Nemera HHT PEN User manual

USER'S MANUAL ®
0197
®
®
®
AUTOMATIC SOMATROPIN PEN INJECTOR
HHT
®PEN20mg
HHT
®
PEN 20mg

before the first use
construction of pen injector, pen needle
and cartridge
installation of cartridge and pen needle
priming your HHT®PEN 20mg
injecting a dose
removing a needle
replacing a cartridge
replacing a needle
storage and cleaning
information from the manufacturer
T
ab
le of content
s
2
3
1
4
5
6
7
8
9
10

b
e
f
ore the
fi
rst
u
s
e
HHT®PEN 20mg is a reusable, intuitive automatic somatropin injector. It provides you or your child with a precise, safe and
effortless way to administer somatropin doses recommended by the doctor, in the range of 0.07 mg (0,01mL) to 4.00 mg
(0,6mL), with incremental dose of 0.07 mg (0,01mL).
HHT®PEN 20mg is intended for use by humans to treat:
a) Kids
Growth disturbance associated with insufficient secretion of growth hormone and growth disturbance associated with Turner
syndrome or chronic renal failure.
b) Adults
Replacement therapy in adults with pronounced growth hormone deficiency.
- Growth hormone deficiency in adults.
HHT®PEN 20mg is intended for use exclusively with standard 3,0 ml somatropin cartridges according to ISO 11608-3.
HHT®PEN 20mg is designed for use with disposable needles: BD 31G(5mm), BD 32G(4 mm) and
BD 31G(8 mm) according to ISO 11608-2.
Use a new needle for each injection to ensure sterility, prevent infections or leakage of somatropin and reduce
the risk of needle clogging.
1

b
e
f
ore the
fi
rst
u
s
e
HHT®PEN 20mg can be used in the home environment by people from different cultural backgrounds, people of different
ethnicity, with all levels of education.
Use HHT®PEN 20mg only with the somatropin recommended by your doctor.
Using HHT®PEN 20mg without somatropin cartridge may cause defective operation.
Use HHT®PEN 20mg only at the dosage recommended by your doctor. If you or your child have administrated a dose
that is too high, proceed according to information provided by the somatropin manufacturer.
Do not use HHT®PEN 20mg if it is not working properly, or any of its parts look damaged.
Contraindications for use:
HHT®PEN 20mg is not recommended for self-administration of somatropin by people who are blind, visually
impaired, with severely limited motor skills or children without the assistance of a third party, trained in its use.
HHT®PEN 20mg is intended for use by one person only and should not be shared with others.
1

construction of the pen injector HHT®PEN 20mg
p
en ca
p
pl
unger
cartridge holder
g
win
dow
of
cartri
dg
e hol
d
e
r
pen bo
dy
p
y
win
d
ow
d
isplayin
g
the end of the in
j
ection
j
s
elector win
d
ow
release
bu
tto
n
dos
e s
ele
ctor
p
en needl
e
somatrop
in
cartri
d
g
e
p
ou
ter nee
dle
sh
iel
d
paper ta
b
i
nner needle shield ru
bb
er cartri
d
ge ti
p
m
etalic cartri
d
ge
tip
sca
le
c
artri
d
ge plunge
r
needle
2

Wash your hands and make sure that
you have the following items:
HHT®PEN 20mg
somatropin cartridge
new pen needle
alcohol swab
3
i
nstallation o
f
cartrid
g
e and
p
en needl
e
S
tep
1
P
ull o
ff
the ca
p
Step 2
Unscrew the cartridge holder from the pen
body by turning it according to the direction
shown on the drawing.
New somatropin cartridge or HHT®PEN 20mg
with cartridge attached
should be taken out of the refrigerator 30
minutes prior the planned injection.

3instalation of cartridge and pen needle
Step 3
Press the plunger into the pen body.
Step 4
Check the somatropin cartridge.
Make sure that it is not cracked or broken, the
somatropin solution is clear and transparent and check
the medicine expiration date.
Do not use the somatropin after the medicine
expiration date.
Wipe the rubber somatropin cartridge tip with the swab.

3instalation of cartridge and pen needle
Step 6
Attach the cartridge holder to the pen
body by turning it according to direction
shown on the drawing, until first
resistance is met.
Step 5
Insert somatropin cartridge into the cartridge holder,
rubber tip to the front.

3
i
nstalation o
f
cartrid
g
e and
p
en needle
Step 7
Take a new sterile needle and
remove the paper tab
from the outer needle shield.
Step 8
Hold the pen injector by the cartridge holder.
Attach the outer needle shield to the cartridge
holder until first resistance is met, according to
the direction shown on the drawing.
For each injection use a new needle.
Do not use needles if the paper cover if damaged.
Reuse of the same needle or needle with a damaged
unit pack (paper cover)is not in line with
epidemiological recommendations.

To minimise the risk of unintended needle penetration
and transmission of infectious diseases, never
replace the inner needle cap once removed. If by
accident you puncture your skin, clean the wounded
spot with a skin disinfectant.
3
i
nstalation o
f
cartrid
g
e and
p
en needle
S
te
p
9
R
emove the o
u
ter needle shield
.
Ret
a
in it for remov
a
l of the nee
d
le
a
fte
r
the completion of the injection process
.
Step 10
Remove the inner needle
shield as recommended by the
manufacturer.

4 priming your HHT®PEN 20mg
Step 11
Using the dose selector, choose 0.13 mg of
somatropin. Turn the dose selector clockwise
until the figure 0.13 appears in the selector window.
S
tep 1
2
T
ake the pen with the needle pointing upwards. Using your thumb, slid
e
the release button in the direction o
f
the needle
.
Hol
d
the release
b
utton until a
g
reen
d
ot a
pp
ear
s
in the window displaying the end of the injection
.
If a drop of somatropin does not appear at the end of the needle, repeat steps
11 and 12. If a drop of somatropin does not appear after several attempts, remove
the needle in accordance with step 17. Repeat steps 7 through 12, afterwards.
Prime your HHT®PEN20mg before each injection.

5injecting a dose
Step 13
Turn dose selector to your desired dose.
Example: 0.13 mg shown in the drawing.
If you dial too many units, you can correct the dose
by turning the dose selector backwards.
Step 14
Select the injection site (abdomen, thighs, buttocks) and
wipe your skin with an alcohol swab.
Rotate your injection sites daily.
Insert the end of the needle into the subcutaneous
tissue. Gently hold a fold of the skin and insert the tip of
the needle into subcutaneous tissue in a 90 degrees
angle. Using your thumb, slide the release button
in the direction of the needle.

5injecting a dose
Step 16
Count at least to ten. Remove the needle from the skin
at the same angle it was inserted into subcutaneous
tissue.
Step 15
Hold the release button until a green dot appears
in the window displaying the end of the injection.
If the green dot does not appear, it means that there
is no somatropin in the cartridge. Note the number of units
remaining as it corresponds to the number of units of somatropin
which you must enter to complete the injection.
Perform the actions described in steps 16 through 18. Prepare your
HHT®PEN 20mg for injection by proceeding in accordance with steps 7
through 12. To complete the interrupted dose delivery, turn the selector
clockwise until the figure, which you have seen in the selector window,
appears, then perform the actions described in steps 14 through 15.
If by accident you inject yourself a dose higher than
prescribed, immediately contact your doctor.

6
r
emoving a nee
d
le
7
r
eplacing a cartri
d
g
e
8
r
eplacing a needl
e
Step 17
Put the outer needle shield on the needle. Rotate the outer
needle shield counterclockwise. Remove the used needle.
Dispose of it in accordance with information provided
by the manufacturer of the needle. Put the cap on the pen
injector.
S
te
p
1
9
F
ollow the guidelines described in step 17.
Then per
f
orm the procedures describe
d
in steps 7 through 8.
Used needles and empty somatropin cartridges are classified among
the potentially dangerous waste, which can cause microbiological
contamination. Keep them out of the reach of children
S
te
p
1
8
Perform the action described in step 2. Shake the empty
p
cartridge to eject it from its holder and dispose of it according
to the information supplied by the manufacturer of somatropin.
Set the dose selector to "0" position by turning it counterclockwise.
Follow steps 3 through 6

Przyczyna: ROZWIĄZANIE:
Używaj zawsze nowej igły
do każdej iniekcji.
Brak zmiany igły po
każdym użyciu.
Wciśnij tłok do obudowy
wstrzykiwacza
9
Nie mogępołączyć
osłony wkładu z obudową
wstrzykiwacza.
Sprawdźczy wkład zostałpoprawnie
włożony do obudowy wkładu
(metalowym pierścieniem do przodu
Problem: HOW TO ELIMINATE:
Incorrectly insert
somatropin cartridge.
Cannot attach the cartridge
holder onto the pen body. Check ifthe cartridge was properly
insert into the cartridge holder
(metallic cap first)
Pushed out
plunger
The needle is not replaced
with each injection.
Possible cause:
HOW TO ELIMINATE:
Use a new needle with each injection.
.
Problem: Possible cause: HOW TO ELIMINATE:
User error. You can correct the dose by turning the
dose selector in the opposite direction.
A higher dose
was dialled then
required.
Push the plunger back into
the pen body.
Possible cause:
Troubleshooting
Problem:
The crystallisation of
somatropin at the
needle tip.
Troubleshooting
Problem:
The crystallisation of
somatropin at the
needle tip.

9
Troubleshooting
Problem:
Despite a number ofpriming
procedures a drop of
somatropin has not appeared
on the end ofthe needle.
Possible cause: HOW TO ELIMINATE:
Possible cause:
Problem:
Note the number of units remaining, as it corresponds
to the number of units of somatropin which you must
inject to complete the injection. Attach the outer needle
shield and remove the needle. Replace the old cartridge
with a new one, accordingly to steps 16 through 18 .
Prepare the pen injector to use accordingly to the
actions described in steps 7 to 10. Perform the priming
dose injection. complete the interrupted dose delivery
by turning the dose selector until the figure, which you
have seen in the selector window, appears. Follow
steps 14 through 15.
Postępuj zgodnie z krokami 14-15.
Clogged pen needle. Replace the needle with a new one
Check if the cartridge was properly
installed. There should be no space
between the plunger and the cartridge.
Incorrectly installed
somatropin cartridge
After the injection the red
dot did not appear in the the
window displaying the end
ofinjection
There was not enough
somatropin in the cartridge to
inject the full set dose .
HOW TO ELIMINATE:

10 storage and cleaning
Do not im-
merse
HHT®PEN
20mg
HHT®PEN 20mg should always be stored and carried with the top cap on, without
into water.
a needle.
HHT®PEN 20mg should be stored in its case.
Clean your HHT®PEN 20mg every day. Use only a damp cloth for cleaning.
Do not immerse the pen injector into water. Do not use alcohol, hydrogen peroxide,
disinfectants or lubricants to clean the pen injector.
HHT®PEN 20mg with the somatropin cartridge should be refrigerated at +2°C to +8°C.
HHT®PEN 20mg should not be stored at more than 70°C or below (-40)°C. Keep
the pen injector far from extreme temperatures, humidity, dust and direct sun exposure.
Always keep your HHT®PEN 20mg and needles out of the reach of
other people, especially children.
HHT®PEN 20mg should be protected against major physical forces.
Do not freeze HHT®PEN 20mg and do not use, if it has
been frozen.

information from the manufacturer
Package contents: HHT®PEN 20mg automatic somatropin pen injector, pen case, user's manual.
HHT®PEN 20mg meets the requirements of ISO 11608-1 standard with respect to general requirements,
dosing accuracy and robustness.
HHT®PEN 20mg is intended for use with disposable needles as per ISO 11608-2.
HHT®PEN 20mg should be replaced after about 3 years of use, when decided by the physician
or in any case when there are doubts as to its functionality.
HHT®PEN 20mg is made of materials that do not make reactions on patient's skin.
Manufacturer:
Nemera Szczecin sp. z o.o.
3 Tytanowa Street
70-856 Szczecin, Poland
plszc_inf[email protected]
www.nemera.net
HT-01/EN-V3
Date of issue: 02/2023
Particular attention should be paid to the information preceded by this sign
which will ensure safe and comfortable use of the device.
In the events of serious incidents, this should be reported to the manufacturer and to the competent authority.
Distributor/Importer:

legend
Indicates the medical device manufacturer
(yellow color) Indicates that caution is necessary when operating the device or control close to where the symbol is
placed or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences
Indicates the need for the user to consult the instructions for use
Patient information website

notes