Levemir® FlexPen is intended for the treatment of diabetes mellitus in adults, adolescents and children from 1 year of age.
Composition
Active ingredient: 1 ml of solution for injection contains 100 U (≈ 14.2 mg) of insulin detemir (RDN) *;
1 pre-filled pen contains 3 ml, equivalent to 300 U;
1 unit (U) of insulin detemir corresponds to 1 IU of human insulin;
Excipients: glycerin phenol; metacresol; zinc acetate, dihydrate; sodium phosphate, dihydrate; sodium chloride, dilute hydrochloric acid, sodium hydroxide, water for injections.
* Produced using rDNA technology in Saccharomyces cerevisiae.
Contraindication
Hypersensitivity to insulin detemir or to any ingredient of the drug.
Method of application
Levemir® FlexPen is a soluble basal insulin analogue with prolonged action (up to 24 hours).
Compared with other insulin preparations, basal-bolus therapy with Levemir® FlexPen does not cause weight gain. The reduced risk of nocturnal hypoglycemia compared with NPH insulin allows for more intensive titration to achieve target blood glucose levels as part of basal-bolus therapy.
Levemir® FlexPen provides better glycemic control as measured by fasting plasma glucose compared to NPH insulin.
Levemir® FlexPen can be used alone as basal insulin or in combination with bolus insulin. The drug can also be used with oral hypoglycemic agents and/or DPP-1 receptor agonists.
Application features
Pregnant women
Levemir® FlexPen can be used during pregnancy, but any potential benefit should be weighed against the possible increased risk of adverse effects on the course of pregnancy.
Children
The medicine is used in children aged 1 year and over.
Drivers
With caution.
Overdose
Although a specific concept of overdose has not been formulated for insulin, after the administration of doses exceeding the patient's insulin requirement, the following sequential stages of hypoglycemia may develop:
Mild hypoglycemia, which can be treated by taking glucose or sweet foods; therefore, diabetics are advised to always carry sweet foods with them; Severe hypoglycemia, when the patient is unconscious. In this case, trained personnel should administer glucagon subcutaneously or intramuscularly (0.5 to 1.0 mg). A healthcare professional may administer glucose to the patient. Glucose should also be administered if the patient does not respond to glucagon within 10-15 minutes.
After the patient regains consciousness, he should take oral carbohydrates to prevent relapse.
Side effects
Hypoglycemia is a common side effect of insulin therapy. Clinical studies have shown that cases of severe hypoglycemia, requiring medical assistance by other people, are observed in approximately 6% of patients taking Levemir® FlexPen.
Interaction
Drugs that may reduce insulin requirements Oral hypoglycemic agents, DPP-1 receptor agonists, MAO inhibitors, non-selective b-blockers, ACE inhibitors, salicylates, anabolic steroids and sulfonamides.
Drugs that may increase insulin requirements: oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Storage conditions
The Levemir® FlexPen syringe pen should be stored in its original packaging.
Before use: store in a refrigerator (at 2° - 8°C), not too close to the freezer.
Do not freeze. Protect from light.
Shelf life - 2.5 years.
