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NORDITROPIN NORDIFLEX 5 MG/1.5 ML SOLUTION FOR INJECTION PRE-FILLED PEN.

Active substance: SOMATROPIN

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PACKAGE LEAFLET

7

Package leaflet: Information for the user
Norditropin NordiFlex 5 mg/1.5 ml 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.
2.

What you need to know before you use Norditropin NordiFlex

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
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If you have stopped growing (closed epiphyses) and you do not have growth hormone
deficiency.

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 your 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
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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 the 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

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 growth 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.
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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 1 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 (Legg-Calvé
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
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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 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 5 mg/1.5 ml, 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 Norditropin NordiFlex pens 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 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.
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 3.3 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
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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
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Luxembourg, Portugal, Sweden,
United Kingdom: Norditropin NordiFlex 5 mg/1.5 ml
France: Norditropine NordiFlex 5 mg/1.5 ml

This leaflet was last revised in 05/2015
Norditropin NordiFlex® is a trademark owned by Novo Nordisk Health Care AG, Switzerland
NovoFine® and NovoTwist® are trademarks owned by Novo Nordisk A/S
© 2015
Novo Nordisk A/S

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Norditropin NordiFlex
5 mg/1.5 ml
How to use the Norditropin
NordiFlex pen

Disposable needle
(example)

Pen cap

Read right through these
instructions before using
Norditropin NordiFlex.











Norditropin NordiFlex
5 mg/1.5 ml is a multi-dose
injection pen pre-filled with
human growth hormone
solution
Norditropin NordiFlex is
designed to be used with
NovoFine or NovoTwist
disposable needles up to a
length of 8 mm
Only use the injection pen if
the growth hormone solution
inside is clear and colourless
Always check the flow
(‘prime’ the pen) before the
first injection from a new
pen – see Step 3, alongside
You can use the dose
selector to dial any dose
from 0.025 to 1.50 mg - your
doctor will decide the
correct dose for you
Do not share your
Norditropin NordiFlex pen
with anyone else.

Outer needle cap

Inner needle cap

Needle
Cartridge
Residual scale
window
Residual
scale

Dosage indicator
window
Dosage
selector

Push button

1. Check the solution




Pull off the pen cap [A]
Check the solution inside the
pen by turning it upside
down once or twice
Only use the Norditropin
NordiFlex pen if the solution
inside is clear and
colourless.

A

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Protective paper
tap

2. Attach the needle





Always use a new
disposable needle for each
injection in order to receive
the correct dose and prevent
contamination
Take a new needle and
remove the protective
paper tab
Push the needle straight
onto the injection pen. Turn
until it is on tight [B].

B

The needle has two needle caps.
You need to remove them both:

Pull off the outer needle
cap and keep it to dispose of
the used needle later

Remove the inner needle
cap by pulling on the
central tip and throw it
away.
3. Check the flow






Before you use a new pen
for the first time, you need
to check the flow (called
‘priming’ the pen) to make
sure you get the proper dose
and do not inject any air:
Dial 0.025 mg [C] This is
one ‘click’ after 0.0 on the
dose selector at the end of
the pen.

C

D

Hold the Norditropin
NordiFlex pen with the
needle pointing upwards and
tap the cartridge gently with
your finger a few times [D].

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Holding the Norditropin
NordiFlex pen with the
needle upwards, press the
push-button at the bottom of
the pen all the way in [E]

Repeat steps C to E until a
drop of growth hormone
solution appears at the
needle tip

Do not use the Norditropin
NordiFlex pen if a drop of
solution does not appear

Always check the flow
(prime the pen) before the
first injection from a new
Norditropin NordiFlex pen.
Check the flow again if your
pen has been dropped or
knocked against a hard
surface, or if you are not
sure that it is working
properly.
4. Dial the dose




E

F

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

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5. Inject the solution






Use the injection method
that has been recommended
to you
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]
After the injection keep the
needle under the skin for at
least 6 seconds and then
withdraw it. Keep the pushbutton fully depressed until
the needle is removed from
the skin. This ensures that
you get the full dose.

G

6. Remove the needle







Replace the outer needle cap
and unscrew the needle.
Throw it away carefully [H]
Always use a new needle for
each injection and always
remove a used needle
immediately after each
injection. If you do not
remove it straight away, air
may get into the cartridge,
which may mean you get the
wrong dose next time
When the Norditropin
NordiFlex pen is empty,
throw it away carefully
without the needle attached
Ask your pharmacist how to
dispose of used needles and
empty Norditropin
NordiFlex pens. Caregivers
should be very careful when
removing and disposing of
used needles to reduce the
risk of injury.

H

7. Maintenance


Look after your Norditropin
NordiFlex pen so that it
continues to work accurately
and safely. Protect your pen
from dust, dirt and direct
sunlight. and any situation
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where it might be damaged
You can clean the outside of
your pen by wiping it with
cotton wool moistened with
alcohol. Do not soak
Norditropin NordiFlex in
alcohol, or wash or lubricate
it as this may damage it.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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