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Dosage form:solution for subcutaneous injections in 3 ml cartridges and pre-field disposable insulin pen

  • Long-acting basal insulin analogue
  • Maintains normal physiological concentration of basal (baseline) insulin
  • Most widely used basal insulin analogue. It is a reference product for all basal insulins
  • Increased duration of action of insulin glargine is associated with subcutaneous microprecipitates generation from which smallamounts of insulin glargine permanently release, which makes it possible to administer the product once a day
  • Concentration: U100
  • Onest of action after subcutaneous administration in 1 hour
  • Maximum action in 29 hours
  • Duration of action - 24 hours.

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.

Pharmacokinetic properties

In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and much more prolonged absorption and showed a lack of a peak after subcutaneous injection of insulin glargine in comparison to human NPH insulin. Concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine. The graph above shows the activity profiles over time of insulin glargine and NPH insulin.

Insulin glargine injected once daily will reach steady state levels in 2-4 days after the first dose.

When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.

After subcutaneous injection of RinGlar in diabetic patients, insulin glargine is rapidly metabolized at the carboxyl terminus of the Beta chain with formation of two active metabolites M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin). In plasma, the principal circulating compound is the metabolite M1. The exposure to M1 increases with the administered dose of RinGlar. The pharmacokinetic and pharmacodynamic findings indicate that the effect of the subcutaneous injection with RinGlar is principally based on exposure to M1. Insulin glargine and the metabolite M2 were not detectable in the vast majority of subjects and, when they were detectable their concentration was independent of the administered dose of RinGlar.

Trade name: RinGlar®

International nonproprietary name (INN): insulin glargin

ATC-code: А10АЕ04

List of excipients

Cartridge, prefilled Rinastra II pen

Metacresol

Glycerol

Zinc chloride or zinc oxide

Diluted hydrochloric acid and/or

Sodium hydroxide solution (for pH adjustment)

Water for injection

Pharmacodynamic effects

The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogues lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.

In clinical pharmacology studies, intravenous insulin glargine and human insulin have been shown to be equipotent when given at the same doses. As with all insulins, the time course of action of insulin glargine may be affected by physical activity and other variables.

In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was smooth and peakless, and the duration of its effect was prolonged.

HOW TO USE RINGLAR®

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

RinGlar® and other medicinal products containing insulin glargine at a dosage of 300 units/ml are not bioequivalent and are not fully interchangeable. The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring. Please, consult your doctor for further information.

Dose

Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will:

determine how much RinGlar® per day you will need and at what time,

tell you when to check your blood sugar level, and whether you need to carry out urine tests,

tell you when you may need to inject a higher or lower dose of RinGlar.

RinGlar® is the long-acting insulin. Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.

Many factors may influence your blood sugar level. You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low. See the box at the end of this leaflet for further information.

Use in children and adolescents

RinGlar® can be used in adolescents and children aged 2 years and above. Use this medicine exactly as your doctor has told you.

Frequency of administration

You need one injection of RinGlar® every day, at the same time of the day.

Method of administration

RinGlar® is injected under the skin. Do NOT inject RinGlar in a vein, since this will change its action and may cause hypoglycaemia.

Your doctor will show you in which area of the skin you should inject RinGlar. With each injection, change the puncture site within the particular area of skin that you are using.

Shelf life

Cartridge, prefilled Rinastra II pen

3 years

Shelf life after the first use of cartridge or pen

The medicinal product can be stored for not more than 4 weeks at maximum temperature of 30°C away from heat and light sources.

Do not store a pen with inserted cartridge or a pen in use in a refrigerator.

It is necessary to put a protective cap on the pen after each injection to protect it from sunlight.

Special precautions for storage

Unused cartridges, unused pens

Store in a refrigerator at 2 to 8°C.

Do not freeze, do not place next to the freezer or ice packs.

Store cartridges or prefilled pens in the outer carton package to protect from sunlight.

Cartridges and pens in use

For information on storage conditions upon the first opening of the medicinal product

Producer: GEROPHARM

The firm accepting claims:

GEROPHARM

Address: Business center "Nevskaya Ratusha" 11B, Degtyarny lane, St. Petersburg, 191144, Russian Federation
Hot-line: 8-800-333-4376 (free call across the Russian Federation)


Решения по упаковке призваны обеспечить безопасность и контроль при использовании инсулина
На упаковку нанесено несколько видов информационных обозначений.
Виды информационных обозначений имеют визуальное исполнение (цифровое) и тактильное – для пациентов с ослабленным зрением.

Цифровое обозначение
Цифровое обозначение представлено QR кодом. QR (Quick Response - Быстрый Отклик) это штрихкод, предоставляющий информацию для быстрого ее распознавания с помощью камеры на мобильном телефоне. Сканированный таким образом QR код направляет врача или пациента на сайт компании ГЕРОФАРМ, на страницу РинГлар®.

Тактильное обозначение
Тактильное обозначение представлено выпуклым обозначением (шрифт Брайля). Таким образом, упаковка пригодна для людей с ослабленным зрением.

Безопасность
Безопасность пациента при использовании упаковки РинГлар® также имеет несколько уровней:
-контроль первого вскрытия упаковки в виде клапана
-свободный край фольги для удобства извлечения картриджа

-все поверхности блистера с картриджами скруглены и не имеют острых краев. Это имеет принципиальное значение для пациентов с сахарным диабетом, у которых может быть ослаблена чувствительность и повреждение кожи может не сопровождаться болью и наступить незаметно.

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