Description
Packaging
5 syringe pens, 3 ml each.
Pharmacological action
NOVOMIX 30 FLEXPEN – an analogue of human insulin of medium duration of action. It forms an insulin-receptor complex with a specific receptor on the outer cytoplasmic membrane of cells, stimulating the synthesis of hexokinase, pyruvate kinase, and glycogen synthetase enzymes. The hypoglycemic effect is associated with increased 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 obtained by biotechnology (in the molecular structure of insulin, the amino acid proline at position B28 is replaced by aspartic acid).
When used in patients with type 1 and type 2 diabetes mellitus, NovoMix 30 FlexPen has the same effect on the level of glycosylated hemoglobin as biphasic human insulin. Insulin aspart and human insulin have the same activity in molar equivalent.
In insulin aspart, the substitution of proline amino acid 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 fat faster than soluble insulin contained in biphasic human insulin. Insulin aspart protamine, like human insulin NPH, is absorbed longer.
Compared to soluble human insulin, insulin aspart (a fast-acting analogue of human insulin) begins to act more quickly, so it can be administered immediately before eating (from 0 to 10 minutes before eating). The effect of crystalline insulin aspart protamine (a medium-duration analogue of human insulin) is similar to the action of human insulin NPH. After s / c administration of the drug NovoMix 30 Flexpen, the effect develops after 10-20 minutes. The maximum effect is observed 1-4 hours after injection. The duration of the drug reaches 24 hours.
Indications
– type 1 diabetes mellitus (insulin-dependent)
– type 2 diabetes mellitus (non-insulin-dependent): stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (during 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.
Pregnancy and lactation
The clinical experience with NovoMix ® 30 FlexPen ® during pregnancy is very limited.
However, data from two randomized controlled clinical trials (respectively of 157 and 14 pregnant women who received insulin aspart in the baseline bolus regimen) did not reveal any adverse effects 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, 13 human insulin), similar safety profiles for both types of insulin were demonstrated.
During the possible pregnancy and throughout its term, careful monitoring of the condition of patients with diabetes mellitus and monitoring the concentration of glucose in the blood should be carried out. 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 birth, the need for insulin quickly returns to the level that was before pregnancy. During breastfeeding, NovoMix ® 30 FlexPen ® can be used without restrictions. The administration of insulin to a nursing mother is not a threat to the baby. However, it may be necessary to adjust the dose of NovoMix ® 30 FlexPen ®.
Special instructions
Before a long trip involving a change of time zones, the patient should consult with their doctor, as changing the time zone means that the patient must eat and administer insulin at a different time.
Hyperglycemia. An insufficient dose of the drug or discontinuation of treatment, especially with type 1 diabetes mellitus, can lead to the development of hyperglycemia and diabetic ketoacidosis. As a rule, symptoms of hyperglycemia appear gradually, over several hours or days. Symptoms of hyperglycemia are a feeling of thirst, an increase in the amount of urine released, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, and the appearance of an odor 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 fatal.
Hypoglycemia. Skipping meals or unplanned intense physical activity can lead to hypoglycemia. Hypoglycemia can also develop, if the dose of insulin is too high in relation to the patient ² ¢s needs (see ² ÑSide effects ² Ñ, ² ÑOverdose ² Ñ).
Compared with biphasic human insulin, the administration of NovoMix ® 30 FlexPen ® has a more pronounced hypoglycemic effect within 6 hours after administration. In this regard, in some cases, it may be necessary to adjust the dose of insulin and / or the nature of the diet. After compensating for carbohydrate metabolism, for example, during intensified insulin therapy, patients may experience typical symptoms of precursors of hypoglycemia, which patients should be informed about. The usual warning signs may disappear with a long course of diabetes. More stringent glycemic control in patients may increase the risk of hypoglycemia, therefore, an increase in the dose of NovoMix ® 30 FlexPen ® must be carried out under strict medical supervision (see ² ÑDosage and Administration ² Ñ).
Since NovoMix ® 30 FlexPen ® should be used in direct connection with food intake, the high rate of onset of the drug effect should be taken into account in the treatment of patients with concomitant diseases or taking drugs that slow food absorption.
Concomitant diseases, especially infectious and accompanied by fever, usually increase the body’s need for insulin. Dose adjustment may also be required if the patient has concomitant diseases of the kidneys, liver, impaired adrenal function, pituitary gland or thyroid gland.
When transferring a patient to other types of insulin, early symptoms of precursors of hypoglycemia may change or become less pronounced compared to those using the previous type of insulin.
Transfer patient from other insulin preparations. The 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 you change the concentration, type, manufacturer and type (human insulin, an analog of human insulin) of insulin preparations and / or the method of production, a dose change may be required. Patients switching from other insulin preparations to treatment with NovoMix ® 30 FlexPen ® may need to increase the frequency of injections or a dose change 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 treatments, reactions may develop at the injection site, which is manifested by pain, redness, hives, inflammation, hematomas, swelling and itching. Regularly changing the injection site in the same anatomical region can reduce symptoms or prevent the development of these reactions. Reactions usually disappear within a few days to several weeks. In rare cases, NovoMix ® 30 FlexPen ® may need to be canceled due to reactions at the injection site.
Concomitant use of thiazolidinedione group and insulin preparations. Cases of the development of chronic heart failure have been reported in the treatment of patients with thiazolidinediones in combination with insulin preparations, especially if such patients have risk factors for the development of chronic heart failure. This fact should be taken into account when prescribing combination therapy with thiazolidinediones and insulin preparations to patients. With the appointment of such combination therapy, it is necessary to conduct medical examinations of patients to identify 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 must be discontinued.
Impact on the ability to drive vehicles and work with mechanisms. The ability of patients to concentrate and the reaction rate may be impaired during hypoglycemia, which can be dangerous in situations where these abilities are especially necessary (for example, when driving vehicles or working with machines and mechanisms).
Patients should be advised to take measures to prevent the development of hypoglycemia while driving. This is especially important for patients with no or diminished symptoms of precursors of developing hypoglycemia or suffering from frequent episodes of hypoglycemia. In these cases, the appropriateness of driving and performing such work should be considered.
Composition
active substance: insulin aspart biphasic 100 PIECES *
excipients: mannitol, phenol, metacresol, zinc chloride, sodium chloride, disodium phosphate dihydrate, protamine sulfate, sodium hydroxide, hydrochloric acid, water d / i.
Dosage and administration
The drug is intended for sc administration. The drug NovoMix 30 FlexPen can not be entered in / in!
The dose is set individually based on blood glucose values. 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 secretion of insulin, it can be reduced.
NovoMix 30 FlexPen should be administered immediately before a meal, if necessary – immediately after a meal.
The temperature of the administered drug should be at room temperature.
Injection is performed subcutaneously in the thigh or anterior abdominal wall, if desired, in the region of the shoulder or buttock. It is necessary to change the injection site within the anatomical region in order to prevent the development of lipodystrophy.
As with any other insulin preparation, the duration of action of NovoMix 30 FlexPen depends on the dose, place of administration, blood flow intensity, temperature and level of physical activity. The dependence of the absorption of NovoMix 30 FlexPen on the injection site has not been studied.
Side effects
Side effects associated with effects on carbohydrate metabolism: often hypoglycemia, symptoms of which may include pale skin, cold sweat, nervousness, tremor, anxiety, unusual tiredness or weakness, disorientation in space, decreased concentration, dizziness, severe hunger, temporary visual impairment, headache, nausea, tachycardia. Severe hypoglycemia can lead to loss of consciousness, a temporary or irreversible disruption of the brain and death.
Allergic reactions: local reactions – redness, swelling, itching at the injection site generalized – skin rash, skin itching, increased sweating, gastrointestinal disorders, angioedema, difficulty breathing, tachycardia, decreased blood pressure.
Other: edema, impaired refraction (usually temporary and observed at the beginning of insulin treatment), development of lipodystrophy at the injection site.
Drug interactions
Hypoglycemic effect of the drug is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, sulfanilamides, tetrafinfilofloflofenolinfolin, tetrafilofloflofenolinfolin, tetrafilofloflofenolinfolin, lithium preparations, ethanol-containing preparations.
Hypoglycemic effect of the drug is weakened by oral contraceptives, GCS, thyroid hormone preparations, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.
Under the influence of reserpine and salicylates, both weakening and enhancing the action of NovoMix ® 30 FlexPen ® are possible.
Beta-blockers may mask the symptoms of hypoglycemia.
Octreotide / lanreotide can both increase and decrease the need for insulin.
Ethanol may enhance and prolong the hypoglycemic effect of insulin.
Incompatibility
Since no compatibility studies have been performed, NovoMix ® 30 FlexPen ® should not be mixed with other drugs.
Overdose
Symptoms: hypoglycemia may develop.
Treatment: The patient may have mild hypoglycemia with glucose, sugar or carbohydrate-rich foods. In severe cases, when unconscious, a 40% dextrose solution is given in w / w or n / a glucagon (0.5-1 mg). After regaining consciousness, the patient is advised to eat carbohydrate-rich foods to prevent hypoglycemia from developing again.
Storage Conditions
The product should be stored in the refrigerator at 2 ° to 8 ° C (in the refrigerator, away from the freezer), not frozen, protected from light.
After first use, the syringe pen should be stored at a temperature not exceeding 30 ° C for 4 weeks. Do not store the used syringe pen in the refrigerator or at a temperature above 30 ° C (if the used syringe pen is still stored in the refrigerator, the contents of the syringe pen should be stirred before further use).
To protect from light, the syringe handle should be closed with a cap.
The product should be stored out of the reach of children.
Shelf life
2 years.
Deystvuyushtee substance
Insulin aspart dvuhfazn y
Prescription conditions from drugstores
Prescription
Dosage form
injection for injection
Possible product names
Neipomax solution in / in and n / to 30 mln / ml 300 mcg # 5 flak.
NovoMix 30 FlexPen 100ED / ml 3ml sh-x5
NOVOMIX 30 FLEXPEN 100ED / ml. 3ml. # 5 syringe pen
NOVOMIX 30 FLEXPEN 100ME / ML 3ML N5 SYRTLE PEN
NovoMix 30 FlexPen 100ME / ml susp. e / subcutaneous introduction. 3ml Syringe pen X5 B (R)
Novo Nordisk, Denmark
