FrancophonIA/ELRC3.0 huggingface dataset:
English: An LDI ≥ 1 appeared to be associated with a greater volume of necrosis on Day 7 MRI and greater share of patients with negative biopsy at 6 months compared with an LDI < 1 (see section 4.2).
Maltese: LDI ≥ 1 deher li kien assoċjat ma' volum ikbar ta' nekrożi fl-MRI ta' Jum 7 u parti akbar ta' pazjenti b'bijopsija negattiva wara 6 xhur meta mqabbel ma' LDI < 1 (ara sezzjoni 4.2).
English: Although they were excluded from the clinical trials, there is a potential risk of increased stenosis post the TOOKAD-VTP procedure in patients with pre-existing stenosis (see section 4.8).
Maltese: Għalkemm dawn ġew esklużi mill-provi kliniċi, hemm riskju potenzjali ta' stenożi miżjuda wara lproċedura TOOKAD-VTP f'pazjenti bi stenożi preeżistenti (ara sezzjoni 4.8).
English: Some cases of hepatotoxicity (1.5 %), such as elevation of transaminases, were also reported.
Maltese: Ġew irrappurtati wkoll xi każijiet ta' epatotossiċità (1.5 %), bħal żieda fit-transaminases.
English: There was a correlation between the total energy delivered and the volume of necrosis observed at day 7.
Maltese: Kien hemm korrelazzjoni bejn l-enerġija totali mwassla u l-volum ta' nekrożi osservat f'jum 7.
English: Padeliporfin is retained within the vascular system.
Maltese: Mekkaniżmu ta' azzjoni Padeliporfin jinżamm fis-sistema vaskulari:
English: Haematoma Hypertension
Maltese: Skumdità addominali
English: Illumination for photoactivation of TOOKAD
Maltese: Illuminazzjoni għall-fotoattivazzjoni ta' TOOKAD
English: A secondary objective was to determine the difference between the two arms with regard to the rate of subsequent radical therapy for prostate cancer.
Maltese: Objettiv sekondarju kien li tiġi ddeterminata d-differenza bejn iż-żewġ fergħat fir-rigward tar-rata ta' terapija radikali sussegwenti għall-kanċer tal-prostata.
English: Hepatic impairment
Maltese: II u Awtorizzazzjoni
English: NAME OF THE MEDICINAL PRODUCT TOOKAD 366 mg powder for solution for injection padeliporfin
Maltese: TAL-PRODOTT MEDIĊINALI TOOKAD 366 mg trab għal soluzzjoni għall-injezzjoni padeliporfin
English: In the pivotal Phase III European study, moderate or severe urethral stenosis developed in 2 (1.0 %) patients 5 to 6 months post-procedure.
Maltese: III, żviluppat stenożi uretreli moderata jew severa f'2 (1.0 %)
English: Perineal injury and perineal pain occurred in 46 (23.4 %) patients in the controlled Phase III European study.
Maltese: Il-korriment perineali u l-uġigħ perineali seħħew f'46 (23.4 %) pazjent fl-istudju Ewropew ta' Fażi
English: The pharmacokinetic properties of TOOKAD were studied in 42 healthy human male subjects (without photoactivation) and in 70 patients with localised prostate cancer (after photoactivation).
Maltese: It-tagħrif farmakokinetiku ta' TOOKAD ġie studjat fi 42 individwu rġiel b'saħħithom (mingħajr il fotoattivazzjoni) u f'70 pazjent b'kanċer tal-prostata lokalizzat (wara l-fotattivazzjoni).
English: Allow the opaque syringe to rest in a vertical position for 3 minutes to ensure any foam disappears.
Maltese: Ħalli s-siringa opaka toqgħod f'pożizzjoni vertikali għal 3 minuti sabiex tiżgura li r-ragħwa tisparixxi.
English: Abdominal discomfort Abnormal faeces Diarrhoea
Maltese: Żieda fil-lactate dehydrogenase fiddemm
English: However, patients weighing more than 115 kg will receive more than 1 mmol potassium.
Maltese: Madankollu, pazjenti li jiżnu aktar minn 115-il kg se jirċievu aktar minn 1 mmol potassium.
English: Sciatica
Maltese: Astenija
English: The use of medicinal products that are substrates of OATP1B1 or OATP1B3 (repaglinide, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan, glyburide) for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.
Maltese: pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan, glyburide) li għalihom ġew osservati avvenimenti avversi serji dipendenti fuq il-konċentrazzjni għandhom jiġu evitati dakinhar tal-infużjoni ta' TOOKAD u għal tal-inqas 24 siegħa wara l-għoti.
English: Very few patients aged over 75 years were enrolled into studies where pharmacokinetic measurements were taken so it is not known if there is a difference in these older patients compared to patients less than 75 years of age (see sections 4.2 and 5.1).
Maltese: Popolazzjoni tal-anzjani Kien hemm ftit wisq pazjenti li kellhom aktar minn 75 sena li ġew irreġistrati fl-istudji fejn ittieħed il kejl farmakokinetiku, għalhekk mhuwiex magħruf jekk hemmx differenza f'dawn il-pazjenti akbar fl età meta mqabbla ma' pazjenti ta' età ta' inqas minn 75 sena (ara sezzjonijiet 4.2 u 5.1).
English: The TOOKAD-VTP procedure is contraindicated in patients with any previous prostatic interventions where the internal urinary sphincter may have been damaged, including transurethral resection of the prostate (TURP) for benign prostatic hypertrophy (see section 4.3).
Maltese: Kwalunkwe intervent prostatiku preċedenti fejn tista' tkun saret ħsara lill-isfinkter tal-awrina intern, inkluż resezzjoni transuretrali tal-prostata (TURP, trans-urethral resection of the prostate) għal ipertrofija prostatika beninna.
English: Sensory disturbance Formication
Maltese: Disturb marbut mas-sensi
English: Prior to launch of TOOKAD in each Member State the marketing authorisation holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: (MAH) għandu jaqbel fuq il-kontenut u l-format tal-programm edukattiv, inkluż il-mezzi tal komunikazzjoni, il-modalitajiet tad-distribuzzjoni, u kull aspett ieħor tal-programm, mal-Awtorità Nazzjonali Kompetenti.
English: Possible side effects can occur with TOOKAD and VTP procedure.
Maltese: Jistgħu jseħħu effetti sekondarji possibbli b'TOOKAD u bil-proċedura VTP.
English: Erythema
Maltese: Ematoma
English: Radical therapy post VTP procedure
Maltese: Il-proċedura VTP
English: However, this will be exceeded in patients heavier than 115 kg.
Maltese: Madankollu, dan se jinqabeż f'pazjenti li jiżnu aktar minn 115-il kg.
English: Ureteric haemorrhage Urethral haemorrhage Urinary tract disorders
Maltese: Mard infjammatorju attiv tal-imsaren
English: In assessing overall tolerability by Month 24, post enrolment patients who underwent a radical therapy were also counted in the scoring of prostate symptoms and erectile function.
Maltese: Fil-valutazzjoni tat-tollerabbiltà globali sa Xahar 24, il pazjenti ta' wara r-reġistrazzjoni li rċivew terapija radikali ngħaddew ukoll fil-punteġġ tas-sintomi tal prostata u tal-funzjoni erettili.
English: The use of medicines such as repaglinide, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan, glyburide should be avoided on the day of TOOKAD administration and for at least 24 hours after administration.
Maltese: Mediċini oħra li jistgħu jinteraġixxu ma' TOOKAD L-użu ta' mediċini bħal repaglinide, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan, glyburide għandu jiġi evitat dakinar tal-għoti ta' TOOKAD u għal tal-inqas 24 siegħa wara l-għoti.
English: When the analysis was restricted to patients that underwent unilateral VTP, 33 (16.8 %) patients experienced erectile dysfunction for more than 6 months, including 17 (8.6 %) patients in whom the erectile dysfunction had not resolved at the end of the study.
Maltese: Meta l-analiżi kienet ristretta għal pazjenti li ħadu VTP unilaterali, 33 (16.8 %) pazjent esperjenzaw disfunzjoni erettili għal aktar minn 6 xhur, inkluż 17
English: Insufficient patients underwent retreatment of the ipsilateral lobe or sequential treatment of the contralateral lobe to determine the efficacy and safety of a second TOOKAD-VTP procedure.
Maltese: Numru insuffiċjenti ta' pazjenti rċievew kura mill-ġdid tal-lobu ipsilaterali jew kura sekwenzjali tallobu kontralaterali sabiex jiġu ddeterminati l-effikaċja u s-sigurtà ta' proċedura TOOKAD-VTP
English: Catheter site pain Laser device failure Infusion site bruising Nodule
Maltese: Sensazzjoni bħal insetti mexjin fuq ilġilda
English: No biopsy result, n (%) Subjects who had radical therapy leading to missing biopsy, n (%)
Maltese: Numru ta' individwi li bdew kura radikali, n (%) Numru ta' individwi li bdew kura radikali wara lprogressjoni, n (%)
English: • Information on adverse drug reactions and the likelihood of them getting them, including: erectile dysfunction, urinary incontinence, urinary retention/urethral stricture, and photosensitivity and the need to follow the rules to protect themselves against the light after the procedure for 48 hours.
Maltese: • Informazzjoni dwar reazzjonijiet avversi għal mediċina u l-probabbiltà li jkollhom minnhom, inkluż: disfunzjoni erettili, inkontinenza tal-awrina, żamma tal-awrina/kontrazzjoni uretrali, u fotosensittività u l-ħtieġa li jiġu segwiti r-regoli sabiex jipproteġu lilhom infushom mid-dawl għal 48 siegħa wara l-proċedura.
English: Prostatic abscess
Maltese: Uġigħ proċedurali
English: The median duration was 21 days (4-197).
Maltese: Id-durata medjana kienet 21 jum (4
English: Healthcare professionals are asked to report any suspected adverse reactions.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni talprodott mediċinali.
English: Patients with a history of urethral stricture or with urinary flow problems may be at increased risk of poor flow and urinary retention post the TOOKAD-VTP procedure.
Maltese: Il-pazjenti bi storja ta' kontrazzjoni uretrali jew bi problemi fil-fluss tal-awrina jistgħu jkunu f'riskju miżjud ta' fluss baxx u żamma tal-awrina wara l-proċedura TOOKAD-VTP.
English: One patient had Grade 3 prostatitis considered as serious that started 4 days after the VTP procedure, and lasted for 31 days before resolving without sequelae.
Maltese: Pazjent wieħed kellu prostatite ta' Grad 3 li ġiet ikkunsidrata serja li bdiet 4 ijiem wara l-proċedura VTP, u damet għal 31 jum qabel issolviet mingħajr konsegwenzi.
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 as well as further characterise the long term safety of TOOKAD, the MAH should submit the results of a randomised phase 3 study in patients with localised prostate cancer compared to active surveillance (7-year follow-up study including in an depth biopsy study) (PCM301 FU5).
Maltese: Sabiex jinvestiga aktar l-effikaċja fittul ta' TOOKAD u l-impatt tagħha fuq il-progressjoni tal-marda inkluż l-impatt potenzjali fuq l effikaċja ta' terapija radikali sussegwenti f'pazjenti b'riskju baxx ta' kanċer tal-prostata kif ukoll biex jikkaratterizza aktar is-sigurtà fit-tul ta' TOOKAD, il-MAH għandu jissottometti r-riżultati ta' studju ta' fażi 3 fejn il-pazjenti ntagħżlu b'mod arbitrarju f'pazjenti b'kanċer tal-prostata lokalizzat meta mqabbel ma' sorveljanza attiva (studju ta' segwitu ta' 7 snin inkluż studju ta' bijopsija fid-dettall) (PCM301 FU5).
English: TOOKAD is prepared by reconstituting the powder for solution for injection with: - 20 mL of 5 % glucose solution for TOOKAD 183 mg,
Maltese: - għal TOOKAD 183 mg: 20 mL ta' soluzzjoni ta' 5 % glukożju fil-kunjett li fih it-trab;
English: TOOKAD 366 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 white plastic flip-off cap, containing 366 mg padeliporfin.
Maltese: 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 abjad, li fih 366 mg padeliporfin.
English: Your doctor may prescribe antibiotics to prevent infection and alpha-blockers (medicines given to prevent difficulties in urinating).
Maltese: It-tabib tiegħek jista' jippreksrivilek antibijotiċi biex jipprevjenu infezzjoni u inibituri alfa (alpha blockersmediċini mogħtija biex jipprevjeni diffkultajiet meta tgħaddi l-awrina).
English: An injection filter of 0.22 µm and an opaque tubing should be used to administer the medicinal product to the patient.
Maltese: 22 µm u tubu opak sabiex jingħata l-prodott mediċinali lill-pazjent.
English: In addition, impaired deformability is thought to enhance erythrocyte aggregability and formation of blood clots at the interface of the arterial supply (feeding arteries) and tumour microcirculation, results in occlusion of the tumour vasculature.
Maltese: Barra minn hekk, huwa maħsub li deformabbiltà indebolita żżid l aggregabilità tal-eritroċiti u l-koagulazzjoni tad-demm fl-interfaċċa tal-provvista arterjali (arterji tat tmigħ) u l-mikroċirkulazzjoni tat-tumur, tirriżulta fl-okklużjoni tal-vaskulatura tat-tumur.
English: The powder is a dark lyophilisate.
Maltese: kura fi proporzjon ta' pazjenti.
English: Of 58 patients that progressed in the TOOKAD-VTP arm, only 11 underwent radical therapy, 18 patients underwent a second VTP procedure and 29 had not received further treatment at the end of the study.
Maltese: Mit-58 pazjent li pprogressaw fil-fergħa ta' TOOKAD-VTP, 11 biss irċivew terapija radikali, 18-il pazjent irċivew proċedura VTP oħra u 29 ma kinux irċivew kura ulterjuri fl-aħħar tal-istudju.
English: * The treated lobe(s) in the AS arm was defined as the lobe(s) with disease at baseline.
Maltese: * Il-lobe/lobes kkurat(i) fil-fergħa AS ġie definit bħala l-lobe/lobes b'marda fil-linja bażi.
English: Adverse reaction Haematospermia
Maltese: Reazzjoni tal-ġilda
English: Groin pain Muscle haemorrhage Haemarthrosis Musculoskeletal pain Pain in extremity
Maltese: inkluż: inċertezzi dwar il-benefiċċju dejjiemi ta' TOOKAD; inċertezzi dwar is-sigurtà fit-tul ta' TOOKAD u l-effikaċja/is-sigurtà ta' kwalunkwe kura oħra meħtieġa bħal prostatektomija radikali
English: Current exacerbation of rectal inflammatory bowel disease (see section 4.4).
Maltese: Din kienet teħtieġ dilatazzjoni uretrali (ara sezzjoni 4.4).
English: This required urethral dilatation (see section 4.4).
Maltese: Prodott, sezzjoni 4.2).
English: This includes sunbeds, bright computer monitor screens and medical examination lights, such as ophthalmoscopes, otoscopes and endoscopy equipment, for 48 hours following the VTP procedure.
Maltese: Dan jinkludi sodod għat-tixmix, skrins talmonitors tal-kompjuters u dwal ta' eżamijiet mediċi, bħal oftalmoskopji, otoskopji u apparat talendoskopija, għal 48 siegħa wara l-proċedura VTP.
English: Extraprostatic necrosis There may be extraprostatic necrosis in the peri-prostatic fat not associated with clinical symptoms.
Maltese: - Testijiet tad-demm anormali relatati mal-koagulazzjoni.
English: In the 24 months of the pivotal European Phase III study, no patients underwent radical radiotherapy post TOOKAD-VTP.
Maltese: *Il-punteġġi f'Xahar 24 jinkludu pazjenti li rċivew terapija radikali 5
English: Table 2: PCM301 - Baseline characteristics by arm for the Intention-To-Treat (ITT) population and patients meeting the indication criteria
Maltese: Tabella 2: PCM301 - Karatteristiċi fil-Linja bażi skont il-fergħa għall-popolazzjoni (ITT,
English: Any medical condition that precludes the administration of a general anaesthetic or invasive procedures.
Maltese: Kwalunkwe kondizzjoni medika li tipprekludi l-għoti ta' anestetiku ġenerali jew proċeduri invażivi.
English: causing local hypoxia that induces the release of nitric oxide (•NO) radicals.
Maltese: 2 ) u b'hekk tikkawża ipoksja lokali li tinduċi r-rilaxx ta' radikali ta' nitric oxide
English: b b f f
Maltese: Fergħa AS
English: In case of unilateral disease, focal treatment of one lobe was to be applied.
Maltese: F'każ ta' marda unilaterali, kellha tiġi applikata kura fokali ta' lobe wieħed.
English: Hepatobiliary disorders
Maltese: Koagulazzjoni anormali
English: Back pain (intervertebral disc protrusion).
Maltese: 5 Uġigħ fid-dahar (id-diska intervertebrali maqbuża ‘l barra).
English: Effect on urinary morbidity (IPSS) and erectile function (IIEF) following TOOKAD-VTP As shown in Table 5, in PCM301 study, the International Prostate Symptoms Score (IPSS) showed, a moderate increase 7 days after the VTP procedure, in both the ITT population and in patients meeting the indication criteria.
Maltese: TOOKAD-VTP Kif muri f'Tabella 5, fl-istudju PCM301, il-Punteġġ Internazzjonali tas-Sintomi tal-Prostata (IPSS,
English: TOOKAD-VTP should only be administered after careful clinical evaluation, to patients with a history of active rectal inflammatory bowel disease or any condition that may increase the risk of recto-urethral fistula formation (see section 4.3).
Maltese: VTP; madankollu, huwa rrakkomandat li mediċini li jaffettwaw il-koagulazzjoni jitwaqqfu qabel u għall-perjodu immedjat wara l-proċedura VTP (ara sezzjoni 4.5).
English: There is limited data on long-term outcomes and on potential consequences of post-TOOKAD local scarring in case of disease progression.
Maltese: Hemm data limitata dwar ir-riżultati fit-tul u dwar il-konsegwenzi potenzjali ta' ċikatriċi lokali wara TOOKAD f'każ ta' progressjoni tal-marda.
English: Urethral stenosis Urinary incontinence
Maltese: Inkontinenza tal-awrina8
English: Residual tumour has been found on follow-up biopsy of the treated lobe at 12 and 24 months, usually outside of the treated volume, but occasionally within the area of necrosis.
Maltese: Instab tumur residwali f'bijospija ta' segwitu tal-lobu kkurat wara 12 u 24 xahar, normalment barra mill-volum ikkurat, iżda f'xi każijiet fil-parti tan-nekrożi.
English: i i j j
Maltese: J/cm.
English: Trans-Urethral Resection of the Prostate (TURP).
Maltese: (TURP, transurethral resection of the prostate) għal ipertrofija prostatika beninna (ara sezzjoni 4.3).
English: TOOKAD is indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and: - Clinical stage T1c or T2a, - Gleason Score ≤ 6, based on high-resolution biopsy strategies, - PSA ≤ 10 ng/mL, - 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm
Maltese: Il-kriterji tal-esklużjoni ewlenin kienu kwalunkwe kura preċedenti jew attwali għall-kanċer talprostata, kwalunkwe intervent kirurġiku għal ipertrofija tal-prostata beninna, stennija ta' għomor ta' inqas minn 10 snin, kondizzjonijiet mediċi li jipprekludu l-użu ta' anesteżija ġenerali.
English: Adjusted Hazard Ratio (95% CI) = 0.31 (0.20 ; 0.50) ; p value ≤ 0.001
Maltese: 31 (0.20 ; 0.50) ; valur p ≤ 0.001 iProporzjon ta' Riskju Aġġustat (95% CI) = 0.
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: NAME OF THE MEDICINAL PRODUCT TOOKAD 183 mg powder for solution for injection padeliporfin
Maltese: U KWANTITATTIVA TOOKAD 183 mg trab għal soluzzjoni għall-injezzjoni
English: Genital haemorrhage Penile swelling Prostatic haemorrhage Testicular swelling
Maltese: Żieda fil-gamma-glutamyltransferase Żieda fil-kolesterol fid-demm Żieda fil-creatine phosphokinase fiddemm
English: In other cases, urethral stenosis may have been a late consequence of TOOKAD-VTP induced necrosis.
Maltese: It-termini li ġejjin jirrappreżentaw grupp ta' avvenimenti relatati li jiddeskrivi kondizzjoni medika aktar milli avveniment wieħed.
English: Excessive extraprostatic necrosis occurred as a result of incorrect calibration of the laser or placement of the light fibres (see section 4.8).
Maltese: Kien hemm nekrożi ekstraprostatika eċċessiva bħala riżultat ta' kalibrazzjoni tal-laser jew tpoġġija ta' fibri tad-dawl mhux korretti (ara sezzjoni 4.8).
English: You will be given a general anaesthetic to send you to sleep before the VTP procedure.
Maltese: Dan għandu jintuża biss minn personal imħarreġ fil proċedura ta' terapija VTP.
English: Prostatitis Genital pain Prostatic pain
Maltese: Żieda fit-trigliċeridi fid-demm
English: Genito-urinary tract infection
Maltese: Disturbi fl-apparat tal-awrina
English: Minimal seminiferous epithelial degeneration was also recorded in one high-dose male with vacuolation.
Maltese: Ġiet osservata wkoll deġenerazzjoni epiteljali seminiferuża (seminiferous epithelial degeneration) minima f'raġel wieħed b'doża għolja b'vacuolation.
English: 50 tubes
Maltese: 50 tubu
English: 2°C to 8°C
Maltese: 2°C - 8°C
English: 1300 Wavre Belgium
Maltese: 1300 Wavre
English: (cases/controls)
Maltese: (każijiet/kontroll i)
English: Intussusception (see section 4.4)
Maltese: Intussuxxezzjoni (ara sezzjoni 4.4)
English: (see section 4.4)
Maltese: (ara sezzjoni 4.8).
English: Expiry date: DD/MM/YY
Maltese: DD/MM/YY
English: Oral applicator Tip-Cap
Maltese: Applikatur talħalq Tip-Cap
English: Severe†
Maltese: Severi†
English: Placebo N=1,302
Maltese: Plaċebo N=1,302
English: Monodose oral tube
Maltese: Monodose tubu orali
English: Oral suspension 1 tube
Maltese: Suspensjoni orali tubu 1
English: (7) NA: Not available.
Maltese: (7) NA: mhux disponibbli.
English: 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)
Maltese: 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)
English: 3, 4 months Czech Republic
Maltese: 3, 4 xhur Repubblika
English: Rotarix is available in a pack of 50 tubes.
Maltese: Rotarix huwa disponibbli f'pakkett ta '50 tubu.
English: America; 11 countries
Maltese: Amerika Latina; 11-il pajjiż
English: Protective efficacy of the liquid formulation
Maltese: Effikaċja protettiva tal-forma likwida
English: 2, 3 months France,
Maltese: 2, 3 xhur Franza,
English: * In these studies, the point estimates and confidence intervals were respectively: 100% (95% CI:1,858.0;100), 100% (95% CI: 21.1;100), 45.4% (95% CI: -81.5;86.6), 74.7 (95% CI :-386.2;99.6).
Maltese: 0;100), 100% (95% CI: 21.1;100), 45.4% (95% CI: -81.5;86.6), 74.7 (95% CI :-386.2;99.6).
English: Connecting bar
Maltese: Bar talkonnessjoni
English: GlaxoSmithKline Biologicals s.a. Parc de la Noire Epine Rue Fleming, 20
Maltese: Parc de la Noire Epine Rue Fleming, 20
English: Severity of gastro-enteritis (GE) was defined according to WHO criteria.
Maltese: Isseverità tal-gastro-enterite (GE) ġiet imfissra skond kriterji tal-WHO.
English: *Produced on Vero cells
Maltese: *Prodotta fuq ċelluli Vero
English: Amino acids
Maltese: Amino aċidi
English: Date of first authorisation: 21 February 2006 Date of latest renewal: 14 January 2016
Maltese: AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 ta' Frar 2006 Data tal-aħħar tiġdid: 14 ta' Jannar 2016
English: 1 dose (1.5 ml)
Maltese: Doża 1 (1.5 ml)
English: 2, 4 months Spain 3, 5 months Finland, Italy 180 3, 4 months Czech
Maltese: 2, 4 xhur Spanja 3, 5 xhur Finlandja, l
English: f) Twist the separated oral tube.
Maltese: f) Dawwar it-tubu orali separat.
English: For instructions for administration, see section 6.6.
Maltese: Għall-istruzzjonijiet dwar l-għoti, ara sezzjoni 6.6.
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2 °C - 8°C).
English: - Urticaria
Maltese: - Urtikarja
English: This product contains sucrose 1,073 mg (see section 4.4).
Maltese: Dan il-prodott fih 1,073 mg sucrose (ara sezzjoni 4.4).
English: 51% (95% CI: 26;67, El Salvador) to 60% (95% CI: 37; 75, Brazil).
Maltese: CI: 26;67 El Salvador) sa 60 % (95 % CI: 37; 75, il-Brażil).
English: Serious adverse events were observed in 5.1% of recipients of Rotarix as compared with 6.8% of placebo recipients.
Maltese: Effetti avversi serji ġew osservati f'5.1% ta' trabi li ngħataw Rotarix meta mqabbla ma' 6.8% ta' trabi li ħadu l-plaċebo.
English: Haematochezia
Maltese: Ematokiżja
English: 1.5 ml of oral suspension in a pre-filled oral applicator (type I glass) with a plunger stopper (rubber butyl) and a protective tip cap (rubber butyl), in pack sizes of 1, 5, 10 or 25.
Maltese: 1.5 ml ta' suspensjoni orali f'applikatur tal-ħalq mimli lest (ħġieġ tat-tip I) b'tapp planġer (rubber butyl) u għatu ‘tip cap' protettiv (rubber butyl) f'pakketti ta' 1, 5, 10 u 25.