Index of drugs

Diabetes that requires insulin therapy.

1 pre-filled pen (3 ml) SoloStar or 1 cartridge (3 ml) for pre-filled pen contains 300 IU. human insulin (25% soluble insulin and 75% crystalline protamine insulin).

Two-phase suspension of isophane insulin (75% protamine insulin and 25% regular insulin). The product contains human insulin with a moderately rapid onset and long duration of action, produced by recombinant DNA in cellsE. coli. Insulin reduces Glucose, exerts anabolic and anti-catabolic action, increases Glucose transport into cells and enhances glycogen synthesis in muscle tissue and liver, improves the use of pyruvate, reduces glycogenolysis and glyconeogenesis, increases lipogenesis in liver and fat tissue, inhibits lipolysis, increases amino acid uptake and protein synthesis, enhances potassium uptake into cells. After the subcutaneous injection, the onset of action occurs within 30-60 min, and the maximum effect after 2-4 h after administration. The duration of action is 12-19 h. T_0,5 insulin in healthy volunteers 4-6 min. It is longer in patients with severe renal failure.

Hypersensitivity to the active substance or to any of the excipients.

patients with hypersensitivity to the drug may, in the absence of a better-tolerated insulin preparation, continue treatment only under strict medical supervision and, if necessary, with the use of anti-allergic drugs. For patients with hypersensitivity to animal-derived insulin, an intradermal test is recommended before starting treatment due to the possibility of cross-allergic reactions. In the event of inadequate blood glucose control or a tendency to develop hyper- or hypoglycaemia, before considering the need to change the dose, check that patients use the drug as directed, check where and how to inject the medicine, and consider other factors affecting the effectiveness of the injection treatment. Changing the power, brand (manufacturer), type (regular, NPH, lente, long-acting etc.), of origin (human, animal, human insulin analogue), as well as the production method may result in the need to change the dosage. The need to correct (eg, reduce) the dose can be clearly seen immediately after the change, or it may appear gradually over several weeks. After switching from animal insulin to human insulin, dose reduction is especially necessary in patients who have previously received adequate control with relatively low blood glucose levels; there is a tendency for hypoglycaemia; previously, high doses of insulin were needed because of the presence of antibodies against insulin. Close monitoring of metabolic parameters is recommended during the transition period and within the first few weeks after its completion. Patients who have used high doses of insulin due to the presence of anti-insulin antibodies should consider a change under the supervision of a physician in hospital or similar conditions. Exercise caution and monitor glucose for hypoglycaemia, especially in patients with significant coronary or cerebral stenosis (risk of cardiac or cerebral complications due to hypoglycaemia), and proliferative retinopathy, especially if they have not been photocoagulated (risk of reversible loss of vision due to hypoglycaemia). The first symptoms of hypoglycaemia may be atypical, be less pronounced, or may not occur at all if: they are present in patients who have achieved good glycemic control; hypoglycaemia develops gradually; patients are elderly; animal insulin has been changed to human insulin; autonomic neuropathy occurs; diabetes has been going on for many years; coexist mental illness; patients take other medicines. In such cases, severe hypoglycaemia (sometimes with loss of consciousness) may occur before the patient becomes aware of it.If the glycated hemoglobin value is normal or decreased, consideration should be given to the occurrence of recurrent, unrecognized hypoglycaemia at night. The patient's compliance with the dosing and administration of insulin, the established diet and the ability to recognize the initial symptoms of hypoglycaemia have a major impact on reducing the risk of hypoglycaemia. Many factors that can increase the risk of hypoglycaemia require careful monitoring and possible dose adjustments. These include: changing the injection site; increasing insulin sensitivity (eg by eliminating stressors); other than normal, more intense or prolonged physical effort; co-occurring diseases (eg diarrhea, vomiting); failure to comply with the diet; leaving the meal; alcohol consumption; some unbalanced endocrine disorders (eg hypothyroidism, anterior pituitary gland or adrenocortical insufficiency); simultaneous use of some other medicines. Co-occurring diseases require intensive metabolic control, it is advisable to perform a urine test for the presence of ketone bodies and it is often necessary to change the insulin dose, because the insulin requirement in such situations often increases. Patients with type 1 diabetes should regularly take even small amounts of carbohydrates, even if they can only consume small amounts of food or do not eat foods at all, e.g. due to vomiting, etc. Never stop taking insulin. Insulin administration may cause the production of anti-insulin antibodies; in rare cases, it may be necessary to change the insulin dose to reduce the tendency to develop hyper or hypoglycaemia.

Insulin does not penetrate the placental barrier. Caution should be exercised in pregnant women. In pre-pregnancy diabetic patients or patients with gestational diabetes, glycemic control and maintenance of normal metabolic parameters throughout pregnancy are of particular importance. In the first trimester of pregnancy, the insulin requirement is generally reduced, while in the second and third trimester it generally rises. Immediately after delivery, the insulin requirement decreases rapidly (the risk of hypoglycaemia increases). The control of blood glucose during this period is of great importance. The drug has no effect on a breastfed baby and can be used during lactation. The dosage of insulin and the diet of lactating women may require changes.

The most common is hypoglycaemia - it can occur when the insulin dose is too high in relation to the insulin requirement (severe hypoglycaemia, especially if recurrent, may cause neurological damage, long-term or severe hypoglycaemia may be life-threatening). Common: swelling, reactions at the injection site. Uncommon: shock, urticaria at the injection site. Not known: early type hypersensitivity reactions (hypotension, angioneurotic edema, bronchospasm, generalized skin reactions), anti-insulin antibodies, sodium retention, proliferative retinopathy, diabetic retinopathy, visual impairment, lipodystrophy, injection site reactions such as inflammation, edema, pain, pruritus or erythema.

The expected blood glucose, type of preparation and dosage of insulin (dose and time of administration) should be determined individually, taking into account the diet, physical activity and lifestyle of the patient. In patients with impaired renal or hepatic function and in elderly patients, the need for insulin may be lower. When changing the strength, brand, type, origin and method of insulin production to another and when changing the weight or lifestyle of the patient or the appearance of other circumstances that may increase the risk of hypo- or hyperglycemia, dosage may need to be changed. The average insulin requirement is usually 0.5-1 IU / kg / day. The basic metabolic requirement is 40-60% of the total daily dose.Way of giving. The drug should not be used in infusion pumps, as well as in external insulin pumps or in the form of an implant. It must not be administered intravenously. The drug is usually injected subcutaneously 30-45 min before a meal, each time changing the injection site within a defined area. Absorption of insulin and, consequently, its hypoglycaemic effect varies depending on the area of ​​injection.SoloStar allows insulin to be administered in the range of 1 to 80 IU, with an accuracy of 1 IU; each cartridge contains multiple doses. The medicine in suspension for injection in a cartridge should only be used in the following pre-filled pens: JuniorStar (which delivers the insulin dose to the nearest 0.5 IU) or OptiPen, ClikStar, Tactipen, Autopen 24 and AllStar (which deliver the dose of insulin to an accuracy of 1 IU) ); if the pen malfunctions, the suspension should be drawn from the cartridge with a syringe (designed for insulin 100 IU / ml) and injected. The medicine in the form of a suspension for injection in a cartridge may be mixed with all human insulin preparations manufactured by Sanofi-Aventis, with the exception of preparations intended for use in insulin pumps; it must not be mixed with insulin preparations of animal origin or with insulin analogues; do not mix the drug with other insulins in the pen cartridge. The suspension preparation for injection in a SoloStar pre-filled pen is not intended to be mixed with other insulin or insulin analogues.