FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC further agreed during its April 2018 plenary meeting to extend the scope to include also parenteral formulations of methotrexate, in view of a number of cases reported with these formulations as well, and due to the fact that for a high number of cases reported as “incorrect schedule of dose administration” with methotrexate, the route of administration and the pharmaceutical form had not been specified.
Maltese: Matul il-laqgħa plenarja tiegħu ta' April 2018, il-PRAC qabel ukoll li jestendi l-kamp ta' applikazzjoni biex jinkludi wkoll formulazzjonijiet parenterali ta' methotrexate, fid-dawl tan-numru ta' każijiet irrappurtati wkoll b'dawn il-formulazzjonijiet, kif ukoll minħabba l-fatt li għal numru kbir ta' każijiet irrappurtati bħala “skeda mhux korretta ta' għoti tad-doża” b'methotrexate, mnejn jingħata u l-għamla farmaċewtika ma kinux speċifikati.
English: Similarly, the boxed warning in SmPC section 4.2 already agreed to be added to the product information of the oral formulations as outcome of the PSUSA should be also reflected in the product information of methotrexate parenteral formulations.
Maltese: Bl-istess mod, it-twissija fil-kaxxa fis-Sezzjoni 4.2 tal-SmPC li għandha tiġi miżjuda mal-informazzjoni dwar il-prodott tal-formulazzjonijiet orali, li diġà kien hemm qbil dwarha bħala eżitu tal-PSUSA, għandha tiġi riflessa wkoll fl-informazzjoni dwar il-prodott talformulazzjonijiet parenterali ta' methotrexate .
English: To minimise the risk of prescribing errors due to lack of knowledge by the prescriber of the weekly dosing schedule of methotrexate for the treatment of auto-immune diseases, the PRAC was of the view that methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy.
Maltese: Id-data wriet li minkejja l-miżuri fis-seħħ ta' minimizzazzjoni tar-riskju, każijiet severi, ta' periklu għall-ħajja kif ukoll każijiet fatali ta' doża eċċessiva minħabba żbalji fil-medikazzjoni bi prodotti mediċinali li fihom methotrexate, għadhom qed jiġu rrappurtati.
English: To gain further knowledge on the reasons leading to medication errors and prevent them adequately, as well as in support of the measurement of the effectiveness of the agreed risk minimisation measures, all MAHs are requested to implement and use a targeted follow-up questionnaire, as agreed by PRAC, for all medication errors reported with methotrexate and resulting in overdose.
Maltese: Minkejja li diġà ġew implimentati miżuri addizzjonali għall-minimizzazzjoni tar-riskju, komplew jiġu riċevuti rapporti ta' dan it-tip.
English: de la Industria Nº 30, 28108 Alcobendas Madrid
Maltese: Avenida de la Industria No 30 28108 Alcobendas Madrid
English: Mania6
Maltese: Manija6
English: Frequency estimate: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Maltese: Komuni ħafna (≥1/10), komuni (≥1/100 sa<1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000).
English: YENTREVE is indicated in adults.
Maltese: YENTREVE huwa indikat għall-adulti.
English: Suicidal ideation5,7
Maltese: ideat suwiċidali5,7
English: SIADH6
Maltese: Iponatrimja SIADH6
English: 3 See section 4.4.
Maltese: 3Ara sezzjoni 4.4
English: Capsule content Hypromellose
Maltese: Il-Kontenut tal-kapsula Hypromellose
English: Multipack: 196 (2 packs of 98 hard gastro-resistant capsules)
Maltese: Pakkett multiplu: 196 (2 pakketti ta' 98) kapsula gastro-reżistenti iebsa
English: Polyvinylchloride (PVC), polyethylene (PE), and polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminium foil.
Maltese: Polyvinylchloride (PVC), Polyethylene (PE), u folja tal-polychlorotrifluoroethylene (PCTFE)
English: Supra-ventricular arrhythmia, mainly atrial fibrillation6
Maltese: Arritmija supra-ventrikolari, l-aktar il-fibrillazzjoni atrijali6
English: Palpitations Tachycardia
Maltese: Palpitazzjonijiet Takikardija
English: YENTREVE increases the levels of serotonin and noradrenaline in the nervous system.
Maltese: YENTREVE jżid il-livelli ta' serotonin u ta' noradrenaline fis-sistema nervuża.
English: Capsule content: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate (See end of section 2 for further information on sucrose).
Maltese: Kontenut tal-kapsula: hypromellose, hypromellose acetate succinate, sucrose, sferi taz-zokkor, talkum,titanium dioxide (E171), triethyl citrate (Ara fl-aħħar ta' sezzjoni 2 għal aktar informazzjoni dwar sucrose)
English: Oy Eli Lilly Finland Ab Puh/Tel: +358-(0) 9 85 45 250
Maltese: Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: +358-(0) 9 85 45 250
English: Haematochezia Microscopic colitis9
Maltese: Kolite mikroskopika9
English: Severe renal impairment (creatinine clearance <30 ml/min) (see section 4.4).
Maltese: Indeboliment sever renali (tneħħija tal-krejatinina <30 ml/min) (ara sezzjoni 4.4).
English: Gastrointestinal haemorrhage7 Gastroenteritis Stomatitis
Maltese: Emorraġija gastro intestinali7
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials.
Maltese: Tabella 1 turi r-reazzjonijiet avversi osservati minn rapporti spontanji u fi provi kliniċi kkontrollati bilplaċebo.
English: YENTREVE 40 mg is available in packs of 28, 56, 98, 140 and 196 (2 x 98) capsules.
Maltese: YENTREVE 40 mg issibu f'pakketti ta' 28, 56, 98, 140 u 196 (2 x 98) kapsula.
English: The active substance is duloxetine.
Maltese: Is-sustanza attiva hija duloxetine.
English: Date of first authorisation: 11 August 2004 Date of latest renewal: 24 June 2009
Maltese: Data tal-aħħar tiġdid: 24 ta' Ġunju 2009
English: Distribution: Duloxetine is approximately 96% bound to human plasma proteins.
Maltese: Duloxetine huwa bejn wieħed u ieħor 96% marbut mal-proteini tal-plażma tal bniedem.
English: Musculoskeletal and connective tissue disorders Musculo-skeletal pain
Maltese: Disturbi muskolu-skeltriki u tat-tessuti konnetivi Uġigħ muskoluskeletriku
English: 98 hard gastro-resistant capsules.
Maltese: 98 kapsula gastro-reżistenti iebsa.
English: 28 hard gastro-resistant capsules 56 hard gastro-resistant capsules 98 hard gastro-resistant capsules 140 hard gastro-resistant capsules
Maltese: 28 kapsula iebsa gastro-reżistenti 56 kapsula iebsa gastro-reżistenti 98 kapsula iebsa gastro-reżistenti 140 kapsula iebsa gastro-reżistenti
English: Hepatic impairment: Moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
Maltese: Insuffiċjenza tal-fwied: Mard moderat fil-fwied (Child Pugh Klassi B) affettwa l-farmakokinetika ta'
English: CNS medicinal products: Caution is advised when YENTREVE is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Maltese: YENTREVE 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: Suicidal behaviour5,6
Maltese: Imġiba suwiċidali5,6
English: Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Maltese: Enzimi tal-fwied għoljin (ALT, AST, alkaline phosphatase)
English: EU/1/04/280/001 EU/1/04/280/002 EU/1/04/280/003 EU/1/04/280/004 EU/1/04/280/005 EU/1/04/280/006 EU/1/04/280/007 EU/1/04/280/008
Maltese: EU/1/04/280/003 EU/1/04/280/004
English: Each capsule may contain up to 37 mg sucrose.
Maltese: Kull kapsula jista' kollha sa 37 mg sucrose YENTREVE 40 mg
English: Duloxetine is extensively metabolised by oxidative enzymes (CYP1A2 and the polymorphic CYP2D6), followed by conjugation.
Maltese: Duloxetine huwa metabolizzat b'mod estensiv minn enzimi ossidattivi (CYP1A2 u dik polimorfika CYP2D6) u mbagħad ikkonjugat.
English: Effects of other medicinal products on duloxetine
Maltese: Effetti ta' prodotti mediċinali oħra fuq duloxetine
English: 56 hard gastro-resistant capsules 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Maltese: 56 kapsula iebsa gastro-reżistenti 28 kapsula iebsa gastro-reżistenti 98 kapsula iebsa gastro-reżistenti
English: Photo-sensitivity reactions
Maltese: Reazzjonijiet ta' fotosensittività
English: After an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/hr (mean 101 l/hr).
Maltese: Wara doża orali, it-tneħħija apparenti ta' duloxetine mill-plażma tvarja minn 33 sa 261 l/siegħa (medja 101 l/siegħa).
English: Black iron oxide - synthetic (E172) Propylene glycol
Maltese: Iron oxide sintetiku iswed (E172) Propylene glycol Shellac
English: Edible ink: synthetic black iron oxide (E172), propylene glycol, shellac.
Maltese: Inkjostru iswed li jittiekel: iron oxide iswed sintetiku (E172), propylene glycol, shellac.
English: Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic).
Maltese: (antidipressiv) u linezolid (antibijotiku).
English: YENTREVE is available in 2 strengths: 20 and 40 mg.
Maltese: YENTREVE issibu f'żewġ dożi : 20 mg u 40 mg.
English: YENTREVE contains sucrose
Maltese: YENTREVE fih s-sucrose
English: YENTREVE should not be used in combination with nonselective, irreversible monoamine oxidase inhibitors - MAOIs (see section 4.5).
Maltese: YENTREVE m'għandux jiġi użat flimkien ma' monoamine oxidase inhibitors irriversibbli u mhux selettivi - MAOIs (ara sezzjoni 4.5).
English: Serotonin syndrome6
Maltese: Sindromu ta' serotonin6
English: YENTREVE contains the active substance duloxetine.
Maltese: YENTREVE fih is-sustanza attiva duloxetine.
English: Using a global improvement scale (PGI), significantly more women using duloxetine considered their symptoms of stress incontinence to be improved with treatment compared with women using placebo (64.6% versus 50.1%, p<0.001).
Maltese: Meta intużat skala li turi t-titjib globali (PGI), numru sinifikanti akbar ta' nisa li użaw duloxetine qiesu li s-sintomi ta' inkontinenza minħabba sforz kienu tjiebu permezz tal-kura meta mqabbla ma' nisa li użaw l-plaċebo (64.6% kontra
English: Extra-pyramidal symptoms6
Maltese: Sintomi ekstrapiramidali6
English: YENTREVE 40 mg is available in packs of 28, 56, 98 and 140 hard gastro-resistant capsules and in a multipack containing 196 (2 packs of 98) hard gastro-resistant capsules.
Maltese: YENTREVE 40 mg issibu f'pakketti ta' 28, 56, 98 u 140 kapsula gastro-reżistenti iebsa u f'pakett multiplu li fih 196 (2 pakketti ta' 98) kapsula gastro-reżistenti iebsa.
English: The benefit of treatment should be re-assessed at regular intervals.
Maltese: Il-benefiċċju tal-kura għandu jerġa' jiġi evalwat f'intervalli regolari.
English: Quality of Life: Incontinence Quality of Life (I-QOL) questionnaire scores were significantly improved in the duloxetine-treated patient group compared with the placebo-treated group (9.2 versus 5.9 score improvement, p<0.001).
Maltese: Il-punteġġi miksuba fil-kwestjonarju dwar l-Inkontinenza u l-Kwalità tal-Ħajja (IQOL) kienu b'mod sinifikanti aħjar fil-grupp ta' pazjenti kkurati b'duloxetine, meta mqabbel mal grupp ikkurat bil-plaċebo (punteġġ ta' titjieb 9.2 kontra 5.9, p<0.001).
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), including duloxetine.
Maltese: Kien hemm rapporti tà fsada mhux normali, bħal ekimożi, purpura, emorraġija gastro-intestinali u emorraġija wara l-ħlas b'inibituri selettivi ta'ġbir mill-ġdid ta' serotonin (SSRIs) u inibituri ta' ġbir mill-ġdid ta' serotonin /noradrenaline (SNRIs), fosthom duloxetine.
English: Ear and labyrinth disorders Vertigo
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Vertigo
English: clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome
Maltese: ħedla, guffaġni, irrekwitezza, sensazzjoni bħallikieku fis-sakra, deni, muskoli riġidi jew għarqana), aċċessjonijiet, kontrazzjoni jew ġbid f'daqqa involontarju tal-muskoli, sensazzjoni ta' rrekwitezza jew l-inkapaċità li wieħed joqgħod mingħajr ma jiċċaqlaq, diffikultà biex tikkontrolla l-movimenti eż. nuqqas ta' koordinazzjoni jew movimenti involontarji tal-muskoli,
English: YENTREVE 20 mg YENTREVE 20 mg is available in packs of 28, 56 and 98 hard gastro-resistant capsules.
Maltese: YENTREVE 20 mg YENTREVE 20 mg issibu f'pakketti ta' 28, 56 u 98 kapsula gastro-reżistenti iebsa.
English: • “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness,
Maltese: “Sindromu ta' Serotonin” (reazzjoni rari li tista' tikkawza sensazzjonijiet ta' kuntentezza kbira,
English: YENTREVE hard gastro-resistant capsules contain sucrose.
Maltese: YENTREVE kapsuli gastro-reżistenti ibsin fihom sucrose.
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: formazzjonijiet difettużi kardjovaskulari u skeletriċi kienu osservati f'livelli ta' espożizzjoni sistemika anqas mill-esponiment massimu kliniku (AUC).
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 wrew tossiċità fuq is-sistema riproduttiva f'livelli ta' esponiment sistemiku (AUC) ta' duloxetine anqas mill-massimu ta' l-espożizzjoni klinika (ara sezzjoni 5.3).
English: After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/hr to 46 l/hr (mean of 36 l/hr).
Maltese: Wara doża ta' ġol-vini t-tneħħija mill-plażma ta' duloxetine tvarja minn 22 l/siegħa sa 46 l/siegħa (medja ta' 36 l/siegħa).
English: YENTREVE 20 mg is available in packs of 28, 56 and 98 capsules.
Maltese: YENTREVE 20 mg issibu f'pakketti ta' 28, 56 u 98 kapsula.
English: Muscle tightness
Maltese: Inka li tittiekel
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'
English: Compared with healthy subjects, the apparent plasma clearance of duloxetine was 79% lower, the apparent terminal half-life was 2.3 times longer, and the AUC was 3.7 times higher in patients with moderate liver disease.
Maltese: 79% anqas, il-half life terminali apparenti kienet 2.3 darbiet itwal u l-AUC kien 3.7 darbiet ogħla f'pazjenti li kellhom mard moderat fil-fwied.
English: Medicines like Yentreve (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Maltese: Mediċini bħal Yentreve ('l hekk imsejħa SSRIs/SNRIs) jistgħu jikkawżaw sintomi ta' disfunzjoni sesswali (ara sezzjoni 4).
English: In a clinical trial, adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with YENTREVE and 24% of patients taking placebo.
Maltese: Fi provi kliniċi effetti avversi bit-twaqqif tal-kura f'daqqa seħħew f'madwar 44% ta' pazjenti b'kura ta' YENTREVE u 24% ta' pazjenti li ħadu l-plaċebo.
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' glucose-galactose jew insuffiċjenza ta' sucraseisomaltase m'għandhomx jieħdu din il-mediċina.
English: Stevens-Johnson Syndrome6
Maltese: Sindrome ta' Stevens-Johnson6 Edima angjonewrotika6
English: Orthostatic hypotension2 Peripheral coldness
Maltese: Ipotensjoni ortostatika2
English: EU/1/04/280/001 (56 hard gastro-resistant capsules) EU/1/04/280/007 (28 hard gastro-resistant capsules) EU/1/04/280/008 (98 hard gastro-resistant capsules)
Maltese: EU/1/04/280/007 (28 kapsula iebsa gastro-reżistenti)
English: Hard gastro-resistant capsule.
Maltese: Kapsula iebsa gastro-reżistenti.
English: Eructation Gastritis Dysphagia Flatulence Breath odour
Maltese: Żieda tal-kolesterol fid-demm Żieda fil-livell talcreatine phosphokinase fiddemm
English: Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), red iron oxide and yellow iron oxide, edible black ink.
Maltese: Il-Qoxra tal-kapsula: ġelatina, sodium lauryl sulphate, titanium dioxide (E171), indigo carmine (E132),
English: Therefore YENTREVE should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Maltese: Għaldaqstant, YENTREVE m'għandux jingħata flimkien ma' inibituri qawwija ta' CYP1A2 bħal fluvoxamine (ara sezzjoni 4.3).
English: EU/1/04/280/002(28 hard gastro-resistant capsules) EU/1/04/280/003 (56 hard gastro-resistant capsules) EU/1/04/280/004 (98 hard gastro-resistant capsules) EU/1/04/280/005 (140 hard gastro-resistant capsules)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/280/001 (56 kapsula iebsa gastro-reżistenti)
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 tas-sess femminili li rċevew duloxetine għal sentejn kellhom inċidenza ogħla ta' adenomi u karċinomi epatoċellulari fid-doża għolja biss (144 mg/kg/jum), imma dawn kienu kkunsidrati li huma sekondarji għall-istimulazzjoni ta' l-enzima mikrożomali tal-fwied.
English: YENTREVE 40 mg Opaque orange body, imprinted with '40 mg' and an opaque blue cap, imprinted with ‘9545'.
Maltese: YENTREVE 40 mg Il-parti prinċipali oranġjo opak, stampat b''40 mg' u għatu ċelesti opak, stampat b' '9545'.
English: Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John's Wort and MAOIs (such as moclobemide and linezolid).
Maltese: Mediċini li jżidu l-livell ta' serotonin: Triptans, tramadol, tryptophan, SSRIs (bħal paroxetine u fluoxetine), SNRIs (bħal venlafaxine), antidipressivi triċikliċi (bħal clomipramine,amitriptyline),
English: YENTREVE should not be used in combination with CYP1A2 inhibitors, like fluvoxamine, ciprofloxacin or enoxacin since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Maltese: YENTREVE m'għandux jiġi użat flimkien ma' inibituri ta' CYP1A2, bħal fluvoxamine, ciprofloxacin jew enoxacin peress li dan iwassal għal konċentrazzjonijiet elevati ta' duloxetine fil-plażma (ara sezzjoni 4.5).
English: The 20 mg capsules are blue and are printed with '20 mg' and the code ‘9544'.
Maltese: Il-kapsuli ta' 20 mg huma ċelesti u huma stampati b'‘20 mg' u l-kodiċi '9544' .
English: YENTREVE 20 mg hard gastro-resistant capsules YENTREVE 40 mg hard gastro-resistant capsules
Maltese: YENTREVE 20 mg kapsuli ibsin gastro-reżistenti YENTREVE 40 mg kapsuli ibsin gastro-reżistenti
English: YENTREVE is a hard gastro-resistant capsule.
Maltese: YENTREVE issibu bħala kapsula gastro-reżistenti iebsa.
English: YENTREVE 40 mg hard gastro-resistant capsules Duloxetine
Maltese: YENTREVE 40 mg kapsuli gastro-reżistenti ibsin Duloxetine
English: Adverse reactions may be more common during concomitant use of YENTREVE and herbal preparations containing St John's wort (Hypericum perforatum).
Maltese: Ir-reazzjonijiet avversi jistgħu jkunu aktar komuni meta YENTREVE u preparazzjonijiet magħmulin mill-ħxejjex li fihom St.John's Wort (Hypericum perforatum) jintużaw fl-istess ħin.
English: Inducers of CYP1A2: Population pharmacokinetic studies analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
Maltese: Sustanzi li jistimulaw CYP1A2: Analiżi farmakokinetiċi ta' popolazzjoni juru li min ipejjep għandu kważi 50% anqas konċentrazzjonijiet fil-plażma ta' duloxetine meta mqabbla ma' min ma jpejjipx.
English: YENTREVE 20 mg hard gastro-resistant capsules Duloxetine
Maltese: YENTREVE 20 mg kapsuli gastro-reżistenti ibsin Duloxetine
English: Galactorrhoea Hyperprolactinae mia
Maltese: Disturbi filmestrwazzjoni Galaktorreja Iperprolaktinimja
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible black ink
Maltese: Titanium dioxide (E171) Indigo carmine (E132)
English: YENTREVE 40 mg hard gastro-resistant capsules YENTREVE 20 mg hard gastro-resistant capsules
Maltese: YENTREVE 40 mg kapsuli gastro-reżistenti ibsin YENTREVE 20 mg kapsuli gastro-reżistenti ibsin
English: These measures will help to protect the environment.
Maltese: Għandu jigi evitat twaqqif f'salt.
English: A meta-analysis of placebocontrolled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Maltese: Analiżi ta' numru ta' studji kliniċi kkontrollati bil-plaċebo ta' prodotti mediċinali antidipressivi li ntużaw f'disturbi psikjatriċi wrew riskju ogħla ta' mġiba suwiċidali bl-antidipressivi meta mqabbla ma' plaċebo f'pazjenti iżgħar minn 25 sena.
English: The requirements for submission of periodic safety update reports for this medicinal product are in accordance with the requirements 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 web Ewropew tal-mediċini.
English: The 40 mg capsules are orange and blue and are printed with '40 mg' and the code ‘9545'.
Maltese: Il-kapsuli ta' 40 mg huma oranġjo u ċelesti u huma stampati b'‘40 mg' u l-kodiċi '9545' .
English: No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine-treated and placebo-treated patients.
Maltese: Ma ġew osservati ebda differenzi klinikament sinifikanti fil-qisien meħuda għall-QT, PR, QRS jew QTcB bejn pazjenti kkurati b'duloxetine u dawk ikkurati bi plaċebo.
English: The primary efficacy measures were Incontinence Episode Frequency (IEF) from diaries and an incontinence specific quality of life questionnaire score (I-QOL).
Maltese: Il-miżuri primarji ta' l effikaċja kienu Frekwenza ta' Episodji ta' Inkontinenza (IEF) permezz ta' dijarji u minn kwestjonarju bil-punteġġi dwar il-kwalità tal-ħajja, speċifiku għall-inkontineza (I-QOL).
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 ta' suwiċidju), u ostilità (l-aktar aggressjoni, imġiba konfrontali, u rabja), kienu osservati aktar spiss fi provi kliniċi fuq tfal u adolexxenti kkurati b'anti depressivi meta mqabbla ma' dawk ikkurati bil-plaċebo.
English: Metabolism and nutrition disorders Appetite decreased
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Tnaqqis fl-aptit
English: Differences were observed at each visit after 4 weeks (duloxetine 54% and placebo 22%), 8 weeks (52% and 29%), and 12 weeks (52% and 33%) of medication.
Maltese: ġimgħat ta' kura (52% u 29%) u 12-il ġimgħa ta' kura (52% u 33%).
English: Falls8
Maltese: Waqgħat8
English: YENTREVE contains sucrose.
Maltese: YENTREVE fih s-sucrose.
English: Hepatitis/increased liver enzymes
Maltese: Epatite/żieda fl-enzimi tal-fwied
English: Gynaecological haemorrhage Menopausal symptoms
Maltese: Emorraġija ginekoloġika