qanastek/EMEA-V3 huggingface dataset:
Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet Prolonged release tablet
Għamla farmaċewtika Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod s Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod Pilloli li jerħu s- sustanza attiva bil- mod
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Mnejn jingħata Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Bottle (HDPE) Bottle (HDPE) Bottle (HDPE) Bottle (HDPE)
Il- pakkett Folja (Alu/ Alu) Folja (Alu/ Alu) Folja (Alu/ Alu) Folja (Alu/ Alu) Folja (Alu/ Alu) Folja (Alu/ Alu) Folja (Alu/ Alu) Folja (Alu/ Alu) Folja (Alu/ Alu) Folja (Alu/ Alu) Folja (Alu/ Alu) Folja (Alu/ Alu) Flixkun (HDPE) Flixkun (HDPE) Flixkun (HDPE) Flixkun (HDPE)
7 tablets 14 tablets 28 tablets 56 tablets 98 tablets 7 tablets 14 tablets 28 tablets 56 tablets 98 tablets 84 tablets 84 tablets 30 tablets 90 tablets 30 tablets 90 tablets
Daqs tal- pakkett 7 14 28 56 98 7 14 28 56 98 84 84 30 90 30 90
What is Tracleer?
X' inhu Tracleer?
Tracleer is a medicine containing the active substance bosentan.
Tracleer huwa mediċina li fiha s- sustanza attiva bosentan.
125 mg).
Dan jinsab disponibbli bħala pilloli oranġjo u bojod (tondi: 62. 5mg; ovali 125mg).
What is Tracleer used for?
Għalxiex jintuża Tracleer?
Tracleer is used for the treatment of patients with class III pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Tracleer huwa użat għal- kura ta ’ pazjenti li jbagħtu minn pressjoni għolja ta ’ klassi III fl- arterji tal - pulmun (PAH - pulmonary arterial hypertension) sabiex itejjeb is- sintomi u l- kapaċità ta ’ eżerċizzju (l- abilità li twettaq attività fiżika).
PAH is abnormally high blood pressure in the arteries of the lungs.
PAH hija pressjoni għolja iktar min- normal fl- arterji tal- pulmun.
The ‘ class ’ reflects the seriousness of the disease: ‘ class III ’ involves marked limitation of physical activity.
Il - ‘ klassi ’ tirifletti s- serjetà tal- marda – klassi III tinvolvi limitazzjoni immarkata ta ’ l- attività fiżika.
The PAH can be: • primary (not linked to another disease):
Il - pressjoni għolja fil- pulmun (PAH) tista ’ tkun: • primarja (li m’ għandhiex x’ taqsam ma ’ ebda marda oħra).
Tracleer can be used in PAH that has no identified cause or is familial; • caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs); • caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and lungs.
Tracleer jista ’ jintuża fil- PAH li għalija m’ hemm l- ebda kawża identifikata jew tkun ereditarja. • ikkawżata permezz ta ’ skleroderma (msejjħa wkoll sklerożi sistematika, marda fejn hemm żvilupp mhux normali ta ’ tessut konnettiv, li jsostni l- ġilda u organi oħra), • ikkawżata permezz ta ’ difetti konġenitali tal- qalb (preżenti mit- twelid) minħabba f ’ passaġġi mhux anomali (shunts) li jikkawżaw il- fluss anormali tad- demm minn ġol qalb u l- pulmuni.
Some improvements have also been shown in patients with class II PAH. ‘ Class II ’ involves slight limitation of physical activity.
Dehru wkoll xi sinjali ta ’ titjib f’ pazjenti b’ PAH klassi II. ‘ Klassi II tinvolvi limitazzjoni żgħira ta ’ attività fiżika.
Tracleer can also be used in patients with systemic sclerosis in whom poor blood circulation caused by the disease has led to the development of ‘ digital ulcers’ (sores on the fingers and toes).
Tracleer jista ’ jiġi użat ukoll f’ pazjenti bi sklerożi sistematika li minħabba fiċ- ċirkolazzjoni tad- demm batuta ikkawżata mill- marda stess, żviluppaw ‘ ulċeri fuq is- swaba ’ (feriti fuq is- swaba ta ’ l- id u tas - sieq).
Tracleer is intended to reduce the number of new digital ulcers that are formed.
Tracleer huwa hawnhekk intiż sabiex inaqqas in- numru ta ’ ulċeri ġodda li jiġu ffurmati fuq swaba ta ’ l- id u tas- sieq.
Because the numbers of patients with PAH and with systemic sclerosis are low, the diseases are considered ‘ rare’, and Tracleer was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 14 February 2001 and on 17 March 2003.
Billi l- għadd ta ’ pazjenti li jbagħtu minn pressjoni għolja fl- arterji tal- pulmun (PAH) u minn sklerożi sistematika huwa wieħed baxx, dawn it- tip ta ’ mard huma meqjusa bħala ‘ rari ’, u Tracleer ġie kkategorizzat bħala ‘ mediċina orfni ’ (mediċina użata f’ mard rari) fl- 14 ta ’ Frar 2001 u fis- 17 ta ’ Marzu 2003.
How is Tracleer used?
Kif jintuża Tracleer?
Treatment with Tracleer should only be initiated and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Il- kura bi Tracleer għandha tinbeda u tiġi sorveljata biss minn tabib li għandu esperjenza fil- kura tal - PAH jew sklerożi sistematika.
Tracleer treatment should be started at a dose of 62.5 mg twice a day for four weeks and then increased to the usual dose of 125 mg twice a day.
Il- kura bi Tracleer għandha tinbeda b’ doża ta ’ 62. 5mg darbtejn kuljum għall- erba ’ ġimgħat u mbagħad miżjuda għad- doża normali ta ’ 125mg darbtejn kuljum.
Tablets are taken morning and evening, with or without food.
Il- pilloli għandhom jittieħdu kemm fil- għodu u kemm fil- għaxija, bl- ikel jew mingħajru.
The doctor should assess the patient’ s response to Tracleer and review the need for further treatment after eight weeks in patients with PAH who have not improved, and on a regular basis in patients with systemic sclerosis and ongoing digital ulcer 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
It- tabib għandu jiżen 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
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 - mail: mail@ emea. europa. eu http: // www. emea. europa. eu
Reproduction is authorised provided the source is acknowledged. disease.
Reproduction is authorised provided the source is acknowledged. ir- reazzjoni tal- pazjent għal- Tracleer u jirrevedi l- bżonn għall- kura ulterjuri wara tminn ġimgħat, f ’ pazjenti li jbagħtu mill- PAH li l- kundizzjoni tagħhom ma tkunx marret għall- aħjar, u fuq bażi regolari f’ pazjenti li jbagħtu minn sklerożi sistematika u mard ta ’ l- ulċeri fis- swaba ta ’ l- id u tas- sieq li ma jkunx għadu fieq.
Patients who take Tracleer must be given the special reminder card that summarises the safety information about the medicine.
Il- pazjenti li jkunu qed jieħdu Tracleer għandhom jingħataw karta ta ’ twissija speċjali li tagħti tagħrif fil- qosor dwar is- sigurtà tal- mediċina.
How does Tracleer work?
Kif jaħdem Tracleer?
The active substance in Tracleer, bosentan, inhibits a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to constrict (narrow).
Is- sustanza attiva fi Tracleer, bosentan, tinibixxi ormon magħruf bħala endotelin- 1 (ET- 1) li jfeġġ b’ mod naturali u li jġiegħel lill- arterji u lill- vini tad- demm jidjiequ (jirqaqu).
Tracleer therefore causes blood vessels to dilate (expand).
Għalhekk Tracleer jġiegħel lill- arterji u lill- vini tad- demm jitwessgħu (jespandu).
PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
PAH hija marda ta ’ indeboliment fejn hemm restrizzjoni qawwija (tidjiq) tal- vini u l- arterji tal- pulmuni.
It causes high blood pressure in the vessels taking blood from the right side of the heart to the lungs.
Din tikkawża pressjoni għolja tad - demm f ’ dawk l- arterji li jieħdu d- demm min- naħa tal- lemin tal- qalb għall- pulmuni.
This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Il- pressjoni tnaqqas l- ammont ta ’ ossiġnu li jkun jista ’ jidħol fid- demm fil- pulmun u b’ hekk tagħmel l- eżerċizzju fiżiku iktar diffiċli.
By dilating these blood vessels, the blood pressure is reduced and symptoms are improved.
Bl- espansjoni ta ’ dawn il- vini u l- arterji tad- demm, il- pressjoni tad- demm tiġi mnaqqsa u s- sintomi jiġu mtejjba.
In patients with systemic sclerosis and ongoing digital ulcer disease, bosentan improves blood circulation in the fingers and toes, preventing the development of new digital ulcers.
F’ pazjenti li jbagħtu minn sklerożi sistematika u mard ta ’ l- ulċeri fis- swaba ta ’ l- id u tas- sieq li ma jkunx għadu fieq, bosentan itejjeb iċ- ċirkolazzjoni tad- demm fis - swaba ta ’ l- idejn u tas- saqajn, u jipprevjeni l- izvilupp ta ’ ulċeri ġodda fuq is- swaba ta ’ l- id u tas- sieq.
How has Tracleer been studied?
Kif ġie studjat Tracleer?
In PAH, four main studies have been carried out: two studies in a total of 245 adults with class III or IV disease that was either primary or caused by scleroderma, one in 54 adults with class III PAH that was associated with congenital heart defects and one in 185 patients with class II disease.
Fil- PAH, ġew kondotti erba ’ studji prinċipali: żewġ studji f’ total ta ’ 245 pazjent adult bi klassi III jew IV tal- marda li kienet jew primarja jew ikkawżata minn scleroderma, wieħed f’ 54 adult bil- PAH klassi III li kienet assoċjata ma ’ difetti konġenitali fil- qalb u wieħed f’ 185 pazjent bil- marda kjlassi II.
The studies compared the effects of Tracleer with those of placebo (a dummy treatment), when they were added to standard treatment.
L - effetti ta ’ Tracleer tqabblu ma ’ dawk ta ’ plaċebo (trattament finta), meta żdiedu mat- trattament eżistenti.
The main measure of effectiveness was how far the patient could walk in six minutes (a way of measuring exercise capacity), but the study in class II disease also looked at the change in the resistance to blood flow in the lungs’ blood vessels (a marker of how narrow the blood vessels are).
Il- kejl ewlieni ta ’ l- effikaċja kienet kemm hi d- distanza li pazjent seta ’ jimxi f’ sitt minuti (mod ta ’ kejl tal- kapaċità tal- eżerċizzju), iżda l- istudju tal- marda klassi II ħares ukoll lejn il- bidla fir - reżistenza għall- fluss tad- demm fl- arterji tal- pulmun (li juri kemm l- areterji huma dojoq).
A study was also carried out in 19 children aged between three and 15 years.
Sar ukoll studju fuq 19 - il tifel u tifla li għandhom età ta ’ bejn tlieta u 15 - il sena.
In systemic sclerosis with digital ulcers, two studies have compared Tracleer with placebo in a total of 312 patients.
Fl- isklerożi sistematika bl- ulċeri fis- swaba ta ’ l- id u tas- sieq, saru żewġ studji li qabblu Tracleer ma ’ plaċebo fuq total ta ’ 312 - il pazjent.
The main measure of effectiveness was based on the number of new digital ulcers developing during the studies.
Il- kejl ewlieni ta ’ l- effikaċja kienet ibbażata fuq in- numru ta ’ ulċeri ġodda fuq is- swaba ta ’ l- id u tas- sieq li żviluppaw waqt l- istudji.
One of the studies also looked at the effect of Tracleer on healing in 190 patients, by measuring the time taken for one selected digital ulcer in each patient to heal completely.
Wieħed mill- istudji ħares ukoll lejn l- effett ta ’ Tracleer fuq il- fejqan f’ 190 pazjent, billi kejjel il- ħin meħud minn ulċera waħda magħżula f’ kull pazjent biex tfiq kompletament.
What benefit has Tracleer shown during the studies?
X' benefiċċji ta 'Tracleer ħarġu matul dawn l- istudji?
In class III or IV PAH that was either primary or caused by scleroderma, the two studies showed that patients treated with Tracleer were able to walk significantly further than patients treated with placebo after 16 weeks (44 metres further in the larger study), but there were too few patients with class IV disease to support the use of the medicine in this group.
Fil- PAH klassi III jew IV li kienet jew primarja jew ikkawżata permezz ta ’ skleroderma, iż- żewġ studji wrew li pazjenti kkurati bi Tracleer kienu kapaċi, wara 16 - il ġimgħa, jimxu il- bogħod b’ mod sinjifikanti aktar minn pazjenti li ġew itrattati bi plaċebo (44 metri iktar milli fl- istudju akbar), iżda kien hemm ftit wisq pazjenti bil- marda klassi IV sabiex isostnu l- użu tal- mediċina f’ dan il- grupp.
In patients with class II disease, Tracleer caused the resistance of the blood vessels to decrease by 23% compared with placebo after six months of treatment, but the distance the patients could walk over six minutes was similar in the two groups.
Riżultati simili dehru f’ pazjenti li jbagħtu minn difetti konġenitali tal- qalb. Fil- pazjenti bil- marda klassi II, Tracleer ikkawża it- tnaqqis ta ’ 23% fir- reżistenza ta ’ l- arterji tad- demm meta mqabla ma ’ plaċebo wara sitt xhur ta ’ trattament, iżda d- distanza li l- pazjenti setgħu jimxu fuq temp ta ’ sitt minuti kienet l- istess fiż- żewġ gruppi.
In systemic sclerosis with digital ulcers, Tracleer was more effective at reducing the development of new digital ulcers than placebo.
Fl- isklerożi sistematika bl- ulċeri fis- swaba ta ’ l- id u tas- sieq, Tracleer kien iktar effettiv fit- tnaqqis ta ’ l- iżvilupp ta ’ ulċeri ġodda fis- swaba ta ’ l- id u tas- sieq mill- plaċebo.
In the first study, patients taking Tracleer had an average of 1.4 new digital ulcers after 16 weeks, compared with 2.7 in the patients taking placebo.
Fl- ewwel studju, il- pazjenti li ħadu Tracleer kellhom medja ta ’ 1. 4 ulċeri diġitali ġodda wara 16 – il ġimgħa meta mqabbla ma ’ 2. 7 fil- pazjenti li ħadu l- plaċebo.
Similar results were seen in the second study after 24 weeks, but Tracleer did not have any effect on digital ulcer healing.
Riżultati simili dehru fit- tieni studju was 24 ġimgħa, imma Tracleer ma kellu l- ebda effett fuq il- fejqan ta ’ l- ulċeri fis- swaba ta ’ l- id u tas- sieq.
What is the risk associated with Tracleer?
X’ inhu r- riskju assoċjat ma ’ Tracleer?
The most common side effect with Tracleer (seen in more than 1 patient in 10) is headache.
L- iktar effett sekondarju komuni bi Tracleer (li deher f' iktar minn pazjent 1 minn kull 10) hu l- uġigħ ta ’ ras.
Tracleer also causes changes in the results of tests carried out to check liver function.
Tracleer jikkawża ukoll bidliet fir- riżultati tat- testijiet li jsiru biex jiċċekkjaw il- funzjoni tal - fwied.
Because of this, the doctor will measure the levels of liver enzymes before treatment, and every month during treatment with Tracleer.
Minħabba f’ hekk, it- tabib għandu jkejjel il- livelli ta ’ l- enżimi tal- fwied qabel il- kura, u kull xahar matul il- kura bi Tracleer.
The effectiveness of some medicines (such as the contraceptive pill) can be affected by taking Tracleer at the same time.
Għal- lista sħiħa ta 'l- effetti sekondarji rrapportati b' Tracleer, ara l - Fuljett ta 'Tagħrif. L- effikaċja ta ’ xi mediċini (bħal ma huma l- pillo kontraċettivi) jistgħu jiġu affettwati bit- teħid ta ’ Tracleer fl- istess ħin.
Tracleer should not be used in people who may be hypersensitive (allergic) to bosentan or any of the other ingredients, who have liver enzyme problems, who are or could be pregnant, or who are taking ciclosporin A (a medicine that acts on the immune system).
2/ 3 Tracleer m’ għandux jintuża fuq persuni li jistgħu ikunu allerġiċi (hypersensitive) għall- bosentan jew għall xi uħud mill- ingredjenti l- oħra, li għandhom problemi ta ’ l- enżimi tal- fwied, li huma jew jistgħu ikunu tqal, jew li qed jieħdu ciclosporin A (mediċina li taġixxi fuq is- sistema immunitarja).
Why has Tracleer been approved?
Għaliex ġie approvat Tracleer?
The Committee for Medicinal Products for Human Use (CHMP) decided that Tracleer’ s benefits are greater than its risks for the treatment of patients with PAH and to reduce the number of new digital
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Tracleer jisbqu r- riskji tiegħu għall- kura ta 'pazjenti bil- PAH u għat- tnaqqis ta ’ ulċeri ġodda fis- swaba ta ’ l- id u tas- sieq f’ pazjenti li jbagħtu minn sklerożi sistematika u mard ta ’ l- ulċeri fis- swaba ta ’ l- id u tas- sieq li ma jkunx għadu fieq.
The Committee recommended that Tracleer be given marketing authorisation.
Il- Kumitat irrakkomanda li Tracleer jingħata l- awtorizzazzjoni għat - tqegħid fis- suq.
Tracleer was originally authorised under ‘ Exceptional Circumstances’, because, as PAH is rare, limited information was available at the time of its initial approval for this disease.
Tracleer ġie oriġinarjament awtorizzat taħt "Ċirkustanzi ta 'Eċċezzjoni", għax minnħabba li l- PAH hija marda rari, kien hemm biss tagħrif limitat disponibbli fi żmien ta ’ l- approvazzjoni inizjali għal din il - marda.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 30 November 2004.
Billi l- kumpanija kienet ipprovdiet it- tagħrif addizzjonali mitlub, iċ - "Ċirkustanzi ta ’ Eċċezzjoni" spiċċaw fit- 30 ta ’ Novembru 2004.
Which measures are being taken to ensure the safe use of Tracleer?
X’ miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta ’ Tracleer?
The company that makes Tracleer will provide an educational kit for prescribers and an information booklet for patients in each Member State, explaining the safety of Tracleer (especially its effects on the liver and in pregnancy) and its interactions.
Il- kumpanija li tipproduċi Tracleer ser tagħti kit edukazzjonali lil min jippreskrivi u ktejjeb bl - informazzjoni lill- pazjenti f’ kull Stat Membru, li jispjegaw is- sigurtà ta ’ Tracleer (b’ mod speċjali l - effetti tiegħu fuq il- fwied u t- tqala) u l- interazzjonijiet tagħha.
The company will also carefully control the distribution of the medicine in each Member State, and collect information on its use in patients with systemic sclerosis and ongoing digital ulcers.
Il- kumpanija se tikkontrolla bir- reqqa wkoll id- distribuzzjoni tal- mediċina f’ kull Stat Membru, u tiġbor l- informazzjoni dwar l- użu tagħha f’ pazjenti li jbagħtu minn sklerożi sistematika u ulċeri fuq is- swaba ta ’ l- id u tas- sieq li ma jkunx għadu fieq.
Other information about Tracleer:
Tagħrif ieħor dwar Tracleer:
The European Commission granted a marketing authorisation valid throughout the European Union to Actelion Registration Ltd on 15 May 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, lill- Actelion Registration Ltd fil- 15 ta ’ Mejju 2002.
The marketing authorisation was renewed on 15 May 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet aġġornata fil- 15 ta ’ Mejju 2007.
The summaries of opinion of the Committee for Orphan Medicinal Products for Tracleer are available here (PAH) and here (systemic sclerosis).
Is- sommarji ta ’ l- opinjoni tal- Kumitat għall- Prodotti Mediċinali Orfni fuq Tracleer huma disponibbli hawnhekk (PAH) u hawnhekk (sklerożi sistematika).
The full EPAR for Tracleer can be found here.
L- EPAR sħiħ għal Tracleer jista ’ jiġi kkonsultat hawnhekk.
EU-number
Numru tal- EU
Pharmaceutical form
Għamla Farmaċewtika
Route of administration
Mnjen jingħata
62.5 mg 62.5 mg 62.5 mg 125 mg 125 mg
62. 5 mg 62. 5 mg 62. 5 mg 125 mg 125 mg
Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu)
Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu) Folja (PVC/ PE/ PVDC/ alu)
14 tablets 56 tablets 112 tablets 56 tablets 112 tablets
14- il pillola 56 pillola 112- il pillola 56 pillola 112- il pillola
Tracleer 62.5 mg film-coated tablets
Tracleer 62. 5 mg, pillola miksija b’ rita
Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Kull pillola fiha 62. 5 mg ta ’ bosentan (bħala monohydrate)
Orange-white, round, biconvex, film-coated tablets, embossed with “ 62,5 ” on one side.
Pilloli miksija b’ rita, oranġjo- bojod, tondi, bil- kitba “ 62. 5 ” imnaqqxa fuq naħa waħda.
Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.
Kura tal- pressjoni għolja arterjali pulmonari (PAH) biex kemm il- kapaċità ta ’ l- eżerċizzju fiżiku kif ukoll is- sintomi tal- pazjenti bi klassi III ta ’ l- istat funzjonali tal- WHO jitjiebu.
Efficacy has been shown in: • Primary (idiopathic and familial) PAH • PAH secondary to scleroderma without significant interstitial pulmonary disease • PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger’ s physiology
L- effikaċja ntweriet fi: • PAH primarja (idjopatika u familjali) • PAH bħala konsegwenza ta ’ l- iskleroderma (meta l- ġilda teħxien) mingħajr mard pulmonari interstizjali sinifikanti • PAH marbuta ma 'shunts sistemiċi- pulmonari konġenitali u fiżjoloġija ta ’ Eisenmenger
Some improvements have also been shown in patients with PAH WHO functional class II (see section 5.1).
Xi titjib intwera wkoll f’ pazjenti b’ PAH ta ’ klassi II ta ’ l- istat funzjonali tal- WHO (ara sezzjoni 5. 1).
Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease (see section 5.1).
Tracleer huwa ndikat ukoll biex inaqqas in- numru ta ’ ulċeri ġodda fis- swaba f’ pazjenti bi sklerosi sistemika u l- preżenza tal- marda tal- ulċeri fis- swaba (ara sezzjoni 5. 1).
Pulmonary arterial hypertension
Ipertensjoni arterjali pulmonari.
Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension.
Il- kura għandha tinbeda u tkun immonitorjata minn tabib b’ esperjenza fil- kura tal- pressjoni għolja arterjali pulmonari.
Tracleer treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Il- kura bi Tracleer għandha tinbeda b’ doża ta ’ 62. 5 mg, darbtejn kuljum għal 4 ġimgħat, u mbagħad tiżdied għad- doża tal- manteniment ta ’ 125 mg darbtejn kuljum.
Tablets are to be taken orally morning and evening, with or without food.
Il- pilloli għandhom jittieħdu mill- ħalq filgħodu u filgħaxija, ma ’ l- ikel jew mingħajru.
In the case of clinical deterioration (e. g., decrease in 6-minute walk test distance by at least 10% compared with pre-treatment measurement) despite Tracleer treatment for at least 8 weeks (target dose for at least 4 weeks), alternative therapies should be considered.
F’ każ li s- sitwazzjoni klinika tmur għall- agħar (eż. tnaqqis fid- distanza tat- test tal- mixja ta ’ 6 minuti ta ’ mill- inqas 10% meta mqabbel mal- kejl ta ’ qabel il- kura) minkejja li l- kura b’ Tracleer għal mill - inqas 8 ġimgħat (bid- doża fil- mira mogħtija għal mill- inqas 4 ġimgħat), terapiji alternattivi għandhom jiġu kkunsidrati.
However, some patients who show no response after 8 weeks of treatment with Tracleer may respond favourably after an additional 4 to 8 weeks of treatment.
Madankollu, xi pazjenti li ma wrew l- ebda rispons wara 8 ġimgħat ta ’ kura bi Tracleer, jistgħu jirrispondu b’ mod favorevoli wara 4- 8 ġimgħat addizzjonali ta ’ kura.
If the decision to withdraw Tracleer is taken, it should be done gradually while an alternative therapy is introduced.
Jekk tittieħed id- deċiżjoni biex Tracleer jitwaqqaf, dan għandu jsir b’ mod gradwali filwaqt li tinbeda terapija alternattiva fl- istess ħin.
In the case of late clinical deterioration despite treatment with Tracleer (i. e., after several months of treatment), the treatment should be re-assessed.
F’ każ li l- istat kliniku jmur għall- agħar wara ħafna żmien li jkun ilu jittieħed Tracleer (i. e. wara ħafna xhur ta ’ kura), il- kura għandha terġa ’ tkun evalwata mill- ġdid.
Some patients not responding well to 125 mg twice daily of Tracleer may slightly improve their exercise capacity when the dose is increased to 250 mg twice daily.
Għandha ssir evalwazzjoni bl- attenzjoni
A careful risk/ benefit assessment should be made, taking into consideration that the liver toxicity is dose dependent (see sections 4.4 and 5.1).
2 tar- riskju/ benefiċċju, u jiġi kkunsidrat il- fatt li t- tossiċità tal- fwied tiddependi mid- doża (ara sezzjonijiet 4. 4 u 5. 1).
2 Discontinuation of treatment
Twaqqif tal- kura
There is limited experience with abrupt discontinuation of Tracleer.
Hemm esperjenza limitata dwar it- twaqqif f’ daqqa tal- kura bi Tracleer.
No evidence for acute rebound has been observed.
Ma kienet osservata l- ebda evidenza ta ’ rebound akuta.
However, to avoid the possible occurrence of harmful clinical deterioration due to potential rebound effect, gradual dose reduction (halving the dose for 3 to 7 days) should be considered.
Madankollu, biex tiġi evitata l- possibbiltà li s- sitwazzjoni klinika tmur għall- agħar minħabba l- effett potenzjali tar- rebound, it- tnaqqis bil- mod tad- doża (id- doża titnaqqas bin- nofs għal 3 sa 7 ijiem) għandu jiġi kkunsidrat.
Intensified monitoring is recommended during the discontinuation period.
Matul dan il- perjodu ta ’ twaqqif, monitoraġġ intensifikat hu rakkomandat.
Systemic sclerosis with ongoing digital ulcer disease
Sklerosi sistemika bil- preżenza tal- marda tal- ulċeri fis- swaba
Treatment should only be initiated and monitored by a physician experienced in the treatment of systemic sclerosis.
Il- kura għandha tinbeda biss u tiġi sorveljata minn tabib b’ esperjenza fil- kura ta ’ sklerosi sistemika.
Tracleer treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Kura bi Tracleer għandha tinbeda b’ doża ta ’ 62. 5 mg darbtejn kuljum għal 4 ġimgħat u mbagħad tiżdied għal doża ta ’ manteniment ta ’ 125 mg darbtejn kuljum.
Tablets are to be taken orally morning and evening, with or without food.
Il- pilloli għandhom jittieħdu mill- ħalq filgħodu u filgħaxija, ma ’ l- ikel jew mingħajr ikel.
Controlled clinical trial experience in this indication is limited to 6 months (see section 5.1).
Esperjenza minn provi kliniċi kkontrollati f’ din l- indikazzjoni hija limitata għal 6 xhur (ara sezzjoni 5. 1).
The patient ’ s response to treatment and need for continued therapy should be re-evaluated on a regular basis.
Ir- respons tal- pazjent għall- kura u l- bżonn ta ’ aktar terapija għandu jiġi evalwat mill- ġdid fuq bażi regolari.
A careful risk/ benefit assessment should be made, taking into consideration the liver toxicity of bosentan (see sections 4.4 and 4.8).
Għandha ssir stima b’ attenzjoni tar- riskju/ benefiċċju b’ konsiderazzjoni tat- tossiċità għall - fwied ta ’ bosentan (ara sezzjonijiet 4. 4 u 4. 8).
Dosage in hepatic impairment
Id- dożaġġ f’ każ ta ’ indeboliment tal- fwied
No dose adjustment is needed in patients with mild hepatic impairment (i. e., Child-Pugh class A) (see section 5.2).
F’ każ ta ’ indeboliment ħafif tal- fwied, m’ hemmx bżonn ta ’ aġġustament fid- doża li tingħata (i. e.
Tracleer is contraindicated in patients with moderate to severe liver dysfunction (see sections 4.3, 4.4 and 5.2).
Tracleer m’ għandux jintuża f’ pazjenti b’ funzjoni ħażina tal - fwied li tkun minn moderata sa severa (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
Dosage in renal impairment
Id- dożaġġ f’ każ ta ’ indeboliment tal- kliewi
No dose adjustment is required in patients with renal impairment.
F’ każ ta ’ indeboliment tal- kliewi, m’ hemmx bżonn ta ’ aġġustament fid- doża.
No dose adjustment is required in patients undergoing dialysis (see section 5.2).
M’ hemmx bżonn ta ’ aġġustament fid- doża f’ pazjenti li jkunu qed jiġu kkurati bid- dijaliżi (ara sezzjoni 5. 2).
Dosage in elderly patients
Id- dożaġġ għall- anzjani
No dose adjustment is required in patients over the age of 65 years.
M’ hemmx bżonn ta ’ aġġustament fid- doża f’ pazjenti li għandhom ’ il fuq minn 65 sena.
Pulmonary arterial hypertension:
Ipertensjoni arterjali pulmonari:
Safety and efficacy in patients under the age of 12 years have not been substantially documented.
Is- sigurtà u l- effikaċja f’ pazjenti ta ’ taħt it- 12- il sena mhumiex iddokumentati biżżejjed.
The following dosing regimen was used in study AC-052-356 (BREATHE-3):
Il- kors tad- dożaġġ li ġej intuża fl- istudju AC- 052- 356 (BREATHE- 3):
Body Weight (kg)
Piż Korporju (kg)
Initiation Dose (4 weeks)
Doża tal- Bidu (4 ġimgħat)
Maintenance Dose
Doża ta ’ Manteniment
10 ≤ × ≤ 20
10≤ x ≤20
31.25 mg once daily
31. 25 mg darba kuljum
31.25 mg twice daily
31. 25 mg darbtejn kuljum
20
20 < x ≤40 > 40
31.25 mg twice daily 62.5 mg twice daily
31. 25 mg darbtejn kuljum 62. 5 mg darbtejn kuljum
62.5 mg twice daily 125 mg twice daily
62. 5 mg darbtejn kuljum 125 mg darbtejn kuljum
This study was primarily designed to assess pharmacokinetics in children.
3 Dan l- istudju kien maħsub primarjament biex jevalwa l- farmakokinetiċi fit- tfal.
The number of patients studied in each dose group was insufficient to establish the optimal dosing regimen in patients under the age of 12 years (see also section 5.1).
In- numru ta ’ pazjenti li ġew studjati f’ kull grupp tad- doża ma kienx biżżejjed biex jiġi stabbilit l- aħjar kors ta ’ dożaġġ għal pazjenti ta ’ taħt it- 12- il sena (ara wkoll sezzjoni 5. 1).
The pharmacokinetic findings showed that systemic exposure was lower than in adults with pulmonary hypertension (see section 5.2) which may provide
Is- sejbiet farmakokinetiċi juru li l- espożizzjoni sistemika kienet inqas minn dik f’ adulti bi pressjoni għolja pulmonari (sezzjoni 5. 2) u dan jista ’ jipprovdi effett li huwa inqas mill- aħjar effett fuq il- vaskulatura pulmonari.
However the safety of higher doses has not been established in children.
Madankollu, is- sigurtà ta ’ dożi ogħla fit- tfal ma kinitx stabbilita.
There is no experience in children below 3 years.
M’ hemmx esperjenza dwar l- użu fit- tfal ta ’ taħt it- tliet snin.
Systemic sclerosis with ongoing digital ulcer disease:
Sklerosi sistemika bil- preżenza tal- marda ta ’ ulċeri fis- swaba:
data on the safety and efficacy in patients under the age of 18 years.
M’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja f’ pazjenti taħt l- età ta ’ 18- il sena.
Patients with low body weight
Pazjenti b’ piż korporju baxx
There is limited experience in patients with a body weight below 40 kg.
Hemm esperjenza limitata f’ pazjenti li jiżnu taħt l- 40 kg.
• Hypersensitivity to the active substance or to any of the excipients • Child-Pugh Class B or C, i. e., moderate to severe hepatic impairment (see section 5.2) • Baseline values of liver aminotransferases, i. e., aspartate aminotransferases (AST) and/ or alanine aminotransferases (ALT), greater than 3 times the upper limit of normal (see section 4.4) • Concomitant use of cyclosporine A (see section 4.5) • Pregnancy • Women of childbearing potential who are not using reliable methods of contraception (see sections 4.4, 4.5 and 4.6)
• Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi. • Il- marda Child- Pugh Klassi B jew Ċ, i. e. ħsara epatika minn moderata sa serja (ara sezzjoni 5. 2) • Valuri tal- linja bażi ta ’ l- aminotransferases fil- fwied, i. e. aspartate aminotransferases (AST) u/ jew alanin aminotransferases (ALT), ta ’ aktar minn tliet darbiet il- limitu ta ’ fuq tan- normal (Upper Limit of Normal) • Użu konkomitanti ta ’ cyclosporine A (ara sezzjoni 4. 5) • Tqala • Nisa li għandhom il- potenzjali li joħorġu tqal u li mhumiex qed jużaw metodu affidabbli ta ’ kontraċezzjoni (ara sezzjonijiet 4. 4, 4. 5 u 4. 6)
The efficacy of Tracleer has not been established in patients with severe pulmonary arterial hypertension.
L- effikaċja ta ’ Tracleer ma ġietx stabbilita f’ pazjenti li għandhom pressjoni għolja serja arterjali pulmonari.
Transfer to a therapy that is recommended at the severe stage of the disease (e. g., epoprostenol) should be considered if the clinical condition deteriorates (see section 4.2).
Jekk il- kundizzjoni klinika tal- pazjent tmur għall- agħar, għandu jiġi kkunsidrat jekk il- kura għandhiex tinbidel għal dik li hi rakkomandata fil- fażi severa tal- marda (eż. epoprostenol) (ara sezzjoni 4. 2).
The benefit/ risk balance of bosentan has not been established in patients with WHO class I functional status of pulmonary arterial hypertension.
Il- bilanċ bejn il- benefiċċju u r- riskju ta ’ bosentan ma ġiex stabbilit f’ pazjenti bi Klassi I ta ’ l- istat funzjonali tal- WHO tal- pressjoni għolja arterjali pulmonari.
Tracleer should only be initiated if the systemic systolic blood pressure is higher than 85 mmHg.
Tracleer għandu jinbeda biss jekk il- pressjoni sistolika tad- demm hi ogħla minn 85 mmHg.
Tracleer has not been shown to have a beneficial effect on the healing of existing digital ulcers.
Tracleer ma ntweriex li għandu xi effett ta ’ benefiċċju fuq il- fejqan ta ’ ulċeri fis- swaba eżistenti.
Liver function
Funzjoni tal- fwied
Elevations in liver aminotransferases, i. e., aspartate and alanine aminotransferases (AST and/ or ALT), associated with bosentan are dose dependent.
Żieda ta ’ aminotransferases fil- fwied, i. e. ta ’ aspartate u ta ’ alanin (AST u/ jew ALT), assoċjata ma ’ bosentan tiddependi mid- doża.
Liver enzyme changes typically occur within the first 26 weeks of treatment but may also occur late in treatment (see section 4.8).
Normalment, tibdiliet fl- enzimi tal- fwied iseħħu fl- ewwel 26 ġimgħa wara l- bidu tal- kura, iżda jistgħu jseħħu wkoll f’ fażi mwaħħra fil- kura (ara sezzjoni 4. 8).
These increases may be partly due to competitive inhibition of the elimination of bile salts from hepatocytes but other mechanisms, which have not been clearly established, are probably also involved in the occurrence of liver dysfunction.
Parti minn din iż- żieda tista ’ tkun parzjalment minħabba l- inibizzjoni kompetittiva ta ’ l- eliminazzjoni tal- bile salts mill- hepatocytes, iżda mekkaniżmi oħrajn, li ma kienux stabbiliti b’ mod ċar, huma wkoll involuti ma ’ funzjoni ħażina tal- fwied.
The accumulation of bosentan in hepatocytes leading to cytolysis with potentially severe damage of the liver, or an immunological mechanism, are not excluded.
L- akkumulazzjoni ta ’ bosentan fiċ- ċelluli tal- fwied li tirriżulta fil- mewt ta ’ dawn iċ- ċelluli bil- potenzjal ta ’ ħsara serja fil- fwied, jew xi mekkaniżmu immunoloġiku, mhumiex esklużi.
Liver dysfunction risk may also be increased when medicinal products that are inhibitors of the bile salt export pump (BSEP), e. g., rifampicin, glibenclamide and cyclosporine A (see sections 4.3 and 4.5), are co- administered with bosentan, but limited data are available.
Madankollu, m’ hemmx biżżejjed informazzjoni dwar dan.
Liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals for the duration of treatment with Tracleer.
4 Il- livelli ta ’ aminotransferase fil- fwied għandhom jiġu eżaminati qabel ma tinbeda l- kura u wara dan, kull xahar għal kemm iddum il- kura bi Tracleer.
In addition, liver aminotransferase levels must be measured 2 weeks after any dose increase.
Flimkien ma ’ dan, il- livelli ta ’ aminotransferase tal- fwied għandhom jiġu eżaminati ħmistax wara kull żieda li ssir fid- doża.
Recommendations in case of ALT/ AST elevations
Rakkomandazzjonijiet f’ każ ta ’ żidiet fl- ALT/ AST
4 ALT/ AST levels > 3 and ≤ 5 × ULN
Livell ta ‘ l- ALT/ AST Rakkomandazzjonijiet dwar il- kura u l- monitoraġġ. > 3 u ≤ 5 × ULN
Treatment and monitoring recommendations Confirm by another liver test; if confirmed, reduce the daily dose or stop treatment (see section 4.2), monitor aminotransferase levels at least every 2 weeks.
Ikkonferma b’ test ieħor tal- fwied; jekk dan jiġi kkonfermat, naqqas id- doża ta ’ kuljum jew waqqaf il- kura (ara sezzjoni 4. 2), iċċekkja l- livelli ta ’ l - aminotransferase mill- inqas darba kull ħmistax.
If the aminotransferase levels return to pre-treatment values consider continuing or re-introducing Tracleer according to the conditions described below.
Jekk il- livelli ta ’ l - aminotransferase jerġgħu lura għall- istess livell ta ’ qabel inbdiet il- kura, għandu jiġi kkunsidrat li Tracleer jitkompla jew jerġa ’ jibda jintuża skond il - kundizzjonijiet deskritti aktar ’ l isfel.
> 5 and ≤ 8 × ULN
> 5 u ≤ 8 × ULN
Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks.
Ikkonferma b’ test ieħor tal- fwied; jekk dan jiġi kkonfermat, waqqaf il- kura u eżamina l- livell ta ’ aminotransferase mill- inqas darba kull ħmistax.
If the aminotransferase levels return to pre-treatment values consider re-introducing Tracleer according to the conditions described below.
Jekk il - livelli ta ’ l- aminotransferase jerġgħu lura għall- istess livell ta ’ qabel inbdiet il - kura, għandu jiġi kkunsidrat li Tracleer jerġa ’ jibda jintuża skond il - kundizzjonijiet deskritti aktar ’ l isfel.
Treatment must be stopped and re-introduction of Tracleer is not to be considered.
Il- kura għandha titwaqqaf u Tracleer m’ għandux jintuża aktar.
In case of associated clinical symptoms of liver injury, i. e., nausea, vomiting, fever, abdominal pain, jaundice, unusual lethargy or fatigue, flu-like syndrome (arthralgia, myalgia, fever), treatment must be stopped and re-introduction of Tracleer is not to be considered.
F’ każ ta ’ sintomi kliniċi assoċjati ma ’ ħsara tal- fwied, i. e. dardir, rimettar, deni, uġigħ addominali, suffejra, telqa u għeja mhux tas- soltu, sindrome bħall- influwenza (uġigħ fil- ġogi, uġigħ fil- muskoli, deni), il- kura għandha titwaqqaf u m’ għandux jiġi kkunsidrat li l- kura bi Tracleer terġa ’ tinbeda.
Re-introduction of treatment Re-introduction of treatment with Tracleer should only be considered if the potential benefits of treatment with Tracleer outweigh the potential risks and when liver aminotransferase levels are within pre-treatment values.
Meta terġa ’ tinbeda l- kura Il- bidu mill- ġdid tal- kura bi Tracleer għandu jiġi kkunsidrat biss jekk il- benefiċċji potenzjali jkunu ikbar mir- riskji potenzjali, u meta l- livelli ta ‘ aminotransferase fil- fwied ikunu bħal dawk ta ’ qabel ma nbdiet il- kura.
The advice of a hepatologist is recommended.
Huwa rakkomandat li jkun hemm konsultazzjoni ma ’ speċjalista tal- fwied.
Re-introduction must follow the guidelines detailed in section 4.2.
Il- kura għandha ssegwi l- linji gwida deskritti fid- dettall f’ sezzjoni 4. 2.
Aminotransferase levels must then be checked within 3 days after re-introduction, then again after a further 2 weeks, and thereafter according to the recommendations above.
Il- livelli ta ’ aminotransferase għandhom jkunu ċċekkjati fi żmien 3 ijiem wara li terġa ’ tinbeda l- kura, u mbagħad mill- ġdid wara ħmistax, u wara dan skond ir- rakkomandazzjonijiet t’ hawn fuq.
ULN= Upper Limit of Normal
ULN= Upper Limit of Normal
Haemoglobin concentration
Konċentrazzjoni ta ’ l- emoglobina
Treatment with bosentan has been associated with dose-related decreases in haemoglobin concentration (see section 4.8).
Il- kura b’ bosentan ġiet assoċjata ma ’ tnaqqis relatat mad- doża fil- konċentrazzjoni ta ’ l- emoglobina (ara sezzjoni 4. 8).
In placebo-controlled studies, bosentan-related decreases in haemoglobin concentration were not progressive, and stabilised after the first 4– 12 weeks of treatment.
Fi studji kkontrollati bil- plaċebo, tnaqqis fil- konċentrazzjoni ta ’ l- emoglobina marbuta ma ’ l- użu ta ’ bosentan ma kienx progressiv u stabbilizza wara l- ewwel 4- 12- il ġimgħa tal - kura.
It is recommended that haemoglobin concentrations be checked prior to initiation of treatment, every month during the first 4 months, and quarterly thereafter.
Hu rakkomandat li l- konċentrazzjonijiet ta ’ l- emoglobina għandhom jiġu ċċekkjati qabel ma tinbeda l- kura, kull xahar matul l- ewwel 4 xhur, u mbagħad kull 4 xhur.
If a clinically relevant decrease in haemoglobin concentration occurs, further evaluation and investigation should be undertaken to determine the cause and need for specific treatment.
Jekk iseħħ tnaqqis li hu klinikament rilevanti fil- konċentrazzjoni ta ’ l- emoglobina, evalwazzjoni u investigazzjoni ulterjuri għandhom isiru biex issir magħrufa l- kawża u l- ħtieġa għal kura speċifika.
In the post-marketing period, cases of anaemia requiring red blood cell transfusion have been reported (see section 4.8).
Fil- perjodu ta ’ wara t - tqegħid fis- suq, ġew irrapportati każijiet ta ’ anemija li kienu jinħtieġu trasfużjoni ta ’ ċelluli ħomor tad - demm (ara sezzjoni 4. 8).
Use in women of child-bearing potential
Użu fin- nisa li jistgħu joħorgu tqal
Tracleer treatment must not be initiated in women of child-bearing potential unless they practice reliable contraception (see section 4.5) and the result of the pre-treatment pregnancy test is negative (see section 4.6).
Il- kura bi Tracleer m’ għandhiex tinbeda f’ nisa li jistgħu joħorgu tqal ħlief jekk dawn jużaw kontraċezzjoni affidabbli (ara sezzjoni 4. 5) u jekk ir- riżultat tat- test tat- tqala ta ’ qabel bdiet il- kura kien negattiv (ara sezzjoni 4. 6).
Before the initiation of Tracleer treatment in women of child-bearing potential, the absence of pregnancy should be checked, appropriate advice on reliable methods of contraception provided, and reliable contraception initiated.
Qabel tinbeda kura b’ Tracleer f’ nisa li jistgħu joħorġu tqal, in- nuqqas tat- tqala għandha tiġi ċċekkjata, għandu jingħata parir xieraq dwar metodi ta ’ kontraċezzjoni affidabbli u għandha tinbeda
Patients and prescribers must be aware that, due to potential pharmacokinetic interactions, Tracleer may render hormonal contraceptives ineffective (see section 4.5).
Pazjenti u tobba għandhom ikunu jafu li, minħabba interazzjonijiet farmakokinetiċi potenzjali, Tracleer jista ’ jneħħi l- effett tal- kontraċettivi ormonali (ara sezzjoni 4. 5).
Therefore, women of child-bearing potential must not use hormonal contraceptives (including oral, injectable, transdermal, and implantable forms) as the sole method of contraception but should use an additional or an alternative reliable method of contraception.
Għalhekk, nisa li jistgħu joħorġu tqal m’ għandhomx jużaw kontraċettivi ormonali (inkluż forom orali, li jiġu njettatii, li jingħataw minn ġol- ġilda, u li jiġu impjantati) bħala l- uniku metodu ta ’ kontraċezzjoni iżda għandhom jużaw metodu affidabbli ieħor jew alternattiv ta ’ kontraċezzjoni.
If there is any doubt on what contraceptive advice should be given to the individual patient, consultation with a gynaecologist is recommended.
Jekk hemm xi dubju dwar liema parir ta ’ kontraċezzjoni għandu jingħata lill- pazjent individwali, konsultazzjoni ma ’ ġinekologu hija rakkomandata.
Because of possible hormonal contraception failure during Tracleer treatment and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with Tracleer are recommended to allow early detection of pregnancy.
Minħabba l- possibbiltà ta ’ falliment ta ’ kontraċezzjoni ormonali waqt kura b’ Tracleer kif ukoll b’ konsiderazzjoni tar- riskju li pressjoni pulmonari għolja tista ’ tiddeterjora b’ mod sever bit- tqala, hu rakkomandat li jsiru testijiet tat- tqala kull xahar matul il- kura bi Tracleer biex tkun possibbli s- sejba bikrija tat- tqala.
5 Pulmonary veno-occlusive disease
Mard veno- okklussiv pulmonari
Cases of pulmonary oedema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease.
Każijiet ta ’ edema pulmonari kienu rrappurtati meta ntużaw mediċini li jwessgħu l- arterji/ vini (l- aktar prostacyclins) meta użati f’ pazjenti li għandhom marda fejn il- vini pulmonari jinsaddu.
Consequently, should signs of pulmonary oedema occur when Tracleer is administered in patients with PAH, the possibility of associated veno-occlusive disease should be considered.
Għalhekk, jekk ikun hemm sinjali ta ’ edema pulmonari waqt li Tracleer ikun qed jingħata lill- pazjenti li għandhom PAH, għandha tiġi kkunsidrata l- possibbiltà li dan jista ’ jkun assoċjat ma ’ mard okklużiv tal- vini pulmonari.
In the post-marketing period there have been rare reports of pulmonary oedema in patients treated with Tracleer who had a suspected diagnosis of pulmonary veno-occlusive disease.
Fil- perjodu wara li l- mediċina bdiet tinbiegħ, kien hemm rapporti rari ta ’ edema pulmonari f’ pazjenti kkurati bi Tracleer li kellhom dijanjosi suspetta ta ’ mard okklużiv tal- vini pulmonari.
Pulmonary arterial hypertension patients with concomitant left ventricular failure
Pazjenti bi pressjoni għolja arterjali pulmonari u kollass ventrikulari tax- xellug
No specific study has been performed in patients with pulmonary hypertension and concomitant left ventricular dysfunction.
Ma sar l- ebda studju speċifiku f’ pazjenti bi pressjoni għolja arterjali pulmonari u funzjoni ħażina ventrikulari tax- xellug.
However, 1,611 patients (804 Tracleer- and 807 placebo-treated patients) with severe chronic heart failure (CHF) were treated for a mean duration of 1.5 years in a placebo- controlled study (study AC-052-301/ 302 [ENABLE 1 & 2]).
Madankollu, 1, 611- il pazjent (804 li kienu qed jieħdu Tracleer u 807 li kienu qed jieħdu l- plaċebo) b’ kollass kroniku tal- qalb (chronic heart failure - CHF) kienu kkurati għal tul ta ’ żmien medju ta ’ sena u nofs fl- istudju kkontrollat bil- plaċebo (studju numru AC- 052- 301/ 302 [ENABLE 1 & 2]).
In this study there was an increased incidence of hospitalisation due to CHF during the first 4 - 8 weeks of treatment with Tracleer, which could have been the result of fluid retention.
F’ dan l- istudju, kien hemm żieda fl- inċidenza tan- numru ta ’ pazjenti li ddaħħlu l - isptar minħabba CHF matul l- ewwel 4- 8 ġimgħat ta ’ kura bi Tracleer, li seta ’ rriżulta minn żamma ta ’ fluwidu.
In this study, fluid retention was manifested by early weight gain, decreased haemoglobin concentration and increased incidence of leg oedema.
F’ dan l- istudju, iż- żamma tal- fluwidu ntweriet f’ żieda fil- piż tal- pazjent fil- bidu tal- kura, tnaqqis fil- konċentrazzjoni ta ’ l- emoglobina u żieda fl- inċidenza ta ’ edema fis- saqajn.
At the end of this study, there was no difference in overall hospitalisations for heart failure nor in mortality between Tracleer- and placebo-treated patients.
Fl- aħħar ta ’ dan l- istudju, ma kien hemm l- ebda differenza fin- numru totali ta ’ pazjenti li ddaħħlu l- isptar minħabba kollass tal- qalb u lanqas fil- mortalità ta ’ pazjenti li kienu kkurati bi Tracleer u dawk bil- plaċebo.
Consequently, it is recommended that patients be monitored for signs of fluid retention (e. g., weight gain), especially if they concomitantly suffer from severe systolic dysfunction.
Għaldaqstant, hu rakkomandat li l- pazjenti għandhom jiġu mmonitorjati għal sinjali ta ’ żamma tal - fluwidu (eż. żieda fil- piż), speċjalment jekk ikunu jbatu fl- istess ħin minn funzjoni ħażina sistolika serja.
Should this occur, starting treatment with diuretics is recommended, or the dose of existing diuretics should be increased.
Jekk dan iseħħ, hu rakkomandat li tingħata l- kura bid- dijuretiċi, jew id- doża ta ’ dijuretiċi eżistenti għandha tiżdied.
Treatment with diuretics should be considered in patients with evidence of fluid retention before the start of treatment with Tracleer.
Il- kura bid- dijuretiċi għandha tiġi kkunsidrata f’ pazjenti b’ sinjali ta ’ żamma ta ’ fluwidu qabel il- bidu tal- kura bi Tracleer.
Pulmonary arterial hypertension associated with HIV infection
Pressjoni għolja arterjali pulmonari marbuta ma ’ infezzjoni bl- HIV