Rinsulin NPH suspension for subcutaneous injection 100 IU/ml vial 10 ml

Composition

1 ml of the drug contains:Active ingredient:human insulin 100 IU; excipients:protamine sulfate 0.34 mg, metacresol 1.6 mg, crystalline phenol 0.65 mg, glycerol 16 mg, sodium hydrophosphate dihydrate 2.25 mg, water for injection up to 1 ml

. Pharmacological action

Pharmacotherapy group

Hypoglycemic agent, insulin of medium duration of action

CodATH-A10AC01.

Pharmacological properties

Pharmacodynamics.

Rinsulin ® NPH is human insulin produced using recombinant DNA technology. Insulin of medium duration of action. 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 synthase, etc. ).

The decrease in blood glucose is due to an increase in its intracellular transport, increased absorption and assimilation by tissues by stimulating lipogenesis, glycogenesis, 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, on the dose, 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, after subcutaneous administration of Rinsulin®, NPH begins to act in 1.5 hours, the maximum effect develops between 4 and 12 hours, and the duration of action is up to 24 hours.

Pharmacokinetics

The completeness of absorption and the onset of the effect of insulin depends on the site of administration (abdomen, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the drug, etc. It is distributed unevenly through the tissues; it does not penetrate through the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and kidneys. It is excreted by the kidneys (30-80%).

Indications

• Type 1 diabetes mellitus.
• Sugar. type 2 diabetes-stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (during combination therapy), intercurrent diseases.
• Type 2 diabetes mellitus in pregnant women.

Contraindications

• Increased individual sensitivity to insulin or any of the components of the drug.
• Hypoglycemia.

Side effects

Due to the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitation, tremor, chills, hunger, agitation, paresthesia of the oral mucosa, weakness, headache, dizziness, decreased visual acuity). Severe hypoglycemia can lead to the development of hypoglycemic coma. Allergic reactions: skin rash, angioedema, anaphylactic shock. Local reactions: hyperemia, – swelling and itching at the injection site, with prolonged use lipodystrophy at the injection site. Other services: edema, transient decrease in visual acuity (usually at the beginning of therapy). If a patient has experienced hypoglycaemia or has experienced an episode of unconsciousness, they should immediately inform their doctor. If any other side effects are detected that are not described above, the patient should also consult a doctor.

Interaction

There are a number of medications that affect the need for insulin. The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, monoamine oxidase inhibitors, angiotensin-converting enzyme inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, preparations containing ethanol. The hypoglycemic effect of insulin is weakened by glucagon, somatropin, estrogens, oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, thiazide diuretics, loop diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, epinephrine, _H1-histamine receptor blockers, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine. Under the influence of reserpine and salicylates, both a weakening and an increase in the effect of the drug is possible.

How to take, course of administration and dosage

The drug is intended for subcutaneous administration. The dose of the drug is determined by the doctor individually in each specific 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 of body weight (depending on the individual characteristics of the patient and the concentration of blood glucose). Intravenous administration of Rinsulin ® NPH is contraindicated. The temperature of the injected insulin should correspond to room temperature. The drug is usually administered subcutaneously in the thigh. Injections can also be made in the anterior abdominal wall, buttock, or shoulder area in the projection of the deltoid muscle. It is necessary to change the injection sites within the anatomical area to prevent the development of lipodystrophy. When injecting insulin subcutaneously, care must be taken to avoid injecting it into a blood vessel. After the injection, do not massage the injection site. Patients should be trained in the correct use of the device for injecting insulin. Rinsulin® NPH cartridges should be rolled between the palms of your hands in a horizontal position 10 times before use and rocked to resuspend the insulin until it looks like a homogeneous cloudy liquid or milk. Do not allow the appearance of foam, which can interfere with the correct dose set. Cartridges should be carefully checked. Do not use insulin if there are flakes in it after mixing, if solid white particles stick to the bottom or walls of the cartridge, giving it the appearance of frozen. The design of the cartridges does not allow their contents to be mixed with other insulins directly in the cartridge itself. The cartridges are not designed to be refilled. When using cartridges, follow the manufacturer’s instructions for refilling the cartridge into the pen and attaching the needle. The drug should be administered in accordance with the instructions of the manufacturer of the pen. After insertion, unscrew the needle using the outer needle cap and immediately destroy it safely. Removing the needle immediately after injection ensures sterility, prevents leakage, air ingress and possible clogging of the needle. Then put the cap on the handle. Needles should not be reused. Store the drug in use at room temperature (from 15 to 25°C). C) not more than 28 days, protect from direct sunlight and heat.

Overdose

In case of overdose of the drug, a hypoglycemic state may develop. The initial symptoms of a hypoglycemic state are sudden increased sweating, palpitations, tremors, hunger, agitation, paresthesia in the mouth, pallor, and headache. In severe cases of overdose, hypoglycemic coma may develop.

Treatment: the patient can eliminate mild hypoglycemia by taking sugar or carbohydrate-rich foods inside. In severe cases,20 – 40 ml of 40% glucose solution is administered intravenously, and 1 mg of glucagon is administered intramuscularly.

Special instructions

Do not use the drug if, after shaking, the suspension does not become white and evenly cloudy. During insulin therapy, constant monitoring of blood glucose concentration is necessary. Causes of hypoglycemia in addition to an overdose of insulin can be: drug replacement, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (liver and kidney disorders, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), changing the injection site, as well as interaction with other medications. The dose of insulin should be adjusted for thyroid disorders, Addison’s disease, hypopituitarism, liver and kidney disorders, and diabetes mellitus in people over 65 years of age. Adjustment of the insulin dose may also be required if the patient increases the intensity of physical activity or changes the usual diet. Concomitant diseases, especially infections and conditions associated with fever, increase the need for insulin. The transfer of a patient to a new type of insulin or an insulin preparation from another manufacturer must be carried out under the supervision of a doctor.

Storage conditions

• In a dark place at temperatures from +2°C to 4-8°C.
• Avoid freezing.

Shelf

life is 2 years.

Active ingredient

Human genetically engineered insulin isophane

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Weight

Weight: 30 gr.