FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically forcetitrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Maltese: B'kollox 697 pazjent intagħżlu b'mod każwali fi proporzjon ta' 2:1 jew għal irbesartan/hydrochlorothiazide 150 mg/12.5 mg jew għal irbesartan 150 mg u ġew titrati bil-forza b'mod sistematiku (qabel ma rrispons tagħhom għal doża iktar baxxa ġie vvalutat) wara ġimgħa għal irbesartan/hydrochlorothiazide 300 mg/25 mg jew irbesartan 300 mg, rispettivament.
English: What Irbesartan Hydrochlorothiazide BMS contains The active substances are irbesartan and hydrochlorothiazide.
Maltese: Is-sustanzi attivi huma irbesartan u hydrochlorothiazide.
English: Renal impairment and kidney transplantation: when Irbesartan Hydrochlorothiazide BMS is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Maltese: Indeboliment renali u trapjant tal-kliewi: meta Irbesartan Hydrochlorothiazide BMS jintuża f'pazjenti b'indeboliment tal-funzjoni renali, hija rrikmandata osservazzjoni perjodika tal-livelli tal-potassium fis-serum, tal-krejatinina u tal-uric acid.
English: Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Maltese: Il-pilloli miksijin b'rita Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg huma fornuti fi strixxi ta' 14, 28, 56, 84 jew 98 pillola miksija b'rita.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Maltese: Pilloli Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg irbesartan/hydrochlorothiazide
English: In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/kg/day in rats and ≥ 100 mg/kg/day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Maltese: Fi studji mhux kliniċi ta' sigurta`, dożi għoljin ta' irbesartan (≥ 250 mg/kg/jum f'firien u ≥ 100 mg/kg/jum f'makakki) ikkawżaw tnaqqis fil-parametri taċ-ċelluli ħomor tad-demm (eritroċiti, emoglobina, ematokrit).
English: What Irbesartan Hydrochlorothiazide BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Maltese: Id-dehra ta' Irbesartan Hydrochlorothiazide BMS u l-kontenuti tal-pakkett Il-pilloli Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg huma lewn il-ħawħa, ibbuzzati fuq iżżewġ naħat, ovali, b'qalb ibbuzzata fuq naħa waħda u n-numru 2775 fuq in-naħa l-oħra.
English: Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses in patients without risk of electrolyte imbalance (see sections 4.4 and 4.5).
Maltese: Il-livelli tal-potassium fis-serum mhumiex affettwati b'mod sinifikanti b'irbesartan waħdu f'dożi rrikmandati lill-pazjenti li m'għandhomx riskju ta' żbilanċ ta' l-elettroliti (ara sezzjonijiet 4.4 u 4.5).
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Maltese: Pilloli Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg irbesartan/hydrochlorothiazide
English: Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film-coated tablets.
Maltese: Il-pilloli miksijin b'rita Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg huma fornuti fi strixxi ta' 14, 28, 56, 84 jew 98 pillola miksija b'rita.
English: What Irbesartan Hydrochlorothiazide BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Maltese: Id-dehra ta' Irbesartan Hydrochlorothiazide BMS u l-kontenuti tal-pakkett Il-pilloli Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg huma lewn il-ħawħa, ibbuzzati fuq iżżewġ naħat, ovali, b'qalb ibbuzzata fuq naħa waħda u n-numru 2776 fuq in-naħa l-oħra.
English: What Irbesartan Hydrochlorothiazide BMS looks like and contents of the pack Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg film-coated tablets are pink, biconvex, ovalshaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Maltese: Id-dehra ta' Irbesartan Hydrochlorothiazide BMS u l-kontenuti tal-pakkett Il-pilloli miksijin b'rita Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg huma roża, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb ibbuzzata fuq naħa waħda u n-numru 2788 fuq in-naħa l-oħra.
English: Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Maltese: Indeboliment epatiku: f'pazjenti b'ċirrożi, minn ħafifa għal moderata, il-parametri farmakokinetiċi ta' irbesartan ma jitbiddlux b'mod sinifikanti.
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains: irbesartan 150 mg and hydrochlorothiazide 12.5 mg
Maltese: Kull pillola fiha: irbesartan 150 mg u hydrochlorothiazide 12.5 mg
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 12.5 mg
Maltese: Kull pillola fiha: irbesartan 300 mg u hydrochlorothiazide 12.5 mg
English: Sun
Maltese: deni
English: MARKETING AUTHORISATION NUMBERS EU/1/06/369/006-010
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/369/006-010
English: Your doctor will instruct you how to switch from the previous treatment to Irbesartan Hydrochlorothiazide BMS.
Maltese: M'hemmx biżżejjed informazzjoni speċifika fuq il-kura ta' doża eċċessiva ta' Irbesartan Hydrochlorothiazide BMS.
English: Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol;
Maltese: L-użu flimkien ta' dijuretiċi thiazide jistgħu jżidu linċidenza ta' reazzjonijiet ta' sensittività eċċessiva għal-allopurinol;
English: Peak plasma concentration occurs at 1.5-2 hours after oral administration for irbesartan and 1-2.5 hours for hydrochlorothiazide.
Maltese: Il-konċentrazzjoni filplażma tilħaq l-ogħla livell 1.5 - 2 sigħat wara li tingħata mill-ħalq għal irbesartan u 1 - 2.5 sigħat għal hydrochlorothiazide.
English: CHINOIN PRIVATE CO. LTD. Lévai u.5.
Maltese: Kif għandek tieħu l-mediċina
English: Because no information is available regarding the use of Irbesartan Hydrochlorothiazide BMS during breast-feeding, Irbesartan Hydrochlorothiazide BMS is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Maltese: Sakemm terapija b'AIIRA ma tkunx meqjusa essenzjali, il-pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti ta' kontra pressjoni għolja alternattivi li għandhom profil ta' sigurtà stabbilit sabiex jintużaw waqt it-tqala.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg pilloli irbesartan/hydrochlorothiazide
English: Due to the hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide BMS, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position.
Maltese: Irbesartan Hydrochlorothiazide BMS ġeneralment jiġi preskritt mit-tabib tiegħek meta l-kura li kont tieħu qabel ma tnaqqasx il-pressjoni tad-demm biżżejjed.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Irbesartan Hydrochlorothiazide BMS 300 mg/12.5 mg pilloli irbesartan/hydrochlorothiazide
English: Since Irbesartan Hydrochlorothiazide BMS contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Maltese: Billi Irbesartan Hydrochlorothiazide BMS fih hydrochlorothiazide, mhux irrikkmandat waqt l-ewwel trimestru tat-tqala.
English: You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium sparing medicines or other diuretics (water tablets) some laxatives medicines for the treatment of gout therapeutic vitamin D supplements medicines to control heart rhythm medicines for diabetes (oral agents or insulins)
Maltese: Jista' jkollok bżonn tagħmel xi kontroll tad-demm jekk tieħu: supplimenti tal-potassium sostituti tal-melħ li fihom il-potassium mediċini li fihom il-potassium, dijuretiċi oħra (pilloli ta' l-ilma) xi lassattivi mediċini għall-kura tal-gotta supplimenti terapewtiċi tal-vitamina D mediċini biex jikkontrolaw ir-ritmu tal-qalb mediċini għad-dijabete (mediċini li jittieħdu mill-ħalq jew insulina)
English: Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Maltese: Hydrochlorothiazide: għalkemm instabet evidenza ekwivoka għall-effett ġenotossiku u karċinoġeniku f'xi mudelli esperimentali, l-esperjenza estensiva fil-bniedem b'hydrochlorothiazide ma rnexxilhiex turi assoċjazzjoni bejn l-użu tagħha u żieda fin-neoplażmi.
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Maltese: Sakemm terapija AIIRAs kontinwa mhijiex meqjusa essenzjali, il-pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti alternattivi ta' kontra l-pressjoni għolja li għandhom profil ta' sigurtà stabbilit għal użu waqt tqala.
English: hyperkalaemia
Maltese: GĦAMLA KWALITATTIVA
English: cardiac arrhythmias
Maltese: Meta tuża mediċini oħra
English: Severe hepatic impairment, biliary cirrhosis and cholestasis
Maltese: Indeboliment epatiku sever, ċirrożi biljari u kolestażi
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) BIOGRASTIM EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) BIOGRASTIM
English: Biograstim is a ‘biosimilar' medicine.
Maltese: Biograstim hija mediċina ‘bijosimili'.
English: The active substance in Biograstim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Maltese: Is-sustanza attiva f'Biograstim, filgrastim hija simili ħafna għal proteina umana msejjħa stimulazzjoni tal-kolownja granuloċijto (G-CSF).
English: The European Commission granted a marketing authorisation valid throughout the EU for Biograstim to CT Arzneimittel GmbH on 15 September 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Biograstim lil CT Arzneimittel GmbH fil-15 ta' Settembru 2008.
English: Biograstim was studied to show that it is comparable to the reference medicine, Neupogen.
Maltese: Biograstim ġie studjat biex jiġi muri li huwa komparabbli mal-mediċina ta' referenza, Neupogen.
English: Treatment with Biograstim and Neupogen brought about similar reductions in duration of severe neutropenia.
Maltese: Trattament bir-Biograstim u n-Neupogen ġab tnaqqis simili fiż-żmien ta' newtropenija severa.
English: During the first 21-day chemotherapy cycle, patients treated with either Biograstim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Maltese: Matul l-ewwel 21 jum ta' ċiklu kemoterapewtiku, pazjenti trattati b'kemm Biograstim jew Neupogen kellhom newtropenija severa għal medja ta' 1.1 jum, kumparat ma' 3.8 jum f'dak li jirċievu placebo.
English: What is the risk associated with Biograstim?
Maltese: X'inhu r-riskju assoċjat ma' Biograstim?
English: • to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV)
Maltese: • Jittratta newtropenija persistenti f'pazjenti bil-vajrus uman ta' l-immunodefiċjenza fi stat avvanzat
English: To study the safety of Biograstim, two further studies were carried out in patients with lung cancer and with non-Hodgkin's lymphoma.
Maltese: Sabiex tiġi studjata s-sigurtà ta' Biograstim, saru żewġ studju oħrajn fuq pazjenti bil-kanċer talpulmun u limfoma non-Hodgkin.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy
Maltese: • Inaqqas iż-żmien ta' newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm) u l każ li jkun hemm newtropenija febbrili (newtropenija fil-fwied) f'pazjenti li jirċievu l kemoterapija (trattament tal-kanċer) li huwa ċitotossiku (joqtol iċ-ċelloli);
English: This means that Biograstim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Maltese: Dan ifisser li Biograstim huwa simili għal mediċina bijoloġika li hija diġà awtorizzata fl-Unjoni Ewropea (UE) u li tinkludi fiha l-istess sustanza attiva (magħrufa bħala ‘mediċina ta' referenza').
English: The reference medicine for Biograstim is Neupogen.
Maltese: Il-mediċina ta' referenza għal Biograstim hija Neupogen.
English: Biograstim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Maltese: Biograstim normalment jingħata f'ċentru ta' trattament speċjalizzat, minkejja li pazjenti li jirċievuh b'injezzjoni taħt il-ġilda jistgħu jinjettaw rwieħhom ladarba jiġu mħarrġa sabiex jagħmlu dan.
English: How has Biograstim been studied?
Maltese: Kif ġie studjat Biograstim?
English: Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal Neupogen, il-benefiċċji jegħlbu r-riskji identifikati.
English: Biograstim was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
Maltese: Biograstim ġie kumparat ma' Neupogen u ma' placebo (trattament fint) fi studju prinċipali li kien jinvolvi
English: Why has Biograstim been approved?
Maltese: Għaliex ġie approvat Biograstim?
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;
Maltese: • Inaqqas iż-żmien ta' newtropenija f'pazjenti li għaddejjin bi trattament li jkisser iċ-ċelloli tal mudullum qabel ma' l-mudullum jiġi trapjantat (bħal f'xi pazjenti bil-lewkimja) jekk ikunu f'riskju ta' newtropenija severa fuq żmien twil;
English: What is Biograstim?
Maltese: X'inhu Biograstim?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Biograstim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkunsidra li, b'mod konformi mal-ħtiġijiet ta' l-Unjoni Ewropea, Biograstim wera li għandu kwalità, sigurtà u effikaċja komparabbli ma' dawk ta' Neupogen.
English: What benefit has Biograstim shown during the studies?
Maltese: X'benefiċċju wera Biograstim matul l-istudji mwettqa?
English: (cancer treatment) that is cytotoxic (cell-killing);
Maltese: Il-mediċina tista' tinkiseb biss b'riċetta tat-tabib.
English: For the full list of all side effects reported with Biograstim, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji kollha rrappurtata b'Biograstim, ara l-Fuljett ta' Tagħrif.
English: • simvastatin (used to treat hypercholesterolaemia).
Maltese: • simvastatin (użat għal trattament ta' iperkolesterolemija).
English: This card contains important information about Tracleer.
Maltese: Din il-kartuna fiha informazzjoni importanti dwar Tracleer.
English: - The active substance is bosentan as monohydrate.
Maltese: - Is-sustanza attiva hi bosentan bħala monohydrate.
English: 56 dispersible tablets (14 x 4)
Maltese: 56 pillola li tinxtered (14 x 4)
English: Aspartame (E951) Acesulfame potassium Magnesium stearate
Maltese: Benna ta' Tutti frutti Aspartame (E951) Acesulfame potassium Magnesium stearate
English: The ‘class' reflects the seriousness of the disease: ‘class III' involves marked limitation of physical activity.
Maltese: Il-‘klassi' tirrifletti s-serjetà tal-marda: ‘klassi III' tinvolvi limitazzjoni sostanzjali ta' attività fiżika.
English: Date of first authorisation: 15 May 2002 Date of latest renewal: 20 April 2012
Maltese: Data tal-aħħar tiġdid: 20 ta' April 2012
English: Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Silica colloidal anhydrous Tartaric acid
Maltese: Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium
English: Cartons contain 14, 56 or
Maltese: KARTUNA B'14, 56
English: Tracleer 32 mg dispersible tablets contain a source of phenylalanine (Aspartame - E951).
Maltese: Tracleer 32 mg pilloli li jinxterdu fihom sors ta' phenylalanine (Aspartame - E951).
English: Tracleer 125 mg film-coated tablets EU/1/02/220/004
Maltese: Tracleer 125 mg pilloli miksija b'rita EU/1/02/220/004
English: Tracleer 62.5 mg film-coated tablets EU/1/02/220/001
Maltese: Tracleer 62.5 mg pilloli miksija b'rita EU/1/02/220/001
English: Tracleer contains aspartame and sodium
Maltese: Tracleer fih aspartame u sodium
English: Baseline (BL); mean (SD) Change from BL; mean (SD) Treatment effects 95% CL
Maltese: Bidla minn BL; medja (SD) Effetti tal-kura 95% CL
English: • glibenclamide (a diabetes medicine), rifampicin (a tuberculosis medicine), fluconazole (a medicine against fungal infections), ketoconazole (a medicine used to treat Cushing's syndrome), or nevirapine (an HIV medicine), as these medicines are not recommended to be used together with Tracleer.
Maltese: • glibenclamide (mediċina għad-dijabete), rifampicin (mediċina għat-tuberkulosi), fluconazole (mediċina kontra infezzjonijiet mill-moffa), ketoconazole (mediċina biex tittratta s-sindrome ta' Cushing), jew nevirapine (mediċina għall-HIV), peress li dawn il-mediċini mhumiex rakkomandati biex jintużaw flimkien ma' Tracleer.
English: Tel: +33 (0)1 55 00 26 66
Maltese: Tél: +33 (0)1 55 00 26 66
English: Date of first monthly test: _________________________________
Maltese: Data tal-ewwel test ta' kull xahar: ____________________________________
English: Tracleer contains sodium
Maltese: Tracleer fih sodium
English: Each dispersible tablet contains 3.7 mg of aspartame (E951).
Maltese: Kull pillola li tinxtered fiha 3.7 mg ta' aspartame (E951).
English: The potential risk for humans is still unknown.
Maltese: Ir-riskju potenzjali filbniedem għadu mhux magħruf.
English: The median bosentan and placebo treatment duration was, respectively, 4.5 days (range 0.5-10.0 days) and 4.0 days (range 2.5-6.5 days).
Maltese: rispettivament, 4.5 ijiem (firxa 0.5-10.0 ijiem) u 4.0 ijiem (firxa 2.5-6.5 ijiem).
English: Cyclosporine A: Co-administration of Tracleer and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' Tracleer u cyclosporine A (impeditur ta' calcineurin) huwa kontraindikat (ara sezzjoni 4.3).
English: Patients were in WHO functional class I (n = 19, 29 %), class II (n = 27, 42%) or class III (n = 18, 28%) at start of study treatment.
Maltese: Il-pazjenti kienu fi klassi funzjonali I tad-WHO (n = 19, 29%), fi klassi II (n = 27, 42%) jew fi klassi III (n = 18, 28%) fil-bidu tal-kura tal-istudju.
English: The Kaplan-Meier estimate of overall survival at 2 years was 91.2%.
Maltese: L-istima KaplanMeier ta' sopravivenza globali wara sentejn kienet ta' 91.2%.
English: Safety and tolerability of bosentan was investigated in an exploratory, uncontrolled 12-week study in 11 patients with pulmonary hypertension secondary to severe COPD (stage III of GOLD classification).
Maltese: Is-sigurtà u t-tollerabilità ta' bosentan kienu investigati fi studju esplorattiv mhux ikkontrollat ta' 12-il ġimgħa fi 11-il pazjent bi pressjoni pulmonari għolja sekondarja għal COPD severa (stadju III talklassifikazzjoni GOLD).
English: System organ class
Maltese: klassi tas-sistemi u tal-organi
English: Peel-push blisters containing 14 dispersible tablets; cartons contain 56 dispersible tablets.
Maltese: Folji ‘peel-push' li fihom 14-il pillola li jinxterdu; kaxxi tal-kartun fihom 56 pillola li tinxtered.
English: There is limited clinical study experience with the use of Tracleer in patients with PAH associated with HIV infection, treated with antiretroviral medicinal products (see section 5.1).
Maltese: Hemm esperjenza limitata minn studji kliniċi bl-użu ta' Tracleer f'pazjenti b'PAH marbuta ma' infezzjoni bl-HIV, ikkurati bi prodotti mediċinali antiretrovirali (ara sezzjoni 5.1).
English: In the patients with Child-Pugh class B liver impairment, the mean (95% CI) steady-state AUC of bosentan was 360 (212613) ng⋅h/mL, i.e., 4.7 times higher, and the mean (95% CI) AUC of the active metabolite Ro 48-5033 was 106 (58.4-192) ng⋅h/mL, i.e., 12.4 times higher than in the patients with normal liver function (bosentan: mean [95% CI] AUC: 76.1 [9.07-638] ng⋅h/mL; Ro 48-5033: mean [95% CI] AUC 8.57 [1.28-57.2] ng⋅h/ml).
Maltese: Fil-pazjenti b'indeboliment tal-fwied Child-Pugh Klassi B, l-AUC medja (CI ta' 95%) fi stat fiss ta' bosentan kienet ta' 360 (212-613) ng h/mL, jiġifieri, 4.7 darbiet ogħla, u l-AUC medja (CI ta' 95%) talmetabolit attiv Ro 48-5033 kienet ta' 106 (58.4-192) ng h/mL, jiġifieri, 12.4 darbiet ogħla milli f'pazjenti b'funzjoni tal-fwied normali (bosentan: medja [CI ta' 95%] AUC:
English: In the adult placebo-controlled studies, a decrease in haemoglobin concentration to below 10 g/dL from baseline was reported in 8.0% of bosentan-treated patients and 3.9% of placebo-treated patients (see section 4.4).
Maltese: 10 g/dL mil-linja bażi kien irrappurtat fi 8.0% ta' pazjenti kkurati b'bosentan u 3.9% ta' pazjenti kkurati bil-plaċebo (ara sezzjoni 4.4).
English: 2 Hypersensitivity reactions were reported in 9.9% of patients on bosentan and 9.1% of patients on placebo.
Maltese: 2 Reazzjonijiet ta' sensittività eċċessiva kienu rrappurtati f'9.9% tal-pazjenti fuq bosentan u f'9.1% tal-pazjenti fuq plaċebo.
English: Tracleer should only be initiated if the systemic systolic blood pressure is higher than 85 mmHg.
Maltese: Tracleer għandu jinbeda biss jekk il-pressjoni sistolika sistemika tad-demm hi ogħla minn 85 mmHg.
English: Tracleer 125 mg tablets bosentan
Maltese: Tracleer 125 mg, pilloli bosentan
English: Tracleer 62.5 mg tablets bosentan
Maltese: Tracleer 62.5 mg, pilloli bosentan
English: - The other ingredients in the tablet core are maize starch, pregelatinised starch, sodium starch glycolate (Type A), povidone, glycerol dibehenate and magnesium stearate.
Maltese: - Is-sustanzi l-oħra fil-qalba tal-pillola huma maize starch, pregelatinised starch, sodium starch glycolate (Tip A), povidone, glycerol dibehenate u magnesium stearate.
English: Concomitant use of Tracleer with glibenclamide, fluconazole and rifampicin is not recommended.
Maltese: L-użu ta' Tracleer flimkien ma' glibenclamide, fluconazole u rifampicin mhux rakkomandat.
English: In the 20 integrated placebo-controlled studies, elevations in liver aminotransferases ≥ 3 ×ULN were observed in 11.2% of the bosentan-treated patients as compared to 2.4% of the placebo-treated patients.
Maltese: Fl-20 studju integrat ikkontrollat bil-plaċebo, żieda fl-aminotransferases tal-fwied ta' ≥ 3 × ULN kienu osservati fi 11.2% ta' pazjenti kkurati b'bosentan meta mqabbla ma' 2.4% tal-pazjenti kkurati bilplaċebo.