FrancophonIA/ELRC3.0 huggingface dataset:
English: Bosulif is a cancer medicine that is used to treat chronic myeloid leukaemia (CML), a cancer of the white blood cells, in adults with a special chromosome in their cells called the Philadelphia chromosome.
Maltese: Bosulif huwa mediċina kontra l-kanċer li tintuża għall-kura tal-lewkimja majelojde kronika (CML), kanċer taċ-ċelloli bojod tad-demm, f'adulti bi kromożoma speċjali fiċ-ċelloli tagħhom imsejħa lkromożoma ta' Philadelphia.
English: Since Bosulif has been granted a conditional approval, the company that markets Bosulif will carry out and submit the results of a larger study with Bosulif in patients with Ph+ CML previously treated with one or more tyrosine kinase inhibitors and for whom dasatinib, imatinib and nilotinib are not considered appropriate treatment options.
Maltese: Minħabba li Bosulif ingħata approvazzjoni kkundizzjonata, il-kumpanija li tqiegħed Bosulif fis-suq ser twettaq u tippreżenta r-riżultati ta' studju akbar b'Bosulif fuq pazjenti b'Ph+ CML li jkunu ngħataw kura preċedenti b'inibitur wieħed jew iktar tat-tirożina kinażi u li għalihom dasatinib, imatinib u nilotinib mhumiex meqjusa bħala alternattivi xierqa ta' kura.
English: Bosulif treatment was effective in patients with an unmet medical need: 18 out of 36 patients with chronic phase CML had a ‘major cytogenetic response', while 7 out of the 16 patients with advanced (accelerated or blast phase) CML also had a sufficient response based on other measurements.
Maltese: Il-kura b'Bosulif kienet effettiva f'pazjenti bi ħtieġa medika mhux sodisfatta: 18 minn 36 pazjent b'CML fil-fażi kronika kellhom “rispons ċitoġenetiku maġġuri”, filwaqt li 7 mis-16-il pazjent b'CML avvanzata (fil-fażi aċċellerata jew blast) kellhom rispons suffiċjenti fuq il-bażi ta' kejl ieħor.
English: Of these, 52 patients were considered to have an unmet medical need, because disease resistance or the risk of severe side effects made other tyrosine kinase inhibitors unsuitable.
Maltese: Minn dawn, 52 pazjent tqiesu li kellhom ħtieġa medika mhux sodisfatta, minħabba li inibituri oħra tat-tirożina kinażi ma tqiesux bħala kura adatta għalihom minħabba r-reżistenza tal-marda jew irriskju ta' effetti sekondarji severi.
English: A second study in 536 newly diagnosed CML patients in the ‘chronic phase' compared Bosulif with imatinib.
Maltese: Studju ieħor fuq 536 pazjent li kienu għadhom kemm ġew dijanjostikati b'CML fil-”fażi kronika” qabbel lil Bosulif ma' imatinib.
English: Side effects reported with Bosulif are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Bosulif huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: As for all medicines, data on the use of Bosulif are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Bosulif hija ssorveljata kontinwament.
English: The main measure of effectiveness was the number of patients who had at least a ‘major cytogenetic response' (where the proportion of white blood cells with the Philadelphia chromosome fell below 35%) after six months of Bosulif treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien l-għadd ta' pazjenti li tal-inqas kellhom “rispons ċitoġenetiku maġġuri” (fejn il-proporzjon taċ-ċelloli bojod tad-demm bil-kromożoma ta' Philadelphia waqa' taħt il-35%) wara sitt xhur ta' kura b'Bosulif.
English: Studies have shown that Bosulif is effective at reducing the proportion of white blood cells with the Philadelphia chromosome.
Maltese: Studji wrew li Bosulif huwa effettiv fit-tnaqqis tal-proporzjon taċ-ċelloli bojod tad-demm bil-kromożoma ta' Philadelphia.
English: Why is Bosulif authorised in the EU?
Maltese: Għaliex Bosulif ġie awtorizzat fl-UE?
English: Ref. EMEA/522632/2008
Maltese: EMEA/605937/2008
English: London, 23 October 2008 Doc.
Maltese: Londra, 23 ta' Ottubru 2008 Dok. Ref.
English: International non-proprietary name (INN): lacosamide
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): lacosamide
English: Lacosamide Pain UCB Pharma contains the active substance lacosamide.
Maltese: Lacosamide Pain UCB Pharma fih is-sustanza attiva lacosamide.
English: Pain was measured by the patients on an 11-point scale.
Maltese: L-uġigħ tkejjel mill-pazjenti fuq skala bi 11-il punt.
English: The effectiveness of three doses of Lacosamide Pain UCB Pharma (200, 400 and 600 mg per day) was compared with that of placebo (a dummy treatment) in a total of 1,724 patients in four main studies.
Maltese: L-effikaċja tat-tliet dożi ta' Lacosamide Pain UCB Pharma (200, 400 u 600 mg kuljum) tqabblet ma dik tal-plaċebo (trattament finta) f'total ta' 1,724 pazjent f'erba' studji ewlenin.
English: What is Lacosamide Pain UCB Pharma?
Maltese: X'inhu Lacosamide Pain UCB Pharma?
English: Lacosamide Pain UCB Pharma was expected to be used in adults to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Maltese: Lacosamide Pain UCB Pharma kien mistenni li jintuża f'adulti biex jittratta l-uġigħ li jirriżulta minn newropatija periferali diabetika (ħsara fin-nervituri fl-estremitajiet li jistgħu jiġru f'pazjenti li jbatu mid-dijabete).
English: On 25 September 2008, UCB Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lacosamide Pain UCB Pharma, for the treatment of diabetic neuropathic pain in adults.
Maltese: Fil-25 ta' Settembru 2008, UCB Pharma S.A. uffiċjalment għarrfet lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Lacosamide Pain UCB Pharma, għat-trattament ta' l-uġigħ tan-newropatija diabetika fl-adulti.
English: Lacosamide has been authorised in the European Union (EU) as an anti-epileptic medicine under the trade name Vimpat since August 2008.
Maltese: Lacosamide ġie awtorizzat fl-Unjoni Ewropea (UE) bħala mediċina antiepilettika taħt l-isem kummerċjali Vimpat f'Awwissu 2008.
English: Questions and answers on the withdrawal of the marketing application for Lacosamide Pain UCB Pharma
Maltese: Mistoqsija u Tweġiba dwar l-irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Lacosamide Pain UCB Pharma
English: The application was at day 181 when the company withdrew.
Maltese: L-applikazzjoni kienet waslet f'jum 181 meta l-kumpanija rtiratha.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Lacosamide Pain UCB Pharma could not have been approved for the treatment of diabetic neuropathic pain in adults.
Maltese: Skond l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fi żmien lirtirar, is-CHMP kellu xi tħassib u kellu opinjoni proviżorja li Lacosamide Pain UCB Pharma ma setax jiġi approvat għat-trattament tal-uġigħ li jirriżulta minn newropatija dijabetika fl-adulti.
English: The effects of Lacosamide Pain UCB Pharma were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Lacosamide Pain UCB Pharma għall-ewwel ġew ittestjati fuq mudelli esperimentali qabel ma ġew studjati fil-bniedem.
English: What is happening with Vimpat used for the treatment of epilepsy?
Maltese: X'isir b'Vimpat li jintuża fit-trattament ta' l-epilessija?
English: How is Lacosamide Pain UCB Pharma expected to work?
Maltese: Kif kien mistenni li jaħdem Lacosamide Pain UCB Pharma?
English: The medicine can also cause side effects affecting the heart and central nervous system (such as dizziness), which are of concern in patients with diabetes.
Maltese: Il-mediċina tista' tikkawża wkoll effetti sekondarji li jaffettwaw il-qalb u s-sistema nervuża ċentrali (bħal sturdament), li huma ta' tħassib f'pazjenti bid-dijabete.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Maltese: CHMP jirrevedihom u jista', qabel ma jagħti opinjoni, jitlob għal xi mistoqsijiet oħra fil-jum 180.Wara l-opinjoni tas-CHMP, normalment il-Kummissjoni Ewropea ddum madwar xahrejn sakemm toħroġ l-awtorizzazzjoni.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Lacosamide Pain UCB Pharma.
Maltese: Il-kumpanija għarrfet lis-CHMP li ma kienx hemm konsegwenzi għall-pazjenti li jkunu għaddejjin minn provi kliniċi jew programmi ta' użu b'kumpassjoni b'Lacosamide Pain UCB Pharma.
English: The exact way in which lacosamide works is still unclear, but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Maltese: Għadu mhuwiex ċar il-mod eżatt kif jaħdem lacosamide iżda jidher li dan inaqqas l-attività tal-kanali tas-sodju (pori fil-wiċċ taċ-ċelloli tan-nervituri) li jippermettu li ssir it-trażmissjoni ta' impulsi elettriċi bejn iċ-ċelloli tan-nervituri.
English: Subcutaneous use pre-filled syringe 1.0 ml (150 mg/ml) 3 (3 x 1) pre-filled syringes (multipack)
Maltese: 1.0 ml (150 mg/ml) 3 (3 x 1) siringi għallest (multipack)
English: Subcutaneous use pre-filled pen 1.0 ml (150 mg/ml) 1 pre-filled pen
Maltese: 1.0 ml (150 mg/ml) 1 pinna mimlija għallest
English: Subcutaneous use pre-filled syringe 1.0 ml (150 mg/ml) 1 pre-filled syringe
Maltese: 1.0 ml (150 mg/ml) 1 siringa mimlija għal-lest
English: INOmax nitric oxide
Maltese: INOmax ossidu nitriku
English: The full EPAR for INOmax 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: The maximum starting dose of INOmax is 20 ppm for children up to 18 years of age, and 40 ppm for adults.
Maltese: Id-doża massima tal-bidu ta' INOmax hija ta' 20 ppm għat-tfal sa 18-il sena, u 40 ppm għall-adulti.
English: INOmax is a gas for inhalation that contains the active substance nitric oxide diluted in nitrogen gas at 400 or 800 parts per million (ppm).
Maltese: INOmax huwa gass għal inalazzjoni li fih is-sustanza attiva ossidu nitriku dilwita f'gass nitroġenu f'400 jew 800 parti kull miljun (ppm).
English: What is INOmax?
Maltese: INOmax?
English: This is a summary of the European public assessment report (EPAR) for INOmax.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal INOmax.
English: In children and adults undergoing heart surgery, treatment usually lasts for 24 to 48 hours.
Maltese: Fit-tfal u l-adulti li għaddejjin minn kirurġija tal-qalb, il-kura ġeneralment iddum għaddejja għal 24 sa 48 siegħa.
English: The most common side effect with INOmax (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), hypokalaemia (low blood potassium levels), hypotension (low blood pressure), atelectasis (collapse of the whole, or part of a, lung), and hyperbilirubinaemia (high blood levels of bilirubin).
Maltese: L-effetti sekondarji l-aktar komuni b'INOmax (li dehru f'aktar minn pazjent 1 minn kull 10) huma tromboċitopinja (għadd baxx ta' pjastrini), ipokalemija (livelli baxxi ta' potassju fid-demm), ipotensjoni (pressjoni tad-demm baxxa), atelektasi (kollass tal-pulmun sħiħ, jew parti minn pulmun) u iperbilirubinemija (livelli għoljin ta' bilirubin fid-demm).
English: The marketing authorisation holder is Linde Healthcare AB.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fus-suq huwa Linde Healthcare AB.
English: The European Commission granted a marketing authorisation valid throughout the European Union for INOmax on 1 August 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal INOmax valida fl-Unjoni Ewropea kollha fl-1 ta' Awwissu 2001.
English: What is the risk associated with INOmax?
Maltese: X'inhu r-riskju assoċjat ma' INOmax?
English: • newborn babies (born after 34 weeks of gestation) with breathing problems associated with pulmonary hypertension (high blood pressure in the lungs).
Maltese: • trabi tat-twelid (li jitwieldu wara 34 ġimgħa ta' ġestazzjoni) bi problemi bin-nifs assoċjati ma' pressjoni għolja pulmonari (pressjoni tad-demm għolja fil-pulmuni).
English: INOmax is used in patients who are undergoing artificial ventilation, once the ventilation is optimised.
Maltese: INOmax jintuża f'pazjenti li tkun qed issirilhom ventilazzjoni artifiċjali, ġa la darba l-ventilazzjoni tkun ottimizzata.
English: In the first main study, 52 (46%) of the 114 neonates receiving INOmax died or needed ECMO, compared with 77 (64%) of the 121 receiving placebo.
Maltese: INOmax mietu jew kellhom bżonn ECMO, meta mqabbla ma' 77 (64%) mill121 li kienu qed jirċievu plaċebo.
English: In the second main study, 30 (31%) of the neonates receiving INOmax needed ECMO, compared with 51 (57%) of the 89 receiving placebo.
Maltese: INOmax ħtieġu ECMO, meta mqabbla ma' 51 (57%) mid-89 li kienu qed jirċievu plaċebo.
English: Why has INOmax been approved?
Maltese: Għaliex ġie approvat INOmax?
English: INOmax has also been studied in 421 neonates from 34 weeks gestation with pulmonary hypertension in two main studies.
Maltese: INOmax ġie studjat ukoll f'421 tarbija tat-twelid minn ġestazzjoni ta' 34 ġimgħa bi pressjoni għolja pulmonari f'żewġ studji ewlenin.
English: In the second study, 186 neonates with respiratory failure received either INOmax or placebo.
Maltese: Fit-tieni studju, 186 tarbija tattwelid b'indeboliment respiratorju irċievew jew INOmax jew plaċebo.
English: The active substance in INOmax, nitric oxide, is a naturally-occurring chemical in the body, which causes the muscles in the lining of the blood vessels to relax.
Maltese: Is-sustanza attiva f'Inomax, ossidu nitriku, hija kimika li sseħħ b'mod naturali fil-ġisem, li tagħmel ilmuskoli tal-inforra tal-vini u tal-arterji sabiex jirrilassaw.
English: In the first study, 235 neonates with respiratory failure received either INOmax or placebo (a dummy treatment).
Maltese: Fl-ewwel studju, 235 tarbija tat-twelid b'indeboliment respiratorju irċievew jew INOmax jew plaċebo (kura finta).
English: INOmax is used in combination with artificial ventilation and other medicines to help improve blood oxygen levels in the following groups of patients:
Maltese: INOmax jintuża f'kombinazzjoni ma' ventilazzjoni artifiċjali u mediċini oħra sabiex jgħin biex itejjeb illivelli ta' ossiġnu fid-demm fil-gruppi ta' pazjenti li ġejjin:
English: How has INOmax been studied?
Maltese: Kif ġie studjat INOmax?
English: How does INOmax work?
Maltese: X'inhu INOmax?
English: Because nitric oxide is a well-known chemical, the company used data from the published literature to support INOmax's use in newborn babies with pulmonary hypertension, and in adults and children undergoing heart surgery.
Maltese: Minħabba li l-ossidu nitriku huwa kimika magħrufa sewwa, il-kumpanija użat dejta mil-letteratura ppubblikata biex issostni l-użu ta' INOmax fit-trabi tat-twelid bi pressjoni għolja pulmonari, u f'adulti u tfal li għaddejjin minn kirurġiji tal-qalb.
English: • patients of all ages who are undergoing or have undergone heart surgery and develop pulmonary hypertension.
Maltese: • pazjenti ta' kull età li jkunu għaddejjin minn jew li għaddew minn kirurġija tal-qalb u jiżviluppaw pressjoni għolja pulmonari.
English: Other information about INOmax
Maltese: Kif jintuża
English: In the two main studies in newborn babies with breathing problems, INOmax was more effective than placebo at reducing the need of ECMO.
Maltese: Fiż-żewġ studji prinċipali fuq trabi tat-twelid bi problemi tan-nifs INOmax kien aktar effettiv minn plaċebo fit-tnaqqis tal-bżonn ta' ECMO.
English: In the published literature, INOmax treatment was shown to reduce the blood pressure in the lungs and improve heart function when used during or after heart surgery.
Maltese: Fid-dokumentazzjoni ppubblikata, il-kura b'INOmax uriet li tnaqqas il-pressjoni tad-demm fil-pulmuni u ttejjeb il-funzjoni tal-qalb meta użata waqt jew wara l-kirurġija tal-qalb.
English: This should then be reduced to 5 ppm, provided the blood in the arteries contains enough oxygen.
Maltese: Din għandha mbagħad titnaqqas għal 5 ppm, dment li d-demm fl-arterji ikun fih biżżejjed ossiġnu.
English: INOmax is used in these babies to improve oxygen supply levels and to reduce the need for extracorporeal membrane oxygenation (ECMO, a technique to oxygenate the blood outside the body using a device similar to a heart-lung machine).
Maltese: INOmax jintuża f'dawn it-trabi biex itejjeb il-provvista tal-livelli tal-ossiġnu u biex inaqqas il-ħtieġa għal ossiġenazzjoni ta' membrana ekstrakorporali (ECMO, teknika biex tagħti l-ossiġnu lid-demm barra l-ġisem permezz tal-użu ta' tagħmir simili għal magna tal-qalb-pulmun).
English: INOmax should not be used in babies who may be hypersensitive (allergic) to nitric oxide or the other ingredient (nitrogen).
Maltese: INOmax m'għandux jintuża fi trabi li jistgħu jkunu ipersensittivi (alleġiċi) għall-ossidu nitriku jew għal xi sustanza oħra tiegħu (nitroġenu).
English: For the full list of all side effects reported with INOmax, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'INOmax, ara l-fuljett ta' tagħrif.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that INOmax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' INOmax huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: When inhaled, it causes the vessels in the lungs to dilate (widen); this allows blood to flow more easily in the lungs to supply oxygen to the rest of the body and remove carbon dioxide, reducing pulmonary hypertension.
Maltese: Meta jittieħed man-nifs, huwa jġiegħel il-vini fil-pulmuni sabiex jinfetħu; dan jippermetti d-demm li jgħaddi b'mod aktar faċli fil-pulmuni biex jissupplixxi l-ossiġnu għall-bqija tal-ġisem u jneħħi d-dijossidu tal-karbonju, u b'hekk inaqqas ilpressjoni għolja pulmonari.
English: Strength Pharmaceutical Form
Maltese: Numru tal-EU Isem Qawwa Għamla farmaċewtika
English: Package size
Maltese: Daqs tal-pakkett blister (PVC/PVDC/alu)
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Mhux magħruf: vaskulite lewkoċitoklastika Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda
English: (see section 5.3).
Maltese: (ara sezzjoni 5.3)
English: Swensweg 5, Postbus 552 2003 RN Haarlem The Netherlands
Maltese: Swensweg 5, Postbus 552 2003 RN Haarlem
English: ATC code: C09C A04
Maltese: Kodiċi ATC: C09C A04.
English: The active substance is irbesartan.
Maltese: Is-sustanza attiva hi irbesartan.
English: musculoskeletal pain*
Maltese: uġigħ muskuloskeletali*
English: TevaPharma, S.L.U.
Maltese: España TevaPharma, S.L.U.
English: List of side effects:
Maltese: Lista ta' effetti sekondarji:
English: Irbesartan Teva contains sodium
Maltese: Irbesartan Teva fih sodium
English: Polydextrose (E1200) Titanium dioxide (E171) Hypromellose (E464) Macrogol 4000
Maltese: Titanium dioxide (E171) Hypromellose (E464)
English: • Tablet coating: polydextrose, titanium dioxide, hypromellose and macrogol 4000.
Maltese: • Il-kisi tal-pillola: polydextrose, titanium dioxide, hypromellose u macrogol 4000.
English: • Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, croscarmellose sodium, colloidal hydrated silica and magnesium stearate.
Maltese: • Qalba tal-pillola: povidone, pregelatinized starch (qamħirrun), poloxamer 188, microcrystalline cellulose, croscarmellose sodium, silika idrat kollojdali u magnesium stearate.
English: The predefined blood pressure goal was ≤ 135/85 mm Hg.
Maltese: L-għan predefinit kien għall-pressjoni ta' ≤ 135/85 mmHg.
English: The total body and renal clearance are 157-176 and 3-3.5 ml/min, respectively.
Maltese: It-tneħħija mill-ġisem kollu u mill-kliewi huma 157-176 u 3-3.5 ml/min, rispettivament.
English: Pack sizes of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98, 100 film-coated tablets in non-perforated blisters.
Maltese: Pakketti b'daqsijiet ta' 7, 14, 28, 30, 56, 60, 80, 84, 90, 98,100 pillola miksija b'rita f'folji mhux ipperforati.
English: Teva Norway AS Tlf: +47 66775590
Maltese: Tlf: +47 66775590
English: The frequency of adverse reactions listed below is defined 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
Maltese: 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: Detailed information on Irbesartan Teva is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini (EMA): http://www.ema.europa.eu/
English: Microcrystalline cellulose Croscarmellose sodium Silica, colloidal hydrated Magnesium stearate
Maltese: microcrystalline cellulose, croscarmellose sodium, silika idrat kollojdali u magnesium stearate.
English: Sími: +358 201805900
Maltese: Finnland Sími: +358 201805900
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: One side of the tablet debossed with the number “93”.
Maltese: Naħa waħda tal-pillola għandha intaljata fuqha n-numru “93”.
English: HU-4042 Debrecen
Maltese: Debrecen H-4042 L-Ungerija
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 80 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets 100 film-coated tablets 50 x 1 film-coated tablets 56 x 1 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 56 pillola miksija b'rita 60 pillola miksija b'rita 80 pillola miksija b'rita 84 pillola miksija b'rita 90 pillola miksija b'rita 98 pillola miksija b'rita 100 pillola miksija b'rita 50 x 1 pillola miksija b'rita 56 x 1 pillola miksija b'rita
English: Approximately 33 % of patients in the irbesartan group reached the primary renal composite endpoint compared to 39 % and 41 % in the placebo and amlodipine groups [20 % relative risk reduction versus placebo (p = 0.024) and 23 % relative risk reduction compared to amlodipine (p = 0.006)].
Maltese: Madwar 33 % tal pazjenti fil-grupp t'irbesartan laħqu l-punt ta' riferiment renali primarju kompost mqabbel ma' 39 % u 41 % fil-gruppi tal-plaċebo u amlodipine [20 % tnaqqis relattiv tar-riskju kontra l-plaċebo (p = 0.024) u 23 % tnaqqis relattiv tar-riskju mqabbel ma' amlodipine (p = 0.006)].
English: dizziness, orthostatic dizziness*
Maltese: pressjoni baxxa ortostatika*
English: 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/day) and normal renal function (serum creatinine ≤ 1.5 mg/dl in males and < 1.1 mg/dl in females).
Maltese: IRMA 2 kien studju double blind ikkontrollat bilplaċebo ta' morbożità f'590 pazjenti b'tip 2 ta' dijabete, mikroalbuminuria (30-300 mg/jum) u funzjoni renali normali (kreatinina fis-serum ≤ 1.5 mg/dl fl-irġiel u < 1.1 mg/dl fin-nisa).