FrancophonIA/ELRC3.0 huggingface dataset:
English: After vaccination, the seroprotection rate, seroconversion rate, and seroconversion factor for anti-HA antibody, as measured by SRH, in, infants, children, and adolescents aged 6 months to 17 years were as follows:
Maltese: Wara t-tilqima, ir-rata ta' seroprotezzjoni, ir-rata ta' serokonverżjoni u l-fattur ta' serokonverżjoni għall-antikorp anti-HA, kif imkejjel minn SRH fi trabi, tfal u adolexxenti ta' età minn 6 xhur sa 17-il sena kienu kif ġej:
English: - Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.
Maltese: - Il-perjodiċità għandha tiġi riveduta mid-Detentur tal-Awtorizzazzjoni għat-Tqiegħed fis-Suq u l-(Ko)Rapporter f'intervalli ta' 6 xhur.
English: The following side effects have been reported in clinical studies in adults and older people.
Maltese: Ġew irrappurtati dawn l-effetti sekondarji fl-istudji kliniċi f'persuni adulti u dawk akbar fl-età.
English: NAME OF THE MEDICINAL PRODUCT PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Suspension for injection
Maltese: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, suspensjoni għall-injezzjoni
English: After primary vaccination the seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in adults aged 18 to 59 years and in older subjects aged 60 years and above were as follows:
Maltese: Wara l-ewwel tilqima, ir-rata ta' seroprotezzjoni, ir-rata ta' serokonverżjoni u l-fattur ta' serokonverżjoni għall-antikorp anti-HA kif imkejjel mill-emolisi radjali waħidha (SRH) f'persuni adulti ta' bejn 18-59 sena u f'persuni aktar anzjani li jkollhom 60 sena jew iżjed kienu hekk:
English: Cough
Maltese: Telqa
English: • Injection site eyrthema
Maltese: .8 Effetti mhux mixtieqa
English: How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Contents of the pack and other information
Maltese: Kif taħżen PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Kontenut tal-pakkett u informazzjoni oħra
English: Seroprotection rates (SRH area ≥ 25 mm²) at 21 days after a 12 months booster vaccination with the 7.5 mcg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, were as follows:
Maltese: Ir-rati tas-seroprotezzjoni (b'erja SRH ta' ≥ 25 mm²) wara 21 jum wara l-vaċċin booster bid-doża ta' 7.5 mcg wara 12-il xahar minn tilqima tar-razza A/Indoneżja/05/2005 ittestjati kontra kemm razez omologi kif ukoll eterologi, kienu kif ġej:
English: What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER looks like and contents of the pack
Maltese: Kif jidher PANDEMIC INFLUENZA VACCINE H5N1 BAXTER u l-kontenut tal-pakkett
English: Nasal congestion Rhinorrhea Dry throat
Maltese: Konġestjoni fl-imnieħer Rinorreja
English: Similarly, the A/lndonesia/05/2005 vaccine was efficacious against a heterologous challenge, showing a vaccine dose-dependent survivorship in the vaccinated cohorts as compared to the control cohort.
Maltese: Bl-istess mod, il-vaċċin A/lndonesja/05/2005 kien effikaċi kontra sfida eterologa, u wera sopravivenza relatata mad-doża tal-vaċċin fil-gruppi mlaqqma meta pparagunat mal-grupp ta' kontroll.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is a vaccine used in individuals aged 6 months adults and older.
Maltese: INFLUENZA VACCINE H5N1 BAXTER huma elenkati f'sezzjoni 6 fl-aħħar tal-fuljett.
English: Uncommon Common Uncommon
Maltese: Mhux komuni Komuni ħafna
English: Influenza-like illness
Maltese: IL-PANDEMIC
English: • A protective response may not be induced in all vaccinees (see section 5.1).
Maltese: • Jista' ma jiġix ikkawżat rispons protettiv fil-vaċċini kollha (ara sezzjoni 5.1).
English: - Vaccination failure:
Maltese: - Falliment tal-vaċċinazzjoni:
English: How PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given Possible side effects
Maltese: Kif jingħata PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Effetti sekondarji possibbli
English: • chest discomfort
Maltese: DISTURBI ĠENERALI
English: All spontaneous adverse reactions by age group, per SOC, HLT and PT, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Maltese: Kull reazzjoni avversa spontaneja skont il-gruppi ta' etajiet li ġejjin, skont SOC, HLT u PT stratifikati skont it-tip ta' rapport (medikament ikkonfermati jew mhux medikament ikkonfermati) għall-perijodu kopert mir-rapport u b'mod kumulattiv:
English: • Injection site swelling
Maltese: • tħossok imdardar
English: Very Common Common Common Common Common Uncommon Uncommon Uncommon
Maltese: Komuni ħafna Komuni Komuni Komuni Mhux komuni
English: All spontaneous adverse reactions (SOC, HLT, PT) occurring in pregnant women, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Maltese: Kull reazzjoni avversi spontaneja (SOC, HLT, PT) li sseħħ f'nisa tqal, stratifikati skont it-tip ta' rapport (medikament ikkonfermati jew mhux medikament ikkonfermati) għall-perijodu kopert mir-rapport u b'mod kumulattiv.
English: • allergic reactions, including severe reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock.
Maltese: • reazzjonijiet allerġiċi, li jinkludu reazzjonijiet severi li jwasslu għal tnaqqis perikoluż fil-pressjoni tad-demm li, jekk ma jiġux ikkurati, jista' jwassal għal xokk.
English: Fatigue
Maltese: Vertiġni
English: Oropharyngeal pain Cough
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Format of the simplified PSUR
Maltese: Format tar-Rapport ta' Aġġornament dwar is-Sigurtà Simplifikat
English: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Maltese: MUSKOLU-SKELETRIĊI U TAT-TESSUTI
English: What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for What you need to know before you are vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Maltese: Għid lit-tabib li jitlob dawn it-testijiet li inti dan l-aħħar irċivejt PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
English: SUBCUTANEOUS TISSUE DISORDERS
Maltese: U TAS-SISTEMA LIMFATIKA
English: Information from non-clinical studies
Maltese: Informazzjoni għall-utent
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be used in lactating women.
Maltese: Għal PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, għad m'hemmx tagħrif ta' wara t-tqegħid fis-suq disponibbli.
English: Date of last renewal: 15/01/2010
Maltese: Data ta' l-aħħar tiġdid: 15/01/2010
English: 1: cell culture infective dose 50% 2: egg infective dose 50%
Maltese: 1: doża infettiva tas-cell culture 50% 2: doża infettiva tal-bajda 50%
English: 69800 SAINT-PRIEST France
Maltese: F-69800 Saint Priest
English: ATC Vet code: QI06AJ02
Maltese: Q106AJ02
English: EU/2/04/049/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/049/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Maltese: EU/2/04/049/001 Lajofiliżejt (10 fliexken ta' doża ) + solvent (10 fliexken ta' doża) EU/2/04/049/002 Lajofiliżejt (50 flixkun ta' doża) + solvent (50 flixkun ta' doża)
English: 1 ml
Maltese: 1 L-ISEM
English: MARKETING AUTHORISATION NUMBER(S) EU/2/04/049/001-002
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/04/049/001-002
English: EXPIRY DATE EXP (mm/yyyy)
Maltese: DATA TA' SKADENZA EXP (xx/ssss)
English: Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus and Chlamydophila felis.
Maltese: Tistimola immunità attiva kontra l-herpesvajrus tar-rinotrakeite fil-qtates, kaliċivirus fil-qtates u Chlamydophila felis.
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs and excretion, - against Chlamydophila felis infection to reduce clinical signs.
Maltese: Immunizzazzjoni attiva tal-qtates ta' 8 ġimgħat u akbar: - kontra r-rinotrakeite virali fil-qtates biex tnaqqas sinjali kliniċi, - kontra l-infezzjoni tal-kaliċivirus biex tnaqqas sinjali kliniċi u eskrezzjoni,
English: Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Maltese: Lajofiliżejt (10 fliexken ta' doża ) + solvent (10 fliexken ta' doża) Lajofiliżejt (50 flixkun ta' doża) + solvent (50 flixkun ta' doża)
English: ROUTE(S) OF ADMINISTRATION Subcutaneous use
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh
Maltese: Purevax RCCh
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh solvent
Maltese: Purevax RCCh solvent.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ...................................... ≥ 104.9 CCID50 Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains) ..................... ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) .................................................................... ≥ 103.0 EID50 Excipient:
Maltese: Antiġeni inattivati tal-Kaliċivirosi fil-qtates (strejn FCV 431 u G1)............................... ≥ 2.0 ELISA U. Chlamydophila felis attenwat (strejn 905) ...................................................................... ≥ 103.0 EID50 Solvent:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/02/2005
Maltese: Data ta' l-ewwel awtorizzazzjoni: 23/02/2005
English: Store and transport refrigerated (2 °C - 8 °C) Protect from light.
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C) Ipproteġi mid-dawl.
English: 4.9 Amounts to be administered and administration route
Maltese: 4.9 Doża rakkomandata u l-metodu ta' amministrazzjoni
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh lyophilisate and solvent for suspension for injection
Maltese: VETERINARJU Purevax RCCh lajofiliżejt u solvent għal suspensjoni għall-injezzjoni.
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Lajofiliżejt u solvent għal suspensjoni għall-injezzjoni.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (EMEA) http://www.emea.europa.eu/
English: Lyophilisate and solvent for suspension for injection.
Maltese: Lajofiliżejt u solvent għal suspensjoni għall-injezzjoni.
English: SPECIAL WARNING(S)
Maltese: TAS-SUSTANZA(I)
English: Gentamicin, at most.......................................................................................................................... 28 µg Solvent:
Maltese: Gentamiċin, massimu ta' .................................................................................................................. 28 µg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Purevax RCCh lyophilisate for injection
Maltese: VETERINARJU Purevax RCCh lajofiliżejt għall-injezzjoni.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIOLOĠIKA(ĊI) ATTIVA(I)
English: Per dose of 1ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
Maltese: FCV (strejn 431 u G1)..................................................................................................... ≥ 2.0 ELISA U. Chlamydophila felis (strejn 905) ....................................................................................... ≥ 103.0 EID50
English: Not applicable.
Maltese: Awtoritajiet kompetenti.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti) jekk ikun hemm bżonn L-ebda effett ħlief dawk imsemmija fis-sezzjoni 4.6 “Effetti mhux mixtieqa” ma ġew osservati, ħlief żieda fit-temperatura tal-ġisem li tista' f'każi eċċezzjonali ddum għal 5 ijiem.
English: Gentamicin, at most.......................................................................................................................... 28 µg
Maltese: Ilma għal injezzjoni ....................................................................................................................... q.s. ml
English: Where high levels of maternal antibodies against R, C or Ch components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Maltese: Fejn livelli għolja ta' antikorpi materni kontra l-komponenti R, C, jew Ch huma mistennija li jkunu preżenti (per eżempju fi frieħ ta' bejn 9 u 12-il ġimgħa mwielda minn nisa li kienu mlaqqma qabel it-tqala u/jew kellhom espożizzjoni preċedenti magħrufa jew issuspettata għall-patoġenu/patoġeni), l-ewwel kors ta' tilqima għandu jiġi rimandat sa l-età ta' 12-il ġimgħa.
English: Per dose of 1ml:
Maltese: U KWANTITATTIVA Għal kull doża ta' ml:
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Maltese: Mhux id-daqsijiet kollha tal-pakketti jistgħu qegħdin fis-suq
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pack of 10 bottles of lyophilisate and 10 bottles of solvent Pack of 50 bottles of lyophilisate and 50 bottles of solvent
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Pakkett li għandu 10 fliexken ta' lajofiliżejt u 10 fliexken ta' solvent Pakkett li għandu 50 flixkun ta' lajofiliżejt u 50 flixkun ta' solvent
English: In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
Maltese: F'kundizzjonijiet normali ta'l-użu, jista' jkun hemm apatija u anoressja li jgħaddu, u ukoll żieda fittemperatura tal-ġisem (li ddum normalment għal ġurnata jew tnejn).
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and Chlamydophila felis components.
Maltese: Ġie muri li l-bidu ta' l-immunità jseħħ, ġimgħa wara l-ewwel kors ta' vaċċinazzjoni għall-komponenti tar-rinotrakeite, kaliċivirus u Chlamydophila felis.
English: Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent
Maltese: Pakkett li għandu 10 fliexken ta' doża ta' lajofiliżejt u 10 fliexken ta' ml ta' solvent Pakkett li għandu 50 flixkun ta' doża ta' lajofiliżejt u 50 flixkun ta' ml ta' solvent
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Is-sommarju tal-karatteristiċi tal-prodott validu, tikkettar u fuljett ta' tagħrif huma l-aħħar verżjonijiet miksuba matul il-proċedura ta' Koordinament tal-grupp.
English: Summary of product characteristics, labelling and package leaflet
Maltese: Sommarju tal-karatteristiċi tal-Prodott, tikkettar u fuljett ta' tagħrif
English: ≥ 40 to < 60 ≥ 60 to < 100
Maltese: ≥ 40 sa < 60 ≥ 60 sa < 100
English: Note: LDH = lactate dehydrogenase; CI = Confidence Interval.
Maltese: Nota: LDH = lactate dehydrogenase; CI = Intervall ta' Kunfidenza (Confidence Interval).
English: FUJIFILM Diosynth Biotechnologies U.S.A., Inc. 6051 George Watts Hill Drive Research Triangle Park, North Carolina 27709 UNITED STATES
Maltese: Diosynth Biotechnologies U.S.A., Inc. 6051 George Watts Hill Drive Research Triangle Park, North Carolina 27709 L-ISTATI
English: 40 to less than 60 60 to less than 100 above 100
Maltese: 40 sa inqas minn 60 60 sa inqas minn 100 aktar minn 100
English: Maintenance dose (mg)
Maltese: Doża ta' manteniment (mg)
English: 5 mg/mL after dilution
Maltese: 5 mg/mL wara d-dilwizzjoni
English: Table 3:
Maltese: Tabella 3:
English: Patheon Biologics LLC 4766 La Guardia Drive St. Louis, Missouri 63134 UNITED STATES
Maltese: Patheon Biologics LLC 4766 La Guardia Drive St.
English: Adult patients with PNH
Maltese: Pazjenti adulti b'PNH
English: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret FRANCE
Maltese: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret Franza
English: Sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, and water for injections.
Maltese: Sodium dihydrogen phosphate dihydrate, disodium phosphate, dihydrate, sodium chloride, polysorbate 80, u ilma għall-injezzjonijiet.
English: The active substance is ravulizumab (300 mg/30 mL in a vial corresponding to 10 mg/mL).
Maltese: − Is-sustanza attiva hi ravulizumab (300 mg/30 mL f'kunjett li jikkorrispondi għal 10 mg/mL).
English: Minimum infusion duration minutes (hours)
Maltese: Tul minimu talinfużjoni minuti (sigħat)
English: The mean total PNH RBC clone size was 60.05 %, mean total PNH granulocyte clone size was 83.30 %, and the mean total PNH monocyte clone size was 85.86 %.
Maltese: Id-daqs tal-klonu PNH RBC medju totali kien 60.05%, id-daqs tal-klonu ta' PNH granuloċita medju totali kien 83.30%, u d-daqs tal-klonu PNH monoċita medju totali kien 85.
English: Vaccines against serogroups A, C, Y, W135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups.
Maltese: Il-vaċċini kontra s-serogruppi A, C, Y, W135 u B, fejn disponibbli, huma rakkomandati għall-prevenzjoni ta' serogruppi meningokokkali patoġeniċi b'mod komuni.
English: This medicine contains sodium (see section 2 “Ultomiris contains sodium”).
Maltese: Din il-mediċina fiha s-sodium (ara sezzjoni 2 “Ultomiris fih is-sodium”).
English: Back pain, Arthralgia, Myalgia, Muscle spasms
Maltese: Uġigħ fid-dahar, Artralġija, Mijalġija, Spażmi tal-muskoli
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 July 2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 02 ta' lulju 2019
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA43
Maltese: Immunosoppressanti, immunosoppressanti selettivi, Kodiċi ATC:
English: The mean (SD) values for terminal elimination half-life and clearance of ravulizumab in patients with PNH are 49.7 (8.9) days and 0.003 (0.001) L/h, respectively.
Maltese: Il-valuri medji (SD) għall-half-life tal-eliminazzjoni u t-tneħħija terminali ta' ravulizumab f'pazjenti b'PNH huma 49.7 (8.9) jiem u 0.003 (0.001) L/h, rispettivament.
English: Meningococcal infection/sepsis
Maltese: Infezzjoni meningokokkali/sepsi
English: Age (years) at PNH diagnosis
Maltese: Età (snin) waqt id-dijanjosi ta' PNH
English: Adverse reactions are listed by MedDRA system organ class (SOC) and frequency, using the following convention: 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); and not known (cannot be estimated from available data).
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi MedDRA (SOC, System Organ Class) u l-frekwenza, bl-użu tal-konvenzjoni li ġejja: 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); u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Ultomiris volume (mL)
Maltese: Volum ta' Ultomiris (mL)
English: Sex (n, %)
Maltese: Sess tal-persuna (n, %)
English: Immunization
Maltese: Immunizzazzjoni
English: Elderly population (> 65 years old)
Maltese: Popolazzjoni anzjana (> 65 sena)
English: Meningococcal infection*
Maltese: Infezzjoni meningokokkali*
English: o No clinical data on exposed pregnancies is available.
Maltese: o M'hemm l-ebda data klinika disponibbli dwar tqaliet esposti.
English: Excipient(s) with known effect: Sodium (5 mmol per vial)
Maltese: Eċċipjent(i) b'effett magħruf: Sodium (5 mmol għal kull kunjett)
English: Mean (SD) Median Min, max
Maltese: Medja (SD) Medjan Min, mass
English: Pregnancy, breast-feeding, and fertility
Maltese: Tqala, treddigħ, u fertilità
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1371/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1371/001
English: Total volume (mL)
Maltese: Volum totali (mL)
English: Table 3 gives the adverse reactions observed from clinical trials.
Maltese: Tabella 3 turi r-reazzjonijiet avversi osservati mill-provi kliniċi.
English: This is equivalent to 133 % of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 133% tal-konsum irrakkomandat fid-dieta ta' kuljum ta' sodium għal persuna adulta.
English: Free C5 levels less than 0.5 µg/mL were correlated with maximal intravascular haemolysis control and complete terminal complement inhibition.
Maltese: Livelli ta' C5 ħielsa ta' inqas minn 0.5 µg/mL kellhom korrelazzjoni mal-kontroll ta' emolisi intravaskulari massimali u inibizzjoni tal-komplement terminali sħiħa.
English: Volume of NaCl diluentb (mL)
Maltese: Volum ta' dilwent NaClb (mL)
English: The prepared solution should be administered immediately following preparation unless it is stored at 2-8°C.
Maltese: Is-soluzzjoni ppreparata għandha tingħata immedjatament wara l-preparazzjoni sakemm ma tinħażinx f'2-8°C.
English: PNH medical history was similar between ravulizumab and eculizumab treatment groups.
Maltese: L-istorja medika ta' PNH kienet simili bejn il-gruppi ta' trattament ta' ravulizumab u eculizumab.
English: Note: The black triangle indicates the non-inferiority margins, and grey dots indicates point estimates Note: LDH = lactate dehydrogenase, CI = Confidence Interval.
Maltese: Nota: It-trijangolu iswed jindika l-marġini ta' noninferjorità, u l-punti griżi jindikaw l-istimi tal-punti Nota: LDH = lactate dehydrogenase, CI = Confidence Interval - Intervall ta' Kunfidenza
English: Ravulizumab is a monoclonal antibody IgG2/4K that specifically binds to the complement protein C5, thereby inhibiting its cleavage to C5a (the proinflammatory anaphylatoxin) and C5b (the initiating subunit of the terminal complement complex [C5b-9]) and preventing the generation of the C5b-9.
Maltese: IgG2/4K li speċifikament jeħel mal-proteina C5 talkomplement, u b'hekk jinibixxi d-dekompożizzjoni tagħha għal C5a (l-anafilatossin proinfjammatorju) u C5b (is-sottounità li tagħti bidu tal-kumpless tal-komplement terminali [C5b-9]) u jipprevjeni l-ġenerazzjoni tas-C5b-9.
English: The coprimary endpoints were transfusion avoidance, and haemolysis as directly measured by normalisation of LDH levels (LDH levels ≤ 1 × ULN; the ULN for LDH is 246 U/L).
Maltese: Il-punti tat-tmiem koprimarji kienu li tiġi evitata t-trasfużjoni, u l-emolisi kif imkejla direttament permezz tan-normalizzazzjoni tal-livelli ta' LDH (livelli ta' LDH ≤ 1 × ULN; l-ULN għal LDH hu 246 U/L).
English: Clear to translucent, slight whitish colour, pH 7.0 solution.
Maltese: Soluzzjoni ċara għal trasluċida, ta' kulur kemxejn bajdani, b'pH ta' 7.0.
English: Ultomiris is used to treat adult patients with a disease called Paroxysmal Nocturnal Haemoglobinuria (PNH).
Maltese: Ultomiris jintuża biex jittratta pazjenti adulti b'marda msejħa Emoglobinurija Notturna Parossimali (PNH - Paroxysmal Nocturnal Haemoglobinuria).
English: However, chemical and physical stability of the diluted product have been demonstrated for up to 24 hours at 2°C-8°C and up to 6 hours at room temperature.
Maltese: Madankollu, l-istabbilità kimika u fiżika tal-prodott dilwit ġew murija għal sa 24 siegħa f'temperatura ta' 2°C-8°C u sa 6 sigħat f'temperatura tal-kamra.
English: Ultomiris 300 mg concentrate for solution for infusion ravulizumab
Maltese: Ultomiris 300 mg konċentrat għal soluzzjoni għall-infużjoni ravulizumab