Composition, form of production and packaging
Suspension for s / c introduction of white, which is stratified, forming a white precipitate and a transparent colorless or almost colorless supernatant; The precipitate is easily resuspended by gentle shaking.
insulin lyspro 100 IU
Auxiliary substances: metacresol 2.2 mg, phenol liquid 1 mg, glycerol 16 mg, protamine sulfate 0.19 mg, sodium hydrogen phosphate heptahydrate 3.78 mg, zinc oxide qs to obtain Zn 2+ 30.5 Ојg, water q / and - up to 1 ml; hydrochloric acid solution of 10% and / or sodium hydroxide solution of 10% - qs to pH 7.0-7.8.
3 ml - cartridges (5) - blisters (1) - a pack of cardboard.
3 ml - the cartridge, built-in the pen-handle KvikPen в„ў (5) - a pack of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
HumalogВ® Mix 50 is a ready-made mixture consisting of a 50% insulin solution of lyspro (high-speed analog of human insulin) and a protamine suspension of insulin lyspro 50% (analog of human insulin of average duration of action).
The main effect of insulin lispro is the regulation of glucose metabolism.
In addition, it has anabolic and anti-catabolic effect on various tissues of the body. 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.
It was shaken that insulin lispro is equimolar to human insulin, but its effect comes faster and lasts less. After a subcutaneous injection of Humalog Mix 50, a rapid onset of action and early onset of the peak of insulin activity of lyspro is observed. The beginning of the drug is approximately 15 minutes, which allows you to inject the drug immediately before meals (0-15 minutes before meals), compared to conventional human insulin. After a subcutaneous injection of Humalog Mix 50, a rapid onset of action and early onset of the peak of insulin activity of lyspro is observed. The profile of the action of insulin lispro protamine is similar to that of normal insulin-isophane with a duration of about 15 hours.
Completeness of absorption and the beginning of the effect of insulin depends on the place of administration (abdomen, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the preparation, etc. Distributed in tissues unevenly; does not penetrate the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and kidneys. It is excreted by the kidneys (30-80%).
- diabetes, requiring insulin therapy.
The dose of Humalog В® Mix 50 is determined by the doctor individually depending on the concentration of blood glucose. Mode of insulin administration is individual.
The drug should be administered only subcutaneously. Intravenous administration of HumalogВ® Mix 50 is not permissible.
The temperature of the drug should be at room temperature. Subcutaneous injections should be done in the area of вЂ‹вЂ‹the shoulder, hips, buttocks or abdomen. The injection sites need to be alternated so that the same place is used no more often than once a month. When subcutaneous administration Humalog Mix 50 should be careful to avoid getting the drug in the lumen of blood vessels. After injection, do not massage the injection site.
Recommendations for installing the cartridge in the device for the introduction of Humalog Mix 50 and attaching a needle to it before the introduction of the drug, read the device for the introduction of insulin in the manufacturer's instructions. Strictly follow the instructions given.
Preparation for introduction
Immediately prior to use, the HumalogВ® Mix 50 cartridge should be rolled between the palms ten times and shaken, turning 180 В° also ten times to resuspend insulin until it looks like a homogeneous turbid liquid. Do not shake vigorously, as this can lead to the appearance of foam, which may interfere with the correct dose set. To facilitate mixing, there is a small glass ball inside the cartridge.
Do not use HumalogВ® Mix 50 if flakes are present after mixing.
1. Wash your hands.
2. Choose a site for injection.
3. Prepare the skin at the injection site in accordance with the doctor's recommendations.
4. Remove the outer protective cap from the needle.
5. Fix the skin, collecting it in a large crease.
6. Insert the needle subcutaneously into the collected fold and perform the injection according to the instructions for using the syringe pen.
7. Remove the needle and gently squeeze the injection site with a cotton swab for a few seconds. Do not rub the injection site.
8. Using the outer protective cap of the needle, unscrew the needle and dispose of it.
9. Put the cap on the syringe handle.
For the preparation HumalogВ® Mix 50 in the QuickK pen pen
Before introducing insulin, it is necessary to read the manual for the use of the QUIKPEN pen syringe.
Hypoglycemia is the most common side effect that occurs when all insulin preparations are introduced, including HumalogВ® Mix 50. Severe hypoglycemia can lead to loss of consciousness and, in exceptional cases, death.
Allergic reactions: in patients, there may be local allergic reactions in the form of redness, swelling, or itching at the injection site. These minor reactions usually disappear within a few days or weeks. In a number of cases, these reactions can be caused by causes not associated with insulin, for example, skin irritation with a cleansing agent or with improper injection.
Systemic allergic reactions caused by insulin occur less frequently, but are more serious. They can manifest generalized itching, difficulty breathing, shortness of breath, lower blood pressure, increased heart rate, increased sweating. Severe cases of systemic allergic reactions can be life threatening. In rare cases of severe allergy to Humalogo Mix 50, immediate treatment is required. It may be necessary to change insulin, or conduct desensitization.
With prolonged use - it is possible to develop lipodystrophy at the injection site.
- Hypersensitivity to insulin or to one of the components of the drug.
The safety and efficacy of HumalogВ® Mix 50 in patients under 18 years of age has not been studied.
PREGNANCY AND LACTATION
Sufficient and well-controlled studies in pregnant women have not been conducted. Patients suffering from diabetes mellitus are advised to inform the doctor about an impending or planned pregnancy. During pregnancy it is especially important to monitor the status of patients receiving insulin therapy. The need for insulin usually decreases during the first trimester and increases during the II and III trimesters. During and immediately after delivery, the need for insulin can dramatically decrease.
Patients with diabetes during breastfeeding may need to adjust their dose of insulin, diet, or both.
APPLICATION FOR CHILDREN
The safety and efficacy of HumalogВ® Mix 50 in patients under 18 years of age has not been studied.
The transfer of a patient to another type or preparation of insulin with a different trade name should occur under strict medical supervision. Changes in the concentration of insulin, the brand (manufacturer), type (Regular, NPH, etc.), species (animal, human, human insulin analog) and / or production method (DNA recombinant insulin or insulin of animal origin) dose adjustment.
For some patients, when switching from animal insulin to human insulin, it may be necessary to adjust the dose. This can happen even with the first injection of the human insulin drug or gradually for several weeks or months after the transfer. Symptoms-precursors of hypoglycemia against the background of the introduction of human insulin in some patients may be less pronounced or different from those that were observed in them against the background of the introduction of insulin of animal origin. When normalizing the blood glucose concentration, for example, as a result of intensive insulin therapy, all or some of the symptoms that precede hypoglycemia may disappear, which patients should be informed about. Symptoms-precursors of hypoglycemia may change or be less pronounced with prolonged course of diabetes mellitus, diabetic neuropathy, or treatment with drugs such as beta-adrenoblockers.
The use of inadequate doses or discontinuation of treatment, especially in patients with type 1 diabetes, can lead to hyperglycemia and diabetic ketoacidosis (potentially potentially life-threatening conditions). The need for insulin may decrease if adrenal, pituitary or thyroid gland function is insufficient, with renal or hepatic insufficiency. With some diseases or with emotional overstrain, the need for insulin can increase. Correction of the dose of insulin may also be required with an increase in physical activity or with a change in the usual diet.
Impact on the ability to drive vehicles and manage mechanisms
During hypoglycemia, the patient's concentration and speed of psychomotor reactions may decrease. This can be dangerous in situations in which these capabilities are particularly needed (for example, driving vehicles or controlling mechanisms). Patients should be advised to take precautions to avoid hypoglycemia while driving vehicles and controlling mechanisms. This is especially important for patients with mild or absent symptoms-precursors of hypoglycemia or with frequent development of hypoglycemia. In such cases, the doctor should evaluate the appropriateness of driving the car by the patient and controlling the mechanisms.
An overdose of insulin causes hypoglycemia, accompanied by the following symptoms: lethargy, increased sweating, tachycardia, pale skin, headache, trembling, vomiting, confusion. Under certain conditions, for example, with a long duration of the disease or with intensive control of diabetes mellitus, symptoms-precursors of hypoglycemia may change.
Light states of hypoglycemia can usually be suppressed by ingesting glucose or sugar. You may need to adjust the dose of insulin, diet or physical activity. Correction of moderate hypoglycemia can be carried out by intramuscular or subcutaneous administration of glucagon, followed by ingestion of carbohydrates. Severe hypoglycemia, accompanied by coma, convulsions or neurological disorders, is stopped by intramuscular / subcutaneous administration of glucagon or by intravenous administration of a concentrated solution of dextrose (glucose).
After the restoration of consciousness, the patient needs to give food rich in carbohydrates, in order to avoid the re-development of hypoglycemia.
It may be necessary to take further carbohydrates and follow up the patient, since there may be a relapse of hypoglycemia.
The hypoglycemic effect of HumalogВ® Mix 50 is reduced when co-administered with the following medicines: oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, danazol, beta 2 -adrenomimetics (eg, ritodrin, salbutamol, terbutaline), thiazide diuretics, chlorprotixen, diazoxide, isoniazid, nicotinic acid, phenothiazine derivatives.
The hypoglycemic effect of HumalogВ® Mix 50 increases: beta-blockers, ethanol and ethanol containing drugs, anabolic steroids, fenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (eg acetylsalicylic acid), sulfonamide antibiotics, some antidepressants (monoamine oxidase inhibitors), inhibitors ACE (captopril, enapril), octreotide, angiotensin II receptor antagonists.
Beta-adrenoblockers, clonidine, reserpine can mask the manifestation of symptoms of hypoglycemia.
The interaction of Humalog Mix 50 with other insulin preparations has not been studied.
TERMS OF RELEASE FROM PHARMACY
TERMS AND CONDITIONS OF STORAGE
At a temperature of 2-8 В° C. Protect from direct sunlight and heat. Do not freeze. The drug in the cartridge / syringe-pen should be stored at a temperature of no higher than 30 В° C for up to 28 days. Keep out of the reach of children. Shelf life - 2 years.