FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the individuals taking Truvada, 0.8% (13 out of 1,576) tested positive for HIV-1 infection over 1 year compared with 3.3% (52 out of 1,578) of those taking placebo.
Maltese: Mill-individwi li kienu qegħdin jieħdu Truvada, 0.8 % (13 minn 1,576) ittestjaw pożittiv għall-infezzjoni tal-HIV-1 fuq medda ta' sena meta mqabbel ma' 3.3 % (52 minn 1,578) ta' dawk li kienu qegħdin jieħdu l-plaċebo.
English: The effectiveness of Truvada in adolescents was supported by studies showing that emtricitabine or tenofovir disoproxil reduced viral load when given with other antivirals to HIV-infected patients aged from 12 to 18 years, as well as evidence that the active ingredients are distributed similarly in the bodies of adolescents to those of adults and so would be expected to act in the same way.
Maltese: L-effikaċja ta' Truvada fl-adolexxenti ġiet appoġġata minn studji li wrew li l-emtriċitabina jew ittenofovir disoprossil naqqsu t-tagħbija virali meta ngħataw ma' antivirali oħrajn lill-pazjenti infettati blHIV ta' bejn it-12 u t-18-il sena, kif ukoll evidenza li s-sustanzi attivi huma mqassmin b'mod simili fliġsma tal-adolexxenti għal dawk tal-adulti u għaldaqstant ikunu mistennija li jaġixxu bl-istess mod.
English: In the first study involving over 2,400 men who have sex with men, 3.9% (48 out of 1,224) individuals taking Truvada tested positive for HIV-1 infection compared with 6.8% (83 out of 1,217) individuals taking placebo.
Maltese: Fl-ewwel studju li involva aktar minn 2,400 raġel li jkollhom sess mal-irġiel, 3.9 % (48 minn 1,224) tal-individwi li kienu qegħdin jieħdu Truvada ttestjaw pożittiv għall-infezzoni tal-HIV-1 meta mqabbel ma' 6.8 % (83 minn 1,217) tal-individwi li kienu qegħdin jieħdu l-plaċebo.
English: Truvada is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Truvada jintuża flimkien ma' mill-inqas mediċina waħda tal-HIV oħra għall-kura ta' adulti infettati bilvirus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindrome tal-immunodefiċjenza akkwiżita (AIDS).
English: Truvada contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir.
Maltese: Truvada fih żewġ sustanzi attivi: l-emtriċitabina, li hija inibitur nukleosidiku tat-traskriptażi inversa; u t-tenofovir disoprossil, li hija ‘promediċina' ta' tenofovir.
English: The second study involved over 4,700 heterosexual couples, each with one partner who did not have HIV-1 infection and the other who had the infection.
Maltese: It-tieni studju involva aktar minn 4,700 koppja eterosesswali, kollha b'sieħeb wieħed li ma kellux infezzjoni tal-HIV-1 u l-ieħor li kellu l-infezzjoni.
English: The first study compared the combination of emtricitabine and tenofovir disoproxil with the combination of lamivudine and zidovudine (other antiviral medicines).
Maltese: L-ewwel studju qabbel il-kombinazzjoni tal-emtriċitabina u tat-tenofovir disoprossil mal-kombinazzjoni ta' lamivudina u żidovudina (mediċini antivirali oħra).
English: Two main studies have evaluated the addition of Truvada to standard preventative measures for preexposure prophylaxis.
Maltese: Żewġ studji ewlenin vvalutaw iż-żieda ta' Truvada mal-miżuri standard ta' prevenzjoni għall-profilassi ta' qabel l-esponiment.
English: Truvada was more effective than placebo for preventing HIV-1 infection.
Maltese: Truvada kien aktar effettiv mill-plaċebo filprevenzjoni tal-infezzjoni tal-HIV-1.
English: Of the patients taking the active substances of Truvada, 80% (194 out of 244) achieved and maintained viral load below 50 HIV1 copies/ml by 48 weeks, compared with 70% of the patients taking the comparator medicines (171 out of 243).
Maltese: HIV-1 kopja/ml sa 48 ġimgħa, meta mqabbla ma' 70 % tal-pazjenti li kienu qegħdin jieħdu mediċini komparaturi (171 minn 243).
English: As for all medicines, data on the use of Truvada is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Truvada hija ssorveljata kontinwament.
English: Both combinations were taken with efavirenz (another antiviral medicine) by patients with HIV-1 infection.
Maltese: Iż-żewġ kombinazzjonijiet ittieħdu ma' efavirenz (mediċina antivirali oħra) minn pazjenti b'infezzjoni tal-HIV-1.
English: For pre-exposure prophylaxis of HIV-1 infection, it is expected that Truvada in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.
Maltese: Għall-profilassi ta' qabel l-esponiment tal-infezzjoni tal-HIV-1, huwa mistenni li Truvada fid-demm iwaqqaf il-virus milli jimmultiplika u jinfirex mis-sit tal-infezzjoni f'każ li l-individwu jiġi espost għallvirus.
English: Truvada is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP).
Maltese: Truvada jintuża wkoll biex jgħin fil-prevenzjoni tal-infezzjoni HIV-1 trażmessa sesswalment fl-adulti u fl-adolexxenti li jinsabu f'riskju għoli li jiġu infettati (profilassi ta' qabel l-esponiment jew PrEP).
English: The company that markets Truvada will provide an information pack to doctors which covers the risk of reduced kidney function with Truvada in adults and children, and information about use in adults for pre-exposure prophylaxis.
Maltese: Il-kumpanija li tqiegħed Truvada fis-suq ser tipprovdi pakkett ta' informazzjoni lit-tobba li jkopri rriskju tal-funzjoni mnaqqsa tal-kliewi bi Truvada fl-adulti u fit-tfal, u informazzjoni dwar l-użu fl-adulti għall-profilassi ta' qabel l-esponiment.
English: Two main studies have examined the effects of Truvada's active substances, emtricitabine and tenofovir disoproxil, in adults infected with HIV-1 who had not been treated before.
Maltese: Żewġ studji ewlenin eżaminaw l-effetti tas-sustanzi attivi ta' Truvada, l-emtriċitabina u t-tenofovir disoprossil, f'adulti infettati bl-HIV-1 li ma kinux ġew ikkurati qabel.
English: How does Truvada work?
Maltese: Kif jintuża Truvada?
English: Truvada's active substances, taken in combination with other antiviral medicines, reduced viral load in the majority of patients and were more effective than the comparator medicines.
Maltese: Is-sustanzi attivi ta' Truvada, meħudin flimkien ma' mediċini antivirali oħra, naqqsu t-tagħbija virali fil-maġġoranza tal-pazjenti u kienu aktar effettivi mill-mediċini komparaturi.
English: Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Maltese: Kemm l-emtriċitabina kif ukoll it-tenofovir jaħdmu b'mod simili billi jimblokkaw l-attività tat-traskriptażi inversa, enzima prodotta mill-HIV li tippermettilha tinfetta ċ-ċelloli u tagħmel aktar virusis.
English: In both studies Truvada was compared with placebo (a dummy treatment) in adults at high risk of sexually transmitted HIV-1 infection.
Maltese: Fiż-żewġ studji Truvada tqabbel mal-plaċebo (kura finta) fl-adulti li jinsabu f'riskju għoli ta' infezzjoni tal-HIV-1 trażmessa sesswalment.
English: Both active substances have been authorised in the European Union (EU) since the early 2000s: emtricitabine was authorised as Emtriva in 2003, and tenofovir disoproxil was authorised as Viread in
Maltese: Iż-żewġ sustanzi attivi ilhom awtorizzati fl-Unjoni Ewropea (UE) mill-bidu tal-2000: l-emtriċitabina ġiet awtorizzata bħala Emtriva fl-2003, u t-tenofovir disoprossil ġiet awtorizzata bħala Viread fl-2002.
English: For the treatment of HIV-1 infection, Truvada, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Għall-kura b'infezzjoni tal-HIV-1, Truvada, meħud ma' mill-inqas mediċina waħda tal-HIV oħra, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: What measures are being taken to ensure the safe and effective use of Truvada?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Truvada?
English: The most common side effects in adults treated with Truvada are diarrhoea and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni fl-adulti kkurati b'Truvada huma dijarea u nawsja (tħossok ma tiflaħx).
English: Truvada does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Truvada ma jfejjaqx l-infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara lis-sistema immuni u l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: Around two-thirds of the patients achieved and maintained viral load below 50 copies/ml after 48 weeks.
Maltese: Madwar żewġ terzi tal-pazjenti laħqu u żammew tagħbija virali taħt 50 kopja/ml wara 48 ġimgħa.
English: Healthcare professionals will also receive a brochure and reminder card to hand out to individuals receiving Truvada for pre-exposure prophylaxis.
Maltese: Il-professjonisti fil-qasam tal-kura tas-saħħa ser jirċievu wkoll fuljett u karta ta' tfakkira biex jagħtu lill-individwi li jkunu qegħdin jirċievu Truvada għall-profilassi ta' qabel l-esponiment.
English: Danmark KRKA Sverige AB
Maltese: KRKA Sverige AB
English: Równoległa 5, 02-235 Warszawa, Poland
Maltese: Równoległa 5, 02-235 Warszawa, Il-Polonja
English: Corticosteroids (systemic route)
Maltese: Kortikosterojdi (rotta sistemika)
English: BLISTER/OPA/Al/PVC Al
Maltese: FOLJA TAL-OPA/Al/PVC Al
English: KRKA-POLSKA Sp. z o.o.
Maltese: KRKA-POLSKA Sp. z o.o. ul.
English: CARTON/BOX
Maltese: KARTUNA/KAXXA
English: 14 tablets 28 tablets 30 tablets 56 tablets 84 tablets 90 tablets 98 tablets 100 tablets
Maltese: 14-il pillola 28 pillola 30 pillola 56 pillola 84 pillola 90 pillola 98 pillola 100 pillola
English: Possible side effects of Tolura:
Maltese: Effetti sekondarji possibbli ta' Tolura:
English: Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC code: C09CA07.
Maltese: Antagonisti ta' Angiotensin II komuni, Kodiċi ATC: C09CA07.
English: Busuttil Ltd.
Maltese: E.J. Busuttil Ltd.
English: <2D barcode carrying the unique identifier included.>
Maltese: <barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: Tablet.
Maltese: Pillola
English: What Tolura contains - The active substance is telmisartan.
Maltese: X'fih Tolura - Is-sustanza attiva hi telmisartan.
English: Gastrointestinal disorders Uncommon:
Maltese: Disturbi gastrointestinali:
English: Immune system disorders Rare:
Maltese: Disturbi tas-sistema immuni Rari
English: Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half-life of >20 hours.
Maltese: Telmisartan hu kkaratterizzat minn farmakokinetiċi b'dekompożizzjoni bi-esponenzjali, b'half-life tal-eliminazzjoni terminali ta' >20 siegħa.
English: sorbitol (E420) and magnesium stearate.
Maltese: (E420) u magnesium stearate.
English: OPA/Al/PVC Al blister.
Maltese: Folja ta' OPA/Al/PVC Al.
English: The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated patients, respectively.
Maltese: Ir-rata ta' mortalità millkawżi kollha kienet ta' 11.6% u 11.8% fost il-pazjenti kkurati b'telmisartan u ramipril rispettivament.
English: The incidence of the primary endpoint was similar in the telmisartan (16.7 %)and ramipril (16.5 %) groups.
Maltese: L-inċidenza ta' punt aħħari primarju kienet simili fil-gruppi ta' telmisartan (16.7 %) u ramipril (16.5 %).
English: Diuretics (thiazide or loop diuretics)
Maltese: Dijuretiċi (thiazide jew dijuretiċi loop)
English: Date of first authorisation: 4 June 2010 Date of latest renewal: 19 March 2015
Maltese: Data tal-aħħar tiġdid: 19 Mar 2015
English: Adverse reactions have been ranked under headings of frequency using the following convention: 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: Ir-reazzjonijiet avversi ġew ikklassifikati skont kategoriji ta' frekwenza bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000), rari ħafna (< 1/10,000).
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia KRKA-POLSKA Sp. z o.o., ul.
Maltese: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja KRKA-POLSKA Sp. z o.o., ul.
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %.
Maltese: Studji farmakokinetiċi f'pazjenti b'indeboliment epatiku juru żieda fil-bijodisponibilità assoluta sa kważi 100 %.
English: Cumulative urinary excretion is <1 % of dose.
Maltese: L-eliminazzjoni kumulattiva fl-awrina hi ta' <1 % taddoża.
English: The mean absolute bioavailability for telmisartan is about 50 %.
Maltese: Il-medja tal-bijodisponibilità assoluta għal telmisartan hi ta' madwar 50 %.
English: - The other ingredients are povidone, meglumine, sodium hydroxide, lactose monohydrate,
Maltese: - Is-sustanzi l-oħra huma povidone, meglumine, sodium hydroxide, lactose monohydrate, sorbitol
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy
Maltese: Stenosi tal-valv mitrali u aortiku, kardjomijopatija ipertropika ostruttiva
English: Patients were randomized to one of the three following treatment groups: telmisartan 80 mg (n = 8542), ramipril 10 mg (n = 8576), or the combination of telmisartan 80 mg plus ramipril 10 mg (n = 8502), and followed for a mean observation time of 4.5 years.
Maltese: Il-pazjenti ġew magħżula b'mod każwali għal wieħed mit-tliet gruppi ta' kura li ġejjin: telmisartan 80 mg (n = 8576), ramipril 10 mg (n = 8576), jew il-kombinazzjoni ta' telmisartan 80 mg flimkien ma' ramipril 10 mg (n = 8502) u segwit għal ħin medja ta' osservazzjoni ta' 4.5 snin.
English: Other medicines and Tolura
Maltese: Mediċini oħra u Tolura
English: The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years).
Maltese: - Dijabete mellitus, indeboliment renali, età (> 70 sena).
English: 1, 2, 3, 4: for further descriptions, please see sub-section “Description of selected adverse reactions”
Maltese: 1,2,3,4: għal deskrizzjonijiet addizzjonali, jekk jogħġbok ara sottosezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula”
English: Renal impairment including acute renal failure
Maltese: Indeboliment tal-kliewi li jinkludi falliment renali akut
English: There was no evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95 % CI 0.85 - 1.24).
Maltese: Ma kienx hemm evidenza dwar is0siwi għal mortalità kardjovaskulari (proporzjon ta' ħsara 1.03, 95 % CI 0.85 - 1.24).
English: The adjusted DBP changes from baseline were -8.4 (1.5) mmHg, -4.5 (1.6) mmHg and -3.5 (2.1) mmHg respectively.
Maltese: (1.5) mmHg,4.5 (1.6) mmHg u -3.5 (2.1) mmHg rispettivament.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Second and third trimester of pregnancy (see sections 4.4 and 4.6) - Biliary obstructive disorders - Severe hepatic impairment
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 - It-tieni u t-tielet trimestru tat-tqala u t-treddigħ (ara sezzjonijiet 4.4 u 4.6) - Disturbi ostruttivi biljari - Indeboliment sever epatiku
English: The antihypertensive efficacy of telmisartan is comparable to that of agents representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril).
Maltese: L-effikaċja anti-ipertensiva ta' telmisartan hi komparabbli ma' dik ta' mediċini li jirrappreżentaw kategoriji oħrajn ta' mediċini anti-ipertensivi (dan intwera fi provi kliniċi li qabblu telmisartan ma' amlodipine, atenolol, enalapril, hydrochlorothiazide, u lisinopril).
English: Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Maltese: Żewġ provi kbar, ikkontrollati, li fihom il-parteċipanti ntgħażlu b'mod każwali (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) u VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) eżaminaw l-użu tal-kombinazzjoni ta' inibitur ta' ACE flimkien ma' imblokkatur tar-riċetturi ta' angiotensin II.
English: Manufacturers
Maltese: MANIFATTURI
English: Telmisartan selectively binds the AT1receptor.
Maltese: Telmisartan jeħel b'mod selettiv mar-riċettur AT1.
English: See also information under the heading “Do not take Tolura”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Tolura”.
English: Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5 % CI 0.901.08), p (non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
Maltese: Telmisartan instab li hu effettiv daqs ramipiril fil-punt aħħari ta' referenza sekondarju sspeċifikat minn qabel dwar mewt kardjovaskulari, infart mijokardjali mhux fatali, u puplesija mhux fatali [0.99 (97.5 % CI 0.90 - 1.08), p (mhux ta' inferjorità) = 0.0004], l-ewwel punt ta' riferiment fl-istudju ta' referenza HOPE (The Heart Outcomes Prevention Evaluation Study - L-Istudju ta' Evalwazzjoni ta' Prevenzjoni mir-Riżultati tal-Qalb), li stħarreġ l-effett ta' ramipril kontra l-plaċebo.
English: In the “Prevention Regimen For Effectively avoiding Second Strokes” (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0,70 % vs. 0,49 % RR 1,43 (95 % confidence interval 1,002,06) the incidence of fatal sepsis cases was increased for patients taking telmisartan (0,33 %) vs. patients taking placebo (0,16 %) RR 2,07 (95 % confidence interval 1,14 - 3,76).
Maltese: Fil-prova “Reġimen ta' prevenzjoni sabiex jiġu evitati attakki pupletiċi secondarji” magħrufa bħala (PRoFESS), li saret fuq pazjenti li għandhom 50 sena jew aktar, li riċentement kellhom attakk pupletiku, ġie nnotat li kien hemm inċidenza ogħla ta' sepsis għal telmisartan meta mqabbel malplaċebo, 0.70 % kontra 0.49 % [RR 1.43 (95 % interval ta' kunfidenza 1.00 - 2.06)]: l-inċidenza ta' każijiet fatali ta' sepsis żdiedet għal pazjenti li kienu qed jieħdu telmisartan (0.33 %) kontra pazjenti li kienu qed jieħdu l-plaċebo (0.16 %) [RR 2.07 (95 % intervall ta' kunfidenza 1.14 - 3.76)].
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list)) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini..
English: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Maltese: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial - Prova Għadejja ta' Telimisartan waħedha bil-punt ta' riferiment aħħari globali ta' Ramipril) qabbel l-effetti ta' telmisartan, ramipril u l-kombinazzjoni ta' telmisartan u ramipril fuq riżultati kardjovaskulari f'25620 pazjent li għandhom 55 sena jew aktar bi storja ta' mard fl-arterji koronarji, puplesija, TIA mard arterjali periferali jew dijabete melittus ta' tip 2 akkumpanjat b'evidenza ta' ħsara ta' tmiem tal-organu (eż. retinopatija, ipertrofija ventrkulari tax-xellug, makro jew mikroalbuminurja) li hi popolazzjoni li tinsab f'riskju ta' każijiet kardjovaskulari.
English: Therefore it is not expected to potentiate bradykininmediated adverse effects.
Maltese: Għalhekk mhux mistenni li ssaħħaħ l-effetti avversi medjati minn bradykinin.
English: Tolura tablets contain sorbitol (E420).
Maltese: Il-pilloli ta' Tolura fihom sorbitol (E420).
English: Muscoloskeletal and connective tissue disorders Uncommon:
Maltese: Disturbi muskolu-skeletriċi u tat-tessut konnettiv:
English: Anaemia Eosinophilia, thrombocytopenia
Maltese: Eosinofilija, tromboċitopenija
English: Contains lactose monohydrate and sorbitol (E420).
Maltese: Fih lactose monohydrate u sorbitol (E420).
English: Infections and infestations Uncommon:
Maltese: Infezzjonijiet u infestazzjonijiet:
English: Excipients with known effect: Each tablet contains 299.7 mg sorbitol (E420) and 114 mg lactose.
Maltese: Kull pillola fiha 299.7 mg sorbitol (E420) u 114 mg lactose.
English: The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5 % CI 0.93 - 1.10, p (non-inferiority) = 0.0019 at a margin of 1.13).
Maltese: Il-proporzjon ta' ħsara għal telmisartan kontra ramipril kien ta' (97.5 % CI 0.93 - 1.10, p (mhux ta' inferjorità) = 0.
English: The concomitant use of Tolura with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Maltese: L-użu fl-istess ħin ta' Tolura ma' prodotti li jkun fihom aliskiren hu kontraindikat f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (GFR < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).
English: After adjustment for age group effects mean SBP changes from baseline (primary objective) were -14.5 (1.7) mmHg in the telmisartan 2 mg/kg group, -9.7 (1.7) mmHg in the telmisartan 1 mg/kg group, and -6.0 (2.4) in the placebo group.
Maltese: Wara aġġustament għalleffetti tal-grupp ta' età, il-medja ta' tibdil tal-SBP mil-linja bażi (oġġettiv primarju) kienet ta'14.5 (1.7) mmHg fil-grupp ta' telmisartan 2 mg/kg, -9.7 (1.7) mmHg fil-grupp ta' telmisartan 1 mg/kg, u -6.0
English: Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli attwalment hi deskritta fis-sezzjonijiet 5.1 u 5.2 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: Tolura is available in blister packs containing 14, 28, 30, 56, 84, 90, 98 and 100 tablets.
Maltese: Tolura jiġi f'folji ta' 14, 28, 30, 56, 84, 90, 98 u 100 pillola.
English: Pack sizes: 14, 28, 30, 56, 84, 90, 98 and 100 tablets in a box.
Maltese: Daqsijiet ta' pakketti ta' 14, 28, 30, 56, 84, 90, 98 u 100, pillola ġo kaxxa.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Tolura.
Maltese: Pazjenti li għandhom problemi ereditarji ta' intolleranza għal galactose, id-defiċjenza ta' Lapp lactase jew nuqqas ta' assorbiment tajjeb ta' glucose-galactose m'għandhomx jieħdu Tolura.
English: Marketing Authorisation Holder KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja