qanastek/EMEA-V3 huggingface dataset:
or th Using Nespo with food and drink
x Meta tuża Nespo ma ’ l- ikel u max- xorb
au Food and drink do not affect Nespo.
du L- ikel u x- xorb ma jeffetwawx lil Nespo.
Pregnancy and breast-feeding
’ g
er Nespo has not been tested in pregnant women.
Nespo ma ġiex ittestjat f’ nisa tqal.
It is important to tell your doctor if you: ng • are pregnant; lo
Huwa importanti li tavża lit- tabib tiegħek jekk: im
• think you may be pregnant; or no
• inti tqila;
• plan to get pregnant. ct
• taħseb li inti tqila; jew il al
You must stop breast-feeding if du
• qed taħseb biex issir tqila. in
you use Nespo. ro
Għandek tieqaf tredda ’ jekk qed tuża Nespo. iċ ed
Driving and using machines lp
Sewqan u tħaddim ta ’ magni
Nespo should not affect your ability to drive or use machinery. a in
Nespo m’ għandux effett fuq il- ħila tiegħek biex issuq jew li tħaddem magni. m t
HOW TO USE NESPO ic
KIF GĦANDEK TUŻA NESPO ot
Following blood tests, your doctor has decided you need Nespo as your haemoglobin level is 10 g/ dl or less.
Wara t- testijiet tad- demm, it- tabib tiegħek iddeċieda li int għandek bżonn Nespo minħabba li l - od
Your doctor will tell you how much and how often you must take Nespoin order to maintain a ed
Dan jista 'jvarja skond jekk Pr
haemoglobin level between 10 and 12 g/ dl.
intix adult jew tifel.
Injecting Nespo yourself
Tinjetta lilek innifsek b' Nespo
Your doctor may decide that it is best for you or a carer to inject Nespo.
It- tabib tiegħek jista ’ jiddeċiedi li jkun aktar konvenjenti għalik jekk inti jew l- carer tiegħek t/ jinjetta Nespo.
Your doctor, nurse or pharmacist will show you how to inject yourself with the pre-filled syringe.
It- tabib, l- infermiera jew l- ispiżjar tiegħek juruk kif tinjetta lilek nnifsek b’ siringa mimlija għal- lest.
Never inject Nespo into a vein yourself.
Qatt m 'għandek tinjetta lilek nnifsek b' Nespo ġo vina.
If you have chronic renal failure
538 Jekk għandek insuffiċjenza renali kronika
Nespo is given as a single injection, either once a week, once every two weeks, or once every month either under your skin (subcutaneous) or into a vein (intravenous).
Nespo jingħata bħala injezzjoni waħda, darba fil- ġimgħa, darba kull ġimgħatejn, jew darba fix- xahar jew taħt il- ġilda jew ġol- vina.
469 In order to correct your anaemia, your initial dose of Nespo per kilogram of your body weight will be either: • 0.75 micrograms once every two weeks, or • 0.45 micrograms once weekly Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose once every four weeks as necessary.
It- tabib tiegħek jeħodlok kampjuni tad- demm regolarment sabiex jara kif l- anemija tiegħek qed
Once your anaemia is corrected, your doctor will continue to regularly check your blood and your dose may be adjusted further in order to maintain long-term control of your anaemia.
riz Meta l- anemija tiegħek tiġi korreta, it- tabib tiegħek jkompli jiċċekkjalek regolarment id- demm u d - doża tiegħek għandha mnejn terġa ’ tiġi aġġustata biex jinżamm kontroll fit- tul ta ’ l- anemija tiegħek.
Your doctor will inform you if your dose changes.
It- tabib tiegħek jgħidlek jekk id- doża tiegħek tinbidillek
ed Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.
to Il- pressjoni tad- demm tiegħek ukoll tiġi eżaminata regolarment, speċjament fil- bidu tal- kura.
In some cases, your doctor may recommend that you take iron supplements.
aw F’ ċertu każijiet, it- tabib tiegħek jista ’ jirrakkomandalek li tieħu l- ħadid bħala supplement.
is or Your doctor may decide to change the way that your injection is given (either under the skin or into a vein).
x It- tabib tiegħek jista ’ jiddeċiedi li jbiddel il- mod ta 'kif tingħatalek l- injezzjoni (jew taħt il- ġilda jew
th take blood samples to make sure that your anaemia is still being managed correctly.
Il- mod ta 'kif tingħata l- injezzjoni hija l- istess im
au If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by gene- technology) to Nespo, they will choose whether you should receive your Nespo injection once weekly
mod bħal ta ’ r- HuEPO iżda t- tabib tiegħek jgħidlek kemm għandek tieħu, u meta, u jista ’ jaġġustalek id- doża tiegħek jekk jkun hemm bżonn. il
er or once every two weeks.
Jekk qed tirċievi l- kimoterapija al
The route of injection is the same as with r-HuEPO but your doctor will tell you how much you should take, and when, and may adjust your dose if necessary. ng If you are receiving chemotherapy lo
Nespo jingħata bħala injezzjoni waħda, darba fil- ġimgħa jew darba kull tliet ġimgħat, taħt il- ġilda. in
Nespo is given as a single injection, either once a week or once every three weeks, under your skin. no
Sabiex tiġi korretta l- anemija tiegħek, id- doża tal- bidu tiegħek tkun ta ’ iċ
In order to correct your anaemia, your initial dose will be • 500 micrograms once every three weeks (6.75 micrograms of Nespo per kilogram of your body ct
• 500 mikrogramma darba kull tliet ġimgħat (6. 75 mikrogrammi ta 'Nespo għal kull kilogramma tal- piż ta ’ ġismek) jew ed
weight), or • 2.25 micrograms (once weekly) of Nespo per kilogram of your body weight. du
• 2. 25 mikrogrammi (darba fil- ġimgħa) ta ’ Nespo għal kull kilogramma tal- piż ta ’ ġismek.
Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose as necessary.
tirrispondi u jista ’ jbiddillek id- doża skond il- bżonn.
Your treatment will continue until approximately four weeks after the ro
Il- kura tiegħek tkompli sa bejn wieħed u ieħor erba ’ ġimgħat wara tmiem il- kimoterapija.
Your doctor will tell you exactly when to stop taking Nespo. lp
It- tabib jgħidlek eżatt meta trid tieqaf tieħu Nespo. t ot
In some cases, your doctor may recommend that you take iron supplements. a
F’ ċertu każijiet, it- tabib tiegħek jista ’ jirrakkomandalek li tieħu l- ħadid bħala supplement. od
If you use more Nespo than you should in
Jekk tuża Nespo aktar milli suppost Pr
However, you should ic
M’ għandux jkollok problemi serji jekk tieħu Nespo aktar milli suppost.
If you feel unwell in any way you should ed
Madankollu, trid tikkuntattja lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek jekk jiġri dan.
M
Jekk b’ xi mod tħossok ma tiflaħx, għandek tikkuntattja lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek immedjatament.
If you forget to inject Nespo
Jekk tinsa tieħu Nespo
If you have forgotten a dose of Nespo, you should contact your doctor to discuss when you should inject the next dose.
Jekk insejt tieħu doża ta ’ Nespo, ikkuntattja lit- tabib tiegħek biex jiddiskuti miegħek meta jmissek tinjetta d- doża li jmiss.
4.
539 4.
Like all medicines, Nespo may cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Nespo jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following side effects have been experienced by some patients taking Nespo:
L- effetti sekondarji li ġejjin seħħew f ’ xi pazjenti li kienu qed jieħdu Nespo:
470 Very Common (seen in more than 10 in 100 people)
Komuni ħafna (seħħew f ’ aktar minn 10 persuni f ’ kull 100 persuna)
• High blood pressure (hypertension) • Fluid retention (oedema)
• Pressjoni tad- demm għolja
Common (seen in more than 1 in 100 people)
t za • Żamma tal- fluwidi (edima)
• Blood clots (thrombosis) • Pain around the area injected • Rash and/ or redness of the skin
Komuni (seħħew f ’ aktar minn persuna waħda f ’ kull 100 persuna)
Rare (seen in more than 1 in 10,000 people)
riz • Biċċiet ta ’ demm magħqud (trombożi)
ed Serious allergic reactions which may include:
to • Uġigħ madwar is- sit ta ’ l - injezzjoni • Raxx u/ jew ħmura tal- ġilda.
is • Sudden life-threatening allergic reactions (anaphylaxis) • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or
aw Rari (seħħew f ’ aktar minn persuna waħda f’ kull 10, 000 persuna)
th • Shortness of breath (dyspnoea) • Skin rash
x Reazzjonijiet allerġiċi serji li jistgħu jinkludu:
au • Hives (urticaria)
du • Reazzjonijiet allerġiċi f’ daqqa li jistgħu jkunu ta ’ periklu għal ħajja (anafilassi) • Nefħa fil- wiċċ, fix- xoftejn, fil- ħalq, fl- ilsien jew fil- griżem li tista ’ tikkawżaw diffkultà biex ħa tibla jew tieħu nifs (angioedema) • Qtugħ ta 'nifs (dispneja) • Raxx tal- ġilda ’ g • Ħorriqija (urtikarja) im
er Very rare (seen in less than 1 in 10,000 people)
Rari ħafna (seħħew f ’ anqas minn persuna waħda f’ kull 10, 000 persuna) il
• Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy)
• Aplażja pura taċ- ċelluli ħomor (PRCA) – (anemija, għeja mhux tas- soltu, nuqqas ta ’ enerġija) al
Convulsions (fits and seizures) have been reported in patients treated with Nespo. lo
Konvulżjonijiet (aċċessjonijiet jew puplesiji) ġew rrappurtati f ’ pazjenti kkurati b’ Nespo. in
If you have any of these symptoms or you notice any side effects that are not mentioned in this leaflet, no
Jekk għandek xi wieħed minn dawn is- sintomi jew jekk tħoss xi effetti sekondarji oħra li mhux iċ
please tell your doctor, nurse or pharmacist. ct
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek. ed
HOW TO STORE NESPO du
KIF TAĦŻEN NESPO m
Keep in the original package in order to protect from ro
Żommu fil- pakkett oriġinali biex tilqa ’ mid- dawl. t
Do not use Nespo if you think it has been frozen. a
Tużax Nespo jekk taħseb li ġie ffriżżat. ot od
approximately 30 minutes before injection it must either be used within 7 days or disposed of. ic
Pr
Do not use Nespo after the expiry date which is stated on the carton and on the pre-filled pen label ed
Tużax Nespo wara d- data ta ’ skadenza li tidher fuq it- tikketta u il- kartuna wara JIS.
M
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
6.
540 6.
What Nespo contains
X’ fih Nespo
Nespo comes in a pre-filled syringe that contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of the active substance darbepoetin alfa.
Nespo jiġi ġo siringa mimlija għal- lest li fiha 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 jew 500 mikrogramma tas- sustanza attiva darbepoetin alfa.
471 Nespo also contains sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.
Nespo fih ukoll sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 u ilma għall- injezzjoni.
What Nespo looks like and contents of the pack
t za Id- dehra ta ’ Nespo u l- kontenuti tal- pakkett:
Nespo is a clear, colourless or slightly pearly liquid.
Jekk jkun
If it is cloudy or there are particles in it, you must not use it.
riz mċajpar jew jekk jkun fih xi frak, m 'għandekx tużah.
Nespo is available in packs of 1 or 4 pre-filled syringes (not all pack sizes may be marketed).
Is- siringi jinstabu jew
The syringes are provided either with (1- & 4-pack) or without (1-pack) a blister-wrapping.
aw ippakkjati ġo folja (pakkett ta '1 u ta' 4) jew mingħajr folja (pakkett ta '1).
ed Dompé Biotec S. p. A.
x Dompé Biotec S. p. A.
th Amgen Europe B. V.
du Via San Martino 12 I- 20122 Milan Italja ħa Il- Manifattur ’ g Amgen Europe B. V.
au Minervum 7061 NL-4817 ZK Breda The Netherlands
Minervum 7061 im
Further information er ng If you want more information about this medicine, please contact the local representative of the lo company that is authorised to market Nespo. no
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - in
This leaflet was last approved in.
Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq: iċ
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web ct
Dan il- fuljett kien approvat l- aħħar f ’. ed
site: http: / /www. emea. europa. eu/ du
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu / m t
INSTRUCTIONS FOR INJECTING WITH THE NESPO PRE-FILLED SYRINGE ro
TAGĦRIF DWAR KIF TINJETTA LILEK INNIFSEK B’ NESPO ot
This section contains information on how to give yourself an injection of Nespo.
Din il- parti tal- fuljett tinkludi tagħrif dwar kif tagħti injezzjoni b 'Nespo lilek innifsek.
It is important that lp
Importanti li od
you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist.
ma tippruvax tagħti l- injezzjoni lilek innifsek jekk ma tkunx irċevejt taħriġ speċjali mit- tabib, mill - infermiera jew mill- ispiżjar tiegħek.
If you have questions about how to inject, please ask your doctor, nurse or pharmacist a
Jekk għandek xi mistoqsijiet dwar kif tinjetta, jekk jogħġbok Pr
for assistance. in ic
staqsi lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek għall- għajnuna.
How do you or the person injecting you, use the Nespo pre-filled syringe? ed
Kif inti jew il- persuna li se tinjettak, tuża is- siringa mimlija għal- lest b 'Nespo?
Your doctor has prescribed an Nespo pre-filled syringe for injection into the tissue just under the skin.
It- tabib tiegħek ordnalek injezzoni b’ siringa mimlija għal- lest b 'Nespo għall- injezzjoni fit- tessut eżatt taħt il- ġilda.
Your doctor, nurse, or pharmacist will tell you how much Nespo you need and how frequently it M
It- tabib, l- infermiera jew l- ispiżjar tiegħek jgħidulek kemm Nespo jkollok bżonn tinjetta u l- frekwenza ta 'l- injezzjonijiet.
Equipment:
541 Apparat:
To give yourself an injection you will need:
Biex tagħti injezzjoni taħt il- ġilda lilek innifsek teħtieġ:
• a new Nespo pre-filled syringe; and
• siringa mimlija għal- lest b’ Nespo ġdida; u
• alcohol wipes or similar.
• msielaħ ta ’ l- alkoħol jew simili;
What should I do before I give myself a subcutaneous injection of Nespo?
X’ għandi nagħmel qabel ma ninjetta lili nnifsi taħt il- ġilda b’ Nespo?
472 1.
t za 1.
Remove the pre-filled syringe from the refrigerator.
Oħroġ s- siringa mimlija għal- lest b’ Nespo mill- friġġ.
Leave the pre-filled syringe at room temperature for approximately 30 minutes.
Ħalliha toqgħod f 'temperatura ambjentali għal bejn wieħed u ieħor 30 minuta.
This will make the injection more comfortable.
Issaħħanx Nespo
Do not warm Nespo in any other way (for example, do not warm it in a microwave or in hot water).
riz bl’ ebda mod ieħor (eżempju: issaħħanx fil- forn li jsaħħan l- ikel aktar malajr bil- majkrowejv jew f’ ilma jaħraq).
Additionally, do not leave the syringe exposed to direct sunlight.
Ukoll, tħallix is- siringa esposta għax- xemx diretta.
3.
aw 3.
ed 5.
x du 5.
Check the expiry date on the pre-filled syringe label (EXP:).
Tużahiex jekk id -
Do not use it if the date has passed the last day of the month shown.
data qabżet l- aħħar ġurnata tax- xahar muri.
Check the appearance of Nespo.
Iċċekkja d- dehra ta ’ Nespo.
If it is
Din għandha tkun likwidu ċar, mingħajr kulur, jew b 'dehra kemm kemm ta' perla.
or cloudy or there are particles in it, you must not use it.
Jekk jkun mċajpar jew jekk jkun fih xi frak, m 'għandekx tużah. ’ g
Wash your hands thoroughly.
Aħsel idejk sew. im
Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Sib post komdu, mdawwal sew, naddaf il- wiċċ, u poġġi dak kollu li għandek bżonn fejn tista 'tilħaqhom. il al
er How do I prepare my Nespo injection?
Kif nipprepara l- injezzjoni ta ’ Nespo? in
lo
Qabel ma tinjetta lil Nespo trid tagħmel dan li ġej: iċ
To avoid bending the needle, gently pull the cover from the needle without twisting as shown in pictures 1 and 2. no
Biex tevita li tgħawweġ il- labra, aqla ’ bil- mod l- għatu minn mal- labra mingħajr ma ddawwar jew tgħawweġ kif muri fi stampi 1 u 2. ed
Do not touch the needle or push the plunger.
Tmissx il- labra u timbuttax il- planġer. m
You may notice a small air bubble in the pre-filled syringe.
Jista 'jkun li tinnota bużżieqa ta' l- arja żgħira ġewwa s- siringa mimlija t
You do not have to remove the air bubble before injecting.
M' hemmx bżonn tneħħi l- bużżieqa ta 'l- arja qabel ma ot
Injecting the ct
tinjetta.
You can now use the pre-filled syringe. du
Pr
Where should I give my injection? ro
Fejn għandi nagħti l- injezzjoni lili nnifsi?
If lp
L- aħjar postijiet fejn tinjetta lilek innifsek huma in- naħa ta ’ fuq ta ’ kuxxtejk u l- addome.
someone else is injecting for you, they can also use the back of your arms. a
Jekk xi ħadd ieħor qed jinjettak, jista ’ wkoll juża n- naħa ta ’ wara ta ’ driegħek.
You may change the injection site if you notice the area is red or sore. in ic
Tista ’ tbiddel is- sit ta 'l- injezzjoni jekk tinnota ħmura jew tbenġil fis- sit ta' l - injezzjoni.
How do I give my injection? ed
542 Kif nagħti l- injezzjoni tiegħi?
M
Iddisinfetta l- ġilda billi tuża mselħa ta ’ l- akoħol u oqros (mingħajr ma tagħfas) il- ġilda bejn sebgħek il- kbir u sebgħek il- werrej.
If you see blood in the syringe, pull the needle out and re-insert it in another place.
Jekk tara d- demm fis- siringa, iġbed l- labra ‘ l barra u erġa 'daħħalha f’ post ieħor.
4.
t za 4.
Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.
Imbotta l- planger bil- mod u bl- istess ritmu, filwaqt li dejjem iżżomm il- ġilda maqrusa, sa kemm is- siringa tkun vojta.
Remove the needle and let go of your skin.
Neħħi l- labra u itlaq il- ġilda.
473 6.
to 6.
If you notice a spot of blood you may gently dab it away with a cotton ball or tissue.
Jekk tinnota qatra demm tista ’ timsaħha b ’ biċċa tajjar jew tixxu.
Do not rub the injection site.
Tgħorokx is- sit ta ’ l - injezzjoni.
If needed, you may cover the injection site with a plaster.
Jekk hemm bżonn, tista ’ tgħatti s- sit ta ’ l- injezzjoni b ’ biċċa stikk.
7.
aw 7.
Do not use any Nespo that is left in the syringe.
Tużax Nespo li jkun fadal ġewwa s- siringa.
Remember:
x Ftakar:
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Jekk għandek xi problemi, jekk jogħġbok tibżax issaqsi lit- tabib jew lill- infermiera tiegħek
Disposing of used syringes
du għal għajnuna jew parir.
• Do not put the cover back on used needles, as you may accidentally prick yourself. • Keep used syringes out of the reach and sight of children.
Rimi ta ’ siringi użati ħa • Terġax tqiegħed l- għatu fuq labar użati, minħabba li tista ’ titnigess bi żball. ’ g • Żomm siringi użati fejn ma jintlaħqux u ma jidhrux mit- tfal. • Is- siringi użati għandhom jintremew kif jitolbu l- liġijiet lokali.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill- ispiżjar dwar kif im
is protect the environment.
għandek tarmi mediċini li m’ għandekx bżonn.
or th au er ng lo no ct du ro ed M
Dawn il- miżuri jgħinu għal protezzjoni ta ’ l - ambjent. il al in iċ ed m t ot od Pr
474 PACKAGE LEAFLET:
543 FULJETT TA ’ TAGĦRIF:
Nespo 15 micrograms solution for injection in a vial Nespo 25 micrograms solution for injection in a vial Nespo 40 micrograms solution for injection in a vial Nespo 60 micrograms solution for injection in a vial darbepoetin alfa
Nespo 15- il mikrogramma soluzzjoni għall- injezzjoni ġo kunjett Nespo 25 mikrogramma soluzzjoni għall- injezzjoni ġo kunjett Nespo 40 mikrogramma soluzzjoni għall- injezzjoni ġo kunjett Nespo 60 mikrogramma soluzzjoni għall- injezzjoni ġo kunjett darbepoetin alfa
Please read this leaflet carefully before you start using this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tuża din il- mediċina.
Keep this leaflet.
t za Żomm dan il- fuljett.
ed If you have any further questions, ask your doctor, nurse or pharmacist.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek.
This medicine has been prescribed for you.
riz Din il- mediċina ġiet mogħtija lilek.
It may harm them, even if
M’ għandekx tgħaddiha lil persuni oħra.
is their symptoms are the same as yours.
Tista ’ tagħmlilhom il -
or If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
to ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
th tell your doctor, nurse or pharmacist.
aw Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek.
au In this leaflet
x F’ dan il- fuljett:
er 1.
du 1.
What Nespo is and what is it used for 2.
X’ inhu Nespo u għalxiex jintuża 2.
Before you use Nespo ng 3.
Qabel ma tuża Nespo ħa 3.
How to use Nespo 4.
Kif għandek tuża Nespo 4.
Possible side effects lo 5.
Effetti sekondarji li jista ’ jkollu ’ g 5.
Further information no
Kif taħżen Nespo Aktar tagħrif 6. im
WHAT NESPO IS AND WHAT IS IT USED FOR ct
X’ INHU NESPO U GĦALXIEX JINTUŻA il
Anaemia is when your du
L- anemija hija meta d - al
blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath. ro
demm tiegħek ma jkollux biżżejjed ċelluli ħomor u s- sintomi jistgħu jkunu għeja, dgħjufija u qtugħ ta ’ in
Erythropoietin is lp
nifs. iċ
produced in your kidneys and encourages your bone marrow to produce more red blood cells.
Nespo jaħdem eżattament fl- istess mod bħall- ormon naturali eritropojetina.
The active substance of Nespo is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary a
L- eritropojetina hija magħmula fil- kliewi tiegħek u ġġiegħel lill- mudullun tiegħek jipproduċi aktar ċelluli ħomor tad - ed
Cells (CHO-K1). in ic
demm.
If you have chronic renal failure ed
Jekk għandek insuffiċjenza renali kronika t ot
In kidney failure, the kidney does not produce enough of the natural M
Meta jkun hemm insuffiċjenza tal- kliewi, il- kilwa ma od
hormone erythropoietin which can often cause anaemia.
Pr
Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect.
Minħabba li ġismek jieħu ż- żmien sakemm jipproduċi aktar ċelluli ħomor, jridu jgħaddu xi erba ’ ġimgħat qabel tinduna b’ xi effett.
475 One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood cells.
544 Wieħed mill- effetti sekondarji ewlenin tal- kimoterapija huwa li twaqqaf il- mudullun milli jipproduċi biżżejjed ċelluli tad- demm.
This is because the red blood cells have a much longer life span in the circulating blood.
Dan minħabba li ċ- ċelluli ħomor tad- demm għandhom ħajja ħafna itwal fiċ- ċirkolazzjoni tad- demm.
BEFORE YOU USE NESPO
QABEL MA TUŻA NESPO
DO NOT use Nespo:
TUŻAX Nespo:
• if you have been diagnosed with high blood pressure which is not being controlled with other
t za • jekk ġejt djanjostikat bi pressjoni għolja li mhix ikkontrollata tajjeb b ’ mediċini oħra li kitiblek it- tabib tiegħek; jew
ed medicines prescribed by your doctor; or
riz • jekk għandek sensittività eċċessiva (allerġija) għal Nespo (darbepoetin alfa), għal r- HuEPO jew
is if you are allergic to Nespo (darbepoetin alfa), r-HuEPO or to any of the other ingredients in Nespo.
to għal xi waħda mis- sustanzi l- oħra ta 'Nespo.
or Take special care wi th Nespo
aw Oqgħod attent ħafna b’ Nespo
th au Please tell your doctor if you are suffering or have suffered from:
Jekk jogħġbok għid lit- tabibtiegħek jekk qed tbati jew jekk qatt batejt minn:
• high blood pressure which is being controlled with medicines prescribed by your doctor;
x du • pressjoni għolja li mhix qed tiġi kkurata b’ mediċini oħra mogħtija mit- tabib tiegħek;
• sickle cell anaemia; er ng • epileptic fits (seizures); lo
• anemija tat- tip sickle cell; ħa • attakki ta ’ epilessija (puplesiji) ’ g
• convulsions (fits or seizures); no
• konvulżjonijiet (aċċessjonijiet jew puplesiji); im
• liver disease; ct
• mard tal- fwied; jew il
• significant lack of response to drugs used to treat anaemia; or du
• nuqqas sinifikattiv ta ’ rispons għal mediċini wżati biex jikkuraw l- anemija. al
Special warnings ro
Twissijiet speċjali in
• If you have symptoms which include unusual tiredness and a lack of energy this could mean lp
• iċ
PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia. a
Aplażja pura ta ’ ed
If you experience these symptoms you should contact your doctor who will determine the best in
ċelluli ħomor (PRCA) tfisser li l- ġisem waqqaf jew naqqas il- produzzjoni taċ- ċelluli ħomor tad - demm li tikkawża anemija severa.
course of action to treat your anaemia. ic
Jekk tesperjenza dawn is- sintomi għandek tikkuntattja lit - tabib tiegħek li jiddetermina l- aħjar mod biex jikkuralek l- anemija. m
• Your doctor should try to keep your haemoglobin between 10 and 12 g/dl. ed
• It- tabib tiegħek għandu jipprova jżommlok l- emoglobina tiegħek bejn 10 u 12 g/ dl. t ot
• If you have chronic renal failure there is an increased risk of serious problems with your heart or M
• Jekk għandek insuffiċjenza renali kronika hemm riskju għola ta ’ problem serji f’ qalbek jew fil - od
blood vessels (cardiovascular events) if your haemoglobin is kept too high.
Pr
Depending on your individual situation a blood transfusion may be preferable.
Skond l- istat individwali tiegħek jista ’ jkun aħjar li tirċievi transfużjoni tad- demm.
• Misuse by healthy people can cause life-threatening problems with the heart or blood vessels.
• L- użu ħażin minn persuni b’ saħħithom jista ’ jikkawża problemi fil- qalb jew fil- vini u arterji li jistgħu jkunu ta ’ periklu għall- ħajja.
Using other medicines
545 Meta tuża mediċini oħra
Cyclosporin and tacrolimus may be affected by the number of red cells in your blood.
Cyclosporin u tacrolimus jistgħu jiġu effettwati mill- kwantità ta ’ ċelluli ħomor fid- demm tiegħek.
It is important to tell your doctor if you are taking either of these drugs.
Huwa importanti li tgħid lit- tabib tiegħek jekk qed tieħu xi waħda minn dawn il- mediċini.
476 Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Using Nespo with food and drink
Meta tuża Nespo ma ’ l- ikel u max- xorb
Food and drink do not affect Nespo.
t za L- ikel u x- xorb ma jeffetwawx lil Nespo.
Nespo has not been tested in pregnant women.
riz Nespo ma ġiex ittestjat f’ nisa tqal.
It is important to tell your doctor if you:
Huwa importanti li tavża lit- tabib tiegħek jekk:
ed • are pregnant;
to • inti tqila;
is think you may be pregnant; or
aw • taħseb li inti tqila; jew
or • plan to get pregnant.
x • qed taħseb biex issir tqila.
th It is not known whether darbepoetin alfa is excreted in human milk.
du Mhuwiex magħruf jekk darbepoetin alfa joħroġx mal- ħalib tal- bniedem.
You must stop breast-feeding if
Għandek tieqaf tredda ’ jekk qed tuża Nespo. ħa Sewqan u tħaddim ta ’ magni ’ g
er Nespo should not affect your ability to drive or use machinery. ng lo
Nespo m’ għandux effett fuq il- ħila tiegħek biex issuq jew li tħaddem magni. im
HOW TO USE NESPO no
KIF GĦANDEK TUŻA NESPO il al
Following blood tests, your doctor has decided you need Nespo as your haemoglobin level is 10 g/dl or less.
Wara t- testijiet tad- demm, it- tabib tiegħek iddeċieda li int għandek bżonn Nespo minħabba li l - emoglobina tiegħek hija 10g/ dl jew anqas.
Your doctor will tell you how much and how often you must take Nespoin order to maintain a haemoglobin level between 10 and 12 g/dl.
It- tabib tiegħek jgħidlek kemm u kemm ta ’ spiss għandek in
child. du
Dan jista 'jvarja skond jekk intix adult jew tifel. iċ ed
If you have chronic renal failure ro
Jekk għandek insuffiċjenza renali kronika
Nespo is given as a single injection, either once a week, once every two weeks, or once every month lp
Nespo jingħata bħala injezzjoni waħda, darba fil- ġimgħa, darba kull ġimgħatejn, jew darba fix- xahar m
either under your skin (subcutaneous) or into a vein (intravenous).
jew taħt il- ġilda jew ġol- vina. t
In order to correct your anaemia, your initial dose of Nespo per kilogram of your body weight will be a
Sabiex tikkoreġi l- anemija tiegħek, l- ewwel doża ta ’ Nespo tiegħek għal kull kilogramma tal- piż ta ’ ot
• 0.75 micrograms once every two weeks, or ic
ġismek tkun ta ’: • 0. 75 mikrogrammi (darba kull ġimgħatejn) jew od
• 0.45 micrograms once weekly Your doctor will take regular blood samples to measure how your anaemia is responding and may ed
• 0. 45 mikrogrammi (darba fil- ġimgħa) It- tabib tiegħek jeħodlok kampjuni tad- demm regolarment sabiex jara kif l- anemija tiegħek qed Pr
M
tirrispondi għall- kura u jista ’ jaġġusta d- doża tiegħek darba kull erba ’ ġimgħat skond il- bżonn.
Once your anaemia is corrected, your doctor will continue to regularly check your blood and your dose may be adjusted further in order to maintain long-term control of your anaemia.
Meta l- anemija tiegħek tiġi korreta, it- tabib tiegħek jkompli jiċċekkjalek regolarment id- demm u d - doża tiegħek għandha mnejn terġa ’ tiġi aġġustata biex jinżamm kontroll fit- tul ta ’ l- anemija tiegħek.
Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.
Il- pressjoni tad- demm tiegħek ukoll tiġi eżaminata regolarment, speċjament fil- bidu tal- kura.
In some cases, your doctor may recommend that you take iron supplements.
F’ ċertu każijiet, it- tabib tiegħek jista ’ jirrakkomandalek li tieħu l- ħadid bħala supplement.
Your doctor may decide to change the way that your injection is given (either under the skin or into a vein).
546 It- tabib tiegħek jista ’ jiddeċiedi li jbiddel il- mod ta 'kif tingħatalek l- injezzjoni (jew taħt il- ġilda jew ġol- vina).
If this changes you will start on the same dose as you have been receiving and your doctor will take blood samples to make sure that your anaemia is still being managed correctly.
Jekk dan jinbidel inti tibda tingħata l- injezzjoni bil- mod il- ġdid bl- istess doża ta ’ qabel u t - tabib tiegħek jeħodlok kampjuni tad- demm sabiex jassiġura li l- anemija għadha qed tiġi kkontrollata tajjeb.
477 If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by gene- technology) to Nespo, they will choose whether you should receive your Nespo injection once weekly or once every two weeks.
Jekk it- tabib tiegħek iddeċieda li jbiddillek il- kura tiegħek minn r- HuEPO (eritropojetina magħmula minn teknoloġija ġenetika) għal Nespo, it- tabib tiegħek jiddeċiedi jekk għandekx tingħata injezzjoni ta 'Nespo darba fil- ġimgħa jew darba kull ġimgħatejn.
The route of injection is the same as with r-HuEPO but your doctor will tell you how much you should take, and when, and may adjust your dose if necessary.
Il- mod ta 'kif tingħata l- injezzjoni hija l- istess mod bħal ta ’ r- HuEPO iżda t- tabib tiegħek jgħidlek kemm għandek tieħu, u meta, u jista ’ jaġġustalek
If you are receiving chemotherapy
t za id- doża tiegħek jekk jkun hemm bżonn.
Nespo is given as a single injection, either once a week or once every three weeks, under your skin.
Jekk qed tirċievi l- kimoterapija
In order to correct your anaemia, your initial dose will be • 500 micrograms once every three weeks (6.75 micrograms of Nespo per kilogram of your body
riz Nespo jingħata bħala injezzjoni waħda, darba fil- ġimgħa jew darba kull tliet ġimgħat, taħt il- ġilda.
ed weight), or • 2.25 micrograms (once weekly) of Nespo per kilogram of your body weight.
to Sabiex tiġi korretta l- anemija tiegħek, id- doża tal- bidu tiegħek tkun ta ’
Your doctor will take regular blood samples to measure how your anaemia is responding and may
aw • 500 mikrogramma darba kull tliet ġimgħat (6. 75 mikrogrammi ta 'Nespo għal kull kilogramma tal- piż ta ’ ġismek) jew • 2. 25 mikrogrammi (darba fil- ġimgħa) ta ’ Nespo għal kull kilogramma tal- piż ta ’ ġismek.
Your treatment will continue until approximately four weeks after the
x It- tabib tiegħek jeħodlok kampjuni regolari tad- demm sabiex jkejjel kif l- anemija tiegħek qed
or end of your chemo therapy.
du tirrispondi u jista ’ jbiddillek id- doża skond il- bżonn.
Your doctor will tell you exactly when to stop taking Nespo.
Il- kura tiegħek tkompli sa bejn wieħed u ieħor erba ’ ġimgħat wara tmiem il- kimoterapija.
th In some cases, your doctor may recommend that you take iron supplements.
It- tabib jgħidlek eżatt meta trid tieqaf tieħu Nespo. ħa F’ ċertu każijiet, it- tabib tiegħek jista ’ jirrakkomandalek li tieħu l- ħadid bħala supplement. ’ g Jekk tuża Nespo aktar milli suppost im
er You should have no serious problems if you take more Nespo than you need.
M’ għandux jkollok problemi serji jekk tieħu Nespo aktar milli suppost.
However, you should contact your doctor, nurse or pharmacist if this does happen.
Madankollu, trid tikkuntattja lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek jekk jiġri dan.
If you feel unwell in any way you should ng contact your doctor, nurse or pharmacist immediately. lo If you forget to inject Nespo no
Jekk b’ xi mod tħossok ma tiflaħx, għandek tikkuntattja lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek immedjatament. il al
If you have forgotten a dose of Nespo, you should contact your doctor to discuss when you should inject the next dose. ct
Jekk insejt tieħu doża ta ’ Nespo, ikkuntattja lit- tabib tiegħek biex jiddiskuti miegħek meta jmissek tinjetta d- doża li jmiss. iċ ed
POSSIBLE SIDE EFFECTS du
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU m
Like all medicines, Nespo may cause side effects, although not everybody gets them. ro
Bħal kull mediċina oħra, Nespo jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd. t
The following side effects have been experienced by some patients taking Nespo: lp
L- effetti sekondarji li ġejjin seħħew f ’ xi pazjenti li kienu qed jieħdu Nespo: ot
Very Common (seen in more than 10 in 100 people) a in
Komuni ħafna (seħħew f ’ aktar minn 10 persuni f ’ kull 100 persuna) od
• High blood pressure (hypertension) ic
• Pressjoni tad- demm għolja Pr
• Fluid retention (oedema) ed
• Żamma tal- fluwidi (edima)
Common (seen in more than 1 in 100 people) M
Komuni (seħħew f ’ aktar minn persuna waħda f ’ kull 100 persuna)
• Blood clots (thrombosis) • Pain around the area injected • Rash and/or redness of the skin
• Biċċiet ta ’ demm magħqud (trombożi) • Uġigħ madwar is- sit ta ’ l - injezzjoni • Raxx u/ jew ħmura tal- ġilda.
Rare (seen in more than 1 in 10,000 people)
Rari (seħħew f ’ aktar minn persuna waħda f’ kull 10, 000 persuna)
Serious allergic reactions which may include: • Sudden life-threatening allergic reactions (anaphylaxis) • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema) • Shortness of breath (dyspnoea)
547 Reazzjonijiet allerġiċi serji li jistgħu jinkludu: • Reazzjonijiet allerġiċi f’ daqqa li jistgħu jkunu ta ’ periklu għal ħajja (anafilassi) • Nefħa fil- wiċċ, fix- xoftejn, fil- ħalq, fl- ilsien jew fil- griżem li tista ’ tikkawżaw diffkultà biex tibla jew tieħu nifs (angioedema) • Qtugħ ta 'nifs (dispneja) • Raxx tal- ġilda • Ħorriqija (urtikarja)
Very rare (seen in less than 1 in 10,000 people)
t Rari ħafna (seħħew f ’ anqas minn persuna waħda f’ kull 10, 000 persuna)
• Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy)
za • Aplażja pura taċ- ċelluli ħomor (PRCA) – (anemija, għeja mhux tas- soltu, nuqqas ta ’ enerġija)
Convulsions (fits and seizures) have been report ed in patients treated with Nespo.
riz Konvulżjonijiet (aċċessjonijiet jew puplesiji) ġew rrappurtati f ’ pazjenti kkurati b’ Nespo.
If you have any of these symptoms or you notice any side effects that are not mentioned in this leaflet, please tell your doctor, nurse or pharmacist.
aw mhux imsemmijinf’ dan il- fuljett, jekk jogħġbok, għid lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek.
HOW TO STORE NESPO
KIF TAĦŻEN NESPO 5.
Keep in the original package in order to protect from
x du Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
th Store in a refrigerator (2°C – 8°C).
Żommu fil- pakkett oriġinali biex tilqa ’ mid- dawl ħa Aħżen fi friġġ (2°C – 8°C).
Do not use Nespo if you think it has been frozen.
Tużax Nespo jekk taħseb li ġie ffriżżat.
au When your vial has been removed from the refrigerator and left at room temperature for approximately 30 minutes before injection it must either be used within 7 days or disposed of.
Meta l- kunjett jkun tneħħa mill- friġġ u tħalla f 'temperatura ambjentali għal bejn wieħed u ieħor 30 ’ g minuta qabel l- injezzjoni għandu jintuża fi żmien sebgħat ijiem jew jintrema. im
er Do not use Nespo after the expiry date which is stated on the carton and on the pre-filled pen label ng after EXP.
Tużax Nespo wara d- data ta ’ skadenza li tidher fuq it- tikketta u il- kartuna wara JIS.
The expiry date refers to the last day of that month. lo
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar. il
Medicines should not be disposed of via wastewater or household waste.
Staqsi lill - al
Ask your pharmacist how to dispose of medicines no longer required.
ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
These measures will help to protect the environment. no
Dawn il- miżuri jgħinu għall - protezzjoni ta ’ l- ambjent. in iċ
FURTHER INFORMATION ct du
AKTAR TAGĦRIF ed
What Nespo contains
X’ fih Nespo m
Nespo comes in a vial that contains either 15, 25, 40 or 60 micrograms of the active substance ro
Nespo jiġi ġo kunjett ta '15- il, 25, 40 jew 60 mikrogramma tas- sustanza attiva darbepoetin alfa. t
darbepoetin alfa. lp
Nespo fih ukoll sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, ot
Nespo also contains sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections. a in
polysorbate 80 u ilma għall- injezzjoni. od
What Nespo looks like and contents of the pack ic
Pr
Nespo is a clear, colourless or slightly pearly liquid.
Nespo huwa likwidu ċar, mingħajr kulur jew likwidu b 'dehra kemm kemm ta' perla.
If it is cloudy or there are particles in it, you must ed
Jekk jkun mċajpar jew jekk jkun fih xi frak, m 'għandekx tużah.
M
Nespo jinstab f 'pakketti ta' kunjett wieħed jew f 'pakketti ta' 4 kunjetti (jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali).
Nespo is available in packs of 1 or 4 vials (not all pack sizes may be marketed).
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Dompé Biotec S.p.A.
548 Dompé Biotec S. p. A.
Amgen Europe B.V.
Il- Manifattur Amgen Europe B. V.
Minervum 7061
Minervum 7061 NL- 4817 ZK Breda L- Olanda
Further information
t za Aktar tagħrif
If you want more information about this medicine, please contact the local representative of the company that is authorised to market Nespo.
riz Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq:
This leaflet was last approv ed in.
to Dan il- fuljett kien approvat l- aħħar f ’.
Detailed information on this med icine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
aw Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
ed is or th au er ng lo no ct du ro ed M
x du ħa ’ g im il al in iċ ed m t ot od Pr
480 PACKAGE LEAFLET:
549 FULJETT TA ’ TAGĦRIF:
Nespo 10 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 15 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 20 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 30 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 40 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 50 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 60 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 80 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 100 micrograms solution for injection in a pre-filled pen (SureClick) Nespo 130 micrograms solution for injection in a pre-filled pen (SureClick)
Nespo 10 mikrogrammi soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Nespo 15- il mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Nespo 20 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Nespo 30 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Nespo 40 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Nespo 50 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Nespo 60 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Nespo 80 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick)
ed Nespo 150 micrograms solution f or injection in a pre-filled pen (SureClick) Nespo 300 micrograms solution for injection in a pre-filled pen (SureClick)
t za Nespo 100 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Nespo 130 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick)
is Nespo 500 micrograms solution for injection in a pre-filled pen (SureClick) darbepoetin alfa
riz Nespo 150 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Nespo 300 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Nespo 500 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick)
au Keep this leaflet.
x Żomm dan il- fuljett.
If you have any further questions, ask your doctor, nurse or pharmacist.
du Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek. ħa Din il- mediċina ġiet mogħtija lilek.
er This medicine has been prescribed for you.
M’ għandekx tgħaddiha lil persuni oħra.
Do not pass it on to others.
Tista ’ tagħmlilhom il - ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. ’ g
It may harm them, even if their ng symptoms are the same as yours. lo
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex im
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. no
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek.
In this leaflet ct
F’ dan il- fuljett: il al
Before you use Nespo du
Qabel ma tuża Nespo in
Possible side effects ro
Effetti sekondarji li jista ’ jkollu iċ
7.
Aktar tagħrif 7.
Instructions for injecting with the Nespo pre-filled pen a in
Tagħrif dwar kif tinjetta lilek innifsek b' Nespo m
WHAT NESPO IS AND WHAT IS IT USED FOR ic
X’ INHU NESPO U GĦALXIEX JINTUŻA t ot
Anaemia is when your ed
It- tabib tiegħek tak Nespo (mediċina anti- anemika) biex tikkuralek l- anemija.
blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.
L- anemija hija meta d - demm tiegħek ma jkollux biżżejjed ċelluli ħomor u s- sintomi jistgħu jkunu għeja, dgħjufija u qtugħ ta ’ od
Nespo works in exactly the same way as the natural hormone erythropoietin.
Nespo jaħdem eżattament fl- istess mod bħall- ormon naturali eritropojetina.
Erythropoietin is produced in your kidneys and encourages your bone marrow to produce more red blood cells.
L- eritropojetina hija magħmula fil- kliewi tiegħek u ġġiegħel lill- mudullun tiegħek jipproduċi aktar ċelluli ħomor tad - demm.
If you have chronic renal failure
550 Jekk għandek insuffiċjenza renali kronika
481 Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect.
Minħabba li ġismek jieħu ż- żmien sakemm jipproduċi aktar ċelluli ħomor, jridu jgħaddu xi erba ’ ġimgħat qabel tinduna b’ xi effett.
If you are receiving chemotherapy
t za Jekk qed tirċievi l- kimoterapija
Nespo is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers (non-myeloid malignancies) who are receiving chemotherapy.
Nespo tintuża biex tikkura l- anemija sintomatika f’ pazjenti adulti bil- kanċer li għandhom tumuri
One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood cells.
riz malinni mhux majelojdi u li qed jirċievu l- kimoterapija.
At first, only white blood cells seem to be affect ed.
to Wieħed mill- effetti sekondarji ewlenin tal- kimoterapija huwa li twaqqaf il- mudullun milli jipproduċi biżżejjed ċelluli tad- demm.
This is because the red blood cells have a
Għall- ewwel, iċ- ċelluli bojod tad- demm biss jidħru li jkunu qed jiġu
ed much longer life span in the circulating blood.
Dan minħabba li ċ- ċelluli ħomor tad- demm għandhom ħajja ħafna itwal fiċ- ċirkolazzjoni tad- demm.
is or 2.
x du 2.
BEFORE YOU USE NESPO
TUŻAX
th au DO NOT use Nespo:
QABEL MA TUŻA NESPO Nespo:
• if you have been diagnosed with high blood pressure which is not being controlled with other
’ g
er
ħa
medicines prescribed by your doctor; or
• jekk ġejt djanjostikat bi pressjoni għolja li mhix ikkontrollata tajjeb b ’ mediċini oħra li kitiblek it- tabib tiegħek; jew im
• if you are allergic to Nespo (darbepoetin alfa), r-HuEPO or to any of the other ingredients in Nespo. lo
• jekk għandek sensittività eċċessiva (allerġija) għal Nespo (darbepoetin alfa), għal r- HuEPO jew għal xi waħda mis- sustanzi l- oħra ta 'Nespo. il al
Take special care with Nespo no
Oqgħod attent ħafna b’ Nespo in
Please tell your doctor if you are suffering or have suffered from: ct
Jekk jogħġbok għid lit- tabib tiegħek jekk qed tbati jew jekk qatt batejt minn: iċ
• high blood pressure which is being controlled with medicines prescribed by your doctor; du
• pressjoni għolja li mhix qed tiġi kkurata b’ mediċini oħra mogħtija mit- tabib tiegħek; ed
• sickle cell anaemia; ro
• anemija tat- tip sickle cell; m
• epileptic fits (seizures); lp
• attakki ta ’ epilessija (puplesiji) t
• convulsions (fits or seizures); a
• konvulżjonijiet (aċċessjonijiet jew puplesiji); ot
liver disease; ic
• mard tal- fwied; od
• significant lack of response to drugs used to treat anaemia; or ed
• nuqqas sinifikattiv ta ’ rispons għal mediċini wżati biex jikkuraw l- anemija; jew Pr
M
• allerġija għall- latex (l- għatu tal- labra tal- pinna mimlija għal- lest fih sustanza mnissla mill - latex)
PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia.
Aplażja pura ta ’ ċelluli ħomor (PRCA) tfisser li l- ġisem waqqaf jew naqqas il- produzzjoni taċ- ċelluli ħomor tad -
• Your doctor should try to keep your haemoglobin between 10 and 12 g/dl.
• It- tabib tiegħek għandu jipprova jżommlok l- emoglobina tiegħek bejn 10 u 12 g/ dl.
482 • If you have chronic renal failure there is an increased risk of serious problems with your heart or blood vessels (cardiovascular events) if your haemoglobin is kept too high.
• Jekk għandek insuffiċjenza renali kronika hemm riskju għola ta ’ problem serji f’ qalbek jew fil - vini u fl- arterji tiegħek (avvenimenti kardjovaskulari) jekk l- emoglobina tiegħek tinżamm wisq għolja.
• If you are a cancer patient you should be aware that Nespo may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
t Jekk għandek kanċer kun af li Nespo jista 'jaħdem bħala fattur ta' tkabbir taċ- ċelluli tad- demm u
Please discuss this with your doctor.
Jekk jogħġbok iddiskuti dan mat- tabib
• Misuse by healthy people can cause life-threatening problems with the heart or blood vessels.
• L- użu ħażin minn persuni b’ saħħithom jista ’ jikkawża problemi fil- qalb jew fil- vini u arterji li
Using other medicines
aw Meta tuża mediċini oħra
ed to tell your doct or if you are taking ei ther of these drugs.
x Huwa importanti li tgħid lit- tabib tiegħek jekk qed tieħu xi waħda minn dawn il- mediċini.
is Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
du Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta. ħa Meta tuża Nespo ma ’ l- ikel u max- xorb ’ g
au Food and drink do not affect Nespo.
L- ikel u x- xorb ma jeffetwawx lil Nespo. im
Pregnancy and breast-feeding
Tqala u Treddigħ il
It is important to tell your doctor if you: ng • are pregnant; lo
Huwa importanti li tavża lit- tabib tiegħek jekk: al
• think you may be pregnant; or no
• taħseb li inti tqila; jew iċ ed
• plan to get pregnant. ct
• qed taħseb biex issir tqila.
It is not known whether darbepoetin alfa is excreted in human milk.
Mhuwiex magħruf jekk darbepoetin alfa joħroġx mal- ħalib tal- bniedem.