Ryzodeg FlexTouch Caution For Usage

Incompatibilities: Substances added to Ryzodeg may cause degradation of insulin degludec and/or insulin aspart.
Ryzodeg must not be added to infusion fluids.
This medicinal product must not be mixed with any other product.
Special precautions for disposal and other handling: The pre-filled pen (FlexTouch) is designed to be used with NovoFine or NovoTwist injection needles up to a length of 8 mm. It delivers 1-80 units in steps of 1 unit.
The pre-filled pen (FlexTouch) is for use by one person only.
The pre-filled pen must not be refilled.
Ryzodeg must not be used if the solution does not appear clear and colorless.
Ryzodeg which has been frozen must not be used.
The patient should discard the needle after each injection.
Any waste material should be disposed of in accordance with local requirements.
Instructions for the patient on how to use Ryzodeg 100 units/mL solution for injection in pre-filled pen (FlexTouch): If the instructions are not followed carefully, there can be a little or too much insulin, which can lead to too high or too low blood sugar level.
Do not use the pen without proper training from the doctor or nurse.
Start by checking the pen to make sure that it contains Ryzodeg 100 units/mL.
If the patient is blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the FlexTouch pre-filled pen.
The pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin. A maximum of 80 units per dose can be selected, in steps of 1 unit. The pen is designed to be used with NovoTwist or NovoFine single-use disposable needles up to a length of 8 mm. Needles are not included in the pack.
1. Prepare the pen. Check the name and strength on the label of the pen, to make sure that it contains Ryzodeg 100 units/mL. This is especially important if the patient takes more than one type of insulin. If the patient takes a wrong type of insulin, his/her blood sugar level may get too high or too low.
Pull off the pen cap.
Check that the insulin in the pen is clear and colorless. Look through the insulin window. If the insulin looks cloudy, do not use the pen.
Take a new needle and tear off the paper tab.
Push the needle straight onto the pen. Turn until it is on tight.
Pull off the outer needle cap and keep it for later. This will be needed after the injection, to correctly remove the needle from the pen.
Pull off the inner needle cap and throw it away. If trying to put it back on, the patient may accidentally stick him/herself with the needle.
A drop of insulin may appear at the needle tip. This is normal, but the patient must still check the insulin flow.
Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Never use a bent or damaged needle.
2. Check the insulin flow. Always check the insulin flow before starting. This helps to ensure that the patient will get full insulin dose. Turn the dose selector to select 2 units. Make sure the dose counter shows 2.
Hold the pen with the needle pointing up. Tap the top of the pen gently a few times to let any air bubbles rise to the top.
Press and hold in the dose button until the dose counter returns to 0. The 0 must line up with the dose pointer.
A drop of insulin should appear at the needle tip.
A small air bubble may remain at the needle tip, but it will not be injected. If no drop appears, repeat steps 2A to 2C up to 6 times. If there is still no drop, change the needle and repeat steps 2A to 2C once more.
If a drop of insulin still does not appear, dispose of the pen and use a new one.
Always make sure that a drop appears at the needle tip before injecting. This makes sure that the insulin flows.
If no drop appears, the patient will not inject any insulin, even though the dose counter may move.
This may indicate a blocked or damaged needle.
Always check the flow before injecting. If patient does not check the flow, the patient may get too little insulin or no insulin at all. This may lead to too high blood sugar level.
3. Selecting the dose. Make sure the dose counter shows 0 before starting. The 0 must line up with the dose pointer.
Turn the dose selector to select the dose needed, as directed by the doctor or nurse.
If a wrong dose is selected, turn the dose selector forwards or backwards to the correct dose.
The pen can dial up to a maximum of 80 units.
The dose selector changes the number of units. Only the dose counter and dose pointer will show how many units is selected per dose.
The patient can select up to 80 units per dose. When the pen contains less than 80 units, the dose counter stops at the number of units left.
The dose selector clicks differently when turned forwards, backwards or past the number of units left. Do not count the pen clicks.
Always use the dose counter and the dose pointer to see how many units the patient has selected before injecting the insulin.
Do not count the pen clicks. If the wrong dose is selected and injected, the blood sugar level may get too high or too low. Do not use the insulin scale, it only shows approximately how much insulin is left in the pen.
4. Injecting the dose. Insert the needle into the skin as the doctor or nurse has shown the patient.
Make sure the patient can see the dose counter. Do not touch the dose counter with the fingers. This could interrupt the injection.
Press and hold down the dose button until the dose counter returns to 0. The 0 must line up with the dose pointer. The patient may then hear or feel a click.
Leave the needle under the skin for at least 6 seconds to make sure the patient gets full dose.
Pull the needle and pen straight up from the skin.
If blood appears at the injection site, press lightly with a cotton swab. Do not rub the area.
The patient may see a drop of insulin at the needle tip after injecting. This is normal and does not affect the dose.
Always watch the dose counter to know how many units injected.
The dose counter will show the exact number of units. Do not count the pen clicks.
Hold the dose button down until the dose counter returns to 0 after the injection. If the dose counter stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.
5. After the injection. Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer cap.
Once the needle is covered, carefully push the outer needle cap completely on.
Unscrew the needle and dispose of it carefully.
Put the pen cap on the pen after each use to protect the insulin from light.
Always dispose of the needle after each injection. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing. If the needle is blocked, any insulin cannot be injected.
When the pen is empty, throw it away without a needle on as instructed by the doctor, nurse, pharmacist or local authorities.
Never try to put the inner needle cap back on the needle. The patient may stick the needle.
Always remove the needle after each injection and store the pen without the needle attached.
This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
6. How much insulin is left. The insulin scale shows approximately how much insulin is left in the pen.
To see precisely how much insulin is left, use the dose counter: Turn the dose selector until the dose counter stops. If it shows 80, at least 80 units are left in the pen.
If it shows less than 80, the number shown is the number of units left in the pen.
Turn the dose selector back until the dose counter shows 0.
If more insulin is needed than the units left in the pen, split the dose between two pens.
Be very careful to calculate correctly if splitting the dose.
If in doubt, take the full dose with a new pen. If the patient splits the dose wrong, the patient will inject too little or too much insulin, which can lead to too high or too low blood sugar level.
Further important information: Always keep the pen with the patient.
Always carry an extra pen and new needles with the patient, in case of loss or damage.
Always keep the pen and needles out of sight and reach of others, especially children.
Never share the pen or the needles with other people. It might lead to cross-infection.
Never share the pen with other people. The medicine might be harmful to their health.
Caregivers must be very careful when handling used needles - to reduce the risk of needle injury and cross-infection.
Caring for the pen: Treat the pen with care. Rough handling or misuse may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
Do not leave the pen in a car or other place where it can get too hot or too cold.
Do not expose the pen to dust, dirt or liquid.
Do not wash, soak or lubricate the pen. If necessary, clean it with mild detergent on a moistened cloth.
Do not drop the pen or knock it against hard surfaces.
If the pen is dropped or suspected a problem, attach a new needle and check the insulin flow before injecting.
Do not try to refill the pen. Once empty, it must be disposed of.
Do not try to repair the pen or pull it apart.