EVER Pharma D-mine Pen User manual

EVER Pharma D-mine®Pen
Pen injector for Apomorphine 10 mg/ml
Instructions for Use
Apomorphine hydrochloride hemihydrate solution for injection
with Dacepton® 3 ml Cartridges
For Subcutaneous Use

3
TABLE OF CONTENTS
Introduction 4
Description of Parts of D-mine®Pen 6
Pen preparation / Changing Cartridge 7
Attachment 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 29
Labelling and Symbols 29
Manufacturer / Distributor 31

4 5
INTRODUCTION
This manual contains instructions for using, storing and cleaning your EVER Pharma D-mine®Pen. The carton contents includes
1 EVER Pharma D-mine®Pen, 1 Pen Case, 1 Instruction for Use. Note: Carton does not include pen needles or 3 ml cartriges.
You
should read the instructions in this manual carefully even if you have used D-mine®Pen or other pen delivery systems before.
The Pen is a maintenance-free and reusable injector with an automatic spring driven delivery-system. The D-mine®Pen fulfills
the regulations of the EU directive on medical products and has been approved according to 93/42/EEC and harmonized stan-
dards and has been marked with a CE symbol (see page 30).
Indication: Pen injector for
Dacepton® 3 ml cartridges (Apomorphine 10 mg/ml) solution for injection from EVER Neuro Pharma
GmbH.
The D-mine®Pen is intended to be used by self-injecting adult patients, health care professionals as well as third
parties such as adult relatives and carers. Please refer to the package leaflet of the pharmaceutical product. Please wash your
hands throughly before using the D-mine®Pen. You will need some surgical wipes and one needle in its protective cone. Using
a surgical wipe, throughly clean around the area of skin where you plan to inject the medicine. Inject into an injection site on
the front of your waist (abdomen) or your outer thighs under the skin (subcutaneously) as shown by your doctor or nurse.
Change your injection site each time you use the D-mine®Pen. Do not inject into an area of skin that is inflamed,
infected or damaged. You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).
Compatible Pen cartridges and needles:
• Dacepton® 3 ml cartridges (Apomorphine 10 mg/ml) from EVER Neuro Pharma GmbH approved according to I SO EN
11608-1
• BD Micro-Fine Ultra™ needles 29 to 31 gauge (diameter 0.25 – 0.33 mm) and 5 - 12.7 mm length.
• Cartridges and Pen needles from other manufacturers can be used according to their stated compatibility details.
Your D-mine®Pen can deliver doses from 0.5 to 6.0 mg, in increments of 0.5 mg (corresponds to 50 μl per increment). If you
have any questions relating to your D-mine®Pen, please contact the support service, (see page 23).

6 7
DESCRIPTION OF PARTS OF D-mine®PEN
Note: The carton contents does not include pen needles or 3 ml cartridges.
outer needle protective cap pen needle
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.
1Remove the pen cap.
graduations in mg

8 9
4Push the threaded rod back completely. This is best
performed using your finger tip (alternatively you
can use also the new cartridge together with the
cartridge sleeve).
3Insert the new cartridge into the cartridge sleeve. 5Push the cartridge sleeve into the housing and turn
anti-clockwise to lock. You will hear a click.

10 11
2Click on / twist on the pen needle to the cartridge
sleeve. Check that the pen needle is attached correctly.
1Pull o the peel foil.
ATTACHMENT OF PEN NEEDLE
Follow the instructions for use of your pen needle.
4Remove and dispose the inner needle protective
cap.
3Remove the outer needle protective cap.
Keep the outer needle protective cap to safely
remove and dispose of the pen needle after use.

12 13
“tap-tap”
2For the function check,
hold the D-mine®Pen
pointing upwards and
gently tap the cartridge
sleeve, so that the air
can rise to the top.
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.
1Dial 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.
3Press the push-button. 4A 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
needle and repeat the function
check (steps 1 to 4).
If still no drops emerge or if
you have any concerns, please
call Service Helpline mentioned
on page 23.

14 15
Dial the required dose
Dial the required dose by turning the dosage wheel clockwise. Cor rect
the dose by turning in anti-clockwise direction. Check the dialed
dose by looking vertically from above and not at an angle onto the
display, so that the numbers are clearly identified.
Note: Each “-“ marking on the dose dialer represents 0.1 mg of me-
dicine. You will hear a click for each increment you dial. Do not rely
on counting these clicks to measure the correct dose. The mg are
displayed in increments of 0.5 mg steps.
Safety stop
The medication dose that can be set on the D-mine®Pen is limited to
the amount remaining in the cartridge. If the amount of medicine left
in the cartridge is no longer sucient for the desired dose, the dosa-
ge wheel cannot be turned any further in a clockwise direction.
SETTING THE DOSE
1Please refer to the package leaflet of the pharmaceutical
product and use the injection technique as recommended
by your physician and/or health care professional. Press the
push-button in fully for injection. Hold the push-button fully
down during medication discharge.
2After the medication has been completely discharged, wait for
6 seconds and then pull out the pen needle slowly. You may
either keep the push-button pressed or release it during the 6
seconds.
INJECTION
3Check that the display is at the “0.0” position to confirm full
dose delivery.
N ote: You can interrupt the injection by releasing the push-button. The
remaining amount of medicine not delivered can be seen on the display
and can be injected by pressing the push-button again.

16 17
Note: The larger notch located on the right
hand side of the carrying case fits to need les
used by healthcare professionals.
Optional:
Place the outer pen needle shield in the
appropriate left notch of your carrying case.
The opening of the needle shield should
be pointing up. Carefully insert the needle
(attached to the pen) into the opening of
the shield. Without holding onto the shield,
push down firmly and turn counter-clockwi se
to twist o the pen needle.
REMOVAL OF PEN NEEDLE AFTER EACH INJECTION
2
Twist o the pen needle by turning the outer shield anti-clock-
wi se and dispose it correctly, according to the advice of your
physician and/or health care professional. Professional health
care personnel should follow the specific directions for health
care personnel including, without limitation, directions regar-
ding recapping and disposal. To obtain the specific directions,
please consult a physician.
Carefully attach the outer needle protective cap on the
pen needle.
1

18 19
Attach the pen cap securely after each use.
ATTACHMENT OF PEN CAP ADDITIONAL INFORMATION
Audible and tactile indications
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
dialed step.
Injection
The medication discharge of your D-mine®Pen is perceptible. An audible click is provided during the discharge and
stops after the dialed amount of medication has been discharged completely.

20 21
Safety stop
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
left in the cartridge is no longer sucient for the desired dose, the dosage wheel cannot be turned any further in a clockwise
direction.
• Do not try to force the dosage wheel to turn further.
• Note the remaining dose that can be dispensed and inject.
• Change the cartridge and pen needle, and carry out function checks (Chapter “Priming / Function Check” step 1 – 4).
• Dial and inject the outstanding dose.
General
Do not 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. 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 be inserted into the cartridge sleeve.
A new needle must be used for each injection.
Please follow local regulations in your country concerning the handling of potentially infectious materials.

22 23
STORAGE AND CARE
Please store and handle your needles and cartridges according to the respective instructions for use.
After each use, securely attach the pen cap. Always keep your D-mine®Pen in the carrying case, without a pen needle attached.
Use and store your D-mine®Pen at a temperature between 5 and 35°C. Failure to observe this can reduce the life expectan-
cy of your D-mine®Pen.
Even though your D-mine®Pen is robust, it can be damaged. Please handle your D-mine®Pen with care. Protect it from
water, dust and moisture.
A damp cloth is sucient 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 relating to your D-mine®Pen, Support Service will be available under the following local support
number:
EVER Neuro Pharma GmbH
34 Shota Nadirashvili, 17B bld,
apt 354, 0144 Tbilisi, Georgia
Phone: [phone] E-Mail: gor[email protected]
or
Phone: [phone]

24 25
WARNINGS / IMPORTANT RISK INFORMATION
If the following instructions are not followed, there is a risk of incorrect medication, incorrect dosage, disease transmission or
infection. Seek immediate medical attention if you have any health concern.
Read this instructions for use before using your D-mine®Pen. Follow the instructions for use of your D-mine®Pen,
pen needle and your cartridge and use your D-mine®Pen only after consultation with your physician and/or health care
professional.
Ensure correct handling by the intended user
• The D-mine®Pen must not be used by blind or visually impaired patients without the help of someone who has
been trained accordingly. In case of hearing or tactile impairment consult your physician.
• Store your D-mine®Pen, the pen needles as well as the cartridges so that they are out of reach of children or other
people who are not familiar with the correct method of use.
Ensure correct application
• Use your D-mine®Pen only as part of the treatment prescribed by your physician and/or health care professional.
• Use the cartridges, dosage amounts and pen needles prescribed by your physician and/or health care professio nal.
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 corresponds to the details on the product leaflet.
• The pen needles and the cartridge must be used by only one person, in order to prevent transmission of disease.
• Do not expose your D-mine®Pen to any extreme temperatures through direct exposure to sunlight or cold (e.g. in
a freezer compartment).
• Use and store your D-mine®Pen at a temperature between 5 and 35°C.
• Do not drop your D-mine®Pen and avoid knocking it against hard surfaces. Avoid immersing your D-mine®Pen
in water. Generally handle it with care. Never use your D-mine®Pen if you have any doubts about its correct
functioning.
• Never try to repair a damaged D-mine®Pen yourself. In case of a damaged or defective D-mine®Pen, please
contact the Support Service (see page 23).

26 27
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
successful.
• Check after each injection according to your physician’s and/or health care professional’s instructions whether
medication drips from the pen needle or D-mine®Pen, or exudes from the injection site. If the medication drips
from the pen needle or D-mine®Pen, or exudes from the injection site, follow your physician’s and/or health care
professional’s instructions regarding the handling of potential under-dosage. Seek medical 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 to EN ISO 11608-1 have been verified for the amount of
injections and cartridge exchanges as defined hereinafter in the table below from the date of first use:
Daily dose
[mg] Injections/ day [#] Dose/injecti- on [mg] Life span [months] Daily dose [mg] Injections/ day [#] Dose/injecti- on [mg] Life span [months]
3 3 1 36 30 6 5 18
6 3 2 36 36 6 6 18
9 3 3 36 35 7 5 12
12 3 4 36 42 7 6 12
15 3 5 36 40 8 5 12
16 4 4 30 48 8 6 12
20 4 5 30 45 9 5 12
24 4 6 30 54 9 6 12
25 5 5 24 50 10 5 12
30 5 6 24 60 10 6 12

28 29
WARRANTY
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 has been developed for use with Dacepton® 3 ml cartridges (Apomorphine 10mg/ml) from EVER Neuro
Pharma GmbH according to EN ISO 11608-1 and may be used only with these cartridges. EVER Neuro Pharma GmbH is
not liable for any damage caused by the use of non-compatible cartridges. The warranty does not cover damage as a result
of improper or careless use, handling or cleaning, and does not apply in the event of use contrary to the instructions for use
and in the event that the pen has been used with a medical device or accessories or consumables other than those
recommended by EVER Neuro Pharma GmbH.
DISPOSAL
Your D-mine®Pen can be disposed of 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.
LABELLING AND SYMBOLS
The D-mine®Pen fulfills the regulations of the EU directive on medical products, 93/42/EEC.
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°
Display: mg Operating conditions: 5 – 35°

30 31
MANUFACTURER / DISTRIBUTOR
Manufacturer:
EVER Neuro Pharma GmbH
Oberburgau 3
4866 Unterach, Austria
Distributor:
EVER Neuro Pharma GmbH
34 Shota Nadirashvili, 17B bld,
apt 354, 0144 Tbilisi, Georgia
EVER Pharma, Dacepton, and D-mine Logo are trademarks of EVER Neuro Pharma GmbH.
Revision: 04/2020 D-mine_IFUPen_64377_GE_V01
0044
Manufacturer's name and
address
Date of manufacture
Batch number
Read instructions for use
Protect from moisture
Protect from heat and
sunlight
Item number
Marking for conformity with the
European Medical Device
Directive and number of the
notified body
0044
Warning: important safety
information in instructions
for use