qanastek/EMEA-V3 huggingface dataset:
Use the other hand to gently pinch the cleaned area of skin and hold it firmly.
Uża l- id l- oħra sabiex toqros daqsxejn iż- żona tal- ġilda mnaddfa 2. u żżommha sew.
After the needle is inserted, let go of the skin and slowly push the plunger all the way down to inject RELISTOR.
Wara li ddaħħal il- labra, ħalli l- ġilda u bil- mod mbotta l- planġer l- isfel għall- kollox sabiex tinjetta RELISTOR.
When you hear a click sound that means the entire contents were injected.
Meta tisma ’ ħoss ta ’ klikk dak ifisser li l- kontenut kollu kien injettat.
The needle will automatically retract from the skin and be capped.
Il- labra awtomatikament ser tinġibed lura minn mal- ġilda u titgħatta.
There may be a little bleeding at the injection site.
Jista ’ jkun hemm daqsxejn ta ’ fsada fis- sit ta ’ l- injezzjoni.
You can press a cotton ball or gauze over the injection site.
Tista ’ tagħfas biċċa tajjara jew garza fuq is- sit ta ’ l- injezzjoni.
Do not rub the injection site.
M’ għandekx togħrok il- post ta ’ l- injezzjoni.
If needed, you may cover the injection site with a plaster.
Jekk ikun hemm bżonn tista ’ tgħatti s- sit ta ’ l- injezzjoni bi stikk.
Dispose the syringe in a closable puncture-resistant container as instructed by your healthcare professional.
Armi s- siringa f’ reċipjent li jingħalaq u li ma jistax jitaqqab kif qallek tagħmel il- professjonist tal- kura tas- saħħa tiegħek.
Step 4b:
Stadju 4b:
Injecting RELISTOR using a standard injection syringe and injection needle
Kif tinjetta RELISTOR permezz ta ’ siringa ta ’ l- injezzjoni u labra ta ’ l- injezzjoni standard.
Holding the filled syringe with the needle pointing up, recheck the syringe for air bubbles.
Fil- waqt li żżomm is- siringa mimlija tipponta ’ l fuq, iċċekkja mill- ġdid is- siringa għal bżieżaq ta ’ l- arja.
If there are bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe.
Jekk ikun hemm bżieżaq, taptap bil- mod is- siringa b’ subgħajk sakemm il- bżieżaq jitilgħu ’ l fuq fis - siringa.
Slowly push the plunger up to force the air bubbles out of the syringe.
Bil- mod imbotta l- planġer ’ l fuq sabiex tisforza l- bżieżaq ’ l barra minn ġos- siringa.
After the needle is inserted, let go of the skin and slowly push the plunger all the way down to inject RELISTOR.
Wara li ddaħħal il- labra, ħalli l- ġilda u bil- mod u mbotta l- planġer l- isfel għall- kollox sabiex tinjetta RELISTOR.
When the syringe is empty, quickly pull the needle out of the skin, being careful to keep it at the same angle as inserted.
Wara li s- siringa tibattal, oħroġ malajr il- labra mill- ġilda, fil- waqt li toqod attent li żżomha l- istess angolu ta ’ kif daħħaltha.
There may be a little bleeding at the injection site.
Jista ’ jkun hemm daqsxejn ta ’ fsada fil- post ta ’ l- injezzjoni.
You can press a cotton ball or gauze over the injection site.
Tista ’ tapplika daqsxejn pressjoni billi tagħfas biċċa tajjara jew garza fuq il- post ta ’ l- injezzjoni.
If needed, you may cover the injection site with a bandage.
Jekk ikun hemm bżonn tista ’ tgħatti s- sit ta ’ l- injezzjoni b’ faxxa.
European Medicines Agency
Aġenzija Ewropea dwar il- Mediċini
What is Remicade?
X’ inhu Remicade?
Remicade is a vial containing a powder to be made up into a solution for infusion.
Remicade huwa kunjett li fih trab li minnu tiġi magħmula soluzzjoni għall- infużjoni.
It contains the active substance infliximab.
Huwa fih is - sustanza attiva infliximab.
What is Remicade used for?
Għalxiex jintuża Remicade?
Remicade is an anti-inflammatory medicine.
Remicade huwa mediċina anti- infjammatorja.
It is used, most often when other medicines or treatments have failed, in adults with the following diseases: • rheumatoid arthritis (an immune system disease causing inflammation of the joints).
• artrite rewmatojde (marda marbuta mas- sistema immunitarja li tikkaġuna infjammazzjoni tal - ġogi).
Remicade is used with methotrexate (a medicine that acts on the immune system), • Crohn’ s disease (a disease causing inflammation of the digestive tract), when the disease is severe or fistulising(with the formation of fistulae, abnormal passageways between the gut and other organs), • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut), • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine), • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints), • psoriasis (a disease causing red, scaly patches on the skin).
Remicade jintuża ma ’ methotrexate (mediċina li taħdem fuq is- sistema immunitarja), • il- marda ta ’ Crohn (marda li tikkaġuna infjammazzjoni tal- passaġġ diġestiv), meta l- marda tkun qawwija jew tkun qed tiffistulizza (bil- formazzjoni ta ’ fistli, passaġġi anormali bejn l- imsaren u l- organi l- oħra), • kolite ulċerattiva (marda li tikkaġuna infjammazzjoni u ulċeri fir- rita ta ’ l- imsaren), • spondilite ankilożanti (marda li tikkaġuna infjammazzjoni u uġigħ fil- ġogi tax- xewka tad- dahar), • artrite psorjatika (marda li tikkaġuna rqajja ’ bi qxur ħomor fil- ġilda u infjammazzjoni tal- ġogi), • psorjasi (marda li tikkaġuna rqajja ’ bi qxur ħomor fuq il- ġilda).
See the Summary of Products Characteristics (also part of the EPAR) for full details.
Ara s- Sommarju tal- Karatteristiċi tal- Prodotti (parti wkoll mill- EPAR) għad- dettalji sħaħ.
How is Remicade used?
Kif jintuża Remicade?
Remicade must be given under the supervision and monitoring of a specialised doctor who has experience in the diagnosis and treatment of the diseases Remicade can be used to treat.
Remicade għandu jingħata taħt is- sorveljanza u l- monitoraġġ ta ’ tabib speċjalizzat li għandu esperjenza fid- dijanjosi u t- trattament tal- mard li Remicade jista ’ jittratta.
Remicade is usually given as 3 mg per kilogram bodyweight in rheumatoid arthritis, although the dose can be increased if necessary.
Remicade huwa ġeneralment mogħti bħala 3 mg għal kull kilogramma tal- piż korporju fl- artrite bir- rewmatiżmu, għalkemm id- doża tista ’ tiżdied jekk meħtieġ.
The dose is 5 mg per kilogram for the other diseases.
Id- doża hija 5 mg kull kilogramm għall- mard l- ieħor.
How often the treatment is repeated depends on the disease being treated, and on the patient’ s response to the medicine.
Kemm- il darba jiġi rrepetut it- trattament jiddependi fuq il- marda li tkun qed tiġi ttrattata, u mir- reazzjoni tal- pazjent għall- mediċina.
Remicade is given by intravenous infusion (drip into a vein) over 2 hours.
Remicade jingħata permezz ta ’ infużjoni intravenuża (dripp għal ġol- vina) fuq sagħtejn.
All patients are monitored for any reactions during the infusion and for at least 1 to 2 hours afterwards.
Il- pazjenti kollha huma sorveljati għal kwalunkwe reazzjoni waqt l- infużjoni u għal ta ’ l- anqas siegħa sa sagħtejn wara.
They may be given other medicines before or during treatment with Remicade to reduce the risk of infusion-related reactions.
Huma jistgħu jingħataw mediċini oħra qabel jew waqt it- trattament b’ Remicade biex jitnaqqas ir- riskju ta ’ reazzjonijiet relatati ma ’ l- infużjoni.
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How does Remicade work?
(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 2007 Ir- riproduzzjoni u/ jew id- distribuzzjoni ta ’ dan id- dokument huma awtorizzati għal għanijiet mhux kummerċjali biss dejjem jekk EMEA tkun rikonoxxuta Pazjenti li jieħdu Remicade għandhom jingħataw il- kartuna ta ’ twissija li tiġbor fil- qosor it- tagħrif ta ’ sigurtà dwar il- mediċina.
The active substance in Remicade, infliximab, is a monoclonal antibody.
Is- sustanza attiva f’ Remicade, infliximab, hija antikorp monoklonali.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in the body.
L- antikorp monoklonali huwa antikorp (tip ta ’ proteina) li ġie mfassal biex jagħraf u jorbot ma ’ struttura speċifika (imsejjħa antiġen) li tinstab fil- ġisem.
Infliximab has been designed to bind to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Infliximab ġie mfassal biex jorbot ma ’ messaġġier kimiku fil- ġisem imsejjaħ fattur- alfa tan- nekrożi tat- tumur (TNF- alpha).
By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases.
Billi jimblokka TNF- alpha, infliximab itejjeb l - infjammazzjoni u sintomi oħra tal- mard.
How has Remicade been studied?
Kif ġie studjat Remicade?
Remicade has been studied in a total of 1,432 patients in two studies for the treatment of rheumatoid arthritis.
Remicade ġie studjat f’ total ta ’ 1, 432 pazjent f’ żewġ studji għat- trattament ta ’ artrite tar- rewmatiżmu.
Remicade was given with methotrexate and compared with methotrexate alone.
Remicade ingħata ma ’ methotrexate u ġie mqabbel ma ’ methotrexate waħdu.
The main measure of effectiveness was the improvement in the signs and symptoms of rheumatoid arthritis, joint damage and the patients’ physical function after up to 54 weeks.
Il- kejl ewlieni ta ’ l - effettività kien titjib fis- sinjali u fis- sintomi ta ’ l- artrite tar- rewmatiżmu, ħsara fil- ġogi u l- funzjoni fiżika tal- pazjenti wara, sa żmien 54 ġimgħa.
For Crohn’ s disease, Remicade has been compared with placebo (a dummy treatment) in 1,090 patients in four studies.
F’ erba ’ studji għal marda ta ’ Crohn, Remicade ġie mqabbel ma ’ plaċebo (trattament finta) f’ 1, 090- il pazjent.
The main measures of effectiveness were the improvement in the severity of symptoms or the healing of fistulae.
Il- miżura ewlenija ta ’ l- effettività kienet titjib fil- qawwa tas- sintomi jew il- fejqan tal- fistli.
The studies examined the effects of a single infusion or repeated infusions over up to a year.
L- istudji eżaminaw l- effetti ta ’ infużjoni waħda jew infużjonijiet irrepetuti fuq żmien sa sena.
For ulcerative colitis (728 patients), ankylosing spondylitis (70 patients), psoriatic arthritis (104 patients) and psoriasis (378 patients), Remicade has been compared with placebo.
Remicade ġie mqabbel ma ’ plaċebo għal, kolité ulċerattiva (728- il pazjent), spondilité ankilożanti (70 - il pazjent), artrité psorjatika (104 pazjenti) u psorjasi (378- il pazjent).
In all studies, the main measure of effectiveness was the change in symptoms after 8 to 16 weeks.
Fl- istudji kollha, il- miżura ewlenija ta ’ l- effettività kienet bidla fis- sintomi wara 8 sa 16- il ġimgħa.
What benefit has Remicade shown during the studies?
X’ benefiċċju wera Remicade waqt l- istudji?
Remicade was more effective than comparator medicines in all studies In both studies of rheumatoid arthritis, more patients taking Remicade in combination with methotrexate showed a 20% reduction in symptoms than those taking methotrexate alone.
Fiż- żewġ studji ta ’ artrite rewmatojde, aktar pazjenti li kienu qed jieħdu Remicade f’ kumbinazzjoni ma ’ methotrexate urew tnaqqis ta ’ 20% fis- sintomi milli dawk li kienu qed jieħdu methotrexate waħdu.
They also experienced less damage to the joints and greater improvements in physical function.
Huma esperjenzaw ukoll anqas ħsara fil- ġogi u titjib akbar fil- funzjoni fiżika.
In patients with active Crohn’ s disease, Remicade produced a greater improvement in symptoms at 4 weeks after a single infusion (65% and 17%, respectively), as well as at 30 weeks after the start of a series of infusions.
F’ pazjenti bil- marda ta ’ Crohn attiva, Remicade ikkaġuna titjib akbar fir- 4 ġimgħa wara infużjoni waħda (65% u 17%, rispettivament), kif ukoll fit- 30 ġimgħa wara l- bidu ta ’ serje ta ’ infużjonijiet.
More patients with fistulising disease also had a 50% reduction in the number of fistulae up to 26 weeks after a single infusion of Remicade than placebo (62% and 26%).
Aktar pazjenti b’ mard fistulizzanti kellhom ukoll tnaqqis ta ’ 50% fl- għadd ta ’ fistli sa 26 ġimgħa wara infużjoni waħda ta ’ Remicade milli bi plaċebo (62% u 26%).
Patients receiving a series of infusions of Remicade also maintained a response to treatment for longer (40 weeks) than those receiving placebo (14 weeks).
Pazjenti li ngħataw serje ta ’ infużjonijiet ta ’ Remicade wkoll żammew reazzjoni għat- trattament għal żmien itwal (40 ġimgħa) milli dawk li ngħataw plaċebo (14- il ġimgħa).
In all other diseases studied, Remicade produced a greater improvement in symptoms than placebo.
Fil- mard l- ieħor kollu studjat, Remicade ġab titjib akbar fis- sintomi milli ġab plaċebo.
What is the risk associated with Remicade?
X’ inhu r- riskju assoċjat ma ’ Remicade?
Most side effects seen in patients taking Remicade are related to the infusion and not to the medicine itself, including dyspnoea (breathlessness), urticaria (itchy rash) and headache.
Il- parti l- kbira ta ’ l- effetti sekondarji li dehru f’ pazjenti li qed jieħdu Remicade huma relatati ma ’ l- infużjoni u mhux mal- mediċina nifisha, inkluż dispneja (qtugħ ta ’ nifs), urtikarja (raxx bil- ħakk) u uġigħ ta ’ ras.
Some patients can experience anaphylactic shock (a severe allergic reaction) during infusion, or delayed hypersensitivity (allergic reaction after the first exposure to the medicine).
Xi pazjenti esperjenzaw xokk anafilattiku (reazzjoni allerġika qawwija) waqt l- infużjoni, jew reazzjoni ta ’ sensittività eċċessiva (reazzjoni allerġika wara l- ewwel espożizzjoni għall- mediċina).
Patients experiencing these symptoms should have their infusion slowed down or treatment interrupted.
Pazjenti li esperjenzaw dawn is- sintomi għandu jkollhom l- infużjoni tagħhom mogħtija aktar bil- mod jew inkella, it- trattament għandu jitwaqqaf.
The most common side effects (seen in between 1 and 10 patients in 100) are viral infection (such as influenza [flu] or herpes), serum sickness-like reactions (including skin rash, joint pain or fever), headache, vertigo (dizziness), flushing, upper respiratory tract infection (colds), lower respiratory tract infection (such as bronchitis or pneumonia), dyspnoea, sinusitis (inflammation of the sinuses), nausea (feeling sick), diarrhoea, abdominal (tummy) pain, dyspepsia (heartburn), rash, pruritus (itching), urticaria (itchy rash), increased sweating, dry skin, fatigue (tiredness), chest pain, fever and elevated liver enzymes in the blood.
L- aktar effetti sekondarji komuni (li dehru f’ madwar 1 u 10 pazjenti f’ 100) huma infezzjoni virali (bħal ma hija influwenza [flu] jew ħerpes), reazzjonijiet tax- xorta tal- marda tas- serum (inkluż raxx fil- ġilda, uġigħ fil- ġogi jew deni), uġigħ ta ’ ras, vertiġini (sturdamenti), fwawar, infezzjonijiet fil- parti ta ’ fuq ta ’ l- apparat respiratorju (irjiħat), infezzjonijiet fil- parti ta ’ isfel ta ’ l- apparat respiratorju (bħal ma huma bronkite jew pnewmonja), dispneja, sinusite (infjammazzjoni tas- sinus), nawsja (dardir), dijarrea, uġigħ addominali (ta ’ żaqq), dispepsja (ħruq ta ’ stonku), raxx, prurite (ħakk), urtikarja (raxx bil- ħakk), żieda fl- għaraq, ġilda xotta, għeja kbira, uġigħ fis- sider, deni u livell għoli ta ’ enzimi tal- fwied fid- demm.
For the full list of all side effects reported with Remicade, see the Package Leaflet.
Għal- lista sħiħa ta ’ l - effetti sekondarji kollha rrapportati b’ Remicade, ara l- Fuljett ta ’ Tagħrif.
Remicade should not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Remicade.
Remicade m’ għandux jintuża f’ pazjenti li fil- passat esperjenzaw sensittività eċċessiva (allerġija) għal infliximab, jew li huma sensittivi (allerġiċi) b’ mod eċċessiv għal proteini tal- ġrieden jew għal kwalunkwe sustanza oħra ta ’ Remicade.
Remicade should not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure.
Remicade m’ għandux jintuża f’ pazjenti bit- tuberkulosi, infezzjonijiet serji oħra, jew mard tal- qalb moderat jew serju.
Why has Remicade been approved?
Għaliex ġie approvat Remicade?
to or cannot take other treatments.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Remicade jisbqu r- riskji tiegħu għat- trattament ta ’ l- artrite b’ rewmatiżmu, il- marda ta ’ Crohn, kolite ulċerattiva, spondilite ankilożanti, artrite psorjatika u psorjasi f’ pazjenti li ma wieġbux b’ mod adegwat għal jew li ma jistgħux jieħdu trattamenti oħra.
The committee recommended that Remicade be given marketing authorisation.
Il- kumitat irrikmanda li Remicade jingħata awtorizzazzjoni ta ’ tqegħid fis- suq.
Remicade was originally authorised under “ Exceptional Circumstances”, because, for scientific reasons, limited information was available at the time of the approval.
Oriġinarjament, Remicade kien awtorizzat taħt “ Ċirkustanzi ta ’ Eċċezzjoni ”, minħabba, li għal raġunijet xjentifiċi, kien hemm ftit tagħrif fil- ħin ta ’ l- approvazzjoni.
As the company had submitted the additional information requested, the “ Exceptional Circumstances ” ended on 8 March 2004.
Minħabba li li l- kumpanija ippreżentat it- tagħrif addizzjonali mitlub, iċ - “ Ċirkustanzi ta ’ Eċċezzjoni ” intemmu fit- 8 ta ’ Marzu 2004.
Other information about Remicade:
Informazzjoni oħra dwar Remicade:
The European Commission granted a marketing authorisation valid throughout the European Union for Remicade to Centocor B. V. on 13 August 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Remicade lil Centocor B. V. nhar it- 13 t’ Awissu 1999.
The marketing authorisation was renewed on 13 August 2004.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fit- 13 ta ’ Awissu 2004.
The full EPAR for Remicade can be found here.
L- EPAR sħiħ dwar Remicade jista ’ jinstab hawnhekk.
EU Number EU/ 1/ 99/ 116/ 001 EU/ 1/ 99/ 116/ 002 EU/ 1/ 99/ 116/ 003 EU/ 1/ 99/ 116/ 004 EU/ 1/ 99/ 116/ 005
Numru ta ’ l- EU EU/ 1/ 99/ 116/ 001 EU/ 1/ 99/ 116/ 002 EU/ 1/ 99/ 116/ 003 EU/ 1/ 99/ 116/ 004 EU/ 1/ 99/ 116/ 005
Invented name Remicade Remicade Remicade Remicade Remicade
Isem inventat Remicade Remicade Remicade Remicade Remicade
Strength 100 mg 100 mg 100 mg 100 mg 100 mg
Qawwa 100 mg 100 mg 100 mg 100 mg 100 mg
Pharmaceutical Form Powder for concentrate for solution for infusion Powder for concentrate for solution for infusion Powder for concentrate for solution for infusion Powder for concentrate for solution for infusion Powder for concentrate for solution for infusion
Għamla farmaċewtika Trab għal konċentrat għal soluzzjoni għall- infużjoni Trab għal konċentrat għal soluzzjoni għall- infużjoni Trab għal konċentrat għal soluzzjoni għall- infużjoni Trab għal konċentrat għal soluzzjoni għall- infużjoni Trab għal konċentrat għal soluzzjoni għall- infużjoni
Route of Administration Intravenous use Intravenous use Intravenous use Intravenous use Intravenous use
Mnejn jingħata Użu għal ġol- vina Użu għal ġol- vina Użu għal ġol- vina Użu għal ġol- vina Użu għal ġol- vina
Packaging vial (glass) vial (glass) vial (glass) vial (glass) vial (glass)
Il- pakkett Kunjett (ħġieġ) Kunjett (ħġieġ) Kunjett (ħġieġ) Kunjett (ħġieġ) Kunjett (ħġieġ)
Package size 1 vial 2 vials 3 vials 4 vials 5 vials
Daqs tal- pakkett Kunjett 1 2 kunjetti 3 kunjetti 4 kunjetti 5 kunjetti
ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
ANNESS KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU FIS- SEĦĦ MILL- ISTATI MEMBRI.
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU INDIRIZZATI MILL- ISTATI MEMBRI.
The Member States should ensure that the MAH provides an educational programme for Remicade to ensure that physicians who intend to prescribe Remicade to paediatric Crohn’ s disease patients are aware of:
L- Istati Membri għandhom jaċċertaw rwieħhom li l- MAH jipprovdi programm edukattiv għal Remicade sabiex jiżgura li t- tobba li jkun bi ħsiebhom jordnaw Remicade lill- pazjenti tfal bil- marda ta ’ Crohn ikunu jafu:
• The risk of opportunistic infections and tuberculosis (TB) in patients treated with Remicade.
• Bir- riskju ta ’ infezzjonijiet opportunistiċi u tuberkulożi (TB) f’ pazjenti ikkurati b’ Remicade.
• The need to assess the risk of TB in patients prior to treating with Remicade.
• Il- bżonn li jiġi evalwat ir- riskju ta ’ TB fil- pazjenti qabel tingħata l- kura b’ Remicade.
• The risk of acute infusion related reactions and delayed hypersensitivity reactions.
• Ir- riskju ta ’ reazzjonijiet akuti relatati ma ’ l- infużjoni u reazzjonijiet ta ’ sensittività eċċessiva ritardati.
• The risk of lymphoma and other malignancies.
• Ir- riskju ta ’ limfoma u tumuri oħrajn.
• The patient alert card, which is to be given to patients using Remicade.
• Il- kartuna ta ’ l- Avviż tal- pazjent, li għandha tingħata lill- pazjenti li jkunu qed jużaw Remicade.
• That children may be at increased risk of developing infections and the need for immunisations to be up to date.
• Li t- tfal jista ’ jkollhom riskju akbar li jiżviluppaw infezzjonijiet u l- ħtieġa li t- tilqim li kellhom jieħdu ħaduhom.
Remicade 100 mg powder for concentrate for solution for infusion.
Remicade 100 mg trab għal konċentrat li jinħall f’ likwidu għall- infużjoni.
Each vial contains 100 mg of infliximab.
Kull kunjett fih 100 mg ta ’ infliximab.
Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced by recombinant DNA technology.
Infliximab huwa antikorp monoklonali IgG1 kimeriku tal - bniedem- ġurdien magħmul b’ teknoloġija ta ’ DNA rikombinat.
After reconstitution each ml contains 10 mg of infliximab.
Wara r- rikostituzzjoni, kull millilitru jkun fih 10 mg ta ’ infliximab.
Powder for concentrate for solution for infusion.
Trab konċentrat li jinħall f’ likwidu għall- infużjoni.
The powder is a freeze-dried white pellet.
It- trab huwa pellit bajda mnixfa bil- friża.
Rheumatoid arthritis:
Sintomi ta ’ l- artrite rewmatika:
Remicade, in combination with methotrexate, is indicated for: the reduction of signs and symptoms as well as the improvement in physical function in: • patients with active disease when the response to disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate. • patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
Remicade, flimkien ma ’ methotrexate, huwa indikat għal: tnaqqis fis- sinjali u s- sintomi kif ukoll għat- titjib fil- funzjoni fiżika: • f’ pazjenti b’ marda attiva meta r- rispons għal mediċini kontra r- rewmatiżmu li jbiddlu l- mard (DMARDs), inkluż methotrexate, ma jkunx adegwat. • f’ pazjenti b’ mard sever, attiv u li qed javanza li ma kienx ikkurat qabel b’ methotrexate jew DMARD’ s oħrajn.
In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated (see section 5.1).
F’ dawn il- popolazzjonijiet ta ’ pazjenti, intwera tnaqqis fir- rata ta ’ avvanz tal- ħsara fil- ġogi, hekk kif imkejla permezz ta ’ X- ray, (ara sezzjoni 5. 1).
Adult Crohn’ s disease:
Marda ta ’ Crohn fl- adulti:
Remicade is indicated for: • treatment of severe, active Crohn’ s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/ or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. • treatment of fistulising, active Crohn’ s disease, in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Remicade huwa indikat għal: • Trattament tal- marda ta ’ Crohn attiva u severa, f’ pazjenti li ma kellhomx rispons minkejja kors sħiħ u adegwat ta ’ terapija b ’ kortikosterojdi u/ jew immunosoppressiv; jew li ma jittollerawx jew ma jistgħux jingħataw dawn it- terapiji għal raġunijiet mediċi. • Trattament tal- marda ta ’ Crohn attiva meta tkun fistulizzanti, f’ pazjenti li ma kellhomx rispons minkejja kors sħiħ u adegwat ta ’ terapija bi trattament konvenzjonali (li jinkludi antibijotiċi, drenaġġ u terapija immunosoppressiva).
Paediatric Crohn’ s disease:
Marda ta ’ Crohn fit- tfal:
Remicade is indicated for:
Remicade jintuża għal:
Treatment of severe, active Crohn’ s disease, in paediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Kura tal- marda ta ’ Crohn attiva, severa, f’ pazjenti tfal ta ’ etajiet bejn 6 sa 17- il sena, li ma kellhomx rispons għat- terapija konvenzjonali inklużi kortikosterojd, immunomodulatur u terapija ta ’ nutrizzjoni primarja, jew li ma jifilħux jew għandhom kontra- indikazzjonijiet għal dawn it- tipi ta ’ terapiji.
Remicade has been studied only in combination with conventional immunosuppressive therapy.
Remicade ġie studjat biss f’ kombinazzjoni ma ’ terapija konvenzjonali immunosoppressiva.
Ulcerative colitis:
Infjammazzjoni ta ’ L- imsaren:
Remicade is indicated for:
Remicade huwa indikat għal:
Treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Trattament ta ’ infjammazzjoni ta ’ l- imsaren moderata għal attiva b’ mod sever f’ pazjenti li ma kellhomx rispons xieraq għat- terapija konvenzjonali, inkluż kortikosterojdi u 6- MP jew AZA, jew li ma jifilħux jew għandhom kontra- indikazzjonijiet mediċi għal terapiji bħal dawn.
2 Ankylosing spondylitis:
2 Ankylosing spondylitis:
Treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Trattament ta ’ ankylosing spondylitis attiva, severa, f’ pazjenti adulti li ma kellhomx rispons xieraq għal terapija konvenzjonali.
Psoriatic arthritis:
Artrite bi psorajiżi:
Treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate.
Trattament ta ’ artrite bi psorajiżi attiva u li tkun qed tavvanza f’ adulti meta r- rispons għal terapija DMARD ma jkunx xieraq.
Remicade should be administered
Remicade għandu jingħata:
- or alone in patients who show intolerance to methotrexate or for whom methotrexate is
flimkien ma ’ methotrexate jew waħdu f’ pazjenti li ma jkunux jittolleraw methotrexate jew li għalihom methotrexate
contraindicated Remicade has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1).
Remicade intwera li jtejjeb il- funzjoni fiżika f’ pazjenti b’ artrite bi psorajiżi, u li jnaqqas ir- rata li bih tavvanza l- ħsara periferali fil- ġogi hekk kif imkejla bl- X- ray f’ pazjenti b’ sottotipi poliartikulari simmetriċi tal- marda (ara Sezzjoni 5. 1).
Psoriasis:
Psorajiżi:
Treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA (see section 5.1).
Trattament għal psorakiżi bi plakka moderata għal severa f’ adulti li ma jkunux urew rispons għal, jew li huma kontra- indikati għal, jew li ma jifilħux terapija sistemika li tinkludi cyclosporine, methotrexate jew PUVA (ara sezzjoni 5. 1).
Remicade treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Il- kura b’ Remicade għandha tibda u tkun imħarsa minn tobba kwalifikati b’ esperjenza tad- dijanjosi u l- kura ta ’ artrite rewmatika, mard ta ’ infjammazzjoni ta ’ l- imsaren, ankylosing spondylitis, artrite bi psorajiżi jew psorajiżi.
Remicade infusions should be administered by qualified healthcare professionals trained to detect any infusion related issues.
Infużjonijiet b’ Remicade għandhom jingħataw minn professjonist fil- qasam tal- kura tas- saħħa mistħarrġa sabiex ikunu kapaċi jgħarfu kwalunkwe problema relatata ma ’ l - infużjoni.
Patients treated with Remicade should be given the package leaflet and the special Alert card.
Pazjenti kkurati b’ Remicade għandhom jingħataw il- fuljett ta ’ tagħrif u l- biljett ta ’ Avviż tal- pazjent.
Remicade is indicated for intravenous use in adults (≥ 18 years) across all approved indications and in paediatric patients, aged 6 to 17 years, with Crohn’ s disease (see section 5.1).
Remicade huwa indikat biex jintuża għal ġol- vina fl- adulti (≥ 18- il sena) għall- indikazzjonijiet appruvati kollha u għal pazjenti tfal, ta ’ etajiet minn 6 sa 17- il sena, bil- marda ta ’ Crohn (ara sezzjoni 5. 1).
Due to insufficient data on safety and efficacy, Remicade is not recommended for use in any other paediatric indication (for juvenile rheumatoid arthritis, see section 4.8).
Minħabba li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja, Remicade mhux irrikkmandat għall- ebda użu ieħor fit- tfal (għall- artrite rewmatika taż- żgħożija, ara sezzjoni 4. 8).
The recommended infusion duration for patients with each indication is described below under the respective indication.
Il- ħinijiet ta ’ l- infużjoni rakkomandati għal pazjenti b’ kull indikazzjoni qed tingħata hawn taħt skond l- indikazzjoni rispettiva..
All patients administered Remicade are to be observed for at least 1-2 hours post infusion for acute infusion-related reactions.
Il- pazjenti kollha li jingħataw Remicade għandhom ikunu osservati għal mill- anqas siegħa jew sagħtejn wara l- infużjoni għal reazzjonijiet akuti relatati ma ’ l- infużjoni.
Emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway must be available.
Tagħmir ta ’ l- emerġenza, bħal adrenaline, anti- istaminiċi, kortikosterojdi u tratt tan- nifs / l- arja artifiċjali għandhom ikunu disponibbli.
Patients may be pre-treated with e. g., an antihistamine, hydrocortisone and/ or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion related reactions especially if infusion-related reactions have occurred previously (see section 4.4).
Pazjenti jistgħu jingħataw kura minn qabel, eż. b’ anti - istamina, hydrocortisone u/ jew paracetamol u r- rata ta ’ l- infużjoni tista ’ titnaqqas biex jonqos ir- riskju ta ’ reazzjonijiet relatati ma ’ l- infużjoni, iktar u iktar jekk reazzjonijiet relatati ma ’ l- infużjoni seħħew qabel (ara sezzjoni 4. 4).
During Remicade treatment, other concomitant therapies, e. g., corticosteroids and immunosuppressants should be optimised.
Waqt it- trattament b ’ Remicade, għandu jsir l- aħjar użu ta ’ terapiji oħra li qed jingħataw fl- istess waqt, eż. kortikosterojdi u immunosoppressivi,
For preparation and administration instructions, see section 6.6.
Għall- istruzzjonijiet ta ’ kif jiġi ppreparat u jingħata, ara sezzjoni 6. 6.
3 Adults (≥ 18 years)
Adulti (≥18- il sena)
Rheumatoid arthritis Patients not previously treated with Remicade:
Sintomi ta ’ l- artrite rewmatika Pazjenti li ma kienux trattati qabel:
3 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 3 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
3 mg/ kg mogħtija bħala infużjoni ġol- vina għal perijodu ta ’ sagħtejn, imbagħad infużjonijiet ta ’ dożi oħra ta ’ 3 mg/ kg ma ’ ġimgħatejn u 6 ġimgħat wara l- ewwel infużjoni, imbagħad wara kull 8 ġimgħat.
In carefully selected patients with rheumatoid arthritis who have tolerated 3 initial 2-hour infusions of Remicade, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
3 F’ pazjenti mgħażulin b’ kawtela b’ artrite rewmatika li kienu jifilħu għall- ewwel 3 infużjonijiet ta ’ sagħtejn b’ Remicade, jista ’ jkun ikkonsidrat l- għotja ta ’ l- infużjonijiet li jkun imiss fuq perijodu ta ’ mhux anqas minn siegħa.
Shortened infusions at doses > 6 mg/ kg have not been studied.
Dożi ta ’ l- infużjoni imnaqqsa għal > 6 mg/ kg ma kienux studjati.
Remicade must be given concomitantly with methotrexate.
Remicade għandu jingħata flimkien ma ’ methotrexate.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
It- tagħrif disponibbli jissuġġerixxi li r- rispons kliniku ssoltu jseħħ sat- tnax- il ġimgħa tat- trattament.
If a patient has an inadequate response or loses response after this period, consideration may be given to increase the dose step-wise by approximately 1.5 mg/ kg, up to a maximum of 7.5 mg/ kg every 8 weeks.
Jekk pazjent ma jkollux rispons xieraq jew juri tnaqqis fir- rispons wara dan il- perijodu, jista ’ jkun ikkonsidrat li tiżdiedlu d- doża bil- mod il- mod b’ madwar 1. 5 mg/ kg, sa massimu ta ’ 7. 5 mg/ kg kull 8 ġimgħat.
Alternatively, administration of 3 mg/ kg as often as every 4 weeks may be considered.
Inkella, jista ’ jkun ikkonsidrat li jingħataw 3 mg/ kg għal mhux aktar spiss minn kull 4 ġimgħat.
If adequate response is achieved, patients should be continued on the selected dose or dose frequency.
Jekk jinkiseb rispons xieraq, il- pazjenti għandhom jitkomplew fuq id- doża magħżula jew frekwenza ta ’ doża.
Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment or after dose adjustment.
Wieħed għandu jerġa jqis sewwa mill- ġdid jekk għandhiex titkompla t- terapija f’ pazjenti li ma wrew l- ebda sinjal ta ’ benefiċċju terapewtiku fl- ewwel tnax- il ġimgħa ta ’ trattament wara li tkun inbidlet id- doża..
Severe, active Crohn’ s disease 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by an additional 5 mg/ kg infusion 2 weeks after the first infusion.
Il- marda ta ’ Crohn attiva u severa mg/ kg mogħtija bħala infużjoni għal ġol- vina fuq perijodu ta ’ sagħtejn segwita b’ infużjoni oħra ta ’ 5 mg/ kg ġimgħatejn wara l- ewwel infużjoni.
If a patient does not respond after 2 doses, no additional treatment with infliximab should be given.
Jekk il- pazjent ma jkollux rispons wara 2 dożi, m’ għandhiex tingħata aktar kura b’ infliximab.
Available data do not support further infliximab treatment, in patients not responding within 6 weeks of the initial infusion.
Tagħrif disponibbli mhuwiex favur li jitkompla t - trattament b’ infliximab f’ pazjenti li ma jurux rispons fi żmien 6 ġimgħat mill- ewwel infużjoni.
In responding patients, the alternative strategies for continued treatment are: • Maintenance:
F’ pazjenti li juru rispons, l- għażliet ta ’ kif għandu jitkompla t- trattament huma: • Manteniment:
Additional infusion of 5 mg/ kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or • Re-administration:
Infużjonijiet oħra ta ’ 5 mg/ kg sitt ġimgħat wara l- ewwel doża, mbagħad infużjonijiet kull 8 ġimgħat jew • Jingħata mill- ġdid:
Infusion of 5 mg/ kg if signs and symptoms of the disease recur (see ‘ Re- administration’ below and section 4.4).
Infużjoni ta ’ 5 mg/ kg jekk is- sinjali u s- sintomi tal- marda jerġgħu jitfaċċaw (ara ‘ Jingħata mill- ġdid ’ hawn taħt u sezzjoni 4. 4).
Although comparative data are lacking, limited data in patients who initially responded to 5 mg/ kg but who lost response indicate that some patients may regain response with dose escalation (see section 5.1).
Għalkemm dejta ta ’ tqabbil huma neqsin, dejta limitata f’ pazjenti li fil- bidu kellhom rispons għal 5 mg/ kg iżda tilfu r- rispons tindika li xi pazjenti jistgħu jiksbu mill- ġdid ir- rispons b’ żieda gradwali tad- doża (ara sezzjoni 5. 1).
Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.
It- tkomplija tal- kura għandha terġa ’ titqies bil- kawtela f’ pazjenti li ma juru l- ebda indikazzjoni ta ’ benefiċċju wara li tiġi aġġustata d- doża.
Fistulising, active Crohn’ s disease 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusions at 2 and 6 weeks after the first infusion.
Il- marda ta ’ Crohn attiva u fistulizzanti 5 mg/ kg mogħtija bħala infużjoni minn ġol- vina fuq perijodu ta ’ sagħtejn għandha tissokta b' infużjonijiet oħra ta ’ 5 mg/ kg ġimgħatejn u sitt ġimgħat wara l- ewwel infużjoni.
If a patient does not respond after 3 doses, no additional treatment with infliximab should be given.
Jekk il- pazjent ma jurix rispons wara dawn l- ewwel tliet dożi, m’ għandux jingħata iktar trattament b’ infliximab.
In responding patients, the alternative strategies for continued treatment are: • Maintenance:
F’ pazjenti li juru rispons, l- għażliet alternattivi ta ’ kif għandu jitkompla t- trattament huma: • Manteniment:
Additional infusions of 5 mg/ kg every 8 weeks or • Re-administration:
Infużjonijiet oħra ta ’ 5 mg/ kg kull 8 ġimgħat jew • Jingħata mill- ġdid:
Infusion of 5 mg/ kg if signs and symptoms of the disease recur followed by infusions of 5 mg/ kg every 8 weeks (see ‘ Re-administration’ below and section 4.4).
Infużjoni ta ’ 5 mg/ kg jekk is- sinjali u s- sintomi tal- marda jerġgħu jitfaċċaw, imbagħad infużjonijiet ta ’ 5 mg/ kg kull 8 ġimgħat (ara ‘ Jingħata mill- ġdid’ hawn taħt u sezzjoni 4. 4)
In Crohn’ s disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/ risk of the alternative strategies for continued treatment are lacking.
Fil- marda ta ’ Crohn, l- esperjenza meta l- mediċina terġa tingħata mill- ġdid jekk is- sinjali u s- sintomi jerġgħu jitfaċċaw hija limitata u hemm nuqqas ta ’ dejta komparattivi dwar il- benefiċċji u r- riskji tal - modi alternattivi ta ’ kif titkompla t- terapija.
4 Ulcerative colitis 5 mg/ kg given as an intravenous infusion over a 2 hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Infjammazzjoni ta ’ l- imsaren 5 mg/ kg mogħtija bħala infużjoni għal ġol- vina fuq perijodu ta ’ sagħtejn segwit b’ infużjonijiet oħra ta ’ dożi ta ’ 5 mg/ kg ma ’ ġimgħatejn u 6 ġimgħat wara l- ewwel infużjoni, imbagħad minn hemm ’ l quddiem kull 8 ġimgħat.
Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i. e. three doses.
4 Tagħrif disponibbli jindika li r- rispons kliniku normalment jinkiseb fi żmien l- 14- il ġimgħa tat - trattament, i. e. tliet dożi.
Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.
It- tkomplija tat- terapija għandha terġa tiġi kkonsidrata mill- ġdid f’ dawk il - pazjenti li ma juru l- ebda benefiċċju terapewtiku f’ dan il- perijodu ta ’ żmien.
Ankylosing spondylitis 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks.
Ankylosing spondylitis 5 mg/ kg mogħtija bħala infużjoni ġol- vina fuq perijodu ta ’ sagħtejn, segwit b’ infużjonijiet oħra ta’ dożi ta ’ 5 mg/ kg ma ’ ġimgħatejn u 6 ġimgħat wara l- ewwel infużjoni, imbagħad minn kull 6 sa 8 ġimgħat.
If a patient does not respond by 6 weeks (i. e. after 2 doses), no additional treatment with infliximab should be given.
Jekk pazjent ma jurix rispons mas- 6 ġimgħa (i. e. wara 2 dożi), it- trattament b’ infliximab m’ għandux jitkompla.
Psoriatic arthritis 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Artrite bi psorajiżi 5 mg/ kg mogħtija bħala infużjoni għal ġol- vina fuq perijodu ta ’ sagħtejn segwit b’ infużjonijiet oħra ta ’ dożi ta ’ 5 mg/ kg ma ’ ġimgħatejn u 6 ġimgħat wara l- ewwel infużjoni, imbagħad minn hemm ’ l quddiem kull 8 ġimgħat.
Psoriasis 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Psorajiżi 5 mg/ kg mogħtija bħala infużjoni għal ġol- vina fuq perijodu ta ’ sagħtejn segwit b’ infużjonijiet oħra ta ’ dożi ta ’ 5 mg/ kg ma ’ ġimgħatejn u ma ’ 6 ġimgħat wara l- ewwel infużjoni, imbagħad minn hemm ’ l quddiem kull 8 ġimgħat.
If a patient shows no response after 14 weeks (i. e. after 4 doses), no additional treatment with infliximab should be given.
Jekk pazjent ma juri l- ebda rispons wara 14- il ġimgħa (i. e. wara 4 dożi), m’ għandux jingħata aktar kura b’ infliximab.
Re-administration for Crohn’ s disease and rheumatoid arthritis If the signs and symptoms of disease recur, Remicade can be re-administered within 16 weeks following the last infusion.
L- għotja mill- ġdid għall- marda ta ’ Crohn u l- artrite rewmatika Jekk is- sinjali u s- sintomi tal- marda jerġgħu jitfaċċaw, Remicade jista ’ jerġa ’ jingħata sa 16- il ġimgħa wara l- aħħar infużjoni.
In clinical studies, delayed hypersensitivity reactions have been uncommon and have occurred after Remicade-free intervals of less than 1 year (see section 4.4 and 4.8: delayed hypersensitivity).
Sensittività eċċessiva ittardjata).
The safety and efficacy of re-administration after a Remicade-free interval of more than 16 weeks has not been established.
Is- sigurtà u l- effikaċja ta ’ meta jerġa ’ jingħata wara intervall mingħajr Remicade ta ’ 16- il ġimgħa ma kienux stabbiliti.
This applies to both Crohn’ s disease patients and rheumatoid arthritis patients.
Dan japplika kemm għall- pazjenti bil- marda ta ’ Crohn kif ukoll għall- pazjenti bl- artrite rewmatika.
Re-administration for ulcerative colitis The safety and efficacy of re-administration, other than every 8 weeks, has not been established.
L- għotja mill- ġdid għall- infjammazzjoni ta ’ l- imsaren Is- sigurtà u l- effikaċja ta ’ l- għotja mill- ġdid, ħlief meta tingħata kull 8 ġimgħat, ma kienux stabbiliti.
Re-administration for ankylosing spondylitis The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established.
L- għotja mill- ġdid għal ankylosing spondylitis Is- sigurtà u l- effikaċja ta ’ l- għotja mill- ġdid, ħlief meta tingħata kull 6 sa 8 ġimgħat, ma kienux stabbiliti..
Re-administration for psoriatic arthritis The safety and efficacy of re-administration, other than every 8 weeks, has not been established.
L- għotja mill- ġdid għal artrite bi psorajiżi Is- sigurtà u l- effikaċja ta ’ l- għotja mill- ġdid, ħlief meta tingħata kull 8 ġimgħat, ma kienux stabbiliti.
Re-administration for psoriasis Limited experience from re-treatment with one single Remicade dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1).
L- għotja mill- ġdid għal psorajiżi Esperjenza limitata bl- għotja mill- ġdid ta ’ doża waħda ta ’ Remicade għal psorajiżi wara intervall ta ’ 20 ġimgħa jindika tnaqqis fl- effikaċja u żieda f’ reazzjonijiet għall- infużjoni ħfief għal moderati meta mqabbla mal- kors tal- bidu (ara sezzjoni 5. 1).
Crohn’ s disease (6 to 17 years) 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Marda ta ’ Crohn (6 sa 17- il sena) 5 mg/ kg mogħtija bħala infużjoni għal ġol- vini fuq perijodu ta ’ sagħtejn segwit b’ dożi ta ’ infużjoni oħrajn ta ’ 5 mg/ kg ma ’ 2 u 6 ġimgħat wara l- ewwel infużjoni, imbagħad kull 8 ġimgħat minn hemm ’ l quddiem.
Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient.
Ċerti pazjenti jistgħu jeħtieġu intervall ta ’ bejn id- dożi iqsar sabiex jinżamm benefiċċju kliniku, filwaqt li għal oħrajn, interval ta ’ bejn id- dożi itwal jista ’ jkun biżżejjed.
Available data do not support further infliximab treatment in paediatric patients not responding within the first 10 weeks of treatment.
Tagħrif disponibbli ma jindikax li jkun jaqbel li titkompla l- kura b’ infliximab f’ pazjenti tfal li ma jkollhomx rispons fl - ewwel 10 ġimgħat ta ’ kura.
5 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
Patients with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections (see section 4.4).
Pazjenti b’ tuberkulożi jew infezzjonijiet oħra qawwija bħal sepsis, qrada u infezzjonijiet opportunistiċi
Patients with moderate or severe heart failure (NYHA class III/ IV) (see sections 4.4 and 4.8).
Pazjenti b’ insuffiċjenza tal- qalb moderata jew serja ħafna (NYHA klassi III/ IV) (ara sezzjonijiet 4. 4 u 4. 8).
Patients with a history of hypersensitivity to infliximab (see section 4.8), to other murine proteins, or to any of the excipients.
Pazjenti li fil- passat kellhom sensittività eċċessiva għal infliximab (ara sezzjoni 4. 8), għall- proteini oħra li joriġinaw mill- ġrieden, jew għal xi wieħed mis- sustanzi mhux attivi.
Infusion reactions and hypersensitivity Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Reazzjonijiet ta ’ l- infużjoni u sensittività eċċessiva Infliximab kien assoċjat ma ’ reazzjonijiet akuti relatati ma ’ l- infużjoni li jinkludu xokk anafilattiku u reazzjoni ta ’ sensittività eċċessiva ittardjata (ara sezzjoni 4. 8).
Acute infusion reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following infusion.
Reazzjonijiet akuti ta ’ l- infużjoni jinkludu reazzjonijiet anafilattiċi li jistgħu jiżviluppaw waqt (f’ sekondi) jew ftit sigħat wara l- infużjoni.
If acute infusion reactions occur, the infusion must be interrupted immediately.
Jekk reazzjonijiet akuti ta ’ l- infużjoni jseħħu, l- infużjoni għandha titwaqqaf mill- ewwel.
Emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway must be available.
Tagħmir ta ’ l- emerġenza, bħal adrenaline, anti- istaminiċi, kortikosterojdi u tratt ta ’ l- arja / tan- nifs artifiċjali għandhom ikunu disponibbli.
Patients may be pre-treated with e. g., an antihistamine, hydrocortisone and/ or paracetamol to prevent mild and transient effects.
Pazjenti jistgħu jingħataw kura minn qabel, eż. b’ anti- istamina, hydrocortisone u/ jew paracetamol biex ikunu evitati effetti ħfief u għal żmien qasir.
Antibodies to infliximab may develop and have been associated with an increased frequency of infusion reactions.
Antikorpi għal infliximab jistgħu jiżviluppaw u dawn kienu assoċjati ma ’ żieda fir- reazzjonijiet ta ’ l - infużjoni.
A low proportion of the infusion reactions was serious allergic reactions.
Proporzjon żgħir tar- reazzjonijiet ta ’ l- infużjoni kien ta ’ reazzjonijiet allerġiċi serji.
An association between development of antibodies to infliximab and reduced duration of response has also been observed.
Kienet ukoll osservata assoċjazzjoni bejn l- iżvilupp ta ’ antikorpi għal infliximab u tnaqqis fid- dewmien tar - rispons.
Concomitant administration of immunomodulators has been associated with lower incidence of antibodies to infliximab and a reduction in the frequency of infusion reactions.
Meta immunomodulaturi ngħataw fl- istess waqt, iffurmaw anqas antikorpi għal infliximab u r- reazzjonijiet ta ’ l- infużjoni kienu anqas frekwenti.
The effect of concomitant immunomodulator therapy was more profound in episodically treated patients than in patients given maintenance therapy.
L- effett ta ’ terapija b’ immunomodulaturi mogħtija fl- istess waqt kien akbar f’ pazjenti ttrattati b’ mod episodiku milli f’ pazjenti li ngħataw terapija ta ’ manteniment.
Patients who discontinue immunosuppressants prior to or during Remicade treatment are at greater risk of developing these antibodies.
Pazjenti li jwaqqfu l- immunosoppressivi qabel jew waqt it- trattament b ’ Remicade għandhom riskju akbar li jiżviluppaw dawn l- antikorpi.