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Insulin lispro biphasic 25

Dosage form: suspension for subcutaneous injections in 3 ml cartriges and pre-filled disposable insulin pen

  • Has fast and predictable effect and the elimination typical for physiologic insulin secretion
  • Prandial component ensures faster and more predictable onest of action as well as fast elimination peculiar to physiologic insulin secretion? extended component ensures smooth peakless profile of basal insulin
  • Onset of action after subcutaneous administrationin -15 min
  • Maximum action - in 0.5–2.5 hours
  • Duration of action up to 15 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.

RinLis® Mix 25 is a biosimilar to Humalog Mix25.

Pharmacokinetic properties

The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak blood levels 30 to 70 minutes following subcutaneous injection. The pharmacokinetics of insulin lispro protamine suspension are consistent with those of an intermediate acting insulin such as NPH. The pharmacokinetics of RinLis Mix 25 are representative of the individual pharmacokinetic properties of the two components. When considering the clinical relevance of these kinetics, it is more appropriate to examine the glucose utilization curves (as discussed in 5.1).

Renal impairment

Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients with renal impairment. In patients with type 2 diabetes over a wide range of renal function the pharmacokinetic differences between insulin lispro and soluble human insulin were generally maintained and shown to be independent of renal function.

Hepatic impairment

Insulin lispro maintains more rapid absorption and elimination when compared to soluble human insulin in patients with hepatic impairment.

Trade name: RinLis® Mix 25

International nonproprietary name (INN):Insulin lispro biphasic 25

Dosage form: suspension for subcutaneous injections in 3 ml cartriges and pre-filled disposable insulin pen

  • Has fast and predictable effect and the elimination typical for physiologic insulin secretion
  • Prandial component ensures faster and more predictable onest of action as well as fast elimination peculiar to physiologic insulin secretion? extended component ensures smooth peakless profile of basal insulin
  • Onset of action after subcutaneous administrationin -15 min
  • Maximum action - in 0.5–2.5 hours
  • Duration of action up to 15 hours

ATC-code: А10АD04

Pharmacodynamic properties

Pharmaco-therapeutic group: Drugs used in diabetes. Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting.

RinLis Mix 25 is a biosimilar to Humalog Mix25.

RinLis Mix 25 is a premixed suspension consisting of insulin lispro (fast-acting human insulin analogue) and insulin lispro protamine suspension (intermediate acting human insulin analogue).

The primary activity of insulin lispro is the regulation of glucose metabolism.

In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues. Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid output.

Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer to a meal (within zero to 15 minutes of the meal) when compared to regular insulin (30 to 45 minutes before). The rapid onset and early peak of activity of insulin lispro is observed following the subcutaneous administration of RinLis Mix 25. Humalog Basal has an activity profile that is very similar to that of a basal insulin (NPH) over a period of approximately 15 hours.

Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial hyperglycaemia with RinLis Mix 25 compared to human insulin mixture 30/70. In one clinical study there was a small (0.38 mmol/l) increase in blood glucose levels at night (3 a.m.).

In the figure below the pharmacodynamics of 25% insulin lispro and 75% insulin lispro protamine suspension mix and Humalog Basal are illustrated.

The above representation reflects the relative amount of glucose over time required to maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these insulins on glucose metabolism over time.

The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment. Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a glucose clamp procedure, were maintained over a wide range of renal function.

Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more rapid and of a shorter duration.

In two 8-month open label crossover studies, type 2 diabetes patients who were either new to insulin therapy or already using one or two injections of insulin, received 4 months of treatment with Humalog Mix25 (used twice daily with metformin) and insulin glargine (used once daily with metformin) in a randomized sequence. Detailed information can be found in the following table.

Pharmacokinetic properties

The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak blood levels 30 to 70 minutes following subcutaneous injection. The pharmacokinetics of insulin lispro protamine suspension are consistent with those of an intermediate acting insulin such as NPH. The pharmacokinetics of RinLis®Mix 25 are representative of the individual pharmacokinetic properties of the two components. When considering the clinical relevance of these kinetics, it is more appropriate to examine the glucose utilization curves (as discussed in 5.1).

Renal impairment

Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients with renal impairment. In patients with type 2 diabetes over a wide range of renal function the pharmacokinetic differences between insulin lispro and soluble human insulin were generally maintained and shown to be independent of renal function.

Hepatic impairment

Insulin lispro maintains more rapid absorption and elimination when compared to soluble human insulin in patients with hepatic impairment.

The 3 ml cartridge is only for use in 3ml pens. It is not for use in 1.5 ml pens.

Always check the pack and the cartridge label for the name and type of the insulin when you get it from your pharmacy. Make sure you get the RinLis® Mix 25 that your doctor has told you to use.

Always use RinLis® Mix 25 exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by you only, even if the needle on the delivery device is changed.

Dosage

· You should normally inject RinLis® Mix 25 within 15 minutes of a meal. If you need to, you can inject soon after a meal. But your doctor will have told you exactly how much to use, when to use it, and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

· If you change the type of insulin you use (for example from a human or animal insulin to a RinLis product), you may have to take

more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months.

· Inject RinLis® Mix 25 under the skin. You should not administer it using a different administration route. Under no circumstances

should RinLis® Mix 25 be given intravenously.

Do not mix any other insulin in a RinLis Mix 25 cartridge. Once the cartridge is empty, do not use it again.

If you take more RinLis® Mix 25 than you need

If you take more RinLis Mix 25 than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you have any further questions on the use of this product, ask your doctor.

POSSIBLE SIDE EFFECTS

Description of side effects

Like all medicines, RinLis® Mix 25 can cause side effects, although not everybody gets them.

Local allergy is common ( 1/100 to <1/10). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

If you think you are having this sort of insulin allergy with RinLis® Mix 25, tell your doctor at once.

Lipodystrophy (thickening or pitting of the skin) is uncommon ( 1/1,000 to <1/100). If you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see further). By reporting side effects, you can help provide more information on the safety of this medicine.

Incompatibilities

Mixing RinLis Mix 25 with other insulins has not been studied. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Unused cartridge / unused pre-filled pen

3 years.

After cartridge insertion / after first use of a pre-filled pen

28 days.

Special precautions for storage

RinLis Mix 25, 100 units/ml, suspension for injection in cartridge

Unused cartridge

Store in a refrigerator (2°C - 8°C). Do not freeze.

Do not expose to excessive heat or direct sunlight.

After cartridge insertion

Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the needle attached.

RinLis Mix 25, 100 units/ml, suspension for injection in a pre-filled pen (Rinastra II)

Unused pre-filled pen

Store in a refrigerator (2°C - 8°C). Do not freeze.

Do not expose to excessive heat or direct sunlight.

After first use

Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the needle attached.

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 РинЛиз® Микс 25.

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

Безопасность
Безопасность пациента при использовании упаковки РинЛиз® Микс 25 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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