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

Active substance: SOMATROPIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Norditropin NordiFlex 5 mg/1.5 ml solution for injection in a pre-filled pen
somatropin

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again

If you have further questions, ask your doctor or pharmacist

This medicine has been prescribed for you personally. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Norditropin NordiFlex is and what it is used for
2.
Before you use Norditropin NordiFlex
3.
How to use Norditropin NordiFlex
4.
Possible side effects
5.
How to store Norditropin NordiFlex
6.
Further 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.

BEFORE YOU USE NORDITROPIN NORDIFLEX

Do not use Norditropin NordiFlex

If you are allergic (hypersensitive) to somatropin, to phenol or to any of the other ingredients of
Norditropin NordiFlex (listed in section 6, Further information)

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.
Tell your doctor if any of these apply to you.

Take special care with 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.
Tell your doctor if any of these apply to you as Norditropin NordiFlex may not be suitable.
Using other medicines
Your doctor needs to know if you are already being treated with:

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.
Tell your doctor or pharmacist if you are taking other medicines or have recently taken any. This
includes medicines obtained without a prescription.
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 Norditropin NordiFlex exactly as your doctor has told you. Check with your doctor or
pharmacist if you are unsure.
Usual 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 25 to 35 microgram 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 45 to 67 microgram 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 50 microgram 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 35 microgram 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 33
and 67 microgram 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 injection pen
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, but key points are as
follows:

Check the solution before use by turning the pen upside down once or twice. Only use the pen if
the solution in the pre-filled pen is clear and colourless

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 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

If you are using Norditropin NordiFlex for growth failure because of Turner syndrome, a
kidney disease or if you were born small for gestational age (SGA), your doctor will
recommend you continue treatment until you stop growing

If you 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 too much:

Tell your doctor if you inject too much Norditropin NordiFlex. Long-term overdosing can
cause abnormal growth and coarsening of facial features.
If you forget a dose:

Take the next dose as usual, at the normal time. Do not take a double dose to make up for a
forgotten dose.
Stopping the treatment

Do not stop using Norditropin NordiFlex without discussing it with your doctor first.

4.

POSSIBLE SIDE EFFECTS
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Like all medicines, Norditropin NordiFlex 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.
Other side effects in children:
Uncommon effects (may affect up to 1 in 100 children):

Headache

Redness, itching and pain in the area of injection.
Rare effects (may affect up to 1 in 1000 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.
Other side effects in adults:
Very common effects (may affect more than 1 in 10 adults):

Swollen hands and feet due to fluid retention.
Common effects (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 effects (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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If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist, as you may need to reduce your dose.

5.

HOW TO STORE NORDITROPIN NORDIFLEX

Keep out of the reach and sight of children.
Do not use Norditropin NordiFlex after the expiry date which is stated on the package. The expiry date
refers to the last day of that month.
Store unused Norditropin NordiFlex pens in a refrigerator (2°C to 8°C) in the outer carton, in order to
protect from light. Do not freeze or expose to heat.
After starting to use a Norditropin NordiFlex 5 mg/1.5 ml pen you can either:

Keep it for up to 4 weeks in a refrigerator (2°C to 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 which has been frozen or exposed to excessive
temperatures.
Do not use any Norditropin NordiFlex pen if the growth hormone solution is not clear and colourless.
Do not keep the needle screwed onto the Norditropin NordiFlex pen when you are not using it.
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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What Norditropin NordiFlex contains

The active substance is somatropin

The solution also contains mannitol; histidine; poloxamer 188; phenol; water for injections;
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:
Novo Nordisk Limited
Broadfield Park
Brighton Road
Crawley
West Sussex
RH11 9RT UK
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Manufactured by:
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 name:
Norditropin NordiFlex 5 mg/1.5 ml, solution for injection, pre-filled pen: Austria, Belgium,
Denmark, Finland, France, Germany, Holland, Ireland, Italy, Luxemburg, Portugal, Spain, Sweden,
United Kingdom
Turn over for information on using your Norditropin NordiFlex pen
This leaflet was last approved in 07/2012

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

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Push button

Protective paper
tap

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.
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].

A

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.

8

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 push
button 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.

10

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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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