NovoMix 30 Flex pen *novo nordisk.
Novo Mix 30 Flex pen *novo nordisk.
Manufacturer: Novo Nordisk
Basic substance : Insulin
Package : 100u/ml * 5 x 3ml pens
Category : HCG
NovoMix is a range of suspensions( insulin) for injection, which are available in cartridges (Penfill) and prefilled pens
NovoMix 30 Flex pen *novo nordisk.
NovoMix 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 h.
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.
individual hypersensitivity to insulin aspart or any component of the drug
It is not recommended to use the drug Novorapid Flexpen in children under 2 years, because clinical studies in children under two years of age was conducted.
– NovoMix 30 has a faster onset of action than biphasic human insulin and should usually be administered immediately before a meal. If necessary, NovoMix 30 can be injected shortly after a meal.
– NovoMix 30 is administered subcutaneously in the thigh or abdominal wall. Depending on the case, it will also be possible to inject into the gluteal or deltoid region. Injection sites should be rotated within the same region. As with all insulins, duration of action varies with dose, injection site, blood flow, temperature, and intensity of physical activity. The influence of the various injection sites on the absorption of NovoMix 30 has not been studied. NovoMix 30 should never be administered intravenously.
– Renal or hepatic disorders may reduce the patient’s insulin requirements.
– NovoMix 30 can be used in children and adolescents aged 10 years or older when premixed insulin is recommended. For children aged 6 to 9 years, there is limited clinical data (see section on pharmacodynamic properties).
The effects of NovoMix 30 have not been studied in children under 6 years of age.
– The dose of NovoMix 30 depends on each individual and is determined according to the needs of the patient.
– In patients with type 2 diabetes, NovoMix 30 can be administered alone or in combination with oral antidiabetic agents for which the combination with insulin has been approved, when blood sugar is insufficiently controlled by these oral antidiabetic agents alone. For patients with type 2 diabetes, the recommended starting dose of NovoMix 30 is 6 U at breakfast and 6 U at dinner (evening meal). NovoMix 30 can also be initiated in one injection per day of 12 U at dinner (evening meal). When NovoMix 30 is used in one injection per day and the dose is 30 units, it is generally recommended to take two injections per day, dividing the dose of breakfast and the dose of dinner equally (evening meal). . If recurrent episodes of hypoglycaemia occur during the day with two daily injections of NovoMix 30, the morning dose may be divided into one dose in the morning and one dose at noon (3 injections per day).
– It is advisable to follow the following titration recommendations for dose adjustment.
Preprandial blood glucose: Dosage adjustment of NovoMix 30.
. <4.4 mmol / L <80 mg / dl: -2 U.
. 4.4-6.1 mmol / L 80-110 mg / dl: 0.
. 6.2-7.8 mmol / L 111-140 mg / dL: +2 U.
. 7.9-10 mmol / L 141-180 mg / dL: +4 U.
. > 10 mmol / L> 180 mg / dL: +6 U.
– The lowest preprandial glucose of the last three days should be taken into account. The dose should not be increased if there has been a hypoglycaemic episode in the past three days. Dose adjustment can be performed once a week until the target HbA1c is reached. Blood glucose levels measured before the meal should be used to adjust the previous dose.
– The combination of NovoMix 30 with pioglitazone should only be considered after clinical evaluation of the risk of occurrence of signs or symptoms of adverse effects related to fluid retention in a treated patient. Initiation of NovoMix 30 should be done with caution by increasing the dosage to the smallest dose required to achieve glycemic control (see section cautionary statements and precautions for use).
– In patients with type 1 diabetes, individual insulin requirements are usually between 0.5 and 1.0 Units / kg / day. They may be covered in whole or in part by NovoMix 30. Daily insulin requirements may be higher in patients with insulin resistance (eg due to obesity) and lower in endogenous insulin secretion. residual.
– When transferring biphasic human insulin to NovoMix 30, first keep the same dose and injection schedule. Then adjust the dose according to individual needs (see the titration recommendations in the table above).
NovoMix 30 can be used in the elderly; however, the experience of using NovoMix 30 in combination with ADO in patients over 75 is limited.
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,