Levemir Flexpen 100u/ml Novo Nordisk treatment for diabetes (5 trees x 3ml)
Dosage form Box of 5 trees x 3ml
Specifications Insulin detemir
Ingredient
Thành phần cho 3ml
| Composition information | Content |
| Insulin detemir | 300U |
Uses
Indications
Levemir Flexpen 100 U/ml is indicated in the treatment of diabetes in adults, teenagers and children aged 1 year and older.
Pharmacokology
Medical therapy group: drugs used in diabetes . Insulin and insulin analogue injected form.
ATC code: A10AE05.
Mechanism of action
Levemir Flexpen is an analog and a long -lasting, soluble, long -lasting effect that has a long -lasting effect used as a background insulin.
Data on the effect time of Levemir Flexpen is significantly less variable than Insulin NPH (Neutral Protamine Hagedorn) and Insulin Glargine.
The prolonged effect of Levemir Flexpen is due to the strong combination of insulin detemir molecules at the injection site and the cohesion with albumin through the fatty acid string. Insulin detemir is distributed more slowly to peripheral target tissues than Insulin NPH. This stretching mechanism makes the chart of absorption and effect of Levemir Flexpen longer than the Insulin NPH.
Time to work up to 24 hours depending on the dose 1 time or 2 times daily. If used 2 times daily, stable state will occur after 2-3 doses of treatment. With doses of 0.2 - 0.4 U/kg, Levemir Flexpen reaches more than 50% of the maximum efficiency after 3-4 hours and lasts up to about 14 hours after injection.
Meeting the pharmacological response to the dose (maximum efficiency, effect time, effect) are observed after subcutaneous injection.
The variation of plasma glucose at lower days of days when treated with Levemir Flexpen compared to insulin NPH has been shown in prolonged clinical trials.
Studies in patients with type 2 diabetes are treated with insulin in combination with oral diabetes drugs that have shown that blood sugar control (HBA1C) with Levemir Flexpen is equivalent to insulin NPH and insulin glargine and less weight gain. See Table 1.
Table 1. 1 time/day levemir flexpen 2 times/day insulin nph An open, random label clinical trial has been conducted in patients with type 2 diabetes without achieving goals for oral diabetes treatment drugs. This test started with a 12 -week test with Liraglutid + Metformin, of which 61% achieved HBA1C Add Levemir has reduced HBA1C 0.5% and 0.51% (from 7.6% to 7.1%) after 26 and 53 weeks, while there is no change for patients using Liraglutid + Metformin (0.02% and 0.01% after 26 and 52 weeks); This change is meaningful when using additional levemir after 26 and 52 weeks (p There are no heavy hypoglycemia . Mild hypoglycemia (patients/year) is higher when adding levemir compared to only Liraglutid + Metformin after 26 weeks (0.286 compared to 0.029, P = 0.0037) and after 52 weeks (0.228 compared to 0.034; P = 0.0011). When supplementing Levemir Flexpen to Liraglutide, the benefits of Liraglutide on weight are maintained, after 26 weeks of change in weight when adding levemir and using Liraglutide + Metformin is -0.16kg compared to -0.95% (P = 0.0283) and after 52 weeks is -0.05 kg compared to --1.02 kg (P = 0.0416). A double, random clinical trial is conducted for 26 weeks to study the effectiveness and safety of the use of additional Liraglutide compared to the group of placebo patients with type 2 diabetes without effective control with base insulin with or without metformin. The dose of insulin is reduced by 20% for patients with HBA1C index levemir is insulin The background is used for 33% of patients (n = 147) (97.3% using metformin). Among those patients, the group used Liraglutide to significantly reduce the HBA1C index compared to the placebo group without adding liraglutide (6.93 % compared to 8.24 %), significantly reducing the glycemic index (7.20 mmol/l compared to 8.13 mmol/l) and significantly reduced weight (3.37 kg compared to 0.43 kg). The basic values for these parameters are similar to the two groups. Observing the rate of negligible hypoglycemia is equivalent and no serious hypoglycemia occurs in both groups. In long-term trials (> 6 months) in patients with type 1 diabetes, which is used for base-nhanh insulin therapy, plasma glucose when hungry is improved with Levemir Flexpen compared to insulin NPH. The control of blood sugar (HBA1C) with Levemir Flexpen is equivalent to insulin NPH, with a lower risk of hypoglycemia at night and not accompanied by weight gain. In clinical trials using foundation-nhanh insulin therapy, the general ratio of hypotension with Levemir Flexpen and Insulin NPH is equivalent. Analysis of hypoglycemia at night in patients with type 1 diabetes shows the risk of mild blood pressure at night significantly lower (can be treated by themselves and confirmed by capillary glucose less than 2.8 mmol/l or 3.1 mmol/l if shown in the form of plasma glucose) compared to insulin NPH, while there is no difference in diabetes at night. Using Levemir Flexpen is more flat and more stable than insulin NPH, leading to lower risk of hypoglycemia at night. The development of antibodies has been observed when using Levemir Flexpen. However, this does not seem to have any effect on blood sugar control. Pregnant women In a randomized clinical trial with a control, pregnant women with type 1 diabetes (n = 310) are used for a foundation-tongromatic therapy, the Levemir Flexpen group (n = 152) is compared to the insulin nPH (n = 158) in combination with insulin aspart, the insulin according to the meal. Levemir Flexpen shows no less than the Insulin NPH under HBA1C measured in the 36th week of pregnancy. HBA1C Average during pregnancy is equivalent on subjects in the Levemir Flexpen and Insulin NPH groups. HBA1C goals The general frequency of side effects in the mother during pregnancy is equivalent to levemir flexpen and insulin NPH treatment groups; However, a frequency of serious side effects during pregnancy is higher in the number of mothers (61 (40%) compared to 49 (31%)) and in children during pregnancy and after birth (36 (24%) compared to 32 (20%)) for Levemir Flexpen compared to the Insulin NPH. The number of children born in pregnant women after being randomly selected is 50 (83%) for Levemir Flexpen and 55 (89%) for insulin NPH. The frequency of children with birth defects is 4 (5%) in Levemir Flexpen and 11 (7%) in the NPH insulin group. In particular, 3 children (4%) in Levemir Flexpen and 3 children (2%) in the Insulin NPH group have great defects. Pediatric patients In the Levemir Flexpen and insulin degludec test test , the ratio of hyperglycemia is significantly higher in Levemir Flexpen, 1.09 and 0.68 for patients to be treated for 1 year. A low ratio of hypoglycemia at night (based on monitoring blood glucose measurements - SMPG) and less weight gain (standard deviation (SD), gender and age adjustment weight) with insulin detemir compared to insulin NPH. A test has been expanded for another 12 months (the total number of treatment data in 24 months) to evaluate the formation of antibodies after long -term treatment with Levemir Flexpen. After increasing insulin antibodies in the first year, insulin antibodies decreased in the second year to a slightly higher level before testing. The results show that the development of antibodies does not have adverse effects on blood sugar control and insulin dose. Effective and safe data for patients who are teenagers with type 2 diabetes are extracted from data for patients who are children, adolescents and adults with type 1 diabetes and patients who are adults with type 2 diabetes. absorption The highest concentration in the serum is about 6-8 hours after the injection. When used 2 times/day, serum concentration in a stable state is achieved after 2-3 doses. Variation of absorption on the same patient of Levemir Flexpen is lower than other background insulin preparations. Distribution The apparent distribution of Levemir Flexpen (about 0.1 liters/kg) shows that most insulin detemir circulation in the blood. Research results on cohesion with in vito and in vivo protein show that there is no clinical interaction between insulin detemir and fatty acids or other protein -connected drugs. Metabolism The regression of Levemir Flexpen is the same as human insulin; All metabolites formed are not active. Elimination The last half -life after subcutaneous injection is determined by the rate of absorption from the subcutaneous tissue. The end of the end of the sale is about 5 - 7 hours depending on the dose. linear Calculating the dosage of serum concentrations (maximum concentrations, absorption level) observed after subcutaneous injection within the treatment dose. There is no clinical difference among the gender in terms of pharmacokinetic properties of Levemir Flexpen. No observations of pharmacokinetic or pharmacokinetic interactions between Liraglutid and Levemir Flexpen when using single dose Levemir Flexpen 0.5 U/kg with Liraglutid 1.8 mg in stable state in patients with type 2 diabetes. Special patient group Levemir Flexpen's pharmacokinetic properties have been studied in young children (1-5 years old), children (6 - 12 years old) and teenagers (13-17 years old) and compared to adults with type 1 diabetes. There is no clinical difference in the pharmacokinetic properties of Levemir Flexpen between the elderly and young people or between kidney failure or liver failure and healthy people. Clinical safety data In vitro tests on cell lines that study the cohesion with the insulin and IGF-1 receptor positions show that insulin detemir has a reduced affinity for both receptors as well as reduced effectiveness on cell growth compared to human insulin . Non -clinical data shows that there is no special risk for people based on regular studies on safety pharmacological pharmacology, repetitive dose, gene toxicity, cancer or toxicity for reproduction. Pharmacokinetics
Before taking Levemir Flexpen 100u/ml Novo Nordisk treatment for diabetes (5 trees x 3ml)
How to use
Levemir Flexpen injection pen only use subcutaneous injection. Levemir Flexpen is not intravenous because it can cause serious hypoglycemia. Injecting should also avoid. Levemir Flexpen is not used in insulin transmission pumps.
Levemir Flexpen is used under the abdominal wall, thigh, upper arm, Delta or buttock area. Should always change the injection site in the same injection area to reduce the risk of fat disorders. As with all insulin preparations, the effect time will vary depending on the dose, injection position, blood flow, temperature and level of physical activity.
Levemir Flexpen is Insulin injection pen pre -pumped pumps designed for use with Novofine or Novotwist needwear for 8 mm long. Flexpen provides 1 - 60 units, each time increasing 1 unit. Levemir Flexpen is colored and closed in the box with a detailed manual.
Dosage
levemir flexpen is an insulin analogue, dissolved time with a long -lasting effect (up to 24 hours). Compared to other insulin, base-nhanh insulin therapy with levemir flexpen does not accompanied by weight gain.
The risk of hypoglycemia at night is lower than the insulin NPH (Neutral Protamine Hagedorn) allows a higher dosage titration to achieve target blood glucose levels in base-tuning insulin therapy.
Levemir Flexpen achieves the effectiveness of blood sugar control (FPG) better than the insulin NPH.
Levemir Flexpen can use single -cement therapy is base insulin or fast insulin combination therapy.
Levemir Flexpen can also be used in combination with oral diabetes treatment drugs and/or GLP-1 receptors.
Dosage
When using Levemir is used in combination with oral diabetes treatment drugs or with GLP -1 receptor, recommends using Levemir Flexpen 1 time/day, the starting dose is 0.1 - 0.2 U/kg or 10 u in adult patients. The dose of Levemir Flexpen should be titrated based on the needs of each patient.
When using GLP-1 receptor is used for patients using Levemir, it is recommended to reduce the initial 20% of Levemir doses to minimize the risk of hypoglycemia. Next, the dose is adjusted to each patient.
For individual dosage adjustments, it is recommended to follow two self -benchmarking guidelines for adults.
Titrate instructions for adults with type 2 diabetes
(163-180 mg/dL)
(145-162 mg/dl)
(127-144 mg/dl)
(109-126 mg/dL)
(73-108 mg/dL)
Unchanged
(target)
3,1-4.0 mmol/l (56-72 mg/dl)
Simple self -benchmark for adults with type 2 diabetes
(80-110 mg/dl)
Unchanged
(target)
When Levemir Flexpen is used as part of the foundation-nhanh insulin therapy, Levemir Flexpen 1 or 2 times a day depending on the needs of the patient. The dose of Levemir Flexpen should be adjusted to each patient.
For patients who need a dose 2 times daily to optimize blood glucose, the evening dose can be used in the evening or at bedtime. The adjustment of the dose may be needed if the patient increases physical activity, changes the normal diet or is having an accompanying disease.
Special patient group
Like all insulin preparations, in elderly patients and patients with renal impairment or liver failure, glucose monitoring should be strengthened and the dose of Levemir Flexpen should be adjusted to each patient.
Pediatric group
levemir flexpen can be used for teenagers and children from 1 year of age (see pharmacokinetics).
When changing the background insulin to use Levemir Flexpen, the reduction of background insulin dose and fast insulin should be considered for each patient, to reduce the risk of hypoglycemia (see the warning and prudent section especially when used)
In children and teenagers, should increase monitoring of glucose and the dose of Levemir Flexpen should be adjusted to each patient.
Efficiency and safety of Levemir Flexpen in children under 1 year of age has not been set. No data.
Switch from other insulin preparations
may need to adjust the dose and time of injection when switching from medium -acting insulin preparations or extended insulin to Levemir Flexpen (see the warning and prudent section especially when used)
As well as all insulin preparations, closely monitoring glucose is recommended in the conversion phase and later start weeks.
may need to adjust the treatment of diabetes with the accompanying diabetes (dose and/or time to use oral diabetes or insulin preparations quickly use simultaneously).
Note
The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? However, hypoglycemia can develop in consecutive stages if the dose is too high compared to the patient's needs:
Mild hypoglycemic stage, can be treated using oral glucose or sugar products. Therefore, patients with diabetes are advised to bring people with sugar products.
Severe hypoglycemia, when the patient is unconscious, can be treated with intramuscular or subcutaneous injection glucagon (0.5 to 1 mg) by a person who has been instructed on how to inject, or using intravenous injection glucose performed by a medical staff. Intravenous glucose must be used, if the patient does not respond to glucagon within 10-15 minutes. When the patient regains consciousness, it is necessary to use foods containing carbohydrates to prevent recurrence.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when forgetting a dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
When using the drug, you may experience unwanted effects (ADR).
Summary of safety data
The side effects have been observed in patients using Levemir Flexpen mainly due to the pharmacological effect of insulin. It is estimated that the total percentage of patients for treatment is expected to experience side effects of the drug is 12%.
The most commonly reported side effect during treatment is hypoglycemia. See the description of selective side effects.
According to clinical studies, severe hypoglycemia, identified as an external intervention, occurring in about 6% of patients treated with Levemir Flexpen.
Local injection reactions are more common when treated with levemir flexpen than human insulin. These reactions include pain, redness, rash urticaria , inflammation, bruises, swelling and itching at the injection site. Most of the mild and transient injecting reactions, meaning they often disappear when continuing to treat for a few days to a few weeks.
At the beginning of insulin treatment, there may be abnormalities in refractive and edema; These reactions are often temporary. The rapid improvement of blood glucose control may be associated with acute neuropathy, which can be recovered. Enhanced insulin therapy with sudden improvement in blood sugar control may be associated with diabetic retinopathy temporarily worse, while improving long -term blood sugar control reduces the risk of progression of diabetic retinopathy.
List of side effects
The side effects are listed below based on clinical data and are classified according to the frequency and system groups of Meddra. The frequency groups are determined according to the following convention: Very common (≥ 1/10); Common (≥ 1/100 to 1/10,000 to Skin disorders and subcutaneous tissue Describe selective side effects Hidden allergic reactions, allergic reactions, urticaria, rash, rash Hidden allergic reactions, hidden allergic reactions, urticaria, rash, rash when Levemir Flexpen are used in foundation-tongromatic insulin therapy. However, when used in combination with oral diabetes treatment, 3 clinical studies have shown the frequency of common (observed allergic reactions and hidden allergic reactions are 2.2%). Anaphylactic reaction The appearance of body hypersensitivity reactions (including body rash, itching, sweating, gastrointestinal disorders, nerve angiema, shortness of breath, chest drums and blood pressure loss ) are very rare but can be life -threatening. Hypoglycemia The most commonly reported side effect is hypoglycemia, which may occur if insulin dose is too high compared to insulin demand. Hypoglycemia can lead to unconsciousness and/or convulsions and may cause temporary or permanent impairment or brain function or even death. Symptoms of hypoglycemia often appear suddenly, may include cold sweat, pale and cold skin, fatigue, restlessness or tremor, anxiety , tired or abnormal, confused, difficult to focus, sleepy, excessive hunger, vision change, headache , nausea and breast drum. Fatty disorder Fat dysplasia (including adipose tissue hypertrophy, fat tissue atrophy) may occur at the injection site. Continuous changes in the injection site in a certain injection area reduces or prevents these reactions. Instructions on how to handle ADR Notify the doctor with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
anti -contraindications in fields that hypersensitize with active ingredients or any excipients of the drug (see the list of excipients).
Be cautious when using
Hyperglycemia
Insulin treatment is not enough or non -continuous, especially in type 1 diabetes, which can lead to hyperglycemia and diabetes getting metica. Typically, the first symptoms of hyperglycemia appear slowly, lasting for several hours or days. These symptoms include thirst, many times, nausea, vomiting, drowsiness, red skin, dry mouth, loss of appetite and acetone smell. In type 1 diabetes, cases of untreated hyperglycemia will eventually lead to diabetes metonic acidosis, which is likely to be fatal.
Hypoglycemia
Skipping a meal or exercise, no plan that can lead to hypoglycemia, in children, so adjust the dose of insulin accordingly (especially the diet based on fast background insulin) between the amount of food in and physical activity to minimize the risk of hypoglycemia.
Hypoglycemia may occur if insulin dose is too high compared to insulin needs (see unwanted and overdose effects).
Patients with blood glucose control are improved, for example, due to positive insulin therapy, there may be changes in the common warning symptoms of hypoglycemia and should be notified by the doctor. Common signal symptoms can be lost in patients with diabetes for a long time.
The accompanying diseases, especially infection and fever, often increases the patient's insulin needs. The accompanying diseases in the kidneys, liver or diseases affect the adrenal glands, pituitary or thyroid gland may require changes in insulin dose.
Switch from other insulin preparations
When transferring patients to use insulin or other insulin brands, it should be performed under the close supervision of medical staff. Changes in concentration, brand (manufacturer), type, origin (human insulin, insulin analog) and/or production method can lead to the need for dose changes. Patients who are transferred to Levemir Flexpen from another type of insulin may need to change the dose of the insulin they have used earlier. If the adjustment is necessary, it can be done at the first dose or in the first few weeks or the first few months.
The response to the injection site
Like any other insulin therapy, there may be reactions at the injection site, including pain, redness, hives, inflammation, bruises, swelling and itching. Continuous changes in the injection site in the injection area can help reduce or prevent these reactions. These reactions are usually fleeting for a few days to a few weeks. In some rare cases, the response to the injection site may have to stop using Levemir Flexpen.
Combining Thiazolidinedione and insulin
There have been reports on cases of congestion heart failure when using Thiazolidinedione in combination with insulin, especially in patients with risk factors for congestive heart failure. This should be remembered if considering the combination of thiazolidinedione with insulin drugs. If used in combination, patients must monitor patients on signs and symptoms of congestive heart failure, weight gain and edema.
Must stop using Thiazolidinedione if any heart worsening symptoms occur.
Avoid confusion/wrong use
Patients must be instructed to always check insulin labels before injection to avoid confusion between levemir flexpen and other insulin drugs.
The ability to drive and operate machinery
The patient's ability to concentrate and react may be detained as a result of hypoglycemia. This can be dangerous in situations where these possibilities are of special importance (such as driving or operating machinery).
Patients should be reminded to be careful to avoid hypoglycemia while driving. This is very important in patients who are difficult to identify whether or not to recognize the warning signs of hypoglycemia or in people who often have hypoglycemia. Consider driving in these cases.
Pregnancy
can be considered for treatment with Levemir Flexpen during pregnancy if the benefits are at risk for possible risks. A random clinical trial with control in pregnant women with type 1 diabetes comparison levemir flexpen (n = 152) with insulin nPH (n = 158), both combined with insulin aspart. The results show that insulin detemir and insulin nPH are equivalent and an equivalent overall safety data during pregnancy, the result of pregnancy as well as for fetus and babies.
After -sales data from about 300 additional results in pregnant women using Levemir Flexpen shows that insulin detemir has no adverse effects on pregnancy and has no toxicity that causes deformities or toxicity to the fetus/infant.
Animal data does not show toxicity to reproduction.
In general, positive control of blood glucose and monitoring of pregnant women with diabetes is recommended during pregnancy and when intended to get pregnant. The demand for insulin usually decreases in the first 3 months of pregnancy and gradually increases in the middle 3 months and the last 3 months of pregnancy. After birth, insulin demand often quickly returns to the values as before pregnancy.
The period of breastfeeding
It is unclear whether the insulin detemir is secreted into breast milk or not. Unknown effects on the metabolism of insulin detemir used for infants/young children breastfed because insulin detemir is a peptide that is digested into amino acids in human gastrointestinal tract.
may need to adjust insulin dose in nursing women.
Interactive drug
Some drugs are known to interact with glucose metabolism.
Medications can reduce the patient's insulin needs
Oral diabetes treatment, GLP-1 receptor, Monoamine oxidase inhibitors (MAII), Beta blockers, Angiotensin (ACE), Salicylate, Salicylate and Sulfonamide.
Medications can increase the patient's insulin demand
Storage
Before opening the lid: Store in the refrigerator (2 ° C - 8 ° C). To far from the cooling unit. Do not freeze. Cover Flexpen to avoid light.
Levemir Flexpen must be protected to avoid excessive heat and light.
During use or provision: Store less than 30 ° C. Can be stored in the refrigerator (2 ° C - 8 ° C). Use within 6 weeks. Do not freeze.
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