qanastek/EMEA-V3 huggingface dataset:
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.
An alternative antidiabetic medicinal product should be used in patients in whom an antidiabetic treatment is indicated.
25 għandhom bżonn ta ’ mediċina antidijabetika għandhom jużaw prodott mediċinali alternattiv kontra d - dijabete.
The possibility 24 of altered efficacy of medicinal products metabolised by these isoenzymes should be considered.
Għandha tkun ikkunsidrata l- possibbiltà li l- effikaċja ta ’ prodotti mediċinali metabolati minn dawn l- isoenzimi tinbidel.
Therefore, hormone- based contraceptives alone, regardless of the route of administration (i.e. oral, injectable, transdermal, and implantable forms), are not considered as reliable methods of contraception (see sections 4.4, 4.6).
Cyclosporine A:
Patients in need of the combination should be closely monitored for adverse events related to Tracleer and for tacrolimus and sirolimus blood concentrations.
26 ssorveljati mill- qrib għal avvenimenti avversi marbuta ma ’ Tracleer u għall- konċentrazzjonijiet ta ’ tacrolimus u sirolimus fid- demm.
Simvastatin: co-administration of Tracleer 125 mg twice daily for 5 days decreased the plasma concentrations of simvastatin (a CYP3A4 substrate), and its active β-hydroxy acid metabolite by 34% 25 and 46%, respectively.
Simvastatin: l- għoti flimkien ta ‘ 125 mg ta ’ Tracleer darbtejn kuljum għal 5 ijiem naqqas il - konċentrazzjonijiet ta ‘ simvastatin fil- plażma (sottostrat ta ‘ CYP3A4), u l- metabolit attiv tiegħu β - hydroxy acid b’ 34% u 46% rispettivament.
Rifampicin: co-administration in 9 healthy subjects of Tracleer 125 mg twice daily for 7 days and rifampicin, a potent inducer of CYP2C9 and CYP3 A4, decreased the plasma concentrations of bosentan by 58%, and this decrease could achieve almost 90% in an individual case.
Rifampicin: l- għoti flimkien f’ 9 pazjenti f' saħħithom ta ’ 125 mg ta ’ Tracleer darbtejn kuljum għal 7 ijiem u rifampicin, inducer potenti ta ’ CYP2C9 u CYP3A4, naqqas il- konċentrazzjonijiet ta ’ bosentan fil- plażma bi 58%, u dan it- tnaqqis laħaq kważi 90% f’ każ individwali.
Data on other CYP3 A4 inducers, e.g. carbamazepine, phenobarbital, phenytoin and St John's wort are lacking, but their concomitant administration is expected to lead to reduced systemic exposure to bosentan.
27 John' s wort, iżda l- għoti flimkien tagħhom hu mistenni li jwassal għal tnaqqis fl- espożizzjoni sistemika għal bosentan.
The re are minimal data on the use of Tracleer in pregnant women.
Hemm informazzjoni minimali fuq l- użu ta ’ Tracleer f’ nisa tqal.
26 Use during lactation
L- użu waqt it- treddigħ
Tracleer may cause dizziness, which could influence the ability to drive or use machines.
Tracleer jista ‘ jikkawża sturdament, li jista ’ jinfluwenza l- ħila biex issuq jew tħaddem il- magni.
In tegrated findings from placebo-controlled trials
Sejbiet integrati minn provi kkontrollati bil- plaċebo
Placebo-controlled trials in primary (idiopathic/familial) PAH and PAH associated with connective tissue diseases
28 Provi kkontrollati bil- plaċebo f’ PAH primarja (idjopatika/ familjali) u PAH marbuta ma ’ mard tat - tessut konnettiv
3. 5%
9 3. 5%
Treatment discontinuations due to adverse events, during the clinical trials in patients with pulmonary arterial hypertension, at doses of 125 and 250 mg twice daily, occurred with the same frequency (5.8%) in bosentan and placebo-treated patients.
It- twaqqif tal- kura minħabba l- effetti avversi, matul il- provi kliniċi fuq pazjenti bi pressjoni għolja arterjali pulmonari, b’ dozi ta ’ 125 u 250 mg darbtejn kuljum, seħħew bl- istess frekwenza (5. 8%) fil- pazjenti li ħadu bosentan u fil- pazjenti li ħadu l- plaċebo.
Placebo-controlled trial in PAH associated with congenital heart disease (BREATHE-5)
Prova kkontrollata bil- plaċebo f' PAH marbuta ma ’ mard konġenitali tal- qalb (BREATHE- 5)
11.8%), palpitations (10.8% vs.
5. 9%) u wġigħ fis- sider (8. 1% vs.
Aspartate aminotransferase increased Alanine aminotransferase increased Liver function test abnormal
Żieda fl- aspartate aminotransferase Żieda fl- alalanine aminotransferase Test tal- funzjoni tal- fwied mhux normali
Laboratory abnormalities
30 Anormalitajiet fil- laboratorju
The y returned, in all cases during the clinical programme, to pre-treatment levels, without sequelae, within a few days to 9 weeks either spontaneously or after dose reduction or discontinuation.
Il- livelli ta ’ aminotransferases f’ kull pazjent fl- istudju kliniku, reġgħu lura għal- livelli ta ’ qabel bdiet il- kura, mingħajr konsegwenzi, fi ftit jiem sa 9 ġimgħat, jew b’ mod spontanju jew wara li tnaqqset jew twaqqfet id- doża.
In studies in patients with pulmonary arterial hypertension, the incidence of elevated liver aminotransferases (> 3 × ULN) was 12.8% in bosentan-treated patients (N = 257), 12.3% in patients treated with 125 mg twice daily and 14.3% in patients treated with 250 mg twice daily.
Fi studji fuq pazjenti bi pressjoni għolja arterjali pulmonari, l- inċidenza taż- żieda fl- aminotransferases tal- fwied (> 3 × LFN) kienet 12. 7% f’ pazjenti kkurati b’ bosentan (N = 256), 12. 3% f’ pazjenti kkurati b’ 125 mg darbtejn kuljum u 14. 3% f’ pazjenti kkurati b’ 250 mg darbtejn kuljum.
In the two studies in patients with digital ulcers the incidence of elevated liver aminotransferases (> 3 × ULN) was 11.3% in bosentan-treated patients (N = 168) compared with 0.8% in placebo-treated patients (N = 1 29).
Fiż- żewġ studji f’ pazjenti b’ ulċeri fis- swaba l- inċidenza ta ’ żieda fl- aminotransferases tal- fwied (> 3 × ULN) kienet ta ’ 11. 3% f’ pazjenti kkurati b’ bosentan (N = 168) meta mqabbla ma ’ 0. 8% f’ pazjenti kkurati bil- plaċebo (N = 129).
In the two studies in patients with digital ulcers, clinically relevant decreases in haemoglobin (decrease from baseline resulting in haemoglobin values < 10 g/dL) were observed in 4.2% of bosentan-treated patients (N = 167), compared with 3.1% of placebo-treated patients (N = 129).
Fiż- żewġ studji f’ pazjenti b’ ulċeri fis- swaba, tnaqqis fl- emoglobina (tnaqqis mill- linja bażi li rriżultaw f’ valuri ta ’ l- emoglobina ta ’ < 10 g/ dL) ta ’ sinifikanza klinika kienu osservati f’ 4. 2% tal- pazjenti kkurati b’ bosentan (N = 167), meta mqabbla ma ’ 3. 1% tal- pazjenti kkurati bil- plaċebo (N = 129).
Post-Marketing Experience
31 Esperjenza ta ’ Wara l- Bejgħ
The neurohormone endothelin-1 (ET-1) is one of the most potent vasoconstrictors known and can also promote fibrosis, cell proliferation, cardiac hypertrophy, and remodeling and is pro-inflammatory.
32 In- newro- ormon endothelin- 1 (ET- 1) huwa wieħed mis- sustanzi magħrufa l- iktar qawwija li jdejjaq il - vini u l- arterji u li jista ’ jikkawża wkoll il- fibrożi, il- proliferazzjoni taċ- ċelluli, it- tkabbir tal- qalb, u jista ’ jerġa ’ jimmudella l- qalb u jippromwovi l- infjammazzjoni.
The differences between the two groups 125 mg twice daily and
Iż- żidiet fid- distanza tal- mixja korretti għal plaċebo, meta mqabbla mal- linja bażi kienu 76 metru (p = 0. 02; t- test) u 44 metru (p = 0. 0002; U test ta ’ Mann- Whitney) fl- endpoint primarju ta ’ kull prova, rispettivament.
31 250 mg twice daily were not statistically significant but there was a trend towards improved exercise capacity in the group treated with 250 mg twice daily.
Id- differenzi bejn iż- żewġ gruppi, fejn grupp ingħata 125 mg darbtejn kuljum u grupp ieħor ingħata 250 mg darbtejn kuljum, ma kienux statistikament sinifikanti imma kien hemm tendenza lejn titjib fil- kapaċità ta ’ l- eżerċizzju fiżiku fil- grupp ikkurat bil- 250 mg darbtejn kuljum.
Of the 7 patients that deteriorated at week 8, 3 improved at week 12/16 and 4 deteriorated compared with baseline.
Mis- 7 pazjenti li
Invasive haemodynamic parameters were assessed in the first study only.
33 marru għall- agħar wara 8 ġimgħat, 3 marru għall- aħjar wara 12/ 16- il ġimgħa u 4 marru għall- agħar meta mqabbla mal- linja bażi.
In a randomised, double-blind, multi-centre, placebo-controlled trial (AC-052-364; EARLY),185 PAH patients in WHO functional class II (mean baseline 6-minute walk distance of 435 metres) received bosentan 62.5 mg b.i.d. for 4 weeks followed by 125 mg b.i.d.
Fi prova randomised, double- blind, multi- centre u kkontrollata bil- plaċebo (AC- 052- 364; EARLY), 185 pazjent b’ PAH fi klassi II ta ’ l- istat funzjonali tal- WHO (medja fil- linja bażi tad- distanza ta ’ mixja f’ 6 minuti ta ’ 435 metru) irċevew bosentan 62. 5 mg b. i. d. għal 4 ġimgħat segwit minn 125 mg b. i. d.
The re was one hospitalisation related to PAH worsening in the bosentan group and 3 hospitalisations in the placebo group.Only one death occurred in each treatment group during the 6-month double-blind study period, therefore no conclusion can be drawn on survival.
F’ kull grupp ta ’ kura seħħet biss mewt waħda waqt il- perijodu ta ’ studju double- blind ta ’ 6 xhur, għalhekk ma tista 'tittieħed l- ebda konklużjoni dwar is- sopravivenza.
The primary objective was to show that Tracleer did not worsen hypoxaemia.
L- għan prinċipali kien li jintwera li Tracleer ma jiggravax il- livell baxx ta ’ ossiġnu fid- demm.
After 16 weeks, the mean oxygen saturation was increased in the bosentan group by 1.0% (95% CI –0.7; 2.8%) as compared to the placebo group, showing that
Wara 16- il ġimgħa, il- medja tas- saturazzjoni ta ’ l- ossiġnu żdiedet fil- grupp ta ’ bosentan minn 1. 0% (95% CI – 0. 7; 2. 8%) meta mqabbla mal- grupp tal- plaċebo, li turi li bosentan ma ’ kompliex jiggrava l- livell baxx ta ’ ossiġnu fid- demm.
The mean pulmonary vascular resistance was significantly reduced in the bosentan group (with a predominant effect observed in the subgroup of patients with bidirectional intracardiac shunt).
Il- medja tar- reżistenza vaskulari pulmonari kienet imnaqqsa b’ mod sinifikattiv fil- grupp ta ’ bosentan (b’ effett predominanti osservat fis - sottogrupp ta ’ pazjenti b’ shunt intrakardijaku bi- direzzjonali).
Patients were treated with Tracleer 62.5 mg bid for 4 weeks followed by 125 mg bid for a further 12 weeks.
Il- pazjenti kienu kkurati bi 62. 5 mg ta ’ Tracleer mogħtija darbtejn kuljum għal 4 ġimgħat, segwiti minn 125 mg mogħtija darbtejn kuljum
The re are no studies to demonstrate beneficial effects on survival of treatment with Tracleer.
M’ hemm l- ebda studji li juru effetti ta ’ beneficcju fuq is- sopravivenza tal- kura bi Tracleer.
AC-052-355 (BREATHE-2) and AC-052-356 (BREATHE-3).
L- użu ta ’ Tracleer flimkien ma ’ epoprostenol Il- kumbinazzjoni ta ’ Tracleer u epoprostenol kienet eżaminata f’ żewg studji AC- 052- 355 (BREATHE- 2) u AC- 052- 356 (BREATHE- 3).
AC-052-355 was a multi-centre, randomised, double-blind, parallel-group trial of Tracleer versus placebo in 33 patients with severe pulmonary arterial hypertension who were receiving concomitant epoprostenol therapy.
AC- 052- 355 kienen prova multi- ċentrika, randomised, double- blind, parallel- group ta ’ Tracleer kontra l- plaċebo fi 33 pazjent bi pressjoni għolja arterjali pulmonari serja li kienu qed jirċievu terapija b’ epoprostenol konkomitanti.
33 Systemic sclerosis with digital ulcer disease Two randomised, double-blind, multi-centre, placebo-controlled trials have been conducted in 122 (Study AC-052-401, RAPIDS-1) and 190 (Study AC-052-331, RAPIDS-2) adult patients with systemic sclerosis and digital ulcer disease (either ongoing digital ulcers or a history of digital ulcers within the last year).
Sklerosi sistemika bil- marda tal- ulċeri fis- swaba Saru żewġ provi kkontrollati bil- plaċebo, randomised, double- blind u multi- centre, f’ 122 (Studju AC - 052- 401, RAPIDS- 1) u 190 (Studju AC- 052- 331, RAPIDS- 2) pazjent adult bi sklerosi sistemika u l - marda tal- ulċeri fis- swaba (preżenza ta ’ ulċeri fis- swaba jew passat ta ’ ulċeri fis- swaba fl- aħħar sena).
In study AC-052-331, patients had to have at least one digital ulcer of recent onset, and across the two studies 85% of patients had ongoing digital ulcer disease at baseline.
Fl- istudju AC- 052- 331, il- pazjenti ried ikkollhom mill- anqas ulċera waħda fis- swaba b’ bidu reċenti, u 35 tul iż- żewġ studji 85% tal- pazjenti kellhom il- preżenza tal- marda tal- ulċeri fis- swaba fil- linja bażi.
Biotransformation and elimination
Bijotransformazzjoni u eliminazzjoni
34 Upon multiple dosing, plasma concentrations of bosentan decrease gradually to 50%–65% of those seen after single dose administration.
Wara ħafna dozi, il- konċentrazzjonijiet ta ’ bosentan fil- plażma jonqsu gradwalment għal 50% – 65% ta ’ dawk li jidhru wara doża waħda.
Bosentan is eliminated by biliary excretion following metabolism in the liver by the cytochrome P450 isoenzymes, CYP2C9 and CYP3A4.
36 Bosentan jiġi eliminat mis- sistema tal- marrara wara metaboliżmu fil- fwied mill- isoenzimi taċ - ċitokromju P450, CYP2C9 u CYP3A4.
Renal impairment In patients with severe renal impairment (creatinine clearance 15–30 ml/min), plasma concentrations of bosentan decreased by approximately 10%.
Indeboliment tal- kliewi F’ pazjenti b’ indeboliment serju tal- kliewi (tneħħija tal- krejatinina 15– 30 ml/ min), il - konċentrazzjonijiet ta ’ bosentan fil- plażma naqsu b’ madwar 10%.
35 5.3 Preclinical safety data
37 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
The re was evidence for a mild thyroid hormonal imbalance induced by bosentan in rats.
Kien hemm evidenza ta ’ żbilanċ żgħir fl- ormoni tat- tirojde ikkawżat minn bosentan fil- firien.
Hypromellose Glycerol triacetate Talc Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Ethylcellulose
Hypromellose Glycerol triacetate Talc Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Ethylcellulose
6.3 Shelf life
38 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Cartons contain 56 or 112 film-coated tablets.
Il- kartun fihom 56 jew 112- il pillola miksija b’ rita.
No t all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal bejgħ.
15 May 2002
15 ta ’ Mejju, 2002 Data ta ’ tiġdid:
Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63-65 79100 Freiburg Germany
Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63- 65 79100 Freiburg Ġermanja
The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all health care professionals who intend to prescribe and/or dispense Tracleer are provided with a Prescriber Kit containing the following:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiftieħem dwar id- dettalji ta ’ sistema ta ’ distribuzzjoni kkontrollata ma ’ l- Awtoritajiet Nazzjonali Kompetenti u għandu jimplimenta dan il - programm b’ mod nazzjonali biex jiżgura li qabel jiġi preskrit il- professjonisti fil- qasam tas- saħħa kollha b’ intenzjoni li jippreskrivu u/ jew iqassamu Tracleer huma pprovduti b’ Kit tat- Tabib li fiha li ġej:
Information about Tracleer Patient Information Booklet/Patient Reminder Card
Informazzjoni dwar Tracleer Fuljett ta ’ Tagħrif għall- Pazjent/ Kartuna biex Tfakkar tal- Pazjent
The MAH shall set up a surveillance programme/registry to collect information on the demographics, safety and outcome data from patients prescribed Tracleer to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jorganizza programm/ reġistru ta ’ sorveljanza biex jiġbor informazzjoni ta ’ demografija, siġurtà u tagħrif dwar ir- riżultat minn pazjenti li ġew preskritti Tracleer biex inaqqas in- numru ta ’ ulċeri fis- swaba ġodda f’ pazjenti bi sklerosi sistemika u l- preżenza tal- marda tal- ulċeri fis- swaba.
The data to be collected shall be agreed with the CHMP.
It- tagħrif li għandu jinġabar ser jiġi miftiehem ma ’ CHMP.
Details of the operation of the surveillance programme/registry shall be agreed with the National Competent Authorities in each Member State.
Dettalji dwar kif jaħdem il- programm/ reġistru ta ’ sorveljanza ser jiġu miftemha ma ’ l - Awtoritajiet Nazzjonali Kompetenti f’ kull Stat Membru.
The information provided about Tracleer shall contain the following key elements:
L- informazzjoni pprovduta dwar Tracleer se jkollha l- punti essenzjali li ġejjin:
That Tracleer is teratogenic in animals o Use in pregnant women is contraindicated o The need for effective contraception o That there is an interaction with hormonal contraceptives o Monthly pregnancy tests in women of child bearing potential are recommended.
Li Tracleer huwa teratoġeniku fl- annimali o Użu f’ nisa tqal huwa kontra- indikat o Il- bżonn ta ’ metodu ta ’ kontraċezzjoni effettiv o Li ma jaqbilx ma ’ kontraċettivi ormonali u jista ’ jbiddel l- effett farmaċewtiku tagħhom o Huwa rakkomandat test għat- tqala kull xahar f’ nisa b’ potenzjal li jkollhom it- tfal.
That Tracleer is hepatotoxic o Tracleer should not be used in Child Pugh Class B or C, ie moderate to severe hepatic impairment. o Need for liver function tests to be measured:
Li Tracleer huwa epatotossiku o Tracleer m’ għandux jintuża fi Klassi Child Pugh B jew C, jiġifieri indeboliment tal- fwied moderat sa sever. o Il- bżonn li jiġu mkejla t- testijiet għall- funzjoni tal- fwied:
Prior to initiation of treatment At monthly intervals during complete course of the treatment Two weeks after any dose increase. o Need for close monitoring and dosage adjustment if levels rise above 3 x upper limit normal (ULN): > 3 and ≤ 5 x ULN:
Il- bżonn għal sorveljanza mill- viċin u bidla fid- doża jekk il- livelli jitilgħu għall - o aktar minn 3 x l- ogħla limitu tan- normal (ULN):
Confirm levels and if confirmed, reduce the daily dose or stop treatment and monitor liver function at least every 2 weeks. > 5 and ≤ 8 x ULN:
Ikkonferma l- livelli u jekk ikkonfermati naqqas id- doża ta ’ kuljum jew waqqaf il- kura u ssorvelja l- funzjoni tal- fwied mill- anqas kull ġimagħtejn. > 5 u ≤ 8 x ULN:
Confirm levels and if confirmed stop treatment and monitor liver function at least every 2 weeks.
Ikkonferma l- livelli u jekk ikkonfermati waqqaf il- kura u ssorvelja l- funzjoni tal- fwied mill- anqas kull ġimagħtejn.
In the above circumstances, if the levels return to pre-treatment values, continuing or re-introducing Tracleer may be considered.
Fiċ- ċirkustanzi ta ’ fuq, jekk il- livelli jirritornaw għall- valuri ta ’ qabel il - kura, jista ’ jiġi kkunsidrat li jitkompla jew jerġa jinbeda mill- ġdid Tracleer. > 8 x ULN jew kull wieħed minn ta ’ fuq flimkien ma ’ sintomi klinikali ta ’ ħsara fil- fwied assoċjati:
Treatment must be stopped and re-introduction of Tracleer is not to be considered.
Il- kura għandha titwaqqaf u bidu ta ’ Tracleer mill - ġdid m’ għandux jiġi kkunsidrat.
That treatment with Tracleer is associated with a decrease in haemoglobin. o Need for blood monitoring Prior to initiation of treatment Monthly during the first 4 months Quarterly thereafter.
Bżonn ta ’ sorveljanża tad- demm o Qabel ma tinbeda l- kura Kull xahar waqt l- ewwel 4 xhur Minn hemm ’ l quddiem kull 3 xhur.
That co-administration of Tracleer with cyclosporine is contraindicated.
L- għotja ta ’ Tracleer flimkien ma ’ cyclosporine hija kontra- indikata.
That the safety database of Tracleer in the indication to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease is limited and physicians are encouraged to enrol patients in the surveillance programme/registry to further increase knowledge about the product.
Li l- ħażna tad- data dwar is- sigurtà ta ’ Tracleer fl- indikazzjoni biex inaqqas in- numru ta ’ ulċeri fis- swaba ġodda f’ pazjenti bi sklerosi sistemika u l- preżenza tal- marda tal- ulċeri fis- swaba huwa limitat u t- tobba huma mħeġġa biex idaħħlu l- pazjenti fil - programm/ reġistru ta ’ sorveljanza biex b’ hekk jiżdied aktar it- tagħrif dwar il- prodott.
The surveillance programme/registry should prompt doctors to report adverse reactions.
Il - programm/ reġistru ta ’ sorveljanza għandu jħeġġeġ lit- tobba biex jirrappurtaw reazzjonijiet avversi.
The patient information shall contain the following information:
L- informazzjoni għall- pazjent se jkollha l- informazzjoni li ġejja:
That Tracleer is teratogenic in animals That pregnant women must not take Tracleer That women of child bearing potential must use effective contraception That hormonal contraceptives on their own are not effective The need for regular pregnancy tests That Tracleer causes a decrease in haemoglobin and the need for regular blood tests That Tracleer is hepatotoxic and the need for regular monitoring of liver function
Li Tracleer huwa teratoġeniku fl- annimali Li nisa tqal m’ għandhomx jieħdu Tracleer Li nisa b’ potenzjal li jkollhom it- tfal għandhom jużaw mezz effettiv ta ’ kontraċezzjoni Li kontraċettivi ormonali waħedhom ma jkunux effettivi Il- bżonn għal testijiet tat- tqala regolari Li Tracleer jikkawża tnaqqis fl- emoglobina u l- bżonn ta ’ testijiet tad- demm regolari Li Tracleer huwa epatotossiku u l- bżonn ta ’ sorveljanza regolari tal- funzjoni tal- fwied.
The MAH shall agree with each National Competent Authority the content of a "Reminder Letter" to all known prescribers of Tracleer, reminding them of the safety concerns with Tracleer in relation to pregnancy.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq ser jiftiehem ma ’ kull Awtorità Kompetenti Nazzjonali dwar il- kontenut ta ’ “ Ittra li Tfakkar ” lil kull minn jippreskrivi Tracleer, li tfakkarhom dwar tħassib ta ’ sigurtà b’ Tracleer b’ konnessjoni mat- tqala.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version dated 23 May 2008 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq iwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza oħrajn dettaljati fil- Pjan ta ’ Farmakoviġilanza kif miftiehem f’ verżjoni datata 23 ta ’ Mejju 2008 tal- Pjan għall- Immaniġġjar ta ’ Riskji (RMP) ippreżentat f’ Modulu 1. 8. 2. ta ’ l - Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti ta ’ l- RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji Gwida tas- CHMP dwar is- Sistemi ta ’ Mmaniġġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil- bniedem, kull RMP mġedded għandu jiġi ppreżentat fl- istess żmien mar- Rapport Perjodiku Aġġornat dwar is- Sigurtà (PSUR) ta ’ wara.
In addition, an updated RMP should be submitted
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Meta tinkiseb informazzjoni ġdida li jista ’ jkollha effett fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà kurrenti, Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskji
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Fi żmien 60 ġurnata wara li tintlaħaq mira mportanti (farmakoviġilanza jew tnaqqis ta ’ riskji)
At the request of the EMEA
Fuq talba ta ’ l- EMEA
The MAH will submit 6-monthly PSURs including liver reports, unless otherwise specified by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq ser jissottometti PSURs kull 6 xhur, inkluż rapporti dwar il- fwied, sakemm speċifikat mod ieħor mis- CHMP.
40 ANNEX III
43 ANNESS III
LABELLING AND PACKAGE LEAFLET
TIKKETTA U FULJETT TA‘ TAGĦRIF
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING [62.5 mg: boxes with 14, 56 and 112 tablets]
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA [62. 5 mg kaxxi b’ 14, 56 u 112- il pillola]
Tracleer 62.5 mg film-coated tablets
Tracleer 62. 5 mg, pilloli miksija b’ rita
One film-coated tablet contains 62.5 mg bosentan (as monohydrate)
Pillola waħda miksija b’ rita fiha 62. 5 mg bosentan (bħala monohydrate)
14 film-coated tablets 56 film-coated tablets 112 film-coated tablets
14- il pillola miksija b’ rita 56- il pillola miksija b’ rita 112- il pillola miksija b’ rita
Marketing Authorisation Holder:
Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING [125 mg: boxes with 56 and 112 tablets]
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA [125 mg: kaxxi b’ 56 u 112- il pillola]
Tracleer 125 mg film-coated tablets
Tracleer 125 mg, pilloli miksija b’ rita
One film-coated tablet contains 125 mg bosentan (as monohydrate)
Pillola waħda miksija b’ rita fiha 125 mg bosendan (bħala monohydrate)
56 film-coated tablets 112 film-coated tablets
56- il pillola miksija b’ rita 112- il pillola miksija b’ rita
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS [62.5 mg]
49 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Tracleer 62.5 mg tablets
Tracleer 62. 5 mg, pilloli
47 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS [125 mg]
50 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Tracleer 125 mg tablets
Tracleer 125 mg, pilloli
48 PATIENT REMINDER CARD
51 KARTUNA BIEX TFAKKAR LILL- PAZJENT ((Faċċata
((Front cover)) Important Safety Reminders for Patients taking
ta ’ quddiem)) Noti importanti dwar is- Sigurtà għall- Pazjenti li qed jieħdu Tracleer (bosentan)
((Back cover)) Contraception
((Faċċata ta ’ wara)) Kontraċezzjoni
Tracleer (bosentan) This card contains important information about Tracleer.
Bħalissa qed tuża jew tieħu kontraċettivi?
Yes No
Din il- kartuna fiha informazzjoni importanti dwar Tracleer.
carefully before starting your treatment with Tracleer.
Jekk jogħġbok aqra din il - kartuna b’ attenzjoni qabel tibda l- kura tiegħek b’ Tracleer
If Yes, write the names of these here:
Iva
Your name: __________________________________________________ Prescribing doctor: ________________________________________
Le
______________________________________ ______________________________________
Ismek: ____________________________________ ______________________________________ It- tabib li kiteb ir- riċetta: ______________________________ ______________________________________ Jekk għandek xi mistoqsijiet dwar Tracleer staqsi lit- tabib tiegħek.
Actelion Registration Ltd.
Ħu din il- kartuna għand it- tabib jew ġinekologu tiegħek fil- vista tiegħek li jmiss u hu/ hi Actelion Registration Ltd.
Take this card to your doctor or your gynaecologist at your next visit and he/she will be able to advise you on whether you need to use additional or alternative contraceptive methods.
jkunu jistgħu jagħtuk parir dwar jekk int għandekx bżonn tuża metodi kontraċettivi oħra jew alternattivi.
((Inside 1)) If you are a female patient of child bearing age read this page carefully Pregnancy Tracleer may harm the development of the foetus.
((Ġewwa 1)) Jekk inti pazjenta femminili b’ età li jista ’ jkollok it- tfal aqra din il- paġna b’ attenzjoni Tqala Tracleer jista ’ jagħmel ħsara lit- tarbija li għadha ma twelditx.
Therefore, you should not take Tracleer if you are pregnant and you should also not become pregnant while taking Tracleer.
Għalhekk, m’ għandekx tieħu Tracleer jekk inti tqila u m’ għandekx toħroġ tqila waqt li qed tieħu Tracleer.
Moreover, if you are treated with Tracleer for pulmonary hypertension disease, the occurrence of a pregnancy can severely deteriorate the symptoms of your
Barra dan, jekk tiġi kkurata b’ Tracleer għall- pressjoni pulmonari għolja, l- okkorrenza ta ’ tqala tista ’ tiddeterjora b’ mod sever is- sintomi tal- marda tiegħek.
((Inside 2)) Blood Test for Liver Function Some patients taking Tracleer were found to have abnormal liver function tests.
((Ġewwa 2)) Test tad- Demm għall- Funzjoni tal- Fwied Instab li xi pazjenti li kienu qed jieħdu Tracleer kellhom testijiet tal- funzjoni tal- fwied mhux normali.
During treatment with Tracleer, your doctor will arrange for regular blood tests to check for changes in your liver function.
Matul il- kura b’ Tracleer, it- tabib tiegħek ser jirranġalek biex isirulek testijiet tad- demm regolari biex jiċċekkja għal bidliet fil- funzjoni tal- fwied tiegħek.
Remember to have your liver blood test every month.
Ftakar biex tagħmel it- test tad- demm tal- fwied kull xahar.
After an increase in dose, an additional test will be done after 2 weeks.
Wara żieda fid- doża, għandu jsir test addizzjonali wara ġimagħtejn.
Date of first monthly test: _________________________________
Data ta ’ l- ewwel test ta ’ kull xahar: _______________________
Contraception Birth control based on hormones – such as oral contraceptives or birth control
Kontraċezzjoni Kontroll tat- twelid ibbażat fuq l- ormoni – bħal kontraċettivi orali jew pilloli għall - kontroll tat- twelid, injezzjonijiet ta ’ l- ormoni, impjanti, jew garża li tipprovdi mediċina
Your monthly liver blood test schedule:
L- iskeda tiegħek ta ’ kull xahar tat- test tad- demm għall- funzjoni tal- fwied:
Jan ______ May ______ Sep _____
Jan ______ Mej ______ Set _____
You need to use a
għall- kontroll tat- twelid li tgħaddi minn ġol- ġilda ma jipprevenux it- tqala b’ mod affidabbli f’ nisa li qed jieħdu Tracleer.
Be sure to discuss
Trid tuża forma ta ’ barriera għall- kontroll tat - twelid – bħal kondom, dijaframma jew sponża vaġinali – barra kull tip ta ’ kontroll tat - twelid ormonali.
any questions you may have with your doctor or your gynaecologist – complete the details on the back of this card and take it to your doctor or gynaecologist at your next visit.
Kun ċert li tiddiskuti kull mistoqsija li jista ’ jkollok mat- tabib jew ġinekologu tiegħek – imla id- dettalji kollha fuq il- parti ta ’ wara ta ’ din il- kartuna u ħudha miegħek fil- vista li jmiss għand it- tabib jew ġinekologu tiegħek.
You should have a pregnancy test before initiation of Tracleer and every month during the treatment even if you think that you are not pregnant.
Għendek tagħmel test tat- tqala qabel tibda tieħu Tracleer u kull xahar waqt il- kura anki jekk taħseb li int mhux tqila.
Date of first monthly test:
Data ta ’ l- ewwel test ta ’ kull xahar:
Apr ______ Aug ______ Dec _____
Frar ______ Ġun ______ Ott _____ Mar ______ Lul ______ Nov _____ Apr ______ Aww ______ Diċ _____
50 PACKAGE LEAFLET:
53 FULJETT TA ’ TAGĦRIF:
Tracleer 62.5 mg film-coated tablets Bosentan
Bosentan
please tell your doctor or pharmacist.
elenkati f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Tracleer is and what it is used for 2.
X’ inhu Tracleer u għalxiex jintuża 2.
Before you take Tracleer 3.
Qabel ma tieħu Tracleer 3.
How to take Tracleer 4.
Kif għandek tieħu Tracleer 4.
Tests during treatment 5.
Testijiet waqt il- kura 5.
How to store Tracleer 7.
Kif taħżen Tracleer 7.
WHAT TRACLEER IS AND WHAT IT IS USED FOR
X’ INHU TRACLEER U GĦALXIEX JINTUŻA
Tracleer tablets are indicated in pulmonary hypertension (high blood pressure in the blood vessels in the lungs).
Il- pilloli Tracleer jintużaw għall- pressjoni għolja pulmonari (pressjoni għolja fil- vini u fl- arterji pulmonari).
Tracleer brings down blood pressure by widening these vessels.
Tracleer iniżżel il- pressjoni tad- demm billi jwessa ’ l- vini u l- arterji.
Tracleer tablets belong to the class of medicines called endothelin receptor antagonists.
Il- pilloli Tracleer jagħmlu parti mill- klassi ta ’ mediċini msejħa antagonisti tar- riċetturi ta ’ endothelin.
Tracleer tablets are also indicated in digital ulcers (ulcers of the fingers) in people with a condition called scleroderma.
Pilloli Tracleer huma ndikati wkoll għall- kura ta ’ ulċeri fis- swaba (ulċeri tas- swaba ta ’ l- id) f’ nies b’ kundizzjoni msejħa skleroderma.
Tracleer reduces the number of new finger ulcers that appear.
Tracleer inaqqas n- numru ta ’ ulċeri ġodda fis- swaba.
BEFORE YOU TAKE TRACLEER
QABEL MA TIEĦU TRACLEER
Do not take Tracleer… • if you are allergic (hypersensitive) to bosentan or any of the other ingredients of the tablet • if you have liver problems (ask your doctor) • if you are pregnant, or could get pregnant because you are not using reliable contraceptive methods (hormonal contraceptives alone are not effective when you take Tracleer) • if you are taking cyclosporine A (a medicine used after a transplant or to treat psoriasis)
• jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal bosentan jew sustanzi oħra ta ’ Tracleer • jekk tbati minn problemi tal- fwied (staqsi lit- tabib tiegħek) • jekk int tqila, jew tista ’ toħrog tqila minħabba li m’ intix qed tuża metodu ta ’ kontraċezzjoni affidabbli (kontraċettivi ormonali waħedhom mhumiex effettivi meta inti tieħu Tracleer) • jekk qed tieħu cyclosporine A (mediċina li tittieħed wara trapjant jew biex tikkura l- psorjasi)
Tests your doctor will do before treatment • A blood test for liver function • A blood test for anaemia • A pregnancy test
Testijiet li għandu jagħmel it- tabib tiegħek qabel il- kura • Test tad- demm għall- funzjoni tal- fwied • Test tad- demm għall- anemija • Test tat- tqala
It is especially important to tell your doctor if you are taking: • hormonal contraceptives (as these are not effective as the sole method of contraception when you take Tracleer).
B’ mod speċjali, għid lit- tabib tiegħek jekk qed tieħu: • kontraċettivi ormonali (peress li dawn mhumiex effettivi bħala metodu waħdu ta ’ kontraċezzjoni meta inti tieħu Tracleer).
Inside your pack of Tracleer tablets you will find a patient reminder card which you should read carefully.
Ġol- pakkett tiegħek tal- pilloli Tracleer ser issib kartuna biex tfakkar lill- pazjent, li inti għandek taqra b’ attenzjoni.
Your doctor and/or gynaecologist will establish the contraception which is appropriate for you.
It- tabib u/ jew ġinekologu tiegħek ser jistabilixxi il- kontraċezzjoni li hija xierqa għalik.
51 • glibenclamide (for diabetes) • cyclosporine A (a medicine used after transplants and to treat psoriasis), or any other drugs used to prevent rejection of transplanted organs • fluconazole (to treat fungal infections) • rifampicin (to treat tuberculosis)
54 • glibenclamide (għad- dijabete) • cyclosporine A (mediċina li tintuża wara t- trapjanti u biex tikkura l- psorjasi), jew kwalunkwe mediċini oħrajn użati għal prevenzjoni tar- rifjut ta ’ organi trapjantati • fluconazole (għall- kura ta ’ infezzjonijiet ikkawżati mill- fungi) • rifampicin (biex tikkura t- tuberkulosi)
Taking Tracleer with food and drink Tracleer can be taken with or without food.
Meta tieħu Tracleer ma ’ l- ikel u x- xorb Tracleer jista ’ jittieħed ma ’ l- ikel jew mingħajr l- ikel.
You should swallow the tablet with a glass of water.
Għandek tibla ’ l- pillola sħiħa ma ’ tazza ilma.
Pregnancy Tell your doctor at once if you are pregnant or plan to become pregnant in the near future.
Tqala Jekk inti tqila, jew jekk qed taħseb biex toħrog tqila fil- futur qarib, avża lit- tabib tiegħek immedjatament.
You must not take Tracleer if you are pregnant and you must also not become pregnant while taking Tracleer, because it cannot be excluded that Tracleer may harm the foetus.
M’ għandekx tieħu Tracleer jekk inti tqila u m’ għandekx toħroq tqila waqt li tkun qed tieħu Tracleer, għaliex ma jistax jiġi eskluż li Tracleer jista ’ jagħmel ħsara lill- fetu.
If you are a woman of childbearing age, your doctor or gynaecologist will advise you about reliable contraceptive methods while taking Tracleer.
Jekk inti ta ’ età li tista ’ toħroġ tqila, it- tabib jew ġinekologu tiegħek ser jagħtik parir dwar metodi ta ’ kontraċezzjoni affidabbli għal meta tkun qed tieħu Tracleer.
Because Tracleer may make hormonal contraception (e.g., oral, injection, implant or skin patches) ineffective, this method on its own is not reliable.
Minħabba li Tracleer jista ’ jirrendi l - kontraċezzjoni ormonali (eż. orali, injezzjoni impjant jew gareż għall- ġilda) mhux effettiva, dan il - metodu waħdu mhuwiex affidabbli.
Therefore, if you use hormonal contraceptives you must also use a barrier method (e.g., female condom, diaphragm, contraceptive sponge or your partner must also use a condom).
Għalhekk, jekk inti qed tuża kontraċettivi ormonali għandek tuża wkoll metodu ta ’ barriera (e. ż., kondom tan- nisa, dijaframma, sponża kontraċettiva jew is- sieħeb tiegħek għandu juża wkoll kondom).
Inside your pack of Tracleer tablets you will find a patient reminder card.
Ġol- pakkett tiegħek ta ’ pilloli Tracleer ser issib kartuna biex tfakkar lill- pazjent.
You should complete this card and take it to your doctor at your next visit so that your doctor or gynaecologist can assess whether you need additional or alternative reliable contraceptive methods.
Għanddek timla din il- kartuna u teħodha lit- tabib tiegħek fil- vista li jmiss biex it - tabib jew ġinekologu jkun jista ’ jivvaluta jekk int għandekx bżonn ta ’ metodi ta ’ kontraċezzjoni affidabli oħra jew alternattivi.
Monthly pregnancy tests are recommended while you are taking Tracleer and you are of childbearing age.
Jekk inti ta ’ età li jista ’ jkollok it- tfal għandek tagħmel test tat- tqala kull xahar waqt li tkun qed tieħu Tracleer.
Breast-feeding Tell your doctor at once if you are breast-feeding.
Jekk qed tredda ’ Għid lit- tabib minnufih tiegħek jekk qed tredda ’.
You are advised to stop breast-feeding if Tracleer is prescribed for you because it is not known if this medicine passes into the milk of women who are taking Tracleer.
Inti avżata biex twaqqaf it- treddigħ jekk tingħata riċetta għal Tracleer, għax mhux magħruf jekk din il- mediċina tgħaddix minn ġol- ħalib tas- sider tan - nisa li jkunu qed jieħdu Tracleer.
Driving and using machines If you feel dizzy while taking Tracleer, do not drive or operate any tools or machines.
Sewqan u tħaddim ta ’ magni Jekk tħossok stordut/ a meta tkun qed tieħu Tracleer, issuqx u tħaddimx għodda jew magni.
HOW TO TAKE TRACLEER
KIF GĦANDEK TIEĦU TRACLEER
Always take Tracleer exactly as your doctor has told you.
Dejjem għandek tieħu Tracleer skond il- parir ta it- tabib.
If you have the impression that the effect of Tracleer is too strong or too weak, talk to your doctor in order to find out whether your dose needs to be changed.
Jekk ikollok l- impressjoni li l- effett ta ’ Tracleer huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew biex issir taf jekk id- doża tiegħek għandhiex bżonn tinbidel.
Usual dose The usual dose is one tablet, twice daily (morning and evening), swallowed with or without food.
Doża normali Id- doża normali hi ta ’ pillola waħda, darbtejn kuljum (filgħodu u filgħaxija), li tinbela ’ ma ’ l- ikel jew mingħajru.
For the first 4 weeks you will take a 62.5 mg tablet twice daily, from then on your doctor will usually advise you to take a 125 mg tablet twice daily, depending on how you react to Tracleer.
Matul l- ewwel 4 ġimgħat int ser tieħu pillola ta ’ 62. 5 mg darbtejn kuljum, u mbagħad it - tabib tiegħek normalment ser jagħtik parir biex tieħu pillola ta ’ 125 mg darbtejn kuljum.
If you take more Tracleer than you should If you take more tablets than you have been told to take, contact your doctor at once.
Jekk tieħu Tracleer aktar milli suppost Jekk tieħu Tracleer aktar milli suppost, ikkuntattja lit- tabib tiegħek immedjatament.
Children The optimal dosing in children under 12 years of age who have pulmonary arterial hypertension has not been established; consult the treating doctor.
Tfal L- aħjar dożaġġ fi tfal ta ’ taħt 12- il sena li għandhom pressjoni arterjali pulmonari għolja ma ġiex stabbilit; kellem lit- tabib li qed jikkura għal parir.
If you forget to take Tracleer If you forget to take Tracleer, take a dose as soon as you remember, then continue to take your tablets at the usual times.
55 Jekk tinsa tieħu Tracleer, ħu d- doża malli tiftakar, u mbagħad kompli ħu l- pilloli fil- ħinijiet li suppost.
Do not take a double dose to make up for forgotten tablets.
M’ għandekx tieħu doża doppja biex tpatti għal pilloli li tkun insejt tieħu.
52 If you stop taking Tracleer Suddenly stopping your treatment with Tracleer may lead to your symptoms getting worse.
Jekk tieqaf tieħu Tracleer Jekk tieqaf tieħu Tracleer f’ daqqa waħda, dan jista ’ jwassal biex is- sintomi tiegħek imorru għall- agħar.
Do not stop taking Tracleer unless your doctor tells you to.
Tieqafx tieħu Tracleer ħlief jekk it- tabib tiegħek jgħidlek tagħmel hekk.
Your doctor may tell you to reduce the dose over a few days before stopping completely.
It- tabib tiegħek jista ’ jgħidlek biex tnaqqas id- doża fuq medda ta ’ ftit jiem qabel ma tieqaf kompletament.
TESTS DURING TREATMENT
TESTIJIET MATUL IL- KURA
Tests your doctor will do during treatment Some patients taking Tracleer were found to have abnormal liver function tests and anaemia (low haemoglobin).
Testijiet li t- tabib tiegħek ser jagħmel matul il- kura Instab li xi pazjenti li kienu qed jieħdu Tracleer kellhom testijiet tal- funzjoni tal- fwied anormali u anemija (livell ta ’ emoglobina baxx).
During treatment with Tracleer, your doctor will arrange for regular blood tests to check for changes in your liver function and haemoglobin level.
Matul il- kura bi Tracleer, it- tabib tiegħek ser jagħmel arranġamenti biex isirulek testijiet regolari tad- demm biex jiċċekkja għal tibdil fil- funzjoni tal- fwied u l- livell ta ’ l- emoglobina.
• Blood tests for liver function These will be done every month for the duration of treatment with Tracleer.
Testijiet tad- demm għall- funzjoni tal- fwied Dawn ser isiru kull xahar għal kemm iddum il- kura b’ Tracleer.
After an increase in dose an additional test will be done after 2 weeks.
Wara żieda fid- doża, ser isir test addizzjonali wara ħmistax.
• Blood tests for anaemia These will be done every month for the first 4 months of treatment, then every 3 months after that.
Testijiet tad- demm għall- anemija Dawn ser isiru kull xahar matul l- ewwel 4 xhur tal- kura, u mbagħad kull tliet xhur.
If these results are abnormal, your doctor may decide to reduce your dose or stop treatment with Tracleer and to perform further tests to investigate the cause.
Jekk dawn it- testijiet ikun anormali, it- tabib tiegħek jista ’ jiddeċiedi li jnaqqas id- doża jew li jwaqqaf il- kura bi Tracleer u jagħmel testijiet addizzjonali biex jinvestiga l- kawża.
For your own safety, it is very important that you have these regular blood tests, both for liver function and anaemia.
Għas- sigurtà tiegħek, huwa importanti ħafna li dawn it- testijiet tad- demm tagħmilhom b’ mod regolari, kemm għall- funzjoni tal- fwied kif ukoll għall- anemija.
We suggest you write the date of your most recent test and also of your next test (ask your doctor for the date) on the patient reminder card, to help you remember when your next test is due.
Nissuġġerixxu li tikteb id- data ta ’ l - iktar test riċenti kif ukoll tat- test li jmiss (staqsi lit- tabib tiegħek għad- data) fuq il- karta tal- pazjent li tfakkrek fid- dati, biex jgħinek tiftakar meta jmissek tagħmel it- test li jmiss.
Your doctor will give this card to you before you start taking Tracleer.
It- tabib tiegħek ser jagħtik din il- karta qabel ma tibda tieħu Tracleer.
• Pregnancy tests for women of childbearing age Due to the risk of failure of hormonal contraception when taking Tracleer and the risk in patients with pulmonary hypertension of rapid and severe deterioration of the disease, monthly pregnancy tests are recommended before and during treatment with Tracleer.
Testijiet tat- tqala għan- nisa li qegħdin fl- età li jistgħu joħorġu tqal Minħabba l- possibbiltà ta ’ falliment ta ’ kontraċezzjoni ormonali waqt kura b’ Tracleer u r- riskju f’ pazjenti b’ pressjoni pulmonari għolja ta ’ deterjorament malajr u sever tal- marda, hu rakkomandat li jsiru testijiet tat- tqala kull xahar qabel u matul il- kura b’ Tracleer.
Like all medicines, Tracleer can cause side effects, although not everybody gets them.
Bħall kull mediċina oħra, Tracleer jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you notice yellowing of the skin or eyes (jaundice), or if you have fever with vomiting or nausea, see your doctor at once because this may be related to abnormal liver function.
Jekk tinduna bi sfura tal- ġilda jew tal- għajnejn (suffejra), jew jekk għandek id- deni bir- rimettar jew dardir, mur fejn it- tabib tiegħek immedjatament għax dan jista ’ jkun marbut ma ’ funzjoni anormali tal- fwied.
If you experience sudden worsening in breathing in the first weeks after starting treatment with Tracleer or changing to a higher dose of Tracleer, contact your doctor immediately as there might be a need to change your treatment.
Jekk it- teħid tan- nifs imur għall- agħar f’ daqqa waħda fl- ewwel ġimgħat wara li tibda l- kura bi Tracleer jew wara li taqleb għal doża ogħla ta ’ Tracleer, ikkuntattja lit- tabib tiegħek minnufih għax jista ’ jkun hemm bżonn li jibdillek il- kura.
• Headache was the most common side effect in clinical studies.
• L- uġigħ ta ’ ras kien l- aktar effett sekondarju komuni fl- istudji kliniċi.
You may also notice one or more of the following side effects:
56 Tista ’ tinnota wkoll wieħed jew iktar minn dawk l- effetti sekondarji li ġejjin:
• flushed appearance, inflammation of the throat and nasal passages, swelling of the legs and ankles or other signs of fluid retention, low blood pressure, palpitations, heartburn, tiredness, itching, nausea, anaemia (low blood count).
• ħmura tal- wiċċ, infjammazzjoni tal- gerżuma u l- passaġġi ta ’ l- imnieħer, nefħa tas- saqajn u tal - għekiesi, jew sinjali oħrajn ta ’ żamma ta ’ fluwidu, pressjoni tad- demm baxxa, palpitazzjonijiet, qrusa fl- istonku, għeja, ħakk, dardir, anemija (għadd tad- demm baxx).
53 Other less common side effects that you might notice include: • vomiting, abdominal pain, diarrhoea, skin rash, reduced blood platelet number.
• rimettar, uġigħ ta ’ żaqq, dijarea, raxx tal- ġilda, numru mnaqqas ta ’ plejtlits fid- demm.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet or signs of allergic reaction (e.g. swelling of the face or tongue, rash, pruritus) while you are taking Tracleer, or if any of the side effects mentioned above worry you, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex elenkati f’ dan il- fuljett jew sinjali ta ’ reazzjoni allergika (eż. nefħa fil- wiċċ jew fl- ilsien, raxx, ħakk) waqt li qed tieħu Tracleer, jew jekk xi wieħed mill- effetti sekondarji msemmi hawn fuq jinkwetak, jekk jogħġbok kellem lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE TRACLEER
KIF TAĦŻEN TRACLEER
Do not use Tracleer after the expiry date which is stated on the carton.
Tużax Tracleer wara d- data ta ’ skadenza li tidher fuq il- kartuna.
What Tracleer contains
X’ fih Tracleer
- The active substance is bosentan.
- Is- sustanza attiva hi bosentan.
- The other ingredients in the tablet core are maize starch, pregelatinised starch, sodium starch
- Is- sustanzi l- oħra fil- qalba tal- pillola huma maize starch, pregelatinised starch, sodium starch
glycollate, povidone, glycerol dibehenate and magnesium stearate.
glycollate, povidone, glycerol dibehenate u magnesium stearate.
The film-coat contains hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and ethylcellulose.
Il- kisja tar- rita fiha hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) u ethylcellulose.
What Tracleer looks like and contents of the pack
Id- Dehra ta ’ Tracleer u l- kontenuti tal- pakkett
Tracleer 62.5 mg film-coated tablets.
Pilloli Tracleer ta ’ 62. 5 mg miksija b’ rita.
Orange-white, round film-coated tablets with “62,5” on one side.
Pilloli miksija b’ rita, oranġjo- bojod, tondi, b ’ “ 62. 5 ” miktuba fuq naħa minnhom.
Cartons contain 14 (62.5mg only), 56 or 112 film-coated tablets.
Kaxxi tal- kartun fihom 14 (62. 5mg biss), 56 jew 112- il pillola miksija b’ rita.
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakketti jistgħu jkunu għall- bejgħ.
Manufacturer responsible for batch release:
Manifattur responsabbli għall- ħruġ tal- lott:
Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63-65 79100 Freiburg Germany
Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63- 65 79100 Freiburg