FrancophonIA/ELRC3.0 huggingface dataset:
English: While the safety of sarolaner has not been evaluated in breeding, pregnant or lactating cats, laboratory studies with sarolaner in rats and rabbits have not produced any evidence of teratogenic effects.
Maltese: Filwaqt li s-sigurtà ta sarolaner ma ġietx evalwata fi qtates tat-tagħmir, qtates tqal jew li qed irreddgħu, studji fil-laboratorju b'sarolaner fil-ġrieden u filfniek ma taw l-ebda evidenza ta' ħsara fuq il-fetu.
English: EMA/3075/2014 EMEA/H/C/002717
Maltese: EMEA/H/C/002717
English: The full EPAR for Brintellix 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: Brintellix can only be obtained with a prescription and is available as tablets (5, 10, 15 and 20 mg) and oral drops (20 mg/ml).
Maltese: Brintellix jista' jinkiseb biss b'riċetta ta' tabib u huwa disponibbli bħala pilloli (5, 10, 15 u 20 mg) u qtar orali (20 mg/ml).
English: This summary was last updated in 01-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 01-2014.
English: The active substance in Brintellix, vortioxetine, is an antidepressant.
Maltese: Is-sustanza attiva fi Brintellix, il-vortioxetine, hija antidepressant.
English: This is a summary of the European public assessment report (EPAR) for Brintellix.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Brintellix.
English: Brintellix is an antidepressant medicine containing the active substance vortioxetine.
Maltese: Brintellix huwa mediċina antidepressanti li fiha s-sustanza attiva vortioxetine.
English: Other information about Brintellix
Maltese: Informazzjoni oħra dwar Brintellix
English: Serotonin is a neurotransmitter, a chemical that transmits signals between nerve cells.
Maltese: Serotonin huwa newrotrasmettitur, kimika li tittrasmetti sinjali bejn iċ-ċelloli tan-nervituri.
English: A 24-week study comparing the effect of Brintellix with placebo in preventing relapses of depression found that the proportion of patients given Brintellix who relapsed during the study was 13%, compared with 26% in the placebo group.
Maltese: Studju ta' 24-ġimgħa li qabbel l-effett ta' Brintellix malplaċebo fil-prevenzjoni ta' rikaduti ta' depressjoni sab li l-proporzjon ta' pazjenti li ngħataw Brintellix li kellhom rikaduta matul l-istudju kien ta' 13%, meta mqabbla ma' 26% fil-grupp tal-plaċebo.
English: Why is Brintellix approved?
Maltese: Għaliex ġie approvat Brintellix?
English: It is used to treat major depression in adults.
Maltese: Jintuża għall-kura ta' depressjoni maġġuri fl-adulti.
English: Brintellix must be used with care and sometimes in adjusted doses in patients taking certain other medicines; it must not be used in patients also taking medicines known as nonselective monoamine oxidase inhibitors (MAOIs) or selective monoamine oxidase A (MAO-A) inhibitors.
Maltese: Brintellix għandu jintuża b'kawtela u xi kultant f'dożi aġġustati f'pazjenti li jkunu qed jieħdu ċerti mediċini oħra; m'għandux jintuża fuq pazjenti li jkunu qed jieħdu wkoll mediċini magħrufa bħala inibituri mhux selettivi ta' monoamine oxidase (MAOIs) jew inibituri selettivi ta' monoamine oxidase A (MAO-A).
English: Studies have shown a clinically relevant improvement in major depressive episodes, and the types of side effects seen were similar to those with other antidepressants that act through serotonin.
Maltese: L-istudji wrew titjib klinikament rilevanti f'episodji depressivi maġġuri, u t-tipi ta' effetti sekondarji li dehru kienu simili għal dawk b'antidepressanti oħra li jaġixxu permezz ta' serotonin.
English: Symptoms often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, a feeling of being slowed down, feelings of anxiety and changes in weight.
Maltese: Sintomi ta' spiss jinkludu dwejjaq kbar, tħossok li ma tiswa għal xejn, telf ta' interess fl-attivitajiet favoriti, disturbi fl-irqad, tħossok li battejt, sentimenti ta' anzjetà u tibdil fil-piż.
English: Patients 65 years of age and over should be started on a lower dose of 5 mg daily.
Maltese: Pazjenti li għadhom aktar minn 65 sena għandhom jinbdew fuq doża aktar baxxa ta' 5 mg kuljum.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Brintellix on 18 December 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Brintellix fit-18 ta' Diċembru 2013.
English: Brintellix has been studied in 12 main short-term studies involving more than 6,700 patients with major depression (including one study in patients aged 65 and over), in which it was compared with placebo (a dummy treatment) for 6 or 8 weeks.
Maltese: Brintellix ġie studjat fi 12-il studju ewlieni fuq perjodu qasir li fihom ħadu sehem aktar minn 6,700 pazjent b'depressjoni maġġuri (fosthom studju wieħed fuq pazjenti li kellhom aktar minn 65 sena), li fih tqabbel ma' plaċebo (kura finta) għal 6 jew 8 ġimgħat.
English: What are the risks associated with Brintellix?
Maltese: X'inhuma r-riskji assoċjati ma' Brintellix?
English: The usual dose is 10 mg once a day.
Maltese: Id-doża tas-soltu hija ta' 10 mg darba kuljum.
English: The main measure of effectiveness in each study was the change in a standard score for symptoms of depression; the studies showed that doses of Brintellix ranging from 5 to 20 mg were generally more effective than placebo in improving depression and resulted in a clinically relevant decrease of the depression scores.
Maltese: Il-kejl ewlieni tal-effikaċja f'kull studju kien il-bidla f'punteġġ standard għal sintomi ta' depressjoni; l-istudji wrew li dożi ta' Brintellix li varjaw minn 5 sa 20 mg kienu ġeneralment aktar effettivi minn plaċebo fit-titjib tad-depressjoni u wasslu għal tnaqqis klinikament rilevanti tal-punteġġi tad-depressjoni.
English: In a 12-week comparison of Brintellix with another antidepressant, agomelatine, Brintellix was more effective than agomelatine in improving the symptom score.
Maltese: Fi tqabbil ta' 12-il ġimgħa ta' Brintellix ma' antidepressant ieħor, agomelatine, Brintellix kien aktar effettiv minn agomelatine fit-titjib tal-punteġġ tas-sintomi.
English: A risk management plan has been developed to ensure that Brintellix is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Brintellix jintuża bl-aktar mod sigur possibbli.
English: Side effects were usually mild or moderate, short-lasting and occurred in the first two weeks of treatment.
Maltese: L-effetti sekondarji kienu ġeneralment ħfief jew moderati, temporanji u seħħew flewwel ġimagħtejn ta' kura.
English: Although there was limited information about the use of doses above 10 mg daily in the elderly this was addressed in the product information.
Maltese: Għalkemm l-informazzjoni dwar l-użu ta' dożi ogħla minn 10 mg kuljum fl-anzjani kienet limitata din kienet indirizzata fl-informazzjoni dwar ilprodott.
English: For the full list of all side effects and restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha, ara l-fuljett ta' tagħrif.
English: In addition, vortioxetine blocks the action of the serotonin transporter, which is responsible for clearing serotonin from its sites of activity in the brain, thus increasing the activity of serotonin.
Maltese: Barra minn hekk, il-vortioxetine timblokka l-azzjoni tat-trasportatur ta' serotonin, li huwa responsabbli mit-tneħħija ta' serotonin mis-siti ta' attività tiegħu fil-moħħ, u b'hekk iżid l-attività ta' serotonin.
English: What measures are being taken to ensure the safe and effective use of Brintellix?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Brintellix?
English: Major depression is a condition in which patients have mood disturbances that interfere with their everyday life.
Maltese: Depressjoni maġġuri hija kundizzjoni li fiha l-pazjenti jkollhom disturbi fil-burdati li jinterferixxu mal-ħajja tagħhom ta' kuljum.
English: Because serotonin is involved in the control of mood, and can regulate the actions of other neurotransmitters that may be involved in depression and anxiety, these actions of vortioxetine are thought to result in its effect in improving depression.
Maltese: Minħabba li serotonin huwa involut fil-kontroll tal-burdati, u jista' jirregola l-azzjonijiet ta' xi newrotrasmettituri li jistgħu jkunu involuti fid-depressjoni u l-anzjetà, dawn l-azzjonijiet ta' vortioxetine huma maħsuba li jwasslu għall-effett fit-titjib tad-depressjoni.
English: It is not intended to provide practical advice on how to use Brintellix.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Brintellix.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Brintellix's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Brintellix huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: It acts on different receptors for serotonin in the brain, blocking the action of some receptors and having some stimulant action on others.
Maltese: Taġixxi fuq riċetturi differenti għal serotonin fil-moħħ, timblokka l-azzjoni ta' ċerti riċetturi u għandha xi azzjoni stimulanti fuq oħrajn.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu304186.
Maltese: Aktar informazzjoni dwar id-denominazzjoni orfni tista' tinstab hawn: ema.europa.eu/medicines/human/orphan-designations/eu304186.
English: Further information on Trecondi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/trecondi.
Maltese: ema.europa.eu/medicines/human/EPAR/trecondi.
English: Other information about Trecondi
Maltese: Informazzjoni oħra dwar Trecondi
English: The active substance in Trecondi, treosulfan, belongs to a group of medicines called alkylating agents.
Maltese: Is-sustanza attiva fi Trecondi, it-treosulfan, tappartjeni għal grupp ta' mediċini msejħin aġenti alkilanti.
English: The active substance in Trecondi is treosulfan.
Maltese: Is-sustanza attiva fi Trecondi hija treosulfan.
English: In one of the studies, involving 570 adults with acute myeloid leukaemia (a blood cancer) or myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced), 64% of patients given Trecondi (with fludarabine) had a successful transplant and were alive and disease-free after 2 years, compared with 51% of patients given busulfan (with fludarabine).
Maltese: F'wieħed mill-istudji, li kienu jinvolvu 570 adult b'lewkimja majelojde akuta (kanċer tad-demm) jew sindromi mjelodisplastiċi (kundizzjonijiet li fihom jiġu prodotti numri kbar ta' ċelloli tad-demm anormali), 64 % tal-pazjenti li ngħataw Trecondi (bi fludarabine) kellhom trapjant b'suċċess u kienu ħajjin u ħielsa minn mard wara sentejn, meta mqabbla ma' 51 % tal-pazjenti li ngħataw busulfan (bi fludarabine).
English: What are the risks associated with Trecondi?
Maltese: X'inhuma r-riskji assoċjati ma' Trecondi?
English: Haematopoietic stem cell transplantation is rare, and Trecondi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 February 2004.
Maltese: It-trapjant taċ-ċelloli staminali ematopojetiċi huwa rari, u Trecondi ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-23 ta' Frar 2004.
English: The most common side effects in adults and children with Trecondi (which may affect more than 1 in 10 people) are infections, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), vomiting, diarrhoea and abdominal pain (belly ache).
Maltese: L-effetti sekondarji l-aktar komuni fl-adulti u fit-tfal bi Trecondi (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma infezzjonijiet, nawżja (tħossok ma tiflaħx), stomatite (infjammazzjoni tal-kisja tal-ħalq), remettar, dijarea u wġigħ addominali (uġigħ ta' żaqq).
English: In an additional study in 70 children with blood cancers, 99% of children given Trecondi (with fludarabine) were alive 3 months after their transplant.
Maltese: Fi studju addizzjonali f'70 tifel u tifla bil-kanċers tad-demm, 99 % tat-tfal li ngħataw Trecondi (bi fludarabine) kienu ħajjin 3 xhur wara t-trapjant tagħhom.
English: Trecondi must not be used in patients with an active, uncontrolled infection, with severe heart, lung, liver or kidney problems, and in patients with Fanconi anaemia and other DNA repair disorders.
Maltese: Trecondi ma għandux jintuża f'pazjenti b'infezzjoni attiva u mhux ikkontrollata, bi problemi severi talqalb, tal-pulmun, tal-fwied jew tal-kliewi, u f'pazjenti b'anemija Fanconi u b'disturbi oħrajn fit-tiswija tad-DNA.
English: As for all medicines, data on the use of Trecondi are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Trecondi hija ssorveljata kontinwament.
English: Like busulfan, Trecondi is considered as a conditioning treatment of ‘reduced-intensity': this means that it is less toxic than standard conditioning treatments which are based on chemotherapy with or without radiation.
Maltese: Bħal busulfan, Trecondi jitqies bħala kura ta' kundizzjonament ta' ‘intensità mnaqqsa': dan ifisser li huwa inqas tossiku minn kuri ta' kundizzjonament standard li huma bbażati fuq kimoterapija b'radjazzjoni jew mingħajrha.
English: Fludarabine is given once a day for 5 days before transplantation.
Maltese: Fludarabine jingħata darba kuljum għal 5 ijiem qabel it-trapjant.
English: Side effects with Trecondi are manageable and comparable to those seen with busulfan.
Maltese: L-effetti sekondarji bi Trecondi huma maniġġabbli u komparabbli ma' dawk li dehru b'busulfan.
English: Tiredness, febrile neutropenia (low white blood cell counts with fever) and high blood levels of bilirubin (a breakdown product of red blood cells) are also seen in more than 1 in 10 adults, and rash also affects more than 1 in 10 children.
Maltese: Għeja, newtropenija febbrili (għadd baxx ta' ċelloli tad-demm bojod bid-deni) u livelli għoljin ta' bilirubina fid-demm (prodott ta' tkissir ta' ċelloli ħomor tad-demm) ukoll jidhru f'aktar minn 1 minn kull 10 adulti, u raxx jolqot ukoll aktar minn 1 minn kull 10 tifel u tifla.
English: How is Trecondi used?
Maltese: Trecondi?
English: There is also sufficient data to show that Trecondi is effective in adults (but not enough data are available in children) with non-cancerous blood disorders.
Maltese: Hemm ukoll biżżejjed data li turi li Trecondi huwa effettiv fl-adulti (iżda m'hemmx biżżejjed data disponibbli fit-tfal) b'disturbi tad-demm mhux kanċerużi.
English: Trecondi is used together with another medicine called fludarabine in adults and children from 1 month of age with blood cancers as well as in adults with other severe disorders requiring a bone marrow transplant.
Maltese: Trecondi jintuża flimkien ma' mediċina oħra msejħa fludarabine fl-adulti u fit-tfal mill-età ta' xahar 'il fuq b'kanċers tad-demm kif ukoll fl-adulti b'disturbi severi oħra li jeħtieġu trapjant tal-mudullun.
English: Trecondi is given as a two-hour infusion (drip) into a vein.
Maltese: Trecondi jingħata bħala infużjoni (dripp) ta' sagħtejn ġol-vina.
English: Trecondi is effective at preparing adults and children with blood cancers for haematopoietic stem cell transplantation.
Maltese: Trecondi huwa effettiv fil-preparazzjoni ta' adulti u tfal b'kanċers tad-demm għal trapjant ta' ċelloli staminali ematopojetiċi.
English: - The active substance is telmisartan.
Maltese: Is-sustanza attiva hi telmisartan.
English: • Baclofen (a muscle relaxant)
Maltese: • Baclofen (rilassant tal-muskoli)
English: Danmark Teva Denmark A/S Tlf: +45 44 98 55 11
Maltese: Teva Denmark A/S Tlf: +45 44 98 55 11
English: Teva Pharma Belgium N.V./S.A.
Maltese: Teva Pharma Belgium N.V./S.
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Maltese: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Ir-Renju Unit
English: • Pharmacovigilance system
Maltese: • Sistema ta' Farmakoviġilanza
English: Visual disturbance
Maltese: Disturbi tal-vista
English: България Тева Фармасютикълс България ЕООД
Maltese: Тева Фармасютикълс България ЕООД Teл:
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Maltese: Impediment doppju tas-sistema renin-angiotensin-aldosterone (RAAS)
English: Táncsics Mihály út 82 Hungary
Maltese: Táncsics Mihály út 82 L-Ungerija
English: Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC Code: C09CA07.
Maltese: Antagonisti ta' angiotensin II, Kodiċi ATC: C09CA07.
English: Bradycardia
Maltese: Bradikardija
English: Immune system disorders Rare:
Maltese: Disturbi fis-sistema immuni Rari:
English: Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Maltese: Telmisartan fil-biċċa l-kbira tiegħu jeħel mal-proteina fil-plażma (> 99.5 %), primarjament mal-albumina u alpha-1 acid glycoprotein.
English: Intravascular hypovolaemia
Maltese: Ipovolemija intravaskulari
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: (See section 5.3).
Maltese: 4.5 u 5.1).
English: Reduction of cardiovascular morbidity in adults with:
Maltese: Tnaqqis ta' morbożità kardjovaskulari f'adulti bi:
English: The adjusted DBP changes from baseline were -8.4 (1.5) mm Hg, -4.5 (1.6) mm Hg and -3.5 (2.1) mm Hg respectively.
Maltese: It-tibdiliet fid-DBP aġġustati mil-linja bażi kienu -8.4 (1.5) mm Hg, -4.5 (1.6) mm Hg and -3.5 (2.1) mm Hg rispettivament.
English: The incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups.
Maltese: L-inċidenza tar-riżultat aħħari primarju kienet simili fil gruppi ta' telmisartan (16.7%) u ramipril (16.5%).
English: Date of latest renewal: 19 December 2014
Maltese: Data tal-aħħar tiġdid: 19/12/2014
English: Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half-life of >20 hours.
Maltese: Eliminazzjoni Telmisartan hu kkaratterizzat minn farmakokinetiċi b'decay bi-esponenzjali, b'half-life tal-eliminazzjoni terminali ta' >20 siegħa.
English: Other possible side effects of telmisartan:
Maltese: Effetti sekondarji possibbli oħrajn ta' telmisartan:
English: Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem, The Netherlands
Maltese: Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem, L-Olanda
English: The mean absolute bioavailability for telmisartan is about 50 %.
Maltese: Il-medja tal-bijodisponibilità assoluta għal telmisartan hi ta' madwar 50%.
English: Or:
Maltese: NN:
English: Pharmachemie B.V. Swensweg 5, 2031 GA, Haarlem, The Netherlands
Maltese: Pharmachemie B.V. Swensweg 5, 2031 GA, Haarlem, L-Olanda
English: Pruritus, hyperhidrosis, rash
Maltese: Ħakk, iperidrosi, raxx
English: Anaphylactic reaction, hypersensitivity
Maltese: Reazzjoni anafilattika, sensittività eċċessiva
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' periklu għal telmisartan vs. ramipril kien ta' 1.01 (97.5% CI 0.93 - 1.10, p (non-inferjorità) = 0.
English: (TPW)
Maltese: (TPW) Tel.:
English: The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated patients, respectively.
Maltese: Ir-rata ta' mortalità mill-kawżi kollha kienet ta' 11.6% u 11.8% fost il-pazjenti kkurati b'telmisartan u ramipril rispettivament.
English: Eosinophilia, thrombocytopenia
Maltese: Eosinofilija, tromboċitopenija
English: 2031GA Haarlem The Netherlands
Maltese: 2031GA Haarlem L-Olanda
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 0.90 - 1.08), 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: Instab li telmisartan kien effettiv bl-istess mod bħal ramipril fir-riżultat aħħari sekondarju speċifikat minn qabel ta' mewt kardjovaskulari, infart mijokardijaku mhux fatali, u puplesija mhux fatali [0.99 (97.5% CI 0.90 - 1.08), p (non-inferjorità) = 0.0004], ir-riżultat aħħari primarju fl-istudju ta' referenza HOPE (The Heart Outcomes Prevention Evaluation Study), li kien investiga l-effett ta' ramipril vs. plaċebo.
English: Táncsics Mihály út 82 Hungary (Headquarters: 4042 Debrecen, Pallagi út 13)
Maltese: 4042 Debrecen, Pallagi út 13)
English: Cumulative urinary excretion is <1 % of dose.
Maltese: L-eliminazzjoni kumulattiva fl-awrina hi ta' < 1% tad-doża.
English: Teva Pharma, S.L.U Tél: +(34) 91 387 32 80
Maltese: L.U Tél: +(34) 91 387 32 80
English: Interstinal lung disease4
Maltese: Mard interstizjali tal-pulmun4
English: • Severe hepatic impairment
Maltese: • Indeboliment sever epatiku
English: • Second and third trimester of pregnancy (see sections 4.4 and 4.6)
Maltese: • It-tieni u t-tielet trimestru tat-tqala u t-treddigħ (ara sezzjonijiet 4.4 u 4.6)
English: The clinical relevance of this observation is not known.
Maltese: Ir-rilevanza klinika ta' din l-osservazzjoni mhux magħruf.
English: • Biliary obstructive disorders
Maltese: • Disturbi ostruttivi biljari
English: After adjustment for age group effects mean SBP changes from baseline (primary objective) were -14.5 (1.7) mm Hg in the telmisartan 2 mg/kg group, -9.7 (1.7) mm Hg in the telmisartan 1 mg/kg group, and -6.0 (2.4) in the placebo group.
Maltese: Wara aġġustament għall-effetti fi gruppi ta' età, it-tibdiliet tal-SBP medji mil-linja bażi (objettiv primarju) kienu -14.5 (1.7) mm Hg fil-grupp telmisartan 2 mg/kg, -9.7 (1.7) mm Hg fil-grupp telmisartan 1 mg/kg, u -6.0 (2.4) fil-grupp tal-plaċebo.
English: The usually effective dose is 40 mg once daily.
Maltese: Id-doża effettiva normalment hi ta' 40 mg darba kuljum.
English: Dyspnoea, cough
Maltese: Dispnea, sogħla
English: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Maltese: Ir-reazzjonijiet avversi ġew ikklassifikati skont kategoriji ta' frekwenza bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100, <1/10); mhux komuni (≥1/1,000, <1/100); rari (≥1/10,000, <1/1,000), rari ħafna (< 1/10,000).
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1
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 ntgħażlu b'mod każwali f'wieħed mit-tliet gruppi ta' kura li ġejjin: telmisartan 80 mg (n = 8542), ramipril 10 mg (n = 8576), jew it-taħlita ta' telmisartan 80 mg flimkien ma' ramipril 10 mg (n = 8502), u li kienu segwiti għal medja ta' żmien ta' osservazzjoni ta' 4.5 snin.
English: Renal impairment including acute renal failure
Maltese: Indeboliment renali li jinkludi insuffiċjenza renali akuta
English: - The other ingredients are microcrystalline cellulose (Avicel PH 102), sodium starch glycolate (Type
Maltese: • Is-sustanzi l-oħra huma microcrystalline cellulose (Avicel PH 102), sodium starch glycolate (Type
English: Telmisartan selectively binds the AT1 receptor.
Maltese: Telmisartan jeħel b'mod selettiv mar-riċettur AT1.
English: How to store Telmisartan Teva
Maltese: Tiħux Telmisartan Teva
English: Progressive scarring of lung tissue (interstitial lung disease).
Maltese: Ċikatriċi progressivi ta' tessut tal-pulmun (mard interstizjali tal-pulmun)