Humulin NPH suspension for subcutaneous injection. 100U / ml, 3ml No. 5 cartridge

• Diabetes mellitus in the presence of indications for insulin therapy;

• newly diagnosed diabetes mellitus;

• pregnancy with type 2 diabetes mellitus (non-insulin dependent).

The dose is set by the doctor individually, depending on the level of glycemia.

The drug should be administered subcutaneously, possibly intramuscularly. IV injection of Humulin NPH is contraindicated!

S / c the drug is injected into the shoulder, thigh, buttocks or abdomen. The injection site must be alternated so that the same site is used no more than about 1 time / month.

When administered subcutaneously, care must be taken to avoid entering the blood vessel. After injection, do not massage the injection site. Patients should be trained in the correct use of insulin delivery devices.

Rules for the preparation and administration of the drug

Before use, Humulin NPH cartridges and vials should be rolled between the palms 10 times and shaken, turning 180 ? also 10 times to resuspend insulin until it looks like a homogeneous cloudy liquid or milk. Do not shake vigorously. this can lead to foam, which can interfere with the correct dosage.

Check cartridges and vials carefully. Insulin should not be used if it contains flakes after stirring, if hard white particles adhere to the bottom or walls of the bottle, creating a frosty pattern effect.

The design of the cartridges does not allow mixing their contents with other insulins directly in the cartridge itself. Cartridges are not refillable.

The contents of the vial should be drawn into an insulin syringe corresponding to the concentration of insulin injected, and the required dose of insulin should be administered as directed by the doctor.

When using cartridges, follow the manufacturer's instructions for cartridge refilling and needle attachment. The drug should be administered in accordance with the instructions of the manufacturer of the syringe pen.

Using the outer needle cap, unscrew the needle immediately after insertion and safely discard. 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.

The needles should not be reused. Needles and pen pens must not be used by others. Use cartridges and vials until they become empty, after which they should be discarded.

Humulin NPH can be administered in combination with Humulin Regular. To do this, short-acting insulin should be drawn into the syringe first to prevent longer-acting insulin from entering the vial. It is desirable to introduce the prepared mixture immediately after mixing. A separate syringe for Humulin Regular and Humulin NPH can be used to inject the exact amount of each type of insulin.

Always use an insulin syringe that matches the concentration of insulin you are administering.

1 ml contains:
The active substance is human insulin 100 IU / ml.
Excipients: metacresol, glycerol (glycerin), phenol, protamine sulfate, sodium hydrogen phosphate, zinc oxide, water for injection, hydrochloric acid solution 10% and / or sodium hydroxide solution 10% can be used in the production process to adjust the pH.

• Hypersensitivity to insulin or to one of the components of the drug.

• Hypoglycemia.

Pharmacological properties
Pharmacodynamics
HumulinЃ NPH is a DNA-recombinant human insulin. The main action of insulin is the regulation of glucose metabolism. In addition, it has anabolic and anti-catabolic effects on various body tissues. In muscle tissue, there is an increase in the content of glycogen, fatty acids, glycerol, an increase in protein synthesis and an increase in the consumption of amino acids, but at the same time there is a decrease in glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and the release of amino acids.
Humulin NPH is a medium-acting insulin preparation. The onset of action of the drug is 1 hour after administration, the maximum effect is between 2 and 8 hours, the duration of action is 18-20 hours. Individual differences in insulin activity depend on factors such as dose, choice of injection site, physical activity of the patient, etc.

Pharmacokinetics
The completeness of absorption and the onset of the effect of insulin depends on the injection site (abdomen, thigh, buttocks), dose (volume of injected insulin), concentration of insulin in the preparation, etc. It is distributed unevenly in tissues; does not penetrate 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%).

Use during pregnancy and lactation
During pregnancy, it is especially important to maintain good control in patients receiving insulin therapy (with insulin-dependent diabetes or gestational diabetes). Insulin requirements usually decrease during the first trimester and increase during the second and third trimesters. During and immediately after childbirth, the need for insulin can drop dramatically. Patients with diabetes mellitus are advised to inform their doctor about pregnancy or planning a pregnancy. In patients with diabetes mellitus, adjustments in insulin dose, diet, or both may be required while breastfeeding.

Side effect
Hypoglycemia is the most common side effect that occurs with the administration of insulin preparations, including HumulinЃ NPH. Severe hypoglycemia can lead to loss of consciousness and, in exceptional cases, death.
Allergic reactions: patients may experience local allergic reactions in the form of redness, swelling or itching at the injection site. These reactions usually stop within a few days to several weeks. In some cases, these reactions can be caused by reasons not related to insulin, for example, skin irritation with a cleansing agent or improper injection.
Systemic allergic reactions caused by insulin are less common but more serious. They can manifest as generalized itching, difficulty breathing, shortness of breath, decreased blood pressure, increased heart rate, increased sweating. Severe cases of systemic allergic reactions can be life threatening. In rare cases of severe allergy to HumulinЃ NPH, immediate treatment is required. You may need to change insulin, or conduct desensitization.
With prolonged use, lipodystrophy may develop at the injection site.

Overdose
Insulin overdose causes hypoglycemia, accompanied by the following symptoms: lethargy, excessive sweating, tachycardia, pallor of the skin, headache, trembling, vomiting, confusion. Under certain conditions, for example, with a long duration or with intensive control of diabetes mellitus, the precursor symptoms of hypoglycemia may change.
Mild conditions of hypoglycemia can usually be controlled by ingestion of glucose or sugar. Adjustments to your insulin dose, diet, or physical activity may be required. Correction of moderate hypoglycemia can be carried out using intramuscular or subcutaneous administration of glucagon, followed by ingestion of carbohydrates. Severe conditions of hypoglycemia, accompanied by coma, seizures or neurological disorders, are stopped by intramuscular / subcutaneous administration of glucagon or intravenous administration of a concentrated glucose solution. After the restoration of consciousness, the patient must be given food rich in carbohydrates in order to avoid the re-development of hypoglycemia.

Interaction with other medicinal products
An increase in insulin dosage may be required in the case of prescribing drugs that increase blood glucose levels, such as: oral contraceptives, glucocorticosteroids, thyroid hormones, danazol, beta2-adrenergic agonists (for example, ritodrin, salbutamol, terbutaline), thiazide diuretics, chlorprothixene, diazidiazid , lithium carbonate, nicotinic acid, phenothiazine derivatives. A decrease in the dosage of insulin may be required in the case of prescribing drugs that lower blood glucose levels, such as: beta-blockers, ethanol and ethanol-containing drugs, anabolic steroids, fenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (for example, acetylsalicylic acid), antibiotics some antidepressants (monoamine oxidase inhibitors),angiotensin-converting enzyme inhibitors (captopril, enapril), octreotide, angiotensin II receptor antagonists.
Beta-blockers, clonidine, reserpine can mask the manifestation of symptoms of hypoglycemia.
Incompatibility. The effects of mixing human insulin with animal insulin or human insulin from other manufacturers have not been studied.

Special instructions
Transfer of a patient to another type or preparation of insulin with a different trade name should take place under strict medical supervision. Changes in the activity of a brand (manufacturer), type (Regular, MZ, animal insulin) may lead to the need for dose adjustment.
For some patients, when switching from animal insulin to human insulin, it may be necessary to adjust the dose. This can occur as early as the first administration of a human insulin preparation, or gradually over several weeks or months after transfer.
Symptoms - precursors of hypoglycemia during the administration of human insulin in some patients may be less pronounced or differ from those observed during the administration of insulin of animal origin. - harbingers of hypoglycemia about which patients should be informed. Symptoms - the precursors of hypoglycemia may change or be less pronounced with a long course of diabetes mellitus, diabetic neuropathy or treatment with drugs such as beta-blockers The use of inadequate doses or discontinuation of treatment, especially in patients with insulin-dependent diabetes mellitus, can lead to hyperglycemia and diabetic ketoacidosis (conditions, potentially threatening the patient's life).
The need for insulin may decrease with insufficient function of the adrenal glands of the pituitary or thyroid gland, with renal or hepatic insufficiency.In some diseases or with emotional overstrain, the need for insulin may increase. Insulin dosage adjustments may also be required if you increase your physical activity or change your usual diet.

Influence on the ability to drive vehicles and control mechanisms
During hypoglycemia, the patient's concentration of attention and the speed of psychomotor reactions may decrease. This can be dangerous in situations where these abilities are especially needed (for example, driving a car or using machinery).
Patients should be advised to take precautions to avoid hypoglycemia while driving. This is especially important for patients with mild or absent symptoms - precursors of hypoglycemia or with frequent development of hypoglycemia. In such cases, the physician should evaluate the appropriateness of the patient's driving.