Patients should have the skills of self-monitoring of diabetes, including monitoring of blood glucose concentration, and adhere to the correct technique of subcutaneous injection and be able to manage hypoglycemia and hyperglycemia. Insulin therapy requires constant alertness regarding the possibility of developing hyperglycemia or hypoglycemia.
In case of insufficient control over the concentration of glucose in the blood, as well as in the presence of a tendency to develop hypo- or hyperglycemia, before proceeding to correct the dosage regimen, it is necessary to check the accuracy of the prescribed treatment regimen, adherence to the directions for the injection site, the correct technique of hypodermic injection and handling of the SoloStar® syringe pen, and also consider the possibility of all other factors capable of causing such a condition.
Hypoglycaemia
The time of development of hypoglycemia depends on the profile of the insulin used and can, therefore, change when the treatment regimen is changed.
Special care should be taken to intensify monitoring of blood glucose concentration in patients with hypoglycemic episodes that may be of particular clinical importance, such as patients with severe stenosis of the coronary arteries or cerebral vessels (risk of cardiac and cerebral complications of hypoglycemia), and also in patients with proliferative retinopathy, especially if they do not receive photocoagulation treatment (the risk of transient loss of vision following hypoglycemia).
As with any insulin, under certain conditions symptoms-precursors of hypoglycemia can change, become less pronounced or absent. These include:
- marked improvement in glycemic control;
- gradual development of hypoglycemia;
- elderly age;
- presence of autonomic neuropathy;
- prolonged anamnesis of diabetes mellitus;
- the presence of mental disorders;
- simultaneous use of insulin glargine with some other medicines (see."Interaction with other drugs").
Such situations can lead to the development of severe hypoglycemia (with possible loss of consciousness) before the patient realizes that he is developing hypoglycemia.
It should be taken into account that the prolonged action of Tougeo SoloStar® with its subcutaneous administration may delay the patient's exit from the state of hypoglycemia.
In the event that normal or decreased glycosylated hemoglobin levels are noted, the possibility of developing recurrent unrecognized episodes of hypoglycemia (especially at night) should be considered.
Patient compliance with the dosing regimen and diet, proper insulin administration and knowledge of hypoglycaemic precursors contribute to a significant reduction in the risk of developing hypoglycemia.
Factors that increase the tendency to hypoglycemia, in the presence of which a particularly careful observation is required and correction of the insulin dose may be necessary:
- change the place of insulin administration;
- increased sensitivity to insulin (for example, when stress factors are eliminated);
- unusual, increased or prolonged physical activity;
- intercurrent diseases, accompanied by vomiting, diarrhea;
- inadequate intake of food;
- consumption of ethanol;
- Some uncompensated endocrine disorders (such as hypothyroidism, anterior pituitary failure, or adrenocortical insufficiency);
- simultaneous use of insulin glargine with some other medicines (see section "Interaction with other drugs").
In patients with renal insufficiency the need for insulin can be reduced by slowing the metabolism of insulin (see sections "Pharmacodynamics", "Pharmacokinetics" and "Method of administration and dose").
In elderly patients progressive deterioration in kidney function can lead to a steady decrease in insulin requirements (see the sections "Pharmacodynamics", "Pharmacokinetics" and "Method of administration and dose").
In patients with severe hepatic insufficiency the need for insulin can be reduced due to a decrease in the ability to gluconeogenesis and slowing down the metabolism of insulin (see the sections "Pharmacodynamics", "Pharmacokinetics" and "Method of administration and dose").
Hypoglycemia, in general, can be eliminated by the immediate administration of rapidly digestible carbohydrates. Since the initial actions to correct hypoglycemia should be carried out immediately, patients should always have at least 20 grams of quick-digesting carbohydrates with them.
Intercurrent diseases
In intercurrent diseases, a more intensive control of the concentration of glucose in the blood is required. In many cases, the analysis of the presence of ketone bodies in the urine is shown, and often a correction of the insulin dosage regimen is required. When an intercurrent disease occurs, the need for insulin often rises. Patients with type 1 diabetes should continue to receive carbohydrates on a regular basis, even if they are able to eat only small amounts or not at all, or if vomiting develops; Patients with type 1 diabetes mellitus should never completely miss the introduction of insulin.
Combination of insulin glargine with pioglitazone
When pioglitazone was used in combination with insulin, cases of heart failure were reported, especially in patients at risk of developing heart failure.This information should be taken into account when considering the use of a combination of pioglitazone with Tougeo SoloStar®. When using this combination, patients should be observed for signs and symptoms of heart failure, such as weight gain, edema. With the appearance or weighting of cardiac symptoms, the use of pioglitazone should be discontinued.
Prevention of errors with the introduction of insulin preparations
In order not to confuse Tougeo SoloStar® with other insulins, always check the label on the syringe pen before each injection. It has been reported that other insulins, in particular short-acting insulins, were accidentally mistakenly introduced, instead of long-acting insulins.
To avoid dosing errors and possible overdose, patients should never use a syringe to remove Tudgeо® from the SoloStar® syringe pen (see "Dosing and Administration", "Overdose").
As with the use of other insulin syringes, patients should visually check the number of dialed dose units in the dose indicator box on the syringe pen.Blind or visually impaired patients should receive assistance from other persons with good eyesight and who are able to use the TUGEO SoloStar® syringe
Recommendations for the storage of syringe pens Tugeo SoloStar®
When storing Tougeo SoloStar® in the refrigerator (unopened / before use), make sure that the syringe pen bags do not directly touch the freezer compartment or frozen food, as the product should not be frozen. If the insulin has been frozen, it can not be used, and the syringe-pen should be disposed of.
Used SoloStar syringes should be stored at a temperature of no higher than 30 ° C, protected from light and heat.
Instructions for using the TUGEO SoloStar® syringe pen (insulin glargine 300 mg / ml)
The Tugeo SoloStar® pen contains insulin glargine in a concentration of 300 mg / ml.
- Never reuse needles. If you reuse the needle because the needle may become clogged, you may not get the dose you need (administering a lower dose) or get too much of a dose (overdose).
- Never use a syringe to remove insulin from the syringe pen.In this case, you can get an excessively high dose of insulin. The scale on most insulin syringes is intended only for non-concentrated insulin.
Important information
X Do not use one syringe pen at the same time as other people, even if you replace the needle. You can get a serious infection from other people or give them a serious infection, transmitted through the blood.
X Never use a syringe pen if it is damaged, or you are not sure that it is working.
! Always conduct a safety test.
! Always carry a spare syringe pen and spare needles in case they become lost or become defective.
- Before using a syringe pen, ask your health care provider how to properly administer subcutaneous injection.
- If you have visual problems, you may need the help of others who are able to follow all of the recommendations of this Tugeo SoloStar® pen.
- Read all of this instruction before using the pen-syringe. If you do not follow all of these recommendations, you can get either too much or too little insulin.
You will additionally need: a new sterile needle (see STEP 2), an alcohol-soaked napkin, a puncture resistant container for used needles and syringes.
Indication of places for injections - see Fig. 2.
Get to know your syringe pen - see Fig. 3.
STEP 1: Checking the syringe pen
!! Remove the new syringe pen from the refrigerator at least 1 hour before the injection. The introduction of cold insulin is more painful.
A Check the insulin name and expiration date on the label of your syringe pen.
- Make sure that you have the right (you need) insulin.
- Never use a syringe pen after the expiration date.
A Remove the cap from the syringe handle.
C Check the transparency of insulin.
- Do not use a syringe pen if the insulin is cloudy, has a color or contains foreign particles.
D Wipe the rubber membrane with a cloth moistened with ethyl alcohol.
- If you have other syringe pens, it is especially important to make sure that you have taken the right (you need) the drug.
STEP 2: Attaching a new needle
! Always use a new sterile needle for each injection.This will help prevent clogging of the needle, contamination and infection. Always use BD Micro-Fine Plus needles.
A Take a new needle and remove the protective coating.
B Hold the needle straight in front of the syringe handle and screw it onto the syringe handle until it stops. Do not apply excessive force when screwing the needle.
C Remove the outer needle cap. Save it for future reference.
D Remove the inner cap from the needle and discard it.
Handling of needles
- Be careful when handling needles - this will prevent needle damage and cross infection.
STEP 3: Carrying out a safety test
! Be sure to perform a safety test before each injection - it is carried out to check the correctness of the syringe handle operation and to avoid the obstruction of the needle, and also to be sure that you will enter the correct dose of insulin.
A Dial 3 units by rotating the dose selector until the dose indicator appears between numbers 2 and 4.
B Press the dose input button as far as it will go.
- If a drop of insulin appears at the tip of the needle, this indicates that the syringe pen is working correctly.
If insulin is not shown at the tip of the needle:
- You may need to repeat this step up to 3 times before insulin appears.
If insulin does not appear at the tip of the needle and after the third repetition of this step, then perhaps the needle is impassable; then replace the needle (see STEP 6 and STEP 2) and then repeat the safety test (STEP 3).
- Do not use a syringe pen if insulin does not show up at the tip of the needle. Use a new syringe pen.
- Never use a syringe to remove insulin from the Tugeo SoloStar® pen.
If you see air bubbles:
- You can see air bubbles in the insulin. This is normal, they will not cause you harm.
STEP 4: Dose Kit
x Never take a dose and do not press the dose button without a needle attached. This can damage the syringe pen.
A Make sure that the needle is attached and the dose is set to �?0’.
В Rotate the dose selector until the dose indicator is on the same line with the dose you need.
- If you rotated the dose selector beyond the required dose, you can turn it back.
- If there are not enough units in the syringe pen for the dose you need, you can enter it in two injections, using a new syringe pen for the second injection, or immediately use a new syringe pen for the entire dose.
How to read the dose indicator window
Even numbers (number of units) are displayed opposite the dose indicator: see Fig. 12.
Odd numbers (number of units) are displayed on the line between even numbers: see Fig. 13.
Units of insulin in the syringe pen
- The syringe pen contains a total of 450 units of insulin. You can dial doses from 1 to 80 units in increments of 1 unit. Each syringe pen contains more than one dose.
- You can approximately determine the number of remaining insulin units by the location of the piston on the insulin scale.
STEP 5: Dosing Introduction
If it is difficult to press the dose button, do not use force, as this can damage the syringe pen. See the section below for descriptions of your actions in this situation.
A Select the injection site, as shown in the figure above.
B Enter the needle into the skin, as shown to you by the medical professional.
- Do not touch the dose button.
C Place your thumb on the dose button. Then press it all the way and hold it in this position.
- Do not press the button at an angle - the thumb can block the rotation of the dose selector.
D Continue to press the dose button, and when you see "0" in the dose window, slowly count to five.
"This will guarantee the full dose."
E After holding down the dose entry button and counting to five, release the dose entry button. Then remove the needle from the skin.
If there are difficulties when you press the dose button: replace the needle (see STEP 6 and STEP 2), then perform a safety test (see STEP 3).
If you still have difficulty in pressing the dose button, take a new pen-syringe.
STEP 6: Removing the needle
! Be careful when handling needles - this will prevent needle damage and cross infection.
x Never again put the inner needle cap on the needle.
A Take the wide end of the outer needle cap with two fingers. Hold the needle straight and insert it into the outer needle cap.
Then firmly press the cap.
- If the needle is inserted into the cap at an angle, it can puncture it.
In the grip grasp the wide part of the outer cap of the needle. Turn your syringe pen several times with the other hand to remove the needle.
- If the needle is not removed the first time, try again.
With Discard the used needle in a tight (puncture-resistant) container, which should be carefully closed and, after filling, disposed of in accordance with the instructions of the medical officer.
D Close the syringe handle with its cap.
- Do not put the pen in the refrigerator.
Term of use
- Use a syringe pen for 4 weeks after first use.
Storage of the syringe pen before first use
- Store new pen-syringes in the refrigerator at a temperature of 2 ° C - 8 ° C.
- Do not freeze the pen-syringe.
After first use
- Store the syringe pen at a temperature below 30 ° C.
- Never put the syringe handle back in the refrigerator.
- Never store the syringe pen with the attached needle.
- Keep the syringe pen closed with a cap.
Handling of the TUGEO SoloStar® syringe pen
Handle the syringe pen with care
- Do not drop the syringe pen or avoid its impact on hard surfaces.
- If you think a syringe pen may be damaged, do not try to fix it, use a new syringe pen.
Protect the syringe handle from getting dust and dirt
- You can clean the outside of the syringe pen by wiping it with a damp cloth. Do not soak, wash or lubricate the syringe - this can damage it.
Disposal of the syringe pen
- Remove the needle before discarding the syringe pen.
- Dispose used used syringes according to the instructions of the health care provider.