Composition, form of production and packaging
Suspension for injection sterile, white, pH 6.9-7.5; when stored, exfoliates to form a white precipitate and a clear supernatant; The pellet is easily resuspended by gentle shaking.
1 ml
human insulin 100 IU
is a two-phase suspension or mixture:
insulin human soluble 30%
suspension of insulin isophane human 70%
Excipients: m-cresol distilled (1.6 mg / ml), glycerol, phenol (0.65 mg / ml), protamine sulfate, sodium phosphate dibasic, zinc oxide, water d / and hydrochloric acid, sodium hydroxide.
3 ml - cartridges (5) - blisters (1) - packs cardboard.
Suspension for s / c introduction of white, which is stratified, forming a white precipitate and a transparent colorless or almost colorless supernatant; The pellet is easily resuspended by gentle shaking.
1 ml
human insulin 100 IU
is a two-phase suspension or mixture:
insulin solution of a human soluble 30%
suspension of insulin isophane human 70%
Auxiliary substances: metacresol, glycerol (glycerol), phenol, protamine sulfate, sodium hydrogen phosphate, zinc oxide, water, hydrochloric acid (10% solution) and / or sodium hydroxide (10% solution) to create the necessary pH.
4 ml - vials (1) - packs cardboard.
10 ml - bottles (1) - packs of cardboard.
Suspension for injection 1 ml
human insulin 100 IU
is a two-phase suspension or mixture:
insulin human soluble 30%
suspension of insulin isophane human 70%
10 ml - bottles (5) - packs of cardboard ..
Suspension for injection 1 ml
human insulin 40 IU
is a two-phase suspension or mixture:
insulin human soluble 30%
suspension of insulin isophane human 70%
10 ml - bottles (5) - packs of cardboard ..
Suspension for s / c introduction of white, which is stratified, forming a white precipitate and a transparent colorless or almost colorless supernatant; The pellet is easily resuspended by gentle shaking.
1 ml
insulin two-phase (human genetically engineered) 100 IU
Auxiliary substances: metacresol 1.6 mg, glycerol 16 mg, phenol liquid 0.65 mg, protamine sulfate 0.244 mg sodium hydrophosphate 3.78 mg zinc oxide 0.011 mg water up to 1 ml hydrochloric acid solution 10 % - qs to pH 6.9-7.8, sodium hydroxide solution 10% - qs to pH 6.9-7.8.
3 ml - cartridges (5) - blisters (1) - a pack of cardboard.
3 ml - the cartridge, built-in the pen-handle KvikPen в„ў (5) - a pack of cardboard.
Suspension for s / c introduction of white, which is stratified, forming a white precipitate and a transparent colorless or almost colorless supernatant; The pellet is easily resuspended by gentle shaking.
1 ml
insulin two-phase (human genetically engineered) 100 IU
Auxiliary substances: metacresol 1.6 mg, glycerol 16 mg, phenol liquid 0.65 mg, protamine sulfate 0.244 mg sodium hydrophosphate 3.78 mg zinc oxide 0.011 mg water up to 1 ml hydrochloric acid solution 10 % - qs to pH 6.9-7.8, sodium hydroxide solution 10% - qs to pH 6.9-7.8.
10 ml - bottles (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The description of the drug was approved by the manufacturer for the 2006 print edition.
PHARMACHOLOGIC EFFECT
DNA-recombinant human insulin of medium duration. It is a two-phase suspension (30% of Humulin Regular and 70% of Khumulina NPH).
The main effect of the drug is the regulation of glucose metabolism. In addition, it has an anabolic effect. In muscle and other tissues (with the exception of the brain), insulin causes rapid intracellular transport of glucose and amino acids, accelerates protein anabolism. Insulin promotes the conversion of glucose into glycogen in the liver, inhibits gluconeogenesis and stimulates the conversion of excess glucose into fat.
PHARMACOKINETICS
Humulin M3 is a medium-duration insulin preparation.
The beginning of the drug - 30 minutes after the injection, the maximum effect of action - between 1 and 8.5 hours, the duration of the action - 14-15 hours.
Individual differences in insulin activity depend on such factors as dose, choice of injection site, physical activity of the patient.
INDICATIONS
- diabetes mellitus in the presence of indications for carrying out insulin therapy;
- newly diagnosed diabetes mellitus;
- Pregnancy for type 2 diabetes mellitus (non-insulin-dependent).
DOSING MODE
The dose is determined individually depending on the level of glycemia.
The drug should be given sc, probably an / m introduction. In / in the introduction Humulin M3 is contraindicated!
The drug is injected into the forearm, thighs, buttocks or abdomen. The injection site must be alternated so that the same place is used no more often than 1 time / month.
With n / to the introduction, care must be taken to avoid getting into the blood vessel. After injection, do not massage the injection site. Patients should be trained in the proper use of insulin delivery devices.
Rules for preparation and administration of the drug
Cartridges and bottles Humulin M3 before use should be rolled between the palms 10 times and shake, turning 180 В° also 10 times to resuspend insulin until it becomes a homogeneous cloudy liquid or milk. Do not shake vigorously. this can lead to the appearance of foam, which can interfere with the correct dose set.
Cartridges and bottles should be carefully checked. Do not use insulin if there are flakes after mixing, if solid white particles adhere to the bottom or walls of the vial, creating the effect of a frosty pattern.
The device of cartridges does not allow to mix their contents with other insulins directly in the cartridge. Cartridges are not intended for refilling.
The contents of the vial should be dialed into an insulin syringe that corresponds to the concentration of insulin administered, and enter the desired dose of insulin according to the doctor's instructions.
When using cartridges, follow the manufacturer's instructions for refilling the cartridge and attaching the needle. The drug should be administered in accordance with the manufacturer's instructions for the syringe pen.
Using the outer needle cap, immediately after insertion, unscrew the needle and safely destroy it. Removing the needle immediately after injection provides 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 syringe-pens should not be used by others. Cartridges and bottles are used until they become empty, after which they should be discarded.
SIDE EFFECT
Side effect associated with the main effect of the drug: hypoglycemia.
Severe hypoglycemia can lead to loss of consciousness and (in exceptional cases) to death.
Allergic reactions: local allergic reactions are possible - hyperemia, edema or itching at the injection site (usually terminate for a period of several days to several weeks); systemic allergic reactions (occur less often, but are more serious) - generalized itching, difficulty breathing, dyspnea, lowering blood pressure, increased heart rate, increased sweating. Severe cases of systemic allergic reactions can be life threatening.
Other: the likelihood of developing lipodystrophy is minimal.
CONTRAINDICATIONS
- hypoglycemia;
- Hypersensitivity to insulin or to one of the components of the drug.
PREGNANCY AND LACTATION
In pregnancy, it is especially important to maintain good control of glycemia in patients with diabetes mellitus. In pregnancy, the need for insulin usually decreases in the I trimester and rises in the II and III trimesters.
Patients with diabetes are advised to inform the doctor about the onset or planning of pregnancy.
Patients with diabetes during lactation (breastfeeding) may need to adjust the dose of insulin, diet, or both.
In studies of genetic toxicity in the in vitro and in vivo series, human insulin did not have a mutagenic effect.
APPLICATION FOR FUNCTIONS OF THE LIVER
The need for insulin may decrease with renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The need for insulin may decrease with hepatic insufficiency.
SPECIAL INSTRUCTIONS
Transfer of a patient to another type of insulin or to a preparation of insulin with a different trade name should occur under strict medical supervision. Changes in the activity of insulin, its type (eg Regular, NPH), species (pig, human insulin, human insulin analog) or production method (DNA-recombinant insulin or insulin of animal origin) may lead to the need for dose adjustment.
The need for dose adjustment may be required already at the first injection of the human insulin drug after an insulin preparation of animal origin or gradually within a few weeks or months after the transfer.
The need for insulin may decrease with insufficient adrenal function, pituitary gland or thyroid gland, with renal or hepatic insufficiency.
With some diseases or emotional stress, the need for insulin can increase.
Dose adjustment may also be required if the exercise is increased or when a normal diet changes.
Symptoms-precursors of hypoglycemia against the background of the introduction of human insulin in some patients may be less pronounced or different from those that were observed in them against the background of the introduction of insulin of animal origin. When normalizing the blood glucose level, for example, as a result of intensive insulin therapy, all or some of the symptoms-precursors of hypoglycemia may disappear, which patients should be informed about.
Symptoms-precursors of hypoglycemia may change or be less pronounced with prolonged course of diabetes mellitus, diabetic neuropathy or with the simultaneous use of beta-blockers.
In some cases, local allergic reactions may be caused by causes not associated with the action of the drug, for example, skin irritation with a cleansing agent or improper injection.
In rare cases of development of systemic allergic reactions, immediate treatment is required. Sometimes it may be necessary to change insulin or conduct desensitization.
Impact on the ability to drive vehicles and manage mechanisms
During hypoglycemia, the patient may be weakened by the concentration of attention and the speed of psychomotor reactions. This can be dangerous in situations in which these abilities are particularly needed.
It should be recommended that patients take precautions to avoid hypoglycemia while driving a car. This is especially important for patients with mild or absent symptoms-precursors of hypoglycemia or with frequent development of hypoglycemia. In such cases, the doctor should assess the advisability of driving a car patient.
OVERDOSE
Symptoms: hypoglycemia, accompanied by lethargy, increased sweating, tachycardia, pale skin, headache, tremor, vomiting, confusion.
Under certain conditions, for example, with a long duration or with intensive control of diabetes mellitus, the symptoms-precursors of hypoglycemia may change.
Treatment: mild conditions of hypoglycemia can usually be quenched by ingestion of glucose (dextrose) or sugar. You may need to adjust the dose of insulin, diet or physical activity.
Correction of moderate hypoglycemia can be carried out with the aid of an / m or n / c injection of glucagon, followed by ingestion of carbohydrates.
Severe hypoglycemia, accompanied by coma, convulsions or neurological disorders, is stopped in / m or by / by administration of glucagon or iv by the administration of a concentrated solution of glucose (dextrose). After the restoration of consciousness, the patient needs to give food rich in carbohydrates, in order to avoid the re-development of hypoglycemia.
DRUG INTERACTION
The hypoglycemic effect of Humulin M3 is reduced by oral contraceptives, corticosteroids, thyroid hormone preparations, thiazide diuretics, diazoxide, tricyclic antidepressants.
The hypoglycemic effect of Humulin M3 is enhanced by oral hypoglycemic drugs, salicylates (eg, acetylsalicylic acid), sulfonamides, MAO inhibitors, beta-blockers, ethanol and ethanol-containing drugs.
Beta-adrenoblockers, clonidine, reserpine can mask the manifestation of symptoms of hypoglycemia.
Pharmaceutical interaction
Effects arising from the mixing of human insulin with animal insulin or human insulin produced by other manufacturers have not been studied.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in the refrigerator at a temperature of 2 В° to 8 В° C, do not allow freezing, protect from direct exposure to light. Shelf life - 2 years.
The drug in the vial or cartridge should be stored at room temperature (15 В° to 25 В° C) for no longer than 28 days.
