FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect up to 1 in 10 people): dizziness vomiting, nausea, diarrhoea, abdominal pain, dyspepsia rash, itchy skin (pruritus) back pain, joint pain (arthralgia), muscle pain (myalgia) and muscle spasms fever (pyrexia), influenza like illness, chills, feeling tired (fatigue, asthenia) meningococcal infection, meningococcal sepsis
Maltese: Komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni): sturdament rimettar, dardir, dijarea, uġigħ addominali, dispepsija raxx, ħakk fil-ġilda (prurite) uġigħ fid-dahar, uġigħ fil-ġogi (artralġija), uġigħ fil-muskoli (mijalġija), spażmi fil-muskoli deni, mard bħal dak tal-influwenza, tertir tal-bard, tħossok għajjien (għeja kbira, astenija) infezzjoni meningokokkali, sepsi meningokokkali
English: Figure 2: Analysis of primary and secondary endpoints - full analysis set (eculizumabexperienced study)
Maltese: Figura 2: Analiżi ta' punti tat-tmiem primarji u sekondarji - sett sħiħ ta' analiżi (studju dwar pazjenti li ġew ikkurati fil-passat b'eculizumab)
English: o The importance of meningococcal vaccination prior to treatment and/or to receive antibiotic prophylaxis.
Maltese: o L-importanza ta' tilqima meningokokkali qabel it-trattament u/jew biex jirċievu profilassi antibijotika.
English: o Treatment with ravulizumab increases the risk of N. meningitidis infections.
Maltese: o Il-kura b'ravulizumab iżżid ir-riskju ta' infezzjonijiet N. meningitidis.
English: Ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH): in patients with haemolysis with clinical symptom(s) indicative of high disease activity in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5.1).
Maltese: Ultomiris huwa indikat fit-trattament ta' pazjenti adulti b'emoglobinurija notturna parossimali (PNHparoxysmal nocturnal haemoglobinuria): f'pazjenti b'emolisi b'sintomu(i) kliniku(iċi) indikattiv(i) ta' attività ta' mard għolja f'pazjenti li huma klinikament stabbli wara li ġew ittrattati b'eculizumab għal mill-inqas l-aħħar 6 xhur (ara sezzjoni 5.1).
English: One vial of 30 mL contains 300 mg of ravulizumab, produced in Chinese hamster ovary (CHO) cell culture by recombinant DNA technology.
Maltese: Kunjett wieħed ta' 30 mL fih 300 mg ta' ravulizumab, magħmul fil-koltura taċ-ċelluli tal-ovarji talħamster Ċiniż (CHO - Chinese hamster ovary) permezz ta' teknoloġija tad-DNA rikombinanti.
English: Ultomiris requires dilution to a final concentration of 5 mg/mL.
Maltese: Ultomiris irid jiġi dilwit għal konċentrazzjoni finali ta' 5 mg/mL.
English: Ultomiris contains sodium
Maltese: Ultomiris fih is-sodium
English: The most serious adverse reactions in patients in clinical trials are meningococcal infection and meningococcal sepsis (see section 4.4).
Maltese: L-aktar reazzjonijiet avversi serji fil-provi kliniċi huma infezzjoni meningokokkali u sepsi meningokokkali (ara sezzjoni 4.4).
English: As an immunoglobulin gamma (IgG) monoclonal antibody, ravulizumab is expected to be metabolized in the same manner as any endogenous IgG (degraded into small peptides and amino acids via catabolic pathways), and is subject to similar elimination.
Maltese: Bħala antikorp monoklonali tal-immunoglobulina gamma (IgG, immunoglobulin gamma), ravulizumab huwa mistenni li jiġi metabolizzat fl-istess mod bħal kwalunkwe IgG endoġena (iddiżintegrat fil-peptides żgħar u fl-amino acids permezz ta' passaġġi kataboliċi), u huwa soġġett għal eliminazzjoni simili.
English: ravulizumab
Maltese: Pożoloġija
English: Adverse reactions MedDRA System Organ Class
Maltese: Sistema tal-Klassifika tal-Organi
English: 30 mL of sterile concentrate in a vial (Type I glass) with a stopper and a seal.
Maltese: 30 mL ta' konċentrat sterili f'kunjett (ħġieġ ta' Tip I), b'tapp u siġill.
English: Volume of NaCl diluent b
Maltese: Volum ta' dilwent NaCl b
English: Ravulizumab was non-inferior compared to eculizumab for both coprimary endpoints, avoidance of pRBC transfusion per protocol-specified guidelines and LDH normalisation from day 29 to day 183, and for all 4 key secondary endpoints (Figure 1).
Maltese: Ravulizumab ma kienx inferjuri meta mqabbel ma' eculizumab għaż-żewġ punti tat-tmiem koprimarji, li tiġi evitata t-trasfużjoni pRBC skont il-linji gwida speċifikati fil-protokoll u n-normalizzazzjoni ta' LDH minn jum 29 sa jum 183, u għall-4 punti tat-tmiem sekondarji ewlenin kollha (Figura 1).
English: How to store Ultomiris 6.
Maltese: Kif taħżen Ultomiris 6.
English: Mean (SD) Median
Maltese: Medja (SD) Medjan
English: This medicinal product when diluted with sodium chloride 9 mg/mL (0.9 %) solution for injection contains 2.65 g sodium per 720 mL at the maximal dose, equivalent to 133 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali meta dilwit b'soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride fih 2.65 g ta' sodium għal kull 720 mL fid-doża massima, ekwivalenti għal 133% tad-doża massima ta' kuljum rakkomandata mill-WHO ta' 2 g ta' sodium għal persuna adulta.
English: Ultomiris must be diluted prior to administration by intravenous infusion over a minimal period of 1.7 to 2.4 hours depending of body weight, see Table 2 below.
Maltese: Ultomiris irid jiġi dilwit qabel jingħata permezz ta' infużjoni ġol-vini fuq perjodu minimu ta' bejn 1.7 u 2.4 sigħat skont il-piż tal-ġisem, ara Tabella 2 hawn taħt.
English: See the leaflet for further information.
Maltese: Sorsi oħra ta' informazzjoni
English: In PNH patient studies (N = 261), only 1 (0.38 %) case with development of treatment-emergent anti-drug antibody has been reported with ravulizumab.
Maltese: Fi studji dwar pazjenti b'PNH (N = 261), ġie rrappurtat każ wieħed biss (0.38%) bi żvilupp ta' antikorp kontra l-mediċina li seħħ minħabba t-trattament b'ravulizumab.
English: A risk to infants cannot be excluded.
Maltese: Ir-riskju gћat-trabi tat-twelid mhux eskluż.
English: After dilution with sodium chloride 9 mg/mL (0.9 %) solution for injection, the final concentration of the solution is 5 mg/mL.
Maltese: Wara d-dilwizzjoni bis-soluzzjoni għall-injezzjoni tas-sodium chloride 9 mg/mL (0.9%), ilkonċentrazzjoni finali tas-soluzzjoni tkun ta' 5 mg/mL.
English: The other ingredients are: - sodium dihydrogen phosphate dihydrate - disodium phosphate dihydrate - sodium chloride - polysorbate 80 Solvent: water for injections
Maltese: − Is-sustanzi mhux attivi l-oħra huma: - sodium dihydrogen phosphate dihydrate - disodium phosphate dihydrate - sodium chloride - polysorbate 80
English: Your doctor will discuss the possible side effects with you and explain the risks.
Maltese: It-tabib tiegħek se jiddiskuti l-effetti sekondarji possibbli miegħek u se jispjega r-riskji.
English: If you have not been vaccinated against meningococcal infection.
Maltese: Jekk qatt ma tlaqqamt kontra infezzjoni meningokokkali.
English: Ravulizumab has been designed to attach to the C5 complement protein, which is a part of the body's defence system called the ‘complement system'.
Maltese: Ravulizumab ġie mfassal biex jeħel mal-proteina C5 tal-komplement, li hija parti mis-sistema ta' difiża tal-ġisem imsejħa s-‘sistema tal-komplement'.
English: Total PNH RBC clone size
Maltese: Ilma għall-injezzjonijiet
English: Ravulizumab was dosed in accordance with the recommended dosing described in section 4.2 (4 infusions of ravulizumab over 26 weeks) while eculizumab was administered according to the approved dosing regimen of eculizumab of 600 mg every week for the first 4 weeks and 900 mg every 2 weeks (15 infusions over 26 weeks).
Maltese: Ravulizumab ingħata f'dożi skont id-dożaġġ rakkomandat deskritt fis-sezzjoni 4.2 (4 infużjonijiet ta' ravulizumab fuq 26 ġimgħa) waqt li eculizumab ingħata skont il-kors ta' dożaġġ approvat ta' eculizumab ta' 600 mg kull ġimgħa għall-ewwel 4 ġimgħat u 900 mg kull ġimagħtejn (15-il infużjoni fuq 26 ġimgħa).
English: Ravulizumab weight-based dosing regimen Body weight range (kg)
Maltese: Doża qawwija tal-bidu (mg) Doża ta' manteniment (mg)
English: What Ultomiris looks like and contents of the pack Ultomiris is presented as a concentrate for solution for infusion (30 mL in a vial - pack size of 1).
Maltese: Ultomiris huwa ppreżentat bħala konċentrat għal soluzzjoni għall-infużjoni (30 mL f'kunjett - daqs talpakkett ta' 1).
English: Human IgG are known to cross the human placental barrier, and thus ravulizumab may potentially cause terminal complement inhibition in the foetal circulation.
Maltese: IgG umani huma magħrufa li jaqsmu l-barriera talplaċenta umana, u għalhekk ravulizumab jista' potenzjalment jikkawża inibizzjoni tal-komplement terminali fiċ-ċirkolazzjoni tal-fetu.
English: Other medicines and Ultomiris
Maltese: Mediċini oħra u Ultomiris
English: Min, max
Maltese: Medjan Min, mass
English: All 3 recovered while continuing treatment with ravulizumab.
Maltese: It-3 li huma rkupraw filwaqt li komplew it-trattament b'ravulizumab.
English: o The risk of developing antibodies to ravulizumab.
Maltese: o Ir-riskju li jiżviluppaw antikorpi għal ravulizumab.
English: The time to maximum observed concentration (tmax) is expected at the end of infusion (EOI) or soon after EOI.
Maltese: Il-ħin biex tintlaħaq ilkonċentrazzjoni massima osservata (tmax) huwa mistenni fl-aħħar tal-infużjoni (EOI - End of Infusion) jew ftit wara l-EOI.
English: Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported in patients treated with other terminal complement inhibitors.
Maltese: Infezzjonijiet serji bi speċi ta' Neisseria (minbarra Neisseria meningitidis), inkluż infezzjonijiet filgonokokku mxerrda, kienu rrappurtati f'pazjenti ttrattati b'inibituri tal-komplement terminali oħrajn.
English: The mean (standard deviation [SD]) volume of distribution at steady state for patients with PNH on the studied weight-based dose regimen was 5.34 (0.92) L.
Maltese: Il-volum medju ta' distribuzzjoni (devjazzjoni standard [SD]) fi stat fiss għal pazjenti b'PNH fuq ilkors ta' dożaġġ studjat ibbażat fuq il-piż tal-ġisem kien ta' 5.34 (0.92) L.
English: Chronic intravenous human immunoglobulin (IVIg) treatment may interfere with the endosomal neonatal Fc receptor (FcRn) recycling mechanism of monoclonal antibodies such as ravulizumab and thereby decrease serum ravulizumab concentrations.
Maltese: Trattament kroniku bl-immunoglobulina umana li tingħata ġol-vini (IVIg, intravenous human immunoglobulin) jista' jinterferixxi mal-mekkaniżmu tar-riċiklaġġ tar-riċettur endosomali Fc ta' trabi tat-twelid (FcRn - neonatal Fc receptor) ta' antikorpi monoklonali bħal ravulizumab u b'hekk inaqqas il-konċentrazzjonijiet ta' ravulizumab fis-serum.
English: Pack size of one vial.
Maltese: Daqs tal-pakkett ta' kunjett wieħed.
English: Eligible patients to enter this trial had to demonstrate high disease activity, defined as LDH level ≥ 1.5 × upper limit of normal (ULN) at screening along with the presence of 1 or more of the following PNH-related signs or symptoms within 3 months of screening: fatigue, haemoglobinuria, abdominal pain, shortness of breath (dyspnoea), anaemia (haemoglobin < 10 g/dL), history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of packed red blood cell (pRBC) transfusion due to PNH.
Maltese: Pazjenti li kienu eliġibbli biex jidħlu f'dan l-istudju kellhom juru attività għolja ta' mard, definita bħala livell ta' LDH ≥ 1.5 × il-limitu ta' fuq tan-normal (ULN, upper limit of normal) waqt l-iscreening flimkien mal-preżenza ta' wieħed jew aktar mis-sinjali jew sintomi marbuta ma' PNH li ġejjin fi żmien 3 xhur mill-iscreening: għeja kbira, emoglobinurija, uġigħ addominali, qtugħ ta' nifs (dispnea), anemija (emoglobina < 10 g/dL), storja medika ta' avveniment vaskulari avvers
English: The MAH shall ensure that in each Member State where Ultomiris is marketed, a system aimed to control distribution of Ultomiris beyond the level of routine risk minimisation measures is in place.
Maltese: L-MAH għandu jiżgura li f'kull Stat Membru fejn Ultomiris jitpoġġa fis-suq, ikun hemm sistema maħsuba biex tikkontrolla d-distribuzzjoni ta' Ultomiris lil hemm mil-livell ta' kontroll żgurata permezz ta' miżuri ta' rutina tal-minimizzazzjoni tar-riskju.
English: Infusion must be administered through a 0.2 µm filter.
Maltese: L-infużjoni għandha tingħata permezz ta' filtru ta' 0.2 µm.
English: Patients with any PNH conditions a prior to informed consent n (%)
Maltese: a qabel il kunsens infurmat n (%)
English: The eculizumab-experienced study was a 26-week, multicentre, open-label, randomised, active-controlled Phase 3 study conducted in 195 patients with PNH who were clinically stable (LDH ≤ 1.5 x ULN) after having been treated with eculizumab for at least the past 6 months.
Maltese: L-istudju dwar pazjenti li ġew ikkurati fil-passat b'eculizumab kien studju ta' Fażi 3 li dam 26 ġimgħa, multiċentriku, open-label, fejn il-pazjenti ntgħażlu b'mod każwali, ikkontrollat b'mod attiv li twettaq fuq 195 pazjent b'PNH li kienu klinikament stabbli (LDH ≤ 1.5 x ULN) wara li kienu ttrattati b'eculizumab għal mill-inqas l-aħħar 6 xhur.
English: The diluted solution should be allowed to warm to room temperature (18°C-25°C) prior to administration by exposure to ambient air during approximately 30 min.
Maltese: - Is-soluzzjoni dilwita għandha titħalla tisħon sat-temperatura tal-kamra (18°C-25°C) billi tesponiha biss għall-arja ambjentali fuq madwar 30 min.
English: Each vial of Ultomiris contains 300 mg of active substance in 30 mL of product solution.
Maltese: Kull kunjett ta' Ultomiris fih 300 mg ta' sustanza attiva f'30 mL ta' soluzzjoni tal-prodott.
English: If patients with PNH discontinue treatment with ravulizumab, they should be closely monitored for signs and symptoms of serious intravascular haemolysis, identified by elevated LDH (lactate dehydrogenase) levels along with sudden decrease in PNH clone size or haemoglobin, or reappearance of symptoms such as fatigue, haemoglobinuria, abdominal pain, shortness of breath (dyspnoea), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction.
Maltese: Jekk pazjenti b'PNH iwaqqfu t-trattament b'ravulizumab, għandhom jiġu mmonitorjati mill-qrib għal sinjali u sintomi ta' emolisi intravaskulari serja, li tkun identifikata minn żieda fil-livelli ta' LDH (lactate dehydrogenase) flimkien ma' tnaqqis f'daqqa fid-daqs tal-klonu ta' PNH jew fl-emoglobina, jew jekk jitfaċċaw mill-ġdid sintomi bħal għeja kbira, emoglobinurija, uġigħ addominali, qtugħ ta' nifs (dispnea), avveniment vaskulari avvers maġġuri (inkluż trombożi), bligħ anormali, jew disfunzjoni erettili.
English: Nonclinical reproductive toxicology studies conducted in mice with a murine surrogate molecule (BB5.1) identified no adverse effect on fertility of the treated females or males.
Maltese: Studji dwar it-tossikoloġija riproduttiva mhux kliniċi li twettqu fil-ġrieden bil-molekula murine surrogate (BB5.1) ma identifikaw l-ebda effetti avversi fuq il-fertilità tan-nisa jew irġiel ġrieden ittrattati.
English: Vaccination reduces, but does not eliminate, the risk of meningococcal infections.
Maltese: It-tilqim inaqqas, iżda ma jeliminax, ir-riskju ta' infezzjonijiet meningokokkali.
English: This medicine when diluted with sodium chloride 9 mg/mL (0.9%) solution for injection for IV administration contains 2.65 g sodium (main component of cooking/table salt) in 720 mL at the maximal dose.
Maltese: Din il-mediċina meta dilwita b'soluzzjoni għal injezzjoni ta' 9 mg/mL (0.9%) sodium chloride għal għoti ġol-vina fiha 2.65 g sodium (il-komponent ewlieni tal-melħ tat-tisjir/tal-mejda) f'720 mL fiddoża massima.
English: Please refer to section 4.4 for information on prevention and treatment of suspected meningococcal infection.
Maltese: Jekk jogħġbok irreferi għal sezzjoni 4.4 għal informazzjoni dwar il-prevenzjoni u t-trattament ta' infezzjoni meningokokkali suspettata.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Maltese: Konċentrat għal soluzzjoni għall-infużjoni (konċentrat sterili).
English: Note: The black triangle indicates the non-inferiority margins, and grey dot indicates point estimates.
Maltese: Nota: It-trijangolu iswed jindika l-marġini ta' noninferjorità, u l-punt griż jindika l-istimi tal-punti.
English: What is Ultomiris
Maltese: X'fih Ultomiris
English: o Signs and symptoms of meningococcal infection and the need to obtain urgent medical care.
Maltese: o Sinjali u sintomi ta' infezzjoni meningokokkali u l-ħtieġa li tikseb kura medika urġenti.
English: Ultomiris is a medicine that contains the active substance ravulizumab and it belongs to a class of medicines called monoclonal antibodies, that attach to a specific target in the body.
Maltese: Ultomiris hija mediċina li fiha s-sustanza attiva ravulizumab u jappartjeni għal klassi ta' mediċini msejħa antikorpi monoklonali, li jeħlu ma mira speċifika fil-ġisem.
English: Study in PNH patients previously treated with eculizumab
Maltese: Studju fuq pazjenti b'PNH li qabel kienu ttrattati b'eculizumab
English: Over the studied dose and regimen range, ravulizumab exhibited dose proportional and time linear pharmacokinetics (PK).
Maltese: Ravulizumab wera farmakokinetika (PK, pharmacokinetics) lineari maż-żmien u proporzjonali għaddoża tal-istudju u l-medda tal-kors.
English: Table 2: Maintenance dose administration reference table
Maltese: Tabella 2: Tabella ta' referenza għall-għoti ta' doża ta' manteniment
English: Rash, Pruritus
Maltese: Raxx, Ħakk
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Ultomiris in one or more subsets of the paediatric population in paroxysmal nocturnal haemoglobinuria (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Ultomiris f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-emoglobinurija notturna parossimali (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Prior to launch of Ultomiris in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational and controlled distribution programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Ultomiris f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq (MAH) irid jaqbel dwar il-kontenut u l-format tal-programm edukattiv u ta' distribuzzjoni kkontrollata, li jinkludi media tal-komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħrajn tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: If you are allergic to ravulizumab, proteins derived from mouse products, other monoclonal antibodies, or any of the other ingredients of this medicine (listed in section 6).
Maltese: Jekk inti allerġiku għal ravulizumab, proteini derivati minn prodotti tal-ġrieden, antikorpi monoklonali oħra, jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: Prepare Ultomiris as follows:
Maltese: Ipprepara Ultomiris kif ġej:
English: By attaching to and blocking the C5 protein, this medicine can stop complement proteins from attacking red blood cells and so control symptoms of the disease.
Maltese: Billi teħel ma' u timblokka l-proteina C5, din il-mediċina tista' twaqqaf proteini tal-komplement milli jattakkaw liċ-ċelluli tad-demm ħomor u b'hekk tikkontrolla s-sintomi tal-marda.
English: Table 1: Ultomiris weight-based dosing regimen
Maltese: Tabella 1: Tabella ta' referenza għall-għoti ta' doża qawwija tal-bidu
English: Meningococcal and other Neisseria infections symptoms Because the medicine blocks the complement system, which is part of the body's defences against infection, the use of Ultomiris increases your risk of meningococcal infection caused by Neisseria meningitidis.
Maltese: Sintomi ta' infezzjoni meningokokkali u infezzjonijiet oħra ta' Neisseria Minħabba li l-mediċina timblokka s-sistema tal-komplement, li hija parti mid-difiżi tal-ġisem kontra infezzjoni, l-użu ta' Ultomiris iżid ir-riskju tiegħek ta' infezzjoni meningokokkali kkawżata minn Neisseria meningitidis.
English: After dilution, the final concentration of the solution to be infused is 5 mg/mL.
Maltese: Wara d-dilwizzjoni, il-konċentrazzjoni finali tas-soluzzjoni li għandha tingħata permezz ta' infużjoni tkun ta' 5 mg/mL.
English: Haematuria or haemoglobinuria Aplastic anaemia Renal failure
Maltese: .6 Prekawzjonijiet speċjali għar-rimi u għal immaniġġar ieħor
English: Meningococcal infection symptoms Because of the importance of rapidly identifying and treating meningococcal infection in patients who receive Ultomiris, you will be provided a ‘patient safety card' to carry with you at all times, listing relevant signs and symptoms of meningococcal infection/sepsis.
Maltese: Minħabba li huwa importanti li l-infezzjoni meningokokkali f'pazjenti li jirċievu Ultomiris tiġi identifikata u ttrattata malajr, int se tkun ipprovdut b'‘kard tas-sigurtà tal-pazjent' li għandek iġġorr dejjem fuqek, li telenka s-sinjali u s-sintomi relevanti ta' infezzjoni meningokokkali/sepsi.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mL
Maltese: INDIVIDWALI 30 mL
English: “Other” category included neutropenia, renal dysfunction, and thrombopenia, as well as a number of other conditions.
Maltese: b Il-kategorija “oħrajn” tinkludi newtropenija, disfunzjoni tal-kliewi, u trombopenija, kif ukoll numru ta' kundizzjonijiet oħra
English: Other systemic infections
Maltese: Infezzjonijiet sistemiċi oħra
English: No formal trial of the effect of sex, race, age (geriatric), hepatic or renal impairment on the pharmacokinetics of ravulizumab was conducted.
Maltese: Ma ġiet imwettqa l-ebda prova tal-effett tas-sess tal-persuna, ir-razza, l-età (ġerjatrika), indeboliment epatiku jew renali fuq il-farmakokinetika ta' ravulizumab.
English: In clinical trials, 3 out of 261 PNH patients developed serious meningococcal infections/sepsis while receiving treatment with ravulizumab; all 3 had been vaccinated.
Maltese: Fil-provi kliniċi, 3 minn 261 pazjent b'PNH żviluppaw infezzjoni meningokokkali/sepsi serja waqt li kienu qed jirċievu t-trattament b'ravulizumab; it-3 li huma kienu rċivew it-tilqima.
English: o Risk of severe haemolysis following discontinuation/postponement of ravulizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing ravulizumab administrations o Potential risks of severe, non-neisserial infections and malignancies and haematologic abnormalities in PNH patients treated with ravulizumab.
Maltese: o Riskju ta' emolisi serja wara t-twaqqif/posponiment tal-għoti ta' ravulizumab, is-sinjali u s-sintomi tagħhom u r-rakkomandazzjoni biex jikkonsultaw lil min jagħti r-riċetta qabel ittwaqqif/posponiment tal-għoti ta' ravulizumab.
English: The safety and efficacy of ravulizumab in children with PNH aged 0 to < 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' ravulizumab fit-tfal b'PNH minn eta` ta' 0 sa < 18-il sena għadhom ma ġewx determinati s'issa.
English: Table 2: Dose administration rate Body weight range (kg)
Maltese: Tabella 2: Rata tal-għoti tad-doża Medda ta' piż tal-ġisem (kg)
English: Animal reproductive toxicology studies have not been conducted with ravulizumab, but were conducted in mice with a murine surrogate complement inhibitory antibody, BB5.1.
Maltese: Ma ġewx imwettqa studji dwar it-tossikoloġija riproduttiva fl-annimali b'ravulizumab, iżda ġew imwettqa fil-ġrieden b'antikorp inibitorju tal-komplement murine surrogate BB5.1.