Levemir flexpen solution for subcutaneous injection 100e for ml 3 ml N5
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Active ingredients
Insulin detemir
Release form
Solution
Composition
Active ingredient: Insulin detemir (Insulin detemir *) Concentration of the active substance (od.): 100EDU
Pharmacological effect
Insulin long acting, soluble analogue of human insulin. It is produced by recombinant DNA biotechnology using the Saccharomyces cerevisiae strain. The prolonged effect is due to the pronounced self-association of insulin molecules to detemir at the injection site and to bind the drug molecules to albumin by connecting to a side chain. Insulin detemir compared with insulin isophane to peripheral target tissues is slower. These combined mechanisms of delayed distribution provide a more reproducible profile of absorption and action of insulin detemir than insulin isophane. It interacts with a specific receptor of the external cytoplasmic cell membrane and forms an insulin-receptor complex that stimulates intracellular processes, including synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthetase). The decrease in blood glucose is due to an increase in its intracellular transport, increased tissue absorption, stimulation of lipogenesis, glycogenogenesis, and a decrease in glucose production rate by the liver. At doses of 0.2-0.4 U / kg 50% maximum effect occurs in the range from 3-4 hours to 14 hours after administration. The duration of action is up to 24 hours, depending on the dose. After the subcutaneous injection, there is a pharmacodynamic response proportional to the dose administered (maximum effect, duration of action, general effect). The night glucose control profile is flatter and more even in insulin detemir compared to insulin isophane, which is reflected in a lower risk of developing nighttime hypoglycemia.
Pharmacokinetics
Terminal T1 / 2 after s / c injection is determined by the degree of absorption from the subcutaneous tissue and is 5-7 hours, depending on the dose.
Indications
Diabetes in adults, adolescents and children over 2 years.
Contraindications
Increased individual sensitivity to insulin detemir or any of the components of the drug. It is not recommended to use Levemir FlexPen in children under 2 years of age, becauseNo clinical studies have been conducted in children under 2 years of age.
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
Currently, there are no data on the clinical use of insulin detemir during pregnancy and lactation. During the period of possible onset and throughout the entire period of pregnancy, it is necessary to carefully monitor the condition of patients with diabetes and monitor plasma glucose levels. 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, it may be necessary to adjust the dose of the drug and diet. In experimental animal studies, the difference between the embryotoxic and teratogenic effects of insulin detemir and human insulin has not been established.
Dosage and administration
The dose of Levemir FlexPen should be adjusted individually in each specific case, based on the patient's needs. Based on the research results, dose titration recommendations are presented below: Average plasma glucose values measured independently before breakfast Dosage correction of Levemir FlexPen (ED)> 10 mmol / L (180 mg / dL) + 89.1-10 mmol / L (163-180 mg / dL) + 68.1-9 mmol / L (145-162 mg / dL) + 47.1-8 mmol / L (127-144 mg / dl) + 26.1-7 mmol / l (109-126 mg / dl) + 24.1-6.0 mmol / l No change (target value) If any single value of plasma glucose : 3.1-4 mmol / l (56-72 mg / dl) -2 <3.1 mmol / l (<56 mg / dl) -4 If Levemir FlexPen is used as part of the baseline / bolus mode, it should be administered 1 or 2 times / days, based on the needs of the patient. Patients who need to use the drug 2 times / day for optimal control of blood glucose levels, can enter the evening dose, either during dinner or before bedtime. Dose adjustment may be necessary when increasing the patient's physical activity, changing his usual diet or with a concomitant disease. The drug Levemir FlexPen can be used both as monotherapy and in combination with bolus insulin. It can also be used in combination with oral hypoglycemic drugs, as well as in addition to existing therapy with liraglutide. In combination with oral hypoglycemic drugs or in addition to liraglutide, it is recommended to apply Levemir FlexPen once a day, starting with a dose of 10 IU or 0.1-0.2 U / I kgThe drug Levemir FlexPen can be administered at any time convenient for the patient during the day, however, having determined the time of the daily injection, it is necessary to adhere to the prescribed injection regimen. Levemir FlexPen is intended only for sc injection. Levemir FlexPen should not be administered in / in, because this can lead to severe hypoglycemia. You should also avoid i / m administration of the drug. Levemir FlexPen is not intended for use in insulin pumps. Levemir FlexPen is injected sc into the thigh, anterior abdominal wall, shoulder, deltoid or gluteal region. Injection sites should be changed regularly, even when injected into the same area to reduce the risk of developing lipodystrophy. As with other insulin preparations, the duration of action depends on the dose, site of administration, blood flow intensity, temperature, and level of physical activity. Particular groups of patients As with other insulin preparations, in elderly patients and patients with renal or hepatic insufficiency should be more carefully control the concentration of glucose in the blood and adjust the dose of insulin detemir individually.
Side effects
Adverse reactions observed in patients using the drug Levemir, mainly develop due to the pharmacological effect of insulin. The proportion of patients receiving treatment who are expected to develop adverse reactions is estimated at 12%. The most common adverse reaction that develops during treatment with Levemir is hypoglycemia. From clinical studies it is known that severe hypoglycemia, requiring the intervention of third parties, develops in approximately 6% of patients receiving Levemir. Reactions at the injection sites can be observed more often with Levemir treatment than with the administration of human insulin. These reactions include pain, redness, urticaria, inflammation, hematomas, swelling and itching at the injection site. Most of the reactions at the sites of administration are insignificant and are transient in nature, i.e. usually disappear with continued treatment for a few days to several weeks. At the initial stage of insulin therapy, refractive disorders and edemas may occur. These symptoms are usually transient.A rapid improvement in glycemic control can lead to a state of acute pain neuropathy, which is usually reversible. Intensification of insulin therapy with a dramatic improvement in the control of carbohydrate metabolism can lead to a temporary worsening of the course of diabetic retinopathy, while at the same time, a long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy. All of the following side effects, based on data from clinical studies, are divided into groups according to developmental frequency in accordance with MedDRA and organ systems. The incidence of adverse reactions is defined as follows: very often (≥1 / 10), often (≥1 / 100 to <1/10), infrequently (≥1 / 1000 to <1/100), rarely (≥1 / 10 000 to <1/1000), very rarely (<1/10 000), unknown (impossible to estimate based on available data). On the immune system, there are rarely - allergic reactions, potentially allergic reactions, urticaria, skin rash, skin rash *; very rarely - anaphylactic reactions * Metabolism very often - hypoglycaemia On the part of the nervous system rarely - peripheral neuropathy (acute pain neuropathy) On the part of the organ of vision it is not often - refractive disorders, diabetic retinopathy. Not often - on the skin and subcutaneous tissues - lipodystrophy * Other often - reactions at the injection site; infrequently - swelling
Overdose
Overdose of the drug is not described.
Interaction with other drugs
Hypoglycemic effect of the body containing ethanol. The hypoglycemic effect of insulin weakens oral contraceptives, GCS, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine, nicotine, morphine, nicotine, blockers of slow calcium channels, diazoxide, morphine, phenytoin, nicotine. Strengthening the action of insulin detemir. An octreotide / lanreotide can both increase,and reduce the body's need for insulin. Beta-blockers can mask the symptoms of hypoglycemia and delay recovery after hypoglycemia. Ethanol can enhance and prolong the hypoglycemic effect of insulin. insulin destruction detemir.
special instructions
It is not recommended to use insulin detemir in children under the age of 6 years. It is believed that intensive therapy with insulin detemir does not lead to an increase in body weight. The lower risk of nocturnal hypoglycemia compared to other insulins allows for more intensive dose selection in order to achieve the target blood glucose level. Insulin detemir provides better glycemic control (based on fasting plasma glucose measurements) compared with the use of isophane insulin. An inadequate dose 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. These symptoms include thirst, frequent urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, the smell of acetone in the exhaled air. In type 1 diabetes without proper treatment, hyperglycemia leads to the development of diabetic ketoacidosis and can be fatal. Hypoglycemia can develop if the insulin dose is too high relative to the insulin requirement. Skipping meals or unplanned intense exercise can lead to hypoglycemia. After compensation carbohydrate metabolism, for example, with intensified insulin therapy, patients may change their typical symptoms — precursors of hypoglycemia, which is pain they must be informed. The usual symptoms of precursors can disappear with long-term diabetes mellitus. Concomitant diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin. Transferring a patient to a new type or preparation of insulin from another manufacturer should take place under strict medical supervision.When changing the concentration, manufacturer, type, species (animal, human, analogues of human insulin) and / or the method of its production (genetically engineered or insulin of animal origin) dose adjustment may be required. Insulin detemir should not be administered in / in, because This can lead to severe hypoglycemia. Mixing insulin with deremyr with a fast acting insulin analogue, such as insulin aspart, leads to an action profile with a reduced and delayed maximum effect compared with their separate administration. ability to drive and control machinery Patients' ability to concentrate and reaction speed may be impaired during hypoglycemia and hyperglycemia, which can be dangerous in situations where 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 and hyperglycemia while driving a car and working with mechanisms. 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 feasibility of performing such work should be considered.