Hypoglycaemia
If you miss a meal or an unplanned intensive physical exertion, the patient may develop hypoglycemia. Hypoglycemia can also develop if the insulin dose is too high in relation to the patient's need (see Sections Side effect and Overdose).
After the compensation of carbohydrate metabolism (for example, with intensified insulin therapy), the symptoms typical for them, precursors of hypoglycemia, may change in patients,about which patients should be informed. Common symptoms-precursors can disappear with prolonged course of diabetes. Concomitant diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin. Correction of the dose of the drug may also be required if the patient has concomitant diseases of the kidneys, liver or disorders of the adrenal, pituitary or thyroid gland function.
As with other basal insulin preparations, recovery from hypoglycemia with Tresiba® FlexTech® may be delayed.
Hyperglycaemia
An insufficient dose of the drug or discontinuation of treatment can lead to the development of hyperglycemia or diabetic ketoacidosis. In addition, concomitant diseases, especially infectious diseases, can promote the development of hyperglycemic conditions and, accordingly, increase the body's need for insulin.
Typically, the first symptoms of hyperglycemia appear gradually, within a few hours or days. These symptoms include: thirst, rapid urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, odor of acetone in the exhaled air.With type 1 diabetes mellitus without appropriate treatment, hyperglycemia leads to the development of diabetic ketoacidosis and can lead to death.
For the treatment of severe hyperglycemia, it is recommended that high-speed insulin be administered.
Transfer of a patient from other insulin preparations
Transfer of a patient to a new type or preparation of insulin of a new brand or other manufacturer should occur under strict medical supervision. The translation may require a dose adjustment.
The simultaneous use of drugs of the thiazolidinedione group and insulin preparations
Cases of chronic heart failure in the treatment of patients with thiazolidinediones in combination with insulin preparations have been reported, especially if such patients have risk factors for developing chronic heart failure. This fact should be taken into account when appointing patients a combination therapy with thiazolidinediones and the preparation of Tresiba® FlexTech®. In the appointment of such combination therapy, it is necessary to conduct medical examinations of patients to identify signs and symptoms of chronic heart failure, increase in body weight and the presence of peripheral edema.If the symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued.
Disturbances on the part of the organ of sight
Intensification of insulin therapy with a sharp improvement in carbohydrate metabolism control may lead to a temporary deterioration in the state of diabetic retinopathy, while a prolonged improvement in glycemic control reduces the risk of progression of diabetic retinopathy.
Prevention of accidental entanglement of insulin preparations
The patient should be instructed to check the labeling on the label before each injection to avoid accidental administration of another dose or other insulin. Before each injection, patients should check the dose counter for the number of units typed in the syringe pen. Thus, only patients who can clearly distinguish the numbers on the dose counter can inject insulin themselves.
It is necessary to inform visually impaired or visually impaired people that they always need the help of persons who do not have vision problems and are trained to work with a syringe pen.
Antibodies to insulin
With the use of insulin, the formation of antibodies is possible.In rare cases, the formation of antibodies may require a dose adjustment of insulin to prevent cases of hyperglycemia or hypoglycemia.
Instructions for patients on the use of the drug Tresiba® FlexTech® solution for subcutaneous administration 100 U / ml
Read these instructions carefully before using the pre-filled Tresib® FlexTouch® syringe pen.
Use a syringe pen only after you learn to use it under the guidance of a doctor or nurse. Check the label on the syringe pen label to make sure it contains the Tresiba® FlexTech® 100 U / mL preparation, and then carefully examine the illustrations below that show the details of the syringe and needle.
If you are visually impaired or you have serious vision problems and you can not distinguish the numbers on the dose counter, do not use a syringe pen without help. You can be helped by a person without visual impairment, trained in the correct use of a pre-filled Flex-Tach® pen. Tresiba® Flex Tach® 100 U / ml is a pre-filled syringe pen containing 300 units of insulin degludec.The maximum dose that you can set is 80 units in 1-step increments. The Tresib® Flex-Tach ® pen is designed for use with NovoFine® or NovoTvist® disposable needles up to 8 mm long. Needles are not included in the packaging.
(!) Important information
Pay attention to the information marked with such icons (!), It is very important for the safe use of the syringe pen.
Tresiba® Flex Tach® 200 U / ml and needle is an example withm. Figure 1-2.
1. Preparing the syringe pen for use
A. Check the name and dosage on the label of the pen syringe to make sure it contains the Tresiba® Flex Tach® 100 ED / mL preparation. This is especially important if you use different types of insulin.
Remove the cap from the syringe pen.
C. Ensure that the insulin preparation in the syringe pen is clear and colorless. Look at the scale of the insulin balance. If the drug is cloudy, the pen can not be used.
C. Take a new disposable needle and remove the protective sticker.
D. Put the needle on the syringe pen and rotate it so that the needle fits tightly on the syringe pen.
E. Remove the outer cap of the needle, but do not throw it away. You will need it after the injection is completed to safely remove the needle.
F. Remove and discard the inner needle cap.If you try to put the inner cap back on the needle, you can prick.
At the end of the needle, a drop of insulin may appear. This is normal, however, you all should check your insulin intake (see Figure 1 A-F).
(!) For each injection, use a new needle to avoid clogging the needle, infecting, infecting and injecting the wrong dose of the drug.
(!) Never use the needle if it is bent or damaged.
2. Insulin intake check
A.
- Before each injection, check the intake of insulin. So you can be sure that the insulin dose is introduced completely
- Dial 2 units of the drug by turning the dose selector. Make sure that the dose counter shows "2" (see Figure 2A).
AT.
Holding the syringe handle with the needle upwards, tap the top of the syringe handle several times with the tip of the finger, so that the air bubbles move upwards (see Fig. 2B).
FROM.
- Press the start button and hold it in this position until the dose counter returns to zero.
"0" must stand in front of the dose indicator At the end of the needle, a drop of insulin should appear (see Fig. 2C).
Sometimes a small air bubble may remain at the end of the needle, but it will not be injected.
If a drop of insulin does not appear at the end of the needle, repeat steps 2A-2C, but no more than 6 times.If a drop of insulin does not appear, change the needle and repeat operations 2A-2C again.
Do not use a syringe pen if a drop of insulin at the end of the needle has not appeared.
(!) Before each injection, make sure that a drop of insulin appears on the tip of the needle. If a drop of insulin does not appear, the dose will not be given, even if the dosage counter moves
3. Setting the dose
A.
- Before starting the injection, make sure that the dose counter is set to "0".
"0" must be in front of the dosing indicator.
- Rotate the dose selector set the dose assigned by the doctor.
If you have set the wrong dose, you can turn the dose selector forwards or backwards until the correct dose is set. The maximum dose that you can set is 80 units (see Figure 3A).
The dose selector sets the number of units. Only the dose counter and dose indicator show the number of units of insulin in the selected dose. The maximum dose you can set is 80 units. If the insulin residue in the syringe pen is less than 80 units, the dose counter will stop on the number of units of insulin that remains in the syringe pen.At each turn of the dose selector, clicks are heard, the sound of clicks depends on which way the dose selector is rotating (forward, backward or if the dialed dose exceeds the number of insulin units left in the pen). Do not count these clicks.
(!) Before each injection, check how many units of insulin you have typed on the dose counter and the dose indicator
Do not set the dose by the number of clicks.
The scale of the insulin residue shows the approximate amount of insulin remaining in the syringe, so it can not be used to measure the dose of insulin
4. Introduction of insulin
A.
- Insert the needle under the skin using the injection technique recommended by your doctor.
- Make sure that the dose counter is in your field of vision.
Do not touch the dose counter with your fingers - this may interrupt the injection.
- Press the start button all the way down and hold it in this position until the dose counter shows "0".
"0" must be exactly opposite the dose indicator. You can hear or feel a click.
- After injection, leave the needle under the skin for at least 6 seconds. This will ensure the introduction of a full dose of insulin (see Figure 4A).
AT.
- Remove the needle from under the skin by pulling the syringe up (see Fig. 4B).
If blood appears at the injection site, gently press a cotton swab into the injection site. Do not massage the injection site.
After completing the injection, you can see a drop of insulin at the end of the needle.
This is normal and does not affect the dose of the drug you entered.
(!) Always check with the dose counter to know how many insulin units you have entered.
Do not count the number of clicks. The dose counter will show the exact number of units.
5. After the injection is completed
A.
- After placing the outer needle cap on a flat surface, insert the end of the needle into the cap, without touching it or until the tip of the needle.
AT.
- When the needle enters the cap, gently place the cap on the needle.
- Unscrew the needle and discard it, observing the precautions.
FROM
- After each injection, put a cap on the syringe pen to protect the insulin contained in it from exposure to light (see Fig. 5A-C).
Discard the needle after each injection, this will ensure a comfortable injection of insulin and prevent clogging of the needle. If the needle is clogged, you can not inject insulin.
Dispose of the used syringe pen with the needle disconnected, as recommended by your doctor, nurse, pharmacist or according to local requirements
(!) To avoid accidental pricking with a needle, never try to put the inner cap back on the needle
(!) Remove the needle from the syringe-pen after each injection
This will prevent clogging of the needle, infection, infection, leakage of insulin from the syringe pen and incorrect dosing
6. How much insulin is left?
A.
- The scale of the insulin residue shows the approximate amount of insulin remaining in the syringe-pen.
AT.
- To find out how much insulin is left in your syringe pen, use a dose counter.
Rotate the dose selector until the dose counter stops.
If the dose counter shows a figure of 80, it means that at least 80 insulin units remain in your syringe pen.
If the dose counter shows less than 80, this means that exactly the number of insulin units that was displayed on the dose counter remained in your syringe pen.
- Rotate the dose selector in the opposite direction until the dose counter shows "0".
- If the insulin remaining in the syringe pen is not enough to administer the full dose, you can enter the dose you need for two injections with the help of two syringes (see Fig. 6 AB).
(!) Be very careful when calculating the remainder of the insulin dose you need to prevent an error.
If you have doubts, better enter a full dose of insulin with a new syringe pen.
(!) Important information
- Always carry a syringe pen with you.
- Always carry a spare syringe pen and new needles in case they are lost or damaged.
- Keep the syringe-pen and needle out of reach of all, and especially for children, the place.
- Never give your syringe pen and needle to it to others.
- Persons caring for the patient should handle the used needles with extreme care to avoid accidental injections and infection.
Care of the syringe pen
- Do not leave a syringe pen in the car or any other place where it can be exposed to too high or too low temperatures.
- Protect the syringe handle from getting on it dust, dirt and all kinds of liquids.
- Do not wash the syringe handle, do not immerse it in liquid and do not lubricate it. If necessary, the syringe pen can be cleaned with a damp cloth moistened with a mild detergent.
- Do not drop or hit the syringe handle on a hard surface.
If you drop a syringe pen or doubt its serviceability, attach a new needle and check the intake of insulin before you inject.
- Do not refill the syringe pen. Do not reuse an empty syringe pen.
- Do not attempt to repair the syringe pen by itself or dismantle it.
Instruction for patients on the use of the drug Tresiba® FlexTech® solution for subcutaneous administration 200 U / ml
Read these instructions carefully before using the pre-filled Tresib® FlexTouch® syringe pen.
Use a syringe pen only after you learn to use it under the guidance of a doctor or nurse. Check the label on the syringe pen label to make sure it contains the Tresib® Flex Tach® 200 U / ml preparation, and then carefully examine the illustrations below, which show the details of the syringe pens and needles.
If you are visually impaired or you have serious vision problems and you can not distinguish the numbers on the dose counter, do not use a syringe pen without help.You can be helped by a person without visual impairment, trained in the correct use of a pre-filled Flex-Tach® pen. Tresiba® Flex Tach® 200 U / ml is a pre-filled syringe pen containing 600 units of insulin degludec. The maximum dose that you can set is 160 units in 2-ED increments. The dose counter shows the exact number of insulin units. You do not need to recalculate the dose. The Tresib® Flex-Tach ® pen is designed for use with NovoFine® or NovoTvist® disposable needles up to 8 mm long. Needles are not included in the packaging.
(!) Important information
Pay attention to the information marked with these icons, it is very important for the safe use of the syringe pen.
Tresiba® Flex Tach® 200 U / ml and needle (example)
1. Preparing the syringe pen for use
A. Check the name and dosage on the label of the pen syringe to make sure it contains the Tresiba® Flex Tach® 200 ED / ml preparation. This is especially important if you use different types of insulin.
Remove the cap from the syringe pen.
C. Ensure that the insulin preparation in the syringe pen is clear and colorless. Look at the scale of the insulin balance.If the drug is cloudy, the pen can not be used.
C. Take a new disposable needle and remove the protective sticker.
D. Put the needle on the syringe pen and rotate it so that the needle fits tightly on the syringe pen.
E. Remove the outer cap of the needle, but do not throw it away. You will need it after the injection is completed to safely remove the needle.
F. Remove and discard the inner needle cap. If you try to put the inner cap back on the needle, you can prick.
At the end of the needle, a drop of insulin may appear. This is normal, however, you still need to check the intake of insulin.
(!) For each injection, use a new needle to avoid clogging the needle, infecting, infecting and injecting the wrong dose of the drug.
(!) Never use the needle if it is bent or damaged.
2. Checking for insulin A
- Before each injection, check the intake of insulin. So you can be sure that the insulin dose is introduced completely
- Dial 2 units of the drug by turning the dose selector. Make sure that the dose counter shows "2".
AT.
Holding the needle pen up with the needle, tap lightly on the top of the syringe pen several times with the tip of the finger so that the air bubbles move upward.
FROM.
- Press the start button and hold it in this position until the dose counter returns to zero.
"O" should stand in front of the dose indicator At the end of the needle, a drop of insulin should appear.
Sometimes a small air bubble may remain at the end of the needle, but it will not be injected.
If a drop of insulin does not appear at the end of the needle, repeat steps 2A-2C, but no more than 6 times. If a drop of insulin does not appear, change the needle and repeat operations 2A-2C again.
Do not use a syringe pen if a drop of insulin at the end of the needle has not appeared.
(!) Before each injection, make sure that a drop of insulin appears on the tip of the needle. If a drop of insulin does not appear, the dose will not be given, even if the dosage counter will move.
3. Setting the dose
A.
- Before starting the injection, make sure that the dose counter is set to "0".
"0" must be in front of the dosing indicator.
- Rotate the dose selector set the dose assigned by the doctor.
- The dose counter shows the exact number of units of insulin.
You do not need to recalculate the dose.
If you have set the wrong dose, you can turn the dose selector forwards or backwards until the correct dose is set. The maximum dose you can set is 160 units.
The dose selector sets the number of units. Only the dose counter and dose indicator show the number of units of insulin in the selected dose.
The maximum dose you can set is 160 units. If the insulin residue in the syringe pen is less than 160 units, the dose counter will stop on the number of units of insulin that remains in the syringe pen. At each turn of the dose selector, clicks are heard, the sound of clicks depends on which way the dose selector is rotating (forward, backward or if the dialed dose exceeds the number of units of insulin remaining in the syringe pen). Do not count these clicks.
(!) Before each injection, check how many units of insulin you have typed on the dose counter and dose indicator.
Do not set the dose by the number of clicks.
The scale of the insulin residue shows the approximate amount of insulin remaining in the syringe, so it can not be used to measure the dose of insulin.
4. Introduction of insulin
A.
- Insert the needle under the skin using the injection technique recommended by your doctor.
- Make sure that the dose counter is in your field of vision.
Do not touch the dose counter with your fingers - this may interrupt the injection.
- Press the start button all the way down and hold it in this position until the dose counter shows "0".
"0" must be exactly opposite the dose indicator. You can hear or feel a click.
- After injection, leave the needle under the skin for at least 6 seconds. This will ensure the introduction of a full dose of insulin.
AT.
- Remove the needle from under the skin by pulling the syringe up.
If blood appears at the injection site, gently press a cotton swab into the injection site. Do not massage the injection site.
After completing the injection, you can see a drop of insulin at the end of the needle.
This is normal and does not affect the dose of the drug you entered.
(!) Always check with the dose counter to know how many insulin units you have entered.
Do not count the number of clicks. The dose counter will show the exact number of units
5. After the injection is completed
A.
- After placing the outer needle cap on a flat surface, insert the end of the needle into the cap, without touching it or until the tip of the needle.
AT.
- When the needle enters the cap, gently place the cap on the needle.
- Unscrew the needle and discard it, observing the precautions.
FROM.
- After each injection, wear on the pen cap to protect the insulin contained therein from light.
Discard the needle after each injection, this will ensure a comfortable injection of insulin and prevent clogging of the needle. If the needle is clogged, you can not inject insulin.
Dispose of the used syringe pen with the needle disconnected, as recommended by your doctor, nurse, pharmacist or according to local requirements.
(!) To avoid accidental pricking with a needle, never try to put the inner cap back on the needle.
(!) Remove the needle from the syringe pen after each injection.
This will prevent clogging of the needle, infection, infection, leakage of insulin from the syringe pen and incorrect dosing
6. How much insulin is left?
A.
- The scale of the insulin residue shows the approximate amount of insulin remaining in the syringe-pen.
AT.
- To find out how much insulin is left in your syringe pen, use a dose counter.
Rotate the dose selector until the dose counter stops.
If the dose counter shows a figure of 160, this means that at least 160 units of insulin remain in your syringe pen.
If the dose counter shows less than 160, it means that in your syringe pen there was exactly that amount of insulin units that was displayed on the dose counter.
- Rotate the dose selector in the opposite direction until the dose counter shows "0".
- If the insulin remaining in the syringe-pen is not enough to introduce the full dose, you can enter the dose you need for two injections with the help of two syringes-pens.
(!) Be very careful when calculating the remainder of the insulin dose you need to prevent an error.
If you have doubts, better enter a full dose of insulin with a new syringe pen.
(!) Important information
- Always carry a syringe pen with you.
- Always carry a spare syringe pen and new needles in case they are lost or damaged.
- Keep the syringe-pen and needle out of reach of all, and especially for children, the place.
- Never give your syringe pen and needle to it to others.
- Persons caring for the patient should handle the used needles with extreme care to avoid accidental injections and infection.
Care of the syringe pen
- Do not leave a syringe pen in the car or any other place where it can be exposed to too high or too low temperatures.
- Protect the syringe handle from getting on it dust, dirt and all kinds of liquids.
- Do not wash the syringe handle, do not immerse it in liquid and do not lubricate it.If necessary, the syringe handle can be cleaned with a damp cloth moistened with a mild detergent.
- Do not drop or hit the syringe handle on a hard surface.
If you drop a syringe pen or doubt its serviceability, attach a new needle and check the intake of insulin before you inject.
- Do not refill the syringe pen. Do not reuse an empty syringe pen.
- Do not attempt to repair the syringe pen by itself or dismantle it.