FrancophonIA/ELRC3.0 huggingface dataset:
English: During the 52-week placebo-controlled 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: When duloxetine was administered at a dose of 60 mg twice daily with a single dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold.
Maltese: Meta duloxetine jingħata f'doża ta' 60 mg darbtejn kuljum ma' doża waħda ta' desipramine, sustrat ta' CYP2D6, l-AUC ta' desipramine żdied bi tliet darbiet.
English: Elimination: The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours).
Maltese: Il-half life ta' l-eliminazzjoni ta' duloxetine tvarja minn 8 sa 17-il siegħa (medja ta' 12il siegħa).
English: Mydriasis Visual impairment
Maltese: Midrijażi Indeboliment fil-vista
English: In patients with insufficient response to 60 mg, escalation up to 90 mg or 120 mg may therefore be considered.
Maltese: F'pazjenti li m'għandhomx rispons suffiċjenti għal 60 mg, għandhom jiġu kkunsidrati żidiet sa 90 mg jew 120 mg.
English: Excipient(s) with known effect Each capsule contains 62.1 mg sucrose.
Maltese: Kull kapsula fiha 62.1 mg ta' sucrose.
English: Dehydration Hyponatraemia SIADH
Maltese: Deidrazzjoni Iponatrimja SIADH
English: Duloxetine 60 mg to 120 mg once daily demonstrated statistically significant superiority compared to placebo (p<0.001) on the prevention of relapse, as measured by time to relapse.
Maltese: Duloxetine 60 mg sa 120 mg kuljum wera superjorità statistikament sinifikanti meta mqabbel ma' plaċebo (p<0.
English: • “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits
Maltese: • “Is-Sindromu ta' Serotonin” (reazzjoni rari li tista' tikkawza sensazzjonijiet ta' kuntentezza kbira, ħedla, guffaġni, irrekwitezza, sensazzjoni bħallikieku fis-sakra, deni, muskoli riġidi jew għarqana), aċċessjonijiet
English: Duloxetine Mylan hard gastro-resistant capsules contain sucrose and sodium.
Maltese: Duloxetine Mylan kapsuli gastro-reżistenti ibsin fihom sucrose u sodium.
English: • contraction of the jaw muscle
Maltese: • kontrazzjoni tal-muskolu tax-xedaq
English: Concomitant use of Duloxetine Mylan with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Maltese: L-użu fl-istess ħin ta' Duloxetine Mylan ma' inibituri ta' monoamine oxidase (MAOIs) irriversibbli u mhux selettivi huwa kontraindikat (ara sezzjoni 4.5).
English: The efficacy of duloxetine 30-120 mg (flexible dosing) once a day in elderly patients (>65 years) with generalised anxiety disorder was evaluated in a study that demonstrated statistically significant improvement in the HAM-A total score for duloxetine treated patients compared to placebo treated patients.
Maltese: L-effikaċja ta' Duloxetine 30-120 mg (dożaġġ flessibbli) darba kuljum f'pazjenti anzjani (>65 sena) b'disturb ta' ansjetà ġeneralizzata ġiet evalwata fi studju li wera titjib statistikament sinifikanti filpunteġġ totali tal-HAM-A f'pazjenti kkurati b'duloxetine meta mqabbel ma' pazjenti kkurati bilplaċebo.
English: • Risk Management Plan (RMP)
Maltese: ● Pjan tal-immaniġġar tar-riskju (RMP)
English: Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Maltese: Imġiba assoċjata mas-suwiċidju (attentati ta' suwiċidju u ħsibijiet suwiċidali), u ostilità (l-aktar aggressjoni, imġiba konfrontali, u rabja), kienu osservati aktar spiss f'provi kliniċi fuq tfal u adolexxenti kkurati b'antidepressivi meta mqabbla ma' dawk ikkurati bil-plaċebo.
English: 60 mg capsules Capsule shell Brilliant blue (E133)
Maltese: Brilliant blue (E133)
English: Therefore Duloxetine Mylan should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Maltese: Għaldaqstant, Duloxetine Mylan m'għandux jingħata flimkien ma' inibituri qawwija ta' CYP1A2 bħal fluvoxamine (ara sezzjoni 4.3).
English: Muscle spasm
Maltese: Spażmu muskolari
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with duloxetine and 23% of patients taking placebo.
Maltese: F'provi kliniċi avvenimenti mhux mixtieqa b'sospensjoni tal-kura f'daqqa seħħew f'madwar 45% ta' pazjenti b'kura ta' Duloxetine Mylan u 23% ta' pazjenti jieħdu lplaċebo.
English: Hard gastro-resistant capsules
Maltese: Disturbi gastro-intestinali
English: Duloxetine Mylan should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Maltese: Duloxetine Mylan m'għandux jiġi użat flimkien ma' fluvoxamine, ciprofloxacin jew enoxacin (jiġifieri inibituri qawwija ta' CYP1A2) billi dan iwassal għal konċentrazzjonijiet elevati ta' duloxetine fil-plażma (ara sezzjoni 4.5).
English: Effects of other medicinal products on duloxetine Antacids and H2 antagonists: Co-administration of duloxetine with aluminium- and magnesiumcontaining antacids or duloxetine with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Maltese: Mediċini kontra l-aċtu fl-istonku u antagonisti ta' H2: It-teħid ta' duloxetine flimkien ma' mediċini kontra l-aċtu fl-istonku li fihom aluminium u magnesium jew ma' famotidine ma kellhiex effett sinifikanti fuq ir-rata jew il-miżura ta' assorbiment ta' duloxetine wara li ngħatat doża orali ta' 40 mg.
English: Suicidal ideation Sleep disorder Bruxism Disorientation Apathy
Maltese: Tgħażżiż tassnin involontarju Diżorjentament Apatija
English: Duloxetine demonstrated statistical superiority over placebo as measured by improvement in the 17-item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
Maltese: Duloxetine statistikament wera superjorità fuq plaċebo kkalkulat skond it-titjib fil-punteġġ totali talHamilton Depression Rating Scale (HAM-D) bi 17-il kriterju (li jinkludu kemm sintomi ta' depressjoni emozzjonali kif ukoll dawk somatiċi).
English: In an embryotoxicity study in the rabbit, a higher incidence of cardiovascular and skeletal malformations was observed at systemic exposure levels below the maximum clinical exposure (AUC).
Maltese: Fi studji embrojotossiċi fil-fenek,inċidenża ogħla ta' malformażżjoniijiet kardjovaskolari u skeletali kienu osservati f'livelli ta' espożiżżjoni sistemika anqas mill-esponiment massimu kliniku (AUC).
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium perforated unit dose blister pack containing 7 x 1, 28 x 1 and 30 x 1 hard gastro-resistant capsules.
Maltese: Pakkett bil-folji perforati tal-PVC/ PCTFE/Aluminju jew OPA/Aluminju/PVC - Aluminju b'doża talunità li jkun fih 7 x 1, 28 x 1 u 30 x 1 kapsula gastro-reżistenti iebsa.
English: Myoclonus Akathisia Nervousness Disturbance in attention
Maltese: Disturb Depressiv Maġġuri u Disturb ta' Ansjetà Ġeneralizzata:
English: Clinical response rates in patients experiencing somnolence were 60% on duloxetine and 30% on placebo.
Maltese: Ir-rati ta' rispons kliniku f'pazjenti li qabadhom in-ngħas kien ta' 60% għal dawk fuq duloxetine u ta' 30% għal dawk fuq plaċebo.
English: The plasma concentration of duloxetine displays large inter-individual variability (see section 5.2).
Maltese: Il-konċentrazzjoni filplażma ta' duloxetine turi varjabbilità kbira bejn individwu u ieħor (ara sezzjoni 5.2).
English: Hepatic impairment
Maltese: Disfunzjoni sesswali
English: Gastrointestinal haemorrhage Gastroenteritis Eructation Gastritis Dysphagia
Maltese: Emorraġija gastrointestinali Gastro-enterite Tifwiq
English: Diabetic Peripheral Neuropathic Pain: The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
Maltese: L-effikaċja ta' Duloxetine bħala kura għall-uġigħ newropatiku tad-dijabete kien stabbilit f'żewġ studji ta' 12-il ġimgħa, b'dożi fissi, ikkontrollati bilplaċebo,randomised u double-blind f'adulti (22 sa 88 sena) li kellhom uġigħ newropatiku tad-dijabete għallinqas għal 6 xhur.
English: 49 hard gastro-resistant capsules
Maltese: 49 kapsula gastroreżistenti ibsin
English: The study included a 13-week double-blind period where patients were randomised to duloxetine 30 mg/60 mg, or placebo daily.
Maltese: L-istudju kien jinkludi perjodu double-blind fejn il-pazjenti b'mod arbitrarju ngħataw duloxetine 30mg/60mg jew plaċebo darba kuljum.
English: EU/1/15/1010/001 EU/1/15/1010/002 EU/1/15/1010/003 EU/1/15/1010/004 EU/1/15/1010/005 EU/1/15/1010/006 EU/1/15/1010/021 EU/1/15/1010/022 EU/1/15/1010/023 EU/1/15/1010/024 EU/1/15/1010/025 EU/1/15/1010/026 EU/1/15/1010/027 EU/1/15/1010/028 EU/1/15/1010/041 EU/1/15/1010/042 EU/1/15/1010/043 EU/1/15/1010/044 EU/1/15/1010/045 EU/1/15/1010/046 EU/1/15/1010/047
Maltese: EU/1/15/1010/025 EU/1/15/1010/026 EU/1/15/1010/027 EU/1/15/1010/028 EU/1/15/1010/037 EU/1/15/1010/038 EU/1/15/1010/041 EU/1/15/1010/042 EU/1/15/1010/043 EU/1/15/1010/044
English: Talk to your doctor before you take Duloxetine Mylan if you: - are taking other medicines to treat depression (see ‘Other medicines and Duloxetine Mylan') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant
Maltese: Duloxetine Mylan'). - qiegħed/qiegħda tieħu St.John's Wort, kura bbażata fuq il-ħxejjex (Hypericum perforatum) - għandek mard tal-kliewi. - għandek passat ta' aċċessjonijiet. - għandek passat ta' manija - tbati minn mard bipolari. - għandek problemi f'għajnejk bħal xi tip ta' glawkoma (pressjoni għolja fl-għajn). - għandek passat ta' emorraġija (tendenza li tiżviluppa tbenġil), speċjalment jekk inti tqila (ara
English: Reproductive system and breast disorders Erectile dysfunction
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Problemi filfunzjoni erettili
English: • sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome, poor sleep quality
Maltese: • kontrazzjoni jew ġbid f'daqqa involontarju tal-muskoli, sensazzjoni ta' rrekwitezza jew linkapaċità li wieħed joqgħod mingħajr ma jiċċaqlaq, tħossok nervuż, diffikultà biex tikkonċentra, ttiegħem l-affarijiet differenti mis-soltu, diffikultà biex tikkontrolla l-movimenti eż. nuqqas ta' koordinazzjoni jew movimenti involontarji tal-muskoli, is-sindromu ta' rrekwitezza fis-saqajn, kwalità hażina ta' irqad
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium perforated unit dose blister pack containing 28 x 1, 30 x 1 and 100 x 1 hard gastro resistant capsules PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 28 x 1 hard gastro-resistant capsules.
Maltese: Pakkett bil-folji perforati tal-PVC/PCTFE/Aluminju jew OPA/Aluminju/PVC - Aluminju b'doża talunità li jkun fih 28 x 1, 30 x 1 u 100 x 1 kapsula gastro-reżistenti iebsa.
English: The no-adverse effect level was determined to be 20 mg/kg/day.
Maltese: Il-livell fejn ġie ddeterminat li ma kien hemm ebda effett avvers kien ta' 20 mg/kg/jum.
English: Dizziness, sensory disturbances (including paraesthesia or electric shock like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Maltese: Sturdament, disturbi tas-sensi (fosthom parastizja jew sensazzjonijiet li jixbħu dak ta' xokk elettriku, speċjalment fir-ras), disturbi fl-irqad, (fosthom insomnja u ħolm intens), għeja, ħedla ta' rqad, aġitazzjoni jew ansjetà, dardir u/jew rimettar, rogħda, wġigħ ta' ras, uġigħ fil-muskoli, irritabilità, dijarea, iperidrożi u vertigo huma l-aktar reazzjonijiet komunement irrappurtati.
English: Female rats receiving duloxetine (45 mg/kg/day) before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
Maltese: Firien tas-sess femminil li rċevew duloxetine (45 mg/kg/ġurnata), qabel u waqt li kienu qed jgħamlu s-sess u fil-bidu tat-tqala, kellhom tnaqqis filkonsum ta' l-ikel matern u fil-piż, diżordni fiċ-ċiklu oestrous, nuqqas fl-indiċi ta' twelid ta' frieħ hajjin u fis-sopravivenza tal-ferħ ta' l-annimal, u dewmien biex jikbru l-frieħ f'livelli ta' espożizzjoni sistemika, stmata li hija mhux anqas mill-esponiment massimu kliniku (AUC).
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of duloxetine 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Maltese: F'studju fit-tul mhux kontrollat u open-label, it-tnaqqis fl-uġigħ f'pazjenti li rrispondew għal 8 ġimgħat ta' kura akuta b'Duloxetine 60 mg darba kuljum ġie mantnut għal 6 xhur oħra kif imkejjel mit-tibdil f'dik il-parti tal-Brief Pain Inventory (BPI) tal-uġigħ medju fuq 24 siegħa.
English: EU/1/15/1010/039 EU/1/15/1010/040 EU/1/15/1010/054
Maltese: EU/1/15/1010/039 EU/1/15/1010/040
English: Tel: +39 02 612 46921
Maltese: Mylan Italia S.r.l Tel: + 39 02 612 46921
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal fructose, assorbiment ħażin ta' glucosegalactose jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu din il-mediċina.
English: When stopping treatment with Duloxetine Mylan the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Maltese: Meta l-kura b'Duloxetine Mylan tkun ser titwaqqaf id-doża għandha tiġi mnaqqsa gradwalment fuq perijodu ta' mill-anqas ġimgħa sa ġimagħtejn sabiex jitnaqqas ir-riskju ta' reazzjonijiet ta' rtirar (ara sezzjonijiet 4.4 u 4.8).
English: Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine (as hydrochloride)
Maltese: Informazzjoni għall-utent Duloxetine Mylan 30 mg kapsuli gastro-reżistenti ibsin Duloxetine Mylan 60 mg kapsuli gastro-reżistenti ibsin duloxetine (bħala hydrochloride)
English: However, as with any medicine, caution should be exercised when treating the elderly, especially with Duloxetine Mylan 120 mg per day for major depressive disorder or generalised anxiety disorder, for which data are limited (see sections 4.4 and 5.2).
Maltese: Madankollu, bħal b'mediċina oħra, il-kura ta' l-anzjani għandha tiġi segwita b'attenzjoni, speċjalment b'Duloxetine Mylan 120 mg kuljum għal disturb depressiv maġġuri jew disturb ta' ansjetà ġeneralizzata, fejn linformazzjoni hija limitata (ara sezzjonijiet 4.4 u 5.2).
English: Constipation Diarrhoea Abdominal pain Vomiting Dyspepsia Flatulence
Maltese: Mard talinterstizju talpulmun Pulmonite eosinofilika
English: Cutaneous vasculitis
Maltese: Vertiġini Uġigħ talwidnejn
English: Mylan Finland OY
Maltese: България Майлан ЕООД
English: Hypertensive crisis
Maltese: Kriżi ipertensiva
English: Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules
Maltese: Duloxetine Mylan 30 mg kapsuli gastro-reżistenti ibsin Duloxetine Mylan 60 mg kapsuli gastro-reżistenti ibsin
English: PVC/PE/PVdC/Aluminium perforated unit dose blister pack containing 7 x 1 and 28 x 1 hard gastro-resistant capsules.
Maltese: Pakkett bil-folji perforati tal- PVC/PE/PVdC/Aluminju b'doża tal-unità li jkun fih 7 x 1 u 28 x 1 kapsula gastro-reżistenti iebsa.
English: • abnormal urine odour
Maltese: • imurlek l-aptit
English: Galactorrhoea Hyperprolactinaemia Postpartum haemorrhage
Maltese: Sintomi talmenopawża Galaktorreja Iperprolaktinimja Emorraġija wara l-ħlas
English: A single study has been performed in paediatric patients with juvenile primary fibromyalgia syndrome (JPFS) in which the duloxetine-treated group did not separate from placebo group for the primary efficacy measure.
Maltese: Sar studju wieħed f'pazjenti pedjatriċi b'sindromu ta' fibromijalġja primarja ġovanili (JPFS- juvenile primary fibromyalgia syndrome) fejn, għall-miżura primarja ta' effikaċja, il-grupp ittrattat b'duloxetine ma ġiex separat mill-grupp ta' plaċebo.
English: At least 30% reported pain reduction was recorded in approximately 65% of duloxetine treated patients versus 40% for placebo.
Maltese: Kważi 65% talpazjenti kkurati b'duloxetine kontra l-40% ta' dawk fuq plaċebo rreġistraw tnaqqis ta' mill-inqas 30% fl-uġigħ li kien ġie rrappurtat.
English: Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.
Maltese: Stima tal-frekwenza ta' reazzjonijiet avversi rrapportati waqt sorveljanza wara li l-prodott tqiegħed fis-suq; mhux osservati f'studji kliniċi kkontrollati bi plaċebo.
English: Age: Pharmacokinetic differences have been identified between younger and elderly females (≥65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Maltese: Differenzi farmakokinetiċi kienu identifikati bejn nisa żgħar u kbar (≥ 65 sena) (l-AUC jiżdied b'madwar 25% u l-half life hi madwar 25% itwal fl-anzjani), għalkemm id-daqs ta' dawn il-bidliet mhux biżżejjed biex jiġġustifikaw tibdil fid-doża.
English: • vomiting blood, or black tarry stools (faeces), gastroenteritis, burping, difficulty swallowing
Maltese: • tirremetti d-demm, jew l-ippurgar (il-feċi) ikun iswed bħall-qatran, gastro-enterite, tfewwiq, diffikultà biex tibla'
English: Serotonergic agents: In rare cases, serotonin syndrome has been reported in patients using SSRIs/SNRIs concomitantly with serotonergic agents.
Maltese: F'każi rari, ġie rrappurtat sindromu ta' serotonin f'pazjenti li jużaw SSRIs/SNRIs fl-istess ħin ma' sustanzi serotoninerġiċi.
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium blister pack containing 14, 28, 84, 98 and multipacks containing 98 (2 packs of 49) hard gastro resistant capsules.
Maltese: Pakkett bil-folji tal-PVC/PCTFE/Aluminju jew OPA/Aluminju/PVC - Aluminju li jkun fih 14, 28, 84, 98 u pakketti multipli li jkun fihom 98 (2 pakketti ta' 49) kapsula gastro-reżistenti iebsa.
English: The effect of duloxetine 60 mg once a day in elderly depressed patients (≥65 years) was specifically examined in a study that showed a statistically significant difference in the reduction of the HAMD17
Maltese: L-effett ta' Duloxetine 60 mg darba kuljum, f'pazjenti anzjani b'depressjoni ( > 65 sena) ġie speċifikament eżaminat f'studju li wera differenza statistikament sinifikanti fit-tnaqqis tal-punteġġ ta' l-HAMD 17 għal pazjenti kkurati b'duloxetine meta mqabbel ma' plaċebo.
English: • dizziness, tingling feelings like pins and needles or electric shock like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
Maltese: • sturdament, sensazzjonijiet ta' tniggiż jew sensazzjonijiet bħal meta tieħu xokk elettriku (speċjalment fir-ras), problemi ta' irqad(ħolm stramb, ħmar il-lejl, ma tkunx tista' torqod), għeja, tħossok li trid torqod, tħossok irrekwet u aġitat, tħossok ansjuż, tħossok ħażin (dardir) jew jagħmillek ħażin (rimettar), ċaqliq (tregħid), uġigħ ta' ras, uġigħ fil-muskoli, tħossok irritabbli, dijarea, għaraq esaġerat jew vertigo.
English: Overall, duloxetine's efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Maltese: B'mod ġenerali , leffikaċja ta' Duloxetine ġiet ipprovata f'dożaġġi ta' kuljum ta' bejn 60 u 120 mg f'total ta' ħamsa minn seba' studji li saru f'sitwazzjonijiet akuti, b'doża fissa, randomised, double-blind u kkontrollati bil-plaċebo f'pazjenti li mhumiex residenti ġo sptar u li għandhom mard depressiv maġġuri.
English: PVC/PCTFE/Aluminium or OPA/Aluminium/PVC - Aluminium blister pack containing 7, 14, 28, 98 and multipacks containing 98 (2 packs of 49) hard gastro-resistant capsules.
Maltese: Pakkett bil-folji tal-PVC/PCTFE/Aluminju jew OPA/Aluminju/PVC - Aluminju li jkun fih 7, 14, 28, 98 u pakketti multipli li jkun fihom 98 (2 pakketti ta' 49) kapsula gastro-reżistenti iebsa.
English: Each capsule contains 60 mg of duloxetine (as hydrochloride).
Maltese: Kull kapsula fiha 60 mg ta ' duloxetine (bħala hydrochloride).
English: Opaque blue cap and opaque yellow body approximately 21.7 mm, imprinted in white ink with ‘MYLAN' over ‘DL 60' on both the cap and the body.
Maltese: Għatu blu opak u korp isfar opak ta' madwar 21.7 mm, stampat b'linka bajda b'MYLAN ' fuq ‘DL 60 ' kemm fuq l-għatu kif ukoll fuq il-korp.
English: Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine
Maltese: Duloxetine Mylan 60 mg kapsuli gastroreżistenti ibsin duloxetine
English: No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min).
Maltese: Mhux neċessarju aġġustament tad-doża għal pazjenti b'disfunzjoni tal-kliewi ħafifa jew moderata (tneħħija tal-kreatinina minn 30 sa 80 ml/min).
English: Hypo-thyroidism
Maltese: Indeboliment tal-kliewi
English: • muscle tightness, muscle twitching
Maltese: • tegħreq iżjed, raxx (bil-ħaqq)
English: Read the package leaflet before use.
Maltese: Jista ' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Hyponatraemia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Maltese: L-iponatrimja tista' sseħħ minħabba sindromu ta' sekrezzjoni mhux f'loka tal-ormon anti-dijuretiku (SIADH).
English: Duloxetine Mylan 30 mg hard gastro-resistant capsules duloxetine
Maltese: Duloxetine Mylan 30 mg kapsuli gastroreżistenti ibsin duloxetine
English: The efficacy of duloxetine at the recommended dose of 60 mg once a day was demonstrated in three out of three randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Maltese: L-effikaċja ta' Duloxetine fid-doża rakkomandata ta' 60mg darba kuljum ġiet ppruvata fit-tlieta minn tliet studji li saru f'sitwazzjonijiet akuti, b'doża fissa, randomised, double-blind u kkontrollati bil-plaċebo f'pazjenti li mhumiex residenti ġo sptar u li għandhom mard depressiv maġġuri.
English: A conclusion on the overall benefit/risk in this age group has not been established (see also sections 4.2 and 4.8).
Maltese: Konklużjoni dwar il-benefiċċju/riskju totali f'dan il-grupp ta' età ma ttieħditx (ara wkoll sezzjonijiet 4.2 u 4.8).