Lilly PA001SPEX06 HumaPen Savvio Instruction Manual

: June 12, 2024
: Lilly

Table of Contents

INTRODUCTION
IMPORTANT NOTES
INSERT THE CARTRIDGE
ATTACH NEEDLE
PRIME THE PEN
INJECT THE DOSE
CARE AND STORAGE
REPLACEMENT AND DISPOSAL OF PEN
FREQUENTLY ASKED QUESTIONS
MAKE SURE YOU HAVE ALL YOUR PEN COMPONENTS.
INSERT THE CARTRIDGE
ATTACH NEEDLE
PRIME THE PEN BEFORE EVERY INJECTION
INJECT THE DOSE
STORE YOUR PEN
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Lilly PA001SPEX06 HumaPen Savvio Instruction Manual

INTRODUCTION

Intended Use: Huma Pen SAVVIO® is a reusable insulin pen intended for the self-injection of insulin available in Lilly 3 ml cartridges using disposable pen needles (sold separately).
Intended Users: The intended users of Huma Pen Savior are those prescribed Lilly 3 ml insulin cartridges, including adults, adolescents and children who are capable of self-injection, or adult caregivers who administer insulin to others.
Contraindications: There are no known contraindications for Huma Pen Savior.
Huma Pen SAVVIO® Pen is designed for ease of use. You can give yourself multiple doses from one Lilly 3 ml insulin cartridge (100 IU/ml or units/ml). You can inject from 1 to 60 units of insulin in each injection. You can dial your dose one unit at a time. If you dial the wrong dose, you can correct the dose without wasting any insulin

For more information on Huma Pen SAVVIO Pens and Lilly insulin, please visit our website at www.lilly.co.uk and www.lilly.ie

Read these instructions completely and follow the directions carefully before using the pen. Failure to follow the instructions may result in the wrong insulin dose being delivered. Do not share your pen with other people, even if the needle has been changed. Do not reuse or share needles with other people. You may give an infection to them or get an infection from them. If any of the parts of your Pen appear broken or damaged, DO NOT USE. Contact your local Lilly affiliate office (see end of leaflet for contact details) or your healthcare professional for a replacement Pen. Huma Pen SAVVIO is not recommended for the blind or visually impaired without the assistance of a sighted individual trained to use it. Always carry a spare insulin pen in case your pen is lost or damaged.

IMPORTANT NOTES

Your healthcare professional has prescribed the type of insulin best for you. Any changes in insulin should be made only under medical supervision.
Huma Pen SAVVIO is for use only with Lilly 3 ml insulin cartridges.
Do not use other brands of insulin cartridges.
Before each injection, read the cartridge label and be sure the pen contains the correct Lilly 3 ml insulin cartridge.
The colour of the pen is not intended to indicate insulin type.

INSERT THE CARTRIDGE

Read and follow the instructions provided in your Lilly 3 ml insulin cartridge Information for the Patient (package leaflet).
Check to make sure the insulin cartridge is not cracked or broken and your insulin is not expired before inserting the insulin cartridge into your pen.
Check the cartridge label for the type of insulin and appearance before each injection.

ATTACH NEEDLE

Huma Pen SAVVIO is suitable for use with BD (Becton, Dickinson and Company) Pen needles.
Use a new needle for each injection. This will help ensure sterility. It will also help prevent leakage of insulin, keep out air bubbles, and reduce needle clogs.
The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.

PRIME THE PEN

Prime every time. The pen must be primed until you see insulin at the needle tip before each injection to make sure the pen is ready to dose.
If you do not prime, you may get the wrong dose.

INJECT THE DOSE

Huma Pen SAVVIO will not allow you to dial more than the number of units left in the cartridge.
Do not push down on the injection button while dialling your dose.
Do not attempt to inject your insulin by turning the dose knob. You will NOT receive your insulin by turning the dose knob. You must PUSH the injection button straight in for the dose to be delivered.
Do not attempt to change the dose while injecting.
You may see a drop of insulin at the needle tip. This is normal and it does not affect the dose you just received.

CARE AND STORAGE

• Remove the needle after every use. Do not store the pen with the
needle attached.
• Keep your HumaPen SAVVIO, Lilly 3 ml insulin cartridges, and needles
out of the reach and sight of children.
• Keep the pen away from dust.
- - Store pen between -40°C and 70°C without the insulin cartridge.
Wipe the pen cap, pen body and case with a damp cloth to clean them.
Do not use alcohol, hydrogen peroxide or bleach on the pen body or dose window. Also, do not cover in liquid, as this could damage the pen.
Do not apply lubrication such as oil, as this could damage the pen.
Keep the pen away from extreme hot or cold temperature, after the Lilly 3 mL insulin cartridge is inserted.
Refer to the insulin cartridge Information for the Patient (package leaflet) for complete insulin storage instructions.

REPLACEMENT AND DISPOSAL OF PEN

Do not use your pen for more than 6 years after the first use or past the use- by date on the carton.

The expired pen may be discarded in your household waste after you have removed the needle. Ask your healthcare professional about options to dispose of the pen properly.
Contact your healthcare professional if a prescription is necessary, or go directly to a pharmacy when you need a new Huma Pen SAVVIO. If you have any questions or problems with your Huma Pen SAVVIO Pen, contact your local Lilly affiliate office or your healthcare professional for assistance.

Record the date your Pen was first used here: / / .
Record the Use-by date from your carton here: / / .

FREQUENTLY ASKED QUESTIONS

QUESTIONS ABOUT INSERTING THE CARTRIDGE

Why doesn’t the screw move out when there is no cartridge in the pen?
The Screw may not move out when you push the injection button unless there is a cartridge in the pen. Once a cartridge is inserted, then the screw will move out when the injection button is pushed.
What should I do if I can’t attach the cartridge holder to the pen body?
Check that the Lilly 3 ml insulin cartridge is correctly inserted into the cartridge holder. Then carefully line up the cartridge holder with the pen body and twist together until secure.

QUESTIONS ABOUT PRIMING THE PEN

Why is it important to prime before every injection?
- Priming helps to ensure that the pen and needle are working properly.
- Priming removes air that may collect in the needle or insulin cartridge during normal use.
  If you do NOT prime, you may get the wrong insulin dose. Priming helps to ensure that the pen and needle are working properly. Once the pen is properly primed, insulin will flow from the needle. You may need to prime several times before you see insulin at the tip of the needle.
Why can it take several attempts to prime when a new cartridge is inserted?
There may be a gap between the screw and the cartridge plunger. Repeating the priming steps will move the screw out to touch the cartridge plunger. Once the end of the screw pushes the cartridge plunger out, insulin will flow from the needle.
Why should I prime until I see insulin at the tip of the needle?
Priming moves the screw into contact with the cartridge plunger and gets the air out of the cartridge.
- You may see insulin on the tip of the needle when you first attach it. This only shows that the needle is attached and not clogged. You must still prime the pen.
- You may also see no insulin at all when you are priming pen. This may be because the screw is moving forward to close a gap between the screw and the cartridge plunger.
- Insulin will flow only when the pen is properly primed.
- If the injection button is hard to push, the needle may be clogged. Attach a new needle. Repeat the priming steps until insulin is seen at the needle tip. If you are still unable to see insulin flow from the needle, do NOT use the pen. Contact your healthcare professional for assistance or to obtain a replacement.
What should I do if I have an air bubble in the cartridge?
Priming your pen will remove air. Point the pen up, and tap the cartridge gently with your finger so any air bubbles can collect near the top. Repeat the priming steps until insulin is seen at the tip of the needle. A small air bubble may remain in the cartridge after completion of the priming steps. If you have properly primed the pen, this small air bubble will not affect your insulin dose.

QUESTIONS ABOUT INJECTING

What should I do if I dial a wrong dose (too high or too low)?
Turn the dose knob backward or forward to correct the dose before injecting.
What should I do if my full dose cannot be dialled?
If your dose is greater than the number of units left in the cartridge, you may either inject the amount remaining in your current cartridge, and then use a new cartridge to complete your dose, OR inject the full dose with a new cartridge. For example, if you need 31 units and only 25 units remain in the cartridge you will not be able to dial past 25. In this instance you will need an additional 6 units. Do not attempt to dial past this point. You may either:
- Inject the partial dose and then inject the remaining dose using a new cartridge. OR
- Inject the full dose with a new cartridge.
Why is it difficult to push the injection button when I try to inject?
- Your needle may be clogged. Try attaching a new needle, and then prime the pen.
- Place your thumb directly on top of the injection button so the dose knob can turn freely.
- Pushing the injection button down quickly may make the button harder to push. Pushing the button more slowly may make it easier.
- Using a larger diameter needle will make it easier to push the injection button during injection. Ask your healthcare professional which needle is best for you. If none of the above steps resolves the problem, your pen may need to be replaced.

Your Injection Button may become harder to push if the inside of your pen gets dirty with insulin, food, drink or other materials. Following the CARE AND STORAGE instructions should prevent this.

If you have any questions or problems with your HumaPen SAVVIO Pen, contact your local Lilly affiliate office or your healthcare professional for assistance.

MAKE SURE YOU HAVE ALL YOUR PEN COMPONENTS.

Wash your hands before each injection.

PEN NEEDLE (sold separately) HUMAPEN SAVVIO PEN PARTS
Pen Components

Be sure to check your insulin cartridge for:

Type of Insulin
Expiration Date
Appearance
Cracks or breakage

INSERT THE CARTRIDGE

Pull off pen cap and set aside.
Insert the Cartridge

Insert small end of Lilly 3 ml insulin cartridge into the cartridge holder.
Insert the Cartridge

Push the cartridge holder and pen body straight together.
Twist the cartridge holder onto the pen body until you feel a click and it is secure.
Insert the Cartridge

Twist cartridge holder to detach.
Insert the Cartridge

If the screw is out, use the cartridge plunger to push it back.
Insert the Cartridge

Wipe the small rubber seal on the end of the cartridge with an alcohol swab.
Insert the Cartridge

ATTACH NEEDLE

Remove the paper tab and discard.

Screw needle straight onto the cartridge holder until secure.
Attach Needle

Pull off outer needle cap. Save the outer needle cap to remove the needle after your injection.

Pull off inner needle cap and throw it away.
Attach Needle

FOR CLOUDY MIXTURE INSULIN ONLY
Follow these instructions before each injection. Roll the pen gently 10 times.

Invert the pen gently 10 times. The insulin should look evenly mixed.

PRIME THE PEN BEFORE EVERY INJECTION

A new cartridge may need to be primed several times before you see insulin at the needle tip.

Dial 2 units
Every Injection

Point pen up. Tap cartridge to collect air at the top for removal.
Every Injection

Push Injection Button. Look for insulin at the tip of the needle. If no insulin is seen repeat priming.
Every Injection

If you do not prime, you may get the wrong dose.

If no insulin is seen after several attempts, the needle on your pen may be clogged. Attach a new needle and repeat the priming steps.

INJECT THE DOSE

Turn dose knob to your desired dose.
Example: 28 units is shown in the drawing below.

**** If you dial too manyunits, you can correct the dose by dialling backwards

Note: The Pen will not allow you to dial more than the number of units left in the cartridge
** The dose knob clicks as you turn it. DO NOT** dial your dose by counting clicks because you may dial the wrong dose.

Insert needle into skin using the injection technique recommended by your healthcare professional.

** Place your thumb on the injection button and then slowly** and firmly push the injection button until it stops moving.

Continue to hold the button for 5 seconds then remove the needle from your skin.

Note: After removal check to make sure you see 0 in the dose window to confirm you received the complete dose If you are not sure you injected your full dose, do not inject another dose. Call your local Lilly affiliate office or your healthcare provider.
Injection the Dose

STORE YOUR PEN

Carefully replace the outer needle cap as instructed by your healthcare professional.

Note: To prevent air from entering the cartridge, do not store the Pen with Needle attached.
Store your pen

While grasping cartridge holder, unscrew the capped needle.

Put used needles in a sharps container or a hard plastic container with a secure lid. Do not throw needles directly into your household waste.
Do not recycle the filled sharps container.
Ask your healthcare provider about options to dispose of the sharps container properly.
The directions regarding needle handling are not intended to replace local, healthcare provider or institutional policies.

Replace the Pen Cap
Store your pen

If you have any questions or problems with your Huma Pen SAVVIO Pen, contact your local Lilly affiliate office (see below) or your healthcare professional for assistance.
Report all MEDICAL DEVICE COMPLAINTS or UNDESIRABLE SIDE EFFECTS, including SUSPECTED SERIOUS INCIDENTS, to local Lilly affiliate office (see below). You are also encouraged to report all UNDESIRABLE SIDE EFFECTS, including SUSPECTED SERIOUS INCIDENTS to United Kingdom: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store Ireland: HPRA Pharmacovigilance, Website:www.hpra.ie Australia :www.tga.gov.au/reporting-problems New Zealand: nzphvc.otago.ac.nz/reporting/ South Africa:www.sahpra.org.za/health-products- vigilance/

Local Lilly affiliate contact details

Eli Lilly Australia Pty Limited 112 Wharf Road West Ryde NSW 2114 Australia
Tel: 1800 454 559
Eli Lilly and Company (NZ) Limited PO Box 109 197 Newmarket Auckland 1149 New Zealand
Tel: 0800 500 056
Eli Lilly and Company Limited Lilly House, Basing View Basingstoke, Hampshire, RG21 4FA United Kingdom
Tel: +44 (0) 1256 315000

Eli Lilly and Company (Ireland) Limited Dunderrow, Kinsale Co. Cork Ireland
Tel: +353 (0) 1 661 4377
Eli Lilly (S.A.)(Pty) Limited First Floor, Golden Oaks House Ballyoaks Office Park 35 Ballyclare Drive Bryanston South Africa, 2191
Tel: +27 11 510 9300

Eli Lilly and Company Pharmaceutical Delivery Systems Lilly Corporate Center Indianapolis, IN 46285, USA

Eli Lilly Nederland B.V. Papendorpseweg 83 3528 BJ UTRECHT The Netherlands

Importer: Lilly S.A. Avenida Industria 30 28108 Alcobendas Madrid, Spain

HumaPen SAVVIO meets the dose accuracy and functional requirements of ISO 11608-1 with Lilly 3 ml cartridges

Non-harmonized Symbol Glossary1

0344
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