OMNITROPE 1.3 MG/ML Roztwór do wstrzykiwań

Treść ulotki

1. Omnitrope 5 mg/1,5 ml injectable solution in cartridge, 10 mg/1,5 ml injectable solution in cartridge
   1. What is Omnitrope and what is it used for
   2. What you need to know before using Omnitrope
   3. How to use Omnitrope
   4. Possible side effects
   5. How to store Omnitrope
   6. Package contents and other information
2. Omnitrope 5 mg/1,5 ml injectable solution in cartridge, 10 mg/1,5 ml injectable solution in cartridge, 15 mg/1,5 ml injectable solution in cartridge
   1. What is Omnitrope and what is it used for
   2. What you need to know before using Omnitrope
   3. How to use Omnitrope
   4. Possible side effects
   5. How to store Omnitrope
   6. Contents of the pack and other information

Omnitrope 5 mg/1,5 ml injectable solution in cartridge, 10 mg/1,5 ml injectable solution in cartridge

somatropina

Read this leaflet carefully before you use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Omnitrope and what is it used for

Omnitrope is a recombinant human growth hormone (also known as somatropin). The
structure is identical to natural human growth hormone, which is needed for the growth of bones and muscles
and promotes the correct development of adipose and muscle tissue. “Recombinant” means that it is not
extracted from human or animal tissues.

In children, Omnitrope is indicated for the treatment of the following growth disorders:

• If they are not growing as they should and do not produce enough growth hormone.
• If they have Turner syndrome. Turner syndrome is a genetic disease that affects children and can impair growth. If they suffer from this syndrome, they have already been informed by their doctor.
• If they have chronic renal insufficiency. If the kidneys lose the ability to function properly, growth may be affected.
• If they were small or underweight at birth. Growth hormone can promote height gain if they have not shown a recovery or continuation of normal growth within four years of age or later.
• If they have Prader-Willi syndrome (a chromosomal disease). Growth hormone promotes growth if they are still growing and improves body composition. Excess fat is reduced and insufficient muscle mass increases.

In adults, Omnitrope is indicated for

• the treatment of people with severe growth hormone deficiency. The deficiency may begin in adulthood or persist from childhood. If they have been treated with Omnitrope due to growth hormone deficiency in childhood, growth hormone levels will be determined again at the end of physical development. If severe growth hormone deficiency is confirmed, the doctor will propose to continue treatment with Omnitrope.

This medicine must be administered to you exclusively by a doctor experienced in the treatment
with growth hormone and who has confirmed the diagnosis.

2. What you need to know before using Omnitrope

Do not use Omnitrope

• if you are allergic (hypersensitive) to somatropin or any of the other ingredients of Omnitrope.
• and inform your doctor if you have an active tumor (cancer). Tumors must be inactive and antitumor therapy must be completed before starting treatment with Omnitrope.
• and inform your doctor if Omnitrope has been prescribed to you to stimulate growth, but you have already stopped growing (epiphyses closed).
• if you are seriously ill (for example, complications from open-heart surgery, abdominal surgery, accidental trauma, acute respiratory failure or similar clinical situations). If you are about to undergo or have undergone major surgery or if you need to be hospitalized for any reason, inform your doctor and remind the doctors who visit you that you are using growth hormone.

Warnings and precautions
Consult your doctor before using Omnitrope.

• If you are taking replacement therapy with glucocorticoids, you should consult your doctor regularly, as you may need to adjust your dose of glucocorticoids.
• If you are at risk of developing diabetes, your doctor will need to check your blood sugar during therapy with somatropin.
• If you have diabetes, you should carefully monitor your blood sugar during treatment with somatropin and discuss the measured values with your doctor, in order to determine whether the dose of the medicines used to treat diabetes needs to be modified.
• After starting treatment with somatropin, some patients may need thyroid hormone replacement therapy.
• If you are already being treated with thyroid hormones, it may be necessary to adjust the dose.
• If you suffer from increased intracranial pressure (which causes symptoms such as severe headache, visual disturbances or vomiting), inform your doctor.
• If you limp or start to limp during treatment with growth hormone, inform your doctor.
• If you are being treated with somatropin due to a growth hormone deficiency for a previous tumor (cancer), you should be checked at regular intervals to detect any tumor recurrence or another type of cancer.
• If you have abdominal pain that worsens, you should inform your doctor.
• Experience in patients over 80 years of age is limited. Elderly people may be more sensitive to the action of somatropin and therefore more prone to developing adverse effects.
• Omnitrope can cause inflammation of the pancreas, which causes severe abdominal and back pain. Contact your doctor if you or the child experience stomach pain after taking Omnitrope.
• An increase in lateral curvature of the spine (scoliosis) may progress in any child during rapid growth. During treatment with somatropin, the doctor will monitor for any signs of scoliosis in you (or your child).

Children with chronic renal insufficiency

• Before starting treatment with somatropin, the doctor will check renal function and growth rate. Pharmacological treatment for renal function must continue. Treatment with somatropin must be discontinued on the occasion of kidney transplantation.

Children with Prader-Willi syndrome

• The doctor will prescribe you a diet to control body weight.
• Before starting treatment with somatropin, the doctor will check for any signs of upper airway obstruction, sleep apnea (interruption of breathing during sleep) or respiratory infection.
• During treatment with somatropin, inform your doctor if you experience signs of upper airway obstruction (such as the appearance or increase of snoring); in this case, the doctor will examine you and possibly interrupt treatment with somatropin.
• During treatment, the doctor will check for signs of scoliosis, a type of spinal deformity.
• Inform your doctor if you develop a lung infection during treatment, so that the infection can be treated.

Children born small or with low birth weight

• If the child was small or of low weight at birth and is now between 9 and 12 years of age, specifically ask your doctor for advice on treatment with this medicine during puberty.
• Treatment should continue until growth is complete.
• The doctor will check blood glucose and insulin levels before starting treatment and annually during therapy.

Other medicines and Omnitrope
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
In particular, inform your doctor if you are taking or have recently taken any of the following
medicines. Your doctor may need to adjust the dosage of Omnitrope or other medicines:

• medicines for the treatment of diabetes,
• thyroid hormones,
• medicines to control epilepsy (anticonvulsants),
• cyclosporine (a medicine that weakens the immune system after a transplant),
• estrogens taken orally or other sex hormones
• synthetic adrenal hormones (corticosteroids). It may be necessary for the doctor to adjust the dose of these medicines or the dose of somatropin.

Pregnancy and breastfeeding
Do not use Omnitrope if you are pregnant or trying to become pregnant.
If you are pregnant or breastfeeding, ask your doctor or
pharmacist for advice. This is because benzyl alcohol can accumulate in the body and can cause adverse
effects (so-called “metabolic acidosis”).

Important information about some excipients of Omnitrope
This medicine contains less than 1 mmol (23 mg) of sodium per mL, i.e. it is practically “sodium-free”.
Omnitrope 5 mg/1.5 ml solution for injection:
This medicine contains 9 mg of benzyl alcohol per ml.
Benzyl alcohol can cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects including breathing problems
(agonal respiratory syndrome) in young children.
Do not administer to infants under 4 weeks of age unless otherwise recommended by your doctor.
Ask your doctor or pharmacist if you have a liver or kidney disease. This is because
large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (such as
metabolic acidosis).
Due to the presence of benzyl alcohol, this medicine should not be given to premature babies
or newborns. It can cause toxic and allergic reactions in children up to 3 years of age.
Do not use for more than one week in young children (under 3 years of age) unless otherwise
recommended by your doctor or pharmacist.

3. How to use Omnitrope

Use this medicine following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, consult your doctor, nurse or pharmacist.
The dose depends on your physical condition, the disease to be treated and the action of growth hormone on
you. Each of us is different from others. The doctor will establish the most suitable dose of Omnitrope for you; the dose
is calculated in milligrams (mg) based on body weight in kilograms (kg) or based on the
body surface area calculated using height and weight and expressed in square meters (m²). The doctor will
also inform you about the treatment schedule. Do not change the dosage and treatment schedule
without consulting your doctor.

The recommended dose is for:
Children with growth hormone deficiency
0.025-0.035 mg/kg of body weight per day, or 0.7-1.0 mg/m² of body surface area per day.
Higher doses may also be used. If growth hormone deficiency persists
during adolescence, treatment with Omnitrope must continue until the end of physical development.

Children with Turner syndrome
0.045-0.050 mg/kg of body weight per day, or 1.4 mg/m² of body surface area per day.

Children with chronic renal insufficiency
0.045-0.050 mg/kg of body weight per day, or 1.4 mg/m² of body surface area per day. If
the growth rate is low, higher doses may be necessary. After six months of treatment
a dosage adjustment may be necessary.

Children with Prader-Willi syndrome
0.035 mg/kg of body weight per day, or 1.0 mg/m² of body surface area per day. The dose
daily should not exceed 2.7 mg. Treatment should not be performed in adolescents who have
almost completed growth after puberty.

Small children or with low birth weight and with growth disorders
0.035 mg/kg of body weight per day, or 1.0 mg/m² of body surface area per day. It is
important to continue treatment until final height is reached. Treatment should be
discontinued after the first year in case of no response or reaching final height
and end of growth.

Adults with growth hormone deficiency
If you continue to take Omnitrope after being treated in childhood, you should start with
0.2-0.5 mg per day.
This dose should be gradually increased or decreased based on blood test results,
clinical response and side effects.
If growth hormone deficiency begins in adulthood, you should start with 0.15-0.3 mg per day.
This dose will be gradually increased based on blood test results, response
clinical and side effects. The daily maintenance dose generally does not exceed 1.0 mg per
day. Women may need higher doses than men. The dosage should be
checked every six months. People over 60 years of age should start with a dose of 0.1-0.2 mg per
day, which should be gradually increased depending on individual needs. The minimum effective dose should be
used. The maintenance dose is rarely greater than 0.5 mg per day.
Follow your doctor's instructions.

Omnitrope Injection
Inject growth hormone every day at approximately the same time. Bedtime is a good time,
because it is easy to remember. In addition, it is natural that growth hormone levels are higher during the night.
Omnitrope 5 mg/1.5 ml is multi-use. It must be injected only with Omnitrope Pen 5, a device for
injections specifically developed for the use of Omnitrope 5 mg/1.5 ml injectable solution.
Omnitrope 10 mg/1.5 ml is multi-use. It must be injected only with Omnitrope Pen 10, a device
for injections specifically developed for the use of Omnitrope 10 mg/1.5 ml injectable solution.
Omnitrope is intended for subcutaneous use. This means that it is injected into the fatty tissue
just below the skin, with a short injection needle. Most people practice injections
in the thigh or buttocks. Practice the injection where your doctor has shown you. The fatty tissue of the
skin may wrinkle at the injection site. To avoid this phenomenon, change
each time slightly the injection site. In this way, the skin and the area under the skin have the
time to recover after the injection before another is made in the same area.
The doctor must already have shown you how to use Omnitrope. Always inject Omnitrope following
exactly the doctor's instructions. If you have any doubts, consult your doctor or pharmacist.

How to inject Omnitrope
The following instructions explain how to inject Omnitrope. Read the instructions carefully and
follow them step by step. The doctor or nurse will show you how to inject Omnitrope. Do not attempt to
perform the injection before you have fully understood the procedure and the requirements for the injection.

• Omnitrope is administered as a subcutaneous injection.
• Before injecting the solution, check it carefully and use it only if it is clear and transparent.
• Change the injection site to reduce the risk of local lipoatrophy (local reduction of subcutaneous fat tissue).

Preparation
Collect everything needed to perform the injection:

• a cartridge with Omnitrope injectable solution.
• the Omnitrope Pen injection device, specifically developed for the use of Omnitrope injectable solution (not included in the package; see the Instructions for Use provided with Omnitrope Pen).
• a pen needle for subcutaneous injection (not included in the package).
• 2 disinfectant cotton swabs (not included in the package).

Wash your hands before proceeding to the next step.

Omnitrope Injection

• With a cotton swab, disinfect the rubber membrane of the cartridge.
• The contents must be clear and colorless.
• Place the cartridge in the pen for injection. Follow the Instructions for Use of the pen injector. To adjust the pen, rotate the dose dial.
• Choose the injection site. The best places for injection are those with a layer of fat between the skin and the muscle, such as the thigh or abdomen (except the navel and waist).
• Be careful to inject 1 cm away from the previous injection site and change the injection sites, as you have been taught.
• Before performing the injection, carefully disinfect the skin with a cotton swab soaked in alcohol. Let the area dry.

• Insert the needle into the skin as you have been taught by your doctor.

After the injection

• After the injection, press the injection site with a cotton swab or sterile gauze for a few seconds. Do not massage.
• Remove the needle from the pen, using the outer cap of the needle, and dispose of it. In this way, the Omnitrope solution is kept sterile and leaks are avoided. Also, air is prevented from entering the pen and the needle from becoming clogged. Do not share needles or even the pen.
• Leave the cartridge in the pen, put the cap on it and store it in the refrigerator
• The solution must be clear when taken from the refrigerator. Do not use if the solution is cloudy or containsdeposit.

If you use more Omnitrope than you should
If you inject a much larger amount than you should, contact your doctor or pharmacist as soon as possible.
Blood sugar levels may drop too low and then rise too high. You may feel dizzy,
drowsy or “feel strange” and may lose consciousness.

If you forget to use Omnitrope
Do not use a double dose to make up for a missed dose. Use growth hormone
regularly. If you forget a dose, practice the next injection the next day, at the usual time. Keep a record of missed doses and inform your doctor at your next check-up visit.

If you stop treatment with Omnitrope
Ask your doctor for advice before stopping treatment with Omnitrope.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common and common side effects in adults may start in the first few months of treatment and
regress spontaneously or with dose reduction.

Very common side effects (which may affect more than 1 in 10 people) include

• joint pain
• fluid retention (which manifests as swelling of the fingers or ankles for a short period at the
  beginning of treatment)
• redness, itching or pain at the injection site

Common side effects (which may affect less than 1 in 10 people) include

• raised and itchy welts on the skin
• skin rash
• numbness/tingling
• stiffness in the arms and legs, muscle pain

In adults

• pain or burning sensation in the hands or forearms (carpal tunnel syndrome)

Uncommon side effects (which may affect less than 1 in 100 people) include

• enlargement of the breasts (gynecomastia)
• itching

Rare side effects (which may affect less than 1 in 1,000 people) include
In children

• leukemia (reported in a small number of patients with growth hormone deficiency, some of whom
  were treated with somatropin. However, there is no evidence of an increased incidence of leukemia
  in subjects receiving growth hormone without predisposing factors)
• increased intracranial pressure (which causes symptoms such as severe headache, visual
  disturbances or vomiting)

Not known (frequency cannot be estimated from available data):

• type 2 diabetes
• reduced levels of cortisol hormone in the blood
• facial swelling
• headache
• hypothyroidism

In adults

• increased intracranial pressure (which causes symptoms such as severe headache, visual
  disturbances or vomiting)

Formation of antibodies against the injected growth hormone, which however do not seem to
compromise the action of the growth hormone. The skin around the injection site may become
irregular or develop nodules, but this can be avoided by injecting the medicine in a different site
each time. Rare cases of sudden death have been observed in patients with Prader-Willi syndrome,
but no correlation between these cases and treatment with Omnitrope has been demonstrated.
The doctor may consider the presence of proximal femoral epiphysis slippage and Legg-Calvé-Perthes
disease in case of discomfort or pain in the hip or knee during treatment with Omnitrope.
Other possible side effects related to treatment with growth hormone may include:
you (or your child) may experience high blood sugar levels or reduced thyroid hormone levels.
These tests can be performed by the doctor, who, if necessary, will prescribe the appropriate
treatment. Rarely, inflammation of the pancreas has been reported in patients treated with growth
hormone.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system indicated in Annex V. By reporting side effects you
can help provide more information on the safety of this medicine.

5. How to store Omnitrope

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
Exp. The expiry date refers to the last day of that month.

• Store and transport in a refrigerator (2°C - 8°C).
• Do not freeze.
• Store in the original packaging to protect the medicine from light.
• After the first injection, the cartridge must be stored in the pen in a refrigerator (between 2°C - 8°C) and used for a maximum of 28 days. Do not use Omnitrope if you notice that the solution is cloudy.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Omnitrope 5 mg/1.5 ml contains

• The active ingredient of Omnitrope is somatropin. Each ml of solution contains 3.3 mg of somatropin (corresponding to 10 IU). One cartridge contains 5.0 mg of somatropin (corresponding to 15 IU) of somatropin in 1.5 ml.
• The other ingredients are:

dibasic sodium phosphate heptahydrate
dibasic sodium phosphate dihydrate
mannitol
poloxamer 188
benzyl alcohol
water for injections

What Omnitrope 10 mg/1.5 ml contains

• The active ingredient of Omnitrope is somatropin. Each ml of solution contains 6.7 mg of somatropin (corresponding to 20 IU). One cartridge contains 10.0 mg (corresponding to 30 IU) of somatropin in 1.5 ml.
• The other ingredients are: dibasic sodium phosphate heptahydrate sodium phosphate monobasic dihydrate glycine poloxamer 188 phenol water for injections

Description of the appearance of Omnitrope and package contents
Omnitrope is a clear and colorless injection solution.
Packs of 1, 5 or 10.
Not all pack sizes may be marketed.

Marketing authorization holder
Sandoz GmbH
Biochemiestr. 10
A-6250 Kundl
Austria

Manufacturer
Sandoz GmbH
Biochemiestr. 10
A-6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestr. 10
A-6336 Langkampfen
Austria
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.
For further information on this medicine, contact the local representative of the marketing
authorization holder:

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Luxembourg/Luxemburg
Sandoz nv/sa (Belgique/Belgien)
Tél/Tel.: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 48 200 600

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
Sandoz Pharmaceuticals d.d.
Τηλ: +357 22 69 0690

United Kingdom (Northern Ireland)
Sandoz GmbH (Austria)
Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Omnitrope 5 mg/1,5 ml injectable solution in cartridge, 10 mg/1,5 ml injectable solution in cartridge, 15 mg/1,5 ml injectable solution in cartridge

somatropina

Read this leaflet carefully before you use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Omnitrope and what is it used for

Omnitrope is a recombinant human growth hormone (also known as somatropin). The
structure is identical to natural human growth hormone, which is needed for the growth of bones and muscles
and promotes the correct development of adipose and muscle tissue. “Recombinant” means that it is not
extracted from human or animal tissues.

In children, Omnitrope is indicated for the treatment of the following growth disorders:

• If they are not growing as they should and do not produce sufficient amounts of growth hormone.
• If they have Turner syndrome. Turner syndrome is a genetic disease that affects children and can impair growth. If they suffer from this syndrome, they have already been informed by their doctor.
• If they have chronic renal insufficiency. If the kidneys lose the ability to function properly, growth may be affected.
• If they were small or underweight at birth. Growth hormone can promote increased height if they have not shown a recovery or continuation of normal growth within four years of age or later.
• If they have Prader-Willi syndrome (a chromosomal disease). Growth hormone promotes growth if they are still growing and improves body composition. Excess fat is reduced and insufficient muscle mass increases.

In adults, Omnitrope is indicated for

• the treatment of people with marked growth hormone deficiency. The deficiency may begin in adulthood or persist from childhood. If they have been treated with Omnitrope due to a growth hormone deficiency in childhood, the levels of growth hormone will be determined again at the end of bodily development. If the marked growth hormone deficiency is confirmed, the doctor will propose to continue treatment with Omnitrope.

This medicine must be administered to you exclusively by a doctor experienced in the treatment
with growth hormone and who has confirmed the diagnosis.

2. What you need to know before using Omnitrope

Do not use Omnitrope

• if you are allergic (hypersensitive) to somatropin or any of the other ingredients of Omnitrope.
• and inform your doctor if you have an active tumor (cancer). Tumors must be inactive and antitumor therapy must be completed before starting treatment with Omnitrope.
• and inform your doctor if Omnitrope has been prescribed to you to stimulate growth, but you have already stopped growing (epiphyses closed).
• if you are seriously ill (for example, complications from open-heart surgery, abdominal surgery, accidental trauma, acute respiratory failure or similar clinical situations). If you are about to undergo or have undergone major surgery or if you need to be hospitalized for any reason, inform your doctor and remind the doctors who visit you that you are using growth hormone.

Warnings and precautions
Talk to your doctor before using Omnitrope.

• If you are taking replacement therapy with glucocorticoids, you should consult your doctor regularly, as you may need to adjust your dose of glucocorticoids.
• If you are at risk of developing diabetes, your doctor will need to check your blood sugar during therapy with somatropin.
• If you have diabetes, you should carefully monitor your blood sugar during treatment with somatropin and discuss the measured values with your doctor, in order to establish whether the dose of the medicines used to treat diabetes needs to be modified.
• After starting treatment with somatropin, some patients may need thyroid hormone replacement therapy.
• If you are already being treated with thyroid hormones, it may be necessary to adjust the dose.
• If you suffer from increased intracranial pressure (which causes symptoms such as severe headache, visual disturbances or vomiting), inform your doctor.
• If you develop a limp or start limping during treatment with growth hormone, inform your doctor.
• If you are being treated with somatropin due to a growth hormone deficiency for a previous tumor (cancer), you should be checked at regular intervals to detect any tumor recurrence or another type of cancer.
• If you have abdominal pain that worsens, you should inform your doctor.
• Experience in patients over 80 years of age is limited. Elderly people may be more sensitive to the action of somatropin and therefore more prone to developing undesirable effects.
• Omnitrope can cause inflammation of the pancreas, which causes severe abdominal and back pain. Contact your doctor if you or the child experience stomach pain after taking Omnitrope.
• An increase in lateral curvature of the spine (scoliosis) can progress in any child during rapid growth. During treatment with somatropin, the doctor will monitor for any signs of scoliosis in you (or your child).

Children with chronic renal insufficiency

• Before starting treatment with somatropin, the doctor will check kidney function and growth rate. Pharmacological treatment for kidney function must continue. Treatment with somatropin must be discontinued on the occasion of kidney transplantation.

Children with Prader-Willi syndrome

• The doctor will prescribe you a diet to control body weight.
• Before starting treatment with somatropin, the doctor will check for any signs of upper airway obstruction, sleep apnea (interruption of breathing during sleep) or respiratory infection.
• During treatment with somatropin, inform your doctor if you experience signs of upper airway obstruction (such as the appearance or increase of snoring); in this case, the doctor will examine you and possibly interrupt treatment with somatropin.
• During treatment, the doctor will check for signs of scoliosis, a type of spinal deformity.
• Inform your doctor if you develop a lung infection during treatment, so that the infection can be treated.

Children born small or with low birth weight

• If the child was small or of low weight at birth and is now between 9 and 12 years old, specifically ask your doctor for advice on treatment with this medicine during puberty.
• Treatment should continue until growth is complete.
• The doctor will check blood glucose and insulin levels before starting treatment and annually during therapy.

Other medicines and Omnitrope
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
In particular, inform your doctor if you are taking or have recently taken any of the following
medicines. Your doctor may need to adjust the dosage of Omnitrope or other medicines:

• medicines for the treatment of diabetes,
• thyroid hormones,
• medicines for the control of epilepsy (anticonvulsants),
• cyclosporine (a medicine that weakens the immune system after a transplant),
• estrogens taken orally or other sex hormones
• synthetic adrenal hormones (corticosteroids). It may be necessary for the doctor to adjust the dose of these medicines or the dose of somatropin.

Pregnancy and breastfeeding
Do not use Omnitrope if you are pregnant or trying to become pregnant.
If you are pregnant or breastfeeding, ask your doctor or
pharmacist for advice. This is because benzyl alcohol can accumulate in the body and can cause adverse
effects (so-called “metabolic acidosis”).

Important information about some excipients of Omnitrope
This medicine contains less than 1 mmol (23 mg) of sodium per mL, i.e. it is practically “sodium-free”.
Omnitrope 5 mg/1.5 ml solution for injection:
This medicine contains 9 mg of benzyl alcohol per ml.
Benzyl alcohol can cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects including breathing problems
(agonal respiratory syndrome) in young children.
Do not administer to infants under 4 weeks of age unless otherwise recommended by your doctor.
Ask your doctor or pharmacist if you have a liver or kidney disease. This is because
large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (such as
metabolic acidosis).
Due to the presence of benzyl alcohol, this medicine should not be given to premature babies
or newborns. It can cause toxic and allergic reactions in children up to 3 years of age.
Do not use for more than one week in young children (under 3 years of age) unless otherwise
recommended by your doctor or pharmacist.

3. How to use Omnitrope

Use this medicine following the instructions of your doctor, pharmacist or
nurse exactly. If you have any doubts, ask your doctor, nurse or pharmacist.
The dose depends on your physical condition, the disease to be treated and the action of growth hormone on
you. Each of us is different from others. Your doctor will establish the most suitable dose of Omnitrope for you; the dose
is calculated in milligrams (mg) based on body weight in kilograms (kg) or based on the
body surface area calculated using height and weight and expressed in square meters (m²). Your doctor will
also inform you about the treatment schedule. Do not change the dosage and treatment schedule
without consulting your doctor.

The recommended dose is for:
Children with growth hormone deficiency
0.025-0.035 mg/kg of body weight per day, or 0.7-1.0 mg/m² of body surface area per day.
Higher doses may also be used. If growth hormone deficiency persists
during adolescence, treatment with Omnitrope must continue until the end of physical development.

Children with Turner syndrome
0.045-0.050 mg/kg of body weight per day, or 1.4 mg/m² of body surface area per day.

Children with chronic renal insufficiency
0.045-0.050 mg/kg of body weight per day, or 1.4 mg/m² of body surface area per day. If
the growth rate is low, higher doses may be necessary. After six months of treatment
a dosage adjustment may be necessary.

Children with Prader-Willi syndrome
0.035 mg/kg of body weight per day, or 1.0 mg/m² of body surface area per day. The dose
daily should not exceed 2.7 mg. Treatment should not be performed in adolescents who have
almost completed growth after puberty.

Small children or with low birth weight and with growth disorders
0.035 mg/kg of body weight per day, or 1.0 mg/m² of body surface area per day. It is
important to continue treatment until final height is reached. Treatment should
be discontinued after the first year in case of no response or reaching final height
and end of growth.

Adults with growth hormone deficiency
If you continue to take Omnitrope after being treated in childhood, you should start with
0.2-0.5 mg per day.
This dose should be gradually increased or decreased based on blood test results,
clinical response and side effects.
If growth hormone deficiency begins in adulthood, you should start with 0.15-0.3 mg per day.
This dose will be gradually increased based on blood test results, response
clinical and side effects. The daily maintenance dose generally does not exceed 1.0 mg per
day. Women may need higher doses than men. The dosage should be
checked every six months. People over 60 years of age should start with a dose of 0.1-0.2 mg per
day, which should be gradually increased according to individual needs. The minimum effective dose should be
used. The maintenance dose is rarely greater than 0.5 mg per day.
Follow your doctor's instructions.

Omnitrope Injection
Inject growth hormone every day at approximately the same time. Bedtime is a good opportunity, because it is easy to remember. Also, it is natural that the levels of growth hormone are higher during the night.
Omnitrope 5 mg/1.5 ml in a cartridge for SurePal 5 is for multi-use. It must be injected only with
SurePal 5, a device for injections specifically developed for the use of Omnitrope 5 mg/1.5 ml
injectable solution.
Omnitrope 10 mg/1.5 ml in a cartridge for SurePal 10 is for multi-use. It must be injected only with
SurePal 10, a device for injections specifically developed for the use of Omnitrope
10 mg/1.5 ml injectable solution.
Omnitrope 15 mg/1.5 ml in a cartridge for SurePal 15 is for multi-use. It must be injected only with
SurePal 15, a device for injections specifically developed for the use of Omnitrope
15 mg/1.5 ml injectable solution.
Omnitrope is intended for subcutaneous use. This means that it is injected into the fatty tissue
just below the skin, with a short injection needle. Most people practice injections
in the thigh or buttocks. Practice the injection where your doctor has shown you. The fatty tissue of the
skin may wrinkle at the injection site. To avoid this phenomenon, change
the injection site slightly each time. This way, the skin and the area under the skin have the
time to recover after the injection before another is performed in the same area.
Your doctor must have already shown you how to use Omnitrope. Always inject Omnitrope following
exactly your doctor's instructions. If you have any doubts, consult your doctor or pharmacist.

How to inject Omnitrope
The following instructions explain how to inject Omnitrope. Read the instructions carefully and
follow them step by step. Your doctor or nurse will show you how to inject Omnitrope. Do not attempt to
perform the injection before you have fully understood the procedure and the injection requirements.

• Omnitrope is administered as a subcutaneous injection.
• Before injecting the solution, check it carefully and use it only if it is clear and transparent.
• Change the injection site to reduce the risk of local lipoatrophy (local reduction of subcutaneous fatty tissue).

Preparation
Collect everything you need to perform the injection:

• a cartridge with Omnitrope injectable solution.

• the SurePal injection device, specifically developed for the use of Omnitrope injectable solution (not included in the package; see the Instructions for Use provided with SurePal).
• a pen needle for subcutaneous injection (not included in the package).
• 2 disinfecting cotton swabs (not included in the package).

Wash your hands before proceeding to the next step.

Omnitrope Injection

• With a cotton swab, disinfect the rubber membrane of the cartridge.
• The contents must be clear and colorless.
• Place the cartridge in the injection pen. Follow the Instructions for Use of the pen injector. To adjust the pen, rotate the dose dial.

• Choose the injection site. The best places for injection are those with a layer of fat between the skin and the muscle, such as the thigh or abdomen (except the navel and waist).
• Be careful to inject 1 cm away from the previous injection site and change the injection sites, as you have been taught.
• Before performing the injection, carefully disinfect the skin with a cotton swab soaked in alcohol. Let the area dry.

• Insert the needle into the skin as you have been taught by your doctor.

After the injection

• After the injection, press the injection site with a cotton swab or sterile gauze for a few seconds. Do not massage.
• Remove the needle from the pen, using the outer cap of the needle, and dispose of it. This keeps the Omnitrope solution sterile and avoids leaks. It also prevents air from entering the pen and the needle from becoming blocked. Do not share needles or the pen.
• Leave the cartridge in the pen, put the cap on it and store it in the refrigerator
• The solution must be clear when taken from the refrigerator. Do not use if the solution is cloudy or containsdeposit.

If you use more Omnitrope than you should
If you inject a much larger amount than you should, contact your doctor or pharmacist as soon as possible.
Blood sugar levels may drop too low and then rise too high. You may feel dizzy,
drowsy or “feel strange” and may lose consciousness.

If you forget to use Omnitrope
Do not use a double dose to make up for a missed dose. Use growth hormone
regularly. If you forget a dose, practice the next injection the next day, at the usual time. Keep a record of missed doses and inform your doctor at your next check-up visit.

If you stop taking Omnitrope
Ask your doctor for advice before stopping treatment with Omnitrope.
If you have any doubts about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common and common side effects in adults may start in the first few months of treatment and
regress spontaneously or with dose reduction.

Very common side effects (which may affect more than 1 in 10 people) include

• joint pain
• fluid retention (which manifests as swollen fingers or ankles for a short period at the beginning of treatment)
• redness, itching or pain at the injection site

Common side effects (which may affect less than 1 in 10 people) include

• raised, itchy welts on the skin
• skin rash
• numbness/tingling
• stiffness in the arms and legs, muscle pain

In adults

• pain or burning sensation in the hands or forearms (carpal tunnel syndrome)

Uncommon side effects (which may affect less than 1 in 100 people) include

• enlargement of the breasts (gynecomastia)
• itching

Rare side effects (which may affect less than 1 in 1,000 people) include
In children

• leukemia (reported in a small number of patients with growth hormone deficiency, some of whom were treated with somatropin. However, there is no evidence of an increased incidence of leukemia in subjects receiving growth hormone without predisposing factors)
• increased intracranial pressure (which causes symptoms such as severe headache, visual disturbances or vomiting)

Not known (frequency cannot be estimated from available data):

• type 2 diabetes
• decreased levels of cortisol hormone in the blood
• facial swelling
• headache
• hypothyroidism

In adults

• increased intracranial pressure (which causes symptoms such as severe headache, visual disturbances or vomiting)

Formation of antibodies against the injected growth hormone, which however do not seem to
compromise the action of the growth hormone. The skin around the injection site may become irregular or
develop nodules, but this phenomenon can be avoided by injecting the medicine in a different site each time.
Rare cases of sudden death have been observed in patients with Prader-Willi syndrome, but
no correlation between these cases and treatment with Omnitrope has been demonstrated.
The doctor may consider the presence of proximal femoral epiphysis slippage and Legg-Calvé-Perthes
disease in case of discomfort or pain in the hip or knee during treatment with Omnitrope.
Other possible side effects related to treatment with growth hormone may include:
you (or your child) may experience high blood sugar levels or reduced thyroid hormone levels. These tests
can be performed by the doctor, who, if necessary, will prescribe the appropriate treatment. Rarely, inflammation
of the pancreas has been reported in patients treated with growth hormone.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system listed in Appendix V. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Omnitrope

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
Exp. The expiry date refers to the last day of that month.

• Store and transport in a refrigerator (2°C - 8°C).
• Do not freeze.
• Store in the original package to protect the medicine from light.
• After the first injection, the cartridge must be stored in the pen in a refrigerator (between 2°C - 8°C) and used for a maximum of 28 days. Do not use Omnitrope if you notice that the solution is cloudy.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Omnitrope 5 mg/1.5 ml contains

• The active substance of Omnitrope is somatropin. Each ml of solution contains 3.3 mg of somatropin (corresponding to 10 IU). One cartridge contains 5.0 mg of somatropin (corresponding to 15 IU) of somatropin in 1.5 ml.
• The other ingredients are: sodium dibasic phosphate heptahydrate, sodium monobasic phosphate dihydrate, mannitol, poloxamer 188, benzyl alcohol, water for injections.

What Omnitrope 10 mg/1.5 ml contains

• The active substance of Omnitrope is somatropin. Each ml of solution contains 6.7 mg of somatropin (corresponding to 20 IU). One cartridge contains 10.0 mg (corresponding to 30 IU) of somatropin in 1.5 ml.
• The other ingredients are: sodium dibasic phosphate heptahydrate, sodium monobasic phosphate dihydrate, glycine, poloxamer 188, phenol, water for injections.

What Omnitrope 15 mg/1.5 ml contains

• The active substance of Omnitrope is somatropin. Each ml of solution contains 10 mg of somatropin (corresponding to 30 IU). One cartridge contains 15.0 mg (corresponding to 45 IU) of somatropin in 1.5 ml.
• The other ingredients are: sodium dibasic phosphate heptahydrate, sodium monobasic phosphate dihydrate, sodium chloride, poloxamer 188, phenol, water for injections.

Description of the appearance of Omnitrope and contents of the pack
Omnitrope is a clear and colourless solution for injection.
Omnitrope 5 mg/1.5 ml solution for injection must be used exclusively with SurePal 5.
Omnitrope 10 mg/1.5 ml solution for injection must be used exclusively with SurePal 10.
Omnitrope 15 mg/1.5 ml solution for injection must be used exclusively with SurePal 15.
Packs of 1, 5 or 10.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
A-6250 Kundl
Austria

Manufacturer
Sandoz GmbH
Biochemiestr. 10
A-6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestr. 10
A-6336 Langkampfen
Austria
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Luxembourg/Luxemburg
Sandoz nv/sa (Belgique/Belgien)
Tél/Tel.: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 48 200 600

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
Sandoz Pharmaceuticals d.d.
Τηλ: +357 22 69 0690

United Kingdom (Northern Ireland)
Sandoz GmbH (Austria)
Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006