Index of drugs

Treatment of diabetes in adults, adolescents and children from the age of 2 years.

1 cartridge (3 ml) contains 300 units of insulin detemir.

Insulin detemir is a long-acting insulin analogue. It is obtained by recombination of DNA usingSaccharomyces cerevisiae. The effect is to lower blood Glucose due to glucose uptake following insulin binding to insulin receptors in muscle and fat cells while inhibiting the release of glucose from the liver. In comparison to NPH insulin, the action profile of insulin detemir is statistically significantly less variable and therefore more predictable. Prolonged action of insulin detemir is possible due to the formation of strong connections between the insulin detemir molecules at the injection site and the binding of albumin via the fatty acid side chain. Distribution of insulin detemir to peripheral tissue is slower compared to NPH insulin. The combination of these lengthening mechanisms provides more reproducible absorption and action profile of insulin detemir compared to NPH insulin. Insider treatment with insulin provides comparable glycemic control to NPH insulin (HbA1c), and is associated with a lower risk of nocturnal hypoglycaemia and no increase in body weight. The duration of action, which is up to 24 hours depending on the dose, allows administration of the drug once or twice a day. When administered twice a day, achieving a dynamic balance will occur after 2-3 doses. For doses of 0.2-0.4 units / kg the drug achieves more than 50% of the maximum effect in 3-4 h to a maximum of 14 h after the injection. The maximum plasma concentration occurs between 6 and 8 h after administration. The variability of drug absorption between individual doses in the same patient is less compared to other basal insulins. The absolute bioavailability of insulin detemir after subcutaneous administration is approximately 60%. The breakdown of insulin detemir is similar to the breakdown of human insulin; all the resulting metabolites are inactive. Final T_0,5 after subcutaneous administration depends on the rate of absorption from the subcutaneous tissue, it is 5-7 h depending on the dose.

Hypersensitivity to the active substance or to any of the excipients.

Inadequate dosing or discontinuation of treatment, particularly in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis. In patients who have improved glycemic control, for example, hypoglycaemia may change from intensive insulin therapy. In patients with long-term diabetes, these symptoms may not be present. At the same time, existing diseases, especially infections and febrile states usually increase the patient's need for insulin. Co-existing kidney or liver problems or diseases affecting the adrenal glands, pituitary glands or thyroid gland may require adjustment of insulin doses. When changing the type of insulin, early warning signs of hypoglycaemia may change or become less pronounced. Changing the type or type of insulin should be done under close medical supervision. If a dose adjustment is necessary, this may occur during the first dose or within the first weeks or months. There are limited data on patients with severe hypoalbuminemia - careful monitoring is recommended in these patients. Patients being treated with pioglitazone in combination with insulin may be at risk of developing heart failure (particularly in patients with risk factors for cardiac failure) - this should be taken into account when considering combination therapy with pioglitazone. If combined treatment is used, patients should be monitored for signs and symptoms of heart failure, weight gain and edema; should discontinue pioglitazone if the cardiac symptoms worsen. Elderly patients and patients with renal or hepatic impairment are advised to monitor blood glucose intensively.The efficacy and safety of the medicine has been demonstrated in adolescents and children from 2 years of age in studies lasting up to 12 months - in this group of patients, intensified monitoring of blood glucose is recommended. There are no studies in children under 2 years of age. The drug should not be administered intravenously. Intramuscular injection should be avoided. Do not use in insulin pumps.

The use of the drug during pregnancy may be considered, while the potential benefits must outweigh the possible increase in the risk of adverse effects during pregnancy. During pregnancy or when planning for patients with diabetes, increased blood glucose control is recommended. The demand for insulin usually decreases in the first trimester and gradually increases during the second and third trimester of pregnancy, after delivery it rapidly returns to pre-pregnancy value. It is not known whether insulin detemir is excreted in human milk; no effect of insulin detemir on neonatal and / or breastfed metabolism has been demonstrated. When breastfeeding, it may be necessary to adjust the insulin dose and diet.

Very common: hypoglycaemia. Common: reactions at the injection site. Uncommon: allergic reactions, potentially allergic reactions, urticaria, rash, eruptions (if used in the basal-bonus regimen, when used in combination with oral antidiabetic medicines, these reactions are common); refraction disorders, diabetic retinopathy, lipodystrophy (including lipohypertrophy, lipoatrophy) at the injection site, edema. Rare: peripheral neuropathy. Very rare: anaphylactic reactions.

Individually, according to the need for insulin. The drug can be used alone as basal insulin (insulin) or in combination with rapid acting insulin (bolus). It may also be used in combination with oral antidiabetic agents or may be added to liraglutide therapy. In combination with oral antidiabetic agents and after addition to liraglutide therapy, it is recommended to use once a day at an initial dose of 10 U or 0.1-0.2 Units / kg. If the drug is used as basal insulin in the "basal-bolus" system, it should be administered once or twice a day depending on the patient's needs. Dosage adjustment may also be necessary when the patient increases physical activity, changes in diet or during concomitant diseases. In elderly patients, individual adjustment of the dose is recommended in patients with impaired renal or hepatic function, as well as in adolescents and children from 2 years of age. When switching from an insulin with an intermediate or long-acting effect to insulin detemir, dosage and timing may need to be adjusted. An additional antidiabetic treatment (dose and / or timing of oral antidiabetic agents or short / fast insulins used) may need to be adjusted. The drug is given by subcutaneous injection into the abdominal region, thigh, shoulder, deltoid region or gluteal area. Injection sites should be changed within the same area. The injection can be done at any time of the day, but every day at the same time. For patients requiring 2 doses to achieve optimal blood glucose control per day, the evening dose may be given in the evening or at bedtime.