AllStar® is a reusable pen for the injection of insulin. AllStar® can only be used with Sanofi 3 mL (300 units) insulin cartridges (U-100) from Sanofi Group.

• Never re-use needles. If you do you might not get your dose as the needle could block.
• Never share your pen and cartridge with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

´           Never use your pen if it is damaged or if you are not sure that it is working properly.

• If you use different types of insulin, you should use a different color or different type of pen for each insulin.
• Always have a back-up method for delivering your insulin available (e.g. a spare insulin cartridge and a spare AllStar® or a U-100 insulin syringe).

ü  Always perform a safety test (see STEP 4 below).

Learn to inject:

• Talk with your healthcare provider about how to inject, before using your pen.
• Ask for help if you have problems handling the pen, for example if you have problems with your sight.
• Read  all  of  these  instructions  before  using  your  pen.  If  you  do  not  follow  all  of  these instructions, you may get too much or too little insulin.

•  Keep this leaflet for further reference.

Need help?

If you have any questions about your pen or about diabetes, ask your healthcare provider, or contact us via http://www.sanofi.in or email to medinfo.india@sanofi.com

Extra items you will need:

•  a new insulin cartridge (see STEP 1).

• an alcohol swab
• a new sterile needle (see STEP 3).
• a puncture resistant container for used needles (see STEP 7).
  
  • Do not replace the insulin cartridge unless it is empty, expired or broken. It can be used for multiple injections.
• For clear insulins: (e.g. Lantus®, Apidra®, Insuman® Rapid)
• For suspension insulins (e.g., Insuman® Comb):
• Making sure you have the correct medicine is especially important if you have other injector pens.
• If there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left.
• Each cartridge contains a total of 300 units. You can select doses from 1 to 80 units in steps of 1 unit. Each insulin cartridge can be used for multiple injections until it is empty or expired. You can see roughly how many units of insulin are left by looking at where the rubber stopper is on the insulin scale.
• Each insulin cartridge can be used for multiple injections. Your AllStar® should be stored with the insulin cartridge inserted, ready for your next injection.
• Do not put the pen in the refrigerator.
  
• Do not store AllStar® with a needle attached.
• Store your pen with the pen cap on.
• Do not store AllStar® in the refrigerator.
• Do not freeze.

Places to inject

Get to know your pen

Step 1: Insert a new cartridge

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Follow STEP 1 the first time you use AllStar

and when replacing an insulin cartridge

üTake a new cartridge out of the refrigerator at least 1 hour before you inject. Cold insulin is more painful to inject.

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1A. Pull off the pen cap from AllStar  .

1B. Unscrew the cartridge holder from the pen body.

• If there is an insulin cartridge that needs to be replaced, remove it from the cartridge holder and discard it.
• If the features are not aligned, unscrew the cartridge holder and try again.
  • Do not use your insulin after the expiration date or after 28 days of use.
  • Do not use a damaged or broken insulin cartridge.

1C. Check the label of your new insulin cartridge for insulin type and expiry date. 1D. Insert the new cartridge, narrow end first, into the cartridge holder.

1E. Align the insulin cartridge holder straight with the pen body and use the cartridge’s rubber stopper to push the plunger back.

•  Do not press on the dose button whilst pushing back the plunger.

1F. Screw the cartridge holder firmly back on to the pen body until it clicks into place.

1G. Check that the alignment marks on the cartridge holder and the pen body line up as shown.

Step 2: Check your insulin

ü  Check insulin before every injection.

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2A. Pull off the pen cap from AllStar  .

2B. Check the label of your insulin cartridge for insulin type and expiry date.

•  Make sure you have the correct insulin.

2C. Check the appearance of your insulin before every injection:

− Do not use the cartridge if the insulin is cloudy, colored or has particles.

− Turn the pen up and down at least 10 times to mix the insulin.Turn the pen gently to avoid foaming in the cartridge.

−  After  mixing,  check  your  insulin.  Insulin  suspensions  must  have  an  even  milky-white appearance.

If you have other injector pens

Step 3. Attach a needle

• Do not re-use needles. Always use a new sterile needle for each injection. This helps stop blocked needles, contamination, and infection.
  
• Do not select a dose AND press the dose button without a needle attached. This may damage your pen.
• If you find it hard to press the dose button in, do not force it as this may break your pen. See the section below for help.
  • This will make sure you get your full dose.
  • Change the needle (see STEP 7 and STEP 3) then do a safety test (see STEP 4).

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• Always  use  needles  that  are  compatible  with  AllStar
• Make sure that you get the correct dose.

Mumford.

3A. Take a new needle and peel off the protective seal.

from  Becton  Dickinson  and  Owen

3B. Keep the needle straight and screw it onto the pen until fixed. Do not over-tighten.

3C. Pull off the outer needle cap. Keep this for later.

3D. Pull off the inner needle cap and throw away.

Handling needles

·  Take care when handling needles to prevent needle injury and cross-infection.

·  Special caution should be exercised if another person performs the injection.

Step 4. Do a safety test

Always do a safety test after the insertion of a new insulin cartridge and before each injection to:

ü Check your pen and the needle to make sure they are working properly.

4A.  Select  2  units  by  turning  the  dose  button  until  the  dose  pointer  lines  up  with  the number 2.

4B. Press the dose button all the way in.

•  When insulin comes out of the needle tip, your pen is working correctly

If no insulin appears:

• You 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: o change the needle (see STEP 7 and STEP 3),

o check that the cartridge is properly inserted or is not damaged and loaded correctly, o then repeat the safety test (STEP 4).

If you see air bubbles

•  You may see air bubbles in the insulin. This is normal, they will not harm you.

Step 5. Select the dose

5A. Make sure a needle is attached and the dose is set to ‘0’.

5B. Turn the dose selector until the dose pointer lines up with your dose.

Even numbers are shown in line with the dose pointer.

Odd numbers are shown as a line between even numbers.

If you turned past your dose, you can turn back down.

•  If you cannot select your full prescribed dose, you can either:

• inject what is left (STEP 6-7), then replace the cartridge with a new one (STEP 1) and complete your dose (STEP 2-7).

ii.  or discard what is left and use a new cartridge for your full dose (STEP 1-7).

Units of insulin in your pen

Step 6. Inject the dose

6A. Choose a place to inject as shown in the picture above (“Places to inject”).

Clean the area of skin to be injected (e.g. with rubbing alcohol/spirit)

6B. Push the needle into your skin as shown by your healthcare provider.

•  Do not touch the dose button yet.

6C. Place your thumb on the dose button. Then slowly press all the way in and hold.

•  Do not press at an angle.

6D. Keep the dose button held in, and when you see “0” in the dose window, slowly count to 10.

6E. After holding and slowly counting to 10, release the dose button. Then remove the needle from your skin.

If you find it hard to press the dose button in:

•  If you still find it hard to press in, change the cartridge or do not use the pen.

Step 7. Remove the needle

üTake care when handling needles to prevent needle injury and cross-infection.

• Do not put the inner needle cap back on.
• Do not store AllStar
  
  • The needle can puncture the cap if it is recapped at an angle.

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in the refrigerator.

7A. Grip the widest part of the outer needle cap. Keep the needle straight and guide it into the outer needle cap. Then push firmly on.

7B. Grip and squeeze the widest part of the outer needle cap. Turn your pen several times with your other hand to remove the needle.

·   Try again if the needle does not come off the first time.

7C. Throw away the used needle in a puncture resistant container (or as instructed by your healthcare provider).

7D. Put your pen cap back on.

Use by

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AllStar

has been designed to be used for up to 3 years after first use.

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Do not use your AllStar

for more than 3 years.

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After 3 years contact your healthcare  provider or pharmacist to get a new AllStar

the pen safely as instructed by your healthcare  provider or local authority.

How to store your pen

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. Dispose of

Keep your AllStar

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and insulin cartridges out of sight and reach of children.

Your AllStar

should be stored with the insulin cartridge inserted.

Depending on the insulin inserted, keep Allstar®   at room temperature either below 25°C[77°F] or 30°C[86°F].

Please check the insulin leaflet for instructions on how to store Allstar® with an insulin cartridge inserted in the pen.

Without a cartridge, Allstar® can be stored upto 30°C [86°F].

How to care for your pen Handle your pen with care

•  Do not drop your pen or knock it against hard surfaces.

• If you think that your pen may be damaged, do not try to repair it. If you are not sure
• You can clean the outside of your pen by wiping it with a damp cloth. Do not soak, wash or lubricate your pen – this may damage it.

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whether or not your AllStar

is broken or damaged, contact your healthcare provider or

contact us via medinfo.india@sanofi.com  or call Sanofi on Tel no. (022) 28032000

Protect your pen from dust and dirt

Consult instructions for use.

Keep away from direct sunlight

Storage temperature for Allstar® without an insulin cartridge inserted.

Please check the insulin leaflet for instructions on how to store Allstar® with an insulin cartridge inserted in the pen.

Batch code  0123

Manufacturer

Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst, D-65926 Frankfurt am Main, Germany.

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AllStar

meets the current dose accuracy and functional requirements of the ISO 11608-1: with

Sanofi Group 3 mL (300 units) insulin cartridges (U-100).

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AllStar

is a registered trademark of the Sanofi Group.

Packed at:

Sanofi India Limited

Plot No.3501,3503-15 & 6310B-14,G.I.D.C. Estate

P.B.No.136,Dist.Bharuch, Ankleshwar-393002, India

Marketed by:

Sanofi India Limited

Sanofi House, CTS No. 117-B, L&T Business Park, Saki Vihar Road, Powai 400072

Updated: December 2017

Source: Allstar CCDM version 6 dated 27th July 2017