FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no clinically significant changes in fasting lipid laboratory tests in patients who switched.
Maltese: Ma kien hemm l-ebda bidla klinikament sinifikanti fit-testijiet tal-laboratorju tal-lipidi waqt is-sawm f'pazjenti li qalbu.
English: Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by prior treatment regimen Boosted PIs Other third agents
Maltese: Proporzjon (%) ta' pazjenti b'HIV-1 RNA ta' < 50 kopja/mL skont il-kors ta' trattament filpassat
English: Interaction not studied with either of the components of Descovy.
Maltese: L-interazzjoni ma ġiet studjata ma' lebda wieħed miż-żewġ komponenti ta' Descovy.
English: Table 7: Pharmacokinetics of emtricitabine and tenofovir alafenamide in antiretroviral-naïve adolescents and adults
Maltese: Il-farmakokinetika ta' emtricitabine u tenofovir alafenamide f'adolexxenti u adulti li qatt ma ngħataw antiretrovirali fil-passat
English: At the start of treatment with E/C/F/TAF, the 72 patients had been HIV-suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months with or without suppression of HBV DNA and had compensated liver function.
Maltese: Fil-bidu tattrattament b'E/C/F/TAF, it-72 pazjent kienu ilhom b'soppressjoni tal-HIV (RNA ta' HIV-1 ta' < 50 kopja/mL) għal mill-inqas 6 xhur bi jew mingħajr soppressjoni ta' DNA ta' HBV u kellhom funzjoni tal-fwied ikkumpensata.
English: In a study in virologically suppressed adult patients, BMD did not change significantly through 48 weeks after switching to Descovy from an abacavir/lamivudine containing regimen compared to maintaining the abacavir/lamivudine containing regimen as measured by DXA analysis of hip (mean change from baseline of 0.3% vs 0.2%, p = 0.55) and lumbar spine (mean change from baseline of 0.1% vs < 0.1%, p = 0.78).
Maltese: DXA tal-ġenbejn (bidla medja mil-linja bażi ta' 0.3% vs 0.2%, p = 0.55) u tas-sinsla lumbari (bidla medja mil-linja bażi ta' 0.1% vs < 0.1%, p = 0.78).
English: No dose adjustment of Descovy is required in elderly patients (see sections 5.1 and 5.2).
Maltese: L-ebda aġġustament fid-doża ta' Descovy mhu meħtieġ f'pazjenti anzjani (ara sezzjonijiet 5.1 u 5.2).
English: E/C/F/TAF = elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide E/C/F/TDF = elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate a Week 48 window was between Day 294 and 377 (inclusive); Week 144 window was between Day 966 and 1049 (inclusive).
Maltese: E/C/F/TAF = elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide E/C/F/TDF = elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate a.
English: No dose adjustment of Descovy is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Maltese: L-ebda aġġustament fid-doża ta' Descovy mhu meħtieġ f'adulti u adolexxenti (li jkollhom 12-il sena u aktar u li jiżnu mill-inqas 35 kg) bi tneħħija tal-krejatinina (CrCl) stmata ta' ≥ 30 mL/min.
English: Tenofovir is renally eliminated by both glomerular filtration and active tubular secretion.
Maltese: Tenofovir jiġi eliminat mill-kliewi, kemm permezz ta' filtrazzjoni glomerulari kif ukoll tnixxija tubulari attiva.
English: Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Maltese: Kull pillola fiha 200 mg ta' emtricitabine u tenofovir alafenamide fumarate, ekwivalenti għal 25 mg ta' tenofovir alafenamide.
English: The mean steady state plasma trough concentration at 24 hours post-dose was equal to or greater than the mean in vitro IC90 value for anti-HIV-1 activity.
Maltese: Il-medja tal-konċentrazzjoni minima fil-plażma fl-istat fiss 24 siegħa wara d-doża kienet daqs jew akbar mill-medja in vitro tal-valur IC90 għall-attività kontra l-HIV-1.
English: Each film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Maltese: Kull pillola fiha 200 mg ta' emtricitabine u tenofovir alafenamide fumarate, ekwivalenti għal 10 mg ta' tenofovir alafenamide.
English: HIV-1 infected patients with mild to moderate renal impairment In Study GS-US-292-0112, the efficacy and safety of emtricitabine and tenofovir alafenamide were evaluated in an open-label clinical study in which 242 HIV-1 infected patients with mild to moderate renal impairment (eGFRCG: 30-69 mL/min) were switched to emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
Maltese: Pazjenti infettati bl-HIV-1 b'indeboliment renali ħafif sa moderat Fi Studju GS-US-292-0112, l-effikaċja u s-sigurtà ta' emtricitabine u tenofovir alafenamide ġew evalwati fi studju kliniku open-label li fih 242 pazjent infettati bl-HIV-1 b'indeboliment renali ħafif sa moderat (eGFRCG:
English: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Maltese: Kien hemm rapporti ta' rata għolja ta' falliment viroloġiku u ta' feġġa ta' reżistenza li seħħew it-tnejn li huma fi stadju bikri, meta tenofovir disoproxil kien ikkombinat ma' lamivudine u abacavir, kif ukoll ma' lamivudine u didanosine bħala kors ta' għoti ta' darba kuljum.
English: Descovy should generally be avoided but may be used in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis if the potential benefits outweigh the potential risks (see section 4.2).
Maltese: Descovy ġeneralment għandu jiġi evitat iżda jista' jintuża f'adulti b'marda tal-kliewi fl-aħħar stadju (CrCl stmata ta' < 15-il mL/min) fuq emodijalisi kronika jekk il-benefiċċji potenzjali jkunu akbar mirriskji potenzjali (ara sezzjoni 4.2).
English: Assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies in which 3,112 HIV-1 infected patients received medicinal products containing emtricitabine and tenofovir alafenamide and from post-marketing experience.
Maltese: L-evalwazzjoni tar-reazzjonijiet avversi hi bbażata fuq dejta dwar is-sigurtà mill-istudji kollha ta' Fażi 2 u 3, li fihom 3,112-il pazjent infettati bl-HIV-1 irċivew prodotti mediċinali li jinkludu emtricitabine u tenofovir alafenamide u mill-esperjenza ta' wara t-tqegħid fis-suq.
English: -10.7% (95% CI: -26.3% to 4.8%)
Maltese: -10.7% (95% CI: -26.
English: In some patients with advanced HIV infection (AIDS) and who have had opportunistic infections in the past (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after antiretroviral treatment is started.
Maltese: F'xi pazjenti b'infezzjoni avvanzata tal-HIV (AIDS) u li kellhom infezzjonijiet opportunistiċi fil-passat (infezzjonijiet li jseħħu f'nies b'sistema immuni dgħajfa), sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet filpassat jistgħu jseħħu dritt wara li tinbeda t-trattament antiretrovirali.
English: Medicines used in treating hepatitis B infection:
Maltese: MEDIĊINI KONTRA L-INFEZZJONIJIET Antifungali
English: Sofosbuvir: AUC: ↔ Cmax: ↑ 27%
Maltese: Darunavir: AUC: ↔ Cmax: ↔ Cmin: ↔
English: At baseline, median plasma HIV-1 RNA
Maltese: L-għoti flimkien ma' prodotti mediċinali oħrajn
English: Emtricitabine systemic exposure was unaffected when emtricitabine was administered with food.
Maltese: L-esponiment sistemiku ta' emtricitabine ma ġiex affettwat meta emtricitabine ngħata mal-ikel.
English: The EC50 values for tenofovir alafenamide were in the range of 2.0 to 14.7 nM. Tenofovir alafenamide displayed antiviral activity in cell culture against all HIV-1 groups
Maltese: (il-figuri ta' EC50 kienu jvarjaw minn 0.10 sa 12.0 nM) u wera attività speċifika tar-razza kontra
English: Adverse reaction
Maltese: Antiretrovirali
English: Through 144 weeks of treatment, no subject discontinued E/C/F/TAF due to a treatment-emergent renal adverse event compared with 12 subjects who discontinued E/C/F/TDF (p < 0.001).
Maltese: Wara 144 ġimgħa ta' trattament, l-ebda individwu ma waqqaf E/C/F/TAF minħabba avveniment avvers fil-kliewi li żviluppa minħabba t-trattament meta mqabbel ma' 12-il individwu li waqqfu E/C/F/TDF (p < 0.001).
English: • abnormal dreams
Maltese: ħolm anormali
English: The safety and efficacy of Descovy in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Descovy fit-tfal ta' età inqas minn 12-il sena, jew li jiżnu < 35 kg, għadhom ma ġewx determinati s'issa.
English: The mean change from baseline in CD4+ cell count at Week 48 was -2 cells/mm3.
Maltese: Il-bidla medja mil-linja bażi fl-għadd ta' ċelluli CD4+ f'Ġimgħa 48 kienet ta' -2 ċelluli/mm3.
English: Patients were virologically suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months before switching.
Maltese: Il-pazjenti kienu soppressi b'mod viroloġiku (RNA ta' HIV-1 ta' < 50 kopja/mL) għal mill-inqas 6 xhur qabel ma qalbu.
English: Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chaintermination.
Maltese: Tenofovir diphosphate jinibixxi r-replikazzjoni tal-HIV permezz ta' inkorporazzjoni fid-DNA virali mill-HIV RT, li tirriżulta fit-terminazzjoni tal-katina tad-DNA.
English: No dose adjustment of Descovy is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, Descovy should generally be avoided but may be used in these patients if the potential benefits are considered to outweigh the potential risks (see sections 4.4 and 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża ta' Descovy f'adulti b'marda tal-kliewi fl-aħħar stadju (CrCl stmata ta' < 15-il mL/min) fuq emodijalisi kronika; madankollu, Descovy ġeneralment għandu jiġi evitat iżda jista' jintuża f'dawn il-pazjenti jekk il-benefiċċji potenzjali huma kkunsidrati akbar mirriskji potenzjali (ara sezzjonijiet 4.4 u 5.2).
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 15 March 2016.
Maltese: Minħabba li l-kumpanija kienet ipprovdiet l-informazzjoni addizzjonali mitluba, iċ-‘ċirkostanzi ta' eċċezzjoni' intemmew fil-15 ta' Marzu 2016.
English: The full EPAR for Bluevac BTV8 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to stimulate a better reaction by the immune system.
Maltese: Il-vaċċin fih ukoll ‘aġġuvanti' (aluminium hydroxide u saponin) biex jistimulaw reazzjoni aħjar mis-sistema immunitarja.
English: The most common side effect with Bluevac BTV8 (which may affect up to 1 in 10 animals) is an increase in body temperature between 0.5 and 1.0˚C that lasts no longer than one to two days.
Maltese: L-effett sekondarju l-aktar komuni b'Bluevac BTV8 (li jista' jaffettwa sa annimal 1 minn 10) huwa żieda fit-temperatura tal-ġisem bejn 0.5 u 1.0˚C li ma jdumx iktar minn ġurnata sa jumejn.
English: Protection lasts for one year.
Maltese: Il-protezzjoni ddum għal sena.
English: Bluevac BTV8 contains bluetongue viruses of one type (‘serotype 8').
Maltese: Bluevac BTV8 fih virusis tal-bluetongue ta' tip wieħed (‘serotip 8').
English: bluetongue virus vaccine serotype 8 (inactivated)
Maltese: vaċċin għall-virus bluetongue, serotip 8 (inattivat)
English: Bluevac BTV8 was originally authorised under ‘exceptional circumstances' because, as bluetongue disease falls under national disease control programmes, limited information was available at the time of approval.
Maltese: Oriġinarjament Bluevac BTV8 kien awtorizzat f'ċirkostanzi ta' eċċezzjoni' għaliex, minħabba li l-marda tal-bluetongue taqa' taħt il-programmi nazzjonali għall-kontroll tal-mard, fiż-żmien tal-approvazzjoni kien hemm informazzjoni limitata disponibbli.
English: The European Commission granted a marketing authorisation valid throughout the EU, for Bluevac BTV8 on 14 April 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Bluevac BTV8 valida fl-UE kollha fl-14 ta' April 2011.
English: Other information about Bluevac BTV8:
Maltese: Informazzjoni oħra dwar Bluevac BTV8:
English: The main measures of the effectiveness of the vaccine were viraemia (levels of BTV8 in the blood) and clinical signs of bluetongue virus infection.
Maltese: Il-kejl ewlieni tal-effettività tal-vaċċin kienu viremija (livelli ta' BTV8 fiddemm) u sinjali kliniċi tal-infezzjoni tal-vajrus tal-bluetongue.
English: Protection starts 31 days after the second injection in cattle and 20 days after the second injection in sheep.
Maltese: Il-protezzjoni tibda 31 ġurnata wara t-tieni injezzjoni fil-frat u 20 ġurnata wara t-tieni injezzjoni fin-nagħaġ.
English: Bluevac BTV8 is a vaccine.
Maltese: Bluevac BTV8 huwa vaċċin.
English: Bluevac BTV8 is a vaccine used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.
Maltese: Bluevac BTV8 huwa vaċċin li jintuża fil-frat u fin-nagħaġ biex jipproteġihom kontra l-marda talbluetongue, li hija infezzjoni kkawżata mill-virus tal-bluetongue trażmess mill-insetti dipteri.
English: For the full list of restrictions and all side effects reported with Bluevac BTV8, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet u tal-effetti sekondarji kollha rrapportati b'Bluevac BTV8, ara l-fuljett ta' tagħrif.
English: When it is given to cattle and sheep, the animals' immune system recognises the virus as ‘foreign' and produces antibodies against it.
Maltese: Meta jingħata lill-frat u lin-nagħaġ, is-sistema immunitarja talannimali tagħraf li l-virus ikun “barrani” u tipproduċi antikorpi kontrih.
English: The studies showed that the vaccine prevents viraemia in sheep and cattle and reduces clinical signs in sheep when infected with bluetongue virus serotype 8.
Maltese: L-istudji wrew li l-vaċċin jipprevjeni l-viremija finngħaġ u l-frat u jnaqqas is-sinjali kliniċi f'nagħaġ li jkunu infettati bil-virus tal-bluetongue serotip 8.
English: The effectiveness of the vaccine was investigated in a number of laboratory trials in sheep and cattle of the minimum recommended age.
Maltese: L-effikaċja tal-vaċċin ġiet investigata f'għadd ta' provi li saru fil-laboratorji fuq nagħaġ u frat fl-età minima rrakkomandata.
English: Clinical signs of the disease include fever, skin ulceration, as well as swelling and occasionally blueish discolouration of the tongue mainly seen in sheep.
Maltese: Sinjali kliniċi tal-marda jinkludu deni, ulċerazzjoni tal-ġilda, kif ukoll nefħa u f'ċerti każijiet skulurazzjoni kaħlanija tal-ilsien prinċipalment innotati fin-nagħaġ.
English: The vaccine contains inactivated (killed) bluetongue virus serotype 8.
Maltese: Il-vaċċin fih il-virus inattivat (maqtul) tal-bluetongue, serotip 8.
English: Why is Bluevac BTV8 approved?
Maltese: Għaliex ġie approvat Bluevac BTV8?
English: Bluevac BTV8 contains a bluetongue virus that has been inactivated so that it cannot cause the disease.
Maltese: Bluevac BTV8 fih virus tal-bluetongue li ġie inattivat biex ma jkunx jista' jikkawża l-marda.
English: What are the risks associated with Bluevac BTV8?
Maltese: X'inhuma r-riskji assoċjati ma' Bluevac BTV8?
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: It-tilqim jaħdem billi “jgħallem” lis-sistema immunitarja (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra l-mard.
English: How is Bluevac BTV8 used?
Maltese: Kif jintuża Bluevac BTV8?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bluevac BTV8'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 Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Bluevac BTV8 huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly.
Maltese: Fil-futur, jekk l-annimali jkunu esposti għall-istess tip ta' vajrus tal-bluetongue, is-sistema immunitarja tkun kapaċi tipproduċi antikorpi aktar malajr.
English: Ref. EMEA/CHMP/194790/2009 EMEA/H/A-29/991
Maltese: EMEA/CHMP/194671/2009 EMEA/H/A-29/991
English: Sanohex is a ‘generic medicine'.
Maltese: Sanohex huwa ‘mediċina ġenerika'.
English: What is Sanohex?
Maltese: X'inhu Sanohex?
English: Questions and answers on the referral for Sanohex salbutamol, metered dose aerosol inhaler, 100 μg/dose
Maltese: Mistoqsija u tweġiba dwar ir-referenza għal Sanohex salbutamol, inalatur ajrosol b'doża mkejla, 100 μg/doża
English: Hexal AG submitted Sanohex to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006.
Maltese: Hexal AG issottomettiet Sanohex lill-aġenzija regolatorja tal-mediċini Żvediża għal proċedura deċentralizzata fil-5 ta' Diċembru 2006.
English: This means that Sanohex is similar to a ‘reference medicine' already authorised in the European Union (EU) called Sultanol inhaler.
Maltese: Dan ifisser li Sanohex huwa simili għal ‘mediċina ta' referenza' li hija diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Sultanol inalatur.
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Sweden) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Austria, Germany, Ireland and Spain).
Maltese: Din hija proċedura meta Stat Membru (l-‘Istat Membru ta' referenza, f'dan il-każ l-Iżvezja) jevalwa mediċina bil-għan li jagħti awtorizzazzjoni għat-tqegħid fissuq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn (l-‘Istati Membri konċernati', f'dan ilkaż, l-Awstrija, il-Ġermanja, l-Irlanda u Spanja).
English: Sanohex is a medicine in a pressurised inhaler that contains salbutamol as active substance.
Maltese: Sanohex hija mediċina f'inalatur taħt pressjoni li fiha salbutamol bħala sustanza attiva.
English: When given by inhalation as in Sanohex, salbutamol directly activates the beta2-receptors in the respiratory system.
Maltese: Meta mogħti b'inalazzjoni bħal f'Sanohex, salbutamol jattiva direttament ir-riċetturi-beta2 fissistema respiratorja.
English: The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Sanohex.
Maltese: L-Aġenzija Ewropea dwar il-Mediċini (EMEA) temmet proċedura ta' referenza wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea fir-rigward tal-awtorizzazzjoni tal-mediċina Sanohex.
English: Sanohex is used to treat the breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD).
Maltese: Sanohex jintuża biex jittratta d-diffikultajiet fit-teħid tan-nifs ikkawżati mill-ażżma u minn mard pulmonari ostruttiv kroniku (COPD).
English: Why was Sanohex reviewed?
Maltese: Għaliex ġie rivedut Sanohex?
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Sanohex outweigh its risks, and that therefore the marketing authorisation for Sanohex should be granted in all concerned member states.
Maltese: IlKumitat għall-Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) tal-Aġenzija ikkonkluda li lbenefiċċji ta' Sanohex huma akbar mir-riskji tiegħu, u li l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fl-Iżvezja kif ukoll fl-Istati Membri tal-Unjoni Ewropea li ġejjin.
English: On 4 March 2008, the Swedish medicines regulatory agency referred the matter to the CHMP.
Maltese: Dawn l-Istati Membri ma setgħux jaslu għal ftehim. Fl-4 ta' Marzu 2008, l-aġenzija regolatorja tal-mediċini tal-Iżvezja rriferiet il-kwistjoni lis-CHMP.
English: 1 pre-filled syringe
Maltese: Daqs talpakkett
English: 4 (4 x 1) pre-filled syringes (multipack)
Maltese: 4 (4 x 1) siringi mimlijin għallest (pakkett multiplu)
English: 0.5 ml (40000 IU/ml) 6 (6 x 1) pre-filled syringes (multipack)
Maltese: IU/ml) 6 (6 x 1) siringi mimlijin għallest (pakkett multiplu)
English: 1.0 ml (40000 IU/ml) 4 (4 x 1) pre-filled syringes (multipack)
Maltese: IU/ml) 4 (4 x 1) siringi mimlijin għallest (pakkett multiplu)
English: 1 g / 1 g Powder for concentrate for solution for infusion
Maltese: Vaborem 1 g / 1 g Trab għal konċentrat għal soluzzjoni għall-infużjoni
English: (Invented) name Strength Pharmaceutical form
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika Mnejn għandu jingħata
English: Intravenous use vial (glass)
Maltese: Il-pakkett li jmiss mal-prodott
English: The full EPAR for Izba 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: Izba contains the active substance travoprost.
Maltese: Izba fih is-sustanza attiva travoprost.
English: What are the risks associated with Izba?
Maltese: X'inhuma r-riskji assoċjati ma' Izba?
English: In patients taking Izba, the average eye pressure (measured at 8 am in the morning) was 19.4, 19.3 and 19.2 mmHg following 2 weeks, 6 weeks and 3 months of treatment, respectively, which matched the pressure seen at similar time points in patients taking Travatan (19.5, 19.3 and 19.3 mmHg).
Maltese: Fil-pazjenti li jieħdu Izba, il-medja tal-pressjoni talgħajn (imkejla fit-8 am filgħodu) kienet 19.4, 19.3 u 19.2 mmHg wara ġimagħtejn, 6 ġimgħat u 3 xhur ta' kura, rispettivament, li qablet mal-pressjoni li dehret f'ħinijiet simili f'pazjenti li jieħdu Travatan (19.5, 19.3 u 19.3 mmHg).
English: This is a summary of the European public assessment report (EPAR) for Izba.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta᾽ valutazzjoni (EPAR) għal Izba.
English: The CHMP noted that Izba 30 microgram/ml is as effective as the 40 microgram/ml solution of travoprost.
Maltese: The CHMP innota li Izba 30 mikrogramma/ml huwa effettiv daqs soluzzjoni ta' 40 mikrogramma/ml ta' travoprost.
English: Izba (30 microgram/ml) has been investigated in a main study involving 864 patients with open-angle glaucoma or ocular hypertension, whose average eye pressure was 27 mmHg.
Maltese: Izba (30 mikrogramma/ml) ġie investigat fi studju ewlieni li involva 864 pazjent bi glawkoma b'angolu miftuħ jew ipertensjoni okulari, li l-pressjoni medja tagħhom tal-għajn kienet 27 mmHg.
English: Why is Izba approved?
Maltese: Għalxiex ġie approvat Izba?
English: The active substance in Izba, travoprost, is a prostaglandin analogue (a man-made version of a prostaglandin, substances naturally found in the body).
Maltese: Is-sustanza attiva f'Izba, travoprost, hija analogu protaglandinu (verżjoni magħmula mill-bniedem ta' prostaglandinu, sustanzi naturali li jinsabu fil-ġisem).
English: By lowering the pressure, Izba reduces the risk of damage.
Maltese: Peress li jbaxxi l-pressjoni, Izba jnaqqas ir-riskju ta' ħsara.
English: Izba is an eye-drop solution that is used to reduce intraocular pressure (pressure inside the eye) in adults who have open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) and in adults with ocular hypertension (when the pressure in the eye is higher than normal).
Maltese: Izba huwa soluzzjoni ta' taqtir għall-għajnejn u jintuża biex inaqqas il-pressjoni intraokulari (ilpressjoni fl-għajn ) u f'adulti bi glawkoma tat-tip open-angle (angolu miftuħ) (marda li tgħolli lpressjoni fl-għajn minħabba li l-fluwidi ma jkunux jistgħu joħorġu) u f'adulti b'ipertensjoni okulari (meta l-pressjoni fl-għajn tkun ogħla min-normal).
English: Other information about Izba
Maltese: Kif jintuża