FrancophonIA/ELRC3.0 huggingface dataset:
English: Week 3 (day 15-21): Take one 15 mg tablet once a day (grey-orange, oval-oblong) for 7 days.
Dutch: Ġimgħa 3 (jum 15-21): Ħu pillola miksija b'rita waħda kuljum ta' 15 mg (oranġjo-griża, ovali-oblong) għal 7 t'ijiem.
English: Do not store above 30°C.
Dutch: Taħżinx f'temperatura 'l fuq minn 30°C.
English: PHARMACEUTICAL FORM
Dutch: PROPRJETAJIET FARMAKOLOĠIĊI
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Dutch: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċjuu rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar riskji).
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Dutch: A. MANIFATTUR RESPONSABBLI GĦALL-ĦRUĠ TAL
English: Pack sizes of 14, 28, 30, 42, 50, 56, 98, 100, 112, and multipacks containing 840 (20 x 42), 980 (10 x 98) or 1000 (20 x 50) tablets are presented.
Dutch: Pakketti multipli ta' 840 (10 x 42), 980 (10 x 98) jew 1000 (20 x 50) pillola.
English: Week 4 (day 22-28): Take one 20 mg tablet per day (grey-red, oval-oblong) for 7 days.
Dutch: Ġimgħa 4 (jum 22-28): Ħu pillola miksija b'rita waħda kuljum ta' 20 mg (ħamra-griża ovali-oblong) għal 7 t'ijiem.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Dutch: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: Film-coated tablet.
Dutch: Kisja tal-pillola
English: Week 1 (day 1-7): Take one 5 mg tablet once a day (white to off-white, oval-oblong) for 7 days.
Dutch: Ġimgħa 1 (jum 1-7): Ħu pillola miksija b'rita waħda ta' 5 mg kuljum (bajda għal offwajt, ovali-oblong) għal 7 t'ijiem.
English: One pump actuation contains 5mg memantine hydrochloride.
Dutch: Għafsa waħda fiha 5 mg ta' Memantine hydrochloride.
English: Fatigue 1 Hallucinations have mainly been observed in patients with severe Alzheimer´s disease.
Dutch: 1 Alluċinazzjonijiet dehru l-aktar f'pazjenti bil-marda ta' Alzheimer severa.
English: Dose titration
Dutch: DATA TA' SKADENZA
English: When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs. 11%, p<0.0001).
Dutch: Meta pazjenti deher li marru għall-agħar fit-tlett oqsma, ir-riżultati wrew effett statistikament sinifikanti ta' memantine biex jevita li jmorru għall-agħar, darbtejn aktar mill-pazjenti ikkurati bi plaċebo hekk kif pazjenti kkurati b'memantine marru għall-agħar fit-tlett oqsma (21% vs. 11%, p<0.0001).
English: How to take Axura
Dutch: X'fih Axura
English: MM/YYYY
Dutch: OĦRAJN
English: Axura 5 mg/pump actuation, oral solution
Dutch: Axura 5 mg/għafsa soluzzjoni orali
English: Uncommon
Dutch: Mhux komuni
English: One pump actuation delivers 0.5 ml solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine.
Dutch: Kull attivazzjoni tal-pompa (għafsa waħda l-isfel) tagħti 0.5 ml ta' soluzzjoni li fiha 5 mg ta' memantine hydrochloride ekwivalenti għal 4.16 mg ta' memantine.
English: 10 mg tablet week 3
Dutch: pillola ta' 10 mg ġimgħa 3
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Dutch: Dan jippermetti monitoraġġ kontinwu tal-bilanċ bejn il-benefiċċju u r-riskju tal-prodott mediċinali.
English: In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
Dutch: F'każ ta' sinjali u sintomi ta' simulazzjoni eċċessiva tas-sistema nervuża ċentrali (SNĊ) ġenerali, għandha titqies kura klinika tas-sintomi bir-reqqa.
English: In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Dutch: Fl-aktar każ estrem ta' doża eċċessiva, il-pazjent irnexxielu jibqa ħaj meta ħa b'mod orali 2000 mg memantine b'effetti fuq is-sistema nervuża ċentrali (koma għal 10 t'ijiem, u wara kellu diplopja u aġitazzjoni).
English: Breast-feeding
Dutch: Il-Ġermanja
English: The use of medicinal products called amantadine (for the treatment of Parkinson´s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Dutch: L-użu ta' prodotti mediċinali msejjħa amantadine (għat-trattament tal-marda ta' Parkinson), ketamine (sustanza li ġeneralment tingħata bħala loppju), dextromethorphan (ġeneralment użata għas-sogħla) u antagonisti oħra ta' NMDA fl-istess ħin għandu jkun evitat.
English: Axura 20 mg tablets
Dutch: Axura pilloli ta' 20 mg
English: Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Dutch: Kull pillola miksija b'rita fiha 10 mg memantine hydrochloride li hi ekwivalenti għal 8.31 mg memantine.
English: Component of a multipack, can't be sold separately.
Dutch: Jagħmel parti minn pakkett multiplu, ma jistax jinbiegħ separatament.
English: From the fourth week on, the usual dose is 2 tablets once a day (1x 20 mg).
Dutch: Mir-4 ġimgħa 'l quddiem, id-doża li ġeneralment tingħata hija ta' 2 pilloli 1 darba kuljum (1x20 mg).
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Dutch: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Axura 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘15' on one side and imprint ‘MEM' on the other side.
Dutch: Il-pilloli miksijin b'rita ta' 15 mg huma oranġjo għal oranġjo griżi, pilloli miksijin b'rita li huma ovalioblong b'intaljar ta' ‘15' fuq naħa u ‘MEM' fuq naħa oħra.
English: 98 film-coated tablets
Dutch: 98 pillola miksija b'rita
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Dutch: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Axura 5 mg film-coated tablets Axura 10 mg film-coated tablets Axura 15 mg film-coated tablets Axura 20 mg film-coated tablets
Dutch: Axura 5 mg pilloli miksijin b'rita Axura 10 mg pilloli miksijin b'rita Axura 15 mg pilloli miksijin b'rita Axura 20 mg pilloli miksijin b'rita
English: No cytochrome P 450 catalysed metabolism has been detected in vitro.
Dutch: L-ebda wieħed minn dawn il-metaboli m'għandu attività antagonista għal NMDA. Ma nstab l-ebda metaboliżmu katalizzat minn cytochrome P 450 in vitro.
English: Common (may affect up to 1 in 10 users):
Dutch: Komuni (jistgħu jaffettwaw sa persuna minn kull 10 utenti):
English: Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms.
Dutch: Dożi eċċessivi relattivament għoljin (200 mg u 105 mg/jum għal 3 ijiem, rispettivament) kienu assoċjati ma' sintomi ta' għeja biss, dgħjufija u/jew dijarea jew ma ebda sintomu.
English: Elderly
Dutch: Treddigħ
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (10 x 50 ml) WRAPPED IN FOIL (INCLUDING BLUE BOX)
Dutch: TIKKETTA TAT-TGEŻWIR TA' BARRA FUQ IL-MULTIPAKKS (10 x 50 ml) MGEŻWRA FIL-FOJL (LI JINKLUDI L-KAXXA BLU)
English: Pack sizes of 14, 28, 42, 56, 98 or multipacks containing 840 (20 x 42) film-coated tablets are presented.
Dutch: Daqsijiet tal-pakkett ta' 14, 28, 42, 56, 98 pillola miksija b'rita huma disponibbli.
English: In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations) per day.
Dutch: F'pazjenti b'indeboliment sever renali (tneħħija tal-kreatinina 5-29 ml/min) id-doża għandha tkun 10 mg (1 ml ta' soluzzjoni,
English: The patient experienced central nervous system symptoms such as restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and unconsciousness.
Dutch: psikożi, alluċinazzjonijiet tal-vista, pro-aċċessjonijiet, ngħas, sturdament u telf mis-sensi.
English: half a 10 mg tablet week 2
Dutch: nofs pillola ta' 10 mg ġimgħa 2
English: Axura 10 mg film-coated tablets Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Dutch: Axura 10 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 10 mg memantine hydrochloride ekwivalenti għal 8.31 mg memantine.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Dutch: Relazzjoni farmaokinetika/farmakodinamika
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 µmol in human frontal cortex.
Dutch: B'doża ta' 20 mg memantine kuljum il-livelli fil-fluwidu ċerebro-spinali (CSF) qablu mal-valur-ki (ki = kostanti ta' l-impediment) ta' memantine, li hija 0.5 µmol fil-kortiċi anterjuri al-bniedem.
English: This leaflet was last revised in MM/YYYY.
Dutch: DATA TA' META ĠIET RIVEDUTA L-KITBA
English: Concomitant use of N-methyl-D-aspartate(NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
Dutch: L-użu fl-istess ħin ta' antagonisti-N-methyl-D-aspartate (NMDA) oħra bħal amantadine, ketamine jew dextromethorphan għandu jkun evitat.
English: A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer's disease (MMSE total scores at baseline of 10 to 22) included 403 patients.
Dutch: Fi studju ieħor b'terapija waħda għal marda ta' Alzheimer ħafifa għal moderata, total ta' 470 pazjent (punteġġi totali MMSE mal-linja bażi ta' 11-23) kienu randomizzati.
English: In patients with mildly impaired renal function (creatinine clearance 50-80 ml/min) no dose adjustment is required.
Dutch: F'pazjenti b'funzjoni renali indebolita b'mod ħafif (tneħħija tal-kreatinina 50-80 ml/min) m'hemmx bżonn li tinbidel id-doża.
English: FREQUENCY ADVERSE REACTION Common
Dutch: FREKWENZA EFFETTI MHUX MIXTIEQA
English: • The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.
Dutch: • Il-mod kif jaħdem jindika li l-effeti ta' L-Dopa, agonisti dopaminerġiċi, u antikolinerġiċi jistgħu jkunu aktar qawwija meta jingħataw flimkien ma' antaginisti ta' NMDA bħal memantine.
English: Axura contains sorbitol
Dutch: Axura fih sorbitolDan il-prodott mediċinali fih ukoll sorbitol.
English: In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or gastrointestinal origin (vomiting and diarrhoea).
Dutch: F'każ ta' sinjali u sintomi ta' simulazzjoni eċċessiva tas- Sistema Nervuża Ċentrali (SNĊ) ġenerali, għandha titqies kura klinika tas-sintomi bir-reqqa.
English: Children and adolescents
Dutch: Tfal u adolexxenti
English: Axura belongs to a group of medicines called NMDAreceptor antagonists.
Dutch: KOMPONENT TA' MULTIPAKK (MINGĦAJR IL-KAXXA BLU) ISEM TAL-PRODOTT MEDIĊINALI
English: Dyspnoea
Dutch: Sturdament
English: • In post-marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
Dutch: • Fl-esperjenza wara t-tqegħid fis-suq, każijiet iżolati b'żidiet fil-proporzjon internazzjonali normalizzat (INR) kienu rrappurtati f'pazjenti li kienu qed jingħataw fl-istess waqt warfarin.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Dutch: Pazjenti bi problemi ereditarji rari ta'
English: • Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Dutch: • Infjammazzjoni tal-frixa, infjammazzjoni tal-fwied (epatite) u reazzjonijiet psikotiċi
English: Axura 10 mg film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side The tablet can be divided into equal halves.
Dutch: Il-pilloli miksijin b'rita ta' 10 mg huma sofor ċari għal sofor, miksijin b'rita u b'forma ovali, b'xaqq minn fejn tista' taqsam il-pillola u mnaqqxin b' “1-0” fuq naħa waħda u b' “M M” fuq in-naħa l-oħra.
English: - if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of Axura oral solution (listed in section 6).
Dutch: - jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għal memantine hydrochloride jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: three pump actuations week 4 and beyond four pump actuations
Dutch: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: Duration of treatment
Dutch: Tqala u Treddigħ
English: Package leaflet: Information for the user Axura 20 mg film-coated tablets
Dutch: Fuljett ta' tagħrif: Informazzjoni għall utent Axura 20 mg pilloli miksijin b'rita
English: Moderate to severe Alzheimer's disease usually causes impairment of driving performance and compromises the ability to use machinery.
Dutch: Il-marda ta' Alzheimer moderata għal severa normalment ma tħallix persuna ssuq tajjeb u l-ħila ta' l-użu ta' makkinarji tiġi kompromessa.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 42, 50 AND 98 TABLETS AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Dutch: KARTUNA GĦAL PILLOLI TA' 42, 50 U 98 PILLOLA BHALA PAKKETT INTERMEDJU /
English: Packaging Content Package size Withdraw al period
Dutch: Toedieningsweg Verpakking Inhoud Verpakkingsgrootte
English: EMEA Number Invented Name Strength Pharmaceutical Form
Dutch: Fantasienaam Sterkte Farmaceutische vorm
English: Route of administration
Dutch: EMEA Procedurenummer
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration and marketing authorisation holders in the Member States
Dutch: LIJST MET NAMEN, FARMACEUTISCHE VORMEN, STERKTEN VAN DE GENEESMIDDELLEN, TOEDIENINGSWEG, HOUDERS VAN DE VERGUNNING VOOR HET IN DE HANDEL BRENGEN IN DE LIDSTATEN
English: Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels,
Dutch: Luxemburg NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels,
English: 4 Theotokopoulou & Astronafton str 151 25 Maroussi, Athens Greece
Dutch: Griekenland AstraZeneca SA 4 Theotokopoulou & Astronafton str 151 25 Maroussi, Athens Greece
English: AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien,
Dutch: Oostenrijk AstraZeneca Österreich GmbH, Schwarzenbergplatz 7,
English: AstraZeneca GmbH, 22876 Wedel, Germany
Dutch: Duitsland AstraZeneca GmbH, 22876 Wedel,
English: AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza 20080 Basiglio (MI), Italy
Dutch: Palazzo Volta, Via F. Sforza 20080 Basiglio (MI), Italy
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels,
Dutch: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgium
English: AstraZeneca AS Postboks 6050, Etterstad 0601 Oslo Norway
Dutch: Noorwegen AstraZeneca AS Postboks 6050,
English: Visacor 5 mg 5 mg
Dutch: Visacor 5 mg
English: Crestor 40 mg comprimate filmate
Dutch: Crestor 40 mg comprimate filmete
English: 4 days (including the day of administration)
Dutch: 4 dagen (inclusief de dag van toediening)
English: Control, N = 10
Dutch: Controle, N = 10
English: Phase 3 study
Dutch: Fase 3-onderzoek
English: Followed by 5 days
Dutch: Gevolgd door 5 dagen
English: This will be repeated on your other eye at least 6 days afterwards.
Dutch: Dit wordt ten minste 6 dagen later herhaald aan uw andere oog.
English: Study 301 was an open-label, randomised, controlled study.
Dutch: Onderzoek 301 was een open-label, gerandomiseerd, gecontroleerd onderzoek.
English: • Change of the electrical activity of the heart
Dutch: • Verandering van de elektrische activiteit van het hart
English: It is important that you take this medicine according to the instructions given.
Dutch: Het is belangrijk dat u dit geneesmiddel volgens de gegeven aanwijzingen gebruikt.
English: Accidental exposure must be avoided.
Dutch: Accidentele blootstelling moet worden vermeden.
English: If it does occur, your doctor will treat the symptoms as necessary.
Dutch: Als dit toch gebeurt, behandelt uw arts de symptomen zoals noodzakelijk is.
English: Do not stop taking the medicine without first talking to your doctor.
Dutch: Stop niet met het gebruik van het geneesmiddel zonder eerst met uw arts te overleggen.
English: System organ class / Frequency
Dutch: Systeem/orgaanklasse / Frequentie
English: 31 subjects were enrolled, 13 males and 18 females.
Dutch: In het onderzoek werden 31 proefpersonen opgenomen, 13 mannen en 18 vrouwen.
English: There are no known clinically significant interactions.
Dutch: Er zijn geen bekende klinisch significante interacties.
English: The effects of this medicine on pregnancy and the unborn child are not known.
Dutch: De effecten van dit geneesmiddel op de zwangerschap en het ongeboren kind zijn niet bekend.
English: • Summary of Product Characteristics (SmPC);
Dutch: • Samenvatting van de Productkenmerken (SmPC);
English: Information on how to obtain the special formats will be provided in the patient card.
Dutch: Informatie over het verkrijgen van de speciale formaten zal worden vermeld op de patiëntenkaart.
English: Vertical dotted lines represent additional 25% above and below the box.
Dutch: Verticale stippellijnen geven 25% extra boven en onder het staafje weer.
English: Your doctor may be able to help reduce any discomfort caused by these temporary disturbances.
Dutch: Uw arts kan helpen het ongemak te verminderen dat door deze tijdelijke problemen wordt veroorzaakt.
English: The virus used to deliver the gene does not cause disease in humans.
Dutch: Het virus dat wordt gebruikt om het gen af te geven, veroorzaakt bij de mens geen ziekte.
English: The interval between injection to the eyes for each subject was from 6 to 18 days.
Dutch: Het interval tussen injectie in de ogen bij elke proefpersoon was 6 tot 18 dagen.
English: 30 June 2030
Dutch: 30 juni 2030
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of voretigene neparvovec in pregnant women.
Dutch: Er zijn geen of een beperkte hoeveelheid gegevens (minder dan 300 zwangerschapsuitkomsten) over het gebruik van voretigene neparvovec bij zwangere vrouwen.
English: Followed by 5 days of one dose every other day
Dutch: Gevolgd door 5 dagen van één dosis om de dag
English: The testing of each subject was videotaped and assessed by independent graders.
Dutch: Het onderzoek van elke persoon werd op video vastgelegd en door onafhankelijke waarnemers beoordeeld.
English: • Some medicine may be present in your tears.
Dutch: • Er kan wat geneesmiddel in uw traanvocht aanwezig zijn.
English: These steps are critical in the biological conversion of a photon of light into an electrical signal within the retina.
Dutch: Deze stappen zijn essentieel bij de biologische omzetting van een lichtfoton in een elektrisch signaal binnen de retina.
English: 10 subjects were randomised to the control (non-intervention) group.
Dutch: 10 personen werden gerandomiseerd naar de controlegroep (groep zonder interventie).
English: This medicinal product must not be administered by intravitreal injection.
Dutch: Dit geneesmiddel mag niet door intravitreale injectie worden toegediend.
English: Change in MLMT score
Dutch: Verandering in MLMT-score
English: Table 5 Full-field light sensitivity testing
Dutch: Tabel 5 'Full-field light sensitivity'-test
English: Talk to your doctor before resuming these activities.
Dutch: Overleg met uw arts voordat u deze activiteiten hervat.
English: What Luxturna is and what it is used for
Dutch: Wat is Luxturna en waarvoor wordt dit middel gebruikt?
English: The average age was 15 years (range 4 to 44 years), including 64% paediatric subjects (n=20, age from 4 to 17 years) and 36% adults (n=11).
Dutch: De gemiddelde leeftijd was 15 jaar (spreiding van 4 tot 44 jaar), waaronder 64% pediatrische patiënten (n = 20, leeftijd van 4 tot 17 jaar) en 36% volwassenen (n = 11).
English: As a precaution, you should not receive Luxturna while you are pregnant.
Dutch: Uit voorzorg mag Luxturna niet worden toegediend terwijl u zwanger bent.
English: Each box represents the middle 50% of distribution of MLMT score change.
Dutch: Elk staafje vertegenwoordigt de middelste 50%-verdeling van de verandering in de MLMT-score.
English: Damage to the tissues of the eye may be accompanied by bleeding and swelling and an increased risk of infection.
Dutch: Beschadiging van de weefsels van het oog kan gepaard gaan met bloeding en zwelling en een verhoogd risico op infectie.
English: Patients and their caregivers should be provided with the patient information pack, including:
Dutch: Patiënten en hun zorgverleners dienen het patiënteninformatiepakket te ontvangen, inclusief:
English: Clinical pharmacokinetics and shedding
Dutch: Klinische farmacokinetiek en shedding
English: • A patient card o Highlights the importance of follow-up visits and reporting side effects to the patient's physician.
Dutch: • Een patiëntenkaart o Benadrukt het belang van vervolgbezoeken en het melden van bijwerkingen aan de arts van de patiënt.
English: Your doctor may delay your treatment until your infection is gone because this medicine may make it more difficult for you to fight an infection.
Dutch: Uw arts stelt dan mogelijk uw behandeling uit tot uw infectie is verdwenen omdat door dit geneesmiddel een infectie mogelijk lastiger te bestrijden is.
English: • Tell your doctor if you have an active infection of any sort.
Dutch: • Neem contact op met uw arts als u een actieve infectie heeft, ongeacht welke.
English: As a precautionary measure, it is preferable to avoid the use of voretigene neparvovec during pregnancy.
Dutch: Uit voorzorg heeft het de voorkeur het gebruik van voretigene neparvovec te vermijden tijdens zwangerschap.
English: In the Phase 3 study, the MLMT used seven levels of illumination ranging from 400 lux to 1 lux (corresponding to, for example, a brightly lit office down to a moonless summer night).
Dutch: In het fase 3-onderzoek werden voor de MLMT zeven niveaus van verlichting gebruikt, uiteenlopend van 400 lux tot 1 lux (overeenkomend met bijvoorbeeld een helder verlicht kantoor tot een maanloze zomernacht).
English: The qualified staff (i.e. vitreoretinal surgeons and pharmacists) at the treatment centres should be provided with educational materials including:
Dutch: Het gekwalificeerd personeel (d.w.z. vitreoretinale chirurgen en apothekers) in de behandelingscentra dient educatieve materialen te ontvangen, waaronder:
English: Voretigene neparvovec has minor influence on the ability to drive and use machines.
Dutch: Voretigene neparvovec heeft geringe invloed op de rijvaardigheid en op het vermogen om machines te bedienen.
English: Your doctor will talk to you about the anaesthesia and how it will be given to you.
Dutch: Uw arts zal met u de verdoving bespreken en hoe die aan u wordt toegediend.
English: Ocular or periocular infection.
Dutch: Oculaire of perioculaire infectie.