FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of Stribild and orally administered midazolam and triazolam is contraindicated (see section 4.3).
Maltese: L-għoti ta' Stribild flimkien ma' midazolam li jingħata mill-ħalq u triazolam hu kontraindikat (ara sezzjoni 4.3).
English: osteomalacia (manifested as bone pain and infrequently contributing to fractures)1,3,5, myopathy1,3
Maltese: osteomalaċja (li tidher bħala wġigħ fl-għadam u b'mod mhux frekwenti tikkontribwixxi għal ksur)1,3,5, mijopatija1,3
English: • If you have kidney problems, or have had kidney problems, or if tests have shown problems with your kidneys.
Maltese: • Jekk għandek mard fil-kliewi, jew jekk kellek problemi fil-kliewi, jew jekk it-testijiet urew li hemm problemi fil-kliewi tiegħek.
English: In subjects with creatinine clearance below 50 mL/min or with end stage renal disease requiring dialysis, Cmax, and AUC of emtricitabine and tenofovir were increased (see section 4.4).
Maltese: F'individwi bi tneħħija tal-krejatinina taħt 50 mL/min jew b'mard tal-kliewi fl-aħħar stadju li jeħtieġ dijalisi, is-Cmax, u l-AUC ta' emtricitabine u tenofovir żdiedu (ara sezzjoni 4.4).
English: See section 4.4 regarding initiation of Stribild in patients with creatinine clearance below 90 mL/min.
Maltese: Ara sezzjoni 4.4 dwar il-bidu ta' Stribild f'pazjenti bi tneħħija tal-krejatinina taħt 90 mL/min.
English: If serum phosphate is confirmed to be < 0.96 mmol/L (3.0 mg/dL) in any paediatric patient receiving Stribild, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Maltese: Jekk il-phosphate fis-serum jiġi kkonfermat bħala < 0.96 mmol/L (3.0 mg/dL) fi kwalunkwe pazjent pedjatriku li jkun qed jirċievi Stribild, il-funzjoni renali għandha tiġi evalwata mill-ġdid fi żmien ġimgħa, inkluż il-kejl tal-konċentrazzjonijiet tal-glucose fid-demm, tal-potassium fid-demm u tal-glucose fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: neutropenia1
Maltese: newtropenja1
English: Effects on drug levels Mean percent change in AUC, Cmax,
Maltese: Effetti fuq il-livelli tal-mediċina Bidla medja f'perċentwali fl-AUC, Cmax, Cmin1
English: In virologically-suppressed patients
Maltese: Suċċess viroloġiku
English: The EC50 values for emtricitabine were in the range of 0.0013 to 0.64 µM.
Maltese: HIV-2 (EC50 ta' 0.53 nM).
English: a Patients were stratified by baseline HIV-1 RNA in both studies.
Maltese: Il-pazjenti ġew stratifikati skont HIV-1 RNA fil-linja bażi fiż-żewġ studji.
English: In patients who received treatment with tenofovir disoproxil, or stavudine or zidovudine, mean lumbar spine BMD Z-score was -1.034 and -0.498, and mean total body BMD Z-score was -0.471 and -0.386, respectively, at baseline.
Maltese: Dejta nieqsa matul l-intervall ta' żmien iżda fuq il-mediċina tal-istudju a L-intervall ta' żmien tal-Ġimgħa 48 hu bejn Jum 309 u 378 (inklużiv).
English: cisapride (used to relieve certain stomach problems) St. John's wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it lovastatin, simvastatin (used to lower blood cholesterol) pimozide, lurasidone (used to treat abnormal thoughts or feelings) sildenafil (used to treat pulmonary arterial hypertension - a lung disease that makes breathing difficult) orally administered midazolam, triazolam (used to help you sleep and/or relieve anxiety)
Maltese: Għalkemm l-etjoloġija hi kkunsidrata li tkun ġejja minn ħafna fatturi (li jinkludi l-użu ta' kortikosterojdi, konsum tal-alkoħol, immunosoppressjoni severa, indiċi ogħla tal-piż tal-ġisem), kienu rrappurtati każijiet ta' osteonekrożi partikularment f'pazjenti li jkollhom mard tal-HIV li jkun fi stadju avvanzat u/jew esponiment fit-tul għal CART.
English: Caution should be exercised when co-administering Stribild and a hormonal contraceptive.
Maltese: Għandu jkun hemm kawtela meta Stribild u kontraċettiv ormonali jingħataw flimkien.
English: The safety of tenofovir disoproxil when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. cobicistat) has not been established.
Maltese: tenofovir disoproxil meta użat ma' ledipasvir/sofosbuvir u potenzjatur farmakokinetiku (eż. cobicistat) għadha ma ġietx stabbilita.
English: Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
Maltese: Każijiet ta' insuffiċjenza tal-kliewi akuta wara l-bidu ta' doża għolja jew mediċini multipli antinfjammatorji mhux sterojdi (NSAIDs, non-steroidal anti-inflammatory drugs) ġew irrappurtati f'pazjenti ttrattati b'tenofovir disoproxil u b'fatturi ta' riskju għal disfunzjoni renali.
English: increased blood creatinine4
Maltese: Fanconi4, proteinurja
English: • medicines used to treat gout:
Maltese: • mediċini li jintużaw għal trattament tal-gotta:
English: Renal and urinary disorders: Common:
Maltese: Disturbi fil-kliewi u fis-sistema urinarja:
English: Adverse reaction
Maltese: ANTIDIPRESSANTI
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of Stribild treatment.
Maltese: Jekk ikun hemm suspett jew jiġu identifikati xi anormalitajiet renali, għandha tinkiseb konsultazzjoni minn nefrologu biex jiġi kkunsidrat il-waqfien temporanju tat-trattament.
English: Stribild is also used to treat HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg, and who have already been treated with other HIV medicines that have caused side effects.
Maltese: Stribild jintuża wkoll biex jittratta adolexxenti infettati bl-HIV-1 b'età ta' 12 sa inqas minn 18-il sena li jiżnu mill-inqas 35 kg, u li kienu diġà ġew ittrattati b'mediċini oħra kontra l-HIV li kkawżaw effetti sekondarji.
English: The pharmacokinetics of elvitegravir, cobicistat and tenofovir have been studied in patients with moderate hepatic impairment.
Maltese: Ilfarmakokinetiċi ta' elvitegravir, cobicistat u tenofovir ġew studjati f'pazjenti b'indeboliment epatiku moderat.
English: Stribild should be discontinued if creatinine clearance declines below 50 mL/min during treatment with Stribild as dose interval adjustment is required for emtricitabine and tenofovir disoproxil and this cannot be achieved with the fixed-dose combination tablet (see sections 4.4 and 5.2).
Maltese: Stribild għandu jitwaqqaf jekk it-tneħħija tal-krejatinina taqa' taħt il-50 mL/min matul it-trattament bi Stribild għax aġġustament fl-intervall tad-doża hu meħtieġ għal emtricitabine u tenofovir disoproxil u dan ma jkunx jista' jinkiseb bil-pillola kombinata ta' doża fissa (ara sezzjonijiet 4.4 u 5.2).
English: The safety of Stribild in 50 HIV-1-infected, treatment-naïve paediatric patients aged 12 to < 18 years was evaluated through 48 weeks in an open-label clinical study (GS-US-236-0112, see section 5.1).
Maltese: Studji bi Stribild Is-sigurtà ta' Stribild f'50 pazjent pedjatriku infettati bl-HIV-1 li qatt ma ngħataw trattament fil-passat b'età ta' 12 sa < 18-il sena ġiet evalwata matul 48 ġimgħa fi studju kliniku open-label
English: In study GS-US-104-0352, 89 paediatric patients with a median age of 7 years (range 2 to 15 years) were exposed to tenofovir disoproxil for a median of 331 weeks.
Maltese: Fl-istudju GS-US-104-0352, 89 pazjent pedjatriku b'età medjana ta' 7 snin (firxa minn sentejn sa
English: Table 5: Changes in pharmacokinetic parameters from the IMPAACT P1026s study for elvitegravir and cobicistat in women receiving cobicistat and elvitegravir-containing regimens during the second and third trimesters of pregnancy compared to paired postpartum data
Maltese: Bidliet fil-parametri tal-farmakokinetika mill-istudju IMPAACT P1026s għal cobicistat u elvitegravir f'nisa li jirċievu korsijiet li jkun fihom cobicistat u elvitegravir matul ittieni u t-tielet trimestru ta' tqala meta mqabbla ma' dejta ta' wara t-twelid akkoppjata.
English: Contraception requirements
Maltese: KONTRAĊETTIVI ORALI
English: However increased postimplantation loss and decreased foetal weights were observed in rats associated with significant decreases in maternal body weights at 125 mg/kg/day.
Maltese: Madankollu żieda fit-telf ta' wara limpjantazzjoni u tnaqqis fil-piżijiet fetali ġew osservati fil-firien, assoċjati ma' tnaqqis sinifikanti fil-piżijiet tal-ġisem tal-omm f'doża ta' 125 mg/kg/kuljum.
English: Co-administration with Stribild may result in increased plasma concentrations of sildenafil and tadalafil, which may result in PDE-5 inhibitor-associated adverse reactions.
Maltese: L-għoti flimkien ma' Stribild jista' jirriżulta f'żieda talkonċentrazzjonijiet ta' sildenafil u tadalafil fil-plażma, li jista' jirriżulta f'reazzjonijiet avversi assoċjati ma' impeditur ta' PDE-5.
English: The safety of tenofovir disoproxil in the setting of ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer has not been established.
Maltese: ledipasvir/sofosbuvir, sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir flimkien ma'
English: Sofosbuvir/Velpatasvir (400 mg/100 mg once daily) + Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil (150 mg/150 mg/200 mg/245 mg once daily)
Maltese: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg darba kuljum)6 +
English: Stribild should not be administered concomitantly with other medicinal products containing tenofovir disoproxil , lamivudine or adefovir dipivoxil used for the treatment of hepatitis B virus infection, or with other medicinal products containing tenofovir alafenamide.
Maltese: Stribild m'għandux jingħata flimkien ma' prodotti mediċinali oħrajn li fihom tenofovir disoproxil, lamivudine jew adefovir dipivoxil li jintużaw għat-trattament ta' infezzjoni bil-virus tal-epatite B, jew ma' prodotti mediċinali oħra li fihom tenofovir alafenamide.
English: If bone abnormalities are detected or suspected in paediatric patients, consultation with an endocrinologist and/or nephrologist should be obtained.
Maltese: Li jekk jiġu identifikati jew ikun hemm suspett ta' xi anormalitajiet fl-għadam, għandha tinkiseb konsultazzjoni minn endokrinologu u/jew nefrologu.
English: 5 This adverse reaction was identified through post-marketing surveillance for emtricitabine or tenofovir disoproxil but not observed in randomised, controlled clinical studies in adults or paediatric HIV clinical studies for emtricitabine or in randomised controlled clinical studies or the tenofovir disoproxil expanded access program for tenofovir disoproxil.
Maltese: Din ir-reazzjoni avversa kienet identifikata minn sorveljanza ta' wara t-tqegħid fis-suq għal emtricitabine jew tenofovir disoproxil iżda mhux osservata fi studji kliniċi kkontrollati randomised fuq pazjenti adulti jew fi studji kliniċi fuq persuni pedjatriċi bl-HIV għal emtricitabine jew fi studji kliniċi kkontrollati randomised jew il-programm ta' aċċess imkabbar ta' tenofovir disoproxil għal tenofovir disoproxil.
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (rats and dogs).
Maltese: It-tossiċità fl-għadam kienet iddijanjostikata bħala osteomalaċja (fix-xadini) u tnaqqis fid-densità minerali tal-għadam (fil-firien u l-klieb).
English: Of the 18 patients with viral resistance development, 13 occurred through Week 48, 3 occurred between Week 48 to Week 96, and 2 occurred between Week 96 to Week 144 of treatment.
Maltese: Mit-18-il pazjent bi żvilupp ta' reżistenza virali, 13 seħħew sal-Ġimgħa 48 u 3 seħħew bejn il-Ġimgħa 48 sal-Ġimgħa 96, u 2 seħħew bejn il-Ġimgħa 96 sal-Ġimgħa 144 ta' trattament.
English: The recommended schedule for monitoring renal function considering the presence or absence of additional risk factors for renal impairment.
Maltese: L-iskeda rakkomandata għall-monitoraġġ tal-funzjoni renali meta wieħed jikkunsidra l-preżenza jew l-assenza ta' fatturi addizzjonali ta' riskju għal indeboliment renali.
English: • lactic acidosis (see Possible serious side effects: tell a doctor immediately)
Maltese: • aċidożi lattika (ara Effetti sekondarji serji possibbli: għid lil tabib immedjatament)
English: The Cmax and AUC of tenofovir increased 20% and 25% respectively with a light meal, while the Cmax was unaffected and AUC increased 25% with a high fat meal.
Maltese: Is-Cmax u l-AUC ta' tenofovir żdiedu b'20% u 25% rispettivament b'ikla ħafifa, filwaqt li s-Cmax ma kienx affettwat u l-AUC żdied b'25% b'ikla b'ammont għoli ta' xaħam.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Maltese: L-effetti avversi ewlenin li kienu rrappurtati huma disturbi ematoloġiċi (anemija,
English: Emtricitabine/Tenofovir disoproxil (200 mg/245 mg once daily)7
Maltese: (200 mg/245 mg darba kuljum)7
English: Interactions between the components of Stribild and potential co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Maltese: Interazzjonijiet bejn il-komponenti ta' Stribild u prodotti mediċinali li potenzjalment jingħataw flimkien huma elenkati fit-Tabella 1 hawn taħt (żieda hija indikata b'“↑”, tnaqqis b'“↓”, ebda bidla b'“↔”).
English: Among the 50 paediatric patients receiving Stribild, mean BMD increased from baseline to Week 48, +0.68% for lumbar spine and +0.77% for total body less head.
Maltese: Fost il-50 pazjent pedjatriku li kienu qed jirċievu Stribild, il-BMD medja żdiedet mil-linja bażi għal Ġimgħa 48, +0.
English: The K65R substitution can also be selected by abacavir, stavudine or didanosine and results in reduced susceptibility to these agents plus lamivudine, emtricitabine and tenofovir.
Maltese: Issostituzzjoni ta' K65R tista' wkoll tintgħażel minn abacavir, stavudine jew didanosine u tikkawża tnaqqis fis-sensittività għal dawn il-mediċini flimkien ma' lamivudine, emtricitabine u tenofovir.
English: Caution is warranted and clinical monitoring is recommended upon co-administration with Stribild.
Maltese: Id-disturbi tal-lipidi għandhom jiġu ġestiti b'mod klinikament xieraq.
English: Following oral administration of boosted [14C]elvitegravir, elvitegravir was the predominant species in plasma, representing ~94% of the circulating radioactivity.
Maltese: elvitegravir kien l-ispeċi predominanti fil-plażma, li jirrappreżenta ~94% tar-radjuattività li kienet tiċċirkola.
English: The types of renal adverse reactions seen with Stribild were consistent with previous experience with tenofovir disoproxil.
Maltese: It-tipi ta' reazzjonijiet avversi tal-kliewi li ġew osservati bi Stribild kienu konsistenti ma' esperjenza fil-passat b'tenofovir disoproxil.
English: Patients who have previously discontinued treatment with tenofovir disoproxil due to renal toxicity, with or without reversal of the effects post-discontinuation, should not be treated with Stribild (see section 4.3).
Maltese: Pazjenti li fil-passat waqqfu t-trattament b'tenofovir disoproxil minħabba tossiċità renali, bi jew mingħajr it-treġġigħ lura tal-effetti wara t-twaqqif, m'għandhomx jiġu ttrattati bi Stribild (ara sezzjoni 4.3).
English: Intramuscular use suspension (H5N1): vial (glass) emulsion (adjuvant): vial (glass)
Maltese: Użu fil-muskolu suspensjoni (H5N1): kunjett (ħġieġ) emulsjoni (stimulat): kunjett (ħġieġ)
English: 2.5 ml (emulsion)
Maltese: 2.5 ml (suspensjoni) 2.5 ml (emulsjoni)
English: Suspension and emulsion for emulsion for injection
Maltese: Suspenjoni u emulsjoni għallemulsjoni għallinjezzjoni
English: BACKGROUND INFORMATION*
Maltese: INFORMAZZJONI ĠENERALI*
English: London, 1 October 2007 EMEA/CHMP/432352/2007
Maltese: Londra, 1 ta' Ottubru 2007 EMEA/CHMP/432352/2007
English: The Rapporteur and Co-Rapporteur appointed were: Eric Abadie and Barbara van Zwieten-Boot, respectively.
Maltese: Ir-Rapporteur u l-Co-Rapporteur appuntati kienu: Eric Abadie u Barbara van Zwieten-Boot, rispettivament.
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68
English: Veralipride was approved since 1979 for the indication of treatment of vasomotor symptoms (hot flushes) associated with the menopause.
Maltese: Veralipride kien approvat mill-1979 għall-indikazzjoni tal-kura tas-sintomi tal-vasomotor (fwawar (hot flushes)) assoċjati mal-menopawsa.
English: COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL FOR Agreal and associated names (see annex I) International Non-Proprietary Name (INN): Veralipride
Maltese: KUMITAT GĦAL PRODOTTI MEDIĊINALI GĦAL UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA REFERENZA SKOND L'ARTIKOLU 31 GĦAL Agreal u denominazzjonijiet oħra assoċjati (ara anness I) Denominazzjoni Komuni Internazzjonali (INN- Internatinal Non-proprietary Name ): Veralipride
English: Veralipride was authorised in 6 European Member States: Belgium, France, Italy, Luxembourg and Portugal.
Maltese: Il-Belġju, Franza, l-Italja, il-Lussemburgu u lPortugal.
English: Until June 2005, veralipride was also marketed in Spain.
Maltese: Sa Ġunju 2005, veralipride kien tpoġġa wkoll fis-suq Spanjol.
English: On 7 September 2006, following the withdrawal of veralipride from the Spanish market due to reports of serious side effects affecting the nervous system, the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/83/EC.
Maltese: Fis-7 ta' Settembru 2006, wara l-irtirar ta' veralipride mis-suq Spanjol minħabba rapporti ta' effetti sekondarji serji li affettwaw is-sistema nervuża, il-Kummissjoni Ewropea irreferiet il-kwistjoni lillEMEA skond l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: On 19 July 2007, based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CHMP considered that the benefit/risk profile of veralipride-containing medicinal products is negative and therefore adopted an opinion recommending the withdrawal of the Marketing Authorisation for all medicinal products containing veralipride.
Maltese: Fid-19 ta' Lulju 2007, abbażi tal-valutazzjoni tad-dejta li hija disponibbli bħalissa u r-rapporti ta' stima tar-Rapporteurs, is-CHMP ikkunsidra li l-profil benefiċċju/riskju ta' prodotti mediċinali li fihom veralipride huwa negattiv u għalhekk adotta opinjoni li tirrakkomanda l-irtirar ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq għall-prodotti mediċinali kollha li fihom veralipride.
English: * Note: The information given in this document and Annexes reflects the CHMP Opinion dated 19 July 2007.
Maltese: L-informazzjoni mogħtija f'dan id-dokument u l-Annessi tirrifletti l-Opinjoni tas-CHMP datata 19 ta' Lulju
English: The referral procedure started on 21 September 2006.
Maltese: Il-proċedura ta' referenza bdiet fil-21 ta' Settembru 2006.
English: Written explanations were provided by the Marketing Authorisation Holder on 4 January 2007.
Maltese: Spjegazzjonijiet bil-miktub ġew mogħtija mid-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq fl-4 ta' Jannar 2007.
English: Oral explanations were given on 20 June
Maltese: Spjegazzjonijiet orali ġew mogħtija fl-20 ta' Ġunju 2007.
English: The full EPAR for Nevanac 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: Nevanac nepafenac
Maltese: Nevanac nepafenak
English: The active substance in Nevanac, nepafenac, is a ‘prodrug' of amfenac.
Maltese: Is-sustanza attiva f'Nevanac, in-nepafenak, hija ‘promediċina' tal-amfenake.
English: An extra drop should be given 30 to 120 minutes before the operation begins.
Maltese: Għandha tingħata taqtira żejda bejn 30 sa 120 minuta qabel jibda l-intervent kirurġiku.
English: In the second and third study, 2.3% and 5.9% of patients taking Nevanac 3 mg/ml developed macular oedema, respectively, compared with between 17.3% and 14.3% of patients taking placebo.
Maltese: Fit-tieni u fit-tielet studju, 2.3% u 5.9% tal-pazjenti li kienu qed jieħdu Nevanac 3 mg/ml żviluppaw edema makulari, rispettivament, meta mqabbla ma' bejn 17.3% u 14.3% tal-pazjenti li kienu qed jieħdu l-plaċebo.
English: This is a summary of the European public assessment report (EPAR) for Nevanac.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Nevanac.
English: In the first study, 3.2% of patients taking Nevanac 1 mg/ml developed macular oedema (4 out of 125), compared with 16.7% of patients taking placebo (21 out of 126).
Maltese: Fl-ewwel studju, 3.2% tal-pazjenti li kienu qed jieħdu Nevanac 1 mg/ml żviluppaw edema makulari (4 minn 125), meta mqabbla ma' 16.7% tal-pazjenti li kienu qed jieħdu l-plaċebo (21 minn 126).
English: This means that it is converted into amfenac in the eye. Amfenac is a non-steroidal anti-inflammatory drug (NSAID).
Maltese: L-amfenake hija mediċina antiinfjammatorja mhux sterojdi (NSAID).
English: Nevanac is an eye drop suspension that contains the active substance nepafenac (1 and 3 mg/ml).
Maltese: Nevanac huwa sospensjoni tal-qtar għall-għajnejn li fih is-sustanza attiva nepafenak (1 u 3 mg/ml).
English: Why has Nevanac been approved?
Maltese: Għaliex ġie approvat Nevanac?
English: Other information about Nevanac
Maltese: Informazzjoni oħra dwar Nevanac
English: When Nevanac was compared with placebo, around 70% of the patients using Nevanac had no signs of inflammation after two weeks, compared with 17% to 59% of those using placebo.
Maltese: Meta Nevanac tqabbel malplaċebo, madwar 70% tal-pazjenti li użaw Nevanac ma kellhomx sinjali ta' infjammazzjoni wara ġimagħtejn, meta mqabbla ma' 17% sa 59% ta' dawk li ħadu l-plaċebo.
English: The main measure of effectiveness was the number of patients who developed macular oedema within 90 days of surgery.
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' pazjenti li żviluppaw edema makulari fi żmien 90 jum mill-kirurġija.
English: For reducing the risk of macular oedema, Nevanac has been compared with placebo in three main studies involving 1483 diabetes patients with retinopathy (damage to the retina) undergoing cataract surgery.
Maltese: Għat-tnaqqis tar-riskju tal-edema makulari, Nevanac tqabbel ma' plaċebo fi tliet studji ewlenin li involva 1483 pazjent li jbatu bid-dijabete retinopatika (ħsara fir-retina) li kienu għaddejjin minn kirurġija tal-katarretti.
English: For the prevention and treatment of pain and inflammation, Nevanac 1 mg/ml has been studied in four main studies involving a total of 1,201 patients undergoing cataract surgery.
Maltese: Għall-prevenzjoni u l-kura tal-uġigħ u l-infjammazzjoni, Nevanac 1 mg/ml ġie studjat f'erba' studji ewlenin li involvew total ta' 1,201 pazjent li kienu għaddejjin minn kirurġiji tal-katarretti.
English: What is Nevanac?
Maltese: X'inhu Nevanac?
English: Nevanac was more effective than placebo and as effective as ketorolac in reducing signs of inflammation.
Maltese: Nevanac kien aktar effettiv mill-plaċebo u effettiv daqs il-ketorolak fit-tnaqqis tas-sinjali ta' infjammazzjoni.
English: Nevanac is also used to reduce the risk of macular oedema (swelling in the macula, the central part of the retina at the back of the eye) that can occur after cataract surgery in adult diabetes patients.
Maltese: Nevanac jintuża wkoll biex jitnaqqas ir-riskju ta' edema makulari (nefħa fil-makula, il-parti ċentrali tarretina fuq wara tal-għajn) li tista' tfeġġ wara kirurġija tal-katarretti f'pazjenti adulti li jbatu biddijabete.
English: The most common side effects with Nevanac (seen in up to 1 in 100 patients) are inflammation of the surface of the eye, defects in the cornea, the sensation of a foreign body in the eye, and crust forming at edge on the eyelids.
Maltese: L-effetti sekondarji l-aktar komuni b'Nevanac (li dehru f'pazjent 1 minn 100) huma infjammazzjoni talwiċċ tal-għajn, difetti fil-kornea, is-sensazzjoni ta' oġġett barrani fl-għajn, u qoxra li tifforma fix-xifer tal-kappell tal-għajn.