Composition, form of production and packaging
Solution for injection 1 ml
insulin human soluble semisynthetic 100 U
10 ml - bottles (1) - packs of cardboard.
3 ml - cartridges (3) - packs cardboard.
3 ml - cartridges (5) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Humodar P 100 is a short-acting human semisynthetic insulin. It interacts with a specific receptor of the external cytoplasmic cell membrane and forms an insulin-receptor complex that stimulates intracellular processes, incl. synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthetase, etc.).Reduction in blood glucose is due to increased intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis, glycogenogenesis, a decrease in the rate of production of glucose by the liver, etc. The duration of action of insulin preparations is mainly due to the rate of absorption, which depends on several factors (for example, , method and place of administration), and therefore the profile of insulin action is subject to significant fluctuations, both in different people and in the same person. On the average, the onset of action of the drug after SC administration occurs 30 minutes later, the maximum effect is in the interval between 1 and 2 hours, the duration of action is 5-7 hours.
PHARMACOKINETICS
Completeness of absorption and the beginning of the effect of insulin depends on the mode of administration (sc, v / m), 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. T 1/2 is a few minutes. It is excreted by the kidneys (30-80%).
INDICATIONS
- diabetes in adults.
DOSING MODE
The drug is intended for p / to, in / m and / in the introduction. The dose and time of administration of the drug are determined by the physician individually in each specific case based on the blood glucose level. On average, the daily dose of the drug ranges from 0.5 to 1 IU / kg body weight (depends on the individual characteristics of the patient and blood glucose level).
The drug is administered 30 minutes before a meal or a light snack containing carbohydrates.
The temperature of the insulin should be appropriate at room temperature.
When monotherapy with the drug, the frequency of administration is 3 times a day (if necessary, 5-6 times / day). At a daily dose exceeding 0.6 IU / kg,
Humodar P 100 should be administered in the form of 2 or more injections in various areas of the body.
The drug is usually injected into the anterior abdominal wall. Injections can also be done in the thigh, buttock, or the deltoid shoulder region. It is necessary to change the injection site within the anatomical area to prevent the development of lipodystrophy. In / m and / in the drug can be administered only under the supervision of a doctor.
Humodar P 100 is a short-acting insulin and is usually used in combination with medium-duration insulin (Humodar D 100).
Instructions to be given to the patient
The technique of injection with the use of insulin in vials
If the patient uses only one type of insulin
1. Disinfect the rubber membrane on the vial
2. Insert the air in the syringe in the amount corresponding to the required dose of insulin. Insert air into the vial with insulin.
3. Turn the bottle with the syringe upside down and type the desired dose of insulin into the syringe. Remove the needle from the vial and remove air from the syringe.Check the correctness of the dose of insulin
4. Immediately inject.
If the patient needs to mix two types of insulin
1. Disinfect the rubber membranes on the vials.
2. Directly before typing, roll a vial of long-acting insulin ("cloudy") between the palms until the insulin becomes evenly white and cloudy.
3. Draw in the syringe air in an amount corresponding to the dose of "cloudy" insulin. Enter the air into the bottle with a "cloudy" insulin and remove the needle from the bottle.
4. Insert the air in the syringe in the amount corresponding to the dose of insulin of short action ("transparent"). Insert air into the bottle with "transparent" insulin.Turn the bottle with the syringe upside down and type the desired dose of "transparent" insulin. Remove the needle and remove air from the syringe. Check the correctness of the dialed dose.
5. Insert the needle into the vial with "cloudy" insulin, flip the bottle with the syringe upside down and type the desired dose of insulin. Remove air from the syringe and check the correctness of the dialed dose. Immediately inject the dialed mixture of insulin.
6. Always take the insulin in the same sequence described above.
The technique of injection with the use of insulin in cartridges
The cartridge with the Humodar P100 preparation is intended only for use in syringe pens. It is necessary to follow carefully the instructions in the instructions for the use of the syringe-pen for the introduction of insulin
Before use, make sure that there is no damage to the Humodar P 100 cartridge (for example, cracks). Do not use the cartridge if there are any visible damage. After the cartridge is inserted into the syringe pen, a colored strip should be visible through the cartridge holder window. After the injection, the needle should remain under the skin for a minimum of 6 seconds. Keep the button depressed until the needle is completely removed from the skin, thus ensuring the correct dose administration and limiting the possibility of blood or lymph flow into the needle or the insulin cartridge.
The cartridge with the Humodar P 100 preparation is intended only for individual use and can not be refilled.
Injection procedure
1.Double with your fingers take the fold of the skin, insert the needle into the base of the fold at an angle of about 45 В° and insert under the skin insulin.
2.After injection, the needle should remain under the skin for at least 6 seconds, in order to ensure that the insulin is injected completely.
3.If after removing the needle at the site of the injection, blood appears, gently press the place of the prick with your finger.
4. It is necessary to change the injection site.
SIDE EFFECT
Due to the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitation, tremor, hunger, agitation, paresthesia in the mouth, headache). Pronounced hypoglycemia can lead to the development of hypoglycemic coma.
Allergic reactions: rarely - skin rash, Quincke's edema; extremely rare - anaphylactic shock.
Local reactions: hyperemia, swelling and itching at the injection site, with prolonged use - lipodystrophy at the injection site.
Other: swelling, transient refractive disorders (usually at the beginning of therapy).
CONTRAINDICATIONS
- hypoglycemia;
- Hypersensitivity to insulin or other components of the drug.
PREGNANCY AND LACTATION
Restrictions on the treatment of diabetes mellitus with insulin during pregnancy are not, because Insulin does not penetrate the placental barrier. When planning pregnancy and during it, it is necessary to intensify the treatment of diabetes. The need for insulin usually decreases in the first trimester of pregnancy and gradually rises in the II and III trimesters. During and immediately after delivery, the need for insulin can dramatically decrease. Shortly after birth, the need for insulin quickly returns to the level that was before pregnancy. There are no restrictions on the treatment of diabetes mellitus with insulin during lactation. However, it may be necessary to reduce the dose of insulin, so careful monitoring is necessary before stabilizing the need for insulin.
APPLICATION FOR FUNCTIONS OF THE LIVER
The dose of insulin must be corrected in case of impaired renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The dose of insulin must be corrected if the liver function is impaired.
APPLICATION IN ELDERLY PATIENTS
The dose of insulin must be corrected in patients older than 65 years.
SPECIAL INSTRUCTIONS
The drug should always remain clear and colorless. Do not use the drug if a precipitate appears in the solution.
On the background of insulin therapy, continuous monitoring of blood glucose levels is necessary. The causes of hypoglycemia in addition to an overdose of insulin may include: drug substitution, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (liver and kidney function, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), change of injection site, as well as interaction with other drugs.
Incorrect dosing or breaks in the introduction of insulin can lead to hyperglycemia. Usually, the first symptoms of hyperglycemia develop gradually, over several hours or days. They include the appearance of thirst, increased urination, nausea, vomiting, dizziness, redness and dryness of the skin, dry mouth, loss of appetite.
The dose of insulin must be corrected in case of thyroid dysfunction, Addison's disease, hypopituitarism, liver and kidney dysfunction and diabetes mellitus in persons over 65 years of age.
Correction of the dose of insulin may also be required if the patient increases the intensity of physical activity or changes the habitual diet.
Concomitant diseases, especially infections and conditions accompanied by fever, increase the need for insulin.
The transition from one type of insulin to another should be carried out under the control of blood glucose levels.
The drug lowers tolerance to alcohol.
Impact on the ability to drive vehicles and manage mechanisms
In connection with the primary appointment of insulin, a change in its type or in the presence of significant physical or mental stress, it is possible to reduce the ability to drive a car or to manage various mechanisms, as well as engaging in other potentially dangerous activities requiring increased attention and speed of mental and motor reactions.
OVERDOSE
Symptoms: hypoglycemia may develop.
Treatment: mild hypoglycemia, the patient can eliminate himself by taking sugar or carbohydrate-rich foods inside. Therefore, patients with diabetes are encouraged to constantly carry sugar, sweets, cookies or sweet fruit juice.
In severe cases, if the patient lost consciousness, intravenously injected 40% solution of dextrose (glucose); in / m, sc, v / in - glucagon. After restoration of consciousness the patient is recommended to take food rich in carbohydrates, to prevent the repeated development of hypoglycemia.
DRUG INTERACTION
There are a number of drugs that affect the need for insulin.
The hypoglycemic effect of Humodore P 100 increases oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, nonselective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, drugs lithium, quinidine, quinine, chloroquine, preparations containing ethanol.
The hypoglycemic effect of the drug is weakened by oral contraceptives, GCS, thyroid hormones, loop and thiazide diuretics, glucagon, somatotropin, estrogens, sulfinpyrazone, marijuana, epinephrine, blockers of histamine H 1 -receptors, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, slow calcium blockers channels, diazoxide, morphine, phenytoin, nicotine.
Under the influence of reserpine and salicylates, both weakening and enhancement of the action of the drug are possible.
Pentamidine can both enhance and weaken the hypoglycemic action of insulin.
Against the background of alcohol consumption, the need for insulin decreases, which requires correction of the dose of the drug.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store the drug at a temperature of 2 В° to 8 В° C. Do not freeze.
The vial with insulin that is used can be stored for 6 weeks, and the cartridge with insulin - for 3 weeks, at room temperature (no higher than 25 В° C), provided protection against direct exposure to heat and light. The drug should always remain clear and colorless. Keep out of the reach of children.
Shelf life - 2 years. Do not use after the expiration date printed on the package.
