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NovoRapid Flexpen 100u/ml

$146.08

NovoRapid Flexpen 100u/ml

Manufacturer: Novo Nordisk
Basic substance : Insulin
Package : 100u/ml * 5 * 3ml
Category : HCG

Novorapid Flexpen has a more rapid onset and shorter duration of action than soluble human insulin.

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Description

NovoRapid Flexpen 100u/ml

Novorapid Flexpen has a more rapid onset and shorter duration of action than soluble human insulin.

Insulin aspart, like human insulin short-acting, produced by the method of biotechnology recombinant DNA using a strain of Saccharomyces cerevisiae, in which the amino acid Proline in position B28 replaced by aspartic acid.

Interacts with the specific receptor zitoplazmaticescoy external cell membrane of cells to form insulin-receptor complex stimulates intracellular processes, including synthesis of several key enzymes (geksokinazoj, pyruvate kinase, glikogensintetaza, etc.). The decrease in the content glucose in the blood due to its increase of intracellular transport, increased assimilation of tissues, stimulation of lipogenesis, glikogenogeneza, a decrease in the rate of glucose production by the liver, etc.

The substitution of Proline at position B28 on the aspartic acid in insulin aspart reduces the tendency of the molecules to the formation of hexamers, which is observed in a solution of regular insulin. In this regard, insulin aspart is much faster absorbed from the subcutaneous fat and starts acting much faster than soluble human insulin. Insulin aspart stronger reduces the level of blood glucose in the first 4 hours after a meal than soluble human insulin.

The duration of action of insulin aspart after subcutaneous injection is shorter than soluble human insulin.

After subcutaneous injection, the drug action begins within 10-20 min after injection. The maximum effect is observed after 1-3 hours after injection. The duration of action of the drug is 3-5 hours.

Clinical studies involving patients with diabetes type 1 diabetes showed a reduced risk of nocturnal hypoglycaemia when using insulin aspart compared to soluble human insulin. The risk of daytime hypoglycaemia was not significantly increased.

Insulin aspart is an equipotential soluble human insulin on the basis of indicators, molarity.

Adults. Clinical studies involving patients with diabetes type 1 demonstrated a lower postprandial blood glucose concentrations when insulin aspart compared to soluble human insulin.

Elderly. It was a randomized, double-blind crossover study of the pharmacokinetics and pharmacodynamics (PK/PD) of insulin aspart and soluble human insulin in elderly patients with diabetes type 2 diabetes (19 patients aged 65-83 years, mean age 70 years). The relative differences in the pharmacodynamic properties between insulin aspart and soluble human insulin in elderly patients were similar to those seen in healthy volunteers and in younger patients with diabetes.

Children and adolescents. The use of insulin aspart in children showed similar results of long-term glycemic control when compared with soluble human insulin.

Clinical study using soluble human insulin before meals and insulin aspart after the meal was spent in small children (26 patients aged 2 to 6 years) as well as pharmacokinetic/pharmacodynamic (PK/PD) study using a single dose was conducted in children (6-12 years) and adolescents (13-17 years). Pharmacodynamic profile of insulin aspart in children was similar to that in adult patients.

Pregnancy. Clinical studies of the comparative safety and efficacy of insulin aspart and human insulin in the treatment of pregnant women with diabetes mellitus type 1 (322 surveyed pregnant women, of whom 157 were receiving insulin aspart, 165 — human insulin) have not revealed any negative effects of insulin aspart on pregnancy or health of the fetus/newborn.

Additional clinical study of 27 women with gestational diabetes treated with insulin aspart and human insulin (insulin aspart, there were 14 women, human insulin, and 13) indicate comparability of safety profiles along with a significant improvement of glucose control after meals in the treatment of insulin aspart.

Preclinical safety data.

Preclinical studies have not revealed any risk for humans based on conventional studies of pharmacological safety, repeated use toxicity, genotoxicity and reproductive toxicity.

In tests in vitro, including the receptors of insulin and insulin-like growth factor-1, and the impact on cell growth, the nature of the behaviour of insulin aspart is very similar to that of human insulin. The research results also showed that the dissociation of binding of insulin aspart with insulin receptor equivalent to that of human insulin.

Indications:

Diabetes.

Contraindications:

individual hypersensitivity to insulin aspart or any component of the drug
hypoglycemia.
It is not recommended to use the drug Novorapid Flexpen in children under 2 years, because clinical studies in children under 2 years of age was conducted.

Dosage :

Novorapid Flexpen has a more rapid onset and shorter duration of action than soluble human insulin. Due to the more rapid onset of action, Novorapid Flexpen, you must enter, as a rule, immediately before meals and, if necessary, you can enter shortly after eating.

The dose is determined individually in each case, on the basis of the level of glucose in the blood. Novorapid Flexpen is usually used in combination with drugs insulin average duration or long-acting, which is administered at least 1 time a day. Usually the total daily insulin requirement is 0.5–1 U/kg of body weight. When the drug is administered before a meal, insulin requirements may be provided by the drug Novorapid Flexpen 50-70%, the remaining need for insulin provided by insulin of the prolonged action.

Temperature of insulin must correspond to room. Novorapid Flexpen is injected subcutaneously in the anterior abdominal wall, hip, shoulder or buttocks. Injection sites within the same area of the body need to be regularly changed. As with any other insulin preparations, the duration of action of Novorapid Flexpen is dependent on dose, site of injection, intensity of flow, temperature and level of physical activity.

Subcutaneous administration into the abdominal wall ensures a faster absorption than administration in other places. However, a more rapid onset of action compared to soluble human insulin is maintained regardless of the location of the injection site.

If necessary, Novorapid Flexpen may be administered in/in, but only qualified medical personnel.

For I/V administration used the infusion system with the drug Novorapid 100 U/ml with a concentration of from 0.05 to 1 U/ml insulin aspart in 0.9% sodium chloride solution 5 or 10% dextrose solution containing 40 mmol/l potassium chloride, using polypropylene containers for infusion. These solutions are stable at room temperature for 24 h During infusion of insulin needed to control blood glucose levels.

Novorapid Flexpen may also be used for continuous subcutaneous insulin infusion (PII) in insulin pumps designed for infusion of insulin. PII should be made in the abdominal wall. Places of the infusion should be changed periodically.

When using an insulin pump for infusion Novorapid Flexpen must not be mixed with other types of insulin. Patients using PII should be trained to use the pump, the relevant reservoir and tubing for the pump. Infusion set (tubing and catheter) should be replaced in accordance with the user manual attached to the infusion set.

Patients receiving Novorapid Flexpen with PII should have additional insulin required in case of failure of the infusion system.

Side effects :

Adverse reactions observed in patients using the drug Novorapid are mainly dose dependent and due to the pharmacological effect of insulin. The most common adverse event with insulin is hypoglycemia. Hypoglycemia develops when, if too high a dose of insulin relative to the needs of the body. Symptoms of hypoglycaemia usually occur suddenly. They can include: cold sweat, pale skin, nervousness or tremor, anxiety,

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