Composition, form of production and packaging
The solution for the / in and / or the introduction of a transparent, colorless.
1 ml
insulin lyspro 100 IU
Auxiliary substances: glycerol (glycerol) 16 mg, metacresol 3.15 mg, zinc oxide (qs for Zn 2+ 0.0197 Ојg), sodium hydrogen phosphate heptahydrate 1.88 mg, hydrochloric acid 10% solution and / or sodium hydroxide solution 10% qs to pH 7.0-8.0, water q / u - qs to 1 ml.
3 ml - cartridges (5) - blisters (1) - packs cardboard.
3 ml - the cartridge, built-in the pen-handle KvikPen в„ў (5) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
DNA-recombinant analog of human insulin. It differs from the latter by the reverse sequence of amino acids in positions 28 and 29 of the B chain of insulin.
The main effect of the drug is the regulation of glucose metabolism. In addition, it has an anabolic effect. In muscle tissue, the content of glycogen, fatty acids, glycerol increases, protein synthesis increases and amino acid consumption increases, but glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid release decrease.
In patients with type 1 and type 2 diabetes, when using insulin, lyspro more significantly reduces hyperglycemia that occurs after eating, compared to soluble human insulin. For patients receiving short-acting and basal insulins, it is necessary to select a dose of both insulin to achieve the optimal blood glucose level throughout the day.
As with all insulin preparations, the duration of action of insulin lispro can vary in different patients or at different times in the same patient and depends on the dose, site of injection, blood supply, body temperature and physical activity.
Pharmacodynamic characteristics of insulin lizpro in children and adolescents is similar to that observed in adults.
In patients with type 2 diabetes mellitus receiving maximum doses of sulfonylurea derivatives, the addition of insulin lispro leads to a significant decrease in glycated hemoglobin.
Insulin treatment of patients with type 1 diabetes mellitus is accompanied by a decrease in the number of episodes of nocturnal hypoglycemia.
The glucodynamic response to the isulin of lyspro is independent of the functional deficiency of the kidneys or liver.
It is shown that insulin lyspro is equimolar to human insulin, but its action occurs more quickly and lasts for a shorter time.
Insulin lyspro is characterized by a rapid onset of action (about 15 min. has a high rate of absorption, and this allows you to enter it immediately before eating (0-15 minutes before meals), in contrast to the usual short-acting insulin (30-45 minutes before meals). Insulin lyspro has a shorter duration of action (2 to 5 hours) compared to conventional human insulin.
PHARMACOKINETICS
Suction and distribution
After sc administration, insulin lyspro is rapidly absorbed and reaches C max in blood plasma after 30-70 min. V d of insulin lispro and conventional human insulin are identical and are in the range 0.26-0.36 l / kg.
Excretion
With n / to the introduction of T 1/2 of insulin, lyspro is about 1 hour. In patients with renal and hepatic insufficiency, a higher rate of absorption of insulin lispro is maintained compared to conventional human insulin.
INDICATIONS
- diabetes mellitus in adults and children, requiring insulin therapy to maintain normal glucose levels.
DOSING MODE
The doctor determines the dose individually, depending on the patient's needs. Humalog В® can be administered shortly before meals, if necessary - immediately after meals.
The temperature of the drug should be at room temperature.
Humalog В® is injected in the form of injections or as an extended infusion with an insulin pump. If necessary (ketoacidosis, acute illness, period between operations or postoperative period), Humalog В® can be administered IV.
S / he should be injected into the shoulder, hips, buttocks or abdomen. The injection sites should be alternated in such a way that one and the same place is used no more than once a month. When n / to the introduction of the preparation Humalog В® it is necessary to exercise caution, in order to avoid getting the drug into a blood vessel. After injection, do not massage the injection site. The patient should be trained in the correct method of injection.
Rules for the administration of Humalog В®
Preparation for introduction
The solution of the preparation Humalog В® should be transparent and colorless. Do not use a cloudy, thickened or slightly colored solution of the drug, or if it visually reveals solid particles.
When installing the cartridge in a syringe pen (pen-injector), attaching a needle and conducting insulin injection, follow the manufacturer's instructions that are attached to each syringe pen.
Introduction
1. Wash your hands.
2. Choose a site for injection.
3. Treate the skin with an antiseptic at the injection site.
4. Remove the cap from the needle.
5. Fix the skin by pulling it or latching a large crease. Insert the needle according to the instructions for using the syringe pen.
6. Press the button.
7. Remove the needle and gently squeeze the injection site for a few seconds. Do not rub the injection site.
8. Using the protective cap of the needle, unscrew the needle and destroy it.
9. Place the injection sites in such a way that one and the same place is used no more often than once a month.
IV injection of insulin
The intravenous injection of Humalog В® should be carried out in accordance with the usual clinical practice of IV injections, for example, intravenous bolus administration or using an infusion system. This requires frequent monitoring of blood glucose levels.
Infusion systems with concentrations from 0.1 IU / ml and up to 1.0 IU / ml of insulin lispro in a 0.9% solution of sodium chloride or 5% dextrose solution are stable at room temperature for 48 hours.
Infusion of insulin with an insulin pump
For the infusion of Humalog В®, you can use Minimed and Disetronic pumps for insulin infusion. It is necessary to strictly follow the instructions attached to the pump.The system for infusion is changed every 48 hours. When connecting the system for infusion, observe aseptic rules. In the case of a hypoglycemic episode, the infusion is stopped until the episode is resolved. If there are recurring or very low blood glucose levels, this should be reported to the physician and the reduction or cessation of insulin infusion should be envisaged. Failure of the pump or clogging of the system for infusion can lead to a rapid rise in glucose levels. In case of suspicion of a violation of the supply of insulin, follow the instructions and, if necessary, inform the doctor. When applying the pump Humalog В® should not be mixed with other insulins.
SIDE EFFECT
Side effect associated with the main effect of the drug: hypoglycemia. Severe hypoglycemia can lead to loss of consciousness (hypoglycemic coma) and, in exceptional cases, death.
Allergic reactions: local allergic reactions are possible - redness, swelling, or itching at the injection site (usually disappear within a few days or weeks); systemic allergic reactions (occur less often, but are more serious) - generalized itching, urticaria, angioedema, fever, dyspnea, lowering blood pressure, tachycardia, increased sweating. Severe cases of systemic allergic reactions can be life threatening.
Local reactions: lipodystrophy at the injection site.
CONTRAINDICATIONS
- hypoglycemia;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
To date, no undesirable effects of insulin lyspro on pregnancy or fetal / newborn health have been identified. No relevant epidemiological studies have been conducted.
The purpose of insulin therapy in pregnancy is to maintain adequate glucose control in patients with insulin-dependent diabetes mellitus or with gestational diabetes.The need for insulin usually decreases in the I trimester and increases in the II and III trimesters of pregnancy. During and immediately after delivery, the need for insulin can dramatically decrease.
Women of childbearing age , suffering from diabetes, should inform the doctor about the coming or planned pregnancy. In pregnancy, patients with diabetes require careful monitoring of blood glucose levels, as well as general clinical control.
Patients with diabetes mellitus during breastfeeding may need to adjust the dose of insulin and / or diet.
APPLICATION FOR FUNCTIONS OF THE LIVER
The need for insulin may decrease with renal failure.
In patients with renal insufficiency, a higher rate of absorption of insulin lispro is maintained compared to conventional human insulin.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The need for insulin may decrease with hepatic insufficiency.
In patients with hepatic insufficiency, a higher rate of absorption of insulin, lyspro, is maintained compared to conventional human insulin.
SPECIAL INSTRUCTIONS
Transfer of the patient to another type or other brand of insulin should be carried out under strict medical supervision. A change in the activity, brand, type (eg Regular, NPH, Lente), species (animal, human, human insulin analog) and / or production method (DNA recombinant insulin or insulin of animal origin) may lead to the need dose changes.
The states in which the early predictive symptoms of hypoglycemia can be nonspecific and less pronounced include the long existence of diabetes mellitus, intensive insulin therapy, diseases of the nervous system in diabetes mellitus, or the administration of medications, such as beta-adrenoblockers.
In patients with hypoglycemic reactions after switching from animal insulin to human insulin, the early symptoms of hypoglycemia may be less pronounced or different from those they experienced when treated with their previous insulin. Unadjusted hypoglycemic or hyperglycemic reactions can cause loss of consciousness, to whom or death.
Use in inadequate doses or discontinuation of treatment, especially with insulin-dependent diabetes mellitus, can lead to hyperglycemia and diabetic ketoacidosis, a condition potentially life-threatening to the patient.
The need for insulin can decrease in patients with renal insufficiency, as well as in patients with hepatic insufficiency as a result of reduced gluconeogenesis and insulin metabolism. However, in patients with chronic hepatic insufficiency, increased insulin resistance may lead to an increased need for insulin.
The need for insulin can increase with infectious diseases, emotional stress, with an increase in the amount of carbohydrates in the diet.
Correction of the dose may be required if the patient's physical activity increases or the usual diet changes. Exercise immediately after eating increases the risk of hypoglycemia. A consequence of the pharmacodynamics of fast acting analog insulin analogs is that if hypoglycemia develops, it may develop after injection earlier than when injected with soluble human insulin.
The patient should be warned that if the doctor has prescribed an insulin preparation with a concentration of 40 IU / ml in the vial, then do not take insulin from the cartridge with an insulin concentration of 100 IU / ml using a 40 IU / ml insulin syringe.
If it is necessary to take other medications simultaneously with the preparation Humalog В®, the patient should consult a doctor.
Impact on the ability to drive vehicles and manage mechanisms
With hypoglycemia or hyperglycemia associated with an inadequate dosing regimen, there may be a disruption in the ability to concentrate and the speed of psychomotor reactions. This can become a risk factor for potentially hazardous activities (including driving vehicles or working with mechanisms).
Patients should be careful to avoid hypolipemia while driving. This is especially important for patients who have a decreased or absent sensation of symptoms-precursors of hypoglycemia, or whose episodes of hypoglycemia are observed frequently. In these circumstances, it is necessary to assess the appropriateness of driving vehicles. Patients with diabetes mellitus can independently suppress perceived mild hypoglycemia by taking glucose or foods high in carbohydrates (it is recommended to always have at least 20 g of glucose with them). About the transferred hypoglycemia the patient should inform the attending physician.
OVERDOSE
Symptoms: hypoglycemia, accompanied by the following symptoms: lethargy, increased sweating, tachycardia, headache, vomiting, confusion.
Treatment: mild conditions of hypoglycemia are usually stopped by ingestion of glucose or other sugar, or products containing sugar.
Correction of moderately severe hypoglycemia can be carried out with the aid of an / m or n / c injection of glucagon followed by ingestion of carbohydrates after stabilization of the patient's condition. Patients who do not respond to glucagon are injected with a / solution of dextrose (glucose).
If the patient is in a coma, then glucagon should be injected in / m or s / c. In the absence of glucagon, or if there is no reaction to its administration, it is necessary to introduce into / into the solution dextrose (glucose). Immediately after restoration of consciousness, the patient needs to give food rich in carbohydrates.
It may be necessary to maintain carbohydrate intake and monitor the patient, since there may be a relapse of hypoglycemia.
DRUG INTERACTION
The hypoglycemic effect of Humalog is reduced by oral contraceptives, GCS, thyroid hormone preparations, danazol, beta 2 -adrenomimetics (including ritodrin, salbutamol, terbutaline), tricyclic antidepressants, thiazide diuretics, chlorprotixen, diazoxide, isoniazid, lithium carbonate, nicotinic acid , phenothiazine derivatives.
Hugogal's hypoglycemic action is enhanced by beta-blockers, ethanol and ethanol containing drugs, anabolic steroids, fenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (eg acetylsalicylic acid), sulfonamides, MAO inhibitors, ACE inhibitors (captopril, enalapril), octreotide, antagonists receptors of angiotensin II.
HumalogВ® should not be mixed with animal insulin preparations.
Humalog В® can be used (under the supervision of a doctor) in combination with a longer-acting human insulin or in combination with oral hypoglycemic agents sulfonylurea derivatives.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of the reach of children, in the refrigerator, at a temperature of 2 В° to 8 В° C; Do not freeze. Shelf life - 2 years.
The drug should be stored at room temperature from 15 В° to 25 В° C; protect from direct sunlight and heat. Shelf life - no more than 28 days.
