Tresiba flekstach solution for subcutaneous injection 100e for ml 3 ml N5
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Active ingredients
Insulin degludek
Release form
Solution
Composition
1 ml contains: Insulin degludek 100 U * (3.66 mg) Excipients: glycerol - 19.6 mg, phenol - 1.5 mg, metacresol - 1.72 mg, zinc - 32.7 mcg (in the form of zinc acetate - 109.7 mcg), hydrochloric acid / sodium hydroxide (for pH ** correction), water d / and - up to 1 ml.
Pharmacological effect
Preparation Tresiba FleksTach - human insulin analog extremely long action produced by recombinant DNA biotechnology using the strain Saccharomyces cerevisiae.Mehanizm deystviyaInsulin degludek specifically binds to human endogenous insulin receptor and interacts with it realizes its pharmacological effect similar to the effect of human insulin action insulina.Gipoglikemicheskoe Degudec is caused by an increase in glucose utilization by tissues after insulin is bound to a prescription. ramie muscle and fat cells and simultaneous reduction in glucose production rate pechenyu.FarmakodinamikaPreparat Tresiba FleksTach basal analogue is human insulin action extremely long; after s / c injection, it forms soluble multihexamers in the subcutaneous depot, from where there is a continuous and prolonged absorption of insulin degludec into the bloodstream, ensuring a long, flat profile of action and a stable hypoglycemic effect of the drug. During the 24-hour period of monitoring the hypoglycemic effect of the drug in patients to whom the dose of insulin degludec was administered 1 time / day, the drug Tresiba FlexTach, unlike insulin, glargine demonstrated a uniform Vd between the first and second 12-hour periods (AUCGIR.0- 12h, SS / AUCGIR, total, SS = 0.5). The duration of action of the drug Tresiba FlexTach is more than 42 hours within the therapeutic dose range. Css of the drug in the blood plasma is reached 2-3 days after the injection of the drug. Insulin degludek in the Css state demonstrates significantly less (4 times) compared to insulin glargine variability of daily profiles of hypoglycemic action, which is estimated by the value of the coefficient of variation (CV) for the study hypoglycemic effect of the drug during one dosing interval (AUCGIR, t, SS) and within the time period from 2 to 24 h (AUCGIR2-24h, SS).
Pharmacokinetics
Absorption The long-lasting action of insulin degludek is due to the specially created structure of its molecule.After s / c injection, the formation of soluble stable multihexamers, which create a depot of insulin in the subcutaneous adipose tissue. Multihexamers gradually dissociate, releasing insulin degludek monomers, resulting in a slow and prolonged release of the drug into the blood. Css of the drug Traciba in plasma is reached 2-3 days after the injection. The effect of insulin degludec is 24 hours with its daily administration 1 time / day is evenly distributed between the first and second 12-hour intervals (AUCGIR.0-12h, SS / AUCGIR, t, SS = 0.5). DistributionThe binding of insulin degludec to plasma proteins (albumin) is> 99%. Metabolism degludek ina similar to that of human insulin; all formed metabolites are inactive. The release of T1 / 2 after s / c injection of the drug Tresiba FlexTach is determined by the rate of its absorption from the subcutaneous tissue, is approximately 25 hours and does not depend on dose. Linearity When s / c administration, total plasma concentrations were proportional to the dose administered range of therapeutic doses. When directly comparing both forms of release of the drug Tresiba FlexTach - 100 U / ml and 200 U / ml, data on the compliance of their bioequivalence with the established requirements were obtained (based on the obtained data on AUCIDeg.t.SS and Cmax, IDeg, SS). Pharmacokinetics in special groups Patients There were no differences in the pharmacokinetic properties of the drug Tresiba FlexTach depending on the gender of the patients. There were no clinically significant differences in the pharmacokinetics of insulin degludek between elderly and young patients, between patients of different ethnic groups. pp between patients with impaired renal and hepatic function and healthy properties patsientami.Farmakokineticheskie degludek insulin in the study in children (6-11 years) and adolescent (12-18 years) with type 1 diabetes are comparable to those in adult patients. Against the background of a single administration of the drug to patients with type 1 diabetes, it was demonstrated that the total dose of the drug in children and adolescents is higher than that in adult patients. Clinical data based on studies of pharmacological safety, repeated dose toxicity, carcinogenic potential,toxic effects on reproductive function, did not reveal any danger of insulin degludek for humans. The ratio of metabolic and mitogenic activities of insulin degludec is similar to that of human insulin.
Indications
- diabetes in adults.
Contraindications
- pregnancy; - lactation period (breastfeeding); - children and adolescents up to 18 years; - increased individual sensitivity to the active substance or to any of the auxiliary components of the drug.
Precautionary measures
When you skip a meal or unplanned intense physical exertion, the patient may develop hypoglycemia. Hypoglycemia may also develop if the insulin dose is too high in relation to the patient’s needs.
Use during pregnancy and lactation
The use of the drug Tresiba FlexTach during pregnancy is contraindicated, because clinical experience of its use in pregnant women is absent. Studies of reproductive function in animals did not reveal differences between insulin degludec and human insulin in terms of embryotoxicity and teratogenicity. Use of Tresiba FlexTach during breastfeeding is contraindicated because clinical experience of its use in nursing women is absent. Studies in animals have shown that in rats insulin degludec is excreted in breast milk, the drug concentration in breast milk is lower than in blood plasma. It is not known whether insulin degludec is excreted in breast milk of women. In animal studies, no adverse effect of insulin degludec on fertility was found.
Dosage and administration
The drug Tresiba FlexTach is an analogue of super-long-acting insulin. The drug is administered n / a 1 time / day at any time, but it is preferable to administer the drug at the same time every day. In patients with type 2 diabetes, Tresiba FlexTach can be used as as monotherapy, as well as in combination with oral hypoglycemic drugs or with bolus insulin. Patients with type 1 diabetes are prescribed Tresiba FlexTach in combination with short / ultrashort insulin for Coverage requirements for prandialny insulin. The dose of the drug Tresiba FlexTach should be determined individually in accordance with the needs of the patient.To optimize glycemic control, it is recommended to adjust the dose of the drug based on fasting plasma glucose. As with any insulin preparations, dose adjustment of the drug Tresiba FlexTach may also be necessary when the patient’s physical activity is increased, his usual diet is changed or with concomitant disease. dose of Tresiba FlexTachPatients with type 2 diabetes mellitusThe recommended initial daily dose of Tresiba FlexTach is 10 IU, followed by Selection of an individual dose of the drug. Patients with type 1 diabetes. The drug Tresiba FlexTach is prescribed 1 time / day in combination with prandial insulin, which is administered together with food intake, followed by the selection of an individual dose of the drug. The drug Tresiba FlexTach is intended only for p / to the introduction. The drug Tresiba FlexTach should not be administered in / in, because this can lead to the development of severe hypoglycemia. The drug Tresiba FlexTach can not be injected in / m, because in this case, the absorption of the drug changes. The drug Tresiba FlexTach cannot be used in insulin pumps. The drug Tresiba FlexTach is injected into the region of the thigh, anterior abdominal wall or shoulder area. Injection sites should be constantly changed within the same anatomical region to reduce the risk of lipodystrophy. The drug Tresiba FlexTach is a pre-filled syringe pen designed for use with disposable injection needles NovoFayn or NovoTvist up to 8 mm long. The drug Tresiba FlexTach and needles are intended only for individual use. Do not refill the cartridge with a syringe pen.
Side effects
Immune system disorders rarely - hypersensitivity reactions Rarely - urticaria Disorders of metabolism and nutrition very often - hypoglycemia Disorders of the skin and subcutaneous tissues infrequently - lipodystrophy General disorders and disorders at the site of injection often - reactions at the site of injection insulin preparations may develop allergic reactions.Allergic reactions of the immediate type to the insulin preparation itself or its auxiliary components can potentially threaten the patient’s life. When using the drug Tresiba FlexTach, hypersensitivity reactions (including swelling of the tongue or lips, diarrhea, nausea, fatigue and itchy skin ) and urticaria were rarely noted. Hypoglycemia Hypoglycemia may develop if the insulin dose is too high in relation to the patient's insulin need. Severe hypoglycemia can lead to loss of consciousness and / or convulsions, temporary or irreversible dysfunction of the brain, or even death. Symptoms of hypoglycemia, as a rule, develop suddenly. They include cold sweat, pale skin, fatigue, nervousness or tremor, anxiety, unusual tiredness or weakness, disorientation, decreased concentration, drowsiness, pronounced hunger, blurred vision, headache, nausea, and palpitations. LipodystrophyLipodystrophy ( including lipohypertrophy, lipoatrophy) may develop at the injection site. Compliance with the rules for changing the injection site within the same anatomical area helps reduce the risk of this adverse reaction. Reactions at the injection site Patients who received Traciba FlexTach received reactions at the injection site (hematoma, pain, local hemorrhage, erythema, connective tissue nodules, swelling , discoloration of the skin, itching, irritation and induration at the injection site). Most of the reactions at the injection site are minor and temporary and usually disappear with continued treatment. Children and adolescents The pharmacokinetic properties of Tresiba FlexTach have been studied in children and adolescents under the age of 18 years. No studies of the efficacy and safety of insulin degludek have been conducted in children and adolescents. Specific patient groups In clinical studies, there were no differences in the frequency, type, or severity of adverse reactions between elderly patients and patients with impaired renal or hepatic function and the general population of patients.
Overdose
The specific dose required for insulin overdose has not been established, however, hypoglycemia can develop gradually if the dose of the drug is too high compared with the patient’s need. Treatment: The patient can eliminate slight hypoglycemia by ingesting glucose or sugar-containing products.Therefore, patients with diabetes are advised to constantly carry with them sugar-containing products. In case of severe hypoglycemia, when the patient is unconscious, he should enter glucagon (from 0.5 to 1 mg) intramuscularly or subcutaneously (a trained person can enter) or / in a solution of dextrose (glucose) (can only enter a medical professional). It is also necessary to introduce dextrose in / in the case if the patient does not regain consciousness 10-15 minutes after the introduction of glucagon. After regaining consciousness, the patient is advised to take carbohydrate-rich food to prevent relapse.
Interaction with other drugs
There are a number of drugs that affect insulin requirements. Insulin requirements can be reduced: oral hypoglycemic drugs, glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1), MAO inhibitors, non-selective beta-adrenergic blockers, ACE inhibitors, salicylates, anabolic steroids sulfonamides. Insulin requirements may increase: oral hormonal contraceptives, thiazide diuretics, GCS, thyroid hormones, sympathomimetics, somatropin and danazol. Beta-adrenergic blockers can maskers Symptoms of hypoglycemia. Octreotide / lanreotide can both increase and decrease the body's need for insulin. Ethanol (alcohol) can both increase and decrease the hypoglycemic effect of insulin. Incompatibility Some medications, when added to Tresiba FlexTach, may cause its destruction. FlexTach cannot be added to infusion solutions. Tresiba FlexTach should not be mixed with other drugs.
special instructions
HypoglycemiaAfter compensating for carbohydrate metabolism (for example, in case of intensified insulin therapy), the symptoms typical for them are precursors of hypoglycemia, which patients should be informed about. 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. Dose adjustment of the drug may also be required if the patient has concomitant diseases of the kidneys, liver or dysfunction of the adrenal glands,pituitary or thyroid gland. As with other basal insulin preparations, recovery from hypoglycemia with Tresiba FlexTach may be delayed. Hyperglycemia An inadequate dose of the drug or discontinuation of treatment can lead to the development of hyperglycemia or diabetic ketoacidosis. In addition, comorbid diseases, especially infectious, can contribute to the development of hyperglycemic conditions and, accordingly, increase the body's need for insulin. 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 mellitus without appropriate treatment, hyperglycemia leads to the development of diabetic ketoacidosis and can lead to death. For treating severe hyperglycemia, it is recommended to inject high-speed insulin. Transferring a patient from other insulin preparations Transferring a patient to a new type of insulin or another brand from another manufacturer should occur strict medical supervision. Dose adjustment may require dose adjustment. Simultaneous use of thiazolidinedione drugs and insulin preparations. There have been reports of the development of chronic heart failure in treating patients with thiazolidinediones in combination with insulin preparations, especially in these patients with risk factors for developing chronic heart failure. This fact should be taken into account when prescribing patients the combination therapy with thiazolidinediones and Tresiba FlexTach. When prescribing such a combination therapy, it is necessary to conduct medical examinations of patients to identify signs and symptoms of chronic heart failure, weight gain and the presence of peripheral edema. If the symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be stopped. Violations on the part of the organ of visionIntensification of insulin therapy with a dramatic improvement in the control of carbohydrate metabolism can lead to a temporary worsening of diabetic retinopathy,At the same time, a long-term improvement in glycemic control reduces the risk of diabetic retinopathy being promoted. Preventing the erroneous administration of insulin preparations. Instruct the patient to check the label on the label before each injection to avoid accidental administration of another dose or other insulin. Before each injection, patients should be checked on the dose counter the number of units in the pen. Thus, only patients who can clearly distinguish the numbers on the dose counter can inject insulin themselves. It is necessary to inform blind patients or people with impaired vision that they always need the help of people who have no vision problems and are trained to work with a syringe. pen. Antibody to insulin. When insulin is used, the formation of antibodies is possible. In rare cases, the formation of antibodies may require dose adjustment of insulin to prevent cases of hyperglycemia or hypoglycemia. Effect on ability to drive vehicles and control mechanisms Patients' ability to concentrate and reaction speed may be impaired during hypoglycemia, which can be dangerous in those situations where the ability is especially needed (for example, when driving a vehicle or machinery). Patients should be advised to take action. s 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 with frequent episodes of hypoglycemia. In these cases, you should consider the feasibility of driving.