FrancophonIA/ELRC3.0 huggingface dataset:
English: After oral dosing of vardenafil AUC and Cmax increase almost dose proportionally over the recommended dose range (5 - 20 mg).
Maltese: Wara doża mill-ħalq, l-AUC u s-Cmax ta' vardenafil jiżdiedu kważi proporzjonalment maddoża fil-firxa tad-doża rrakkomandata (5 - 20 mg).
English: When vardenafil (20 mg film-coated tablets) and alcohol (mean maximum blood alcohol level of 73 mg/dl) were taken together, vardenafil did not potentiate the effects of alcohol on blood pressure and heart rate and the pharmacokinetics of vardenafil were not altered.
Maltese: Meta vardenafil (20 mg pilloli miksija b'rita) ingħata flimkien ma' xorb alkoħoliku (medja ta' livell massimu ta' alkoħol fid-demm ta' 73 mg/dl), vardenafil ma qawwiex l-effetti ta' l-alkoħol fuq il pressjoni u r-rata li tħabbat il-qalb, u l-farmakokinetika ta' vardenafil ma nbidlitx.
English: The onset of activity may be delayed if taken with a high fat meal (see section 5.2).
Maltese: Jekk jittieħed ma' ikla li jkun fiha ħafna xaħmijiet, l-effett jista' jdum aktar biex jidher (ara sezzjoni 5.2).
English: In a specific study, where vardenafil (20 mg) was co-administered with slow release nifedipine (30 mg or 60 mg) in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 6 mmHg and supine diastolic blood pressure of 5 mmHg accompanied with an increase in heart rate of 4 bpm.
Maltese: Fi studju speċifiku, fejn vardenafil (20 mg) ingħata flimkien ma' nifedipine li jintreħa bilmod (30 mg jew 60 mg) lill-pażjenti li jsofru minn pressjoni għolja, f'dawn il-pażjenti, il-pressjoni sistolika f'pożizzjoni minduda naqset b'6 mmHg aktar u l-pressjoni dijastolika f'pożizzjoni minduda naqset b' 5 mmHg aktar, waqt li r-rata li tħabbat il-qalb żdiedet b'4 bpm.
English: In patients with moderate impairment (Child-Pugh B), the mean AUC and Cmax increased by 160% and 133% respectively, compared to healthy control subjects (see section 4.2).
Maltese: F'pazjenti li kellhom indeboliment moderat tal-fwied (Child-Pugh B), l-AUC medja għoliet b'160% u s-Cmax għoliet b'133% meta mqabbla ma' grupp ta' kontroll ta' rġiel b'saħħithom (ara sezzjoni 4.3).
English: Levitra 5 mg film-coated tablets vardenafil
Maltese: Levitra 5 mg pilloli miksija b'rita Vardenafil
English: Each tablet contains 5 mg of vardenafil (as hydrochloride).
Maltese: Kull pillola fiha 5 mg Vardenafil (bħala hydrochloride).
English: Cerebral haemorrhage
Maltese: Konġestjoni fl-imnieħer
English: Marketing Authorisation Holder Bayer AG
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Bayer AG
English: Each tablet contains 10 mg vardenafil (as hydrochloride).
Maltese: Kull pillola fiha 10 mg Vardenafil (bħala hydrochloride).
English: In two interaction studies with healthy normotensive volunteers after forced titration of the alpha-blockers tamsulosin or terazosin to high doses, hypotension (in some cases symptomatic) was reported in a significant number of subjects after co-administration of vardenafil.
Maltese: F'żewġ studji ta' interazzjoni fuq voluntiera b'saħħithom u bi pressjoni normali, wara titrazzjoni bil-fors ta' dożi għolja ta' l-alfa-blockers tamsulosin jew terazosin, kienet irrappurtata pressjoni baxxa (xi kultanti sinptomatika) f'numru sinifikattiv tas-suġġetti wara li ngħataw ukoll vardenafil.
English: Each tablet of 10 mg film-coated tablets contains 10 mg of vardenafil (as hydrochloride).
Maltese: Kull pillola ta' 10 mg pilloli miksija b'rita fiha 10 mg ta' vardenafil (bħala hydrochloride).
English: Mean vardenafil AUC was increased by 21 to 29% (middle aged and elderly ED patients) or 44% (young healthy subjects) with 10 mg orodispersible tablets compared to film-coated tablets as a result of local oral absorption of a small amount of drug in the oral cavity.
Maltese: L-AUC medja ta' vardenafil żdiedet b'21 sa 29% (pazjenti b'ED ta' età medja u anzjani) jew b'44% (individwi żgħażagħ b'saħħithom) b'10 mg pilloli li jinħallu fil-ħalq meta mqabbla ma' pilloli miksija b'rita bħala riżultat ta' assorbiment lokali mill-ħalq ta' ammont żgħir ta' mediċina fil-bokka tal-ħalq.
English: (≥1/10,000 to
Maltese: Rari (≥1/10,000 u
English: Although a specific interaction study has not been conducted, the co-administration of clarithromycin can be expected to result in similar effects on vardenafil AUC and Cmax.
Maltese: Għalkemm studju speċifiku ta' l-interazzjoni għadu ma sarx, meta clarithromycin jingħata flimkien ma' vardenafil huwa mistenni li dan jirriżulta f'effetti simili fuq l-AUC u Cmax ta' vardenafil.
English: The co-administration of PDE5 inhibitors, including vardenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section
Maltese: L-għoti ta' inibituri ta' PDE5, inkluż vardenafil, flimkien ma' stimulaturi ta' guanylate cyclase, bħal riociguat, huwa kontraindikat għax jista' jwassal għal pressjoni baxxa sintomatika (ara sezzjoni 4.5). 4.4
English: Dyspnoea Sinus congestion
Maltese: Colloidal silica anidru
English: Based on tolerability and efficacy, the dose may be increased to Levitra 10 mg and 20 mg film-coated tablets, or Levitra 10 mg orodispersible tablets.
Maltese: Skont kemm tkun ittollerata u effettiva, id-doża tista' tiġi miżjuda għal Levitra 10 mg u 20 mg pilloli miksija b'rita, jew Levitra 10 mg pilloli li jinħallu fil-ħalq.
English: The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: - severe hepatic impairment (Child-Pugh C), - end stage renal disease requiring dialysis, - hypotension (blood pressure <90/50 mmHg), - recent history of stroke or myocardial infarction (within the last 6 months), - unstable angina, and known hereditary retinal degenerative disorders such as retinitis pigmentosa.
Maltese: Dawn ir-riżultati kienu riflessi wkoll fis-sottogruppi, f'pazjenti anzjani (65%), f'pazjenti b'passat ta' dijabete mellitus (63%), pazjenti b'passat ta' dislipidemija (66%) u pressjoni għolja (70%) ta' kull tentattiv sesswali rrappurtati li kellhom penetrazzjoni b'suċċess.
English: may affect up to 1 in 100 users - Swelling of skin and mucous tissue including swollen face, lips or throat - Sleep disorder - Numbness and impaired perception of touch - Sleepiness - Effects on vision, redness of the eye, effects on colour vision, eye pain and discomfort, light sensitivity - Ringing in the ears, vertigo - Fast heart beat or pounding heart - Breathlessness - Stuffy nose - Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling sick (nausea), dry mouth - Raised levels of liver enzymes in your blood - Rash, reddened skin - Back or muscle pain, increase in blood of a muscle enzyme (creatine phosphokinase), muscle stiffness - Prolonged erections - Malaise
Maltese: - Taħbit mgħaġġel tal-qalb jew tħoss qalbek ser toħroġ minn sidrek - Qtugħ ta' nifs - Imnieħer miżdud - Rifluss tal-aċidu, gastrite, uġigħ ta' żaqq, dijarea, rimettar, tħossok ma tiflaħx (tqalligħ), ħalq xott
English: Each tablet contains 10 mg of vardenafil (as hydrochloride).
Maltese: Kull pillola fiha 10 mg vardenafil (bħala hydrochloride).
English: After a meal containing 30% fat, the rate and extent of absorption of vardenafil (tmax, Cmax and AUC) are unchanged compared to administration under fasting conditions.
Maltese: Wara ikla li jkun fiha 30% xaħmijiet, ir-rata u l-kwantità ta' assorbiment ta' vardenafil (tmax, Cmax u AUC) ma jinbidlux meta mqabbla ma' pazjenti sajma.
English: Patients with left ventricular outflow obstruction, e.g. aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors.
Maltese: taki-arritmija ventrikulari, anġina pektoris, u disturbi ċerebrovaskulari (inkluż attakk iskemiku temporanju u emorraġija ċerebrali), kienu rrappurtati f'assoċjazzjoni temporali ma' vardenafil.
English: No effect on blood pressure was observed when nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg film-coated tablets.
Maltese: Ma kien osservat l-ebda effett fuq il-pressjoni tad-demm meta nitroglicerine ittieħed 24 siegħa wara l-għoti ta' doza waħda ta' 20mg vardenafil pilloli miksija b'rita.
English: In pooled data from the two vardenafil 10 mg orodispersible tablets trials, IIEF-EF domain scores were significantly higher with vardenafil 10 mg orodispersible tablet versus placebo.
Maltese: • Meta vardenafil (pilloli miksija b'rita) ingħata f'dożi ta' 5 jew 10 mg lil pazjenti stabbli fuq terapija b'alfuzosin, meta mqabbel mal-plaċebo, ma kien hemm l-ebda tnaqqis sintomatiku filpressjoni tad-demm.
English: • When vardenafil (film-coated tablets) was given at doses of 5, 10 or 20 mg on a background of stable therapy with tamsulosin, there was no symptomatic reduction in blood pressure, although 3/21 tamsulosin treated subjects exhibited transient standing systolic blood pressures of less than 85 mmHg.
Maltese: stabbli fuq terapija b'tamsulosin, ma kien hemm l-ebda tnaqqis sintomatiku fil-pressjoni taddemm, għalkemm 3/21 pazjent kkurat b'tamsulosin kellhom pressjoni tad-demm sistolika temporanja bil-wieqfa ta' anqas minn 85 mmHg • Meta vardenafil 5 mg (pilloli miksija b'rita) ingħata flimkien ma' terazosin 5 jew 10 mg, wieħed minn 21 pazjent kellu pressjoni baxxa sintomatika bil-wieqfa.
English: In patients with severe renal impairment (creatinine clearance <30 ml/min) a starting dose of Levitra 5 mg film-coated tablets should be considered.
Maltese: F'pazjenti b'indeboliment renali sever (tneħħija tal-krejatinina <30 ml/min) għandha tiġi kkunsidrata doża tal-bidu ta' Levitra 5 mg pilloli miksija b'rita.
English: In patients with mild to moderate hepatic impairment (Child-Pugh A and B), the clearance of vardenafil was reduced in proportion to the degree of hepatic impairment.
Maltese: F'pazjenti b'indeboliment tal-fwied ħafif sa moderat (Child-Pugh A u B), it-tneħħija mill-ġisem ta' vardenafil naqset proporzjonalment ma' kemm il-fwied ma kienx qed jaħdem.
English: The primary objective of this study was to rule out a greater than 10 msec effect (i.e. to demonstrate lack of effect) of a single 80 mg oral dose of vardenafil on QTc interval compared to placebo, as measured by the change in Fridericia's correction formula (QTcF=QT/RR1/3) from baseline at the 1 hour post-dose time point.
Maltese: Il-mira prinċipali ta' dan l-istudju kienet biex jiġi aċċertat li m'hemmx effett akbar minn 10 msec fuq l-intervall QTc (i.e. biex jintwera nuqqas ta' dan leffett) ta' doża waħda ta' 80 mg ta' vardenafil mogħtija mill-ħalq, meta mqabbla mal-plaċebo, kif imkejjel mill-bidla fil-formola ta' korrezzjoni ta' Fridericia (QTcF=QT/RR1/3) mill-linja bażi siegħa wara li ngħatat id-doża.
English: Common:
Maltese: Sími:
English: Therefore, the current information of section 4.8 should be revised to highlight the temporal association with vardenafil.
Maltese: Għalhekk, l-informazzjoni attwali fis-sezzjoni 4.8 għandha tiġi riveduta biex tenfasizza l-assoċjazzjoni temporali ma' vardenafil.
English: 6-Minute Walk Distance (m)
Maltese: Distanza ta' Mixja f'6 Minuti (m)
English: EXP {MM/YYYY}
Maltese: EXP {XX/SSSS}
English: Placebo (n=88) Bosentan (n=80) Placebo (n=91) Bosentan (n=86)
Maltese: Plaċebo (n =88) Bosentan (n=80) Plaċebo (n=91) Bosentan (n=86)
English: Pregelatinised starch Sodium starch glycolate (Type A) Povidone
Maltese: Pregelatinised starch Sodium starch glycolate (Tip A) Povidone
English: Syncope1, 4
Maltese: Sinkope1, 4
English: CL = confidence limit; PVR = pulmonary vascular resistance; SD = standard deviation.
Maltese: CL = limitu ta' kunfidenza; PVR = reżistenza vaskulari fil-pulmun; SD = devjazzjoni standard.
English: For further information see sections 4.5 and 4.6.
Maltese: Għal aktar informazzjoni ara sezzjonijiet 4.5 u 4.6.
English: Haupt Pharma Wülfing GmbH Bethelner Landstraße 18 31028 Gronau/Leine Germany
Maltese: Haupt Pharma Wülfing GmbH Bethelner Landstraße 18
English: • simvastatin (used to treat hypercholesterolaemia).
Maltese: • simvastatin (użat għal trattament ta' iperkolesterolemija)
English: Pharmacokinetics were studied in paediatric patients in 4 clinical studies (BREATHE-3, FUTURE 1, FUTURE-3 and FUTURE-4; see section 5.1).
Maltese: Il-farmakokinetika kienet studjata f'pazjenti pedjatriċi f'4 studji kliniċi (BREATHE-3, FUTURE 1, FUTURE-3 u FUTURE-4; ara sezzjoni 5.1).
English: ULN = upper limit of normal
Maltese: ULN= limitu ta' fuq tan-normal
English: This card contains important information about STAYVEER.
Maltese: Din il-kartuna fiha informazzjoni importanti dwar STAYVEER.
English: ((Inside 1))
Maltese: ((Ġewwa 1))
English: Study performed in neonates with persistent pulmonary hypertension of the newborn (PPHN):
Maltese: (PPHN - persistent pulmonary hypertension of the newborn):
English: However, decreases in exposure were as much as 56% and 66%, respectively, in individual subjects.
Maltese: Madankollu, tnaqqis fl-espożizzjoni kien sa 56% u 66%, rispettivament, f'pazjenti individwali.
English: • Baseline values of liver aminotransferases, i.e., aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), greater than 3 × the upper limit of normal (ULN; see section 4.4)
Maltese: • Valuri tal-linja bażi tal-aminotransferases fil-fwied, i.e. aspartate aminotransferase (AST) u/jew alanine aminotransferase (ALT), ta' aktar minn 3 × il-limitu ta' fuq tan-normal (ULN - upper limit of normal; ara sezzjoni 4.4)
English: This interaction is unlikely to be of clinical relevance.
Maltese: Din l-interazzjoni mhux mistennija li tkun ta' rilevanza klinika.
English: Palpitations1, 4
Maltese: Palpitazzjonijiet1, 4
English: • Concomitant use of cyclosporine A (see section 4.5)
Maltese: • Użu konkomitanti ta' cyclosporine A (ara sezzjoni 4.5)
English: The ‘class' reflects the seriousness of the disease: ‘class III' involves marked limitation of physical activity.
Maltese: Il-‘klassi' tirrifletti s-serjetà talmarda: ‘klassi III' tinvolvi limitazzjoni sostanzjali ta' attività fiżika.
English: Pulmonary veno-occlusive disease
Maltese: Mard veno-okklussiv pulmonari
English: ((Inside 2))
Maltese: ((Ġewwa 2))
English: • Pregnancy (see sections 4.4 and 4.6)
Maltese: • Tqala (ara sezzjonijiet 4.4 u 4.6)
English: The film-coat contains hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and ethylcellulose.
Maltese: Il-kisja tar-rita fiha hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) u ethylcellulose.
English: The most frequent adverse events were upper respiratory tract infections (25%), pulmonary (arterial) hypertension (20%), nasopharyngitis (17%), pyrexia (15%), vomiting (13%), bronchitis (10%), abdominal pain (10%), and diarrhoea (10%).
Maltese: L-avvenimenti avversi l-aktar frekwenti kienu infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju (25%), pressjoni għolja (fl-arterji) tal-pulmun (20%), nażofarinġite (17%), deni (15%), rimettar (13%), bronkite (10%),
English: In vitro data demonstrated that bosentan had no relevant inhibitory effect on the CYP isoenzymes tested (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1, 3A4).
Maltese: Tagħrif minn studji in vitro juri li bosentan ma kellu l-ebda effett rilevanti ta' inibizzjoni fuq l isoenzimi CYP li ġew ittestjati (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1, 3A4).
English: Treatment with bosentan led to a WHO functional class improvement in 42.4% of patients (placebo 30.4%).
Maltese: Funzjonali tal-WHO fi 42.4% tal-pazjenti (plaċebo 30.4%).
English: Pharmacotherapeutic group: other antihypertensives, ATC code: C02KX01
Maltese: Kategorija farmakoterapewtika: sustanzi oħra kontra l-pressjoni għolja, Kodiċi ATC: C02KX01 Mekkaniżmu ta' azzjoni
English: At steady state, the systemic exposures in paediatric patients weighing 10-20 kg, 20-40 kg and > 40 kg were 43%, 67% and 75%, respectively, of the adult systemic exposure.
Maltese: Fl-istat fiss, l-espożizzjonijiet sistemiċi fit-tfal li jiżnu 10-20 kg, 20-40 kg u > 40kg kienet 43%, 67% u 75%, rispettivament, tal-espożizzjoni sistemika fl-adulti.
English: STAYVEER 125 mg film-coated tablets EU/1/13/832/002
Maltese: STAYVEER 125 mg pilloli miksija b'rita EU/1/13/832/002
English: STAYVEER contains sodium
Maltese: STAYVEER fih sodium
English: Rare (may affect up to one in 1000 people):
Maltese: Rari (jistgħu jaffettwaw sa persuna waħda minn kull 1000):
English: For PVC/PE/PVDC/aluminium-blisters:
Maltese: Għall-folji tal-PVC/PE/PVDC/aluminju:
English: Hypersensitivity reactions (including dermatitis, pruritus and rash)2
Maltese: Reazzjonijiet ta' sensittività eċċessiva (inkluż dermatite, ħakk u raxx)2
English: STAYVEER 62.5 mg film-coated tablets EU/1/13/832/001
Maltese: STAYVEER 62.5 mg pilloli miksija b'rita EU/1/13/832/001
English: FUTURE 3/Extension, elevations in liver aminotransferases ≥ 3 × ULN were observed in 2% of patients.
Maltese: FUTURE 3/Estensjoni, elevazzjonijiet fl-aminotransferases tal-fwied ta' ≥ 3 × ULN kienu osservati f'2% tal-pazjenti.
English: The Kaplan-Meier estimate of overall survival at 2 years was 91.2%.
Maltese: istima Kaplan-Meier ta' sopravivenza globali wara sentejn kienet ta' 91.2%.
English: Pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD)
Maltese: Pressjoni pulmonari għolja sekondarja għall-marda kronika ostruttiva tal-pulmun (COPD - chronic obstructive pulmonary disease)
English: Bosentan is a dual endothelin receptor antagonist (ERA) with affinity for both endothelin A and B (ETA and ETB) receptors.
Maltese: Bosentan huwa antagonist doppju tar-riċetturi ta' endothelin (ERA) b'affinità għar-riċetturi ta' endothelin A u B (ETA u ETB).
English: Treatment with bosentan was associated with a significant reduction in the rate of clinical worsening compared with placebo at 28 weeks (10.7% vs 37.1%, respectively; p = 0.0015).
Maltese: tnaqqis sinifikanti fir-rata tas-sitwazzjoni klinika li tmur għall-agħar meta mqabbla mal-kura bil plaċebo wara 28 ġimgħa (10.7% vs 37.1%, rispettivament; p = 0.0015).
English: Bosentan is an inducer of CYP2C9 and CYP3A4 and possibly also of CYP2C19 and the P-glycoprotein.
Maltese: Bosentan jinduċi CYP2C9 u CYP3A4 u possibbilment CYP2C19 ukoll u P-glycoprotein.
English: The NOAEL was 21 times (at Day 21 post partum) and 2.3 times (Day 69 post partum) the human therapeutic exposure, respectively.
Maltese: L-NOAEL kien 21 darba (f'Jum 21 post partum) u 2.3 darbiet (Jum 69 post partum) l-esponiment terapewtiku tal-bniedem, rispettivament.
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%)
English: Oedema, fluid retention5
Maltese: Edima, Żamma ta' fluwidu5
English: Treatment with bosentan was associated with a reduction in the rate of clinical worsening, defined as a composite of symptomatic progression, hospitalisation for PAH and death, compared with placebo (proportional risk reduction 77%, 95% confidence interval [CI] 20-94%, p = 0.0114).
Maltese: Kura b'bosentan kienet assoċjata ma' tnaqqis fir-rata ta' rkadar kliniku, definita bħala taħlita ta' progressjoni sintomatika, żamma l-isptar minħabba PAH u mewt, meta mqabbla mal-plaċebo (tnaqqis proporzjonali fir-riskju ta' 77%, intervall ta' kunfidenza ta' 95% [CI - confidence interval] 20-94%, p = 0.0114).
English: Bosentan was negative in tests for genotoxicity.
Maltese: Bosentan kien negattiv fit-testijiet għal ġenotossiċità.
English: CARTON WITH 56 TABLETS
Maltese: KARTUNA B'56 PILLOLA
English: P-value
Maltese: Valur-p
English: The most frequent adverse reactions are headache (11.5%), oedema / fluid retention (13.2%), abnormal liver function test (10.9%) and anaemia / haemoglobin decrease (9.9%).
Maltese: L-aktar reazzjonijiet avversi frekwenti huma uġigħ ta' ras (11.5%), edima / żamma ta' fluwidu (13.2%), test tal-funzjoni tal-fwied mhux normali (10.9%) u anemija / tnaqqis tal-emoglobina (9.9%).
English: The mechanism for this interaction may be induction of P-glycoprotein.
Maltese: Il-mekkaniżmu għal din linterazzjoni jista' jkun l-induzzjoni ta' P-glycoprotein.
English: These measures will help to protect the environment.
Maltese: inibituri ta' protease.
English: The duration of double-blind therapy was 16 weeks in study AC-052-401, and 24 weeks in study AC-052-331.
Maltese: It-terapija double-blind damet 16-il ġimgħa fl-istudju AC-052-401, u 24 ġimgħa fl-istudju AC-052-331.
English: Anaemia, haemoglobin decrease, (see section 4.4)
Maltese: Anemija, tnaqqis fl-emoglobina, (ara sezzjoni 4.4)
English: Bosentan is highly bound (> 98%) to plasma proteins, mainly albumin.
Maltese: Distribuzzjoni Bosentan jeħel sew (> 98%) mal-proteini tal-plażma, l-aktar mal-albumina.
English: The potential risk for humans is still unknown.
Maltese: Ir-riskju potenzjali fil-bniedem għadu mhux magħruf.
English: • Women of childbearing potential who are not using reliable methods of contraception (see sections 4.4, 4.5 and 4.6)
Maltese: • Nisa li għandhom il-potenzjal li joħorġu tqal u li mhumiex qed jużaw metodi affidabbli ta' kontraċezzjoni (ara sezzjonijiet 4.4, 4.5 u 4.6)
English: Elevations to ≥ 8 × ULN were seen in 3.6% of the bosentan-treated patients and 0.4% of the placebo-treated patients.
Maltese: Żidiet sa ≥ 8 × ULN kienu osservati fi 3.6% tal-pazjenti kkurati b'bosentan u 0.4% tal pazjenti kkurati bil-plaċebo.
English: Adverse reactions observed in 20 placebo-controlled studies and post-marketing experience with bosentan are ranked according to frequency using the following convention: very common (≥ 1/10); common (≥1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi osservati f'20 studju kkontrollat bil-plaċebo u waqt esperjenza ta' wara ttqegħid fis-suq b'bosentan huma kklassifikati skont il-frekwenza bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 5.2)
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1 • Indeboliment tal-fwied minn moderat sa sever, i.e. Child-Pugh klassi B jew Ċ (ara sezzjoni 5.2)
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: 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 tal klassifikazzjoni GOLD).
English: Cyclosporine A: Co-administration of STAYVEER and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' STAYVEER u cyclosporine A (impeditur ta' calcineurin) huwa kontraindikat (ara sezzjoni 4.3).
English: 1 Data derived from post-marketing experience, frequencies based on statistical modelling of placebo-controlled clinical trial data.
Maltese: 1 Dejta derivata minn esperjenza ta' wara t-tqegħid fis-suq, frekwenzi bbażati fuq mudellar statistiku ta' dejta minn provi kliniċi kkontrollati bil-plaċebo.
English: • Thrombocytopenia (low number of blood platelets)
Maltese: • Tromboċitopenija (numru baxx ta' plejtlits fid-demm)
English: • primary (with no identified cause or familial);
Maltese: • primarja (bl-ebda kawża identifikata jew familjari);