Novo Nordisk NovoPen 3 PenMate Instruction Manual
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Novo Nordisk NovoPen 3 PenMate Instruction Manual

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NDA 19-938/S-037
Page 1
®
NovoPen
3
®
PenMate
Instruction Manual
For use with the
®
following NovoPen
devices:
®
NovoPen
3,
®
NovoPen
3 Demi,
®
or NovoPen
Junior
Read this carefully before you use
®
NovoPen
3 PenMate
®
NovoPen
3, NovoPen
®
NovoPen
Junior
NNPI submission date: 5/17/05
insulin delivery
®
with
®
3 Demi, or

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Summary of Contents for Novo Nordisk NovoPen 3 PenMate

  • Page 1 NDA 19-938/S-037 Page 1 ® NovoPen ® PenMate Instruction Manual For use with the ® following NovoPen insulin delivery devices: ® NovoPen ® NovoPen 3 Demi, ® or NovoPen Junior Read this carefully before you use ® ® NovoPen 3 PenMate with ®...
  • Page 2 NDA 19-938/S-037 Page 2 NNPI submission date: 5/17/05...
  • Page 3 NDA 19-938/S-037 Page 3 NNPI submission date: 5/17/05...
  • Page 4 NDA 19-938/S-037 Page 4 NNPI submission date: 5/17/05...
  • Page 5 “NovoPen 3 PenMate system”. With NovoPen 3 PenMate system, you don’t see a needle when you give an injection. If you use NovoPen 3 PenMate with NovoPen 3, you can dial doses from 2 to 70 units in one unit steps.
  • Page 6 NDA 19-938/S-037 Page 6 Please complete and return the NovoPen 3 PenMate Warranty Card for full warranty protection. NNPI submission date: 5/17/05...
  • Page 7 PenMate replaces. Look at the illustration inside the front cover for the names of the different parts of NovoPen devices and NovoPen 3 PenMate. You can unfold the illustration to help you while you follow the instructions. NNPI submission date: 5/17/05...

  • Page 8: Table Of Contents

    Choosing your dose ..................10 SECTION 4: Giving the injection...................12 SECTION 5: Mechanical function check of NovoPen 3 PenMate system ......17 SECTION 6: For subsequent injections ................18 SECTION 7: What to do if the 3 mL PenFill cartridge is nearly empty ......19 SECTION 8: Changing 3mL PenFill cartridge ..............20...

  • Page 9: Assembly Of The Novopen 3 Penmate System

    NDA 19-938/S-037 Page 9 SECTION 1 Assembly of the NovoPen 3 PenMate system Assembly of the NovoPen 3 PenMate system 1 Take the NovoPen 3 out of its case by pressing the top of the Pen cap, or take NovoPen 3 Demi or NovoPen Junior out of the soft carrying case.
  • Page 10 NDA 19-938/S-037 Page 10 SECTION 1 (cont.) 5 Press the push button all the way in until you see zero (0) in the dose indicator window. The zero should be lined up with the stripe next to the dose indicator window.
  • Page 11 If you use more than one type of insulin in PenFill cartridges, use a separate NovoPen 3 PenMate system for each type of insulin to avoid giving an injection with the wrong type of insulin. NNPI submission date: 5/17/05...
  • Page 12 NDA 19-938/S-037 Page 12 SECTION 1 (cont.) 9 Take NovoPen 3 PenMate out of its case. Pull off the cap and put it to one side. 10 Put the PenFill cartridge into the NovoPen 3 PenMate. The threaded plastic cap goes in first.
  • Page 13 PenFill cartridge “Information For The Patient” leaflet. Never place a NovoFine disposable needle on your NovoPen 3 PenMate system until you are ready to do an air shot and give an injection. If the NovoFine needle is left on, some insulin may leak out from the PenFill cartridge.

  • Page 14: Air Shot Before Each Injection

    Check that the dial-a-dose • selector is set to zero. Dial 2 units. • Hold the NovoPen 3 PenMate • system with the NovoFine needle pointing up and tap gently near the window of NovoPen 3 PenMate with your finger a few If you dialed more than 2 units, times.

  • Page 15: Choosing Your Dose

    The NovoPen 3 PenMate system can deliver from 2 to 70 units of insulin in one unit increments if you use NovoPen 3 and from 1 to 35 units of insulin in half (½) unit increments if you use NovoPen 3 Demi and NovoPen Junior.
  • Page 16 NDA 19-938/S-037 Page 16 extra insulin will squirt out of the needle. For instructions on how to reset the dose to zero (0), see step 17. NNPI submission date: 5/17/05...
  • Page 17 Page 17 SECTION 3 (cont.) 17 If you dialed a larger dose than you need, you need to reset your NovoPen 3 PenMate system to zero by following the instructions below: a. Pull the barrel of the NovoPen device and the NovoPen 3...

  • Page 18: Giving The Injection

    Hold the NovoPen 3 PenMate system at the correct site on the body for an injection. Use the injection technique recommended by your health care professional.
  • Page 19 NDA 19-938/S-037 Page 19 SECTION 4 (cont.) 19 To inject your dose, press the push button on the barrel of the NovoPen device as far as it will go to inject the insulin. Do not force it (see arrow in diagram). To make sure that all of the insulin is injected, keep the NovoFine needle in the skin for...
  • Page 20 Remove the NovoFine needle (see step 20). c. Unscrew the barrel of the NovoPen device from the NovoPen 3 PenMate system. d. Remove the empty PenFill cartridge (see steps 26 and 27). e. Insert a new 3 mL PenFill cartridge (see steps 5 to 10).
  • Page 21 See steps 21 and 22 to perform a mechanical function check of NovoPen 3 PenMate system. If you suspect that your NovoPen 3 PenMate is not working properly, call...
  • Page 22 NDA 19-938/S-037 Page 22 SECTION 4 (cont.) 20 Immediately after the injection, place an outer needle cap on the needle and carefully remove the needle. Hold the NovoPen 3 PenMate system firmly while you unscrew the NovoFine disposable needle. Used NovoFine disposable needles should be placed in sharps containers (such as red...

  • Page 23: Mechanical Function Check Of Novopen 3 Penmate System

    NDA 19-938/S-037 Page 23 SECTION 5 Mechanical function check of NovoPen 3 PenMate system Mechanical function check of NovoPen 3 PenMate system 21 Hold the NovoPen 3 PenMate system with the needle pointing Grip the barrel of the NovoPen •...

  • Page 24: For Subsequent Injections

    NDA 19-938/S-037 Page 24 SECTION 6 For subsequent injections For subsequent injections 23 Remove the NovoPen 3 PenMate cap. Check that the needle has been removed since your last injection. Make sure that NovoPen 3 PenMate system contains the correct type of insulin for an injection.

  • Page 25: What To Do If The 3 Ml Penfill Cartridge Is Nearly Empty

    12 units of insulin must be in the PenFill cartridge for adequate mixing with the glass ball. With the NovoPen 3 PenMate system, it is possible to select a dose that is larger than the number of units left in the PenFill cartridge.

  • Page 26: Changing 3Ml Penfill Cartridge

    Changing 3 mL PenFill cartridge Changing 3 mL PenFill cartridge: 26 a. Unscrew the barrel of the NovoPen device from the NovoPen 3 PenMate system. b. Press the push button of the NovoPen device to set the dose indicator back to zero (0).

  • Page 27: Function Check

    If it happens again, do not use the NovoPen device. Contact Novo Nordisk Inc. at the toll free number 1-800-727-6500. DO NOT try to repair a NovoPen device or a NovoPen 3 PenMate. NNPI submission date: 5/17/05...

  • Page 28: Important

    Make sure that the piston rod is not sticking out before you screw together the • barrel of the NovoPen device and the NovoPen 3 PenMate. (see steps 5 to 6). Always screw the mechanical section of the NovoPen device and NovoPen 3 •...
  • Page 29 • impaired patients, without the assistance of a sighted individual trained to use If you use more than one type of insulin in Novo Nordisk 3 mL PenFill • cartridge, use a separate NovoPen 3 PenMate system for each type of insulin to avoid giving an injection with a wrong type of insulin.
  • Page 30 • and with the NovoPen 3 PenMate cap placed in its position. Leaving the needle on the NovoPen 3 PenMate system can cause the insulin to leak. This may change the concentration (strength) of a suspension insulin (white and cloudy).

  • Page 31: What To Do If

    Page 31 WHAT TO DO IF ... Here are the answers to some questions you might have when using your NovoPen 3 PenMate system. • Check that your NovoPen 3 No insulin appears when I try to clear the air PenMate system was put bubbles.
  • Page 32 • Check if your skin is wet at the injection site. Carry out the mechanical function check of the NovoPen 3 PenMate system as described in steps 21 and 22. • Do the function check as I think my NovoPen 3, NovoPen 3 Demi, NovoPen described in step 28.

  • Page 33: Maintenance

    If you find your NovoPen 3 You can put PenFill cartridges in PenMate system faulty, Novo NovoPen 3 PenMate system or carry Nordisk will replace it if: them with you as spares. Please read the “Information For The You call Novo Nordisk Inc.

  • Page 34: Warranty

    Physical damage to the • NovoPen 3 PenMate No other warranty is made with caused by neglect, misuse, respect to NovoPen 3 PenMate. The unauthorized repair, mechanical section of the NovoPen accident, or other devices is covered by its own breakage.
  • Page 35 NDA 19-938/S-037 Page 35 ® ® ® ® ® ® NovoPen , Novo Nordisk , PenMate , PenFill , NovoFine , Novolin ® NovoLog are registered trademarks owned by Novo Nordisk A/S. NNPI submission date: 5/17/05...
  • Page 36 For assistance or further information, write to: Novo Nordisk Inc. Customer Relations 100 College Road West Princeton, NJ 08540 Or call: 1-800-727-6500 © 2002, 2005 Novo Nordisk Inc. Novo Nordisk Inc. Princeton, NJ 08540-7810 www.novonordisk-us.com 8-4241-31-001-2 5/17/05 Draft NNPI submission date: 5/17/05...
  • Page 37 Please note the special directions under PREPARING THE INJECTION. ® ® ® Novolin R PenFill 3 mL is designed for use with Novo Nordisk 3 mL PenFill cartridge ® compatible insulin delivery devices, with or without the addition of a NovoPen ® ®...
  • Page 38 DNA technology utilizing Saccharomyces cerevisiae (bakers' yeast) as the production organism. INSULIN DELIVERY SYSTEMS ® These Novolin R PenFill 3 mL cartridges are designed for use with Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery devices, with or without the addition of a ®...
  • Page 39 NDA 19-938/S-037 Page 3 Never use any Novolin R PenFill cartridge if the insulin becomes viscous (thickened) or cloudy; use it only if it is clear and colorless. IMPORTANT Failure to follow the antiseptic measures listed below may lead to infections at the injection site.
  • Page 40 NDA 19-938/S-037 Page 4 Hypoglycemia can also happen if you combine insulin therapy and other medications that lower blood glucose, such as oral antidiabetic agents or other prescription and over-the-counter drugs. The first symptoms of an insulin reaction usually come on suddenly.
  • Page 41 Protected by U.S. Patent No. 6,126,646 and Des. 347,894 and other U.S. Patents Pending, recommended for use with Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery devices, with or without a NovoPen 3 PenMate, and Novo Nordisk pen needles.
  • Page 42 For information contact: Protected by Novo Nordisk Inc. U.S. Patent No. 5,980,491 and other Patents Pending. Princeton, NJ 08540 Designed and recommended for use with Novo Nordisk 3 mL ® ® Manufactured in Denmark for: PenFill insulin cartridges and NovoPen devices.
  • Page 43 NDA 19-938/S-037 FDA revision 12/20/04 Page 2 End Flap: List: 185242 ® ® NovoPen 3 PenMate Batch: End Flap: List: 185242 ® ® NovoPen 3 PenMate...
  • Page 44 ® ® Novolin R PenFill Regular, Human Insulin Injection (rDNA origin) 100 units/mL ® For use with Novo Nordisk 3mL PenFill cartridge compatible insulin delivery devices For information contact: BARCODE Novo Nordisk Inc. Princeton, NJ 08540 1-800-727-6500 8-0199-31- Exp.Date: 201-X/12 -7-04/DRAFT Control...
  • Page 45 ® Novolin R PenFill Regular, 3 mL Human Insulin Injection (recombinant DNA origin) For use with Novo Nordisk 3 mL PenFill® cartridge compatible insulin delivery devices Keep in a cold place Avoid freezing 100 units/mL (U-100) 5x3 mL Novo Nordisk ™...

This manual is also suitable for:

Novopen 3Novopen 3 demiNovopen junior

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