EVER Pharma D-mine Pen Manual de usuario
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 sucient 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.
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