HUMULYN regulars

Active material: insulin human
When ATH: A10AB01
CCF: Short-acting human insulin
ICD-10 codes (testimony): E10, E11
When CSF: 15.01.01.01
Manufacturer: ELI LILLY VOSTOK S.A.. (Switzerland)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Solution for injection sterile, clear, colorless, pH 7-7.8.

Excipients: m-cresol distilled (2.5 mg / ml), glycerol, water d / and, hydrochloric acid, Sodium hydroxide.
3 ml – cartridges (5) – blisters (1) – packs cardboard.

Solution for injection clear, colorless.

Excipients: cresol, glycerol (glycerol), water d / and, hydrochloric acid (solution 10%) and/or sodium hydroxide (solution 10%) to create the required pH level.

10 ml – bottles (1) – packs cardboard.

Solution for injection.

10 ml – bottles (1) – packs cardboard.

Solution for injection.

10 ml – bottles (1) – packs cardboard.

Solution for injection clear, colorless.

Excipients: cresol, glycerol (glycerol), water d / and, hydrochloric acid (solution 10%) and/or sodium hydroxide (solution 10%) to create the required pH level.

3 ml – cartridges (5) – blisters (1) – packs cardboard.

Solution for injection clear, colorless.

Excipients: cresol, glycerol (glycerol), water d / and, hydrochloric acid (solution 10%) and/or sodium hydroxide (solution 10%) to create the required pH level.

4 ml – bottles (1) – packs cardboard.
10 ml – bottles (1) – packs cardboard.

Pharmacological action

DNA recombinant human insulin. Is a short-acting insulin.

The main effect of the drug is the regulation of glucose metabolism. Besides, it has an anabolic effect. In muscle and other tissues (except brain) insulin induces rapid intracellular transport of glucose and amino acids, accelerates protein anabolism. Insulin promotes the conversion of glucose to glycogen in the liver, inhibits gluconeogenesis and stimulates the conversion of excess glucose into fat.

Pharmacokinetics

Humulin Regular is a short-acting insulin preparation..

The onset of the drug's action is 30 minutes after administration, maximum effect of action - between 1 and 3 no, duration of action 5-7 no.

Individual differences in insulin activity depend on such factors, how dose, choice of injection site, physical activity of the patient.

Testimony

- diabetes mellitus in the presence of indications for insulin therapy;

- newly diagnosed diabetes mellitus;

- Pregnancy with type 2 diabetes 2 (insulin-independent).

Dosage regimen

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

The drug should enter n/a, I /, possible intramuscular injection.

S / c the drug is injected into the shoulder area, hips, buttock or abdomen. The injection site must be alternated as follows, so that the same place is used no more often than 1 times / month.

When s / to a need for caution, to avoid getting into a blood vessel. After injection, do not massage the injection site. Patients should be trained in the correct use of insulin delivery devices.

Terms of preparation and administration

Cartridges and vials of Humulin Regular do not require resuspension and can only be used if, if their content is a clear, colorless liquid with no visible particles.

Cartridges and vials should be checked carefully. The drug should not be used, if it contains cereal, if solid white particles adhere to the bottom or sides of the bottle, creating the effect of a frosty pattern.

The device 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 administered, and administer the correct dose of insulin as directed by your doctor.

When using cartridges, follow the manufacturer's instructions for refilling the cartridge and fixing the needle. 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 dispose of 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. Needles and pens must not be used by others. Use cartridges and vials until, until they are empty, after which they should be thrown away.

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

Always use an insulin syringe, corresponding to the concentration of insulin administered.

Side effect

Side effect, associated with the main action of the drug: gipoglikemiâ.

Severe hypoglycemia can cause loss of consciousness and (in exceptional cases) death.

Allergic reactions: possible local allergic reaction – hyperemia, swelling or itching at the injection site (usually stop over a period of days to weeks); systemic allergic reactions (occur less frequently, but are more serious) – generalized itching, difficulty breathing, breathlessness, decrease in blood pressure, increased heart rate, increased perspiration. Severe cases of systemic allergic reactions may be life threatening.

Other: the likelihood of developing lipodystrophy is minimal.

Contraindications

- Gipoglikemiâ;

- hypersensitivity to insulin or to one of the components of the drug.

Pregnancy and lactation

It is especially important during pregnancy to maintain good glycemic control in patients with diabetes.. During pregnancy, the need for insulin usually decreases in the first trimester and increases in the second and third trimesters..

Patients with diabetes are advised to inform their doctor about the onset or planning of pregnancy.

In patients with diabetes mellitus during lactation (breast-feeding) may require dose adjustment of insulin, diet or both.

In studies of genetic toxicity in in vitro and in vivo series, human insulin did not have a mutagenic effect.

Cautions

The transfer of a patient to another type of insulin or to an insulin preparation with a different trade name must be carried out under strict medical supervision.. Changes in insulin activity, his type (eg, M3, NPH), specific accessory (pork, human insulin, human insulin analog) or production method (DNA recombinant insulin or animal insulin,) may lead to the need for dose adjustment.

The need for dose adjustment may be required as early as the first administration of a human insulin preparation after an animal insulin preparation or gradually over several weeks or months after transfer.

Insulin requirements may decrease with insufficient adrenal function, pituitary or thyroid, with kidney or liver failure.

With some diseases or with emotional stress, the need for insulin may increase.

Dose adjustments may also be required if you increase exercise or change your usual diet.

Symptoms-precursors of hypoglycemia against the background of human insulin administration in some patients may be less pronounced or differ from those, they have seen on the background of introduction of animal insulin. When normalizing blood glucose levels, for example as a result of intensive insulin therapy, may disappear some or all symptoms-harbingers of hypoglycemia, what patients should be informed.

Symptoms-harbingers of Hypoglycemia may change or be less pronounced with a long course of diabetes mellitus, diabetic neuropathy or with the simultaneous use of beta-blockers.

In some cases, local allergic reactions can be caused by reasons, not related to the action of the drug, for example, skin irritation with a cleansing agent or improper injection.

In rare cases of systemic allergic reactions, immediate treatment is required. Sometimes insulin changes or desensitization may be required.

Effects on ability to drive vehicles and management mechanisms

During hypoglycemia, the patient's ability to concentrate may deteriorate and the speed of psychomotor reactions may decrease.. This can be dangerous in situations, where these abilities are especially needed (driving or controlling mechanisms). Patients should be advised to take precautions to avoid hypoglycemia while driving.. This is especially important for patients with mild or absent symptoms that predict hypoglycemia or with frequent hypoglycemia.. In such cases, the physician should assess the appropriateness of the patient's driving..

Overdose

Symptoms: gipoglikemiâ, lethargic, increased sweating, taxikardiej, paleness of skin, headache, tremor, vomiting, confusion.

Under certain conditions, for example, with long duration or with intensive control of diabetes mellitus, symptoms gipoglikemii may change harbingers.

Treatment: mild hypoglycemic conditions can usually be controlled by ingestion of glucose (dextrose) or sugar. May require insulin dose adjustment, diet or physical activity.

Correction of moderate hypoglycemia can be carried out with the help of intramuscular or subcutaneous administration of glucagon, followed by ingestion of carbohydrates..

Heavy state of hypoglycemia, accompanied by coma, convulsions or neurological disorders, stop in / m or s / c with the introduction of glucagon or / in the introduction of a concentrated glucose solution (dextrose). After regaining consciousness of the patient is necessary to give food, rich in carbohydrates, in order to avoid a recurrence of hypoglycemia.

Drug Interactions

The hypoglycemic effect of Humulin Regular is reduced by oral contraceptives, corticosteroids, thyroid hormone drugs, thiazide diuretics, diazoksid, tricyclic antidepressants.

The hypoglycemic effect of Humulin Regular is enhanced by oral hypoglycemic drugs., salicilaty (eg, acetylsalicylic acid), sulfonamides, MAO inhibitors, beta-blockers, ethanol etanolsoderzhaschie drugs.

Beta-blockers, clonidine, rezerpin may mask symptoms gipoglikemii.

Pharmaceutical interaction

Effects, arising from mixing human insulin with animal insulin or human insulin, produced by other manufacturers, We have not been studied.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in a refrigerator at 2 ° to 8 ° C, keep from freezing, keep away from direct exposure to light. Shelf life – 2 year.

The drug in use in a vial or cartridge should be stored at room temperature. (from 15 ° to 25 ° C) no more 28 days.