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.
The plant producing gene-engineering insulin is unique because it makes it possible to go through the production process from synthesis of an active substance to release of finished dosage form.
This drug is a prescribed medicine. It can be dispensed on a doctor's prescription only. There are contraindications. Please read the patient information leaflet. Do not use the medicinal agent if it was not prescribed by your treating physician. Always follow the patient information leaflet and your doctor’s recommendations.
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.
Trade name: Rinsulin® NPH.
International nonproprietary name (INN): Insulin – isophane (human gene-engineering).
Dosage form: Suspension for subcutaneous administration
Composition: 1 ml of the medicinal product contains: human insulin 100 IU.
Pharmacotherapeutic group: Hypoglycaemic product, middle-term effect insulin.
ATC code – A10AC01.
Pharmacodynamics. Rinsulin® NPH is human insulin produced using recombinant DNA technology. Middle-term effect insulin. Reduced blood glucose content is caused by increased transportation thereof, intensified absorption and digestion by the tissues, lipogenesis and glycogenogenesis stimulation, lowered speed of glucose production by liver, etc. On average, the effect of Rinsulin®NPH starts in 1,5 hours after subcutaneous injection, maximal effect is between 4 and 12 hours, the effect lasts for 24 hours.
Indications for use: Type 1 diabetes; Type 2 diabetes: stage of resistance to oral hypoglycaemic medicinal products, partial resistance to these drugs (in case of combined therapy), intercurrent diseases; Type 2 diabetes in pregnant women.
Contradictions: hypersensitivity to insulin or to any component of the medicinal product; hypoglycaemia.
Directions for use and dosage: the drug is intended for subcutaneous administration. An average daily dose of the drug varies from 0.5 to 1 IU/kg of the body weight (depends on individual features of the patient’s personal characteristics and glucose concentration in blood).
Intravenous administration of Rinsulin® NPH is not allowed: the drug is usually injected subcutaneously into the thigh. The drug may also be injected into the thigh, the buttock or into the shoulder in the deltoid projections. Rinsulin® NPH can be administered both independently and in combination with a short-term effect insulin (Rinsulin® R).
The spots of injections should be changed within a single anatomical region to prevent development of lipodystrophy. Be careful in case of subcutaneous injections of insulin not to pierce a blood vessel. Do not massage the spot of injection. Patients should be taught to use the insulin administration device properly.
For cartridges: before use cartridges Rinsulin® NPH should be rolled between hands horizontally 10 times and shaken for resuspension of the insulin until it looks like a homogenous turbid liquid or milk. Do not allow foaming as it can prevent proper filling.
Cartridges should be thoroughly checked. Do not use the insulin if after shaking it contains flakes, if solid white particles stick to the bottom or the walls of the cartridge making it look like frozen.
The structure of cartridges dose not allow to mix the content thereof with other insulins in the cartridge itself. The cartridges are non-refillable.
When using the cartridges together with reusable pen-injector follow the manufacturer’s instructions in relation to insertion of the cartridges into the pin-injector and fixation of the needle. The medicinal product should be administered in accordance with the instructions of the manufacturer of the pin-injector.
After injection remove the needle using the external needle cap and destroy it safely. Immediate removal of the needle after injection provides for sterility, prevents leakages, introduction of air and possible contamination of the needle. Then put the cap onto the pen.
For disposable pen-injectors: if using multi-dose disposable pen-injectors shake suspension Rinsulin® NPH in the pen-injector right before using. Properly shaken suspension should be homogenously white and turbid.
Do not use Rinsulin® NPH from the pen-injector if it was frozen.
When using pre-filled multi-dose disposable pen-injectors for multiple injections the pen-injector should be removed from the fridge before the first use so that the drug reaches the room temperature. Follow accurate instructions for use of the pin-injector from the leaflet supplied with the drug.
Rinsulin® NPH from the pin-injector and the needles are intended for individual use only. Cartridges of the pin-injector cannot be refilled.
The needles should not be reused.
Close the pin-injector with the cap to protect from the light.
Do not keep the pin-injector used in the fridge.
Keep the drug used at room temperature (from 15 to 25 °C) for no more than 28 days, protect from direct sunlight and heating.
For cartridges with the use of reusable pen-injectors: Cartridges with Rinsulin® NPH can be applied with a reusable pin-injector:
- Pen-injector Autopen Classic 3 ml 1 Unit (1–21 units) AN3810, Autopen Classic 3 ml 2 Unit (2–42 units) AN3800 manufactured by Owen Mumford Ltd., Great Britain;
- Insulin pen-injectors HumaPen® Ergo II and HumaPen® Luxura manufactured by Eli Lilly and Company, USA;
- Pen-injector OptiPen® Pro1 manufactured by Aventis Pharma Deutschland GmbH, Germany;
- Pen-injector BiomaticPen® manufactured by Ypsomed AG, Switzerland.
Side effect: caused by the influence on the metabolism of carbohydrates: hypoglycaemic conditions (skin paleness, sweating, feeling of the heart beats, tremor, hunger, anxiety, paraesthesias of oral mucosa, weakness, headache, dizziness, blurred vision). Obvious hypoglycaemia can cause hypoglycaemic coma. Allergic reactions: skin rash, angioedema, anaphylactic shock. Local reactions: hyperemia, swelling and itch in the spot of injection, in case of long-term use – lipodystrophy in the spot of injection. Others: swelling, temporary blurred vision (usually at the start of therapy). If a patients notices hypoglycaemia or he fainted, he should seek for medical attention immediately. In case of any side effects not mentioned above, a patients should also see a doctor.
Dosage form: suspension for subcutaneous administration 100IU/ml. 10 ml of the drug in a vial made of colorless glass. 3 ml of the drug in glass cartridges with rubber plungers. A cartridge mounted into a plastic multi-dose disposable pen-injector for multiple injections.
Storage conditions: protected from light at 2–8 °C. Do not freeze. Keep out of reach of children.
Shelf-life: 2 years.
Dispensing conditions: on a doctor's prescription.
Producer: GEROPHARM
The firm accepting claims:
GEROPHARM
Hot-line: 8-800-333-4376 (free call across the Russian Federation)
Marketing authorization: LS-001809 (vials), LP-001560 (cartridges, pen-injectors).
Please read the patient information leaflet for detailed information on the drug.
Solutions relating the package should provide safety and control when using different types of Rinsulin – of short-term effect (R) or middle-term effect (NPH).
The package has several types of informational indications of Rinsulin type.
The informational indications are visual (colorful, numeral) and tactile – for patients with poor eyesight.
Color indication
Color indication of Rinsulin type is given in accordance with IDF color chart (International Diabetes Federation).
For Rinsuin NPH this is a light-green strip on the package and on the cartridge. If the cartridge is already mounted into RinAstra NPH pen, the button for dose administration of such pen is light-green with two light-green strips at the label of the pen case.
For Rinsuin R this is a yellow strip on the package and on the cartridge. If the cartridge is already mounted into RinAstra R pen, the button for dose administration of such pen is yellow with two yellow strips at the label of the pen case.
Numeral indication
Numeral indication of Rinsulin type is given as QR code. QR (Quick Response) is a barcode giving information for fast recognition thereof with the help of the mobile phone’s camera. QR code scanned this way directs a doctor or a patient to the website of GEROPHARM to the page about Rinsulin®.
Tactile indication
Tactile indication of Rinsulin type is given as a convex indication (Braille). So the package is suitable for people with poor eyesight.
Safety
Patient safety when using different types and packages of Rinsulin can be of several levels:
• control of the first opening of the package in the form of a valve;
• free edge of the foil for easy removal of the cartridge of Rinsulin;
• all the surfaces of a blister with Rinsulin cartridges are rounded without sharp edges. This is significant for patients with diabetes mellitus who can have reduced sensitivity and they can damage their skin without noticing and feeling pain.
