injection

Check the label to make sure that your NovoMix 30 FlexPen contains the correct type of insulin. When using NovoMix 30 FlexPen for the first time, you must mix the insulin in the pen:

1. Mixing is best done when the liquid in the cartridge is at room temperature. Remove the cap from the pen.

2. Roll NovoMix 30 FlexPen between your palms 10 times, making sure that the cartridge remains horizontal.

3. After that, repeat at least 10 times

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