Description
Packaging
5 syringe pens 3 ml each.
Indications
Diabetes mellitus in adults.
Contraindications
pregnancy
lactation (breastfeeding)
children and adolescents under 18
increased individual sensitivity to the active substance or any of the auxiliary components of the drug.
Special instructions
Hypoglycemia
If you skip a meal or have unplanned intense physical exertion, the patient may develop hypoglycemia. Hypoglycemia can also develop if the dose of insulin is too high in relation to the patient’s needs.
After compensating for carbohydrate metabolism (for example, with intensified insulin therapy), patients may experience typical symptoms of signs of hypoglycemia, which patients should be informed about. The usual warning signs may disappear with a long course of diabetes.
Concomitant diseases, especially infectious and accompanied by fever, usually increase the body’s need for insulin. Dose adjustment may also be required if the patient has concomitant kidney, liver, or adrenal gland, pituitary, or thyroid problems.
As with other basal insulin preparations, recovery after hypoglycemia with Tresib FlexTouch may be delayed.
Hyperglycemia
An insufficient dose or discontinuation of treatment can lead to hyperglycemia or diabetic ketoacidosis. In addition, concomitant diseases, especially infectious ones, can contribute to the development of hyperglycemic conditions and, accordingly, increase the body’s need for insulin.
Typically, the first symptoms of hyperglycemia appear gradually over several hours or days. These symptoms include thirst, rapid urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, smell of acetone in exhaled air. In type 1 diabetes mellitus, without appropriate treatment, hyperglycemia leads to the development of diabetic ketoacidosis and can lead to death.
Fast-acting insulin is recommended for the treatment of severe hyperglycemia.
Transfer of a patient from other insulin preparations
Transfer of a patient to a new type or drug of a new brand of insulin or from another manufacturer must be under strict medical supervision. When translating, dose adjustment may be required.
Concomitant use of thiazolidinedione and insulin preparations
Cases of chronic heart failure have been reported in the treatment of patients with thiazolidinedione in combination with insulin, especially if these patients have risk factors for developing chronic heart failure. This fact should be taken into account when prescribing combination therapy with thiazolidinediones and Tresib FlexTouch. When prescribing such 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 must be discontinued.
Visual impairment
Intensification of insulin therapy with a sharp improvement in carbohydrate metabolism control may lead to a temporary deterioration in the manifestations of diabetic retinopathy, at the same time, continued improvement in glycemic control reduces the risk of progressing diabetic retinopathy.
Preventing the erroneous administration of insulin preparations
Instruct the patient to check the label on each label before each injection to prevent accidental administration of a different dose or different insulin. Before each injection, patients should check on the dose counter the number of units recruited into the syringe pen. Thus, only patients who can clearly distinguish the numbers on the dose counter can administer insulin on their own.
It is necessary to inform blind patients or visually impaired people that they always need the help of people who have no vision problems and are trained to work with a syringe pen.
Antibodies to insulin
Antibodies are possible when using insulin. In rare cases, antibody formation may require dose adjustment of insulin to prevent cases of hyperglycemia or hypoglycemia.
Influence on the ability to drive vehicles and control mechanisms
The ability of patients to concentrate and reaction speed may be impaired during hypoglycemia, which can be dangerous in situations where this ability is especially necessary (for example, when driving vehicles or machinery).
Patients should be advised to take measures to prevent the development of hypoglycemia while driving. This is especially important for patients with no or diminished symptoms of precursors of developing hypoglycemia or with frequent episodes of hypoglycemia. In these cases, the appropriateness of driving a vehicle should be considered.
Composition of
1 ml of the solution contains:
active substance:
insulin deglodek 100 units,
excipients:
glycerol,
phenol,
metacresol,
zinc (in the form of sodium chloride hydrochloride (sodium sulfide hydrochloride) pH),
water for injection.
Side effects of
The most common side effect reported during treatment with degludec insulin is hypoglycemia.
System of frequencies Frequency
Immune system disorders rare – hypersensitivity reactions
rare – urticaria
Metabolism and nutrition disorders very often –
hypoglycemia Skin and subcutaneous tissue disorders infrequently –
lipodystrophy General disorders and disorders in place – reactions at the injection site
infrequently – peripheral edema
Description of individual adverse reactions
Immune disorders of the
system With the use of insulin preparations, the development of all ergic reactions. Allergic reactions of an immediate type to the insulin preparation itself or the auxiliary components that make up it can potentially threaten the patient’s life.
When using the drug Tresib FlexTouch hypersensitivity reactions (incl. swelling of the tongue or lips, diarrhea, nausea, tiredness and skin itching) and urticaria were rare.
Hypoglycemia
Hypoglycemia can develop if the dose of insulin is too high in relation to the patient’s need for insulin. Severe hypoglycemia can lead to loss of consciousness and / or convulsions, temporary or irreversible impairment of brain function up to a fatal outcome. Symptoms of hypoglycemia, as a rule, develop suddenly. These include cold sweat, pallor of the skin, increased fatigue, nervousness or tremors, anxiety, unusual tiredness or weakness, disorientation, decreased concentration, drowsiness, severe hunger, blurred vision, headache, nausea, or palpitations.
Lipodystrophy
Lipodystrophy (including lipohypertrophy, lipoatrophy) may develop at the injection site. Compliance with the rules for changing the injection site within the same anatomical area helps to reduce the risk of developing this adverse reaction.
Reactions at the injection site
Patients treated with the Tresiba FlexTouch preparation showed reactions at the injection site (hematoma, pain, local hemorrhage, erythema, connective tissue nodules, swelling, discoloration of the skin, itching, irritation and tightening at the injection site). Most reactions at the injection site are minor and temporary and usually disappear with continued treatment.
Children and adolescents
The pharmacokinetic properties of Treshiba FlexTouch have been studied in children and adolescents under 18 years of age. Studies of the effectiveness and safety of insulin degludec in children and adolescents have not been conducted.
Special patient groups
No clinical differences were found in clinical trials on the frequency, type, or severity of adverse reactions between elderly patients and patients with impaired renal or hepatic function and the general patient population.
Drug Interactions
There are a number of drugs that affect the need for insulin.
The need for insulin can be reduced: oral hypoglycemic drugs, glucagon-like peptide-1 receptor agonists (GLP-1), MAO inhibitors, non-selective beta-blockers, ACE inhibitors, salicylates, anabolic steroids and sulfonamides.
The need for insulin can increase: oral hormonal contraceptives, thiazide diuretics, corticosteroids, thyroid hormones, sympathomimetics, somatropin and danazole.
Beta-blockers may mask the symptoms of hypoglycemia.
Octreotide / lanreotide can both increase and decrease the body’s need for insulin.
Ethanol (alcohol) can both enhance and reduce the hypoglycemic effect of insulin.
Incompatibility
Some drugs, when added to Tresib FlexTouch, may cause its destruction.
Tresib FlexTouch cannot be added to infusion solutions.
Do not mix Treciba FlexTouch with other medicines.
Overdose
No specific dose required for insulin overdose has been established, however, hypoglycaemia may develop gradually if the dose of the drug is too high compared to the patient’s need.
Treatment: The patient can eliminate mild hypoglycemia by taking glucose or sugary products by himself. Therefore, patients with diabetes mellitus are advised to carry sugar products with them constantly.
In case of severe hypoglycaemia, when the patient is unconscious, he / she should administer glucagon (0.5 to 1 mg) / m or p / k (may be administered by a trained person) or in / into dextrose (glucose) solution (only medical worker). It is also necessary to introduce dextrose in / in case the patient does not regain consciousness 10-15 minutes after the administration of glucagon. After regaining consciousness, the patient is advised to eat carbohydrate-rich foods to prevent relapse.
Storage Conditions
The product should be stored at 2 ° to 8 ° C (in the refrigerator), but not near the freezer. Do not freeze.
For used or portable syringe handle: do not refrigerate. Store at a temperature not exceeding 30 ° C for 8 weeks. After use, close the syringe handle with a cap to protect it from light. Keep out of reach of children.
Shelf life
30 months.
Deystvuyushtee substance
Insulin degludek
Conditions of release from
pharmacies Prescription of
dosage form
injection
Possible product names
Tresiba Flex Touch syringe pens 100 IU / ml 3 ml, 5 pcs.
TRESIBA FLEKSTACH RR FOR P / K INTRODUCTION. 100ED / ML 3ML No. 5
TRESIBA FLEKSTACH R-R P / K 100ED / ML 3ML No. 5 (SYRINGE HANDLES)
Tresiba FlexTouch syringe pens 100 IU / ml 3 ml, 5 pcs.
Novo Nordisk, Denmark
