Humalog (Solution for injection)
Active material: Insulin lispro
When ATH: A10AB04
CCF: Short-acting human insulin
ICD-10 codes (testimony): E10, E11
When CSF: 15.01.01.01
Manufacturer: LILLY FRANCE S.A.S. (France)
PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING
Solution for injection clear, colorless.
| 1 ml | |
| insulin lispro * | 100 ME |
Excipients: glycerol (glycerol), Zinc oxide (zinc oxide), sodium hydrogen phosphate (sodium phosphate dibasic), cresol, water d / and, hydrochloric acid (solution 10%) and sodium hydroxide (solution 10%) (to adjust the pH).
3 ml – cartridges (5) – blisters (1) – packs cardboard.
* international non-proprietary name, recommended by the WHO – Insulin lispro.
Pharmacological action
DNA-recombinant human insulin analog. It differs from the latter back to the amino acid sequence at positions 28 and 29 Insulin B chain.
The main effect of the drug is the regulation of glucose metabolism. Besides, it has an anabolic effect. The muscle tissue is increased glycogen content, fatty acids, glycerol, Increased protein synthesis and increased consumption of amino acids, but there is a decrease glycogenolysis, gluconeogenesis, ketogeneza, lipolysis, protein catabolism and amino acid release.
In patients with diabetes mellitus type 1 and 2 with insulin lispro significantly reduced hyperglycemia more, postprandial, compared to soluble human insulin. Patient, receiving short-range and basal insulin, you need to adjust the dose of both insulin, to achieve an optimal blood glucose level throughout the day.
As with all insulin preparations, duration of action of insulin lispro may vary in different patients or at different times from the same patient and dose-dependent, injection site, blood supply, body temperature and physical activity.
Pharmacodynamic characteristics of insulin lispro in children and adolescents is similar to that, which is observed in adults.
In patients with diabetes mellitus type 2, receiving the maximum dose of sulfonylureas, addition of insulin lispro leads to a significant decrease in glycated hemoglobin.
Treatment with insulin lispro in patients with diabetes mellitus type 1 and 2 accompanied by a decrease in the number of episodes of nocturnal hypoglycemia.
Glyukodinamichesky response to isulin lispro is not dependent on functional impairment of kidney or liver.
Displaying, Insulin lispro equimolar human insulin, but its action occurs more quickly and lasts for a shorter time.
Insulin lispro has a rapid onset of action (about 15 m), tk. It has a high rate of absorption, and it allows him to enter directly before meals (for 0-15 minutes before eating) Unlike conventional short-acting insulin (for 30-45 minutes before eating). Insulin lispro has a shorter duration of action (from 2 to 5 no) in comparison with human insulin.
Pharmacokinetics
Absorption and distribution
After p / to the introduction of insulin lispro is rapidly absorbed, reaching Cmax in plasma 30-70 m. Vd Lispro insulin and human insulin are identical and are within the 0.26-0.36 l / kg.
Deduction
When s / to a T1/2 Insulin lispro is about 1 no. In patients with renal or hepatic insufficiency maintains higher rate of absorption of insulin lispro compared with human insulin.
Testimony
- Diabetes in children and adults, requires insulin to maintain normal glucose levels.
Dosage regimen
The dose is determined individually by the physician, depending on the needs of the patient. Humalog® It may be administered shortly before a meal, if necessary – after meals.
The temperature of the injected drug must comply room.
Humalog® injected s / c in the form of injection or in the form of extended p / infusion via an insulin pump. If necessary, (Ketoacidosis, acute illness, Between operations or postoperative period) Humalog® may be administered in / in.
P / to be administered to the shoulder, hips, buttock or abdomen. Injection sites should be alternated so, to the same place to use no more 1 once a month. When s / to a Humalog product® caution must be exercised, to avoid contact with the drug in the blood vessel. After injection should not be massaged injection site. The patient should be taught proper technique of injection.
Terms of Humalog injection®
Preparations for the introduction of
A solution of the drug Humalog® It must be transparent and colorless. Not to be used turbid, thickened, or slightly colored solution preparation, or if it is detected visually solids.
When the cartridge is inserted into the pen (and ïnektor), attaching the needle and carrying insulin injections is necessary to perform the manufacturer's instructions, which are attached to each injection pen.
Introduction
1.Wash hands.
2. Choose an injection site.
3. Process antiseptic skin at the injection site.
4. Remove the needle cap.
5. Secure skin, pulling it or fold greater zaschepit. Introduce the needle in accordance with the instructions for use of the pen.
6. Push 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. Injection sites should be alternated so, to the same place to use not more than approximately 1 once a month.
B / insulin
B / injection drug Humalog® It must be performed in accordance with normal clinical practice in / injection, eg, / in bolus or infusion using the system. This requires frequently monitor glucose levels in the blood.
Infusion systems at concentrations from 0.1 IU / mL and 1.0 IU / ml insulin lispro in 0.9% sodium chloride or 5% dextrose are stable at room temperature for 48 no.
P / insulin infusion via an insulin pump
For infusion Humalog® You can use Minimed pump and Disetronic insulin infusion. It is necessary to strictly follow the instructions, attached to the pump. Infusion systems are changed every 48 no. When connecting the system to comply with the rules of aseptic infusion. In the case of a hypoglycemic episode conducting the infusion is stopped until the resolution of the episode. If there is recurring or very low blood glucose levels, it should inform the physician and provide for a reduction or cessation of insulin infusion. Faulty pump or blockage of the infusion may result in a rapid rise in glucose levels. In the case of suspected violation of the insulin delivery instructions and must be followed, if necessary, inform the doctor. When using Humalog drug pumps® should not be mixed with other insulins.
Side effect
Side effect, associated with the main action of the drug: gipoglikemiâ. Severe hypoglycemia may lead to unconsciousness (gipoglikemicheskaya coma) and, in exceptional cases, death.
Allergic reactions: possible local allergic reaction – redness, swelling or itching at the injection site (usually disappear within a few days or weeks); systemic allergic reactions (occur less frequently, but are more serious) – generalized itching, hives, angioedema, fever, breathlessness, decrease in blood pressure, tachycardia, increased perspiration. Severe cases of systemic allergic reactions may be life threatening.
Local reactions: lipodystrophy at the injection site.
Contraindications
- Gipoglikemiâ;
- Hypersensitivity to the drug.
Pregnancy and lactation
So far not revealed any undesirable effect of insulin lispro on pregnancy or the health of the fetus / newborn. Relevant epidemiological studies have been conducted.
The goal of insulin therapy during pregnancy is to maintain adequate glucose control in patients with insulin-dependent diabetes or gestational diabetes. Insulin requirements usually reduced in the I trimester and increases in the II and III trimester of pregnancy. During childbirth and immediately after their need for insulin can dramatically decrease.
Women of childbearing age, diabetics, You must inform the doctor about the ensuing or planned pregnancy. In pregnancy, patients with diabetes requires careful monitoring of blood glucose, as well as the overall clinical monitoring.
Diabetic patients during breast-feeding may require dose adjustment of insulin and / or diet.
Cautions
Transfer the patient to another type or another brand of insulin should be done under strict medical supervision. Change of activity, brand (Manufacturer), type (eg, Regular, NPH, Tape), specific accessory (animal, human, human insulin analog) and / or method of manufacture (DNA recombinant insulin or animal insulin,) It may result in a change in dose.
States, where prognostic early symptoms of hypoglycemia may be non-specific and less pronounced, They include the continued existence of diabetes, intensive insulin therapy, nervous system diseases or diabetes medication, eg, beta-blockers.
In patients with hypoglycemic reactions after transfer from animal insulin to human insulin, Early symptoms of hypoglycemia may be less pronounced or different from those, that they experienced in the treatment of their previous insulin. Not adjusted hypoglycemic or hyperglycemic reactions can cause loss of consciousness, coma or death.
The use of inadequate doses or discontinuation of treatment, especially in insulin-dependent diabetes mellitus, It may lead to hyperglycemia and diabetic ketoacidosis, – states, potentially life-threatening patient.
Insulin requirements may be reduced in patients with renal insufficiency, and in patients with hepatic insufficiency due to a decrease gluconeogenesis and insulin metabolism. However, patients with chronic liver disease increased insulin resistance may lead to an increased demand for insulin.
Insulin requirements may increase in infectious diseases, emotional stress, by increasing the amount of carbohydrates in the diet.
Dose adjustment may be required in the case, if the patient is increased physical activity or change usual diet. Exercise immediately after meals to increase the risk of hypoglycemia. A consequence of the pharmacodynamics of rapid-acting insulin analogues is that, that if developing hypoglycaemia, it can develop early after injection, than with injection of soluble human insulin.
Patients should be warned about, if your doctor has prescribed the drug insulin concentration 40 IU / ml in vial, one should not gain the insulin from the cartridge with insulin concentration 100 IU / ml with a syringe for insulin with a concentration 40 IU / mL.
If necessary, taking other medications simultaneously with the drug Humalog® the patient must consult a doctor.
Effects on ability to drive vehicles and management mechanisms
Prix gipoglikyemii Ili gipyerglikyemii, associated with inadequate dosing regimen, possible violation of the ability to concentrate attention and speed of psychomotor reactions. This could be a risk factor for potentially dangerous activities (incl. driving vehicles or operating machinery).
Patients should use caution, to avoid gipolikemii while operating motor vehicles. This is especially important for patients, who have reduced or absent sense of the symptoms of hypoglycemia-precursors, or who have hypoglycemia often observed. In these circumstances, it is necessary to assess the feasibility of control truck. Diabetics can cut short felt by their own light hypoglycemia by receiving glucose or a meal high in carbohydrates (it is always recommended to have with you at least 20 g glucose). The transfer of hypoglycemia should inform the patient doctor.
Overdose
Symptoms: gipoglikemiâ, accompanied by the following symptoms: slackness, increased perspiration, tachycardia, headache, vomiting, confusion.
Treatment: light condition of hypoglycemia usually cropped ingestion of glucose or other sugar, or products, Sugarless.
Correction of moderately severe hypoglycaemia can be accomplished using the / m or s / c administration of glucagon, followed by ingestion of carbohydrates after the stabilization of the patient's condition. Patients, who do not respond to glucagon, introduced in / dextrose solution (Glucose).
If the patient is comatose, the glucagon should be entered in the / m or s / c. In the absence of glucagon or if no response to its administration, must enter in / dextrose solution (Glucose). Immediately after the restoration of the patient's consciousness is necessary to give food, rich in carbohydrates.
You may need to continue to support the carbohydrate intake and observation of the patient, tk. you may experience a relapse of hypoglycaemia.
Drug Interactions
Hypoglycemic effect of Humalog® reduce oral contraceptives, GCS, thyroid hormone drugs, danazol, beta2-adrenomimetiki (incl. ritodrin, salbutamol, terbutaline), tricyclic antidepressants, thiazide diuretics, chlorprothixene, diazoksid, Isoniazid, Lithium carbonate, a nicotinic acid, phenothiazines.
Hypoglycemic effect of Humalog® increase beta-blockers, ethanol etanolsoderzhaschie drugs, anabolic steroid, fenfluramin, guanethidine, tetracikliny, oral hypoglycemic drugs, salicilaty (eg, acetylsalicylic acid), sulfonamides, MAO inhibitors, ACE inhibitors (captopril, Enalapril), Octreotide, angiotensin II receptor antagonists.
Humalog® should not be mixed with animal insulin preparations.
Humalog® It may be used (under the supervision of a physician) in combination with human insulin longer acting, or in combination with oral hypoglycemic sulfonylureas.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
List B. The drug should be stored out of reach of children, in a refrigerator, at 2 ° to 8 ° C; Do not freeze. Shelf life – 2 year.
Located in the use of the drug should be stored at room temperature between 15 ° and 25 ° C; Protect from direct sunlight and heating. Shelf life – no more 28 days.
