NEORECORMON 500 IU Powder and solvent for injectable solution

Зміст інструкції

1. NeoRecormon 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU
   1. What is NeoRecormon and what is it used for
   2. What you need to know before using NeoRecormon
   3. How to use NeoRecormon
   4. Possible side effects
   5. How to store NeoRecormon
   6. Contenuto della confezione e altre informazioni

NeoRecormon 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU

NeoRecormon 6000 IU
NeoRecormon 10000 IU
NeoRecormon 20000 IU
NeoRecormon 30000 IU
injectable solution in pre-filled syringe
epoetin beta

Read this leaflet carefully before you start using 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 NeoRecormon is and what it is used for
• 2. What you need to know before you use NeoRecormon
• 3. How to use NeoRecormon
• 4. Possible side effects
• 5. How to store NeoRecormon
• 6. Contents of the pack and other information

1. What is NeoRecormon and what is it used for

NeoRecormon is a clear and colorless solution for injection under the skin ( subcutaneously) or into
a vein ( intravenously). It contains a hormone called epoetin beta, which stimulates the
production of red blood cells. Epoetin beta is produced using a special genetic engineering technique and
acts exactly like the natural hormone erythropoietin.
Consult your doctor if you do not feel better or if you feel worse.
NeoRecormon is indicated exclusively for:

• the treatment of symptomatic anemia caused by chronic renal failure(renal anemia) in patients undergoing dialysis or not yet undergoing dialysis;
• the prevention of anemia in premature infants(weighing between 750 and 1500 g and with a gestational age of less than 34 weeks);
• the treatment of anemia, with related symptoms, in adult patients with cancerundergoing chemotherapy;
• the treatment of patients who donate blood in anticipation of surgery.Injections of epoetin beta increase the amount of blood that can be drawn from the body before surgery and that can be transfused during or after surgery (this is an autologous transfusion).

2. What you need to know before using NeoRecormon

Do not use NeoRecormon:

• ( if you are allergicto epoetin beta or to any of the other ingredients of this medicine (listed in section 6);
• if you have uncontrolled high blood pressure;
• if you donate blood before surgery and:
• you have had a heart attackor a strokein the month before treatment;
• you suffer from unstable angina pectoris- recent or worsening chest pain;
• if you are at risk of developing blood clotsin the veins ( deep vein thrombosis) - for example if you have had clots before.

If any of the above applies to you, or has applied to you in the past, tell your doctor immediately.

Warnings and precautions:
Talk to your doctor before using NeoRecormon

• If your child needs treatment with NeoRecormon, they will need to becarefully monitored for the risk of potential effects on theeyes.
• if your anemia does not improvefollowing treatment with epoetin;
• if you have low levels of certain B vitamins(folic acid or vitamin B12);
• if you have very high levels of aluminumin your blood;
• if you have a high number of platelets;
• if you have chronic liver disease;
• if you have epilepsy;
• if you have developed antibodies to erythropoietin andpure red cell aplasia (reduced or absent production of red blood cells) during previous exposure to any erythropoietic substance. In this case, you should not switch to treatment with NeoRecormon.

Be particularly careful with other products that stimulate red blood cell production:
NeoRecormon belongs to a group of products that stimulate the production of red blood cells such as
human erythropoietin protein. Your doctor should always record the specific product you are
using.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with epoetin treatment.
Stevens-Johnson syndrome and toxic epidermal necrolysis can initially appear as red or target-like patches or circular patches often with blisters in the center on the trunk. Mouth, throat, nose, genitals and eye (red and swollen eyes) ulcers can also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to skin exfoliation and life-threatening complications.
If you develop a severe rash or any other of these skin symptoms, stop taking it and contact your
doctor immediately.

Special warnings:
During treatment with NeoRecormon

If you have chronic kidney failure, and especially if you do not respond adequately to
NeoRecormon, your doctor will check the dose of NeoRecormon you receive because if you do not respond to
treatment, repeated dose increases of NeoRecormon may increase the risk of heart or blood vessel problems and may increase the risk of myocardial infarction, stroke and death.

If you have cancer, you should know that NeoRecormon can act as a growth factor for blood cells and that, in some circumstances, it may have negative effects on the tumor. Depending on the specific
situation, a blood transfusion may be preferred. Discuss this with your doctor.

If you have nephrosclerosisand are not undergoing dialysis, your doctor will decide whether the treatment is appropriate
for your case, as it is not possible to completely rule out a possible acceleration of
kidney disease progression.

Your doctor may regularly prescribe blood teststo check:

• potassium levels. If you have high or rising potassium levels, your doctor may reconsider treatment;
• platelet count. The number of platelets may increase from mild to moderate during epoetin treatment and this may cause changes in blood coagulation.

If you have kidney disease and are undergoing hemodialysis,your doctor may adjust the dose
of heparin. This will prevent blockage of the dialysis system.

If you have kidney disease, are undergoing hemodialysis and are at risk of shunt thrombosis,it is
possible that clots (thrombosis)will form in your shunt(blood vessel used for
connection to the dialysis system). Your doctor may prescribe acetylsalicylic acid or change
the shunt.

If you donate blood before surgery,your doctor must:

• check that you are able to donate blood, especially if you weigh less than 50 kg
• check that you have a sufficient level of red blood cells (hemoglobin levels of at least 11 g/dl);
• ensure that a single donation does not exceed 12 % of your blood.

Do not misuse NeoRecormon
Improper use of NeoRecormon by healthy individuals can cause an increase in blood cells and consequently make the blood thicker. This can in turn induce complications affecting the heart or blood vessels, which are life-threatening.

Other medicines and NeoRecormon
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.

Pregnancy, breastfeeding and fertility
Experience with NeoRecormon in pregnant or breastfeeding women is limited.
Ask your doctor or pharmacist for advice before taking any medicine.
Evidence indicates that NeoRecormon does not impair fertility in animals. The potential risk to
humans is unknown.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.

NeoRecormon contains phenylalanine and sodium
This medicine contains phenylalanine and may be harmful to people with phenylketonuria.
If you have phenylketonuria, talk to your doctorregarding treatment with NeoRecormon.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially “sodium-free”.

3. How to use NeoRecormon

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
The doctor will use the lowest effective dose to control the symptoms of anemia.
If you do not respond adequately to NeoRecormon, the doctor will check the administered dose and
inform you if it is necessary to modify the doses of the medicine.
Treatment must be initiated under the supervision of your doctor. Subsequent injections
may be administered by your doctor or, after training, you may inject
NeoRecormon yourself (see instructions at the end of this leaflet).
NeoRecormon can be injected under the skin in the abdomen, arm, or thigh,
or into a vein. Your doctor will decide which site is most suitable for you.
The doctor will perform regular blood tests to verify if the anemia responds to
treatment by measuring the hemoglobin level.

Dosage of NeoRecormon
The dose of NeoRecormon depends on the condition of your illness, the route of administration
of the injection (under the skin or into a vein), and your body weight. The doctor will assess the exact dose for
you.
The doctor will use the lowest effective dose to control the symptoms of anemia.
If you do not respond adequately to NeoRecormon, the doctor will check the dose you receive and
inform you if it needs to be modified.

• Symptomatic anemia caused by chronic renal failureInjections are given under the skin or into a vein.If the solution is injected into a vein, the injection should last approximately 2 minutes, for example, patients undergoing hemodialysis will receive the injection through the arteriovenous access at the end of dialysis. Patients not undergoing hemodialysis will usually receive injections under the skin.

Treatment with NeoRecormon is divided into two phases:

a)Correction of anemia
The initial dose for subcutaneous injectionsis 20 IU per injection per kg of body weight,
administered three times a week.

After 4 weeksthe doctor will perform tests and, if the response to treatment is insufficient,
may increase the dose to 40 IU/kg per injection, three times a week. If necessary, the
doctor may continue to increase the dose at monthly intervals.
The weekly dose can also be divided into daily doses.

The initial dose for intravenous injectionsis 40 IU per injection per kg of body weight,
administered three times a week.

After 4 weeksthe doctor will perform tests and, if the response to treatment is insufficient,
may increase the dose to 80 IU/kg per injection, three times a week. If necessary, the
doctor may continue to increase the dose at monthly intervals.

For both types of injectionthe maximum dose should not exceed 720 IU per kg of body
weight per week.

b)Maintenance of sufficient red blood cell levels
Maintenance dose:once the red blood cells have reached an acceptable level, the dose
is reduced to half of that administered for the correction of anemia. The weekly dose can
be administered once a week, or it can be divided into three or seven doses per week. If
with weekly administration your red blood cell level is stable, you can switch to a
dose every two weeks. In this case, dose increases may be necessary.

Every one or two weeksthe doctor may modify the dosage in order to identify the individual
maintenance dose.

Childrenwill begin treatment following the same criteria. In clinical studies, children have
usually required higher doses of NeoRecormon (the younger the child, the higher the dose).
Treatment with NeoRecormon is normally long-term. However, if necessary, it can be
interrupted at any time.

• Anemia in premature infants

Injections are given under the skin.
The initial doseis 250 IU per injection per kg of body weight of the newborn, three times a
week.
Premature infants who have received transfusions before starting treatment with
NeoRecormon are unlikely to benefit as much as infants who have not been transfused.
The recommended duration of treatment is 6 weeks.

• Adults with symptomatic anemia undergoing chemotherapy for cancer

Injections are given under the skin.
The doctor may start treatment with NeoRecormon if the hemoglobin level is equal to or
less than 10 g/dl.
After starting therapy, the doctor will maintain the hemoglobin level between 10 and 12 g/dl.

The initial weekly dose is30,000 IU. This can be administered as a single
weekly injection or it can be fractionated into 3 - 7 weekly injections. The doctor will regularly take
blood samplesand may increase or decrease the dose, or interrupt the
treatment based on the test results. Hemoglobin values must not exceed 12 g/dl.
Therapy should continue for 4 weeks after the end of chemotherapy.

The maximumweekly dose should not exceed 60,000 IU.

• Patients donating blood before surgery

Injections are given intravenously over 2 minutes or under the skin.
The dose of NeoRecormondepends on your health condition, red blood cell levels, and the
amount of blood that will be donated before surgery.
The dose calculated by the doctor will be administered twice a week for 4 weeks. When
donating blood, you will receive NeoRecormon at the end of the donation session.

The maximum doseshould not exceed

• for intravenous injections: 1600 IU per kg of body weight per week;
• for subcutaneous injections: 1200 IU per kg of body weight per week.

If you receive too high a dose of NeoRecormon
Do not increase the dose prescribed by the doctor. If you believe you have injected a dose of NeoRecormon
higher than necessary, contact your doctor. It is unlikely to be a serious problem. No
symptoms of poisoning have been observed even at very high blood levels.

If you forget to take NeoRecormon
If you have forgotten to perform an injection or if you have injected a dose too low, contact your doctor.

Do not take a double doseto make up for missed doses.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Side effects that may occur in any patient

• In many patients (very common effects may affect more than 1 in 10 people) there is adecrease in iron levels in the blood.Almost all patients need to be treated with iron supplements during therapy with NeoRecormon.
• Rarely (effects may affect up to 1 in 1,000 people)allergies or skin reactionshave occurred, such as rash or hives, itching or reactions around the injection site.
• Very rarely (effects may affect up to 1 in 10,000 people) a severe allergic reactionhas occurred, especially immediately after the injection, a condition that needs to be treated immediately. If you notice unusual wheezing or have difficultybreathing; swelling (oedema) of the tongue, face or throat, or swellingaround the injection site; if you feel confused or feel faint or collapse, call yourdoctor immediately.
• Very rarely (effects may affect up to 1 in 10,000 people) patientshave experienced flu-like symptoms, especially at the beginning of treatment. Thesesymptoms includefever, chills, headache, limb pain, bone pain and/or general malaise. These reactions have usually been mild to moderate in intensity and have disappeared within a few hours or days.
• In association with treatment with epoetin, severe skin reactions have been reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as red, target-like lesions or circular patches often with blisters in the centre on the trunk, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes and may be preceded by fever and flu-like symptoms. Stop using NeoRecormon if you develop any of these symptoms and contact your doctor immediately. See also paragraph 2.

Additional side effects in patients with chronic renal failure (renal anaemia)

• Increased blood pressure, worsening of pre-existing hypertension andheadacheare the most common side effects (very common effects may affect more than 1 in 10 people). The doctor will check your blood pressure regularly, especially at the beginning of therapy. The doctor may treat hypertension with medication or temporarily interrupt therapy with NeoRecormon.
• Call your doctor immediatelyif you experience headache, especially sudden,severe and migraine-like, confusion, speech disturbances, unsteady walking,convulsions.These may be signs of very high blood pressure ( hypertensivecrisis), even if blood pressure is usually normal or low. This condition needs to be treated immediately.
• If you have hypotension (low blood pressure) or complications of the shunt,you may be at risk of shunt thrombosis(a blood clot in the blood vessel used for connection to the dialysis system).
• Very rarely (effects may affect up to 1 in 10,000 people), patientshave presented with high levels of potassium or phosphate in the blood.These can be treated by the doctor.
• Pure red cell aplasia (PRCA) caused by neutralizing antibodies has been observedduring therapy with erythropoietin, including isolated cases during therapy with NeoRecormon. The presence of pure red cell aplasia means that the body has stopped or reduced the production of red blood cells. This causes severe anaemia, whose symptoms include unusual fatigue and lack of energy. If the body produces neutralizing antibodies, the doctor will stop the therapy with NeoRecormon and establish the best therapy to treat the anaemia.

Additional side effects in adults undergoing chemotherapy for cancer

• Increased blood pressure and headachecan occasionally occur. The doctor may treat hypertension with medication.
• An increase in the formation ofblood clotshas been observed.

Additional side effects in patients who donate blood before surgery

• A slight increase in the formation ofblood clotshas been observed.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system listed in Annex V. By reporting side effects you can
help to provide more information on the safety of this medicine.

5. How to store NeoRecormon

• Keep this medicine out of the sight and reach of children.
• Do not use NeoRecormon after the expiry date which is stated on the package and on the label
• Store in a refrigerator (2°C - 8°C).
• The syringe can be removed from the refrigerator and left at room temperature for a single period of a maximum of 3 days (but not above 25°C).
• Keep the pre-filled syringe in the outer packaging to protect it from light
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contenuto della confezione e altre informazioni

Cosa contiene NeoRecormon

• Il principio attivo è epoetina beta. Una siringa preriempita contiene 500, 2000, 3000, 4000, 5000, 6000, 10000, 20000 o 30000 UI (unità internazionali) di epoetina beta in 0,3 ml o 0,6 ml di soluzione..
• Gli eccipienti sono urea, sodio cloruro, polisorbato 20, sodio fosfato monobasico diidrato, sodio fosfato dibasico dodecaidrato, calcio cloruro diidrato, glicina, L-leucina, L-isoleucina, L- treonina, L-acido glutammico e L-fenilalanina e acqua per preparazioni iniettabili (vedere paragrafo 2 “ NeoRecormon contiene fenilalanina e sodio”).

Descrizione dell’aspetto di NeoRecormon e contenuto della confezione
NeoRecormon è una soluzione iniettabile in siringa pre-riempita
La soluzione è incolore, da chiara a lievemente opalescente.
NeoRecormon 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU and 6000 IU : ogni siringa pre-riempita
contiene 0.3 ml di soluzione iniettabile.
NeoRecormon 10,000 IU, 20,000 IU and 30,000 IU: ogni siringa pre-riempita contiene 0.6 ml di
soluzione iniettabile.
NeoRecormon viene fornito nelle seguenti confezioni:
NeoRecormon 500 IU
1 siringa pre-riempita con 1 ago (30G1/2) o
6 siringhe pre-riempite con 6 aghi (30G1/2).
NeoRecormon 2000 IU, 3000 IU, 4000 IU, 5000 IU, 6000 IU e 10.000 IU e 20.000 IU
1 siringa pre-riempita con 1 ago (27G1/2) o
6 siringhe pre-riempite con 6 aghi (27G1/2).
NeoRecormon 30.000 IU
1 siringa pre-riempita con 1 ago (27G1/2) o
4 siringhe pre-riempite con 4 aghi (27G1/2).
È possibile che non tutte le confezioni siano commercializzate.

Titolare dell’autorizzazione all’immissione in commercio
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germania

Produttore
Roche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Wyhlen
Germania
Per ulteriori informazioni su questo medicinale, contatti il rappresentante locale del titolare
dell’autorizzazione all’immissione in commercio:

België/Belgique/Belgien
N.V. Roche S.A.
Tél/Tel: +32 (0) 2 525 82 11

Lietuva
UAB “Roche Lietuva”
Tel: +370 5 2546799

България
Рош България ЕООД
Тел: +359 2 818 44 44

Luxembourg/Luxemburg
(Voir/siehe Belgique/Belgien)

Česká republika
Roche s. r. o.
Tel: +420 - 2 20382111

Magyarország
Roche (Magyarország) Kft.
Tel: +36 - 1 279 4500

Danmark
Roche Pharmaceuticals A/S
Tlf: +45 - 36 39 99 99

Malta
(See Ireland)

Deutschland
Roche Pharma AG
Tel: +49 (0) 7624 140

Nederland
Roche Nederland B.V.
Tel: +31 (0) 348 438050

Eesti
Roche Eesti OÜ
Tel: + 372 - 6 177 380

Norge
Roche Norge AS
Tlf: +47 - 22 78 90 00

Ελλάδα
Roche (Hellas) A.E.
Τηλ: +30 210 61 66 100

Österreich
Roche Austria GmbH
Tel: +43 (0) 1 27739

España
Roche Farma S.A.
Tel: +34 - 91 324 81 00

Polska
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88

France
Roche
Tél: +33 (0)1 47 61 40 00

Portugal
Roche Farmacêutica Química, Lda
Tel: +351 - 21 425 70 00

Hrvatska
Roche d.o.o
Tel: +385 1 4722 333

România
Roche România S.R.L.
Tel: +40 21 206 47 01

Ireland
Roche Products (Ireland) Ltd.
Tel: +353 (0) 1 469 0700

Slovenija
Roche farmacevtska družba d.o.o.
Tel: +386 - 1 360 26 00

Ísland
Roche Pharmaceuticals A/S
c/o Icepharma hf
Sími: +354 540 8000

Slovenská republika
Roche Slovensko, s.r.o.
Tel: +421 - 2 52638201

Suomi/Finland
Roche Oy
Puh/Tel: +358 (0) 10 554 500

Kύπρος
Γ.Α.Σταμάτης & Σια Λτδ.
Τηλ: +357 - 22 76 62 76

Italia
Roche S.p.A.
Tel: +39 - 039 2471

Sverige
Roche AB
Tel: +46 (0) 8 726 1200

Latvija
Roche Latvija SIA
Tel: +371 - 6 7039831

United Kingdom (Northern Ireland)
Roche Products (Ireland) Ltd.
Tel: +44 (0) 1707 366000
Informazioni più dettagliate su questo medicinale sono disponibili sul sito web della Agenzia europea
dei medicinali, http://www.ema.europa.eu.

Siringa preriempita di NeoRecormon
Istruzioni per l’uso
Le istruzioni riportate di seguito illustrano come praticare un’iniezione di NeoRecormon. Prima di
iniettare NeoRecormon, si accerti di leggere, comprendere e seguire le istruzioni per l’uso e il foglio
illustrativo. L’operatore sanitario deve mostrarle come preparare e iniettare correttamente
NeoRecormon prima che lei lo utilizzi per la prima volta.

Nonsi inietti da solo il medicinale senza aver prima ricevuto un adeguato addestramento. Se necessita
di altre informazioni, consulti l’operatore sanitario.
Seguire sempre tutte le indicazioni contenute in tali Istruzioni per l'uso in quanto potrebbero differire
dalle proprie esperienze. Queste istruzioni ridurranno al minimo rischi, come quello di puntura
accidentale con l’ago e a prevenirne l'uso non corretto.
NeoRecormon può essere somministrato in 2 modi; sarà il medico a decidere quale sia quello più
indicato per lei:

• Somministrazione endovenosa (in vena o tramite portvenoso), che deve essere effettuata soltanto dagli operatori sanitari.
• Somministrazione sottocutanea (al di sotto della pelle).

Prima di iniziare

• Nontogliere il cappuccio dell’ago fino a quando non si è pronti a iniettare NeoRecormon.
• Nontentare mai di aprire la siringa.
• Nonriutilizzare la stessa siringa.
• Nonusare se la siringa è caduta o risulta danneggiata.
• Nonlasciare la siringa incustodita.
• Tenere la siringa, l’ago e il contenitore a prova di perforazioneperperforazioneper lo smaltimento di oggetti appuntiti fuori dalla portata dei bambini.
• In caso di domande, contattare l’operatore sanitario.

Istruzioni per la conservazione

• Tenere la o le siringhe inutilizzate e gli aghi nella confezione originale e conservarle in frigorifero a 2°C- 8°C.
• Tenere la siringa e l’ago al riparo dalla luce diretta del sole.
• Noncongelare.
• Nonusare se la siringa è stata congelata.
• Tenere sempre la siringa e l’ago asciutti.

Materiali necessari per praticare l’iniezione
Inclusi nella confezione:

• Siringa o siringhe preriempite di NeoRecormon.

Corpo in vetro
Stantuffo Gommino

• Ago o aghi per iniezione (da 27G o 30G) (a seconda dei dosaggi di medicinale prescritti )con protezione di sicurezza (per la preparazione, la definizione della dose e l’iniezione del medicinale).

Protezione di
sicurezza
Cappuccio dell’ago
NB: ogni confezione di NeoRecormon contiene 1 siringa/1 ago, 4 siringhe/4 aghi o 6 siringhe/6 aghi.

Non inclusi nella confezione:

• 1 tampone imbevuto d’alcol.
• 1 tampone sterile asciutto.
• 1 contenitore a prova di perforazione/per oggetti appuntiti per lo smaltimento sicuro del tappo in gomma, del cappuccio dell’ago e della siringa usata.

Preparazione dell’iniezione
1Scegliere una superficie di lavoro ben illuminata, piana e pulita.

• Togliere dal frigorifero la confezione contenente la o le siringhe e i relativi aghi.

2Verificare la confezione, la dentellatura sulla parte anteriore della scatola e il sigillo. Controllare
anche la data di scadenza.

• Nonusare se la data di scadenza è stata superata, o se risulta danneggiata la confezione. In tal caso, passare al punto 20e contattare l’operatore sanitario.● Nonusare se la dentellatura o il sigillo risultano danneggiati. In tal caso, passare al punto 20e contattare l’operatore sanitario.

3 Aprire la confezione premendo sulla dentellatura attorno al sigillo.

4Prelevare una siringa dalla confezione e un ago dall’apposita scatola. Prestare attenzione nel
momento in cui si preleva la siringa. Accertarsi di impugnare sempre la siringa come illustrato
nell’immagine.

• Noncapovolgere la confezione per prelevare la siringa.
• Nonmanipolare la siringa impugnandola dallo stantuffo o dal cappuccio dell’ago.

Attenzione:se si dispone di una confezione multipla, riporre la scatola con la o le siringhe rimanenti

e i relativi aghi in frigorifero.

5Ispezionare attentamente la siringa e l’ago.

• Verificare la siringa e l’ago per escludere eventuali danni. Nonusare la siringa se è caduta o se una delle sue componenti appare danneggiata.
• Verificare la data di scadenza riportata sulla siringa e sull’ago. Nonusare la siringa o l’ago se la data di scadenza è stata superata.
• Verificare il liquido contenuto all’interno della siringa. Il liquido deve essere limpido e incolore. Nonusare la siringa se il liquido risulta torbido, presenta alterazioni del colore o contiene particelle.

6Posizionare la siringa su una superficie piana e pulita.

• Lasciar riposare la siringa per 30 minuti in modo che raggiunga da sola la temperatura ambiente. Nell’attesa, lasciare il cappuccio dell’ago sulla siringa.
• Nonaccelerare in alcun modo il processo di raggiungimento della temperatura ambiente e noncollocare la siringa nel microonde o in acqua calda. Attenzione:il mancato raggiungimento della temperatura ambiente da parte della siringa può far sìche l’iniezione risulti fastidiosa e rendere difficile la pressione dello stantuffo.

7Applicare l’ago sulla siringa.

• Togliere l’ago dal blister.
• Sfilare il tappo in gomma dall’estremità della siringa (A).
• Smaltire subito il tappo in gomma riponendolo in un contenitore a prova di perforazione o per oggetti appuntiti.
• Nontoccare la punta della siringa.
• Nonpremere né tirare lo stantuffo.
• Impugnare il corpo della siringa e inserire l’ago su di essa (B).
• Ruotare delicatamente fino a quando l’ago non sarà perfettamente fissato (C).

A) Tappo di gomma Tappo in gomma

B)

C)

8Posizionare la siringa su una superficie piana e pulita fino a quando non si è pronti a utilizzarla.

9Lavarsi le mani con acqua e sapone.

10Scegliere una sede di iniezione:

• Le sedi raccomandate consistono nella parte superiore della coscia o nella parte inferiore dell’addome, al di sotto dell’ombelico.
• Nonpraticare l’iniezione nell’area di 5 cm direttamente circostante l’ombelico.
• Scegliere una sede diversa per ogni nuova iniezione.
• Nonpraticare l’iniezione in corrispondenza di nei, cicatrici, lividi o aree in cui la pelle è dolorante, arrossata, indurita o non intatta.
• Nonpraticare l’iniezione in vena o nei muscoli.

= sedi di iniezione

11Disinfettare la sede di iniezione con un tampone imbevuto d’alcool e lasciarla asciugare per 10
secondi.

• Nonsventolare né soffiare sull’area disinfettata.
• Nontoccare più la sede di iniezione prima di praticare l’iniezione.

Somministrazione dell’iniezione sottocutanea
12Allontanare la protezione di sicurezza dall’ago verso la direzione spostandola verso il corpo della
siringa.

13Impugnare saldamente la siringa e l’ago nel punto di intersezione e sfilare attentamente il
cappuccio dell’ago per l’iniezione dalla siringa. Usare la siringa entro 5 minuti dalla rimozione
del cappuccio per evitare che l’ago si ostruisca.

• Nonimpugnare lo stantuffo durante la rimozione del cappuccio dell’ago.
• Nontoccare l’ago dopo aver tolto il relativo cappuccio.
• Noninserire nuovamente il cappuccio sull’ago.● Non raddrizzare l'ago se l'ago è piegato o danneggiato. Smaltire subito il cappuccio dell’ago riponendolo nel contenitore per oggetti appuntiti.

14Hold the syringe with the needle pointing upwards. Remove larger air bubbles by gently tapping the fingers on the body of the syringe, until the bubbles rise to the top. Then slowly press the plunger to expel the air bubbles from the syringe.

15Adjust the syringe content to the prescribed dose by slowly pressing the plunger.

16Pinch the chosen injection site and insert the needle completely at an angle of 45-90°, with a quick and decisive movement.

• Do nottouch the plunger while inserting the needle into the skin.
• Do notinsert the needle through clothing. After inserting the needle, release the skin and hold the syringe firmly in place.

17Inject slowlythe prescribed dose by gently pressing the plunger all the way down.

• Withdraw the needle and syringe from the injection site maintaining the same angle used during insertion.

After the injection
18Slight bleeding may occur at the injection site. It is possible to press a dry, sterile swab onto the injection site. Do notrub the injection site.

• If necessary, the injection site can be covered with a light bandage.
• If the medicine comes into contact with the skin, rinse the affected area with water.

19Move the safety shield forward by 90°, away from the syringe body (A).
Holding the syringe with one hand, press the safety shield down onto a flat surface, with a quick and decisive movement, until you hear a “click” (B).

• If you do not hear a “click”, verify that the needle is completely covered by the safety shield.
• Always keep your fingers behind the safety shield and away from the needle.

A)

B)

20Place the used syringe in a sharps container immediately after use.

• Do notattempt to remove the needle used for the injection from the used syringe.
• Do notre-attach the cap to the needle used for the injection.
• Do notdiscard the syringe in household waste. Important:always keep the sharps container out of reach of children.

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Instructions for intravenous administration, for healthcare professionals only
The instructions below illustrate how to perform an intravenous injection of NeoRecormon.
Before injecting NeoRecormon, ensure you read, understand and follow the instructions for use and the

Administration of the intravenous injection (for healthcare professionals only)
Preparation of the injection: follow steps 1 to 9 for subcutaneous administration (see above)

10Choose a vein. Change vein with each injection to avoid soreness at the site.

• Do notinject into areas that are red or swollen.
• Do notinject into muscles. Disinfect the skin at the vein with an alcohol swab and let it dry.
• Do notwave or blow on the disinfected area.
• Do nottouch the injection site again before performing the injection.

11Prepare the syringe and needle: follow steps 12 to 15for subcutaneous administration (see above).

16Insert the needle into the vein.

• Do nothold or press the plunger while inserting the needle. 17Inject the prescribed dose slowly by gently pressing the plunger all the way down. Withdraw the needle and syringe from the injection site maintaining the same angle used during insertion.

After the injection follow steps 18 to 20 for subcutaneous administration (see above).

Administration of the intravenous injection via dedicatedport(for healthcare
professionals only)
Preparation of the injection: follow steps 1 to9 for subcutaneous administration (see above).

10Disinfect the skin at the injection portwith an alcohol swab and let it dry.
Disinfect the injection portfollowing the supplier’s instructions.

• Do notwave or blow on the disinfected area.
• Do nottouch the injection site again before performing the injection.

11Prepare the syringe and needle: follow steps 12 to 15 for subcutaneous administration (see above).

16Insert the needle into the port(follow the supplier’s instructions for the injection port).

• Do nothold or press the plunger while inserting the needle. 17Inject the prescribed dose slowly by gently pressing the plunger all the way down. Withdraw the needle and syringe from the portmaintaining the same angle used during insertion.

After the injection follow steps 18 to 20 for subcutaneous administration (see above).