FrancophonIA/ELRC3.0 huggingface dataset:
English: Clopidogrel Sandoz is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel Sandoz huwa mediċina li fiha s-sustanza attiva clopidogrel.
English: What are the benefit and risk of Clopidogrel Sandoz?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Clopidogrel Sandoz?
English: Clopidogrel Sandoz can be given to the following groups of patients:
Maltese: Clopidogrel Sandoz jista' jingħata lill-gruppi ta' pazjenti li ġejjin:
English: Because Clopidogrel Sandoz is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Billi Clopidogrel Sandoz huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: What is Clopidogrel Sandoz?
Maltese: X'inhu Clopidogrel Sandoz?
English: Because Clopidogrel Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Billi Clopidogrel Sandoz huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċju u r-riskju tiegħu huma meqjusa l-istess bħal dawk tal-mediċina ta' referenza.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Sandoz to Acino Pharma GmbH on 21 september 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Clopidogrel Sandoz lil Acino Pharma
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Sandoz has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Clopidogrel Sandoz wera li għandu kwalità komparabbli ma' u huwa bijoekwivalenti għal Plavix.
English: How has Clopidogrel Sandoz been studied?
Maltese: Kif ġie studjat Clopidogrel Sandoz?
English: The standard dose of Clopidogrel Sandoz is one 75 mg tablet once a day, taken with or without food.
Maltese: Id-doża standard ta' Clopidogrel Sandoz hija ta' pillola waħda ta' 75 mg darba kuljum, mal-ikel jew fuq stonku vojt.
English: Why has Clopidogrel Sandoz been approved?
Maltese: Għaliex ġie approvat Clopidogrel Sandoz?
English: Clopidogrel Sandoz is a ‘generic medicine'.
Maltese: Clopidogrel Sandoz jista'
English: August 2012.
Maltese: Billi
English: The studies with the US and Canadian products were performed by Apotex Research Inc., Toronto, Canada.
Maltese: L-istudji bil-prodotti Amerikani u Kanadiżi kienu saru minn Apotex Research Inc., f'Toronto, il-Kanada.
English: Leflunomide Apotex is available as 10 mg and 20 mg tablets.
Maltese: Leflunomide Apotex jiġi bħala pilloli ta' 10 mg u ta' 20 mg.
English: Leflunomide Apotex contains leflunomide, a pyrimidine synthesis inhibitor belonging to the DMARD (disease-modifying antirheumatic drug) class of drugs, which are chemically and pharmacologically very heterogeneous.
Maltese: Leflunomide Apotex fih leflunomide, inibitur tas-sinteżi ta' pyrimidine li jagħmel parti mill-klassi ta' mediċini DMARD (mediċini antirewmatiċi li jimmodifikaw il-marda), li kimikament u farmakoloġikament huma eteroġenji ħafna.
English: The US Food and Drug Administration informed the European Medicines Agency that following an inspection, concerns have been raised about the conduct of bio-analytical studies performed by the Cetero Research facilities in Houston (Texas, USA) during the period from April 2005 to June 2010.
Maltese: Il-US Food and Drug Administration infurmat lill-Aġenzija Ewropea għall-Mediċini li wara spezzjoni, tqajjem tħassib dwar twettiq ta' studji bijoanalitiċi li saru mill-faċilitajiet ta' Cetero Research fi Houston (Texas, USA) matul il-perjodu minn April 2005 sa Ġunju 2010.
English: The clinical phase of the study was performed in January and February 2006 at Gateway Medical Research Inc. in St. Charles (USA) while the analytical phase was performed at BA Research International LP in Houston (USA) and the statistical phase was performed at BA Research International LP in Austin (USA) in February and March 2006.
Maltese: Il-fażi klinika tal-istudju kienet saret f'Jannar u fi Frar 2006 f'Gateway Medical Research Inc. f'St Charles (USA) filwaqt li l-fażi analitika kienet saret f'BA Research International LP fi Houston (USA) u l-fażi statistika kienet saret f'BA Research International LP f'Austin (USA) fi Frar u f'Marzu 2006.
English: The results of the pivotal bioequivalence study showed that the 90% confidence intervals were within the 80% to 125% limits for AUC0-72 and Cmax and the pharmacokinetic data was therefore considered to demonstrate that the Leflunomide Apotex 20 mg tablets and the reference product 20 mg tablets were bioequivalent under fasting conditions.
Maltese: Ir-riżultati tal-istudju pivotali ta' bijoekwivalenza wrew li l-intervalli ta' fiduċja ta' 90% kienu fil-limiti ta' 80% sa 125% għall-AUC0-72 u s-Cmax u d-dejta farmakokinetika kienet għalhekk meqjusa li turi li Leflunomide Apotex pilloli ta' 20 mg u l-pilloli ta' 20 mg tal-prodott ta' referenza kienu bijoekwivalenti taħt kundizzjonijiet ta' sawm.
English: It is used in the treatment of adults with active moderate to severe rheumatoid arthritis and psoriatic arthritis.
Maltese: Jintuża fil-kura ta' adulti b'artrite rewmatika attiva minn moderata sa severa u b'artrite psorjatika.
English: All three facilities became part of Cetero Research.
Maltese: It-tliet faċilitajiet kollha kienu saru parti minn Cetero Research.
English: Regarding the safety profile of Leflunomide Apotex, the MAH performed a search for lack of effect / drug ineffectiveness in all case reports for leflunomide in the MAH's global pharmacovigilance database, from the date of first authorization of Leflunomide Apotex (08 September 2004) to 08
Maltese: Fir-rigward tal-profil tas-sigurtà ta' Leflunomide Apotex, l-MAH għamel tfittxija għal nuqqas ta' effett / nuqqas ta' effikaċja tal-mediċina fir-rapporti kollha dwar il-każ għal leflunomide fil-bażi tad-data globali ta' farmakoviġilanza tal-MAH, mid-data tal-ewwel awtorizzazzjoni ta' Leflunomide Apotex (08 ta' Settembru 2004) sat-08 ta' Awwissu 2012.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for Leflunomide Apotex and associated names.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal Leflunomide Apotex u ismijiet assoċjati.
English: The CHMP also noted the safety assessment carried out by the MAH but carried out a separate search of EudraVigilance, identifying 14 cases of lack of efficacy specifically for generic products.
Maltese: Is-CHMP innota wkoll il-valutazzjoni dwar is-sigurtà mwettqa mill-MAH iżda wettaq tfittxija separata ta' EudraVigilance, li identifikat 14-il każ ta' nuqqas ta' effikaċja speċifikament għall-prodotti ġeneriċi.
English: The single pivotal bioequivalence study B050309 conducted to support the marketing authorization application was a comparative, parallel, three arm study to compare the relative bioavailability of Leflunomide Apotex 20 mg tablets with that of the EU reference product Arava 20 mg tablets in healthy, adult volunteers under fasting conditions.
Maltese: L-istudju pivotali uniku ta' bijoekwivalenza B050309 li kien sar biex jappoġġja l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq kien studju komparattiv, parallel, bi tliet fergħat biex iqabbel ilbijodisponibilità relattiva ta' Leflunomide Apotex pilloli ta' 20 mg ma' dik tal-prodott ta' referenza tal-UE Arava pilloli ta' 20 mg f'voluntiera adulti b'saħħithom, taħt kundizzjonijiet ta' sawm.
English: Overall summary of the scientific evaluation of Leflunomide Apotex (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Leflunomide Apotex (ara Anness I)
English: Finally, the MAH provided comparative dissolution profiles between Leflunomide Apotex 10 and 20 mg, tablets and reference product 10 and 20 mg tablets from various markets, supporting the MAH view that the dissolution profiles of Leflunomide Apotex and the reference product are similar.
Maltese: Fl-aħħar nett, l-MAH ipprovda profili komparattivi ta' dissoluzzjoni bejn Leflunomide Apotex pilloli ta' 10 u 20 mg, il-pilloli ta' 10 u 20 mg tal-prodott ta' referenza minn diversi swieq, li jappoġġjaw il-fehma tal-MAH li l-profili ta' dissoluzzjoni ta' Leflunomide Apotex u tal-prodott ta' referenza huma simili.
English: Although the company did not discuss any other potential safety signals, the CHMP acknowledged that there are no signals of increased adverse events when compared to the reference product, based on the data in the last PSUR (reporting period 28-10-2010 until 27-10-2011).
Maltese: Għalkemm il-kumpanija ma ddiskutiet l-ebda sinjal potenzjali oħra ta' sigurtà, is-CHMP irrikonoxxa li ma hemm l-ebda sinjal ta' żieda fl-avvenimenti avversi meta mqabbla malprodott ta' referenza, abbażi tad-dejta fl-aħħar PSUR (perjodu ta' rapportar 28-10-2010 sas-27-10-2011).
English: For ten of these cases, the potential involvement of Leflunomide Apotex was ruled out.
Maltese: Għal għaxra minn dawn il-każijiet, l-involviment potenzjali ta' Leflunomide Apotex kien eskluż.
English: However, according to the new bioequivalence guideline, such studies should be performed without the addition of surfactants and in media pH 1.2, 4.5, 6.8 and with the quality control method.
Maltese: Madankollu, skont il-linja gwida l-ġdida ta' bijoekwivalenza, studji bħal dawn għandhom isiru mingħajr iż-żieda ta' surfetanti u b'pH fil-midja ta' 1.2, 4.5, 6.8 u bil-metodu ta' kontroll tal-kwalità.
English: 102 case reports related to leflunomide were identified, out of which 10 could be identified as lack of effect /drug ineffective case reports, all related to Leflunomide Apotex.
Maltese: leflunomide, li minnhom 10 jistgħu jiġu identifikati bħala rapporti dwar il-każ b'nuqqas ta' effett / mediċina ineffikaċi, kollha relatati ma' Leflunomide Apotex.
English: The annual PSUR (data lock point 27 October 2011) submitted to the European authorities did not identify any lack of efficacy cases reported globally and the MAH therefore concluded that there was no change to the benefit risk ratio of Leflunomide Apotex.
Maltese: Il-PSUR annwali (data lock point 27 ta' Ottubru 2011) sottomess lillawtoritajiet Ewropej ma identifika l-ebda każ ta' nuqqas ta' effikaċja rapportat globalment u l-MAH għalhekk ikkonkluda li ma kien hemm l-ebda tibdil fil-proporzjon tar-riskju-benefiċċju ta' Leflunomide Apotex.
English: For six of the reports, quality assurance investigations were conducted by the MAH and no problems were identified with Leflunomide Apotex.
Maltese: L-MAH wettaq investigazzjonijiet dwar l-assigurazzjoni tal-kwalità fuq sitta mir-rapporti u ma ġiet identifikata l-ebda problema bi Leflunomide Apotex.
English: In addition, all Leflunomide Apotex products for these markets are manufactured at the same manufacturing site, Apotex Inc., Toronto (Canada), according to the same manufacturing process.
Maltese: Barra minn hekk, il-prodotti kollha ta' Leflunomide Apotex għal dawn is-swieq jiġu mmanifatturati fl-istess sit ta' manifattura, Apotex Inc, Toronto (il-Kanada), skont l-istess proċess ta' manifattura.
English: The MAH also provided details of 4 bio-equivalence studies, conducted to support the marketing authorisation application in the United States and Canada, comparing Leflunomide Apotex with their reference product, under fasting and fed conditions.
Maltese: L-MAH ipprovda wkoll dettalji ta' 4 studji ta' bijoekwivalenza, li saru biex jappoġġjaw l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Uniti u fil-Kanada, li qabblu lil Leflunomide Apotex mal-prodott ta' referenza tagħhom, taħt kundizzjonijiet ta' sawm u mhux ta' sawm.
English: Of the four remaining cases potentially attributable to Leflunomide Apotex, two involved arthralgia and swollen joints not related to rheumatoid arthritis (RA) while one was confounded by the concomitant use of other drugs while the last suggested concomitant use of TNF-alpha inhibitors.
Maltese: Mill-erba' każijiet li kien għad fadal li potenzjalment kienu attribwibbli għal Leflunomide Apotex, tnejn kienu jinvolvu artralġja u ġogi minfuħin li mhumiex relatati mal-artrite rewmatika (RA) filwaqt li wieħed kien konfuż bl-użu konkomitanti ta' mediċini oħra filwaqt li tal-aħħar issuġġerixxa l-użu konkomittanti ta' inibituri ta' TNF-alfa.
English: The CHMP noted the data from the bioequivalence studies performed with the US and Canadian product and identified some minor protocol violations.
Maltese: Is-CHMP innota d-dejta mill-istudji ta' bijoekwivalenza li saru bil-prodott Kanadiż u Amerikan u identifika xi ksur minuri fil-protokoll.
English: 5 were from Canada and 5 from the USA, with no reports coming from Europe.
Maltese: 5 kienu mill-Kanada u 5 mill-Istati Uniti, u ma kien hemm l-ebda rapport ġej mill-Ewropa.
English: The dissolution testing data submitted was not considered complete as it was performed with a surfactant and only done in water and was therefore considered to be only of limited value.
Maltese: Id-dejta dwar l-ittestjar tad-dissoluzzjoni sottomessa ma kinitx ikkunsidrata kompluta peress li kienet saret b'surfetant u kienet saret biss fl-ilma u għalhekk kienet meqjusa li kienet biss ta' valur limitat.
English: In response to the CHMP list of questions, the MAH submitted a review of the benefit-risk balance of Leflunomide Apotex.
Maltese: Bi tweġiba għal-lista ta' mistoqsijiet tas-CHMP, l-MAH issottometta reviżjoni tal-bilanċ tal-benefiċċju-riskju ta' Leflunomide Apotex.
English: The MAH considered that the data described in this PSUR did not change the benefit-risk balance of Leflunomide Apotex.
Maltese: L-MAH fis-suq ikkunsidra li d-dejta deskritta f'dan il-PSUR ma bidlitx il-bilanċ tal-benefiċċju-riskju ta' Leflunomide Apotex.
English: The AUC, Cmax and Tmax of the US and Canadian fasting studies were comparable to the values obtained in the European study, which was also performed in fasting state.
Maltese: L-AUC, is-Cmax u t-Tmax tal-istudji Kanadiżi u Amerikani li saru waqt issawm kienu komparabbli mal-valuri li nkisbu fl-istudju Ewropew, li kien sar ukoll fi stat ta' sawm.
English: The Committee, as a consequence, recommended the suspension of the marketing authorisations for Leflunomide Apotex and associated names, pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable and b. the particulars supporting the application as provided in Article 10 of Directive 2001/83/EC cannot be considered correct
Maltese: • Il-Kumitat, bħala konsegwenza, irrakkomanda s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal Leflunomide Apotex u ismijiet assoċjati, skont l-Artikolu 116 tad-Direttiva 2001/83/KE; peress li a. il-bilanċ tal-benefiċċju-riskju ma jistax jitqies bħala favorevoli u b. id-dettalji li jappoġġjaw l-applikazzjoni kif previst fl-Artikolu 10 tad-Direttiva 2001/83/KE ma jistgħux jitqiesu bħala korretti
English: In all 4 studies, the 90% confidence intervals for AUC0-72 and Cmax were within the 80% to 125% limits.
Maltese: L-istudji kellhom disinn cross-over b'ġimagħtejn mingħajr kura (wash-out) bejn ilperjodi tal-istudju. Fl-4 studji kollha, l-intervalli ta' fiduċja ta' 90% għall-AUC0-72 u s-Cmax kienu fil-limiti ta' 80% sa 125%.
English: One case report reported lack of efficacy, where the product was used for lupus mixed connective tissue disease, which is not an approved indication.
Maltese: Rapport wieħed dwar il-każ irrapporta nuqqas ta' effikaċja, fejn il-prodott intuża għall-mard imħallat tat-tessut konnettiv tal-lupus, li mhuwiex indikazzjoni approvata.
English: As further evidence of the bioequivalence of Leflunomide Apotex with the reference product, the MAH provided an overview of the qualitative and quantitative composition of its 10 and 20 mg tablets intended for the US, Canadian and European market, considering them to be identical.
Maltese: Bħala evidenza ulterjuri talbijoekwivalenza ta' Leflunomide Apotex mal-prodott ta' referenza, l-MAH ipprovda ħarsa ġenerali talkompożizzjoni kwalitattiva u kwantitattiva tal-pilloli tiegħu ta' 10 mg u ta' 20 mg maħsuba għas-suq Amerikan, Kanadiż u Ewropew, u kkunsidrahom li kienu identiċi.
English: Therefore, the CHMP did not consider the available data to be sufficient to support the bioequivalence of the EU formulation of Leflunomide Apotex to the EU reference product.
Maltese: Għalhekk, is-CHMP ma kkunsidrax li d-dejta disponibbli kienet biżżejjed biex tappoġġa l-bijoekwivalenza tal-formulazzjoni tal-UE ta' Leflunomide Apotex mal-prodott ta' referenza tal-UE.
English: Package Leaflet 1.
Maltese: Fuljett ta' Tagħrif 1.
English: Do not take bromocriptine if:
Maltese: Tiħux bromocriptine jekk:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni tal-prodott tista 'tiġi sussegwentement aġġornata mill-awtoritajiet kompetenti tal-Istati Membri, b'kollaborazzjoni mal-Istat Membru ta' Referenza, kif xieraq, bi qbil mal-proċeduri stabbiliti filKapitolu 4 tat-Titolu III tad-Direttiva 2001/83 / KE.
English: Bromocriptine may be used for:
Maltese: Bromocriptine jista' jintuża għal:
English: These are very rare, but may include high blood pressure, heart attack, convulsion, stroke or mental problems.
Maltese: Dawn huma rari ħafna, imma jistgħu jinkludu pressjoni tad-demm għolja, attakk tal-qalb, konvulżjoni, puplesija jew problemi mentali.
English: In rare cases serious adverse events, including hypertension, myocardial infarction, seizures, stroke, or psychiatric disorders have been reported in post-partum women treated with bromocriptine for the inhibition of lactation.
Maltese: F'każijiet rari, reazzjonijiet avversi serji, li jinkludu pressjoni għolja, infart mijokardjali, aċċessjonijiet, puplesija, jew disturbi psikjatriċi ġew rapportati wara l-ħlas f'nisa ttrattati b'bromocriptine għallimpediment ta' treddigħ.
English: [For products of 1 mg and 2.5 mg strengths only, this section should be amended as appropriate to reflect the wording below]
Maltese: [Għal prodotti ta' qawwa ta' 1 mg u 2.5 mg biss, din is-sezzjoni għandha tiġi emendata biex tirrifletti lkliem testwali t'hawn isfel]
English: Bromocriptine is contraindicated in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post-partum and in the puerperium.
Maltese: Bromocriptine hu kontraindikat f'pazjenti bi pressjoni għolja mhix ikkontrollata, disturbi marbuta ma' pressjoni għolja fit-tqala (li jinkludu eklampsja, pre-eklampsja jew pressjoni għolja indotta minn tqala), pressjoni għolja wara l-ħlas u fil-pwerperjum.
English: Bromocriptine is contraindicated for use in the suppression of lactation or other non-life threatening indications in patients with a history of coronary artery disease or other severe cardiovascular conditions, or symptoms/history of severe psychiatric disorders.
Maltese: Bromocriptine hu kontraindikat għal użu fis-soppressjoni ta' treddigħ jew indikazzjonijiet oħra li mhumiex ta' periklu għal ħajja f'pazjenti bi storja medika ta' mard fl-arterja koronarja jew kondizzjonijiet kardjovaskulari severi oħrajn, jew sintomi/storja medika ta' disturbi psikjatriċi severi.
English: Bromocriptine is not recommended for the routine suppression of lactation or for the relief of symptoms of post-partum pain and engorgement which can be adequately treated with nonpharmacological intervention (such as firm breast support, ice application) and/or simple analgesics.
Maltese: Bromocriptine mhuwiex rakkomandat għas-soppressjoni ta' rutina ta' treddigħ jew għal serħan missintomi ta' uġigħ ta' wara l-ħlas u l-mili tas-sider bil-ħalib li jistgħu jiġu trattati b'intervent mhux farmakoloġiku (bħal sostenn sod għas-sider, applikazzjoni ta' silġ) u/jew analġeżiċi sempliċi.
English: 4.1 Therapeutic indications [A. For products of 1 mg and 2.5 mg strengths, the current indication related to lactation inhibition in post-partum, including the examples of mastitis and painful breast engorgement, should be deleted and the below wording should be included in its place]
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu [Għal prodotti ta' qawwa ta' 1 mg u 2.5 mg biss, din is-sezzjoni għandha tiġi emendata biex tirrifletti lkliem testwali t'hawn isfel]
English: - You have high blood pressure, - You have ever had blood pressure problems during pregnancy or after giving birth, such as eclampsia, pre-eclampsia, pregnancy-induced high blood pressure, high blood pressure after giving birth.
Maltese: - Għandek pressjoni tad-demm għolja - Inti kellek xi darba problemi tal-pressjoni tad-demm marbuta mat-tqala jew wara l-ħlas, bħal eklampsja, pre-eklampsja, pressjoni tad-demm għolja indotta mit-tqala, pressjoni tad-demm għolja wara l-ħlas.
English: - You have, or have ever had, heart disease, or other severe blood vessel disease - You have, or have ever had, serious mental health problems
Maltese: - Għandek, jew qatt kellek, problemi ta' saħħa mentali serji.
English: [B. For product of higher strengths (5 mg and 10 mg) the indication related to inhibition of lactation in post-partum, including the examples of mastitis and painful breast engorgement, should be removed and the complete SmPC should be revised to remove wording related to the deleted indication]
Maltese: Għal prodotti ta' qawwa akbar (5 mg u 10 mg) l-indikazzjoni marbuta ma' impediment ta' treddigħ wara l-ħlas, li jinkludu l-eżempji ta' mastite u l-mili b'ħalib tas-sider bl-uġigħ, għandha tiġi mħassra u s-SKP komplut għandu jiġi rivedut biex jitneħħa l-kliem testwali marbut mal-indikazzjoni mħassra]
English: Speak immediately to your doctor if you experience high blood pressure, chest pain or unusually severe or persistent headache (with or without vision problems).
Maltese: Kellem minnufih lit-tabib tiegħek jekk tesperjenza pressjoni tad-demm għolja, uġigħ fis-sider jew uġigħ ta' ras sever jew persistenti mhux tas-soltu (bi jew mingħajr problemi viżwali)
English: EU/2/06/058/004 Flexicam 5 mg/ml
Maltese: Kunjett ta' linjezzjoni (ħġieġ)
English: Target species Route of administration
Maltese: Kif jingħata Ippakkjar Kontenut Daqs talpakkett
English: Ref.: EMA/751799/2009 EMA/H/C/572
Maltese: EMEA/751799/2009 EMEA/H/C/572
English: Cymbalta duloxetine EPAR summary for the public
Maltese: Cymbalta duloxetine Sommarju tal-EPAR għall-pubbliku
English: Cymbalta must not be used together with monoamine oxidase inhibitors (another group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Maltese: Cymbalta ma għandux jintuża flimkien ma' inibituri tal-monoamino ossidażi (monoamine oxidase inhibitors, grupp ieħor ta' antidepressivi), fluvoxamine (antidepressiv ieħor), jew ciprofloxacin jew enoxacin (tipi ta' antibijotiċi).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cymbalta to Eli Lilly Nederland BV on 17 December 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Cymbalta lil Eli Lilly Nederland BV fis-17 ta' Diċembru 2004.
English: The active substance in Cymbalta, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Maltese: Is-sustanza attiva f'Cymbalta, duloxetine, hija inibitur tal-assorbiment mill-ġdid tas-serotonina u tannoradrenalina (serotonin-noradrenaline re-uptake inhibitor).
English: Cymbalta is a medicine that contains the active substance duloxetine.
Maltese: Cymbalta huwa mediċina li fih is-sustanza attiva duloxetine.
English: For major depression, the recommended dose of Cymbalta is 60 mg once a day.
Maltese: Għad-depressjoni qawwija, id-doża rakkomandata ta' Cymbalta hija 60 mg kuljum.