FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on MabThera can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/mabthera.
Maltese: Aktar informazzjoni dwar MabThera tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/mabthera.
English: MabThera (rituximab)
Maltese: MabThera (rituksimab)
English: Other information about MabThera
Maltese: Informazzjoni oħra dwar MabThera
English: • severe rheumatoid arthritis (an inflammatory condition of the joints);
Maltese: • artrite rewmatika severa (kundizzjoni infjammatorja tal-ġogi);
English: MabThera contains the active substance rituximab.
Maltese: MabThera fih is-sustanza attiva rituksimab.
English: MabThera is given as an infusion (drip) into a vein.
Maltese: MabThera jingħata bħala infużjoni (dripp) ġol-vina.
English: The company marketing MabThera will provide doctors and patients using the medicine for rheumatoid arthritis, GPA, MPA or pemphigus with educational material on the risk of infection including of a rare severe infection known as progressive multifocal leukoencephalopathy (PML).
Maltese: Il-kumpanija li tqiegħed MabThera fis-suq sejra tipprovdi lit-tobba u lill-pazjenti li jużaw il-mediċina għal artrite rewmatodje, GPA, MPA jew pemfigus b'materjal edukattiv dwar ir-riskju ta' infezzjoni inkluż infezzjoni severa rari magħrufa bħala lewkoenċefalopatija multifokali progressiva (PML, progressive multifocal leukoencephalopathy).
English: • In a study of 517 patients with rheumatoid arthritis, MabThera was more effective than placebo: 51% of the patients receiving MabThera had an improvement in symptoms, compared with 18% of the patients receiving placebo.
Maltese: • Fi studju ta' 517-il pazjent b'artrite rewmatojde, MabThera kien iktar effettiv minn plaċebo: 51 % tal-pazjenti li kienu qed jingħataw MabThera kellhom titjib fis-sintomi, meta mqabbla ma' 18 % talpazjenti li kienu qed jingħataw plaċebo.
English: • In a studies of MabThera given on its own (203 patients), 48% of the patients with follicular lymphoma who had failed previous treatment responded to MabThera.
Maltese: • Fl-istudji ta' MabThera mogħti waħdu (203 pazjenti), 48 % tal-pazjenti b'linfoma follikulari li l-kura preċedenti tagħhom ma ma rnexxietx, irrispondew għal MabThera.
English: • In a study of 817 patients with CLL, patients who had not been treated before lived for an average of 39.8 months without their disease getting worse when they received MabThera in addition to chemotherapy, compared with 32.2 months in patients receiving chemotherapy alone.
Maltese: • Fi studju ta' 817-il pazjent b'CLL, il-pazjenti li ma kinux ġew ikkurati qabel, għexu medja ta' 39.8 xhur mingħajr ma l-marda tagħhom aggravat meta ngħataw MabThera flimkien ma' kimoterapija, meta mqabbla ma' 32.2 xhur f'pazjenti li ngħataw kimoterapija biss.
English: MabThera received a marketing authorisation valid throughout the EU on 2 June 1998.
Maltese: MabThera ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-2 ta' Ġunju 1998.
English: • In a maintenance study in patients whose follicular lymphoma had come back after previous treatment, patients who received MabThera alone lived for an average of 42.2 months without the disease getting worse, compared with 14.3 months in patients who did not receive the medicine.
Maltese: • Fi studju ta' manteniment f'pazjenti li l-linfoma follikulari tagħhom reġgħet feġġet wara kura preċedenti, il-pazjenti li ħadu MabThera waħdu għexu medja ta' 42.2 xhur qabel ma bdiet tiggravalhom il-marda, meta mqabbla ma' 14.3 xhur fil-pazjenti li ma kinux ingħataw il-mediċina.
English: The study showed that only 5% of patients treated with MabThera had a relapse, compared with 29% of patients treated with azathioprine (another medicine used to treat GPA and MPA).
Maltese: L-istudju wera li 5 % biss tal-pazjenti kkurati b'MabThera kellhom rikaduta, meta mqabbla ma' 29 % tal-pazjenti kkurati bl-ażatjoprina (mediċina oħra li tintuża għall-kura ta' GPA u MPA).
English: In patients whose disease had come back after previous treatment, those receiving MabThera lived for 30.6 months without their disease getting worse, compared with 20.6 months in those receiving chemotherapy alone.
Maltese: F'pazjenti li l-marda tagħhom reġgħet feġġet wara kura preċedenti, dawk li kienu qed jingħataw MabThera għexu għal 30.6 xhur mingħajr ma l-marda tagħhom aggravat, meta mqabbla ma' 20.6 xhur f'dawk li ngħataw kimoterapija biss.
English: The active substance in MabThera, rituximab, is a monoclonal antibody designed to recognise and attach to a protein called CD20 present on the surface of B-lymphocytes.
Maltese: Is-sustanza attiva f'MabThera, ir-rituksimab, hija antikorp monoklonali, imfassal biex jagħraf u jeħel ma' proteina magħrufa bħala CD20, preżenti fuq wiċċ il-linfoċiti-B.
English: When rituximab attaches to CD20, it causes the death of B-lymphocytes, which helps in lymphoma and CLL (where B-lymphocytes have become cancerous) and in rheumatoid arthritis (where B-lymphocytes are involved in joint inflammation).
Maltese: Meta r-rituksimab teħel ma' CD20, tikkawża l-mewt ta' linfoċiti-B, u dan jgħin fil-linfoma u fis-CLL (fejn linfoċiti-B ikunu saru kanċerużi) u fl-artrite rewmatojde (fejn linfoċiti-B huma involuti fl-infjammazzjoni tal-ġogi).
English: • follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's lymphoma, a blood cancer);
Maltese: • linfoma follikulari u linfoma diffuża mhux ta' Hodgkin b'ċelloli B kbar (żewġ tipi ta' linfomi mhux ta'
English: • In a study of 198 patients with GPA or MPA, 64% of patients given MabThera were in complete remission after six months, compared with 55% given cyclophosphamide, a comparator medicine.
Maltese: • Fi studju ta' 198 pazjent b'GPA jew MPA, 64 % tal-pazjenti li ngħataw MabThera kienu f'remissjoni kompleta wara sitt xhur, meta mqabbla ma' 55 % li ngħataw iċ-ċiklofosfamida, mediċina komparatur, It-tieni studju f'117-il pazjent ħares lejn il-proporzjon ta' pazjenti li l-kundizzjoni tagħhom reġgħet feġġet fi żmien 28 xahar.
English: As for all medicines, data on the use of MabThera are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' MabThera hija ssorveljata kontinwament.
English: How is MabThera used?
Maltese: MabThera?
English: Wegener's granulomatosis) and microscopic polyangiitis (MPA);
Maltese: • żewġ kundizzjonijiet infjammatorji tal-vażi magħrufin bħala granulomatożi b'polianġite (GPA jew granulomatożi ta' Wegener) u b'polianġite mikroskopika (MPA).
English: • moderate to severe pemphigus vulgaris, an autoimmune disease characterised by widespread blistering and erosion of the skin and mucous membranes (the linings of internal organs).
Maltese: • pemfigus vulgaris moderata għal severa, marda awtoimmunitarja karatterizzata b'infafet u erożjoni tal-ġilda mifruxa u membrani mukużi (il-kisjiet tal-organi interni). ‘Awtoimmunitarja' tfisser li l marda hija kkawżata mis-sistema immunitarja (id-difiżi naturali tal-ġisem) li tattakka ċ-ċelloli tal ġisem stess.
English: For the full list of side effects of MabThera, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' MabThera, ara l-fuljett ta' tagħrif.
English: The company that markets MabThera will also submit reports from a study on the effectiveness of MabThera in previously diagnosed pemphigus vulgaris patients and on the long-term effects of the medicine on the progression of the disease.
Maltese: Il-kumpanija li tqiegħed MabThera fis-suq ser tippreżenta wkoll rapporti minn studju dwar l-effikaċja ta' MabThera f'pazjenti li kienu preċedentement dijanjostikati b'pemfigus vulgaris u dwar l-effetti fit-tul tal-mediċina fuq il-progressjoni tal-marda.
English: Before each infusion or injection, the patient should be given an antihistamine (to prevent allergic reactions) and an anti-pyretic (a medicine for fever).
Maltese: Qabel kull infużjoni jew injezzjoni, il-pazjent għandu jingħata antiħistamina (għall-prevenzjoni ta' reazzjonijiet allerġiċi) u antipiretiku (mediċina għad-deni).
English: • chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells);
Maltese: • lewkimja linfoċitika kronika (CLL, kanċer ieħor tad-demm li jaffettwa ċ-ċelloli bojod tad-demm);
English: What is the risk associated with MabThera?
Maltese: X'inhuma r-riskji assoċjati ma' MabThera?
English: A maintenance study in previously untreated patients showed the likelihood for the disease to get worse was reduced by 50% for patients who received MabThera.
Maltese: Studju ta' manteniment f'pazjenti li qatt ma ngħataw kura wera li f'dawk li ngħataw MabThera lpossibbiltà li l-marda tiggrava naqset b'50 %.
English: Depending on the condition it is used to treat, MabThera may be given on its own, or with chemotherapy, methotrexate or a corticosteroid.
Maltese: Skont il-kondizzjoni li għaliha jintuża biex jikkuraha, MabThera jista' jingħata waħdu, jew flimkien malkimoterapija, metotreksat jew kortikosterojdi.
English: The most common side effects with MabThera intravenous infusions are reactions related to the infusion (such as fever, chills and shivering) while most common serious side effects are infusion reactions, infections and heart-related problems.
Maltese: L-effetti sekondarji l-aktar komuni b'infużjonijiet ġol-vini ta' MabThera huma reazzjonijiet relatati malinfużjoni (bħal deni, tertir u rogħda) filwaqt li l-effetti sekondarji serji l-aktar komuni huma reazzjonijiet għall-infużjoni, infezzjonijiet u problemi relatati mal-qalb. Effetti sekondarji simili jidhru meta MabThera jiġi injettat taħt il-ġilda, bl-eċċezzjoni ta' reazzjonijiet madwar is-sit tal-injezzjonijiet (uġigħ, nefħa u raxx), li jseħħu aktar ta' spiss bl-injezzjonijiet fil-ġilda.
English: • In a study of 399 patients with diffuse large B-cell lymphoma, patients adding MabThera to chemotherapy lived for an average of 35 months without the disease getting worse or the need for a change in treatment, compared with 13 months in those receiving chemotherapy alone.
Maltese: • Fi studju ta' 399 pazjent b'linfoma diffuża taċ-ċelloli-B kbar, il-pazjenti li żiedu MabThera malkimoterapija għexu medja ta' 35 xahar mingħajr ma ggravatilhom il-marda jew mingħajr ma kellhom bżonn jibdlu l-kura, meta mqabbla ma' 13-il xahar f'dawk li kienu qegħdin jirċievu kimoterapija biss.
English: • In a study of 90 patients newly diagnosed with pemphigus, rituximab in combination with prednisone (a corticosteroid) was shown to be more effective than prednisone alone at clearing skin lesions.
Maltese: • Fi studju ta' 90 pazjent li kienu għadhom kif ġew dijanjostikati b'pemfigus, ir-rituksimab flimkien mal-predniżon (kortikosterojde) intwera li kien iktar effettiv mill-predniżon waħdu fit-tneħħija ta' leżjonijiet tal-ġilda.
English: Following 2 years of treatment, 90% of patients treated with MabThera and shortterm (up to 6 months) prednisone were in complete remission (meaning that skin and mucosa had healed and there were no new or old lesions) after stopping prednisone for 2 months or more, compared with 28% of patients treated with prednisone alone.
Maltese: Wara sentejn ta' kura, 90 % tal-pazjenti kkurati b'MabThera u predniżon għal perjodu qasir (sa sitt xhur) kienu f'remissjoni kompleta (jiġifieri l-ġilda u l-mukoża kienu fiequ u ma kien hemm l-ebda leżjoni ġdida jew qadima) wara li predniżon twaqqaf għal xahrejn jew iktar, meta mqabbla ma' 28 % tal-pazjenti kkurati bi predniżon waħdu.
English: Side effects reported with MabThera are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'MabThera huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Depending on the condition being treated, the patients can also be given other medicines.
Maltese: Skont il-kundizzjoni li qed tiġi kkurata, ilpazjenti jistgħu jingħataw ukoll mediċini oħra.
English: London, 14 August 2008 EMEA/CHMP/524135/2008
Maltese: Londra, 14 ta' Awwissu 2008 EMEA/CHMP/364412/2008
English: The arbitration procedure was discussed by the CHMP at its plenary meeting in November 2007 and a Rapporteur (Dr Harald Enzmann) and Co-Rapporteur (Dr. Pieter Neels) were appointed.
Maltese: Il-proċedura ta' arbitraġġ ġiet diskussa mis-CHMP fil-laqgħa plenarja tiegħu f'Novembru 2007 u nħatru Rapporteur (Dr Harald Enzmann) u Ko-Rapporteur (Dr. Pieter Neels).
English: Actira was initially approved in June 1999.
Maltese: Actira ġie approvat inizjalment f'Ġunju 1999.
English: Actira film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Maltese: Actira pilloli miksijin b'rita fihom 400 mg moxifloxacin bħala hydrochloride.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL Actira and associated names International non-proprietary name (INN): moxifloxacin BACKGROUND INFORMATION *
Maltese: (CHMP) WARA RIFERIMENT SKOND L-ARTIKOLU 6 (12) Actira u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): moxifloxacin INFORMAZZJONI TA' SFOND *
English: ∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 19 March 2008.
Maltese: ∗ Noti: l-informazzjoni mogħtija f'dan id-dokument u l-annessi tiegħu jirriflettu biss l-opinjoni tas-CHMP datata d-19 ta' Marzu 2008.
English: Written explanations were provided by the Marketing Authorisation Holders (MAH) on 18 January 2008 and 27 February 2008.
Maltese: Spjegi bil-miktub ġew ipprovduti mid-Detenturi tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq (MAH) nhar it-18 ta' Jannar 2008 u s-27 ta' Frar 2008.
English: The CHMP considered that moxifloxacin cannot be used in the setting of PID in empirical monotherapy due to the increasing incidence of fluoroquinolone-resistant N. gonorrhoeae, unless a resistant strain can be excluded.
Maltese: Is-CHMP qies li moxifloxacin ma jistax jintuża fl-istabbiliment tal-PID f'monoterapija empirika dovuta għal inċidenza miżjuda ta' fluoroquinolone-resistant N. gonorrhoeae, sakemm razza reżistenti tista' tiġi eskluża.
English: The Referral procedure was initiated on 15 November with the adoption of a CHMP List of Questions to be addressed by the MAHs.
Maltese: Il-proċedura ta' Riferiment inbdiet fil-15 ta' Novembru bl-adozzjoni ta' Lista ta' Mistoqsijiet tas-CHMP sabiex tiġi indirizzata mid-Detenturi ta' l-Awtorizzazzjoni g]at-Tqeg]id fis-Suq (MAHs).
English: At the end of the mutual recognition procedure there was a discrepancy between different EU Member States regarding the wording of the indication that should adequately reflect the clinical data submitted by the company, and an official referral for arbitration according to Article 6(12) of Commission Regulation EC No 1084/2003, as amended, was notified by Belgium to the CHMP on 19 October
Maltese: Fi tmiem il-proċedura ta' rikonoxximent reċiproku, kien hemm diskrepanza bejn l-Istati Membri differenti tal-UE fir-rigward tal-formolazzjoni tal-indikazzjoni li tirrifletti b'mod adegwat id-dejta klinika ippreżentata mill-kumpanija, u riferiment uffiċjali għall-arbitraġġ skont l-Artikolu 6(12) tarRegolament tal-Kummissjoni KE Nru 1084/2003, kif emendat, ġie nnotifikat mill-Belġju lis-CHMP fid-19 ta' Ottubru 2007.
English: It is approved for the treatment of the following bacterial infections if they are caused by bacteria susceptible to moxifloxacin: acute exacerbation of chronic bronchitis; community acquired pneumonia, except severe cases; acute bacterial sinusitis (adequately diagnosed).
Maltese: Huwa approvat għallkura tal-infezzjonijiet batteriċi li ġejjin jekk ikunu kkawżati minn batterji suxxettibbli għal moxifloxacin: taħrix akut tal-bronkite kronika; pnewmonja akkwistata mill-Komunità, għajr għal każijiet severi; sinusite batterjali akuta (dijanjostikata b'mod adegwat).
English: This Referral procedure relates to a request for arbitration concerning a type II variation for a new indication to include treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis.
Maltese: Din il-proċedura ta' Riferiment għandha x'taqsam ma' talba għal arbitraġġ li tikkonċerna l-varjazzjoni ta' tip II għal indikazzjoni ġdida biex tinkludi l-kura ta' mard infjammatorju tal-pelvi ħafif għal moderat (PID), jiġifieri infezzjonijiet fil-parti ta' fuq tal-passaġġ ġenitali, inkluż salpinġite u endometrite.
English: The Committee further considered that the benefit/risk balance concerning the use of moxifloxacin up to 14 days in the PID indication remains positive, and that information and recommendations on the use of moxifloxacin, and the measures that should be taken before it is prescribed, are adequately addressed in the ‘contraindications' and ‘special warnings and precautions for use' sections of the EU SPC.
Maltese: Il-Kumitat ikkunsidra wkoll li l-bilanċ bejn il-benefiċċju/riskju dwar l-użu ta' moxifloxacin sa 14-il jum fl-indikazzjoni PID jibqa' pożittiv, u li l-informazzjoni u r-rakkomandazzjonijiet dwar l-użu ta' moxifloxacin, u l-miżuri li għandhom jittieħdu qabel ma jingħata, huma indirizzati adegwatament fissezzjonijiet ‘kontraindikazzjonijiet' u ‘twissijiet speċjali u prekwazjonijiet għall-użu' tal-SPC tal-UE.
English: In clinical trials the tablets have been studied for up to 14 days treatment.
Maltese: Fil-provi kliniċi, il-pilloli ġew studjati għal kura ta' mhux aktar minn 14-il jum.
English: Moxifloxacin should therefore be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) for the treatment of mild to moderate PID, unless moxifloxacin-resistant N. gonorrhoeae can be excluded.
Maltese: Għaldaqstant, Moxifloxacin għandu jingħata f'kombinazzjoni ma' sustanza anti batterjali xierqa oħra (eż. cephalosporin) għall-kura ta' PID ħafifa għal moderata, sakemm N. gonorrhoeae reżistenti għal moxifloxacin tkun tista' tiġi eskluża.
English: The main unresolved areas of concern identified by Belgium were in terms of efficacy the emergence of moxifloxacin-resistant strains of N. gonorrhoeae and the feasibility of the treatment in the proposed indication in clinical practice.
Maltese: L-oqsma ta' tħassib ewlenin mhux riżolti identifikati mill-Belġju kienu, f'termini ta' effikaċja, il-feġġa ta' razez reżistenti għal moxifloxacin ta' N. gonorrhoeae u l-fattibbiltà tal-kura fl-indikazzjoni proposta fil-prattika klinika.
English: In view of the data provided on efficacy and safety, the benefit/risk of the proposed extended indication “mild to moderate pelvic inflammatory disease” was therefore considered to be positive by the CHMP as the initially proposed wording was adequately revised to reflect the current knowledge.
Maltese: Minħabba d-dejta pprovduta dwar l-effikaċja u s-sigurtà, il-benefiċċju/riskju tal-indikazzjoni estiża proposta “mard infjammatorju ħafif għal moderat tal-pelvi” għaldaqstant tqies bħala wieħed pożittiv mis-CHMP minħabba li l-formolazzjoni proposta inizjalment ġiet riveduta adegwatament sabiex tirrifletti l-għarfien attwali.
English: Pack size
Maltese: Il-pakkett taddaqsijiet
English: MA (EU) Number
Maltese: (PVC/PVDC/ALU)
English: Giovanni Ogna E Figli S.p.A. Viale Zara 23
Maltese: Giovanni Ogna E Figli S.p.A.
English: Lithuania
Maltese: Italy
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the member states
Maltese: rotta ta' amministrazzjoni, detenturi tal-awtorizzazzjoni tal kummerċjalizzazzjoni fl-istati membri
English: EMA/803932/2014 EMEA/H/C/001146
Maltese: EMEA/H/C/001146
English: The full EPAR for Telmisartan Teva 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: It is available as tablets (20, 40 and 80 mg).
Maltese: Jiġi f'għamla ta' pilloli (20 mg, 40 mg u 80 mg).
English: Telmisartan Teva is a ‘generic medicine'.
Maltese: Telmisartan Teva huwa “mediċina ġenerika”.
English: Telmisartan Teva is a medicine that contains the active substance telmisartan.
Maltese: Telmisartan Teva huwa mediċina li fiha s-sustanza attiva telmisartan.
English: This is a summary of the European public assessment report (EPAR) for Telmisartan Teva.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Telmisartan Teva.
English: The CHMP concluded that, in accordance with EU requirements, Telmisartan Teva has been shown to have comparable quality and to be bioequivalent to Micardis.
Maltese: Is-CHMP ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Telmisartan Teva għandu kwalità komparabbli u li huwa bijoekwivalenti għal Micardis.
English: The European Commission granted a marketing authorisation valid throughout the EU for Telmisartan Teva on 26 January 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Telmisartan Teva fis-26 ta' Jannar 2010.
English: For the treatment of essential hypertension, the recommended dose of Telmisartan Teva is 40 mg once a day, but some patients may benefit from using a 20 mg dose.
Maltese: Għall-kura ta' ipertensjoni essenzjali, id-doża rrakkomandata tas-soltu ta' Telmisartan Teva hija 40 mg darba kuljum, iżda xi pazjenti jistgħu jibbenefikaw mill-użu tad-doża ta' 20 mg.
English: For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day.
Maltese: Għall-prevenzjoni ta' problemi kardjovaskulari, id-doża rakkomandata hija 80 mg darba kuljum.
English: This means that Telmisartan Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis.
Maltese: Dan ifisser li Telmisartan Teva huwa simili għall“mediċina ta' referenza” diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Micardis.
English: The active substance in Telmisartan Teva, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Telmisartan Teva, it-telmisartan, hija tip ta' ‘antagonist tar-riċetturi tal-anġjotensina
English: Because Telmisartan Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis.
Maltese: Billi Telmisartan Teva huwa mediċina ġenerika, l-istudji fin-nies ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza Micardis.
English: What is Telmisartan Teva?
Maltese: Kif jintuża Telmisartan Teva?
English: It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.
Maltese: Dan jippermetti wkoll lil qalb tippompja d-demm b'mod aktar faċli, li jista' jgħin inaqqas ir-riskju ta' problemi kardjovaskolari futuri.
English: reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Maltese: tad-demm mixtieqa ma tintlaħaqx, id-doża tista' tiżdied għal 80 mg, jew inkella tista' tiżdied mediċina oħra għall-ipertensjoni, bħal idroklorotiażid.
English: Because Telmisartan Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Billi Telmisartan Teva huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, tqies li lbenefiċċji u r-riskji huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Why has Telmisartan Teva been approved?
Maltese: Għaliex ġie approvat Telmisartan Teva?
English: What are the benefits and risks of Telmisartan Teva?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Telmisartan Teva?
English: Telmisartan Teva is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Maltese: Telmisartan Teva jintuża wkoll għall-prevenzjoni ta' problemi kardjovaskulari (problemi tal-qalb u talvażijiet) bħal attakki tal-qalb jew puplesiji.
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: II huwa vażokostrittur qawwi (sustanza li ddejjaq l-arterji u l-vini).