FrancophonIA/ELRC3.0 huggingface dataset:
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 5hydroxy,6-methoxy duloxetine.
Maltese: Kemm 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' 5-hydroxy 6methoxy duloxetine.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of duloxetine (as hydrochloride) Excipients: sucrose 8.6 mg.
Maltese: Kull kapsula fiha 30 mg ta' duloxetine (bħala hydrochloride) Sustanzi mhux attivi: sucrose 8.6 mg.
English: - are taking other medicines to treat depression(see ‘Taking other medicines') - 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) - are at risk of low sodium levels - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine - have intolerance to some sugars (see end of Section 2) - are considering stopping DULOXETINE BOEHRINGER INGELHEIM (see section 3)
Maltese: qiegħed/qiegħda tieħu mediċini oħra biex tikkura d-depressjoni (ara ‘Meta tieħu mediċini oħra). 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). qiegħed/qiegħda f'riskju li jitbaxxielek il-livell ta' sodium qiegħed/qiegħda tirċievi fl-istess waqt kura b'mediċina oħra li tista' tikkawżalek ħsara filfwied. qiegħed/qiegħda tieħu mediċini oħra li fihom duloxetine għandek intollerenza għal xi zokkor (ara fl-aħħar ta' sezzjoni 2) għandek il-ħsieb li twaqqaf DULOXETINE BOEHRINGER INGELHEIM (ara sezzjoni 3)
English: For selective, reversible MAOIs, like moclobemide, the risk of serotonin syndrome is lower.
Maltese: Għal MAOIs riversibbli u selettivi, bħal moclobemide, ir-riskju ta' sindromu ta' serotonin huwa anqas.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilMediċini (EMEA): http://www.emea.europa.eu.
English: Edible White Ink: titanium dioxide (E171), propylene glycol, shellac, povidone.
Maltese: Inkjostru abjad li jittiekel: titanium dioxide (E171), propylene glycol, shellac, povidone.
English: Blood pressure increase Peripheral coldness Orthostatic hypotension2 Syncope2
Maltese: Ksieħ periferiku ortostatika2 Sinkope2
English: DULOXETINE BOEHRINGER INGELHEIM increases the levels of serotonin and noradrenaline in the nervous system.
Maltese: DULOXETINE BOEHRINGER INGELHEIM iżid il-livelli ta' serotonin u ta' noradrenaline fissistema nervuża.
English: Consequently, caution is advised when DULOXETINE BOEHRINGER INGELHEIM is taken in combination with other centrally acting medicinal products and substances including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Maltese: Konsegwentement, huwa rrakkomandat li DULOXETINE BOEHRINGER INGELHEIM jingħata b'attenzjoni meta jittieħed flimkien ma' prodotti mediċinali u sustanzi li jaħdmu b'mod ċentrali fosthom alkoħol u prodotti mediċinali sedattivi (eż. benzodiazepines, morfinomimetiċi, anti-psikotiċi, phenobarbital, anti-istamini sedattivi).
English: The MAH must ensure that the system of pharmacovigilance, as described in Edition 5.2 dated April 2009 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Maltese: L-MAH għandu jassigura li s-sistema ta' farmakoviġilanza ,kif deskritta fl-Edizzjoni 5.2 li ġġib iddata ta' April 2009 ippreżentata f'Modulu 1.8.1 ta' l-Applikazzjoni għall-Awtorizzazzjoni għatTqegħid fis-Suq, hija stabbilita u mħaddma qabel u waqt li l-prodott tqiegħed fis-suq.
English: Oral contraceptives and other steroidal agents: results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A.
Maltese: Kontraċettivi orali u sustanzi sterojdi oħra: riżultati ta' studji in vitro juru li duloxetine ma jistimulax l-attività katalitika ta' CYP3A.
English: Tachycardia Supraventricular arrhythmia, mainly atrial fibrillation
Maltese: Takikardija Arritmija supraventrikolari, laktar fibrillazzjoni ta' l-atrija
English: For patients not experiencing somnolence, clinical response was observed in 47% of patients receiving duloxetine and 27% patients on placebo.
Maltese: F'pazjenti li ma qabadhomx inngħas,ir-rispons kliniku kien osservat f'47% tal-pazjenti li rċevew duloxetine u f'27% tal-pazjenti li kienu fuq plaċebo.
English: INFORMATION IN BRAILLE DULOXETINE BOEHRINGER INGELHEIM 60 mg
Maltese: INFORMAZZJONI BIL-BRAILLE DULOXETINE BOEHRINGER INGELHEIM 60mg
English: There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs).
Maltese: Ġew irrappurtati fsada mhux normali, bħal ekimosi, purpura u emorraġija gastro-intestinali b'inibituri selettivi ta'ġbir mill-ġdid ta' serotonin (SSRIs) u inibituri ta' ġbir mill-ġdid ta' serotonin /noradrenaline (SNRIs).
English: Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure (see section 5.3).
Maltese: Studji fl-annimali juru tossiċità fissistema riproduttiva f'livelli ta' esponiment sistemiku (AUC) ta' duloxetine anqas mill-esponiment kliniku massimu (ara sezzjoni 5.3).
English: Edible green ink: black iron oxide-synthetic (E172), yellow iron oxide- synthetic (E172), propylene glycol, shellac.
Maltese: Inkjostru aħdar li jittiekel: iron oxide sintetiku iswed (E172), iron oxide sintetiku isfar (E172), propylene glycol, shellac.
English: Cardiac Disorders
Maltese: Deidrazzjoni Iponatrimja
English: MARKETING AUTHORISATION HOLDER Boehringer Ingelheim International GmbH, Binger Str. 173 D-55216 Ingelheim am Rhein, Germany.
Maltese: Boehringer Ingelheim International GmbH, Binger Str. 173 D-55216 Ingelheim am Rhein, IlĠermanja
English: Edible White Ink contains: Titanium Dioxide (E171) Propylene glycol Shellac
Maltese: L-inkjostru Abjad li jittiekel fih : Titanium Dioxide (E171) Propylene Glycol Shellac
English: Menopausal symptoms
Maltese: Sintomi talmenopawża
English: PHARMACEUTICAL FORM AND CONTENTS 7 hard gastro-resistant capsules, 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 7 kapsuli gastro-reżistenti ibsin 28 kapsula gastro-reżistenti iebsa 98 kapsula gastro-reżistenti iebsa
English: Myoclonus Nervousness Disturbance in
Maltese: Mijoklonus Nervożità Disturbi flattenzjoni
English: Sugar spheres
Maltese: Sferi taz-zokkor
English: DULOXETINE BOEHRINGER INGELHEIM 60 mg is available in packs of 28 and 98 capsules.
Maltese: DULOXETINE BOEHRINGER INGELHEIM 60mg issibu f'pakketti ta' 28 u 98 kapsula.
English: Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Edible Green Ink
Maltese: Sodium Lauryl Sulfate Titanium Dioxide (E171)
English: No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetinetreated and placebo-treated patients.
Maltese: Ma ġiet osservata l-ebda differenza klinikament sinifikanti meta ġie kkalkulat il-QT, il-PR, il-QRS, jew il-QTcB bejn pazjenti fuq kura ta' duloxetine u pazjenti fuq plaċebo.
English: Therefore DULOXETINE BOEHRINGER INGELHEIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Maltese: Għaldaqstant, DULOXETINE BOEHRINGER INGELHEIM m'għandux jingħata flimkien ma' inibituri qawwija ta' CYP1A2 bħal fluvoxamine (ara sezzjoni 4.3).
English: Metabolism and Nutrition Disorders Decreased
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Tnaqqis flaptit
English: DULOXETINE BOEHRINGER INGELHEIM contains sucrose.
Maltese: DULOXETINE BOEHRINGER INGELHEIM fih s-sucrose.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucroseisomaltase insufficiency should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal fructose, assorbiment ħażin ta' glucose-galactose jew insuffiċjenza ta' sucrose-isomaltase m'għandhomx jieħdu din il-mediċina.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, Binger Str. 173 D-55216 Ingelheim am Rhein, Germany.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq: Boehringer Ingelheim International GmbH, Binger Str. 173 D-55216 Ingelheim am Rhein, Il-Ġermanja.
English: Serotonin syndrome: in rare cases, serotonin syndrome has been reported in patients using SSRIs (e.g. paroxetine, fluoxetine) concomitantly with serotonergic medicinal products.
Maltese: Sindromu ta' serotonin: f'każi rari, ġie rrappurtat sindromu ta' serotonin f'pazjenti li jużaw SSRIs (eż. paroxetine, fluoxetine) fl-istess ħin ma' prodotti mediċinali serotoninerġiċi.
English: Apathy
Maltese: Ematokeżja
English: Hyponatremia has been reported rarely, predominantly in the elderly, when administering DULOXETINE BOEHRINGER INGELHEIM.
Maltese: L-iponatrimja ġiet irrappurtata rarament, l-aktar fl-anzjani, fit-teħid ta' DULOXETINE BOEHRINGER INGELHEIM.
English: For patients with severe renal impairment, see section 4.3. ee section 4.2 for information on patients with mild or moderate renal dysfunction.
Maltese: Għal pazjenti b'indeboliment gravi tal-kliewi, ara sezzjoni 4.3. Ara sezzjoni 4.2 għal informazzjoni f'pazjenti b'disfunzjoni talkliewi ħafifa jew moderata.
English: Tel. + 48 22 4403300
Maltese: Eli Lilly Polska Sp. z o.o. Tel. + 48 22 4403300
English: The therapeutic benefit should be reassessed regularly (at least every three months) (see Section 5.1).
Maltese: Il-benefiċċju terapewtiku għandu jerġa' jiġi valutat regolarment (mill-anqas kull tliet xhur) (ara Sezzjoni 5.1).
English: DULOXETINE BOEHRINGER INGELHEIM gastro-resistant capsules contain sucrose.
Maltese: DULOXETINE BOEHRINGER INGELHEIM kapsuli gastro-reżistenti ibsin fihom sucrose.
English: Lilly S.A.
Maltese: Lilly SA
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 sintetiku iswed (E172) Iron oxide sintetiku isfar (E172) Propylene glycol Shellac
English: Oral anticoagulants: medicines which thin the blood.
Maltese: Antikoagulanti orali: mediċini li jraqqu d-demm.
English: Medicines that increase the level of serotonin: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St John's Wort and venlafaxine.
Maltese: SSRIs (bħal paroxetine u fluoxetine), triċikliċi (bħal clomipramine,amitriptyline) u venlafaxine.
English: Concomitant use of DULOXETINE BOEHRINGER INGELHEIM with nonselective, irreversible Monoamine Oxidase Inhibitors (MAOIs) is contraindicated (see section 4.5).
Maltese: L-użu fl-istess ħin ta' DULOXETINE BOEHRINGER INGELHEIM ma' Inibituri ta' Monoamine Oxidase (MAOIs) irriversibbli u mhux selettivi huwa kontra-indikat (ara sezzjoni 4.5).
English: Luxembourg/Luxemburg S.C.S.
Maltese: Luxembourg/Luxemburg S.C.S. Boehringer Ingelheim Comm.V.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in Revision 0 of 24 April 2008 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: L-MAH jikkommetti ruħu li jagħmel l-istudji u l-attivitajiet ta' farmakoviġilanza addizzjonali mniżżla fil-Pjan ta' Farmakoviġilanza, kif miftiehem fir-Reviżjoni 0 ta' l-24 ta' April 2008 tal- Pjan għallImmaniġġjar tar-Riskju (RMP) ippreżentat f'Modulu 1.8.2 ta' l- Applikazzjoni għall-Awtorizzazzjoni għat-Tqegħid fis-Suq u f'aġġornamenti sussegwenti tal-RMP kif miftiehem mas-CHMP.
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: Età: 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: Nervous System Disorders Headache
Maltese: Disturbi fis-sistema endokrinarja
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: Glaucoma
Maltese: L-KITBA
English: DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Maltese: DULOXETINE BOEHRINGER INGELHEIM m'għandux jiġi użat f'pazjenti b'indeboliment gravi tal-kliewi (tneħħija tal-krejatinina <30 ml/min) (ara sezzjoni 4.3) (ara sezzjoni 4.3).
English: The plasma concentration of duloxetine displays large inter-individual variability (see 5.2).
Maltese: Il-konċentrazzjoni filplażma ta' duloxetine turi varjabbilità kbira bejn individwu u ieħor (ara 5.2).
English: 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' 12-il siegħa).
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Maltese: • Meta tiġi miġbura xi informazzjoni ġdida li tista' taffetwa l-iSpeċifikazzjoni ta' Sigurta', il-Pjan ta' Farmakoviġilanza jew l-attivitajiet ta' tnaqqis ta' riskji attwali
English: The 60 mg capsules has an opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Maltese: Il-kapsuli ta' 60mg għandhom il-parti prinċipali aħdar opak stampati b'‘60mg' u l-parti ta' fuq blu opak stampati b'‘9542'
English: DULOXETINE BOEHRINGER INGELHEIM should not be used in combination with fluvoxamine, ciprofloxacin or enoxacine (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Maltese: DULOXETINE BOEHRINGER INGELHEIM m'għandux jiġi użat flimkien ma' fluvoxamine, ciprofloxacin jew enoxacine (jiġifieri inibituri qawwija ta' CYP1A2) billi dan iwassal għal konċentrazzjonijiet elevati ta' duloxetine fil-plażma (ara sezzjoni 4.5).
English: Reproductive System and Breast Disorders Erectile dysfunction
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Problemi fil-funzjoni erettili
English: This risk persists until significant remission occurs.
Maltese: Dan ir-riskju jippersisti sakemm iseħħ tnaqqis sinifikanti taddepressjoni.
English: Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, headache, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Maltese: Sturdament, disturbi tas-sensi (fosthom parastizja), disturbi fl-irqad, (fosthom insomnja u ħolm intens), aġitazzjoni jew ansjetà, dardir u/jew rimettar, rogħda, wġigħ ta' ras, irritabilità, dijarea, iperidrożi u vertigo huma l-aktar reazzjonijiet komunement irrappurtati.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 60 mg of duloxetine (as hydrochloride)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kapsula fiha 60mg ta' duloxetine (bħala hydrochloride)
English: Stomatitis Breath odour Haematochezia
Maltese: Urtikarja Dermatite minħabba kuntatt
English: Liver disease resulting in hepatic impairment (see section 5.2).
Maltese: Madankollu, il-kura ta' l-anzjani għandha tiġi segwita b'attenzjoni (ara sezzjoni 5.2).
English: Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
Maltese: Kull kapsula fiha 60 mg ta' duloxetine (bħala hydrochloride).
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: DETENTUR(I) TA' L-AWTORIZZAZZJONI TALMANIFATTURA RESPONSABBLI
English: Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor ,headache, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Maltese: Sturdament, disturbi tas-sensi (fosthom parastiżja), disturbi fl-irqad, (fosthom insomnja u ħolm intens), aġitazzjoni jew ansjetà, dardir u/jew rimettar, rogħda, wġigħ ta' ras, irritabilità, dijarea, iperidrożi u vertigo huma l-aktar reazzjonijiet komunement irrappurtati.
English: Gender: pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximatively 50% lower in females).
Maltese: Sess: differenzi farmakokinetiċi kienu identifikati bejn l-irġiel u n-nisa ( it-tneħħija apparenti millplażma huwa bejn wieħed u ieħor 50% inqas fin-nisa).
English: Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Maltese: Il-parti prinċipali aħdar opak, stampat b' ‘60 mg' u l-parti ta' fuq blu opak, stampat b' ‘9542'.
English: 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 bil-plaċebo,randomised u double-blind f'adulti (22 sa 88 sena) li kellhom uġigħ newropatiku tad-dijabete għallinqas għal 6 xhur.
English: The initiation of treatment with DULOXETINE BOEHRINGER INGELHEIM is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
Maltese: Huwa kontra-indikat li tinbeda l-kura b'DULOXETINE BOEHRINGER INGELHEIM f'pazjenti b'pressjoni għolja mhux ikkontrollata li tista' tesponi l-pazjenti għal riskju potenzjali ta' kriżi ipertensiva (ara sezzjonijiet 4.4 u 4.8).
English: Constipation Diarrhoea Vomiting Dyspepsia Flatulence
Maltese: Mijoklonus Nervożità Disturbi flattenzjoni Ħedla
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take DULOXETINE BOEHRINGER INGELHEIM.
Maltese: Għandek tistenna ta' l-anqas 14-il ġurnata wara li tkun waqaft tieħu xi MAOI biex tkun tista' tieħu DULOXETINE BOEHRINGER INGELHEIM.
English: Dizziness attention Lethargy Dysgeusia Dyskinesia Restless legs syndrome sleep symptoms Akathisia Psychomotor restlessness
Maltese: Sindrome ta' serotonin Sintomi ekstrapiramidali Akatiżja Irrekwitezza psikomotorja
English: HOW TO TAKE DULOXETINE BOEHRINGER INGELHEIM
Maltese: DULOXETINE BOEHRINGER INGELHEIM
English: Tremor Paraesthesia
Maltese: Disturbi vaskulari
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of DULOXETINE BOEHRINGER INGELHEIM 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 BOEHRINGER INGELHEIM 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: Caution is advised if DULOXETINE BOEHRINGER INGELHEIM 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 BOEHRINGER INGELHEIM 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: PHARMACEUTICAL FORM AND CONTENTS 28, hard gastro-resistant capsules 98, hard gastro-resistant capsules.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 28, kapsula gastro-reżistenti iebsa
English: When stopping treatment with DULOXETINE BOEHRINGER INGELHEIM 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 BOEHRINGER INGELHEIM tkun ser titwaqqaf id-doża għandha tiġi mnaqqsa gradwalment fuq perijodu ta' millanqas ġimgħa sa ġimagħtejn sabiex jitnaqqas ir-riskju ta' reazzjonijiet ta' rtirar (ara sezzjonijiet 4.4 u 4.8).
English: NAME OF THE MEDICINAL PRODUCT DULOXETINE BOEHRINGER INGELHEIM 30 mg hard gastro-resistant capsules
Maltese: TAL-PRODOTT MEDIĊINALI DULOXETINE BOEHRINGER INGELHEIM 30 mg kapsuli gastro-reżistenti ibsin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 30 mg of duloxetine (as hydrochloride)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kapsula fiha 30mg ta' duloxetine (bħala hydrochloride)
English: Hyponatremia
Maltese: Emorraġija
English: Caution is advisable if DULOXETINE BOEHRINGER INGELHEIM is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, St John's wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan.
Maltese: Is-sinjali u s-sintomi ta' doża eċċessiva (duloxetine waħdu jew b'taħlit ta' prodotti mediċinali) jinkludu ngħas, koma, sindromu ta' serotonin,aċċessjonijiet, rimettar u takikardija.
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: Hypersensitivity disorder Anaphylactic reaction
Maltese: Mard ta' sensitività eċċessiva Reazzjoni anafilattika
English: Abnormal dreams
Maltese: Insomnja Aġitazzjo ni
English: MAOI.
Maltese: Eżitazzjoni
English: NAME OF THE MEDICINAL PRODUCT DULOXETINE BOEHRINGER INGELHEIM 60 mg hard gastro-resistant capsules
Maltese: TAL-PRODOTT MEDIĊINALI DULOXETINE BOEHRINGER INGELHEIM 60 mg kapsuli gastro-reżistenti ibsin
English: NAME OF THE MEDICINAL PRODUCT DULOXETINE BOEHRINGER INGELHEIM 60 mg hard gastro-resistant capsules Duloxetine
Maltese: TAL-PRODOTT MEDIĊINALI DULOXETINE BOEHRINGER INGELHEIM 60mg kapsuli gastro-reżistenti ibsin Duloxetine