qanastek/EMEA-V3 huggingface dataset:
You must stop breast-feeding if du
Għandek tieqaf tredda ’ jekk m
you use Nespo. ro
qed tuża Nespo. t
Driving and using machines lp
Sewqan u tħaddim ta ’ magni ot
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. od Pr
HOW TO USE THE NESPO PRE-FILLED PEN (SURECLICK) ic
KIF GĦANDEK TUŻA IL- PINNA MIMLIJA GĦAL- LEST B 'NESPO (SURECLICK)
Your injection is to be given under the skin (subcutaneous), and so you may use the Nespo ed
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 tieħu Nespo sabiex jinżamm il- livell ta ’ l- emoglobina bejn 10 u 12 g/ dl.
This may vary depending on whether you are M
Dan jista 'jvarja skond jekk intix adult jew tifel.
Injecting Nespo yourself
552 Tinjetta lilek innifsek b' Nespo
Your doctor has decided that the Nespo pre-filled pen is the best way for you, a nurse, or a carer to inject Nespo.
It- tabib tiegħek iddeċieda li l- pinna mimlija għal- lest b 'Nespo hija l- meżż ta' injezzjoni l- aktar konvenjenti għalik, għal infermiera, jew għal carer.
Your doctor, nurse or pharmacist will show you how to inject yourself with the pre- filled pen.
It- tabib, l- infermiera jew l- ispiżjar tiegħek juruk kif tagħmel dan bil- pinna mimlija għal- lest.
Never inject Nespo into a vein yourself.
Qatt m' għandek tinjetta lilek nnifsek b' Nespo ġo vina.
The pre-filled pen is designed to inject the area under your skin only.
Il- pinna mimlija għal- lest hija magħmula biex tinjetta taħt il- ġilda biss.
For instructions on use of the pre-filled pen, please read the section at the end of this leaflet.
Il- pinna mimlija għal- lest b' Nespo tingħata bħala injezzjoni waħda, darba fil- ġimgħa, darba kull
483 If you have chronic renal failure
t za ġimgħatejn, jew darba fix- xahar.
The Nespo pre-fill ed pen is given as a single injection, either once a week, once every two weeks, or once every month.
Sabiex tikkoreġi l- anemija tiegħek, l- ewwel doża ta ’ Nespo għal kull kilogramma tal- piż ta ’ ġismek
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.
to • 0. 45 mikrogrammi (darba fil- ġimgħa) It- tabib tiegħek jeħodlok kampjuni tad- demm regolarment sabiex jara kif l- anemija tiegħek qed
ed Once your anaemia is c orrected, 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.
aw tirrispondi għall- kura u jista ’ jaġġusta d- doża tiegħek darba kull erba ’ ġimgħat skond il- bżonn.
Your doctor will inform you if your dose changes.
Meta l- anemija tiegħek tiġi korreta, it- tabib tiegħek jkompli jiċċekkjalek regolarment id- demm u d -
is or Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.
x doża tiegħek għandha mnejn terġa ’ tiġi aġġustata biex jinżamm kontroll fit- tul ta ’ l- anemija tiegħek.
th In some cases, your doctor may recommend that you take iron supplements.
du It- tabib tiegħek Jgħidlek jekk id- doża tiegħek tinbidillek
au Your doctor may decide to change the way that your injection is given (eith er under the skin or into a vein).
It- tabib tiegħek jista ’ jiddeċiedi li jbiddel il- mod ta 'kif tingħatalek l- injezzjoni (jew taħt il- ġilda jew im
If this changes you will start on the same dose as you have been receiving and your doctor will
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. il al
er take blood samples to make sure that your anaemia is still being managed correctly. ng 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 lo 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 in
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. no
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 iċ
If you are receiving chemotherapy ct
Jekk qed tirċievi l- kimoterapija m
Nespo is given as a single injection, either once a week or once every three weeks, under your skin. du
Nespo jingħata bħala injezzjoni waħda, darba fil- ġimgħa jew darba kull tliet ġimgħat, taħt il- ġilda. t
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 ro
Sabiex tiġi korretta l- anemija tiegħek, id- doża tal- bidu tiegħek tkun ta ’ ot
weight, or • 2.25 micrograms (once weekly) of Nespo per kilogram of your body weight. lp
• 500 mikrogramma darba kull tliet ġimgħat (6. 75 mikrogrammi ta 'Nespo għal kull kilogramma tal- piż ta ’ ġismek) jew od
Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose as necessary.
• 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 a
It- tabib tiegħek jeħodlok kampjuni regolari tad- demm sabiex jkejjel kif l- anemija tiegħek qed Pr
end of your chemotherapy.
tirrispondi u jista ’ jbiddillek id- doża skond il- bżonn.
Your doctor will tell you exactly when to stop taking Nespo. in
It- tabib jgħidlek eżatt meta trid tieqaf tieħu Nespo.
In some cases, your doctor may recommend that you take iron supplements. ic ed
F’ ċertu każijiet, it- tabib tiegħek jista ’ jirrakkomandalek li tieħu l- ħadid bħala supplement.
If you use more Nespo than you should M
553 Jekk tuża Nespo aktar milli suppost
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.
If you feel unwell in any way you should contact your doctor, nurse or pharmacist immediately.
Jekk b’ xi mod tħossok ma tiflaħx, għandek tikkuntattja lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek immedjatament.
484 4.
t za 4.
Like all medicines, Nespo may cause side effects, although not everybody gets them.
riz 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:
to L- effetti sekondarji li ġejjin seħħew f ’ xi pazjenti li kienu qed jieħdu Nespo:
Very Common (seen in more than 1 0 in 100 people)
aw Komuni ħafna (seħħew f ’ aktar minn 10 persuni f ’ kull 100 persuna)
Common (seen in more than 1 in 100 people)
x • Pressjoni tad- demm għolja
ed • Blood clots (thrombosis)
du • Żamma tal- fluwidi (edima)
is • Pain around the area injected • Rash and/or redness of the skin
Komuni (seħħew f ’ aktar minn persuna waħda f ’ kull 100 persuna) ħa • Biċċiet ta ’ demm magħqud (trombożi) ’ g • Uġigħ madwar is- sit ta ’ l - injezzjoni • Raxx u/ jew ħmura tal- ġilda. im
or th Rare (seen in more than 1 in 10,000 people)
Rari (seħħew f ’ aktar minn persuna waħda f’ kull 10, 000 persuna) il
au 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
• 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 in
er breathing (angioedema) • Shortness of breath (dyspnoea) ng • Skin rash • Hives (urticaria) lo
tibla jew tieħu nifs (angioedema) • Qtugħ ta 'nifs (dispneja) iċ
Very rare (seen in less than 1 in 10,000 people) no
• Ħorriqija (urtikarja)
• Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy) ct
Rari ħafna (seħħew f ’ anqas minn persuna waħda f’ kull 10, 000 persuna) m
Convulsions (fits and seizures) have been reported in patients treated with Nespo. du
• Aplażja pura taċ- ċelluli ħomor (PRCA) – (anemija, għeja mhux tas- soltu, nuqqas ta ’ enerġija) t ot
If you have any of these symptoms or you notice any side effects that are not mentioned in this leaflet, ro
Konvulżjonijiet (aċċessjonijiet jew puplesiji) ġew rrappurtati f ’ pazjenti kkurati b’ Nespo. od
please tell your doctor, nurse or pharmacist. lp
Pr
HOW TO STORE NESPO a in
KIF TAĦŻEN NESPO
Keep the pre-filled pen in the original package in order to protect from light. ic ed
Żomm il- pinna mimlija għal- lest fil- pakkett oriġinali biex tilqa ’ mid- dawl.
M
Tużax Nespo jekk taħseb li ġie ffriżżat.
When your pen 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.
554 Meta l- pinna tkun tneħħiet mill- friġġ u tħalliet f 'temperatura ambjentali għal bejn wieħed u ieħor 30 minuta qabel l- injezzjoni għandha tintuża fi żmien sebgħat ijiem jew tintrema.
Do not use Nespo after the expiry date which is stated on the carton and on the pre-filled pen label after EXP.
Tużax Nespo wara d- data ta ’ skadenza li tidher fuq il- kartuna u t- tikketta tal- pinna mimlija għal- lest wara JIS.
485 6.
t za 6.
What Nespo contains
riz X’ fih Nespo
Nespo (SureClick) comes in a pre-filled pen that contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of the active substance darbepoetin alfa.
to Nespo (SureClick) jiġi ġo pinna 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.
Nespo also contains sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.
aw 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
x du Id- dehra ta ’ Nespo u l- kontenuti tal- pakkett:
If it is cloudy or there are particles in it, you must not use it.
Nespo huwa likwidu ċar, mingħajr kulur jew likwidu b 'dehra kemm kemm ta' perla.
is Nespo (SureClick) is available in packs containing 1 or 4 pre-filled pens (not all pack sizes may be
Jekk jkun ħa mċajpar jew jekk jkun fih xi frak, m 'għandekx tużah. ’ g Nespo (SureClick) jinstab f' pakketti ta 'pinna mimlija għal- lest waħda jew f' pakketti ta '4 pinen mimlija għal- lest (jista' jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali). im
or marketed).
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
au Dompé Biotec S.p.A.
Dompé Biotec S. p. A. il
Via San Martino 12 I-20122 Milan
Via San Martino 12 I- 20122 Milan al
er Italy ng Manufacturer:
Italja in
Amgen Europe B.V. lo Minervum 7061 NL-4817 ZK Breda no
Minervum 7061 ed
The Netherlands
NL- 4817 ZK Breda L- Olanda m
Further information ct
Aktar tagħrif t ot
If you want more information about this medicine, please contact the local representative of the du
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq: od
This leaflet was last approved in. lp
Dan il- fuljett kien approvat l- aħħar f ’ Pr
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ a in ic
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
INSTRUCTIONS FOR INJECTING WITH THE NESPO PRE-FILLED PEN (SURECLICK) ed
TAGĦRIF DWAR KIF TINJETTA LILEK INNIFSEK B’ NESPO
This section contains information on how to properly use the Nespo pre-filled pen.
Din il- parti tal- fuljett tinkludi tagħrif dwar kif tuża sew il- pinna mimlija għal- lest b 'Nespo.
It is important that M
Importanti li ma tippruvax tagħti l- injezzjoni lilek innifsek jekk ma tkunx irċevejtx taħriġ speċjali
you do not try to give yourself the injection unless you have received training from your doctor, nurse, or pharmacist.
555 mit- tabib, mill- infermiera jew mill- ispiżjar tiegħek.
If you have questions about how to inject, please ask your doctor, nurse, pharmacist for assistance.
Jekk għandek xi mistoqsijiet dwar kif tinjetta, jekk jogħġbok staqsi lit- tabib, lill- infermiera jew lill- ispiżjar għall- għajnuna.
How do you, or the person injecting you, use Nespo pre-filled pen (SureClick)?
Kif inti, jew il- persuna li se tinjettak, tuża il- pinna mimlija għal- lest b' Nespo (SureClick)?
Your doctor, nurse, or pharmacist will tell you how much Nespo you need and how frequently it should be injected.
It- tabib tiegħek ordnalek injezzjoni b ’ pinna mimlija għal- lest b 'Nespo għall- injezzjoni fit- tessut eżatt taħt il- ġilda It- tabib, l- infermiera jew l- ispiżjar tiegħek jgħidulek kemm Nespo jkollok bżonn u l - frekwenza ta' l- injezzjonijiet.
Only use each pre-filled pen for one injection.
Uża kull pinna mimlija għal- lest għal injezzjoni waħda
486 Equipment:
Apparat:
To give yourself an injection you will need:
t za Biex tagħti injezzjoni lilek innifsek teħtieġ:
• a new Nespo pre-filled pen and
pinna ġdida mimlija għal- lest b’ Nespo; u
• alcohol wipes or similar.
msielaħ ta’ l- alkoħol jew simili;
Preparing for an Nespo injection?
aw Tipprepara għall- injezzjoni b 'Nespo?
Remove the pen from the refrigerator.
Oħroġ il- pinna mimlija għal- lest b’ Nespo mill- friġġ.
For a more comfortable injection, leave the pen at room
Ħalliha toqgħod f 'temperatura ambjentali
ed temperature for approximately 30 minutes.
x għal bejn wieħed u ieħor 30 minuta.
Additionally, do not leave the pre-filled pen
Issaħħanx Nespo bl’ ebda mod ieħor (eżempju: issaħħanx fil -
is exposed to direct sunlight.
Ukoll, tħallix il- pinna
Do not shake the pre-filled pen.
Tħawwadx il- pinna mimlija għal- lest.
Do not remove the grey needle cap from the pre-filled pen until you are ready to inject.
Tneħħix l- għatu griż tal- labra tal- pinna mimlija għal- lest qabel ma tkun lest biex tinjetta. im
Check that it is the correct dose that your doctor has prescribed.
Iċċekkja li d- doza tal- pinna mimlija għal- lest hija dik li ordnalek it- tabib tiegħek.
Check the expiry date on the pre-filled pen label (EXP:).
Iċċekkja d- data ta ’ skadenza fuq it- tikketta tal- pinna mimlija għal- lest (JIS).
Check the appearance of Nespo through the inspection window.
Iċċekkja d- dehra ta ’ Nespo minn ġo t- tieqa għal ispezzjoni.
It must be a clear, colourless or lo
Din għandha tkun likwidu ċar, in
slightly pearly liquid.
mingħajr kulur jew b 'dehra kemm kemm ta' perla.
If it is cloudy or there are particles in it, you must not use it. no
Jekk jkun mċajpar jew jekk jkun fih xi frak, m 'għandekx tużah. iċ ed
Find a comfortable, well-lit, clean surface and put all the equipment you need within reach. ct du
Sib post komdu, mdawwal sew, naddaf il- wiċċ, u poġġi dak kollu li għandek bżonn fejn tista 'm
Grey needle lp
tilħaqhom. t ot
cap ro
Buttuna l- ħamra Għatu ta 'sigurtà griż tal- labra od
Inspection window a in
Tagħżel u tipprepara s- sit għall- injezzjoni
7a.
Pr
Choose an injection site ed
Tagħżel sit għall- injezzjoni
M
Tieqa għal ispezzjoni Is- sit għall- injezzjoni jrid jkun sod sabiex il- pinna taħdem sew.
The preferred injection site for using the Nespo pre-filled pen is the front of the thigh.
L- aħjar sit għall- injezzjoni biex tuża l- pinna mimlija għal- lest b ’ Nespo hija n- naħa ta ’ quddiem tal - koxxa.
Rotate injection site:
Biddel is- sit għall- injezzjoni:
You may rotate the site for each injection to avoid soreness at any one site.
Tista ’ tbiddel is- sit għall- injezzjoni għal kull injezzjoni sabiex tevita tbenġil f’ sit wieħed partikulari.
Do not inject into areas where the skin is tender, bruised, red, or hard.
556 Tinjettax f ’ siti fejn il- ġilda hija misjura, mbenġla, ħamra jew iebsa.
Avoid areas with scars or stretch marks.
Evita siti b ’ marki ta ’ ġrieħi u stretch marks.
Instructions for preferr ed injection site
Tgħarif għal l- aħjar sit ta ’ l- injezzjoni
The front of the thigh is the preferred injection site.
In- naħa ta ’ quddiem ta ’ kuxxtejk
Instructions f or alternate injection sites
t za hija l- aħjar sit ta ’ l- injezzjoni.
is When using alternate injection sites, it is particularly important to create enough surface tension on the
Tgħarif għal siti ta ’ l- injezzjoni alternattivi
or site to be able to successfully complete the injection.
aw Meta tuża siti għal injezzjoni alternattivi, huwa importanti li toħloq biżżejjed tensjoni fil- wiċċ tas- sit sabiex tkun tista ’ tgħati l- injezzjoni kompluta b ’ suċċess.
th au Stretch technique
x du Teknika ta 'kif tiġbed il- ġilda. ħa Assigura ruħek li l- ġilda taħt u madwar il- pinna mimlija għal- lest Iġbed hija soda u miġbuda biex tipprovdi biżżejjed reżistenza biex l - ’ g għatu ta ’ sigurtà jinġibed lura kompletament u il- pinna “ tinħeles ”. im il al in iċ
Make sure that skin under and around the pre-filled pen is firm and Stretch
Tista ’ tuża l- addome, ħlief id- dawra ta ’ żewġ pulzieri/ 5cm ta ’ madwar iz- zokkra.
er tight to provide enough resistance to fully retract the safety guard and “unlock” the pen. ng lo no ct du
tiġbed il- ġilda fis- sit ta ’ l- injezzjoni biex toħloq wiċċ sod u miġbud. m t ot od
You can use the abdomen, except for the 2 inch/5 cm area around the belly button (navel).
Jekk xi ħadd ieħor ser jinjettak, jistgħu ukoll jużaw in- naħa ta ’ barra tal- parti ta ’ fuq tad- driegħ.
If someone else is giving you the injection, they can also use the outer ed
Għan- naħa ta ’ fuq tad- driegħ, huwa Pr
M
rrakkomandat li tiġbed il- ġilda fis- sit ta ’ l- injezzjoni sabiex toħloq wiċċ iebes u sod.
Prepare the site
Ipprepara s- sit
To prepare the area of skin where Nespo will be injected, wipe the injection site with an alcohol wipe.
Biex tipprepara s- sit fil- ġilda fejn se tinjetta lil Nespo, imsaħ is- sit ta ’ l- injezzjoni b ’ mselħa ta’ l - akoħol.
Do not touch this area again before giving the injection.
Terġax tmiss dan is- sit ta ’ l- injezzjoni qabel ma ’ tinjetta.
Injecting Nespo using the pre-filled pen
Tinjetta Nespo bil- pinna mimlija għal- lest
Pull off the grey needle cap.
Neħħi l- għatu tal- labra l- griż.
Pull off the grey needle cap
t za Neħħi l- għatu tal- labra l- griż
Do not tw ist the grey needle cap
Tgħawwiġx l- għatu ta ’ sigurtà griż.
Do not try to put the needle cap back onto the pre-filled pen
Terġax tipprova
ed Do pull the grey cap straight off
aw tqiegħed l- għatu ta ’ sigurtà fuq il- pinna.
is Safety guard
x Iġbed l- għatu l- griż
or th au 2.
du dritt
Do not touch the red button.
Għatu ta ’ sigurtà. im il
er ng lo
’ g
Locked with safety guard out no ct du ro
ħa
Unlocked with safety guard fully retracted
al in iċ ed m t ot od Pr
in
558 2.
a
Imblukkat bl- għatu ta ’
lp
t sigurtà maħruġ
∅ Do not press the red button until the safety guard is fully retracted. ic ed
za riz to aw Unlocked with safety guard fully retracted
M
x du ∅ Tgħafasx il- buttuna l- ħamra qabel ma l- għatu ta 'sigurtà jkun daħal' l ġewwa kompletament ħa Żomm pressa ‘ l isfel biżżejjed sabiex l- għatu ta ’ sigurtà isfar jinġibed lura u biex iżżomm il - buttuna l- ħamra ħielsa. ’ g Żomm il- pinna mimlija għal- lest b' angolu ta '90 º grad fuq is- sit ta ’ l- injezzjoni. im il al in iċ ed m t ot od Pr
489 3.
559 3.
Briefly press and release red button.
Fi ftit ħin għafas u itlaq il- buttuna l- ħamra.
Release button
Itlaq il- buttuna
th the skin during the injection
t za riz to aw Żommha mgħafusa mal- ġilda waqt l - injezzjoni.
au er 4.
x du 4.
Count slowly to 15 seconds for injection to end. lo no ct du ro
Għodd bil- mod sa 15- il sekonda sa kemm tispiċċa l- injezzjoni. ħa ’ g im il al in iċ
Medicine will be automatically lp
Il- mediċina tiġi njettata awtomatikament. ed m
∅ Do not move the pre-filled pen during the injection. ic ed
∅ Tressaqx il- pinna mimlija għal- lest waqt l- injezzjoni. t ot
Do wait for the injection to finish before releasing pressure.
Stenna sa kemm tkun tlesta l- injezzjoni qabel ma ’ tieqaf tgħafas.
M
Tista ’ tisma ’ ħoss ta ’ klik hekk kif il- buttuna l- ħamra taqbeż lura f’ postha. od Pr
490 5.
560 5.
Do check the inspection window to confirm it has turned yellow.
Iċċekkja t- tieqa għal ispezzjoni biex tikkonferma li ngħata d- doża kollha.
If the inspection window is not yellow, you must contact your doctor, nurse or pharmacist.
Iċċekkja t- tieqa għal ispezzjoni biex tikkonferma li saret safra.
ed is or th au Safety guard down after use.
t Jekk it- tieqa għal ispezzjoni
You can press a cotton ball or gauze over the ng injection site lo
za mhix safra għandek tikkuntatja lit- tabib, lill- infermiera jew lill -
Do not rub the injection site.
to aw x du G ħ atu ta 'sigurtà mniżżel wara l - Jista ’ joħroġlok ftit demm mis- sit ta ’ l- injezzjoni.
If needed, you may cover the injection site with a plaster. no
Jekk hemm bżonn, tista ’ tgħatti s- sit ta ’ l- injezzjoni b ’ biċċa stikk. ’ g
Remember
Ftakar im
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice. ct du
Jekk għandek xi problemi, jekk jogħġbok tibżax issaqsi lit- tabib jew lill- infermiera tiegħek għal għajnuna jew parir. il al
Disposing of used pre-filled pens
Rimi ta’ pinen mimlija għal- lest użati in
• The Nespo pre-filled pen should NEVER be reused. ro
• Pinen mimlija għal- lest b ’ Nespo QATT m ’ għandhom jerġgħu jintużaw. • QATT terġa 'tqiegħed l- għatu griż tal- labra lura fuq il- pinna mimlija għal- lest użata. iċ
• NEVER put the grey needle cap back into the used pre-filled pen. lp
• Il- pinna mimlija għal- lest użata għandha tintrema kif jitolbu l- liġijiet lokali.
Ask your pharmacist how to dispose of medicines no longer required.
dwar kif għandek tarmi mediċini li m’ għankekx bżonn.
These measures will help to protect the environment. a in ic
Dawn il- miżuri jgħinu għall - protezzjoni ta ’ l- ambjent. m t ot od Pr
Optional separate additional insert: ed
561 Għandek għażla ta ’ fuljett ta ’ tagħrif ieħor:
M
QUDDIEM - Nespo gwida biex tibda:
Nespo SureClick Pre-filled pen - Read package leaflet before use ENGLISH
Nespo SureClick pinna mimlija għal- lest - Aqra dan il- fuljett qabel l- użu
Preferred site is front of the thigh
L- aħjar sit huwa n- naħa ta ’
Alternate sites are the abdomen or outer
Siti alternattivi huma
Stretch the skin on alternate injection
Iġbed il- ġilda f’ siti
Turn over for injection steps
Aqleb għall - istruzzjonijiet dwar l -
area of upper arms
quddiem tal- koxxa
sites
l- addome jew in- naħa
Stretch Injection site must be firm and tight
għall- injezzjoni
491 BACK- Neso getting started guide:
injezzjoni
ENGLISH
MALTI
(1) Pull off grey needle cap
ta ’ barra tal- parti ta ’
(2) Do not touch red button.
alternattivi
(3) Briefly press and release red button.
fuq tad- driegħ
(4) Count slowly to 15 for injection to end.
t za Iġbed Is- sit għall- injezzjoni
(5) Check window
riz jrid jkun sod u miġbud.
safety guard.
to WARA - Nespo gwida biex tibda:
∅ Do not twist
aw
X Locked
(1) Neħħi l- għatu
Click
(2) Tmissx il -
Complete
(3) Fi ftit ħin
the grey ne edle cap
(4) Għodd bil -
when yellow
(5) Iċċekkja t -
Unlocked
Għafas il- pinna
Keep unlocked against skin
mod sa 15 sabiex tispiċċa l -
ed is or th au er ng lo no ct du ro ed M
du mal- ġilda sabiex teħles l- għatu ta ’ MALTI
ic
im
in
’ g
lp
il
492
562
What is Neulasta?
X' inhu Neulasta?
Neulasta is a solution for injection that contains the active ingredient pegfilgrastim.
Neulasta hu soluzzjoni għall- injezzjoni li fiha s- sustanza attiva pegilgrastim.
It is available in a pre-filled syringe and a pre-filled pen (SureClick), each containing 6 mg pegfilgrastim.
Huwa disponibbli f’ siringa mimlija minn qabel u f’ forma ta ’ pinna mimlija minn qabel (SureClick) li kull waħda fiha 6 mg ta ’ pegfilgrastim.
What is Neulasta used for?
Għalxiex tintuża Neulasta?
Neulasta is used in cancer patients to help with some of the side effects of their treatment.
Neulasta tintuża f’ pazjenti bil- kanċer li jsofru minn effetti sekondarji tat- trattament tagħhom.
Chemotherapy (cancer treatment) that is cytotoxic (cell-killing) also kills white blood cells, which can lead to neutropenia (low white blood cell counts) and the development of infections.
Il - kemoterapija (trattament tal- kanċer) lihuwa ċitotissiku (joqtol iċ- ċelloli) joqtol ukoll iċ- ċelloli bojod tad- demm, li jistgħu jwasslu għal newtropenija (tnaqqis fil- għadd ta ’ ċelloli bojod fid- demm) u l - iżvilupp ta ’ infezzjonijiet.
Neulasta is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Neulasta huwa użat sabiex inaqqas iż- żmien ta ’ newtropenija u l- każ li jkun hemm newtropenija febbrili (newtropenija bid- deni).
Neulasta can be used for many types of cancer, except for chronic myeloid leukaemia (a cancer of the white blood cells).
Neulasta jista ’ jintuża għal bosta tipi ta ’ kanċer, ħlief il- lewkemja mijelojde kronika (kanċer taċ- ċelloli bojod tad- demm).
It also cannot be used in patients with myelodysplastic syndromes, a disease in which too many white blood cells are produced, and which can develop into leukaemia.
Din tista ’ tintuża wkoll minn pazjenti bis- sindrome mijelodisplatika, marda li fiha jiġu prodotti ħafna ċelloli bojod tad- demm u li jistgħu jiżviluppaw il- lewkemja.
How is Neulasta used?
Kif tintuża Neulasta?
Neulasta treatment should be initiated and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Trattament Neulasta għandu jinbeda u jiġi sorveljat minn tabib li għandu esperjenza fil- kura ta ’ pazjenti bil- kanċer jew problemi fid- demm.
Neulasta is given as a single 6 mg injection under the skin around 24 hours after the end of each cycle of chemotherapy.
Neulasta tingħata bħal injezzjoni waħda ta ’ 6 mg taħt il - ġilda madwar 24 siegħa wara t- tmeim ta ’ kull ċiklu ta ’ kemoterapija.
Patients can inject themselves if they have been trained appropriately.
Il- pazjenti jistgħu jinjettaw rwieħhom ladarba dawn jiġu mħarrġa b’ mod xieraq.
Neulasta is not recommended for use in children, due to a lack of information on its safety and effectiveness in this group.
Neulasta mhux rakkomandat għat- tfal, minħabba nuqqas ta 'tagħrif dwar is- sigurtà u l- effikaċja f' dan il- grupp.
How does Neulasta work?
Kif taħdem Neulasta?
The active substance in Neulasta, pegfilgrastim, is an immunostimulant that belongs to the group ‘ colony stimulating factors’.
Is- sustanza attiva Neulasta, pegilgrastim hija immunostimulant li jaqa ’ fil- grupp ta ’ ‘ fatturi ta ’ stimulazzjoni tal- kolownja ’.
It consists of filgrastim, a copy of a human protein called granulocyte colony stimulating factor (G-CSF), which has been ‘ pegylated’ (coated with a chemical called polyethylene glycol).
Din tikkonsisti f’ filgrastim, kopja ta ’ proteini umani msejjħas fattur ta ’ stimulazzjoni tal- kolownja granuloċijto (G- CSF), li kien ġie ‘ pegilati ’ (miksija b’ kimika msejjħa glikol polietilenju.
Filgrastim works by encouraging the bone marrow to produce more white blood cells, increasing white blood cell counts and treating neutropenia.
Filgrastim jaħdem billi jinkoraġġixxi l- mudullum sabiex jipproduċi aktar ċelloli bojod fid- demm, żjieda fl- għadd taċ- ċelloli bojod fid- demm u t- trattament newtropenija.
Filgrastim has been available in other medicines in the European Union (EU) for a number of years.
Filgrastim sar disponibbli f’ mediċini oħrajn fl- Unjoni Ewropea (EU) għal numru ta ’ snin.
Because it is pegylated in pegfilgrastim, the rate at which the medicine is removed from the body is decreased, allowing the medicine to be given less often.
Minħabba li huwa pegilat f’ pegfilgrastim, ir- rata li biha l- mediċina titneħħa mill- ġisem tonqos, tippermetti li l- mediċina tingħata anqas sikwit.
The filgrastim in Neulasta is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim.
Il- filgrastim f’ Neulasta jiġi prodott b' metodu magħruf bħala teknoloġija 'rikombinanti tad- DNA ’: hija magħmula minn batterju li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi filgrastim.
The replacement acts in same way as naturally produced G-CSF.
Is - sostituzzjoni taħdem bl- istess mod bħal G- CSF alpha prodott b’ mod naturali.
How has Neulasta been studied?
Kif ġie studjat Neulasta?
Neulasta has been studied in two main studies involving 467 patients with breast cancer who were being treated with cytotoxic chemotherapy.
Neulasta ġiet studjata f’ żewġ studji prinċipali li jinvolvu 467 pazjent bil- kanċer tas- sider li kienu qed jiġu trattati bil- kemoterapija ċitototossika.
In both studies, the effectiveness of a single injection of Neulasta was compared with multiple daily injections of filgrastim during each of four chemotherapy cycles.
Fiż- żewġ studji, l- effikaċja ta ’ injezzjoni waħda ta ’ Neulasta ġiet kumparata ma ’ diversi injezzjonijiet ta ’ kuljum ta ’ filgrastim matul kull ċiklu ta ’ erba ’ kemoterapiji.
The main measure of effectiveness was the duration of severe neutropenia during the first cycle of chemotherapy.
Il- miżura prinċipali ta ’ effikaċja kienet iż- żmien ta ’ newtropenija severa matul l- ewwel ċiklu ta ’ kemoterapija.
What benefit has Neulasta shown during the studies?
X' benefiċċji write Neulasta tul l- istudji?
Neulasta was as effective as filgrastim in reducing the duration of severe neutropenia.
Neulasta kienet effettiva bħala filgrastim fit- tnaqqis ta ’ żmien ta ’ newtropenija severa.
In both studies, the patients had severe neutropenia for around 1.7 days during their first chemotherapy cycle.
Fiż- żewġ studji, il- pazjenti kellhom newtropenija severa għal madwar 1. 7 jum matul iċ- ċiklu ta ’ l- ewwel kemoterapija tagħhom.
What is the risk associated with Neulasta?
X' inhu r- riskju assoċjat ma 'Neulasta?
Most of the side effects seen in patients taking Neulasta in studies are due to their underlying disease or chemotherapy.
Bosta effetti sekondarji f’ pazjenti li jieħdu Neulasta fi studji huma dovoti għal marda jew kemoterapija.
The most common side effects with Neulasta (seen in more than 1 in 10 patients) are bone pain and raised levels of lactate dehydrogenase (a marker of red blood cell breakdown).
L- aktar effetti sekondarji komuni b’ Neulasta (murija f’ aktar minn pazjent minn kull 10) huma uġiegħ fl- għadam u livelli miżjuda ta ’ diħirogenażju lattaż (markatur ta ’ tkissir ta ’ ċellola ħamra tad- demm).
For the full list of all side effects reported with Neulasta, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrapportati b' Neulasta, ara l- Fuljett ta' Tagħrif.
Neulasta should not be used in people who may be hypersensitive (allergic) to pegfilgrastim or any of the other ingredients.
Neulasta m’ għandhiex tintuża minn persuni ipersensittivi (allerġiċi) għal pegfilgrastim jew għal xi ingredjenti oħra tiegħu.
Why has Neulasta been approved?
Għaliex ġiet approvata Neulasta?
The Committee for Medicinal Products for Human Use (CHMP) decided that Neulasta’ s benefits are greater than its risks for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ddeċieda li l- benefiċċji ta ’ Neulasta huma akbar mir- riskji tagħha għat- tnaqqis taż- żmien ta ’ newtropenija u l- inċidenza ta ’ newtropenija febbrili trattata b’ kemoterapija ċitotossika kontra l- malinjetà.
The Committee recommended that Neulasta be given marketing authorisation.
Il- Kumitat jirrakkomanda li Neulasta tingħata awtorizzazzjoni għal tqegħid fis- suq.
Other information about Neulasta:
Informazzjoni oħra dwar Neulasta:
The European Commission granted a marketing authorisation valid throughout the EU for Neulasta to Amgen Europe B. V. on 22 August 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Neulasta lil Amgen Europe B. V. fit- 22 ta ’ Awwissu 2002.
The marketing authorisation was renewed on 22 August 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet aġġornata fit- 22 ta ’ Awwissu 2007.
The full EPAR for Neulasta can be found here.
http: // www. emea. europa. eu/ humandocs/ Humans/ EPAR/ neulasta/ neulasta. htmL- EPAR sħiħ għal Neulasta jista ’ jinstab hawnhekk
This summary was last updated in 02-2008.
Dan is- sommarju ġie aġġornat l- aħħar f' 02- 2008.
EU Number
Numru ta ’ l- EU EU/ 1/ 02/ 227/ 001
Invented name
Isem inventat Neulasta
Strength
Qawwa 6 mg
Pharmaceutical Form
Għamla farmaċewtika soluzzjoni għall
Route of Administration
Mnejn jingħata Użu għal taħt il- ġilda
Packaging
Il- pakkett siringa mimlija għal- lest (ħġieġ)
Content
Kontenut 0. 6 ml (10 mg/ ml)
Package size
Daqs tal- pakkett Siringa waħda mimlija għal - lest
Solution for injection Solution for injection
soluzzjoni għall
Subcutaneous use Subcutaneous use
Użu għal taħt il- ġilda
pre-filled syringe (glass) pre-filled syringe (glass)
siringa mimlija għal- lest (ħġieġ)
1 pre-filled syringe 1 pre-filled syringe (non-blister)
Siringa waħda mimlija għal - lest (mhux ġo folja)
Solution for injection
soluzzjoni għall
pre-filled pen (glass) (SureClick)
pinna mimlija għal- lest (ħġieġ) (SureClick)
1 pre-filled pen
Pinna waħda mimlija għal - lest
pre-filled syringe (glass) with needle guard
siringa mimlija għal- lest (ħġieġ) b’ għatu ta ’ protezzjoni tal- labra
1 pre-filled syringe
Siringa waħda mimlija għal - lest b’ għatu ta ’ protezzjoni tal- labra
Neulasta 6 mg solution for injection.
Neulasta 6 mg soluzzjoni għall- injezzjoni.
Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 ml solution for injection.
Kull siringa mimlija għal- lest fiha 6 mg ta ’ pegfilgrastim * f ’ 0. 6 ml soluzzjoni għall- injezzjoni.
The concentration is 10 mg/ ml based on protein only**.
Il - konċentrazzjoni hija ta ’ 10 mg/ ml ibbażata fuq il- proteina biss **.
*Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG). ** The concentration is 20 mg/ ml if the PEG moiety is included.
* Magħmul f ’ ċellui ta ’ Escherichia coli b ’ teknoloġija rikombinanti- DNA u wara b ’ konjugazzjoni ma ’ polyethylene glycol (PEG). ** Il- konċentrazzjoni hija ta ’ 20 mg/ ml jekk tiġi nkluża l- porzjoni PEG.
The potency of this product should not be compared to the potency of another pegylated or non- pegylated protein of the same therapeutic class.
Il- qawwa ta ’ dan il- prodott m’ għandix tiġi mqabbla mal- qawwa ta ’ proteina pegylated jew mhux pegylated oħra ta ’ l- istess klassi terapewtika.
For more information, see section 5.1.
Għal aktar informazzjoni, are sezzjoni 5. 1.
Excipients known to have a recognised action: sorbitol E420, sodium acetate (see section 4.4).
Sustanzi mhux attivi li għandhom azzjoni magħrufa: sorbitol E- 420, sodium acetate (ara sezzjoni 4. 4).
Clear, colourless solution for injection.
Soluzzjoni għall- injezzjoni ċara u mingħajr kulur.
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Tnaqqis fid- dewmien tan- newtropenja u ta ’ l- inċidenza ta ’ newtropenja bid- deni f’ pazjenti kkurati b’ kimoterapija ċitotossika għal tumur malinn (bl- eċċezzjoni ta ’ lewkimja majelojde kronika u sindromi majelodisplastiċi).
Neulasta therapy should be initiated and supervised by physicians experienced in oncology and/ or haematology.
Il- kura b’ Neulasta għandha tinbeda u tiġi segwita minn tobba b’ esperjenza fl- onkoloġija u/ jew fl - ematoloġija.
One 6 mg dose (a single pre-filled syringe) of Neulasta is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy.
Doża waħda ta ’ 6 mg (siringa waħda mimlija għal- lest) ta ’ Neulasta hija rrakkomandata għal kull ċiklu ta ’ kimoterapija, mogħtija bħala injezzjoni taħt il- ġilda bejn wieħed u ieħor 24 siegħa wara l - kimoterapija ċitotossika.
Neulasta is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.
Neulasta mhux rakkomandat għall- użu fit- tfal taħt it- 18- il sena minħabba nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja.
Renal impairment: no dose change is recommended in patients with renal impairment, including those with end stage renal disease.
Indeboliment renali: l- ebda tibdil fid- doża m’ hu rrakkomandat f’ pazjenti b’ indeboliment renali, inklużi dawk b ’’ mard renali ta ’ l- aħħar stadju.
Hypersensitivity to the active substance or to any of the excipients.
Sensittivita` eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (see section 5.1).
Tagħrif kliniku limitat jissuġerixxi li l- effett fuq il- ħin biex tirkupra minn newtropenja severa f 'pazjenti li reġgħet qabdithom lewkimja majelojde mill- ġdid, hija komparabbli bejn dawk li ngħataw pegfilgrastim u dawk li ngħataw filgrastim (ara sezzjoni 5. 1).
However, the long-term effects of Neulasta have not been established in acute myeloid leukaemia; therefore, it should be used with caution in this patient population.
Mandanakollu, l- effett fit- tul ta 'Neulasta għad ma ġiex stabbilit f' lewkimja majelojde akuta, għalhekk Neulasta għandu jintuża b 'kawzjoni f' dawn il- pazjenti.
Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Il- fattur li jistimola l- kolonji ta ’ granuloċiti jista 'jippromwovi it- tkabbir ta' ċelluli majelojdi in vitro u effetti simili jistgħu jidhru fi ftit ċelluli mhux majelojdi in vitro.
The safety and efficacy of Neulasta have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary Acute Myeloid Leukaemia (AML); therefore, it should not be used in such patients.
Is- sigurta 'u l- effikaċja ta' Neulasta għad ma ġewx investigati f 'pazjenti b' sindromu majelodisplastiku, lewkimja mjeloġenika kronika, u f 'pazjenti b' Lewkimja Majelojde Akuta sekondarja; għalhekk, Neulasta m 'għandux jintuża f' pazjenti bħal dawn.
The safety and efficacy of Neulasta administration in de novo AML patients aged < 55 years with cytogenetics t(15; 17) have not been established.
Is- sigurtà u l- effikaċja ta 'l- għoti ta' Neulasta ma 'ċitoġenetiċi t( 15; 17) f' pazjenti taħt il- 55 sena li reġgħet qabdithom lewkimja majelojde akuta mill- ġdid, għad ma ġewx stabiliti.
The safety and efficacy of Neulasta have not been investigated in patients receiving high dose chemotherapy.
Is- sigurta` u l- effikaċja ta ’ Neulasta ma ġewx investigati f’ pazjenti li qed jirċievu doża għolja ta ’ kimoterapija.
Rare (≥ 1/ 10,000 to < 1/ 1,000) pulmonary adverse effects, in particular interstitial pneumonia, have been reported after G-CSF administration.
Effeti mhux mixtieqa rari (≥ 1/ 10, 000 u < 1/ 1, 000) tal- pulmun, b 'mod partikulari pulmonite interstizjali, ġew rrappurtati wara l- għoti tal- fattur li jistimola l- kolonji ta ’ granuloċiti.
The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Adult Respiratory Distress Syndrome (ARDS).
Bidu ta ’ sinjali pulmonari bħal sogħla, deni u qtugħ ta ’ nifs flimkien ma ’ sinjali radjuloġiċi ta ’ infiltrati pulmonari, u deterjorazzjoni tal- funzjoni tal- pulmun flimkien ma ’ żjieda fl- għadd ta ’ newtrofili jistgħu jkunu sinjali tal- bidu tas- sindromu tat- tbatija respiratorja fl- adulti (ARDS).
In such circumstances Neulasta should be discontinued at the discretion of the physician and the appropriate treatment given.
F’ ċirkostanzi bħal dawn Neulasta għandu jitwaqqaf skond il- parir tat- tabib u għandha tingħata l- kura addattata.
Common (1/ 100 to < 1/ 10) but generally asymptomatic cases of splenomegaly and very rare (< 1/ 10,000) cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim.
Ġew irrappurtati wara l- għoti ta 'pegfilgrastim, każijiet ta' tkabbir tal- milza, dawn kienu komuni (≥ 1/ 100 u < 1/ 10) iżda ġeneralment mingħajr sintomi, u każijiet rari ħafna (< 1/ 10, 000) ta 'milza mifqugħha, fosthom ftit każijiet fatali.
Therefore, spleen size should be carefully monitored (e. g. clinical examination, ultrasound).
Għalhekk, id- daqs tal- milza għandu jiġi monitorjat b' attenzjoni (per eżempju b 'eżaminazzjoni klinika, b' eżami ultrasoniku).
A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
Dijanjożi ta ’ milza mifqugħha għandha tkun ikkunsidrata f’ pazjenti b ’ uġigħ addominali fin- naħa ta ’ fuq tax- xellug jew fit- tarf ta ’ l- ispalla.
Treatment with Neulasta alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule.
Kura b’ Neulasta waħdu ma jeskludix tromboċitopenija u anemija minħabba li tinżamm id- doża sħiħa ta 'kimoterapija majelosoppressiva fl- iskeda preskritta.
Regular monitoring of platelet count and haematocrit is recommended.
Huwa rakkommandat li isir immonitorjar regolari ta ’ l- għadd ta ’ plejtlits u l- ematokrit.
Neulasta should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Neulasta m’ għandux jintuża biex tiżdied id- doża ta ’ kimoterapija ċitotossika għal aktar mill- limiti stabiliti tad- dożaġġ.
Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell disease.
Kriżijiet tal- marda taċ- ċellula b’ forma ta ’ minġel ġew assoċjati ma ’ l- użu ta ’ pegfilgrastim f’ pazjenti b’ mard taċ- ċellula b’ forma ta ’ minġel.
Therefore, physicians should exercise caution when administering Neulasta in patients with sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of Neulasta with splenic enlargement and vaso-occlusive crisis.
Għalhekk, it- tobba għandhom joqgħodu attenti meta jagħtu Neulasta lil pazjenti b’ mard taċ- ċellula b’ forma ta ’ minġel, għandhom jikkontrollaw il- parametri kliniċi xierqa u l- qagħda tal- parametri tal- laboratorju u joqgħodu attenti għall- assoċjazzjoni possibbli bejn Neulasta u t- tkabbir tal- milza u kriżi vaso- okklusiva.
White blood cell counts of 100 x 109/ l or greater have been observed in less than 1% of patients receiving Neulasta.
Għadd taċ- ċelluli bojod ta ’ 100 x 109 / l jew aktar ġew osservati f’ inqas minn 1% tal- pazjenti li ngħataw Neulasta.
No adverse events directly attributable to this degree of leukocytosis have been reported.
Ma ġie osservat l- ebda effett mhux mixtieq attribwit direttament għal dan il- grad ta ’ lewkoċitosi.
Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of Neulasta.
Din iż- żjieda taċ- ċelluli bojod hija temporanja, tipikament osservata 24 sa 48 siegħa wara l- għoti u hija konsistenti ma ’ l- effetti farmakodinamiċi ta ’ Neulasta.
The safety and efficacy of Neulasta for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
3 Ma ġewx evalwati b’ mod xieraq is- sigurta` u l- effikaċja ta ’ Neulasta għall- mobiliżazzjoni taċ- ċelluli proġenitriċi tad- demm f ’ pazjenti jew f 'donaturi b’ saħħithom.
3 The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
L- għatu tal- labra tas- siringa mimlija għal- lest fih lastiku naturali niexef (mnissel mill- latex), li jista 'jikkawza reazzjonijiet allerġiċi.
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging findings.
Żjieda fl- attività ematopojetika fil- mudullun f' rispons għal terapija ta 'fattur tat- tkabbir ġiet assoċjata ma' sejbiet temporanji posittivi fl- istampi tal- għadam.
Neulasta contains sorbitol.
Neulasta fih sorbitol.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Pazjenti bi problemi ereditarji rari ħafna ta ’ intoleranza għal fructose m ’ għandhomx jieħdu din il- mediċina.
Neulasta contains less than 1 mmol (23 mg) sodium per 6 mg dose, i. e. essentially ‘ sodium-free’.
Neulasta fih anqas minn 1 mmol (23 mg) sodium għal kull doża ta ’ 6 mg, għalhekk huwa essenzjalment ‘ mingħajr sodium ’.
Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Neulasta should be administered approximately 24 hours after administration of cytotoxic chemotherapy.
Minħabba s- sensittivita` potenzjali għal kimoterapija ċitotossika ta ’ ċelluli majelojdi li qed jiddividu malajr, Neulasta għandu jingħata bejn wieħed u ieħor 24 siegħa wara l- għoti ta ’ kimoterapija ċitotossika.
In clinical studies, Neulasta has been safely administered 14 days before chemotherapy.
Fl- istudji kliniċi, Neulasta ingħata mingħajr problemi 14- il jum qabel il- kimoterapija.
Concomitant use of Neulasta with any chemotherapy agent has not been evaluated in patients.
Ma ġiex evalwat f’ pazjenti l- użu ta ’ Neulasta flimkien ma ’ kwalunkwe aġent kimoterapewtiku.
In animal models concomitant administration of Neulasta and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Fi studji fuq annimali, l- għoti ta ’ Neulasta ma ’ 5- fluorouracil (5 - FU) jew anti- metaboliti oħra wriet żjieda fil - majelosoppressjoni.
Possible interactions with other haematopoietic growth factors and cytokines have not been specifically investigated in clinical studies.
Ma ġewx investigati speċifikament fi studji kliniċi l- interazzjonijiet possibbli ma ’ fatturi ta ’ tkabbir ematopojetiċi u ċitokini.
The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Il- potenzjal ta ’ interazzjoni ma ’ lithium, li wkoll jippromovi il- ħelisen ta ’ newtrofili, ma ġiex speċifikament investigat.
There is no evidence that such an interaction would be harmful.
M’ hemm l- ebda evidenza li interazzjoni bħal din tista ’ tkun ta ’ ħsara.
The safety and efficacy of Neulasta have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e. g., nitrosoureas.
Is- sigurta` u l- effikaċja ta ’ Neulasta ma ġewx evalwati f’ pazjenti li qed jirċievu kimoterapija assoċjata ma ’ majelosoppressjoni ittardjata eż, nitrosureja.
Specific interaction or metabolism studies have not been performed, however, clinical studies have not indicated an interaction of Neulasta with any other medicinal products.
Ma sarux studji speċifiċi dwar l- interazzjonijiet u l- metaboliżmu, madanakollu, studji kliniċi ma indikawx interazzjoni ta ’ Neulasta ma ’ prodotti mediċinali oħra.
Studies in animals have shown reproductive toxicity (see section 5.3).
M’ hemmx tgħarif biżżejjed dwar l- użu ta’ pegfilgrastim waqt it- tqala. Studji fuq bhejjem urew ħsara fuq is- sistema riproduttiva (ara 5. 3).
Neulasta should not be used during pregnancy unless clearly necessary.
Neulasta m’ għandux jintuża waqt it- tqala jekk mhux assolutament meħtieġ.
There is no clinical experience with breast-feeding women, therefore Neulasta should not be administered to women who are breast-feeding.
M’ hemm l- ebda esperjenza klinika f’ nisa li qed ireddgħu, għalhekk Neulasta m’ għandux jingħata lil nisa li qed irreddgħu.