En DE FR ES PL
NovoMix - instructions for use, reviews, analogues and form of release (suspension or solution for subcutaneous administration of 100 units per ml in a syringe pen or cartridge) of a drug for the treatment of diabetes mellitus in adults, children and pregnancy

NovoMix - instructions for use, reviews, analogues and form of release (suspension or solution for subcutaneous administration of 100 units per ml in a syringe pen or cartridge) of a drug for the treatment of diabetes mellitus in adults, children and pregnancy

In this article, you can read the instructions for using the drug NovoMix. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of NovoMix in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues NovoMix in the presence of existing structural analogs.Use for the treatment of diabetes in adults, children, as well as during pregnancy and lactation.

 

NovoMix hypoglycemic agent. It is a two-phase suspension consisting of soluble insulin aspart (30% of short-acting insulin analog) and insulin crystals of aspart protamine (70% of insulin analog of average duration of action). Novomix active substance is insulin aspart produced by biotechnology of recombinant deoxyribonucleic acid (DNA) using the strain Saccharomyces cerevisiae. Insulin aspart is an equipotential soluble human insulin based on the molarity index.

 

Reduction of blood glucose level occurs due to the increase of its intracellular transport after binding of insulin aspart with insulin receptors of muscle and fat tissues and simultaneous inhibition of glucose production by the liver. After the subcutaneous injection of NovoMix, the effect develops within 10-20 minutes. The maximum effect is observed in the range from 1 to 4 hours after the injection. The duration of the drug reaches 24 hours.

 

Composition

 

Insulin aspart two-phase + auxiliary substances (30 Penfill, 30 FlexPen, 50 FlexPen, 70 FlexPen).

 

Pharmacokinetics

 

In insulin aspart, the replacement of the amino acid proline in position B28 by aspartic acid reduces the tendency of the molecules to form hexamers in the soluble fraction of NovoMix that is observed in soluble human insulin. In this regard, insulin aspart (30%) is absorbed from the subcutaneous fat faster than soluble insulin contained in biphasic human insulin. The remaining 70% is attributable to the crystalline form of protamine-insulin aspart, the rate of absorption of which is the same as that of human neutral protamine Hagedorn (NPH insulin). In healthy volunteers, after a subcutaneous injection of NovoMix at a rate of 0.2 units per kg of body weight, the maximum serum insulin concentration in the blood serum was reached after 60 minutes. The duration of the half-life of the NovoMix preparation, which reflects the rate of absorption of the protamine-related fraction, was 8-9 hours. The insulin level in the serum returned to the baseline 15-18 hours after the subcutaneous administration of the drug.In patients with type 2 diabetes, the maximum concentration was reached 95 minutes after administration and remained above the original at least 14 hours.

 

Indications

  • non-insulin dependent diabetes mellitus;
  • insulin dependent diabetes mellitus.

 

Forms of release

 

Suspension for subcutaneous administration of 100 units per ml in a syringe pen or cartridge 3 ml (sometimes mistakenly referred to as a solution).

 

Instructions for use and dosing regimen

 

The drug is administered subcutaneously. You can not inject NovoMix intravenously, as this can lead to severe hypoglycemia. You should also avoid intramuscular injection of NovoMix. You can not use NovoMix for subcutaneous insulin infusions in insulin pumps.

 

The dose of NovoMix is ​​determined by the doctor individually in each case, in accordance with the patient's needs. To achieve the optimal level of glycemia, it is recommended to monitor the concentration of glucose in the blood and correct the dose of the drug.

 

Patients with type 2 diabetes mellitus Novomix can be prescribed in the form of monotherapy or in combination with oral hypoglycemic drugs, in those cases when the blood glucose level is not adequately regulated by oral hypoglycemic drugs alone.

 

Initiation of therapy

 

For patients with type 2 diabetes, who are prescribed insulin for the first time, the recommended initial dose of NovoMix is ​​6 units before breakfast and 6 units before dinner. It is also possible to administer 12 units once a day in the evening (before dinner).

 

Transfer of the patient from other insulin preparations

 

When transferring a patient from a two-phase human insulin to NovoMix, one should start with the same dose and administration regimen. Then adjust the dose according to the individual needs of the patient. As always, when transferring a patient to a new type of insulin, strict medical control is necessary during the transfer of the patient and in the first weeks of using the new drug.

 

Intensification of therapy

 

To strengthen therapy NovoMixom it is possible by means of transition from a single daily dose on twofold. It is recommended after passing the dose of 30 units of the drug to switch to the application NovoMix 2 times a day, dividing the dose into two equal parts - morning and evening (before breakfast and dinner).

 

The transition to the application of NovoMix 3 times a day is possible by dividing the morning dose into two equal parts and introducing these two parts in the morning and at lunch (three times the daily dose).

 

Correction of dose

 

To adjust the dose of NovoMix, the lowest value of the fasting blood glucose concentration obtained during the last three days is used. To assess the adequacy of the previous dose, use the blood glucose value before the next meal.

 

Dose adjustment can be done once a week until the target glycated hemoglobin (HbA1c) is reached. Do not increase the dose of the drug, if this period was observed hypoglycemia. Dose adjustment may be necessary if the patient's physical activity is increased, his usual diet changes, or if there is a concomitant disease.

 

If the concentration of glucose in the blood before eating is less than 4.4 mmol / l (less than 80 mg / dl), the dose of NovoMix should be reduced by 2 units. At a glucose concentration in the blood before eating 4,4-6,1 mmol / l (80-110 mg / dl), dose adjustment is not required. If the concentration of glucose in the blood before meals is 6.2-7.8 mmol / l (111-140 mg / dl), the dose should be increased by 2 units. At a glucose level of 7.9-10 mmol / l (141-180 mg / dl) - increase by 4 units. If the concentration of glucose in the blood before eating more than 10 mmol / l (more than 180 mg / dl) - increase by 6 units.

 

When using insulin preparations, patients of special groups should more closely monitor the concentration of glucose in the blood and adjust the dose of insulin aspart individually.

 

NovoMix should be injected subcutaneously into the thigh or anterior abdominal wall. If desired, the drug can be injected into the shoulder or buttock area. It is necessary to change the injection site within the anatomical area to prevent the development of lipodystrophy.

 

As with any other insulin preparation, the duration of Novomix depends on the dose, place of administration, intensity of blood flow, temperature and level of physical activity.

 

Compared with the two-phase human insulin, NovoMix begins to act more quickly, so it should be injected immediately before taking the nurse. If necessary, you can enter NovoMix shortly after receiving a niche.

 

Instructions for the patient

 

NovoMix and needles are for individual use only. Do not refill the cartridge or the syringe pen. Always use a new needle for each injection to prevent infection.It should be emphasized to the patient that it is necessary to mix the NovoMix suspension immediately before use.

 

Before using NovoMix, check the label to make sure that the correct type of insulin is selected. Always check the cartridge, including the rubber piston. Do not use the cartridge if it has visible damage or if there is a gap between the piston and the white strip on the cartridge. For further instructions, refer to the instructions for using the system to introduce insulin.

 

You can not use NovoMix in the following situations:

  • if the patient has an allergy (hypersensitivity) to insulin aspart or any of the components that make up Novomix;
  • if the patient feels the approach of hypoglycemia (low blood sugar);
  • for subcutaneous insulin infusions in insulin pumps;
  • if the cartridge or insertion device with the cartridge installed is dropped, or the cartridge is damaged or crushed;
  • if the storage conditions of the preparation have been violated or it has been frozen;
  • if insulin does not become uniformly white and cloudy after mixing;
  • if in the preparation after mixing left white lumps or white particles,which adhere to the bottom or walls of the cartridge.

 

Side effect

  • urticaria, rashes on the skin;
  • anaphylactic reactions;
  • hypoglycemia;
  • peripheral neuropathy (acute pain neuropathy);
  • violation of refraction;
  • diabetic retinopathy;
  • lipodystrophy;
  • edema;
  • reactions at the injection site.

 

Hypoglycemia is the most common side effect. It can develop if the dose of insulin is too high in relation to the need for insulin. Severe hypoglycemia can lead to loss of consciousness and / or convulsions, temporary or irreversible impairment of brain function up to a lethal outcome. Symptoms of hypoglycemia, as a rule, develop suddenly. They may include cold sweats, pale skin, increased fatigue, nervousness or tremor, anxiety, unusual fatigue or weakness, impaired orientation, decreased concentration, drowsiness, severe hunger, visual impairment, headache, nausea and heart palpitations. Clinical studies have shown that the incidence of hypoglycemia varies depending on the patient population, dosing regimen, and glycemic control.Clinical studies showed no difference in the overall incidence of episodes of hypoglycemia in patients receiving insulin aspart therapy and patients using human insulin preparations.

 

Contraindications

  • increased individual sensitivity to insulin aspart or any of the components of the drug;
  • children's age till 6 years.

 

Application in pregnancy and lactation

 

The clinical experience of NovoMix in pregnancy is limited. Studies on its use in pregnant women have not been conducted.

 

In the period of possible pregnancy and throughout its term, it is necessary to carefully monitor the status of patients with diabetes mellitus and monitor the concentration of glucose in the blood. The need for insulin, as a rule, decreases in 1 trimester and gradually rises in 2 and 3 trimesters of pregnancy. Shortly after birth, the need for insulin quickly returns to the level that was before pregnancy.

 

During breastfeeding, NovoMix can be used without restrictions. The introduction of insulin to a nursing mother does not pose a threat to the child.However, it may be necessary to adjust the dose of the drug.

 

Use in children

 

It is not recommended for use in children under 6 years of age, as clinical studies on the use of NovoMix 30 Penfill or FlexPen have not been carried out.

 

NovoMix can be used to treat children and adolescents over 10 years of age when pre-mixed insulin is preferred. There are limited clinical data for children 6-9 years of age.

 

Application in elderly patients

 

NovoMix can be used in elderly patients, but experience with its use in combination with oral hypoglycemic drugs in patients older than 75 years is limited.

 

special instructions

 

Before a long trip associated with the change of time zones, the patient should consult with his attending physician, as changing the time zone means that the patient must take food and inject insulin at another time.

 

Hyperglycaemia

 

Insufficient dose of the drug or discontinuation of treatment, especially in type 1 diabetes, can lead to the development of hyperglycemia or diabetic ketoacidosis.Typically, the first symptoms of hyperglycemia appear gradually over several hours or days. Symptoms of hyperglycemia are thirst, frequent urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, and the smell of acetone in the exhaled air. Without proper treatment, hyperglycemia in patients with type 1 diabetes mellitus can lead to diabetic ketoacidosis - a condition that is potentially lethal.

 

Hypoglycaemia

 

Skipping meals or unplanned intense exercise can lead to hypoglycemia. Hypoglycemia can also develop if the insulin dose is too high in relation to the patient's need. Compared with a two-phase human insulin, NovoMix has a more pronounced hypoglycemic effect within 6 hours after administration. In this regard, in some cases, you may need to adjust the dose of insulin and / or the nature of nutrition.

 

After the compensation of carbohydrate metabolism, for example, with intensified insulin therapy, the symptoms typical for them-precursors of hypoglycemia may change in patients, which patients should be informed about.Common symptoms-precursors can disappear with prolonged course of diabetes. Since Novomix should be used in direct connection with food intake, it is necessary to take into account the high rate of onset of the drug effect in the treatment of patients who have concomitant diseases or who take medications that slow food intake.

 

Concomitant diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin. Correction of the dose of the drug may also be required if the patient has concomitant diseases of the kidneys, liver, adrenal, pituitary or thyroid gland disorders.

 

When transferring the patient to other types of insulin, early symptoms-precursors of hypoglycemia may change or become less pronounced compared to those observed with the application of the previous type of insulin.

 

Transfer of a patient from other insulin preparations

 

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 the concentration, type, producer and species (human insulin, human insulin analog) of insulin preparations and / or production method changes, a dose change may be required. Patients switching from other insulin preparations to Novomix may need an increase in the frequency of injections or a change in dose compared to the doses of previously used insulin preparations. If it is necessary to adjust the dose, it can be done already at the first administration of the drug or during the first weeks or months of treatment.

 

Reactions at the site of administration

 

As with other insulin preparations, reactions at the injection site may develop, which is manifested by pain, redness, hives, inflammation, bruising, swelling and itching. Regular change of injection site in the same anatomical area reduces the risk of these reactions. Reactions usually disappear over a period of several days to several weeks. In rare cases, it may be necessary to cancel NovoMix because of reactions at the injection site.

 

Antibodies to insulin

 

With the use of insulin, the formation of antibodies is possible.In rare cases, the formation of antibodies may require a dose adjustment of insulin to prevent cases of hyperglycemia or hypoglycemia.

 

Impact on the ability to drive vehicles and manage mechanisms

 

The patient's ability to concentrate and the reaction rate can be violated during hypoglycemia that may constitute a danger in situations where these capabilities are especially needed (e.g., when driving or operating machinery). Patients should be advised to take measures to prevent hypoglycemia when driving vehicles or working with mechanisms. This is especially important for patients with a lack or decrease in the severity of symptoms-precursors of developing hypoglycemia or suffering from frequent episodes of hypoglycemia. In these cases, the expediency of driving vehicles and performing such work should be considered.

 

Drug Interactions

 

There are a number of drugs that affect the need for insulin. Hypoglycemic effect of insulin enhance oral hypoglycemic agents, inhibitors of monoamine oxidase (MAO)inhibitors of angiotensin-converting enzyme (ACE), inhibitors of carbonic anhydrase, nonselective beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, salicylates.

 

The hypoglycemic effect of insulin is weakened by oral contraceptives, glucocorticosteroids (GCS), thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatropin, danazol, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

 

Beta-blockers can mask symptoms of hypoglycemia.

 

Octreotide / lanreotide can both increase and decrease the body's need for insulin.

 

Alcohol can increase or decrease the hypoglycemic effect of insulin.

 

Chronic heart failure (CHF) has been reported in the treatment of patients with thiazolidinediones in combination with insulin preparations, especially if such patients have risk factors for CHF. This fact should be taken into account when appointing patients combination therapy with thiazolidinediones and insulin preparations.When this combination therapy is prescribed, it is necessary to conduct medical examinations of patients to identify signs and symptoms of CHF, increase in body weight and the presence of edema. If the symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued.

 

Since compatibility studies have not been conducted, NovoMix should not be mixed with other drugs.

 

Analogues of Novomix medicinal product

 

Structural analogs for the active substance:

  • NovoMix 30 Penfill;
  • NovoMiks 30 FlexPen;
  • NovoMiks 50 FlexPen;
  • NovoMix 70 FlexPan.

 

Analogues of NovoMix on the pharmacological group (insulins):

  • Actrapid;
  • Apidra;
  • Berselsulin;
  • Biosulin;
  • Brinsulmidi;
  • Brinsulrapi;
  • We will win;
  • Gensulin;
  • Depo-insulin C;
  • Isofan-Insulin World Cup;
  • Iletin;
  • Insulin aspart;
  • Insulin glargine;
  • Insulin glulisine;
  • Insulin Detemir;
  • Insulin Isophanycum;
  • Insulin Lente;
  • Insulin Maxiprapid;
  • Insulin is a soluble neutral;
  • Insulin C;
  • Insulin pork high-purity MK;
  • Insulin Semilente;
  • Insulin Ultralente;
  • Human insulin;
  • Insulin SQM;
  • Insulong;
  • Insulrape;
  • Insuman;
  • Insuran;
  • Inutral;
  • Comb-insulin C;
  • Lantus;
  • Levemir;
  • Mixtard;
  • Monoinsulin;
  • Monotard;
  • NovoMix 30 Penfill;
  • NovoMiks 30 FlexPen;
  • NovoMiks 50 FlexPen;
  • NovoMix 70 FlexPen;
  • NovoRapid;
  • Pensulin;
  • Protamine-insulin;
  • Protafan;
  • Recombinant human insulin;
  • Rinsulin;
  • Rosinsulin;
  • Tresib;
  • Tudzheo SoloStar;
  • Ultradard NM;
  • Homolong;
  • Homorap;
  • Humalog;
  • Humodar;
  • Khumulin.

 

Review of the endocrinologist

 

All my patients with diabetes have home glucometers. I try to teach all sick people how to correctly use NovoMix, how to correctly adjust the dose. But, unfortunately, not all diabetics are responsibly approaching treatment. Therefore, there are cases when they develop hypoglycemic or hyperglycemia of varying severity. Some patients even have to be hospitalized. But in general, NovoMix is ​​well tolerated. Other adverse reactions to it are extremely rare. Only here lipodystrophies in the fields of drug administration diabetics with experience can not be avoided in any way.

Similar medicines:

Other medicines:

Reviews (0):

Rules for publishing reviews and visitor questions