Related Manuals for EVER Pharma D-mine Pen
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 Dacepton 3 ml Cartridges ® Apomorphine hydrochloride hemihydrate solution for injection For Subcutaneous Use...
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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
Change your injection site each time you use the D-mine Pen. Do not inject into an area of skin that is inflamed, ® This manual contains instructions for using, storing and cleaning your EVER Pharma D-mine ® Pen. The carton contents includes infected or damaged. -
Page 4: Description Of Parts Of D-Mine ® Pen
PEN PREPARATION / CHANGING CARTRIDGE DESCRIPTION OF PARTS OF D-mine ® Note: The carton contents 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... - 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 (alternatively you anti-clockwise to lock. You will hear a click. can use also the new cartridge together with the cartridge sleeve).
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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 package leaflet 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 health care professional. -
Page 9: Removal Of Pen Needle
REMOVAL OF PEN NEEDLE AFTER EACH INJECTION Carefully attach the outer needle protective cap on the Twist off the pen needle by turning the outer shield anti-clock- Optional: wise and dispose it correctly, according to the advice of your pen needle. Place the outer pen needle shield in the physician and/or health care professional. -
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 click and a noticeable resistance will be provided. Dose Dialing During dose dialing and dose correction your D-mine Pen provides an audible click and a noticeable resistance for each... - 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.
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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 successful. -
Page 15: Warranty
WARRANTY DISPOSAL EVER Neuro Pharma guarantees the proper functioning of the pen for two years when used according to instructions for use. The warranty is limited to replacement of the pen. Your D-mine Pen can be disposed of according to the instructions by the local authorities or with your household waste. ®... -
Page 16: Manufacturer / Distributor
354, 0144 Tbilisi, Georgia Marking for conformity with the Read instructions for use European Medical Device 0044 EVER Pharma, Dacepton, and D-mine Logo are trademarks of EVER Neuro Pharma GmbH. Directive and number of the notified body Revision: 04/2020 D-mine_IFUPen_64377_GE_V01...
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