Skip to Content

UK Edition. Click here for US version.

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

Active substance(s): SOMATROPIN / SOMATROPIN / SOMATROPIN

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET

9

Package leaflet: Information for the user
Norditropin FlexPro 15 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
10



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

Warnings and precautions
Talk to your 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:
11






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.
12

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.
13

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 them from light. Do not freeze or expose to heat.
While using Norditropin FlexPro 15 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 injections;
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 10 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
14

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, Cyprus, Denmark, Finland, Germany, Greece, Hungary, Ireland, Luxembourg,
Netherlands, Portugal, Spain, Slovenia, United Kingdom: Norditropin FlexPro 15 mg/1.5 ml
Sweden: Somatropin Novo Nordisk 15 mg/1.5 ml
This leaflet was last revised in 10/2016.

15

Norditropin FlexPro 15 mg/1.5 ml
Instructions on how to use Norditropin FlexPro
Please read these instructions carefully before using your Norditropin FlexPro pen.
Start by checking the name, strength and coloured label of your Norditropin FlexPro pen to make
sure that it contains the growth hormone strength you need.
Read on to learn about:
Preparing your Norditropin FlexPro pen
Checking the growth hormone flow with each new pen
Selecting your dose
Injecting your dose
Caring for your Norditropin FlexPro pen
Important information
Norditropin FlexPro
Pen cap

Growth hormone
scale

Display

Pointer

Dose
selector

Dose
button

Needle (example)
Outer needle
cap

Inner
needle cap

Needle

Paper tab

Your Norditropin FlexPro pen is a pre-filled growth hormone pen. Norditropin FlexPro contains
15 mg human growth hormone solution and delivers doses from 0.1 mg to 8.0 mg, in increments of
0.1 mg. Norditropin FlexPro is designed to be used with NovoFine or NovoTwist disposable needles
up to a length of 8 mm.
Preparing your Norditropin FlexPro pen
Check the name, strength and coloured label of your Norditropin FlexPro pen to make sure that
it contains the growth hormone strength you need.
A

Pull off the pen cap.

A

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.

B

Always use a new needle for each injection. This reduces the risk of contamination, infection,
16

leakage of growth hormone, blocked needles and inaccurate dosing.
Never bend or damage the needle.
C

Pull off the outer needle cap and save it.

C

After injection, you will need it to correctly remove the
needle from the pen.

D

Pull off the inner needle cap and throw it away.

D

If you try to put it back on, you may accidentally stick
yourself with the needle.
A drop of growth hormone may appear at the needle tip.
This is normal.

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

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

E

0.1 mg
selected

F

Hold the pen with the needle pointing up.

F

Tap the top of the pen a few times to let any air bubbles
rise to the top.

17

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.

G

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 you inject your first dose with
each new pen.
Selecting your dose
Use the dose selector on your Norditropin FlexPro pen to select up to 8.0 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.
When the pen contains less than 8.0 mg, the dose selector
stops at the number of mg left.

H

1.2 mg
selected
5.9 mg
selected

The dose selector clicks differently when turned forwards, backwards or past 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 8.0 mg:
Turn the dose selector until it stops. The figure that lines up with the pointer shows how many
mg are left.
If you need more growth hormone than you have left in your pen, you can use a new pen or split
your dose between your current pen and a new pen.

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

18

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.

I

As you do this, you may hear or feel a click.
6 seconds

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.

J

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.
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.

K

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. You may
accidentally stick yourself with the needle.
Always store the pen without a needle attached. This reduces the risk of contamination,
infection, leakage of growth hormone, blocked needles and inaccurate dosing.
Caring for your Norditropin FlexPro pen
Treat your Norditropin FlexPro pen with care:







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, liquid or direct light.
Do not try to wash, soak or lubricate your pen. If necessary, clean it with a mild detergent on a
moistened cloth.
19







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 or your needles with other people. It might lead to cross-infection.
Caregivers must be very careful when handling used needles – to reduce the risk of needle
injury and cross-infection.
Important information
Pay special attention to these notes as they are important for safe use of the pen.
Additional information

Norditropin FlexPro
15 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
© 2016 Novo Nordisk A/S

20

Expand Transcript

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.

Hide