Buy Levemir FlexPen pen 100 IU/ml 3 ml, 5 pcs

Levemir® [Insulin Detemir]

Brand Novo Nordisk

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Clinical Pharmacology

Levemir FlexPen is a hypoglycemic agent, an analogue of long-acting human insulin.
The drug Levemir FlexPen is produced by recombinant DNA biotechnology using the strain Saccharomyces cerevisiae. It is a soluble basal analogue of long-acting human insulin with a flat profile of action.
The action profile of the drug Levemir FlexPen is significantly less variable compared to isophane-insulin and insulin glargine.
The prolonged action of the drug Levemir FlexPen is due to the pronounced self-association of insulin molecules detemir at the injection site and the binding of the drug's molecules to albumin by connecting to a side fatty acid chain. Insulin detemir compared with isophane-insulin to peripheral target tissues goes slower. These combined mechanisms of delayed distribution provide a more reproducible profile for the absorption and action of Levemir Penfill compared with isophane-insulin.
It interacts with a specific receptor in 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, etc.).
The decrease in glucose in the blood is due to an increase in its intracellular transport, increased tissue uptake, stimulation of lipogenesis, glycogenogenesis, a decrease in the rate of glucose production by the liver, etc. For doses of 0.2 - 0.4 U / kg 50%, the maximum effect of the drug comes in the range of -4 hours to 14 hours after administration. The duration of action is up to 24 hours, depending on the dose, which provides the possibility of single and double daily administration.
After subcutaneous administration, a pharmacodynamic response was observed, proportional to the dose administered (maximum effect, duration of action, overall effect).
In long-term studies, low rates of daily fluctuations in plasma glucose concentrations were demonstrated when patients were treated with Levemir FlexPen, unlike isophane-insulin.

Indications

Diabetes.

Composition

1 ml contains:
active substance: insulin detemir - 100 IU (one syringe pen (3 ml) - 300 IU);
Excipients: glycerol, phenol, metacresol, zinc acetate, sodium hydrogen phosphate dihydrate, sodium chloride, hydrochloric acid or sodium hydroxide, water for injection.

One unit of insulin detemir contains 0.142 mg of salt-free insulin detemir. One unit of insulin detemir (AU) corresponds to one unit of human insulin (ME).

Insulin Detemir is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Levemir FlexPen	Novo Nordisk	Denmark	pen
Levemir Penfill	Novo Nordisk	Denmark	cartridge

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Dosage and Administration

Levemir FlexPen is intended for subcutaneous administration.
The dose and frequency of administration of the drug Levemir FlexPen is determined individually in each case.
Treatment with Levemir FlexPen in combination with oral hypoglycemic drugs, it is recommended to start once a day at a dose of 10 IU or 0.1-0.2 U / kg. The dose of Levemir Penfill should be adjusted individually based on plasma glucose values.
If the drug Levemir FlexPen is used as part of the basis-bolus regimen, it should be administered 1 or 2 times a day based on the needs of the patient. Patients who need to use the drug twice a day to optimally control the glycemic level can take an evening dose either during dinner, or before bedtime, or 12 hours after the morning dose.
Levemir Penfill is injected subcutaneously in the thigh, anterior abdominal wall or shoulder. Injection sites should be changed even when injected into the same area.
Dose adjustment
As with other insulins, in elderly patients and patients with renal or hepatic impairment, the concentration of glucose in the blood should be more carefully controlled and the dose of insulin detemir should be corrected individually.
Dose adjustment may also be necessary when the patient’s physical activity is increased, his usual diet changes, or with concomitant disease.
Transfer from other insulin preparations
Translation from medium-length insulins and prolonged insulins to Levemir FlexPen may require dose adjustment and time of administration.
As with other insulin preparations, careful monitoring of blood glucose concentration is recommended during translation 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).

Adverse reactions

Adverse reactions observed in patients using the drug Levemir FlexPen are mainly dose-dependent and develop due to the pharmacological effect of insulin. Hypoglycemia is usually the most common side effect. Hypoglycemia develops if an excessively high dose of the drug is administered relative to the body's need for insulin. From clinical studies it is known that severe hypoglycemia, requiring the intervention of third parties, develop in approximately 6% of patients receiving Levemir FlexPen.

Reactions at the injection sites can be observed more frequently with Levemir FlexPen treatment 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.

The proportion of patients receiving treatment and who are expected to develop side effects is estimated at 12%. The incidence of side effects, which by the general assessment are related to the drug Levemir FlexPen, during clinical studies, is presented below.

Metabolic disorders and eating disorders: hasthma - Hypoglycemia. Symptoms of hypoglycemia usually develop suddenly. They include "cold sweat", pallor of the skin, fatigue, nervousness or tremor, anxiety, unusual tiredness or weakness, disorientation, decreased concentration, drowsiness, marked hunger, impaired vision, headache, nausea, palpitations. Severe hypoglycemia can lead to loss of consciousness and / or seizures, temporary or irreversible dysfunction of the brain, or even death.

Common disorders and reactions at the injection sites: frequent - redness, swelling and itching at the injection site. These reactions are usually temporary and disappear with continued treatment.
Rare - lipodystrophy. It may develop at the injection site as a result of non-compliance with the rule of changing the injection site within one area.
Edema may occur at the initial stage of insulin therapy. These symptoms are usually temporary.

Immune system disorders: rare - Allergic reactions, urticaria, skin rash. Such symptoms may develop due to generalized hypersensitivity. Other signs of generalized hypersensitivity may include itching, sweating, gastrointestinal disorders, angioedema, difficulty in breathing, palpitations, and lower blood pressure. Generalized hypersensitivity reactions (anaphylactic reactions) are potentially life-threatening.

Impaired visual function: rare - refractive disorders, diabetic retinopathy.

Nervous system disorders: very rare - peripheral neuropathy.

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 6 years, because No clinical trials have been conducted in children under 6 years of age.

Drug interactions

There are a number of drugs that affect the need for insulin. Hypoglycemic effect of the containing ethanol. The hypoglycemic effect of insulin weakens oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, somatropin, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, “slow” calcium channel blockers, “slow”, Idiazid, Idazine, Idazine, Idazine, Idragon, slow-acting calcium channel blockers, slow-acting calcium channel blockers, slow-acting calcium channel blockers, slow-acting calcium channel blockers, slow-acting calcium channel blockers, slow-acting calcium channel blockers, slow-acting calcium channel blockers, dysfunctional glucose, tacyclic diuretics, heparin, tricyclic antidepressant drugs
Under the influence of reserpine and salicylates, both weakening and strengthening of the drug action 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.
Alcohol can enhance and prolong the hypoglycemic effect of insulin.
Some drugs, for example, those containing the thiol or sulfite groups, when Penfill is added to the drug Levemir, can cause insulin destruction detemir. Levemir FlexPen should not be added to infusion solutions.

Pregnancy and Lactation

Clinical experience with Levemir FlexPen during pregnancy and breastfeeding is limited.
A study of reproductive function in animals showed no differences between insulin detemir and human insulin in terms of embryotoxicity and teratogenicity.
In general, careful observation of pregnant women with diabetes mellitus during the entire period of pregnancy, as well as when planning 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 birth, the need for insulin quickly returns to the level that was before pregnancy. In lactating women, insulin dosage and dietary adjustment may be required.

Special instructions

Levemir FlexPen is a soluble basal insulin analogue with a flat and predictable activity profile with a prolonged effect.
Unlike other insulins, intensive care with Levemir Penfill does not lead to weight gain.
The lower risk of nocturnal hypoglycemia compared to other insulins allows for more intensive dose selection in order to achieve the target blood glucose.
Levemir FlexPen provides better glycemic control (based on fasting plasma glucose measurement) compared with isophane-insulin. An inadequate dose of the drug or cessation 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, increased 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 lead to death.
Hypoglycemia can 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, about which patients should be informed. The usual symptoms of 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.
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, 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. Patients who are switching to treatment with Levemir FlexPen may need to change the dose compared to doses of previously used insulin preparations. The need for dose adjustment may occur already after the first dose or during the first few weeks or months.
As with the treatment of other insulin preparations, reactions may develop at the sites of administration, which manifests as pain, itching, urticaria, swelling, inflammation. Changing the injection site in the same anatomical area can reduce the symptoms or prevent the reaction from developing. Reactions usually disappear within a few days to a few weeks. In rare cases, reactions at the injection sites require cessation of treatment.
Levemir FlexPen should not be administered intravenously, as this can lead to severe hypoglycemia.
Intramuscular suction occurs faster and to a greater extent than subcutaneous administration.
If Levemir FlexPen is mixed with other insulin preparations, the profile of one or both components will change. Mixing Levemir Penfill with a fast-acting insulin analogue, such as insulin aspart, results in an action profile with a reduced and delayed maximum effect compared with their separate administration.
Levemir FlexPen is not intended for use in insulin pumps.

Overdosage

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

Treatment: The patient can eliminate a slight hypoglycemia himself, having taken 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, from 0.5 to 1 mg of glucagon should be administered intramuscularly or subcutaneously (a trained person can enter), or an intravenous dextrose (glucose) solution (only a medical professional can enter). Dextrose should also be administered intravenously if the patient does not regain consciousness 10-15 minutes after the administration of glucagon. After regaining consciousness, the patient is recommended to take carbohydrate-rich food to prevent the recurrence of hypoglycemia.