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NORDITROPIN FLEXPRO 5 MG/1.5 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN

Active substance(s): SOMATROPIN

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PACKAGE LEAFLET

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Package leaflet: Information for the user
Norditropin FlexPro 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 FlexPro is and what it is used for
2.
What you need to know before you use Norditropin FlexPro
3.
How to use Norditropin FlexPro
4.
Possible side effects
5.
How to store Norditropin FlexPro
6.
Contents of the pack and other information
Instructions on how to use Norditropin FlexPro
1.

What Norditropin FlexPro is and what it is used for

Norditropin FlexPro 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 FlexPro 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 FlexPro is used as a growth hormone replacement in adults
In adults Norditropin FlexPro 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 FlexPro

Do not use Norditropin FlexPro

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 FlexPro

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 FlexPro

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 FlexPro
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 FlexPro 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 FlexPro

Breast-feeding - do not use Norditropin FlexPro while you are breast-feeding because
somatropin might pass into your milk.
Driving and using machines
Norditropin FlexPro does not affect the use of any machines or the ability to drive safely.
3.

How to use Norditropin FlexPro

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:

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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 FlexPro
Inject your daily dose into the skin every evening just before bedtime.
How to use Norditropin FlexPro
Norditropin FlexPro growth hormone solution comes in a multi-dose disposable 1.5 ml pre-filled pen.
Full instructions on how to use Norditropin FlexPro 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 (see page 8, step A)

Norditropin FlexPro 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
before the first injection from a new Norditropin FlexPro pen. Do not use the pen if a drop of
growth hormone solution does not appear at the needle tip (see pages 10 to 11, steps E to G)

Do not share your Norditropin FlexPro 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 FlexPro without discussing it with your doctor first.
If you use more Norditropin FlexPro 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 FlexPro
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 FlexPro
Do not stop using Norditropin FlexPro 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 FlexPro 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 FlexPro), 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 FlexPro have experienced hip and knee pains 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 FlexPro.
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.
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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 FlexPro

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 FlexPro 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 FlexPro 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 FlexPro pens if they have been frozen or exposed to excessive
temperatures.
Do not use Norditropin FlexPro pens where the growth hormone solution is cloudy or discoloured.
Always store Norditropin FlexPro without a needle attached.
Always keep the pen cap fully closed on Norditropin FlexPro 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 FlexPro 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 FlexPro looks like and contents of the pack
Norditropin FlexPro 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 FlexPro 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) in pack sizes of 1 or 5 pre-filled pens. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
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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, Cyprus, Denmark, Finland, Germany, Greece, Hungary, Ireland, Lithuania,
Luxembourg, Malta, Netherlands, Portugal, Romania, Spain, Slovenia, United Kingdom: Norditropin
FlexPro 5 mg/1.5 ml
Sweden: Somatropin Novo Nordisk 5 mg/1.5 ml
This leaflet was last revised in 05/2015.

Instructions on how to use Norditropin FlexPro
Please read these instructions carefully before using your Norditropin FlexPro pen.
Use the coloured label to make sure that your Norditropin FlexPro pen contains the growth hormone
strength you need.
Read on to learn about:
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Preparing your Norditropin FlexPro pen
Checking the growth hormone flow
Selecting your dose
Injecting your dose
Caring for your Norditropin FlexPro pen
Important information

Norditropin FlexPro
Pen cap

Growth
Display
hormone scale

Dose
Pointer Dose
selector button

Needle (example)
Outer
Inner
Needle
needle cap needle cap

Paper
tab

Your Norditropin FlexPro pen is an easy-to-use pre-filled growth hormone pen with a light-touch dose
button. Norditropin FlexPro contains 5 mg human growth hormone solution and delivers doses from
0.025 mg to 2.0 mg, in increments of 0.025 mg. Norditropin FlexPro is designed to be used with
NovoFine or NovoTwist disposable needles up to a length of 8 mm.

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Preparing your Norditropin FlexPro pen
Check the coloured label on your Norditropin FlexPro pen to make sure that it contains the
growth hormone strength you need.
A

Pull off the pen cap.
Check that the growth hormone solution
in the pen is clear and colourless by
tipping it upside down once or twice. If
the solution looks unclear or cloudy, do
not use the pen.

B

Take a new disposable needle. Tear the
paper tab off and screw the needle
straight onto the pen. Make sure the
needle is on tight.

Always use a new needle for each injection as this will prevent contamination.
Never bend or damage the needle.

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C

Pull off the outer needle cap and save it.
After injection, you will need it to safely
remove the needle from the pen.

D

Pull off the inner needle cap and throw it
away.
If you try to put it back on, you may
accidentally hurt yourself with the
needle.
A drop of growth hormone may appear
at the needle tip. This is normal.

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Checking the growth hormone flow
Make sure that you receive your full dose by checking the growth hormone flow before you
select and inject your first dose.
E

Turn the dose selector to select the
minimum dose, 0.025 mg.

F

Hold the pen with the needle pointing
up.
Tap the top of the pen a few times to let
any air bubbles rise to the top.

G

Press the dose button until the figure 0
in the display lines up with the pointer
and a drop of growth hormone appears
at the needle tip.
If no drop appears, repeat steps E to G
up to 6 times. If no drop appears after
these new attempts, change the needle
and repeat steps E to G once more.
Do not use the pen if a drop of growth
hormone still does not appear.

Always make sure that a drop appears at the needle tip before your first injection.

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Selecting your dose
Use the dose selector on your Norditropin FlexPro pen to ensure exact and easy dose selection.
You can select up to 2.0 mg per dose.
H

Select or adjust the dose you need by
turning the dose selector forwards or
backwards until the right number of mg
lines up with the pointer.
To guide you, the dose selector clicks
differently when turned forwards,
backwards or past the number of mg
left.
When the pen contains less than 2.0 mg,
the dose selector stops at the number of
mg left.
How much growth hormone is left?
You can use the growth hormone scale
to see approximately how much growth
hormone is left in the pen.
You can use the dose selector to see
exactly how much growth hormone is
left – if the pen contains less than 2.0
mg:
Turn the dose selector until it stops. The
figure that lines up with the pointer
shows how many mg are left.

Never use the pen clicks to count the number of mg you select. Only the display and pointer will
indicate the exact number of mg.
Never use the growth hormone scale to measure how much growth hormone to inject.Only the
display and pointer will indicate the exact number of mg.

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Injecting your dose
Make sure that you receive your full dose by using the right injection technique.
I

Insert the needle into your skin as your
doctor or nurse has shown you. Press the
dose button to inject until the figure 0 in
the display lines up with the pointer.
As you do this, you may hear or feel a
click.
Leave the needle under the skin for at
least 6 seconds to make sure that you
get your full dose.
You can let go of the dose button while
you wait.

J

Remove the needle from the skin.
After that, you may see a drop of growth
hormone at the needle tip. This is
normal and has no effect on the dose
you just received.

Never use the pen clicks to count the number of mg you inject. Only the display and pointer will
indicate the exact number of mg.
Never touch the display when you inject, as this can block the injection.

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K

Put the outer needle cap back on
carefully without touching the needle.
Unscrew the needle and throw it away
carefully as instructed by your doctor or
nurse.
Put the pen cap back on after every use.
When the pen is empty, throw it away
without a needle on as advised by your
doctor or nurse and local authorities.
Never put the inner needle cap back on once you have removed it from the needle. This
reduces the risk of hurting yourself with the needle.

Always store the pen without a needle attached. This prevents contamination, infection and leakage
of growth hormone.

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Caring for your Norditropin FlexPro pen
Your Norditropin FlexPro pen is accurate and safe to use. But you must take care of it:


Do not drop your pen or knock it against hard surfaces. If you do drop it or suspect that
something is wrong with it, always screw on a new disposable needle and check the growth
hormone 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.



Do not expose your pen to dust, dirt or any kind of liquid.



Do not try to wash, soak or lubricate your pen. If necessary, clean it with a mild detergent on a
moistened cloth.



See section 5 “How to store Norditropin FlexPro” in the physician part for information about
how to store your pen.



Important information
Always keep your pen and needles out of reach of others, especially children.



Never share your pen with anyone.



Caregivers should be most careful when handling used needles to avoid hurting themselves.

Norditropin FlexPro
5 mg/1.5 ml
Somatropin
Norditropin and FlexPro are trademarks owned by Novo Nordisk Health Care AG, Switzerland
NovoFine and NovoTwist are trademarks owned by Novo Nordisk A/S, Denmark
© 2015 Novo Nordisk A/S

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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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