Ryzodeg Flextouch 100units/ml of diabetes treatment (5 trees x 3ml)

Dosage form Box of 5 trees x 3ml
Specifications Insulin degludec, insulin aspart

Ingredient

Composition informationContent
Insulin degludec2.56mg
Insulin aspart1.05mg

Uses

Indications

Ryzodeg flextouch injection pens are indicated for treatment of diabetes in adults, adolescents and children aged 2 and older.

Pharmacokology

Mechanism of action

insulin degludec and insulin aspart are specialized in human insulin receptors; And the effect of pharmacological effects similar to human insulin.

The effect of reducing insulin blood glucose is because it makes the absorption of glucose easier after insulin attaches to receptors on muscle cells and fat cells, while inhibiting the production of glucose from the liver.

Pharmacological effect

The pharmacological effect of Ryzodeg is clearly separated for 2 components (Figure 1) and the path of representation of the effect reflects the separate components of the Insulin ASPART effect quickly and the insulin degludec (background) is prolonged.

The extended ingredient (background) of Ryzodeg (Insulin Degludec) forms many dissolved hexamers when injected under the skin, effectively creating a reserve from which insulin degudec is absorbed continuously and slowly in circulating, leading to the effect of reducing glucose prolonged, flat and stable. This effect is maintained in the formula combined with insulin aspart and does not affect the effects of the monomers (monomers) insulin aspart.

Ryzodeg Flextouch 100U/ml injection pen has a quick act, which occurs immediately after the injection provides insulin supply over time of meals while the background component shows a flat and stable effect, providing continuous supply of background insulin needs. The acting time of a single dose of Ryzodeg is more than 24 hours.

Figure 1: Pharmacokology, single dose - Performance of average glucose transmission speed - subjects with diabetes tip 1 - 0.8 U/kg Ryzodeg - Test 3539

Figure 1: Pharmacological, single -dose - Performing average glucose transmission rate - subjects with diabetes tip 1 - 0.8 U/kg Ryzodeg - Test 3539

The maximum and maximum reducing glucose and maximum glucose of Ryzodeg increases with increased dose. Stable state will occur after 2-3 days of using the drug.

There is no difference in the pharmacological effect of Ryzodeg between elderly patients and young patients.

Pharmacokinetics

absorption

After subcutaneous injection, the hexamers of insulin degludec dissolve and stabilize are formed, creating an insulin storage in the subcutaneous tissue, while not hindering the rapid release of monomer (monomer) of the insulin aspart in circulation. The monomer (monomer) insulin degudec gradually separated from this hexamer, thus leading to slow and continuous insulin degludec separation. Serum Insulin component concentration in stable state (insulin degludec) is achieved after 2-3 days of Ryzodeg injection.

The rapid absorption of insulin aspart has been clearly defined by Ryzodeg. The pharmacokinetic pathway of Insulin Aspart appears 14 minutes after the injection at the peak concentration after 72 minutes.

Distribution

The affinity of insulin degludec with serum albumin corresponds to the cohesion of plasma protein> 99% in human plasma. Insulin Aspart has a connection with low plasma proteins (

Biological Change

The divestation of insulin degludec and insulin aspart is similar to human insulin; All metabolites formed are not active.

Elimination

Semi -waste time after subcutaneous Ryzodeg is determined by the absorption rate from subcutaneous tissue. The sale time of the Insulin component (insulin degludec) in a stable state is 25 hours regardless of the dose.

linear

The total exposure level with Ryzodeg is proportional to the dose of the background insulin component (insulin degludec) and insulin ingredients (insulin aspart) in patients with type 1 and tube 2.

Gender

There is no gender difference to the pharmacokinetic properties of Ryzodeg.

Elderly, racial, kidney failure and liver failure

There is no clinical difference in pharmacokinetics of Ryzodeg between elderly patients and young adult patients, between races or between healthy patients and patients with renal impairment or liver failure.

Group of children's patients

Ryzodeg's pharmacokinetic properties in patients with type 1 diabetes have been studied in children (6 - 11 years old) and teenagers (12 - 18 years old) and compared to adults after injection 1 single dose.

The stable pharmacokinetic properties of insulin degludec are the component of Ryzodeg that has been studied using pharmacokinetic analysis in children aged 1 and older. The total survey and peak concentration of insulin aspart is higher than that of children and similar to adults and adults.

Insulin degudec pharmacokinetic properties in children (1 - 11 years old) and teenagers (12-18 years old) in a stable stage are equivalent to the pharmacokinetic properties observed in adults with type 1 diabetes.

Before taking Ryzodeg Flextouch 100units/ml of diabetes treatment (5 trees x 3ml)

How to use

Ryzodeg flextouch injection pen only used subcutaneously.

Ryzodeg is not intravenous because it can lead to severe hypoglycemia.

Ryzodeg is not intramuscularly because it can change the absorption.

Ryzodeg is not used in insulin transmission pumps.

Ryzodeg must not be drawn from the tube of the pen to the syringe.

Ryzodeg flextouch injection pen is used under the abdominal wall, upper arm or thigh. Should always change the vaccinated position in the same injection area to reduce the risk of fat disorders. Patients should be instructed to always use new needles. The reuse of needles increases the risk of needle blockage, which can cause insufficient doses or overdose. In the metal occlusion, the patient must follow the instructions described in the accompanying manual.

Ryzodeg is packed in a Flextouch pump (Flextouch) designed for use with Novofine or Novotwist needles. The pump pen is available for 1 - 80 units, with hiccups per unit.

Dosage

Ryzodeg injection pen is a soluble insulin product including insulin degludec (background) for a long -lasting effect and an insulin aspart fast -acting on meals.

Ryzodeg can be used once or twice daily with the main meals. When necessary, the patient can change the use time as long as Ryzodeg is used with the largest meal when used 1 time/day.

Effect of insulin analogues, including Ryzodeg, is shown in the unit (U). One (1) Ryzodeg unit (U) Ryzodeg is equivalent to an international unit (IU) human insulin, 1 unit of Insulin Glargine, 1 insulin detemir unit or an Insulin aspart unit of two -phase.

In patients with type 2 diabetes, Ryzodeg can be used alone, in combination with other oral diabetes treatment drugs and combined with insulin bolus.

In type 1 diabetes, Ryzodeg is combined with short -acting insulin/insulin -acting effects at the remaining meals.

Ryzodeg diabetes pen is used depending on the needs of each patient. The recommended dose adjustment is mainly based on plasma glucose measurements.

As with all insulin products, the adjustment of the dose may be necessary if the patient increases physical activity, changes the normal diet or is with an accompanying disease.

Flexibility about drug use time

Ryzodeg allows flexibility to use insulin as long as the drug is used for the main meals.

Start

Patients with type 2 diabetes

Total daily starting dose is recommended as 10 units according to meals, then adjust the dose for each patient.

Patients with type 1 diabetes

The starting dose of the insulin Ryzodeg pen is 60 - 70% of the total daily insulin demand.

Ryzodeg injection pen is used 1 time/day over the time of the meal in combination with short -acting insulin/insulin effects on the remaining meals, then adjust the dose for each patient.

switches to other insulin

Advice to closely monitor glucose during the conversion period and in the following weeks. The dosage and time may be needed and the time to use insulin products quickly or shortly or effectively or treat other diabetes to use at the same time.

Patients with type 2 diabetes

Patients who move from insulin (background) are long -lasting or mixed insulin (2 phases) used 1 time/day can be converted to Ryzodeg 1 time/day conversion 1: 1 unit with total insulin dose like the total daily insulin dose of the patient before.

Patients who switch from insulin (background) are long -lasting or mixed insulin (2 phases) for more than 1 time/day can be converted to Ryzodeg twice a day with the total insulin doses such as the patient's total daily insulin daily.

Patients who switch from insulin (background) The effect/insulin quickly shifted to Ryzodeg will need to convert the dose based on the needs of each patient. In general, the patient is started to dose according to the number of units of insulin (background) for a long effect.

Patients with type 1 diabetes

Ryzodeg dose is recommended to be 60 - 70% of the total daily insulin demand in combination with short -acting insulin/insulin -acting insulin at the remaining meals, then adjust the dose with each patient.

Special patient groups

Elderly (≥ 65 years)

Ryzodeg pen can be used in elderly patients. Glucose monitoring should be enhanced and adjust the dose of insulin with each patient.

kidney failure and liver failure

Ryzodeg can be used in patients with renal impairment and patients with liver failure. Glucose monitoring should be enhanced and adjust the dose of insulin with each patient.

Group of children's patients

Ryzodeg Flextouch 100U/ml injection pen can be used in teenagers and children 2 years and older. When changing from other insulin modes to Ryzodeg, it is necessary to consider reducing the total dose of insulin in each patient to minimize the risk of hypoglycemia.

Ryzodeg should be used carefully in children from 2 to 5 years old because clinical data shows that there is a risk of high hypoglycemia in children in this age group.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? However, hypoglycemia can develop in consecutive stages if the dose of insulin is more than the patient's needs:

Mild hypoglycemic stage, can be treated using oral glucose or sugar products. Therefore, patients with diabetes are advised to bring people with sugar products.

Severe hypoglycemia, when patients cannot handle themselves, can be treated with glucagon (0.5 to 1 mg) intramuscularly or subcutaneous injection by a person who has been instructed on how to inject, or use intravenous glucose by a medical staff. Intravenous glucose must be used if the patient does not respond to glucagon within 10-15 minutes. When the patient wakes up, the food contains carbohydrates to prevent recurrence.

What to do when forgetting a dose? Patients should not take an extra dose to compensate for the forgotten dose.

Side Effects

When using Ryzodeg® Flextouch, you may experience unwanted effects (ADR).

Summary of safety data

The most commonly reported side effect during treatment is hypoglycemia.

List of side effects

The side effects are listed below based on clinical data and are classified in the medra system group. The frequency groups are determined according to the following convention: Very common (≥ 1/10); Common (≥ 1/100 to Agency system group frequency - Hypoglycemia

immune system disorders

Allergic reactions may occur when using insulin preparations. Instant allergic reaction to Insulin itself or with dysentery excipients.

With Ryzodeg, there is a rare report on hypersensitivity (manifested by swelling of the tongue and lips, diarrhea, nausea, fatigue and itching) and urticaria.

Hypoglycemia

Hypoglycemia may occur if insulin dose is too high compared to insulin needs. Hypoglycemia can lead to unconsciousness and/or convulsions and may cause temporary or permanent brain failure or even death. Symptoms of hypoglycemia often appear suddenly, may include cold sweat, pale and cold skin, fatigue, restlessness or tremor, anxiety, tired or abnormal weakness, confusion, difficulty concentrating, drowsiness, intense hunger, vision change, headache, nausea and brush.

Fatty disorder

Fat dysplasia (including adipose tissue hypertrophy, fat tissue atrophy) may occur at the injection site. Continuous changes in the injection site in a certain injection area can help reduce the risk of these reactions.

The response to the injection site

Initial reaction (including hematoma in the injection site, pain, hemorrhage, erythema, small tumor, swelling, discoloration, itching, hot feeling and in the injection site) occurs in patients treated with Ryzodeg. These reactions are often mild, transient and often disappeared when continuing treatment.

Group of children's patients

Ryzodeg has been used for children and teenagers under 18 years of age to study pharmacokinetic properties. Safety and effectiveness are proven in children's tests from 2 to 18 years old. The frequency, type and severity of adverse reactions in children not only differ from the experience in the group of common diabetes patients, except for serious hypoglycemia that occurs more than the background-tongromous mode in children's groups, especially in children aged 2 to 5 years old.

Other special patient groups

Based on the results from clinical trials, the frequency, type and severity of the side effects observed in elderly patients and in patients with renal impairment or liver failure, do not show any difference with a wider experience in the common population group.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Ryzodeg flextouch drugs are contraindicated for patients with hypersensitivity to active ingredients or any excipients of the drug.

Caution when using

Read the instructions carefully before use. If you need more information, please consult your doctor.

This drug is only used by a doctor.

Hypoglycemia

Skipping a meal or physical exercise, no plan that can lead to hypoglycemia.

Hypoglycemia may occur if insulin dose is too high compared to insulin needs. In children, pay more attention when choosing insulin dose to suit food and physical activities to minimize the risk of hypoglycemia. Ryzodeg may be related to a higher number of serious hypoglycemia than a fast -backing insulin mode in children, especially in children from 2 to 5 years old (see pharmacological properties). For this age group, it is advisable to consider using Ryzodeg on each individual.

Patients with improved blood glucose control (for example, enhanced insulin therapy), may have changes in the common warning symptoms of hypoglycemia and must be notified by the doctor. Common warning symptoms can be lost in patients with diabetes for a long time.

The accompanying diseases, especially infection and fever, often increases the patient's insulin needs. The accompanying diseases in the kidneys, liver or diseases affect the adrenal glands, pituitary or thyroid gland may require changes in insulin dose.

As with other prolonged insulin products (backgrounds) or insulin products with background components, prolonged effects of Ryzodeg injection pen can slow down after hypoglycemia.

Hyperglycemia

The use of fast -acting insulin is recommended in severe hyperglycemia.

The treatment is not enough and/or not continuous in patients who need insulin that can lead to hyperglycemia and potentially causing diabetes getting metica. Moreover, the accompanying pathologies, especially infections, can lead to hyperglycemia and thus increases insulin demand.

Normally, the first symptoms of hyperglycemia appear slowly, lasting for several hours or days. These symptoms include thirst, many times, nausea, vomiting, drowsiness, red skin, dry mouth, loss of appetite and acetone smell. In type 1 diabetes, cases of untreated hyperglycemia will eventually lead to diabetes metonic acidosis, which is likely to be fatal.

Switch from other insulin products

When transforming patients to use other insulin, other insulin brands or other manufacturers must be performed under strict medical supervision and can lead to the need for dose changes.

Combining thiazolidinedione and insulin drugs

There have been reports on heart failure when using thiazolidinedione combined with insulin, especially in patients with risk factors for heart failure. This should be remembered if considering the combination of thiazolidinedione with Ryzodeg. If used in combination, patients must monitor the signs and symptoms of heart failure, weight gain and edema. Thiazolidinedione should be stopped if there is any bad symptoms of cardiovascular risk.

Eye disorders

Enhanced insulin therapy with sudden improvement in blood sugar control may be associated with diabetes due to temporary deterioration of diabetes, while improving long -term blood sugar control reduces the risk of progression of diabetic retinopathy.

Avoid confusion due to unintentional

Patients must be instructed to always check insulin labels before each injection to avoid confusion between Ryzodeg and other insulin products due to unintentional.

Patients must check the naked eye in terms of the number of units that have been rotated on the dose of the pen. Therefore, the requirement for self -injection patients is that they can read the dose of the dose on the injection pen. Patients with blindness or poor vision must be instructed to always receive help/support from another person with good vision and trained to use insulin injection tools. To avoid dosage errors and overdose, patients and medical staff should never use the injection pump from the syringe in the injection pen.

In the metal constrict, the patient must follow the instructions described in the accompanying user instruction sheet (see special caution when abandoning and processing other).

Insulin antibodies

Using insulin can cause antibody formation of insulin antibodies. In rare cases, the presence of insulin antibodies may require adjusting insulin dose to adjust the trend of hyperglycemia or hypoglycemia.

The ability to drive and operate machinery

The patient's concentration and reaction ability may be impaired as a result of hypoglycemia. This can be dangerous in situations where these possibilities are of special importance (such as driving or operating machinery).

Patients must be notified to take measures to prevent hypoglycemia while driving. This is especially important in patients who are difficult to identify whether or not to recognize the warning signs of hypoglycemia or in people who often have hypoglycemia. It is necessary to consider the suitability of driving in these cases.

Pregnancy

There is no clinical experience in using Ryzodeg in pregnant women.

Animal studies have not detected any differences between insulin degludec and human insulin in toxicity of embryos and teratogenic properties.

In general, enhancing blood glucose control and monitoring of pregnant women with diabetes are recommended during pregnancy and when intended to get pregnant. The demand for insulin usually drops in the first three months of pregnancy and then increases in the middle and the last three months of pregnancy. After birth, insulin demand often quickly returns to the values ​​as before pregnancy.

The period of breastfeeding

has no clinical experience in the use of Ryzodeg injection pen while breastfeeding. In rats, insulin degludec is excreted in mouse milk, the concentration of milk is lower in plasma.

It is unclear whether the insulin deglan

Interactive drug

Some drugs are known to interact with the metabolism of glucose.

The following substances can reduce insulin demand

Oral diabetes drugs, GLP-1 receptor receptors, Monoamine oxidase inhibitors (MAOI), beta blockers, enzyme inhibitors Angiotensin (ACE), Salicylate, Siles and Sulfonamide.

The following substances can increase insulin demand

Oral contraceptives, thiazide, glucocorticoid, thyroid hormone, sympathetic substance, growth hormone and Danazol.

Beta blockers can cover the symptoms of hypoglycemia. Octreotide/Lanreotide may increase or reduce insulin demand.

Alcohol may increase or reduce the hypoglycemic effect of insulin.

Storage

Before using the first time

Store in the refrigerator (2 ° C - 8 ° C). To far from the cooling unit.

Do not freeze.

Cover the pen to avoid light.

After the first use or carrying out the backup

The product can be stored for up to 4 weeks. Do not store over 30 ° C. Can be stored in the refrigerator (2 ° C - 8 ° C)

Cover the pen to avoid light.

To be out of reach and vision of children.

Do not use Ryzodeg® Flextouch 100 units/ml expiry date printed on packaging.

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