FrancophonIA/ELRC3.0 huggingface dataset:
English: The inverted black triangle symbol '▼' serves as a reminder to report any suspected side effects, either because the medicine is new or because there is a particular need to find out more about its long-term safety.
Maltese: Mhux dejjem tista' tkun ċert/a li dak li qiegħed tesperjenza huwa kkawżat mill-mediċina, imma billi tirrapporta l-effetti sekondarji suspettati tista' tgħin lillawtoritajiet fl-istħarriġiet tagħhom, u dan iwassal għall-mediċini aktar siguri.
English: What happens to my report after I've sent it?
Maltese: X'jiġri mir-rapport tiegħi wara li nkun bgħattu?
English: If you think a medicine has caused a side effect, please check the package leaflet that comes with the medicine for information on how to report it.
Maltese: Bħala pazjent, għandek id-dritt li tirrapporta l-effetti sekondarji mhux mixtieqa tal-mediċini direttament lill-awtoritajiet.
English: You can usually report side effects by filling in a form online or from your doctor or local pharmacy.
Maltese: Ħafna drabi tista' tirrapporta effett sekondarju billi timla formola online jew min għand it-tabib tiegħek jew l-ispiżerija lokali.
English: After evaluating the safety signal and all other relevant data, medicines authorities may issue new warnings or advice on how the medicine should be used, and can even stop its use.
Maltese: Wara li jiġi vvalutat s-sinjal tassigurta u d-data kollha rilevanti, l-awtoritajiet tal-mediċini jistgħu joħorġu twissijiet ġodda jew pariri dwar kif il-mediċina għandha tintuża, u jistgħu saħansitra jwaqqfu l-użu tagħha.
English: How do I know I've experienced a side effect?
Maltese: Nista' ningħata għajnuna biex nirrapporta effett sekondarju?
English: Although they are tested extensively in clinical trials before they are authorised, not everything can be known about their side effects until they have been used by many people over time.
Maltese: Minkejja li huma ttestjati b'mod estensiv fi provi kliniċi qabel ma jiġu awtorizzati, ma jistax ikun magħruf kollox dwar l-effetti sekondarji tagħhom sakemm ma jintużawx minn ħafna nies matul iż-żmien.
English: A side effect (also called an adverse reaction) is an unwanted symptom or effect caused by a medicine.
Maltese: Effett sekondarju (magħruf ukoll bħala reazzjoni mhux mixtieqa) huwa sintomu jew effett mhux mixtieq ikkawżat minn mediċina.
English: The active substance in Silodosin Recordati, silodosin, is an alpha-adrenoreceptor antagonist.
Maltese: Is-sustanza attiva f'Silodosin Recordati, is-silodosin, hija antagonista alfa-adrenoriċettur.
English: Further information on Silodosin Recordati can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/silodosin-recordati.
Maltese: Aktar informazzjoni dwar Silodosin Recordati tinsab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/silodosin-recordati.
English: This medicine is identical to Urorec, which has been authorised in the EU since 29 January 2010.
Maltese: Din il-mediċina hija identika għal Urorec, li ilu awtorizzat fl-UE sa mid-29 ta' Jannar 2010.
English: Silodosin Recordati is a medicine used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults.
Maltese: Silodosin Recordati huwa mediċina li tintuża għall-kura ta' sintomi ta' iperplażja prostatika beninnja (BPH - benign prostatic hyperplasia, tkabbir tal-glandola tal-prostata) fl-adulti.
English: For men with moderate kidney problems, the starting dose should be 4 mg once a day.
Maltese: Għall-irġiel bi problemi moderati filkliewi, id-doża tal-bidu għandha tkun ta' 4 mg darba kuljum.
English: In the third study, the IPSS was around 19 points before treatment and fell by 7 points with Silodosin Recordati compared with 6.7 points in men who took tamsulosin (another medicine used for BPH) and 4.7 points with placebo.
Maltese: Fit-tielet studju, l-IPSS kien madwar 19-il punt qabel il-kura u naqas b'7 punti b'Silodosin Recordati meta mqabbel ma' 6.7 punti fl-irġiel li ħadu tamsulosin (mediċina oħra użata għal BPH) u ma' 4.7 punti bi plaċebo.
English: The recommended dose is one 8 mg capsule once a day.
Maltese: Id-doża rakkomandata hija ta' kapsula waħda ta' 8 mg darba kuljum.
English: The symptoms were measured using the international prostate symptom score (IPSS).
Maltese: Is-sintomi tkejlu bl-użu tal-punteġġ internazzjonali tas-sintomi tal-prostata (IPSS - international prostate symptom score)
English: When these receptors are activated, they cause the muscles controlling the flow of urine to contract.
Maltese: Meta dawn ir-riċetturi jiġu attivati, jikkawżaw kontrazzjoni fil-muskoli li jikkontrollaw il-fluss tal-urina.
English: Other information about Silodosin Recordati
Maltese: Informazzjoni oħra dwar Silodosin Recordati
English: Intra operative floppy iris syndrome (IFIS) occurs in some patients taking alpha adrenoreceptor antagonists and may lead to complications during cataract surgery.
Maltese: Is-sindrome talħabba tal-għajn ratba intraoperattiv (IFIS - intra operative floppy iris syndrome) iseħħ f'xi pazjenti li jieħdu antagonisti adrenoriċetturi alfa u jista' jwassal għal kumplikazzjonijiet matul il-kirurġija talkatarretti.
English: It works by blocking receptors (targets) called alpha1A adrenoreceptors in the prostate gland, the bladder and the urethra (the tube that leads from the bladder to the outside of the body).
Maltese: Din taħdem billi timblokka r-riċetturi (miri) imsejħa adrenoriċetturi alfa 1A fil-glandola tal-prostata, il-bużżieqa talawrina u l-uretra (it-tubu li jwassal mill-bużżieqa tal-awrina għan-naħa ta' barra tal-ġisem).
English: After 12 weeks, the IPSS fell by 6.4 points in the men who took Silodosin Recordati compared with 3.5 points in the men who took placebo (a dummy treatment).
Maltese: Wara 12-il ġimgħa, l-IPSS naqas b'6.4 punti fl-irġiel li ħadu Silodosin Recordati meta mqabbel ma' 3.5 punti fl-irġiel li ħadu plaċebo (kura finta).
English: Silodosin Recordati is effective at reducing problems with urinating in men with BPH and its side effects are comparable to those seen with other medicines of the same class.
Maltese: Silodosin Recordati huwa effettiv biex inaqqas il-problemi li l-irġiel b'BPH ikollhom biex jgħaddu lawrina u l-effetti sekondarji tiegħu huma komparabbli ma' dawk li dehru b'mediċini oħra tal-istess klassi.
English: Silodosin Recordati can only be obtained with a prescription and is available as capsules (4 and 8 mg).
Maltese: Silodosin Recordati jista' jinkiseb biss b'riċetta ta' tabib u jiġi bħala kapsuli (4, u 8 mg).
English: What are the risks associated with Silodosin Recordati?
Maltese: X'inhuma r-riskji assoċjati ma' Silodosin Recordati?
English: As for all medicines, data on the use of Silodosin Recordati are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Silodosin Recordati hija ssorveljata kontinwament.
English: Three main studies in over 1,800 men showed that Silodosin Recordati was effective at reducing symptoms of BPH, such as problems with urinating.
Maltese: Tliet studji ewlenin fuq aktar minn 1,800 raġel urew li Silodosin Recordati kien effettiv biex inaqqas issintomi ta' BPH, bħal pereżempju problemi biex wieħed jgħaddi l-awrina.
English: For the full list of side effects and restrictions of Silodosin Recordati, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha ta' Silodosin Recordati, ara l-fuljett ta' tagħrif.
English: How is Silodosin Recordati used?
Maltese: Kif jintuża Silodosin Recordati?
English: CAPROAMIN FIDES 4 g SOLUCIÓN INYECTABLE
Maltese: CAPROAMIN FIDES 4 g SOLUCIÓN
English: 2500 mg/10 ml
Maltese: Epsicaprom 25 2500 mg/10 ml
English: HU - Hungary PannonPharma Kft. Pannonpharma út 1.
Maltese: Kft. Pannonpharma út 1.
English: Member State (EU/EEA)
Maltese: UE/ŻEE
English: Bial - Aristegui, Produtos Farmacêuticos,S.A.
Maltese: Bial - Aristegui,
English: Aminocaproic acid containing medicinal products with Marketing Authorisation in the European Union
Maltese: Prodotti mediċinali li fihom Aminocaproic acid b'Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Unjoni Ewropea Stat Membru
English: List of the invented names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Maltese: Lista tal-ismijiet ivvintati, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-detenturi talawtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: Avda.
Maltese: Qawwa
English: Group III vPDT
Maltese: Grupp III vPDT
English: (maintenance of vision, primary endpoint)
Maltese: (żamma tal-vista, endpoint primarju)
English: Singapore 637394
Maltese: Singapor 637394
English: 30-Jun-2020
Maltese: 30-Ġun-2020
English: 30-Jun-2023
Maltese: 30-Ġun-2023
English: 90429 Nuremberg
Maltese: 90429 Nürnberg
English: For information on preparation of Lucentis, see section 6.6.
Maltese: Għal informazzjoni dwar il-preparazzjoni ta' Lucentis, ara sezzjoni 6.6.
English: 2870 Puurs Belgium
Maltese: 2870 Puurs Il-Belġju
English: Figure 4 Figure 5
Maltese: Figura 4 Figura 5
English: Difference in proportion (%), CI
Maltese: Differenza filproporzjon (%), CI
English: • The treatment of proliferative diabetic retinopathy (PDR)
Maltese: • Kura ta' retinopatija proliferattiva dijabetika (PDR)
English: 6.1 List of excipients α,α-trehalose dihydrate Histidine hydrochloride, monohydrate Histidine
Maltese: 6.1 Lista ta' eċċipjenti α,α-trehalose dihydrate Histidine hydrochloride, monohydrate Histidine
English: Two different pack types are available:
Maltese: Huma disponibbli żewġ tipi ta' pakketti differenti:
English: Populations with limited data
Maltese: Popolazzjonijiet li hemm dejta limitata fuqhom
English: Table 6 Outcomes in study D2304 (RETAIN)
Maltese: Tabella 6 Riżultati fl-istudju D2304 (RETAIN)
English: The key outcomes from RADIANCE are summarised in Table 2 and Figure 2.
Maltese: Ir-riżultati ewlenin minn RADIANCE jinsabu mqassra f'Tabella 2 u f'Figura 2.
English: Laser* N=90
Maltese: Lejżer* N=90
English: Table 8 Outcomes at Month 6 and 12 (BRAVO and CRUISE)
Maltese: Tabella 8 Riżultati f'Xahar 6 u 12 (BRAVO u CRUISE)
English: Laser n=110
Maltese: Lejżer n=110
English: Bilateral treatment
Maltese: Kura bilaterali
English: ADULTS
Maltese: Adulti
English: Adults
Maltese: ADULTI
English: (stage 3+) or AP-ROP (aggressive posterior ROP) disease.
Maltese: żona II (stadju 3+) jew b'AP-ROP (ROP aggressiva posterjuri).
English: • an intraocular pressure of ≥30 mmHg;
Maltese: • il-pressjoni ta' ġo l-għajn ≥30 mmHg;
English: Ranibizumab 0.2 mg vs laser
Maltese: Ranibizumab 0.2 mg vs lejżer
English: There is a potential for immunogenicity with Lucentis.
Maltese: Hemm potenzjal ta' immunoġenetiċità b'Lucentis.
English: • Key signs and symptoms of serious adverse events including increased intraocular pressure,
Maltese: • Sinjali u sintomi kruċjali ta' effetti avversi serji inkluż żieda fil-pressjoni intraokulari,
English: Rubber stopper
Maltese: Stoper tal-lastku
English: • Zone I, stage 1+, 2+, 3 or 3+ disease, or
Maltese: • Marda f'żona I, stadju 1+, 2+, 3 jew 3+, jew
English: p-value b
Maltese: valur-p b
English: Single dose for adults: 0.5 mg/0.05 ml.
Maltese: Doża singola għall-adulti: 0.5 mg/0.05 ml.
English: In RVO patients, 48.2% (253 of 525) had renal impairment (36.4% mild, 9.5% moderate and 2.3% severe).
Maltese: F'pazjenti b'RVO, 48.2% (253 minn 525) kellhom indeboliment renali (36.4% ħafif, 9.5% moderat u 2.3% sever).
English: Date of first authorisation: 22 January 2007 Date of latest renewal: 11 November 2016
Maltese: Data tal-aħħar tiġdid: 11 Novembru 2016
English: • Aggressive posterior (AP)-ROP
Maltese: • ROP posterjuri aggressiva (AP)
English: Systemic effects following intravitreal use
Maltese: Effetti sistemiċi wara użu intravitreali
English: 95% CI Comparison Odds ratio (OR)
Maltese: Odds ratio (OR)
English: a p<0.00001 comparison with vPDT control b
Maltese: a p<0.00001 imqabbel mal-kontroll vPDT
English: A total of 1,323 patients (879 active and 444 control) were enrolled in these studies.
Maltese: Total ta' 1,323 pazjent (879 attivi u 444 kontroll) kienu reklutati f'dawn listudji.
English: Post-authorisation efficacy study (PAES): CRFB002H2301E1
Maltese: CRFB002H2301E1
English: In a population pharmacokinetic analysis of neovascular AMD patients, 68% (136 of 200) of patients had renal impairment (46.5% mild [50-80 ml/min], 20% moderate [30-50 ml/min], and 1.5% severe [<30 ml/min]).
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' pazjenti b'AMD neovaskulari, 68% (136 minn 200) tal-pazjenti kellhom indeboliment renali (46.5% ħafif [50-80 ml/min], 20% moderat [30-50 ml/min] u 1.5% sever [<30 ml/min]).
English: Patient numbers [n] (treatment +sham)
Maltese: L-għadd ta' pazjenti [n] (trattament +sham)
English: Table 3 Outcomes at Month 2 (MINERVA)
Maltese: Tabella 3 Riżultati fit-2 Xahar (MINERVA)
English: • The treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II
Maltese: • Kura ta' retinopatija minħabba prematurità (ROP) bil-marda f'żona I (stadju 1+, 2+, 3 jew 3+),
English: Laser therapy (N=74)
Maltese: Terapija billejżer (N=74)
English: - Macular oedema (swelling of the centre of the retina).
Maltese: - Edima makulari (nefħa taċ-ċentru tar-retina).
English: • The treatment of visual impairment due to choroidal neovascularisation (CNV)
Maltese: • Kura ta' indeboliment tal-vista minħabba neovaskularizzazzjoni korojdali (CNV)
English: The estimated difference between ranibizumab and laser was 27.4% (95% CI: [18.9, 35.9]).
Maltese: Id-differenza stmata bejn ranibizumab u l-lejżer kienet ta' 27.4% (95% CI: [18.9, 35.9]).
English: Limited data on bilateral use of Lucentis (including same-day administration) do not suggest an increased risk of systemic adverse events compared with unilateral treatment.
Maltese: Dejta limitata dwar l-użu bilaterali ta' Lucentis (inkluż għoti fl-istess jum) ma tissuġġerixxix riskju akbar ta' avvenimenti avversi sistemiċi meta mqabbla ma' kura unilaterali.
English: The difference in least square means was 3.5 letters (95% CI: [0.2 to 6.7]).
Maltese: Id-differenza fil-medja tal-anqas kwadru kienet ta' 3.5 ittri (95% CI: [0.2 sa 6.7]).
English: Group II Ranibizumab 0.5 mg “disease activity” (n=116)
Maltese: Grupp II Ranibizumab 0.5 mg “attività talmarda” (n=116)
English: Data from two studies (MONT BLANC, BPD952A2308 and DENALI, BPD952A2309) conducted post approval confirmed the efficacy of Lucentis but did not demonstrate additional effect of the combined administration of verteporfin (Visudyne PDT) and Lucentis compared to Lucentis monotherapy.
Maltese: Dejta minn żewġ studji (MONT BLANC, BPD952A2308 u DENALI, BPD952A2309) li saru wara li l-prodott ġie approvat ikkonfermat l-effikaċja ta' Lucentis imma ma wrietx effett addizzjonali b'għoti ta' verteporfin (Visudyne PDT) flimkien ma' Lucentis meta tqabblet ma' terapija b'Lucentis waħdu.
English: Table 10 Outcomes at Week 24 (RAINBOW)
Maltese: Tabella 10 Ir-riżultati f'Ġimgħa 24 (RAINBOW)
English: Alcon-Couvreur NV Rijksweg 14
Maltese: Alcon-Couvreur N.V.
English: Treatment n/M (%)
Maltese: Trattament n/M (%) 95% CI
English: • The treatment of neovascular (wet) age-related macular degeneration (AMD)
Maltese: • Kura ta' deġenerazzjoni makulari neovaskulari (mxarrba) relatata ma' l-età (AMD)
English: In the phase IIIb study D2304 (RETAIN), 372 patients were randomised in 1:1:1 ratio to receive:
Maltese: Fl-istudju ta' fażi IIIb D2304 (RETAIN), 372 pazjent kienu rrandomizzati skont il-proporzjon 1:1:1 biex jirċievu:
English: One pre-filled syringe contains 0.165 ml, equivalent to 1.65 mg ranibizumab.
Maltese: Kull siringa mimlija għal-lest fiha 0.165 ml, ekwivalenti għal 1.65 mg ranibizumab.
English: intraocular inflammation, retinal detachment & retinal tear and infectious endophthalmitis
Maltese: infjammazzjoni intraokulari, tneħħija tar-retina u tiċrita tar-retina u endoftalmite infettuża
English: One-sided p<0.001 comparison with sham control b
Maltese: Tqabbil minn naħa waħda p<0.001 mal-kontroll bix-sham b
English: 1x 0.23 ml vial, 1 filter needle.
Maltese: Kunjett ta' 0.23 ml x1, labra 1 b'filtru.
English: -0.4 letters
Maltese: -0.4 ittri
English: The usual dose of an injection is 0.02 ml (which contains 0.2 mg of active substance).
Maltese: Id-doża ta' injezzjoni s-soltu tkun ta' 0.02 ml (li fih 0.2 mg ta' sustanza attiva).
English: The number of scheduled treatment visits after the initial 3 injections, was 13 and 20 for the TE and PRN regimens, respectively.
Maltese: In-numru ta' visti ta' kura ipprogrammati wara l-ewwel 3 injezzjonijiet, kienu 13 u 20 għall-korsijiet TE u PRN, rispettivament.
English: Overall, ranibizumab treatment was well tolerated.
Maltese: B'mod ġenerali, it-trattament b'ranibizumab kien toleranti.
English: The apparent systemic half-life was approximately 6 days.
Maltese: Il-half-life sistemika apparenti kien ta' madwar 6 ijiem.
English: The adverse reactions are listed by system organ class and frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma elenkati skont il-klassifika tas-sistema tal-organi u l-frekwenza billi ntużat il-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: It binds with high affinity to the VEGF-A isoforms (e.g. VEGF110, VEGF121 and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2.
Maltese: Teħel b'affinità kbira ma' l-iżoformi VEGF-A (e.ż. VEGF110, VEGF121 u VEGF165), u b'hekk ma tħallix VEGF-A jeħel mar-riċetturi tiegħuVEGFR-1 u VEGFR-2.
English: A total of 868 patients (708 active and 160 control) were enrolled in these studies.
Maltese: Total ta' 868 pazjent (708 attivi u 160 ikkontrollati) ħadu sehem f'dawn l-istudji.
English: Aseptically and firmly assemble an injection needle (30G x ½″, 0.3 mm x 13 mm) onto the syringe.
Maltese: B'mod asettiku u sod, arma labra tal-injezzjoni (30G x ½″, 0.3 mm x 13 mm) fuq is-siringa.
English: One ml contains 10 mg ranibizumab*.
Maltese: Millilitru wieħed fih 10 mg ranibizumab*.
English: • The treatment of visual impairment due to diabetic macular oedema (DME)
Maltese: • Kura ta' indeboliment tal-vista minħabba edima makulari dijabetika (DME)
English: Group I Ranibizumab 0.5 mg “vision stability” (n=105)
Maltese: Grupp I Ranibizumab 0.5 mg “stabbiltà viżwali” (n=105)
English: Sham (n=238)
Maltese: Plaċebo (n=238)
English: 9.5 letters
Maltese: 9.5 ittri
English: In the pivotal study G2301 (MINERVA), five adolescent patients aged 12 to 17 years with visual impairment secondary to CNV received open-label treatment with ranibizumab 0.5 mg at baseline followed by an individualised treatment regimen as for the adult population.
Maltese: G2301 (MINERVA), ħames pazjenti adolexxenti li kellhom bejn 12 u 17-il sena b'indeboliment tal-vista sekondarju għall-CNV ingħataw trattament open-label b'ranibizumab 0.5 mg fil-linja bażi segwiti b'reġim ta' trattament individwalizzat bħal popolazzjoni adulta.
English: What Lucentis contains - The active substance is ranibizumab.
Maltese: X'fih Lucentis - Is-sustanza attiva hi ranibizumab.
English: Patient-reported benefits were observed with ranibizumab treatment arms over vPDT (p-value <0.05) in terms of improvement in the composite score and several subscales (general vision, near activities, mental health and dependency) of the NEI VFQ-25.
Maltese: Kienu osservati rapporti ta' benefiċċju minn pazjenti fil-grupp mogħti ranibizumab imqabbel malvPDT (valur-p <0.05) skont it-termini ta' titjib fl-iskor kompost u f'bosta sottoskali (vista ġenerali, attivitajiet mill-viċin, saħħa mentali u dipendenza) tan-NEI VFQ-25.
English: In the phase II study D2201 (RESOLVE), 151 patients were treated with ranibizumab (6 mg/ml, n=51, 10 mg/ml, n=51) or sham (n=49) by monthly intravitreal injections.
Maltese: Waqt it-II fażi tal-istudju D2201 (RESOLVE), 151 pazjent kienu kkurati b'ranibizumab (6mg/ml, n=51, 10 mg/ml, n=51) jew b'mod falz (n=49) permezz ta' injezzjonijiet ġol-vitriju kull xahar.
English: Solution for injection Novartis Pharma GmbH Roonstrasse 25
Maltese: Soluzzjoni għall-injezzjoni Novartis Pharma GmbH Roonstrasse 25
English: There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors.
Maltese: Hemm riskju teoretiku ta' każijiet tromboemboliċi tal-arterji, fosthom puplesija u infart mijokardjali, wara l-użu ġol-vitriju ta' impedituri VEGF.
English: A total of 88 eyes (22.3%) had baseline DME: 42 (22.0%) and 46 (22.7%) eyes in the ranibizumab and PRP groups, respectively.
Maltese: 42 (22.0%) u 46 (22.7%) għajn fil-gruppi mogħtija ranibizumab u PRP, rispettivament.
English: Withholding Lucentis
Maltese: X'inhu Lucentis
English: In study FVF2598g (MARINA), 716 patients with minimally classic or occult with no classic lesions were randomised in a 1:1:1 ratio to receive monthly injections of Lucentis 0.3 mg, Lucentis 0.5 mg or sham.
Maltese: Fl-istudju FVF2598g (MARINA), 716-il pazjent bi ġrieħi minimament klassiċi jew okkulti mingħajr komponent klassiku kienu rrandomizzati skont proporzjon ta' 1:1:1 biex jingħataw injezzjonijiet kull xahar ta' Lucentis 0.3 mg, Lucentis 0.5 mg jew sham.
English: The usual dose of an injection is 0.05 ml (which contains 0.5 mg of active substance).
Maltese: Iddoża ta' injezzjoni s-soltu tkun ta' 0.05 ml (li fih 0.5 mg ta' sustanza attiva).
English: Cmax was dose proportional over the dose range of 0.05 to 1.0 mg/eye.
Maltese: Cmax kien proporzjonali mad-doża fil-medda tad-doża minn 0.05 sa 1.0 mg/għajn.
English: a p<0.0001for both comparisons in BRIGHTER at Month 6: Lucentis 0.5 mg vs Laser and Lucentis 0.5 mg + Laser vs Laser.
Maltese: Lucentis 0.5 mg vs Lejżer u Lucentis 0.5 mg + Lejżer vs Lejżer.
English: Odds ratio is calculated by using Cochran-Mantel-Haenszel test with ROP zone at baseline (zone I and II; per CRF) as stratum factor.
Maltese: L-odds ratio tinħadem billi jintuża t-test Cochran-Mantel-Haenszel biż-żona ROP fil-linja bażi (żona I u II; għal kull CRF) bħala l-fattur tal-istrat.
English: One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution and 1 blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 µm).
Maltese: Kunjett wieħed (ħġieġ tip I) b'tapp (lasktu chlorobutyl) li fih 0.23 ml ta' soluzzjoni sterili u labra 1 spuntata b'filtru (18G x 1½″, 1.2 mm x 40 mm, 5 µm).
English: Prior laser n=74
Maltese: Lejżer minn qabel n=74
English: Table 2 Outcomes at Month 3 and 12 (RADIANCE)
Maltese: Tabella 2 Riżultati fit-3 u fit-12-il Xahar (RADIANCE)
English: Table 1 Outcomes at Month 12 and Month 24 in study FVF2598g (MARINA) and FVF2587g (ANCHOR)
Maltese: Tabella 1 Kisbiet ma' Xahar 12 u Xahar 24 fl-istudju FVF2598g (MARINA) u FVF2587g (ANCHOR)
English: Key outcome measures from BRIGHTER and CRYSTAL are shown in Table 9.
Maltese: Evalwazzjoni tar-riżultati ewlenin minn BRIGHTER u CRYSTAL qed tidher f'Tabella 9.
English: In the ranibizumab-treated group, ≥2-step improvement in DRSS from baseline was observed in 58.5% (n=24) of eyes with baseline DME and 37.8% (n=56) of eyes without DME.
Maltese: Fil-grupp ittrattat b'ranibizumab, kien osservat titjib fid-DRSS mil-linja bażi ta' ≥2 livelli fost 58.5% (n=24) tal-għajnejn b'DME fil-linja bażi u fost 37.8% (n=56) talgħajnejn mingħajr DME.