View Patient Information Leaflet

View Patient Information Leaflet
Merck Serono SA
Aubonne Branch
Route de La Verrerie 6
CH-1267 Coinsins
Name:
Marie-Claude Chollet
Tel.:
+41 (0)21 821 76 78
E-mail:
Marie-Claude.Chollet@external.merckgroup.com
N1280202H
COORDINATOR
IDENTIFICATION OF THE COMPONENT
ERP component code:
N1280202H
Local product name:
SAIZEN
Strength (s):
8 mg
1. WHAT SAIZEN IS AND WHAT IT IS USED FOR
TECHNICAL DATA
Packaging site:
Merck Serono Bari
Technical layout ref:
FL02 - 560 x 160 mm
COLOURS
Printed colour(s)
Black (+15% halftone value)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Technical information(s)
n/a
n/a
8 mg click.easy
FONT SIZE
Regul. text min. font size:
9 pt
®
powder and solvent for solution for injection
BARCODE
somatropin
Bar code type:
Code 128 B
Alpha numeric content:
N1280202H
Spotmark:
n/a
VARIABLE DATA
Online printed prefixes
What is in this leaflet:
1. What Saizen is and what it is used for
2. What you need to know before your use Saizen
3. How to use Saizen
4. Possible side effects
5. How to store Saizen
6. Contents of the pack and other information
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Prefixes in English
Original Prefixes
Date Format
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2. n/a
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3. n/a
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AGENCY
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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 symptoms 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.
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.
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 deficiency ( 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. 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 or the liquid used to make up the
injection (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 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.
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.
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).
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.
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.
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.
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 stomachache and contact your doctor.
Some patients may develop swelling of the brain,
while taking Saizen. If you (or your child) suffer from
a bad or recurrent headache, have 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.
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
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.
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.
Treatment with Saizen will be stopped in children with
chronic kidney failure at the time of kidney transplant.
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.
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.
It is usually safe to use 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.
Dosage
It is recommended that Saizen be administered at
bedtime.
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:
1 mg/m2 body surface area, approximately
equal to 0.035 mg/kg body weight each day by
subcutaneous administration (under the skin).
Adults:
• Growth Hormone Deficiency in adults:
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.
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
8 mg click.easy should be administered each day by
subcutaneous injection (under the skin).
The product (powder in vials) must be reconstituted
with the enclosed bacteriostatic solvent using the
click.easy reconstitution device.
The reconstituted solution is intended for
subcutaneous administration (under the skin) and
should be clear with no particles. If the solution
contains particles, it must not be injected. The
reconstituted solution contains 8 mg of Saizen (5.83
mg/ml).
Important information
Patients should be thoroughly instructed in the
reconstitution procedure.
For young children, the reconstitution process should
be supervised by an adult.
For administration of Saizen 8 mg click.easy, please
read the following instructions carefully.
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.
A separate leaflet in this box gives you detailed
instructions in pictures about how to use this
reconstitution kit.
Please consult your doctor, or pharmacist, if you have
any questions concerning the reconstitution process.
page 1
TRACEABILITY (VERSIONS)
Vx
Date
Designer
01
18.05.2015
Yolanda Perdicaro
02
22.05.2015
03
28.05.2015
Yolanda Perdicaro
04
n/a
n/a
05
n/a
n/a
Yolanda Perdicaro
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
(e) Tamper
evident seal
(g) Cap
IDENTIFICATION OF THE COMPONENT
ERP component code:
N1280202H
Local product name:
SAIZEN
Strength (s):
8 mg
(c) Solvent
Cartridge
(b) Sterile
transfer cannula
TECHNICAL DATA
Packaging site:
Technical layout ref:
FL02 - 560 x 160 mm
Printed colour(s)
Black (+15% halftone value)
Technical information(s)
n/a
FONT SIZE
Regul. text min. font size:
9 pt
BARCODE
Bar code type:
Code 128 B
Alpha numeric content:
N1280202H
Spotmark:
n/a
VARIABLE DATA
Online printed prefixes
(d) Tamper
evident seal
(a) Saizen® vial
Merck Serono Bari
COLOURS
n/a
(f) Green
button
n/a
Prefixes in English
Original Prefixes
Date Format
1. n/a
n/a
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2. n/a
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3. n/a
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AGENCY
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How to prepare your solution of Saizen 8 mg
click.easy
• Make sure the click.easy is complete by checking
that the Saizen vial (a), the sterile transfer cannula
(b) and the solvent cartridge (c) are present.
• Check that the tamper evident seals on the click.
easy housing (d) and on the cap (e) are not broken.
If either of the tamper evident seals are broken
return it to your pharmacist or doctor.
• Place all elements needed for the preparation of
the solution on a clean surface.
• Wash your hands with soap and water.
1. Place the click.easy reconstitution device vertically
on a flat surface with the vial at the bottom and
the cap (g) facing upward.
2. Push the cap down until it will go no further. (Note:
The tamper evident seal on the click.easy housing
is now broken).
3. Turn slightly the cap clockwise until the green
button (f) is positioned in the vertical opening.
4. Continue pushing the cap down very slowly until it
will go no further to transfer the solvent from the
cartridge into the vial (Note: The tamper evident
seal on the cap is now broken). It is important to
push slowly to avoid foam formation in the vial.
Check that all the solvent has been transferred
into the vial.
5. Dissolve the powder with the solvent by gently
swirling the click.easy (Please note that you should
not shake the solution strongly or you will cause
the solution to foam). Avoid vigorous shaking to
prevent creation of foam. Let the solution stand
until the powder is completely dissolved. If the
solution contains particles, it must not be injected.
Push the cap back down until it will go no further
and keep it in position.
6. Turn the click.easy so that the vial is at the top and
pull the cap slowly downwards until the solution is
completely drawn back into the cartridge.
Check that no more than one or two drops of
solution remain in the vial.
If there are more than one or two drops of solution
remaining in the vial, slowly push the cap up until
some of the solution is back in the vial and gently
tap the click.easy. Then draw the solution slowly
again back into the cartridge.
7. Remove any excess air that has been drawn into
the cartridge by pushing slowly the cap up until no
air is visible in the cartridge.
(Note: Avoid pulling the cap down too fast, as this
will draw air into the cartridge).
8. Keeping the click.easy in this position (vial on the
top) unscrew the cap and remove it.
Still keeping the same position (vial on the top)
remove the cartridge containing the reconstituted
solution for injection from the click.easy.
9. Carefully peel off the outer label using the tab
provided. Write the reconstitution date on the
transparent inner label on the cartridge. Discard
the click.easy safely in accordance with your local
requirements.
The cartridge containing the reconstituted solution
of Saizen is now ready to be used for administration
with your one.click auto-injector, cool.click needlefree auto-injectors or easypod auto-injector.
The reconstituted solution should be clear with no
particles. If the solution contains particles, it must
not be injected.
How to perform your daily self-administration
of Saizen
For instructions on how to load the cartridge into
the one.click auto-injector, how to use the cool.click
needle-free auto-injectors or easypod auto-injector
and inject the reconstituted 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
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.
Frequency of administration
It is recommended that Saizen be administered at
bedtime.
Side effects may occur with certain frequencies,
which are defined as follows:
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.
• common: may affect up to 1 in 10 people
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
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.
If you forget to use Saizen
If you miss a dose, tell your doctor as it may be
necessary to slightly change the dose to make up for
this.
If you stop taking Saizen
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.
• very common: may affect more than 1 in 10 people
• uncommon: may affect up to 1 in 100 people
• rare: may affect up to 1 in 1,000 people
• very rare: may affect up to 1 in 10,000 people
• not known: frequency cannot be estimated from
the available data.
Common side effects:
• Redness and itching at the site of injection. If this
appears to be particularly troublesome, you should
discuss it with your doctor.
• 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.
Uncommon side effects:
• Carpal tunnel syndrome that is characterized by
persistent stinging, burning sensation, pain and/or
numbness in the hand. (Isolated) headache.
• 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 high blood sugar
further to growth hormone treatment.
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.
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.
Reporting of side effects:
If you get any side effects, 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
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE SAIZEN
Keep this medicine out of the sight and reach of
children.
Do not use Saizen after the expiry date which is stated
on the vial after EXP. The expiry date refers to the last
day of that month.
Do not store above 25°C. Do not freeze. Store in the
original package in order to protect from light.
Saizen 8 mg click.easy reconstituted solution should
be stored in a refrigerator (2°C-8°C) in the cartridge
and should be used within 28 days.
When using the easypod and one.click auto-injectors,
the cartridge is kept in the device and the device must
be stored in the refrigerator. When using the cool.
click needle-free auto-injectors, only the cartridge of
reconstituted Saizen should be stored in a refrigerator
(2°C-8°C).
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.
What Saizen looks like and contents of the pack
Saizen 8 mg click.easy is a powder for solution for
injection. It is available in the following pack sizes:
• 1 vial of Saizen 8 mg product and 1 cartridge of
bacteriostatic solvent (water for injection and
metacresol) pre-assembled in 1 reconstitution
device (click.easy).
• 5 vials of Saizen 8 mg product and 5 cartridges
of bacteriostatic solvent (water for injection and
metacresol) pre-assembled in 5 reconstitution
devices (click.easy).
Not all pack sizes may be marketed.
Marketing Authorization Holder
Merck Serono Limited
Bedfont Cross
Stanwell Road
Feltham
Middlesex
TW14 8NX
United Kingdom
Manufacturer
Merck Serono SpA, Modugno, Bari, Italy
This leaflet was last revised in March 2015
The product has the same name in all countries where
it is marketed.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Saizen contains
The active substance is somatropin (Recombinant
Human Growth Hormone) 8 mg.
The other ingredients are sucrose, phosphoric acid
and sodium hydroxide (for pH-adjustment).
The solvent is metacresol (as preservative 0.3% w/v)
solution in water for injection.
TW864513
N1280202H
page 2
TRACEABILITY (VERSIONS)
Vx
Date
Designer
01
18.05.2015
Yolanda Perdicaro
02
22.05.2015
03
28.05.2015
Yolanda Perdicaro
04
n/a
n/a
05
n/a
n/a
Yolanda Perdicaro
1
3
6
4
2
5
i
i
6
6
6
I1979 Black
Item code
N1280004B
I1979 Cyan
Item Description
FPP SAIZEN CE NEW DOUBLE
LOGO IFU INT B
I1979 Magenta
I1979 Yellow
Replaced item code Folded Size
N1280004A
04/08/11
01
160 x 225 mm
Remarks
7a
7b
7c
u
u
u
8
9a
9b
3x
6
N1280004B
I1979 Black
Item code
N1280004B
I1979 Cyan
Item Description
FPP SAIZEN CE NEW DOUBLE
LOGO IFU INT B
I1979 Magenta
I1979 Yellow
Replaced item code Folded Size
N1280004A
04/08/11
01
160 x 225 mm
Remarks
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