FrancophonIA/ELRC3.0 huggingface dataset:
English: In 2006 it was concluded that a small increase in the absolute risk of thrombotic events could not be excluded for NSAIDs as a class, especially when used at high-doses and long-term therapy, although the risk was considered to be higher for the selective cyclooxygenase-2 (Cox-2) inhibitors (also known as coxibs) compared to NSAIDs.
Maltese: Fl-2006 ġie konkluż li ma setgħetx tiġi eskluża żieda żgħira fir-riskju assolut ta' avvenimenti trombotiċi għall-NSAIDs bħala klassi, speċjalment meta jintużaw f'dożi għoljin u għal terapija fit-tul, għalkemm irriskju kien ikkunsidrat ogħla għall-inibituri selettivi ta' cyclooxygenase-2 (Cox-2) (magħrufa wkoll bħala coxibs) meta mqabbla ma' NSAIDs.
English: The available information on the dose effect of diclofenac is limited.
Maltese: L-informazzjoni disponibbli dwar l-effett tad-doża ta' diclofenac hija limitata.
English: • The PRAC considered the totality of the data available in relation to the cardiovascular safety of diclofenac containing medicinal products, acknowledging the conclusions from previous reviews by the CHMP, the submissions by marketing authorisation holders in writing and at an oral explanation, and emerging data from independent researchers.
Maltese: • Il-PRAC ikkunsidra t-totalità tad-dejta disponibbli fir-rigward tas-sigurtà kardjovaskulari ta' prodotti mediċinali li fihom diclofenac, filwaqt li jirrikonoxxi l-konklużjonijiet minn reviżjonijiet preċedenti mis-CHMP, is-sottomissjonijiet mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq bil-miktub u waqt spjegazzjoni orali, u dejta emerġenti minn riċerkaturi indipendenti.
English: The PRAC concluded that the benefit-risk balance for diclofenac containing medicinal products (systemic formulations) remains favourable subject to the agreed restrictions, warnings, other changes to the product information and additional risk minimisation measures, in the form of a communication letter.
Maltese: Il-PRAC ikkonkluda li l-bilanċ tal-benefiċċju-riskju għal prodotti mediċinali li fihom diclofenac (formulazzjonijiet sistemiċi) jibqa' favorevoli soġġett għar-restrizzjonijiet, twissijiet, tibdil ieħor lillinformazzjoni dwar il-prodott u miżuri addizzjonali għall-minimizzazzjoni tar-riskji maqbula, fil-forma ta' ittra ta' komunikazzjoni.
English: This review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: Din ir-reviżjoni kienet immexxija millKumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC).
English: The data available today do not allow conclusion on the specific mechanisms underlying the cardiovascular thrombotic risks of diclofenac, although several studies have explored different options and it can be noted that is unlikely that one single mechanism would explain the risk.
Maltese: Id-dejta attwalment disponibbli ma tippermettix konklużjoni dwar il-mekkaniżmi speċifiċi sottostanti għar-riskji trombotiċi kardjovaskulari ta' diclofenac, għalkemm diversi studji esploraw alternattivi differenti u jista' jiġi nnotat li huwa improbabbli li mekkaniżmu uniku sejjer jispjega r-riskju.
English: Risk minimisation measures (in the form of contraindications and warnings in the product information) were implemented at the time for Cox-2 inhibitors.
Maltese: Miżuri għall-minimizzazzjoni tar-riskji (fil-forma ta' kontraindikazzjonijiet u twissijiet fl-informazzjoni dwar il-prodott) dak iż-żmien ġew implimentati għallinibituri ta' COX-2.
English: Data provided by the MAHs in writing and at an oral explanation and relevant data made available by independent researchers were also considered.
Maltese: Id-dejta pprovduta mill-MAHs bil-miktub u waqt spjegazzjoni orali u dejta rilevanti magħmula disponibbli minn riċerkaturi indipendenti kienet ukoll ikkunsidrata.
English: The CMDh, having considered the PRAC recommendation dated 13 June 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of diclofenac containing medicinal products for which the amendments to the product information are set out in annex III.
Maltese: Il-CMDh, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata t-13 ta' Ġunju 2013 skont lArtikolu 107k(1) u (2) tad-Direttiva 2001/83/KE, laħaq pożizzjoni dwar il-varjazzjoni talawtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti mediċinali li fihom diclofenac li għalihom l-emendi għall-informazzjoni dwar il-prodott huma stabbiliti fl-Anness
English: The PRAC concluded that diclofenac is effective in reducing inflammation and pain.
Maltese: Il-PRAC ikkonkluda li diclofenac huwa effettiv fit-tnaqqis tal-infjammazzjoni u l-uġigħ.
English: The PRAC therefore recommended an amendment to the product information for diclofenac to include an updated contraindication in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Maltese: Il-PRAC għalhekk jirrakkomanda emenda lill-informazzjoni dwar il-prodott għal diclofenac sabiex tiġi nkluża kontraindikazzjoni aġġornata f'pazjenti b'insuffiċjenza konġestiva tal-qalb stabbilita (NYHA II-IV), mard iskemiku tal-qalb, mard arterjali periferali u/jew mard ċerebrovaskulari.
English: The PRAC considered that the recommendation for update of the product information should be applicable to all medicinal products containing diclofenac (systemic formulations), regardless of dose.
Maltese: Il-PRAC ikkunsidra li r-rakkomandazzjoni għal aġġornament tal-informazzjoni dwar il-prodott għandha tkun applikabbli għall-prodotti mediċinali kollha li fihom diclofenac (formulazzjonijiet sistemiċi), irrispettivament mid-doża.
English: Meta-analyses of observational data and individual observational studies also consistently indicated that diclofenac is associated with a similar level of risk as Cox-2 inhibitors.
Maltese: Meta-analiżi ta' dejta ta' osservazzjoni u studji individwali ta' osservazzjoni ndikaw ukoll b'mod konsistenti li diclofenac huwa assoċjat ma' livell simili ta' riskju bħall-inibituri ta' COX-2.
English: NSAIDs, such as diclofenac, are indicated in the relief of all grades of pain and inflammation associated with a wide range of conditions, including arthritic conditions, acute musculo-skeletal disorders and other painful conditions resulting from trauma.
Maltese: NSAIDs, bħal diclofenac, huma ndikati għas-solliev tal-gradi kollha ta' uġigħ u infjammazzjoni assoċjati ma' firxa wiesgħa ta' kundizzjonijiet, inkluż kundizzjonijiet tal-artrite, disturbi muskoloskeletriċi akuti u kundizzjonijiet oħra bl-uġigħ li jirriżultaw minn trawma.
English: For more information on the review conducted in 2012, please refer to the assessment report for the procedure at http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/11/WC500134717.pdf compared to other NSAIDs and that the risk with diclofenac is similar to that of coxibs.
Maltese: Għal aktar informazzjoni dwar ir-reviżjoni li saret fl-2012, jekk jogħġbok irreferi għar-rapport ta' valutazzjoni għall-proċedura fuq http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/11/WC500134717.pdf
English: Phase III Study (PCM301)
Maltese: III (PCM301)
English: Range: min, max PSA (ng/mL)
Maltese: Medda: min, mass PSA (ng/mL)
English: Range: min, max
Maltese: Medda: min, mass
English: The median duration was 10 days (1-344).
Maltese: Id-durata medjana kienet 10 ijiem (1-344).
English: OATP1B1 and OATP1B3 transporters
Maltese: Trasportaturi ta' OATP1B1 u OATP1B3
English: The injection lasts 10 minutes.
Maltese: Kull injezzjoni ddum 10 minuti.
English: The median time to onset of genito-urinary infections was 22.5 days (4-360).
Maltese: Iż-żmien medjan għall-bidu ta' infezzjonijiet ġenito-urinarji kien 22.5 jiem (4-360).
English: Negative biopsy in the treated lobe*, n (%)
Maltese: Bijopsija negattiva fil-lobe kkurat*, n (%)
English: Mannitol (E421)
Maltese: Mannitol (E421) 6.2 Inkompatibbiltajiet
English: Padeliporfin di-potassium is highly bound to human plasma proteins (99 %).
Maltese: Padeliporfin di-potassium jorbot ħafna mal-proteini tal-plażma tal-bniedem (99 %).
English: The final solution concentration is 9.15 mg/mL.
Maltese: Il-konċentrazzjoni finali tas-soluzzjoni hija ta' 9.15 mg/mL.
English: Photosensitisers
Maltese: Fotosensitizzaturi
English: In 5 (2.5 %) patients, the infection was considered serious.
Maltese: F'5 (2.5 %) pazjenti, l-infezzjoni ġiet ikkunsidrata serja.
English: Range: min, max Estimated prostate volume (cc) Mean (SD)
Maltese: Medda: min, mass Volum stmat tal-prostata (cc) Medja (SD)
English: Surgical procedure repeated Contusion
Maltese: Proċedura kirurġika repetuta Kontużjoni
English: Penile swelling (balanoposthitis).
Maltese: 13 Nefħa tal-pene (balanoposthitis).
English: Hepatotoxicity (alanine aminotransferase increased, aspartate aminotransferase increased).
Maltese: 4 Epatotossiċità (żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase).
English: In vitro studies indicate that TOOKAD is unlikely to be an inhibitor of CYP450 enzymes.
Maltese: Studji in vitro jindikaw li TOOKAD mhuwiex probabbli li jkun inibitur ta' enzimi ta' CYP450.
English: Erectile dysfunction may occur even if radical prostatectomy is avoided.
Maltese: Jista' jkun hemm disfunzjoni erettili anki jekk tiġi evitata prostatektomija radikali.
English: This is very rare.
Maltese: Dan huwa rari ħafna.
English: ITT population
Maltese: Popolazzjoni ITT
English: AS arm N = 78
Maltese: N = 78
English: Of the 206 subjects randomised TOOKAD-VTP, 10 did not receive treatment for various reasons including study withdrawal, meeting exclusion criteria, non-compliance and other medical events.
Maltese: Mill-206 individwi randomizzati b'TOOKAD-VTP, 10 ma rċivewx kura għal diversi raġunijiet inkluż irtirar mill-istudju, is-sodisfazzjoni ta' kriterji ta' esklużjoni, non-konformità u avvenimenti mediċi oħra.
English: Additional VTP procedures of the prostate are not recommended.
Maltese: Mhumiex rakkomandati proċeduri VTP addizzjonali tal prostata.
English: EXP:
Maltese: ATC:
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to
Maltese: (≥ 1/10), komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100).
English: a a e e
Maltese: Waqgħa
English: In small surgical series, there have been reports of T3 tumours, positive margins and impotence.
Maltese: F'serje ta' kirurġiji żgħar, kien hemm rapporti ta' tumuri T3, marġini pożittivi u impotenza.
English: TOOKAD-VTP arm N = 80
Maltese: TOOKAD-VTP N = 80
English: TOOKADVTP arm N = 80
Maltese: TOOKADVTP N = 80
English: Follow-up post TOOKAD-VTP
Maltese: TOOKAD-VTP
English: In the Phase III European study, 25 (12.7 %) patients experienced urinary incontinence (including incontinence, stress urinary incontinence and urge incontinence).
Maltese: III, 25 (12.7 %) pazjent esperjenzaw inkontinenza tal-awrina (inkluż inkontinenza, inkontinenza tal-awrina ta' stress u inkontinenza b'urġenza).
English: Unspecific adverse events probably linked to the general anaesthesia were also observed: transient global amnesia, bradycardia, sinus arrhythmia, atrial fibrillation, hypotension, bronchospasm, pharyngeal inflammation, respiratory tract congestion, nausea, vomiting, constipation, pyrexia, procedural hypotension.
Maltese: Ġew osservati wkoll avvenimenti avversi mhux speċifiċi probabbilment marbutin mal-anesteżija ġenerali: amnesija globali tranżitorja, bradikardija, aritmija tas-sinus, fibrillazzjoni atrijali, pressjoni baxxa, bronkospażmu, infjamazzjoni farinġeali, konġestjoni tal-apparat respiratorju, nawżja, remettar, stitikezza, deni, pressjoni baxxa proċedurali.
English: AS arm N = 207
Maltese: N = 207
English: Urinary incontinence (urge incontinence, incontinence, stress urinary incontinence).
Maltese: 8 Inkontinenza tal-awrina (inkontinenza b'urġenza, inkontinenza, inkontinenza tal-awrina ta' stress).
English: Minimal metabolism of padeliporfin was observed in in vitro metabolism studies in human liver microsomes and S9 fractions.
Maltese: Ġie osservat metaboliżmu minimu ta' padeliporfin fi studji tal-metaboliżmu in vitro f'mikrosomi tal fwied tal-bniedem u frazzjonijiet S9.
English: Anorectal discomfort (proctalgia, rectal tenesmus).
Maltese: 2 Skumdità anorettali (proktalġja, tenesmus tar-rektum).
English: The following types of medicines may be ones that your doctor will advise you to stop temporarily:
Maltese: It-tipi ta' mediċini li ġejjin jistgħu jkunu dawk li t-tabib tiegħek se jirrakkomandalek li twaqqaf temporanjament:
English: TOOKADVTP arm N = 206
Maltese: TOOKADVTP N = 206
English: Based on popPK analysis the estimated half-life is 1.19 h ± 0.08 at 4 mg/kg of padeliporfin di-potassium.
Maltese: Abbażi tal-analiżi popPK, il-half-life stmata hija 1.19 h ± 0.08 b'4 mg/kg ta' padeliporfin di-potassium.
English: n Mean score (SD) Baseline 179 7.6 (6.09) 185 6.6 (5.30) 71 6.7 (5.69) 73 6.0 (4.34) Day 7 180 14.8 (8.64)
Maltese: Bażi 179 7.6 (6.09) 185 6.6 (5.30) 71 6.7 (5.69) 73 6.0 (4.34) Jum 7 180 14.8 (8.64)
English: TOOKAD-VTP arm
Maltese: TOOKAD-VTP.
English: TOOKAD is a medicine that contains padeliporfin (as potassium salt).
Maltese: TOOKAD huwa mediċina li fiha padeliporfin (bħala potassium salt).
English: Adverse reactions reported are listed below in Table 1 by organ class and frequency.
Maltese: Ir-reazzjonijiet avversi rrappurtati huma elenkati hawn taħt f'Tabella 1 skont il-klassifika tal-organi u l-frekwenza.
English: Month 3 179 9.6 (6.86) 190 7.2 (5.75) 71 8.7 (5.72) 72 6.6 (5.11) Month 6 182 7.5 (6.06) 189 6.8 (5.84) 74 6.4 (5.33) 73 6.3 (5.36) Month 12 177 7.2 (5.85) 173 7.3 (5.95) 71 5.7 (5.01) 68 7.1 (5.75) Month 24* 165 6.6 (5.47) 154 8.2 (6.47) 66 5.5 (5.34) 55 8.6 (6.56) *Scores at Month 24 include patients who underwent radical therapy
Maltese: Xahar 3 179 9.6 (6.86) 190 7.2 (5.75) 71 8.7 (5.72) 72 6.6 (5.11) Xahar 6 182 7.5 (6.06) 189 6.8 (5.84) 74 6.4 (5.33) 73 6.3 (5.36) Xahar 12 177 7.2 (5.85) 173 7.3 (5.95) 71 5.7 (5.01) 68 7.1 (5.75) Xahar 24* 165 6.6 (5.47) 154 8.2 (6.47) 66 5.5 (5.34) 55 8.6 (6.56)
English: VTP procedure.
Maltese: VTP).
English: Clinical stages
Maltese: Stadji kliniċi
English: TOOKAD-VTP arm N = 206
Maltese: TOOKAD-VTP N = 206
English: In vitro studies indicate that TOOKAD is unlikely to be a substrate of OATP1B1, OATP1B3, OCT1, OATP2B1, P-gp, BCRP, MRP2 or BSEP hepatic uptake transporters.
Maltese: Studji in vitro jindikaw li TOOKAD aktarx mhuwiex substrate ta' trasportaturi ta' uptake tal-fwied OATP1B1, OATP1B3, OCT1, OATP2B1, P-gp, BCRP, MRP2 jew BSEP.
English: See also under “Other medicines and TOOKAD” for photosensitizing medicines.
Maltese: Ara wkoll taħt “Mediċini oħra u TOOKAD” għal mediċini fotosensitizzanti.
English: Severe long-term urinary incontinence was observed in a patient who underwent a previous transurethral prostatectomy (TURP).
Maltese: L-inkontinenza tal-awrina fit-tul u severa ġiet osservata f'pazjent li kellu prostatektomija transuretrali preċedenti (TURP, transurethral prostatectomy).
English: 60 watts or equivalent (i.e. 6 watts for LED lights, 12 watts for fluorescent low-energy lights).
Maltese: 60 watt jew ekwivalenti (jiġifieri 6 watts għal dawl LED, 12-il watt għal dawl fluworexxenti li juża ftit enerġija).
English: Other reasons d, n (%) Positive biopsy, n (%) Positive biopsy in the treated lobe*, n (%) Risk Ratio (95% CI) = 3.62 (2.50 ; 5.26) ; p value < 0.001 Risk Ratio (95% CI) = 3.24 (2.41 ; 4.36) ; p value < 0.001 Among the 60 patients who had radical therapy, 5 patients had a Month 24 biopsy For example: study withdrawal, medical reason, subject refusal Risk Ratio (95% CI) = 4.39 (2.18 ; 8.83) ; p value < 0.001 Risk Ratio (95% CI) = 4.61 (2.60 ; 8.16) ; p value < 0.001 B: Difference in rate of treatment failure associated with observed progression of disease Number of subjects progressed at Month 24, n (%)
Maltese: Bijopsija pożittiva fil-lobe kkurat*, n (%) aProporzjon ta' Riskju (95% CI) = 3.62 (2.50 ; 5.26) ; valur p < 0.001 bProporzjon ta' Riskju (95% CI) = 3.24 (2.41 ; 4.36) ; valur p < 0.001 cFost is-60 pazjent li kellhom terapija radikali, 5 pazjenti kellhom bijopsija ta' Xahar 24
English: Genito-urinary infections
Maltese: Infezzjonijiet ġenito-urinarji
English: Prostatic pain (prostatism, prostatic disorders, prostatic fibrosis).
Maltese: 12 Uġigħ fil-prostata (prostatiżmu, disturbi fil-prostata, fibrożi fil-prostata).
English: n Mean score (SD)
Maltese: n Punteġġ medju (SD)
English: Swirl the vial gently for 2 minutes.
Maltese: Il-kunjett għandu mbagħad jitħallat bil-mod għal 2 minuti.
English: In vitro studies predict that TOOKAD at therapeutic concentrations is unlikely to inhibit cytochrome P450 enzymes but could inhibit OATP1B1 and OATP1B3 transporters (see section 5.2).
Maltese: Studji in vitro jipprevedu li TOOKAD f'konċentrazzjonijiet terapewtiċi mhuwiex probabbli li jinibixxi enzimi taċ-ċikotromu P450 iżda jista' jinibixxi trasportaturi ta' OATP1B1 u OATP1B3 (ara sezzjoni 5.2).
English: Standard handling of syringes should follow.
Maltese: Għandu jiġi segwit il-maniġġjar standard tas-siringi.
English: Tumour localisation
Maltese: Lokalizzazzjoni tat-tumur
English: Perineal injury
Maltese: Korriment perineali
English: 12-48 hours after VTP procedure
Maltese: 12-48 siegħa wara proċedura VTP
English: Perineal injury, perineal pain and prostatitis
Maltese: Korriment perineali, uġigħ perineali u prostatite
English: Clearance of padeliporfin di-potassium in healthy male subjects treated from 1.25 mg/kg up to 15 mg/kg of padeliporfin di-potassium ranged from 0.0245 to 0.088 L/h/kg.
Maltese: It-tneħħija ta' padeliporfin di-potassium f'individwi rġiel b'saħħithom kkurati minn 1.25 mg/kg sa15 mg/kg ta' padeliporfin di-potassium varjat minn 0.0245 sa 0.088 L/h/kg.
English: Eye irritation Photophobia
Maltese: Irritazzjoni tal-għajnejn Fotofobija
English: Prostatitis occurred in 7 (3.6 %) patients in the controlled Phase III European study.
Maltese: Il-prostatite seħħet f'7 (3.6 %) pazjenti fl-istudju Ewropew ta' Fażi
English: Children and adolescents This medicine should not be given to children and adolescents less than 18 years of age.
Maltese: Din il-mediċina m'għandhiex tingħata lil tfal u adolexxenti ta' età ta' inqas minn 18-il sena.
English: Anticoagulants (medicines that prevent the blood from clotting) These medicines (e.g. acenocoumarol, warfarin) should be stopped at least 10 days before the VTP procedure with TOOKAD.
Maltese: Antikoagulanti (mediċini li jipprevjenu l-koagulazzjoni tad-demm) Dawn il-mediċini (eż. acenocoumarol, warfarin) għandhom jitwaqqfu tal-inqas 10 ijiem qabel ilproċedura VTP b'TOOKAD.
English: Limited information is available regarding the safety and efficacy of radical prostatectomy after TOOKAD-VTP.
Maltese: Hemm informazzjoni limitata disponibbli dwar is-sigurtà u l-effikaċja ta' prostatektomija radikali wara
English: There is limited clinical information on overdose involving TOOKAD.
Maltese: Hemm informazzjoni klinika limitata dwar doża eċċessiva li tinvolvi TOOKAD.
English: One serious adverse event of prostatic abscess which was considered severe was reported in the study performed in Latin America in a patient who had a unilateral VTP procedure.
Maltese: Ġie rrappurat avveniment avvers serju wieħed ta' axxess fil-prostata li ġie kkunsidrat sever fl-istudju li sar fl-Amerika Latina f'pazjent li kellu proċedura VTP unilaterali.
English: Medicinal products which have potential photosensitising effects (such as tetracyclines, sulphonamides, quinolones, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin or amiodarone) should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.
Maltese: Prodotti mediċinali li għandhom effetti fotosensitizzanti potenzjali (bħal tetracyclines, sulphonamides, quinolones, phenothiazines, aġenti ipogliċemiċi sulfonylureas, dijuretiċi thiazide, griseofulvin jew amiodarone) għandhom jitwaqqfu għal tal-inqas 10 ijiem qabel il-proċedura b'TOOKAD u għal talinqas 3 ijiem wara l-proċedura jew għandhom jiġu sostitwiti b'kuri oħrajn mingħajr karatteristiċi fotosensitizzanti.
English: The median time to onset of urinary incontinence was 4 days (1-142).
Maltese: Iż-żmien medjan għallbidu ta' inkontinenza tal-awrina kien 4 ijiem (1-142).
English: Muscular and connective tissue disorders
Maltese: Disturbi tal-muskoli u tattessuti konnettivi
English: In healthy human male subjects, the mean volume of distribution ranged from 0.064-0.279 L/kg, for posologies from 1.25 to 15 mg/kg of padeliporfin di-potassium indicating distribution into extracellular fluid.
Maltese: F'individwi rġiel b'saħħithom, il-volum medju ta' distribuzzjoni varja minn 0.064-0.279 L/kg, għal pożoloġiji minn 1.25 sa 15 mg/kg ta' padeliporfin di-potassium li jindika distribuzzjoni fil-fluwidu ekstraċellulari.
English: Patients on a controlled potassium diet
Maltese: Pazjenti fuq dieta ta' potassium kkontrollat
English: The most frequently reported adverse reactions in the Phase II and III clinical studies were urinary and reproductive system disorders: dysuria (25.1 %), erectile dysfunction (21.1 %), haematuria (19.6 %), perineal pain/haematoma (15.3 %), urinary retention (13.3 %), micturition urgency (9.0 %), pollakiuria (7.3 %), urinary tract infection (5.5 %), incontinence (5.3 %) and ejaculation failure
Maltese: ematurja (19.6 %), uġigħ perineali/ematoma (15.3 %), żamma tal-awrina (13.3 %), urġenza biex tgħaddi l-awrina (9.0 %), pollakjurja (7.3 %), infezzjoni fl-apparat tal-awrina (5.5 %), inkontinenza
English: All patients had Gleason score ≤ 3 + 3 at baseline.
Maltese: Il-pazjenti kollha kellhom punteġġ Gleason ≤ 3 + 3 fil-linja bażi.
English: This medicine contains potassium.
Maltese: Din il-mediċina fiha l-potassium.
English: AS involved serial absolute PSA measurements and ultrasound-guided prostatic biospy at 12 and 24 months.
Maltese: AS involviet kejl serjali u assolut tal-PSA u bijopsija tal-prostata ggwidata minn ultrasound wara 12 u 24 xahar.
English: Moderate/higher risk prostate cancer was defined as any of the following: > 3 cores definitively positive for cancer; Gleason primary or secondary pattern ≥ 4; at least 1 cancer core length > 5 mm; PSA > 10 ng/mL in 3 consecutive measures; T3 prostate cancer; metastasis; prostate cancer-related death.
Maltese: Riskju moderat/għoli ta' kanċer tal-prostata ġie definit bħala waħda milli ġejjin: > 3 cores pożittivi definittivament għall-kanċer; tendenza ta' Gleason primarja jew sekondarja ≥ 4; tal-inqas tul ta' core tal-kanċer 1 ta' > 5 mm; PSA > 10 ng/mL fi tliet kejliet konsekuttivi; kanċer tal-prostata T3; metastażi, mewta relatata mal-kanċer tal-prostata.
English: Only 1 (0.5 %) patient had a severe (Grade 3) urinary incontinence.
Maltese: Pazjent 1 (0.5 %) biss kellu inkontinenza tal-awrina severa (Grad 3).
English: Not applicable 72 14.2 (8.89)
Maltese: 72 14.2 (8.89) Mhux applikabbli
English: When activated with 753 nm wavelength laser light, padeliporfin triggers a cascade of pathophysiological events resulting in focal necrosis within a few days.
Maltese: (wavelength) ta' 753 nm, padeliporfin jikkawza kaskata ta' avvenimenti patofiżjoloġiċi li jirriżultaw f'nekrożi fokali fi ftit jiem.
English: The body weight of patients (range 60-120 kg) presented a minor impact on the TOOKAD pharmacokinetic parameters for doses up to 5 mg/kg of padeliporfin di-potassium.
Maltese: Il-piż tal-ġisem tal-pazjenti (medda 60-120 kg) ippreżenta impatt żgħir fuq il-parametri talfarmakokinetika ta' TOOKAD għal dożi sa 5 mg/kg ta' padeliporfin di-potassium.