Protafan NM suspension d / n / c injection 100 IU / ml, 10 ml No. 1

Diabetes

The drug is intended for subcutaneous administration.

The dose of the drug is selected individually, taking into account the needs of the patient. Typically, the need for insulin is between 0.3 and 1 IU / kg / day. The daily insulin requirement may be higher in patients with insulin resistance (for example, during puberty, as well as in obese patients), and lower in patients with residual endogenous insulin production. In addition, the doctor determines how many injections the patient should receive per day - one or more. Protafan NM can be administered both as monotherapy and in combination with fast or short acting insulin. If it is necessary to carry out intensive insulin therapy, this suspension can be used as a basal insulin (injection is carried out in the evening and / or in the morning), in combination with fast or short-acting insulin,injections of which should be timed to coincide with meals. If patients with diabetes mellitus achieve optimal glycemic control, the complications of diabetes tend to develop later. In this regard, one should strive to optimize metabolic control, in particular by carefully monitoring blood glucose levels.

Protafan NM is usually injected subcutaneously into the thigh area. If it is convenient, then injections can also be done in the anterior abdominal wall, in the gluteal region or in the region of the deltoid muscle of the shoulder. When the drug is injected into the thigh area, there is a slower absorption than when the drug is introduced into the anterior abdominal wall. If the injection is made into a retracted skin fold, then the risk of accidental intramuscular injection of the drug is minimized.

It is necessary to change injection sites within the anatomical region to prevent the development of lipodystrophies.

Suspensions of insulin, under no circumstances, should not be administered intravenously.

Dose adjustment

With kidney or liver damage, the need for insulin decreases.

Instructions for use of Protafan NM to be given to the patient

Vials with Protafan NM can only be used in conjunction with insulin syringes with a scale that allows you to measure the dose in units of action. Vials with Protafan NM are intended for individual use only. Before using a new bottle of Protafan NM, it is recommended to allow the preparation to warm to room temperature before stirring.

Before using the drug Protafan NM, you must:

1.Check the packaging to make sure the correct type of insulin is selected.

2. Disinfect the rubber stopper with a cotton swab.

Protafan NM should not be used in the following cases:

1.Do not use the drug in insulin pumps.

2. Patients need to be explained that if a new bottle just received from the pharmacy does not have a protective cap or it does not fit tightly, such insulin must be returned to the pharmacy.

3. If the insulin was stored incorrectly, or if it was frozen.

4. If, while stirring the contents of the vial according to the instructions for use, the insulin does not become uniformly white and cloudy.

Injection technique

If the patient is using only one type of insulin

1. Immediately before dialing, roll the bottle between your palms until the insulin is uniformly white and cloudy. Resuspension is facilitated if the drug is at room temperature.

2. Draw air into the syringe in the amount corresponding to the required dose of insulin.

3. Introduce air into the insulin vial by piercing the rubber stopper with a needle and pressing the plunger.

4. Turn the syringe bottle upside down.

5. Draw the required dose of insulin into the syringe.

6. Remove the needle from the vial.

7. Remove air from the syringe.

8. Check that the dose is set correctly.

9. Inject immediately.

If the patient needs to mix Protafan NM with short-acting insulin

1. Roll the bottle of Protafan HM ('cloudy') between your palms until the insulin is uniformly white and cloudy. Resuspension is facilitated if the drug is at room temperature.

2. Fill the syringe with air in the amount corresponding to the dose of Protafan NM ('cloudy' insulin). Introduce air into the 'cloudy' insulin vial and remove the needle from the vial.

3. Draw in the syringe the amount of air that corresponds to the dose of short-acting ('clear') insulin. Introduce air into the vial with this drug. Turn the syringe bottle upside down.

4. Draw up the desired dose of short-acting ('clear') insulin. Remove the needle and remove air from the syringe. Check the correct dose.

5. Insert the needle into the vial with Protafan HM ('cloudy' insulin) and turn the vial with the syringe upside down.

6. Dial the required dose of Protafan NM. Remove the needle from the vial. Remove air from the syringe and check that the correct dose is drawn.

7. Immediately inject the short-acting and long-acting drawn insulin mixture.

Always draw short-acting and long-acting insulins in the same sequence as described above.

Instruct the patient to administer insulin in the same sequence as described above.

1. With two fingers, gather a fold of skin, insert the needle into the base of the fold at an angle of about 45 degrees, and inject insulin under the skin.

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

Suspension for subcutaneous administration of white color, stratifies upon standing, forming a white precipitate and a colorless or almost colorless supernatant liquid; with stirring, the precipitate should be resuspended.

1 ml 1 fl.

insulin isophane (human genetic engineering) 100 IU * 1000 IU *

Excipients: zinc chloride, glycerol, metacresol, phenol, sodium hydrogen phosphate dihydrate, protamine sulfate, hydrochloric acid and / or sodium hydroxide (to maintain the pH level), water d / i.

* 1 IU corresponds to 35 ?g of anhydrous human insulin.

• Hypoglycemia;

• hypersensitivity to human insulin or to any component that is part of this drug.

pharmachologic effect

Protafan NM is an intermediate-acting human insulin produced by recombinant DNA biotechnology using the Saccharomyces cerevisiae strain. It interacts with a specific receptor of the outer cytoplasmic membrane of cells 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.). A decrease in blood glucose is due to an increase in its intracellular transport, increased absorption by tissues, stimulation of lipogenesis, glycogenogenesis, a decrease in the rate of glucose production by the liver, etc.

The duration of action of insulin preparations is mainly determined by the rate of absorption, which depends on several factors (for example, the dose, route, site of administration, and type of diabetes). Therefore, the profile of insulin action is subject to significant fluctuations, both in different people and in the same person. Its action begins within 1.5 hours after administration, and the maximum effect appears within 4-12 hours, while the total duration of action is about 24 hours.

Pharmacokinetics

Suction

The completeness of absorption and the onset of the effect of insulin depends on the route of administration (subcutaneous injection, intramuscular injection), the injection site (abdomen, thigh, buttocks), dose (volume of insulin injected), and the concentration of insulin in the preparation. Cmax of insulin in plasma is achieved within 2-18 hours after subcutaneous administration.

Distribution

There is no pronounced binding to plasma proteins, sometimes only circulating antibodies to insulin are detected.

Metabolism

Human insulin is cleaved by insulin protease or insulin-cleaving enzymes, and possibly also by protein disulfide isomerase. It is assumed that there are several cleavage sites (hydrolysis) in the human insulin molecule; however, none of the metabolites resulting from degradation are active.

Withdrawal

T1 / 2 is determined by the rate of absorption from the subcutaneous tissue. Thus, T1 / 2 is more likely a measure of absorption, and not actually a measure of the removal of insulin from the plasma (T1 / 2 of insulin from the bloodstream is only a few minutes). Studies have shown that T1 / 2 is about 5-10 hours.

Preclinical safety data

In the course of preclinical studies, which included studies of toxicity with repeated administration of a dose, studies of genotoxicity, carcinogenic potential and toxic effects on the reproductive sphere, no specific risk to humans was identified.

Side effect

From the immune system: infrequently - urticaria, rash; very rarely - anaphylactic reactions. Symptoms of generalized hypersensitivity may include generalized skin rash, itching, sweating, gastrointestinal disorders, angioedema, shortness of breath, palpitations, decreased blood pressure, fainting / loss of consciousness. Generalized hypersensitivity reactions can be life-threatening.

From the nervous system: very rarely - peripheral neuropathy. If improvement in blood glucose control is achieved very quickly, a condition called acute painful neuropathy may develop, which is usually reversible.

From the side of the organ of vision: very rarely - refractive errors. Refractive errors are usually noted at the initial stage of insulin therapy. As a rule, these symptoms are reversible. Uncommon - diabetic retinopathy. If adequate glycemic control is ensured for a long time, then the risk of diabetic retinopathy progression is reduced. However, the intensification of insulin therapy with a sharp improvement in glycemic control can lead to a temporary increase in the severity of diabetic retinopathy.

From the side of the skin: infrequently - lipodystrophy. Lipodystrophy can develop at the injection site if there is no constant change of the injection site within the same area of ??the body.

On the part of the body as a whole, as well as reactions at the injection site: infrequently - reactions at the injection site. Against the background of insulin therapy, reactions may occur at the injection site (skin redness, swelling, itching, soreness, hematoma formation at the injection site). However, in most cases, these reactions are transient and disappear in the process of continuing therapy.

Infrequently - puffiness. Swelling is usually noted at the initial stage of insulin therapy. As a rule, this symptom is transient.

Application during pregnancy and lactation

There are no restrictions on the use of insulin during pregnancy because insulin does not cross the placental barrier. Moreover, if you do not treat diabetes mellitus during pregnancy, then there is a danger to the fetus. Therefore, diabetes therapy must be continued during pregnancy.

Both hypoglycemia and hyperglycemia, which can develop in cases of insufficiently selected therapy, increase the risk of fetal malformations and intrauterine fetal death. Pregnant women with diabetes should be monitored throughout their pregnancy, and they should have enhanced blood glucose control; the same recommendations apply to women who are planning a pregnancy. The need for insulin usually decreases in the first trimester of pregnancy and gradually increases in the II and III trimesters.

After childbirth, insulin requirements quickly return to pre-pregnancy levels.

There are also no restrictions on the use of Protafan NM during lactation. Providing insulin therapy to nursing mothers does not pose a danger to the baby. However, the mother may need to adjust the dosage regimen of Protafan NM and / or diet.

special instructions

With an incorrectly selected dose or with discontinuation of therapy, hyperglycemia may develop, especially in patients with type 1 diabetes mellitus. The first symptoms of hyperglycemia usually appear gradually, over several hours or days. Symptoms include nausea, vomiting, severe drowsiness, reddened, dry skin, dry mouth, increased urination, thirst, loss of appetite, and acetone odor from the mouth. If left untreated, hyperglycemia in type 1 diabetes can lead to life-threatening diabetic ketoacidosis. In cases of a significant improvement in glycemic control, for example, due to intensified insulin therapy, habitual symptoms-precursors of hypoglycemia may also change, and patients should be warned about this.In patients with long-term diabetes, the usual precursor symptoms of hypoglycemia may disappear,

With concomitant diseases, especially with infections and febrile conditions, patients' need for insulin usually increases.

If the patient is transferred from one type of insulin to another, then the early warning signs of hypoglycemia may change or become less pronounced than those that were noted with the introduction of the previous insulin.

The transfer of patients to another type of insulin or to insulin from another manufacturer should only be carried out under medical supervision. Changes in biological activity, change of manufacturer, type, species (animal, human, analog of human insulin) and / or manufacturing method may require a change in the dosage regimen.

Some patients who experienced episodes of hypoglycemia after switching from animal insulin reported that the early symptoms of hypoglycemia were less pronounced or different from those that were when using animal insulin.

If a dose adjustment is necessary, this can be done already with the introduction of the first dose or in the first weeks or months of therapy.

Skipping meals or unplanned strenuous exercise can cause hypoglycemia.

If the patient is going to travel across time zones, then he should consult a doctor, as he will have to change the time of insulin administration and meals.

Protafan HM should not be used in insulin pumps for continuous subcutaneous insulin administration.

The composition of the drug Protafan NM contains metacresol, which can cause allergic reactions.

Overdose

The specific dose, with the introduction of which one could talk about an overdose of insulin, has not been established, however, in cases where patients are administered too high doses that exceed their needs, hypoglycemia of varying severity may develop:

Mild hypoglycemia can be eliminated by the patient himself by ingesting sugar or carbohydrate-rich foods. Therefore, diabetics are advised to carry sugar, sweets, cookies or sweet fruit juice with them at all times.

In severe cases, when the patient loses consciousness, a 40% dextrose (glucose) solution is injected intravenously; i / m, s / c - glucagon (0.5-1 mg). After regaining consciousness, the patient is recommended to take food rich in carbohydrates to prevent the recurrence of hypoglycemia.

Drug interactions

There are a number of medications that affect your insulin requirement. The physician should know what medications the patient is taking in order to take into account possible drug interactions.

The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, drugs, ketoconazole, meboxinendazolum, drugs containing ethanol.

The hypoglycemic effect of insulin is weakened by oral contraceptives, GCS, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, growth hormone (somatropin), danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, fenytoxide.

Under the influence of reserpine and salicylates, both weakening and strengthening of the drug's action are possible.

Beta-blockers can mask the symptoms of hypoglycemia and make it difficult to eliminate hypoglycemia.

Octreotide / lanreotide can both decrease and increase insulin requirements.

Alcohol can increase and prolong the hypoglycemic effect of insulin.

Incompatibility

In general, insulin can only be used with compounds with which it is known to be compatible. Insulin suspensions should not be added to infusion solutions.