HUMATROPEN® 6 mg - Eli Lilly Canada
Contents
1. PV 7971 CAP HUMATROPEN 6 MG PARTS PEN NEEDLE PARTS PEN NEEDLES NOT INCLUDED Humatrope somatropin Humatrope Injection 6 mg Cartridge Button sold separately 6 mg Screw Pen Body Inner Cap Paper Tab HUMATROPEN 6 mg ean a Growth Hormone Delivery System 1 M a e P an Injection Device for Use with PEN USER MANUAL mg Humatrope somatropin Cartridges Outer Cap Naadle Pen Rubber Front Dose Cap Seal Housing Window a Whit Dose www lilly ca Lilt a ree Read this section completely before you begin Read and follow the directions in this section only after Then move on to Section 2 you have read Section I WHAT YOU NEED TO KNOW ABOUT THE HUMATROPEN 6 MG GETTING STARTED Read these instructions carefully BEFORE using your HumatroPen 6 mg You need to use the Pen correctly in order to get the most benefit from the Humatrope treatment Failure to follow these instructions completely may result in too much or too little Humatrope being injected Be sure to follow the reconstitution mixing directions as described in the Humatrope Cartridge Kit Perform the New Cartridge Setup only once at the beginning of each new Cartridge For daily use DO NOT REPEAT this one time only New Cartridge Setup If you do you may run out of Humatrope early INTRODUCTION NEW CARTRIDGE SETUP The HumatroPen 6 mg is an injection device intended for use with Humatrope 6 mg Cartridges Your healthcare2. How can tell when the injection is complete professional counter clockwise Discard the Needle as The injection is complete when directed by your healthcare professional You have slowly counted to five while you are still holding the Injection Button in and before you e DO NOT STORE the Pen with a Needle attached to prevent air from entering the Cartridge remove the Needle from the skin e DO NOT REMOVE this Cartridge from the Pen until the Cartridge is empty or needs to be replaced to avoid the possibility AND of an inaccurate dose 0 00 is in the center of the Dose Window STEP 5 STORE PEN AND CARTRIDGE FOR NEXT USE II What do I do if dial past my prescribed dose e Ifyou dial a dose higher than your prescribed dose just dial the knob back to your prescribed dose without pushing in on the Injection Button Store the HumatroPen 6 mg properly See Care and Storage for the HumatroPen 6 mg in Section 1 of this user manual for more information When it is time for your next routine dose go to Section 3 and repeat Steps I 95 Packaged by Lilly Pharma Fertigung und Distribution GmbH amp Co KG 35387 Giessen Germany Manufactured by Eli Lilly and Company Pharmaceutical Delivery Systems Lilly Corporate Center Indianapolis IN 46285 USA Authorized Representative in the EU Eli Lilly and Company Ltd Erl Wood Manor Windlesham Surrey GU2O0 6PH UK For assistance or further information write to Eli
3. Lilly Canada Inc 3650 Danforth Avenue Toronto ON C MIN 2E8 PV 7971 CAP HumatroPen and the H Block designs are trademarks of Eli Lilly and Company Humatrope is a registered trademark of Eli Lilly and Company The HumatroPen 6 mg is for use with Humatrope 6 mg Cartridges only 2012 Eli Lilly and Company All rights reserved User Manual Revision Date 29 June 2012 Lilly 7 24 12 12 14 PM PV7971CAP P1V1 indd 2
4. professional STEP A CHECK THE PEN AND CARTRIDGE has prescribed the Humatrope dose and Pen that you or your child should receive DO NOT CHANGE the dose or Pen unless directed by your healthcare professional i Before using your HumatroPen 6 mg make sure that you thoroughly read this user manual It explains the Pen operations and has a troubleshooting guide should questions arise _ A A mg If you have any questions about your HumatroPen 6 mg please contact your healthcare professional or A AN call Lilly Customer Response Centre at 1 888 545 5972 CE WARNING DO NOT USE THE HUMATROPEN 6 mg INJECTION DEVICE AND HUMATROPE CARTRIDGES IF YOU ARE ALLERGIC TO METACRESOL OR GLYCERIN IMPORTANT INFORMATION ABOUT THE HUMATROPEN 6 MG Be sure to check the Cartridge Pull off the Pen Cap Look at the Injection Button and e For 6 mg Cartridge Label the Front Housing to confirm it is e Where you see A in this manual please pay special attention e For expiration date ADT Et e Contents should be clear and free e DO NOT USE the Pen if any part of the Pen or Cartridge appears broken or damaged Contact your healthcare of particles professional or the Lilly Customer Response Centre 1 888 545 5972 Check that the number on the Front e Confirm that you have a 6 mg Humatrope Cartridge to match the HumatroPen 6 mg If it does not match DO NOT Uvoulad Housing matches the Cartridge USE and contact your healthcare professional seer Pen Ha part H the h stre
5. d the each injection Using a new Needle for each injection will help minimize the risk of infection prevent leakage of THe Sece Front Housing to confirm it is a 6 mg Humatrope prevent air bubbles from entering the cartridge and reduce Needle clogs ji Pen The screw may not be out when you How do throw away used Needles get the Pen e Throw away used Needles as directed by your healthcare professional If the Cartridge is not completely attached the Screw may not move and an incorrect dose may be given CARE AND STORAGE FOR THE HUMATROPEN 6 MG STEP C ATTACH THE NEEDLE Care e Soiled parts can be cleaned with a damp cloth DO NOT USE alcohol or other cleaning agents e DO NOT SOAK or immerse the Pen in liquid e DO NOT APPLY oil or any other lubricant v 1 A e Protect the pen and case from moisture especially when transporting in the travel cooler bag EN 5 OP FQ a Store the HumatroPen 6 mg with attached Humatrope Cartridge in the storage case in the refrigerator until the time of the next injection DO NOT FREEZE e All Humatrope Cartridges and diluent must be refrigerated at temperatures between 2 C and 8 C 36 to 46 F DO NOT FREEZE A prepared Cartridge can be left on a Pen for 28 days in the refrigerator DO NOT USE Remove the Paper Tab from the end Push the Needle straight onto e Pull off the Quter Cap and the Inner any prepared Cartridge after 28 days of the Outer Cap the 6 mg Cartridge and screw on Ca
6. dge DO NOT STORE the Pen with a Needle attached e Perform the New Cartridge Setup to remove air bubbles from the Cartridge e Remove the Paper Tab from the end of the Outer Cap Holding the Needle by the outer cap push the Needle straight onto the 6 mg Cartridge and screw on clockwise until secure e Pull off the Outer Cap and the Inner Cap e Keep the Outer Cap to remove the Needle after the injection Hidden Needle Cover is available separately from the HumatroPen 6 mg Kit Refer to the Hidden Needle Cover user manual for instructions STEP 3 DIAL AND INJECT THE DOSE Turn the Dose Knob to desired dose 0 25 mg shown in the drawing above lf you dial past the desired dose you can correct the dose by dialing backwards D 5 seconds Insert the Needle as directed by your healthcare professional Place your thumb on the Injection Button then slowly and firmly push the Injection Button until it stops moving It is possible to set a dose larger than the amount of Humatrope left in the Cartridge At the end of the injection the number in the Dose Window should be 0 00 If it 9 6 T e Small air bubbles are normal They will not harm you nor affect the dose Why doesn t the Screw move out when there is no Cartridge attached to the Pen e The Screw may not move out when you push the Injection Button unless there is a Cartridge in the Pen This feature allows you to easily push the Scr
7. e e No The New Cartridge Setup is done only once for each Cartridge just before a new Cartridge is used for the first time e The purpose of the setup is to make sure the HumatroPen 6 mg and 6 mg Cartridge are ready to use e If you repeat the New Cartridge Setup before each routine dose you may run out of Humatrope early The small amount of product used in the New Cartridge Setup will not affect the supply of Humatrope What should I do if the Cartridge Label and Pen do not match e DO NOT USE the Pen if the Cartridge strength on the Humatrope Cartridge label does not match the number on the Pen s Front Housing e Contact your healthcare professional for assistance or to obtain a replacement What should do if the Humatrope is not clear after mixing e Be sure to gently invert the Pen up and down 10 times DO NOT SHAKE Then let the Pen sit for at least three minutes If the solution remains cloudy or has particles gently invert the Pen up and down I0 more times Let the Pen sit for five more minutes e If the solution remains cloudy or contains particles after reconstitution mixing DO NOT USE Contact your healthcare professional for assistance or Lilly at 888 545 5972 Why are there air bubbles in the Cartridge e Air bubbles may remain in the Cartridge after reconstitution mixing Aa S gt e Ai Ss NX t o E e Ifthe Pen is stored with a Needle attached air bubbles may form in the Cartri
8. ew into the Pen Body when replacing a Cartridge e Once a Cartridge is attached the Screw will move out when the Injection Button is pushed What should I do if can t attach the Cartridge to the Pen Body e Check that the Cartridge is not damaged or broken e Carefully line up the Cartridge with the Pen Body and screw together until secure If the Cartridge and Pen cannot be screwed together contact your healthcare professional Why is it difficult to push the Injection Button when try to inject the dose e The Needle may be clogged Try attaching a new Needle e Pushing the Injection Button down quickly may make the Injection Button harder to push Pushing the Injection Button more slowly may make it easier e 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 e The Injection Button may become harder to push if the inside of your Pen gets dirty with Humatrope is not this is the amount of Humatrope you DID NOT receive food drink or other materials Maintain pressure on the Injection Button for five seconds then remove the Needle from the skin Consult with your healthcare professional on how to handle a partial dose Remove the Needle and empty Cartridge 8 Why doesn t the Dose Knob go to zero when inject the dose e This can happen if the Humatrope Cartridge does not have enough Humatrope left in i
9. imitation or how long a warranty lasts so this limitation may not apply to you This Limited Warranty gives you specific legal rights You may have rights other than those provided for above Please see the accompanying complete Humatrope Patient Information Sheet For additional information call 888 545 5972 e Cartridge Setup is only done at the start of every new cartridge e Leave the Cartridge attached and DO NOT REMOVE until the Cartridge is empty e Go to Section 3 Step 3 for instructions on how to inject the first dose A Lilt PV7971CAP P1V1 indd 1 7 24 12 12 14 PM ETIO STEP 1 CHECK THE PEN Pull off the Pen Cap DO NOT USE the Pen if any part of the Pen or Cartridge appears broken or damaged Contact your healthcare professional Now that you have done the one time only New Cartridge Setup follow Section 3 for all of your injections DAILY USE Be sure to check the Cartridge e For 6 mg Cartridge Label e For expiration date e Contents should be clear and free of particles STEP 2 ATTACH THE NEEDLE Look at the Injection Button and the Front Housing to confirm it is a 6 mg Pen Check that the number on the Front Housing matches the Cartridge strength on the Cartridge label If the Pen and Cartridge do not match contact your healthcare professional 2 3 4 ssecrion 4 COMMONLY ASKED QUESTIONS Do need to perform the New Cartridge Setup before every dos
10. ngth on the Cartridge label or Laririage appears broken or damaged If the Pen and Cartridge do not match e ONLY follow Section 2 to set up a new Cartridge before first use of each new cartridge j Contact your healthcare professional contact your healthcare professional e Section 3 of this manual should be followed for daily injection e DO NOT SHARE your HumatroPen 6 mg or Pen Needles as this may risk transmission of infectious agents e The HumatroPen 6 mg is not recommended for use by blind or visually impaired individuals without the assistance of a sighted individual trained in its use STEP B ATTACH THE CARTRIDGE ABOUT PEN NEEDLES N we s ai N What kinds of Needles can be used with the HumatroPen 6 mg W o wa Pen o man ea EAA E A E oe pa Aa J e Pen Needles are not included You may need a prescription to get the Needles from your pharmacist i p a e Becton Dickinson and Company Pen Needles are suitable for use with the HumatroPen 6 mg ld O e Ask your healthcare professional what Needle gauge and length is best for you A gt f Must a new Needle be used for each injection e Yes a new Needle must be used for each injection si nae i A the Cartridge to Asal vile 1 eg U ush the Screw back artridge into the Pen Body Screw anti e Remove the Needle from the HumatroPen 6 mg prior to returning the device to its case Use a new Needle for P the ee B entail Cartridge Look at the Injection Button an
11. p clockwise until secure e Keep the Outer Cap to remove the e Let the HumatroPen 6 mg with attached Humatrope Cartridge stand at room temperature for 10 minutes before injecting Discomfort may be noticed at the injection site if Humatrope is injected cold Needle after your injection e Daily room temperature exposure should not exceed 30 minutes DO NOT STORE the Pen with the Needle attached STEP D REMOVE AIR FROM NEW CARTRIDGE REPLACEMENT h r AY The HumatroPen 6 mg has been designed to be used for up to 3 years after first use Record the date the Pen was first a used here __ __ _ Contact your healthcare professional if a new HumatroPen 6 mg is needed or when the Pen a has been used for 3 years HumatroPen 6 mg Limited Warranty Eli Lilly Canada Inc Lilly warrants the HumatroPen 6 mg against defects in workmanship and materials for a period of three years from the date of its receipt by original user This warranty does not apply if the pen has been modified altered improperly handled stored or operated in a way not described in Lilly s written specifications and instructions This Limited Warranty is Dial 1 25 mg e Point the Needle straight up NONTRANSFERABLE and NONASSIGNABLE e Push the Injection Button and hold for five seconds If the HumatroPen 6 mg fails to function during the warranty period Lilly will replace the pen at Lilly s expense In order to return e Dial 0 05 mg and repeat these
12. steps until you see a stream of liquid a HumatroPen 6 mg for warranty replacement please call Lilly s Customer Response Centre 1 888 545 5972 for instructions sys i E SA ad Ue leh e The Pen and cartridge must be set up before injecting the first dose from each new 6 mg Cartridge This limited warranty is the user s exclusive remedy for any I breach of this warranty 2 claim 3 loss or 4 damage arising out of e Setting up the new Cartridge is important to remove large air bubbles that may be present after reconstitution mixing the use of the HumatroPen 6 mg whether based on contract tort or strict liability Lilly is not liable for any incidental consequential e Ifa stream is not seen after several attempts contact your healthcare professional or Lilly at 1 888 545 5972 or other damages of any kind however occasioned whether by negligence or otherwise Some provinces may not allow some or e The Hidden Needle Cover should not be used during the pen and cartridge set up all of this exclusion or the exclusion of incidental or consequential damages so some or all of this exclusion may not apply to you THIS THREE YEAR LIMITED WARRANTY IS IN LIEU OF AND SPECIFICALLY EXCLUDES AND REPLACES ALL OTHER EXPRESS OR IMPLIED WARRANTIES WHETHER ORAL WRITTEN OR IN ANY OTHER FORM INCLUDING BUT NOT LIMITED TO WARRANTIES OF STEP E CONTINUE ON TO DAILY USE MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Some provinces may not allow all of this l
13. t for the full dose It is possible to set a dose larger than the amount of Humatrope left in the Cartridge At the end of the injection the number in the Dose Window should be 0 00 If it is not this is the amount of Humatrope you DID NOT receive Consult with your healthcare professional on how to handle a partial dose Remove the Needle and empty Cartridge For the next daily use attach a new Cartridge as shown in Section 2 Step A and continue with New Cartridge Setup Section 2 Check to make sure you see a 0 00 in the Dose Window to confirm you received the complete dose For the next daily use attach a new Cartridge as shown in Section 2 Step A and continue with New Cartridge Setup Section 2 STEP 4 REMOVE AND DISPOSE OF THE NEEDLE 9 Why do see Humatrope leaking from the Needle after have finished the injection e lt is normal for a single drop to remain on the tip of the Needle after the injection is complete If you see more than one drop You may not have received your full dose DO NOT INJECT another dose Consult with your healthcare professional for assistance To prevent this for your next dose firmly push and hold the Injection Button in and slowly count to five before removing the needle from the skin see Section 3 Step 3 Carefully replace the Outer Cap While holding the cartridge in one hand Replace the Pen Cap eae as instructed by your healthcare unscrew the capped Needle by turning 10
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