Buy NovoRapid FlexPen solution intravenously and subcutaneously 100 units/ml 3ml No. 5 in pharmacies
Instructions for use NovoRapid FlexPen solution IV and SC 100 U/ml 3ml No. 5
Dosage forms injection solution 100U/ml 3ml Synonyms NovoRapid Penfil Group Short-acting insulins International nonproprietary name Insulin aspart Composition Active substance - insulin aspart. Manufacturers Novo Nordisk A/S (Denmark), Novo Nordisk A/S, packer Novo Nordisk LLC (Denmark) Pharmacological action Hypoglycemic drug, an analogue of short-acting human insulin, produced by recombinant DNA biotechnology using the Saccharomyces cerevisiae strain The decrease in blood glucose is caused by increasing its intracellular transport, enhancing tissue uptake, stimulating lipogenesis, glycogenogenesis, reducing the rate of glucose production by the liver. Insulin aspart is absorbed much more quickly from subcutaneous fat and begins to act faster than soluble human insulin; it also lowers blood glucose levels more strongly in the first 4 hours after a meal than soluble human insulin. After subcutaneous administration, the effect of the drug begins within 10-20 minutes after administration. The maximum effect is observed 1-3 hours after injection. The duration of action of the drug is 3-5 hours. Insulin concentration returns to the original level 4-6 hours after administration of the drug. Side effects Side effects associated with the effect on carbohydrate metabolism: hypoglycemia (increased sweating, pale skin, nervousness or tremors, anxiety, unusual fatigue or weakness, disorientation, impaired concentration, dizziness, severe hunger, temporary visual impairment, headache, nausea, tachycardia). Severe hypoglycemia can lead to loss of consciousness and/or seizures, temporary or permanent impairment of brain function, and death. Allergic reactions: urticaria, skin rash, anaphylactic reactions. Generalized allergic reactions may include skin rash, itchy skin, increased sweating, gastrointestinal disorders, angioedema, difficulty breathing, tachycardia, and decreased blood pressure. Local reactions: allergic local reactions (redness, swelling, itching of the skin at the injection site), usually temporary and passing as treatment continues, lipodystrophy. Other: edema, refractive error. These side effects are usually temporary. Indications for use : type 1 diabetes mellitus (insulin dependent); — diabetes mellitus type 2 (non-insulin dependent): stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (during combination therapy), intercurrent diseases. Contraindications - hypoglycemia; - increased individual sensitivity to insulin aspart or any of the components of the drug. It is not recommended to use insulin aspart in children under 6 years of age. Pregnancy and lactation During the possible onset of pregnancy and throughout its entire period, it is necessary to carefully monitor the condition of patients suffering from diabetes mellitus and monitor blood glucose levels. During lactation (breastfeeding), insulin aspart can be used without restrictions. Overdose Symptoms: hypoglycemia. Treatment: the patient can eliminate mild hypoglycemia on his own by ingesting glucose, sugar or carbohydrate-rich foods (patients are advised to carry sugar, sweets, cookies or sweet fruit juice with them at all times). In severe cases, when the patient loses consciousness, a 40% dextrose (glucose) solution is administered intravenously; IM or SC - glucagon (0.5-1 mg). After regaining consciousness, the patient is advised to eat a meal rich in carbohydrates to prevent the recurrence of hypoglycemia. Interaction The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenflura min, lithium preparations , preparations containing ethanol. The hypoglycemic effect of insulin is weakened by oral contraceptives, corticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine. Under the influence of reserpine and salicylates, it is possible to both weaken and enhance the effect of the drug. Pharmaceutical incompatibility Medicines containing thiol or sulfite, when added to insulin, cause its destruction. Special instructions Insufficient dosage of the drug or discontinuation of treatment, especially in type 1 diabetes, can lead to the development of hyperglycemia or diabetic ketoacidosis. After compensation of carbohydrate metabolism, for example, with intensified insulin therapy, patients may experience changes in their typical symptoms that are precursors of hypoglycemia, of which patients should be informed. In patients with diabetes mellitus, with optimal metabolic control, late complications of diabetes develop later and progress more slowly. A consequence of the pharmacodynamic properties of short-acting insulin analogues is that the development of hypoglycemia with their use begins earlier than with the use of soluble human insulin. Insulin aspart should be used in direct connection with food intake. The high rate of onset of the drug's effect should be taken into account when treating patients with concomitant diseases or taking medications that slow down the absorption of food. Impaired kidney or liver function may reduce insulin requirements. When transferring a patient to other types of insulin, early symptoms that are precursors of hypoglycemia may change or become less pronounced compared to those when using the previous type of insulin. Transferring a patient to a new type of insulin or an insulin preparation from another manufacturer must be carried out under strict medical supervision. Patients switching to insulin aspart treatment may require an increase in the frequency of injections or a dose change compared to the doses of previously used insulin preparations. If necessary, dose adjustment can be made already at the first administration of the drug or during the first weeks or months of treatment. In addition, a change in the dose of the drug may be required when changing the diet and with increased physical activity. Exercise performed immediately after eating may increase the risk of hypoglycemia. Skipping meals or unplanned exercise can lead to hypoglycemia. A significant improvement in carbohydrate metabolism compensation can lead to a state of acute painful neuropathy, which is usually reversible. Long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy. Patients should be advised to take measures to prevent the development of hypoglycemia and hyperglycemia when driving a car and working with machinery. For more detailed information, see the instructions for use.
Storage conditions List B. Unused NovoRapid FlexPen should be stored at a temperature of 2° to 8°C (in the refrigerator), but not near the freezer; do not freeze. To protect from light, store NovoRapid FlexPen with the protective cap on. It is not recommended to store NovoRapid FlexPen in the refrigerator. Store at a temperature not exceeding 30°C for 4 weeks from the start of use.
Pharmacological properties of the drug Novorapid Flexpen
NovoRapid FlexPen is an analogue of short-acting human insulin produced by biotechnology (the amino acid proline at position 28 of the B chain is replaced by aspartic acid). The hypoglycemic effect of insulin aspart is to improve the uptake of glucose into tissues after insulin binds to the receptors of muscle and fat cells, as well as to simultaneously inhibit the release of glucose from the liver. The effect of NovoRapid FlexPen occurs earlier than with the administration of soluble human insulin, and the level of glucose in the blood becomes lower during the first 4 hours after ingestion. When administered subcutaneously, the duration of action of NovoRapid FlexPen is shorter compared to soluble human insulin and occurs 10–20 minutes after administration. The maximum effect develops between 1 and 3 hours after injection. Duration of action: 3–5 hours. Adults. The results of clinical studies in patients with type 1 diabetes mellitus showed that with the administration of the drug NovoRapid FlexPen, the glucose level after meals is lower than with the administration of human insulin. Elderly and senile people. A randomized, double-blind study conducted in 19 patients with type II diabetes aged 65–83 years (mean age 70 years) compared the pharmacodynamics and pharmacokinetics of insulin aspart and soluble human insulin. The relative differences in the values of pharmacodynamics indicators (maximum rate of glucose infusion - GIRmax and AUC rate of its infusion within 120 minutes after administration of insulin preparations - AUC GIR 0-120 min) between insulin aspart and human insulin were the same as in practically healthy individuals and patients diabetes under 65 years of age Children and adolescents. In children treated with NovoRapid FlexPen, the effectiveness of long-term control of blood glucose levels is the same as when treated with soluble human insulin. A clinical study of children aged 2–6 years compared the effectiveness of glycemic control between soluble human insulin administered before meals and insulin aspart administered after meals, and also determined pharmacokinetics and pharmacodynamics in children aged 6–12 years and adolescents 13–17 years old. years. The pharmacodynamic profile of insulin aspart was similar in children and adults. The results of clinical studies in patients with type I diabetes mellitus showed that when using insulin aspart, the risk of developing hypoglycemia at night is lower compared to soluble human insulin; As for the frequency of hypoglycemia during the day, no significant differences were noted. Pregnancy period. A clinical study conducted in 322 pregnant women with type 1 diabetes mellitus compared the safety and effectiveness of insulin aspart and human insulin. 157 people 165 people received insulin aspart. - human insulin. However, no negative effects of insulin aspart on a pregnant woman, fetus or newborn were detected compared to human insulin. In addition, in a study conducted on 27 pregnant women with diabetes, 14 people. 13 people received insulin aspart. - human insulin. The study results showed a similar level of safety for these insulin preparations. When calculating the dose (in moles), insulin aspart is equivalent to soluble human insulin. Pharmacodynamics. Substitution of the amino acid proline in position B-28 of the insulin molecule in NovoRapid FlexPen with aspartic acid leads to a decrease in the formation of hexamers, which is noted when soluble human insulin is administered. Consequently, NovoRapid FlexPen is absorbed more quickly into the bloodstream from subcutaneous fat tissue compared to soluble human insulin. The time to reach the maximum concentration of insulin in the blood is on average half that when injecting soluble human insulin. The maximum concentration of insulin in the blood of patients with type I diabetes mellitus 492±256 pmol/l is achieved 30–40 minutes after subcutaneous administration of NovoRapid FlexPen at the rate of 0.15 U/kg body weight. Insulin levels return to baseline 4–6 hours after administration. The intensity of absorption is slightly lower in patients with type II diabetes mellitus. Therefore, the maximum insulin concentration in such patients is slightly lower - 352±240 pmol/l and is achieved later - on average after 60 minutes (50-90) minutes. When administering the drug NovoRapid FlexPen, the variability in the time to reach maximum concentration in the same patient is significantly less, and the variability in the level of maximum concentration is greater than when administering human soluble insulin. Children and teenagers. The pharmacokinetics and pharmacodynamics of NovoRapid FlexPen were studied in children (2–6 years and 6–12 years) and adolescents (13–17 years) with type I diabetes. Insulin aspart was rapidly absorbed in both age groups, and the time to reach Cmax in the blood was the same as in adults. However, the Cmax level was different in children of different ages, which indicates the importance of individual selection of doses of NovoRapid FlexPen. Elderly and senile people. In patients with type II diabetes aged 65–83 years (average age - 70 years), the relative differences in pharmacokinetic parameters between insulin aspart and human insulin were the same as in practically healthy individuals and diabetic patients under the age of 65 years. In patients in the older age group, the rate of absorption is reduced, as evidenced by a longer time to reach Cmax of insulin - 82 minutes with an interquartile range of 60–120 minutes, while its Cmax values were the same as in patients with type II diabetes under the age of 65 years. and slightly lower than in patients with type I diabetes. Liver dysfunction. In 24 people with varying levels of liver function (from normal to severe liver failure), the pharmacokinetics of insulin aspart was determined after a single dose. In patients with moderate and severe liver dysfunction, the intensity of absorption decreased and was more variable, as evidenced by an increase in the time to reach Cmax to 85 minutes (in individuals with normal liver function this time is 50 minutes). AUC, Cmax and CL/F values in subjects with reduced liver function were the same as in subjects with normal liver function. Renal dysfunction. In 18 individuals with varying levels of renal function (from normal to severe renal failure), the pharmacokinetics of insulin aspart was determined after a single dose. At different levels of creatinine clearance, there were no significant differences in the AUC, Cmax and CL/F values of insulin aspart. Data on patients with moderate to severe renal impairment were limited. Patients with renal failure undergoing hemodialysis were not studied.
Storage conditions for the drug Novorapid Flexpen
Shelf life - 2.5 years. The used syringe pen with NovoRapid FlexPen should not be stored in the refrigerator. The syringe pen, which is used or carried with you as a spare, should be stored for no more than 4 weeks (at a temperature not exceeding 30 ° C). An unused syringe pen with NovoRapid FlexPen should be stored in the refrigerator at a temperature of 2–8 ° C (away from the freezer). Do not freeze. To protect from light, store the pen with the cap on.
List of pharmacies where you can buy Novorapid Flexpen:
- Moscow
- Saint Petersburg
Side effects of the drug Novorapid Flexpen
Adverse reactions observed in patients using NovoRapid FlexPen are mainly associated with the size of the administered dose of the drug and are a manifestation of the pharmacological action of insulin. The most commonly reported side effect of insulin therapy is hypoglycemia. It can develop if the dose significantly exceeds the patient's need for insulin. Severe hypoglycemia can lead to loss of consciousness and/or seizures, followed by temporary or permanent impairment of brain function and even death. According to the results of clinical studies, as well as data recorded after the drug was marketed, the incidence of severe hypoglycemia varies in different patient groups and with different dosage regimens; The incidence of severe hypoglycemia in patients receiving insulin aspart is the same as in patients receiving human insulin. Below is the frequency of adverse reactions that, according to clinical studies, may be associated with the administration of NovoRapid. Based on the frequency of occurrence, these reactions are divided into those that occur sometimes (1/1000, ≤1/100) and rarely (1/10,000, ≤1/1000). Individual spontaneous cases were classified as very rare (≤1/10,000). From the immune system : Sometimes: urticaria, itching, skin rashes. Very rare: anaphylactic reactions. Generalized hypersensitivity reactions may include skin rashes, itching, sweating, gastrointestinal disturbances, angioedema, difficulty breathing, palpitations and decreased blood pressure. These reactions are potentially life-threatening. From the nervous system. Rarely: peripheral neuropathies. Rapid improvement in blood glucose control may cause acute painful neuropathy, usually transient. Visual disturbances : Sometimes: refractive errors; diabetic retinopathy. Transient refractive errors may occur at the beginning of insulin therapy. Long-term maintenance of glycemic control reduces the risk of progression of diabetic retinopathy. However, intensifying insulin therapy to rapidly improve glycemic control may cause a temporary exacerbation of diabetic retinopathy. From the skin and subcutaneous tissue Sometimes : lipodystrophies can occur at injection sites as a result of non-compliance with the recommendation to change the site of drug administration within the same area; local hypersensitivity. When administering insulin, reactions at injection sites are sometimes noted as manifestations of local hypersensitivity (redness, swelling and itching). These reactions are usually transient and disappear with continued treatment. General disorders and reactions at injection sites Sometimes: swelling may develop at the beginning of insulin therapy. These symptoms are usually temporary.
Interactions of the drug Novorapid Flexpen
A number of drugs affect glucose metabolism. Drugs that may reduce the need for insulin: oral hypoglycemic agents, octreotide, MAO inhibitors, non-selective beta-blockers, ACE inhibitors, salicylates, alcohol, anabolic steroids, sulfonamides. Drugs that may increase the need for insulin: oral contraceptives, thiazides, corticosteroids, thyroid hormones, sympathomimetics, danazol. β-adrenergic blockers may mask symptoms of hypoglycemia. Alcohol can enhance and prolong the hypoglycemic effect of insulin. Incompatibility. Adding some drugs to insulin can cause it to inactivate, such as drugs containing thiols or sulfites.
Overdose of Novorapid Flexpen, symptoms and treatment
Although there is no specific definition of overdose for insulin, hypoglycemia may develop after its administration. In case of mild hypoglycemia, it is necessary to ingest glucose or sweet foods. Therefore, patients with diabetes are recommended to always have a few pieces of sugar or sweets with them. In case of severe hypoglycemia, when the patient is unconscious, it is necessary to administer an intramuscular or subcutaneous injection of glucagon (0.5–1 mg), which can be given by persons who have received appropriate instructions. A healthcare professional may give the patient IV glucose. Glucose should also be administered intravenously if the patient does not respond to glucagon administration within 10–15 minutes. After the patient regains consciousness, he should take carbohydrates orally to prevent relapse of hypoglycemia.
Use of the drug Novorapid Flexpen
Doses. The dosage of NovoRapid FlexPen is individual and determined by the doctor in accordance with the characteristics and needs of the patient. Typically, NovoRapid FlexPen is used in combination with intermediate-acting or long-acting insulin preparations, which are administered at least once a day. The individual insulin requirement is usually 0.5–1.0 U/kg/day. With a frequency of use in accordance with food intake, 50–70% of the insulin requirement is met by NovoRapid FlexPen, and the rest by intermediate-acting or long-acting insulins. The method of administration of NovoRapid FlexPen is characterized by a faster onset and shorter duration of action compared to soluble human insulin. Due to the faster onset of action, NovoRapid FlexPen should usually be administered immediately before meals. If necessary, this drug can be administered soon after meals. NovoRapid is injected under the skin of the anterior abdominal wall, thigh, in the area of the deltoid muscle of the shoulder or buttocks. Injection sites should be changed even within the same area of the body. With subcutaneous injections in the area of the anterior abdominal wall, the effect of the drug begins within 10–20 minutes. The maximum effect is between 1-3 hours after injection. Duration of action is 3–5 hours. As with all insulins, subcutaneous injection into the anterior abdominal wall ensures faster absorption than when administered to other sites. However, the faster onset of action of NovoRapid FlexPen, compared to soluble human insulin, remains regardless of the site of administration. If necessary, NovoRapid FlexPen can be administered intravenously; these injections can only be performed under the supervision of a physician. NovoRapid can be used for continuous subcutaneous administration using appropriate infusion pumps. Continuous subcutaneous injection is carried out into the anterior abdominal wall; the injection sites should be changed periodically. When used in infusion pumps, NovoRapid should not be mixed with any other insulin preparations. Patients using infusion pumps should receive detailed instruction in the use of these systems and use the appropriate containers and tubing. The infusion set (tubes and cannulas) should be changed in accordance with the requirements of the attached instructions. Patients using NovoRapid in a pump system must have insulin in case of pump failure. Impaired liver and kidney function can reduce the patient's need for insulin. Instead of soluble human insulin, NovoRapid FlexPen should be administered to children in cases where it is desirable to obtain rapid insulin action, for example, before meals. NovoRapid FlexPen is a pre-filled pen designed for use with NovoFine® short cap needles. The package with NovoFine® needles is marked with the symbol S. FlexPen allows you to administer from 1 to 60 units of the drug with an accuracy of 1 unit. It is necessary to follow the instructions for medical use of the drug, which are in the package. NovoRapid FlexPen is intended for individual use only and cannot be reused. Instructions for use of the drug NovoRapid FlexPen NovoRapid is intended for subcutaneous injection or continuous administration using infusion pumps. NovoRapid can also be administered intravenously under the strict supervision of a physician. Use in infusion pumps For infusion pumps, tubes are used whose inner surface is made of polyethylene or polyolefin. Some insulin is initially absorbed on the inner surface of the infusion container. Use for intravenous administration Infusion systems with the drug NovoRapid 100 U/ml at a concentration of insulin aspart from 0.05 to 1.0 U/ml in an infusion solution containing 0.9% sodium chloride, 5 or 10% dextrose and 40 mmol/l potassium chloride, are in polypropylene infusion containers, are stable at room temperature for 24 hours. During the insulin infusion, it is necessary to monitor the concentration of glucose in the blood. Instructions for using the drug NovoRapid FlexPen for a patient Before using the drug NovoRapid FlexPen, check the label to see if the type of insulin you are using is correct. Always use a new needle for each injection to avoid infection. Do not use the pen: if the FlexPen pen has been dropped, damaged or deformed, as in these cases insulin may leak. If the syringe pen was stored incorrectly or was frozen. If the insulin solution does not appear clear or colorless. To avoid the formation of infiltrates, injection sites should be constantly changed. The best places for injection are the anterior abdominal wall, buttocks, anterior thigh or shoulder. Insulin works faster when injected into the waist area. How to administer this insulin preparation: Insulin should be injected under the skin, following the doctor's recommendations or the instructions for using the syringe pen.
