FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 467 paediatric patients initially randomized to duloxetine in clinical trials experienced a 0.1 kg mean decrease in weight at 10-weeks compared with a 0.9 kg mean increase in 353 placebotreated patients.
Maltese: F'provi kliniċi, total ta' 467 pazjent pedjatriku, li għall-ewwel ġew mogħtija b'mod arbitrarju duloxetine, kellhom medja ta' tnaqqis fil-piż ta' 0.1 kg fl-10 ġimgħa meta mqabbel ma' żieda medja ta' 0.9 kg f'353 pazjent ikkurat bil-plaċebo.
English: Concomitant use of Duloxetine Zentiva with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Maltese: L-użu fl-istess ħin ta' Duloxetine Zentiva ma' inibituri ta' monoamine oxidase (MAOIs) irriversibbli u mhux selettivi huwa kontraindikat (ara sezzjoni 4.5).
English: ANNEX II
Maltese: Suffejra6
English: The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 h).
Maltese: Il-half life ta' l-eliminazzjoni ta' duloxetine tvarja minn 8 sa 17-il siegħa (medja ta' 12-il siegħa).
English: Duloxetine Zentiva must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Maltese: Duloxetine Zentiva ma jistax jintuża f'pazjenti b'indeboliment gravi tal-kliewi (tneħħija tal-kreatinina < 30 ml/min; ara sezzjoni 4.3).
English: • contraction of the jaw muscle;
Maltese: • kontrazzjoni tal-muskolu tax-xedaq;
English: A total of 509 paediatric patients aged 7 to 17 years with major depressive disorder and 241 paediatric patients aged 7 to 17 years with generalised anxiety disorder were treated with duloxetine in clinical trials.
Maltese: F'provi kliniċi, total ta' 509 pazjenti pedjatriċi b'etajiet minn 7 sa 17-il sena b'disturb depressiv maġġuri u 241 pazjent pedjatrika b'etajiet minn 7 sa 17-il sena b'disturb ta' ansjetà ġeneralizzata ġew ikkurati b'duloxetine.
English: Duloxetine Zentiva gastro-resistant hard capsules contain sucrose.
Maltese: Duloxetine Zentiva kapsuli gastro-reżistenti ibsin fihom sucrose.
English: Duloxetine Zentiva 60 mg gastro-resistant hard capsules 28, 56, 84 and 98 capsules
Maltese: Duloxetine Zentiva 60 mg kapsuli gastro-reżistenti ibsin 28, 56, 84 u 98 kapsula
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 u 23% ta' pazjenti jieħdu lplaċebo.
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: 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 massuwiċidju (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: 28 gastro-resistant hard capsules 56 gastro-resistant hard capsules 84 gastro-resistant hard capsules 98 gastro-resistant hard capsules
Maltese: 28 kapsula gastro-reżistenti iebsa 56 kapsula gastro-reżistenti iebsa 84 kapsula gastro-reżistenti iebsa 98 kapsula gastro-reżistenti iebsa
English: • have had mania;
Maltese: • għandek passat ta' manija;
English: Inhibitors of CYP1A2
Maltese: Sustanzi li jistimulaw CYP1A2
English: Gastroenteritis Eructation Gastritis Dysphagia
Maltese: Gastrite Diffikultà biex tibla'
English: Duloxetine demonstrated statistical superiority over placebo as measured by improvement in the 17item 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: Therefore Duloxetine Zentiva should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Maltese: Għaldaqstant, Duloxetine Zentiva m'għandux jingħata flimkien ma' inibituri qawwija ta' CYP1A2 bħal fluvoxamine (ara sezzjoni 4.3).
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: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PAPER FOLDING BOX
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Duloxetine Zentiva 30 mg gastro-resistant hard capsules Each capsule contains duloxetine hydrochloride equivalent to 30 mg duloxetine.
Maltese: U KWANTITATTIVA Duloxetine Zentiva 30 mg kapsuli gastro-reżistenti ibsin Kull kapsula fiha duloxetine hydrochloride ekwivalenti għal 30 mg duloxetine.
English: Duloxetine Zentiva 60 mg gastro-resistant hard capsules Hard opaque gelatin capsules of length approx. 19.4 mm with ivory opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets.
Maltese: Duloxetine Zentiva 60 mg kapsuli gastro-reżistenti ibsin Kapsuli tal-ġelatina ibsin u opaki b'tul ta' madwar 19.4 mm bil-parti prinċipali ivorju opak u b'kappa opaka blu ċar li fihom pritkuni sferikali ta' kulur offwajt għal isfar - kannella ċar.
English: Stevens-Johnson Syndrome6
Maltese: Sindromu ta' Stevens-Johnson6 Edima anġjonewrotika6
English: Duloxetine Zentiva 30 mg gastro-resistant hard capsules Duloxetine Zentiva 60 mg gastro-resistant hard capsules
Maltese: Duloxetine Zentiva 30 mg kapsuli gastro-reżistenti ibsin Duloxetine Zentiva 60 mg kapsuli gastro-reżistenti ibsin
English: Antacids and H2 antagonists
Maltese: Mediċini kontra l-aċtu fl-istonku u antagonisti ta' H2
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għal fructose jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Capsule content Sucrose
Maltese: Kontenut tal-kapsula:
English: Nervousness Disturbance in attention
Maltese: Disturb ta' Ansjetà Ġeneralizzata
English: Duloxetine Zentiva 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 Zentiva 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: For depression and diabetic neuropathic pain:
Maltese: Antidepressivi oħra Kodiċi ATC:
English: Serotonin syndrome6 Convulsion1
Maltese: Sindrome ta' serotonin6
English: 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: Constipation Diarrhoea Abdominal pain Vomiting Dyspepsia Flatulence
Maltese: Nervożità Disturbi flattenzjoni Disgewżja Diskinesja Sindromu ta' rrekwitezza fissaqajn
English: Duloxetine Zentiva 60 mg gastro-resistant hard capsules Capsule cap
Maltese: Duloxetine Zentiva 60 mg kapsuli gastro-reżistenti ibsin Kappa tal-kapsula
English: 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: Duloxetine Zentiva 30 mg gastro-resistant hard capsules Capsule cap
Maltese: Duloxetine Zentiva 30 mg kapsuli gastro-reżistenti ibsin Kappa tal-kapsula
English: • have liver disease;
Maltese: • żieda fil-piż;
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: • abnormal urine odour;
Maltese: • imurlek l-aptit;
English: The study included a 13weekdouble-blind period where patients were randomised to duloxetine 30 mg/60 mg, or placebo daily.
Maltese: L-istudju kien jinkludi perjodu double-blind ta' 13-il ġimgħa fejn ilpazjenti b'mod arbitrarju ngħataw duloxetine 30mg/60mg jew plaċebo darba kuljum.
English: Duloxetine Zentiva contains the active substance duloxetine.
Maltese: Duloxetine Zentiva fih is-sustanza attiva duloxetine.
English: Sleep disorder Bruxism Disorientation Apathy
Maltese: Problemi ta' irqad Tgħażżiż tas-snin involontarju Diżorjentament Apatija
English: However, as with any medicine, caution should be exercised when treating the elderly, especially with duloxetine 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 120 mg kuljum għal disturb depressiv maġġuri jew disturbi ta' ansjetà ġeneralizzata, fejn linformazzjoni hija limitata (ara sezzjonijiet 4.4 u 5.2).
English: When stopping treatment with Duloxetine Zentiva 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 Zentiva 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: 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 score for duloxetine-treated patients compared to placebo.
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: 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: • muscle tightness, muscle twitching;
Maltese: • rassa fil-gerżuma, tinfaraġ;
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: CNS medicinal products
Maltese: GĦAMLA FARMAĊEWTIKA
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: Population pharmacokinetic analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
Maltese: Analiżi farmakokinetiċi ta' popolazzjoni juru li min ipejjep għandu kważi 50% anqas konċentrazzjonijiet fil-plażma ta' duloxetine meta mqabbla ma' min ma jpejjipx.
English: The 60 mg capsules are hard opaque gelatin capsules of length approx. 19.4 mm with ivory opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets.
Maltese: Il-kapsuli ta' 60 mg huma kapsuli tal-ġelatina ibsin u opaki b'tul ta' madwar 19.4 mm bil-parti prinċipali ivorju opak u b'kappa opaka blu ċar opak li fihom pritkuni sferikali ta' kulur offwajt għal isfar - kannella ċar.
English: Each capsule contains duloxetine hydrochloride equivalent to 30 or 60 mg duloxetine.
Maltese: Kull kapsula fiha duloxetine hydrochloride ekwivalenti għal 30 jew 60 mg ta' duloxetine.
English: Caution is advised if duloxetine 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 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: • 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: 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'provi kliniċi kkontrollati bi plaċebo.
English: The main ingredient of Duloxetine Zentiva, duloxetine, is used in other medicines for other conditions: diabetic neuropathic pain, depression, anxiety and urinary incontinence.
Maltese: Is-sustanza l-aktar importanti f'Duloxetine Zentiva, duloxetine, hija użata f'medicini oħra għal kundizzjonijiet oħra:uġigħ newropatiku tad-dijabete, depressjoni, ansjetà u inkontinenza urinarja.
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, l-effikaċja 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: Interstitial lung disease10
Maltese: Marda tal-interstizju tal-pulmun10
English: − Gelatin
Maltese: − Ġelatina
English: Other medicines and Duloxetine Zentiva
Maltese: Mediċini oħra u Duloxetine Zentiva
English: Data on the use of duloxetine 120 mg in elderly patients with major depressive disorder and generalised anxiety disorder are limited.
Maltese: L-informazzjoni dwar l-użu ta' duloxetine 120 mg f'pazjenti anzjani b'disturb depressiv maġġuri u b'disturb ta' ansjetà ġeneralizzata hija limitata.
English: 8 Falls were more common in the elderly (≥ 65 years old) 9 Estimated frequency based on all clinical trial data.
Maltese: 8 Il-waqgħat kienu aktar komuni fl-anzjani (> 65 sena) 9 Stima tal-frekwenza bbażata fuq tagħrif mill-provi kliniċi kollha. 10 Stima tal-frekwenza bbażata fuq provi kliniċi kkontrollati bi plaċebo
English: How to take Duloxetine Zentiva
Maltese: Tiħux Duloxetine Zentiva jekk
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,
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: • Duloxetine Zentiva may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol.
Maltese: • Duloxetine Zentiva jista' jkollu effetti li ma tkunx taf dwarhom bħal żidiet fl-enzimi tal-fwied jew fil-livelli tal-potassju, tal-creatine phosphokinase, taz-zokkor jew tal-kolesterol fid-demm.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains duloxetine hydrochloride equivalent to 60 mg duloxetine.
Maltese: Kull kapsula fiha duloxetine hydrochloride ekwivalenti għal 60 mg duloxetine
English: The concomitant use of Duloxetine Zentiva with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Maltese: Mhux irrakkomandat l-użu fl-istess ħin ta' Duloxetine Zentiva ma' MAOIs riversibbli u selettivi bħal moclobemide (ara sezzjoni 4.4).
English: As with other medicinal products with similar pharmacological action (antidepressants), isolated cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation.
Maltese: Uġigħ Newropatiku Periferiku Tad-dijabete:Bħal bi prodotti mediċinali oħra li għandhom azzjoni farmakoloġika simili (anti-depressivi), ġew irrappurtati każi iżolati ta' formazzjoni ta' ideat suwiċidali u mġiba suwiċidali waqt terapija ta' duloxetine jew kmieni wara sospensjoni tal-kura.
English: • are taking other medicines to treat depression (see ‘Other medicines and Duloxetine Zentiva');
Maltese: • qiegħed/qiegħda tieħu mediċini oħra li fihom duloxetine (ara ‘Mediċini oħra u Duloxetine Zentiva').
English: What Duloxetine Zentiva looks like and contents of the pack Duloxetine Zentiva is a gastro-resistant hard capsule.
Maltese: Kif jidher Duloxetine Zentiva u l-kontenut tal-pakkett Duloxetine Zentiva issibu bħala kapsula gastro-reżistenti, iebsa.
English: The efficacy of duloxetine at the recommended dose of 60 mg once a day was demonstrated in three out of three randomised, doubleblind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Maltese: L-effikaċja ta' duloxetine 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: Very common Common
Maltese: Orgażmu mhux normali
English: Major Depressive Disorder and Generalised Anxiety Disorder Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suiciderelated events).
Maltese: Id-depressjoni hija assoċjata ma' riskju akbar ta' ħsibijiet suwiċidali, ħsara lill-persuna nnifisha, u suwiċidju (avvenimenti marbuta ma' suwiċidju).
English: NAME OF THE MEDICINAL PRODUCT Duloxetine Zentiva 60 mg gastro-resistant hard capsules Duloxetine
Maltese: Duloxetine Zentiva 60 mg kapsuli gastro-reżistenti ibsin Duloxetine
English: Excipient(s) with known effect: each capsule contains 84.51 - 93.14 mg of sucrose.
Maltese: 51 - 93.14 mg ta' sucrose.
English: NAME OF THE MEDICINAL PRODUCT Duloxetine Zentiva 30 mg gastro-resistant hard capsules Duloxetine
Maltese: Duloxetine Zentiva 30 mg kapsuli gastro-reżistenti ibsin Duloxetine
English: Caution is advisable if duloxetine 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: 5 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4).
Maltese: 5 Ġew irrapportati każijiet ta' formazzjoni ta' ideat suwiċidali u ta' mġiba suwiċidali waqt il-kura b'duloxetine jew ftit wara li twaqqfet il-kura (ara sezzjoni 4.4).
English: • dizziness, feeling sluggish, tremor, numbness, including numbness, pricking or tingling of the skin;
Maltese: • ħsibijiet ta' suwiċidju, diffikultà biex torqod, tgħażiż tas-snien, tħossok diżorjentat, nuqqas ta' motivazzjoni;
English: Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUCo-t 6-fold.
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' CYP1A2, naqqas it-tneħħija tal-plażma apparenti ta' duloxetine b'madwar 77% u żied b'6 darbiet l-AUCo-t.
English: Renal and urinary disorders Dysuria
Maltese: Kontraċettivi orali u sustanzi sterojdi oħra
English: Duloxetine Zentiva 30 mg is available in packs of 7, 28, 56, 84 and 98 capsules.
Maltese: Duloxetine Zentiva 30 mg issibu f'pakketti ta' 7, 28, 56, 84 u 98 kapsula Duloxetine Zentiva 60 mg issibu f'pakketti ta' 28, 56, 84 u 98 kapsula.
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: • increased sweating, (itchy) rash;
Maltese: • tegħreq iżjed, raxx (bil-ħaqq);