Gensulin R - instructions for use, doses, side effects, contraindications

Name of components	amount
Active substance:
Human recombinant insulin	100 ME
Excipients:
Metacresol	3.0 mg
Glycerol	16 mg
Hydrochloric acid or sodium hydroxide	q.s. up to pH 7.0-7.6
Water for injections	up to 1 ml

Description:

A clear, colorless solution.

Pharmacotherapeutic group:Hypoglycemic agent - short-acting insulin

ATX: & nbsp

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

Pharmacodynamics:

Gansulin P is a human insulin obtained using recombinant DNA technology. It is a short-acting insulin preparation. The main effect of insulin is the regulation of glucose metabolism. Interacts with a specific receptor 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 synthetase, etc.). In addition, insulin has an anabolic and anti-catabolic effect on various tissues. In muscle tissue, this is manifested by increased synthesis of glycogen, fatty acids, glycerol and protein, with simultaneous suppression of glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism, and amino acid release.Patients may deviate from the mean time of onset and / or the severity of insulin effects. Individual variability may depend on factors such as dose, injection site, body temperature and physical activity of the patient.

The action profile for subcutaneous injection (approximate figures): the onset of action after 30 minutes, the maximum effect is in the interval between 1 and 3 hours, the duration of the action is up to 8 hours.

Pharmacokinetics:

The pharmacokinetics of insulin does not reflect the metabolic action of this hormone. Therefore, when considering the activity of insulin, it is more expedient to study the glucose utilization curves.

Completeness of absorption and the beginning of the effect of insulin depend on the place of administration (abdomen, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the preparation, etc. Insulin is distributed unevenly across the tissues: it 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, which needs insulin therapy.

Contraindications:

- Increased individual sensitivity to insulin or any other component included in the preparation;

- hypoglycemia.

Pregnancy and lactation:

Pregnancy

During pregnancy it is especially important to maintain good glycemic control in patients with diabetes who are receiving insulin therapy. During the first trimester, the need for insulin usually decreases and increases during the II and III trimesters. Women with diabetes should inform their doctors about the presence or planning of pregnancy.

Pregnant women with diabetes require careful monitoring of glucose concentration and general health.

Immediately after delivery, the need for insulin decreases dramatically.

Breastfeeding period

During breastfeeding, patients with diabetes may require a dose adjustment of insulin and / or diet, since during breastfeeding the need for insulin is lower than before pregnancy. Return to the initial state occurs in 6-9 months.

Dosing and Administration:

The drug Gensulin R is intended for subcutaneous, intramuscular and intravenous administration.The dose and route of administration of the drug is determined by the physician individually in each case based on the concentration of glucose in the blood.

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 glucose in the blood).

In type 2 diabetes, the mean initial dose is 0.2 IU / kg body weight.

The drug Gansulin P can be used in intensified insulin therapy as prandial insulin associated with ingestion.

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 a day). At a daily dose exceeding 0.6 IU / kg, the drug should be administered as 2 or more injections in various areas of the body.

The drug Gansulin P is usually injected subcutaneously into the anterior abdominal wall. Injections can also be done in the thigh area, buttock or shoulder area in the projection of the deltoid muscle. At least once a month, it is necessary to change the injection site within the anatomical area to prevent the development of lipodystrophy.

Careful adherence to the rules for administering the drug is necessary to prevent the needle from entering the blood vessel. In this regard, the patient should be trained in the technique of injecting insulin. Do not massage the injection site of insulin after its injection.

Intramuscularly and intravenously, the drug Gensulin P can be administered only under the supervision of a doctor.

The drug Gansulin P can be administered in combination with insulin of medium duration (Gensulin N) (see section "Instructions for use").

The drug Gansulin P should be administered 30 minutes before meals.

The drug Gansulin P can be used in combination with oral hypoglycemic drugs.

Instructions for use

The drug Gansulin P in the vial and cartridge does not require stirring before use. Gansulin P can be used only when the contents are a clear, colorless solution without insoluble particles and looks like water.

The technique of injection with the use of insulin in vials

For the introduction of insulin, special syringes are used depending on the concentration of insulin administered.It is recommended to use syringes of the same type and of one manufacturer. It is necessary to check the correctness of syringe calibration taking into account the concentration of used insulin.

Preparation for injection

- Remove the protective aluminum cap from the vial.

- Disinfect the vial with alcohol. Do not remove the rubber plug!

- Introduce air into the syringe in an amount corresponding to the dose of insulin.

- Insert the needle into the center of the rubber stopper and draw air into the vial.

- Turn the vial with insulin upside down with the needle inside.

- Make sure that the end of the needle is in the insulin solution.

- Collect the necessary dose of insulin in a syringe.

- Remove air bubbles from the syringe.

- Check the correctness of the dose of insulin and remove the needle from the vial.

Dosing Introduction

- Disinfect the skin at the injection site with alcohol.

- With one hand, straighten or fold a large area of skin.

- With the other hand, insert the syringe needle at an angle of 90 °. Make sure that the needle is inserted completely and is in the subcutaneous fat, and not in the deeper layers of the skin (in very thin people it may be necessary to insert the needle at an angle of 45 °, and not perpendicularly).

- To enter the insulin, you must push the piston all the way down, injecting the dose in less than 5 seconds.

- Carefully remove the needle from the skin by holding a tampon with alcohol. Press the swab to the injection site for a few seconds. Do not rub the injection site after injection.

- To avoid tissue damage, it is recommended that you use different locations for each injection. The new injection site should be at least 1-2 cm from the previous site.

The technique of injection with the use of insulin in cartridges

Cartridges with the preparation Gensulin R are intended for use with syringe-pens for the introduction of insulin (for example, Bioton Pen and Gensupen). The patient should carefully study the instructions for the use of the syringe-pen for insulin administration and follow the instructions in the instructions for the use of the syringe pen.

The cartridge device does not allow mixing of its contents with other insulins directly in the cartridge. Empty cartridges are not refilled.

Dosing Introduction

Enter the necessary dose of insulin prescribed by your doctor. The injection site should be changed so that the same place is used no more often than once a month.

Mixing solution for injection Gansulin P with suspension for subcutaneous administration Gansulin N

The decision on the need to mix a solution for injection Gansulin R with a suspension for subcutaneous administration Gansulin N can be taken only by a doctor. During the preparation of the mixture, insulin with a shorter action (Gensulin P preparation) should be taken into the syringe first. The introduction of insulin occurs as described above.

Side effects:

Hypoglycemia is the most common undesirable reaction in the treatment of insulin, which develops in patients with diabetes mellitus. Severe hypoglycemia can lead to loss of consciousness and, in extreme cases, death. The frequency of hypoglycemia is not represented, since hypoglycemia can result from both an overdose of insulin and other factors, for example, dietary errors and excessive physical exertion.

Frequency of occurrence is defined as follows: Often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1 000 and <1/100), rarely (≥ 1/10 000 and <1/1 000), rarely (< 1/10 000).

Frequency of occurrence of undesirable reactions

Immune system disorders

Infrequently: urticaria, skin rash.

Rarely: systemic allergy.

Frequency unknown: the formation of antibodies to insulin.

Systemic allergy is very rare, but a potentially more serious condition is a generalized hypersensitivity to insulin. It can cause a generalized rash, shortness of breath, noisy breathing, lowering blood pressure, tachycardia, or excessive sweating. Severe cases of generalized allergies can be life threatening. In rare cases of severe allergy to Gansulin P, immediate treatment is required.

You may need to change your insulin or desensitization.

Disturbances on the part of the organ of sight

Infrequently: violation of refraction.

Frequency unknown: temporary worsening of the course of diabetic retinopathy.

Disturbances from the skin and subcutaneous tissues

Infrequently: lipodystrophy at the injection site.

General disorders and disorders at the site of administration

Often: peripheral edema.

Often: local allergy.

At the injection site of insulin, erythema, edema and pruritus can be observed. This condition is usually resolved within a few days or weeks. In some cases, local reactions may be due to factors,not associated with insulin, in particular, irritating components of skin disinfectants or a violation of injection technology.

Overdose:

Insulin has no specific symptoms of overdose, since the concentration of glucose in the blood is the result of complex metabolic processes. Hypoglycemia can result from an excess of insulin relative to the food intake and energy expenditure.

Hypoglycemia can be manifested by apathy, confusion, tachycardia, headache, increased sweating and vomiting, hunger, palpitation, tremors, paleness of the skin, headache, dizziness, anxiety, decreased visual acuity, decreased concentration, impaired orientation and paresthesia of the oral mucosa.

Cases of mild hypoglycemia the patient can eliminate himself by taking sugar or carbohydrate-rich foods inside. Therefore, patients with diabetes are encouraged to always carry sugar (but not sugar substitutes), sweets, cookies or sweet fruit juice.

In case of moderate hypoglycemia can be limited to intramuscular or subcutaneous administration of glucagon followed by oral ingestion of carbohydrates. In the absence of response to the introduction of glucagon, patients need to inject a solution of dextrose (glucose) intravenously.

Severe hypoglycemia can manifest neurological disorders, including convulsions, and lead to the development of coma. When developing hypoglycemic coma should be introduced glucagon intramuscularly or subcutaneously. However, in the absence of glucagon or a response to its administration, intravenous glucose solution is indicated. After restoration of consciousness the patient is recommended to take food rich in carbohydrates, to prevent the repeated development of hypoglycemia.

Long-term carbohydrate intake and observation are necessary because hypoglycemia can occur after a visible clinical recovery.

Interaction:

A number of drugs affect the metabolism of glucose. The doctor should consider possible interactions and ask the patient about taking other medications.

Hypoglycemic action of insulin enhances oral hypoglycemic drugs, salicylates (for example, acetylsalicylic acid), some antidepressants (monoamine oxidase inhibitors), some angiotensin-converting enzyme inhibitors (captopril, enalapril), inhibitors of carbonic anhydrase, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, nonselective β-adrenoconverters and preparations containing ethanol.

Hypoglycemic action of insulin weakens glucocorticosteroids, thyroid hormones, somatropin, danazol, β2-sympatomimetics (ritodrin, salbutamol, terbutaline), thiazide diuretics, niacin, oral contraceptives, heparin, tricyclic antidepressants, clonidine, blockers of "slow" calcium channels, diazoxide, morphine, phenytoin, nicotine, estrogens, glucagon, epinephrine, blockers H₁-gistaminovyh receptors.

Under the influence of reserpine and salicylates, analogues of somatostatin (octreotide, lanreotide), both attenuation and enhancement of insulin action are possible.

Incompatibility

The drug Gansulin P should not be mixed with insulin produced by other manufacturers, or with insulin of animal origin.

Special instructions:

The drug Gansulin P should be used with caution in patients with severe stenosis of the coronary and cerebral arteries (due to the increased risk of cardiac or cerebral complications of hypoglycemia) and in patients with proliferative retinopathy, especially those who are not receiving photocoagulation (laser coagulation), because of the risk of amaurosis blindness).

Transfer of the patient to another type or preparation of insulin with another trade name should be carried out under strict medical supervision. Changes in the dose, trademark (manufacturer), type (soluble, isophane, biphasic mixture), species (animal, human, human insulin analog) and / or production method (recombinant DNA or animal source of insulin) may necessitate dose adjustment.

In the case of transfer from animal insulin to human insulin, some patients may require a dose adjustment. Dose adjustment can be performed with the administration of the first dose or during the first few weeks or months.

In some patients, after the transfer to human insulin, early precursors of hypoglycemia may occur,less pronounced or different from those that were observed earlier with the introduction of animal insulin. In patients whose blood glucose concentration has significantly decreased (for example, with intensified insulin therapy), the precursors of hypoglycemia may be less pronounced or not manifest at all, which patients should be informed about. Other conditions that may alter the manifestations of hypoglycemia precursors or reduce their severity include a prolonged history of diabetes mellitus, diabetic neuropathy, or the administration of medications such as β-adrenoceptor blockers. Uncorrected hypoglycemic or hyperglycemic reactions can lead to loss of consciousness, coma or death.

Incorrect dosing or cancellation of insulin therapy, especially in type 1 diabetes, can cause hyperglycemia and diabetic ketoacidosis, which can lead to death. The first symptoms of hyperglycemia and diabetic ketoacidosis develop gradually over a period of several hours or days. These include the appearance of thirst, increased frequency of urination, nausea, vomiting, dizziness,redness and dryness of the skin, dryness of the oral mucosa, loss of appetite, odor of acetone in the exhaled air. Treatment with human insulin can cause the formation of antibodies, but in lower titres than when treated with purified insulin of animal origin.

The need for insulin can vary significantly in pancreatic diseases, adrenal gland failure, pituitary gland or thyroid gland, as well as in renal or hepatic impairment and in patients older than 65 years.

The need for insulin can increase with febrile illness, severe infectious diseases and gastrointestinal disorders such as nausea, vomiting, diarrhea, delayed gastric emptying and malabsorption, as well as in the case of neurological disorders.

Correction of the dose of insulin may also be required if the patient increases the intensity of physical activity or changes the habitual diet, when changing the place of injection of insulin, as well as when taking other medications.

Patients intending to cross at least two time zones should consult with their doctor about the scheme of insulin therapy.During travel, insulin should be stored in hand luggage, and not in the luggage compartment (insulin can not be frozen!).

With prolonged insulin therapy, insulin resistance can develop. In this case, higher doses of insulin should be used.

Do not apply Gensulin P if it becomes cloudy, colored or if solid particles are detected.

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

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.

Combined use of the drug Gensulin P and thiazolidinediones

There have been reports of chronic heart failure in the treatment of patients with type 2 diabetes mellitus with insulin preparations in combination with thiazolidinediones, especially if there are risk factors for developing chronic heart failure. This should be borne in mind when combined use of pioglitazone and the drug Gansulin R. In this case, it is necessary to conduct a medical examination of patients in order to exclude the symptoms of chronic heart failure, increase in body weight and edema.With the progression of symptoms from the cardiovascular system, the use of pioglitazone should be discontinued.

Special precautions for disposal and other treatments

Do not reuse the needle. Dispose of the needles according to the instructions. Needles and syringe-pens are items of individual use. The drug contained in the cartridges can be used completely, the cartridges must be disposed of in accordance with the regulations in force. It is necessary to dispose of any unused product or waste in accordance with current requirements.

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

As a result of hypoglycemia, the patient's ability to concentrate and react may be compromised. This can create a risk in situations where these capabilities are particularly important (for example, when driving vehicles and / or working with mechanisms).

Patients are advised to take precautions to avoid hypoglycemia in the management of vehicles and mechanisms. This is especially important for patients who have a weakened or lack of sense of precursors of hypoglycemia or frequent cases of hypoglycemia.In such cases it is necessary to assess the appropriateness of driving vehicles and mechanisms.

Form release / dosage:

Solution for injection, 100 IU / ml.

Packaging:

For 10 ml in a vial of clear, colorless glass (type 1), sealed with a rubber stopper, covered with an aluminum cap with or without a snap-off lid. For 1 bottle with instructions for use in a cardboard bundle.

For 3 ml in a glass cartridge (type 1), equipped with a rubber piston, a rubber disk, coated with an aluminum cap. 5 cartridges per blister. For 1 blister with instructions for use in a cardboard bundle.

Packing in bulk:

For 10 ml in a vial of clear, colorless glass (type 1), sealed with a rubber stopper, covered with an aluminum cap with or without a snap-off lid.

153 bottles are placed in a cardboard box.

For 3 ml in a glass cartridge (type 1), equipped with a rubber piston, a rubber disk, coated with an aluminum cap. 5 cartridges per blister.

52 blisters are placed in a cardboard box.

Storage conditions:

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

After opening the package, store the drug at a temperature of no higher than 25 ° C for 28 days, in a dark place.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001978

Date of registration:10.08.2010 / 08.04.2015

Expiration Date:Unlimited

The owner of the registration certificate:BIOTEK MFPDK, CJSC BIOTEK MFPDK, CJSC Russia

Manufacturer: & nbsp

BIOTON, S.A. Poland

Information update date: & nbsp23.03.2017

Illustrated instructions

Instructions

Gensulin R (Gensulin R)