FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Committee took into account all available data, including the responses from the MAHs and the conclusion of the SAG Oncology;
Maltese: • Il-Kumitat ikkunsidra d-dejta kollha disponibbli, inklużi t-tweġibiet mill-MAHs u l-konklużjoni tas-SAG Onkoloġija;
English: The dose ratio of dexrazoxane to epirubicin remained unchanged at 10:1.
Maltese: Il-proporzjon tad-doża ta' dexrazoxane għal epirubicin baqa' l-istess fi 10:1.
English: In addition, considering the observed risks, including myelosuppression and excess early mortality reported in placebo-controlled US studies employing a dexrazoxane:doxorubicin dose ratio of 20:1, the CHMP considered that a reduction in the dexrazoxane dose is expected to have a favourable effect on dose-related safety issues.
Maltese: Barra minn hekk, meta kkunsidra r-riskji osservati, inklużi l-majelosoppressjoni u ż-żieda fil-mortalità bikrija rrapportati fi studji kkontrollati bi plaċebo fl-Istati Uniti, li użaw proporzjon ta' doża ta' dexrazoxane:doxorubicin ta' 20:
English: Overall summary of the scientific evaluation of dexrazoxane-containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali li fihom dexrazoxane (ara Anness I)
English: • The Committee considered that the benefit-risk balance of dexrazoxane for the prevention of anthracycline (doxorubicin and epirubicin)-induced cardiotoxicity remains favourable in adult patients with advanced and/or metastatic breast cancer who have received a minimum prior cumulative dose of anthracyclines; therefore the CHMP recommended a restriction of the indication accordingly.
Maltese: • Il-Kumitat ikkunsidra li l-bilanċ tal-benefiċċju-riskju ta' dexrazoxane għall-prevenzjoni ta' kardjotossiċità indotta b'anthracycline (doxorubicin u epirubicin) jibqa' favorevoli fil-pazjenti adulti bil-kanċer tas-sider avvanzat u/jew metastatiku li fil-passat kienu rċevew doża minima kumulattiva ta' anthracyclines; għalhekk is-CHMP irrakkomanda restrizzjoni tal-indikazzjoni kif xieraq.
English: In particular, three open randomised studies conducted in the EU and the US and two placebo controlled studies conducted in the US showed that dexrazoxane significantly reduced the incidence of cardiac events (primarily a fall in left ventricular ejection fraction - LVEF) in breast cancer patients treated with doxorubicin.
Maltese: B'mod partikolari, tliet studji randomizzati miftuħa li saru fl-UE u fl-Istati Uniti u żewġ studji kkontrollati bi plaċebo li saru fl-Istati Uniti wrew li dexrazoxane naqqas l-inċidenza ta' avvenimenti kardijaċi (primarjament tnaqqis fil-frazzjoni ta' tfigħ 'il barra ventrikulari tax-xellugLVEF) fuq pazjenti bil-kanċer tas-sider kkurati b'doxorubicin b'mod sinifikanti.
English: Dexrazoxane is authorised in Europe through mutual recognition (MR), decentralised and national procedures for the prevention of anthracycline (doxorubicin or epirubicin)-induced cardiotoxicity.
Maltese: Dexrazoxane huwa awtorizzat fl-Ewropa permezz ta' rikonoxximent reċiproku (MR), proċeduri nazzjonali u deċentralizzati għall-prevenzjoni ta' kardjotossiċità indotta minn anthracycline (doxorubicin jew epirubicin).
English: Dexrazoxane efficacy in the prevention of anthracycline cardiotoxicity is supported by available clinical trial data.
Maltese: L-effikaċja ta' Dexrazoxane fil-prevenzjoni ta' kardjotossiċità b'anthracycline hija appoġġata minn dejta disponibbli minn provi kliniċi.
English: In addition to serious infections, other important potential safety risks include a higher incidence of death observed in some studies in groups treated with dexrazoxane plus chemotherapy compared to those treated with chemotherapy alone, and evidence of possible interference with anthracycline efficacy.
Maltese: Barra minn infezzjonijiet serji, riskji importanti potenzjali oħra għas-sigurtà jinkludu inċidenza ogħla ta' mwiet osservati f'xi studji fi gruppi kkurati bi dexrazoxane flimkien ma' kimoterapija meta mqabbla ma' dawk kkurati b'kimoterapija weħidha, u evidenza ta' interferenza possibbli mal-effikaċja ta' anthracycline.
English: The fact that clinical trials of razoxane (a racemic mixture of S(+)dexrazoxane and R(-) levrazoxane) were suspended due to safety concerns related to AML added to the concerns.
Maltese: Il-fatt li l-provi kliniċi ta' razoxane (taħlita raċemika ta' S(+)dexrazoxane u R(-) levrazoxane) kienu sospiżi minħabba tħassib dwar is-sigurtà fir-rigward ta' AML żied mat-tħassib.
English: • The Committee recommended conditions to the marketing authorisation, including a direct healthcare professional communication, the shortening of the PSUR submission cycle to an annual submission and the monitoring of the effectiveness of the risk minimisation measures by means of a drug utilisation study.
Maltese: • Il-Kumitat irrakkomanda kundizzjonijiet tal-awtorizzazzjoni għat-tqegħid fis-suq, inkluż komunikazzjoni diretta minn professjonista tal-kura tas-saħħa, it-tnaqqis taċ-ċiklu ta' sottomissjoni tal-PSUR għal sottomissjoni annwali u l-monitoraġġ tal-effikaċja tal-miżuri għall-minimizzazzjoni tar-riskju permezz ta' studju dwar l-użu tal-mediċina.
English: Dexrazoxane is indicated in combination with anthracycline chemotherapy, and the risk of myelosuppressive effects may be additive to those of chemotherapy, which increases the risk of developing serious infections.
Maltese: Dexrazoxane huwa indikat f'kombinazzjoni ma' kimoterapija b'anthracycline, u r-riskju ta' effetti majelosuppressivi jista' jkun addittiv ma' dawk tal-kimoterapija, li jżid ir-riskju għall-iżvilupp ta' infezzjonijiet serji.
English: • The Committee considered that use of dexrazoxane in children and adolescents up to 18 years of age is associated with second primary malignancies and should therefore be contraindicated;
Maltese: • Il-Kumitat ikkunsidra li l-użu ta' dexrazoxane fit-tfal u l-adoloxxenti iżgħar minn 18-il sena huwa assoċjat ma' tumuri malinni sekondarji primarji u għalhekk għandu jiġi kontra-indikat;
English: Regarding use of dexrazoxane in paediatric patients, available data on the efficacy of dexrazoxane was considered very limited by the CHMP, as only one adequately sized randomised study which used troponin T as a surrogate endpoint is available.
Maltese: Fir-rigward tal-użu ta' dexrazoxane fuq pazjenti pedjatriċi, is-CHMP ikkunsidra li d-dejta disponibbli dwar l-effikaċja ta' dexrazoxane kienet limitata ħafna, minħabba li huwa disponibbli studju wieħed biss randomizzat u ta' daqs addattat li uża troponin T bħala endpoint sostitut.
English: The role of dexrazoxane in preventing epirubicin cardiotoxicity was also investigated in clinical studies which reported a reduction in the incidence of cardiac events (primarily a fall in LVEF) in patients treated with dexrazoxane and epirubicin compared with epirubicin alone.
Maltese: Sub-analiżi ta' dawn l-istudji wrew ukoll tnaqqis sinifikanti ta' avvenimenti ta' insuffiċjenza konġestiva tal-qalb (CHF) u tnaqqis fis-severità ta' avvenimenti CHF. Ir-rwol ta' dexrazoxane fil-prevenzjoni ta' kardjotossiċità b'epirubicin ġie investigat ukoll fi studji kliniċi li rrapportaw tnaqqis fl-inċidenza ta' avvenimenti kardijaċi (primarjament tnaqqis fl-LVEF) f'pazjenti kkurati b'dexrazoxane u epirubicin meta mqabbla ma' epirubicin waħdu.
English: The CHMP further advised that dexrazoxane should not be used in combination with adjuvant breast cancer therapy or chemotherapy intended as curative.
Maltese: Is-CHMP ta wkoll parir li dexrazoxane ma għandux jintuża f'kombinazzjoni ma' terapija aġġuvanti għall-kanċer tas-sider jew kimoterapija maħsuba bħala kurattiva.
English: Sertraline - Maculopathy (EPITT no 19341)
Maltese: Sertraline - Makulopatija (EPITT nru 19341)
English: Pantoprazole - Colitis microscopic (EPITT no 19342)
Maltese: Pantoprazole - Kolite mikroskopika (EPITT nru 19342)
English: - anti-retroviral medicines (medicines to treat HIV infections).
Maltese: - mediċini antiretrovirali (mediċini għall-kura ta' infezzjonijiet bl-HIV).
English: Not known: maculopathy
Maltese: Mhux magħruf: makulopatija
English: 3 Citalopram; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline 4 Clomipramine and vortioxetine were part of the signal assessment but are not concerned by the recommendation to update the product information.
Maltese: 3 Citalopram; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline 4 Clomipramine u vortioxetine kienu parti mill-valutazzjoni tas-sinjali iżda mhumiex ikkonċernati mir-rakkomandazzjoni biex tiġi aġġornata l-informazzjoni dwar il-prodott.
English: Clopidogrel; clopidogrel, acetylsalicylic acid - Interaction with boosted antiviral human immunodeficiency virus (HIV) therapy leading to insufficient inhibition of platelet aggregation (EPITT no 19325)
Maltese: 1. Clopidogrel; clopidogrel, acetylsalicylic acid - Interazzjoni ma' terapija tal-virus tal-immunodefiċjenza tal-virus uman (HIV) imsaħħa li wasslet għal inibizzjoni insuffiċjenti talaggregazzjoni tal-pjastrini (EPITT nru 19325)
English: Serotonin and noradrenaline reuptake inhibitors (SNRI)2; selective serotonin reuptake inhibitors (SSRI)3 4 - Persistent sexual dysfunction after drug withdrawal (EPITT no 19277)
Maltese: Inibituri tal-assorbiment mill-ġdid ta' serotonina noradrenalina (SNRI)2; inibituri selettivi tal-assorbiment mill-ġdid ta' serotonina (SSRI)3 4 - Disfunzjoni sesswali persistenti wara t-twaqqif tal-mediċina (EPITT nru 19277)
English: Interaction with other medicinal products and other forms of interaction A significantly lower exposure to clopidogrel active metabolite and reduced platelet inhibition have been demonstrated in HIV-infected patients treated with ritonavir- or cobicistat-boosted anti-retroviral therapies (ART).
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Intwera kemm esponiment ferm aktar baxx għall-metabolit attiv clopidogrel kif ukoll inibizzjoni talpjastrini mnaqqsa f'pazjenti infettati bl-HIV li ġew ikkurati b'terapiji antiretrovirali (ART) imsaħħa ta' ritonavir jew cobicistat.
English: Adopted at the 13-16 May 2019 PRAC
Maltese: Adottati fil-PRAC ta' bejn it-13 u s-16 ta' Mejju 2019
English: There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.
Maltese: Kien hemm rapporti ta' disfunzjoni sesswali fit-tul fejn is-sintomi komplew minkejja l-waqfien ta' SSRIs/SNRI.
English: Rare: spots in front of eyes, glaucoma, double vision, light hurts eye, blood in the eye, unequal sized pupils, vision abnormal, tear problem
Maltese: Rari: tikek quddiem l-għajnejn, glawkoma, vista doppja, id-dawl iweġġa' l-għajn, demm fl-għajn, ħbub tal-għajnejn li ma jkunux indaqs, vista anormali, problema ta' dmugħ
English: Medicines like [Invented name] (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Maltese: Mediċini bħal [Isem ivvintat] ('l hekk imsejħa SSRIs/SNRIs) jistgħu jikkawżaw sintomi ta' disfunzjoni sesswali (ara sezzjoni 4).
English: Although the clinical relevance of these findings is uncertain, there have been spontaneous reports of HIV-infected patients treated with boosted ART, who have experienced reocclusive events after de-obstruction or have suffered thrombotic events under a clopidogrel loading treatment schedule.
Maltese: Għalkemm ir-rilevanza klinika ta' dawn is-sejbiet hija inċerta, kien hemm rapporti spontanji ta' pazjenti infettati bl-HIV li ġew ikkurati b'ART imsaħħa, li esperjenzaw avvenimenti riokklussivi wara t-tneħħija tal-ostaklu jew li sofrew avvenimenti trombotiċi taħt skeda ta' kura tat-tagħbija bi clopidogrel.
English: What you need to know before you take [X] Other medicines and [X]
Maltese: X'għandek tkun taf qabel ma tieħu [X] Mediċini oħra u [X]
English: Undesirable effects Tabulated list of adverse reactions Gastrointestinal disorders Frequency not known: Microscopic colitis
Maltese: Effetti mhux mixtieqa Disturbi fl-għajnejn
English: BACKGROUND:
Maltese: SFOND:
English: It follows from the above:
Maltese: ID-DEĊIŻJONI ATTWALI:
English: • Nimesulide presents a risk of hepatotoxicity, including risk of fulminant hepatic failure.
Maltese: • Nimesulide jippreżenta riskju ta' epatotossiċità, inkluż riskju ta' attakk epatiku f'daqqa waħda.
English: • This disagreement was also observed in the Standing Committee meeting of 20 January 2008.
Maltese: • Dan in-nuqqas ta' ftehim deher ukoll fil-laqgħa tal-Kumitat Permanenti tal-20 ta' Jannar 2008.
English: Upon recommendation from the CHMP, given that an assessment of the gastrointestinal toxicity of nimesulide was outside the scope of the review procedure under Article 107, the Commission will initiate a referral under Article 31 of Directive 2001/83/EC, under which a full risk-benefit assessment will be undertaken.
Maltese: Fuq rakkomandazzjoni mis-CHMP, billi stima tat-tossiċità gastrointestinali ta' nimesulide ma kinitx fl-ambitu tal-proċedura ta' reviżjoni skont l-Artikolu 107, il-Kummissjoni se tagħti bidu għal rikors skont l-Artikolu 31 tad-Direttiva 2001/83/KE, li permezz tiegħu se titwettaq stima sħiħa tarriskju/benefiċċju.
English: It was furthermore noted that alternative products also present some risks, namely of gastrointestinal bleeding.
Maltese: Ġie wkoll innutat li prodotti alternattivi fihom ukoll xi riskji, l-aktar ta' emorraġija gastrointestinali.
English: The opinion adopted by the Committee for Medicinal Products for Human Use on 20 September 2007 recommended the maintenance of the national marketing authorisations for nimesulide-containing medicinal products with the introduction of several risk minimisation measures (limitation of the maximum duration of treatment, safety warnings in the product information, additional safety studies).
Maltese: L-opinjoni adottata mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem fl-20 ta' Settembru 2007 rrakkomandat iż-żamma tal-awtorizzazzjonijiet nazzjonali ta' tqegħid fis-suq għal prodotti mediċinali li fihom nimesulide bid-dħul ta' bosta miżuri ta' minimizzazzjoni tar-riskju (limitazzjoni tat-tul ta' żmien massimu tat-trattament, twissijiet ta' sikurezza fl-informazzjoni talprodott, studji ta' sikurezza addizzjonali).
English: ANNEX V DETAILED EXPLANATION OF THE REASONS FOR THE ADDITIONAL CONDITIONS AND RESTRICTIONS TO THE CHMP OPINION
Maltese: GĦALL-OPINJONI CHMP
English: Therefore, an increase in gastrointestinal toxicity events may occur if nimesulide ceases to be available.
Maltese: tossiċità gastrointestinali tista' sseħħ jekk nimesulide ma jibqax disponibbli.
English: By letter dated 26 June 2008, the Chairman of the CHMP has informed the Commission that following the assessment of the new additional reports and consideration of other risk minimisation measures, the assessment report was updated with the new factual information and a CHMP opinion containing the same recommendations as the September opinion was put to a vote in the CHMP.
Maltese: B'ittra bid-data tas-26 ta' Ġunju 2008, il-President tas-CHMP għarraf lill-Kummissjoni li wara l-istima tar-rapporti addizzjonali ġodda u meqjusa miżuri oħra ta' minimizzazzjoni tar-riskju, ir-rapport talistima ġie aġġornat bl-informazzjoni ġdida tal-fatti u opinjoni tas-CHMP li fiha l-istess rakkomandazzjonijiet bħal dawk tal-opinjoni ta' Settembru tressqet għal vot fis-CHMP.
English: The Standing Committee for Medicinal Products for Human Use discussed the matter on 20 January 2008.
Maltese: Il-Kumitat Permanenti għall-Prodotti Mediċinali għall-Użu mill-Bniedem iddiskuta l-kwistjoni fl20 ta' Jannar 2008.
English: The relevant sections of the Summary of Product Characteristics and Package Leaflet of systemic formulations of nimesulide and of the Conditions of the Marketing Authorisation are amended as set out in Annexes III and IV of this Decision.
Maltese: It-taqsimiet rilevanti tat-Taqsira tal-Karatteristiċi tal-Prodott u l-Fuljett tal-Pakkett ta' formulazzjonijiet sistemiċi ta' nimesulide u tal-Kondizzjonijiet tal-Awtorizzazzjoni ta' Tqegħid fisSuq huma emendati kif stabbilit fl-Anness
English: A significant number of members of the Committee expressed however a divergent opinion, sustaining that the benefit/risk profile of these products should be considered negative and that the marketing authorisations should rather be revoked.
Maltese: Għadd sinifikanti ta' membri tal-Kumitat esprimew madankollu opinjoni diverġenti, u sostnew li l-profil benefiċċju/riskju ta' dawn il-prodotti għandu jitqies bħala negattiv u jkun aħjar jekk jiġu revokati l-awtorizzazzjonijiet għat-tqegħid fis-suq.
English: Moreover, the relevance of new information was discussed in the meeting.
Maltese: Barra minn hekk, fil-laqgħa ġiet diskussa r-rilevanza ta' informazzjoni ġdida.
English: In view of this situation, the Commission chairman decided not to submit the draft decision to a vote by the Standing Committee during the meeting but to refer the matter to the CHMP for further examination of any new reports of suspected hepatotoxicity related to nimesulide and identification and consideration of existing national measures, such as guidelines or recommendations, in relation to the use of nimesulide with a view to recommending necessary risk minimisation measures.
Maltese: Fid-dawl ta' din is-sitwazzjoni, il-president tal-Kummissjoni ddeċieda li ma jressaqx l-abbozz taddeċiżjoni għal vot mill-Kumitat Permanenti matul il-laqgħa iżda li jirreferi l-kwistjoni lis-CHMP għal eżami ulterjuri ta' xi rapporti ġodda ta' epatotossiċità suspettata marbuta ma' nimesulide u identifikazzjoni u konsiderazzjoni ta' miżuri nazzjonali attwali, bħal linji gwida jew rakkomandazzjonijiet, għal dak li għandu x'jaqsam ma' nimesulide bil-ħsieb li jiġu rrakkomandati miżuri meħtieġa ta' minimizzazzjoni tar-riskju.
English: • There are divergent views within the CHMP on the assessment of whether this risk may be addressed through risk minimisation measures allowing maintenance of the products on the market or whether the risk is such that the authorisation should be revoked.
Maltese: • Hemm opinjonijiet diverġenti fi ħdan is-CHMP dwar l-istima jekk dan ir-riskju jistax jiġi indirizzat permezz ta' miżuri ta' minimizzazzjoni tar-riskju filwaqt li jinżammu l-prodotti fis-suq jew jekk ir riskju huwa tali li l-awtorizzazzjoni għandha tiġi revokata.
English: • On the other hand, the switching from nimesulide to other Non-Steroidal Anti-inflamatory drugs may lead to an increase of gastrointestinal toxicity occurrences.
Maltese: • Min-naħa l-oħra, il-qlib minn nimesulide għal mediċini mhux Sterojdali kontra l-infjammazzjoni jista' jwassal għal żieda ta' inċidenza ta' tossiċità gastrointestinali.
English: This approach is strengthened by the fact that a full risk-benefit assessment is to be conducted in the framework an Article 31 procedure, where the risks of nimesulide will be weighted vis-à-vis the gastrointestinal risks of other products.
Maltese: Dan l-approċċ huwa msaħħaħ mill-fatt li stima sħiħa tar-riskju/benefiċċju se titwettaq fil-qafas ta' proċedura tal-Artikolu 31, fejn ir-riskji ta' nimesulide jitqabblu mar-riskji gastrointestinali ta' prodotti oħrajn.
English: However, in view of the severity of the adverse events, these measures should in the Commission's perspective be further intensified by (1) limiting the prescription of nimesulide to second line treatment and by (2) introducing a clear obligation upon the marketing authorisation holder to inform healthcare professionals of the safety risks associated with this product.
Maltese: Iżda, fid-dawl tal-ħruxija tal-okkorrenzi avversi, dawn il-miżuri għandhom jissaħħu aktar filperspettiva tal-Kummissjoni (1) bil-limitazzjoni tal-preskrizzjoni ta' nimesulide għal trattament meta ma jkunx irnexxa l-ewwel trattament u (2) bid-dħul ta' obbligu ċar fuq id-detentur tal-awtorizzazzjoni tat-tqegħid fis-suq li jgħarraf lill-professjonisti tal-kura tas-saħħa dwar ir-riskji ta' sikurezza marbuta ma' dan il-prodott.
English: The restriction of the indication to second line treatment is intended to ensure that nimesulide is not used as a routine pain killer where other treatment options which present a reduced hepatotoxic risk are available.
Maltese: Ir-restrizzjoni tal-indikazzjoni ta' trattament meta ma jkunx irnexxa l-ewwel trattament hija maħsuba biex tiżgura li nimesulide ma jintużax bħala rutina kontra l-uġigħ meta jeżistu għażliet oħra ta' trattament li fihom riskju epatotossiku mnaqqas.
English: It also appeared from the discussions that certain Member States were applying at national level measures not reflected in the harmonised product information and intended to further reduce the risks associated with nimesulide.
Maltese: Deher ukoll middiskussjonijiet li ċerti Stati Membri kienu qed japplikaw miżuri fil-livell nazzjonali li ma jidhrux flinformazzjoni armonizzata tal-prodott u kien beħsiebhom inaqqsu aktar ir-riskji marbuta ma' nimesulide.
English: It also appeared that a fundamental disagreement persisted among Member States competent authorities on whether risk minimisation measures were capable of addressing the risk of hepatotoxicity of the product.
Maltese: Deher ukoll li baqa' nuqqas ta' qbil fundamentali fost l-awtoritajiet kompetenti tal-Istati Membri dwar jekk il-miżuri ta' minimizzazzjoni setgħux jindirizzaw ir-riskju tal-epatotossiċità tal-prodott.
English: Tolucombi is a ‘generic medicine'.
Maltese: Tolucombi huwa ‘mediċina ġenerika'.
English: The full EPAR for Tolucombi 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.
English: Tolucombi is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide) to be taken by mouth once a day with liquid.
Maltese: Tolucombi jiġi f'pilloli (40 mg jew 80 mg telmisartan u 12.5 mg idroklorotijażide; 80 mg telmisartan u 25 mg idroklorotijażide) li jittieħdu oralment darba kuljum ma' likwidu.
English: This is a summary of the European public assessment report (EPAR) for Tolucombi.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Tolucombi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tolucombi on 13 March 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Tolucombi fil-13 ta' Marzu 2013.
English: Tolucombi contains two active substances, telmisartan and hydrochlorothiazide.
Maltese: Tolucombi fih żewġ sustanzi attivi, it-telmisartan u l-idroklorotijażide.
English: This means that Tolucombi is similar to a ‘reference medicine' already authorised in the European Union (EU) called MicardisPlus.
Maltese: Dan ifisser li Tolucombi huwa simili għall-“mediċina ta' referenza” diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem MicardisPlus.
English: Because Tolucombi is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, MicardisPlus.
Maltese: Peress li Tolucombi huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet li jistabbilixxu lbijoekwivalenza tiegħu mal-mediċina ta' referenza, MicardisPlus.
English: The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to Tolucombi.
Maltese: Il-pilloli tat-80/25 mg jintużaw minn pazjenti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata permezz tal-pilloli tat80/12.5 mg jew li l-qagħda tagħhom tkun saret stabbli permezz ta' żewġ sustanzi attivi meħuda separatament qabel ma qalbu għal Tolucombi.
English: The dose of Tolucombi to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Maltese: Id-doża ta' Tolucombi li għandha tintuża tiddependi mid-doża tat-telmisartan li l-pazjent kien qiegħed jieħu qabel: il-pazjenti li kienu qed jieħdu 40 mg telmisartan għandhom jieħdu l-pilloli tal-40/12.5 mg filwaqt li l-pazjenti li kienu qed jieħdu 80 mg telmisartan għandhom jieħdu l-pilloli tat-80/12.5 mg.