active substance: human insulin (rdnc)
1 ml of solution for injection contains 100 IU of insulin human biosynthetic (recombinant DNA derived from Saccharomyces cerevisiae)
one MO (international Unit) is equal to 0,035 mg of anhydrous human insulin;
other ingredients:zinc chloride, glycerin, metacresol, sodium hydroxide, diluted hydrochloric acid, water for injections.The
Solution for injection.The
Antidiabetic drugs. Insulin and short-acting analogues. PBX code A10A B01.
treatment of diabetes mellitus.
Hypersensitivity to human insulin or to any ingredient of the drug. Hypoglycemia.
ActrapidNM Panfilis a drug of short-acting insulin, so it is often used in combination with long-acting insulin.
the Dosage of insulin the individual and is determined by a physician in accordance with the needs of the patient.
The individual daily insulin requirement is usually between 0.3 and 1.0 IU/kg/day. Daily insulin demand may increase in patients with insulin resistance (for example, in the puberty period or obesity) and decrease in patients with residual endogenous insulin production.
Injection should be done 30 minutes prior to lunch or another meal containing carbohydrates.
Concomitant diseases, especially infections and feverish conditions, usually increase the patient's need for insulin. Concomitant diseases of the kidneys, liver or adrenal glands, pituitary or thyroid gland require changes in the dose of insulin.
dose adjustment may also be required when patients change physical activity or their usual diet. Dose selection may also be required when transferring patients to other insulin drugs.
ActrapidNM Panfilis intended for subcutaneous or intravenous injection. Administration of the drug ActrapidNM Penfilfrom the cartridge is performed only in cases where there are no bottles. In this case, the drug should be collected with a syringe for insulin, removing air from the syringe, and perform infusion or inject the drug by infusion. This procedure should be performed only by a doctor.
product actrapideNM Penfil100 IU/ml at a concentration of human insulin from 0.05 U/ml in an infusion solution containing 0.9% sodium chloride, 5% or 10% glucose and 40 mmol/l potassium chloride and is in polypropylene infusion containers, is stable at room temperature for 24 hours. A certain amount of insulin in the beginning can be adsorbed on the inner surface of the infusion tank. During insulin infusion it is necessary to monitor the concentration of glucose in the blood.
actrapidenm Penfilis usually administered subcutaneously in areas of the anterior abdominal wall, as well as the thighs, buttocks or deltoid muscle of the shoulder.
in subcutaneous injections into the anterior abdominal wall, insulin absorption occurs faster than in other parts of the body.
The introduction to the delayed fold of the skin significantly reduces the risk of contact with the muscle.
after injection, the needle should remain under the skin for at least 6 seconds. This will ensure the introduction of the full dose.
to reduce the risk of lipodystrophy, the injection site should always be changed even within one area of the body.
Intramuscular injections can be done under the supervision of a physician.
Cartridges Penfillis intended for use with pen pen Novo Nordisk and needles Novofeinor Novotwist. You should follow the detailed instructions for using these medical devices.
Instructions for use of the drug ActrapidNM Panfilfor the patient
do Not use ActrapidNM Penfil:
in infusion pumps;
if you are allergic (hypersensitivity) to human insulin or any other ingredient of the drug
if you suspect that you are developing hypoglycemia (low blood sugar)
if the cartridge or the device containing the cartridge, fell, damaged or creased;
if the medicine has been stored improperly or has been frozen;
if insulin is not transparent and colorless.
before use ActrapidNM Penfil:
make sure the insulin type matches the prescribed one;
you should always check the cartridge, including the rubber plunger (stopper). Do not use the cartridge if there is any external damage or if the visible portion of the rubber piston exceeds the width of the white strip. The damaged cartridge should be returned to the supplier;
always use a new needle for each injection to prevent contamination;
needle and cartridge with ActrapidNM Penfilare intended for individual use only.
How to use this insulin drug
Actrapid NM Penfill is administered by injection under the skin (subcutaneously). Always change the injection site even within one area of the body to reduce the risk of developing seals or smallpox on the skin. The best places for self-injection is the front of the abdomen, buttocks, front hips or shoulders. Insulin will act faster if you enter it in the abdomen.
how to administer this insulin drug
Inject insulin under the skin as recommended by the doctor or nurse as described in the instructions, added to the syringe pen.
after injection, the needle should remain under the skin for at least 6 seconds. To remove the needle from the skin should be pressed until it stops on the piston pen. This will ensure the correct dosage of insulin and limit the possibility of blood entering the needle or cartridge with insulin.
after each injection, the needle should be detached and ejected. ActrapidNM Panfilshould be stored without the needle, otherwise the liquid may leak out which can lead to incorrect dosing.
Do not fill the ink cartridge ActrapidNM Penfilagain.
Cartridges Penfillis intended for use in syringe pens Novo Nordisk needles Novofineor Novotwist.
with simultaneous treatment with ActrapidNM Penfiland another type of insulin in penfilcartridges for each cartridge, use a separate syringe pen, one for each type of insulin.
you Should always have a spare syringe pen and the cartridge as a preventive measure in case of loss or damage.
Frequent side effect of therapy is hypoglycemia. It can occur when the dose significantly exceeds the needs of the patient in insulin. According to clinical studies, as well as data on the use of the drug after its release to the market, the frequency of hypoglycemia varies in different groups of patients, with different dosing regimens and levels of control of glycemia.
at the beginning of insulin therapy, refraction, swelling and reaction disorders may occur at the injection site (pain, redness, urticaria, inflammation, bruising, swelling and itching at the injection site). These reactions are usually transient. Rapid improvement of glucose control in the blood can result in of course a reversible state of acute painful neuropathy. Long-term well-established glycemic control reduces the risk of diabetic retinopathy progression. However, the intensification of insulin therapy to quickly improve glycemic control can cause a temporary exacerbation of diabetic retinopathy.
according to clinical studies, the following are adverse reactions classified by frequency and classes of organ systems according to MedDRA.
in frequency of occurrence these reactions were divided into those that occur very often (?1/10), often (?1/100 to <1/10), sometimes (>1/1000 to< 1/100), rarely (>1/10000 to <1/1000), very rarely (< 1/10000), with unknown frequency (cannot be determined based on available data).
by the immune system
Anaphylactic reactions - very rarely.
Violation metabolism and nutrition
Hypoglycaemia is very common.
from nervous system
Peripheral neuropathy (painful neuropathy) is sometimes.
Diabetic retinopathy is very rare.
skin and subcutaneous tissue Reactions
Lipodystrophy is sometimes.
Generalized disturbances and reactions at the injection site
reactions at the injection site - sometimes.
when insulin is administered at injection sites, skin reactions (redness, swelling and itching, pain, hematoma) may occur, which usually take place during the continuation of treatment.
Individual adverse reactions
symptoms of generalized hypersensitivity (including generalized skin rashes, itching, sweating, digestive disorders, angioedema, shortness of breath, rapid heartbeat, low blood pressure and dizziness/loss of consciousness) are very rare but can be potentially life-threatening.
a Frequent side effect is hypoglycemia. It can occur when the dose significantly exceeds the needs of the patient in insulin. Severe hypoglycemia can lead to loss of consciousness and/or seizures with subsequent temporary or permanent disorders of brain function and even death. Symptoms of hypoglycemia usually occur suddenly. They may include cold sweat, pale and cold-blooded skin, fatigue, nervousness or tremor, anxiety, unusual fatigue or weakness, confusion, difficulty concentrating, drowsiness, excessive hunger, visual changes, headache, nausea and palpitations.
lipodystrophy was reported occasionally. Lipodystrophy may develop at the injection site.
Although insulin specific concept of overdose is not formulated, but after its introduction may develop hypoglycemia in the form of successive stages, if used too high in comparison with the needs of the patient dose.The
once the patient comes, he should take foods that contain carbohydrates to prevent relapse.
Since insulin does not pass through the placental barrier, there are no restrictions in treating diabetes with insulin during pregnancy.
during the whole period of pregnancy and suspected pregnancy, it is recommended to strengthen the control over the treatment of pregnant women with diabetes, as inadequate control of diabetes increases the risk of malformations and death of the fetus, both hypoglycemia and hyperglycemia.
insulin Demand usually decreases in the first trimester of pregnancy and gradually increases in the second and third trimesters. After birth, insulin demand usually quickly returns to its baseline.
restrictions on the treatment of diabetes drug Actrapidnm Penfilduring breastfeeding is 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 and diet for the mother.The
Preparations of biosynthetic human insulin are effective and safe medicines at treatment of diabetes mellitus of children and teenagers of different age groups. The daily insulin requirement in children and adolescents depends on the stage of the disease, body weight, age, diet, physical activity, degree of insulin resistance and dynamics of glycemic level.
Inadequate dosing or discontinuation of treatment (especially in type I diabetes) can lead tohyperglycemia. Usually the first symptoms of hyperglycemia develop gradually, within a few hours or days. They include a sense of thirst, frequent urination, nausea, vomiting, drowsiness, redness and dry skin, dry mouth, loss of appetite, and the smell of acetone in exhaled air.
in type 1 diabetes, hyperglycemia, which is not treated, leads to diabetic ketoacidosis, which is potentially deadly.
Hypoglycemiamay occur at a very high dose of insulin relative to insulin requirements.
Missing a meal or unexpected increased exercise may result in hypoglycemia.
Patients who have significantly improved blood glucose control due to intensive insulin therapy may note changes in the usual symptoms of hypoglycemic harbingers, as they should be warned in advance.
Common precursor symptoms may disappear in patients with long-term diabetes.
transfer the patient to another type or type of insulin takes place under strict medical supervision. Changing the concentration, type (producer), type, origin of insulin (human or equivalent of human insulin) and/or method of production may require correction of insulin dose. Patients who are transferred to ActrapidNM Penfilwith another type of insulin may require an increase in the number of daily injections or a change in dosage compared to insulin, which they usually used. The need for dose selection may occur as the first introduction of a new drug, and during the first few weeks or months of its application.
when applying any insulin therapy, reactions may occur at the injection site, which may include pain, redness, itching, urticaria, swelling, bruising and inflammation. Constant change of injection site in one area can reduce or prevent the occurrence of these reactions. Reactions usually disappear within a few days or weeks. In rare cases, the reaction at the injection site may require discontinuation of treatment with ActrapidNM Penfil.
before traveling with a change of time zones, patients should get a doctor's advice, as this changes the schedule of insulin injections and meals.
ActrapidNM Panfilshould not be used in insulin pumps for long-term subcutaneous administration of insulin in connection with the risk of the formation of sediment in their tubes.
Combination of thiazolidindiones and insulin products
when using thiazolidindiones in combination with insulin, cases of congestive heart failure were reported, especially in patients with risk factors for congestive heart failure. This should be taken into account when prescribing treatment with a combination of thiazolidindiones with insulin. The combined use of these drugs patients should be kept under medical supervision for the development of signs and symptoms of congestive heart failure, weight gain and edema formation. In the event of any deterioration in heart function treatment with Thiazolidinediones should be discontinued.The
the patient's Reaction and ability to concentrate may be impaired by hypoglycemia. This can be a risk factor in situations where these abilities are of particular importance (e.g. when driving or working with other machinery).
Patients should be advised to take measures to prevent hypoglycemia before you drive. This is especially important for patients who have weakened or no symptoms-hypoglycemic precursors or episodes of hypoglycemia occur frequently. In such circumstances, it is necessary to weigh the feasibility of driving.The
a number of drugs are known to affect glucose metabolism.
Medicines that may reduce insulin demand
Oral hypoglycemic agents (MSS), monoamine oxidase inhibitors (MAO), non-selective b-adrenoblockers, ACE inhibitors (ACE), salicylates, anabolic steroids and sulfanilamides.
Medicines that may increase insulin requirementThe
the Hypoglycemic effect of insulin is to promote the absorption of glucose by tissues after binding insulin with receptors of muscle and fat cells, as well as the simultaneous inhibition of glucose release from the liver.
the results of a clinical study in one intensive care unit in the treatment of hyperglycemia (blood glucose levels above 10 mmol/l) in 204 patients with diabetes, and 1344 patients without diabetes, who underwent major surgery, showed that normoglycemia (glucose level 4, 4-6, 1 mmol/l), induced by the introduction of Actrapidnm Penfil>, decreased by 42% (mortality by 8%). compared to 4.6%).
ActrapidNM Panfilis a drug of short-acting insulin.
onset of action poteryatsya for 30 minutes, the maximum effect is reached within 1.5-3.5 hours and duration of action is approximately 7-8 hours.
the half-life of insulin from the blood is a few minutes, so the profile of the insulin drug is determined solely by the absorption characteristics. This process depends on a number of factors (for example, on the dose of insulin, the method and place of injection, the thickness of subcutaneous tissue, type of diabetes), which causes a significant variability in the effect of insulin preparation in both one and different patients.
Absorption.the Peak concentration in plasma is reached within 1.5-2.5 hours after drug administration.
Distribution.Significant binding of insulin to plasma proteins, with the exception of circulating antibodies to it (if any), has not been revealed.
Metabolism.Human insulin insulin is cleaved by the protease or insulinzawisimy enzymes and possibly proteincarbohydrate. A number of sites where breaks (hydrolysis) of the human insulin molecule occur are revealed. None of the metabolites formed after hydrolysis, has no biological activity.
Output.the duration of the final half-life of insulin is determined by the rate of its absorption from the subcutaneous tissue. That is why the duration of the final half-life (t?) indicates the rate of absorption rather than elimination (as such) of insulin from the blood plasma (t ? of insulin from the bloodstream is only a few minutes). According to the studies, t ? is 2-5 hours.
children and adolescents
the Pharmacokinetic profile of the drug Actrapidnm Penfilwas studied in a small number (n = 18) of children (6-12 years) and adolescents (13-17 years) with diabetes. Limited evidence suggests that the pharmacokinetic profile of insulin in children, adolescents and adults is almost the same. However, the level ofmax(maximum concentration) was different in children of different ages, indicates the importance of individual selection of doses of the drug.
Preclinical safety data
Preclinical studies (toxicity of repeated administration, genotoxicity, Carcinogenicity, toxic effects on reproductive capacity) did not reveal any risk of drug administration ActrapidNM Panfil.
a colourless, transparent liquid containing no foreign particles may show traces of very fine sediment during storage.The
generally, insulin can be added to the substances with which his response compatibility is known. Drugs that are added to insulin can cause its destruction, such as drugs that contain thiols or sulfites.The
Store in a refrigerator at 2 ° C - 8 ° C. do Not freeze.
store cartridges in secondary packaging to protect against exposure to light.
after opening: use within 6 weeks. Do not store in the refrigerator. Store at a temperature not exceeding 30 ° C.
do not use after the expiry date indicated on the package.
keep out of reach of children.The
Glass cartridge (type 1) with a capacity of 3 ml that the rubber piston (bramborova rubber) and closed with rubber disk (bramborova/polyisoprene rubber). 5 cartridges in a cardboard box.The
According to the recipe.The
A/T Novo Nordisk, Denmark.
Novo Nordisk A/S, Denmark.The
Novo alle, DK-2880, Bagsvaerd, Denmark.
Novo Alle, DK-2880 Bagsvaerd, Denmark.
Actrapid NM Penfil is an antidiabetic agent included in the group of insulin and short-acting analogues. The drug is a solution for injection. Available as a transparent liquid, placed in 3 ml glass cartridge (first type). In 1 milliliter of the drug contains 100 IU human insulin. The package of cardboard 5 cartridges.
the Hypoglycemic properties of insulin are due to the binding of the element with receptors in muscle and fat cells. Thereby increasing the uptake of glucose by body tissues and the simultaneous oppression of component selection in the liver.
onset of action of the drug occurs within 30 minutes after ingestion. The maximum effect is observed after 2-3 hours.
the drug is indicated for the treatment of diabetes mellitus.
the Dosage and duration of therapy are determined by the specialist based on the needs of the patient. The normal daily requirement for the tool can be 0.3-1 IU per 1 kg/day. The amount of medication consumed may be affected by factors such as:
Actrapid NM Penfill administered subcutaneously or intravenously. To do this, take an insulin syringe, collect the solution from the cartridge, remove the air and make the infusion.