FrancophonIA/ELRC3.0 huggingface dataset:
English: As shown in Table 6, in the VTP arm of PCM301 study, erectile function domain scores of the 15-question International Index of Erectile Function (IIEF-15) questionnaire showed a marked decrease, 7 days after the VTP procedure followed by a subsequent improvement in the following months up to Month 24, in the ITT population and in patients meeting the indication criteria.
Maltese: Kif muri f'Tabella 6, fil-fergħa VTP tal-istudju PCM301, il-punteġġi fil-qasam tal-funzjoni erettili talkwestjonarju ta' 15-il mistoqsija Indiċi Internazzjonali tal-Funzjoni Erettili (IIEF-15, 15-question International Index of Erectile Function) urew tnaqqis sinifikanti, 7 ijiem wara l-proċedura VTP segwiti minn titjib sussegwenti fix-xhur ta' wara sa Xahar 24, fil-popolazzjoni ITT u fil-pazjenti li jissodisfaw il-kriterji tal-indikazzjoni.
English: - The other ingredient is mannitol.
Maltese: - L-ingredjent l-ieħor huwa mannitol.
English: Each vial of TOOKAD 366 mg contains 366 mg of padeliporfin (as potassium salt).
Maltese: Kull kunjett ta' TOOKAD 366 mg fih 366 mg ta' padeliporfin (bħala potassium salt).
English: Taking into account its molecular mass and the very low urinary excretion of the molecule, faecal elimination is the most probable route of elimination in human.
Maltese: Meta tiġi kkunsidrata l-massa molekulari tiegħu u l-eliminazzjoni baxxa ħafna tal-molekula mill-awrina, leliminazzjoni mill-ippurgar hija l-aktar rotta probabbli ta' eliminazzjoni fil-bniedem.
English: Other medicines and TOOKAD
Maltese: Mediċini oħra u TOOKAD
English: - A medicine used to treat fungal infections (griseofulvin).
Maltese: - Mediċina li tintuża biex tikkura infezzjonijiet fungali (griseofulvin).
English: Table 5: PCM301 - Effect on urinary morbidity (IPSS) - ITT population and patients meeting the indication criteria
Maltese: Tabella 5: PCM301 - Effett fuq il-morbidità urinarja (IPSS) - popolazzjoni ITT u pazjenti li jissodisfaw il-kriterji tal-indikazzjoni
English: Each vial of TOOKAD 183 mg contains 183 mg of padeliporfin (as potassium salt).
Maltese: Kull kunjett ta' TOOKAD 183 mg fih 183 mg ta' padeliporfin (bħala potassium salt).
English: - A medicine used to treat cardiac arrhythmia (amiodarone).
Maltese: - Mediċina li tintuża biex tikkura arritmija kardijaka (amiodarone).
English: Place a 0.22 μm injection filter on the syringe.
Maltese: 22 µm fuq is-siringa.
English: Characteristic
Maltese: Deskrizzjoni
English: - 40 mL of 5 % glucose solution for TOOKAD 366 mg.
Maltese: - 20 mL ta' soluzzjoni ta' 5 % glukożju għal TOOKAD 183 mg, - 40 mL ta' soluzzjoni ta' 5 % glukożju għal TOOKAD 366 mg,
English: In Phase II studies, treatment conditions corresponding to an LDI ≥ 1 were associated with a mean rate of necrosis of the targeted zone at day 7 of 89 % ± 20.75 for unilateral treatment.
Maltese: II, il-kondizzjonijiet tal-kura li jikkorrispondu għal LDI ≥ 1 ġew assoċjati ma' rata medja ta' nekrożi tal-parti fil-mira f'jum 7 ta' 89 % ± 20.75 għal kura unilaterali.
English: 1 mL of reconstituted solution contains 9.15 mg of padeliporfin.
Maltese: 1 mL ta' soluzzjoni rikostitwita fih 9.15 mg ta' padeliporfin.
English: Rapid consumption of the •NO radicals, by oxygen radicals, leads to the formation of reactive nitrogen species (RNS) (e.g. peroxynitrite), in parallel to arterial constriction.
Maltese: Il-konsum mgħaġġel tar-radikali ta' •NO mir-radikali tal-ossiġenu, jwassal għall formazzjoni ta' speċi tan-nitroġenu reattivi (RNS, reactive nitrogen species) (eż. peroxynitrite), flistess ħin ma' kostrizzjoni arterjali.
English: Table 1: Summary of adverse reactions considered related to TOOKAD and/or the study device and/or the study procedure in the pooled safety analysis (N=398)
Maltese: Tabella 1: Sommarju tar-reazzjonijiet avversi kkunsidrati relatati ma' TOOKAD u/jew l apparat tal-istudju u/jew il-proċedura tal-istudju fl-analiżi tas-sigurtà miġbura (N=398)
English: Of 121 patients that progressed in the AS arm, 54 underwent radical therapy and 67 had not received any active treatment at the end of the study.
Maltese: Mill-121 pazjent li pprogressaw fil-fergħa ta' AS, 54 irċivew terapija radikali u 67 ma kinux irċivew xi kura attiva fl-aħħar tal-istudju.
English: At present TOOKAD-VTP has been shown to defer the need for radical therapy and its associated toxicity.
Maltese: TOOKAD-VTP intwera li jiddeferixxi l-ħtieġa għal terapija radikali u t-tossiċità assoċjata magħha.
English: Posology The recommended posology of TOOKAD is one single dose of 3.66 mg/kg of padeliporfin.
Maltese: Pożoloġija Il-pożoloġija rakkomandata ta' TOOKAD hija doża singola waħda ta' 3.66 mg/kg ta' padeliporfin.
English: An overdose of the laser light may increase the risk of undesirable extraprostatic necrosis (see section 4.4).
Maltese: Doża eċċessiva tad-dawl laser tista' żżid ir-riskju ta' nekrożi ekstraprostatika mhux mixtieqa (ara sezzjoni 4.4).
English: For instructions on reconstitution of TOOKAD before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni ta' TOOKAD qabel jingħata, ara sezzjoni 6.6.
English: - Certain medicines used in type II diabetes (hypoglycaemic sulphonamides).
Maltese: - Ċerti mediċini li jintużaw fid-dijabete tat-tip II (sulphonamides ipogliċemiċi).
English: In patients with localised prostate cancer who received TOOKAD-VTP, necrosis was observed by Magnetic Resonance Imaging (MRI) at day 7.
Maltese: F'pazjenti b'kanċer tal-prostata lokalizzat li rċivew TOOKAD-VTP, ġiet osservata nekrożi permezz ta' Immaġini b'Reżonanza Manjetika (MRI, Magnetic Resonance Imaging) f'jum 7.
English: Perineal pain (pelvic pain).
Maltese: 9 Uġigħ perineali (uġigħ pelviku).
English: Pharmacotherapeutic group: Sensitizers used in photodynamic/radiation therapy, ATC code: L01XD07
Maltese: Sensitizzanti użati f'terapija fotodinamika/ta' radjazzjoni, Kodiċi
English: Only use light bulbs with a maximum power of 60 watts (for an incandescent light bulb) or 6 watts (for LED lights), or 12 watts (for fluorescent low-energy lights).
Maltese: Uża biss bozoz b'potenza massima ta' 60 watt (għal bozza talfilament) jew ta' 6 watts (għal dawl LED), jew ta' 12-il watt (għal dawl fluworexxenti li juża ftit enerġija).
English: Weight decreased
Maltese: Stenożi uretrali
English: The VTP procedure consisted of a 10 minutes IV injection of 4 mg/kg of TOOKAD followed by 22 minutes 15 seconds of illumination with 753 nm laser light at 200 J/cm of fibre delivered using interstitial optical fibres, inserted transperineally into the prostate gland.
Maltese: Il-proċedura VTP ikkonsistiet minn 10 minuti ta' injezzjoni ġol-vini ta' 4 mg/kg ta' TOOKAD segwita minn 22 minuta u 15-il sekonda ta' illuminazzjoni b'dawl laser ta' 753 nm b'200
English: Common side effects (may affect up to 1 in 10 people) - Anorectal discomfort (discomfort near the anus and just inside the anus), haemorrhoids (piles),
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10) - Skumdità anorettali (skumdità ħdejn l-anus jew eżatt ġol-anus), murliti (piles), proktalġja (uġigħ fil-parti anali),
English: - Certain medicines used to treat psychiatric conditions (phenothiazines).
Maltese: - Ċerti mediċini li jintużaw biex jikkuraw kondizzjonijiet psikjatriċi (phenothiazines).
English: This medicinal product contains potassium and in general the dose (3.66 mg/kg) will be less than 1 mmol (39 mg) i.e. essentially ‘potassium free'.
Maltese: Dan il-prodott mediċinali fih il-potassium u b'mod ġenerali, id-doża (3.66 mg/kg) se tkun inqas minn 1 mmol (39 mg) jiġifieri essenzjalment “ħieles mill- potassium”.
English: Total number of positive cores Mean (SD)
Maltese: Numru totali ta' cores pożittivi Medja (SD)
English: Rectal haemorrhage (anal haemorrhage).
Maltese: 3 Emorraġija tar-rektum (emorraġija anali).
English: In healthy human male subjects, the Cmax was shown to be linear from 1.25 mg/kg to 15 mg/kg of padeliporfin di-potassium, covering the therapeutic range.
Maltese: F'individwi rġiel b'saħħithom, is-Cmax intweriet li kienet lineari minn 1.25 mg/kg sa 15 mg/kg ta' padeliporfin di-potassium, li tkopri l-medda terapewtika.
English: In the Phase III European study, 20 (10.2 %) patients in the TOOKAD-VTP arm experienced genito-urinary infection.
Maltese: II, 20 (10.2 %) pazjent fil-fergħa ta' TOOKAD-VTP esperjenzaw infezzjoni ġenitourinarja.
English: Any previous prostatic interventions where the internal urinary sphincter may have been damaged, including trans-urethral resection of the prostate (TURP) for benign prostatic hypertrophy.
Maltese: - Inti għaddejt minn proċedura biex tikkura ipertrofija prostatika beninna (benign prostatic hyperplasia) inkluż Resezzjoni Transuretrali tal-Prostata (TURP - Trans-Urethral Resection of the Prostate).
English: Healthy subjects have been exposed to doses up to 15 mg/kg of padeliporfin di-potassium (corresponding to 13.73 mg/kg of padeliporfin) without light activation and 23 patients have been treated with 6 mg/kg of padeliporfin di-potassium (corresponding to 5.49 mg/kg of padeliporfin) without significant safety issues.
Maltese: Individwi b'saħħithom ġew esposti għal dożi sa 15 mg/kg ta' padeliporfin di-potassium (li jikkorrispondu għal 13.73 mg/kg ta' padeliporfin) mingħajr attivazzjoni tad-dawl u 23 pazjent ġew ikkurati b'6 mg/kg ta' padeliporfin di-potassium(li tikkorispondi għal 5.49 mg/kg ta' padeliporfin) mingħajr problemi sinifikanti tas-sigurtà.
English: In general, the dose of TOOKAD contains less than 1 mmol (39 mg) potassium, i.e. essentially ‘potassium free'.
Maltese: B'mod ġenerali, id-doża ta' TOOKAD fiha inqas minn 1 mmol (39 mg) potassium, jiġifieri essenzjalment “ħieles mill- potassium”.
English: Anticoagulants and antiplatelet agents
Maltese: Antikoagulanti u sustanzi kontra l-pjastrini (antiplatelet agents)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1228/002
Maltese: EU/1/17/1228/001 EU/1/17/1228/002
English: See section 4.5 for interactions with photosensitizing medicinal products.
Maltese: Ara sezzjoni 4.5 għal interazzjonijiet ma' prodotti mediċinali li jagħmlu fotosensittività.
English: Abnormal clotting (fibrin D dimer increased, aPTT prolonged, INR increased).
Maltese: Koagulazzjoni anormali (żieda fil-fibrin D dimer, aPTT imtawwal, żieda fl-INR). 15
English: The main inclusion criteria were low-risk prostate cancer with Gleason 3 + 3 prostate adenocarcinoma as a maximum, two to three cores positive for cancer and a maximum cancer core length of 5 mm in any core (at least 3 mm for patients with only one positive core), clinical stage up to T2a, PSA ≤ 10 ng/mL, prostate volume equal or greater than 25 cc and less than 70 cc.
Maltese: Il-kriterji tal-inklużjoni ewlenin kienu kanċer tal-prostata ta' riskju baxx b'adenokarċinoma talprostata ta' Gleason 3 + 3 bħala massimu, żewġ sa tliet cores pożittivi għall-kanċer u tul massimu tal core tal-kanċer ta' 5 mm fi kwalunkwe core (tal-inqas 3 mm għall-pazjenti b'core pożittiv wieħed biss), stadju kliniku sa T2a, PSA ≤ 10 ng/mL, volum tal-prostata daqs jew ikbar minn 25 cc u inqas minn 70 cc.
English: g g h
Maltese: Fergħa
English: The most common infections are orchitis, epididymitis and urinary tract infections including cystitis.
Maltese: L-aktar infezzjonijiet komuni huma orkite, epididimite u infezzjonijiet fl-apparat tal-awrina inkluż ċistite.
English: The patient may watch television from a distance of 2 metres and, from 6 hours onwards, may use electronic devices such as smartphones, tablets and computers.
Maltese: Tista' tara t-televixin minn distanza ta' 2 metri u, minn 6 sigħat wara l-proċedura, tista' tuża apparat elettroniku bħal smartphones, tablets u kompjuters.
English: Then the prostate is illuminated immediately for 22 minutes 15 seconds by laser light at 753 nm delivered via interstitial optical fibres from a laser device at a power of 150 mW/cm of fibre, delivering an energy of 200 J/cm.
Maltese: Imbagħad ikun hemm illuminazzjoni immedjata fuq il-prostata għal 22 minuta u 15-il sekonda b'dawl ta' laser b'753 nm li jitwassal permezz ta' fibri ottiċi interstizjali minn apparat tal-laser b'potenza ta' 150 mW/cm ta' fibra, li jwassal enerġija ta' 200
English: In a patient treated at 2 mg/kg of TOOKAD, one case of Grade 3 ischaemic optic neuropathy was reported 33 days after the VTP procedure.
Maltese: F'pazjent ikkurat b'2 mg/kg ta' TOOKAD, każ wieħed ta' newropatija ottika iskemika ta' Grad 3 ġie rrappurtat 33 jum wara l-proċedura VTP.
English: In vitro studies indicate that TOOKAD does not inhibit P-gp, OAT1, OAT3, OCT2, OCT1, BCRP and BSEP but it could inhibit both OATP1B1 and OATP1B3 transporters (see section 4.5).
Maltese: Studji in vitro jindikaw li TOOKAD ma jinibixxix P-gp, OAT1, OAT3, OCT2, OCT1, BCRP u BSEP iżda jista' jinibixxi kemm lil trasportaturi OATP1B1 kif ukoll ta' OATP1B3 (ara sezzjoni 4.5).
English: Activation within the illuminated tumour vasculature, generates oxygen radicals (•OH, O•
Maltese: L-attivazzjoni fl-vaskolatura tat-tumur illuminat, tiġġenera radikali talossiġenu (•OH, O•
English: Connect an opaque tube to the filter.
Maltese: Qabbad tubu opak mal-filtru.
English: n Mean score (SD) Baseline 184 18.6 (10.22) 188 20.6 (9.92) 74 18.4 (10.31) 74 20.8 (10.02) Day 7 165 11.5 (10.96)
Maltese: Bażi 184 18.6 (10.22) 188 20.6
English: TOOKAD 183 mg powder for solution for injection TOOKAD 366 mg powder for solution for injection padeliporfin
Maltese: TOOKAD 183 mg trab għal soluzzjoni għall-injezzjoni TOOKAD 366 mg trab għal soluzzjoni għall-injezzjoni padeliporfin
English: In 18 patients the adverse event resolved with a median duration of 63.5 days (1-360), and the adverse event was still ongoing at the end of the study for 7 patients.
Maltese: Fi 18-il pazjent, l-avveniment avvers issolva b'durata medjana ta' 63.5 jiem (1-360), u l-avveniment avvers kien għadu għaddej f'7 pazjenti fl-aħħar tal-istudju.
English: The LDI corresponds to the ratio of the cumulative length of illuminated fibre tips (cm) to the volume (cc) of the targeted zone to be treated.
Maltese: L-LDI jikkorrispondi mal-proporzjon tat-tul kumulattiv tat-truf tal-fibri illuminati (cm) għall-volum (cc) tal parti fil-mira li se tiġi kkurata.
English: Perineal injury (post-procedural haematoma, necrosis, perineal haematoma, pelvic haematoma).
Maltese: Korriment perineali (ematoma ta' wara l-proċedura, nekrożi, ematoma perineali, ematoma pelvika).
English: In the Phase III European study, 30 (15.2 %) patients experienced urinary retention.
Maltese: III, 30 (15.2 %) pazjent esperjenzaw żamma tal-awrina.
English: The solution is administered by intravenous injection over 10 minutes.
Maltese: Is-soluzzjoni tingħata b'injezzjoni ġol-vini fuq 10 minuti.
English: Adjusted Hazard Ratio (95% CI) = 0.11 (0.05 ; 0.25) ; p value ≤ 0.001
Maltese: 12 ; 0.27) ; valur p ≤ 0.001 jProporzjon ta' Riskju Aġġustat (95% CI) = 0.11 (0.05 ; 0.25) ; valur p ≤ 0.001
English: Urethral stenosis
Maltese: Ġilda xotta
English: TOOKAD is contraindicated in patients who have been diagnosed with cholestasis (see section 4.3).
Maltese: TOOKAD huwa kontraindikat f'pazjenti li ġew dijanjostikati b'kolestażi (ara sezzjoni 4.3).
English: Dysuria (bladder pain, bladder spasm, hypertonic bladder, urethral spasm, urinary tract pain).
Maltese: 6 Diżurja (uġigħ fil-bużżieqa tal-awrina, spażmu fil-bużżieqa tal-awrina, bużżieqa tal-awrina ipertonika, spażmu uretrali, uġigħ fl-apparat tal-awrina).
English: Table 3: PCM301 - Co-primary efficacy endpoints - Whole prostate gland and treated lobe(s)* - ITT population and patients meeting the indication criteria
Maltese: Tabella 3: PCM301 - Punti ta' tmiem (endpoints) koprimarji tal-effikaċja - Glandola talprostata sħiħa u lobe/lobes kkurat(i)* - popolazzjoni ITT u pazjenti li jissodifsaw il-kriterji talindikazzjoni
English: Genito-urinary tract infection (urinary tract infection, orchitis, epididymitis, cystitis).
Maltese: 1 Infezzjoni fl-apparat ġenito-urinarju (infezzjonijiet fl-apparat tal-awrina, orkite, epididimite, ċistite).
English: Table 6: PCM301 - Effect on erectile function (IIEF) - ITT population and patients meeting the indication criteria
Maltese: Tabella 6: PCM301 - Effett fuq il-funzjoni erettili (IIEF) - popolazzjoni ITT u pazjenti li jissodisfaw il-kriterji tal-indikazzjoni
English: Adjusted Hazard Ratio (95% CI) = 0.34 (0.24 ; 0.46) ; p value ≤ 0.001
Maltese: Proporzjon ta' Riskju Aġġustat (Adjusted Hazard Ratio) (95% CI) = 0.34 (0.24 ; 0.46) ; valur p ≤ hProporzjon ta' Riskju Aġġustat (95% CI) = 0.
English: Problem associated with the urethra
Maltese: Problema assoċjata mal-uretra
English: See also under “Other medicines and TOOKAD” for the effects of anticoagulants and antiplatelet medicines.
Maltese: Ara wkoll taħt “Mediċini oħra u TOOKAD” għall-effetti tal-antikoagulanti u tal-mediċini kontra l pjastrini (patelets).
English: PSA should be tested every 3 months for first 2 years post VTP and every 6-months thereafter in order to assess PSA dynamics (PSA Doubling Time (DT), PSA velocity).
Maltese: VTP u kull 6 xhur wara dan sabiex jiġu evalwati d-dinamiċi tal-PSA (Irduppjar tal-ħin tal-PSA (DT, PSA Doubling Time), u veloċità tal-PSA).
English: Effects of covariates on pharmacokinetic properties The effects of age, weight and race were investigated in healthy volunteers and patients.
Maltese: L-effetti tal-età, tal-piż u tar-razza ġew investigati f'voluntiera u f'pazjenti b'saħħithom.
English: Submission of final study results:
Maltese: finali talistudju:
English: Table 4: PCM301 - Number of subjects with radical treatment at 24 months - ITT population and patients meeting the indication criteria
Maltese: Tabella 4: PCM301 - Numru ta' individwi b'kura radikali wara 24 xahar - popolazzjoni
English: Padeliporfin has not been tested for reproductive toxicity and fertility.
Maltese: Padeliporfin ma ġiex ittestjat għal effett tossiku fuq is-sistema riproduttiva u l-fertilità.
English: TOOKAD 183 mg powder for solution for injection TOOKAD 366 mg powder for solution for injection
Maltese: TOOKAD 183 mg trab għal soluzzjoni għall-injezzjoni TOOKAD 366 mg trab għal soluzzjoni għall-injezzjoni
English: Each vial contains 366 mg of padeliporfin (as di-potassium salt).
Maltese: Kull kunjett fih 366 mg ta' padeliporfin (bħala di-potassium salt).
English: A similar mean distribution volume was seen in patients with localised prostate cancer treated with 2 and 4 mg/kg of padeliporfin di-potassium (0.09-0.10 L/kg respectively).
Maltese: Volum ta' distribuzzjoni medju simili deher f'pazjenti b'kanċer tal-prostata lokalizzat b'2 u 4 mg/kg ta' padeliporfin di-potassium(0.
English: Padeliporfin was shown to be cytotoxic in the presence of UVA irradiation (in vitro) and considered phototoxic in the guinea pig (in vivo).
Maltese: Padeliporfin intwera li huwa ċitotossiku fil-preżenza ta' irradjazzjoni UVA (in vitro) u ġie kkunsidrat fototossiku fil-fenek tal-Indi (in vivo).
English: Prophylactic antibiotics and alpha-blockers may be prescribed at the physician's discretion.
Maltese: Jistgħu jiġu preskritti antibijotiċi profilattiċi u inibituri alfa (alpha-blockers) skont id-diskrizzjoni tat-tabib.
English: Ecchymosis
Maltese: Ekkimożi (Ecchymosis)
English: TOOKAD 183 mg powder for solution for injection Amber type I glass vial, sealed with a rubber stopper crimped with an aluminium seal and covered with a blue plastic flip-off cap, containing 183 mg padeliporfin.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih TOOKAD 183 mg trab għal soluzzjoni għall-injezzjoni Kunjett tal-ħġieġ kulur l-ambra tat-tip I, issiġillat b'tapp tal-gomma rbattut b'siġill tal-aluminju u mgħotti b'għatu tat-tip flip-off tal-plastik blu, li fih 183 mg padeliporfin.
English: Pruritus
Maltese: KUNJETT
English: Each vial contains 183 mg of padeliporfin (as di-potassium salt).
Maltese: Kull kunjett fih 183 mg ta' padeliporfin (bħala di-potassium salt).
English: The chemical and physical stability of TOOKAD after reconstitution with 5 % glucose solution, in its vial, has been demonstrated for 8 hours at 15°C-25°C and at 5°C ± 3°C.
Maltese: Wara rikostituzzjoni b'soluzzjoni ta' 5 % glukożju fil-kunjett tiegħu, l-istabbiltà kimika u fiżika ta' TOOKAD intweriet għal 8 sigħat f'15°C-25°C u f'5°C ± 3°C.
English: Libido decreased Affective disorder Encopresis
Maltese: Libido mnaqqas Disturb affettiv Enkopreżi (Encopresis)
English: The pivotal open-label Phase III study (PCM301), conducted in 10 European countries, randomised 413 patients to TOOKAD-VTP arm or AS arm.
Maltese: III (PCM301), li sar f'10 pajjiżi Ewropej, qassam b'mod arbitrarju lil 413-il pazjent jew għall-fergħa ta' TOOKAD-VTP jew għall-fergħa ta' AS.
English: Medicines with a potentially photosensitising effect: - Certain antibiotics used to treat infection (tetracyclines, sulphonamides, quinolones).
Maltese: - Ċerti antibijotiċi li jintużaw biex jikkuraw infezzjoni (tetracyclines, sulphonamides,
English: The safety and efficacy of subsequent radical therapy (surgery or radiotherapy) is uncertain.
Maltese: Terapija radikali wara proċedura VTP Is-sigurtà u l-effikaċja ta' terapija radikali sussegwenti (kirurġija jew radjoterapija) huma inċerti.
English: Two cases of excessive extraprostatic necrosis occurred due to incorrect laser calibration without clinical sequelae.
Maltese: Seħħew żewġ każijiet ta' nekrożi ekstraprostatika eċċessiva minħabba kalibrazzjoni tal-laser skoretta imma mingħajr konsegwenzi kliniċi.
English: Post-authorisation efficacy study (PAES): In order to further investigate long-term efficacy of TOOKAD and its impact on disease progression including potential impact on the efficacy of subsequent radical therapy in patients with low risk prostate cancer (excluding very low risk) as well as further characterise the long term safety of TOOKAD, the MAH should conduct and submit the results of a long-term observational cohort study of patients with unilateral low risk localised prostate cancer treated with TOOKAD VTP (CLIN1501 PCM401).
Maltese: għandu jwettaq u jissottometti r-riżultati ta' studju ta' gruppi ta' osservazzjoni fit-tul ta' pazjenti b'kanċer tal-prostata lokalizzat ta' riskju baxx unilaterali kkurati b'TOOKAD VTP (CLIN1501 PCM401).
English: TOOKAD is locally activated immediately after injection by laser light at 753 nm delivered via interstitial optical fibres from a laser device at a power of 150 mW/cm of fibre, delivering an energy of 200 J/cm over 22 minutes 15 seconds.
Maltese: TOOKAD jiġi attivat lokalment immedjatament wara l-injezzjoni permezz ta' dawl laser b'753 nm li jitwassal permezz ta' fibri ottiċi interstizjali minn apparat tal-laser b'potenza ta' 150 mW/cm ta' fibra, li jwasslu enerġija ta' 200
English: There could be an additional risk of eye photosensitivity in patients who have received intra-occular anti-VEGF therapy.
Maltese: Jista' jkun hemm riskju addizzjonali ta' fotosensittività tal-għajnejn f'pazjenti li rċivew terapija kontra
English: The magnitude of interaction has not been investigated clinically but a transient increase in the plasma concentration of co-administered substrates of OATP1B1 and OATP1B3 cannot be ruled out.
Maltese: Id-daqs tal-interazzjoni ma ġiex investigat klinikament iżda żieda tranżitorja fil-konċentrazzjoni filplażma ta' substrates ta OATP1B1 u OATP1B3 mogħtija flimkien ma tistax tiġi eskluża.
English: In vitro genotoxicity testing identified padeliporfin as having weak potential to induce clastogenicity when illuminated by ultraviolet (UV); this correlates with the mechanism of action (formation of reactive oxygen species).
Maltese: Ittestjar in vitro dwar l-effett tossiku fuq il-ġeni identifika li padeliporfin għandu potenzjal baxx li jinduċi klastoġeniċità meta illuminat minn raġġi ultravjola (UV, ultraviolet); dan jikkorrelata mal mekkaniżmu ta' azzjoni (formazzjoni ta' speċi ta' ossiġenu reattivi).
English: Blood lactate dehydrogenase increased Blood triglyceride increased Gamma-glutamyltransferase increased Blood cholesterol increased Blood creatine phosphokinase increased Blood potassium decreased Low density lipoprotein increased Neutrophil count increased PSA increased
Maltese: Dan jintuża biex jikkura rġiel adulti li jkollhom kanċer tal-prostata lokalizzat ta' riskju baxx f'lobe wieħed biss, bl-użu ta' teknika li jisimha terapija Fotodinamika Mmirata lejn il-Vaskulari (Vascular-Targeted Photodynamic therapy