FrancophonIA/ELRC3.0 huggingface dataset:
English: Diabetic Peripheral Neuropathic Pain: The efficacy of Duloxetine Lilly 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 Lilly bħala kura għall-uġigħ newropatiku tad-dijabete kien stabbilit f'żewġ studji ta' 12-il ġimgħa, b'dożi fissi, ikkontrollati bil plaċebo,randomised u double-blind f'adulti (22 sa 88 sena) li kellhom uġigħ newropatiku tad-dijabete għallinqas għal 6 xhur.
English: In studies of up to 9 months an overall mean decrease of 1% in height percentile (decrease of 2% in children (7-11 years) and increase of 0.3% in adolescents (12-17 years)) was observed in duloxetinetreated paediatric patients (see section 4.4).
Maltese: 0.3% fl-adolexxenti (12-17-il sena)) (ara sezzjoni 4.4).
English: However, as with any medicine, caution should be exercised when treating the elderly, especially with Duloxetine Lilly 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 Lilly 120 mg kuljum għal disturb depressiv maġġuri jew disturb ta' ansjetà ġeneralizzata, fejn l informazzjoni hija limitata (ara sezzjonijiet 4.4 u 5.2).
English: Duloxetine Lilly 60 mg hard gastro-resistant capsules duloxetine
Maltese: Duloxetine Lilly 60 mg kapsuli gastro-reżistenti ibsin duloxetine
English: Vascular disorders
Maltese: GASTRO-REŻISTENTI
English: At least 30% reported pain reduction was recorded in approximately 65% of duloxetine treated patients versus 40% for placebo.
Maltese: 65% tal-pazjenti kkurati b'duloxetine kontra l-40% ta' dawk fuq plaċebo rreġistraw tnaqqis ta' mill inqas 30% fl-uġigħ li kien ġie rrappurtat.
English: Chest pain7
Maltese: Uġigħ fis sider7
English: Female mice receiving duloxetine for 2 years had an increased incidence of hepatocellular adenomas and carcinomas at the high dose only (144 mg/kg/day), but these were considered to be secondary to hepatic microsomal enzyme induction.
Maltese: Ġrieden tassess femminili li rċevew duloxetine għal sentejn kellhom inċidenza ogħla ta' adenomi u kanċer epatoċellulari fid-doża għolja biss (144 mg/kg/ġurnata), imma dawn kienu kkunsidrati li huma sekondarji għall-istimulazzjoni ta' l-enżima mikrożomali tal-fwied.
English: Hyponatraemia
Maltese: FARMAĊEWTIKU
English: Clinical response rates in patients experiencing somnolence were 60% on duloxetine and 30% on placebo.
Maltese: 60% għal dawk fuq duloxetine u ta' 30% għal dawk fuq plaċebo.
English: 10Estimated frequency based on placebo-controlled clinical trials.
Maltese: Stima tal-frekwenza bbażata fuq provi kliniċi kkontrollati minn plaċebo ċ.
English: Renal impairment
Maltese: Rogħda Parastiżja
English: Duloxetine Lilly 30 mg hard gastro-resistant capsules duloxetine
Maltese: Duloxetine Lilly 30 mg kapsuli gastro-reżistenti ibsin duloxetine
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant
Maltese: Tagħrif minn studji kliniċi wera li hemm żieda fir-riskju ta' mġiba suwiċidali f'adulti li għandhom inqas minn 25 sena, bi problemi psikjatriċi u li kienu kkurati b'antidepressivi.
English: Overall, Duloxetine Lilly'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 , l-effikaċja ta' Duloxetine Lilly 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, doubleblind u kkontrollati bil-plaċebo f'pazjenti li mhumiex residenti ġo sptar u li għandhom mard depressiv maġġuri.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Duloxetine Lilly hard gastro-resistant capsules contain sucrose.
Maltese: Duloxetine Lilly kapsuli gastro-reżistenti ibsin fihom sucrose.
English: Duloxetine Lilly with food, drink and alcohol
Maltese: Duloxetine Lilly mal-ikel, max-xorb u mal-alkoħol
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: sustrat ta' CYP2D6, l-AUC ta' desipramine żdied bi tliet darbiet.
English: Dizziness Lethargy Tremor
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: Each capsule contains 60 mg of duloxetine (as hydrochloride).
Maltese: Kull kapsula fiha 60 mg ta' duloxetine (bħala hydrochloride).
English: Disturbance in attention
Maltese: Disturb ta' ansjetà ġeneralizzata
English: Myoclonus Akathisia7
Maltese: Waqgħat8
English: duloxetine
Maltese: Tkexkix
English: Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Maltese: Differenzi farmakokinetiċi kienu identifikati bejn l-irġiel u n-nisa (it-tneħħija apparenti mill-plażma huwa bejn wieħed u ieħor 50% inqas fin-nisa).
English: Constipation Diarrhoea Abdominal pain Vomiting Dyspepsia Flatulence
Maltese: Tnaqqis fil-piż Żieda fil-piż Żieda fil creatine phosphokinase fid-demm
English: Chills
Maltese: IBSIN
English: EU/1/14/972/001 (7 hard gastro-resistant capsules) EU/1/14/972/002 (28 hard gastro-resistant capsules) EU/1/14/972/003 (98 hard gastro-resistant capsules)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/972/001 7 kapsula gastro-reżistenti iebsa EU/1/14/972/002 28 kapsula gastro-reżistenti iebsa EU/1/14/972/003 98 kapsula gastro-reżistenti iebsa
English: Hepatic failure6 Jaundice6
Maltese: Insuffiċjenza epatika6 Suffejra6
English: Cutaneous vasculitis
Maltese: TWISSIJA(IET) SPEĊJALI
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: espożiżżjoni sistemika anqas mill-esponiment massimu kliniku (AUC).
English: Each capsule contains 60 mg of duloxetine (as hydrochloride)
Maltese: Kull kapsula fiha 60 mg ta' duloxetine (bħala hydrochloride)
English: Edible green ink contains: Black iron oxide - synthetic (E172) Yellow iron oxide - synthetic (E172) Propylene glycol
Maltese: L-inkjostru aħdar li jittiekel fih: Iron oxide iswed - sintetiku (E172)
English: Therapeutic response is usually seen after 2-4 weeks of treatment.
Maltese: Ir-rispons għat-terapija ġeneralment jidher wara 2-4 ġimgħat ta' kura.
English: 20 hard gastro-resistant capsules.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 20 kapsula gastro-reżistenti iebsa.
English: Caution is advised if Duloxetine Lilly is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Maltese: Hu rrakkomandat li Duloxetine Lilly jingħata b'attenzjoni jekk jittieħed flimkien ma' prodotti mediċinali li huma fil-biċċa l-kbira metabolizzati min CYP2D6 (risperidone, anti-depressivi triċikliċi [TCAs] bħal nortriptyline, amitriptyline, u imipramine) speċjalment jekk għandhom indiċi terapewtiku dejjaq (bħal flecainide, propafenone u metoprolol).
English: 6 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: The efficacy of Duloxetine Lilly 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: effikaċja ta' Duloxetine Lilly fid-doża rakkomandata ta' 60 mg 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: Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment.
Maltese: It-tagħrif farmakokinetiku fuq duloxetine huwa limitat f'pazjenti b'indeboliment tal-kliewi ta' grad ħafif jew wieħed moderat.
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with Duloxetine Lilly (see section 4.4).
Maltese: L-antibijotiku linezolid huwa MAOI riversibbli u mhux selettiv u m'għandux jingħata lill-pazjenti kkurati b'Duloxetine Lilly (ara sezzjoni 4.4).
English: In patients responding to duloxetine, and with a history of repeated episodes of major depression, further long-term treatment at a dose of 60 to 120 mg/day could be considered.
Maltese: F'pazjenti li sejrin tajjeb fuq duloxetine u li għandhom passat ta' episodji ripetuti ta' depressjoni maġġura, tista' tiġi kkunsidrata kura għal tul itwal ta' żmien b'doża ta' 60 sa 120 mg/ġurnata.
English: In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label Duloxetine Lilly 60 mg once daily were randomised to either Duloxetine Lilly 60 mg once daily or placebo for a further 6-months.
Maltese: Fi studju ta' prevenzjoni ta' rikaduta, pazjenti li rrispondew għal 12-il ġimgħa ta' kura akuta b'openlabel Duloxetine Lilly 60 mg darba kuljum, kienu b'mod arbitrarju mgħotija jew Duloxetine Lilly 60 mg darba kuljum jew plaċebo għal 6 xhur oħra.
English: • constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking wind
Maltese: • uġigħ newropatiku tad-dijabete, depressjoni, ansjetà u inkontinenza urinarja
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
Maltese: Indigo carmine (E132) Iron oxide isfar (E172) Inkjostru abjad li jittiekel
English: How to take Duloxetine Lilly
Maltese: X'fih Duloxetine Lilly
English: Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic pain, major depressive disorder, generalised anxiety disorder and stress urinary incontinence).
Maltese: Duloxetine huwa użat taħt trejdmarks differenti f'ħafna indikazzjonijiet (kura ta' uġigħ newropatiku tad-dijabete, disturb depressiv maġġuri, disturb ta' ansjetà ġeneralizzata u inkontinenza ta' l-urina minħabba sforz).
English: − are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Lilly')
Maltese: - qiegħed/qiegħda tieħu mediċini oħra li fihom duloxetine (ara ‘Mediċini oħra u Duloxetine Lilly')
English: In both studies, Duloxetine Lilly 60 mg once daily and 60 mg twice daily significantly reduced pain compared with placebo.
Maltese: Fiż-żewġ studji, Duloxetine Lilly 60 mg darba kuljum u 60 mg darbtejn kuljum naqqsu b'mod sinifikanti l-uġigħ meta mqabbla ma' plaċebo.
English: Pharmacokinetics of duloxetine in paediatric patients aged 7 to 17 years with major depressive disorder following oral administration of 20 to 120 mg once daily dosing regimen was characterized using population modelling analyses based on data from 3 studies.
Maltese: Il-farmakokinetika ta' duloxetine, wara l-għoti mill-ħalq b'skeda ta' dożaġġ ta' 20 sa 120 mg darba kuljum f'pazjenti pedjiatriċi b'etajiet minn 7 sa 17-il sena b'disturb depressiv maġġuri, ġiet ikkaratterizzata bl-użu ta' analiżi ta' mudelli ta' popolazzjoni bbażati fuq tagħrif minn 3 studji.
English: During 52 weeks of placebo-controlled double blind treatment, duloxetine-treated patients with recurrent MDD had a significantly longer symptom free period (p<0.001) compared with patients randomised to placebo.
Maltese: Matul it-52 ġimgħa ta' kura double-blind u kkontrollata bil-plaċebo, pazjenti b'DDM rikorrenti kkurati b'duloxetine kellhom, b'mod sinifikanti, perijodu itwal mingħajr sintomi (p< 0.001) meta mqabbel ma' pazjenti li b'mod arbitrarju ġew mogħtija plaċebo.
English: The concomitant use of Duloxetine Lilly with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Maltese: Mhux irrakkomandat l-użu fl-istess ħin ta' Duloxetine Lilly ma' MAOIs riversibbli u selettivi bħal moclobemide (ara sezzjoni 4.4).
English: However, the majority of common adverse reactions were mild to moderate, they usually started early in therapy, and most tended to subside even as therapy was continued.
Maltese: iżda, kienu ħfief jew moderati, ġeneralment bdew kmieni fit-terapija, u ħafna minnhom kellhom tendenza li jonqsu anki waqt it-tkomplija tat-terapija.
English: Urine odour abnormal
Maltese: Ħolm mhux normali
English: Lilly S.A.
Maltese: Dista S.A..
English: The dose may be adjusted up to 120 mg a day based on your response to Duloxetine Lilly.
Maltese: Issuqx u tagħmilx użu minn għodda jew tħaddem magni sakemm tkun taf b'liema mod jaffettwak Duloxetine Lilly.
English: Very rare side effects (may affect up to 1 in 10,000 people)
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000)
English: Haemorrhage
Maltese: Ipotirojdiżmu
English: As with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition, may occur with duloxetine treatment, particularly with concomitant use of other serotonergic agents (including SSRIs, SNRIs tricyclic antidepressants or triptans), with agents that impair metabolism of serotonin such as MAOIs, or with antipsychotics or other dopamine antagonists that may affect the serotonergic neurotransmitter systems (see sections 4.3 and 4.5).
Maltese: Bħal kull sustanza serotonerġika oħra, il-kura b'duloxetine tista' tikkawża s-sindromu ta' serotonin, kundizzjoni li tista' tkun ta' periklu għall-ħajja, speċjalment jekk fl-istess ħin ikun qed jintużaw sustanzi serotonerġiċi oħra (li jinkludu SSRIs, antidipressivi triċikliċi SNRIs jew triptans), sustanzi li jnaqqsu l-metaboliżmu ta' serotonin bħal MAOIs jew antipsikotiċi jew antagonisti oħra ta' dopamine li jistgħu jaffettwaw is-sistemi ta' newrotrasmissjoni seotonerġiċi (ara sezzjonijiet 4.3 u 4.5).
English: The effect of Duloxetine Lilly 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 score for duloxetine-treated patients compared to placebo.
Maltese: L-effett ta' Duloxetine Lilly 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'
English: Over the entire 36-week course of the study, 6 out of 333 patients initially randomized to duloxetine and 3 out of 225 patients initially randomized to fluoxetine experienced suicidal behaviour (exposure adjusted incidence 0.039 events per patient year for duloxetine and 0.026 for fluoxetine).
Maltese: Matul il-kors kollu tal-istudju li dam 36 ġimgħa, 6 mit-333 pazjent li għall-ewwel, b'mod arbitrarju, ġew mogħtija duloxetine u 3 mill-225 pazjent li għall-ewwel, b'mod arbitrarju, ġew mogħtija fluoxetine esperjenzaw imġiba suwiċidali (l-inċidenza aġġustata skont l-espożizzjoni kienet ta' 0.039 avvenimenti għal kull sena ta' pazjent għal duloxetine u 0.026 avvenimenti għal kull sena ta' pazjent għal fluoxetine).
English: Hard gastro-resistant capsule.
Maltese: GĦAMLA FARMAĊEWTIKA Kapsula gastro-reżistenti iebsa.
English: Duloxetine Lilly 60 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.004) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
Maltese: Duloxetine Lilly 60 mg darba kuljum wera superjorità statistikament sinifikanti meta mqabbel ma' plaċebo (p=0.004) f'daq li għandu x'jaqsam ir-riżultat primarju, il-prevenzjoni ta' rikaduta depressiva, ikkalkulata permezz taż-żmien li għadda sar-rikaduta.
English: Pollakiuria
Maltese: Midrijażi
English: The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients.
Maltese: Każi ta' kriżi ipertensiva b'duloxetine ġew irrapurtati, speċjalment f'pazjenti li diġà kellhom l-ipertensjoni.
English: In a relapse prevention study, patients responding to 6 months of acute treatment with open-label Duloxetine Lilly were randomised to either Duloxetine Lilly or placebo for a further 6-months.
Maltese: F'studju ta' prevenzjoni ta' rikaduta, pazjenti li kienu qed jirrispondu għal 6 xhur ta' kura b'mod akut b'Duloxetine Lilly open-label, ġew mogħtija b'mod arbitrarju jew Duloxetine Lilly jew plaċebo għal 6 xhur oħra.
English: Caution is advisable if Duloxetine Lilly is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Maltese: Barra dan, hemm nuqqas ta' informazzjoni f'tfal u f'adolexxenti dwar is-sigurtà fit-tul li jirrigwarda l-iżvilupp tal-ġisem, il-maturazzjoni u l-iżvilupp konjittiv u ta' l-imġiba (ara sezzjoni 4.8).
English: Concerning risk factors for suicidality in depression, see above.
Maltese: Dan ir-riskju jippersisti sakemm iseħħ tnaqqis sinifikanti tad-depressjoni.
English: Hypo-thyroidism
Maltese: Mijoklonus
English: Feeling hot Gait disturbance
Maltese: Disturbi fis-sistema nervuża Uġigħ ta' ras
English: Inhibitors of CYP1A2: Because CYP1A2 is involved in duloxetine metabolism, concomitant use of duloxetine with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
Maltese: Peress li CYP1A2 huwa involut fil-metaboliżmu ta' duloxetine, bl-użu fl-istess ħin ta' duloxetine ma' inibituri qawwija ta' CYP1A2 hemm probabbiltà li jirriżultaw konċentrazzjonijiet ogħla ta' duloxetine. Fluvoxamine (100 mg darba kuljum), inibitur qawwi ta'
English: Each capsule contains 30 mg of duloxetine (as hydrochloride)
Maltese: Kull kapsula fiha 30 mg ta' duloxetine (bħala hydrochloride)
English: For depression and diabetic neuropathic pain:
Maltese: Disturb Depressiv Maġġuri u Disturb ta' Ansjetà Ġeneralizzata:
English: Blood pressure increase3
Maltese: Żieda fil pressjoni taddemm3
English: Dysgeusia Dyskinesia Restless legs syndrome Poor quality sleep
Maltese: L-iponatrimja tista' sseħħ minħabba sindromu ta'
English: Symptoms of overdose include sleepiness, coma, 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, vomiting and fast heart rate.
Maltese: Sintomi ta' doża eċċessiva jinkludu ngħas, koma, is-sindromu ta' serotonin (reazzjoni rari li tista' tikkawża sensazzjonijiet ta' kuntentezza kbira, ħedla, guffaġni, irrekwitezza, sensazzjoni bħallikieku fis-sakra, deni, muskoli riġidi jew għarqana), aċċessjonijiet, rimettar u l-qalb tħabbat b'mod mgħaġġel.
English: Duloxetine Lilly must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Maltese: Duloxetine Lilly ma jistax jintuża f'pazjenti b'mard tal-fwied li jwassal għal indeboliment tal-fwied (ara sezzjonijiet 4.3 u 5.2).
English: Activated charcoal may be useful in limiting absorption.
Maltese: Activated charcoal jista' jkun ta' għajnuna biex jillimita l-assorbiment.
English: Duloxetine should not be used in children and adolescents under the age of 18 years for the treatment of major depressive disorder because of safety and efficacy concerns (see sections 4.4, 4.8 and 5.1).
Maltese: Minħabba problemi ta' sigurtà u effikaċja, duloxetine m'għandux jintuża fit-tfal u fl-adolexxenti taħt it-18-il sena għall-kura ta' distrub depressiv maġġuri (ara sezzjonijiet 4.4, 4.8 u 5.1).
English: The most commonly reported adverse reactions in patients treated with Duloxetine Lilly were nausea, headache, dry mouth, somnolence, and dizziness.
Maltese: L-aktar reazzjonijiet avversi komunement irrappurtati f'pazjenti fuq kura ta' Duloxetine Lilly kienu dardir, uġigħ ta' ras, ħalq xott, ngħas u sturdament.
English: Therefore Duloxetine Lilly should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section
Maltese: Għaldaqstant, Duloxetine Lilly m'għandux jingħata flimkien ma' inibituri qawwija ta' CYP1A2 bħal fluvoxamine (ara sezzjoni 4.3).
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: mg/kg/ġurnata), qabel u waqt li kienu qed jagħmlu s-sess u fil-bidu tat-tqala, kellhom tnaqqis fil konsum 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 patients with insufficient response to 60 mg, escalation up to 90 mg or 120 mg may therefore be considered.
Maltese: 90 mg jew 120 mg.
English: Major Depressive Disorder: Duloxetine Lilly was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Maltese: pazjent (1,285 pazjenti-snin ta' espożizzjoni) li laħaq il-kriterji DSM-IV għal depressjoni maġġuri.
English: In general, the adverse reaction profile of duloxetine in children and adolescents was similar to that seen for adults.
Maltese: B'mod ġenerali, il-profil tar-reazzjonijiet avversi ta' duloxetine fit-tfal u fl adolexxenti kien simili għal dak li deher fl-adulti.
English: The efficacy and safety of Duloxetine Lilly 30-120 mg once daily in elderly patients with generalised anxiety disorder was similar to that seen in studies of younger adult patients.
Maltese: L-effikaċja u s-sigurtà ta' Duloxetine Lilly 30-120 mg mogħti darba kuljum f'pazjenti anzjani b'disturb ta' ansjetà ġeneralizzata kienu simili għal dak li ħareġ mill-istudji fuq pazjenti adulti iżgħar.
English: The pharmacokinetics of duloxetine in patients who are poor metabolisers with respect to CYP2D6 has not been specifically investigated.
Maltese: Il-farmakokinetika ta' duloxetine f'pazjenti li huma metabolizzaturi dgħajjfa fir-rigward ta' CYP2D6 ma kinitx investigata b'mod speċifiku.
English: Serotonergic agents: In rare cases, serotonin syndrome has been reported in patients using SSRIs/SNRIs concomitantly with serotonergic agents.
Maltese: SSRIs/SNRIs fl-istess ħin ma' sustanzi serotoninerġiċi.
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 żieda tal-pressjoni fl-għajnejn (glawkoma)
English: Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.
Maltese: Dawn jinkludu mediċini mgħotija mit-tabib tiegħek permezz ta' ricetta inklużi l-benżodijażepini, mediċini qawwijin kontra l-uġigħ, antipsikotiċi, phenobarbital u antiistaminiċi.