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SAIZEN 8MG/ML SOLUTION FOR INJECTION

Active substance(s): SOMATROPIN

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Merck Serono SA
Aubonne Branch
Route de La Verrerie 6
CH-1267 Coinsins
COORDINATOR
Name:

Marie-Claude Chollet

Tel.:

+41 (0)21 821 76 78

E-mail:

Marie-Claude.Chollet@external.merckgroup.com

IDENTIFICATION OF THE COMPONENT
ERP component code:

N12Z0201G

Local product name:

SAIZEN

Strength (s):

20 mg 12 mg

1. What Saizen is and what it is used for
Saizen is a growth hormone. Saizen's main action is
to increase growth in children and adolescents and to
treat adults with growth hormone deficiency.

TECHNICAL DATA

Package leaflet: Information for the user

Packaging site:

Merck Serono Aubonne

Technical layout ref:

PIL C_560 x 160 V01

8 mg/ml

COLOURS

solution for injection
somatropin

Printed colour(s)
Black (+15% halftone value)
Technical information(s)

Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.

Keyline
FONT SIZE
Regul. text min. font size:

9 pt

• Keep this leaflet. You may need to read it again.

BARCODE
Bar code type:

Code 128 B

Alpha numeric content:

N12Z0201G

Spotmark:

n/a

• 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 symptoms are the same as yours.

VARIABLE DATA
Online printed datamatrix

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Online printed prefixes

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Prefixes in English

• 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.

Original Prefixes

Date Format

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AGENCY

What is in this leaflet:
1. What Saizen is and what it is used for
2. What you need to know before you use Saizen
3. How to use Saizen
4. Possible side effects
5. How to store Saizen
6. Contents of the pack and other information

The growth hormone (somatropin) contained in
Saizen is almost the same as human’s natural growth
hormone except that it is made outside the body
by a process called “recombinant DNA technology”
(genetic engineering).
Saizen is used:
In children and adolescents:
• in the treatment of children with short stature
who have failed to grow because their body
produces no growth hormone or insufficient levels
of growth hormone
• in the treatment of girls who have failed to grow
due to gonadal dysgenesis (also referred to as
Turner Syndrome), confirmed by a test on the
chromosomes
• in the treatment of pre-pubertal children who
have failed to grow due to chronic renal failure, a
condition in which kidneys are damaged
• in the treatment of growth problems in children
who were born small and who have not reached
normal height by the age of 4 years or later.
In adults:
• in the treatment of adults with a marked lack of
growth hormone ( growth hormone deficiency).
This therapy is given to adults who have a serious
growth hormone deficiency that has been medically
diagnosed by a test.

The doctor or pharmacist will be able to explain why
this medicine has been given to you or to your child.
2. What you need to know before you use Saizen
Do not use Saizen
• If you (or your child) are allergic (hypersensitive) to
somatropin or any of the other ingredients of this
medicine (listed in section 6).
• If you have been told that your child’s bones have
stopped growing and that he/she has therefore
reached his/her final height.
• 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 Saizen.
• If you (or your child) have diabetes and are suffering
from an associated eye disease (proliferative or
preproliferative diabetic retinopathy).
• If you or your child have an acute critical illness,
suffering complications following open heart
surgery, abdominal surgery, multiple accidental
trauma, acute respiratory failure or similar
conditions.
Treatment with Saizen has to be stopped in children
with chronic kidney disease at time of kidney
transplantation.
Warnings and precautions
Talk to your doctor before using Saizen.

Saizen therapy should be carried out under regular
guidance of a doctor who is experienced in the
diagnosis and management of patients with growth
hormone deficiency.

Rarely Saizen may cause an inflammation of the
pancreas, which causes severe pain in the abdomen
and back. Please consider this especially if your child
suffers from stomach ache and contact your doctor.

X-rays of the hip should be obtained prior to initiating
therapy. If your child develops a limp or complains of
hip or knee pain while being treated with Saizen, tell
your doctor.

Shortly after Saizen is given, you (or your child) may
feel shaky or light-headed due to low blood sugar
levels. These feelings will quickly disappear. Your
(or your child’s) blood sugar levels may then rise
above normal 2-4 hours after administration. Since
treatment with growth hormone can alter how your
body handles sugar, your (or your child’s) sugar levels
will be tested regularly by a doctor. Somatropin may
cause you (or your child’s) blood sugar to increase.

Some patients may develop swelling of the brain,
while taking Saizen. If you (or your child) suffer
from a bad or recurrent headache, problems with
your eyesight, feel sick (nausea) and/or being sick
(vomiting), contact your doctor immediately. In this
case it may be necessary to stop the growth hormone
treatment, although treatment may be re-started at
a later date. If the symptoms of brain swelling come
back, treatment with Saizen should be discontinued.

Treatment with Saizen will be stopped in children with
chronic kidney failure at the time of kidney transplant.

If you (or your child) are diabetic or a member of your
family has diabetes, your doctor will monitor closely
your blood sugar level and may adjust the treatment
for diabetes while you are being treated with Saizen.

When the medicine is injected into the same place
over a long period of time, it can cause damage to
this area. It is therefore important to keep changing
the injection site. Your doctor or pharmacist can speak
to you about which parts of the body should be used
(see section 3 How to use Saizen).

Please be aware that you may need regular eye tests
after having this medicine.
Saizen may affect how your thyroid works. Your
doctor may test your blood for levels of thyroid
hormones and prescribe another hormone if you
(or your child) are found to have developed a lack of
thyroid hormone.
Saizen may cause fluid retention in adult patients.
This may appear as swelling and joint or muscle pain.
If you feel these symptoms tell your doctor who may
decide to adjust your dose of Saizen.
If you have had a tumour in your childhood and
were treated with Saizen, there is an increased risk
to develop a new tumour. If in the past you (or your
child) have had a condition affecting the brain, e.g. a
tumour, the doctor will examine you (or your child)
regularly to check that this has not come back again.

Some children with growth hormone deficiency
have developed leukaemia (increased number of
white blood cells), whether or not they have received
treatment with growth hormone. However there is
no evidence that leukaemia incidence is increased
in growth hormone recipients without predisposing
factors. No cause and effect relationship with growth
hormone treatment has been proven.
Hip problems may occur more commonly in children
with hormone or kidney problems. If your child has
chronic renal failure, which can occur when kidneys are
damaged, he or she should be examined periodically
for evidence of bone disease. It is uncertain whether
the bone disease in children with hormone or kidney
problems is affected by growth hormone therapy.

Saizen is not indicated for the long-term treatment
of paediatric patients who have growth failure due
to genetically confirmed Prader-Willi Syndrome,
unless they also have a diagnosis of growth
hormone deficiency. There have been reports of sleep
apnoea and sudden death after initiating therapy
with growth hormone in paediatric patients with
Prader-Willi Syndrome who had one or more of the
following risk factors: severe obesity, history of upper
airway obstruction or sleep apnoea, or unidentified
respiratory infection.
Growth hormone should generally not be used by
people who are seriously ill.
If you do not respond to the therapy with Saizen,
you may have developed antibodies to growth
hormone. Your doctor will conduct appropriate tests
to determine this.
If you are over 60 years old or if you are taking
Saizen for a long time you should be examined more
frequently by your doctor. As there is less experience
both in the treatment of older people and in prolonged
treatment with Saizen, special care is required.

It is usually safe to take other medicines. However,
if you (or your child) are using corticosteroids, it is
important to tell the doctor or pharmacist. These
medicines could interact with Saizen and therefore
your doctor may need to adjust the dose of these
medicines or your Saizen dose. Corticosteroids are
used to treat several illnesses including asthma,
allergies, kidney rejection and rheumatoid arthritis.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
There is currently insufficient evidence from human
studies on the safety of growth hormone treatment
during pregnancy and breast feeding. Saizen should
be discontinued, if pregnancy occurs.
Driving and using machines
No studies on the effects of Saizen on the ability to
drive and use machines have been performed.
Somatropin-containing products have no influence
on the ability to drive and use machines.
3. How to use Saizen
Always use this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.

Other medicines and Saizen
Tell your doctor or pharmacist if you (or your child)
are using, have recently used or might use any other
medicines.

The dose and frequency of administration of Saizen
will be decided by your doctor and will depend on your
(or your child’s) body weight or body surface area.
Children and adolescents:
• Short stature due to a lack of, or insufficient levels
of natural growth hormone:
0.7-1.0 mg/m2 body surface area each day or
0.025-0.035 mg/kg body weight each day by
subcutaneous administration (under the skin)
• Growth failure in girls due to gonadal dysgenesis
(Turner Syndrome):
1.4 mg/m2 body surface area per day or
0.045-0.050 mg/kg body weight each day by
subcutaneous administration (under the skin).
If your daughter is treated for Turner Syndrome
and she receives non-androgenic anabolic steroids
as well , growth response may be enhanced. Ask
your doctor or pharmacist if you are not sure
about these drugs.
• Growth failure in pre-pubertal children due to
chronic renal failure, a condition in which kidneys
are damaged:
1.4 mg/m2 body surface area, approximately equal
to 0.045-0.050 mg/kg body weight each day by
subcutaneous administration (under the skin).
• Growth problems in children who were born small:

Dosage
It is recommended that Saizen be administered at
bedtime.

1 mg/m2 body surface area, approximately
equal to 0.035 mg/kg body weight each day by
subcutaneous administration (under the skin).

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Date
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Designer
Yolanda Perdicaro

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Merck Serono SA
Aubonne Branch
Route de La Verrerie 6
CH-1267 Coinsins
COORDINATOR
Name:

Marie-Claude Chollet

Tel.:

+41 (0)21 821 76 78

E-mail:

Marie-Claude.Chollet@external.merckgroup.com

IDENTIFICATION OF THE COMPONENT

Adults:

ERP component code:

N12Z0201G

• Growth Hormone Deficiency in adults:

Local product name:

SAIZEN

Strength (s):

20 mg 12 mg

At the start, low doses of 0.15-0.30 mg each day
are recommended by subcutaneous injection (under
the skin). The dose will be adjusted in stages by your
doctor. The recommended final dose of growth
hormone rarely exceeds 1.0 mg/day. In general the
lowest efficacious dose that works for you should be
administered. If you are older or overweight, a lower
dose may be necessary.

TECHNICAL DATA
Packaging site:

Merck Serono Aubonne

Technical layout ref:

PIL C_560 x 160 V01

COLOURS
Printed colour(s)

Method and route of administration
The dose and frequency of administration of Saizen
will be decided by your doctor and will depend on your
(or your child’s) size or body weight. In general Saizen
should be administered each day by subcutaneous
injection (under the skin).

Black (+15% halftone value)
Technical information(s)
Keyline
FONT SIZE
Regul. text min. font size:

9 pt

Important information

BARCODE
Bar code type:

Code 128 B

Alpha numeric content:

N12Z0201G

Spotmark:

n/a

For administration of Saizen, please read the following
instructions carefully.

VARIABLE DATA
Online printed datamatrix
Online printed prefixes

n/a
n/a

Prefixes in English

Original Prefixes

Date Format

1.

n/a

n/a

n/a

2.

n/a

n/a

n/a

3.

n/a

n/a

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AGENCY

When the medicine is injected into the same place
every time for a long time, it can cause damage. It
is important to keep changing the place where you
have your injection. Your doctor or pharmacist can
speak to you about which part of the body you should
use. Do not use any areas in which you feel lumps,
firm knots, depressions, or pain; talk to your doctor
or pharmacist about anything you find. Clean the skin
at the injection site with soap and water.
The cartridge containing the solution of Saizen is
ready to be used for administration with your cool.
click needle-free auto-injectors or easypod autoinjector.

Place all elements needed for the injection of the
solution on a clean surface and wash your hands with
soap and water.
The solution should be clear to slightly opalescent
with no particles and without visible signs of
deterioration. If the solution contains particles, it
must not be injected.

to changes in blood sugar levels which could mean
that you (or your child) will feel shaky and lightheaded. If this happens contact your doctor as soon
as possible.

• very rare: may affect up to 1 in 10,000 people
• not known: frequency cannot be estimated from
the available data.

If you forget to use Saizen

Common side effects:

If you miss a dose, tell your doctor as it may be
necessary to slightly change the dose to make up for
this.

• Redness and itching at the site of injection If this
appears to be particularly troublesome, you should
discuss this with your doctor.

For instructions on how to load the cartridge into
the cool.click needle-free auto-injectors or easypod
auto-injector and inject the solution of Saizen, please
carefully read the corresponding instruction manual
provided with each auto-injector. Intended users
of easypod are primarily children starting from the
age of 7 up to adults. Use of the devices by children
should always be made under adult’s supervision.

If you stop taking Saizen

• Oedema (swelling), muscle pain, joint pain, and
joint disorders in adult users. These side-effects
appear usually early in the treatment and are
short-lived.

Frequency of administration

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

How to perform your daily self-administration of
Saizen

It is recommended that Saizen be administered at
bedtime.
Duration of treatment
Your child should stop using this treatment when he
or she reaches a satisfactory adult height or his or
her bones cannot grow any longer, as assessed by his
or her doctor. Treatment with Saizen will be stopped
in children with chronic kidney failure at the time of
kidney transplant.
If you use more Saizen than you should
If you inject too much Saizen, you should tell your
doctor as it may be necessary to change slightly the
dose to make up for this. Injecting too much can lead

Do not stop taking Saizen without speaking with your
doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects

Tell your doctor immediately if you experience
strong and recurrent headaches associated
with feeling sick (nausea), vomiting or sight
disturbances. These are symptoms of a side effect
called benign intracranial hypertension and it is
uncommon.
Side effects may occur with certain frequencies,
which are defined as follows:
• very common: may affect more than 1 in 10 people
• common: may affect up to 1 in 10 people
• uncommon: may affect up to 1 in 100 people
• rare: may affect up to 1 in 1,000 people

• (Isolated) headache.
Uncommon side effects:
• Carpal tunnel syndrome that is characterized by
persistent stinging, burning sensation, pain and/
or numbness in the hand.
• Oedema (swelling), muscle pain, joint pain, and
joint disorders in children. These side-effects
appear usually early in the treatment and are
short-lived.
Very rare side effects:
• Slipped capital femoral epiphysis (a hip problem
that starts if the growing end of the thigh bone
slips from the ball of the hip joint) and avascular
necrosis of the femoral head. If your child shows
an unexplained limp and hip or knee pain, please
contact your doctor or pharmacist.

• Growth hormone treatment may reduce the levels
of thyroid hormone. This can be tested by your
doctor and if necessary your doctor will prescribe
the adequate treatment.
You (or your child) can experience allergic reactions
due to the treatment with Saizen.

Ireland:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2
Tel:+353 1 6764971
Fax:+353 1 6762517

You (or your child) can experience high blood sugar
further to growth hormone treatment.

Website:www.hpra.ie

Leukemia has been reported in a small number of
growth hormone deficiency patients, some of whom
have been treated with somatropin. However, there
is no evidence that leukaemia incidence is increased
in growth hormone recipients without predisposing
factors.

By reporting side effects you can help provide more
information on the safety of this medicine.

Rarely an inflammation of the pancreas has been
reported in patients treated with growth hormone.
Very rarely a patient could develop antibodies (type
of protein that helps protect the body) to somatropin.
These are usually not associated with any side effects
and do not usually interfere with growth.

e-mail:medsafety@hpra.ie

5. How to store Saizen

The other ingredients are sucrose, poloxamer 188,
phenol, citric acid (for pH adjustment), sodium
hydroxide (for pH adjustment), water for injection.

Store the unused Saizen cartridge in a refrigerator
(2°C-8°C) in the original package to protect from
light. Do not freeze.

What Saizen looks like and contents of the pack

After first injection, the Saizen cartridge or the
easypod auto-injector containing the Saizen cartridge
has to be stored in a refrigerator (2°C-8°C) for a
maximum of 28 days, of which up to 7 consecutive
days can be outside of a refrigerator at or below
25°C. When stored outside of the refrigerator for up
to 7 consecutive days, the Saizen cartridge must be
returned to the refrigerator and used within 28 days
after first injection.

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

This leaflet was last revised in August 2016

6. Contents of the pack and other information

Do not use Saizen after the expiry date which is stated
on the cartridge after EXP. The expiry date refers to
the last day of that month.

After first injection, use within 28 days.

Merck Serono SpA, Modugno, Bari, Italy

What Saizen contains
The active substance is somatropin (Recombinant
Human Growth Hormone)..

If you get any side effects, talk to your doctor,
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via

Manufacturer

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 to protect the environment.

Keep this medicine out of the sight and reach of
children.

Reporting of side effects

UK:

When using the easypod auto-injector, the cartridge
is kept in the device. The cool.click needle-free autoinjector should be stored outside of a refrigerator
always separately from the Saizen cartridge. Protect
the used cartridge from light.

Saizen 8 mg/ml is a solution for injection in a prefilled cartridge (type 1 glass) with a plunger stopper
(rubber) and a crimp cap (aluminium and rubber).
Pack sizes of 1 and 5 cartridges containing 1.50 ml
solution (12 mg somatropin) or 2.50 ml solution
(20 mg somatropin).
Not all pack sizes may be marketed.
Marketing Authorization Holder
Merck Serono Limited, Bedfont Cross, Stanwell Road,
Feltham, Middlesex, TW14 8NX, UK.

TW828674/1119576

N12Z0201G

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page 2

TRACEABILITY (VERSIONS)
Vx
01

Date
15.08.2016

Designer
Yolanda Perdicaro

02

16.08.2016

Yolanda Perdicaro

03

n/a

n/a

04

n/a

n/a

05

n/a

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+ 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.

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