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WARRANTY 

EVER Neuro Pharma GmbH as manufacturer of the D-

mine

®

 Pen warrants the proper functioning of the D-

mine

®

 Pen for a 

period of two years from the date of delivery when used in accordance with these Instructions For Use. 

Your D-

mine

®

 Pen is distributed in Australia by Pfizer Australia Pty Ltd and in New Zealand by Pfizer New Zealand Limited 

(refer to page 32 of these Instructions For Use for contact details). 
Your D-

mine

®

 Pen has been developed for use with Apomine

®

 Intermittent in 3 mL cartridges (Apomorphine hydrochloride 

hemihydrate 10 mg/mL) in compliance with EN ISO 11608-1 and may be used only with these cartridges.   

If you believe that your D-

mine

®

 Pen is not functioning in accordance with these Instructions For Use, contact the ANSSER 

nurse service in your location immediately (refer to Page 23 of these Instructions For Use for contact details). 

How to make a claim: 

 To make a warranty claim you will need to contact the ANSSER nurse service in your location.  

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. 

Consumer law rights:  

The benefits given to you under this warranty are in addition to other rights and remedies you may 

have at law. 
For Australian patients we advise that:  Our goods come with guarantees that cannot be excluded under the Australian 
Consumer Law. You are entitled to a replacement or refund for a major failure and compensation for any other reasonably 
foreseeable loss or damage. You are also entitled to have the goods repaired or replaced if the goods fail to be of acceptable 
quality and the failure does not amount to a major failure.

Conditions: 

 EVER Neuro Pharma GmbH and its distributors do not accept liability for any loss or damage suffered, caused 

by or arising out of:  (a) improper or careless use, handling or cleaning misuse, accident, or normal wear and tear;  (b) any 
failure to use the  D-

mine

®

 Pen  in accordance with these Instructions For Use; (c) the use of the D-

mine

®

 Pen  with a medical 

device or accessories or consumables other than those recommended by EVER Neuro Pharma GmbH.

Summary of Contents for D-mine Pen

Page 1: ...ER Pharma D mine Pen Pen injector for Apomorphine 10 mg mL Instructions for Use Apomorphine hydrochloride hemihydrate solution for injection with Apomine Intermittent 3 mL Cartridges For subcutaneous use ...

Page 2: ...ment of Pen Needle 10 Priming Function Check 12 Setting the Dosage 14 Injection 15 Removal of Pen Needle 16 Attachment of Pen Cap 18 Additional Information 19 Storage and Care 22 Warnings Important Risk Information 24 Confirmed Life Span 27 Warranty 28 Disposal 30 Labelling and Symbols 31 Manufacturer Distributor 32 ...

Page 3: ...re professionals as well as third parties such as adult relatives and carers Please refer to the product information of the pharmaceutical product Before using the D mine Pen wash your hands You will need some surgical wipes and one needle in its protective cone Using a surgical wipe clean the area of skin where you plan to inject the medicine and around it Inject into an injection site on the fro...

Page 4: ...eedle inner needle protective cap peel foil cartridge flange threaded rod display window push button pen cap cartridge sleeve housing dosage wheel PEN PREPARATION CHANGING CARTRIDGE 2 Remove the cartridge sleeve by twisting it clockwise You will hear a click Remove the empty cartridge if necessary 1 Remove the pen cap graduations in mg ...

Page 5: ... is best performed using your finger tip but you can also use the new cartridge to push the rod in 3 Insert the new cartridge into the cartridge sleeve 5 Push the cartridge sleeve into the housing and turn anti clockwise to lock You will hear a click ...

Page 6: ...ed correctly 1 Pull off the peel foil ATTACHMENT OF PEN NEEDLE Follow the instructions for use of your pen needle 4 Remove and dispose the inner needle protective cap 3 Remove the outer needle protective cap Keep the outer needle protective cap to safely remove and dispose of the pen needle after use ...

Page 7: ...achment of pen needles 1 Dial the test dose forward by turning the dosage wheel Check the dialed dose by looking vertically from above and not at an angle onto the display so that the symbol is clearly displayed 3 Press the push button 4 A few drops of medicine will emerge from the pen needle tip If no drops emerge repeat steps 1 to 4 If after several function checks no drops emerge change the pen...

Page 8: ...nt for the desired dose the dosa ge wheel cannot be turned any further in a clockwise direction SETTING THE DOSE 1 Please refer to the Product Information of the pharmaceutical product and use the injection technique as recommended by your physician and or your ANSSER nurse Press the push button in fully for injection Hold the push button fully down during medication discharge 2 After the medicati...

Page 9: ...to the opening of the shield Without holding onto the shield push down firmly and turn counter clockwise to twist off the pen needle Discard the used needle into a sharps bin REMOVAL OF PEN NEEDLE AFTER EACH INJECTION Twist off the pen needle by turning the outer shield clockwise and dispose it correctly according to the advice of your phy sician and or your ANSSER nurse Professional health care p...

Page 10: ...ng 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 each dialed step Injection The medication discharge of your D mine Pen is perceptible An audible signal is provided during the discharge and stops after the dialed amount of ...

Page 11: ...use the D mine Pen if it is damaged or if you have any doubts about its correct functioning Once the cartridge has been inserted it can remain in your D mine Pen until empty Please follow the storage instructions provided by the manufacturer of your medication When changing the cartridge you should ensure that a new cartridge is inserted into the cartridge sleeve Partially used cartridges may not ...

Page 12: ...it can be damaged Please handle your D mine Pen with care Protect it from water dust and moisture 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 If you have any questions or problems relating to your D mine Pen your ANSSER nurse will be available at the toll free num...

Page 13: ...cian and or health care professional Use the cartridges dosage amounts and pen needles prescribed by your physician and or health care professional Any changes must be made under the supervision of a physician and or health care professional Before each injection check that your D mine Pen contains the correct type of medication Check that the cartridge is undamaged and that the medication corresp...

Page 14: ... attention if you have any health concern In the event of interruption of injection by releasing the push button check on the display the amount of medicine not delivered The remaining amount can be injected by pressing the push button again In the event of accidental medication injection seek immediate medical attention CONFIRMED LIFE SPAN The continued dosing accuracy and requirements according ...

Page 15: ... 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 Consumer law rights The benefits given to you under this warranty are in addition to other rights and remedies you may have at law For Australian patients we advise that Our goods come with guarantees that cannot ...

Page 16: ...Technical Data Length 170 mm Scale 0 5 mg Diameter 17 mm Resolution of injection volume 0 5 mg Weight 40 g Max dose injection 6 mg Filling Volume 3 mL Storage conditions 5 35 C Display mg Operating conditions 5 35 C DISPOSAL 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 ...

Page 17: ...f EVER Neuro Pharma GmbH Revision 06 2018 D mine_IFUPen_64363_AUS_V02 0044 New Zealand Sponsor Pfizer New Zealand Limited PO Box 3998 Auckland New Zealand 1140 Toll free number 0800 736 363 Australian Sponsor Pfizer Australia Pty Ltd Sydney NSW Australia Medical information 1800 675 229 medicalaffairs anz pfizer com ...

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