Novomix 30 Flekspen syringe pen 100m/ml 3ml n5

Suspension for subcutaneous injection

Composition

Insulin aspart two phase 100 U *

Excipients: mannitol, phenol, metacresol, zinc chloride, sodium chloride, disodium phosphate dihydrate, protamine sulfate, sodium hydroxide, hydrochloric acid, water d / and.

Mechanism of action

Novomix 30 Flekspen - an analog of human insulin of average duration of action. It forms an insulin-receptor complex with a specific receptor of the external cytoplasmic membrane of cells, stimulating the synthesis of the enzymes hexokinase, pyruvate kinase, glycogen synthetase. The hypoglycemic effect is associated with an increase in intracellular transport and increased glucose uptake by tissues, stimulation of lipogenesis, glycogenogenesis, and a decrease in the rate of glucose production by the liver.

Novomix 30 FlexPen is a biphasic suspension consisting of soluble insulin aspart (30%) and crystalline insulin aspart protamine (70%). Insulin aspart was obtained by biotechnology (in the molecular structure of insulin, the amino acid proline in position B28 is replaced with aspartic acid).

When used in patients with diabetes mellitus type 1 and 2, NovoMix 30 FlexPen has the same effect on glycated hemoglobin levels as biphasic human insulin. Insulin aspart and human insulin have the same activity in molar equivalent.

In insulin aspart, the substitution of the amino acid proline at position B28 for 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 is absorbed from subcutaneous fatty tissue faster than soluble insulin contained in biphasic human insulin. Insulin aspart protamine, like human NPH insulin, is absorbed longer.

Compared with soluble human insulin, insulin aspart (a fast-acting analogue of human insulin) begins to act more quickly, so it can be administered just before a meal (from 0 to 10 minutes before a meal). The effect of crystalline insulin aspart protamine (analogue of human insulin of average duration of action) is similar to the action of human insulin NPH. After s / c administration of the drug Novomix 30 FlexPen, the effect develops in 10-20 minutes. The maximum effect is observed 1-4 hours after injection. The duration of the drug reaches 24 hours.

Indications and usage

- 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.

Do not 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.

Dosage and administration

The drug is intended for s / c administration. The drug Novomix 30 FlexPen can not be entered in / in!

Dose set individually on the basis of indicators of the level 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.

Adverse reactions

Adverse reactions associated with the effect on carbohydrate metabolism: often - hypoglycemia, the symptoms of which may include pale skin, cold sweat, nervousness, tremor, anxiety, unusual tiredness or weakness, disorientation, concentration disorder, dizziness, marked 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.

Overdosage

Symptoms: hypoglycemia may develop.

Treatment: the patient may stop mild hypoglycemia by ingesting glucose, sugar, or carbohydrate-rich foods. In severe cases, with loss of consciousness, a 40% dextrose solution is injected; i / m or s / c - glucagon (0.5-1 mg). After regaining consciousness, the patient is recommended to take carbohydrate-rich food to prevent the recurrence of hypoglycemia.