FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on Keytruda's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Keytruda?
Maltese: Kif jaħdem Keytruda?
English: Keytruda has been authorised in the EU since July 2015.
Maltese: Keytruda ilu awtorizzat fl-UE sa minn Lulju 2015.
English: Keytruda is also authorised to treat melanoma (a skin cancer), classical Hodgkin lymphoma (a blood cancer) and urothelial cancer (a cancer of the bladder and urinary tract).
Maltese: Keytruda huwa wkoll awtorizzat biex jikkura l-melanoma (kanċer tal-ġilda), limfoma ta' Hodgkin klassika (kanċer tad-demm) u kanċer uroteljali (kanċer tal-bużżieqa tal-awrina u tal-passaġġ talawrina).
English: Keytruda was also expected to be used in combination with the chemotherapy medicines pemetrexed and carboplatin in NSCLC patients with metastatic ‘non-squamous' NSCLC, irrespective of whether their tumour produced the PD-L1 protein.
Maltese: Keytruda kien mistenni wkoll li jintuża flimkien mal-mediċini ta' kimoterapija pemetrexed u carboplatin f'pazjenti b'NSCLC b'NSCLC “mhux skwamuż” metastatiku, irrispettivament jekk it-tumur tagħhom ipproduċix il-proteina PD-L1.
English: The applicant presented data from a study involving 123 patients with locally advanced or metastatic NSCLC, which compared Keytruda taken together with pemetrexed and carboplatin chemotherapy with chemotherapy alone.
Maltese: L-applikant ippreżenta data minn studju li involva 123 pazjent b'NSCLC lokalment avvanzat jew metastatiku, li qabbel Keytruda meħud flimkien ma' kimoterapija b'pemetrexed u carboplatin malkimoterapija waħedha.
English: What was Keytruda expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Keytruda?
English: On 11 October 2017, Merck Sharp & Dohme officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend the use of Keytruda in nonsmall cell lung cancer (NSCLC) to include metastatic non-squamous NSCLC in combination with chemotherapy.
Maltese: Fil-11 ta' Ottubru 2017, Merck Sharp & Dohme għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għall-awtorizzazzjoni għattqegħid fis-suq għal Keytruda, għall-kanċer mhux ta' ċelloli żgħar (NSCLC, non-small cell lung cancer) biex jinkludi NSCLC mhux skwamuż metastatiku flimkien mal-kimoterapija.
English: By blocking PD-1, pembrolizumab stops the cancer switching off these immune cells, thereby increasing the ability of the immune system to kill the cancer cells.
Maltese: Billi jimblokka PD-1, il-pembrolizumab twaqqaf lill-kanċer milli jitfi dawn iċ-ċelloli immuni, b'hekk iżid l-abbiltà tas-sistema immuni biex toqtol iċ-ċelloli tal-kanċer.
English: Keytruda is a cancer medicine already authorised for use on its own to treat NSCLC.
Maltese: Keytruda huwa mediċina tal-kanċer li diġà ġiet awtorizzata għall-użu waħedha biex tikkura NSCLC.
English: The active substance in Keytruda, pembrolizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and block a receptor called PD-1.
Maltese: Is-sustanza attiva f'Keytruda, il-pembrolizumab, hija antikorp monoklonali (tip ta' proteina) li tfasslet biex tagħraf u timblokka riċettur imsejjaħ PD-1. Xi kanċers jistgħu jagħmlu proteini li jissejħu PD-L1 u PD-L2 li jikkombinaw ma' PD-1 biex jitfu l-attività ta' ċerti ċelloli tas-sistema immuni (id-difiżi naturali tal-ġisem) u tipprevjenihom milli jattakkaw il-kanċer.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Keytruda could not have been approved for the treatment of metastatic non-squamous NSCLC in combination with pemetrexed and carboplatin.
Maltese: Fuq il-bażi tar-reviżjoni tad-data u t-tweġibiet tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fiżżmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Keytruda ma setax jiġi approvat għall-kura ta' NSCLC mhux skwamuż mestastatiku flimkien ma' pemetrexed u carboplatin.
English: Keytruda is used specifically when the tumour produces a protein known as PD-L1 and is advanced or has spread to other parts of the body (metastatic).
Maltese: Keytruda jintuża speċifikament meta t-tumur jipproduċi proteina magħrufa bħala PD-L1 u jkun avvanzat jew ikun infirex għal partijiet oħra fil-ġisem (metastatiku).
English: The full EPAR for Ketek can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Ketek.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ketek.
English: This summary was last updated in 11-2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'12-2012.
English: The recommended dose of Ketek is 800 mg (two tablets) once a day.
Maltese: Id-doża rakkomandata ta' Ketek hija 800 mg (żewġ pilloli) kuljum.
English: Why has Ketek been approved?
Maltese: Għaliex ġie approvat Ketek?
English: The active substance in Ketek, telithromycin, is an antibiotic belonging to the class ‘ketolides'.
Maltese: Is-sustanza attiva f'Ketek, it-telitromiċina, hija antibijotiku li tappartjeni għall-klassi tal-‘ketolidi'.
English: • acute exacerbation (flare-up) of chronic bronchitis (long-lasting inflammation of the airways in the
Maltese: • taħrix akut ta' bronkite kronika (infjammazzjoni fit-tul tal-passaġġi tal-arja fil-pulmuni).
English: Ketek is a medicine that contains the active substance telithromycin.
Maltese: Ketek huwa mediċina li fiha s-sustanza attiva telitromiċina.
English: How is Ketek used?
Maltese: Kif jintuża Ketek?
English: However, the Committee noted that Ketek is associated with a greater risk of certain side effects than other antibiotics.
Maltese: Madankollu l-Kumitat irrimarka li Ketek huwa assoċjat ma' żieda fir-riskju ta' ċerti effetti sekondarji apparagun ma' antibijotiċi oħrajn.
English: Ketek has been studied in 10 main studies involving a total of over 4,000 patients.
Maltese: Ketek ġie studjat fi għaxar studji ewlenin li fihom b'kollox ħadu sehem 4,000 pazjent.
English: For pneumonia and chronic bronchitis, Ketek was as effective as amoxicillin, clarithromycin, trovafloxacin, amoxicillin/clavulanic acid and cefuroxime axetil, with between 82 and 95% of the patients having no symptoms at the end of treatment.
Maltese: Għall-pulmonite u l-bronkite kronika, Ketek kien effikaċi daqs l-amoxicillin, clarithromycin, trovafloxacin, amoxicillin/clavulanic acid u cefuroxime axetil.
English: For tonsillitis or pharyngitis, between 84 and 92% of the patients taking Ketek, penicillin or clarithromycin had a satisfactory reduction in bacterial levels
Maltese: Bejn 82% u 95% tal-pazjenti ma kellhom l-ebda sintomu fi tmiem it-trattament.
English: • acute sinusitis (short-lived infection of the sinuses, air-filled passageways in the bones around the
Maltese: • sinużite akuta (infezzjoni mhux fit-tul tas-sinus, passaġġi mimlijin bl-arja fl-għadam ta' madwar l
English: Ketek is also used to treat patients aged 12 years or over who have tonsillitis or pharyngitis (infections of the tonsils or throat) caused by the bacterium Streptococcus pyogenes.
Maltese: Ketek jintuża wkoll biex jittratta pazjenti minn 12-il sena 'l fuq li jkollhom it-tunsillite jew il-farinġite (infezzjonijiet tat-tunsilli jew tal-gerżuma) kkawżati mill-batterju Streptococcus pyogenes.
English: A lower dose may be needed in patients who have severe kidney problems.
Maltese: Jista' jkun hemm bżonn tintuża doża iżgħar f'pazjenti bi problemi gravi fil-kliewi.
English: The main measure of effectiveness was the proportion of patients who were cured at the end of treatment as determined by a reduction in symptoms, or who had ‘satisfactory' reductions in the amount of bacteria detected in samples taken
Maltese: Ilkejl ewlieni tal-effikaċja kien il-proporzjon ta' pazjenti li ġew ikkurati fl-aħħar tat-trattament, imkejjel skont it-tnaqqis tas-sintomi, jew inkella t-tnaqqis “sodisfaċenti” fl-ammont ta' batterji li jiġu identifikati
English: Four studies looked at its effects in mild to moderate community-acquired pneumonia, two looked at acute sinusitis, two looked at acute exacerbations of chronic bronchitis and two looked at tonsillitis or pharyngitis.
Maltese: Erba' studji stħarrġu l-effetti tiegħu fil-pulmonite minn ħafifa għal moderata akkwiżita f'komunità, tnejn oħra analizzaw is-sinużite akuta, tnejn oħra stħarrġu t-taħrix akut tal-bronkite kronika u tnejn oħra analizzaw it-tonsillite u l-farinġite.
English: Telithromycin works by blocking the bacteria's ribosomes (the parts of the cells where proteins are produced), inhibiting the growth of the bacteria.
Maltese: It-telitromiċina taħdem billi timblokka r-ribożomi tal-batterji (ilparti taċ-ċelloli li fihom jiġu prodotti l-proteini), u b'hekk trażżan l-iżvilupp tal-batterji.
English: In patients with acute sinusitis, five- and 10-day courses of Ketek led to similar cure rates, which were similar to that seen with amoxicillin/clavulanic acid.
Maltese: F'pazjenti li kellhom sinużite akuta, korsijiet ta' ħamest ijiem u ta' għaxart ijiem taw rati ta' kura simili, li kienu simili għal dak li rriżulta bl-użu tal-amoxicillin/aċtu klavulaniku.
English: For more information, see
Maltese: Għal iktar informazzjoni, ara l-fuljett ta' tagħrif.
English: Ketek is used to treat adults with mild or moderate community-acquired pneumonia (an infection of the lungs that is caught outside of hospital).
Maltese: Ketek jintuża biex jittratta adulti li jkollhom pulmonite ħafifa jew moderata akkwiżita f'komunità (infezzjoni tal-pulmuni li tittieħed barra minn sptar).
English: Some of these side effects can be serious, including a worsening of myasthenia gravis, transient loss of consciousness and temporary disturbances to vision.
Maltese: Uħud minn dawn leffetti sekondarji jistgħu jkunu serji, u jistgħu jinkludu taħżin fil-mijastenija gravi, telf temporanju talkoxjenza u disturbi temporanji fil-vista.
English: Therefore, the Committee decided that its use should be reserved to the treatment of communityacquired pneumonia, to the treatment of bronchitis and sinusitis when caused by bacteria that are resistant to beta-lactam or macrolide antibiotics, and to tonsillitis/pharyngitis when these antibiotics
Maltese: Għalhekk il-Kumitat iddeċieda li l-użu tiegħu għandu jinżamm biss għat-trattament tal-pulmonite akkwiżita f'komunità, għat-trattament tal-bronkite u tas-sinożite meta dawn ikunu ġew ikkaġunati minn batterji reżistenti għall-antibijotiċi beta-lattamiċi jew makrolidi, u għat-trattament tat-tunsillite/farinġite meta dawn l-antibijotiċi ma jkunux jistgħu jintużaw.
English: The CHMP concluded that Ketek's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP ikkonkluda li l-benefiċċji ta' Ketek huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Taking Ketek at bedtime may reduce the potential impact of side effects such as visual disturbances and loss of consciousness.
Maltese: It-teħid ta' Ketek qabel ħin l-irqad jista' jnaqqas l-impatt potenzjali tal-effetti sekondarji bħal disturbi fil-vista jew telf ta' koxjenza.
English: EMA/CHMP/602611/2012 EMEA/H/C/002027
Maltese: EMEA/H/C/002027
English: The application was withdrawn at ‘day 120'.
Maltese: L-applikazzjoni ġiet irtirata f' ‘jum 120'.
English: Withdrawal of the marketing authorisation application for SecreFlo (secretin human) EMA/602611/2012
Maltese: 14 ta' Settembru 2012 EMA/602611/2012
English: What is SecreFlo?
Maltese: X'inhu SecreFlo?
English: SecreFlo is a medicine that contains the active substance secretin human.
Maltese: SecreFlo huwa mediċina li fiha s-sustanza attiva sekretina umana.
English: The active substance in SecreFlo is a copy of human secretin, a natural hormone that stimulates the pancreas to secrete fluids into the small intestine.
Maltese: Is-sustanza attiva f'SecreFlo hija kopja tas-sekretina umana, ormon naturali li jistimula l-frixa biex tnixxi fluwidi fl-intestin iż-żgħir.
English: On 15 August 2012, Repligen Europe Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for SecreFlo, intended for use in the detection of duct abnormalities in the pancreas.
Maltese: Fil-15 ta' Awwissu 2012 Repligen Europe Limited għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għallawtorizzazzjoni għat-tqegħid fis-suq għal SecreFlo, li huwa prodott mediċinali maħsub biex jidentifika abnormalitajiet fil-frixa.
English: Withdrawal of the marketing authorisation application for SecreFlo (secretin human)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal SecreFlo (sekretina umana)
English: Page 2/2
Maltese: Mistoqsijiet u tweġibiet
English: How is SecreFlo expected to work?
Maltese: Għal xiex kien mistenni jintuża SecreFlo?
English: The company presented data from one main study, which involved 270 patients with a history of acute pancreatitis who had MRI scans with or without previous SecreFlo injections.
Maltese: Il-kumpanija ppreżentat dejta minn studju ewlieni wieħed fuq 270 pazjent bi storja medika ta' pankreatite akuta li sarulhom skansjonijiet bl-MRI. Uħud minnhom kienu ngħataw injezzjoni b'SecreFlo mentri oħrajn le.
English: This means that the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Maltese: Dan ifisser li s-CHMP kien ivvaluta d-dokumentazzjoni inizjali mressqa mill-kumpanija u fassal lista ta' mistoqsijiet.
English: SecreFlo was expected to be used in patients undergoing magnetic resonance imaging (MRI, a type of scan where images of the internal organs are taken) to obtain a clearer image of their pancreas.
Maltese: SecreFlo kien mistenni jintuża fuq pazjenti li ssirilhom immaġni b'riżonanza manjetika (MRI, tip ta' skanner li jipproduċi stampi tal-organi interni) biex tinkiseb stampa iktar ċara tal-frixa tagħhom.
English: The main measures of effectiveness were based on the sensitivity of the scans (how well they detected abnormalities in the ducts) and their specificity (how well normal ducts were identified as normal).
Maltese: Il-kejl ewlieni tal-effikaċja kien ibbażat fuq is-sensittività tal-iskansjonijiet (kemm irnexxilhom jidentifikaw abnormalitajiet fil-kanali) u l-ispeċifiċità tagħhom (kemm irnexxilhom jidentifikaw il-kanali normali bħala normali).
English: At the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that SecreFlo could not have been approved.
Maltese: Fiż-żmien tal-irtirar is-CHMP kien imħasseb dwar xi fatturi u kien tal-fehma proviżorja li SecreFlo ma setax jiġi approvat.
English: SecreFlo was to be injected into a patient's vein just before undergoing a MRI scan.
Maltese: Is-CHMP rrimarka wkoll li rrelevanza klinika tar-riżultati tal-istidju ma kinitx ċara.
English: Images from the scans were read by expert radiologists without prior knowledge of the patients' condition and the results were compared with what was already known from other tests.
Maltese: L-istampi mill-iskansjonijiet inqraw minn radjoloġisti esperti li ma kinux jafu minn qabel bil-kundizzjoni tal-pazjenti u r-riżultati tqabblu ma' dak li diġà kien magħruf minn testijiet oħra.
English: The medicine's use in visualising the pancreatic ducts is based on its action of stimulating fluid secretion, which causes the ducts in the pancreas to widen significantly and therefore appear more clearly in a scan.
Maltese: L-użu tal-mediċina fil-viżwalizzazzjoni tal-kanali tal-frixa huwa bbażat fuq l-azzjoni tagħha ta' stimulazzjoni tat-tnixxija tal-fluwidi, li twassal biex il-kanali fil-frixa jitwessgħu b'mod notevoli u għaldaqstant jidhru b'mod ikar ċar taħt l-iskanner.
English: The company informed the CHMP that there were no ongoing clinical trials with SecreFlo at the time of the withdrawal.
Maltese: Il-kumpanija għarrfet lis-CHMP li ma kien hemm l-ebda prova klinika għaddejja b'SecreFlo fiż-żmien tal-irtirar.
English: It was to be available as a solution for injection.
Maltese: Kellu jiġi f'soluzzjoni għal injezzjoni.
English: -- 1 Inactivated West Nile virus, strain VM-2: RP* 1.0-2.2/ml.
Maltese: -- 1 Virus West Nile inattivat, razza VM-2
English: * Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
Maltese: RP* 1.0 - 2.2 *Qawwa relattiva b'metodu in vitro, imqabbel ma' vaċċin ta' referenza li ntwera li kien effikaċi fiż-żwiemel.
English: (see section 4.7).
Maltese: (ara sezzjoni 4.7).
English: N. Ireland
Maltese: L-Irlanda
English: Tel: +353 (1) 526 6789
Maltese: Tel: +353 (1) 526 6789 Fax:
English: Analysis Set (n)
Maltese: Sett ta' Analiżi (n)
English: Tel: +353 (1) 526 6789 Fax: +353 (1) 526 6888 eMail: regulatory@omeros.ie
Maltese: +353 (1) 526 6888 eMail: regulatory@omeros.ie
English: The most frequently reported adverse reactions were, eye pain (4.8%), anterior chamber inflammation (3.9%), conjunctival hyperaemia (2.2%), photophobia (1.7%), corneal oedema (1.3%) and inflammation (1.3%).
Maltese: Ir-reazzjonijiet avversi rrappurtati b'mod l-aktar frekwenti kienu, uġigħ fl-għajnejn (4.8%), infjammazzjoni tal-kompartiment anterjuri (3.9%), iperimija konġuntivali (2.2%), fotofobija (1.7%), edema tal-kornea (1.3%) u infjammazzjoni (1.3%).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1018/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1018/001
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 July 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 28 ta' Lulju 2015
English: Multipack containing 10 (1 pack of 10) single-use vials.
Maltese: Pakkett multiplu: 10 (pakkett 1 ta' 10) kunjetti
English: See section 4.8 for further details regarding possible visual disturbances.
Maltese: Ara sezzjoni 4.8 għal aktar dettalji dwar disturbi possibbli fil-vista.
English: Patients were randomised to either Omidria or placebo (1:1).
Maltese: Il-pazjenti kienu randomizzati jew għal Omidria jew għal plaċebo (1:1).
English: The population in the trials was 26 to 90 years of age (59% female, 41% male; 80% white, 12% black and 8% other race).
Maltese: Il-popolazzjoni fil-provi kienet bejn is-26 u d-90 sena (59% nisa, 41% irġiel; 80% bojod, 12% suwed u 8% ta' razza oħra).
English: The active substances are phenylephrine (as hydrochloride) and ketorolac (as trometamol).
Maltese: Is-sustanzi attivi huma fenilefrina (bħala idroklorur) u ketorolac (bħala trometamol).
English: The frequency of adverse reactions is defined as follows: 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: Il-frekwenza tar-reazzjonijiet avversi hija definita kif ġej: 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: Study 1 Analysis Set (n)
Maltese: Studju 2 Sett ta' Analiżi (n)
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Sussegwentement, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista fl-Artikolu 107c(7) tadDirettiva 2001/83/KE u ppubblikati fuq il-portal web Ewropew tal-mediċini.
English: Uncommon side effects: - nausea - pain - headache
Maltese: Effetti sekondarji mhux komuni: - nawżja - uġigħ - Uġigħ ta' ras
English: Nineteen percent of cataracts were LOCS II Nuclear Grade 2 or 3.
Maltese: Dsatax fil-mija tal-katarretti kienu LOCS II Nuclear tal-Grad 2 jew 3.
English: The maximum ketorolac concentration seen was 4.2 ng/mL.
Maltese: Il-konċentrazzjoni massima ta' ketorolac osservata kienet ta' 4.2 ng/mL.
English: The safety profile of Omidria is based on data from 459 adult patients collected during clinical development obtained in randomised controlled trials.
Maltese: Il-profil tas-sigurtà ta' Omidria huwa bbażat fuq data minn 459 pazjent adult miġbura matul l-iżvilupp kliniku miksub fi provi kkontrollati randomizzati.
English: The efficacy and safety of Omidria was evaluated in two Phase 3, randomised, multicentre, doublemasked, placebo-controlled clinical trials in 808 adult patients undergoing intraocular lens replacement.
Maltese: L-effikaċja u s-sigurtà ta' Omidria ġiet ivvalutata f'żewġ provi kliniċi randomizzati, multiċentriċi, bi blindaġġ doppju, ikkontrollati bi plaċebo tal-Fażi 3, fuq 808 pazjenti adulti li kienu għaddejjin minn sostituzzjoni tal-lenti intraokulari.
English: Statistical tests for the change from baseline in pupil diameter (mm) during surgery were carried out with the Cochran-Mantel-Haenszel (CMH) test adjusted for the randomisation strata.
Maltese: Testijiet statistiċi għall-bidla mil-linja bażi fid-dijametru tal-pupilla (mm) waqt il-kirurġija saru permezz tat-test ta' Cochran-Mantel-Haenszel (CMH) aġġustat għar-randomizzazzjoni tal-istrata.
English: For dilution instructions, see section 6.6.
Maltese: Għall-istruzzjonijiet dwar id-dilwizzjoni, ara sezzjoni 6.6.
English: Intraoperative pupil diameter (mm) change-from-baseline
Maltese: Bidla fid-dijametru intraoperattiv tal-pupilla (mm) mil-linja bażi
English: Other medicines and Omidria
Maltese: Mediċini oħra u Omidria
English: There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: Hemm il-potenzjal għal sensittività inkroċjata għal acetylsalicylic acid, għal derivati ta' phenylacetic acid, u għal mediċini antinfjammatorji nonsterojdali (NSAIDs) oħra.
English: Uncommon side effects (may affect up to 1 in 100 people): - eye discomfort - eye inflammation - eye irritation - eye redness - problems with the cornea - dilated pupil - blurred vision - reduction in sharpness of vision - small, dark shapes moving in the field of vision - itchy eyes - eyelid pain - sensation of foreign bodies in the eyes - glare - increased eye pressure
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100): - skumdità fl-għajnejn - infjammazzjoni fl-għajnejn - irritazzjoni fl-għajnejn - ħmura fl-għajnejn - problemi bil-kornea - pupilla dilatata - vista mċajpra - tnaqqis fl-akutezza viżiva - oġġetti żgħar u skuri li jiċċaqalqu fil-kamp viżiv - ħakk fl-għajnejn - uġigħ fil-kappell tal-għajnejn - sensazzjoni ta' oġġetti barranin fl-għajnejn - leħħa - żieda fil-pressjoni fl-għajnejn
English: Omidria is indicated in adults for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.
Maltese: Omidria huwa indikat fl-adulti għaż-żamma ta' midrijasi intraoperattiva, għall-prevenzjoni ta' mijosi intraoperattiva u għat-tnaqqis ta' uġigħ okulari akut wara operazzjoni f'kirurġija ta' sostituzzjoni tallenti intraokulari.