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NORDITROPIN SIMPLEXX 5MG/1.5ML SOLUTION FOR INJECTION IN CARTRIDGE

Active substance: SOMATROPIN

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1. What Norditropin® SimpleXx® is and what it is used for
Norditropin® SimpleXx® 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® SimpleXx® comes as a solution in a cartridge ready for
you to inject after you have put it in the matching NordiPen® injection
pen.
Norditropin® SimpleXx® 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).

8-2070-01-003-1

Package leaflet: Information for the user

Norditropin® SimpleXx®
5 mg/1.5 ml
solution for injection in cartridge
somatropin

Package leaflet: Information for the user

Norditropin® SimpleXx®
5 mg/1.5 ml
solution for injection in cartridge
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® SimpleXx® is and what it is used for
2. What you need to know before you use Norditropin®
SimpleXx®
3. How to use Norditropin® SimpleXx®
4. Possible side effects
5. How to store Norditropin® SimpleXx®
6. Contents of the pack and other information.

Norditropin® SimpleXx® is used as a growth hormone
replacement in adults:
In adults Norditropin® SimpleXx® 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®
SimpleXx®
Do not use Norditropin® SimpleXx®
• 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® SimpleXx®
• 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.
Warnings and precautions
Talk to you doctor or pharmacist before using Norditropin® SimpleXx®
• 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® SimpleXx®
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® SimpleXx® 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® SimpleXx®

• Breast-feeding. Do not use Norditropin® SimpleXx® while you are
breast-feeding as somatropin might pass into your milk.
Driving and using machines
Norditropin® SimpleXx® does not affect the use of any machines or
the ability to drive safely.
3. How to use Norditropin® SimpleXx®
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 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 on the right dose.
The usual maximum dose is 1.0 mg per day.
When to use Norditropin® SimpleXx®
Inject your daily dose into the skin every evening just before bedtime.
How to use Norditropin® SimpleXx®
• Norditropin® SimpleXx® solution comes in cartridges with a color
coded cap and is ready to be used in the matching color coded
NordiPen®. If the corresponding NordiPen® is not used it will result
in incorrect dosing. The NordiPen® instruction manual tells you how
to use the cartridges in the injection pen
• Check each new Norditropin® SimpleXx® cartridge before you use
it. Do not use any cartridge that is damaged or cracked
• Do not use the Norditropin® SimpleXx® cartridges if the solution
inside is cloudy or discoloured
• Vary the area you inject so you do not harm your skin
• Do not share your Norditropin® SimpleXx® cartridge 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® SimpleXx® without discussing it
with your doctor first.
If you use more Norditropin® SimpleXx® 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® SimpleXx®:
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® SimpleXx®
Do not stop using Norditropin® SimpleXx® 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® SimpleXx® 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® SimpleXx®), 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® SimpleXx® 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® SimpleXx®.
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.

While using Norditropin® SimpleXx® 5 mg/1.5 ml cartridge in an
injection pen you can either:
• Keep it in the pen for up to 4 weeks in a refrigerator (2°C – 8°C),
or
• Keep it in the pen for up to 3 weeks at room temperature
(below 25°C).
Do not continue to use Norditropin® SimpleXx® cartridges if they have
been frozen or exposed to excessive temperatures.
Check each new Norditropin® SimpleXx® cartridge before you use it.
Do not use any cartridge that is damaged or cracked.
Do not use Norditropin® SimpleXx® cartridges if the solution inside is
cloudy or discoloured.
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® SimpleXx® 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® SimpleXx® looks like and contents
of the pack
Norditropin® SimpleXx® is a clear and colourless solution in a 1.5 ml
glass cartridge ready for injection in the NordiPen® injection pen.
1 ml of solution contains 3.3 mg somatropin.
1 mg of somatropin corresponds to 3 IU of somatropin.
Norditropin® SimpleXx® 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
This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Lithuania,
Luxembourg, Malta, Netherlands, Portugal, Spain, Slovak Republic,
Slovenia, Sweden, United Kingdom: Norditropin® SimpleXx® 5 mg/1.5
ml
France: Norditropine® SimpleXx® 5 mg/1.5 ml
This leaflet was last revised in 05/2015

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® SimpleXx®
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® SimpleXx® cartridges in a refrigerator
(2°C – 8°C) in the outer carton, in order to protect from light. Do not
freeze or expose to heat.

Norditropin®, SimpleXx® and
NordiPen® are trademarks owned by
Novo Nordisk Health Care AG, Switzerland
© 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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