Instructions for use: Ryzodeg FlexTouch solution for injection 100 U/ml cartridge inserted into a 3 ml syringe pen No. 5
Composition
active ingredients: insulin degludec, insulin aspart;
1 ml of solution contains 100 U of insulin degludec/insulin aspart*, which contains 70% insulin degludec (equivalent to 2.56 mg) and 30% insulin aspart (equivalent to 1.05 mg).
1 pre-filled pen contains 3 ml of solution, equivalent to 300 U of insulin degludec/insulin aspart;
excipients: glycerol; metacresol; phenol; sodium chloride; zinc acetate, dihydrate; hydrochloric acid (for pH adjustment); sodium hydroxide (for pH adjustment); water for injections.
*produced using rDNA technology in Saccharomyces cerevisiae.
Dosage form
Solution for injection.
Main physicochemical properties: clear liquid without turbidity, practically free of mechanical inclusions.
Pharmacotherapeutic group
Digestive tract and metabolism. Drugs used in diabetes mellitus. Insulins and analogues for injection, combinations of short-acting insulins with intermediate- and long-acting insulins. ATX code A10A D06.
Pharmacological properties
Pharmacodynamics
Mechanism of action
Insulin degludec and insulin aspart bind specifically to the human insulin receptor and produce the same pharmacological effect as human insulin.
The blood sugar-lowering effect of insulin consists in promoting the absorption of glucose by tissues after insulin binds to receptors on muscle and fat cells, as well as in simultaneously inhibiting the release of glucose from the liver.
Pharmacodynamics.
The pharmacodynamic effect of Ryzodeg® FlexTach® is clearly formed by two components, and the resulting action profile reflects the action of the individual components – rapid-acting insulin aspart and basal insulin degludec.
The basal component of the drug (insulin degludec) when injected subcutaneously forms a soluble multihexamer, resulting in the formation of a depot from which insulin degludec is continuously and slowly absorbed into the bloodstream, which provides a uniform and sustained decrease in blood glucose levels. This property is preserved in the combined drug containing insulin degludec and aspart, and does not interfere with the absorption of monomers of fast-acting insulin aspart.
The onset of action of Ryzodeg® FlexTach® occurs rapidly, shortly after injection, ensuring that insulin requirements are met during meals, while the basal component has a uniform and stable action profile and ensures continuous coverage of basal insulin requirements. The duration of action of a single dose of the drug is more than 24 hours.
The overall maximum blood sugar-lowering effect of the drug increases linearly with increasing dose. Steady-state blood concentrations are achieved after 2–3 days of drug administration.
No differences in the pharmacodynamic effect of Ryzodeg® FlexTach® were found in young and elderly patients.
Clinical efficacy and safety
Five multinational, randomized, controlled, open-label, to-target clinical trials of 26 weeks and 52 weeks duration were conducted with Ryzodeg® FlexTach® in a total of 1,360 patients with diabetes mellitus (362 patients with type 1 diabetes mellitus and 998 patients with type 2 diabetes mellitus). Two of the trials in patients with type 2 diabetes mellitus compared Ryzodeg® FlexTach® once daily in combination with oral hypoglycemic agents with insulin glargine once daily in combination with oral hypoglycemic agents. In two studies in patients with type 2 diabetes, Ryzodeg® FlexTach® twice daily in combination with oral hypoglycemic agents was compared with biphasic insulin aspart 30 twice daily in combination with oral hypoglycemic agents. In patients with type 1 diabetes, Ryzodeg® FlexTach® once daily in combination with insulin aspart was compared with insulin detemir once or twice daily in combination with insulin aspart.
In two studies of the combination of insulin and oral hypoglycemic agents in patients with type 2 diabetes, including patients who were previously insulin-naive and patients who were undergoing insulin therapy intensification, Ryzodeg® FlexTach® once daily demonstrated similar glycaemic control (HbA1C) compared to insulin glargine (used as directed). Because Ryzodeg® FlexTach® contains a rapid-acting mealtime insulin (insulin aspart), mealtime glycaemic control was improved compared to basal insulin alone. A lower incidence of nocturnal hypoglycemic episodes (defined as an episode occurring between midnight and 6 a.m., as confirmed by plasma glucose) was observed with Ryzodeg® FlexTach® twice daily. Ryzodeg® FlexTach® twice daily demonstrated similar glycemic control (HbA1C) compared to biphasic insulin aspart 30 twice daily. Ryzodeg® FlexTach® improved fasting plasma glucose control compared to biphasic insulin aspart 30. Ryzodeg® FlexTach® reduces total and nocturnal hypoglycemia.
In patients with type 1 diabetes, once-daily administration of Ryzodeg® FlexTach® in combination with insulin aspart (to cover insulin requirements at non-meal times) demonstrated similar glycemic control (HbA1C and fasting plasma glucose) with a lower incidence of nocturnal hypoglycemic episodes compared to a basal-bolus regimen of insulin detemir in combination with insulin aspart (to cover insulin requirements at all meals).
There are no data on the development of clinically significant insulin antibodies during long-term treatment with Ryzodeg® FlexTach®.
Children
The efficacy and safety of Ryzodeg® FlexTach® was evaluated in a 16-week randomized clinical trial (n = 362) in children and adolescents with type 1 diabetes. The study included 40 children aged 2 to 5 years, 61 children aged 6 to 11 years, and 80 adolescents aged 12 to 17 years. Ryzodeg® FlexTach® administered once daily with a main meal plus insulin aspart with other meals demonstrated similar reductions in glycated hemoglobin at 16 weeks and no differences in fasting plasma glucose and self-monitored plasma glucose compared to insulin detemir administered once or twice daily plus insulin aspart with meals. At week 16, the mean total daily dose of Ryzodeg® FlexTach® and insulin detemir was 0.88 versus 1.01 U/kg, respectively. The rates (events per patient-year of exposure) of confirmed hypoglycemia (ISPAD-2009 definition: 46.23 versus 49.55) and confirmed nocturnal hypoglycemia (5.77 versus 5.40) were comparable between the Ryzodeg® FlexTach® and insulin detemir groups, while the rate of severe hypoglycemia (0.26 versus 0.07) was higher in the Ryzodeg® FlexTach® group, although the difference was not statistically significant. Multiple episodes of severe hypoglycemia were reported in each group; The incidence of severe hypoglycemia in the Ryzodeg® FlexTach® group was higher in patients aged 2–5 years compared with patients aged 6–11 years or 12–17 years (0.42 vs. 0.21 and 0.21, respectively). The efficacy and safety assessment in adolescents with type 2 diabetes was conducted using data from a study involving adolescents and adults with type 1 diabetes and adults with type 2 diabetes. This assessment supports the use of Ryzodeg® FlexTach® in adolescents with type 2 diabetes.
Pharmacokinetics
Absorption.
After subcutaneous injection, soluble and stable multihexamers of insulin degludec are formed, which form a depot of insulin in the subcutaneous tissue, which does not interfere with the rapid release of insulin aspart monomers into the bloodstream. Insulin degludec monomers gradually separate from the multihexamers, which ensures a slow and constant flow of insulin degludec into the bloodstream. The equilibrium concentration of the basal component (insulin degludec) in the blood serum is achieved after 2–3 days of daily administration of the drug Ryzodeg® FlexTach®.
The rapid absorption characteristic of the well-studied insulin aspart is maintained in Ryzodeg® FlexTach®. The pharmacokinetic profile of insulin aspart is apparent 14 minutes after injection, with peak plasma concentrations achieved at 72 minutes.
Distribution
The affinity of insulin degludec for human plasma albumin is > 99%. Insulin aspart has low plasma protein binding (
Metabolism
The degradation of insulin degludec and insulin aspart is similar to that of human insulin; none of the metabolites formed has biological activity.
Breeding
After subcutaneous administration of Ryzodeg® FlexTach®, the elimination half-life is determined by the rate of absorption from the subcutaneous tissue. The elimination half-life of the basal component (insulin degludec) at steady state is 25 hours, regardless of dose.
The total exposure of Ryzodeg® FlexTach® increases in proportion to the increase in the dose of the basal component (insulin degludec) and the prandial component (insulin aspart) in type 1 and type 2 diabetes mellitus.
Sex
No differences in the pharmacokinetic properties of the drug were found depending on the patient's gender.
Age, race, renal and hepatic insufficiency
No clinically significant differences in the pharmacokinetics of Ryzodeg® FlexTach® were found between elderly and young adult patients, between patients of different races, and between healthy volunteers and patients with renal or hepatic insufficiency.
Children
The pharmacokinetics of Ryzodeg® FlexTach® in type 1 diabetes mellitus were studied in children (6–11 years) and adolescents (12–18 years) and compared to adults after a single dose. The steady-state pharmacokinetics of insulin degludec, a component of Ryzodeg® FlexTach®, were studied using a population pharmacokinetic analysis in children under 1 year of age.
Total exposure and peak insulin aspart concentrations were higher in children than in adults and were similar in adolescents and adults.
The pharmacokinetic properties of insulin degludec in children (1–11 years) and adolescents (12–18 years) at steady state were comparable to those in adults with type 1 diabetes. The total exposure to insulin degludec after a single dose was, however, higher in children and adolescents than in adults with type 1 diabetes.
Indication
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and older.
Contraindication
Hypersensitivity to insulin degludec, insulin aspart or to any of the excipients included in the preparation.
Interaction with other medicinal products and other types of interactions
As is known, a number of medications affect glucose metabolism.
Drugs that may reduce insulin requirements
Oral hypoglycemic agents (OHAs), GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOIs), beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, salicylates, anabolic steroids, and sulfonamides.
Drugs that may increase insulin requirements
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
β-blockers may mask the symptoms of hypoglycemia.
Octreotide/lanreotide may either decrease or increase insulin requirements.
Alcohol may enhance or reduce the hypoglycemic effect of insulin.
Application features
Hypoglycemia
Skipping meals or intense physical activity can lead to hypoglycemia.
Hypoglycemia can occur if the insulin dose is too high relative to insulin requirements.
Use in children requires special care: insulin doses should be adjusted to meals and exercise to minimize the risk of hypoglycemia. Ryzodeg® FlexTach® may increase the risk of severe hypoglycemia compared with basal-bolus insulin regimens in children, especially in children aged 2 to 5 years (see section 5.1). The appropriateness of using Ryzodeg® FlexTach® in this age group should be considered on an individual basis.
Patients whose blood glucose control has improved significantly with intensive insulin therapy may experience a change in the usual symptoms of hypoglycemia, and should be warned about this in advance. The usual symptoms may disappear in patients with long-standing diabetes.
Concomitant diseases, especially infections and fever, usually increase the patient's insulin requirements. Concomitant diseases of the kidneys, liver, or diseases of the adrenal, pituitary, or thyroid glands may necessitate adjustment of the insulin dose.
As with other basal insulins or insulins containing a basal component, the prolonged action of Ryzodeg® FlexTach® may delay recovery of blood glucose levels after hypoglycemia.
Hyperglycemia
Administration of rapid-acting insulin is recommended in case of severe hyperglycemia.
Inappropriate dosing or discontinuation of treatment in patients requiring insulin may lead to hyperglycemia and diabetic ketoacidosis. In addition, concomitant diseases, especially infections, may lead to hyperglycemia and thus to increased insulin requirements.
The first symptoms of hyperglycemia usually develop gradually, over a period of hours or days. They include thirst, frequent urination, nausea, vomiting, drowsiness, flushing and dryness of the skin, dry mouth, loss of appetite, and the smell of acetone on the exhaled breath. In type 1 diabetes, untreated hyperglycemia leads to diabetic ketoacidosis, which is fatal.
Transferring a patient from another type of insulin
Transferring a patient to another type or brand of insulin or to insulin from another manufacturer should be done under strict medical supervision and may require adjustment of the insulin dose.
Cases of congestive heart failure have been reported with pioglitazone in combination with insulin, particularly in patients with risk factors for the development of congestive heart failure. This should be borne in mind when prescribing pioglitazone in combination with Ryzodeg® FlexTach®. Patients should be monitored for symptoms of congestive heart failure, weight gain and oedema when these drugs are used in combination. If any deterioration in cardiac function occurs, pioglitazone should be discontinued.
Vision impairment
Intensification of insulin therapy with a sharp improvement in glycemic control may temporarily exacerbate diabetic retinopathy, whereas long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy.
Preventing accidental errors
Patients should be advised to check the insulin label before each injection to avoid accidental mix-ups between Ryzodeg® FlexTach® and other insulin products.
Patients should visually check the number of units dialed on the dose counter of the pen. Blind patients and patients with poor vision should seek help from another person who has good vision and knows how to use the insulin delivery device.
To avoid dosing errors and potential overdose, patients and physicians should never use a syringe to withdraw medication from a pre-filled pen cartridge.
In the event of blocked needles, patients should follow the recommendations described in the instructions for use of the syringe pen (see “Rules for care and handling of the syringe pen”).
Production of antibodies to insulin
Insulin administration may result in the production of insulin antibodies. In rare cases, the presence of such antibodies may require adjustment of the insulin dose to correct the tendency to hyperglycemia or hypoglycemia.
Ability to influence reaction speed when driving vehicles or other mechanisms
The patient's reactions and ability to concentrate may be impaired during hypoglycemia. This may be a risk factor, for example, when driving a car or operating other machinery.
Patients should take precautions to prevent hypoglycemia before driving. This is especially important for patients who have reduced or absent warning signs of hypoglycemia or who experience frequent episodes of hypoglycemia. In such circumstances, the advisability of driving should be considered.
Use during pregnancy or breastfeeding
Pregnancy
There is no clinical experience with the use of Ryzodeg® FlexTach® in pregnant women.
Animal reproduction studies have not revealed any differences in embryotoxicity and teratogenicity between insulin degludec and human insulin.
In general, increased blood glucose control and monitoring of pregnant women with diabetes are recommended during pregnancy and when planning a pregnancy. Insulin requirements usually decrease in the first trimester and increase during the second and third trimesters. After delivery, insulin requirements usually return rapidly to pre-pregnancy levels.
Breast-feeding
There is no clinical experience with the use of Ryzodeg® FlexTach® during breastfeeding. In animals, insulin degludec was excreted in breast milk, with concentrations in milk lower than in plasma.
It is not known whether insulin degludec, insulin aspart are excreted in human milk. Metabolic adverse effects in breastfed newborns/infants are not expected.
Fertility
Animal reproductive studies with insulin degludec have not revealed any adverse effects on fertility.
Method of administration and doses
Dosage
The drug Ryzodeg® FlexTach® is a soluble insulin preparation consisting of ultra-long-acting basal insulin – degludec and rapid-acting prandial insulin – aspart.
The drug can be administered once or twice daily with the main meal. If necessary, the patient can change the time of administration of the drug, provided that the drug Ryzodeg® FlexTach® when administered once daily is used together with the main meal.
The potency of insulin analogues, including Ryzodeg® FlexTach®, is expressed in units (U). 1 unit (U) of Ryzodeg® FlexTach® is equal to 1 international unit (IU) of human insulin, 1 unit of insulin glargine, 1 unit of insulin detemir, or 1 unit of biphasic insulin aspart.
In patients with type 2 diabetes, the drug can be administered alone or in combination with oral hypoglycemic agents or in combination with bolus insulin.
In patients with type 1 diabetes, the drug is used in combination with short/rapid-acting insulin during additional meals.
As with other insulin preparations, dose adjustment may also be required if patients change their physical activity or usual diet, or if they have concomitant diseases.
Flexibility in choosing the time of entry
The drug Ryzodeg® FlexTach® allows for flexible timing of insulin administration, provided that it is used together with the main meal.
If a dose is missed, the patient may take the missed dose with the next main meal of the same day and then resume their usual schedule. Patients should not take an extra dose to make up for the missed dose.
Start of application
Patients with type 2 diabetes
The recommended total daily starting dose is 10 units with meals, followed by individual dose adjustment.
Patients with type 1 diabetes
The recommended starting dose of Ryzodeg® FlexTach® is 60–70% of the total daily insulin requirement.
The drug should be used once a day in combination with short/rapid-acting insulin during additional meals, with subsequent individual dose adjustment.
Switching from other insulin preparations
Close monitoring of blood glucose levels is recommended during the transition to Ryzodeg® FlexTach® and during the first weeks of use. Adjustment of the dose and timing of short-/rapid-acting insulin or other glucose-lowering agents may be necessary.
Patients with type 2 diabetes
For patients switching from basal or premixed insulin to once-daily insulin, the dose of Ryzodeg® FlexTach® (when used once daily) can be converted to a unit-for-unit dose of the previous insulin at the same total insulin dose that the patient was previously receiving.
For patients switching from basal or premixed insulin to more than once daily insulin, the dose of Ryzodeg® FlexTach® (when used twice daily) can be converted to a unit-for-unit dose of the previous insulin at the same total insulin dose that the patient was previously receiving.
Patients switching from basal-bolus insulin therapy to Ryzodeg® FlexTach® should have their dose adjusted based on individual needs. In general, therapy should be initiated with the same number of units of basal insulin.
Patients with type 1 diabetes
The recommended initial dose of the drug is 60–70% of the total daily insulin requirement, which is administered in combination with short/rapid-acting insulin during additional meals, with subsequent individual dose adjustment.
Special populations
Elderly patients (≥ 65 years)
Ryzodeg® FlexTach® can be used in elderly patients. Blood glucose levels should be monitored more closely and the dose adjusted individually (see Pharmacokinetics).
Liver and kidney dysfunction
The drug can be used in patients with impaired liver and kidney function. More careful monitoring of blood glucose levels should be carried out and the dose should be adjusted individually (see section "Pharmacokinetics").
Drug administration
Ryzodeg® FlexTach® is administered subcutaneously only, by injection into the anterior abdominal wall, upper arm or thigh. To reduce the risk of lipodystrophy, injection sites should always be rotated within the same area.
The drug cannot be administered:
intravenously, as this may lead to the development of severe hypoglycemia; intramuscularly, as this may lead to changes in the rate of absorption; in an insulin infusion pump.
Ryzodeg® FlexTach® should not be drawn into a syringe from a pre-filled pen cartridge (see Precautions).
Patients should be instructed to always use a new needle for injection. Reusing needles to inject insulin from a pen increases the risk of blocked needles, which may result in under- or overdosing. In the event of blocked needles, patients should follow the recommendations described in the instructions for use of the pen (see “Pen Care and Handling”).
Precautions for handling and disposal
The FlexTouch® pre-filled pen is for use by one person only. It cannot be refilled.
Ryzodeg® FlexTach® should not be used if the solution is not clear and colorless.
Ryzodeg® FlexTouch® that has been frozen should not be used.
A new needle must be attached before each use. Needles cannot be reused. Patients should remove the needle after each use.
In the event of blocked needles, patients should follow the recommendations described in the instructions for use of the syringe pen.
Any waste must be disposed of in accordance with local requirements.
For more detailed information, see the Ryzodeg® FlexTach® Patient Information Leaflet.
Patient instructions for use of Ryzodeg® FlexTach®
Before using your FlexTouch® pen, you must read these instructions carefully. If you do not follow these instructions exactly, you may receive too little or too much insulin, which can cause your blood sugar to become too high or too low.
Do not use the pen without instruction from a doctor or nurse.
First, check the label to see that the pen contains Ryzodeg® FlexTach® 100 U/mL, and then look at the illustrations below to get information about the different parts of the pen and the needle.
Blind patients or patients with poor vision who cannot visually check the number of units dialed on the dose counter of the pen should not use the pen without the help of another person. Ask for help from another person who has good vision and knows how to use the insulin delivery device.
The pre-filled pen contains 300 U of insulin. The FlexTouch® 100 U/ml pen allows you to deliver doses from 1 to 80 units per injection in increments of 1 unit.
Ryzodeg® FlexTouch® is intended for use with NovoTwist® or NovoFine® disposable injection needles up to 8 mm in length. Needles are not included in the package.
Important information.
Please read these instructions carefully as they are important for the correct use of the pen.
1. Preparing the pen for injection
Check the insulin name and strength on the label of your pen to make sure it contains Ryzodeg® FlexTach® 100 U/ml. This is especially important if you use more than one type of insulin. If you choose the wrong type of insulin, your blood sugar may become too high or too low. Remove the cap from the pen. |
| Make sure the insulin in the pen is clear and colorless. Look through the insulin cartridge: if the insulin looks cloudy, do not use that pen. |
| Take a new needle and remove the paper membrane from it. |
| Screw the needle onto the pen. Turn the needle until it is snug. |
| Remove the large outer needle cap. Do not throw it away; you will need it after the injection to properly remove the needle from the pen. |
| Remove the inner needle cap and throw it away: if you try to put it back on, you may accidentally inject yourself. A drop of insulin may appear at the tip of the needle. This is normal, but you should still check the insulin flow. |
Always use a new needle for each injection to reduce the risk of infection, insulin leakage, blocked needles, or incorrect insulin dosing.
Never use a bent or damaged needle.
2. Checking insulin flow
Always check the insulin flow before injecting. This will help ensure that the full dose of the drug has been administered. Turn the dose selector to set 2 units. Make sure the dose counter shows 2. |
| Holding the pen vertically with the needle pointing upwards, gently tap the cartridge several times with your finger to collect any air bubbles at the top of the cartridge. |
Press and hold the dose button until the dose counter returns to “0”. The “0” mark should line up with the dose indicator. A drop of insulin should appear at the tip of the needle. |
A small air bubble may remain at the tip of the needle, but it will not be introduced during the injection.
If a drop of insulin does not appear, repeat the step-by-step test (Fig. A to Fig. C) up to 6 times. If a drop of insulin does not appear again, change the needle and repeat steps Fig. A to Fig. C one more time.
If a drop of insulin still does not appear, throw away this pen and get a new one.
Always check that a drop of insulin appears at the tip of the needle before injecting. This ensures that insulin is being delivered. If a drop does not appear, do not inject insulin, even if the dose counter is turning. This may indicate a blocked or damaged needle.
Always check the flow of insulin through the needle before injecting. If you do not check the flow of insulin, you may receive too little insulin or no insulin at all. This can lead to a significant increase in your blood sugar.
3. Setting the dose
Before injection, make sure the dose counter is set to “0.” The “0” mark should line up with the dose pointer. Turn the dose selector to set the dose required for administration as prescribed by your doctor. The set dose can be adjusted both upwards and downwards by turning the dose selector in the appropriate direction. The syringe pen provides a single dose of up to 80 units. |
The dose selector changes the number of units. Only the counter and dose pointer show how many units have been selected for injection.
The dose selector clicks differently when turned to decrease/increase the dose or when more units are selected than are left in the pen. Do not count the clicks of the pen when selecting the insulin dose.
Always use the dose counter and pointer to check the number of units set before injecting the medicine.
Do not count the clicks of the pen to select the dose. If you select and inject the wrong dose, your blood sugar level may increase or decrease significantly.
Do not use the insulin level scale, which only shows approximately how much insulin is left in the pen.
4. Insulin administration
Insert the needle under your skin. Follow the injection technique your doctor or nurse has taught you. Make sure you can see the dose counter. Do not touch the dose counter with your fingers: this may stop the insulin delivery. Press and hold the dose button until the dose counter returns to “0”. The “0” should line up with the dose pointer and you may hear a click. The needle should be kept under the skin for at least 6 seconds. This ensures that the full dose of the drug is administered. |
Remove the needle from the skin at a right angle. If there is any bleeding at the injection site, apply light pressure to the area with a cotton swab. Do not rub the injection site. |
Sometimes you may see a drop of insulin at the tip of the needle after the injection. This is acceptable and does not affect the dosage in any way.
Always watch the dose counter to monitor the number of units injected.
The dose counter shows the exact number of units.
Do not count the clicks of the pen to determine the number of units.
Keep the dose button pressed until the dose counter returns to “0” after the injection. If the dose counter stops at “0”, the full dose will not be delivered, which could cause your blood sugar to rise too high.
5. Removing the needle after injection
| On a flat surface, carefully cover the needle with the large outer cap without touching the needle or the outer cap. |
| Once the needle is closed, gently push the outer cap back until it stops, then unscrew the needle. |
| After each use, put the cap on the syringe pen to protect the medicine from light. |
Always remove the needle after each injection. This will reduce the risk of infection, insulin leakage, blocked needles, and inaccurate dosing. Insulin cannot be injected if the needle is blocked.
Dispose of the used pen without the needle as instructed by your doctor, nurse, pharmacist, or local authorities.
To avoid accidental needle stick injury, never put the inner cap back on once it has been removed.
Always remove the needle and store the pen without the needle after each injection. This will reduce the risk of infection and prevent insulin leakage, blocked needles, and incorrect dosing.
6. Determining the amount of insulin in the syringe pen.
| The insulin level scale only shows approximately how much insulin is left in the pen. |
To determine how much insulin is left in the pen, use the dose counter: turn the dose selector until the dose counter stops. If the dose counter shows 80, there are at least 80 units of insulin left in the pen. If the dose counter shows less than 80, the number of units corresponds to the amount of insulin left in the pen. Turn the dose selector in the opposite direction until the dose counter shows “0”. If you need to inject a larger dose of insulin than the units left in the pen, you can inject part of the missing dose from a second pen. |
Calculate your dose carefully when using two pens. If in doubt, it is best to inject the full dose from a new pen. If you miscalculate your dose when using two pens, you may inject too little or too much insulin, which can cause your blood sugar to rise or fall significantly.
Other important information:
Always keep your pen with you. Always carry a spare pen and new needles in case your pen is damaged or lost. Always keep your pen and needles out of the reach of other people, especially children. Needles
