Description
First gene-engineering human insulin in Russia produced from the domestic substance. Quality parameters of the medicinal product and its purity are at the level of world’s standards imposed for insulins.
RINSULIN® NPH 100 IU/ml is a middle-term effect insulin (analogues include Protafan NM (Novo Nordisk, Denmark), Humulin NPH (Eli Lilly, USA), Insuman Basal GT (Sanofi, France).
Effect profile of the product: the effect starts in 1.5 hours, maximal effect is between 4 and 12 hours, the effect lasts for 24 hours.
Additional information
Insulin is a pancreatic hormone regulating process of the metabolism of carbohydrates and maintenance of normal blood sugar level.
Number of people with diabetes mellitus in the Russian Federation as in the entire world is constantly increasing and according to the official date currently there are 4 million of patients and most of them need everyday insulin administration.
Production of gene-engineering insulin is a complicated bio technological process and only 5 countries know this technology. Russia represented by GEROPHARM is the fifth country in the world possessing its own technology of full-cycle production of high quality gene-engineering insulin.
Certain sequence developed by the company and combination of technological methods of separation and purification makes it possible to obtain a substance of recombinant insulin identical to the natural human insulin that complies with the requirements of domestic and foreign pharmacopoeias.
The domestic technology of production of gene-engineering insulin is based on use of the company’s own producing strain containing plasmid coding hybrid protein with peptide sequence of proinsulin. As a result of technological methods similar to metabolism in the human body using E.Coli hybrid protein they get high-quality insulin identical to human insulin (patents No. 2141531, 2144957, 2232813, 22631470).
Based on the company’s own substance of human gene-engineering insulin finished dosage forms of short-term and middle-term effect most frequently used in clinical practice – Rinsulin® R and Rinsulin® NPH – were developed.
In accordance with the Program approved by Pharmacological State Committee the substance and finished dosage forms have undergone pre-clinical trials in full. The study showed high quality of the medicinal products, their full identity to human insulin, minimal number of impurities, especially proinsulin, no allergenicity and production of insulin antibodies at the level of the best foreign analogues.
Effectiveness and safety of Rinsulin is proved by comprehensive clinical studies carried out in:
Scientific Centre of Endocrinology – Academician of the Russian Academy of Sciences (RAS) and the Russian Academy of Medical Sciences (RAMS) I. I. Dedov;
Russian Medical Academy of Postgraduate Education – Professor A. S. Ametov;
I. M. Sechenov First Moscow State Medical University – Professor M. I. Balabolkin;
Military Medical Academy – Professor S. B. Shustov.
It was an opened controlled study in accordance with the decision of the Pharmacological Committee under the Ministry of Health of the Russian Federation dated January 27, 2000 within a single protocol with filling in of standardized individual observation charts. 100 patients with type 1 diabetes participated in the study. Before the study the patients undergone insulin therapy in the form of multiple injections of insulin produced by Novo Nordisk (Actrapid, Protafan, Monotard) and Eli Lilly (Humalog, Humulin Regular and NPH).
The data of four clinics prove that the main performance indicators of insulin (fasting glycaemia and glycated hemoglobin by the moment of observation completion) tended decrease if body weight of the patients and total daily dose of insulin were stable. Apart from that, there was no growth of insulin antibody identified. There was no episodes of ketoacidosis, hypoglycaemia and allergic reactions requiring treatment observed. It should be mentioned that daily doses of insulin stayed almost the same but diabetes compensation improved as illustrated by reduction of glycated hemoglobin in blood.
Postregistration approbation in 36 Russian clinics showed no negative effects when switching from imported medicinal products to Rinsulin® and no need to increase the dose.
RINSULIN® NPH 100 IU/ml is a middle-term effect insulin (analogues include Protafan NM (Novo Nordisk, Denmark), Humulin NPH (Eli Lilly, USA), Insuman Basal GT (Sanofi, France).
Effect profile of the product: the effect starts in 1.5 hours, maximal effect is between 4 and 12 hours, the effect lasts for 24 hours.
Additional information
Insulin is a pancreatic hormone regulating process of the metabolism of carbohydrates and maintenance of normal blood sugar level.
Number of people with diabetes mellitus in the Russian Federation as in the entire world is constantly increasing and according to the official date currently there are 4 million of patients and most of them need everyday insulin administration.
Production of gene-engineering insulin is a complicated bio technological process and only 5 countries know this technology. Russia represented by GEROPHARM is the fifth country in the world possessing its own technology of full-cycle production of high quality gene-engineering insulin.
Certain sequence developed by the company and combination of technological methods of separation and purification makes it possible to obtain a substance of recombinant insulin identical to the natural human insulin that complies with the requirements of domestic and foreign pharmacopoeias.
The domestic technology of production of gene-engineering insulin is based on use of the company’s own producing strain containing plasmid coding hybrid protein with peptide sequence of proinsulin. As a result of technological methods similar to metabolism in the human body using E.Coli hybrid protein they get high-quality insulin identical to human insulin (patents No. 2141531, 2144957, 2232813, 22631470).
Based on the company’s own substance of human gene-engineering insulin finished dosage forms of short-term and middle-term effect most frequently used in clinical practice – Rinsulin® R and Rinsulin® NPH – were developed.
In accordance with the Program approved by Pharmacological State Committee the substance and finished dosage forms have undergone pre-clinical trials in full. The study showed high quality of the medicinal products, their full identity to human insulin, minimal number of impurities, especially proinsulin, no allergenicity and production of insulin antibodies at the level of the best foreign analogues.
Effectiveness and safety of Rinsulin is proved by comprehensive clinical studies carried out in:
Scientific Centre of Endocrinology – Academician of the Russian Academy of Sciences (RAS) and the Russian Academy of Medical Sciences (RAMS) I. I. Dedov;
Russian Medical Academy of Postgraduate Education – Professor A. S. Ametov;
I. M. Sechenov First Moscow State Medical University – Professor M. I. Balabolkin;
Military Medical Academy – Professor S. B. Shustov.
It was an opened controlled study in accordance with the decision of the Pharmacological Committee under the Ministry of Health of the Russian Federation dated January 27, 2000 within a single protocol with filling in of standardized individual observation charts. 100 patients with type 1 diabetes participated in the study. Before the study the patients undergone insulin therapy in the form of multiple injections of insulin produced by Novo Nordisk (Actrapid, Protafan, Monotard) and Eli Lilly (Humalog, Humulin Regular and NPH).
The data of four clinics prove that the main performance indicators of insulin (fasting glycaemia and glycated hemoglobin by the moment of observation completion) tended decrease if body weight of the patients and total daily dose of insulin were stable. Apart from that, there was no growth of insulin antibody identified. There was no episodes of ketoacidosis, hypoglycaemia and allergic reactions requiring treatment observed. It should be mentioned that daily doses of insulin stayed almost the same but diabetes compensation improved as illustrated by reduction of glycated hemoglobin in blood.
Postregistration approbation in 36 Russian clinics showed no negative effects when switching from imported medicinal products to Rinsulin® and no need to increase the dose.