FrancophonIA/ELRC3.0 huggingface dataset:
English: A mean maximum plasma concentration of 492±256 pmol/l was reached 40 (interquartile range: 30-40) minutes after a subcutaneous dose of 0.15 unit/kg bodyweight in type 1 diabetic patients.
Maltese: Bħala medja, f'pazjenti bid-dijabete tat-tip l, il-konċentrazzjoni massima fil-plażma ta' 492±256 pmol/l intlaħqet 40 (marġni interkwartili:
English: Combination of NovoRapid with pioglitazone
Maltese: Selettur taddoża Buttuna talinjezzjoni
English: a) Summary of serious and very common side effects
Maltese: Effetti sekondarji rari
English: Hyperglycaemia
Maltese: Kejl talinsulina
English: Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti (ara sezzjoni
English: The company that applied for authorisation is Centauri Biotech SL.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija Centauri Biotech SL.
English: What is Horse Allo 20?
Maltese: X'inhu Horse Allo 20?
English: Horse Allo 20 is a veterinary medicine that contains allogeneic equine mesenchymal stem cells as active substance.
Maltese: Horse Allo 20 huwa mediċina veterinarja li fiha ċelloli staminali meżenkimatiċi ekwini alloġeniċi bħala sustanza attiva.
English: The main measure of effectiveness was a reduction in 1 or more grades of lameness using a scoring system that runs from 1 to 5.
Maltese: ewlieni tal-effikaċja kien it-tnaqqis fi grad wieħed jew aktar ta' zappip permezz ta' sistema ta' punteġġ minn 1 sa 5.
English: The applicant presented data from a field study involving horses from 2 years of age with osteoarthritis, where 37 horses were treated with Horse Allo 20 while 33 horses received a dummy treatment.
Maltese: L-applikant ippreżenta data minn studju fuq il-post li involva żwiemel bl-osteoartrite mhux iżgħar minn sentejn, fejn 37 żiemel ġew ikkurati b'Horse Allo 20 filwaqt li 33 żiemel ingħataw kura finta.
English: On 21 June 2018, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Horse Allo 20, intended for the treatment of lameness in adult horses with osteoarthritis.
Maltese: Fil-21 ta' Ġunju 2018, il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) adotta opinjoni negattiva, li tirrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Horse Allo 20, intiż għall-kura taz-zappip fi żwiemel adulti bl-osteoartrite.
English: On 24 January 2019, the CVMP revised part of its opinion but confirmed its recommendation to refuse the marketing authorisation.
Maltese: Fl-24 ta' Jannar 2019, is-CVMP irreveda parti mill-opinjoni tiegħu iżda kkonferma r-rakkomandazzjoni tiegħu għar-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: Horse Allo 20 was expected to be used to treat lameness in adult horses with osteoarthritis.
Maltese: Horse Allo 20 kien mistenni li jintuża għall-kura taz-zappip fi żwiemel adulti bl-osteoartrite.
English: What was Horse Allo 20 expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Horse Allo 20?
English: Following a request from the European Commission, the CVMP revised part of its opinion concerning compliance with Good Manufacturing Practice (GMP).
Maltese: Wara talba mill-Kummissjoni Ewropea, is-CVMP irreveda parti mill-opinjoni tiegħu dwar il-konformità mal-Prassi Tajba ta' Manifattura (PTM).
English: It was to be available as a suspension for injection into a joint.
Maltese: Kellu jkun disponibbli bħala sospensjoni għal injezzjoni f'ġog.
English: Horse Allo 20 was developed as a novel therapy medicine containing cells that have been manipulated so that they can be used to repair, regenerate or replace tissue.
Maltese: Horse Allo 20 ġie żviluppat bħala mediċina ta' terapija ġdida li fiha ċelloli li ġew immanipulati sabiex ikunu jistgħu jintużaw għat-tiswija, għar-riġenerazzjoni jew għas-sostituzzjoni ta' tessut.
English: The CVMP noted that there were problems with the way the main study was designed and carried out, and concluded that the effectiveness of the medicine had not been sufficiently demonstrated.
Maltese: Is-CVMP innota li kien hemm problemi fil-mod kif kien iddisinjat u kif twettaq l-istudju ewlieni, u kkonkluda li l-effikaċja tal-mediċina ma ntwerietx biżżejjed.
English: The active substance in Betmiga, mirabegron, is a beta-3-adrenergic-receptor agonist.
Maltese: Is-sustanza attiva f'Betmiga, il-mirabegron, hija agonista beta-3-adrenergic-receptor.
English: It is available as prolonged-release tablets (25 mg, 50 mg).
Maltese: Jiġi bħala bħala pilloli b'rilaxx prolongat (25 mg, 50 mg).
English: Patients received Betmiga (25 mg, 50 mg or 100 mg) or placebo (a dummy treatment) every day for 3 months.
Maltese: Il-pazjenti ngħataw Betmiga (25 mg, 50 mg jew 100 mg) jew plaċebo (kura finta) kuljum għal 3 xhur.
English: Serious but uncommon side effects include atrial fibrillation (cardiac rhythm disorder).
Maltese: Effetti sekondarji serji iżda mhux komuni jinkludu fibrillazzjoni atrijali (disturb fir-ritmu tal-qalb).
English: Other information about Betmiga
Maltese: Informazzjoni oħra dwar Betmiga
English: This is a summary of the European public assessment report (EPAR) for Betmiga.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Betmiga.
English: Betmiga is a medicine containing the active substance mirabegron.
Maltese: Betmiga huwa mediċina li fiha s-sustanza attiva mirabegron.
English: Betmiga 50 mg resulted in a reduction of 1.5 incontinence episodes per day compared with a reduction of 1.1 incontinence episodes per day for placebo.
Maltese: Betmiga ta' 50 mg irriżulta fi tnaqqis ta' 1.5 episodji ta' inkontinenza fil-ġurnata, imqabbel ma' tnaqqis ta' 1.1 episodji ta' inkontinenza fil-ġurnata għall-plaċebo.
English: Treatment with 50 mg a day of Betmiga was shown to be effective in reducing the number of urination and incontinence episodes.
Maltese: Il-kura b'50 mg ta' Betmiga kuljum uriet li kienet effettiva fit-tnaqqis tan-numru ta' episodji ta' urinazzjoni u inkontinenza.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Betmiga on 20 December 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Betmiga valida fl-Unjoni Ewropea kollha fl-20 ta' Diċembru 2012.
English: After 3 months of treatment, on average Betmiga 50 mg reduced the number of urinations by 1.8 per day compared with a reduction of 1.2 per day for placebo.
Maltese: Wara 3 xhur ta' kura, bħala medja, Betmiga ta' 50 mg naqqas in-numru ta' drabi ta' urinazzjoni b'1.8 fil-ġurnata, imqabbla ma' tnaqqis ta' 1.2 fil-ġurnata għall-plaċebo.
English: The most common side effects with Betmiga are tachycardia (rapid heartbeat) seen in just over 1 person in 100, and urinary tract infection (infection of the structures that carry urine) seen in just under 3 people in 100.
Maltese: L-effetti sekondarji l-aktar komuni b'Betmiga huma takikardija (rati għolja ta' taħbit tal-qalb), li dehret fi ftit aktar minn persuna waħda minn kull 100, u infezzjoni fis-sistema urinarja (infezzjoni tal-istrutturi li jġorru l-awrina), li dehret fi ftit inqas minn 3 persuni minn kull 100.
English: What is the risk associated with Betmiga?
Maltese: X'inhu r-riskju assoċjat ma' Betmiga?
English: A risk management plan has been developed to ensure that Betmiga is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Betmiga jintuża bl-aktar mod sigur possibbli.
English: The recommended dose of Betmiga is 50 mg once a day.
Maltese: Id-doża rrakkomandata ta' Betmiga hija ta' 50 mg darba kuljum.
English: How has Betmiga been studied?
Maltese: Kif ġie studjat Betmiga?
English: The full EPAR for Betmiga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Għal aktar tagħrif dwar il-kura b'Betmiga, aqra l-fuljett tal-pakkett (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: Betmiga has been studied in three main studies involving 4,611 patients with overactive bladder syndrome.
Maltese: Betmiga ġie studjat fi tliet studji ewlenin li kienu jinvolvu 4,611-il pazjent li għandhom is-sindrome ta' bużżieqa tal-awrina attiva b'mod eċċessiv.
English: Why has Betmiga been approved?
Maltese: Għaliex ġie approvat Betmiga?
English: What is Betmiga?
Maltese: X'inhu Betmiga?
English: The CHMP noted that the beneficial effects seen with Betmiga were modest but comparable to the benefits of other medicines authorised for this condition.
Maltese: Is-CHMP innota li l-effetti ta' benefiċċju osservati b'Betmiga kienu modesti iżda komparabbli malbenefiċċji ta' mediċini oħrajn li huma awtorizzati għal din il-kondizzjoni.
English: Betmiga is used in adults with overactive bladder syndrome.
Maltese: Betmiga jintuża f'persuni adulti li jkollhom is-sindrome ta' bużżieqa tal-awrina attiva b'mod eċċessiv.
English: It is used to treat certain symptoms of the condition: urgency (sudden urge to urinate), increased urinary frequency (the need to urinate frequently) and urge incontinence (involuntary leakage of urine from the bladder when a sudden strong need to urinate is felt).
Maltese: Jintuża biex jikkura ċerti sintomi tal-kondizzjoni l-urġenza (urġenza f'daqqa biex tagħmel l-awrina), żieda fil-frekwenza urinarja (il-ħtieġa li tagħmel l-awrina aktar ta' spiss) u l-inkontinenza urġenti (nuqqas ta' kontroll għal għarrieda fuq il-ħruġ tal-awrina mill-bużżieqa tal-awrina meta tinħass ħtieġa qawwija f'daqqa li tagħmel l-awrina).
English: Experimental studies have shown that, when activated, beta-3 receptors cause the bladder muscles to relax.
Maltese: Listudji sperimentali li saru juru li, meta jiġu attivati, il-beta-3 receptors jikkawżaw rilassament filmuskoli tal-bużżieqa tal-awrina.
English: Betmiga must not be used in people who have hypertension (high blood pressure) that is severe and uncontrolled.
Maltese: Betmiga ma għandux jingħata lil pazjenti li jkollhom ipertensjoni (pressjoni tad-demm għolja) li hija gravi u mhux ikkontrollata.
English: What measures are being taken to ensure the safe and effective use of Betmiga?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Betmiga?
English: For the full list of all side effects reported with Betmiga, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Betmiga, ara l-fuljett ta' tagħrif.
English: The main measure of effectiveness was the change in the number of urinations and incontinence episodes per day after 3 months of treatment.
Maltese: Il-kejl ewlieni ta' effikaċja kien il-bidla fin-numru ta' għamil tal-awrina u ta' episodji ta' inkontinenza fil-ġurnata wara 3 xhur ta' kura.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Betmiga, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Abbażi ta' dan il-pjan, fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward is-sigurtà ta' Betmiga, inklużi l-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti tal-kura tas-saħħa u l-pazjenti.
English: The potential risk of hypersensitivity (allergic reactions) and effects on the heart has been adequately addressed in the product information.
Maltese: Ir-riskju potenzjali tal-ipersensittività (reazzjonijiet allerġiċi) u tal-effetti fuq il-qalb ġie indirizzat b'mod adegwat fit-tagħrif dwar il-prodott.
English: How does Betmiga work?
Maltese: Għal xiex jintuża Betmiga?
English: ‘Prolonged-release' means that mirabegron is released slowly from the tablet over a few hours.
Maltese: ‘Rilaxx prolongat' ifisser li l-mirabegron iddum ftit sigħat biex tiġi rilaxxata mill-pillola.
English: Regarding its safety, most side effects are comparable to those of other medicines used for treating overactive bladder syndrome.
Maltese: Fir-rigward tas-sigurtà tagħha, il-maġġoranza tal-effetti sekondarji huma komparabbli ma' dawk ta' mediċini oħrajn li jintużaw għallkura tas-sindrome tal-bużżieqa tal-awrina attiva b'mod eċċessiv.
English: The CHMP therefore decided that Betmiga's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Għalhekk, is-CHMP iddeċieda li l-benefiċċji ta' Betmiga huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-qegħid fis-suq.
English: Cymbalta is indicated in adults.
Maltese: Cymbalta huwa indikat għall-adulti.
English: Multipack: 500 (25 packs of 20) hard gastro-resistant capsules Multipack: 100 (5 packs of 20) hard gastro-resistant capsules
Maltese: Pakkett multiplu: 500 (25 pakkett ta' 20) kapsula gastro-reżistenti iebsa Pakkett multiplu: 100 (5 pakketti ta' 20) kapsula gastro-reżistenti iebsa
English: de la Industria Nº 30, 28108 Alcobendas Madrid
Maltese: 28108 Alcobendas
English: Cymbalta increases the levels of serotonin and noradrenaline in the nervous system.
Maltese: Cymbalta jżid il-livelli ta' serotonin u ta' noradrenaline fis sistema nervuża.
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: <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000).
English: Both cytochromes P450-2D6 and 1A2 catalyse the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulfate conjugate of 5-hydroxy 6-methoxy duloxetine.
Maltese: Kemm iċ-ċitokrom P450-2D6 kif ukoll 1A2 jikkatalizzaw il formazzjoni taż-żewġ prodotti metaboliċi prinċipali l-glukuronidu kkonjugat ta' 4-hydroxy duloxetine u l-konjugat tas-sulfat ta' 5-hydroxy 6-methoxy duloxetine.
English: Excipient(s) with known effect Each capsule may contain up to 111 mg sucrose.
Maltese: Kull kapsula jista' jkollha sa 111 mg sucrose.
English: Cymbalta is available in 2 strengths: 30 mg and 60 mg.
Maltese: Cymbalta huwa disponibbli f'żewġ dożi: 30 mg u 60 mg
English: Cymbalta 60 mg is available in packs of 28, 56, 84 and 98 hard gastro-resistant capsules and in multipacks containing 100 (5 packs of 20) and 500 (25 packs of 20) hard gastro-resistant capsules.
Maltese: Cymbalta 60 mg issibu f'pakketti ta' 28, 56, 84 u 98 kapsula gastro-reżistenti iebsa u f'pakketti multipli li fihom 100 (5 pakketti ta' 20) u 500 (25 pakkett ta' 20) kapsula gastro-reżistenti iebsa.
English: EU/1/04/296/001 EU/1/04/296/002 EU/1/04/296/003 EU/1/04/296/004 EU/1/04/296/005 EU/1/04/296/006 EU/1/04/296/007 EU/1/04/296/008 EU/1/04/296/009
Maltese: EU/1/04/296/007 EU/1/04/296/008 EU/1/04/296/009
English: Duloxetine did not show efficacy in reducing pain as measured by primary outcome measure of Brief Pain Inventory (BPI) average pain score endpoint: least squares (LS) mean change from baseline in BPI average pain score at 13 weeks was -0.97 in the placebo group, compared with -1.62 in the duloxetine 30/60 mg group (p = 0.052).
Maltese: Duloxetine ma weriex effikaċja fit-tnaqqis ta' uġigħ kif imkejjel mill-miżura tal-effett primarju tal-punt finali ta' punteġġ medju ta' uġigħ tal-Brief Pain Inventory (BPI): l-inqas bidla medja fil-kwadranti (least squares -LS) mil-linja bażi fil-punteġġ medju ta' uġigħ BPI wara 13-il ġimgħa kien ta' -0.97 fil-grupp ta' plaċebo, mqabbel ma' -1.62 fil-grupp ta' duloxetine 30/60 mg (p = 0.052).
English: Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) (60 mg only) and edible green ink (30 mg) or edible white ink (60 mg).
Maltese: Il-Qoxra tal-kapsula: ġelatina, sodium lauryl sulphate, titanium dioxide (E171), indigo carmine (E132), iron oxide isfar (E172) (għas-60 mg biss) u inkjostru aħdar li jittiekel (30 mg) jew inkjostru abjad li jittiekel (60 mg).
English: Cymbalta contains sucrose
Maltese: Cymbalta fih s-sucrose
English: The incidence of relapse during the 6months double-blind follow-up period was 14% for Cymbalta and 42% for placebo.
Maltese: L-inċidenza ta' rikaduta waqt il-perijodu miżjud ta' 6 xhur li kien double-blind kien ta' 14% b'Cymbalta u ta' 42%
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with Cymbalta 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' Cymbalta u 23% ta' pazjenti jieħdu l-plaċebo.
English: Cymbalta contains sucrose.
Maltese: Cymbalta fih s-sucrose.
English: During the 52-week placebocontrolled double blind treatment phase 14.4% of the duloxetine-treated patients and 33.1% of the placebo-treated patients experience a return of their depressive symptoms (p<0.001).
Maltese: 14.4% tal-pazjenti kkurati b'duloxetine u 33.1% tal-pazjenti kkurati bil-plaċebo reġgħu ħassew is sintomi depressivi tagħhom (p< 0.001).
English: Consequently, caution is advised when Cymbalta 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: Konsegwentement, huwa rrakkomandat li Cymbalta jingħata b'attenzjoni meta jittieħed flimkien ma' prodotti mediċinali jew sustanzi li jaħdmu b'mod ċentrali fosthom alkoħol u prodotti mediċinali sedattivi (eż. benzodiazepines, morfinomimetiċi, anti-psikotiċi, phenobarbital,
English: EU/1/04/296/001 (28 hard gastro-resistant capsules) EU/1/04/296/006 (7 hard gastro-resistant capsules) EU/1/04/296/009 (98 hard gastro-resistant capsules)
Maltese: EU/1/04/296/001 (28 kapsula gastro-reżistenti iebsa) EU/1/04/296/006 (7 kapsuli gastro-reżistenti ibsin) EU/1/04/296/009 (98 kapsula gastro-reżistenti iebsa)
English: Major Depressive Disorder: Cymbalta was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Maltese: Cymbalta ġie studjat f'programm kliniku li kien jinvolvi 3,158 pazjent (1,285 pazjenti-snin ta' espożizzjoni) li laħaq il-kriterji DSM-IV għal depressjoni maġġuri.
English: Cymbalta 30 mg Cymbalta 30 mg is available in packs of 7, 28 and 98 hard gastro-resistant capsules.
Maltese: Cymbalta 30 mg Cymbalta 30 mg issibu f'pakketti ta' 7, 28 u 98 kapsula gastro-reżistenti iebsa.
English: Cymbalta 30 mg hard gastro-resistant capsules Cymbalta 60 mg hard gastro-resistant capsules
Maltese: Cymbalta 30 mg kapsuli gastro-reżistenti ibsin Cymbalta 60 mg kapsuli gastro-reżistenti ibsin
English: Cymbalta must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Maltese: Cymbalta ma jistax jintuża f'pazjenti b'indeboliment gravi tal-kliewi (tneħħija tal-kreatinina < 30 ml/min; ara sezzjoni 4.3).
English: Therefore Cymbalta should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Maltese: Għaldaqstant, Cymbalta m'għandux jingħata flimkien ma' inibituri qawwija ta' CYP1A2 bħal fluvoxamine (ara sezzjoni 4.3).
English: Medicines like Cymbalta (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Maltese: Mediċini bħal Cymbalta ('l hekk imsejħa SSRIs/SNRIs) jistgħu jikkawżaw sintomi ta' disfunzjoni sesswali (ara sezzjoni 4).
English: Respiratory, thoracic and mediastinal disorders Yawning
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
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: Effetti ta' prodotti mediċinali oħra fuq duloxetine 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: Edible green ink contains: Black iron oxide - synthetic (E172) Yellow iron oxide - synthetic (E172) Propylene glycol
Maltese: Iron oxide iswed - sintetiku (E172) Iron oxide isfar - sintetiku (E172) Propylene glycol
English: EU/1/04/296/002 (28 hard gastro-resistant capsules) EU/1/04/296/003 (84 hard gastro-resistant capsules) EU/1/04/296/004 (98 hard gastro-resistant capsules) EU/1/04/296/005 (56 hard gastro-resistant capsules)
Maltese: EU/1/04/296/002 (28 kapsula gastro-reżistenti iebsa) EU/1/04/296/003 (84 kapsula gastro-reżisistenti iebsa) EU/1/04/296/004
English: Tolerability of Cymbalta 60 mg once daily in elderly patients was comparable to that seen in the younger adults.
Maltese: Cymbalta 60 mg darba kuljum f'pazjenti anzjani kien simili għal dak osservat fl-adulti iżgħar.
English: Concomitant use of Cymbalta with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Maltese: L-użu fl-istess ħin ta' Cymbalta ma' inibituri ta' monoamine oxidase (MAOIs) irriversibbli u mhux selettivi huwa kontraindikat (ara sezzjoni 4.5).
English: The efficacy of Cymbalta 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' Cymbalta 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 fil punteġġ totali tal-HAM-A f'pazjenti kkurati b'duloxetine meta mqabbel ma' pazjenti kkurati bil plaċebo.
English: Cymbalta 60 mg hard gastro-resistant capsules Duloxetine
Maltese: Cymbalta 60 mg kapsuli gastro-reżistenti ibsin Duloxetine
English: EU/1/04/296/007 (500 hard gastro-resistant capsules) (25 packs of 20) EU/1/04/296/008 (100 hard gastro-resistant capsules) (5 packs of 20)
Maltese: EU/1/04/296/007 (500 kapsula gastro-reżistenti iebsa (25 pakkett ta' 20 )
English: Cymbalta 30 mg hard gastro-resistant capsules Duloxetine
Maltese: Cymbalta 30 mg kapsuli gastro-reżistenti ibsin Duloxetine
English: Some patients who stop taking Cymbalta suddenly have had symptoms such as:
Maltese: Xi pazjenti li waqqfu jieħdu Cymbalta f'daqqa kellhom sintomi bħal:
English: Other medicines and Cymbalta
Maltese: Mediċini oħra u Cymbalta
English: Cymbalta hard gastro-resistant capsules contain sucrose.
Maltese: Cymbalta kapsuli gastro-reżistenti ibsin fihom sucrose.
English: Cymbalta 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: Cymbalta m'għandux jiġi użat flimkien ma' fluvoxamine, ciprofloxacin jew enoxacin (jiġifieri inibituri qawwija ta' CYP1A2) billi dan iwassal għal konċentrazzjonijiet elevati ta' duloxetine filplażma (ara sezzjoni 4.5).
English: Diabetic Peripheral Neuropathic Pain: The efficacy of Cymbalta 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' Cymbalta bħala kura għall-uġigħ newropatiku tad-dijabete kien stabbilit f'żewġ studji ta' 12-il ġimgħa, b'dożi fissi, ikkontrollati bilplaċebo,randomised u double-blind f'adulti (22 sa 88 sena) li kellhom uġigħ newropatiku tad-dijabete għallinqas għal 6 xhur.
English: Cymbalta 30 mg is available in packs of 7, 28 and 98 hard gastro-resistant capsules.
Maltese: Cymbalta 30 mg issibu f'pakketti ta' 7, 28 u 98 kapsula gastro-reżistenti iebsa.