GENOTROPIN 5.3 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance: SOMATROPIN (RBE)

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PACKAGE LEAFLET: INFORMATION FOR THE USER

8R3200
423

5.3 mg and 12 mg powder and solvent
for solution for injection
RECTO

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 any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. 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 gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5
6.

What Genotropin is and what it is used for
Before you use Genotropin
How to use Genotropin
Possible side effects
How to store Genotropin
Further information

1. What Genotropin is and what it is used for

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Genotropin is a recombinant human growth hormone (also called somatropin). It has the
same structure as natural human growth hormone which is needed for bones and
muscles to grow. It also helps your fat and muscle tissues to develop in the right
amounts. It is recombinant meaning it is not made from human or animal tissue.
In children, Genotropin is used to treat the following growth disturbances:
• If you are not growing properly and you do not have enough of your own growth
hormone.
• If you have Turner syndrome. Turner syndrome is a chromosomal error in girls that can
affect growth - your doctor will have told you if you have this.
• If you have chronic renal (kidney) insufficiency. As kidneys lose their ability to function
normally, this can affect growth.
• If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help
you grow taller if you are still growing, and will also improve your body composition.
Your excessive fat will decrease and your reduced muscle mass will improve.
• If you were small or too light at birth. Growth hormone can help you grow taller if you
have not been able to catch up or maintain normal growth by four years of age or
later.
In adults, Genotropin is used to treat persons with pronounced growth hormone
deficiency. This can start during adult life, or it can continue from childhood.
If you have been treated with Genotropin for growth hormone deficiency during
childhood, your growth hormone status will be retested after completion of growth. If

severe growth hormone deficiency is confirmed, your doctor will propose continuation of
Genotropin treatment.
You should only be given this medicine by a doctor who has experience with growth
hormone treatment and who has confirmed your diagnosis.

2. Before You Use Genotropin
Do not use Genotropin and tell your doctor if
• You are allergic (hypersensitive) to somatropin or any of the other ingredients of
Genotropin.
• 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 Genotropin.
• You are seriously ill (for example, complications following open heart surgery,
abdominal surgery, acute respiratory failure, accidental trauma or similar conditions). If
you are about to have, or have had, a major operation, or go into hospital for any
reason, tell your doctor and remind the other doctors you are seeing that you use
growth hormone.
• Genotropin has been prescribed to stimulate growth but you have already stopped
growing (closed epiphyses).

Take special care with Genotropin and tell your doctor if any of
the following statements apply to you

• If you are at risk of developing diabetes, your doctor will need to monitor your blood
sugar level during treatment with Genotropin.
• If you have diabetes, you should closely monitor your blood sugar level during
treatment with Genotropin and discuss the results with your doctor to determine
whether you need to change the dose of your medicines to treat diabetes.
• After starting Genotropin treatment some patients may need to start thyroid hormone
replacement.
• If you are receiving treatment with thyroid hormones it may be necessary to adjust
your thyroid hormone dose.
• If you are taking growth hormone to stimulate growth and walk with a limp, or if you
start to limp during your growth hormone treatment due to pain in your hip, you should
inform your doctor.
• If you develop raised intracranial pressure (with symptoms such as strong headache,
visual disturbances or vomiting) you should inform your doctor about it.
• If your doctor confirms that you have developed inflammation of the muscles near the
injection site because of the preservative metacresol, you should use a Genotropin
product without metacresol.
• If you are receiving Genotropin for growth hormone deficiency following a previous
tumour (cancer), you should be examined regularly for recurrence of the tumour.
• Experience in patients above 80 years of age is limited. Elderly persons may be more
sensitive to the action of Genotropin, and therefore may be more prone to develop
side effects.

Children with chronic renal (kidney) insufficiency:

• Your doctor should examine your kidney function and your growth rate before starting
Genotropin. Medical treatment for your kidney condition should be continued.
Genotropin treatment should be stopped at kidney transplantation.

Children with Prader-Willi syndrome:

• Your doctor will give you diet restrictions to follow to control your weight.

• Your doctor will assess you for signs of upper airway obstruction, sleep apnoea (where
your breathing is interrupted during sleep), or respiratory infection before you start
treatment with Genotropin.
• During treatment, if you show signs of upper airway obstruction (including starting to
snore or worsening of snoring), your doctor will need to examine you and may
interrupt your treatment with Genotropin.
• During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity.
• During treatment, if you develop a lung infection, tell your doctor so that he can treat
the infection.

Children born small or too light at birth:

• If you were small or too light at birth and are aged between 9 and 12 years, ask your
doctor for specific advice relating to puberty and treatment with this product.
• Your doctor will check your blood sugar and insulin levels before the start of treatment
and every year during treatment.
• Treatment should be continued until you have stopped growing.

Using other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other
medicines, including medicines obtained without a prescription.
You should tell your doctor if you are using:
• medicines to treat diabetes,
• thyroid hormones,
• synthetic adrenal hormones (corticosteroids),
• sex hormones (for example oestrogens),
• ciclosporin (a medicine that weakens the immune system after transplantation),
• medicines to control epilepsy (anticonvulsants).
Your doctor may need to adjust the dose of these medicines or the dose of Genotropin.

Pregnancy and breast-feeding

You should not use Genotropin if you are pregnant, think you may be pregnant or are
trying to become pregnant.
Ask your doctor for advice before using this medicine while breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Children with Turner syndrome:
0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.
Children with chronic renal (kidney) insufficiency:
0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day).
Higher doses may be necessary if the rate of growth is too low. Dosage adjustment may
be necessary after 6 months of treatment.
Children with Prader-Willi syndrome:
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. The daily
dosage should not exceed 2.7 mg. Treatment should not be used in children who have
almost stopped growing after puberty.
Children born smaller or lighter than expected and with growth disturbance:
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day). It is important to
continue treatment until final height is reached. Treatment should be discontinued after the first
year if you are not responding or if you have reached your final height and stopped growing.
Adults with growth hormone deficiency:
If you continue Genotropin after treatment during childhood you should start with
0.2-0.5 mg per day. This dosage should be gradually increased or decreased according
to blood test results as well as clinical response and side effects.
If your growth hormone deficiency starts during adult life you should start with
0.15-0.3 mg per day. This dosage should be gradually increased according to blood test
results as well as clinical response and side effects. The daily maintenance dose seldom
exceeds 1.0 mg per day. Women may require higher doses than men. Dosage should be
monitored every 6 months. Persons above 60 years should start with a dose of
0.1–0.2 mg per day which should be slowly increased according to individual
requirements. The minimum effective dose should be used. The maintenance dose
seldom exceeds 0.5 mg per day. Follow the instructions given to you by your doctor.

Injecting Genotropin

Genotropin is intended for subcutaneous use. This means that it is injected through a
short injection needle into the fatty tissue just under your skin. Your doctor should have
already shown you how to use Genotropin. Always inject Genotropin exactly as your
doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Recommended dosage

The instructions for using the pre-filled pen GoQuick® are provided
in the carton with the pre-filled pen.
The instructions for using the Genotropin two-chamber cartridge
with the Genotropin Pen or Genotropin Mixer are provided with
your devices.
Refer to the instuctions for use before using your medicine.

The dose depends on your size, the condition for which you are being treated and how
well growth hormone works for you. Everyone is different. Your doctor will advise you
about your individualised dose of Genotropin in milligrams (mg) from either your body
weight in kilograms (kg) or your body surface area calculated from your height and weight
in square metres (m2), as well as your treatment schedule. Do not change the dosage and
treatment schedule without consulting your doctor.

When using a pre-filled pen, a pen injection device or reconstitution device, the needle
must be screwed on before mixing. A new needle must be used for each injection.
Needles must not be re-used.
• Preparing the injection:
You can take your Genotropin out of the refrigerator half an hour before your injection.
This lets it warm up slightly and can make your injections more comfortable.

Children with growth hormone deficiency:
0.025-0.035 mg/kg body weight per day or 0.7-1.0 mg/m2 body surface area per day.
Higher doses can be used. When growth hormone deficiency continues into
adolescence, Genotropin should be continued until completion of physical development.

The GoQuick pre-filled pen contains the two-chamber cartridge that has both the growth
hormone and the dissolving liquid in it. The growth hormone and the dissolving liquid are
mixed together by twisting the cartridge holder (see the detailed steps in the Instructions
for Use). A separate device is not needed.

Important information about some of the ingredients of Genotropin
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially
‘sodium-free’.

3. How To Use Genotropin

Genotropin in a two-chamber cartridge contains both the growth hormone and the
dissolving liquid and it is to be used in a Genotropin device. The growth hormone and the
dissolving liquid in the two-chamber cartridge can be mixed together using a Genotropin
Mixer or by screwing the Genotropin Pen device together.

VERSO

For both the GoQuick pre-filled pen and the two-chamber cartridge, dissolve the powder
by gently tipping it back and forth 5-10 times until the powder is dissolved.
When you are mixing your Genotropin, DO NOT SHAKE the solution. Mix it gently.
Shaking the solution could make your growth hormone foam and damage the active
substance. Check the solution and do not inject if the solution is cloudy or has particles in
it.
• Injecting Genotropin:
Remember to wash your hands and clean your skin first.
Inject your growth hormone at about the same time every day. Bedtime is a good time
because it is easy to remember. It is also natural to have a higher level of growth
hormone at night.
Most people do their injections into their thigh or their bottom. Do your injection in the
place you have been shown by your doctor. Fatty tissue of the skin can shrink at the site
of injection. To avoid this, use a slightly different place for your injection each time. This
gives your skin and the area under your skin time to recover from one injection before it
gets another one in the same place.
Remember to put your Genotropin back in the refrigerator straight after your injection.

If you use more Genotropin than you should

If you inject much more than you should, contact your doctor or pharmacist as soon as
possible. Your blood sugar level could fall too low and later rise too high. You might feel
shaky, sweaty, sleepy or “not yourself”, and you might faint.

If you forget to use Genotropin

Do not use a double dose to make up for a forgotten dose.
It is best to use your growth hormone regularly. If you forget to use a dose, have your
next injection at the usual time the next day. Keep a note of any missed injections and tell
your doctor at your next check-up.

If you stop using Genotropin

Ask for advice from your doctor before you stop using Genotropin.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4. Possible Side Effects
Like all medicines, Genotropin can cause side effects, although not everybody gets them.

Common side effects (likely to occur in fewer than 1 in 10
patients) include:

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Formation of antibodies to the injected growth hormone but these do not seem to stop
the growth hormone from working.

In children:

• Temporary reddening, itchiness or pain at the injection site.

In adults:

• Numbness / tingling,
• Stiffness in the arms and legs, joint pain, muscle pain,
• Water retention (which shows as puffy fingers or swollen ankles). These symptoms
may be seen for a short time at the start of treatment, but they disappear
spontaneously or when the dosage is lowered.
These common side effects in adults may start within the first months of treatment and
may either stop spontaneously or if your dose is reduced.

Uncommon side effects (likely to occur in fewer than 1 in 100
patients) include:
In children:

• Numbness / tingling,
• Stiffness in the arms and legs, joint pain, muscle pain,
• Water retention (which shows as puffy fingers or swollen ankles, for a short time at the
start of treatment).

In adults:

• Pain or burning sensation in the hands or underarms (known as Carpal Tunnel
Syndrome).

Rare side effects (likely to occur in fewer than 1 in 1,000 patients)
include:
• Type 2 diabetes mellitus,
• Increased intracranial pressure (which causes symptoms such as strong headache,
visual disturbances or vomiting).

Very rare side effects (likely to occur in fewer than 1 in 10,000
patients) include:
• Leukemia.

The skin around the injection area can get uneven or lumpy, but this should not happen if
you inject in a different place each time.
A very rare side effect that can occur because of the preservative metacresol is
inflammation of the muscles near the injection site. If your doctor confirms that you have
developed this, you should use a Genotropin product without metacresol.
There have been rare cases of sudden death in patients with Prader-Willi syndrome.
However, no link has been made between these cases and treatment with Genotropin.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. How To Store Genotropin
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton as
MM/YYYY. The expiry date refers to the last day of that month.
Before reconstitution:
Store in a refrigerator (2°C – 8°C). Keep the two-chamber cartridge in the outer carton in
order to protect from light.
Before opening, the product may be taken out of the refrigerator, without being replaced,
for a maximum period of 1 month at a temperature not above 25°C but after this it must
be discarded.

After reconstitution:
Store in a refrigerator (2°C – 8°C) for up to 4 weeks. Do not freeze. Keep the GoQuick
pre-filled pen in the GoQuick outer carton, or the two-chamber cartridge in the Pen box
in order to protect from light.
Do not use this medicine if you notice particles or if the solution is not clear.
Do not freeze or expose Genotropin to frost. If it freezes, do not use it.
Never throw away needles or partly used or empty cartridges with your ordinary rubbish.
When you have finished with a needle, you must discard it carefully so that no-one will be
able to use it or prick themselves on it. You can get a special “sharps” bin from your
hospital or growth clinic.
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.

Manufacturer

Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs
Belgium
This medicinal product is authorised in the Member States of the EEA under the following
names:
Genotropin: Austria, Denmark, Finland, Germany, Greece, Ireland, Italy, Netherlands,
Portugal, Sweden, United Kingdom
Genotonorm: Belgium, France, Luxembourg
Genotonorm Kabipen: Spain

This leaflet was last approved in 09/2013
Ref No: GN30_0

6. Further Information
What Genotropin contains





The active substance is somatropin*.
One cartridge contains 5.3 mg or 12 mg of somatropin*.
After reconstitution the concentration of somatropin* is 5.3 mg or 12 mg per ml.
The other ingredients in the powder are: glycine (E640), mannitol (E421), sodium
dihydrogen phosphate anhydrous (E339), and disodium phosphate anhydrous (E339).
• The ingredients in the solvent are: water for injections, mannitol (E421) and metacresol.
* Produced in Escherichia coli cells by recombinant DNA technology

What Genotropin looks like and contents of the pack

Genotropin is a powder and solvent for solution for injection, in a two-chamber cartridge
containing the powder in one section and the solvent in the other (5.3 mg/ml or 12
mg/ml). The cartridge may be contained in a pre-filled pen. Pack size of 1 or 5 pre-filled
pen(s), or 1 or 5 or 20 cartridge(s).
Not all strengths and pack sizes may be marketed.
The powder is white and the solvent is clear.
You can use the cartridges in a specific pen injection device for Genotropin. Genotropin
cartridges are colour coded and must be used with the matching colour coded
Genotropin Pen to give the correct dose: The Genotropin 5.3 mg cartridge (blue) must be
used with the Genotropin Pen 5.3 (blue). The Genotropin 12 mg cartridge (purple) must
be used with the Genotropin Pen 12 (purple).
The instructions for use of the device are enclosed in the device package. You should
ask your doctor for an injection or reconstitution device if you do not already have one.

Marketing Authorisation Holder
UK PL Holder:
Ireland PA Holder:
Pfizer Limited,
Ramsgate Road,
Sandwich, Kent,
CT13 9NJ, UK

Pfizer Healthcare Ireland,
9 Riverwalk, National Digital Park
Citywest Business Campus,
Dublin 24, Ireland

8R3200

inks on file

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Black

Ask your doctor for advice before using this medicine while breast-feeding.

somatropin

Important information about some of the ingredients of Genotropin
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e.
essentially ‘sodium-free’.

RECTO

PACKAGE LEAFLET: INFORMATION FOR THE USER
GENOTROPIN® 5.3 mg and 12 mg powder and solvent for solution for injection

8R3198
121

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 any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. 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 gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Genotropin is and what it is used for
2. Before you use Genotropin
3. How to use Genotropin
4. Possible side effects
5. How to store Genotropin
6. Further information

1. What Genotropin is and what it is used for
Genotropin is a recombinant human growth hormone (also called somatropin).
It has the same structure as natural human growth hormone which is needed
for bones and muscles to grow. It also helps your fat and muscle tissues to
develop in the right amounts. It is recombinant meaning it is not made from
human or animal tissue.
In children, Genotropin is used to treat the following growth disturbances:
• If you are not growing properly and you do not have enough of your own
growth hormone.
• If you have Turner syndrome. Turner syndrome is a chromosomal error in
girls that can affect growth - your doctor will have told you if you have this.
• If you have chronic renal (kidney) insufficiency. As kidneys lose their ability to
function normally, this can affect growth.
• If you have Prader-Willi syndrome (a chromosomal disorder). Growth
hormone will help you grow taller if you are still growing, and will also
improve your body composition. Your excessive fat will decrease and your
reduced muscle mass will improve.
• If you were small or too light at birth. Growth hormone can help you grow
taller if you have not been able to catch up or maintain normal growth by four
years of age or later.
In adults, Genotropin is used to treat persons with pronounced growth hormone
deficiency. This can start during adult life, or it can continue from childhood.
If you have been treated with Genotropin for growth hormone deficiency during
childhood, your growth hormone status will be retested after completion of
growth. If severe growth hormone deficiency is confirmed, your doctor will
propose continuation of Genotropin treatment.
You should only be given this medicine by a doctor who has experience with
growth hormone treatment and who has confirmed your diagnosis.

2. Before You Use Genotropin

Process Black

Ask your doctor or pharmacist for advice before taking any medicine.

• If you have diabetes, you should closely monitor your blood sugar level
during treatment with Genotropin and discuss the results with your doctor to
determine whether you need to change the dose of your medicines to treat
diabetes.
• After starting Genotropin treatment some patients may need to start thyroid
hormone replacement.
• If you are receiving treatment with thyroid hormones it may be necessary to
adjust your thyroid hormone dose.
• If you are taking growth hormone to stimulate growth and walk with a limp,
or if you start to limp during your growth hormone treatment due to pain in
your hip, you should inform your doctor.
• If you develop raised intracranial pressure (with symptoms such as strong
headache, visual disturbances or vomiting) you should inform your doctor
about it.
• If your doctor confirms that you have developed inflammation of the muscles
near the injection site because of the preservative metacresol, you should
use a Genotropin product without metacresol.
• If you are receiving Genotropin for growth hormone deficiency following a
previous tumour (cancer), you should be examined regularly for recurrence of
the tumour.
• Experience in patients above 80 years of age is limited. Elderly persons may
be more sensitive to the action of Genotropin, and therefore may be more
prone to develop side effects.
Children with chronic renal (kidney) insufficiency:
• Your doctor should examine your kidney function and your growth rate before
starting Genotropin. Medical treatment for your kidney condition should be
continued. Genotropin treatment should be stopped at kidney transplantation.
Children with Prader-Willi syndrome:
• Your doctor will give you diet restrictions to follow to control your weight.
• Your doctor will assess you for signs of upper airway obstruction, sleep
apnoea (where your breathing is interrupted during sleep), or respiratory
infection before you start treatment with Genotropin.
• During treatment, if you show signs of upper airway obstruction (including
starting to snore or worsening of snoring), your doctor will need to examine
you and may interrupt your treatment with Genotropin.
• During treatment, your doctor will check you for signs of scoliosis, a type of
spinal deformity.
• During treatment, if you develop a lung infection, tell your doctor so that he
can treat the infection.
Children born small or too light at birth:
• If you were small or too light at birth and are aged between 9 and 12 years,
ask your doctor for specific advice relating to puberty and treatment with this
product.
• Your doctor will check your blood sugar and insulin levels before the start of
treatment and every year during treatment.
• Treatment should be continued until you have stopped growing.

Do not use Genotropin and tell your doctor if
• You are allergic (hypersensitive) to somatropin or any of the other ingredients
of Genotropin.
• 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
Genotropin.
• You are seriously ill (for example, complications following open heart surgery,
abdominal surgery, acute respiratory failure, accidental trauma or similar
conditions). If you are about to have, or have had, a major operation, or go
into hospital for any reason, tell your doctor and remind the other doctors you
are seeing that you use growth hormone.
• Genotropin has been prescribed to stimulate growth but you have already
stopped growing (closed epiphyses).

Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used any
other medicines, including medicines obtained without a prescription.

Take special care with Genotropin and tell your doctor if any of the
following statements apply to you
• If you are at risk of developing diabetes, your doctor will need to monitor your
blood sugar level during treatment with Genotropin.

Pregnancy and breast-feeding
You should not use Genotropin if you are pregnant, think you may be pregnant
or are trying to become pregnant.

You should tell your doctor if you are using:
• medicines to treat diabetes,
• thyroid hormones,
• synthetic adrenal hormones (corticosteroids),
• sex hormones (for example oestrogens),
• ciclosporin (a medicine that weakens the immune system after
transplantation),
• medicines to control epilepsy (anticonvulsants).
Your doctor may need to adjust the dose of these medicines or the dose of
Genotropin.

3. How To Use Genotropin
Recommended dosage
The dose depends on your size, the condition for which you are being treated
and how well growth hormone works for you. Everyone is different. Your doctor
will advise you about your individualised dose of Genotropin in milligrams (mg)
from either your body weight in kilograms (kg) or your body surface area
calculated from your height and weight in square metres (m2), as well as your
treatment schedule. Do not change the dosage and treatment schedule without
consulting your doctor.
Children with growth hormone deficiency:
0.025-0.035 mg/kg body weight per day or 0.7-1.0 mg/m2 body surface area
per day. Higher doses can be used. When growth hormone deficiency
continues into adolescence, Genotropin should be continued until completion of
physical development.
Children with Turner syndrome:
0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per
day.
Children with chronic renal (kidney) insufficiency:
0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per
day. Higher doses may be necessary if the rate of growth is too low. Dosage
adjustment may be necessary after 6 months of treatment.
Children with Prader-Willi syndrome:
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day.
The daily dosage should not exceed 2.7 mg. Treatment should not be used in
children who have almost stopped growing after puberty.
Children born smaller or lighter than expected and with growth disturbance:
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. It
is important to continue treatment until final height is reached. Treatment
should be discontinued after the first year if you are not responding or if you
have reached your final height and stopped growing.
Adults with growth hormone deficiency:
If you continue Genotropin after treatment during childhood you should start
with 0.2-0.5 mg per day. This dosage should be gradually increased or
decreased according to blood test results as well as clinical response and side
effects.
If your growth hormone deficiency starts during adult life you should start with
0.15-0.3 mg per day. This dosage should be gradually increased according to
blood test results as well as clinical response and side effects. The daily
maintenance dose seldom exceeds 1.0 mg per day. Women may require
higher doses than men. Dosage should be monitored every 6 months. Persons
above 60 years should start with a dose of 0.1–0.2 mg per day which should
be slowly increased according to individual requirements. The minimum
effective dose should be used. The maintenance dose seldom exceeds 0.5 mg
per day. Follow the instructions given to you by your doctor.
Injecting Genotropin
Genotropin is intended for subcutaneous use. This means that it is injected
through a short injection needle into the fatty tissue just under your skin. Your
doctor should have already shown you how to use Genotropin. Always inject
Genotropin exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The instructions for using the pre-filled pen GoQuick® are provided in
the carton with the pre-filled pen.
The instructions for using the Genotropin two-chamber cartridge with
the Genotropin Pen or Genotropin Mixer are provided with your devices.
Refer to the instuctions for use before using your medicine.
When using a pre-filled pen, a pen injection device or reconstitution device, the
needle must be screwed on before mixing. A new needle must be used for
each injection. Needles must not be re-used.
• Preparing the injection:
You can take your Genotropin out of the refrigerator half an hour before your
injection. This lets it warm up slightly and can make your injections more
comfortable.
The GoQuick pre-filled pen contains the two-chamber cartridge that has both
the growth hormone and the dissolving liquid in it. The growth hormone and
the dissolving liquid are mixed together by twisting the cartridge holder (see the
detailed steps in the Instructions for Use). A separate device is not needed.
Genotropin in a two-chamber cartridge contains both the growth hormone and
the dissolving liquid and it is to be used in a Genotropin device. The growth
hormone and the dissolving liquid in the two-chamber cartridge can be mixed
together using a Genotropin Mixer or by screwing the Genotropin Pen device
together.

For both the GoQuick pre-filled pen and the two-chamber cartridge, dissolve
the powder by gently tipping it back and forth 5-10 times until the powder is
dissolved.
When you are mixing your Genotropin, DO NOT SHAKE the solution. Mix it
gently. Shaking the solution could make your growth hormone foam and
damage the active substance. Check the solution and do not inject if the
solution is cloudy or has particles in it.
• Injecting Genotropin:
Remember to wash your hands and clean your skin first.
Inject your growth hormone at about the same time every day. Bedtime is a
good time because it is easy to remember. It is also natural to have a higher
level of growth hormone at night.
Most people do their injections into their thigh or their bottom. Do your injection
in the place you have been shown by your doctor. Fatty tissue of the skin can
shrink at the site of injection. To avoid this, use a slightly different place for
your injection each time. This gives your skin and the area under your skin time
to recover from one injection before it gets another one in the same place.

If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.

5. How To Store Genotropin
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton as
MM/YYYY. The expiry date refers to the last day of that month.
Before reconstitution:
Store in a refrigerator (2°C – 8°C). Keep the two-chamber cartridge in the
outer carton in order to protect from light.
Before opening, the product may be taken out of the refrigerator, without being
replaced, for a maximum period of 1 month at a temperature not above 25°C
but after this it must be discarded.
After reconstitution:
Store in a refrigerator (2°C – 8°C) for up to 4 weeks. Do not freeze. Keep the
GoQuick pre-filled pen in the GoQuick outer carton, or the two-chamber
cartridge in the Pen box in order to protect from light.

Remember to put your Genotropin back in the refrigerator straight after your
injection.

Do not use this medicine if you notice particles or if the solution is not clear.

If you use more Genotropin than you should
If you inject much more than you should, contact your doctor or pharmacist as
soon as possible. Your blood sugar level could fall too low and later rise too
high. You might feel shaky, sweaty, sleepy or “not yourself” and you might
faint.

Never throw away needles or partly used or empty cartridges with your ordinary
rubbish. When you have finished with a needle, you must discard it carefully so
that no-one will be able to use it or prick themselves on it. You can get a
special “sharps” bin from your hospital or growth clinic.

If you forget to use Genotropin
Do not use a double dose to make up for a forgotten dose.
It is best to use your growth hormone regularly. If you forget to use a dose,
have your next injection at the usual time the next day. Keep a note of any
missed injections and tell your doctor at your next check-up.
If you stop using Genotropin
Ask for advice from your doctor before you stop using Genotropin.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4. Possible Side Effects
Like all medicines, Genotropin can cause side effects, although not everybody
gets them.
Common side effects (likely to occur in fewer than 1 in 10 patients)
include:
Formation of antibodies to the injected growth hormone but these do not seem
to stop the growth hormone from working.
In children:
• Temporary reddening, itchiness or pain at the injection site.
In adults:
• Numbness / tingling,
• Stiffness in the arms and legs, joint pain, muscle pain,
• Water retention (which shows as puffy fingers or swollen ankles). These
symptoms may be seen for a short time at the start of treament, but they
disappear spontaneously or when the dosage is lowered.
These common side effects in adults may start within the first months of
treatment and may either stop spontaneously or if your dose is reduced.
Uncommon side effects (likely to occur in fewer than 1 in 100
patients) include:
In children:
• Numbness / tingling,
• Stiffness in the arms and legs, joint pain, muscle pain,
• Water retention (which shows as puffy fingers or swollen ankles, for a short
time at the start of treatment).
In adults:
• Pain or burning sensation in the hands or underarms (known as Carpal
Tunnel Syndrome).
Rare side effects (likely to occur in fewer than 1 in 1,000 patients)
include:
• Type 2 diabetes mellitus,
• Increased intracranial pressure (which causes symptoms such as strong
headache, visual disturbances or vomiting).
Very rare side effects (likely to occur in fewer than 1 in 10,000
patients) include:
• Leukemia.
The skin around the injection area can get uneven or lumpy, but this should not
happen if you inject in a different place each time.
A very rare side effect that can occur because of the preservative metacresol is
inflammation of the muscles near the injection site. If your doctor confirms that
you have developed this, you should use a Genotropin product without
metacresol.
There have been rare cases of sudden death in patients with Prader-Willi
syndrome. However, no link has been made between these cases and
treatment with Genotropin.

Do not freeze or expose Genotropin to frost. If it freezes, do not use it.

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. Further Information
What Genotropin contains
• The active substance is somatropin*.
• One cartridge contains 5.3 mg or 12 mg of somatropin*.
• After reconstitution the concentration of somatropin* is 5.3 mg or 12 mg
per ml.
• The other ingredients in the powder are: glycine (E640), mannitol (E421),
sodium dihydrogen phosphate anhydrous (E339), and disodium phosphate
anhydrous (E339).
• The ingredients in the solvent are: water for injections, mannitol (E421) and
metacresol.
* Produced in Escherichia coli cells by recombinant DNA technology
What Genotropin looks like and contents of the pack
Genotropin is a powder and solvent for solution for injection, in a two-chamber
cartridge containing the powder in one section and the solvent in the other
(5.3 mg/ml or 12 mg/ml). The cartridge may be contained in a pre-filled pen.
Pack size of 1 or 5 pre-filled pen(s), or 1 or 5 or 20 cartridge(s).
Not all strengths and pack sizes may be marketed.
The powder is white and the solvent is clear.
You can use the cartridges in a specific pen injection device for Genotropin.
Genotropin cartridges are colour coded and must be used with the matching
colour coded Genotropin Pen to give the correct dose: The Genotropin 5.3 mg
cartridge (blue) must be used with the Genotropin Pen 5.3 (blue). The
Genotropin 12 mg cartridge (purple) must be used with the Genotropin
Pen 12 (purple).
The instructions for use of the device are enclosed in the device package. You
should ask your doctor for an injection or reconstitution device if you do not
already have one.
Marketing Authorisation Holder
UK PL Holder:
Ireland PA Holder:
Pfizer Limited,
Pfizer Healthcare Ireland,
Ramsgate Road,
9 Riverwalk, National Digital Park
Sandwich, Kent,
Citywest Business Campus,
CT13 9NJ, UK
Dublin 24, Ireland
Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs
Belgium
This medicinal product is authorised in the Member States of the EEA under
the following names:
Genotropin: Austria, Denmark, Finland, Germany, Greece, Ireland, Italy,
Netherlands, Portugal, Sweden, United Kingdom
Genotonorm: Belgium, France, Luxembourg
Genotonorm Kabipen: Spain
This leaflet was last approved in 09/2013
Ref: GN30_0

structure

VERSO

INSTRUCTIONS FOR USE
Important Information
Please read these instructions completely before using GoQuick.
If you have any questions about your dose or your treatment with Genotropin, call your
doctor or nurse.
About GoQuick
GoQuick is a prefilled, multidose, disposable injection pen that holds 5.3 mg of
somatropin. The Genotropin in the pen is mixed only once, when you start a new pen. A
single pen can be used up to 28 days after mixing. You never have to change cartridges.
When the pen is empty, you just start a new pen.
The pen has dose memory. The dose is set once on a new pen. The pen then gives the
same dose for each injection. You can use the pen with or without the optional needle
guard.
Before You Use GoQuick
• Get training from your doctor or nurse.
• Know your dose. Know the pen parts.
• Make sure you have the pen with the blue injection button.
• Wash your hands.

Step 4. Attach the Needle Guard
(Optional)
a. Pull the black cap off the needle guard.
(Figure 4a)
• If the needle shield slides out, push it
back into the needle guard until it
clicks into place.

b. Hold the pen in one hand below the blue
logo. With the other hand, hold the needle
guard below the needle shield. (Figure 4b)
c. Line up the black logo on the needle
guard with the
blue logo on the pen. Carefully push the
needle guard onto the pen until it snaps
into place.

Step 5. Prime the Pen
a. Pull the inner needle cover off.Throw it
away (Figure 5a)

b. Check that 0.1 mg is set in the memory
window.
c. Turn the grey dial in the direction of the
arrows until it stops clicking. (Figure 5b)

Setting Up and Using a New GoQuick
Step 1. Attach the Needle
a. Pull the white pen cap straight off the
pen.
b. Peel the seal from a new needle.
c. Firmly grasp the cartridge holder. (Figure
1)
d. Push the needle onto the cartridge
holder tip.
e. Gently screw the needle onto the pen.
Do not overtighten.
f. Leave both needle covers on the needle.
Step 2. Mix the Genotropin
a. Hold the pen with the needle-end
pointing up and the A facing you. (Figure
2)
b. Firmly twist the cartridge holder into
the pen until B clicks into the notch.
• Gently tilt the pen from side to side. Do
not shake the pen. Shaking may
damage the growth hormone.
c. Check that the liquid in the cartridge is
clear. All the powder should be
dissolved.
• If not, gently tilt the pen from side to
side a few more times.
d. Check the liquid again. Make sure it is
clear.
• If the liquid is clear, go to Step 3.
• If the liquid is still cloudy or you see
any powder, use a new pen.

Process Black

P285C

Step 3. Remove the Air
a. Pull the outer needle cover off. Save it to
remove the needle. (Figure 3a)
b. Leave the inner needle cover on.

c. Hold the pen with the needle-end
pointing up. (Figure 3b)
d. Tap the cartridge holder gently to help
any trapped air move to the top.
e. Firmly twist the cartridge holder into
the pen until C clicks into the notch.
• Some liquid may appear around the
inner needle cover.

Step 7. Draw Up a Dose
a. Turn the grey dial in the direction of the
arrow until the clicking stops. (Figure 7a)
b. Your dose on the black rod should line
up with the white pointer.

c. Check that the dose you drew up on the
black rod is the same as the dose you
set in the memory window. Figure 7b
shows an example.
d. If the doses do not match, make sure
you have turned the grey dial in the
direction of the arrow until it does not
click anymore.

Step 8. Give the Injection
a. Prepare an injection site as your doctor
or nurse has told you.
b. Hold the pen over the injection site.
c. Push the pen down to insert the needle
into the skin.
d. Using your thumb, push the blue
injection button down until it stops
clicking. (Figure 8)
• Count for 5 seconds before you pull
the needle out of the skin. Keep light
pressure on the button with your
thumb while you count.
e. Pull the pen straight out from the skin.

• Without the needle guard:
• Attach a new needle to the cartridge
holder tip.

3. Remove both needle covers. Save
the outer needle cover to remove the
needle.

4. If you use the needle guard, press
the black release button to extend
the needle shield.

5. To draw up the dose, turn the grey
dial until it stops clicking.

d. Hold the pen with the needle pointing
up. (Figure 5c with and without needle
guard)
e. Push the blue injection button until liquid
appears.
f. If liquid does not appear at Step “e”,
repeat Steps b-e in this seciton up to
two more times.
g. If liquid still does not appear, do not use
the pen.
• See the Questions and Answers
section below for more information

h. If you use the needle guard, press the
black button to release the needle
shield. (Figure 5d)

Step 9b: Without needle guard
a. Do not touch the needle.
b. Carefully cover the needle with the outer
needle cover. (Figure 9b)
c. Use the needle cover to unscrew the
needle and put it
in a proper container for used needles.
d. Place the white cap on the pen. Store
your pen in the refrigerator.

Routine Use of GoQuick
Step 6. Set the Dose
• Use the black ring to set the dose. Be
careful not to turn the grey dial while
setting the dose.
a. Hold the black ring as shown in Figure
6.
b. Turn the black ring until your dose lines
up with the white pointer. Your doctor or
nurse has told you your dose.
c. If you turn your dose past the white
pointer, just turn the black ring back to set
the correct dose.
d. Once you have set your dose, do not
change it unless your doctor or nurse tells
you.
Note: If you cannot turn the black ring,
press in the blue injection button until it
stops clicking. Then continue to set your
dose using the black ring (for more
information, see also the Questions and
Answers section below)

1. Pull the black cap from the needle
guard or the white cap from the pen.

Handling
• Do not mix the powder and liquid of
GoQuick unless a needle is on the pen.
• Do not store your GoQuick with the
needle attached. The Genotropin may
leak from the pen and air bubbles may
form in the cartridge. Always remove the
needle and attach the pen cap or needle
guard cap before storing.
• Take care not to drop your GoQuick.
• If you do drop the pen you must perform
another prime as decribed in Step 5
(Setting Up and Using a New GoQuick).
But if any part of your GoQuick appears
broken or damaged, do not use the pen.
Contact your doctor or nurse for another
pen.
• Clean the pen and needle guard with a
damp cloth. Do not put the pen in water.

Needles
• Always use a new needle for each
injection.
• Put all used needles in an appropriate
“sharps” container. Follow your local
health and safety laws to dispose of your
needles. Ask your doctor or nurse, if you
are not sure what to do.
• Do not share your pen or needles.
General
• The numbers and lines on the cartridge
holder can help you estimate how much
Genotropin is left in the pen.
• If in routine use Step 6 the pen does not
have a full dose of Genotropin, the scale
on the black rod indicates the amount of
drug remaining in the pen.
• Patients who are blind or who do not see
well should only use GoQuick with the
help of someone trained to use the pen.
• Follow your doctor or nurse’s instructions
for cleaning your hands and skin when
you prepare and give the injection.
• Do not discard your needle guard, to
remove it from the pen just twist it off.
Save it to use with each new pen.
• If you have questions about how to use
GoQuick, ask you doctor or nurse.

QUESTIONS AND ANSWERS

Question

Step 9. Remove the Needle; Cap and
Store Your Pen
Step 9a: With needle guard
a. Place the outer needle cover into the
end of the needle shield. (Figure 9a)
b. Use the needle cover to push in the
needle shield until
it locks into place.
c. Use the needle cover to unscrew the
needle and put it
in a proper container for used needles.
d. Leave the needle guard on the pen.
e. Place the black cap on the needle
guard. Store your
pen in the refrigerator.

ADDITIONAL INFORMATION
Storage
• See the other side of this leaflet for how
to store your GoQuick.
• After 4 weeks, dispose of the pen (or
discard) even if there is some medicine
left.
• Do not freeze or expose GoQuick to frost.
• Do not use your GoQuick after its expiry
date.
• Follow your local health and safety laws
to dispose of (or discard) your pen. Ask
your doctor or nurse, if you are not sure
what to do.

6. Check that the dose you drew up is
the same as the dose you set in the
memory window.
• If the dose you drew up is smaller, the
pen does not have a full dose of
Genotropin.
• Follow what your doctor or nurse told you
to do when the pen does not have a full
dose left.
7. Prepare an injection site as your
doctor or nurse has told you.
8. Give the injection.
• Push the pen down to insert the needle
into the skin.
• Push the blue injection button down until
it stops clicking.
• Count for 5 seconds before you pull the
needle out of the skin. Keep light
pressure on the button with your thumb
while you count.
• Pull the pen straight out from the skin.
9. Remove the needle.
• With the needle guard:
• Use the outer needle cover to push
in the needle shield until it locks into
place.
• Without the needle guard:
• Carefully cover the needle with the
outer needle cover.

Answer

What should I do if I see more than a small
drop of liquid on the needle after giving
my injection?

For your next injection wait the full time of
5 seconds before taking the needle from the
skin. If you still see some liquid after you
take out the needle, hold in for a little longer
next time.

Is it a problem if I see air bubbles in the
cartridge?

No, small amounts of air may be present in
the cartridge during normal use.

What should I do if I see Genotropin leaking Make sure that the needle has been from
the pen?
attached correctly.
What should I do if the pen that I am using
was not put in the refrigerator overnight?

Discard the pen and use a new GoQuick.

What should I do if I can’t turn the black
ring?

You have probably accidentally turned the
grey dial. If you have turned the grey dial the
pen will prevent you from turning the black
ring so that your dose does not change
during your injection.
To release the black ring, press in the blue
injection button until it stops. Note that liquid
will come out of the needle. Then continue
to set your dose using the black ring.

What if my doctor changes my dose when
I’ve already started a pen?

Set the new dose by turning the black ring.

What if I inject the wrong dose?

Call your doctor or nurse immediately and
follow his/her instructions.

What if my pen will not prime (i.e. if liquid
did not appear in step 5g)?

Call your doctor or nurse and follow his/her
instructions.

What doses can my pen deliver?

The pen can deliver doses from 0.10 mg to
1.5 mg of Genotropin. Each click of the
black ring changes the dose by 0.05 mg.

• Use the outer needle cover to unscrew
the needle. Throw the needle away in a
proper container for used needles.

2. Attach a new needle.
• With the needle guard:
• If the needle shield releases, push it
back into place.
• Attach a new needle to the cartridge
holder tip.

10. Cap your needle guard or pen and
store it in the refrigerator.

8R3198

Expand view ⇕

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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