Puregon® cartridge

Transcription

Puregon® cartridge

0344
Becton Dickinson France S.A.S., 38800 Le Pont de Claix, BP 4, France
BD Medical - Pharmaceutical Systems, 1 Becton Drive, Franklin Lakes, NJ 07417, USA
Manufactured for N.V. Organon, Kloosterstraat 6, Postbus 20, 5340 BH, Oss, The Netherlands by
Treatment Diary
Back Cover
(follitropin beta injection)
Puregon® cartridge
Pharmacode
direction
For use only with
56704703 56704703 56704703 56704703 56704703 56704703
Position - 70mm
from this side and
half way through
the spine.
Height 10mm
Front Cover
For use only with
Puregon® cartridge
INSTRUCTIONS FOR USE
0344
Pharmacode No:
8 - 6 outside 2 inside Site of Origin:
Colours:
45
Pharmacode:
01110
No. of plates:
Item No.:
56704703
Replacing:
56704447
Ver. No.:
Description: Puregon Pen Booklet
07.B
Barcode No.:
n/a
Country:
English Neutral
Barcode Type.:
n/a
Status:
Language:
English
Operator:
EMK
Date:
Size:
180mm x 68mm
Date:
15 Oct 2009
Signature:
SP Swords
PMS 2727
PMS 1665
Cyan Yellow
Magenta Black
IMPORTANT NOTICE:
1.
2.
Inside
Front Cover
3.
4.
5.
6.
7.
8.
9.
10.
RA 253 OS IFU 2 (REF 4.0)
September 2009
Please read this safety information first.
Puregon Pen® is a precision device. It is very important that you read and follow all directions for its use. It is also important that you read the User Package Leaflet
enclosed with your Puregon® cartridge. As with all injection systems, failure to do so could result in an incorrect dose being given.
The Puregon Pen® must only be used together with Puregon® cartridges.
Please keep this information and read it carefully before you start using Puregon® with the Puregon Pen® and every time you replace the cartridge.
Injecting cold drug is likely to cause discomfort. Therefore, it is recommended you allow the drug to reach room temperature before taking the injection. The needle should
not be attached until just before the injection.
When injecting beneath the skin, always fully depress the Injection Button for a full 5 seconds. During these 5 seconds, leave the needle in the skin to ensure delivery of
the full dose of Puregon®.
Puregon Pen® is designed for use by one person only and should not be shared with others.
The BD Micro-Fine™ Pen Needle is for use only with Puregon Pen®. Each needle is for one injection only.
Puregon Pen® is not recommended for the blind or visually impaired user without the assistance of an individual with good vision, trained in the proper use of the device.
Keep a record of every injection that has been taken from a Puregon® Cartridge. This will allow you to calculate the daily amount of medication remaining in the cartridge
by subtracting the injected amount from the 300IU, 600IU or 900IU as indicated on the cartridge label.
Your doctor will decide on the dose of Puregon® to be given. This dose may be increased or decreased as your treatment progresses depending on your individual type of
treatment. If you have previously used gonadotropins, your dose may be different with Puregon®. Again, your doctor will decide the dose based upon your medical history.
Some of the wording in this booklet specifically addresses the major group of users that are on a daily treatment regimen. If your doctor has given you other instructions on
your treatment regimen, always follow his or her instructions.
Inside
Back Cover
Puregon® and Puregon Pen® are trademarks of N.V. Organon
BD, BD logo and BD Micro-Fine™ are trademarks of Becton, Dickinson and Company
BKLT-56704703 - Guts:BKLT-56704703 - Guts
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INTRODUCTION
BEFORE USING PUREGON PEN FOR THE FIRST TIME, READ THESE INSTRUCTIONS CAREFULLY.
THEY ARE DIVIDED INTO SECTIONS. EACH SECTION HAS A NUMBER OF STEPS.
KEEP BOOKLET AND PATIENT LEAFLET IN A SAFE PLACE AND REFER TO THEM WHEN QUESTIONS ARISE.
®
The main actions contained in this booklet that must be learned are:
1. Using and loading the Puregon Pen® with a new Puregon® cartridge
2. Dialling the prescribed dose
3. Using the Puregon Pen® to give yourself an injection of Puregon®
4. Removing the needle and cartridge after use
The Puregon Pen® is provided in a unit carton containing one Puregon Pen® in a carrying case and this instruction manual.
The Puregon Pen® is a very precise drug delivery device that is both easy and convenient to use and allows safe and effective injections of Puregon®.
Puregon® can be administered in prescribed doses from 50 International Units (IU) up to 450IU, in marked increments of 25IU (Puregon Pen® complies
with the accuracy requirements of the International Standard ISO 11608-1). The Dosage Scale on the Pen has easy-to-read numbers and audible clicks to
help you set the correct dose. Incorrect settings are easily corrected without loss of drug.
Item No.:
56704703
Replacing:
56704447
Ver. No.:
Description: Booklet Puregon Pen
07.B
No. of Plates:
3
Site of Origin:
SP Swords
Pharmacode No:
45
Colours:
Pharmacode:
01110
PMS 288
Yellow
Black
Barcode No.:
n/a
Country:
English Neutral
Barcode Type.:
n/a
Status:
Language:
English
Operator:
EMK
Date:
Size:
180mm x 68mm
Date:
15 Oct 2009
Signature:
1
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13:47
Page 2
• Puregon® cartridges and BD Micro-Fine™ Pen Needles may only be used with Puregon Pen®.
• Do not separate these three parts of the Puregon Pen® until told to do so in the instructions.
Puregon Pen® Parts
Protective Cap
Puregon® Cartridge and Needle Unit Parts
Puregon® Cartridge
Cartridge Holder
Pocket Clip
Cartridge Holder
Body
Black Rod
Dosage Window
Rubber Inlay
Metal Rimmed
Cap
BD Micro-Fine™ Pen Needle Unit
Protective
Paper Seal
Outer Needle Shield
Dosage Scale
Rubber Piston
Injection
Button
Dosage Knob
Inner Needle
Shield
Needle
Clear
Threaded Hub
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P U R E G O N P E N ® A N D T H E P U R E G O N ® C A RT R I D G E
General Information
Puregon® solution for injection in cartridges has been developed for use
with the Puregon Pen® and should be given subcutaneously (beneath the skin).
The daily dose (IU of Puregon® to be injected each day) will be determined by your doctor. A Treatment Diary is located in the back of this booklet. Use it to keep a
record of your Puregon® injections.
During your treatment cycle, your doctor will advise you of the best time of the day to inject yourself. Try to inject yourself at the same time of day every day.
WHAT YOU WILL NEED FOR GIVING YOURSELF THE INJECTION
• Puregon Pen®, a Puregon® cartridge, the needle provided with the cartridge
• Alcohol, cotton balls or alcohol pads/swabs, sterile gauze, antibacterial soap and a special safety container to discard the used needles, cartridges and/or other
supplies
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USING THE PUREGON PEN®
Follow steps 1-7:
Before you use the Puregon Pen® for the first time
and when you replace the cartridge
1. While holding the Pen
Body firmly with one
hand, pull off the
Protective Cap with
your other hand. Put
the cap aside on a
clean, dry surface.
2. Unscrew the
entire Pen Body
from the Cartridge
Holder. Place the
Cartridge Holder
and the Pen Body
aside on a clean,
dry surface.
Important:
• Always wash your hands thoroughly with antibacterial
soap and water before you use the Puregon Pen®
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LOADING THE PUREGON PEN ®
3. Puregon® cartridges are available in
several doses and you may be prescribed
different cartridge doses to be used during
your treatment. Check that you are using
the correct cartridge dose as
recommended by your doctor. Remove the
cartridge from the blister pack. Do not use
the Puregon® cartridge if the medicine
contains particles or it is not clear. Make
sure the medicine is at room temperature
before using. Clean the Rubber Inlay on
the cartridge with an alcohol pad. Pick up
the Cartridge Holder and place the
cartridge into the Cartridge Holder. Insert
the Metal Rimmed Cap end first.
4. Pick up the Pen Body and lower it into
the Cartridge Holder. The black rod must press
against the Rubber Piston on the cartridge.
Screw the Pen Body fully onto the Cartridge
Holder. Make sure there is no gap between the
Pen Body and the Cartridge Holder. The
arrowon the Cartridge Holder must point to
the middle of the yellow alignment mark on the
blue Pen Body.
Prior to checking the drug flow (step 12)
and again before injecting your dose (steps
15-16), always check that the arrow on the
Cartridge Holder and the alignment mark
on the Pen Body are still aligned.
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AT TA C H I N G T H E B D M I C R O - F I N E ™ P E N N E E D L E
5. You must use a
new needle with
each injection.
Never reuse a
needle. Attach a
new needle after
you make sure
there is a
Puregon® cartridge in the Cartridge Holder. Clean the
open end of the Cartridge Holder with an alcohol
pad.
6. Pick up your needle that is in an Outer
Needle Shield. Peel off the Protective
Paper Seal. Do not touch the needle or
place an open needle on any surface.
7. Hold the Outer
Needle Shield
firmly in one
hand while
holding the
Cartridge Holder
firmly in the
other hand.
Push the end of the Cartridge Holder into the Outer
Needle Shield. Screw them tightly together. Place
your Puregon Pen® with the attached needle, flat on a
clean, dry surface.
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P R E PA R I N G T H E I N J E C T I O N S I T E
8. The best place for injection is in the abdomen, which is
the stomach area below the belly button (navel), or in
the upper leg. Your doctor can show you other places
where you can inject Puregon®. Change your injection
site a little bit with each injection to lower your chances
of developing skin reactions.
9. Use a swab moistened with
alcohol to clean the skin
area where the needle will
enter to remove surface
bacteria. Clean about 4-5
cm around the injection site
where the needle will be
inserted. Let the alcohol dry
on your skin for at least one
minute before injecting the
medicine.
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C H E C K I N G T H E F L O W O F P U R E G O N ® C A RT R I D G E T H R O U G H T H E
BD MICRO-FINE™ PEN NEEDLE
10. Pull the Outer Needle
Shield gently, leaving the
Inner Needle Shield in
place (covering the needle,
which is now attached to
the Pen). Place the outer
needle shield with the open
end upwards on the table.
You will need this later to safely remove the needle after your
injection. (See ‘REMOVING & DISPOSING OF THE
BD MICRO-FINE™ PEN NEEDLE’.)
Important:
• Do not touch the needle or
leave it uncapped without the
Inner Needle Shield in place
so that it remains sterile
• Use a new, sterile needle
for each injection
11. Carefully remove the Inner
Needle Shield and discard it.
Do not touch the needle or
let it touch any surface
while uncapped.
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C H E C K I N G T H E F L O W O F P U R E G O N ® C A RT R I D G E T H R O U G H T H E
BD MICRO-FINE™ PEN NEEDLE - CONTINUED
12. Hold the Puregon Pen® with the needle pointing upwards. Tap the Cartridge Holder gently with
your finger to help air bubbles rise to the top of the needle. The small amount of air bubble will
not affect the amount of medicine you receive. If you have loaded a new, unused cartridge into
the Puregon Pen®, always follow these steps:
a. Dial the Dosage Knob until you hear one click. With the needle pointing upwards, push in the
Injection Button
b. Look for the droplet at the tip of the needle
c. If you do not see a droplet, repeat step a (above) until a droplet appears. You must make sure
you see a droplet of medicine or you may not inject the correct amount
If you have already used the Puregon® cartridge to give yourself a dose of Puregon®, simply attach a
new needle and look for a droplet forming at the tip of the needle. If you see a droplet, go to step 13.
If no droplet is seen, follow steps a, b and c above.
Important:
• Steps a, b and c need to be
performed every time you load a
new, unused cartridge in the
Puregon Pen®
• Always check the drug flow by
following the directions in Step
12. This will ensure that the
correct dose of Puregon® is
injected. If you do not check the
drug flow, you may receive less
drug than the dose that you
dialled
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DIALLING THE DOSE
13. Your Puregon® cartridge will contain one of the following colour-coded doses: 300IU
(silver), 600IU (gold), 900IU (blue). Record the Puregon® cartridge content in your
Puregon Pen® Treatment Diary (refer to ‘CHECKING THE DRUG LEVEL’ for more
information). This will allow you to calculate how much Puregon® is available in each
cartridge prior to each injection. If there is insufficient drug remaining in the cartridge to
complete your full dose, refer to the ‘IF THERE IS NOT ENOUGH PUREGON® IN THE
CARTRIDGE’ section below. For doses of 50IU up to 450IU, turn the Dosage Knob
until the correct dosage aligns with the dosage markers on each side of the dose
window.
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DIALLING THE DOSE - CONTINUED
14. If by mistake you dial past the
correct number, do not try to turn
the Dosage Knob backward to
fix the mistake. Continue to turn
the Dosage Knob in the same
direction past the 450IU mark, as
far as it will turn. The Dosage
Scale must move freely.
Push the Injection Button in all the way. Start to dial again starting from
‘0’ upwards.
By following these directions, you will not lose any of your prescribed
Puregon® dose.
Important:
• If you do turn the Dosage Knob
backward to correct the mistake, it will
not hurt the Pen, but you will lose
some drops of Puregon® solution from
the tip of the needle
• Never dial your dose or try to correct a
dialling mistake when the needle is
still in your skin as this may result in
receiving an incorrect dose
• If your prescribed dose is greater than
450 IU, you will need to give yourself
more than one injection
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U S I N G T H E P U R E G O N P E N ® TO G I V E Y O U R S E L F A N I N J E C T I O N O F P U R E G O N ®
Once you have set the Puregon Pen® to the correct dose, you are ready for your injection.
15. Pinch the
already
swabbed
area of the
skin
between
two fingers.
With the
other hand, insert the entire needle straight into the
skin. Press the Injection Button in all the way to make
sure you give yourself a full injection. Wait for five
seconds before pulling the needle out of the skin.
16. Pull out the needle
and firmly press
down on the
injection site with
an alcohol swab.
Use the needle for
one injection only. If
you are giving an
injection to another person, be very
careful when removing the needle from the
skin. Accidental needle sticks can transmit
potentially serious or grave infections.
Important:
• If, during your injection, the
Injection Button cannot be fully
pushed all the way in, do not try to
force down the button. Your
Puregon® cartridge is probably
empty. This means you have not
received your full dose. Do not
adjust the setting on the Dosage
Scale. Follow the instructions for ‘IF
THERE IS NOT ENOUGH
PUREGON® IN THE CARTRIDGE’
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REMOVING AND DISPOSING OF THE BD MICRO-FINE™ PEN NEEDLE
17. Place the Outer
Needle Shield on a flat
table surface with
the opening pointing up.
The opening of the Outer
Needle Shield is the wider
end with the rim. Without
holding on to the Outer
Needle Shield, carefully
insert the needle (attached
to the Puregon Pen®) into
the opening of the Outer
Needle Shield and push
down firmly. The Outer Needle Shield
should now be attached to the Cartridge
Holder and cover the needle.
18. Grip the Outer
Needle Shield and use
it to unscrew the
needle from the
Cartridge Holder. Your
doctor can advise you
on how to obtain a
secure container for
proper needle
disposal. Safely dispose of the Outer Needle Shield with
the used needle right away. If there is enough Puregon®
left for further injections, put the Pen Cap back on the
Pen Body and store your Puregon Pen® in a safe place
in the refrigerator at 2-8°C (36-46°F) (do not freeze) or
alternatively, at or below 25°C (77°F) Never store the
Puregon Pen® with a needle attached to it.
Important:
• Use the needle for one injection only.
• Dispose of the used needle inside the Outer Needle
Shield immediately in a secured container as
instructed by your doctor. Never leave needles where
anyone can accidentally prick themselves.
• Always unscrew the needle by following the
directions in Steps 17 and 18 before you put the
Puregon Pen® away.
• Never store the Puregon Pen® with a needle attached
to it. If you store the Puregon Pen® with the needle
attached, the drug could leak out and there is risk
of contamination.
• Never leave needles where others can pick them up.
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R E M O V I N G T H E E M P T Y P U R E G O N ® C A RT R I D G E
19. Before you remove the empty
Puregon® cartridge from the
Puregon Pen®, unscrew the
needle by following Steps 17
and 18. Unscrew the Pen
Body from the Cartridge
Holder.
20. Put the Pen Body down on a
clean, dry surface and remove the
empty Puregon® cartridge from the
Cartridge Holder. Safely dispose
of the empty Puregon® cartridge
right away in the same secure
container that you used for the
needle disposal. At the end of
your treatment cycle, your doctor
can advise you on how to properly
dispose of the secure container.
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R E M O V I N G T H E E M P T Y P U R E G O N ® C A RT R I D G E - C O N T I N U E D
Now, you may either:
• Put the Puregon Pen® back together without a Puregon® cartridge and store for your next injection
•
OR
Insert a new Puregon® cartridge into the Cartridge Holder, put your Puregon Pen® back together, and store safely in
the refrigerator at 2-8°C (36-46°F) (do not freeze), or alternatively, at or below 25°C (77°F)
Important:
• Upon dispensing, the product may be stored safely by the patient in the refrigerator at 2–8°C (36–46°F) until
the expiration date, or alternatively, at or below 25°C (77°F) for 3 months or until expiration date, whichever
occurs first. Do not freeze. Protect from light
• Once the Rubber Inlay of the Puregon® cartridge has been pierced by a needle, the product can only be
stored for a maximum of 28 days
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CHECKING THE DRUG LEVEL
When you are advised on the number of prescribed doses which can be extracted from the full unused Puregon® cartridge (follitropin
beta injection), then do not use the cartridge beyond the advised number of doses. Otherwise, you will run the risk that there will not
be enough volume of drug for your prescribed dose.
Starting with the initial injection, you should begin using your Puregon Pen® Treatment Diary (located in the back of this booklet) as follows:
A. Record the Puregon® cartridge content. This will either be 300, 600 or 900IU depending on what your doctor has prescribed for you.
B. Record the daily dose you have been prescribed for your injection.
C. Subtract your Day 1 dose from the Puregon® cartridge content (300, 600 or 900IU) (see example below). This will give you the remaining
Puregon® cartridge content.
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CHECKING THE DRUG LEVEL - CONTINUED
After Day 1, continue to record your daily injections in your Treatment Diary as follows:
D. Place the number recorded on Day 1 in the Remaining Puregon® Cartridge Content box in the Day 2 Puregon® Cartridge Content box.
E. Subtract your Day 2 dose from the Puregon® Cartridge Content you just recorded in Step D. This will give you the Remaining Puregon® Cartridge
Content. Again, record this number in the correct box.
Date
dd/mm/yy
dd/mm/yy
dd/mm/yy
Daily Dose to be used
(IUs/day)
150 (B)
150
150
Puregon®
Cartridge Content
600 (A)
450 (D)
300
Remaining Puregon®
Cartridge Content
450 (C)
300 (E)
150
If there is any doubt that there is not enough drug in the Puregon® cartridge for your prescribed dose, see section ‘IF THERE IS NOT
ENOUGH PUREGON® IN THE CARTRIDGE’ on page 18.
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IF THERE IS NOT ENOUGH PUREGON ® IN THE CARTRIDGE
If you realise you do not have enough drug remaining in your Puregon® cartridge, you have 2 options:
1. If you want to avoid having two injections, remove the Puregon® cartridge as outlined in Steps 19 and 20. Insert a new cartridge into the
Puregon Pen® (see Steps 3 and 4). Continue with Steps 5 – 18 for your injection.
If you would rather use up the remaining drug in the cartridge, you should check your Treatment Diary to confirm how much Puregon® is
available for injection. After attaching a new needle and checking the drug flow you should set the dosage knob to this amount and inject the
dose as described in Steps 15 and 16 above. Once you have given the injection, remove the needle and replace the cartridge with a new one.
You then need to subtract the amount you have already given from your prescribed daily dose to determine how much remaining drug you
need to inject from the new cartridge. A new needle should be attached, the drug flow checked, the remaining dose dialled and then injected to
complete your prescribed dose.
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IF THERE IS NOT ENOUGH PUREGON ® IN THE CARTRIDGE - CONTINUED
2. If you have already inserted the needle at the injection site, and tried to inject your prescribed dose and there is not enough drug in the
cartridge, the Injection Button will not push in all the way and the number in the Dosage Window will not read ‘0’ but will read the number of
units you will need to complete your prescribed dose. Wait 5 seconds before withdrawing the needle from your skin and gently apply pressure
to the injection site with an alcohol pad. Dispose of the used needle properly as outlined in Steps 17 and 18. Remember to write down the
number of units needed to complete your dose. Using the Dosage Knob, reset the Dosage Window to ‘0’ by turning the Dosage Knob past the
450 IU mark as far as it will turn and push the Injection Button in all the way. Insert a new cartridge into the Puregon Pen® and attach a new
needle (see Steps 3 – 12). Dial to the number of units you have written down to complete your prescribed dose. Prepare a different injection site
and inject the remaining drug to complete your dose (see ‘USING THE PUREGON PEN® TO GIVE YOURSELF AN INJECTION OF
PUREGON® ’).
Important:
• Always remove the needle from the Puregon Pen® after you have completed your injection. If you store the
Pen with the needle attached, the drug could leak out and there is risk of contamination. Dispose of the
used needle in a properly secured container as instructed by your doctor
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S O LV I N G P R O B L E M S
PROBLEM
POSSIBLE CAUSES
WHAT TO DO
The Pen Body will not screw tightly
into the Cartridge Holder.
Is something in the way?
Take out the Puregon® cartridge and check the Cartridge
Holder to see if anything is in the way. If nothing is there,
carefully repeat Steps 1 and 2.
No drug is coming out while checking
the flow.
The Cartridge Holder and the Pen Body are
not properly screwed together.
Remove the current needle (steps 17-18), tighten the Pen Body to
the Cartridge Holder ensuring the arrow on the Cartridge Holder is
pointing to the middle of the yellow alignment mark on the blue
Pen Body (step 4). Attach a new needle to the Pen and repeat
“Checking the Drug Flow” steps (Steps 10-12).
Is the Puregon® cartridge empty?
Has the needle been properly attached to the
Puregon Pen® ?
Change to a new cartridge – See page 18.
Remove needle and replace with a new one, ensuring that the
needle is screwed on tightly to the Pen. Repeat “Checking the Drug
Flow” steps (Steps 10-12).
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S O LV I N G P R O B L E M S - C O N T I N U E D
PROBLEM
POSSIBLE CAUSES
WHAT TO DO
You are concerned that you can turn the
Dosage Knob to the next number without
clicking and the injection button spins
freely.
This is not a problem.
The system is in the reset mode. The Injection Button and
Dosage Knob must be pushed all the way down to ‘0’ to
re-engage the mechanism and the correct dose can now be set.
A click will be heard for each setting in the viewing window.
The Dosage Knob does not go back to
‘0’ while you are injecting.
Is the Puregon® cartridge empty?
Change to a new cartridge – See page 19.
Is the needle blocked?
a) Remove the needle from the skin and dispose of safely.
b) Check the Dosage Window and note down how much
remaining drug to inject.
c) Attach a new needle (steps 5-7), repeat “Checking the
Drug Flow” (steps 10-12) and dial remaining dose.
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PROBLEM
POSSIBLE CAUSES
WHAT TO DO
Some of the drug is dripping out of the
needle when you withdraw it from your
skin.
Did you take the needle out of your skin
before waiting 5 seconds as directed in
Step 15?
If this happens you should inform your doctor. To avoid this
problem again, you should always wait 5 seconds after you
push the Injection Button before you withdraw the needle from
your skin. See Step 15.
The needle is left on the
Puregon Pen®.
Have you missed any of the instructions?
Dispose of the needle in a properly secured container
as instructed by your doctor. Change to a new
Puregon® cartridge and a new needle.
After your last injection, a remaining volume
may be left in the cartridge in addition to the
normal quantity of drug dispensed.
The cartridge contains extra volume for
checking the drug flow.
This is not a problem.
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PROBLEM
POSSIBLE CAUSES
WHAT TO DO
You cannot get the cartridge out of
the Puregon Pen®.
Is the needle attached?
Remove the needle from the Puregon Pen® and dispose of
properly (See Steps 17 and 18). Unscrew the Cartridge Holder
from the Pen Body and take out the cartridge (See Steps 19
and 20).
You are not sure how much drug is
left in the cartridge and you do not
want to start an injection and then find
out that there is not enough drug.
Have you kept good records of your
doses?
In case of any doubt, you should load a new, unused
Puregon® cartridge into the Puregon Pen® . To avoid this
problem again, you should use the Treatment Diary to record
your daily injections. Refer to the section ‘IF THERE IS NOT
ENOUGH PUREGON® IN THE CARTRIDGE’ for further
advice. Talk to your doctor if you are still concerned.
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M O R E I N F O R M AT I O N
Caring for your Puregon Pen®
1. Clean all exposed surfaces of the Puregon Pen® with a clean, damp cloth. Never wash it in water, detergent or strong medical cleaners.
2. Handle the Pen carefully to avoid causing damage. You could damage the Pen by dropping it or handling it roughly.
3. Keep the Pen away from dust and dirt.
4. If the Pen breaks or is damaged, do not try to fix it yourself. Contact your doctor to arrange for a replacement Pen.
Storing
1. When the Pen contains a Puregon cartridge, store it refrigerated at 2–8°C (36–46°F) until dispensed. Do not freeze. Upon dispensing, the Pen with cartridge
may be stored by the patient at 2–8°C (36–46°F) until the expiration date of the cartridge, or alternatively, at or below 25°C (77°F) for 3 months or until
expiration date of the cartridge, whichever occurs first. Once the Rubber Inlay of the Puregon cartridge has been pierced by a needle, the product can only be
stored for a maximum of 28 days.
For proper storage of unused Puregon cartridges, please see the package insert enclosed with Puregon cartridges.
2. Both the Puregon Pen® and Puregon® cartridge should be protected from light.
3. Do not use beyond the indicated expiration date of the Puregon® cartridge.
4. Keep the Puregon Pen®, the Puregon® cartridge and any other components out of the reach and sight of children.
5. After your treatment is finished, store the Puregon Pen® device as instructed by your doctor.
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Page 25
PRECAUTIONS
• Follow the instructions in this booklet carefully to ensure the correct administration of your prescribed dose of Puregon®
• Some of the wording in this booklet specifically addresses the major group of users that are on a daily treatment regimen. If your doctor has given you
other instructions on your treatment regimen, always follow his or her instructions
• Do not share your Puregon Pen® with another person
• The Puregon Pen® is not recommended for the blind or visually impaired user without the assistance of an individual with good vision, trained in the
proper use of the device
• The Puregon Pen® is only indicated for use with a Puregon® cartridge when prescribed for subcutaneous injection
25
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PRECAUTIONS - CONTINUED
Care while using the BD Micro-Fine™ Pen Needle
• Only attach the needle when you are ready to inject. Always remove the needle from the Puregon Pen® immediately and dispose of it properly in its Outer
Needle Shield after you complete your injection
• The needle unit is sterile. To avoid contaminating the needle after opening, do not place it on any surface or touch exposed parts
• Before attempting to replace a Puregon® cartridge, be sure that a needle is not attached to the Puregon Pen®
• Never dial your dose or attempt to correct a dialling error with the needle in your skin. This could be harmful and result in an incorrect dose being given
• Proper procedures should be used for the disposal of the used needles (fixed in the Outer Needle Shield), ‘empty’ cartridges, and leftover medication.
Consult your doctor only on the proper procedures for disposal
• The Puregon Pen® is only intended for self-injection of Puregon®. If you are giving an injection to another person, be very careful when removing the
needle from the skin. Accidental needle sticks can transmit infectious diseases
26
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Page 27
CUSTOMER SERVICE
Each Puregon Pen® is guaranteed for 2 years from the date of receipt.
To maintain the high quality of both Puregon® and the Puregon Pen®, your local distributor (see page 28) is keen to receive any comments concerning these
products.
If you have any complaints or problems relating to Puregon® or the Puregon Pen®, you can either discuss these with your doctor or you can report these directly to
the Drug Safety Officer of your local distributor. If you have any other comments or suggestions, please contact your local distributor.
Puregon Pen® is manufactured for N.V. Organon by
Important:
Always mention the LOT number of your Puregon Pen® as printed on the pen body.
Please do not discard any product or packaging (including needles)
27
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Page 28
Local Distributor
Please see carton for local distributor’s address.
Instructions for use can also be found at www.puregonpen.com
28
Becton Dickinson France S.A.S., 38800 Le Pont de Claix, BP 4, France
Back Cover
0344
Manufactured for N.V. Organon, Kloosterstraat 6, Postbus 20, 5340 BH, Oss, The Netherlands by
Treatment Diary
Puregon® cartridge
For use only with
Pharmacode
direction
56704703 56704703 56704703 56704703 56704703 56704703
Position - 70mm
from this side and
half way through
the spine.
Height 10mm
Front Cover
For use only with
Puregon® cartridge
INSTRUCTIONS FOR USE
0344
No. of plates:
56704447
Replacing:
56704703
Item No.:
Ver. No.:
07.B
Description: Puregon Pen Booklet
Pharmacode No:
8 - 6 outside 2 inside Site of Origin:
Colours:
45
n/a
Barcode No.:
01110
Pharmacode:
Signature:
15 Oct 2009
Date:
180mm x 68mm
Size:
Date:
EMK
Operator:
English
Language:
Status:
n/a
Barcode Type.:
English Neutral
Country:
SP Swords
PMS 2727
PMS 1665
Cyan Yellow
Magenta Black
Inside
Front Cover
IMPORTANT NOTICE:
RA 253 OS IFU 2 (REF 4.0)
September 2009
Please read this safety information first.
1. Puregon Pen® is a precision device. It is very important that you read and follow all directions for its use. It is also important that you read the User Package Leaflet
enclosed with your Puregon® cartridge. As with all injection systems, failure to do so could result in an incorrect dose being given.
2. The Puregon Pen® must only be used together with Puregon® cartridges.
Please keep this information and read it carefully before you start using Puregon® with the Puregon Pen® and every time you replace the cartridge.
3. Injecting cold drug is likely to cause discomfort. Therefore, it is recommended you allow the drug to reach room temperature before taking the injection. The needle should
not be attached until just before the injection.
4. When injecting beneath the skin, always fully depress the Injection Button for a full 5 seconds. During these 5 seconds, leave the needle in the skin to ensure delivery of
the full dose of Puregon®.
5. Puregon Pen® is designed for use by one person only and should not be shared with others.
6. The BD Micro-Fine™ Pen Needle is for use only with Puregon Pen®. Each needle is for one injection only.
7. Puregon Pen® is not recommended for the blind or visually impaired user without the assistance of an individual with good vision, trained in the proper use of the device.
8. Keep a record of every injection that has been taken from a Puregon® Cartridge. This will allow you to calculate the daily amount of medication remaining in the cartridge
by subtracting the injected amount from the 300IU, 600IU or 900IU as indicated on the cartridge label.
9. Your doctor will decide on the dose of Puregon® to be given. This dose may be increased or decreased as your treatment progresses depending on your individual type of
treatment. If you have previously used gonadotropins, your dose may be different with Puregon®. Again, your doctor will decide the dose based upon your medical history.
10. Some of the wording in this booklet specifically addresses the major group of users that are on a daily treatment regimen. If your doctor has given you other instructions on
your treatment regimen, always follow his or her instructions.
Inside
Back Cover
Puregon® and Puregon Pen® are trademarks of N.V. Organon
BD, BD logo and BD Micro-Fine™ are trademarks of Becton, Dickinson and Company
13:48
Page 36
dd/mm/yy
dd/mm/yy
dd/mm/yy
Puregon®
Cartridge Content
600 (A)
450 (D)
300
(IUs/day)
150 (B)
150
150
15/10/2009
Date
Remaining Puregon®
Cartridge Content
450 (C)
300 (E)
150
1
56704703 56704703 56704703
How to use the Treatment Diary
Starting with the initial injection, you should begin using your Puregon Pen® Treatment Diary (see example below) as follows:
A. Record the Puregon® cartridge content. This will either be 300, 600 or 900IU depending on what your doctor has prescribed for you.
B. Record the daily dose you have been prescribed for your injection.
C. Subtract your Day 1 dose from the Puregon® cartridge content (300, 600 or 900IU). This will give you the remaining Puregon® cartridge content.
After Day 1, continue to record your daily injections in your Treatment Diary as follows:
D. Place the number recorded on Day 1 in the Remaining Puregon® Cartridge Content box in the Day 2 Puregon® Cartridge Content box.
E. Subtract your Day 2 dose from the Puregon® Cartridge Content you just recorded in Step D. This will give you the Remaining Puregon® Cartridge
Content. Again, record this number in the correct box.
Use the Treatment Diary below to record your daily injections.
After recording the injection information for Day 1, write the number from the last column (‘Remaining Puregon® Cartridge Content’) in the
‘Puregon® Cartridge Content’ column for Day 2. On Day 2, subtract your ‘Daily Dose to be Used’ amount from the ‘Puregon® Cartridge Content’
amount. Record the number in the last column. Repeat this procedure for subsequent days.
Puregon®
Cartridge Content
(IUs/day)
Remaining Puregon®
Cartridge Content
†
† Carry over to next day’s third column (‘Puregon® Cartridge Content’)
2
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13:48
Page 35
Date
* Bring over from previous day’s last column (‘Remaining Puregon® Cartridge Content’)
Puregon®
Cartridge Content
(IUs/day)
Remaining Puregon®
Cartridge Content
*
3
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Page 34
Date
Puregon®
Cartridge Content
(IUs/day)
Remaining Puregon®
Cartridge Content
*
4
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Page 33
Date
Puregon®
Cartridge Content
(IUs/day)
Remaining Puregon®
Cartridge Content
*
5
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Page 32
Date
Puregon®
Cartridge Content
(IUs/day)
Remaining Puregon®
Cartridge Content
*
6
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Page 31
Date
Puregon®
Cartridge Content
(IUs/day)
Remaining Puregon®
Cartridge Content
*
7
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Page 30
Date
Puregon®
Cartridge Content
(IUs/day)
Remaining Puregon®
Cartridge Content
*
8
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13:48
Page 29
Date

Puregon® cartridge

Transcription

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