FrancophonIA/ELRC3.0 huggingface dataset:
English: Adempas 0.5 mg - pack of 84 film-coated tablets - EU/1/13/907/002
Maltese: Adempas 0.5 mg - pakkett ta' 84 pillola miksija b'rita - EU/1/13/907/002
English: Tel: + 386 1 5204201 msd_slovenia@merck.com
Maltese: Tel: + 421 2 58282010 dpoc_czechslovak@merck.com
English: Monitor for signs and symptoms of hypotension on initiation and on treatment.
Maltese: Issorvelja għal sinjali u sintomi ta' pressjoni baxxa fil-bidu u waqt ittrattament.
English: Mean change from PVR baseline (dyn·s·cm-5) [SD]
Maltese: Bidla medja mil-linja bażi PVR (dyn·s·cm-5)
English: Therefore, female patients at potential risk of pregnancy must use an effective method of contraception.
Maltese: Għalhekk, pazjenti nisa f'riskju potenzjali ta' tqala għandhom jużaw metodu effettiv ta' kontraċezzjoni.
English: Haemoptysis, Epistaxis, Nasal congestion
Maltese: Dispepsja, Dijarea, Dardir, Rimettar
English: Adempas 2 mg - pack of 294 film-coated tablets - EU/1/13/907/019
Maltese: Adempas 2 mg - pakkett ta' 294 pillola miksija b'rita - EU/1/13/907/019
English: • 0.5 mg tablet: white, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 0.5 and an “R” on the other side.
Maltese: • Pillola ta' 0.5 mg: pilloli bojod, tondi, bikonvessi ta' 6 mm, immarkati bis-salib ta' Bayer fuq naħa waħda u 0.5 u “R” fuq in-naħa l-oħra.
English: Each 2 mg film-coated tablet contains 36.3 mg lactose (as monohydrate).
Maltese: Adempas 2 mg pilloli miksija b'rita Kull pillola miksija b'rita ta' 2 mg fiha 36.3 mg ta' lactose (bħala monohydrate).
English: Adempas 1.5 mg film-coated tablets
Maltese: Adempas 1.5 mg pilloli miksija b'rita
English: Patients with mild and moderate renal impairment (creatinine clearance <80 - 30 mL/min) showed a higher exposure to this medicinal product (see section 5.2).
Maltese: Pazjenti b'indeboliment ħafif u moderat tal-kliewi (tneħħija tal-krejatinina ta' <80 - 30 mL/min) urew esponiment ogħla għal dan il-prodott mediċinali (ara sezzjoni 5.2).
English: An open-label extension study (PATENT-2) included 396 patients who had completed PATENT-1 at the cut-off-date.
Maltese: Studju open-label ta' estensjoni (PATENT-2) kien jinkludi 396 pazjent li kienu temmew PATENT-1 fid-data tal-għeluq.
English: Data in patients with creatinine clearance <30 mL/min are limited and there are no data for patients on dialysis.
Maltese: Data f'pazjenti bi tneħħija tal-krejatinina ta' <30 mL/min hi limitata u m'hemmx data għal pazjenti fuq id-dijalisi.
English: Adempas 1 mg film-coated tablets Adempas 1.5 mg film-coated tablets
Maltese: Adempas 1 mg pilloli miksija b'rita Adempas 1.5 mg pilloli miksija b'rita
English: Each 0.5 mg film-coated tablet contains 37.8 mg lactose (as monohydrate).
Maltese: Adempas 0.5 mg pilloli miksija b'rita Kull pillola miksija b'rita ta' 0.5 mg fiha 37.8 mg ta' lactose (bħala monohydrate).
English: Vascular disorders
Maltese: Disturbi gastrointestinali
English: You will receive Adempas only for special types of pulmonary arterial hypertension (PAH), see section 1.
Maltese: Int se tirċievi Adempas biss għal tipi speċjali ta' pressjoni għolja fl-arterji tal-pulmun (PAHpulmonary arterial hypertension), ara sezzjoni 1.
English: Antifungals
Maltese: Pożoloġija
English: Patient population with CTEPH post-PEA
Maltese: Disturbi fil-qalb
English: • Assess the benefit-risk for each patient individually before prescribing Adempas in patients on stable doses of strong multi pathway CYP and P-gp/BCRP inhibitors.
Maltese: • Evalwa l-benefiċċju u r-riskju għal kull pazjent b'mod individwali qabel ma tippreskrivi Adempas f'pazjenti fuq dożi stabbli ta' inibituri qawwija ta' passaġġi multipli ta' CYP u P-gp/BCRP.
English: The safety and efficacy of riociguat in children and adolescents below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' riociguat fit-tfal u fl-adolexxenti b'età inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: Merck Sharp & Dohme (Sweden) AB Tel: + 46 77 5700488 medicinskinfo@merck.com
Maltese: Tel: + 46 77 5700488 medicinskinfo@merck.com
English: They are available in packs of:
Maltese: Huma disponibbli f'pakketti ta':
English: • 1 mg tablet: pale yellow, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 1 and an “R” on the other side.
Maltese: • Pillola ta' 1 mg: pilloli sofor ċari, tondi, bikonvessi ta' 6 mm, immarkati bis-salib ta' Bayer fuq naħa waħda u 1 u “R” fuq in-naħa l-oħra.
English: België / Belgique / Belgien MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Maltese: +32(0)27766211 dpoc_belux@merck.com
English: FC II patients
Maltese: Konġestjoni fl-imnieħer
English: Mean change from baseline (m) [SD]
Maltese: Bidla medja mil-linja bażi (m) [SD]
English: Patients treated with riociguat showed significant improvement in Borg CR 10 dyspnoea score (mean change from baseline (SD): riociguat -0.4 (2), placebo 0.1 (2); p = 0.0022).
Maltese: Il-pazjenti kkurati b'riociguat urew titjib sinifikanti fil-punteġġ ta' qtugħ ta' nifs Borg CR 10 (bidla medja mil-linja bażi (SD): riociguat -0.4
English: Medicinal products strongly inhibiting P-gp/BCRP such as the immuno-suppressive cyclosporine A, should be used with caution (see sections 4.4 and 5.2).
Maltese: Prodotti mediċinali li jinibixxu b'mod qawwi lil P-gp/BCRP bħall-immunosoppressiv cyclosporine A, għandhom jintużaw b'attenzjoni (ara sezzjonijiet 4.4 u 5.2).
English: * fatal pulmonary haemorrhage was reported in uncontrolled long term extension studies
Maltese: * emorraġija fil-pulmun fatali kienet irrappurtata fi studji ta' estensjoni fit-tul mhux ikkontrollati
English: Improvement in exercise capacity was accompanied by consistent improvement in multiple clinicallyrelevant secondary endpoints.
Maltese: It-titjib fil-kapaċità tal-eżerċizzju kienet akkumpanjata minn titjib konsistenti fil-punti finali sekondarji multipli klinikament rilevanti.
English: Each 1.5 mg film-coated tablet contains 36.8 mg lactose (as monohydrate).
Maltese: Adempas 1.5 mg pilloli miksija b'rita Kull pillola miksija b'rita ta' 1.5 mg fiha 36.8 mg ta' lactose (bħala monohydrate).
English: With increased doses, over additive effects on systemic blood pressure were observed in some cases.
Maltese: B'żieda fid-dożi, f'xi każijiet kienu osservati effetti addittivi eċċessivi fuq il-pressjoni sistematika.
English: In PATENT-2, all patients received an individualised riociguat dose up to 2.5 mg three times daily.
Maltese: F'PATENT-2, il-pazjenti kollha rċivew doża individwalizzata ta' riociguat sa 2.5 mg tliet darbiet kuljum.
English: RESPITE was a 24-week, uncontrolled study to investigate switching from PDE5 inhibitors to riociguat, in 61 adult PAH patients on stable PDE5 inhibitors.
Maltese: RESPITE kien studju mhux ikkontrollat ta' 24 ġimgħa biex jinvestiga l-bidla minn inibituri ta' PDE5 għal riociguat, f'61 pazjent adult li jbatu minn PAH fuq inibituri stabbli ta' PDE5.
English: There is no experience in patients with severe hepatic impairment (Child Pugh C); riociguat is contraindicated in these patients (see section 4.3).
Maltese: M'hemmx esperjenza f'pazjenti b'indeboliment sever tal-fwied (Child Pugh Ċ); riociguat hu kontraindikat f'dawn il-pazjenti (ara sezzjoni 4.3).
English: Film-coat:
Maltese: Kodiċi ATC:
English: Very common: may affect more than 1 in 10 people - headache - dizziness - indigestion (dyspepsia) - swelling of limbs (oedema peripheral) - diarrhoea - feeling or being sick (nausea and vomiting)
Maltese: Komuni ħafna: jistgħu jaffettwaw iktar minn persuna waħda minn kull 10 - uġigħ ta' ras - sturdament - indiġestjoni (dispepsja) - nefħa fir-riġlejn/dirgħajn (edima periferali) - dijarea - tħossok imdardar jew tirremetti (dardir u rimettar)
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel: + 421 2 58282010 dpoc_czechslovak@merck.com
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204201 msd_slovenia@merck.com
English: It is recommended to monitor for signs and symptoms of hypotension after any transition (see sections 4.3, 4.5 and 5.1).
Maltese: Huwa rakkomandat li timmonitorja għal sinjali u sintomi ta' pressjoni baxxa wara kwalunkwe bidla (ara sezzjonijiet 4.3, 4.5 u 5.1).
English: Riociguat IDT (n=232)
Maltese: IDT (n=232)
English: - Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH
Maltese: - Pazjenti bi pressjoni għolja pulmonari assoċjata ma' pulmonite interstizjali idjopatika (PH-IIP)
English: Serious haemoptysis and pulmonary haemorrhage, including cases with fatal outcome have been observed in patients with CTEPH or PAH treated with Adempas (see section 4.4).
Maltese: Emoptisi serja u emorraġija fil-pulmun, li jinkludu każijiet b'riżultati fatali kienu osservati f'pazjenti b'CTEPH jew PAH ikkurati b'Adempas (ara sezzjoni 4.4).
English: For the transition from PDE5 inhibitors to riociguat, median treatment-free time for sildenafil was 1 day and for tadalafil 3 days.
Maltese: Għat-transizzjoni minn inibituri ta' PDE5 għal riociguat, iż-żmien medjan mingħajr trattament għal sildenafil kien ta' ġurnata u għal tadalafil kien ta' 3 ijiem.
English: Riociguat IDT (n=108)
Maltese: IDT (n=108)
English: Riociguat IDT (n = 254)
Maltese: IDT (n=254)
English: All patients were WHO Functional Class III and 82% received background therapy with an endothelin receptor antagonist (ERA).
Maltese: III u 82% irċevew terapija fl-isfond b'antagonist tar-riċettur ta'
English: Elimination half-life is about 7 hours in healthy subjects and about 12 hours in patients.
Maltese: Il-half-life tal-eliminazzjoni hi madwar 7 sigħat f'individwi f'saħħithom u madwar 12-il siegħa fil-pazjenti.
English: In chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy is the treatment of choice as it is a potentially curative option.
Maltese: Fi pressjoni għolja pulmonari tromboembolika kronika, endarterektomija pulmonari hija l-kura ppreferita peress li hija għażla b'potenzjal ta' fejqan.
English: The safety of Adempas has been evaluated in phase III studies of 681 patients with CTEPH and PAH receiving at least one dose of riociguat (see section 5.1).
Maltese: III ta' 681 pazjent b'CTEPH u PAH, li rċivew mill-inqas doża waħda ta' riociguat (ara sezzjoni 5.1).
English: Concomitant use with medicinal products increasing gastric pH
Maltese: Użu flimkien ma' prodotti mediċinali li jżidu l-pH tal-istonku
English: In rats, an increased rate of cardiac malformation was observed as well as a reduced gestation rate due to early resorption at maternal systemic exposure of about 7-fold of human exposure (2.5 mg three times daily).
Maltese: Fil-firien, kienet osservata żieda fir-rata ta' malformazzjoni kardijaka kif ukoll rata mnaqqsa ta' ġestazzjoni minħabba assorbiment mill-ġdid bikri f'esponiment sistemiku tal-omm ta' madwar 7 darbiet l-esponiment fil-bniedem (2.5 mg tliet darbiet kuljum).
English: EU/2/16/203/001 VarroMed 44 mg/ml / 5 mg/ml
Maltese: 44 mg/ml / 5 mg/ml
English: Packaging Content Package size
Maltese: Ippakkjar Kontenut Daqs tal-pakke tt
English: Bottle (HDPE)
Maltese: Naħla tal-għasel Użu fid-doqqajs Flixkun (HDPE)
English: EU/2/16/203/002 VarroMed 660 mg / 75 mg
Maltese: Flixkun 1 Għasel: Żero jiem mg/75 mg
English: Sachet (PET/Alu/L DPE)
Maltese: Naħla tal-għasel Użu fid-doqqajs Qartas (PET/Alu/LD
English: 12 sachets Honey: Zero days
Maltese: 12-il qartas
English: Suicidal behaviour5,7 Mania
Maltese: Imġiba suwiċidali5,7 Manija
English: Capsule content: sucrose, maize starch, hypromellose, talc, hypromellose acetate succinate, triethyl citrate.
Maltese: Kontenut tal-kapsula: sucrose, maize starch, hypromellose, talc, hypromellose acetate succinate, triethyl citrate.
English: • depression;
Maltese: • depressjoni
English: Frequency estimate: 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).
Maltese: Komuni ħafna ( 1/10), komuni ( 1/100 sa  1/10), mhux komuni ( 1/1,000 sa  1/100), rari ( 1/10,000 sa  1/1,000), rari ħafna (< 1/10,000).
English: Monoamine oxidase inhibitors (MAOIs)
Maltese: Inibituri ta' monoamine oxidase (MAOIs)
English: S.C. Zentiva S.A Theodor Pallady Nr 50 032266 Bucharest Romania
Maltese: S.A Theodor Pallady Nr 50 032266 Bucharest Ir-Rumanija
English: Excipient(s) with known effect: each capsule contains 42.26 - 46.57 mg of sucrose.
Maltese: Eċċipjent(i) b'effett magħruf: kull kapsula fiha 42.26 - 46.57 mg ta' sucrose.
English: Myoclonus Akathisia7
Maltese: Mijoklonus Akatiżja7
English: − Yellow iron oxide (E172)
Maltese: − Iron oxide isfar (E172)
English: • are taking St. John's Wort, a herbal treatment (Hypericum perforatum);
Maltese: John's wort (Hypericum perforatum).
English: Moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
Maltese: Mard moderat fil-fwied (Child Pugh Klassi B) affettwa l-farmakokinetika ta' duloxetine.
English: Medicinal products metabolised by CYP2D6
Maltese: Prodotti mediċinali li jiġu metabolizzati minn CYP2D6
English: Duloxetine is a moderate inhibitor of CYP2D6.
Maltese: Duloxetine huwa inibitur moderat ta' CYP2D6.
English: Duloxetine Zentiva 30 mg gastro-resistant hard capsules EU/1/15/1028/001
Maltese: Duloxetine Zentiva 30 mg kapsuli gastro-reżistenti ibsin EU/1/15/1028/001
English: Duloxetine Zentiva contains sucrose
Maltese: Duloxetine Zentiva fih s-sucrose
English: Inducers of CYP1A2
Maltese: Inibituri ta' CYP1A2
English: Stomatitis Haematochezia Breath odour Microscopic colitis9
Maltese: Ematokeżja Riħa ħażina fil-ħalq Kolite mikroskopika9
English: Duloxetine Zentiva is indicated in adults.
Maltese: Duloxetine Zentiva huwa indikat għall-adulti.
English: Duloxetine Zentiva 60 mg gastro-resistant hard capsules EU/1/15/1028/004
Maltese: Duloxetine Zentiva 60 mg kapsuli gastro-reżistenti ibsin EU/1/15/1028/004
English: Gastrointestinal haemorrhage7
Maltese: Emorraġija gastro-intestinali7
English: Duloxetine is extensively metabolised by oxidative enzymes (CYP1A2 and the polymorphic CYP2D6), followed by conjugation.
Maltese: Duloxetine huwa metabolizzat b'mod estensiv minn enzimi ossidattivi (CYP1A2 u dik polymorfika CYP2D6) u mbagħad ikkonjugat.
English: • feeling of dizziness or “spinning” (vertigo), ear pain;
Maltese: • sensazzjoni ta' surdament jew ‘spinning'(vertiġini), uġigħ fil-widnejn;
English: • Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St. John's Wort and MAOIs (such as moclobemide and linezolid).
Maltese: • Mediċini li jżidu l-livell ta' serotonin:Triptans, tramadol, tryptophan, SSRIs (bħal paroxetine u fluoxetine), SNRIs (bħal venlafaxine), antidipressivi triċikliċi (bħal clomipramine, amitriptyline), pethidine, St.John's Wort u MAOIs (bħal moclobemide u linezolid).
English: Duloxetine did not show efficacy in reducing pain as measured by primary outcome measure of Brief Pain Inventory (BPI) average pain score endpoint: least squares (LS) mean change from baseline in BPI average pain score at 13 weeks was -0.97 in the placebo group, compared with -1.62 in the duloxetine 30/60 mg group (p = 0.052).
Maltese: Duloxetine ma weriex effikaċja fit-tnaqqis ta' uġigħ kif imkejjel mill-miżura tal-effett primarju tal-punt finali ta' punteġġ medju ta' uġigħ tal-Brief Pain Inventory (BPI): l-inqas bidla medja fil-kwadranti (least squares -LS) mil-linja bażi fil-punteġġ medju ta' uġigħ BPI wara 13-il ġimgħa kien ta' -0.97 filgrupp ta' plaċebo, mqabbel ma' -1.62 fil-grupp ta' duloxetine 30/60 mg (p = 0.052).
English: The incidence of relapse during the 6-months double-blind follow-up period was 14% for duloxetine and 42% for placebo.
Maltese: L-inċidenza ta' rikaduta waqt il-perijodu miżjud ta' 6 xhur li kien double-blind kien ta' 14 % b'duloxetine u ta' 42 % bi plaċebo.
English: Both cytochromes P450-2D6 and 1A2 catalyse the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulphate conjugate of 5-hydroxy 6-methoxy duloxetine.
Maltese: Kemm iċ-ċitokrom CYP 2D6 kif ukoll CYP 1A2 jikkatalizzaw il-formazzjoni taż-żewġ prodotti metaboliċi prinċipali l-glukuronidu kkonjugat ta' 4-hydroxy duloxetine u l-konjugat tas-sulfat ta' 5hydroxy 6-methoxy duloxetine.
English: The safety results from this study were consistent with the known safety profile of duloxetine.
Maltese: Irriżultati ta' sigurtà minn dan l-istudju kienu konsistenti mal-profil ta' sigurtà magħruf ta' duloxetine.
English: Tachycardia Supra-ventricular arrhythmia, mainly atrial fibrillation
Maltese: Takikardija Arritmija supraventrikolari, laktar fibrillazzjoni ta' l-atrija
English: • muscle pain, muscle spasm;
Maltese: • uġigħ fil-muskoli, spażmu fil-muskolu;
English: INFORMATION IN BRAILLE Duloxetine Zentiva 60 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Duloxetine Zentiva 60 mg
English: After an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/h (mean 101 l/h).
Maltese: Wara doża orali, it-tneħħija apparenti ta' duloxetine mill-plażma tvarja minn 33 sa 261 l/hr (medja 101 l/hr).
English: Oral contraceptives and other steroidal agents Results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A.
Maltese: Riżultati ta' studji in vitro juru li duloxetine ma jistimulax l-attività katalitika ta' CYP3A.
English: • generalised anxiety disorder (chronic feeling of anxiety or nervousness);
Maltese: • disturb ta' l-ansjetà ġeneralizzata (sensazzjoni kronika ta' ansjetà jew nervożità)
English: After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/h to 46 l/h (mean of 36 l/h).
Maltese: Wara doża minn ġol-vini t-tneħħija mill-plażma ta' duloxetine tvarja minn 22 l/hr sa 46 l/hr (medja ta' 36 l/hr).
English: Consequently, caution is advised when duloxetine is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Maltese: Konsegwentement, huwa rrakkomandat li duloxetine jingħata b'attenzjoni meta jittieħed flimkien ma' prodotti mediċinali jew sustanzi li jaħdmu b'mod ċentrali fosthom alkoħol u prodotti mediċinali sedattivi (eż. benzodiazepines, morfinomimetiċi, anti-psikotiċi, phenobarbital, anti-istamini sedattivi).
English: Duloxetine Zentiva increases the levels of serotonin and noradrenaline in the nervous system.
Maltese: Duloxetine Zentiva jżid il-livelli ta' serotonin u ta' noradrenaline fis-sistema nervuża.
English: • blurred eyesight;
Maltese: • vista mċajpra;
English: Duloxetine Zentiva is available in 2 strengths: 30 mg and 60 mg.
Maltese: Duloxetine Zentiva huwa disponibbli f'żewġ dożi: 30 mg u 60 mg
English: INFORMATION IN BRAILLE Duloxetine Zentiva 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Duloxetine Zentiva 30 mg
English: EU/1/15/1028/004 EU/1/15/1028/005 EU/1/15/1028/006 EU/1/15/1028/007
Maltese: EU/1/15/1028/005 EU/1/15/1028/006 EU/1/15/1028/007
English: Duloxetine was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Maltese: Duloxetine ġie studjat f'programm kliniku li kien jinvolvi 3,158 pazjent (1,285 pazjenti-snin ta' espożizzjoni) li laħaq il-kriterji DSM-IV għal depressjoni maġġuri.
English: Effects of other medicinal products on duloxetine
Maltese: Effetti ta'prodotti mediċinali oħra fuq duloxetine
English: The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by coadministration with duloxetine (60 mg twice daily).
Maltese: Il-farmakokinetika ta' theophylline, sustrat ta' CYP1A2, ma ġietx affettwata b'mod sinifikanti meta ngħata flimkien ma' duloxetine (60 mg darbtejn kuljum).
English: Neither duloxetine (30-120 mg) nor the active control arm (fluoxetine 20-40 mg) statistically separated from placebo on change from baseline to endpoint in the Children´s Depression Rating Scale-Revised (CDRS-R) total score.
Maltese: Bħala bidla mil-linja bażi sar-riżultat finali, la duloxetine (30-120 mg) u lanqas il-fergħa ta' kontroll attiv (fluoxetine 2040 mg) ma sseparaw b'mod statistiku mill-plaċebo fil-valur totali taċ-Children´s Depression Rating Scale-Revised (CDRS-R).
English: Hallucinations Aggression and anger4
Maltese: Alluċinazzjonijiet Aggressjoni u rabja4
English: Capsule cap: Indigo carmine (E132), titanium dioxide (E171), gelatin Capsule body: titanium dioxide (E171), gelatin
Maltese: Indigo carmine (E132), titanium dioxide (E171), ġelatina Parti prinċipali tal-kapsula:
English: Hyperglycaemia (reported especially in diabetic patients)
Maltese: Ipergliċemija (irrapportata liżjed f'pazjenti dijabetiċi)
English: Tolerability of duloxetine 60 mg once daily in elderly patients was comparable to that seen in the younger adults.
Maltese: It-tollerabilità ta' duloxetine 60 mg darba kuljum f'pazjenti anzjani kien simili għal dak osservat fl-adulti iżgħar.
English: Capsule cap: Indigo carmine (E132), titanium dioxide (E171), gelatin Capsule body: yellow iron oxide (E172), titanium dioxide (E171), gelatin
Maltese: Indigo carmine (E132), titanium dioxide (E171), ġelatina Parti prinċipali tal-kapsula: titanium dioxide (E171), ġelatina Duloxetine Zentiva 60 mg:
English: Medicines like Duloxetine Zentiva (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Maltese: Mediċini bħal Duloxetine Zentiva ('l hekk imsejħa SSRIs/SNRIs) jistgħu jikkawżaw sintomi ta' disfunzjoni sesswali (ara sezzjoni 4).
English: • are a young adult.
Maltese: • inti adult/a żgħir/a.
English: The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71 %, but does not affect the pharmacokinetics of its active 5hydroxyl metabolite and no dosage adjustment is recommended.
Maltese: L-AUC fiss ta' tolterodine (2 mg darbtejn kuljum) tiżdied b'71% meta jingħata flimkien ma' duloxetine (40 mg darbtejn kuljum), iżda ma jaffettwax il-farmakokinetika tal-metabolat attiv tiegħu 5-hydroxyl u mhux irrakkomandat li jsir aġġustament ta' doża.
English: Major Depressive Disorder
Maltese: Disturb depressiv maġġuri
English: Major depressive disorder
Maltese: Disturb Depressiv Maġġuri
English: During the 52-week placebocontrolled double blind treatment phase 14.4% of the duloxetine-treated patients and 33.1% of the placebo-treated patients experience a return of their depressive symptoms (p < 0.001).
Maltese: Matul il-fażi ta' kura double-blind u kkontrollata bil-plaċebo li damet 52 ġimgħa, 14.4% tal-pazjenti kkurati b'duloxetine u 33.1% tal-pazjenti kkurati bil-plaċebo reġgħu ħassew issintomi depressivi tagħhom (p< 0.001).
English: Duloxetine may increase the risk of postpartum haemorrhage (see section 4.6).
Maltese: Duloxetine jista' jżid ir-riskju ta' emorraġija wara l-ħlas (ara sezzjoni 4.6).
English: Duloxetine Zentiva 30 mg gastro-resistant hard capsules 7, 28, 56, 84 and 98 capsules
Maltese: Duloxetine Zentiva 30 mg kapsuli gastro-reżistenti ibsin 7, 28, 56, 84 u 98 kapsula
English: Duloxetine demonstrated statistically significant superiority over placebo as measured by improvement in the Hamilton Anxiety Scale (HAM-A) total score and by the Sheehan Disability Scale (SDS) global functional impairment score.
Maltese: Duloxetine wera superjorità statistikament sinifikanti fuq plaċebo kemm meta kkalkulat skond it-titjib fil-punteġġ totali tal-Hamilton Anxiety Scale(HAM-A) u kemm skond il-punteġġ ta' indeboliment funzjonali globali tas-Sheehan Disability Scale (SDS).
English: Medicinal products metabolised by CYP1A2
Maltese: Prodotti mediċinali li jiġu metabolizzati minn CYP1A2
English: Galactorrhoea Hyperprolactinaemia Postpartum haemorrhage6
Maltese: Sintomi talmenopawża Galaktorreja Iperprolaktinimja Emorraġija wara lħlas6
English: Capsule shell:
Maltese: Kappa tal-kapsula:
English: Orthostatic hypotension2
Maltese: Ipertensjoni3,7 Ipotensjoni ortostatika2
English: 7 gastro-resistant hard capsules 28 gastro-resistant hard capsules 56 gastro-resistant hard capsules 84 gastro-resistant hard capsules 98 gastro-resistant hard capsules
Maltese: 7 kapsuli gastro-reżistenti ibsin 28 kapsula gastro-reżistenti iebsa 56 kapsula gastro-reżistenti iebsa 84 kapsula gastro-reżistenti iebsa 98 kapsula gastro-reżistenti iebsa