Buy Novomix 30 FlexPen syringe 100 IU/ml 3 ml, 5 pcs

NovoMix® [biphasic Insulin aspart]

Brand Novo Nordisk

In stock 10 Items

Available since: 2019-09-19

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Clinical Pharmacology

NOVOMIX 30 FLEXPEN - an analogue of human insulin of average duration of action. It forms an insulin-receptor complex with a specific receptor of the external cytoplasmic cell membrane, which stimulates the synthesis of hexokinase, pyruvate kinase, 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 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 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 two-phase 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 action 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 after 1-4 h after injection. The duration of the drug reaches 24 hours.

Indications

- 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 combined therapy is used), intercurrent diseases.

Composition

active substance: insulin aspart biphasic 100 IU *

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

biphasic Insulin aspart is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Novomix 30 FlexPen	Novo Nordisk	Denmark	syringe
Novomix 30 Penfill	Novo Nordisk	Denmark	cartridge

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Dosage and Administration

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

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 FlexPen should be entered immediately before a meal; if necessary, immediately after a meal.

The temperature of the drug should be at room temperature.

Injection is made p / to the region of the thigh or the 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 to prevent the development of lipodystrophies.

As with any other insulin preparations, the duration of action of NovoMix 30 FlexPen depends on the dose, the site of administration, the intensity of blood flow, the temperature and the 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 effects on carbohydrate metabolism: often - hypoglycemia, the symptoms of which may include pallor of the skin, cold sweat, nervousness, tremor, anxiety, unusual tiredness or weakness, loss of orientation in space, decreased concentration, dizziness, pronounced feeling 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.

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.

Drug interactions

Hypoglycemic effect of the body .

The hypoglycemic effect of the drug weakens oral contraceptives, GCS, thyroid hormone drugs, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Under the influence of reserpine and salicylates, both the weakening and strengthening of the action of NovoMix® 30 FlexPen® is possible.

Beta-blockers may mask the symptoms of hypoglycemia.

Octreotide / Lanreotide can both increase and decrease the need for insulin.

Ethanol can enhance and prolong the hypoglycemic effect of insulin.

Incompatibility

Since compatibility studies have not been carried out, NovoMix® 30 FlexPen® should not be mixed with other drugs.

Pregnancy and Lactation

Clinical experience with NovoMix® 30 FlexPen® during pregnancy is very limited.

However, data from two randomized controlled clinical trials (157 and 14 pregnant women, respectively, who received insulin aspart in the basis-bolus therapy regimen) did not reveal any adverse effect of insulin aspart on the course of pregnancy or the health of the fetus / newborn compared to soluble human insulin. In addition, a clinical randomized trial involving 27 women with gestational diabetes who received insulin aspart and soluble human insulin (14 women received insulin aspart, human insulin 13) showed similar safety profiles for both types of insulin.

During the period of possible pregnancy and throughout its life, it is necessary to carefully monitor the condition of patients with diabetes mellitus and monitor 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. 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 introduction of insulin nursing mother does not pose a threat to the child. However, it may be necessary to adjust the dose of NovoMix® 30 FlexPen®.

Special instructions

Before a long trip related to the change of time zones, the patient should consult with his doctor, because changing the time zone means that the patient must eat and inject insulin at another time.

Hyperglycemia. An inadequate dose of the drug or discontinuation of treatment, especially for 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 include thirst, increased urine output, nausea, vomiting, drowsiness, redness and dry skin, dry mouth, loss of appetite, and the smell of acetone in exhaled air. Without appropriate treatment, hyperglycemia in patients with type 1 diabetes mellitus can lead to diabetic ketoacidosis, a condition that is potentially fatal.

Hypoglycemia. Skipping meals or unplanned intense exercise can lead to hypoglycemia. Hypoglycemia may also develop if the insulin dose is too high in relation to the patient’s needs (see “Side effects”, “Overdose”).

Compared to biphasic human insulin, 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 diet. After compensation of carbohydrate metabolism, for example, in case of intensified insulin therapy, the typical symptoms of hypoglycemia, which are typical for them, may change in patients, about which patients should be informed. The usual symptoms of precursors can disappear with a long course of diabetes. Stricter glycemic control in patients may increase the risk of hypoglycemia, therefore, increasing the dose of NovoMix® 30 FlexPen® should be carried out under strict medical supervision (see “Dosage and Administration”).

Since NovoMix® 30 FlexPen® should be used in direct connection with food intake, it is necessary to take into account the high rate of onset of the effect of the drug in the treatment of patients with concomitant diseases or receiving drugs that slow down the absorption of food.

Concomitant diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin.Dose adjustment of the drug 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 transferring a patient to other types of insulin, the early symptoms, precursors of hypoglycemia, may change or become less pronounced compared to those of the previous type of insulin.

Transfer of the patient from other insulin preparations. Transferring a patient to a new type of insulin or another manufacturer’s insulin should be carried out under strict medical supervision. When changing the concentration, type, manufacturer and type (human insulin, human insulin analogue) of insulin preparations and / or production method, a dose change may be required. or a change in dose compared with 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 the treatment of other insulin preparations, reactions may develop at the site of administration, which is manifested by pain, redness, urticaria, inflammation, hematomas, swelling and itching. Regularly changing the injection site in the same anatomical area can reduce the symptoms or prevent the development of these reactions. Reactions usually disappear within a few days to a few weeks. In rare cases, NovoMix® 30 FlexPen® may need to be canceled due to reactions at the sites of administration.

The simultaneous use of preparations of the 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 when these patients have risk factors for the development of chronic heart failure. This fact should be taken into account when prescribing thiazolidinediones and insulin combination therapy to patients. When prescribing such a combination therapy, it is necessary to conduct medical examinations of patients to identify their signs and symptoms of chronic heart failure, weight gain and the presence of edema. In case of worsening of the symptoms of heart failure in patients, treatment with thiazolidinediones should be stopped.

Influence on ability to control vehicles and work with mechanisms. The ability of patients to concentrate and the speed of reaction may be impaired during hypoglycemia, which can be dangerous in those situations when these abilities are especially necessary (for example, when driving or working with machines and mechanisms).

Patients should be advised to take measures to prevent the development of hypoglycemia when driving. This is especially important for patients with the absence 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 and performing such work should be considered.

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.