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NORDITROPIN NORDIFLEX 15 MG/1.5 ML SOLUTION FOR INJECTION PRE-FILLED PEN

Active substance(s): SOMATROPIN

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8-2042-01-001-8_v1-5:Layout 1

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55.5 mm

2016-09-29
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8-2042-01-001-8

Package leaflet:
Information for the user

2. What you need to know before
you use Norditropin NordiFlex®

Norditropin
NordiFlex®
15 mg/1.5 ml

Do not use Norditropin
NordiFlex®
• If you are allergic to somatropin,
to phenol, or to any of the other
ingredients of this medicine (listed
in section 6)
• If you have had a kidney
transplant
• If you have an active tumour
(cancer). Tumours must be inactive
and you must have finished your
anti-tumour treatment before you
start your treatment with
Norditropin NordiFlex®
• If you have an acute critical
illness e.g. open heart surgery,
abdominal surgery, multiple
accidental trauma, or acute
respiratory failure
• If you have stopped growing
(closed epiphyses) and you do not
have growth hormone deficiency.

solution for injection in
pre-filled pen
somatropin
Read all of this leaflet carefully
before you start using this
medicine because it contains
important information for you.
• Keep this leaflet. You may need to
read it again
• If you have any further questions,
ask your doctor or pharmacist
• This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same
as yours
• If you get any side effects talk to
your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Norditropin NordiFlex® is
and what it is used for
2. What you need to know before
you use Norditropin NordiFlex®
3. How to use Norditropin
NordiFlex®
4. Possible side effects
5. How to store Norditropin
NordiFlex®
6. Contents of the pack and other
information
Overleaf: Using your Norditropin
NordiFlex® pen
1. What Norditropin NordiFlex® is
and what it is used for
Norditropin NordiFlex® contains
a biosynthetic human growth hormone called somatropin which is
identical to the growth hormone produced naturally in the body. Children
need growth hormone to help them
grow, but adults also need it for their
general health.
Norditropin NordiFlex® is used to
treat growth failure in children:
• If they have no or very low
production of growth hormone
(growth hormone deficiency)
• If they have Turner syndrome
(a genetic problem which may
affect growth)
• If they have reduced kidney function
• If they are short and were born
small for gestational age (SGA).
Norditropin NordiFlex® is used as
a growth hormone replacement
in adults:
In adults Norditropin NordiFlex® is
used to replace growth hormone if
their growth hormone production
has been decreased since childhood
or has been lost in adulthood because
of a tumour, treatment of a tumour,
or a disease that affects the gland
which produces growth hormone. If
you have been treated for growth
hormone deficiency during childhood, you will be retested after
completion of growth. If growth hormone deficiency is confirmed, you
should continue treatment.

Warnings and precautions
Talk to you doctor or pharmacist
before using Norditropin NordiFlex®
• If you have diabetes
• If you have ever had a cancer or
another kind of tumour
• If you have recurrent headaches,
eyesight problems, nausea, or if
vomiting occurs
• If you have abnormal thyroid
function
• If you develop a limp or low-back
pain as these could be signs of
a curved spine (scoliosis)
• If you are over 60 years of age,
or have received somatropin
treatment as an adult for more than
5 years, as experience is limited
• If you suffer from kidney disease
as your kidney function should be
monitored by your physician.
Other medicines and Norditropin
NordiFlex®
Tell you doctor or pharmacist if you
are using, have recently used or
might use any other medicines.
• Glucocorticoids or sex steroids
(for example anabolic steroids and
estrogen) – your adult height may
be affected if you use Norditropin
NordiFlex® and glucocorticoids or
sex steroids at the same time
• Cyclosporin (immunosuppressive)
– as your dose may need to be
adjusted
• Insulin – as your dose may need
to be adjusted
• Thyroid hormone – as your dose
may need to be adjusted
• Gonadotrophin (gonad
stimulating hormone) – as your
dose may need to be adjusted
• Anticonvulsants – as your dose
may need to be adjusted.
Pregnancy and breast-feeding
Somatropin containing products are
not recommended in women of
childbearing potential not using
contraception.
• Pregnancy. Stop the treatment
and tell your doctor if you become
pregnant while you are using
Norditropin NordiFlex®
• Breast-feeding. Do not use
Norditropin NordiFlex® while you are
breast-feeding because somatropin
might pass into your milk.

Driving and using machines
Norditropin NordiFlex® does not
affect the use of any machines or the
ability to drive safely.
3. How to use Norditropin
NordiFlex®
Always use this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are
not sure.
Recommended dose
The dose for children depends on
their body weight and body surface
area. Later in life, the dose depends
on your height, weight, gender, and
growth hormone sensitivity and will
be adjusted until you are on the right
dose.
• Children with low production
or lack of growth hormone:
The usual dose is 0.025 to
0.035 mg per kg body weight per
day or 0.7 to 1.0 mg per m2 body
surface area per day
• Children with Turner syndrome:
The usual dose is 0.045 to
0.067 mg per kg body weight per
day or 1.3 to 2.0 mg per m2 body
surface area per day
• Children with kidney disease:
The usual dose is 0.050 mg per kg
body weight per day or 1.4 mg per
m² body surface area per day
• Children born small for
gestational age (SGA):
The usual dose is 0.035 mg per kg
body weight per day or 1.0 mg per
m2 body surface area per day until
final height is reached. (In clinical
trials of short children born SGA
doses of 0.033 and 0.067 mg per
kg body weight per day have
typically been used)
• Adults with low production or
lack of growth hormone:
If your growth hormone deficiency
continues after completion of
growth, treatment should be
continued. The usual starting dose
is 0.2 to 0.5 mg per day. Dose will
be adjusted until you are on the
right dose. If your growth
hormone deficiency starts during
adult life, the usual starting dose is
0.1 to 0.3 mg per day. Your doctor
will increase this dose each month
until you are getting the dose you
need. The usual maximum dose is
1.0 mg per day.
When to use Norditropin
NordiFlex®
Inject your daily dose into the skin
every evening just before bedtime.
How to use Norditropin NordiFlex®
Norditropin NordiFlex® growth hormone solution comes in a multi-dose
disposable 1.5 ml pre-filled pen.
Full instructions on how to use the
Norditropin NordiFlex® pen are given
overleaf. The instructional key points
are as follows:
• Check the solution before use by
turning the pen upside down once
or twice. Do not use the pen if the
solution is cloudy or discoloured
• Norditropin NordiFlex® is designed
to be used with NovoFine® or
NovoTwist® disposable needles up
to a length of 8 mm
• Always use a new needle for each
injection

Regulatory Operations
Insert: 2010-420 x 296-007 Current: 1.0 Readability
Norditropin NordiFlex: 5 mg, 10 mg, 15 mg Colour: PMS 280C + PMS 376C

• Vary the area you inject so you do
not harm your skin
• To make sure you get the proper
dose and do not inject air, check
the growth hormone flow (called
‘priming’ the pen) before the first
injection from a new Norditropin
NordiFlex® pen. Do not use the
pen if a drop of hormone solution
does not appear at the needle tip
• Do not share your Norditropin
NordiFlex® pen with anyone else.
How long you will need
treatment for
• Children with growth failure
because of Turner syndrome,
kidney disease, or SGA: Your
doctor will recommend you
continue treatment until you stop
growing
• Children or adolescents who lack
growth hormone: Your doctor will
recommend you continue
treatment into adulthood
• Do not stop using Norditropin
NordiFlex® without discussing it
with your doctor first.
If you use more Norditropin
NordiFlex® than you should
• Tell your doctor if you inject too
much somatropin. Long-term
overdosing can cause abnormal
growth and coarsening of facial
features.
If you forget to use Norditropin
NordiFlex®
• Take the next dose as usual, at the
normal time. Do not take
a double dose to make up for
a forgotten dose.
If you stop using Norditropin
NordiFlex®
• Do not stop using Norditropin
NordiFlex® without discussing it
with your doctor first.
If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
Effects seen in children and
adults (unknown frequency):
• Rash; wheezing; swollen
eyelids, face or lips; complete
collapse. Any of these may be
signs of allergic reactions
• Headache, eyesight problems,
feeling sick (nausea) and being
sick (vomiting). These may be
signs of raised pressure in the brain
• Serum thyroxin levels may
decrease
• Hyperglycaemia (elevated levels
of blood glucose).
If you get any of these effects, see
a doctor as soon as possible. Stop
using Norditropin NordiFlex® until
your doctor says you can continue
treatment.
Formation of antibodies directed
against somatropin has been rarely
observed during Norditropin therapy.
Increased levels of liver enzymes have
been reported.
Cases of leukaemia and relapse of
brain tumours have also been
reported in patients treated with
somatropin (the active ingredient in

Norditropin NordiFlex®), although
there is no evidence that somatropin
was responsible.
If you think you are suffering from
any of these diseases, speak to your
doctor.
Additional side effects in
children:
Uncommon (may affect up to 1 in
100 children):
• Headache
• Redness, itching and pain in the
area of injection.
Rare (may affect up to one in
1,000 children):
• Rash
• Muscle and joint pain
• Swollen hands and feet due to
fluid retention.
In rare cases, children using
Norditropin NordiFlex® have experienced hip and knee pain or have
started limping. These symptoms
may be caused by a disease affecting
the top of the thigh bone (LeggCalvé disease) or because the end of
the bone has slipped from the cartilage (slipped capital femoral
epiphysis) and may not be due to
Norditropin NordiFlex®.
In children with Turner syndrome,
a few cases of increased growth of
hands and feet compared to height
have been observed in clinical trials.
A clinical trial in children with Turner
syndrome has shown that high doses
of Norditropin can possibly increase
the risk of getting ear infections.
If any of these side effects gets
serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist, as the
dose may need to be reduced.
Additional side effects in adults:
Very common (may affect more
than 1 in 10 adults):
• Swollen hands and feet due to
fluid retention.
Common (may affect up to 1 in
10 adults):
• Headache
• Feeling of skin crawling
(formication) and numbness or
pain mainly in fingers
• Joint pain and stiffness; muscle
pain.
Uncommon (may affect up to 1 in
100 adults):
• Type 2 diabetes
• Carpal tunnel syndrome;
tingling and pain in fingers and
hands
• Itching (can be intense) and pain
in the area of injection
• Muscle stiffness.
Reporting of side effects
If you get any side effect, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet.
You can also report side effects
directly via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information
on the safety of this medicine.

5. How to store Norditropin
NordiFlex®
Keep this medicine out of the sight
and reach of children.
Do not use this medicine after the
expiry date which is stated on the
package after EXP/. The expiry date
refers to the last day of that month.
Store unused Norditropin NordiFlex®
pens in a refrigerator (2°C – 8°C) in
the outer carton, in order to protect
from light. Do not freeze or expose
to heat.
While using Norditropin NordiFlex®
15 mg/1.5 ml pen you can either:
• Keep it for up to 4 weeks in
a refrigerator (2°C – 8°C), or
• Keep it for up to 3 weeks at room
temperature (below 25°C).
Do not continue to use
a Norditropin NordiFlex® pen if they
have been frozen or exposed to
excessive temperatures.
Do not use Norditropin NordiFlex®
pens if the growth hormone solution
is cloudy or discoloured.
Always store Norditropin NordiFlex®
without a needle attached.
Always keep the pen cap fully closed
on the Norditropin NordiFlex® pen
when you are not using it.
Always use a new needle for each
injection.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment

This medicinal product is authorised
in the Member States of the EEA
under the following names:
Austria, Belgium, Denmark, Finland,
Ireland, Italy, Luxembourg, Portugal,
Sweden, United Kingdom:
Norditropin NordiFlex® 15 mg/1.5 ml
France: Norditropine NordiFlex®
15 mg/1.5 ml
This leaflet was last revised in
10/2016

6. Contents of the pack and other
information
What Norditropin NordiFlex®
contains
• The active substance is somatropin
• The other excipients are mannitol;
histidine; poloxamer 188; phenol;
water for injection; hydrochloric
acid; and sodium hydroxide.
What Norditropin NordiFlex® looks
like and contents of the pack
Norditropin NordiFlex® is a clear and
colourless solution for injection in
a multi-dose disposable 1.5 ml
pre-filled pen.
1 ml of solution contains 10 mg
somatropin.
1 mg of somatropin corresponds to
3 IU of somatropin.
Norditropin NordiFlex® is available in
three strengths:
5 mg/1.5 ml, 10 mg/1.5 ml and
15 mg/1.5 ml (equivalent to
3.3 mg/ml, 6.7 mg/ml and 10 mg/ml,
respectively).
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Novo Nordisk Limited
3 City Place
Beehive Ring Road
Gatwick
West Sussex
RH6 0PA
Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Norditropin NordiFlex® is
a trademark owned by
Novo Nordisk Health Care AG,
Switzerland
NovoFine® and NovoTwist® are
trademarks owned by
Novo Nordisk A/S
© 2016
Novo Nordisk A/S

8-2042-01-001-8_v1-5:Layout 1

2016-09-29

12:18 PM

Page 2

Norditropin NordiFlex®
15 mg/1.5 ml

1. Check the pen

Instructions on how to use the Norditropin NordiFlex® pen
Read these instructions carefully before using Norditropin NordiFlex®.
• Norditropin NordiFlex® 15 mg/1.5 ml is a multi-dose injection pen pre-filled
with human growth hormone solution.
• You can use the dosage selector to select any dose from 0.075 to 4.50 mg,
in increments of 0.075 mg. Your doctor will decide the correct dose for you.
• Norditropin NordiFlex® is designed to be used with NovoFine® or
NovoTwist® disposable needles up to a length of 8 mm.
• Start by checking the name, strength and coloured label of your
Norditropin NordiFlex® pen to make sure that it contains the growth
hormone strength you need.
• Only use the pen if the growth hormone solution inside the cartridge is
clear and colourless.
• Always use a new needle for each injection.
• Always check the flow before the first injection with each new pen – see
step 3. Check the flow.
• Never share your pen or your needles with anyone else. It might lead to
cross-infection.
• Always keep your pen and needles out of sight and reach of children.
• Caregivers must be very careful when handling used needles – to reduce
the risk of needle sticks and cross-infection.

Needle (example)

Pen Cap

Outer
needle cap

A

• Check the name, strength and
coloured label of your
Norditropin NordiFlex® pen to
make sure that it contains the
growth hormone strength you
need.
• Pull off the pen cap [A].
• Check that the solution inside the
cartridge is clear and colourless by
tipping the pen upside down once or twice.
• Do not use the pen if the solution inside the cartridge is unclear or cloudy.

2. Attach the needle

3. Check the flow

C

• Before your first injection with
each new pen, you need to check
the flow to make sure you get the
correct dose and do not inject any
air:
Select 0.075 mg [C]. This is one
‘click’ after 0.0 on the dosage
selector at the end of the pen.
• Hold the pen with the needle
pointing up and tap the top of the
pen a few times to let any air
bubbles rise to the top [D].

D

• Holding the pen with the needle
up, press the push button at the
bottom of the pen all the way in
[E]. A drop of solution will appear
at the needle tip.
• If no drop appears, repeat steps
C to E up to 6 times until a drop
appears. If there is still no drop,
change the needle and repeat step
C to E once more.
• Do not use the pen if a drop
does not appear. Use a new pen.
• Always check the flow before the
first injection with each new pen.
Check the flow again if your pen
has been dropped or knocked
against a hard surface, or if you
suspect something is wrong with it.

E

4. Select the dose

F

Residual
scale window
Residual
scale

Dosage indicator
window

Dosage
selector
Push button

Regulatory Operations
Insert: 2010-420 x 296-007 Current: 1.0 Readability
Norditropin NordiFlex: 5 mg, 10 mg, 15 mg Colour: PMS 280C + PMS 376C

• Use the injection method shown
to you by your doctor or nurse.
• Vary the area you inject so you do
not harm your skin.
• Insert the needle into your skin.
Deliver the dose by pressing the
push button all the way in. Be
careful only to press the push
button when injecting [G].
• Keep the push button fully
depressed and let the needle
remain under the skin for at
least 6 seconds. This will ensure
that the full dose has been
delivered.

6. Remove the needle

H

• Carefully put the outer needle cap
back on the needle without
touching the needle. Unscrew the
needle and throw it away carefully
as instructed by your doctor or
nurse [H].
Never put the inner needle cap
back on once you have removed it
from the needle. You may
accidentally stick yourself with the needle.
• Put the pen cap back on after every use.
• Always remove and dispose of the needle after each injection and
store the pen without the needle attached. This reduces the risk of
contamination, infection, leakage of solution, blocked needles, and
inaccurate dosing.
• When the pen is empty, throw it away without a needle on as advised by
your doctor or nurse and local authorities.
• Caregivers must be very careful when handling used needles - to
reduce the risk of needle sticks and cross-infection.

Needle

Paper tab

G

B

• Always use a new needle for
each injection. This reduces the
risk of contamination, infection,
leakage of solution, blocked
needles, and inaccurate dosing.
Never bend or damage the needle.
• Remove the protective paper tab
from the needle.
• Screw the needle straight onto the
pen [B]. Make sure the needle is on tight.
The needle has two needle caps. You need to remove them both:
• Pull off the outer needle cap and keep it to correctly remove the needle
from the pen after the injection.
• Remove the inner needle cap by pulling on the central tip and throw it
away.

Inner
needle cap

Cartridge

5. Inject the dose

• Check that the dosage selector is
set at 0.0. Select the number of
mg your doctor has prescribed for
you [F].
• The dose can be increased or
decreased by turning the dosage
selector in either direction. When
turning the dosage selector
backwards, be careful not to press
the push button as solution will come out.
You cannot set a dose larger than the number of mg left in the pen.

7. Maintenance
• Your Norditropin NordiFlex® pen must be handled with care.
• Do not drop your pen or knock it against hard surfaces. If you drop it or
suspect that something is wrong with it, always screw on a new needle and
check the flow before you inject.
• Do not try to refill your pen – it is pre-filled.
• Do not try to repair your pen or pull it apart.
• Protect your pen from dust, dirt, frost and direct sunlight.
• Do not try to wash, soak or lubricate your pen. If necessary clean it with
a mild detergent on a moistened cloth.

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