NovoMix Flexpen suspension for n / a injection 100U / ml, 3ml No. 5 syringe-pen

Diabetes.

NovoMixЃ 30 FlexPenЃ is intended for subcutaneous administration. Do not administer NovoMixЃ 30 FlexPenЃ IV, because this can lead to severe hypoglycemia. IM administration of NovoMixЃ 30 FlexPenЃ should also be avoided. Do not use NovoMixЃ 30 FlexPenЃ for subcutaneous insulin infusions (PPII) in insulin pumps.

The dose of NovoMixЃ 30 FlexPenЃ 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 adjust the dose of the drug.

For patients with type 2 diabetes mellitus NovoMixЃ 30 FlexPenЃ can be prescribed both as monotherapy and in combination with oral hypoglycemic drugs in cases where blood glucose is insufficiently regulated only by oral hypoglycemic drugs.

Initiation of therapy

For patients with type 2 diabetes mellitus who have been prescribed insulin for the first time, the recommended initial dose of NovoMixЃ 30 FlexPenЃ is 6 U before breakfast and 6 U before dinner. It is also allowed to administer 12 UNITS NovoMixЃ 30 FlexPenЃ once a day in the evening (before dinner).

Transfer of a patient from other insulin preparations

When transferring a patient from biphasic human insulin to NovoMixЃ 30 FlexPenЃ, one should start with the same dose and administration regimen. Then adjust the dose in accordance with the individual needs of the patient (see the recommendations below for titrating the dose of the drug). As always, when transferring a patient to a new type of insulin, strict medical supervision is required during the transfer of the patient and in the first weeks of using the new drug.

Intensification of therapy

The therapy with NovoMixЃ 30 FlexPenЃ can be intensified by switching from a single daily dose to a double dose. It is recommended, after reaching a dose of 30 IU of the drug, to switch to the use of NovoMixЃ 30 FlexPenЃ 2 times a day, dividing the dose into two equal parts - morning and evening (before breakfast and dinner).

The transition to the use of NovoMixЃ 30 FlexPenЃ 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 lunchtime (three times daily dose).

Dose adjustment

To adjust the dose of NovoMixЃ 30 FlexPenЃ, the lowest value of fasting blood glucose concentration obtained during the last three days is used.

To assess the adequacy of the previous dose, use the value of the concentration of glucose in the blood before the next meal.

Dose adjustments can be made once a week until the target HbA1c value is reached. Do not increase the dose of the drug if hypoglycemia was observed during this period.

A dose adjustment may be necessary if the patient is more physically active, changes his usual diet, or has a concomitant disease.

To adjust the dose of NovoMixЃ 30 FlexPenЃ, recommendations for titration are given below (see table).

Special patient groups

As always with the use of insulin preparations, in patients of special groups, the concentration of glucose in the blood should be more closely monitored and the dose of insulin aspart should be adjusted individually.

Elderly and senile patients. NovoMixЃ 30 FlexPenЃ can be used in elderly patients, however, the experience of its use in combination with oral hypoglycemic drugs in patients over 75 years old is limited.

Patients with insufficiency of night and liver function. In patients with renal or hepatic impairment, the need for insulin may be reduced.

Children and adolescents. NovoMixЃ 30 FlexPenЃ can be used to treat children and adolescents over the age of 10 years in cases where it is preferable to use premixed insulin. There are limited clinical data for children aged 6-9 years (see Pharmacodynamics).

NovoMixЃ 30 FlexPenЃ should be injected subcutaneously into the thigh or anterior abdominal wall. If desired, the drug can be injected into the shoulder or buttocks area.

It is necessary to change injection sites within the anatomical region to prevent the development of lipodystrophy.

As with any other insulin preparations, the duration of action of NovoMixЃ 30 FlexPenЃ depends on the dose, site of administration, blood flow intensity, temperature and level of physical activity.

Compared to biphasic human insulin, NovoMixЃ 30 FlexPenЃ begins to act more quickly, therefore it should be administered immediately before taking the pauper. If necessary, NovoMixЃ 30 FlexPenЃ can be administered shortly after taking the pauper.

Suspension for s / c administration is white, homogeneous (not containing lumps, flakes may appear in the sample); stratifies upon standing, forming a white precipitate and a colorless or almost colorless supernatant; with gentle stirring, a homogeneous suspension should form.

1 ml

insulin aspart biphasic 100 UNITS *

insulin aspart soluble 30%

insulin aspart crystalline protamine 70%

Excipients: glycerol - 16 mg, phenol - 1.5 mg, metacresol - 1.72 mg, zinc chloride - 19.6 ?g, sodium chloride - 0.877 mg, sodium hydrogen phosphate dihydrate - 1.25 mg, protamine sulfate ~ 0.33 mg, sodium hydroxide ~ 2.2 mg, hydrochloric acid ~ 1.7 mg, water d / i - up to 1 ml.

Increased individual sensitivity to insulin aspart or any of the components of the drug.

It is not recommended for use in children under 6 years of age. clinical studies on the use of NovoMixЃ 30 FlexPenЃ were not carried out in them.

pharmachologic effect

It is a two-phase suspension consisting of a mixture of insulin analogs: soluble insulin aspart (30% short-acting insulin analog) and insulin aspart protamine crystals (70% medium-acting insulin analog).

A decrease in the level of glucose in the blood occurs due to an increase in its intracellular transport after the binding of insulin aspart biphasic to the insulin receptors of muscle and adipose tissues and the simultaneous inhibition of glucose production by the liver.

Side effect

From the immune system: infrequently - urticaria, skin rash, skin rashes; very rarely - anaphylactic reactions.

From the side of metabolism and nutrition: very often - hypoglycemia.

From the nervous system: rarely - peripheral neuropathy (acute painful neuropathy).

From the side of the organ of vision: infrequently - refractive errors, diabetic retinopathy.

On the part of the skin and subcutaneous tissues: infrequently - lipodystrophy.

General reactions: infrequently - edema.

Application during pregnancy and lactation

Clinical experience with pregnancy is limited.

During the period of the possible onset of pregnancy and throughout its entire period, it is necessary to closely monitor the condition of patients with diabetes mellitus and control the concentration of glucose in the blood. The need for insulin, as a rule, decreases in the first trimester and gradually increases in the second and third trimesters of pregnancy. Soon after childbirth, the need for insulin quickly returns to pre-pregnancy levels.

During breastfeeding, you can use it without restrictions. The administration of insulin to a nursing mother does not pose a threat to the baby. However, it may be necessary to adjust the dose.

Application in children

It is not recommended for use in children under 6 years of age. clinical studies were not carried out with them.

Can be used to treat children and adolescents over the age of 10 years in cases where the use of premixed insulin is preferred. There are limited clinical data for children aged 6-9 years.

Use in elderly patients

Elderly patients can be used, but the experience of its use in combination with oral hypoglycemic drugs in patients over 75 years of age is limited.

special instructions

Before a long trip involving a change in 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.

An insufficient dose of the drug or discontinuation of treatment, especially in type 1 diabetes mellitus, can lead to the development of hyperglycemia or diabetic ketoacidosis. As a rule, the first symptoms of hyperglycemia appear gradually, over several hours or days. Symptoms of hyperglycemia are thirst, increased urine output, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, and the smell of acetone in the exhaled air. Without appropriate treatment, hyperglycemia in patients with type 1 diabetes mellitus can lead to diabetic ketoacidosis, a condition that is potentially fatal.

Skipping meals or unplanned strenuous exercise can lead to hypoglycemia. Hypoglycemia can also develop if a dose of insulin that is too high in relation to the patient's needs is administered.

After compensation of carbohydrate metabolism, for example, with intensified insulin therapy, patients may change their typical symptoms, precursors of hypoglycemia, about which patients should be informed. The usual precursor symptoms can disappear with prolonged diabetes mellitus.

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

When the patient is switched to other types of insulin, the early warning signs of hypoglycemia may change or become less pronounced, compared with those when using the previous type of insulin.

Transfer of a patient to a new type of insulin or insulin preparation from another manufacturer must be carried out under strict medical supervision. Changes in concentration, type, manufacturer and type (human insulin, human insulin analog) of insulin preparations and / or production method may require a change in dose.

Cases of chronic heart failure have been reported when patients are treated 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 for patients. When prescribing such a combination therapy, it is necessary to conduct medical examinations of patients in order 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 should be discontinued.

Influence on the ability to drive vehicles and mechanisms

The ability of patients to concentrate and reaction speed can be impaired during hypoglycemia, which can be dangerous in situations where these abilities are especially needed (for example, when driving 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 decreased severity of precursor symptoms in developing hypoglycemia or suffering from frequent episodes of hypoglycemia. In these cases, the feasibility of driving and performing such work should be considered.

Drug interactions

There are a number of medications that affect your insulin requirement. The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, meloxinendazolithium, drugs ...

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

Beta-blockers can mask the 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.