TOUJEO Insulin Glargine 300Units / mL Solution for SC Injection 1's

If the patient is pregnant or breast-feeding, thinks might be pregnant or is planning to have a baby, ask the doctor for advice before using this medicine. The insulin dose may need to be changed during pregnancy and after giving birth. For the health of the baby, it is particularly important to carefully control the diabetes and to prevent hypoglycaemia.
If the patient is breast-feeding, talk to a doctor, as the insulin doses and the diet might need to be changed.

 

 

Instruction for Use: Toujeo SoloStar contains 300 units/mL insulin glargine in a 1.5 mL disposable prefilled pen.
Never re-use needles. If the patient does the patient might not get the dose (underdosing) or get too much (overdosing) as the needle could block.
Never use a syringe to remove insulin from the pen. If the patient does the patient will get too much insulin. The scale on most syringes is made for non-concentrated insulin only.
Important Information: Never share the pen - it is only for the patient. Never use the pen if it is damaged or if the patient is not sure that it is working properly. Always perform a safety test. Always carry a spare pen and spare needles in case they got lost or stop working.
Learn to Inject: Talk with a doctor, pharmacist or nurse about how to inject, before using the pen.
Ask for help if the patient had problems handling the pen, for example if the patient has problems with sight. Read all of these instructions before using the pen. If the patient does not follow all of these instructions, the patient may get too much or too little insulin.
Extra Items the Patient Will Need: A new sterile needle (see Step 2 as follows). A puncture resistant container for used needles and pens.
Use By: Only use the pen for up to 4 weeks after its first use.
How to Store the Pen: Before First Use: Keep new pens in a fridge, at 2°C to 8°C. Do not freeze.
After First Use: Keep the pen at room temperature, below 30°C. Never put the pen back in the fridge. Never store the pen with the needle attached. Store the pen with the pen cap on.
How to Care for the Pen: Handle the Pen with Care: Do not drop the pen or knock it against hard surfaces. If the patient thinks that the pen may be damaged, do not try to repair it, use a new one.
Protect the Pen from Dust and Dirt: Clean the outside of the pen by wiping it with a damp cloth. Do not soak, wash or lubricate the pen - this may damage it.
Throwing the Pen Away: Remove the needle before throwing the pen away. Throw away the used pen as told by the pharmacist or local authority.
Step 1: Check the Pen: Take a new pen out of the fridge at least 1 hour before injecting. Cold insulin is more painful to inject.
A. Check the name and expiration date on the label of the pen.
Make sure the patient has the correct insulin. This is especially important if the patient has other injector pens.
Never use the pen after the expiration date.
B. Pull off the pen cap.
C. Check that the insulin is clear.
Do not use the pen if the insulin looks cloudy, coloured or contains particles.
Step 2: Attach a New Needle: Always use a new sterile needle for each injection. This helps stop blocked needles, contamination and infection.
Only use needles that are compatible for use with Toujeo (e.g. needles from BD, Ypsomed, Artsana or Owen Mumford).
A. Take a new needle and peel off the protective seal.
B. Keep the needle straight and screw it onto the pen until fixed. Do not overtighten.
C. Pull off the outer needle cap. Keep this for later.
D. Pull off the inner needle cap and throw away.
Handling Needles: Take care when handling needles - this is to prevent needle injury and cross-infection.
Step 3: Do a Safety Test: Always do a safety test before each injection - this is to: Check the pen and the needle are working properly. Make sure that the patient gets the correct insulin dose.
A. Select 3 units by turning the dose selector until the dose pointer is at the mark between 2 and 4.
B. Press the injection button all the way in.
When insulin comes out of the needle tip, the pen is working correctly.
If No Insulin Appears: The patient may need to repeat this step up to 3 times before seeing insulin.
If no insulin comes out after the third time, the needle may be blocked. If this happens: Change the needle (see Step 6 and Step 2), then repeat the safety test (Step 3).
Do not use the pen if there is still no insulin coming out of the needle tip. Use a new pen.
Never use a syringe to remove insulin from the pen.
If the Patient Sees Air Bubbles: The patient may see air bubbles in the insulin. This is normal, they will not harm the patient.
Step 4: Select the Dose: Never select a dose or press the injection button without a needle attached. This may damage the pen.
A. Make sure a needle is attached and the dose is set to '0'.
B. Turn the dose selector until the dose pointer lines up with the dose.
If the patient turns past the dose, the patient can turn it back down.
If there are not enough units left in the pen for the dose, the dose selector will stop at the number of units left.
If the patient cannot select the full prescribed dose, split the dose into two injections or use a new pen.
How to Read the Dose Window: Even numbers are shown in line with the dose pointer. Odd numbers are shown as a line between even numbers.
Units of Insulin in the Pen: The pen contains a total of 450 units of insulin. The patient can select doses from 1 to 80 units in steps of 1 unit. Each pen contains more than one dose.
The patient can see roughly how many units of insulin are left by looking at where the plunger is on the insulin scale.
Step 5: Inject the Dose: If the patient finds it hard to press the injection button in, do not force it as this may break the pen.
A. Choose a place to inject (upper arms, stomach, thighs).
B. Push the needle into the skin as shown by the doctor, pharmacist or nurse.
Do not touch the injection button yet.
C. Place thumb on the injection button. Then press all the way in and hold.
Do not press at an angle - the thumb could block the dose selector from turning.
D. Keep the injection button held in and when the patient sees "0" in the dose window, slowly count to 5.
This will make sure the patient gets the full dose.
E. After holding and slowly counting to 5, release the injection button. Then remove the needle from the skin.
If the Patient Finds It Hard to Press the Button In: Change the needle (see Step 6 and Step 2) then do a safety test (see Step 3). If the patient still finds it hard to press in, get a new pen. Never use a syringe to remove insulin from the pen.
Step 6: Remove the Needle: Take care when handling needles - this is to prevent needle injury and cross-infection.
Never put the inner needle cap back on.
A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.
To reduce the risk of accidental needle injury, never replace the inner needle cap.
If the injection is given by another person, or if giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
Follow recommended safety measures for removal and disposal of needles (contact the doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
B. Throw away the used needle in a puncture resistant container, or as told by the pharmacist or local authority.
C. Put the pen cap back on.
Do not put the pen back in the fridge.

 

Before First Use: Store in a refrigerator (2°C-8°C).
Do not freeze or place next to the freezer compartment or a freezer pack.
Keep the pen in the outer carton in order to protect from light.
After First Use or If Carried as a Spare: Do not store the pen in a refrigerator. The pen may be stored for a maximum of 6 weeks below 30°C and away from direct heat or direct light. Discard the pen after this time period. Do not leave the insulin in a car on an exceptionally warm or cold day. Always keep the cap on the pen when not using it in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines that are no longer used. These measures will help protect the environment.