Levemir flexpen subcutaneous injection 100 units/ml syringe pen 3 ml №5

Indications

- diabetes in adults, adolescents and children over 2 years.

Dosage and administration

Dose of the drug Levemir ^® FlexPen^® should be selected individually in each case, based on the needs of the patient.

Based on the results of the research, recommendations on dose titration are presented below:

If drug Levemir^® FlexPen^® It is used as part of the baseline / bolus mode, it should be administered 1 or 2 times per day, based on the needs of the patient.

Patients who require the use of the drug 2 times / day for optimal control of the level of glycemia, can enter the evening dose, either during dinner or before bedtime. Dose adjustment may be necessary with increasing physical activity of the patient, changing his usual diet or with concomitant disease.

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, Levemir is recommended.^® FlexPen^® 1 time / day, starting with a dose of 10 IU or 0.1–0.2 U / kg. Drug Levemir^® FlexPen^® You can enter at any time convenient for the patient during the day, however, having determined the time of daily injection, you should adhere to the established mode of injection.

Levemir^® FlexPen^® intended only for s / c introduction. 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^® not intended for use in insulin pumps.

Levemir^® FlexPen^® n / a in 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 the use of other insulin preparations, the duration of action depends on the dose, the site of administration, the intensity of blood flow, temperature and level of physical activity.

Special patient groups

As with the use of other insulin preparations, elderly patients and patients with renal or hepatic failure the concentration of glucose in the blood should be more carefully controlled and the dose of insulin detemir should be adjusted individually.

Kids and teens

Efficacy and safety of the drug Levemir^® FlexPen^® at adolescents and children over 2 years old confirmed in clinical studies lasting up to 12 months.

Transfer from other insulin preparations

The transfer from medium-length insulin preparations and from prolonged insulin preparations to Levemir® FlexPen® may require dose adjustment and time of administration.

As with the use of other insulin preparations, careful monitoring of the glucose concentration in the blood is recommended during the transfer and in the first weeks of prescribing a new drug.

May require correction of concomitant hypoglycemic therapy (dose and time of administration of short-acting insulin preparations or dose of oral hypoglycemic drugs).

Rules of use of the drug Levemir^® FlexPen^®

Levemir^® FlexPen^® syringe pen with dispenser. The insulin dose administered from 1 to 60 units may vary in increments of 1 unit. Novofine needles^® and NovoTvist^® up to 8 mm long are designed for use with Levemir^® FlexPen^®. For safety precautions, you should always carry a replacement insulin device with you in case of loss or damage to FlexPen.^®.

Before using the drug Levemir^® FlexPen^® make sure that the correct type of insulin is selected.

Preparations for the injection: cap should be removed; disinfect the rubber membrane with a swab moistened with medical alcohol; remove the protective sticker from the disposable needle; carefully and tightly screw the needle on Levemir^® FlexPen^®; remove the large outer (do not throw it away) and inner (discard) caps off the needle.For each injection, you should always use a new needle. Needles do not bend or damage. To avoid accidental pricking, do not put the inner cap back on the needle.

Preliminary removal of air from the cartridge. During normal use, air can accumulate in the needle and in the reservoir before each injection. To avoid an air bubble and to enter the prescribed dose of the drug, you must follow the following instructions:

- dial 2 units of the drug;

- position Levemir^® FlexPen^® vertically with the needle up and several times lightly tapping the tank with your fingertip so that the air bubbles move to the upper part of the cartridge;

- holding Levemir^® FlexPen^® needle up, press the start button all the way; the dosage selector will return to zero;

- At the end of the needle should appear a drop of insulin; if this does not happen, then repeat the procedure, but not more than 6 times. If insulin does not come from the needle, this indicates that the pen is defective and cannot be used any further.

Set the dose. Verify that the dosage selector is set to “0”. Gather the amount of AU needed for the injection. The dose can be adjusted by rotating the dosage selector in any direction. When rotating the dosage selector, care should be taken not to accidentally press the start button, in order to avoid the release of insulin dose. Set the dose in excess of the number of units remaining in the cartridge is impossible.You cannot use the residue scale to measure the dose of insulin.

The introduction of the drug. Introduce the needle subcutaneously. To make an injection, press the start button all the way until a “0” appears opposite the dosage indicator. With the introduction of the drug should be pressed only on the start button. When you turn the selector dosage dose will not occur. After injection, the needle should be left under the skin for 6 seconds (this will ensure the introduction of a full dose of insulin). When removing the needle, keep the trigger button fully depressed, this will ensure the introduction of a full dose of the drug.

Needle removal. Close the needle with the outer cap and unscrew it from the syringe handle. Throw the needle in, taking precautions. After each injection, remove the needle. Otherwise, liquid may leak out of the syringe handle, which may result in improper dosage.

Medical personnel, relatives and other caregivers should follow the general rules of precaution when removing and discarding needles to avoid the risk of an accidental needle being pricked.

Used levemir^® FlexPen^® should be discarded with the needle disconnected.

Storage and care. The surface of the pen can be cleaned with a cotton swab dipped in medical alcohol. You can not immerse the pen in alcohol, wash and lubricate it because It may damage the device. Damage to the syringe pen with the Levemir dispenser should be avoided.^® FlexPen^®. Do not refill the syringe pen.

Side effect

Adverse reactions observed in patients using Levemir^® FlexPen^®are largely dose-dependent and develop due to the pharmacological effect of insulin. The most frequent side effect is hypoglycemia, which develops with the introduction of too high doses of the drug relative to the body's need for insulin. From clinical studies it is known that severe hypoglycemia, defined as the need for third-party intervention, develops in approximately 6% of patients receiving Levemir^® FlexPen^®.

Reactions at the injection sites can be observed more frequently with Levemir^® FlexPen^®rather than with the introduction of human insulin. These reactions include redness, inflammation, bruising, swelling and itching at the injection site. Most of the reactions at the sites of administration are insignificant and temporary. disappear with continued treatment for several days to several weeks.

Proportion of patients treated with Levemir^® FlexPen^®who are expected to develop side effects, estimated at 12%. The frequency of side effects, which by the general assessment relate to the drug Levemir^® FlexPen^®, during clinical studies, is presented below.

Adverse reactions associated with the effect on carbohydrate metabolism: often (> 1/100, <1/10) - hypoglycemia, the symptoms of which, as a rule, develop suddenly and may include pallor of the skin,cold sweat, fatigue, nervousness, tremor, anxiety, unusual tiredness or weakness, disorientation, concentration disorder, drowsiness, marked hunger, blurred vision, headache, nausea, palpitations. Severe hypoglycemia can lead to loss of consciousness and / or convulsions, temporary or irreversible dysfunction of the brain, or even death.

Local reactions: often (> 1/100, <1/10) - local hypersensitivity reactions (redness, swelling and itching at the injection site), as a rule, are temporary, i.e. disappear with continued treatment; rarely (> 1/1000, <1/100) - lipodystrophy (as a result of non-compliance with the rule of changing the injection site within one area), edema (occurring at the initial stage of insulin therapy and usually are temporary).

Allergic reactions: rarely (> 1/1000, <1/100) - urticaria, skin rash, as well as generalized reactions - pruritus, increased sweating, disorders of the gastrointestinal tract, angioedema, difficulty breathing, tachycardia, decreased blood pressure. Generalized (anaphylactic) reactions are potentially life threatening.

On the part of the organ of vision: rarely (> 1/1000, <1/100) - impaired refraction (usually temporary and observed at the beginning of insulin treatment), diabetic retinopathy (prolonged improvement in glycemic control reduces the risk of progression of diabetic retinopathy; howeverIntensification of insulin therapy with a dramatic improvement in the control of carbohydrate metabolism can lead to a temporary deterioration of diabetic retinopathy.

From the nervous system: very rarely (> 1/10 000, <1/1000) - peripheral neuropathy, which is usually reversible. Rapid improvement in glycemic control may be associated with the development of acute neuropathic pain, which is usually reversible.

Contraindications

- increased individual sensitivity to insulin detemir or any of the components of the drug.

Do not use the drug Levemir^® FlexPen^® in children under 2 years, because No clinical studies have been conducted in children under 2 years of age.

Use during pregnancy and lactation

When using the drug Levemir^® FlexPen^® during pregnancy, it is necessary to consider how far the benefits of its use outweigh the possible risks.

One of the randomized controlled clinical trials involving pregnant women with type 1 diabetes mellitus, during which the efficacy and safety of combination therapy with Levemir were studied^® FlexPen^® with insulin aspart (152 pregnant women), compared with isophane-insulin therapy in combination with insulin aspart (158 pregnant women), did not reveal differences in the overall safety profile during pregnancy, outcomes of pregnancy or the health of the fetus and newborn.

Additional data on the efficacy and safety of drug treatment Levemir^® FlexPen^®, obtained from approximately 300 pregnant women in post-marketing use, indicate the absence of undesirable side effects of insulin detemir, leading to congenital malformations and malformative or feto / neonatal toxicity.

Reproductive studies in animals did not reveal the toxic effect of the drug on the reproductive system.

In general, careful observation of pregnant women with diabetes mellitus during the entire period of pregnancy, as well as when planning a pregnancy is necessary. The need for insulin in the first trimester of pregnancy usually decreases, then increases in the second and third trimesters. Shortly after giving birth, the need for insulin quickly returns to the level that was before pregnancy.

It is not known whether insulin detemir is excreted in breast milk. It is assumed that insulin detemir does not affect the metabolic reactions in the body of newborns / infants during the breastfeeding period, as it belongs to a group of peptides that are easily broken down in the digestive tract into amino acids and are absorbed by the body.

In lactating women, insulin dosage and dietary adjustment may be required.

Application for violations of the liver

At abnormal liver function the blood glucose level should be more carefully controlled and the dose of the drug should be adjusted.

Application for violations of kidney function

At renal dysfunction the blood glucose level should be more carefully controlled and the dose of the drug should be adjusted.

Use in children

Do not use the drug Levemir^® FlexPen^® in children under the age of 6 years, because clinical studies in this group of patients were not conducted.

Use in elderly patients

Have patients old age the blood glucose level should be more carefully controlled and the dose of the drug should be adjusted.

special instructions

Levemir^® FlexPen^® is a soluble basal analogue of insulin, which has a prolonged action (up to 24 hours).

Unlike other insulin preparations, the baseline / bolus therapy with Levemir^® FlexPen^® does not lead to weight gain.

Drug treatment Levemir^® FlexPen^® provides a smaller increase in body weight, compared with the use of isophane-insulin and insulin glargine.

The lower risk of nocturnal hypoglycemia compared with isophane-insulin allows for a more intensive dose titration in order to achieve the target blood glucose in basal / bolus therapy.

Compared with other insulins, in particular, with isophane-insulin, the lower risk of the occurrence of episodes of light night hypoglycemia allows for more intensive dose selection in order to achieve the target blood glucose level during treatment with Levemir^® FlexPen^® in combination with oral hypoglycemic drugs.

Levemir^® FlexPen^® provides better glycemic control (based on fasting plasma glucose measurement) compared with insulin isophane.

Before a long trip associated with a change of time zones, the patient should consult with your doctor, because changing the time zone means that the patient must eat and inject insulin at another time.

An inadequate dose or discontinuation of treatment, especially for type 1 diabetes, can lead to hyperglycemia or diabetic ketoacidosis. As a rule, the first symptoms of hyperglycemia appear gradually, over several hours or days. These symptoms include thirst, increased urination, nausea, vomiting, drowsiness, redness and dry skin, dry mouth, loss of appetite, the smell of acetone in exhaled air. In type 1 diabetes without proper treatment, hyperglycemia leads to the development of diabetic ketoacidosis and can lead to death.

Hypoglycemia may develop if the insulin dose is too high in relation to the need for insulin, when you skip a meal or unplanned intense exercise.

After compensation of carbohydrate metabolism, for example, with the intensified insulin therapy, the typical symptoms of hypoglycemia, which are typical for them, may change in patients, which patients should be informed about. The usual symptoms, precursors can 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 of the drug may also be required if the patient has concomitant diseases of the kidneys, liver or impaired adrenal, pituitary, or thyroid function.

Transferring a patient from other insulin preparations

The transfer of a patient to a new type or drug of insulin from another manufacturer must take place under strict medical supervision. If you change the concentration, manufacturer, type, type (human, human insulin analogue) and / or the method of its production, dose adjustment may be required. Patients undergoing treatment with Levemir^® FlexPen^® with a different type of insulin, you may need to change the dose compared to doses of previously used insulin preparations. Dose adjustment can be carried out with the first dose or during the first few weeks or months.

Reactions at the injection site

As with the treatment of other insulin preparations, reactions can develop at the sites of administration, which manifests itself as pain, itching, hives, swelling, hematomas, itching, inflammation. Regular change of the injection site in the same anatomical area can reduce the symptoms or prevent the development of the reaction. Reactions usually disappear within a few days to a few weeks. In rare cases, reactions at the injection sites require cessation of treatment.

The simultaneous use of preparations of the thiazolidinedione group and insulin preparations

Cases of the development of chronic heart failure have been reported in the treatment of patients with thiazolidinediones in combination with insulin preparations, especially when these patients have risk factors for the development of chronic heart failure. This fact should be taken into account when prescribing thiazolidinediones and insulin combination therapy to patients. When prescribing such a combination therapy, it is necessary to conduct medical examinations of patients in order to identify their signs and symptoms of chronic heart failure, weight gain and the presence of edema. If the symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued.

Influence on ability to drive motor transport and control mechanisms

The ability of patients to concentrate and the reaction rate may be impaired due to hypoglycemia, which can be dangerous in those situations when 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 when driving 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, consideration should be given to the expediency of driving a vehicle or performing similar work.

Overdose

The specific dose required for insulin overdose has not been established, however, hypoglycemia can develop gradually if an excessive dose has been administered for a particular patient.

Treatment: The patient can eliminate a slight hypoglycemia himself, having taken in glucose, sugar or foods rich in carbohydrates. Therefore, patients with diabetes are advised to constantly carry with them sugar, sweets, cookies or sweet fruit juice.

In the case of severe hypoglycemia, when the patient is unconscious, you should enter from 0.5 to 1 mg of glucagon intramuscularly or s / c (a trained person can enter), or in / into a dextrose (glucose) solution (only a medical professional can enter). It is also necessary to introduce dextrose in / in the case if the patient does not regain consciousness 10-15 minutes after the administration of glucagon. After the recovery of consciousness, the patient is recommended to take carbohydrate-rich food to prevent the recurrence of hypoglycemia.

Drug interaction

Hypoglycemic effect of the body containing ethanol.

The hypoglycemic effect of insulin is weakened by oral contraceptives, GCS, iodine-containing thyroid hormones, somatotropin, thiazide diuretics, Heparin , tricyclic antidepressants, sympathomimetics, danazol, clonidine, slow Calcium channel blockers, phyroxide, morphine, morph, syrinophomas, morphine, danazol, clonidine.

Under the influence of reserpine and salicylates, both weakening and strengthening the effect of the drug are possible.

Octreotide, lanreotide can both increase and decrease the body's need for insulin.

Beta-blockers may mask the symptoms of hypoglycemia and delay recovery after hypoglycemia.

Ethanol can enhance and prolong the hypoglycemic effect of insulin.

Pharmaceutical Interaction

Some drugs, for example, containing thiol or sulfite groups, when added to the drug Levemir^® FlexPen^®may cause destruction of insulin detemir.

Levemir^® FlexPen^® should not be added to infusion solutions.

List B. The drug should be stored in a refrigerator at a temperature of 2 ° to 8 ° C (in the refrigerator, but away from the freezer); do not freeze. Expiration date - 30 months.

To protect from light, the pen should be stored with the cap on.

After first use Levemir^® FlexPen^® can not be stored in the refrigerator. Used or transferred as a spare pen syringe with Levemir^® FlexPen^® should be stored at a temperature not higher than 30 ° С

The drug should be kept out of the reach of children.