Ferring ZOMA-Jet 10 User manual

Instructions for Use
For use with
10 mg vial

Table of Contents
Parts of the ZOMA-Jet®10.......................................................................... 1
Supplies you will need to mix a ZOMACTON®10 mg Vial............................. 2
Mix a ZOMACTON®10 mg vial .................................................................... 3
Reset the ZOMA-Jet®10............................................................................. 6
Attach a Needle-Free Head ......................................................................... 7
Prime the ZOMA-Jet®10 ............................................................................ 8
Inject with the ZOMA-Jet®10 ................................................................... 10
Evaluate your Injections ............................................................................ 13
Store the ZOMA-Jet®10 and ZOMACTON®10 mg vial .............................. 13
Remove a Needle-Free Head..................................................................... 14
Disposal of your ZOMA-Jet®10, Needle-Free Head,
and ZOMACTON®10 mg Vial..................................................................... 15
Maintenance and Storage ......................................................................... 16

11
Needle-Free
Head
Viewing
Notch
Injector
Body
Dosage/Black
Bar Window
(displays dosage
or black bar)
Safety
Switch
Winding
Grip
Injector
Button
Parts of the ZOMA-Jet®10
The ZOMA-Jet®10 is a device used to administer ZOMACTON®human
growth hormone of recombinant DNA (rDNA) origin.
Do not share the ZOMA-Jet®10 device, the needle-free head, or the
ZOMACTON®10 mg vial with anyone else. You may give an infection to them
or get an infection from them.
Figure A

22
Supplies you will need to mix
a ZOMACTON® 10 mg Vial
• Prelled Syringe (liquid)
• ZOMACTON® 10 mg Vial (powder)
• Vial Adapter
• Alcohol Swab
Prelled
Syringe
Plunger
ZOMACTON® 10 mg Vial
Alcohol Swab
Vial Adapter
with Mating
Piece
Figure B

33
• Remove the plastic cap from
the ZOMACTON® 10 mg vial
and clean the top of the vial
with an alcohol swab. See
Figure C.
• Open a new Vial Adapter
package. The Vial Adapter is
sterile as long as the package
is not opened or damaged.
• Place the pointed tip of the
Vial Adapter in the center of
the vial. Firmly push down
turning left, counterclockwise,
gently until it pushes through
the rubber seal and snaps
onto the vial. See Figure D.
Figure C
Figure D
Mix a ZOMACTON®10 mg vial
ZOMACTON® 10 mg is not ready to be used right away. You must
mix (reconstitute) the dry powder in the ZOMACTON® 10 mg vial
with the Prelled Syringe using the Vial Adapter. Both the Prelled
Syringe and Vial Adapter come with your medicine.

44
• Grasp the Vial Adapter just under
the cap with 1 hand. Pull the cap
up with your other hand to remove
it. See Figure E. Do not hold the
vial upside down. This may cause
the vial to leak.
• Remove the rubber cap from the
Prelled Syringe. See Figure F.
• Insert the nipple end of the syringe
into the Vial Adapter and rmly
push down to secure it in place.
See Figure G.
• Slowly push the plunger into
the syringe to inject all of
the liquid into the ZOMACTON® 10
mg vial. All of the liquid must be
removed from the syringe to make
sure you get the right dose.
Figure E
Figure G
Figure F
Vial Adapter with
Mating Piece
Nipple

55
• Firmly hold the Vial Adapter with 1
hand and remove the emptied Syringe
(along with the already connected
Syringe Mating Piece) with your other
hand. See Figure H.
• Hold the vial between your hands
and gently roll it to dissolve the mixture until
it is clear. Do not shake the vial. Do not
use mixed ZOMACTON® if it is cloudy or
if you see particles oating in the mixture.
Call the ZoGo Patient support at
844.944.ZOGO (9646) if your ZOMACTON® is cloudy.
Important: Write the date you mixed ZOMACTON®on the vial label with a
marker. Use your mixed ZOMACTON® 10 mg vial within 28 days.
The ZOMACTON® 10 mg vial is now mixed and ready for use with the
ZOMA-Jet® 10.
Syringe
Syringe Mating
Piece
Vial Adapter
Vial
Figure H

66
Reset the ZOMA-Jet® 10
• Hold the ZOMA-Jet® 10 device so that you can see the Dosage Window.
Turn the Winding Grip in the direction of “Reset” until you see the black bar
in the Dosage Window. See Figure I.
Important: Do not turn the Winding Grip beyond the black bar. You should be
able to see the green band on the Injector Button.
• Turn the Winding Grip in the direction of “Fill” until you see 0.0 in the
Dosage Window.
The ZOMA-Jet® 10 is now reset and ready for use.
Winding Grip
Arrows
Dosage/Black
Bar Window
Injector
Button Out
Figure I

77
Attach a Needle-Free Head
• Reset the device (see page 6).
• Open a new Needle-Free Head package. See Figure J. The Needle-Free Head is
sterile as long as the package is not opened or damaged. Do not remove the cap
while attaching the Needle-Free Head.
Write down the date of opening a new Needle-
Free Head in your Daily Planner. Important:
Each Needle-Free Head should be used for
only 1 week.
• Line up the square blocks of the
Needle-Free Head with the Viewing
Notch of the ZOMA-Jet® 10. See Figure K.
• Firmly push the Needle-Free Head straight
into the Injector Body until it stops and the
ring can no
longer be seen.
• While pushing down on the Needle-Free
Head, turn right (clockwise) until it locks into place
and you hear a click. The tabs on the side of the
Needle-Free Head must line up with the marks on
the ZOMA-Jet® 10. Pull straight up on the Needle-
Free Head to make sure it is locked into place.
See Figure L.
Important: Your injection
training nurse will let you
know if Needle-Free Head
size B or C is needed. If it
is determined that you need
size B or C, call the ZoGo
Patient Support Program at
844.944.ZOGO (9646).
Figure L
Square
block
Ring
Viewing
notch
Figure K
Tab
Mark
Figure J
6815-02
For use with ZOMA-Jet and ZOMACTON
(somatropin) for Injection only
• See instructions for use
• Rx only
Lot Number:
P/N 300414-001
Expiration Date:
Sterile and Non-Pyrogenic
• Must be used by only one person
• Discard 7 days after opening
Manufactured for:
Ferring Pharmaceuticals Inc.
Parsippany, NJ 07054
ZOMA-Jet
Needle – Free Head A

88
Prime the ZOMA-Jet® 10
You must prime your ZOMA-Jet® 10 with ZOMACTON®10 mg each time
you use a new Needle-Free Head and to make sure you get the right dose.
Priming also removes most of the air bubbles inside the Needle-Free Head.
Important: Make sure that the Injector Button is popped out and that 0.0
is showing in the Dosage Window of the ZOMA-Jet® 10 before you begin the
following steps.
• Remove the cap from the Needle-Free
Head. Line up the tabs on the Needle-
Free Head with the slots in the Vial
Adapter and push straight down until
it locks into place. See Figure M.
• Turn the ZOMA-Jet® 10 over so that the
vial is upside down.
• Turn the Winding Grip in the direction
of “Fill” until 0.1 appears in the Dosage
Window. See Figure N.
0.1
Figure M
Figure N

99
• Turn the ZOMA-Jet® 10 back over so that
the vial can be placed on a at surface.
Hold on to the Vial Adapter and pull the
ZOMA-Jet® 10 straight off. See Figure O.
• Unlock the safety switch and point your
ZOMA-Jet® 10 so that it is facing down.
See Figure P. Press the Injector Button to
empty the liquid from the ZOMA-Jet® 10.
See Figure Q.
Important: Do not point and press the
Injector Button towards any person.
Your ZOMA-Jet® 10 is now primed.
Figure O
Figure P
Figure Q
Unlocked position

10 10
Inject with the ZOMA-Jet® 10
You are now ready for your injection.
Step 1. Turn the Winding Grip in the direction of “Reset” until you see the
black bar in the Dosage Window. You should be able to see the green
band on the Injector Button. See Figure R.
Step 2. Turn the Winding Grip in the
direction of “Fill” until you see
0.0 in the Dosage Window.
Step 3. Line up the tabs on the Needle-
Free Head with the slots in the Vial
Adapter and push straight down
until it locks into place.
See Figure S.
Winding Grip
Arrows
Dosage/Black
Bar Window
Injector
Button Out
Figure R
Figure S

11 11
Step 4. Turn the ZOMA-Jet® 10 over so that
the vial is upside down.
Step 5. Turn the Winding Grip in the
direction of “Fill” until you see your
prescribed dose in the Dosage
Window. If you go beyond the
dose your doctor prescribed, turn
the Winding Grip in the opposite
direction to your prescribed dose.
See Figure T.
Important: If you see air bubbles
inside of the Needle-Free Head,
rmly tap the side of the ZOMA-Jet®
10 with your nger to move them to
the top. Turn the Winding Grip in the
direction of “Reset” until the bubbles
go into the vial. Fill the ZOMA-Jet®
10 to your prescribed dose.
Follow these instructions if you need another vial of
ZOMACTON® 10 mg to get your full dose:
• Mix (reconstitute) a second ZOMACTON® 10 mg vial (refer back to
the “Mix a ZOMACTON® 10 mg Vial” section on pages 3–5).
• Repeat steps 3–6 on pages 10–11
Important: Do not wind beyond the red
bar in either direction.
Step 6. Turn the ZOMA-Jet® 10 over so
that the vial can be placed on a at
surface. Hold on to the Vial Adapter
and pull the ZOMA-Jet® 10 straight
off. See Figure U.
Figure T
Figure U

12 12
Step 7. Sit or lie down so that the injection site can be seen clearly and your
muscles are relaxed.
Step 8. Choose an injection site with fatty tissue from the following places. See
Figure V. Choose a different site each time you inject ZOMACTON®.
Back of the
upper arms
Upper buttocks
(child should lie face down
on a flat surface with toes
pointing inward)
Upper thighs
(child can sit with feet flat on
the floor or lie down)
Stomach
(except the belly button)
Step 9. Wipe the Needle-Free Head with an alcohol
swab and unlock the Safety Switch. See
Figure W. Now that the Needle-Free Head
has been cleaned, be sure not to touch the
tip before injecting. Clean the injection site
with an alcohol swab.
Step 10. Place the ZOMA-Jet® 10 rmly against
the skin (do not pinch) at a right angle
to the injection site, then press the
Injector Button. See Figure X. Hold in
place for 2 seconds after you hear a
noise. This means that the injection
is complete.
You have now injected with the ZOMA-Jet® 10.
Important: Each Needle-Free Head should be
used for only 1 week.
Figure V
Figure W
Figure X
Unlocked position

13 13
Store the ZOMA-Jet® 10 and ZOMACTON® 10 mg Vial
Step 11. After the injection is complete, turn the Winding Grip in the direction
of “Reset” until you see the black bar in the Dosage Window. You
should be able to see the green band on the Injector Button.
Step 12. Turn the Winding Grip in the direction of “Fill” until you see 0.0 in the
Dosage Window. This will reset the device. See Figure Y.
Important: The ZOMA-Jet® 10 must be stored with the green band of the
injector button visible and 0.0 in the Dosage Window or the Needle-Free Head
will break.
Step 13. Wipe the Needle-Free Head with an alcohol swab. Make sure the
Safety Switch is in the locked position.
Evaluate your Injections
The following may happen at the injection site:
• Small amount of dampness
• Pinpoint of blood
• A tingly sensation
Important: If you feel pain, discomfort, or ZOMACTON® leaks from the
injection site, or you have problems with injecting, call ZoGo Patient Support at
844.944.ZOGO (9646).
If you experience an adverse event, please discuss it with your doctor. You
are encouraged to report adverse events of prescription drugs to Ferring
Pharmaceuticals at 1-888-FERRING (1-888-337-7464). You can also call FDA
at 1-800-FDA-1088 or visit the FDA website www.fda.gov/medwatch.
Figure Y
Store with Injector
Button Out
Store with 0.0 in
Dosage/Black Bar Window

14 14
Step 14. Place the cap on the Needle-Free Head, and put the ZOMA-Jet® 10 in
its carrying case until the next injection.
Important: Do not store your ZOMA-Jet® 10 in the refrigerator.
Step 15. Place the cap on the mixed ZOMACTON® 10 mg
vial and store in an upright position in the
refrigerator. See Figure Z.
Remove a Needle-Free Head
Each Needle-Free head must be replaced after 1 week.
• Turn the Winding Grip in the direction of “Reset”
until you can see the black bar in the Dosage
Window. You should be able to see the green band
on the Injector Button.See Figure AA.
• Turn the Winding Grip in the direction of “Fill” until
you see 0.0 in the Dosage Window. See Figure BB.
• To unlock the Needle-Free Head, turn left (counter-
clockwise), then pull it straight off of the Injector
Body. (If the inner part of the Needle-Free Head
stays attached to the ZOMA-Jet® 10, remove it
and throw it away.)
Figure AA
Figure Z
Figure BB
1.
2.

15 15
Disposal of Your ZOMA-Jet®10, Needle-Free Head,
and ZOMACTON®10 mg Vial:
• Put your used ZOMA-Jet®10, needle-free head, and ZOMACTON®vial in
a FDA-cleared sharps disposal container after use. Do not throw away
(dispose of) your ZOMA-Jet®10, needle-free head, and ZOMACTON®10mg
Vial in your household trash.
• If you do not have a FDA-cleared sharps disposal container, you may use a
household container that is:
• made of a heavy-duty plastic,
• can be closed with a tight-tting, puncture-resistant lid, without
sharps being able to come out,
• upright and stable during use,
• leak-resistant, and
• properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow
your community guidelines for the right way to dispose of your sharps
disposal container. There may be state or local laws about how you should
throw away used ZOMA-Jet®10, needle-free head, and ZOMACTON® 10 mg
Vial. For more information about safe sharps disposal, and for specic
information about sharps disposal in the state that you live in, go to the
FDA’s website at: http://www.fda.gov/safesharpsdisposal
• Do not dispose of your used ZOMA-Jet®10, needle-free head, and
ZOMACTON®10 mg Vial in your household trash unless your community
guidelines permit this. Do not recycle your used sharps disposal container.

16 16
Please see enclosed full prescribing information for ZOMACTON®.
Maintenance and Storage
ZOMACTON® 10 mg Vial [medicine]
• Store your ZOMACTON® 10 mg vial upright in a refrigerator at 36°F to 46°F
(2°C to 8°C) for up to 28 days after mixing.
ZOMA-Jet® 10 Device
• Clean the outside of your ZOMA-Jet® 10 device with a damp cloth. Do not hold
your device under water.
• The ZOMA-Jet® 10 must be stored at room temperature and reset (Injector
Button popped out with green band showing and with 0.0 showing in the
Dosage Window). Do not store your ZOMA-Jet® 10 device in the refrigerator.
• Stop using and contact the ZOMACTON® patient support center if your device is
not working the way it should or you notice any damage.
• The ZOMA-Jet® 10 device can be used for about 4 years.
ZOMA-Jet® 10 Components
• The Needle-Free Head must be replaced 1 week after opening.
• Use 1 Vial Adapter with each ZOMACTON® 10 mg Vial.
• To order replacement Vial Adapters and Needle-Free Heads, call
ZoGo Patient Support at 844.944.ZOGO (9646).
• Do not use your ZOMA-Jet® 10 without Needle-Free Head attached or when
Needle-Free Head is empty.
This Instructions for Use has been approved by the Food and
Drug Administration.

17 17
ZOMACTON® and ZOMA-Jet®are trademarks of Ferring B.V.
©2016, Ferring B.V.
6965-01