Summary of Contents for Novo Nordisk NovoPen 3 PenMate
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§ NovoFine® 30G/8 mm and NovoFine® 31G/6 mm needles. NovoFine disposable needles are for single-use only. The NovoPen 3 PenMate can be used the same way as the NovoPen 3 insulin pen. Its design allows you to use the same recommended injection technique as for the NovoPen 3 insulin pen.
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If you are treated with more than one type of insulin in PenFill cartridges, you should use a separate NovoPen 3 PenMate and NovoPen 3 for each type of insulin. If you have any questions about your NovoPen 3 PenMate or your NovoPen 3 insulin delivery device, please call Novo Nordisk Pharmaceuticals, Inc. at 1-800-727-6500.
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Also included is a diagram showing a side-by-side comparison of the NovoPen 3 and the NovoPen 3 PenMate. This illustration allows you to see which part of the NovoPen 3 the NovoPen 3 PenMate replaces. The main differences between the NovoPen 3 and the NovoPen 3 PenMate are as...
SECTION 3: Choosing your dose............10 SECTION 4: Giving the injection............12 SECTION 5: Mechanical function check of NovoPen 3 PenMate..17 SECTION 6: For subsequent injections..........18 SECTION 7: What to do when PenFill is nearly empty......19 SECTION 8: Changing PenFill............
SECTION 1 Assembly of the NovoPen3 PenMate Assembly of the NovoPen 3 PenMate 1 Take NovoPen 3 out of its case by pressing the top of the pen cap. 2 Gently twist the pen cap until it separates from the barrel.
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4 Unscrew and remove the PenFill holder from the barrel* * See diagram. You will not use the pen cap and PenFill holder with the NovoPen 3 PenMate but you should store them in the case if you want to use NovoPen 3 without NovoPen 3 PenMate in the future.
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NovoPen 3 PenMate Instruction Manual Page 10 FDA revision #4 (final) Need Help? Call 1-800-727-6500 You should not reset the piston rod again until it is time to remove the used PenFill 3 mL cartridge and insert a new one.
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NovoPen 3 PenMate Instruction Manual Page 11 FDA revision #4 (final) SECTION 1 (cont.) 6 Press the push button all the way in until zero (0) appears in the window. The zero should be lined up with the stripe below the dose indicator window.
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Information For The Patient supplied with the PenFill cartridges. The expiration date on the cartridge is for unused cartridges under refrigeration. SECTION 1 (cont.) Take the NovoPen 3 PenMate out of its case. Pull off the pen cap and put it to one side.
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Put the PenFill cartridge into the NovoPen 3 PenMate. The threaded plastic cap goes in first. 8 Tightly screw the barrel of the NovoPen 3 into the NovoPen 3 PenMate. Make sure that the dose indicator window on the mechanical section is aligned with the yellow push button on NovoPen 3 PenMate.
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For users of Novolin 70/30 or Novolin N insulin: Always remix the insulin before each injection. To remix the insulin, turn the NovoPen 3 PenMate up and down between positions A and B, as on page 4, 10 times or until the insulin looks uniformly white and cloudy.
§ Check that the dial-a-dose selector is set at zero. § Dial 2 units. Hold the NovoPen 3 PenMate with the needle upwards and tap gently near the window of NovoPen 3 PenMate with your finger a few times.
PenFill cartridge. Always check that there is enough insulin left for the injection. To activate, grip the barrel and the NovoPen 3 PenMate and firmly pull in opposite directions until you hear a click.
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(0) so you can start again, see the next page. SECTION 3 (cont.) 14 If you dial a larger dose than you need, you need to reset your NovoPen 3 PenMate to zero. To reset to zero (0) if you set the wrong dose: a.
15 Before injecting always check the dose indicator window to make sure you have dialed the correct number of units. After the airshot (see page 9) and choosing your dose, hold the NovoPen 3 PenMate at the correct site on the body for an injection. Use the injection technique recommended by your healthcare professional.
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NovoPen 3 PenMate Instruction Manual Page 21 FDA revision #4 (final) SECTION 4 (cont.) 16 To inject your dose, press the push button of the barrel section as far as it will go. Do not force it (see arrow in diagram).
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NovoPen 3 PenMate Instruction Manual Page 23 FDA revision #4 (final) When you press the push button, the piston rod presses against the rear rubber stopper of the cartridge. This moves the rear rubber stopper and pushes the correct amount of insulin out through the needle.
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NovoPen 3 PenMate Instruction Manual Page 24 FDA revision #4 (final) SECTION 4 (cont.) 17 After the injection, remove the needle without recapping it. Hold the NovoPen 3 PenMate firmly while you unscrew the NovoFine disposable needle. Place the NovoFine disposable needle in a puncture-resistant disposable container.
18 Hold the NovoPen 3 PenMate with the needle pointing upwards. To activate, grip the barrel and the PenFill holder of the NovoPen 3 PenMate and firmly pull in opposite directions until you hear a click. If you do not hear a click, contact Customer Relations at our toll free number 1-800-727-6500.
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You should now be able to see the needle and the control line. If you cannot see the needle, do not use the NovoPen 3 PenMate. Never use the NovoPen 3 PenMate unless you are sure that it is working properly.
NovoPen 3 PenMate Instruction Manual Page 27 FDA revision #4 (final) Need Help? Call 1-800-727-6500 SECTION 6 For subsequent injections...
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Check that NovoPen 3 PenMate contains the type of insulin you want to inject. If the PenFill holder of your NovoPen 3 PenMate contains a clear insulin PenFill cartridge such as Novolin R, follow steps 9 to 17.
The glass ball must have adequate space to resuspend the insulin. With the NovoPen 3 PenMate, it is possible to select a dose that is larger than the number of units left in the PenFill cartridge. If...
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NovoPen 3 PenMate Instruction Manual Page 31 FDA revision #4 (final) When you get near the end of a PenFill cartridge, you may need to give yourself two injections to receive your full dose. If, after giving an injection, zero does not appear in...
Changing PenFill Changing PenFill 23 a) Unscrew the barrel from the NovoPen 3 PenMate. b) Press the push button to set the dose indicator to zero. c) Make sure that the piston rod is not out (see Section 1, Page 5). (Twist it gently from side to side, if necessary).
Function check Function check 25 If you think your NovoPen 3 PenMate is not working properly, follow this procedure: a) Check that the barrel and the NovoPen 3 PenMate are screwed together tightly and that the dose indicator window on the barrel is aligned with the yellow push button on the NovoPen 3 PenMate.
§ Always clear air bubbles with the needle pointing upwards before each injection (see step 11). § With the NovoPen 3 PenMate, it is possible to select a dose which is larger than the number of units left in the PenFill cartridge. Before you inject, always check on the insulin scale that there is enough insulin left in the PenFill cartridge for your dose.
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§ Use only a new PenFill cartridge when loading the NovoPen 3 PenMate. Never load the NovoPen 3 PenMate with a partially filled PenFill cartridge. § The NovoPen 3 PenMate is designed for use with PenFill 3 mL insulin cartridges and NovoFine single-use disposable needles.
Check that your NovoPen 3 PenMate was put together correctly when you changed the PenFill cartridge. Make sure that the piston rod is completely inside the reset mechanism. Also make sure that the barrel and the NovoPen 3 PenMate are screwed tightly together (see steps 5 and 25).
Do not drop. Do not expose to excessive pressure or blows. Keep them in the soft case whenever possible. You can put PenFill cartridges in NovoPen 3 PenMate or carry them with you as spares. Please read the Information For The Patient supplied with the PenFill cartridges for details of how to store the cartridges and how long to keep them.
Bang & Olufsen A/S cannot beheld responsible in the case of defects or damages arising from: § The use of the NovoPen 3 PenMate with products other than NovoPen 3, PenFill 3 mL cartridges, and NovoFine single-use disposable needles.
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--------------------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------------------- --------------------- David Orloff 3/11/02 05:06:34 PM...
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