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AllStar: Read this page first - Important facts about your new reusable insulin delivery device

Instructions for use
AllStar
Reusable insulin delivery device

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Before you start

AllStar is a reusable pen for the injection of insulin.
Read these instructions and follow them completely each time you use AllStar to ensure that you inject the correct dose.

  • If you do not follow these instructions completely, you may get too much or too little insulin, which may affect your blood glucose levels.
  • If you are not able to follow all the instructions on your own, only use AllStar if you have help from a person who is able to follow the instructions completely.
  • Please retain these instructions for future reference.

 

Cold insulin is more painful to inject. If your insulin cartridge is in cool storage (for example refrigerator) take it out 1 to 2 hours before you

inject.
AllStar can only be used with Sanofi 3ml (300 units) insulin cartridges (100 units per ml).

  • You can set doses from 1 to 80 units in steps of 1 unit.
  • The insulin cartridge can be used for multiple injections until it is empty, reaches its expiry date, or 28 days have passed after its first use (whichever comes first).
  • The plunger will only reach the end of the cartridge when all 300 units have been given.

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

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Do not use your AllStar pen for more than 3 years. After 3 years contact your healthcare provider or pharmacist to get a new
AllStar pen.

Reading the dose remaining scale

The approximate number of units remaining in the cartridge is shown on the scale by the end of the rubber stopper nearest
to the needle.

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You cannot select more units than what is remaining in the cartridge.

  • If less than 80 units are left, the exact number can be found by:
            - turning the dose button as far as it will turn easily
            - reading the number in the dose window.

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Important information for use of AllStar

  • If you are giving an injection to another person, take special care not to touch the needle tip to avoid accidental needle injury and passing of infectious diseases.
  • Each AllStar, each cartridge and each needle are only for one person's use. Do not share with anyone else.
  • For use in a multi-patient environment, e.g. hospital or nursing home, special caution must be taken to ensure identification
    of the correct pen for each patient.
  • If you use different types of insulin, you should use a different colour or different type of pen for each insulin.
  • Never use AllStar or an insulin cartridge if it is damaged or if you are not sure that it is working properly.
    Before each injection, always:
  • Check the label of your insulin cartridge (Step 2, see reverse side of this page).
  • Attach a new needle (Step 3, see reverse side of this page).
     - Use only compatible Type A pen needles available from Becton Dickinson.
  • Perform a safety test (Step 4, see reverse side of this page).

Storage and maintenance of AllStar

Keep your AllStar pen and insulin cartridges out of sight and reach of children.

  • It is recommended to store AllStar in the carry case provided.

Your AllStar should be stored with the insulin cartridge attached, ready for your next injection.

  • Do not store AllStar with a needle attached.
  • Do not store AllStar in the refrigerator.
  • Lantus, Apidra and Insuman cartridges can be safely stored at temperatures up to 25°C (77°F) for up to 28 days.

Read the leaflet included with your Sanofi 3ml (insulin cartridge) for complete cartridge storage information.
Your AllStar is designed to work accurately and safely. It should be handled with care.

Avoid situations where AllStar might be damaged.

  • Do not use excessive force when turning or pressing the dose button or when pushing the plunger back in.
  • Protect your AllStar from dust, dirt, high temperatures and direct sunlight.

Do not soak, wash or lubricate AllStar as this may cause damage.

  • You can clean the outside surfaces of AllStar by wiping it with a damp cloth.

If your AllStar is broken or damaged then it is no longer safe to use.

  • Never attempt to repair a broken AllStar.
  • If you are not sure whether or not your AllStar is broken or damaged, contact your healthcare professional or call Sanofi on +91-22-28278000.
54A, Sir Mathuradas Vasanji Road
Andheri (E)
Mumbai 400 093
India
If you have any questions about AllStar or
about diabetes:
• ask your healthcare professional
• call Sanofi on +91-22-28278000
• email Sanofi at allstar.india@sanofi.com
AllStar is a trademark of the Sanofi Group.
AllStar meets the current dose accuracy and
functional requirements of ISO 11608-1:2000
with Sanofi 3 ml (300 units) insulin cartridges
(100 units per ml). Date of revision: April 2012

 Key to symbols on AllStar packaging / pen

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AllStar: Giving injections with your reusable insulin delivery device

ENSURE THAT YOU READ THE FULL INSTRUCTIONS FOR USE BEFORE USING ALLSTAR.
There are important instructions on the other side of the page.

What you need for your injection:

  •  Your AllStar reusable insulin injection pen.
  • One Sanofi 3 ml (300 units) insulin cartridge (100 units per ml) (not part of this pack).
  • A new pen needle (not part of this pack).
  • A puncture resistant container for disposing of used needles (not part of this pack).

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Step 1. Insert a new insulin cartridge (or replace a cartridge)

  •  If your AllStar pen already contains an insulin cartridge you can go straight to Step 2.

 A. Pull off the pen cap from AllStar.

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B. Unscrew the cartridge holder from the pen body.

  • If there is an insulin cartridge that needs to be replaced, remove it and discard it.

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

D. Insert the new cartridge, narrow end first, into the cartridge holder.

  • Do not insert a partially used cartridge.

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E. If the plunger is extended use the cartridge's rubber stopper to push it back.

  • Do not press on the dose button whilst pushing back the plunger. This will cause the plunger to jam.

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

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The alignment marks on the cartridge holder and the pen body must line up as shown.

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Step 2. Check your insulin before every injection

A. Check your insulin cartridge.

  • Make sure you have the correct insulin. Using the wrong insulin may result in unwanted changes in your blood sugar levels that could be harmful to your health.
  • Do not use an insulin cartridge if it is damaged or after the expiry date on the cartridge label.
  • Follow the instructions provided with your insulin cartridge.

B. For Clear insulins (e.g. Lantus, Apidra or Insuman Rapid):

  • Check the appearance of your insulin.
  • Do not use the cartridge if the insulin is cloudy, coloured or has particles.

                              OR
For Suspension insulins (e.g. Insuman Basal, Insuman Comb 25/75 or Insuman Comb 50/50):

  • Turn the pen gently up and down at least 10 times to mix the insulin.
  • After mixing, check your insulin. Insulin suspensions must have an even milky-white appearance.

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Step 3. Attach a new needle before every injection

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Always use a new sterile needle for every injection. This helps to prevent contamination, inaccurate dosing and needle
blockage.
Follow any instructions included with your needles.
A. Remove the protective seal from a new needle.

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B. Line up the needle with the pen and keep it straight as you screw it onto the cartridge holder.

  • If the needle is not kept straight, it can damage the cartridge or the needle.

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  • Do not over-tighten. This will make it difficult to remove the needle after the injection.

C. Pull off the outer needle cap.

  • Keep it safe to unscrew the needle after the injection.

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D. Pull off the inner needle cap and discard it.

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Make sure that the needle is properly attached.


Step 4. Perform a safety test before every injection

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Always perform a safety test before each injection to make sure that you get the correct dose of insulin.

  • The safety test removes air bubbles and checks that your pen and needle are working properly.

A. Select a dose of 2 units by turning the dose button.

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B. Holding the pen with the needle pointing upwards, tap the cartridge holder so that any air bubble rises up towards the needle.

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C. Press the dose button all the way in and hold it in for 10 seconds.

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  • Check that insulin comes out of the needle tip.
  • Check that the dose window returns to "0".
  • If not, repeat the safety test (Step 4).

You may have to repeat the safety test several times before you see insulin.

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If still no insulin comes out of the needle tip:

  • The needle may be blocked. Remove the needle (Step 7) and replace with a new needle (Step 3).
  • Check that the cartridge is properly inserted (Step 1) and is not damaged. If it is damaged, use a new one (Step 1).

After doing all this repeat the safety test again (Step 4).
If still no insulin comes out, do not use this AllStar.
Contact your healthcare professional or call Sanofi on +91-22-28278000.

Step 5. Select your dose 

The maximum dose you can dial is 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.
A. Check that the dose window shows "0" following the safety test (see Step 4).

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B. Select your required dose by turning the dose button.

  • If you turn past your dose, you can turn back in the reverse direction without losing insulin.
  • Do not push the dose button while turning, as insulin will come out.

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If the dose button does not turn easily do not force it.

  • AllStar will not let you select more units than what is left in the cartridge.

If your dose is more than what is left you can either:
    - inject what is left (Steps 6-7), then replace the cartridge with a new one (Step 1) and  complete your dose (Steps 2-7).
    - or discard what is left and use a new cartridge for your full dose (Steps 1-7).

Step 6. Inject your dose
Inject your dose exactly as shown by your healthcare provider.
A. Insert the needle into the skin.

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B. Inject your dose by pressing the dose button, slowly, all the way in.

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C. Keep the dose button pressed all the way in. Slowly count to 10.

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D. Remove the needle from the skin.

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You have received your full dose only if the dose window shows "0".

  • If not, repeat Step 6.

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Each cartridge can be used for multiple injections up to a total of 300 units.

  • The rubber stopper reaches the end of the cartridge only when all 300 units have been used.

Step 7. Remove the needle after every injection and dispose of it safely

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Always remove the needle after every injection. Do not store AllStar with a needle attached.

  • This helps to prevent air from entering the cartridge, insulin leakage, contamination, inaccurate dosing and needle blockage.

If you are giving an injection to another person take extra special care not to touch the needle tip.

  • This is to reduce the risk of accidental needle injury and passing of infectious diseases.

Never replace inner needle cap.

  • The inner needle cap is small and difficult to replace safely.

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A. Carefully put the outer needle cap back on to the needle.

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B. Hold the cartridge holder and outer needle cap.

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  • Pull off the needle.

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C. Dispose of the needle safely in a puncture resistant container.

  •  There may be local or state laws for disposing of used needles.
  •  Needle containers should be sealed and disposed of properly.

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Step 8. Store AllStar until your next injection
A. Replace the pen cap back on AllStar after use. Store the pen safely until your next injection.

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You do not need to remove the cartridge after the injection unless it is empty.

  • Each insulin cartridge is reusable. Your AllStar should be stored with the insulin cartridge inserted, ready for your next injection.

You should not store AllStar in the refrigerator.

Lantus, Apidra and Insuman cartridges can be safely stored at temperatures up to 25°C (77°F) for up to 28 days.

 

* Criteria defined

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