Insuman belongs to the group of insulins and their analogues.
Release form and composition
Insuman is available in dosage forms: suspension for s / c infusion of Insuman Bazal GT, injection solution for Insuman Rapid GT and suspension for s / c infusion of Insuman Comb 15 GT, 25 GT, 50 GT.
Suspension for sub-to the introduction of Insuman Bazal GT and injection solution of Insuman Rapid GT are implemented in this form:
- Cartridges of colorless glass of 3 ml, which is 5 pcs. placed in mesh blister packs. A carton pack contains 1 package;
- Cartridges of colorless glass of 3 ml, which are mounted in disposable syringe pens SoloStar and 5 pcs. placed in cartons;
- Bottles of colorless glass in 5 ml, which is 5 pcs. placed in packs of cardboard.
Suspension for sub-to the introduction of the Insuman Komb 15, 25 and 50 GT is sold in clear glass bottles of 5 ml or 10 ml, which is 5 pcs. Placed in packs of cardboard, as well as in cartridges for OptiPen syringe pens, 5 pcs. in a carton box.
The active substance of Insuman Bazal GT is insulin-isophane (human genetic engineering), in 1 ml of the suspension contains 3.571 mg of the active substance. Excipients: metacresol, protamine sulfate, zinc chloride, phenol, sodium dihydrogen phosphate dihydrate, sodium hydroxide, hydrochloric acid, glycerol, water for injection.
1 ml of Insuman Rapid GT contains 3.571 mg of the active substance insulin soluble (human genetically engineered). Excipients: sodium dihydrogen phosphate dihydrate, metacresol, sodium hydroxide, glycerol, hydrochloric acid, water for injection.
The active ingredient of Insuman Comb 15, 25 and 50 GT is a mixture of insulin suspension of isophane and human insulin insulin. 1 ml of the preparation contains 100 IU of active substance (15, 25 and 50 IU of a neutral insulin solution and 85, 75 and 50 IU of crystalline protamine insulin) or 40 IU (6, 10 and 20 IU of a neutral insulin solution and 34, 30 and 20 IU crystalline protamine insulin). Excipients: m-cresol, protamine sulfate, zinc chloride, phenol, glycerol 85%, sodium dihydrogen phosphate dihydrate, concentrated hydrochloric acid, sodium hydroxide, water for injection.
Indications for use
Indications for use of Insuman Basal GT are insulin-dependent diabetes mellitus.
Insuman Rapid GT is prescribed for the following diseases and conditions:
- Diabetes mellitus, which requires insulin treatment;
- Ketoacidosis and diabetic coma;
- Surgical intervention in patients with diabetes mellitus.
Indications for taking Insuman Comb 15, 25 and 50 GT:
- Type 1 diabetes mellitus (insulin-dependent);
- Type 2 diabetes mellitus (non-insulin-dependent), in particular with partial or complete resistance to oral hypoglycemic drugs; for intercurrent diseases, surgical interventions; during pregnancy in case of failure of diet therapy.
Contraindications to the use of Insuman:
- Increased individual sensitivity to the components of the drug, except when insulin therapy is necessary for health reasons;
- Insulinoma (when taking Insuman Comb 15, 25 and 50 GT).
Caution is prescribed by Insuman for such diseases and conditions:
- Renal failure;
- Liver failure;
- Severe stenosis of the cerebral and coronary arteries;
- Proliferative retinopathy;
- Intercurrent illness;
- Elderly age.
Dosing and Administration
Insulin preparations necessary for use, the target concentration of glucose in the blood, insulin dosing regimen is determined and adjusted individually, in accordance with the lifestyle, diet and level of physical activity of the patient.
Precisely established rules for dosing insulin are absent. The average daily insulin dose is 0.5-1 IU / kg of body weight per day, while the proportion of prolonged-acting human insulin is 40-60% of the required daily insulin dose.
The patient is given recommendations on the frequency of determining the concentration of glucose in the blood, including in the case of any changes in the mode of insulin therapy or diet.
Switching from another type of insulin to Insuman Bazal GT or Insuman Rapid GT may require correction of the dosing regimen. For example, during the transition:
- From animal insulin to human insulin;
- From one human insulin preparation to another;
- With a soluble human insulin treatment regimen for a regimen that includes longer-lasting insulin.
The need for dose adjustment can develop within a few weeks or appear immediately after switching to another type of insulin.
Sometimes it is necessary to lower the dose of insulin after switching from the insulin of the animal to human insulin. This is important for patients who were previously conducted at fairly low concentrations of glucose in the blood, as well as for patients who previously needed high doses of insulin (as a result of the presence of antibodies to insulin).
When switching from one drug to another and in the first weeks thereafter, control of the concentration of glucose in the blood is needed. Patients who received high doses of insulin due to the appearance of antibodies should switch to a different type of drug in stationary conditions.
Additional dose adjustment.
Improving metabolic control sometimes contributes to increased insulin sensitivity. This reduces the need for insulin.
Changing the dose is often necessary when changing lifestyle, diet, body mass, level of physical activity and other circumstances that can increase the susceptibility to hypo- and hyperglycemia.
The need for insulin can be reduced in patients with renal or hepatic insufficiency, as well as in elderly patients.
Insuman Bazal GT is administered deep s / c 45-60 minutes before meals. Insuman Rapid GT is injected deep s / c 15-20 minutes before meals. Insuman Combe 15 GT and Insuman Combe 25 GT are administered 30-45 minutes before a meal, Insuman Combe 50 GT - 20-30 minutes before a meal.
Changing the injection site is carried out only after consulting with the doctor. Insuman can not be used in insulin pumps.
Insuman Rapid GT is allowed to enter in / in in a hospital.
Absolutely excluded in / in the introduction of the Insuman Bazal GT and Insuman Comb 15, 25 and 50 GT.
Do not mix Insuman with insulin of animal origin, insulin of other concentration, insulin analogues, insulin, intended for use in insulin pumps, as well as with other drugs.
It is allowed to mix insuman with insulin preparations of the human company Sanofi-aventis group.
You should only use plastic syringes that are designed for this concentration of insulin (when using vials) or KlikStar or OptiPen Pro 1 syringe pens (when using cartridges).
Rules for the use of Insuman vials.
First you need to remove the plastic cap. Before the set, the suspension is stirred (the bottle is kept between the palms at an acute angle and gently turned) until it has a uniform consistency and a milky white color. The solution for injection of Insuman Rapid GT should be colorless and completely transparent.
Before taking the drug from the vial, a volume of air equal to the required insulin dose is taken into the syringe and injected into the vial. After that, the bottle together with the syringe is turned over with a syringe downwards and the prescribed amount of insulin is collected. Remove air bubbles from the spitz.
At the injection site, a skin fold is taken, a needle is inserted under the skin and insulin is slowly injected. Then slowly remove the needle and apply a tampon to the injection site. On the label of the bottle write the date of the first set of the drug.
Opened vials stored for 4 weeks at a temperature not exceeding 25 ° C.
Using Insuman in cartridges.
Before installing the cartridge in the syringe pen, it is kept for 1-2 hours at room temperature. Air bubbles are removed from the cartridge prior to injection.
Mixing Insuman with other insulins is unacceptable when using a cartridge. In the event of a syringe pen failure, the required dose can be inserted from the cartridge using a conventional syringe. Refilling the cartridge is not recommended.
After installation, the cartridge is used for 4 weeks. Store cartridges at a temperature not higher than 25 ° C. After installing a new cartridge, the correct operation of the syringe pen is checked before the first dose is administered.
Use and handling of a pre-filled Solostar syringe pen.
The insuman in a disposable spitz-stick is used only for sc injection. Before the first use, the pen is kept for 1-2 hours at room temperature. The insulin solution in the cartridge inside the syringe pen should be completely transparent, the suspension should be of a uniform consistency and a milky white color. Empty syringe pens destroy, their repeated use is prohibited.
Before using the syringe pen, you should carefully read the instructions for use.
Before each use, attach a new needle and perform a safety test.
Only needles compatible with SoloStar are used.
In order to avoid accidents it is necessary to observe precautionary measures. A damaged pen should not be used. A spare pen should be available.
The SoloStar syringe pen should be protected from dirt and dust; situations that could lead to damage should be avoided. The outside of the pen can be wiped with a damp cloth, but it should not be immersed in a liquid or rinsed.
Operation syringe pens SoloStar:
- Insulin control. Check the label on the pen to make sure it contains the correct insulin. For Insuman Bazal GT, the syringe pen is white with a green button for drug administration, for Insuman Rapid GT it is white with a yellow button. After removing the cap, check the appearance of the drug;
- Attaching the needle. After removing the cap, carefully position the needle;
- Security test It is carried out before each injection. Remove the outer and inner caps, measure out the dose of 2 units. Holding the syringe pen with the needle up, gently tap your finger on the cartridge, directing air bubbles to the needle. Then completely press the injection button. When the syringe handle is working properly, insulin appears on the tip of the needle. If necessary, the procedure is repeated until the appearance of insulin;
- Dose selection. Dose set with an accuracy of 1-80 units. If necessary, a dose of more than 80 units, spend two or more injections;
- Dosing The needle is led under the skin, press the injection button all the way. Until the needle is removed, the button is held in this position for 10 seconds. In this case, the selected dose of insulin is fully injected.
- Extraction and destruction of the needle. The needle is removed and discarded after each injection. Care must be taken when removing and destroying the needle. After removing the needle, the SoloStar syringe handle is closed with a cap.
The Insuman Combe 25 GT cartridge is used for OptiPen syringe pens.
The use of Insuman can cause the development of such side effects:
- Hypoglycemia. Usually develops in case of exceeding the dose of insulin injected needs for it. In severe repeated episodes of hypoglycemia, neurological symptoms may develop, including seizures and coma;
- On the part of the metabolism: often - edema, with unknown frequency - sodium retention;
- Since the cardiovascular system: lower blood pressure;
- On the part of the organs of vision: transient visual disturbances, temporary worsening of diabetic retinopathy, transient amaurosis;
- On the part of the skin and subcutaneous tissue: lipodystrophy at the site of injection and slowing the local absorption of the substance;
- Allergic reactions: infrequently - anaphylactic shock, with an unknown frequency - the formation of antibodies to insulin, bronchospasm, angioedema, generalized skin reactions;
- Disorders at the injection site: redness, hives, itching, pain, swelling, or an inflammatory reaction.
The transition from one type of insulin to another is carried out by controlling the level of glucose in the blood.
In the case of an overdose of insulin, if the patient is consciously injected with glucose orally, in an unconscious state, glucagon is administered subcutaneously, intravenously or intramuscularly, or glucose intravenously.
The initial use of insulin, a change in its type or the presence of significant stress can lead to a decrease in the ability to concentrate and the speed of psychomotor reactions.
Insuman’s hypoglycemic effect is enhanced by MAO inhibitors, fenfluramine, cyclophosphamide, clofibrate, tetracyclines, anabolic steroids, sulfonamides, non-selective beta-andrenoblockers.
The hypoglycemic effect of Insuman lowers oral contraceptives, tricyclic antidepressants, lithium preparations, heparin, thiazide diuretics, thyroid hormones, glucocorticoids.
Ethanol reduces the biological activity of insulin.
As a strengthening, yet the weakening of the action of Insuman is possible under the influence of salicylates and reserpine.
Terms and conditions of storage
Store in a dry, dark place at a temperature of 2-8 ° C. Keep out of the reach of children. Shelf life - 2 years.