EVER Pharma D-mine Pen Manuale utente

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

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

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.

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

to twist o the pen needle.

REMOVAL OF PEN NEEDLE AFTER EACH INJECTION

Twist o the pen needle by turning the outer shield anti-clock-

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.

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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