Insulin Tujeo SoloStar syringe pen 300 units/ml 1.5 ml N5 (Sanofi)
Hypersensitivity to insulin glargine or to any of the excipients of the drug. Age under 18 years (due to the lack of clinical data confirming the effectiveness and safety of the drug in children and adolescents). With caution: In pregnant women (the possibility of changes in insulin requirements during pregnancy and after childbirth), elderly patients (see sections “Pharmacokinetics”, “Pharmacodynamics”, “Method of administration and dosage” and “Special instructions”); patients with uncompensated endocrine disorders (such as hypothyroidism, insufficiency of the adenohypophysis and adrenal cortex); for diseases accompanied by vomiting or diarrhea; with severe stenosis of the coronary arteries or cerebral vessels; with proliferative retinopathy (especially if patients have not undergone photocoagulation; with renal failure; with severe liver failure (see section "Special instructions"). Pregnancy and lactation: Patients with diabetes mellitus should inform their doctor about the current or planned pregnancy. No randomized studies have been conducted controlled clinical studies on the use of the drug Tujeo SoloStar® in pregnant women. A large number of observations (more than 1000 pregnancy outcomes with retrospective and prospective observation) with post-marketing use of insulin glargine 100 U/ml showed the absence of any specific effects on the course and outcome of pregnancy , fetal or neonatal health. In addition, to evaluate the safety of insulin glargine and insulin isophane in pregnant women with pre-existing or gestational diabetes mellitus, a meta-analysis of eight observational clinical studies was conducted that included women who used insulin glargine 100 U/ml (n=331) and insulin isophane (n=371). This meta-analysis found no significant differences in maternal or neonatal safety between insulin glargine and isophane insulin during pregnancy. In animal studies, there was no direct or indirect evidence of the embryotoxic or fetotoxic effects of insulin glargine 100 U/ml when used in doses 6-40 times higher than recommended doses in humans. For patients with pre-existing or gestational diabetes mellitus, it is important to maintain adequate metabolic regulation throughout pregnancy to prevent adverse outcomes associated with hyperglycemia. If necessary, the use of Tujeo SoloStar® during pregnancy may be considered. Insulin requirements may decrease during the first trimester of pregnancy and generally increase during the second and third trimesters. Immediately after birth, the need for insulin decreases rapidly (the risk of hypoglycemia increases). In these conditions, careful monitoring of blood glucose concentrations is essential. Patients during breastfeeding may require adjustments to their insulin dosage regimen and diet.
