How to inject insulin basal gt. International nonproprietary name
Country of origin
Germany Germany/RussiaProduct group
Digestive tract and metabolismHuman insulin average duration actions
Release forms
- 3 ml - colorless glass cartridges, mounted in SoloStar® syringe pens (5) - cardboard packs. 5 ml - colorless glass bottles (5) - cardboard packs.
Description of the dosage form
- Suspension for subcutaneous administration, white or almost white, easily dispersible.
Pharmacological action
Hypoglycemic drug, intermediate-acting insulin. Insuman® Basal GT contains insulin, identical in structure to human insulin, obtained by genetic engineering using E. coli K12 135 pINT90d. Mechanism of action: - reduces the concentration of glucose in the blood, promotes anabolic effects and reduces catabolic effects; - increases the transport of glucose into cells and the synthesis of glycogen in muscles and liver, improves the utilization of pyruvate, inhibits glycogenolysis and gluconeogenesis; - increases lipogenesis in the liver and adipose tissue and suppresses lipolysis; - promotes the entry of amino acids into cells and protein synthesis; - increases the flow of potassium into cells. The effect of Insuman® Basal GT begins gradually and continues long time. After subcutaneous administration, the hypoglycemic effect occurs within 1 hour and reaches a maximum after 3-4 hours. The effect lasts for 11-20 hours.Pharmacokinetics
In healthy patients, T1/2 of plasma insulin is approximately 4-6 minutes and is prolonged in renal failure. However, it should be noted that the pharmacokinetics of insulin does not reflect its metabolic action.Special conditions
If glycemic control is insufficient or a tendency toward episodes of hyper- or hypoglycemia appears, before deciding to adjust the insulin dose, be sure to check compliance with the prescribed insulin regimen, ensure that insulin is injected into the recommended area, check the correct injection technique and all other factors which may affect the effect of insulin. Since the simultaneous use of a number of drugs can weaken or enhance the hypoglycemic effect of the drug Insuman Basal GT, when using it, you should not take any other drugs without the special permission of a doctor. Hypoglycemia Hypoglycemia occurs when the dose of insulin exceeds the need. The risk of developing hypoglycemia is high at the beginning of insulin treatment, when switching to another insulin drug, in patients with low maintenance blood glucose concentrations. As with all insulins, extreme caution is warranted and intensive monitoring of blood glucose concentrations is recommended in patients for whom hypoglycemic episodes may be particularly problematic. clinical significance, such as patients with severe coronary stenosis or cerebral arteries(risk of cardiac or cerebral complications of hypoglycemia), as well as in patients with proliferative retinopathy, especially if they have not undergone photocoagulation (laser therapy), since they have a risk of transient amaurosis (complete blindness) with the development of hypoglycemia. There are certain clinical symptoms and signs that should indicate to the patient or others about developing hypoglycemia. These include: increased sweating, humidity skin, tachycardia, disorders heart rate, increased blood pressure, chest pain, tremor, anxiety, hunger, drowsiness, sleep disturbances, fear, depression, irritability, unusual behavior, anxiety, paresthesia in and around the mouth, pale skin, headache, impaired coordination of movements, as well as transient neurological disorders (impaired speech and vision, paralytic symptoms) and unusual sensations. With an increasing decrease in glucose concentration, the patient may lose self-control and even consciousness. In such cases, the skin may become cold and damp, and cramps may occur. Therefore, every patient, with diabetes mellitus People receiving insulin must learn to recognize unusual symptoms that indicate developing hypoglycemia. Patients who regularly monitor blood glucose concentrations are less likely to develop hypoglycemia. The patient himself can correct the decrease in blood glucose concentration that he notices by taking sugar or eating with high content carbohydrates. For this purpose, the patient should always have 20 g of glucose with him. With more severe conditions hypoglycemia, a subcutaneous injection of glucagon is indicated (which can be done by a doctor or nursing staff). After sufficient improvementCompound
- insulin-isophane (human genetically engineered) 3.571 mg (100 IU) Excipients: protamine sulfate - 318 mcg, metacresol (m-cresol) - 1.5 mg, phenol - 600 mcg, zinc chloride - 47 mcg, sodium dihydrogen phosphate dihydrate - 2.1 mg, glycerol 85% - 18.824 mg, sodium hydroxide (to adjust pH) - 576 mcg, hydrochloric acid (to adjust pH) - 246 mcg, liquid water - up to 1 ml. insulin-isophane (human genetically engineered) 3.571 mg (100 IU) Excipients: protamine sulfate - 318 mcg, metacresol (m-cresol) - 1.5 mg, phenol - 600 mcg, zinc chloride - 47 mcg, sodium dihydrogen phosphate dihydrate - 2.1 mg, glycerol 85% - 18.824 mg, sodium hydroxide (to adjust the pH) - 576 mcg, hydrochloric acid (to adjust the pH) - 246 mcg, water for injection - up to 1 ml.
Insuman Basal GT indications for use
- - diabetes mellitus requiring treatment with insulin.
Insuman Basal GT contraindications
- - hypoglycemia; - increased sensitivity to insulin or to any of the auxiliary components of the drug, except in cases where insulin therapy is vital. With caution - in case of renal failure (a decrease in the need for insulin is possible due to a decrease in insulin metabolism); - in elderly patients (a gradual decrease in renal function can lead to an ever-increasing decrease in the need for insulin); - in patients with liver failure(insulin requirements may be reduced due to decreased gluconeogenesis capacity and decreased insulin metabolism); - in patients with severe stenosis of the coronary and cerebral arteries (in these patients, hypoglycemic episodes may be of particular clinical significance, since there is increased risk cardiac or cerebral complications of hypoglycemia); - in patients with proliferative retinopathy, especially those who have not received treatment with photocoagulation (laser therapy)
Insuman Basal GT dosage
- 100 IU/ml
Insuman Basal GT side effects
- Hypoglycemia Hypoglycemia, the most common side effect of insulin therapy, can occur if the dose of insulin administered exceeds the need. Severe repeated episodes of hypoglycemia can lead to the development of neurological symptoms, including coma and seizures. Prolonged or severe episodes of hypoglycemia can be life-threatening for patients. In many patients, symptoms and manifestations of neuroglycopenia may be preceded by symptoms of reflex (in response to developing hypoglycemia) activation of the sympathetic nervous system. Typically, with a more pronounced or faster decrease in blood glucose concentration, the phenomenon of reflex activation of the sympathetic nervous system and its symptoms are more pronounced. At sharp decline concentration of glucose in the blood, hypokalemia may develop (complications from cardiovascular system) or the development of cerebral edema. Listed below adverse events, observed in clinical studies, which are classified by system-organ classes and in order of decreasing frequency of occurrence. Violations by immune system Allergic reactions immediate type on insulin or excipients drug (frequency unknown), may manifest as generalized skin reactions (frequency unknown), angioedema (frequency unknown), bronchospasm (frequency unknown), decreased blood pressure (frequency unknown) and anaphylactic shock(infrequent reactions) and may be life threatening
Drug interactions
Combined use with hypoglycemic agents for oral administration, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, amphetamine, anabolic steroids and male sex hormones, cybenzoline, cyclophosphamide, fenfluramine, guanethidine, ifosfamide, phenoxybenzamine, phentolamine, and its analogues, sulfonamides, tetracyclines , tritoqualine or trophosfamide may enhance the hypoglycemic effect of insulin and increase the susceptibility to the development of hypoglycemia. Combined use with corticotropin, corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens (for example, those present in combination contraceptives), phenothiazine derivatives, somatotropin, sympathomimetic agents (for example, epinephrine, salbutamol, terbutaline), thyroid hormones, barbiturates, nicotinic acid, phenolphthaleinoStorage conditions
- store in a dry place
- Store refrigerated (t 2 - 5)
- keep away from children
- store in a place protected from light
Synonyms
- Biogulin Lente U40, Isofan Insulin ChM, Levulin L, Levulin N, Monotard, Humulin L, Humulin N
Instructions for medical use
medicine
Insuman ® Basal GT
Trade name
Insuman ® Basal GT
International nonproprietary name
Human insulin
Dosage form
Suspension for subcutaneous administration 100 IU/ml
Compound
1 ml of suspension contains
active substance - human insulin 100 IU (3.571 mg),
excipients: glycerin 85%, protamine sulfate, metacresol, phenol, zinc chloride, sodium hydrogen phosphate dihydrate, sodium hydroxide, concentrated hydrochloric acid, water for injection.
Description
Rapidly dispersing suspension of white or almost white color. The supernatant liquid is clear or almost clear.
Pharmacotherapeutic group
Medicines for the treatment of diabetes mellitus. Insulins and their analogues of medium duration of action.
ATS code A10AC01
Pharmacological properties
Pharmacokinetics
Insuman ® Basal GT (isophane insulin suspension) is an insulin with a gradually developing and long-lasting effect. After subcutaneous administration, the effect occurs within 60 minutes, the phase of maximum action is observed 3-4 hours after injection, the effect lasts 11-20 hours.
The half-life of insulin from serum is about 4-6 minutes. It lasts longer in severe renal failure. It should be noted that the pharmacokinetics of insulin does not reflect its metabolic action.
Pharmacodynamics
Insuman ® Basal GT contains insulin, identical in structure to human insulin, obtained using recombinant DNA technology using Escherichia coli.
Insuman ® Basal GT
Reduces blood glucose levels and promotes anabolic effects and reduces catabolic effects
Enhances the transport of glucose into cells, as well as the formation of glycogen in muscles and liver, improves the utilization of pyruvate. It inhibits glycogenolysis and glyconeogenesis
Enhances lipogenesis in the liver and adipose tissue and suppresses lipolysis
Promotes the consumption of amino acids by cells and activates protein synthesis
Increases potassium consumption by cells.
Indications for use
Diabetes mellitus, when treatment with insulin is necessary
Directions for use and doses
Desired blood glucose levels, insulin preparations to be used and dosage regimen (doses, time distribution) are selected individually in accordance with diet, level physical activity and the patient's lifestyle.
Daily doses and administration time
There are no fixed rules for insulin dosing. The average daily insulin requirement is 0.5-1.0 IU per kg of patient body weight. The basic metabolic requirement for insulin is 40-60% of the total daily requirement. Insuman ® Basal GT is administered subcutaneously 45-60 minutes before meals.
Secondary dose adjustment
Improved metabolic control may result in increased insulin sensitivity, resulting in decreased insulin requirements. Dose adjustment may be required if there is a change in the patient's weight, lifestyle, or other circumstances that may contribute to an increased tendency to hypoglycemia or hyperglycemia (see "Special Instructions").
Special patient groups
The need for insulin may be reduced in cases of impaired liver or kidney function and in old age (see "Special Instructions").
Introduction
Intravenous administration is absolutely excluded.
Insuman ® Basal GT is administered subcutaneously.
Insulin absorption, and therefore the hypoglycemic effect of the injection, may vary depending on the injection site (eg, abdominal wall vs. femoral area). The injection site must be changed within the same area each time.
Side effects
The following side effects associated with the use of the drug and observed in clinical studies are listed in order of decreasing frequency: very common (≥ 1/10), common (≥ 1/100,< 1/10), нечастые (≥ 1/1.000, < 1/100), редкие (≥ 1/10.000, < 1/1.000), очень редкие (< 1/10.000) и частота неизвестна (на основании имеющихся данных не определяется).
Very often
Hypoglycemia
Often
Edema (result of metabolic disorders)
Injection site reactions
Uncommon
Shock (immune origin)
Urticaria at the injection site
Rarely
The presence of antibodies to insulin, which may necessitate insulin dosage adjustments to correct the tendency toward hyperglycemia or hypoglycemia
Frequency unknown
Immediate allergic reactions (hypotension, angioedema, bronchospasm, generalized skin reactions) to insulin or excipients may be life-threatening
Formation of antibodies to insulin
Sodium retention in the body
Proliferative retinopathy, diabetic retinopathy, visual impairment - lipodystrophy, at the injection site, leading to slow absorption of insulin. Constantly changing injection sites within a given injection area may help reduce or prevent such reactions.
Inflammation, swelling, pain, itching, hyperemia at the injection site, which goes away after a few days or weeks
Contraindications
Increased sensitivity to active substance or to any of the excipients
Intravenous administration of Insuman Basal GT
Use in an infusion pump, external or implanted insulin pump
Drug interactions
Row medicines may affect glucose metabolism and may require dose adjustment human insulin.
To drugs that can enhance the hypoglycemic effect of insulin and increase susceptibility to hypoglycemia include oral antidiabetic agents, angiotensin-converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors (MAOIs), pentoxifylline, propoxyphene, salicylates and sulfonamides.
To drugs that can weaken the hypoglycemic effect of insulin, include corticosteroid hormones, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens (for example, in contraceptives for oral administration), phenothiazine derivatives, somatropin, sympathomimetics [eg, epinephrine (adrenaline), salbutamol, terbutaline], hormones thyroid gland, protease inhibitors and atypical antipsychotic drugs (eg, olanzapine and clozapine).
Beta blockers, clonidine, lithium salts and alcohol can either enhance or weaken the hypoglycemic effect of insulin.
Pentamidine can cause hypoglycemia, which sometimes gives way to hyperglycemia.
In addition, under the influence of sympatholytic drugs such as beta-blockers, clonidine, guanethidine and reserpine, signs of adrenergic counterregulation may be mild or absent.
Special instructions
Patients with hypersensitivity to Insuman ® Basal GT, for the treatment of which no other insulin preparations are currently available that they would tolerate better introduction it must be continued under strict conditions medical control and, if necessary, in combination with antiallergic measures.
In case of allergy to animal insulin, before transferring the patient to Insuman ® Basal GT is recommended to carry out an intradermal test, since they may have cross-immune reactions.
Insulin can cause sodium retention and edema, especially if previously poor metabolic control improves with increased insulin therapy.
If renal function is impaired, insulin requirements may be reduced due to decreased insulin metabolism. The progressive decline in kidney function in old age can lead to a steadily decreasing need for insulin.
In patients with severe hepatic impairment, insulin requirements may be reduced due to a reduction in gluconeogenesis and insulin metabolism.
If, as a result of treatment, it is not possible to achieve the desired glucose level, or there is a tendency to episodes of hypo- or hyperglycemia, then before adjusting the dose, it is necessary to check how clearly the patient follows the instructions for the administration regimen and dosage of the drug, injection technique -tions, injection sites and the presence of other factors influencing the effectiveness of treatment.
Transition to Insuman ® Basal GT
Switching a patient to another type or brand of insulin should be done under the strict supervision of a physician. Due to changes in concentration, grade (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of production, it may be necessary to change the dosage.
The need for dose adjustment (for example, reduction) may become obvious immediately after changing the drug and, conversely, may develop gradually over several weeks.
After switching from animal insulin to human insulin, a dosage reduction may be necessary in the following groups of patients:
Those who previously achieved lower blood glucose levels with treatment
Which have a tendency to develop hypoglycemia
Which previously required high doses insulin due to the presence of insulin antibodies.
Close metabolic monitoring is recommended during transfer and in the first weeks after transfer. Patients who require higher doses of insulin due to the presence of antibodies may require medical supervision in an inpatient or similar setting when switching from one insulin product to another.
Hypoglycemia
Hypoglycemia most common undesirable effect insulin therapy may develop if the insulin dose is too high compared to the insulin requirement. Frequency varies with population and dose regimen, so it is not possible to indicate a specific frequency.
Severe and especially repeated attacks of hypoglycemia can cause neurological disorders. Prolonged and severe attacks of hypoglycemia can pose a threat to the patient's life.
In many patients, signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counterregulation. The more and faster the blood glucose level decreases, the more pronounced the phenomenon of counterregulation and its symptoms are.
Particular caution should be exercised and enhanced monitoring of blood glucose levels is recommended in patients whose episodes of hypoglycemia may be of particular clinical significance, for example, in patients with severe stenosis coronary arteries or cerebral arteries (risk of developing cardiac or cerebral complications of hypoglycemia), as well as in patients with proliferative retinopathy, especially if they have not been treated with photocoagulation (risk of developing transient amaurosis after hypoglycemia). A marked change in glycemic control may cause temporary visual impairment due to a temporary change in the swelling of the eye's lens and its refractive index). The long-term existence of improved glycemic control reduces the risk of progression of diabetic retinopathy. However, intensification of insulin therapy with a sharp improvement in glycemic control may be combined with a temporary worsening of diabetic retinopathy.
Patients should be familiar with the circumstances in which the warning signs of hypoglycemia are mild. IN separate groups risk, warning signs of hypoglycemia may vary, be less pronounced, or be absent. Such patients include:
Patients whose glycemic control has improved markedly
Patients in whom hypoglycemia develops gradually
Elderly patients
After switching from animal to human insulin
In the presence of autonomic neuropathy
With long-term diabetes mellitus
If you have a psychiatric illness
When simultaneously treated with certain other drugs (see “Drug Interactions”)
In such cases, hypoglycemia can take a severe form (with possible loss consciousness) even before the patient realizes that he has hypoglycemia.
In the presence of normal or reduced levels of glycosylated hemoglobin, the likelihood of repeated, unrecognized (especially nocturnal) episodes of hypoglycemia should be assumed.
Patient adherence to dosage and diet, correct administration of insulin, and awareness of the signs of hypoglycemia are essential to reduce the risk of hypoglycemia. Factors that increase susceptibility to hypoglycemia require particularly careful monitoring and may require dose adjustment. These include:
Changing the injection site
Increased insulin sensitivity (eg, as a result of removal of stressors)
Unusual, increased or prolonged physical activity
Intercurrent illness (eg, vomiting, diarrhea)
Inadequate food intake
Skipping meals
Alcohol consumption
Some uncompensated endocrine disorders(for example, with hypothyroidism and insufficiency of the anterior pituitary gland or adrenal cortex)
Concomitant treatment with certain other drugs
Intercurrent diseases
Intercurrent diseases require intensive monitoring of metabolism. In many cases, urine tests for ketones are indicated, and insulin dosage adjustments are often necessary. The need for insulin often increases. In the case of type 1 diabetes, patients should continue to regularly consume carbohydrates, at least small quantities, even if they are able to consume a small amount of food or may not eat at all or they have vomiting, etc. These patients should never skip insulin injections entirely.
Mixing insulins
Do not mix Insuman ® Basal GT with insulins of animal origin and insulin analogues.
Insuman ® Basal GT can be mixed with all Sanofi-Aventis human insulin products, with the exception of insulins intended for use in insulin pumps.
If you need to draw two different insulins into one injection syringe, it is recommended to draw more insulin first. short acting to avoid contamination of the vial with a longer-acting drug. It is advisable to administer immediately after mixing. Do not mix insulins of different concentrations (for example, 100 IU/ml and 40 IU/ml).
Any unused product or waste should be disposed of in accordance with local regulations.
Instructions for use
Insuman ® Basal GT (cartridge) to be used in conjunction with insulin pens such as OptiPen and other pens suitable for Insuman cartridges.
The instructions for use of the pens regarding filling the cartridge, inserting the injection needle and administering the insulin injection should be strictly followed.
Before inserting into the Insuman pen ® Basal GT should be kept at room temperature for 1-2 hours, and then the suspension should be mixed well again to check the contents. This is best done with with the help of the lung rocking the cartridge back and forth (at least ten times). Each cartridge contains three small metal balls to facilitate rapid and thorough mixing of the contents of the cartridge.
After installing the cartridge in the syringe pen, before each injection, you will need to resuspend the insulin again. This is best done by gently rocking back and forth (at least ten times).
After mixing, the suspension should have a uniform consistency and milky white color. If this cannot be achieved (the suspension remains transparent, lumps, suspended particles or flakes appear in the insulin, or on the walls or bottom of the cartridge (such changes sometimes give the cartridge a frozen appearance), use Insuman ® Basal GT is not allowed. In such cases, you need to use another cartridge that satisfies the above conditions. It is also necessary to replace the cartridge with a new one if the need for insulin has changed significantly.
If an insulin pen is damaged or does not work well (due to a mechanical defect), it should be thrown away and a new insulin pen used.
If the pen does not work well (see instructions for use of the pen), the suspension can be withdrawn from the cartridge into an injection syringe (suitable for 100 IU/ml insulin) and injected.
Before injection, remove any air bubbles from the cartridge (see pen instructions for use). Empty cartridges cannot be refilled.
Insuman cartridges ® Basal GTs are designed to prevent mixing in the cartridge with any other insulin.
Insuman ® Basal GT (bottles)
It must be remembered that 1 ml of suspension contains 100 IU of insulin, so you must use only injection syringes designed for given concentration insulin (100 IU/ml). The syringe must not contain any other drug or its residues (for example, residues of heparin).
Before the first set of insulin and the vial, you must remove the plastic protective cap.
Immediately before taking the insulin from the bottle into the injection syringe, mix it well. This is best done by rolling the bottle at an angle between your palms. Do not shake the bottle vigorously, as this may cause changes in the suspension (giving the bottle a frozen appearance) and cause the formation of foam. Foam may prevent accurate dosage measurement.
After mixing, the suspension should have a uniform consistency and milky white color. If this cannot be achieved (the suspension remains transparent, the insulin, or lumps, suspended particles or flakes appear on the walls or bottom of the bottle (such changes sometimes give the bottle a frozen appearance), use Insuman ® Basal GT is not allowed. In such cases, you need to use another bottle that satisfies the above conditions. It is also necessary to replace the bottle with a new one if the need for insulin has changed significantly.
Like all insulin preparations, Insuman ® Basal GT should not be mixed with solutions containing reducing substances such as thiols and sulfites. It must be remembered that insulin protamine crystals dissolve at acidic pH.
Avoid contact with alcohol and other disinfectants into an insulin suspension.
Pregnancy and lactation
There are no data on the effects of human insulin during pregnancy. Insulin does not penetrate the placental barrier. When prescribing the drug to pregnant women, caution should be exercised.
For patients with pre-existing or gestational diabetes mellitus, it is important to maintain good level metabolism throughout pregnancy. Insulin requirements may decrease in the first trimester of pregnancy and usually increase in the second and third trimesters. Immediately after birth, insulin requirements drop rapidly (increased risk of hypoglycemia). Careful monitoring of blood glucose levels is necessary.
No effect is expected on breastfed children. Insuman ® Basal GT can be used during breastfeeding. However, women who are breastfeeding may need to adjust their insulin dose and diet.
Features of the effect of the drug on the ability to drive vehicle or potentially dangerous mechanisms
The patient's ability to concentrate and react may be reduced as a result of hypoglycemia or hyperglycemia, or as a result of visual impairment. This is dangerous in situations where the above abilities have special meaning(for example, while driving a car or operating machinery).
Patients should be warned about the need to take precautions to avoid the development of hypoglycemia while driving. This is especially important for those who have mild or absent warning symptoms of hypoglycemia, or frequent episodes of hypoglycemia. The question should be raised about the advisability of driving a car and operating machinery under such circumstances.
Overdose
Symptoms: severe and sometimes prolonged life-threatening hypoglycemia.
Treatment: taking oral carbohydrates during episodes of mild hypoglycemia. It is possible to adjust the dosage regimen of the drug, diet or physical activity. Intramuscular or subcutaneous administration of glucagon or intravenous administration concentrated glucose is possible in more severe cases, occurring with coma, convulsions or neurological disorders. Prolonged administration of carbohydrates and prolonged observation of the patient may be required due to possible relapse hypoglycemia after obvious clinical recovery.
Release forms and packaging
Cartridge
3 ml of suspension in a cartridge (colorless glass type I) with a piston (elastomer rubber) and a flange cap (aluminum) with a stopper (elastomer rubber). 5 cartridges are placed in a blister pack. 1 blister pack is placed in a cardboard box along with instructions for medical use in the state and Russian languages.
Bottle
5 ml of suspension in a bottle (type I flint glass) with a stopper (aluminum flange closure, tamper evident, elastomeric rubber) and a tear-off cap. 5 bottles are placed in a cardboard box along with instructions for medical use in the state and Russian languages.
Storage conditions
Before opening the original packaging
Store at temperatures from 2° to 8° C.
Do not freeze! Avoid contact with the walls of the refrigerator.
X wound at a temperature not exceeding 25ºС.
Store cartridges and vials in outer cardboard packaging to protect from light.
After each injection, the pen cap should be placed back on the pen to protect it from light.
Keep out of the reach of children!
Shelf life
Before opening the original packaging
2 years
Do not use after the expiration date stated on the package.
After opening the original packaging
Cartridge
After the first use of the cartridge inserted into the pen, the product can be used for 4 weeks.
Bottles
After the first withdrawal of the suspension from the vial, the product can be used for 4 weeks. It is recommended to indicate on the label the date of first use of insulin.
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Among the numerous human insulins, intermediate-acting drugs occupy a special place. Main feature – active use at treatment of both type 1 and type 2 diabetes sugar disease. The manufacturer of the drug is Sanofi-Aventis.
Insulin Insuman Basal can be an excellent assistant in compensating for stable diabetes (against the background of moderate hyperglycemia with relatively stable blood sugar levels). It is used for classical intensive insulin therapy with double (morning and evening) injections of an artificial hormone of prolonged action.
The main task of the drug is to imitate the natural basal secretion, which is normally produced by the pancreas throughout the day. The effect of the medicine begins 1-1.5 hours after injection under the skin and lasts from 11 to 20 hours. The peak occurs between 4-6 hours from the start of administration. The duration of work depends on the chosen dosage of the injection site, individual characteristics body. Usually, before breakfast, the drug is used 45-55 minutes before meals.
To obtain ideal compensation, it is advisable to initially select the dosage in a specialized hospital, taking into account the daily glycemic profile. When transferring a patient from porcine insulin to human insulin, most often a reduction in the usual dosage is required. Particular attention should be paid to selecting the amount of the drug for small children and patients who need a little help. external hormone to avoid heavy .
Insuman Basal gt is only suitable for subcutaneous administration. It is believed that its use can restore the sensitivity of cells to their own hormone, therefore, in type 2 diabetes, prescribed insulin therapy is often only temporary.
Can be used to administer the drug subcutaneously a regular syringe or a modern syringe pen. The use of the device can significantly simplify daily injections and improve the patient’s quality of life. The appearance of the device and its compact size are also pleasantly pleasing.
Mix this drug It is possible with other drugs from Sanofi-Aventis, if their concentration is the same (i.e., mixing 100 and 40 units/ml is strictly forbidden!). It is also not allowed to combine the drug in one bottle with animal insulins, drugs intended for pompotherapy and analogues.
Remember: when mixing, the short-acting hormone is always drawn into the syringe first!
Insuman Rapid
Human genetically engineered insulin actively used in the treatment of diabetes mellitus. Refers to short-acting drugs. It begins to work within 50 minutes, peaks within 1-4 hours, and remains effective for up to 7 hours. A pronounced peak allows you to plan a carbohydrate load for a long time, adjusting the food regimen to the action profile of the drug.
It is injected under the skin using an insulin syringe. There are also special Solostar pen syringes. Disposable devices must be destroyed after the cartridge runs out.
It is most suitable for compensation in adults who are able to adhere to a certain daily routine and adequately plan physical activity. Used as the main drug in children with low insulin requirements. Renders positive action on the formation of glycogen reserves in the liver and muscles.
The main side effect is severe hypoglycemia. Usually occurs when the dosage is unjustifiably exceeded. Sometimes it happens allergic reactions in the form of urticaria, local swelling, itching. Suitable for joint use tablets of glucose-lowering drugs on the recommendation of the attending physician.
Successfully used for treatment. Does not require discontinuation of use during lactation. Dosages may vary depending on the individual needs of the body.
Storage
An opened bottle of Insuman Rapid or Insuman Basal gt remains valid for 28 days. Stored at room temperature, do not freeze. A new bottle should be kept in a temperature regime of +2+8 for no longer than two years. After the expiration date, use may be hazardous to health.
Remember, any methods of therapy for endocrine pathologies can only be used after agreement with the attending physician! Self-medication can be dangerous.
Insulin is the main hormone that reduces the concentration of sugar and is responsible for the delivery of glucose to every cell of the body. Also, the functions of the hormone are to activate the synthesis of proteins, fats and accelerate the transport of amino acids, potassium, magnesium, phosphorus and other blood elements.
If the pancreas, which is supposed to produce insulin, is disrupted, the body stops receiving energy from food. As a result, insulin levels decrease, and blood glucose levels, on the contrary, increase. However, such an abundance of sugar is not used for its intended purpose, which is why the body experiences energy starvation and its cells begin to die.
This is how diabetes develops. Previously, people with this disease were doomed, but today, thanks to the development of scientists and doctors, they have the opportunity to maintain their vital functions with the help of artificial insulin.
Insulin drugs come in bolus and basal forms. The former are used to compensate for the condition after eating, and the latter are intended for general support of the body. One of best medicines from this group is Basal insulin.
Insulin Basal: main characteristics
It is a hypoglycemic drug used in insulin-dependent diabetes. Active ingredient means - human insulin.
The medicine is a white suspension for subcutaneous administration. It belongs to the group of insulins and their analogues, which have an average effect.
Insulin Insuman Basal GT acts slowly, but the effect after administration lasts quite a long time. The highest peak concentration is reached 3-4 hours after injection and lasts up to 20 hours.
The principle of action of the drug is as follows:
- slows down glycogenolysis and glyconeogenesis;
- lowers the concentration of glucose in the blood, slows down the catabolic effect, promoting anabolic reactions;
- inhibits lipolysis;
- stimulates the formation of glycogen in muscles, liver and transports glucose into the middle of cells;
- promotes the flow of potassium to cells;
- activates protein synthesis and the process of delivering amino acids to cells;
- improves lipogenesis in the liver and adipose tissue;
- promotes the utilization of pyruvate.
U healthy people The half-life of the drug from the blood takes from 4 to 6 minutes. But with kidney disease, the time increases, but this does not affect the metabolic effect of the drug.
Instructions for use of the medicine
Sugar level
The average daily dose ranges from 0.5 to 1.0 IU/per 1 kg of weight. In this case, 40-60% of the dose is allocated for long-acting insulin.
It is worth noting that when switching from animal insulin to human insulin, a dosage reduction may be required. And if a transfer is made from other types of drugs, then medical supervision is necessary. Particular care must be taken to monitor carbohydrate metabolism in the first 14 days after the transition.
Insulin Basal is injected under the skin over 45-60 minutes. before meals, but sometimes the patient is given intramuscular injections. It is worth noting that each time the places where the injection will be administered must be changed.
Every diabetic should know that basal insulin is not used for insulin pumps, including implanted ones. In this case, intravenous administration of the drug is contraindicated.
In addition, the drug must not be mixed with insulins of different concentrations (for example, 100 IU/ml and 40 IU/ml), other medications and animal insulins. The concentration of Basal Insulin in the vial is 40 IU/ml, so you should use only plastic syringes that are designed specifically for this concentration of the hormone. Moreover, the syringe should not contain any remnants of previous insulin or other medicine.
Before taking the solution from the bottle for the first time, you must open the package by removing the plastic cap from it. But first, the suspension should be shaken a little so that it becomes milky white with a uniform consistency.
If after shaking the medicine remains transparent or lumps or sediment appear in the liquid, then it is not recommended to use the product. In this case, you need to open another bottle that will meet all the above requirements.
Before drawing insulin from the package, a little air is introduced into the syringe and then inserted into the vial. Next, the package is turned over with the syringe down and a certain volume of solution is drawn into it.
Before injecting, the air must be released from the syringe. Having collected a fold of skin, a needle is inserted into it, and then the solution is slowly introduced. After this, the needle is carefully removed from the skin and a cotton swab is pressed to the injection site for a few seconds.
Feedback from many diabetics is that insulin syringes are an inexpensive option, but they are quite inconvenient to use. Today, to facilitate this process, a special syringe pen is used. This is an insulin delivery device that can last up to 3 years.
Basal GT syringe pen is used as follows:
- You need to open the device by holding it mechanical part and pulling the cap to the side.
- The cartridge holder is unscrewed from the mechanical unit.
- The cartridge is inserted into the holder, which is screwed back (all the way) to the mechanical part.
- Before injecting the solution under the skin, the syringe pen should be slightly warmed in the palms of your hands.
- The outer and inner caps are carefully removed from the needle.
- For a new cartridge, one injection dose is 4 units, to install it you need to pull it towards yourself start button and rotate it.
- The needle (4-8 ml) of the syringe pen is inserted into the skin vertically; if its length is 10-12 mm, then the needle is inserted at an angle of 45 degrees.
- Next, you should smoothly press the start button of the device and inject the suspension until a click appears, signaling that the dose indicator has dropped to zero.
- Then you should wait 10 seconds and pull the needle out of the skin.
The date of the first set of suspension must be written on the package label. It is worth noting that after opening, the suspension can be stored at temperatures above 25 degrees for 21 days in a dark and cool place.
Side effects, contraindications, overdose
Insuman Basal GT does not have many contraindications and adverse reactions. Often it all comes down to individual intolerance. In this case, Quincke's edema, shortness of breath may develop, and rashes appear on the skin and sometimes it itches.
Other side effects They mainly occur due to incorrect treatment, non-compliance with medical recommendations, or improper administration of insulin. In these situations, the patient often experiences hypoglycemia, which may be accompanied by disturbances in the nervous system, migraines, and deterioration in speech, vision, unconscious states and even coma.
Also, reviews from diabetics state that with a low dose, non-compliance with the diet and skipping an injection, hyperglycemia and diabetic acidosis may occur. These conditions are accompanied by coma, drowsiness, fainting, thirst and poor appetite.
In addition, the skin at the injection site may itch, and sometimes bruises form on it. In addition, an increase in the titer of anti-insulin antibodies is possible, which can lead to hyperglycemia. Some patients experience immunological cross reactions with a hormone synthesized by the body.
In case of insulin overdose, hypoglycemia may develop varying degrees gravity. At mild form When the patient is conscious, he urgently needs to drink a sweet drink or eat a carbohydrate-containing product. In case of loss of consciousness, 1 mg of Glucagon is administered intramuscularly; if it is ineffective, a glucose solution (30-50%) is used.
In case of prolonged or severe hypoglycemia, after administration of Glucagon or glucose, infusion with a weak glucose solution is recommended, which will prevent relapse.
Severe patients are hospitalized in the department intensive care to carefully monitor their condition.
Special instructions
Insulin Basal cannot be used with a number of medications. These include drugs that have a hypoglycemic effect, IAF, disopyramides, Pentoxifylline, monoamine oxidase inhibitors, Fluoxetine, fibrates, Propoxyphene, sex hormones, anabolics and salicylates. Also, basal insulin should not be combined with Phentolamine, Cybenzoline, Ifosfamide, Guanethidine, Somatostatin, Fenfluramine, Phenoxybenzamine, Cyclophosphamide, Trophosfamide, Fenfluramine, sulfonamides, Tritoqualine, tetracyclines,
If you use basic insulin together with Isoniazid, phenothiazine derivatives, Somatotropin, Corticotropin, Danazol, progestogens, glucocorticosteroids, Diazoxide, Glucagon, diuretics, estrogens, Isoniazid and other drugs, the effect of insulin can significantly weaken. Lithium salts, Clonidine and beta-blockers have a similar effect.
Combination with ethanol weakens or potentiates the hypoglycemic effect. At joint reception with Pentamidine, hypoglycemia may develop, which sometimes turns into hyperglycemia. If you combine the use of insulin with sympatholytic drugs, then a weakening or absence of reflex activation of the sympathetic nervous system is possible.
The dosage regimen for certain groups of patients is selected individually. Thus, in elderly diabetics and patients with liver disease, renal failure Over time, the need for insulin decreases. And if the dose is selected incorrectly, then such patients may develop hypoglycemia.
It is worth noting that with stenosis of the cerebral or coronary arteries and proliferative retinopathy (in the case of laser exposure), it is necessary to carefully monitor glycemic levels. Since, in these cases, a strong decrease in glucose levels can lead to complete loss vision.
During pregnancy, therapy with Insuman Bazaol GT should be continued. It is worth remembering that after the first trimester, the need for insulin will increase. But after childbirth, the need, on the contrary, will decrease, so insulin may appear and need to be adjusted.
IN lactation period Insulin therapy must be continued. But in some cases, diet and dosage adjustments may be necessary.
The cost of Basal insulin ranges from 1228 to 1600 rubles. The price of syringe pens varies from 1,000 to 38,000 rubles.
The video in this article shows how to inject insulin correctly.
Sugar level
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Target blood glucose concentrations, the insulin preparations to be used, and the insulin dosing regimen (dose and timing of administration) must be determined and adjusted individually to suit the patient's diet, physical activity level, and lifestyle.
There are no precisely regulated rules for insulin dosing. However, the average daily dose of insulin is 0.5-1 IU/kg/day, with long-acting human insulin accounting for 40-60% of the required daily dose insulin.
The doctor should give the necessary instructions on how often to determine the concentration of glucose in the blood, and also give appropriate recommendations in case of any changes in diet or insulin regimen.
Switching from another type of insulin to Insuman ® Basal GT
When switching patients from one type of insulin to another, adjustments to the insulin dosage regimen may be necessary: for example, when switching from animal insulin to human insulin, or when switching from one human insulin preparation to another, or when switching from a treatment regimen with soluble human insulin to a regimen including longer-acting insulin.
After switching from animal-derived insulin to human insulin, a reduction in the insulin dose may be necessary, especially in patients who were previously managed on sufficiently low blood glucose concentrations; in patients prone to developing hypoglycemia; in patients who previously required high doses of insulin due to the presence of antibodies to insulin. The need for dose adjustment (reduction) may arise immediately after switching to new look insulin or develop gradually over several weeks.
When switching from one type of insulin to another and then in the subsequent first weeks, careful monitoring of blood glucose concentrations is recommended. In patients who required high doses of insulin due to the presence of antibodies, it is recommended to switch to another type of insulin under medical supervision in the hospital.
Additional insulin dose changes
Improved metabolic control may lead to increased insulin sensitivity, which may reduce the body's need for insulin.
A dose change may also be necessary if:
Changes in the patient's body weight;
Lifestyle changes (including diet, level of physical activity, etc.);
Other circumstances that may increase susceptibility to hypo- or hyperglycemia.
Dosage regimen for special groups of patients
Elderly persons. In older people, the need for insulin may be reduced. It is recommended that initiation of treatment, increase in doses and selection of maintenance doses in elderly patients with diabetes mellitus be carried out with caution to avoid hypoglycemic reactions.
Patients with liver or kidney failure. In patients with liver or kidney failure, the need for insulin may be reduced.
Administration of the drug Insuman ® Basal GT
Insuman ® Basal GT is usually administered deeply subcutaneously 45-60 minutes before meals. The injection site within the same injection area must be changed each time. Changing the area of insulin administration (for example, from the abdominal area to the thigh area) should only be done after consultation with a doctor, because Insulin absorption and, accordingly, the effect of lowering blood glucose concentrations may vary depending on the area of administration (for example, the abdominal area or the thigh area).
Insuman ® Basal GT is not used in various types of insulin pumps (including implanted ones).
IV administration of the drug is absolutely excluded!
Do not mix Insuman ® Basal GT with insulins of other concentrations, with insulins of animal origin, insulin analogues or other drugs.
Insuman ® Basal GT can be mixed with all human insulin products from the Sanofi-aventis group. Insuman ® Basal GT must not be mixed with insulin intended specifically for use in insulin pumps.
It must be remembered that the insulin concentration is 100 IU/ml (for 5 ml bottles or 3 ml cartridges), so you must use only plastic syringes designed for this insulin concentration when using bottles, or OptiPen Pro1 or ClickSTAR syringe pens in when using cartridges. The plastic syringe must not contain any other drug or its residues.
Before the first set of insulin from the bottle, you must remove the plastic cap (the presence of a cap is evidence of an unopened bottle). Immediately before collection, the suspension should be well mixed, and no foam should form. This is best done by turning the bottle while holding it under acute angle between the palms. After mixing, the suspension should have a uniform consistency and milky white color. The suspension cannot be used if it is of any other type, i.e. if it remains transparent or flakes or lumps have formed in the liquid itself, on the bottom or walls of the bottle. In such cases, you should use another bottle that meets the above conditions, and you should also inform your doctor.
Before drawing insulin from the vial, a volume of air equal to the prescribed dose of insulin is sucked into the syringe and injected into the vial (not into the liquid). Then the bottle together with the syringe is turned over with the syringe down and drawn required quantity insulin. Before injection, it is necessary to remove air bubbles from the syringe. A fold of skin is taken at the injection site, a needle is inserted under the skin and insulin is slowly injected. After the injection, the needle is slowly removed and the injection site is pressed with a cotton swab for several seconds. The date of the first draw of insulin from the vial should be written on the bottle label.
Once opened, the vials can be stored at a temperature not exceeding 25 °C for 4 weeks, protected from light and heat.
Before installing the cartridge (100 IU/ml) into the OptiPen Pro1 and ClickSTAR syringe pen, it is necessary to keep it for 1-2 hours at room temperature (injections of cooled insulin are more painful). After this, gently turn the cartridge over (up to 10 times) to obtain a homogeneous suspension. Each cartridge additionally has 3 metal balls for faster mixing of its contents. After installing the cartridge in the syringe pen, before each insulin injection, the syringe pen should be turned over several times to obtain a homogeneous suspension. After mixing, the suspension should have a uniform consistency and milky white color. The suspension cannot be used if it is of any other type, i.e. if it remains transparent or flakes or lumps have formed in the liquid itself, on the bottom or walls of the cartridge. In such cases, you should use another cartridge that meets the above conditions, and you should also inform your doctor. Remove any air bubbles from the cartridge before injection (see instructions for using OptiPen Pro1 or ClickSTAR syringe pens).
The cartridge is not designed for mixing Insuman ® Basal GT with other insulins. Empty cartridges cannot be refilled. If the syringe pen breaks down, you can administer the required dose from the cartridge using a regular syringe. It must be remembered that the insulin concentration in the cartridge is 100 IU/ml, so you must use only plastic syringes designed for this insulin concentration. The syringe must not contain any other drug or its residues.
After installing the cartridge, it can be used for 4 weeks. It is recommended to store at a temperature not exceeding 25 °C in a place protected from light and heat. While using the cartridge, the pen syringe should not be stored in the refrigerator (as injections with chilled insulin are more painful). After installing a new cartridge, it is necessary to check the correct operation of the syringe pen before injecting the first dose (see Instructions for using the OptiPenPro1 or ClickSTAR syringe pens.
Instructions for use and handling of the pre-filled syringe pen SoloStar ®
Before first use, the syringe pen must be kept at room temperature for 1-2 hours.
Before use, you should inspect the cartridge inside the syringe pen after thoroughly mixing the suspension in it by rotating the syringe pen around its axis, holding it at an acute angle between the palms. It should only be used if, after mixing, the suspension has a uniform consistency and a milky white color. A syringe pen cannot be used if the suspension in it after mixing has any other form, i.e. if it remains transparent or flakes or lumps have formed in the liquid itself, on the bottom or walls of the cartridge. In such cases, you should use a different syringe pen and also inform your doctor.
Empty SoloStar ® syringe pens should not be reused and must be destroyed.
To prevent infection, the prefilled pen should only be used by one patient and not shared with another person.
Handling the SoloStar ® syringe pen
Before using the SoloStar ® syringe pen, you should carefully read the information on use.
Important information on using the SoloStar ® syringe pen
Before each use, carefully attach a new needle to the pen and perform a safety test. Only needles compatible with SoloStar ® should be used.
Special precautions must be taken to avoid needle-related accidents and the possibility of transmitting infection.
Under no circumstances should the SoloStar ® syringe pen be used if it is damaged or if the patient is not sure that it will work properly.
It is always necessary to have a spare SoloStar ® syringe pen available in case of loss or damage to a working copy of the SoloStar ® syringe pen.
Storage instructions
It is necessary to study the section “Storage Conditions” regarding the rules for storing the SoloStar ® syringe pen.
If the SoloStar ® syringe pen is stored in the refrigerator, it should be removed from there 1-2 hours before the intended injection so that the suspension reaches room temperature. Injecting chilled insulin is more painful.
The used SoloStar ® syringe pen must be destroyed.
Operation
The SoloStar ® syringe pen must be protected from dust and dirt.
The outside of the SoloStar ® syringe pen can be cleaned by wiping it with a damp cloth.
Do not immerse, rinse or lubricate the SoloStar ® syringe pen in liquid, as this can damage it.
The SoloStar ® syringe pen accurately doses insulin and is safe to use. It also requires careful handling. Situations in which damage to the SoloStar ® syringe pen may occur should be avoided. If the patient suspects that a working copy of the SoloStar ® syringe pen may have been damaged, a new syringe pen should be used.
Stage 1: Insulin control
It is necessary to check the label on the SoloStar ® pen to ensure that it contains the appropriate insulin. For Insuman ® Basal GT, the SoloStar ® syringe pen is white with a green button for administering the injection. After removing the cap of the syringe pen, control appearance insulin contained in it: the insulin suspension after mixing should have a uniform consistency and milky white color.
Stage 2. Connecting the needle
It is necessary to use only needles that are compatible with the SoloStar ® syringe pen.
For each subsequent injection, always use a new sterile needle. After removing the cap, the needle must be carefully installed on the syringe pen.
Stage 3. Carry out the safety test (always carried out after mixing the suspension, see above).
Before each injection, a safety test must be performed to ensure that the pen and needle are working properly and that air bubbles have been removed.
Measure out a dose equal to 2 units.
The outer and inner needle caps must be removed.
With the syringe pen facing upward, gently tap the insulin cartridge with your finger so that all air bubbles are directed towards the needle.
Fully press the injection button.
If insulin appears at the tip of the needle, this means the pen and needle are working correctly.
If no insulin appears at the needle tip, then step 3 can be repeated until insulin appears at the needle tip.
Stage 4. Dose selection (always carried out after mixing the suspension, see above)
The dose can be set with an accuracy of 1 unit: from minimum dose— 1 unit before maximum dose— 80 units. If it is necessary to administer a dose exceeding 80 units, 2 or more injections should be given.
The dosage window should show "0" after completion of the safety test. After this, the required dose can be set.
Stage 5. Dose administration
The patient should be informed about the injection technique by a healthcare professional.
The needle must be inserted under the skin. The injection button must be pressed fully. It is held in this position for another 10 s until the needle is removed. This ensures that the selected dose of insulin is administered completely.
Stage 6: Removing and discarding the needle
In all cases, the needle should be removed and discarded after each injection. This prevents contamination and/or infection, air from entering the insulin container, and insulin leakage.
Special precautions must be taken when removing and discarding the needle. Recommended safety precautions for removing and disposing of needles (such as one-handed capping techniques) should be followed to reduce the risk of needle-related accidents and infection.
After removing the needle, you should close the SoloStar ® syringe pen with the cap.
