Protafan nm penfill instructions for use, contraindications, side effects, reviews

Suspension for subcutaneous administration1 ml
active substance:
insulin isophane (human genetically engineered)100 IU (3.5 mg)
(1 IU corresponds to 0.035 mg of anhydrous human insulin)
Excipients: zinc chloride, glycerin (glycerol), metacresol, phenol, sodium hydrogen phosphate dihydrate, protamine sulfate, sodium hydroxide and / or hydrochloric acid (for pH adjustment), water for injection
1 bottle contains 10 ml of the drug, which corresponds to 1000 IU

Protafan ® HM Penfill ®

Suspension for subcutaneous administration1 ml
active substance:
insulin isophane (human genetically engineered)100 IU (3.5 mg)
(1 IU corresponds to 0.035 mg of anhydrous human insulin)
Excipients: zinc chloride, glycerin (glycerol), metacresol, phenol, sodium hydrogen phosphate dihydrate, protamine sulfate, sodium hydroxide and / or hydrochloric acid (for pH adjustment), water for injection
1 Penfill ® cartridge contains 3 ml of the drug, which corresponds to 300 IU

Release form Protafan nm penfill, product packaging and composition.

Suspension for s / c injection of white, when standing, stratified, forming a white precipitate and a colorless or almost colorless supernatant, with stirring, the precipitate should be resuspended.

1 ml
insulin isophane (human genetically engineered)
100 IU *

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

* 1 IU corresponds to 35 µg of anhydrous human insulin.

3 ml - colorless glass cartridges (5) - blisters (1) - packs cardboard.

DESCRIPTION OF ACTIVE SUBSTANCE.
All the above information is presented only for familiarization with the drug, the possibility of the use need to consult with your doctor.

How to use Protaphan?

Insulin dosage is individual and is determined by the doctor in accordance with the needs of the patient.

On average, the daily need for insulin in the treatment of diabetes is from 0.5 to 1.0 IU / kg body weight. In prepubertal children, it varies from 0.7 to 1.0 IU / kg. During the period of partial remission, the need for insulin can significantly decrease, whereas, in conditions of insulin resistance, for example, during puberty or during obesity, the daily need for insulin can increase significantly.

Initial doses of insulin for patients with type 2 diabetes are often lower, for example, from 0.3 to 0.6 IU / kg / day.

The doctor determines the number of injections per day (one or more) that are necessary for the patient. Protafan can be administered separately or mixed with high-speed insulin. With intensive insulin therapy, suspensions are used as basal insulin, which is administered in the evening and / or in the morning, and fast-acting insulin is administered before a meal.

Optimizing metabolic control in diabetic patients delays the onset and slows down the development of late complications of diabetes. Therefore, it is recommended to monitor blood glucose levels.

In elderly and senile patients, the first task of treatment is to alleviate the symptoms of diabetes and prevent the development of hypoglycemia.

Protafan NM is intended for subcutaneous injections.

Protafan NM is usually injected under the skin of the thigh. You can also enter in the region of the anterior abdominal wall, buttocks or deltoid shoulder muscles.

With subcutaneous injections in the thigh, insulin absorption is slower than when administered to other parts of the body.

Introducing a skin fold is greatly reducing the risk of getting into the muscle.

To prevent lipodystrophy injections should be changed places even within the same area of ​​the body.

Insulin suspensions should never be administered intravenously.

Pharmachologic effect

It interacts with a specific plasma membrane receptor and enters the cell, where it activates the phosphorylation of cellular proteins, stimulates glycogen synthase, pyruvate dehydrogenase, hexokinase, inhibits adipose tissue lipase, and lipoprotein lipase. In combination with a specific receptor, it facilitates the penetration of glucose into cells, enhances its absorption by tissues and promotes its conversion into glycogen. Increases the supply of glycogen in the muscles, stimulates the synthesis of peptides.

Clinical Pharmacology

The effect develops 1.5 hours after s / c administration, reaches a maximum after 4–12 hours and lasts 24 hours. Protafan NM Penfill with insulin-dependent diabetes mellitus is used as basal insulin in combination with short-acting insulin, with non-insulin-dependent - as for monotherapy , and in combination with high-speed insulin.

Interaction

Acetylsalicylic acid, alcohol, alpha- and beta-adrenergic blockaders, cephrafts, anabolic steroids, clofibrate, cyclophosphamide, trifluramine, fluoxetine, ifosfamide, MAO inhibitors, methyldopa, tetracyclines, tritoqualine, trifluramine, trifluramine thiazides), glucocorticoids, heparin, hormonal contraceptives, isoniazid, lithium carbonate, nicotinic acid, phenothiazines, sympathomimetics, tricyclic antidepressants.

Dosage and administration

Protafan ® HM Penfill ®

PC. The drug is intended for subcutaneous administration. Insulin suspensions should not be administered IV.

The dose of the drug is selected individually, taking into account the needs of the patient. Usually the need for insulin ranges from 0.3 to 1 IU / kg / day. The daily insulin requirement may be higher in patients with insulin resistance (for example, during puberty, as well as in patients with obesity), and lower in patients with residual endogenous insulin production.

Protafan ® NM can be used both in monotherapy and in combination with insulin of quick or short action.

Protafan ® NM is usually injected subcutaneously in the thigh. If this is convenient, then injections can also be made in the anterior abdominal wall, in the gluteal region, or in the deltoid muscle of the shoulder. With the introduction of the drug in the thigh region, a slower absorption is observed than with the introduction in other areas. If the injection is made into a skin fold, the risk of accidental intramuscular injection of the drug is minimized.

The needle must remain under the skin for at least 6 s, which ensures complete dose administration. It is necessary to constantly change the injection sites within the anatomical region in order to prevent the development of lipodystrophies.

Protafan ® NM Penfill ® is designed for use with injection systems for administering insulin from Novo Nordisk and NovoFine ® or NovoTvist ® insulin. Follow the detailed recommendations on the use and administration of the drug.

Concomitant diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin. Dosage adjustment of the drug may also be required if the patient has concomitant diseases of the kidneys, liver, dysfunction of the adrenal glands, pituitary gland or thyroid gland. The need for dose adjustment may also occur when changing physical activity or the usual diet of the patient. Dose adjustment may be required when transferring a patient from one type of insulin to another.

Overdose

Symptoms: development of hypoglycemia (cold sweat, palpitations, tremor, hunger, agitation, irritability, pallor, headache, drowsiness, uncertainty of movements, impaired speech and vision, depression). Severe hypoglycemia can lead to temporary or permanent dysfunction of the brain, coma and death.

Treatment: sugar or glucose solution inside (if the patient is conscious), p / c, v / m or v / v - glucagon or v / v - glucose.

Prices in Moscow pharmacies

Fit to seriesprice, rub.Pharmacies
9568879.00
To pharmacy
650.00
To pharmacy

The presented information on the prices of drugs is not an offer to sell or buy a product.
The information is intended solely for comparing prices in stationary pharmacies operating in accordance with Article 55 of the Federal Law “On Circulation of Medicinal Products” dated April 12, 2010 N 61-ФЗ.

Pharmacokinetics

The half-life of insulin from the bloodstream is just a few minutes.

The duration of the action of insulin preparations is mainly due to the rate of absorption, which depends on several factors (for example, on the insulin dose, the method and place of administration, the thickness of the subcutaneous fat layer and the type of diabetes mellitus). Therefore, the profile of the pharmacokinetic parameters of insulin is subject to significant inter- and intra-individual fluctuations.

Maximum concentration (Cmaxa) Insulin in plasma is reached within 2-18 hours after subcutaneous administration.

There is no marked binding to plasma proteins, with the exception of antibodies to insulin (if present).

Human insulin is cleaved by insulin protease or insulin cleaving enzymes, and possibly also by protein disulfide isomerase. It is assumed that in the human insulin molecule there are several cleavage sites (hydrolysis), but none of the metabolites formed due to cleavage is active.

Elimination half-life (t½) is determined by the rate of absorption from subcutaneous tissue. So t½ rather, it is a measure of absorption, rather than the actual measure of insulin elimination from plasma (T½ insulin from the bloodstream is only a few minutes). Studies have shown that T½ is about 5-10 hours.

Preclinical safety data

In the course of preclinical studies, including pharmacological safety studies, toxicity studies with repeated dosing, genotoxicity, carcinogenic potential and toxic effects on the reproductive sphere, no specific human risk was identified.

Pregnancy and lactation period

Restrictions on the use of insulin during pregnancy does not exist, since insulin does not penetrate the placental barrier.

Both hypoglycemia and hyperglycemia, which can develop in cases of insufficiently well-chosen therapy, increase the risk of fetal malformations and fetal death. Pregnant women with diabetes throughout pregnancy should be monitored, they need to exercise enhanced control of blood glucose levels, the same recommendations apply to women who are planning a pregnancy.

Insulin requirements usually decrease in the first trimester of pregnancy and gradually increase in the second and third trimesters.

After childbirth, the need for insulin, as a rule, quickly returns to the level that was noted before pregnancy.

There are also no restrictions for the use of the drug Protafan® NM in the period of lactation. Conducting insulin therapy for lactating mothers is not dangerous for the child. However, the mother may need to adjust the dosage regimen of Protafan® NM and / or diet.

Side effect

The most common adverse event with insulin is hypoglycemia. During clinical trials, as well as during the use of the drug after its release on the consumer market, it was found that the frequency of hypoglycemia varies depending on the patient population, the dosage regimen of the drug and the level of glycemic control (see "Descriptionseparate adverse reactions ").

At the initial stage of insulin therapy, refractive disorders, edema and reactions at the injection sites (including pain, redness, urticaria, inflammation, bruising, swelling and itching at the injection site) can occur. These symptoms are usually temporary. A rapid improvement in glycemic control can lead to a state of “acute pain neuropathy,” which is usually reversible. Intensification of insulin therapy with a dramatic improvement in the control of carbohydrate metabolism can lead to a temporary deterioration of diabetic retinopathy, while at the same time, a prolonged improvement in glycemic control reduces the risk of progression of diabetic retinopathy.

The list of side effects is presented in the table.

All the side effects presented below, based on data from clinical trials, are grouped according to developmental frequency in accordance with MedDRA and organ systems. The incidence of side effects is defined as: very often (≥ 1/10), often (≥ 1/100 to

Precautionary measures

Hypoglycemia can develop if an excessively high dose of insulin is administered in relation to the patient’s needs.

Skipping meals or unplanned intense exercise can lead to hypoglycemia.

After compensation of carbohydrate metabolism, for example, in case of intensified insulin therapy, the typical symptoms of hypoglycemia, which are typical for them, may change in patients, about which patients should be informed. The usual symptoms, precursors can disappear with a long course of diabetes.

Transfer of patients to another type of insulin or insulin of another manufacturer company should be carried out only under medical supervision. When changing the concentration, type, type (human insulin, human insulin analogue) and / or method of manufacture, it may be necessary to change the insulin dose. Patients who switch to treatment with Protafan® NM may need to change the dose or increase the frequency of injections compared to previously used insulin preparations. If, when transferring patients to treatment with Protafan® NM, a dose adjustment is necessary, this can be done already with the first dose or in the first weeks or months of therapy.

As with the treatment of other insulin preparations, reactions can develop at the injection site, which is manifested by pain, redness, urticaria, inflammation, bruising, swelling and itching. Regularly changing the injection site in the same anatomical area will help reduce the symptoms or prevent the development of these reactions. Reactions usually disappear within a few days to a few weeks. In rare cases, it may be necessary to discontinue Protafan® NM due to reactions at the sites of administration.

Before traveling, associated with the change of time zones, the patient should consult with your doctor, because the change of time zone means that the patient must eat and inject insulin at another time.

Insulin suspensions cannot be used in insulin pumps.

The simultaneous use of preparations of the thiazolidinedione group and insulin preparations

Cases of the development of congestive heart failure have been reported in the treatment of patients with thiazolidinediones in combination with insulin preparations, especially when these patients have risk factors for the development of congestive heart failure. This fact should be taken into account when prescribing the combination therapy for thiazolidindions and insulin preparations to patients.When prescribing such a combination therapy, it is necessary to conduct medical examinations of patients in order to identify their signs and symptoms of congestive heart failure, weight gain and the presence of edema. In case of worsening in patients with symptoms of heart failure, treatment with thiazolidinediones should be stopped.

Influence on ability to drive and work with mechanisms

The ability of patients to concentrate and the speed of reaction may be impaired during hypoglycemia, which can be dangerous in those situations when these abilities are especially necessary (for example, when driving a car or working with machines and mechanisms).

Patients should be advised to take measures to prevent the development of hypoglycemia while driving. This is especially important for patients with the absence or decrease in the severity of symptoms, precursors of developing hypoglycemia or suffering from frequent episodes of hypoglycemia. In these cases, you should consider the feasibility of driving and performing similar work.

Storage conditions

At a temperature of 2 ° C to 8 ° C (in the refrigerator), but not near the freezer. Do not freeze.

Store cartridges in a carton box to protect from light.

For opened cartridges: Do not refrigerate. Store at a temperature not exceeding 30 ° C for 6 weeks.

Protafan ® NM Penfill ® should be protected from exposure to excessive heat and light.

Keep out of the reach of children. Keep out of the reach of children.

Instructions for the patient

Protafan NM in vials used with special insulin syringes, which have an appropriate calibration. The drug is intended for individual use only.

Before using the drug Protafan NM, you should make sure that this is the type of insulin that is prescribed. It is necessary to disinfect the surface of the rubber stopper of the bottle.

When the patient uses only Protafan NM:

  • Immediately before use, roll a bottle of insulin between your hands until the liquid turns white and evenly turbid.
  • Type in a syringe air volume equal to the dose of insulin injected.
  • Inject air into the vial.
  • Turn the bottle with the syringe upside down.
  • Type in the syringe required dose of insulin.
  • Remove the needle from the vial.
  • Expel air from the syringe.
  • Check if the dose is correct.
  • Immediately make an injection.
When a patient should mix Protafan NM with short-acting insulin:
  • Immediately before use, roll a bottle of Protaphan NM between your palms until the liquid turns white and evenly turbid.
  • Type in a syringe air volume equal to the dose Protafanu NM. Inject air into the vial with Protafan NM and remove the needle from the vial.
  • Type in a syringe of air volume equal to the dose of short-acting insulin. Inject air into a vial of short-acting insulin. Turn the bottle with the syringe upside down.
  • Draw in a syringe the required dose of short-acting insulin. Remove the needle from the vial. Expel air from the syringe. Check if the dose is correct.
  • Insert the needle into the bottle with Protafan NM. Turn the bottle with the syringe upside down.
  • Gather in the syringe the necessary dose of Protafan NM. Remove the needle from the vial. Throw out the air from the syringe and check that the dose is correctly taken.
  • Immediately introduce the mixture.
  • Always mix short and long-acting insulin in the same sequence.

How to enter insulin

Cover the skin with two fingers, insert the needle into the skin fold and make a subcutaneous injection of insulin.

Hold the needle under the skin for at least 6 seconds to ensure that all insulin is injected.

Inadequate dosages or discontinuation of treatment (especially in type 1 diabetes) can lead to hyperglycemia and diabetic ketoacidosis. Usually, the first symptoms of hyperglycemia develop gradually, over several hours or days. They include: feeling of thirst, frequent urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, and the smell of acetone in the exhaled air (see section Side Effects).

In type 1 diabetes, hyperglycemia, which is not treated, leads to diabetic ketoacidosis, which is potentially deadly.

Hypoglycemia can occur if the insulin dose exceeds the need for it. In general, hypoglycemia can be treated by ingesting carbohydrates. Patients should be able to do this immediately, so they are advised to always have glucose with them.

Skipping meals or unanticipated increased physical exertion can lead to hypoglycemia.

Patients who have significantly improved blood glucose control due to intensive insulin therapy may notice changes in the usual symptoms of precursors of hypoglycemia, which should be prevented in advance (see the section Side effects).

The usual symptoms of precursors can disappear in people with diabetes for a long time.

Concomitant diseases, especially infections and febrile conditions, usually increase the patient’s need for insulin.

Renal or hepatic impairment can lead to cumulation of insulin.

The need to adjust the dose of insulin may occur in cases where patients increase physical activity or change their usual diet.

The transfer of the patient to another type or type of insulin occurs under strict medical supervision. Changes in concentration, type (manufacturer), type (fast-acting insulin, biphasic insulin, long-acting insulin), the origin of insulin (animal, human or analogue of human insulin) and / or the method of production (recombinant DNA compared to animal insulin) may necessitate correction insulin doses. When transferring a patient to Protafan NM injections, there may be a need to change the usual dose of insulin. The need for dose selection may arise both at the first injection of a new drug, and during the first few weeks or months of its use.

Some patients who, after switching from animal to human insulin, had hypoglycemic reactions, noted a reduction or alteration of the symptoms that preceded hypoglycemia.

Patients should consult a physician before traveling in different time zones, as this changes the schedule for insulin injections and food intake.

Insulin suspensions cannot be used in insulin pumps for continuous subcutaneous administration of insulin.

Protafan NM contains metacresol, which can cause allergic reactions.

Pregnancy and breastfeeding

Since insulin does not pass through the placental barrier, there are no restrictions on treating diabetes with insulin during pregnancy. It is recommended to strengthen control over the treatment of pregnant women with diabetes during the entire period of pregnancy, as well as when pregnancy is suspected, because with inadequate control of diabetes, both hypoglycemia and hyperglycemia increase the risk of malformations and fetal death.

The need for insulin usually decreases in the first trimester of pregnancy and increases significantly in the second and third trimesters.

After delivery, the need for insulin quickly returns to its original level.

Restrictions on the treatment of diabetes with insulin during lactation are also not, because the treatment of the mother does not pose any risk to the child. However, it may be necessary to adjust the dose.

Influence on the ability to drive vehicles and mechanisms.

The reaction of the patient and his ability to concentrate attention may be impaired with hypoglycemia. This can be a risk factor in situations where these abilities are of particular importance (for example, when driving a car or machinery).

Patients should be advised to take measures to prevent hypoglycemia before getting behind the wheel. This is especially important for patients who have weakened or absent symptoms, precursors of hypoglycemia, or episodes of hypoglycemia occur frequently. Under such circumstances, the question of whether to drive a car in general should be resolved.

Incompatibility

As a rule, insulin can be added to substances with which its compatibility is known. Insulin suspensions should not be mixed with infusion solutions. Drugs added to an insulin suspension can cause its destruction, for example, preparations containing thiols or sulfites.

Protafan NM Penfil - 3 ml cartridges for use with the Novo Nordisk insulin syringe pens and NovoFine needles. Cartridges should be used only with syringe pens that are compatible with them and ensure the safety and effectiveness of cartridge use.

Insulin dosage is individual and is determined by the doctor in accordance with the needs of the patient.

On average, the daily need for insulin in the treatment of diabetes is from 0.5 to 1.0 IU / kg and more, depending on the condition of the individual patient.

Dosage and method of use of the drug.

Enter n / a, 1-2 times / day, 30-45 minutes before breakfast. The injection site should be replaced each time. In special cases, a / m introduction is possible.

In / in the introduction of insulin of the average duration of action is not allowed.

Doses set individually, depending on the content of glucose in the blood and urine, the characteristics of the disease.

Use during pregnancy and lactation.

During pregnancy, it is necessary to take into account a decrease in the need for insulin in the first trimester or an increase in the second and third trimesters. During childbirth and immediately after them, the need for insulin can decrease dramatically.

During lactation, daily observation is necessary for several months (until the need for insulin is stabilized).

Special instructions for use Protafan nm penfill.

With caution is carried out the selection of the dose of the drug in patients with previously existing cerebral circulatory disorders of the ischemic type and with severe forms of coronary artery disease.
The need for insulin can change in the following cases: when switching to another type of insulin, when changing diet, diarrhea, vomiting, when changing the usual amount of physical activity, with kidney, liver, pituitary, thyroid, changing the injection site.
Insulin dose adjustment is required for infectious diseases, thyroid dysfunction, Addison's disease, hypopituitarism, chronic renal failure, and diabetes mellitus in patients over 65 years of age.

The transfer of a patient to a person’s insulin must always be strictly justified and carried out only under the supervision of a physician.

The causes of hypoglycemia can be: insulin overdose, replacement of the drug, skipping meals, vomiting, diarrhea, physical stress, diseases that reduce the need for insulin (severe kidney and liver disease, as well as hypofunction of the adrenal cortex, pituitary gland or thyroid gland), change of injection site (for example, abdominal skin, shoulder, thigh), as well as interaction with other drugs. Perhaps a decrease in the concentration of glucose in the blood when transferring a patient from animal insulin to human insulin.

The patient should be informed about the symptoms of the hypoglycemic state, the first signs of diabetic coma and the need to inform the doctor about all changes in his condition.

In the case of hypoglycemia, if the patient is conscious, dextrose is administered orally, subcutaneously, intramuscularly or intravenously, glucagon or intravenous hypertonic dextrose is administered. With the development of hypoglycemic coma, a dose of 20-40 ml (up to 100 ml) of a 40% dextrose solution is injected into the jet stream until the patient leaves the comatose state.

Patients with diabetes can stop the mild hypoglycemia felt by themselves by taking sugar or food that is high in carbohydrates (patients are always advised to have at least 20 grams of sugar with them).

Alcohol tolerance in patients receiving insulin is reduced.

Influence on ability to drive motor transport and control mechanisms

Tendency to the development of hypoglycemia may impair the ability of patients to drive vehicles and work with mechanisms.