qanastek/EMEA-V3 huggingface dataset:
Aranesp 10 micrograms solution for injection in a pre-filled pen (SureClick) Aranesp 15 micrograms solution for injection in a pre-filled pen (SureClick) Aranesp 20 micrograms solution for injection in a pre-filled pen (SureClick) Aranesp 30 micrograms solution for injection in a pre-filled pen (SureClick) Aranesp 40 micrograms solution for injection in a pre-filled pen (SureClick) Aranesp 50 micrograms solution for injection in a pre-filled pen (SureClick) Aranesp 60 micrograms solution for injection in a pre-filled pen (SureClick) Aranesp 80 micrograms solution for injection in a pre-filled pen (SureClick) Aranesp 100 micrograms solution for injection in a pre-filled pen (SureClick) Aranesp 130 micrograms solution for injection in a pre-filled pen (SureClick) Aranesp 150 micrograms solution for injection in a pre-filled pen (SureClick) Aranesp 300 micrograms solution for injection in a pre-filled pen (SureClick) Aranesp 500 micrograms solution for injection in a pre-filled pen (SureClick) darbepoetin alfa
Aranesp 10 mikrogrammi soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Aranesp 15- il mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Aranesp 20 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Aranesp 30 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Aranesp 40 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Aranesp 50 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Aranesp 60 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Aranesp 80 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Aranesp 100 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Aranesp 130 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Aranesp 150 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Aranesp 300 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) Aranesp 500 mikrogramma soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (SureClick) darbepoetin alfa
Instructions for injecting with the Aranesp pre-filled pen
Tagħrif dwar kif tinjetta lilek innifsek b' Aranesp
If you have chronic renal failure
485 Jekk għandek insuffiċjenza renali kronika
421 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.
• an allergy to latex (the needle cover on the pre-filled pen contains a derivative of latex).
• allerġija għall- latex (l- għatu tal- labra tal- pinna mimlija għal- lest fih sustanza mnissla mill - latex)
422 • 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.
HOW TO USE THE ARANESP PRE-FILLED PEN (SURECLICK)
KIF GĦANDEK TUŻA IL- PINNA MIMLIJA GĦAL- LEST B 'ARANESP (SURECLICK)
Your injection is to be given under the skin (subcutaneous), and so you may use the Aranesp pre-filled pen.
Wara t- testijiet tad- demm, it- tabib tiegħek iddeċieda li int għandek bżonn Aranesp minħabba li l - emoglobina tiegħek hija 10 g/ dl jew anqas.
Injecting Aranesp yourself
487 Tinjetta lilek innifsek b' Aranesp
Your doctor has decided that the Aranesp pre-filled pen is the best way for you, a nurse, or a carer to inject Aranesp.
It- tabib tiegħek iddeċieda li l- pinna mimlija għal- lest b 'Aranesp hija l- meżż ta' injezzjoni l- aktar konvenjenti għalik, għal infermiera, jew għal carer.
The pre-filled pen is designed to inject the area under your skin only.
Qatt m' għandek tinjetta lilek nnifsek b' Aranesp ġo vina.
For instructions on use of the pre-filled pen, please read the section at the end of this leaflet.
Il- pinna mimlija għal- lest hija magħmula biex tinjetta taħt il- ġilda biss.
423 If you have chronic renal failure
Jekk għandek insuffiċjenza renali kronika
The Aranesp pre-filled pen is given as a single injection, either once a week, once every two weeks, or once every month.
Il- pinna mimlija għal- lest b' Aranesp tingħata bħala injezzjoni waħda, darba fil- ġimgħa, darba kull ġimgħatejn, jew darba fix- xahar.
In order to correct your anaemia, your initial dose of Aranesp 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.
Sabiex tikkoreġi l- anemija tiegħek, l- ewwel doża ta ’ Aranesp għal kull kilogramma tal- piż ta ’ ġismek tkun ta ’ • 0. 75 mikrogrammi (darba kull ġimgħatejn) jew • 0. 45 mikrogrammi (darba fil- ġimgħa) It- tabib tiegħek jeħodlok kampjuni tad- demm regolarment sabiex jara kif l- anemija tiegħek qed 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.
It- tabib tiegħek Jgħidlek jekk id- doża tiegħek tinbidillek
If you use more Aranesp than you should
488 Jekk tuża Aranesp aktar milli suppost
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.
Jekk għandek xi wieħed minn dawn is- sintomi jkompli jew jekk tħoss xi effetti sekondarji oħra li mhux imsemmijinf’ dan il- fuljett, jekk jogħġbok, għid lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek.
Keep the pre-filled pen in the original package in order to protect from light.
Żomm il- pinna mimlija għal- lest fil- pakkett oriġinali biex tilqa ’ mid- dawl.
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.
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 Aranesp after the expiry date which is stated on the carton and on the pre-filled pen label after EXP.
489 Tużax Aranesp wara d- data ta ’ skadenza li tidher fuq il- kartuna u t- tikketta tal- pinna mimlija għal- lest wara JIS.
Aranesp (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.
Aranesp (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.
Aranesp (SureClick) is available in packs containing 1 or 4 pre-filled pens (not all pack sizes may be marketed).
Aranesp (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).
If you want more information about this medicine, please contact the local representative of the company that is authorised to market Aranesp.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq:
Deutschland AMGEN GmbH Tel: +49 (0)89 1490960
490 Deutschland AMGEN GmbH Tel: +49 (0) 89 1490960
INSTRUCTIONS FOR INJECTING WITH THE ARANESP PRE-FILLED PEN (SURECLICK)
TAGĦRIF DWAR KIF TINJETTA LILEK INNIFSEK B’ ARANESP
This section contains information on how to properly use the Aranesp pre-filled pen.
Din il- parti tal- fuljett tinkludi tagħrif dwar kif tuża sew il- pinna mimlija għal- lest b 'Aranesp.
It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse, or pharmacist.
Importanti li ma tippruvax tagħti l- injezzjoni lilek innifsek jekk ma tkunx irċevejtx taħriġ speċjali
427 How do you, or the person injecting you, use Aranesp pre-filled pen (SureClick)?
Kif inti, jew il- persuna li se tinjettak, tuża il- pinna mimlija għal- lest b' Aranesp (SureClick)?
Your doctor, nurse, or pharmacist will tell you how much Aranesp you need and how frequently it should be injected.
It- tabib tiegħek ordnalek injezzjoni b ’ pinna mimlija għal- lest b 'Aranesp għall- injezzjoni fit- tessut eżatt taħt il- ġilda It- tabib, l- infermiera jew l- ispiżjar tiegħek jgħidulek kemm Aranesp jkollok bżonn u l- frekwenza ta' l- injezzjonijiet.
• a new Aranesp pre-filled pen and
pinna ġdida mimlija għal- lest b’ Aranesp; u
Preparing for an Aranesp injection?
Tipprepara għall- injezzjoni b 'Aranesp?
Remove the pen from the refrigerator.
Ħalliha toqgħod f 'temperatura
For a more comfortable injection, leave the pen at room temperature for approximately 30 minutes.
ambjentali għal bejn wieħed u ieħor 30 minuta.
Additionally, do not leave the pre- filled pen exposed to direct sunlight.
Ukoll, tħallix il- pinna esposta għax- xemx diretta.
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.
Check the appearance of Aranesp through the inspection window.
Iċċekkja d- dehra ta ’ Aranesp minn ġo t- tieqa għal ispezzjoni.
It must be a clear, colourless or slightly pearly liquid.
Din għandha tkun likwidu ċar, mingħajr kulur jew b 'dehra kemm kemm ta' perla.
Grey needle cap
Tagħżel u tipprepara s- sit għall- injezzjoni
Red button
Buttuna l- ħamra
Choosing and preparing an injection site
Għatu ta 'sigurtà griż tal- labra
Choose an injection site
Tagħżel sit għall- injezzjoni
The injection site must be firm for the device to work properly.
Is- sit għall- injezzjoni jrid jkun sod sabiexgħal ispezzjoni sew.
The preferred injection site for using the Aranesp pre-filled pen is the front of the thigh.
L- aħjar sit għall- injezzjoni biex tuża l- pinna mimlija għal- lest b ’ Aranesp hija n- naħa ta ’ quddiem tal - koxxa.
428 Do not inject into areas where the skin is tender, bruised, red, or hard.
492 Tinjettax f ’ siti fejn il- ġilda hija misjura, mbenġla, ħamra jew iebsa.
Instructions for preferred 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 hija l- aħjar sit ta ’ l- injezzjoni.
Instructions for alternate injection sites
Tgħarif għal siti ta ’ l- injezzjoni alternattivi
When using alternate injection sites, it is particularly important to create enough surface tension on the site to be able to successfully complete the injection.
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.
Stretch technique
Teknika ta 'kif tiġbed il- ġilda.
Make sure that skin under and around the pre-filled pen is firm and Stretch tight to provide enough resistance to fully retract the safety guard and “ unlock” the pen.
Assigura ruħek li l- ġilda taħt u madwar il- pinna mimlija għal- lest Iġbed hija soda u miġbuda biex tipprovdi biżżejjed reżistenza biex l - għatu ta ’ sigurtà jinġibed lura kompletament u il- pinna “ tinħeles ”.
You can use the abdomen, except for the 2 inch/ 5 cm area around the belly button (navel).
Tista ’ tuża l- addome, ħlief id- dawra ta ’ żewġ pulzieri/ 5cm ta ’ madwar iz- zokkra.
For the abdomen, it is recommended to lie down on your back, and stretch the skin at the injection site to create a firm and tight surface.
Għall- addome, huwa rrakkomandat li timtedd fuq dahrek, u tiġbed il- ġilda fis- sit ta ’ l- injezzjoni biex toħloq wiċċ sod u miġbud.
If someone else is giving you the injection, they can also use the outer area of the upper arms.
Jekk xi ħadd ieħor ser jinjettak, jistgħu ukoll jużaw in- naħa ta ’ barra tal- parti ta ’ fuq tad- driegħ.
For the upper arms, it is recommended to stretch the skin at the injection site to create a firm and tight surface.
Għan- naħa ta ’ fuq tad- driegħ, huwa rrakkomandat li tiġbed il- ġilda fis- sit ta ’ l- injezzjoni sabiex toħloq wiċċ iebes u sod.
To prepare the area of skin where Aranesp will be injected, wipe the injection site with an alcohol wipe.
Biex tipprepara s- sit fil- ġilda fejn se tinjetta lil Aranesp, imsaħ is- sit ta ’ l- injezzjoni b ’ mselħa ta’ l - akoħol.
429 7b.
493 7b.
Injecting Aranesp using the pre-filled pen
Tinjetta Aranesp bil- pinna mimlija għal- lest
Pull off the grey needle cap
Neħħi l- għatu tal- labra l- griż
Do not twist 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 tqiegħed l- għatu ta ’ sigurtà fuq il- pinna.
Do pull the grey cap straight off Safety guard
Iġbed l- għatu l- griż dritt
Do not touch the red button.
Tmissx il- buttuna l- ħamra.
Press the pre-filled pen onto the skin to unlock the safety guard.
Għafas il- pinna mimlija għal- lest mal- ġilda sabiex teħles l- għatu ta ’ sigurtà.
Locked with safety guard out
Imblukkat bl- għatu ta ’ sigurtà maħruġ
Unlocked with safety guard fully retracted
Unlocked with safety guard fully retracted
∅ Do not press the red button until the safety guard is fully retracted.
∅ Tgħafasx il- buttuna l- ħamra qabel ma l- għatu ta 'sigurtà jkun daħal' l ġewwa kompletament
Do keep enough downward pressure to fully retract the yellow safety guard and to keep the red button unlocked.
Żomm pressa ‘ l isfel biżżejjed sabiex l- għatu ta ’ sigurtà isfar jinġibed lura u biex iżżomm il - buttuna l- ħamra ħielsa.
Do hold the pre-filled pen at a right angle (90º) to the injection site.
Żomm il- pinna mimlija għal- lest b' angolu ta '90 º grad fuq is- sit ta ’ l- injezzjoni.
430 3.
494 3.
Do maintain pressure on the skin during the injection
Żommha mgħafusa mal- ġilda waqt l - injezzjoni.
Count slowly to 15 seconds for injection to end.
Għodd bil- mod sa 15- il sekonda sa kemm tispiċċa l- injezzjoni.
Medicine will be automatically injected
Il- mediċina tiġi njettata awtomatikament.
∅ Do not move the pre-filled pen during the injection.
∅ Tressaqx il- pinna mimlija għal- lest waqt l- injezzjoni.
You may hear a second click as the red button pops back up.
Tista ’ tisma ’ ħoss ta ’ klik hekk kif il- buttuna l- ħamra taqbeż lura f’ postha.
431 5.
495 5.
Check window to confirm delivery of full dose
Iċċekkja t- tieqa għal ispezzjoni biex tikkonferma li ngħata d- doża kollha.
Do check the inspection window to confirm it has turned yellow.
Iċċekkja t- tieqa għal ispezzjoni biex tikkonferma li saret safra.
If the inspection window is not yellow, you must contact your doctor, nurse or pharmacist.
tikkuntatja lit- tabib, lill - infermiera jew lill- ispiżjar tiegħek.
Safety guard down after use.
Għatu ta 'sigurtà mniżżel wara l- użu
There may be a little bleeding at the injection site.
Jista ’ joħroġlok ftit demm mis- sit ta ’ l- injezzjoni.
You can press a cotton ball or gauze over the injection site
Tista ’ tgħafas biċċa tajjar jew garża fuq is- sit ta ’ l - injezzjoni.
Disposing of used pre-filled pens
Rimi ta’ pinen mimlija għal- lest użati
• The Aranesp pre-filled pen should NEVER be reused. • NEVER put the grey needle cap back into the used pre-filled pen. • The used pre-filled pen should be disposed of in accordance with local requirements.
• Pinen mimlija għal- lest b ’ Aranesp QATT m ’ għandhom jerġgħu jintużaw. • QATT terġa 'tqiegħed l- għatu griż tal- labra lura fuq il- pinna mimlija għal- lest użata. • Il- pinna mimlija għal- lest użata għandha tintrema kif jitolbu l- liġijiet lokali.
Ask your pharmacist how to dispose of medicines no longer required.
Dawn il- miżuri jgħinu għall - protezzjoni ta ’ l- ambjent.
These measures will help to protect the environment.
496 Għandek għażla ta ’ fuljett ta ’ tagħrif ieħor:
Optional separate additional insert:
L- aħjar sit huwa n- naħa ta ’ quddiem tal- koxxa
FRONT- Aranesp getting started guide:
Siti alternattivi huma l- addome jew in- naħa ta ’ barra tal- parti ta ’
Aranesp SureClick Pre-filled pen - Read package leaflet before use ENGLISH
Iġbed il- ġilda f’ siti għall- injezzjoni alternattivi
Preferred site is front of the thigh
Aqleb għall - istruzzjonijiet dwar l - injezzjoni
Alternate sites are the abdomen or outer
fuq tad- driegħ Iġbed Is- sit għall- injezzjoni jrid jkun sod u miġbud.
Stretch the skin on alternate injection
WARA - Aranesp gwida biex tibda:
Turn over for injection steps
(1) Neħħi l- għatu
area of upper arms
(2) Tmissx il -
sites
(3) Fi ftit ħin
Stretch Injection site must be firm and tight
(4) Għodd bil -
432 BACK- Aranesp getting started guide:
(5) Iċċekkja t -
(1) Pull off grey needle cap
tal- labra l- griż.
(2) Do not touch red button.
buttuna l- ħamra.
Press the pen onto the skin to unlock
Għafas il- pinna mimlija għal- lest mal- ġilda sabiex teħles l- għatu ta ’
(3) Briefly press and release red button.
għafas u itlaq il - buttuna l- ħamra.
(4) Count slowly to 15 for injection to end.
mod sa 15 sabiex tispiċċa l - injezzjoni.
(5) Check window
tieqa għal ispezzjoni
safety guard.
sigurtà.
∅ Do not twist
∅ Tgħawwiġx l -
X Locked
X Imblukkat
Complete
Lesta meta issir
the grey needle cap
għatu ta ’ sigurtà griż
when yellow
safra
Unlocked
Ħieles
Keep unlocked against skin
Żommha ħielsa mal- ġilda
What is Arava?
X’ inhi Arava?
Arava is a medicine containing the active substance leflunomide.
Arava hija mediċina li fiha s- sustanza attiva leflunomide.
It is available as tablets (10 mg: white, round; 20 mg: yellow, triangular; 100 mg: white, round).
Hija tiġi bħala pilloli (10 mg: bojod, tondi; 20 mg: sofor, triangulari; 100 mg: bojod, tondi).
What is Arava used for?
Għal xiex tintuża Arava?
Arava is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Arava tintuża għat- trattament ta ’ adulti bl- artrite rewmatika (marda tas- sistema immunitarja li tikkawża infjammazzjoni tal- ġogi) jew bl- artrite psorjatika attiva (marda li tikkawża dbabar ħomor bil - qoxra fil- ġilda u infjammazzjoni tal- ġogi).
How is Arava used?
Kif tintuża Arava?
Arava treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
It- trattament b’ Arava għandu jinbeda u jiġi sorveljat minn speċjalista li jkollu esperjenza fit- trattament ta ’ l- artrite rewmatika u l- artrite psorjatika.
The doctor should carry out blood tests to check the patient ’ s liver function, white blood cell counts and platelet counts before prescribing Arava, and regularly during treatment.
It- tabib għandu jagħmel testijiet tad- demm biex jiċċekkja l- funzjoni tal- fwied, l- għadd ta ’ ċelloli bojod u l- għadd ta ’ platelets tal- pazjent qabel ma jippreskrivi Arava, u għandu jagħmel dan b’ mod regolari waqt it- trattament.
Arava treatment starts with a loading dose of 100 mg once a day for three days, followed by a maintenance dose.
It- trattament b’ Arava jibda b’ doża inizjali ta ’ 100 mg darba kuljum għal tlett ijiem, segwiti b’ doża ta ’ manutenzjoni.
The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Id- doża ta ’ manutenzjoni rakkomandata hija ta ’ bejn 10 u 20 mg darba kuljum f’ pazjenti bl- artrite rewmatika, u 20 mg darba kuljum f’ pazjenti bl- artrite psorjatika.
The medicine usually starts to have an effect after four to six weeks.
Il- mediċina ġeneralment jibda jkollha effett wara bejn erba ’ u sitt ġimgħat.
Its effect may improve further for up to six months.
L- effett tagħha jista ’ jkompli jitjieb sa sitt ġimgħat.
Arava is not recommended for use in under-18s with juvenile rheumatoid arthritis.
Arava mhijiex rakkomandata għall- użu minn pazjenti ta ’ inqas minn 18- il sena bl- artrite rewmatika ġovanili.
How does Arava work?
Kif taħdem Arava?
The active substance in Arava, leflunomide, is an immunosuppressant.
Is- sustanza attiva f’ Arava, leflunomide, hija mediċina immunosuppressiva.
It reduces inflammation by reducing the production of immune cells called ‘ lymphocytes’, which are responsible for inflammation.
Tnaqqas l- infjammazzjoni bit- tnaqqis tal- produzzjoni ta ’ ċelloli immunitarji magħrufa bħala ‘ limfoċiti ’, li huma responsabbli għall- infjammazzjoni.
Leflunomide does this by blocking an enzyme called ‘ dihydroorotate dehydrogenase’, which is necessary for the lymphocytes to multiply (‘ proliferation’).
Leflunomide jagħmel hekk billi jimblokka enzim magħruf bħala ‘ dihydroorotate dehydrogenase ’, li huwa meħtieġ għat- tkattir (‘ proliferazzjoni ’) tal- limfoċiti.
With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
B’ inqas limfoċiti, ikun hemm inqas infjammazzjoni, u dan jgħin fil- kontroll tas- sintomi ta ’ l- artrite.
How has Arava been studied?
Kif ġiet studjata Arava?
The effectiveness of Arava in rheumatoid arthritis has been studied in four main studies involving over 2,000 patients.
L- effikaċja ta ’ Arava fl- artrite rewmatika ġiet studjata f’ erba ’ studji ewlenin li fihom ħadu sehem iktar minn 2, 000 pazjent.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Arava tqabblet mal- plaċebo (trattament finta), jew ma ’ methotrexate jew ma ’ 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged two lasted a year.
Żewġ studji damu sitt xhur, u tnejn damu sena.
These two longer studies were extended, with patients remaining on the medicines for at least one further year.
Dawn l- istudji li damu iktar ġew estiżi, bil- pazjenti jibqgħu jieħdu l- mediċini għal ta ’ l- inqas sena oħra.
Arava was also studied in 186 patients with psoriatic arthritis, who were treated with Arava or placebo for six months.
Arava ġiet studjata woll f’ 186 pazjent bl- artrite psorjatika, li kienu ġew trattati b’ Arava jew bil - plaċebo għal sitt xhur.
In all of the studies, the main measure of effectiveness was the proportion of the patients who responded to treatment, as defined by disease-specific criteria (American College of Rheumatology response rates for rheumatoid arthritis, and the Psoriatic Arthritis treatment Response Criteria for psoriatic arthritis).
Fl- istudji kollha, il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien il- proporzjon ta ’ pazjenti li rrispondew għat- trattament, kif definiti minn kriterji speċifiċi għall- ċeta taip ta ’ mard (Ir- rati ta ’ rispons għall - artrite rewmatojde tal- Kulleġġ Amerikan għar- Rewmatoloġija, u l- Kriterji ta ’ Rispons għat- trattament ta ’ Artrite Psoratika għal din it- tip ta ’ artrite.).
What benefit has Arava shown during the studies?
X’ benefiċċji wriet Arava waqt l- istudji?
In rheumatoid arthritis, Arava was more effective than placebo, and as effective as sulphasalazine.
Fl- artrite rewmatika, Arava kienet iktar effettiva mill- plaċebo, u effettiv daqs sulfasalazine.
The proportion of responders in the Arava group was between 49 and 55%, compared with 26 to 28% for patients taking placebo, and 54% for patients taking sulphasalazine.
Il - proporzjon ta ’ pazjenti li wieġbu għat- trattament fil- grupp ta ’ Arava kien ta ’ bejn 49 u 55%, meta mqabbla ma ’ 26 u 28% għal pazjenti li ħadu l- plaċebo, u 54% għall- pazjenti li ngħataw sulfasalazine.
These results were maintained in the extension studies.
Dawn ir- riżultati inżammu fl- istudji ta ’ estensjoni.
Over the first year of treatment, Arava was as effective as methotrexate, but only when it was taken with folate (a type of vitamin B).
Matul l- ewwel sena ta ’ trattament, Arava kienet effettiva daqs methotrexate, iżda biss meta ttieħed mal- folate (tip ta ’ vitamina B).
Arava was not as effective as methotrexate in the extension study.
Arava ma kinitx effettiva daqs methotrexate fl- istudju ta ’ estensjoni.
In psoriatic arthritis, Arava was more effective than placebo, with 59% of the patients taking Arava responding to treatment, compared with 30% of those taking placebo.
Fl- artrite psorjatika, Arava kienet iktar effettiva mill- plaċebo, b’ 59% tal- pazjenti li ħadu Arava jirrispondu għat- trattament, meta mqabbla ma ’ 30% ta ’ dawk li ħadu l- plaċebo.
What is the risk associated with Arava?
X’ inhu r- riskju assoċjat ma ’ Arava?
The most common side effects with Arava (seen in between 1 and 10 patients in 100) are leucopenia (low white blood cell counts), mild allergic reactions, anorexia (loss of appetite), weight loss, headache, dizziness, paraesthesia (abnormal skin sensations), mild increase in blood pressure, diarrhoea, nausea (feeling sick), vomiting, inflammation of the mouth such as mouth ulcers, abdominal (tummy) pain, increased liver enzyme levels, hair loss, eczema, dry skin, rash, pruritus pruritus (itching), tenosynovitis (inflammation of the sheath surrounding a tendon) and asthenia (weakness).
L- iktar effetti sekondarji komuni ma ’ Arava (li dehru f’ bejn pazjent wieħed u 10 minn kull 100) huma l- lewkopenja (għadd baxx ta ’ ċelloli tad- demm bojod), reazzjonijiet allerġiċi ħfief, anoressija (nuqqas ta ’ aptit), telf ta ’ piż, uġigħ ta ’ ras, sturdament, paraesteżija (sensazzjonijiet mhux normali fil- ġilda), żieda ħafifa fil- pressjoni, dijarrea, nawżea, rimettar, infjammazzjoni tal- ħalq bħal ulċeri tal- ħalq, uġigħ addominali (fiż- żaqq), żieda fil- livelli ta ’ l- enzimi tal- fwied, telf ta ’ xagħar, ekżema, ġilda niexfa, raxx, prurite (ħakk), tenosinovite (infjammazzjoni tal- kisi ta ’ tendon) u astenja (dgħufija).
For the full list of all side effects reported with Arava, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati b’ Arava, ara l- Fuljett ta ’ Tagħrif.
Arava should not be used in people who may be hypersensitive (allergic) to leflunomide or to any of the other ingredients.
Arava m’ għandhiex tintuża minn persuni li huma allerġiċi għal leflunomide jew għal xi sustanzi oħra tiegħu.
Arava should not be used in patients with: • liver disease, • severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS), • poor bone marrow function or low blood cell counts (red cells, white cells or platelets) caused by conditions other than rheumatoid or psoriatic arthritis, • serious infections, • moderate to severe kidney disease, • severe hypoproteinaemia (low blood protein levels).
Arava m’ għandiex tintuża minn pazjenti b ’: • Mard tal- fwied, • Stati ta ’ immunodefiċjenza severa, bħas- sindromu ta ’ l- immudodefiċjenza miksuba (AIDS), • Funzjoni dgħajfa tal- marrara tal- għadam jew ta ’ għadd baxx ta ’ ċelloli tad- demm (ċelloli bojod, ħomor jew platelets) ikkawżata minn kundizzjonijiet oħra ħlief l- artrite rewmatika jew psorjatika, • infezzjonijiet serji, • mard tal- kliewi moderat jew sever, • livell baxx ħafna ta ’ proteini fid- demm.
Arava should not be used in pregnant women, in women who may become pregnant, or during breast- feeding.
Arava m’ għandhiex tintuża minn nisa tqal, minn nisa li jistgħu joħorġu tqal, jew li jkunu qegħdin ireddgħu.
Doctors prescribing Arava need to be aware of the risk of liver problems associated with the medicine.
It- tobba li jippreskrivu Arava għandhom ikunu konxji mir- riskju ta ’ problemi bil- fwied assoċjati ma ’ din il- mediċina.
They also need to take special care when switching a patient to Arava, or when switching a patient who is receiving Arava to another treatment.
Iridu joqogħdu attenti ħafna wkoll meta jibdlu t- trattament ta ’ pazjent għal Arava, jew meta jibdlu t- trattament minn Arava għal trattament ieħor.
Why has Arava been approved?
Għaliex ġiet approvata Arava?
The Committee for Medicinal Products for Human Use (CHMP) decided that Arava’ s benefits are greater than its risks for the treatment of adult patients with active rheumatoid arthritis as a ‘ disease- modifying antirheumatic drug ’ (DMARD), and active psoriatic arthritis.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (is- CHMP) iddeċieda li l- benefiċċji ta ’ Arava huma ikbar mir- riskji taggħa għat- trattament ta ’ pazjenti adulti bl- artrite rewmatika attiva bħala ‘ mediċina antirewmatika għall- modifikazzjoni tal- marda ’ (DMARD), u l- artrite psojatika attiva.
The Committee noted that, when starting treatment with Arava, doctors should assess the benefits very carefully in the context of the risk of the serious liver problems that may be associated with its use, particularly in patients who have taken or are taking other DMARDs that can affect the blood or the liver.
Il - Kumitat irrimarka li meta jibdew it- trattament b’ Arava, it- tobba għandhom jivvalutaw il- benefiċċji b’ attenzjoni kbira, fil- kuntest tar- riskju ta ’ problemi serji fil- fwied li jistgħu jkunu assoċjati ma ’ l- użu tiegħu, partikolarment f’ pazjenti li jkunu ħadu jew sa jieħdu DMARDs oħra li jistgħu jaffettwaw id - demm jew il- fwied.
The Committee recommended that Arava be given marketing authorisation.
Il- Kumitat irrakkomanda li Arava tingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Arava:
Tagħrif ieħor dwar Arava:
The marketing authorisation was renewed on 2 September 2004.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Arava valida fl- Unjoni Ewropea kollha lil sanofi- aventis Deutschland GmbH fit- 2 ta ’ Settembru 1999.
This summary was last updated in 12-2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 2 ta ’ Settembru 2004.
Arava 10 mg film-coated tablets
Arava 10 mg pilloli miksija b’ rita.
Each film-coated tablet contains 10 mg of leflunomide and 78 mg of lactose.
Kull pillola miksija b’ rita fiha 10 mg ta ’ leflunomide u 78 mg ta ’ lactose.
For a full list of excipients, see section 6.1.
Għall- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1
White to almost white, round film-coated tablet with a diameter of about 7 mm, imprinted with ZBN on one side.
Pillola miksija b’ rita, bajda jew kważi bajda, tonda b’ dijametru ta ’ madwar 7 mm, stampata b’ ZBN fuq faċċata waħda.
Leflunomide is indicated for the treatment of adult patients with: • active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD), • active psoriatic arthritis,.
Leflunomide huwa indikat għall- kura ta ’ pazjenti adulti li jbatu minn: • artrite attiva, tat- tip rewmatojde bħala “ mediċina antirewmatika li timmodifika l- marda ” (DMARD), • artrite psorjatika attiva.
Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e. g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit/ risk aspects.
Kura reċenti, jew flimkien ma ’ mediċini tat- tip DMARD, li huma tossiċi għall- fwied jew għad- demm (e. g. methotrexate), tista ’ żżid ir- riskju li jkun hemm reazzjonijiet avversi serji; għalhekk, qabel ma wieħed jibda l- kura b’ leflunomide, wieħed għandu jiżen sew l- aspetti ta ’ benefiċċji kontra r- riskji.
Moreover, switching from leflunomide to another DMARD without following the washout procedure (see section 4.4) may also increase the risk of serious adverse reactions even for a long time after the switching.
Barra minn dan, il- bidla minn leflunomide għal DMARD ieħor, mingħajr ma tkun segwita l- proċedura biex l- ewwel titneħħa din is- sustanza mill- ġisem (ara sezzjoni 4. 4), tista ’ żżid ir- riskju li jkun hemm reazzjonijiet avversi serji, anke wara żmien twil mill- bidla.
The treatment should be initiated and supervised by specialists experienced in the treatment of rheumatoid arthritis and psoriatic arthritis.
It- trattament għandu jkun mibdi u ssorveljat minn speċjalisti li għandhom esperjenza fil- kura ta ’ l - artrite rewmatika u l- artrite psorjatika.
The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months.
L- effett terapewtiku normalment jibda minn 4 sa 6 ġimgħat wara li tinbeda l- kura u tista ’ tkompli titjieb minn 4 sa 6 xhur wara..
Arava is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Arava mhux irrakkomandat għall- użu f’ pazjenti taħt it- 18- il sena għax l- effikaċja u s- sigurtà fl- artrite rewmatika fiż- żgħażagħ (JRA) mhumiex stabbiliti (ara sezzjoni 5. 1 u 5. 2).
Alanine aminotransferase (ALT) (orserum glutamopyruvate transferase SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency: • before initiation of leflunomide, • every two weeks during the first six months of treatment, and • every 8 weeks thereafter (see also section 4.4).
Alanine aminotransferase (ALT) (jew serum glutamopyruvate transferase SGPT) u test komplut tad - demm, fejn jingħaddu ċ- ċelluli kollha, inklużi t- tipi diversi kollha taċ- ċelluli bojod u l- plejtlits, iridu jsiru simultanjament u bl- istess frekwenza: • qabel ma jinbeda leflunomide, • kull ġimgħatejn fl- ewwel sitt xhur tal- kura, u • kull 8 ġimgħat minn hemm ’ il quddiem (ara wkoll sezzjoni 4. 4).
Leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days. • The recommended maintenance dose for rheumatoid arthritis is leflunomide 10 mg to 20 mg once daily.
Il- kura b`lefunomide tibda b’ doża kbira inizjali, ta` 100 mg darba kuljum għal tlitt ijiem. • Id- doża irrakkomandata ta` leflunomide li għandha tinżamm wara, għall- artrite rewmatika, hija ta ’ bejn 10 mg u 20 mg darba kuljum.
Patients may be started on leflunomide 10 mg or 20 mg depending on the severity (activity) of the disease. • The recommended maintenance dose is 20 mg once daily for patients with psoriatic arthritis (see section 5.1).
Il- pazjenti jistgħu jinbdew fuq 10 mg jew 20 mg leflunomide skond is- severità (attività) tal- marda. • Id- doża regolari, miżmuma u irrakkomandata għall- pazjenti bl- artrite psorjatika hija ta ’ 20 mg darba kuljum (ara sezzjoni 5. 1).
There is no dose adjustment recommended in patients with mild renal insufficiency.
M’ hemmx bżonn ta ’ tibdil fid- doża f’ pazjenti li għandhom insuffiċjenza ħafifa tal- kliewi.
No dosage adjustment is required in patients above 65 years of age.
M’ hemmx bżonn ta ’ tibdil fid- doża f’ pazjenti ta’ età ’ l fuq minn 65 sena.
Administration
It- teħid tal- mediċina
Arava tablets should be swallowed whole with sufficient amounts of liquid.
Il- pilloli Arava għandhom jinbelgħu sħaħ b’ ammont adegwat ta ’ likwidu.
The extent of leflunomide absorption is not affected if it is taken with food.
L- ammont ta ’ leflunomide li jiġi assorbit ma jiġix effetwat jekk jittieħed ma ’ l- ikel.
• hypersensitivity to the active substance (especially previous Stevens- Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) or to any of the excipients,
sensitività eċċessiva għas- sustanza attiva (speċjalment jekk kellhom preċedentement is- sindromu Stevens- Johnson, in- nekrożi tossika u esfoljattiva tal- ġilda, l- eritema multiforme), jew għal xi wieħed mis- sustanzi mhux attivi.
• patients with impairment of liver function,
• pazjenti li għandhom indeboliment tal- fwied,
AIDS,
• pazjenti li għandhom stat ta ’ defiċjenza immunoloġika e. g. l- AIDS,
• patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid or psoriatic arthritis,
• pazjenti li għandhom indeboliment sinifikanti fil- funzjoni tal- mudullun, jew anemija sinifikanti, lewkopenja, newtropenja jew tromboċitopenja u dawn jekk dovuti għal kwalunkwe kawża, għajr dik ta ’ l- artrite rewmatika jew psorjatika,
• patients with serious infections (see section 4.4),
• pazjenti b’ infezzjonijiet severi, (ara sezzjoni 4. 4)
• patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group,
• pazjenti b’ indeboliment moderat jew sever tal- kliewi, għax m’ hemmx esperjenza klinika biżżejjed f’ dawn il- pazjenti,
• patients with severe hypoproteinaemia, e. g. in nephrotic syndrome,
• pazjenti li għandhom livelli baxxi ħafna tal- proteini fid- demm, e. g. is- sindromu nefrotiku,
• pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with leflunomide and thereafter as long as the plasma levels of the active metabolite are above 0.02 mg/ l (see also section 4.6).
• nisa tqal b’ tarbija, jew dawk in- nisa li għadhom fl- età li jkollhom it- tfal u mhux qegħdin jużaw kontraċettivi effettivi waqt il- kura b’ leflunomide, u wara, sakemm il- livelli fil- plażma tal - prodott metaboliku attiv ikunu ’ l fuq minn 0. 02 mg/ l (ara wkoll sezzjoni 4. 6).
Pregnancy must be excluded before start of treatment with leflunomide,
It- tqala trid tkun eskluża qabel tinbeda l- kura b’ lefunomide.
• breast-feeding women (see also section 4.6).
(ara wkoll sezzjoni 4. 6).
Arava should be administered to patients only under careful medical supervision.
Arava għandu jingħata lill- pazjenti taħt sorveljanza medika u attenta biss.
Concomitant administration of hepatotoxic or haematotoxic DMARDs (e. g. methotrexate) is not advisable.
It- teħid flimkien ta ’ mediċini tal- klassitad- DMARD li huma tossiċi għall- fwied u għad- demm (e. g. methotrexate) mhux irrakkomandat.
The active metabolite of leflunomide, A771726, has a long half-life, usually 1 to 4 weeks.
Il- prodott metaboliku attiv ta ’ leflunomide, A771726, għandu half- life twila, ġeneralment 1 sa 4 ġimgħat.
Serious undesirable effects might occur (e. g. hepatotoxicity, haematotoxicity or allergic reactions, see below), even if the treatment with leflunomide has been stopped.
Jista` jkun hemm effetti mhux mixtieqa u serji (e. g. tossiċità għall- fwied jew għad- demm u reazzjonijiet allerġiċi, ara hawn taħt), anke meta l- kura b’ leflunomide titwaqqaf.
Therefore, when such toxicities occur or if
Għalhekk, meta jkun
3 for any other reason A771726 needs to be cleared rapidly from the body, the washout procedure has to be followed.
3 hemm dawn l- effetti tossiċi, jew jekk għal xi raġuni oħra A771726 għandu jiġi mneħħi malajr mill - ġisem, il- proċedura li tneħħi din ta ’ l- aħħar mill- ġisem trid tkun segwita.
The procedure may be repeated as clinically necessary.
Il- proċedura tista ’ tiġi rrepetuta kif klinikament meħtieġa.
For washout procedures and other recommended actions in case of desired or unintended pregnancy see section 4.6.
Għal dan il- għan, u xi miżuri oħra irrakkomandati f’ każ ta ’ tqala mixtieqa jew mhux ippjanata, ara sezzjoni 4. 6.
Liver reactions
Reazzjonijiet fil- fwied
Rare cases of severe liver injury, including cases with fatal outcome, have been reported during treatment with leflunomide.
Każijiet rari ta ’ ħsara severa fil- fwied, inklużi dawk fatali, kienu rrapportati waqt il- kura b’ leflunomide.
Most of the cases occurred within the first 6 months of treatment.
Il- biċċa l- kbira tal- każijiet ġraw fl- ewwel 6 xhur tal- kura.
Co- medication with other hepatotoxic medicinal products was frequently present.
Fil- biċċa l- kbira ta` dawn il - każijiet, il- kura kienet qed tittieħed flimkien ma ’ prodotti mediċinali oħra, li huma tossiċi għall- fwied.
It is considered essential that monitoring recommendations are strictly adhered to.
Huwa meqjus essenzjali li l- osservazzjoni, skond ir- rakkomandazzjonijiet, tkun segwita mill- qrib.
ALT (SGPT) must be checked before initiation of leflunomide and at the same frequency as the complete blood cell count (every two weeks) during the first six months of treatment and every 8 weeks thereafter.
Il- livell ta ’ l- ALT (SGPT) għandu jiġi ċċekjat qabel tibda l- kura b’ leflunomide, u għandu jsir bl- istess frekwenza tat- testijiet ta ’ l- għadd sħiħ taċ- ċelluli tad- demm (kull ġimgħatejn) matul l- ewwel sitt xhur ta ’ kura, u wara dan, kull 8 ġimgħat.
For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, dose reduction from 20 mg to 10 mg may be considered and monitoring must be performed weekly.
F’ każ li l- livelli ta ’ l- ALT (SGPT) ikunu għoljin minn darbtejn sa 3 darbiet l- ogħola limitu tan- normal, trid titqies jekk għandiex titnaqqas id- doża minn 20 mg għal 10 mg, u l- osservazzjoni għandha ssir kull ġimgħa.
If ALT (SGPT) elevations of more than 2-fold the upper limit of normal persist or if ALT elevations of more than 3-fold the upper limit of normal are present, leflunomide must be discontinued and wash-out procedures initiated.
Jekk il- livelli ta ’ l- ALT (SGPT) huma għoljin aktar minn darbtejn l- ogħla livell tan - normal u jippersistu, jew jekk l- ALT elevat ikun akbar minn 3 darbiet l- ogħla livell tan- normal, leflunomide irid jitwaqqaf u l- proċeduri biex jitneħħa mill- ġisem jinbdew.
It is recommended that monitoring of liver enzymes be maintained after discontinuation of leflunomide treatment, until liver enzyme levels have normalised.
Huwa irrakkomandat li tibqa ’ ssir l- osservazzjoni ta` l- enżimi tal- fwied wara li titwaqqaf il- kura b’ leflunomide, sakemm il - livelli ta ’ l- enżimi tal- fwied jinnormaliżżaw.
Due to a potential for additive hepatotoxic effects, it is recommended that alcohol consumption be avoided during treatment with leflunomide.
Minħabba r- riskju ta` effetti addittivi u tossiċi fuq il- fwied, huwa irrakkomandat li l- konsum ta ’ l - alkoħol, waqt il- kura b’ leflunomide, jieqaf.
Since the active metabolite of leflunomide, A771726, is highly protein bound and cleared via hepatic metabolism and biliary secretion, plasma levels of A771726 are expected to be increased in patients with hypoproteinaemia.
Peress li l- prodott metaboliku attiv ta` leflunomide, A771726, jintrabat sew mal- proteina fid- demm u jitneħħa permezz tal- metaboliżmu tal- fwied u s- sekrezzjoni biljari, il- livelli ta ’ A771726 fil- plażma mistennija li jiżdiedu f’ pazjenti li għandhom livelli baxxi ta ’ proteini fid- demm.
Arava is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Arava huwa kontra- indikat f’ pazjenti li għandhom livelli baxxi ħafna ta ’ proteini fid- demm jew indeboliment tal - fwied (ara sezzjoni 4. 3).
Haematological reactions
Reazzjonijiet ematoloġiċi
Together with ALT, a complete blood cell count, including differential white blood cell count and platelets, must be performed before start of leflunomide treatment as well as every 2 weeks for the first 6 months of treatment and every 8 weeks thereafter.
Flimkien ma ’ l- ALT, il- għadd sħiħ taċ- ċelluli tad- demm, inklużi t- tipi diversi taċ- ċelluli bojod, kif ukoll il- plejtlits, għandu jsir qabel ma tinbeda l- kura b’ leflunomide, kif ukoll kull ġimgħatejn fl- ewwel 6 xhur tal- kura, u wara dan kull 8 ġimgħat.
In patients with pre-existing anaemia, leucopenia, and/ or thrombocytopenia as well as in patients with impaired bone marrow function or those at risk of bone marrow suppression, the risk of haematological disorders is increased.
F’ pazjenti li kellhom minn qabel l- anemija, lewkopenja u/ jew tromboċitopenja, kif ukoll dawk li għandhom indeboliment tal- mudullun, jew dawk li qegħdin f’ riskju ta ’ trażżin tal- mudullun, ir- riskju ta ’ problemi ematoloġiċi jiżdied.
If such effects occur, a washout (see below) to reduce plasma levels of A771726 should be considered.
Jekk ikun hemm dawn l- effetti, il- proċeduri biex jitnaqqas il- livell ta ’ A771726 mill- plażma jridu jkunu ikkunsidrati.
In case of severe haematological reactions, including pancytopenia, Arava and any concomitant myelosuppressive medication must be discontinued and a leflunomide washout procedure initiated.
F’ każ ta ’ reazzjonijiet ematoloġiċi severi, nkluża l- panċitopenja, Arava, u kwalunkwe kura konkomitanti li trażżan l- mudullun, għandhom jitwaqqfu, u l- proċedura biex jitneħħa leflunomide mill- ġisem tinbeda.
Combinations with other treatments
Użu konkomitanti ma ’ kuri oħra
The use of leflunomide with antimalarials used in rheumatic diseases (e. g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive agents (with the exception of methotrexate, see section 4.5) has not been studied up to now.
L- użu ta` leflunomide, flimkien mal- mediċini kontra l- malarja, użati fir- rewmatiżmu, (e. g. chloroquine u hydroxychloroquine), deheb li jingħata sew fil- muskoli kif ukoll mill- ħalq, D- penicillamine, azathioprine u sustanzi oħra li jrażżnu l- istat immuni (bl- eċċezzjoni ta ’ methotrexate, ara sezzjoni 4. 5), s’ issa għadu mhux studjat.
The risk associated with combination therapy, in particular in long-term treatment, is unknown.
Ir- riskju assoċjat ma ’ terapija konkomittanti, speċjalment għal tul ta` żmien, għadu mhux magħruf.
Since such therapy can lead to additive or even synergistic toxicity (e. g. hepato- or haematotoxicity), combination with another DMARD (e. g. methotrexate) is not advisable.
4 rigward tat- tossiċità (e. g. tossiċità għall- fwied u għad- demm), it- teħid flimkien ma ’ prodott ieħor tal - klassi tad- DMARD (e. g. methotrexate) mhux ta ’ min jirrakkomandah.
4 Caution is advised when leflunomide is given together with drugs, other than NSAIDs, metabolised by CYP2C9 such as phenytoin, warfarin, phenprocoumon and tolbutamide.
Huwa rrakomandat li tittieħed il- kawtela meta leflunomide jingħata flimkien ma ’ mediċina oħra, ħlief l- NSAIDs, li huma metaboliżżati minn CYP2C9 bħal phenytoin, warfarin, phenprocoumon u tolbutamide.
Switching to other treatments
Meta ssir il- bidla għal kuri oħra
As leflunomide has a long persistence in the body, a switching to another DMARD (e. g. methotrexate) without performing the washout procedure (see below) may raise the possibility of additive risks even for a long time after the switching (i. e. kinetic interaction, organ toxicity).
Peress li leflunomide jibqa ’ fil- ġisem għal żmien twil, il- bidla għal sustanza oħra tad- DMARD (e. g. methotrexate), mingħajr ma ssir il- proċedura tat- tneħħija mill- ġisem (ara hawn taħt), tista ’ żżid ir - riskji anke għal żmien twil wara l- bidla (i. e. interazzjoni kinetika, tossiċità ta ’ l- organi).
Similarly, recent treatment with hepatotoxic or haematotoxic medicinal products (e. g. methotrexate) may result in increased side effects; therefore, the initiation of leflunomide treatment has to carefully be considered regarding these benefit/ risk aspects and closer monitoring is recommended in the initial phase after switching.
Dawn jistgħu jikkawżaw aktar effetti mhux mixtieqa; għalhekk, l- kura b ’ leflunomide għandha tkun ikkonsidrata skond l- aspetti ta ’ benefiċji kontra r- riskji u huwa irrakkomandat li jkun hemm osservazzjoni aktar mill- qrib fil- fażi inizjali wara li ssir il- bidla fil- mediċina.
Skin reactions
Reazzjonijiet fil- ġilda
In case of ulcerative stomatitis, leflunomide administration should be discontinued.
F’ każ ta ’ stomatite bl- ulċeri, leflunomide għandu jitwaqqaf.
Very rare cases of Stevens Johnson syndrome or toxic epidermal necrolysis have been reported in patients treated with leflunomide.
Każjiet rari ħafna tas- sindrome ta ’ Stevens- Johnson jew in- nekrożi tossika u esfoljattiva tal- ġilda kienu irrapportati f’ pazjenti fuq leflunomide.
As soon as skin and/ or mucosal reactions are observed which raise the suspicion of such severe reactions, Arava and any other possibly associated medication must be discontinued, and a leflunomide washout procedure initiated immediately.
Hekk kif wieħed jinduna b’ reazzjonijiet tal- ġilda u/ jew tal- mukoża li jistgħu jqajmu suspett ta ’ dawn ir- reazzjonijiet severi, Arava u kwalunkwe mediċina oħra assoċjata magħha, għandhom jitwaqqfu kompletament, u l- proċedura biex jitneħħa leflunomide kollu mill- ġisem tinbeda minnufih.
A complete washout is essential in such cases.
Huwa essenzjali li din issir bir- reqqa kollha f’ dawn il- każijiet.
In such cases re-exposure to leflunomide is contra-indicated (see section 4.3).
F’ każijiet bħal dawn, l- użu mill- ġdid ta ’ leflunomide huwa kontra- indikat (ara sezzjoni 4. 3).