EVER Pharma D-mine Pen Instructions For Use Manual

EVER Pharma D-mine Pen Instructions For Use Manual

Pen injector for apomorphine 10 mg/ml
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EVER Pharma D-mine
Pen
®
Pen injector for Apomorphine 10 mg/mL
Instructions for Use
with Apomine
Intermittent
3 mL Cartridges
®
Apomorphine hydrochloride hemihydrate solution for injection
For subcutaneous use

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Summary of Contents for EVER Pharma D-mine Pen

  • Page 1 EVER Pharma D-mine ® Pen injector for Apomorphine 10 mg/mL Instructions for Use with Apomine Intermittent 3 mL Cartridges ® Apomorphine hydrochloride hemihydrate solution for injection For subcutaneous use...
  • Page 2: Table Of Contents

    TABLE OF CONTENTS Introduction Confirmed Life Span Description of Parts of D-mine Warranty ® Pen preparation / Changing Cartridge Disposal Attachment of Pen Needle Labelling and Symbols Priming / Function Check Manufacturer / Distributor Setting the Dosage Injection Removal of Pen Needle Attachment of Pen Cap Additional Information Storage and Care...
  • Page 3: Introduction

    Before using the D-mine Pen wash your hands. You will need some surgical wipes and one needle in its protective cone. ® This manual contains instructions for using, storing and cleaning your EVER Pharma D-mine ® Pen. The carton contents include Using a surgical wipe, clean the area of skin where you plan to inject the medicine and around it.
  • Page 4: Description Of Parts Of D-Mine ® Pen

    DESCRIPTION OF PARTS OF D-mine PEN PREPARATION / CHANGING CARTRIDGE ® Note: The carton does not include pen needles or 3 mL cartridges. Remove the pen cap. Remove the cartridge sleeve by twisting it clockwise. outer needle protective cap pen needle threaded rod push-button You will hear a click.
  • Page 5 Insert the new cartridge into the cartridge sleeve. Push the threaded rod back completely. This is best Push the cartridge sleeve into the housing and turn performed using your finger tip (but you can also use anti-clockwise to lock. You will hear a click. the new cartridge to push the rod in).
  • Page 6: Attachment Of Pen Needle

    ATTACHMENT OF PEN NEEDLE Follow the instructions for use of your pen needle. Pull off the peel foil. Click on / twist on the pen needle to the cartridge Remove the outer needle protective cap. Remove and dispose the inner needle protective sleeve.
  • Page 7: Priming / Function Check

    PRIMING / FUNCTION CHECK The function check ensures that any remaining air in the cartridge is removed and that no blockage is present in the needle. Priming is recommended before every use, including cartridge change and attachment of pen needles. Dial the test dose forward by turning the dosage wheel.
  • Page 8: Setting The Dosage

    SETTING THE DOSE INJECTION Dial the required dose Please refer to the Product Information of the pharmaceutical Dial the required dose by turning the dosage wheel clockwise. Correct product and use the injection technique as recommended the dose by turning in anti-clockwise direction. Check the dialed by your physician and/or your ANSSER nurse.
  • Page 9: Removal Of Pen Needle

    REMOVAL OF PEN NEEDLE AFTER EACH INJECTION Option 1: Option 2: Twist off the pen needle by turning the outer shield clockwise and dispose it correctly, according to the advice of your phy- Place the outer pen needle shield in the appropriate left Carefully attach the outer needle protective cap on the notch of your carrying case.
  • Page 10: Attachment Of Pen Cap

    ATTACHMENT OF PEN CAP ADDITIONAL INFORMATION Audible and tactile indications Attach the pen cap securely after each use. Your D-mine Pen features the following audible and/or tactile indications: ® Remove/Lock Cartridge Sleeve When removing or locking the cartridge sleeve an audible signal and a noticeable resistance will be provided. Dose Dialing During dose dialing and dose correction your D-mine Pen provides an audible signal and a noticeable resistance for...
  • Page 11 Safety stop General The dose that can be set on the D-mine ® Pen is limited to the amount remaining in the cartridge. If the amount of medicine Do not use the D-mine ® Pen if it is damaged or if you have any doubts about its correct functioning. left in the cartridge is no longer sufficient for the desired dose, the dosage wheel cannot be turned any further in a clockwise direction.
  • Page 12: Storage And Care

    STORAGE AND CARE A damp cloth is sufficient to clean your D-mine ® Pen. Please do not use alcohol, other solvents or cleaning agents. Never immerse your D-mine Pen in water, as this could damage the pen. ® Please store and handle your needles and cartridges according to the respective instructions for use. After each use, securely attach the pen cap.
  • Page 13: Warnings / Important Risk Information

    WARNINGS / IMPORTANT RISK INFORMATION Ensure correct application • Use your D-mine Pen only as part of the treatment prescribed by your physician and/or health care professional. ® • If the following instructions are not followed, there is a risk of incorrect medication, incorrect dosage, disease transmission or Use the cartridges, dosage amounts and pen needles prescribed by your physician and/or health care professional.
  • Page 14: Confirmed Life Span

    CONFIRMED LIFE SPAN Ensure correct delivery of medication • Before each injection, carry out a function check (Chapter “Priming / Function Check” step 1 – 4) to prevent incorrect dosage caused by air in the cartridge or a blocked pen needle. Use a new pen needle if priming is not The continued dosing accuracy and requirements according to EN ISO 11608-1 have been verified for the amount of injec- successful.
  • Page 15: Warranty

    WARRANTY ANSSER will advise you of the return process, which in many cases will involve returning your D-mine ® Pen to your ANSSER nurse. Defective D-mine Pen will be replaced and shipped at no cost to you. ® EVER Neuro Pharma GmbH as manufacturer of the D-mine ®...
  • Page 16: Disposal

    DISPOSAL Manufacturer's name and Warning: important safety Protect from heat and address sunlight information in instructions for use Your D-mine ® Pen can be disposed off according to the instructions by the local authorities or with your household waste. Your D-mine Pen does not contain substances harmful to the environment.
  • Page 17 Pfizer New Zealand Limited Sydney, NSW Australia PO Box 3998 Medical information : 1800 675 229 Auckland, New Zealand, 1140 medicalaffairs.anz@pfizer.com Toll free number : 0800 736 363 EVER Pharma, and D-mine Logo are trademarks of EVER Neuro Pharma GmbH. Revision: 06/2018 D-mine_IFUPen_64363_AUS_V02...

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