Patient Information Leaflet

Norditropin NordiFlex, 5 mg/1.5 ml, solution for injection in a pre-filled pen
somatropin
Please read all of this leaflet carefully before 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, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents
1. What Norditropin NordiFlex is and what it is used for
2. What you need to know before using Norditropin NordiFlex
3. How to use Norditropin NordiFlex
4. Possible side effects
5. How to store Norditropin NordiFlex
6. Contents of the pack and other information
On the reverse: Instructions for use of the Norditropin NordiFlex injection pen

1. What Norditropin NordiFlex is and what it is used for

Norditropin NordiFlex contains a biosynthetic human growth hormone called somatropin, which is identical to the growth hormone naturally produced in the human body. Growth hormone is essential for normal growth in children and for normal body function in adults.
Norditropin NordiFlex is used to treat growth disorders in children:

in cases of growth hormone deficiency or insufficient growth hormone secretion;
in Turner syndrome (a genetic condition that may affect growth);
in cases of renal insufficiency;
in cases of short stature and in children born small for gestational age;
in Noonan syndrome (a genetic condition that may impair growth).

Norditropin NordiFlex is used as replacement growth hormone in adults:
In adults, Norditropin NordiFlex is used to replace growth hormone when growth hormone secretion was insufficient during childhood or when its production has become impaired in adulthood due to a tumour, tumour treatment, or a disease affecting the gland responsible for growth hormone secretion. Patients who were treated for growth hormone deficiency during childhood should undergo re-evaluation after completion of growth. If growth hormone deficiency is confirmed, treatment should be continued.

2. Important information before using Norditropin NordiFlex

When not to use Norditropin NordiFlex

if the patient is allergic to somatropin, phenol, or any of the other ingredients of this medicine (listed in section 6);
after kidney transplantation;
if there is an active tumour (cancer). Any diagnosed tumours must be inactive and anti-tumour treatment must have been completed before starting Norditropin NordiFlex;
in acute critical conditions, such as open-heart surgery, abdominal surgery, multiple trauma from an accident, or acute respiratory failure;
after completion of growth (closure of epiphyses), if there is no growth hormone deficiency.

Warnings and precautions
Before starting treatment with Norditropin NordiFlex, talk to your doctor or pharmacist:

if the patient has diabetes;
if the patient has ever had cancer or any other type of tumour;
in case of recurring headaches, visual disturbances, nausea, or vomiting;
if the patient has thyroid function disorders;
during rapid growth, every child may develop worsening of spinal curvature (scoliosis). During treatment with Norditropin NordiFlex, the doctor will check whether the patient (child or adult) shows signs of scoliosis;
if the patient limps or begins to limp during growth hormone treatment, they should inform the doctor;
if the patient is over 60 years of age or has been treated with somatropin in adulthood for longer than 5 years, due to limited experience;
in case of kidney disease, kidney function should be monitored by the doctor;
if the patient is receiving replacement glucocorticoid therapy, regular consultations with the doctor are necessary, as the glucocorticoid dose may need adjustment;
Norditropin NordiFlex may cause pancreatitis, which causes severe abdominal and back pain. If abdominal pain occurs in a child or adult after administration of Norditropin NordiFlex, contact a doctor immediately.

Norditropin NordiFlex and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor if the patient is currently taking or has recently taken any of the following medicines. The doctor may need to adjust the dose of Norditropin NordiFlex or other medicines:

glucocorticoids – concomitant use of Norditropin NordiFlex and glucocorticoids may affect growth in adults;
cyclosporine (an immunosuppressive medicine) – dose adjustment may be necessary;
insulin – dose adjustment may be necessary;
thyroid hormone – dose adjustment may be necessary;
gonadotropin (a hormone stimulating the sex glands) – dose adjustment may be necessary;
anticonvulsants – dose adjustment may be necessary;
oral estrogens or other sex hormones.

Pregnancy and breastfeeding

Pregnancy – If a patient becomes pregnant while using Norditropin NordiFlex, treatment must be stopped and the doctor should be consulted.
Breastfeeding – Do not use Norditropin NordiFlex during breastfeeding, as somatropin may pass into breast milk.

Driving and using machines
Norditropin NordiFlex has no effect on the ability to drive or operate machinery.

Norditropin contains sodium
Norditropin contains less than 1 mmol of sodium (23 mg) per 1.5 ml, i.e. it is essentially "sodium-free".

3. How to use Norditropin NordiFlex

This medicine should always be used as directed by the doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose
The recommended dose for children depends on body weight and body surface area. The recommended dose for adults depends on height, body weight, gender and sensitivity to growth hormone; the dose should be adjusted until the required dose is achieved.

Children with growth hormone deficiency or lack of growth hormone: The usual recommended dose is 0.025 to 0.035 mg per kg of body weight per day or 0.7 to 1.0 mg per m² of body surface area per day.
Children with Turner syndrome: The usual recommended dose is 0.045 to 0.067 mg per kg of body weight per day or 1.3 to 2.0 mg per m² of body surface area per day.
Children with kidney disease: The usual recommended dose is 0.050 mg per kg of body weight per day or 1.4 mg per m² of body surface area per day.
Children born small for gestational age: The usual recommended dose is 0.035 mg per kg of body weight per day or 1.0 mg per m² of body surface area per day until target height is reached. (In clinical trials in children born small for gestational age, doses of 0.033 and 0.067 mg per kg of body weight per day were usually used.)
Children with Noonan syndrome: The usual recommended dose is 0.066 mg per kg of body weight per day, although the doctor may decide that a dose of 0.033 mg per kg of body weight per day is sufficient.
Adults with growth hormone deficiency or lack of growth hormone: If growth hormone deficiency persists after completion of growth, treatment should be continued. The usual starting dose is 0.2 to 0.5 mg per day. The dose should be adjusted until the appropriate dose is established. In adults with growth hormone deficiency, the usual starting dose is 0.1 to 0.3 mg per day. This dose is increased at monthly intervals until the appropriate dose for the individual patient is reached. The maximum daily dose is usually 1.0 mg.

When to use Norditropin NordiFlex
The recommended daily dose should be injected subcutaneously every evening, just before bedtime.

How to use Norditropin NordiFlex
Norditropin NordiFlex contains a solution of growth hormone in a 1.5 ml pre-filled, multi-dose, single-use, semi-automatic injection device.
Full instructions for using the Norditropin NordiFlex injection device are provided on the reverse.
Key points from the instructions:

Check the solution before use by turning the injection device upside down once or twice. Do not use the injection device if the solution is cloudy or has changed colour.
Norditropin NordiFlex is intended for use with single-use NovoFine or NovoTwist needles up to 8 mm in length.
Always use a new needle for each injection.
Rotate injection sites to avoid skin damage.
To ensure the full dose is delivered and to avoid injecting air bubbles, always perform the flow check (the so-called "flow check") before administering the first injection with a new Norditropin NordiFlex injection device. If a drop of growth hormone solution does not appear at the needle tip, do not use the injection device.
Never share your Norditropin NordiFlex injection device with anyone else.

How long should treatment last

Children with growth disorders due to Turner syndrome, kidney disease, being born small for gestational age, or Noonan syndrome: treatment should be continued until growth is complete, as directed by the doctor.
Children or adolescents with growth hormone deficiency: treatment should be continued into adulthood, as directed by the doctor.

Do not stop using Norditropin NordiFlex without first discussing it with your doctor.

Use of a higher than recommended dose of Norditropin NordiFlex
If an overdose of somatropin is taken, contact your doctor immediately.
Prolonged overdosage may cause excessive growth and coarsening of facial features.

Missed dose of Norditropin NordiFlex
Take the next dose at the usual time. Do not use a double dose to make up for a missed dose.

Stopping Norditropin NordiFlex treatment
Do not stop using Norditropin NordiFlex without first discussing it with your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Reactions observed in children and adults (frequency unknown):

rash, wheezing, eyelid, facial or lip swelling, loss of consciousness – these may be symptoms of an allergic reaction;
headache, vision problems, nausea and vomiting – these may be symptoms of increased intracranial pressure;
serum tyroxine concentration may be reduced;
hyperglycaemia (elevated blood sugar levels).

If any of the above adverse reactions occur, you should contact your doctor as soon as possible. Use of Norditropin NordiFlex should be discontinued until your doctor advises continuing treatment.

During treatment with Norditropin, formation of antibodies against somatropin has been observed rarely.
Increased liver enzyme activity has been reported.
Cases of leukaemia and brain tumour recurrence have been reported in patients treated with somatropin (the active substance in Norditropin NordiFlex); however, there is no evidence of a causal relationship between somatropin and these conditions.

If a patient suspects they have any of the above conditions, they should speak with their doctor.

Additional adverse reactions in children:
Uncommon (may occur in no more than 1 in 100 children):

headache,
redness, itching and pain at the injection site,
breast enlargement (gynaecomastia).

Rare (may occur in no more than 1 in 1,000 children):

rash,
muscle and joint pain,
swelling of hands and feet due to fluid retention.

In rare cases, children receiving Norditropin NordiFlex may experience knee or hip pain or begin to limp. These symptoms may be caused by a disorder affecting the upper part of the femur (Legg-Calvé-Perthes disease) or by slipping of the femoral epiphysis (juvenile epiphyseal separation), and are not related to the use of Norditropin NordiFlex.

In clinical studies in children with Turner syndrome, several cases of excessive growth of hands and feet relative to body height were observed.
A clinical study in children with Turner syndrome showed that a high dose of Norditropin may possibly increase the risk of ear infections.

If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist, as it may be necessary to reduce the dose.

Additional adverse reactions in adults:
Very common (may occur in more than 1 in 10 adults):

swelling of hands and feet due to fluid retention.

Common (may occur in no more than 1 in 10 adults):

headache,
skin tingling, numbness and pain, mainly in the fingers,
joint stiffness and pain, muscle pain.

Uncommon (may occur in no more than 1 in 100 adults):

type 2 diabetes,
carpal tunnel syndrome, tingling and pain in fingers and hands,
itching (which may be intense) and pain at the injection site,
muscle stiffness,
breast enlargement (gynaecomastia).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Norditropin NordiFlex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following “Expiry date”. The expiry date refers to the last day of the stated month.
Before use, store the Norditropin NordiFlex injection device in the refrigerator (2°C – 8°C) inside its outer packaging to protect it from light. Do not freeze or expose to high temperatures. Do not store near any cooling elements.
During use, Norditropin NordiFlex 5 mg/1.5 ml may be:

stored in the refrigerator (2°C – 8°C) for up to 4 weeks or
stored at room temperature (below 25°C) for up to 3 weeks.

Do not use Norditropin NordiFlex injection devices if they have been frozen or exposed to high temperatures.
Do not use the Norditropin NordiFlex injection device if the growth hormone solution is cloudy or has changed colour.
The Norditropin NordiFlex injection device must always be stored without a needle attached.
Always replace the cap on the Norditropin NordiFlex injection device when not in use.
Always use a new needle for each injection.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Norditropin NordiFlex contains

The active substance is somatropin.
The other ingredients are: mannitol, histidine, poloxamer 188, phenol, water for injections, hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

What Norditropin NordiFlex looks like and contents of the pack
Norditropin NordiFlex is a clear and colourless solution for injection in a single-use, prefilled multidose pen injector with a capacity of 1.5 ml.
1 ml of solution contains 3.3 mg of somatropin.
1 mg of somatropin corresponds to 3 IU of somatropin.
Norditropin NordiFlex is available in the following strengths:
5 mg/1.5 ml (corresponding to 3.3 mg/ml),
10 mg/1.5 ml (corresponding to 6.7 mg/ml).
Pack sizes available: 1 prefilled pen injector, and multipacks containing 5 or 10 prefilled pen injectors. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

This medicinal product is authorised for marketing in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, Greece, Spain, Ireland, Iceland, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Sweden, Hungary, United Kingdom (Northern Ireland), Italy: Norditropin NordiFlex 5 mg/1.5 ml
France: Norditropine NordiFlex 5 mg/1.5 ml

Other sources of information
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: http://www.urpl.gov.pl.

Norditropin NordiFlex
5 mg/1.5 ml
Instructions for use of the Norditropin NordiFlex pen injector
Before using Norditropin NordiFlex, carefully read the instructions below.

Norditropin NordiFlex 5 mg/1.5 ml is a prefilled multidose pen injector containing a solution of human growth hormone.
Doses from 0.025 to 1.50 mg can be set using the dose-setting knob in increments of 0.025 mg. The appropriate dose for each patient is determined by the physician.
Norditropin NordiFlex is intended for use with single-use NovoFine or NovoTwist needles up to 8 mm in length.
Always begin by checking the name, strength, and colour of the Norditropin NordiFlex pen injector to ensure it contains the growth hormone strength appropriate for the patient.
Only use the pen injector if the growth hormone solution in the cartridge is clear and colourless.
Always use a new needle for each injection.
Always check the flow before administering the first injection with a new pen injector – see section 3. Checking the flow.
Never share your pen injector or needles with anyone else. This may lead to cross-infection.
Always store the pen injector and needles out of sight and out of reach of children.
Caregivers must exercise the highest caution when removing and disposing of used needles to reduce the risk of needlestick injury and cross-infection.

Needle (example) Syringe Outer needle cap Inner needle cap Needle Cartridge Paper label Viewing window of the injector Scale of the injector Dose indicator window Dose adjustment knob Dose injection button
1. Checking the injector Check the name, strength and colour of the injector Norditropin NordiFlex to ensure it contains the growth hormone of the correct strength. Remove the injector cap [A]. Check that the solution in the cartridge is clear and colourless by turning the injector upside down once or twice. Do not use the injector if the solution in the cartridge is not clear and colourless.	A
2. Attaching the needle Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of solution, needle blockage and inaccurate dosing. Never use a bent or damaged needle. Peel off the paper label from the needle cap. Screw the needle onto the injector, holding it straight [B]. Ensure it is securely attached. The needle has two caps; remove both:	B
Remove the outer needle cap and keep it for later use to safely remove the needle from the injector. Remove the inner needle cap by grasping its end and dispose of it.
3. Checking the flow Before the first injection with each new injector, check the flow to ensure proper dose delivery and to avoid injecting air: Select 0.025 mg [C]. This is one 'click' of the dose adjustment knob located at the end of the injector.	C
Holding the injector with the needle pointing upwards, gently tap the upper part several times with your finger so that air bubbles rise to the top [D].	D
While keeping the injector with the needle still pointing upwards, press the dose injection button fully [E]. A drop of solution should appear at the tip of the needle. If no drop appears, repeat steps C to E up to 6 times until a drop appears. If no drop appears, replace the needle and repeat steps C to E once again. If no drop of solution appears, do not use this injector. Use a new one. Always check the flow before the first injection with a new injector. Check the flow again if the injector has been dropped or hit against a hard surface, or if you suspect it is not working properly.	E
4. Setting the dose Check that the dose adjustment knob is in the 0.0 position. Set the number of mg prescribed by your doctor [F]. The dose can be increased or decreased by turning the dose adjustment knob in opposite directions. When turning the dose adjustment knob backwards, be careful not to press the dose injection button, as this may cause leakage of solution. You cannot set a dose higher than the number of mg remaining in the injector.	F
5. Administering the injection Follow your doctor's or nurse's instructions when administering the injection. Rotate injection sites to avoid skin damage. Insert the needle under the skin. Inject the dose by pressing the dose injection button fully. Press the dose injection button only during injection [G]. While keeping the dose injection button fully pressed, leave the needle under the skin for at least 6 seconds. This ensures the full dose is delivered.	G
6. Removing the needle Carefully place the outer needle cap back onto the needle without touching the needle. Unscrew the needle and dispose of it carefully according to your doctor's or nurse's instructions [H]. Never recap the needle with the inner needle cap. You may accidentally prick yourself with the needle. After each use, replace the cap on the injector. After each injection, always remove and dispose of the needle, and store the injector without a needle attached. This reduces the risk of contamination, infection, leakage of solution, needle blockage and inaccurate dosing. When the injector is empty, dispose of it without the needle attached, following instructions provided by your doctor, nurse or according to local regulations. Caregivers must exercise extreme caution when removing and disposing of used needles to reduce the risk of needlestick injury and cross-infection.	H
7. Handling the injector Handle the Norditropin NordiFlex injector with care. Do not drop the injector or hit it against hard surfaces. If the injector has been dropped or you suspect it may not be working properly, always attach a new needle and check the solution flow before administering an injection. Do not refill the injector – it is a pre-filled semi-automatic injector. Do not attempt to repair or disassemble the injector. Protect the injector from dust, dirt, frost and direct sunlight. Do not attempt to wash, soak or lubricate the injector. If necessary, clean it with a cloth dampened with a mild detergent. Do not freeze the injector or store it near any cooling element, such as the wall of a refrigerator.

For information on storage of the injector, see section 5. How to store Norditropin NordiFlex at the back of this leaflet.

Norditropin nordiflex