Humodar P 100 Rec - instructions for use, dose, side effects, contraindications

Excipients: meta-cresol, sodium dihydrogen phosphate dihydrate, glycerol 100%, sodium hydroxide, sodium chloride, hydrochloric acid concentrated, water for injection.

Description:

A clear, colorless liquid.

Pharmacotherapeutic group:hypoglycemic agent - short-acting insulin

ATX: & nbsp

A.10.A.B.01 Insulin (human)

Pharmacodynamics:

Humodar® R 100 Rec is a short-acting human recombinant insulin preparation. It interacts with specific receptors of the external cytoplasmic cell membrane and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, 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 average, the onset of action of the drug after subcutaneous administration occurs in 30 minutes, the maximum effect is in the interval between 1 and 2 hours, the duration of action - 5-7 hours.

Pharmacokinetics:

Completeness of absorption and the beginning of the effect of insulin depends on the mode of administration (subcutaneously, intramuscularly), 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. The half-life is a few minutes. It is excreted by the kidneys (30-80%).

Indications:

Diabetes mellitus in adults.

Contraindications:

- Hypersensitivity to insulin or other components of the drug;

- ghypoglycaemia.

Pregnancy and lactation:

There are no restrictions on the treatment of diabetes mellitus with insulin, since 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 breastfeeding. However, it may require a reduced dose of insulin, so careful observation for several months to stabilize insulin requirements.

Dosing and Administration:

The drug is intended for subcutaneous, intramuscular and intravenous administration.

The dose and time of administration of the drug are determined by the physician individually in each case based on the concentration of blood glucose. 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 the concentration of blood glucose).

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, up to 5-6 times a day). At a daily dose exceeding 0.6 IU / kg, Humodar® R 100 Rivers should be administered in the form of 2 or more injections in different areas of the body.

The drug is usually administered subcutaneously in the anterior abdominal wall. Injections can also be done in the thigh, buttock, or shoulder in the projection of the deltoid muscle. It is necessary to change the injection site within the anatomical area to prevent the development of lipodystrophy. Intramuscular and intravenous drug can be administered only under the supervision of a doctor.

Humodar® P 100 Rek is a short-acting insulin and is usually used in combination with medium-duration insulin (Humodar® 100 Rivers).

Side effects:

Due to the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitation, tremor, hunger, excitement, paresthesia of the oral mucosa, headache). Pronounced hypoglycemia can lead to the development of hypoglycemic coma.

Allergic reactions: rarely - skin rash, angioedema; very rarely - anaphylactic shock.

Local Reactions: hyperemia, puffiness and itching at the injection site; with prolonged use - lipodystrophy at the injection site.

Other: edema, transient refractive disorders (usually at the beginning of therapy).

Overdose:

Overdose may develop hypoglycemia.

Treatment: the patient can eliminate mild hypoglycemia himself by taking sugar or carbohydrate-rich foods. 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 administered 40% solution of dextrose (glucose); intramuscularly, subcutaneously, intravenously - glucagon. After restoration of consciousness the patient is recommended to take food rich in carbohydrates, to prevent the repeated development of hypoglycemia.

Interaction:

Pharmaceutically incompatible with solutions of other drugs.

There are a number of drugs that affect the need for insulin.

Hypoglycemic action of insulin enhances nonselective beta-blockers, quinidine, quinine, chloroquine, monoamine oxidase inhibitors, angiotensin converting enzyme inhibitors, carbonic anhydrase inhibitors, octreotide, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, preparations containing ethanol.

Hypoglycemic action of insulin weakens glucagon, somatropin, estrogens, oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, thiazide diuretics, loop diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, sulfinpyrazone, epinephrine, blockers H₁-gistaminovyh receptors, blockers of "slow" calcium channels, diazoxide, morphine, phenytoin, nicotine.

Reserpine, salicylates can both enhance and weaken the hypoglycemic effect of insulin.

Special instructions:

On the background of insulin therapy, a constant control of the concentration of glucose in the blood is necessary.

Causes hypoglycemia In addition to an overdose of insulin, there may be: drug substitution, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (liver and kidney dysfunction, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), injection site change, and interaction with other drugs.

Incorrect dosing or breaks in the administration of insulin, especially in patients with type 1 diabetes, can lead to hyperglycemia. Usually the first symptoms of hyperglycemia develop gradually, over a period of 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, odor of acetone in the exhaled air. If not treated, hyperglycemia in type 1 diabetes mellitus can lead to the development of life-threatening diabetic ketoacidosis.

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 the concentration of glucose in the blood.

The drug reduces tolerance to alcohol.

Due to the possibility of precipitation in some catheters, the use of the drug in insulin pumps is not recommended.

The drug should always remain clear and colorless.

Do not use the drug if a precipitate appears in the solution.

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 of the vial.

2. Draw the air into the syringe in the volume corresponding to the desired 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 of 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 the air into the syringe in a volume 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 air into the syringe in a volume corresponding to a short-acting insulin dose ("clear"). 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 Humodar® R 100 Rec is intended only for use in syringe pens. Care should be taken to follow the instructions in the instructions for using the syringe pen for insulin administration.

Before using, make sure that there are no damages (for example, cracks) on the cartridge with Humodar® R 100 Rivers. 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 Humodar® R 100 Rec is intended only for individual use and can not be refilled.

Injection procedure

- Before the introduction of insulin, disinfect the injection site.

- With two fingers, assemble the skin fold, insert the needle into the base of the fold at an angle of about 45° and put under the skin insulin.

- After the injection, the needle should remain under the skin for at least 6 seconds, in order to ensure that the insulin is injected completely.

Effect on the ability to drive transp. cf. and fur:

In connection with the primary appointment of insulin, a change in its type or in the presence of significant physical or mental stress, because of the risk of hypoglycemia, it is possible to disrupt the ability to drive vehicles or various mechanisms,and also engage in other potentially dangerous activities that require increased attention and speed of mental and motor reactions.

Form release / dosage:Solution for injection, 100 IU / ml.

Packaging:

1) In bottles of transparent colorless glass of 10 ml. One bottle together with the instruction for use is placed in an individual pack of cardboard.

2) In cartridges of transparent colorless glass of 3 ml. Three or five cartridges, together with instructions for use, are packed in a pack of cardboard.

Storage conditions:

At a temperature of 2 to 8 ° C. Do not freeze.

The vial of insulin that is used, can be stored for 6 weeks, and the cartridge with insulin - for 3 weeks, at room temperature (not higher 2 ° C), subject to protection from 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.

Terms of leave from pharmacies:On prescription

Registration number:LSR-007463/10

Date of registration:30.07.2010

The owner of the registration certificate:Indar, Inc. for the production of insulin Indar, Inc. for the production of insulin Ukraine

Manufacturer: & nbsp

Indar ZAO for the production of insulin Ukraine

Information update date: & nbsp29.10.2015

Illustrated instructions

Instructions

Humodar® R 100 Rivers (Humodar®R 100 Rec)