NUTROPINAQ 2 ML Инъекционный раствор

Содержание инструкции

1. NutropinAq 10 mg/2ml (30 IU), injectable solution
   1. What is NutropinAq and what is it used for
   2. What you need to know before using NutropinAq
   3. How to use NutropinAq
   4. Possible side effects
   5. How to store NutropinAq
   6. ALTRE INFORMAZIONI

NutropinAq 10 mg/2ml (30 IU), injectable solution

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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet

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

1. What is NutropinAq and what is it used for

NutropinAq contains somatropin, which is a recombinant growth hormone similar to the natural human growth hormone (GH) produced by the body. Recombinant means that it is produced in a laboratory using a special technique. Growth hormone is produced by a small gland in the brain called the pituitary gland. In children, growth hormone stimulates body growth, helps bones develop normally and, in adulthood, helps maintain a normal structure and function of the body.

In children NutropinAq is indicated:

• When the body does not produce sufficient levels of growth hormone and for this reason growth is not adequate.
• When affected by Turner syndrome, a genetic abnormality in girls (absence of female sex chromosome(s)) that prevents growth.
• When the kidneys are damaged and lose their ability to function normally with a consequent impact on growth.

In adults NutropinAq is indicated

• If the body does not produce enough growth hormone in adulthood. This situation can begin in adulthood or continue from pediatric age.

The benefits of using this medicine
In children, it helps body growth and normal bone development.
In adults, it helps maintain the normal structure and function of the body; for example, it helps maintain levels of fats and blood sugar.

2. What you need to know before using NutropinAq

Do not use NutropinAq:

• if you are allergic to somatropin or any of the ingredients of this medicine (listed in section 6).
• in children if the growth of the bones has already stopped.
• if you have an active tumor (cancer). Tell your doctor if you have or have had an active tumor. Tumors must be inactive and anti-tumor treatment must be completed before starting treatment with NutropinAq.
• if you have had complications after major surgery (open heart or abdominal surgery), multiple trauma, acute respiratory failure, or similar conditions.

Warnings and precautions
Talk to your doctor or pharmacist before using NutropinAq:

• If you experience changes in vision, severe or frequent headaches, associated with nausea or vomiting, especially at the beginning of treatment, tell your doctor immediately. These could be signs of a temporary increase in pressure inside the brain (intracranial hypertension).
• If limping or pain in the hip or knee develops during growth, consult your doctor for advice.
• If scoliosis develops in the child; this should be checked frequently by the doctor, as scoliosis can progress in rapidly growing children.
• The doctor must check blood sugar levels (hyperglycemia) during treatment with NutropinAq. If you are being treated with insulin, your doctor may need to adjust the dose of insulin. If you have diabetes associated with severe eye complications or in progression, treatment with NutropinAq should be avoided.
• The doctor must check the function of the thyroid gland periodically and, if necessary, prescribe appropriate treatment. If you have reduced thyroid function leading to low levels of thyroid hormones (hypothyroidism), this condition must be treated before starting therapy with NutropinAq otherwise NutropinAq may not work.
• If you are undergoing treatment with glucocorticoid replacement therapy, you should consult your doctor regularly as it may be necessary to adjust the dose of glucocorticoids.
• If you have had a tumor (cancer) in the past, especially a tumor affecting the brain, your doctor must pay particular attention and must visit you regularly to rule out a possible return of the tumor.
• A small number of patients with growth hormone deficiency treated with growth hormone have developed leukemia (blood cancer). However, no cause-and-effect relationship with treatment with growth hormone has been demonstrated. If you have undergone a kidney transplant, treatment with NutropinAq must be discontinued.
• In case of complications after surgery (open heart or abdominal surgery), trauma, acute respiratory failure, or similar conditions, the doctor will assess whether to continue treatment with NutropinAq.
• There is an increased risk of developing inflammation of the pancreas (pancreatitis), which causes severe pain in the abdomen and lower back. See your doctor if you or the child experience abdominal pain after administering NutropinAq.
• If you suffer from Prader-Willi syndrome, you should not be treated with NutropinAq unless there is a growth hormone deficiency.

Other medicines and NutropinAq
Tell your doctor or pharmacist if you are taking or have recently taken or might take
any other medicine.

• if you are taking glucocorticoid replacement therapy, this may reduce the effect of NutropinAq on growth. It is recommended to consult your doctor regularly, as it may be necessary to adjust the dose of glucocorticoids.
• if you are being treated with insulin, your doctor may need to adjust the dose of insulin.
• if you are being treated with sex steroids, anticonvulsant medicines or cyclosporine consult your doctor for advice.
• if, during treatment with NutropinAq, you have been diagnosed with adrenal insufficiency, steroid treatment is necessary. If you are already taking therapy for adrenal insufficiency, it may be necessary to adjust the dose of steroids.
• in particular, tell your doctor if you are taking or have recently taken any of the following medicines. Your doctor may need to adjust the dosage of NutropinAq or other medicines:
• Estrogens taken orally or other sex hormones

Pregnancy and breastfeeding
Taking NutropinAq must be stopped in case of pregnancy.
Caution should be exercised during breastfeeding. If you are pregnant, suspect or are
planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before taking this medicine.

Driving and using machines
No effects on the ability to drive and use machines have been observed during
the use of NutropinAq.

NutropinAq is essentially "sodium-free".
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially
"sodium-free".

3. How to use NutropinAq

Use this medicine following the instructions of your doctor or pharmacist exactly. Always.
If you have any doubts, ask your doctor or pharmacist.
Therapy with NutropinAq must be carried out under the constant supervision of a doctor experienced in
growth hormone deficiency.
The dose of NutropinAq to be injected is established by the doctor. Do not change the dose without consulting
the doctor.
The recommended dose is:
In boys and girls with growth hormone deficiency:
from 0.025 to 0.035 mg/kg of body weight, administered every day under the skin (subcutaneous
injection).
In girls affected by Turner Syndrome:
up to 0.05 mg/kg of body weight, administered every day under the skin (subcutaneous injection).
In boys and girls with chronic renal insufficiency:
up to 0.05 mg/kg of body weight, administered every day under the skin (subcutaneous injection).
Treatment with NutropinAq may be continued until the time of kidney transplantation.
In adults affected by growth hormone deficiency:
Initial use of low doses of somatropin, 0.15 - 0.3 mg, administered every
day under the skin (subcutaneous injection) is recommended. Subsequently, the doctor may increase the dose to
according to the response. The final dose rarely exceeds 1.0 mg/day. In general, the
minimum effective dose that leads to a response should be administered.
Treatment with NutropinAq is a long-term treatment. For further information, consult your
doctor.

How to inject NutropinAq
The dose of NutropinAq to be injected is established by the doctor. It is necessary to inject NutropinAq every
day under the skin (subcutaneous injection). It is important to alternate the injection site every day to
avoid damaging the skin.
NutropinAq is supplied as a multi-dose solution. After removal from the refrigerator, if the
solution is cloudy, the contents should not be injected. Shake gently. Do not shake vigorously, as this could damage the medicine.
To inject NutropinAq, you must use the NutropinAq Pen. A new sterile injection needle must be used for each injection. Read all instructions for use carefully
(on the back) before using the NutropinAq Pen.
At the beginning of therapy, it is recommended that a doctor or nurse administer the injection and
provide instruction on the use of the NutropinAq Pen.
Subsequently, you will be able to inject the medicine yourself or receive the injection from a person
adequately trained.
If you use more NutropinAq than you should
If you have injected an excessive amount of NutropinAq, ask your doctor for advice.
If you inject an excessive amount of NutropinAq, blood sugar levels may decrease and
become too low and then rise to too high levels (hyperglycemia).
If you inject NutropinAq in excess for a long period of time (years), excessive growth may occur
of some parts of the body such as the ears, nose, lips, tongue and cheekbones (gigantism and/or
acromegaly).
If you forget to take NutropinAq
Do not use a double dose to make up for a missed dose.
Continue administering the usual dose the next day and inform the doctor at
the next appointment.
If you stop using NutropinAq
Ask your doctor for advice before stopping the use of NutropinAq. If the treatment with NutropinAq
is interrupted too early or too late, the results will not be as expected.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Immediately inform your doctor if you notice any change or increase in the growth of angiomas
and/or moles. In the case of a tumor or recurrence of previous tumors (confirmed by the doctor), treatment
with NutropinAq must be stopped immediately. This side effect is uncommon, can affect up to 1 in 100 patients.
Immediately inform your doctor if you have vision changes, severe or frequent headaches, or
accompanied by a feeling of nausea or vomiting. These may be symptoms of a temporary increase in
pressure inside the brain (intracranial hypertension). If intracranial hypertension occurs, the doctor may decide to reduce or temporarily interrupt therapy with NutropinAq.
Subsequently, therapy may be restarted after the episode has resolved. This side effect is rare, and can affect up to 1 in 1,000 patients.

Other side effects include:

Very common (may affect more than 1 in 10 people)
Swelling of the hands and feet due to fluid retention (peripheral edema) sometimes associated with
localized muscle pain (myalgia) and joint pain (arthralgia). These side effects usually occur in adults at the beginning of treatment and are of short duration. Edema has been
reported as a common side effect in children.

Common (may affect up to 1 in 10 people)
Reduced thyroid function leading to low levels of thyroid hormones (hypothyroidism). If
hypothyroidism is not treated, this may prevent NutropinAq from working. The doctor
must check how the thyroid is functioning periodically and, if necessary, prescribe appropriate treatment.
Reduced ability to absorb sugar (glucose) from the blood leading to high blood sugar levels (hyperglycemia). The doctor must assess these signs during treatment with NutropinAq.
If you are being treated with insulin, your doctor should assess whether it is necessary to adjust the insulin dose.
Feeling of weakness (asthenia) and increased muscle tension (hypertonia)
Pain, bleeding, bruising, rash, and itching at the injection site. This can be
avoided by using the correct injection technique and alternating injection sites.
Some patients may develop antibodies (a type of protein produced by the body) to
somatropin. In some patients, these antibodies have not prevented growth.

Uncommon (may affect up to 1 in 100 people)
Decreased number of red blood cells in the blood (anemia), decreased blood sugar levels (hypoglycemia), and increased phosphate levels (hyperphosphatemia).
Changes in personality or abnormal behavior.
Persistent burning, tingling, pain and/or numbness in the palm of the hand caused
by carpal tunnel syndrome.
Rapid involuntary eye movements (nystagmus), swelling of the optic nerve in the eye
(papilledema), double vision (diplopia), headache, drowsiness, and dizziness.
Increased heart rate (tachycardia) and blood pressure (hypertension).
Vomiting, stomach pain, flatulence, and nausea.
Sensitive and dry skin (exfoliative dermatitis), changes in skin thickness, excessive growth of
facial and body hair (hirsutism), hives (skin rash).
Scoliosis. If you have scoliosis, you should monitor the progression of scoliosis frequently.
Bone disease in which the upper part of the leg (femur) moves from the hip (femoral epiphysiolysis). This usually occurs in patients who are growing rapidly. Patients with hormonal disorders are more likely to develop a slipped femoral head epiphysis.
Decreased muscle mass (muscle atrophy), joint pain (arthralgia), and bone pain.
Urinary incontinence, increased frequency (pollakiuria), and excessive urine production (polyuria).
Uterine bleeding (bleeding), genital discharge, and abnormal development of male mammary glandular tissue (gynecomastia).
Loss/increase of localized fat tissue (lipodystrophy, atrophy/hypertrophy at the injection site).
Enlargement of the adenoids with symptoms similar to those of enlarged tonsils (see
rare side effects).

Rare (may affect up to 1 in 1,000 people)
Increased blood sugar levels (hyperglycemia, diabetes mellitus). Diabetes mellitus can
cause an increase in urination, thirst, and appetite. If any of these symptoms occur, you should
inform your doctor.
Enlarged tonsils cause snoring, difficulty breathing or swallowing, brief
interruption of breathing during sleep (sleep apnea), or fluid in the ear, as well as ear infections. If this is particularly bothersome, you should see your doctor.
Abnormal sensations of tingling, prickling, or numbness (paresthesia), abnormal development of
bones, degenerative-type abnormalities at the bone and growth cartilage level
(osteochondrosis), and muscle weakness.
Other rare side effects observed with NutropinAq treatment include itching all over the
body, rashes, blurred vision, weight gain, dizziness, diarrhea, facial swelling,
fatigue, pain, fever, depression, and difficulty sleeping (insomnia).
Adverse events detected during clinical trials
In children with growth hormone deficiency, brain tumors have been reported as common adverse events.
Of the 236 patients who participated in clinical trials, 3 patients developed a brain tumor.
Of the 3 patients with brain tumors, 2 patients had a recurrence of malignant cerebellar tumor (medulloblastoma) and 1 patient developed a soft tissue tumor (histiocytoma).
See also the section “Warnings and precautions”.
Girls with Turner syndrome have commonly reported particularly heavy bleeding during their menstrual cycle.
In children with chronic renal insufficiency ,inflammation have been commonly reported
of the membrane lining the abdominal cavity (peritonitis), death of cells of bone tissue
(osteonecrosis), and an increase in blood creatinine levels.
They were more likely to develop increased intracranial pressure (intracranial hypertension)
with a greater risk at the beginning of treatment, although children with
insufficient endogenous growth hormone secretion and with Turner syndrome also present
a higher incidence.
Adults with growth hormone deficiency have commonly reported an abnormal sensation of
itching, tingling, or numbness (paresthesia), excessively high sugar (glucose) levels in the
blood, excess lipids (fats) in the blood, insomnia, joint disorders, osteoarthritis (degenerative disease of the articular cartilages), muscle weakness, back pain, breast pain and
enlargement of the breasts (gynecomastia).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or
pharmacist.
You can also report side effects directly through the national reporting system reported in
Appendix V.
By reporting side effects, you can help provide more information on the safety of
this medicine.

5. How to store NutropinAq

Keep NutropinAq out of the sight and reach of children.
Do not use NutropinAq after the expiry date which is reported on the cartridge label and on the
box after EXP / Scad. The expiry date refers to the last day of the month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
Keep the blister in the outer packaging.
After the first administration, the cartridge can be stored for up to 28 days at a temperature
between 2°C and 8°C. Between one injection and the next, do not remove the cartridge in use from the
NutropinAq Pen.
Do not use NutropinAq if the solution appears cloudy.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. ALTRE INFORMAZIONI

Cosa contiene NutropinAq

• Il principio attivo di NutropinAq è la somatropina*. * Somatropina è l’ormone della crescita umano prodotto da cellule di Escherichia Coli con tecnologia del DNA ricombinante.
• Gli eccipienti sono sodio cloruro, fenolo liquido, polisorbato 20, sodio citrato diidrato, acido citrico anidro e acqua per preparazioni iniettabili.

Descrizione dell’aspetto di NutropinAq e contenuto della confezione
NutropinAq è una soluzione iniettabile (in cartuccia (10mg/2ml) - confezioni: 1, 3 e 6). La soluzione,
da usare per più somministrazioni, è limpida e incolore.
È possibile che non tutte le confezioni siano commercializzate.

Titolare dell’autorizzazione all’immissione in commercio e Produttore:
Titolare dell’autorizzazione all’immissione in commercio:
Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, Francia
Produttore:
IPSEN PHARMA BIOTECH S.A.S., Parc d’Activités du Plateau de Signes, CD n° 402, 83870 Signes,
Francia
Per ulteriori informazioni su NutropinAq, contatti il rappresentante locale del titolare
dell'autorizzazione all’immissione in commercio.

België/Belgique/Belgien,
Luxembourg/Luxemburg
Ipsen NV Guldensporenpark 87
B-9820 Merelbeke
België /Belgique/Belgien
Tél/Tel: + 32 - 9 - 243 96 00

Latvija
Ipsen Pharma pārstāvniecība
Kalnciema iela 33-5
Rīga, LV 1046
Tel: +371 67622233

Česká republika
Ipsen Pharma, s.r.o.
Olbrachtova 2006/9,
140 00 Praha 4
Česká republika
Tel: + 420 242 481 821

Lietuva
Ipsen Pharma SAS Lietuvos filialas
Narbuto g. 5,
08103 Vilnius
Tel. +370 700 33305

Danmark, Norge, Suomi/Finland, Sverige,
Ísland
Institut Produits Synthèse (IPSEN) AB
Kista Science Tower Färögatan 33
SE- 164 51 Kista Sverige/Ruotsi/Svíþjóð
Tlf/Puh/Tel/Sími: +46 8 451 60 00

Magyarország
Ipsen Pharma Hungary Kft.
Váci út 33. IX. em..
H-1134 Budapest
Tel.: + 36-1-555-5930

Deutschland, Österreich
Ipsen Pharma GmbH
Einsteinstraße 174
D-81677 München
Tel: + 49 89 2620 432 89

Nederland
Ipsen Farmaceutica B.V.
Taurusavenue 33b
NL-2132 LS Hoofddorp
Tel: + 31 (0) 23 55 41 600

Eesti
CentralPharma Communications OÜ
Selise 26 - 1113522 Tallinn
Tel: +372 601 5540

Polska
Ipsen Poland Sp. z o.o.
Al. Jana Pawła II 29
00-867 Warszawa
Tel.: + 48 (0) 22 653 6800

Ελλάδα, Κύπρος, Malta
Ipsen Μονοπρόσωπη EΠΕ
Αγ. Δημητρίου 63 Άλιμος
GR-17456 Αθήνα Ελλάδα
Τηλ: + 30 - 210 - 984 3324

Portugal
Ipsen Portugal - Produtos Farmacêuticos S.A.
Alameda Fernão Lopes, nº 16A, 1°B
1495-190 Algés
Portugal
Tel: + 351 - 21 - 412 3550

España
Ipsen Pharma S.A.
Torre Realia, Plaza de Europa, 41-43 08908
L’Hospitalet de Llobregat, Barcelona
Tel: + 34 - 936 - 858 100

România
Ipsen Pharma România SRL
Sectorul 1, Strada Grigore Alexandrescu nr. 59,
Bucureşti, 010623
Tel: + 40 (021) 231 27 20

France
Ipsen Pharma
65 quai Georges Gorse
F-92100 Boulogne-Billancourt
Tél: + 33 - 1 - 58 33 50 00

Slovenija
PharmaSwiss d.o.o.
Brodišče 32
SI-1236 Trzin
Tel: + 386 1 236 47 00

Ireland
Ipsen Pharmaceuticals Limited.
Blanchardstown Industrial Park
Blanchardstown
IRL-Dublin 15, Ireland
Tel: +353 1 809 8256

Slovenská republika
Ipsen Pharma, organizačná zložka
Zámocká 3
SK-811 01 Bratislava
Tel: + 420 242 481 821

Italia
Ipsen SpA
Via del Bosco Rinnovato n. 6
Milanofiori Nord Palazzo U7
20090 Assago (Mi)
Tel: + 39 - 02 - 39 22 41

United Kingdom
Ipsen Limited.
190 Bath Road
Slough,
Berkshire SL1 3XE
Tel: + 44 - (0)1753 - 62 77 00

България
PharmaSwiss EOOD
16, Troyanski Prohod Street
Floor 3, Office 8, Lagera
1612 Sofia

Тел.: +359 2 8952 110
Questo foglio è stato approvato l’ultima volta DD/MM/YYYY
Informazioni più dettagliate su questo medicinale sono disponibili sul sito web dell’Agenzia Europea
dei Medicinali (EMA): http://www.ema.europa.eu .

Penna NutropinAq Pen Istruzioni per l’uso con NutropinAq
NON INIETTARE IL MEDICINALE FINCHÉ NON ABBIA RICEVUTO ISTRUZIONI SULL’USO
CORRETTO DA PARTE DEL MEDICO O DELL’INFERMIERE.

Attenzione:
Prima di usare la penna NutropinAq Pen leggere attentamente le seguenti istruzioni. Si consiglia
inoltre di consultare il medico o l’infermiere, per una dimostrazione.
La penna NutropinAq Pen è concepita esclusivamente per l’uso con le cartucce di NutropinAq (solo
per uso sottocutaneo).
Come mostrato nell’illustrazione sotto riportata, la penna e le cartucce NutropinAq sono disponibili in
due versioni (con o senza il colore giallo aggiuntivo). Il funzionamento della penna ed il contenuto
delle cartucce sono identici per entrambe le versioni. Entrambi i tipi di cartuccia possono essere usati
con entrambe le versioni della penna NutropinAq Pen.

Utilizzare solo gli aghi per la penna consigliati dal medico o dall’infermiere.
La scala graduata di dosaggio accanto alla finestrella del porta-cartuccia non va utilizzata per misurare
la dose, ma solo per stimare la dose rimasta nella cartuccia. Fare sempre riferimento al display a
cristalli liquidi, e non agli scatti che si sentono, per eseguire le regolazioni per l’iniezione di
NutropinAq. Gli scatti sono solo una semplice conferma udibile dello spostamento della rondella nera
della dose.
Conservare sempre penna e cartucce in un luogo pulito e sicuro in frigorifero, a una temperatura
compresa tra 2ºC e 8ºC e fuori dalla vista e dalla portata dei bambini. Proteggere dalla luce intensa. In
viaggio, conservare la penna NutropinAq Pen in una borsa refrigerante. NutropinAq può essere tenuto
fuori dal frigorifero al massimo per un’ora al giorno. Evitare temperature estreme. Controllare la data
di scadenza riportata sulla cartuccia prima di usarla.

Per proteggersi dalla trasmissione di infezioni, attenersi alle seguenti misure di sicurezza:

• Lavarsi a fondo le mani con acqua e sapone prima di usare la penna.
• Pulire il sigillo di gomma della cartuccia con un tampone imbevuto di alcool, o con un batuffolo di cotone imbevuto di alcool.
• Evitare di toccare il sigillo di gomma della cartuccia.
• Se si tocca accidentalmente il sigillo di gomma della cartuccia, pulirlo con un tampone imbevuto di alcool.
• Non utilizzare lo stesso ago su più di una persona.
• Utilizzare gli aghi una sola volta.

Componenti della penna NutropinAq Pen:
Segue un elenco dei componenti necessari per fare un’iniezione. Prima dell’uso, preparare tutti questi
componenti

La cartuccia NutropinAq e la penna NutropinAq Pen verranno fornite separatamente.

• I. Preparazione e iniezione

Seguire le istruzioni contenute in questo paragrafo quando si usa la penna per la prima volta, oppure
quando si sostituisce una cartuccia vuota.
Ispezionare tutte le nuove cartucce prima dell’uso. Occasionalmente, dopo aver refrigerato la cartuccia
si potrebbe notare la presenza di piccole particelle incolori nella soluzione di NutropinAq. Questo non
è insolito per le soluzioni contenenti proteine come NutropinAq e non ha effetti sul dosaggio del
prodotto. Lasciare che la cartuccia giunga a temperatura ambiente, poi ruotarla piano. Non agitare. Se
la soluzione è torbida o non limpida, oppure se contiene materiale solido, non utilizzare la cartuccia.
Restituire la cartuccia al farmacista o al medico che l’ha prescritta.

• 1.Togliere il cappuccio verde dalla penna e svitare il porta-cartuccia dalla penna. Se necessario, rimuovere la cartuccia vuota e smaltirla in modo appropriato.
• 2.Premere il pulsante bianco di riazzeramento.

• 3.Girare in senso antiorario la rondella nera della dose, fino alla posizione di partenza, ossia fino a quando non gira più ( Vedere illustrazione). Ora girare in senso orario la rondella nera della dose, fino a giungere alla prima posizione di scatto (circa 1/4 di giro). In questo modo si garantisce che l’asta dello stantuffo sia riazzerata alla posizione di partenza. Se non si esegue questa operazione quando si preme per la prima volta la rondella di dosaggio, si sprecherà NutropinAq, oppure la cartuccia potrebbe incrinarsi.

• 4.Inserire la cartuccia sul porta-cartuccia, poi riavvitare il porta-cartuccia sulla penna ( Fare attenzione a non toccare il sigillo di gomma).
• 5.Rimuovere la protezione di carta da un nuovo gruppo ago, poi avvitare sul porta-cartuccia.

• 6.Rimuovere con attenzione entrambi i cappucci protettivi dall’ago, tirandoli piano. Non gettare il cappuccio grande, poiché lo si userà più avanti per la rimozione e lo smaltimento corretti dell’ago.
• 7.Tenendo la penna con l’ago rivolto verso l’alto, picchiettare piano sul porta- cartuccia per spostare verso l’alto le eventuali bollicine d’aria presenti. Tenendo sempre la penna in posizione verticale, premere la rondella nera della dose fino a quando non scatta in posizione. Ora dovrebbe apparire una goccia di soluzione.

Siate pazienti: se il medicinale non dovesse apparire entro qualche secondo, forse
sarà necessario premere nuovamente il pulsante di riazzeramento.

• 8.Se la goccia di medicinale non appare, premere nuovamente il pulsante bianco di riazzeramento. Ora girare in senso orario la rondella nera della dose (vedereillustrazione), di uno scatto (0,1 mg). Se la si gira troppo, tornare indietro di uno scatto (0,1 mg).
• 9.Sempre tenendo la penna in posizione verticale, ora premere nuovamente la rondella nera della dose e osservare la punta dell’ago. Dovrebbe apparire una goccia di medicinale, altrimenti ripetere i punti 8 e 9 della procedura finché non la si vede apparire.
• 10.Premere il pulsante bianco di riazzeramento.

• 11.Impostare la dose necessaria girando la rondella nera della dose. Se non risulta possibile impostare la dose totale, iniziare una nuova cartuccia (come descritto nella Parte I della procedura), oppure iniettare la dose parziale. In seguito, iniziare una nuova cartuccia (come descritto nella Parte I) per somministrare la rimanente parte del medicinale. Il medico o l’infermiere consiglierà la procedura di somministrazione dell’ultima dose nella cartuccia.

Preparare il sito di iniezione strofinandovi un tampone impregnato di antisettico Fra i siti di
iniezione possono esservi la parte superiore delle braccia, l’addome e la parte superiore delle
cosce. Alternare i siti di iniezione per evitare disturbi. Anche se si hanno preferenze per un
particolare sito di iniezione, alternarlo comunque.

Parte superiore del braccio
Addome

Thigh

• 12.If you are using passive protection (or if you are not using any protection), proceed to point 13. If, however, you are using active protection, slide it onto the pen and push the 2 black locking washers onto the needle protection, in the direction of the tip.
• 13.Place the tip of the pen on the properly prepared injection site, then press the needle into the skin by pushing the pen downwards, until the protection disappears. Your doctor or nurse will show you how to do this. You are now ready to administer the dose. Press on the black dose washer. Wait 5 seconds after pressing the button, then retract the pen from the skin. A drop of blood may appear. If you wish, apply a bandage to the injection site.
• 14.Pull off the protection to detach it from the needle (if one was used) and place the large cap on a flat surface. Insert the needle to lift it and push the cap all the way onto the needle. Unscrew the needle and dispose of it appropriately. Your doctor or nurse will explain how to properly dispose of the used injection components. Always keep the disposal container out of the reach of children.
• 15.Insert the cap onto the pen and put it back in the case, with the black dose washer pressed. Always store the pen in the refrigerator. Do not freeze.

For subsequent injections with the NutropinAq Pen, attach a new needle, press the
white reset button and set the desired dose.
II: Storage and maintenance

• Follow these tips for proper care of the NutropinAq Pen:
• Always keep the NutropinAq Pen and the cartridge in the refrigerator and protect them from light when not in use.
• You can remove the pen and cartridge from the refrigerator up to 45 minutes before use.
• Do not allow the NutropinAq Pen and/or the cartridge to freeze. Contact your doctor or nurse for a replacement pen or cartridge in case of malfunction.
• Avoid extreme temperatures. The solution in the cartridge remains stable for 28 days after the first administration, if stored at a temperature between 2ºC and 8ºC.
• If you need to clean the pen, do not immerse it in water. Use a damp cloth to wipe away dirt. Do not use alcohol.
• When inserting a new cartridge, you may need to repeat points 8 and 9 of Part I a total of 6 times (0.6 mg) to expel air bubbles. Small bubbles may remain, but these do not affect the dose.
• The pen must contain the NutropinAq product to be used. Do not remove the cartridge between injections.
• You can use the NutropinAq cartridge for up to 28 days after the first administration.
• Do not store the NutropinAq Pen with the needle still attached.

III: Needles for the NutropinAq Pen
Your doctor or nurse will recommend a needle suitable for you. Always use the recommended needles.
Needles from other regions or countries may not be compatible with the NutropinAq Pen. If
you travel outside the European Union, make sure you have enough needles with you for
the entire duration of your stay.

IV: Frequently Asked Questions
Q: Do I have to change the needle every time I use the NutropinAq Pen?
A: Yes, a new needle must be used for each injection. The needle is only sterile upon first use.

Q: Where should I store the NutropinAq Pen?
A: The NutropinAq Pen should be stored inside the case, in the refrigerator if a
cartridge is inserted. When traveling, put the pen in a cooler bag. DO NOT FREEZE.
Q: Why should the medicine be stored in the refrigerator?
A: To maintain the dosage of NutropinAq.

Q: Can I store the NutropinAq Pen in the freezer?
A: No. Freezing damages the pen and the medicine.

Q: How long can I keep the NutropinAq Pen and the cartridge out of the refrigerator?
A: It is not recommended to keep them out of the refrigerator for more than an hour. Your doctor or nurse will give
advice on how to store the pen.

Q: What is the maximum dose that can be administered with the NutropinAq Pen in a single injection?
A: The NutropinAq Pen allows a minimum dose of 0.1 mg and a maximum dose of 4.0 mg (40
clicks). Attempting to administer a dose greater than 4 mg at once may cause the
medicine to leak from the needle and be lost, or may cause excessive pressure at
the level of the cartridge which may break.

Q: Can I turn the black dose washer backwards if I click it too many times?
A: Yes, you can turn the black dose washer backwards until the display shows the
correct number.

Q: What should I do if there is not enough solution in the cartridge for the next
administration?
A: Your doctor or nurse will tell you what to do for the last remaining dose in the cartridge.

Q: Why do I have to turn the black dose washer on the NutropinAq Pen backwards every
time I change the cartridge?
A: This ensures that the plunger rod is completely reset to the starting position. If you do not perform this operation, liquid will come out of the needle when you insert a new
cartridge onto the pen.

Q: Can I use the NutropinAq Pen without the protections?
A: Yes. The NutropinAq Pen works even without protections. The protections are optional and
assist in administering the injection.

Q: What should I do if the NutropinAq Pen falls?
A: If you drop the NutropinAq Pen, check that the cartridge is not damaged.
Also check that the black dose washer on the pen moves correctly up and down and
that the LCD indicator works. If the cartridge or pen is damaged, request a
replacement from your doctor or nurse.

Q: How long can I use the NutropinAq Pen?
A: The NutropinAq Pen is designed to last 24 months from the first time you use the pen.

Q: What does the flashing ‘bt’ indication on the LCD mean?
A: It means that the battery of the NutropinAq Pen is running low. Contact your doctor or
nurse for a replacement. Normally the batteries last 24 months and retain their charge for
4 weeks from the first appearance of the flashing ‘bt’ indication on the LCD.

Q: How can I change the NutropinAq Pen?
A: Contact your doctor or nurse if a replacement component is needed, or if the
entire pen needs to be replaced.
For further information about the product, please contact the local representative. The local representative
and the manufacturer of the NutropinAq Pen are the same as the medicinal product, listed on the
back (see point 6).

Manufacturer:
IPSEN PHARMA BIOTECH S.A.S., Parc d’Activités du Plateau de Signes, CD n° 402, 83870 Signes,
France

This leaflet was approved on
CE 0459
NutropinAq is a registered trademark of Genentech, Inc.

APPENDIX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATIONS FOR THE VARIATION OF THE TERMS
OF THE MARKETING AUTHORISATION
Scientific conclusions
Taking into account the assessment of the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Report (PSUR) for somatropin, the scientific conclusions are as follows:
In light of the available data on risks from clinical studies, literature, spontaneous reports
including in some cases a close temporal relationship, a de-challenge and/or a positive re-challenge,
the PRAC Rapporteur considers that there is at least a reasonable possibility of a causal relationship
between somatropin and acute pancreatitis. The PRAC Rapporteur concludes that Paragraph 4.4
of the Product Information of products containing somatropin should be
modified to add a warning about pancreatitis.
Furthermore, the PRAC Rapporteur considers that a causal relationship between somatropin and
gynecomastia is established and concludes that Paragraph 4.8 of the SmPC of products containing somatropin should
be modified, to add the adverse reaction gynecomastia with a frequency of uncommon.
The Committee for Medicinal Products for Human Use (CHMP) agrees with the scientific conclusions
of the PRAC.

Justifications for the variation of the terms of the marketing authorisations
Based on the scientific conclusions on somatropin the CHMP considers that the benefit/risk balance of the medicinal products containing somatropin is unchanged subject to the proposed changes
to the product information.
The CHMP recommends the variation of the terms of the marketing authorisations.