FrancophonIA/ELRC3.0 huggingface dataset:
English: <Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:>
Maltese: <Ma dehrux effetti mhux mixtieqa waqt studji kliniċi, iżda dehru f'annimali f'livelli ta' esponiment simili għal-livelli ta' esponiment kliniku u b'rilevanza possibbli għall-użu kliniku kif spjegat:>
English: Do not <take> <use> X
Maltese: <Tiħux> <Tużax> X<:>
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.>
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.>
English: <Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 <or {name of the residue(s)}>.>
Maltese: <Sensittività eċċessiva għas-sustanza(i) attiva(i) jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1 <jew {isem tar-residwu(i)}>.>
English: <This medicine has been given ‘conditional approval'.
Maltese: <Din il-mediċina ngħatat ‘approvazzjoni kondizzjonali'.
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS>
Maltese: ISTRUZZJONIJIET GĦALL-PREPARAZZJONI TA' PRODOTTI RADJUFARMAĊEWTIĊI>
English: Pharmacotherapeutic group: {group}, ATC code: <{code}> <not yet assigned>
Maltese: {kategorija}, Kodiċi ATC:
English: <The European Medicines Agency has waived the obligation to submit the results of studies with <{(Invented) name}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in all subsets of the paediatric population in {condition as per paediatric investigation plan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Maltese: <il-prodott mediċinali ta' referenza li fih {isem tas-sustanza(i) attiva(i)}>] f'kull sett tal-popolazzjoni pedjatrika fil-{kondizzjoni kif imniżżel fid-deċiżjoni tal-Pjan ta' Investigazzjoni Pedjatrika (PIP), fl-indikazzjoni mogħtija} (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).>
English: See section 4.8 for how to report adverse reactions.> [For medicinal products subject to additional monitoring ONLY]
Maltese: Ara sezzjoni 4.8 dwar kif għandhom jiġu rappurtati reazzjonijiet avversi.> [Għal prodotti mediċinali li huma suġġetti għal monitoraġġ addizzjonali
English: <{X} is contraindicated in children aged {x to y} <years> <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] <for the indication of...> (see section 4.3).>
Maltese: <{X} huwa kontraindikat fit-tfal minn età {x sa y} <snin> <xhur> [jew xi kategoriji rilevanti oħra eż. piż, età tal-pubertà, sess] <għal-indikazzjoni ta'…> (ara sezzjoni 4.3).>
English: Italia {Nome} <{Indirizzo} I-00000 {Località}> Tel: +{Numero di telefono} <{e-mail}> Suomi/Finland {Nimi/Namn} <{Osoite/Adress} FIN-00000 {Postitoimipaikka/Stad}> Puh/Tel: +{Puhelinnumero/Telefonnummer} <{e-mail}>
Maltese: I-00000 {Località}> Tel: + {Numero di telefono} <{e-mail}> Suomi/Finland {Nimi/Namn} <{Osoite/Adress}
English: <2.2 Qualitative and quantitative composition> [For advanced therapy products only]
Maltese: Għamla kwalitattiva u kwantitattiva> [Għal prodott/i ta' terapija avvanzata biss]
English: <This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:>
Maltese: <Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14a(4) tar-Regolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li gejjin:
English: Description Due date
Maltese: Deskrizzjoni Data mistennija
English: <The <safety> <and> <efficacy> of {X} in children aged {x to y} <months> <years> [or any other relevant subsets, e.g. weight, pubertal age, gender] <has> <have> not <yet> been established.>
Maltese: <Is- <sigurtà> <u> l- <effikaċja> ta'{X} fit-tfal minn età { x sa y} <xhur> <snin> [jew xi kategoriji rilevanti oħra eż. piż, età tal- pubertà, sess] <għadu> <għadhom> <ma ġiex/ma ġewx> determinati s'issa.>
English: <Additional side effects in children <and adolescents>>
Maltese: <Effetti sekondarji oħra fit-tfal <u l-adolexxenti>>
English: <Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: <Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi attiva/i
English: <{MM/YYYY}>
Maltese: {NATURA/TIP}
English: <Breast-feeding>
Maltese: <Użu fil-popolazzjoni pedjatrika>
English: <This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:>
Maltese: <Peress li din hi approvazzjoni taħt ċirkustanzi eċċezzjonali u skont l-Artikolu 14(8) tar-Regolament (KE) 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li ġejjin:
English: <Date of first authorisation: {DD month YYYY}>
Maltese: <Data tal-aħħar tiġdid: <{JJ xahar SSSS}>
English: <For storage conditions after <reconstitution> <dilution> <first opening> of the medicinal product, see section 6.3.>
Maltese: <Għall-kondizzjonijiet ta' ħażna wara <r-rikostituzzjoni> <d-dilwizzjoni> <l-ewwel ftuħ> tal-prodott mediċinali, ara sezzjoni 6.3.>
English: <Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).>
Maltese: <Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).>
English: <X contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU.
Maltese: <X fih l-istess sustanza attiva u jaħdem bl-istess mod bħal ‘prodott mediċinali ta' referenza' diġà awtorizzat fl-UE.
English: <For instructions on <reconstitution> <dilution> of the medicinal product before administration, see section <6.6> <and> <12>.>
Maltese: <Għal istruzzjonijiet fuq <ir-rikostituzzjoni> <dilwizzjoni> tal-prodott mediċinali qabel jingħata, ara sezzjoni <6.6><u><> <12>.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu<, and on the website of {name of Member State Agency (link)}>.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu ˂ u fuq is-sit elettroniku ta' {isem ta' l-Istat Membru/ Aġenzija (link)}>.
English: <There is no relevant use of {X} <in the paediatric population> <in children aged {x to y} <years> <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] <for the indication of...>.>
Maltese: <M'hemm l-ebda użu rilevanti ta'{X} <fil-popolazzjoni pedjatrika> <fit-tfal minn età {x sa y} <snin>, <xhur> [jew xi kategoriji rilevanti oħra eż. piż, età tal-pubertà, sess] <għal indikazzjoni ta'...>.>
English: <X contains {name the excipient(s)}>
Maltese: X'inhu X u għalxiex jintuża
English: Periodic safety update reports (PSURs)
Maltese: Rapporti perjodiċi aġġornati dwar is-sigurtà (PSURs)
English: <{X} is indicated in <adults> <neonates> <infants> <children> <adolescents> <aged {x to y}> <years> <months>.>
Maltese: <{X} huwa indikat <f' adulti> <fi trabi tat-twelid sa żmien xahar > <fi trabi minn eta' ta' xahar sa' sentejn (2)> <fit-tfal > <fl-adolexxenti> <minn età {x sa y}> <snin> <xhur>.>
English: <Non-interventional post-authorisation safety study (PASS):>>
Maltese: <Studju mhux intervenzjonali dwar is-sigurta wara l-awtorizzazzjoni (PASS):
English: A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: BIJOLOĠIKA(ĊI ATTIVA/I U> MANIFATTUR(I) RESPONSABBLI GĦALL-ĦRUĠ TAL-LOTT
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.>
Maltese: Skont l-Artikolu 114 tad-Direttiva 2001/83/KE, il-ħruġ tal-lott uffiċjali għandu jsir minn laboratorju tal-istat jew laboratorju ieħor li jintgħażel għal dak il-għan.>
English: The other <ingredient(s)> <(excipient(s))> is (are)...
Maltese: ˂Is-sustanza(i) mhux attiva(i)˃ <(eċċipjent(i)) > l-oħra hija / huwa (huma)…
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: KOndizzjonijiet jew restrizzjonijiet fir-rigward tal-użu siGur u effettiv tal-prodott mediċinali
English: <The reference medicinal product containing {active substance} has been authorised under ‘exceptional circumstances'.
Maltese: < Il-prodott mediċinali ta' referenza li fih {isem tas-sustanza(i) attiva(i)}ġie awtorizzat taħt ‘ċirkustanzi eċċezzjonali'.
English: <None.>
Maltese: <Xejn.>
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.
Maltese: 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-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Name and address of the manufacturer(s) responsible for batch release
Maltese: <Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott>
English: <This leaflet is available in all EU/EEA languages on the European Medicines Agency website.>
Maltese: <Dan il-fuljett huwa disponibbli fil-lingwi kollha tal-UE/ŻEE fis-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini.>
English: Do not use this medicine after the expiry date which is stated on the <label> <carton> <bottle> <…> <after {abbreviation used for expiry date}.> <The expiry date refers to the last day of that month.>
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq <it-tikketta><il-kartuna><il-flixkun> <…> <wara {abbrevjazzjoni li tintuża għad-data ta' meta tiskadi}> <Id-data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.>
English: България {Име} <{Адрес} {Град} {Пощенски код}> Teл.
Maltese: Deutschland {Name} <{Anschrift}
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.*
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V*.
English: <Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.>
Maltese: <Fi studji mhux kliniċi, l-effetti dehru biss wara esponimenti meqjusa ferm aktar għolja mill-massimu ta' esponiment fil-bniedem, li juru ftit li xejn rilevanza għall-użu kliniku.>
English: <{X} should not be used in children aged {x to y} <years> <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] because of <safety> <efficacy> concern(s).>
Maltese: <{X} m'għandux jintuża fit-tfal minn età {x sa y} <snin> <xhur> [jew xi kategoriji rilevanti oħra eż. piż, età tal-pubertà, sess] minħabba tħassib dwar <sigurtà> <effikaċja>.>
English: - <if you are allergic to {active substance(s)} or any of the other ingredients of this medicine (listed in section 6).>
Maltese: <jekk inti allerġiku għal {sustanza(i) attiva(i)} jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).>
English: The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary accordingly to the reference medicinal product SmPC.>
Maltese: L-Aġenzija Ewropea għall-Mediċini ser tirrevedi informazzjoni ġdida dwar dan il-prodott mediċinali gћall inqas darba fis-sena u dan l-SmPC ser jiġi aġġornat kif meħtieġ.>
English: (Invented) name Strength Pharmaceutical form
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: The full EPAR for Zinbryta 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: In another study involving 1,841 patients, patients receiving Zinbryta 150 mg every 4 weeks had on average 0.22 relapses over a year compared with 0.39 in those receiving interferon beta-1a, another medicine used for multiple sclerosis.
Maltese: Fi studju ieħor bl-involviment ta' 1 841 pazjent, il-pazjenti li kienu qed jieħdu Zinbryta 150 mg kull 4 ġimgħat kellhom medja ta' 0.22 ta' reċidività matul sena meta mqabbla ma' 0.39 f'dawk li kienu qed jieħdu l-interferon beta-1a, mediċina oħra użata għall-isklerożi multipla.
English: Zinbryta is a medicine used to treat adults with the relapsing forms of multiple sclerosis.
Maltese: Zinbryta huwa mediċina użata għall-kura ta' adulti bil-forom reċidivanti ta' sklerożi multipla.
English: This is a summary of the European public assessment report (EPAR) for Zinbryta.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zinbryta.
English: Daclizumab may also have other effects that reduce the immune system's damaging effects on nerve cells.
Maltese: Daclizumab jista' jkollu wkoll effetti oħra li jnaqqsu l-effetti danneġġanti tas-sistema immunitarja fuq iċ-ċelloli tan-nervaturi.
English: Other information about Zinbryta
Maltese: Informazzjoni oħra dwar Zinbryta
English: The most common side effects with Zinbryta (which may affect more than 1 in 100 people) are rash, increased liver enzymes in the blood, depression, inflamed and sore nose and throat, influenza and upper respiratory tract infection such as colds and lymphadenopathy (swollen glands).
Maltese: L-iktar effetti sekondarji komuni assoċjati ma' Zinbryta (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 100) huma raxx, enzimi tal-fwied ogħla fid-demm, dipressjoni, imnieħer u griżmejn infjammati u b'uġigħ, influwenza u infezzjonijiet fil-parti ta' fuq tal-kanal respiratorju bħal irjiħat u limfadenopatija (glandoli minfuħin).
English: Why is Zinbryta approved?
Maltese: Għaliex ġie approvat Zinbryta?
English: Zinbryta contains the active substance daclizumab.
Maltese: Zinbryta hija mediċina li fiha s-sustanza attiva daclizumab.
English: In multiple sclerosis, the body's immune (defence) system incorrectly attacks and damages the protective sheath around the nerve cells in the central nervous system (the brain and spinal cord).
Maltese: L-isklerożi multipla, is-sistema (ta' difiża) immunitarja tal-ġisem bi żball tattakka u tagħmel ħsara lillgħata protettiva madwar iċ-ċelloli tan-nervaturi fis-sistema nervuża ċentrali (il-moħħ u l-korda spinali).
English: Patients receiving Zinbryta 150 mg every 4 weeks had on average 0.21 relapses over a year compared with 0.46 in those receiving placebo.
Maltese: Il-pazjenti li kienu qed jieħdu Zinbryta 150 mg kull 4 ġimgħat kellhom medja ta' 0.21 ta' reċidività matul sena meta mqabbla ma' 0.46 f'dawk li ħadu lplaċebo.
English: By attaching to the T cells, daclizumab blocks interleukin-2, so preventing T cells from
Maltese: Billi jeħel maċ-ċelloli T, daclizumab jimblokka l-interleukin-2, u b'hekk
English: Zinbryta has been found to be effective in studies carried out over up to 3 years.
Maltese: Zinbryta nstab li huwa effettiv fi studji mwettqa fuq aktar minn 3 snin.
English: In one study involving 600 patients, Zinbryta was found to be more effective than placebo (a dummy treatment) at reducing relapses of the condition.
Maltese: Fi studju wieħed bl-involviment ta' 600 pazjent, Zinbryta nstab li huwa aktar effettiv minn plaċebo (kura finta) biex inaqqas ir-reċidività tal-kundizzjoni.
English: Treatment is associated with adverse effects on the liver and an increased risk of infections but the CHMP considered these could be managed with regular monitoring.
Maltese: Il-kura hija assoċjata ma' effetti negattivi fuq il-fwied u riskju ogħla ta' infezzjonijiet iżda s-CHMP qies li dawn jistgħu jiġu ġestiti b'monitoraġġ regolari.
English: What are the risks associated with Zinbryta?
Maltese: X'inhuma r-riskji assoċjati ma' Zinbryta?
English: The active substance in Zinbryta, daclizumab, is a monoclonal antibody that attaches to T cells.
Maltese: Is-sustanza attiva f'Zinbryta, daclizumab, hija antikorp monoklonali li jeħel maċ-ċelloli T. Dawn iċ-ċelloli jiffurmaw parti mis-sistema immunitarja tal-ġisem u huma attivati b'interleukin-2, proteina ta' senjalazzjoni fil-ġisem.
English: Relapsing means that the patient has flare-ups of the symptoms.
Maltese: Reċidivanti tfisser li l-pazjent ikollu taħrix f'daqqa tas-sintomi.
English: Zinbryta has been found effective for treating relapsing multiple sclerosis in two main studies involving over 2,400 patients.
Maltese: Zinbryta nstab li huwa effettiv għall-kura tal-isklerożi multipla reċidivanti f'żewġ studji ewlenin li jinvolvu 'l fuq minn 2 400 pazjent.
English: The recommended dose is 150 mg once a month by injection under the skin.
Maltese: Id-doża rakkomandata hija ta' 150 mg darba fix-xahar b'injezzjoni taħt il-ġilda.
English: What measures are being taken to ensure the safe and effective use of Zinbryta?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Zinbryta?
English: The most common serious side effects of Zinbryta are liver damage and severe skin reactions.
Maltese: L-iktar effetti sekondarji serji komuni ta' Zinbryta huma ħsara filfwied u reazzjonijiet severi tal-ġilda.
English: For the full list of restrictions and of all side effects reported with Zinbryta, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet u tal-effetti sekondarji kollha rrappurtati b'Zinbryta, ara l-fuljett ta' tagħrif.
English: The company that markets Zinbryta will issue educational materials for healthcare professionals and for patients about liver damage and how to prevent or reduce the damage.
Maltese: Il-kumpanija li tikkummerċjalizza Zinbryta ser toħroġ materjal edukattiv għall-professjonisti tal-kura tas-saħħa u għall-pazjenti dwar il-ħsara għall-fwied u kif tista' tiġi pprevenuta jew imnaqqsa l-ħsara.
English: How does Zinbryta work?
Maltese: Kif jintuża Zinbryta?
English: 6 See section 4.4.
Maltese: 6 Ara sezzjoni 4.4.
English: MedDRA system organ class (SOC)
Maltese: Klassifika tas-sistemi u tal-organi MedDRA (SOC - system organ class)
English: Body weight, gender, age, race
Maltese: Piż tal-ġisem, sess, età, razza
English: ATC code: H05BX04
Maltese: H05BX04
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 November 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 1 ta' Novembru 2016
English: Pack sizes of 1, 6, 12 and 42 vials.
Maltese: Daqsijiet tal-pakkett ta' 1, 6, 12 u 42 kunjett.
English: For albumin levels < 4.0 g/dL cCa (mg/dL) = Total Ca (mg/dL) + (4 - albumin[g/dL])*0.8.
Maltese: Għal-livelli ta' albumina < 4.0 g/dL cCa (mg/dL) = Ca Totali (mg/dL) + (4 - albumina[g/dL])*0.8.
English: Hypocalcaemia1, 5
Maltese: Ipokalċimija1, 5
English: For additional information see section 4.
Maltese: Għal aktar informazzjoni ara s-sezzjoni 4.
English: Convulsions6
Maltese: Konvulżjonijiet6
English: < 8.3 mg/dL (2.08 mmol/L) and ≥ 7.5 mg/dL (1.88 mmol/L)
Maltese: < 8.3 mg/dL (2.08 mmol/L) u ≥ 7.5 mg/dL (1.88 mmol/L)
English: Hypersensitivity reactions1 (including anaphylaxis)
Maltese: Reazzjonijiet ta' sensittività eċċessiva1 (inkluża l-anafilassi)
English: Headache Paraesthesia3
Maltese: Uġigħ ta' ras Parasteżija3
English: Parsabiv 2.5 mg solution for injection EU/1/16/1142/001 - 1 vial EU/1/16/1142/002 - 6 vials EU/1/16/1142/003 - 12 vials EU/1/16/1142/004 - 42 vials Parsabiv 5 mg solution for injection EU/1/16/1142/005 - 1 vial EU/1/16/1142/006 - 6 vials EU/1/16/1142/007 - 12 vials EU/1/16/1142/008 - 42 vials Parsabiv 10 mg solution for injection EU/1/16/1142/009 - 1 vial EU/1/16/1142/010 - 6 vials EU/1/16/1142/011 - 12 vials EU/1/16/1142/012 - 42 vials
Maltese: Parsabiv 2.5 mg soluzzjoni għall-injezzjoni EU/1/16/1142/001 - kunjett wieħed EU/1/16/1142/002 - 6 kunjetti EU/1/16/1142/003 - 12-il kunjett EU/1/16/1142/004 - 42 kunjett Parsabiv 5 mg soluzzjoni għall-injezzjoni EU/1/16/1142/005 - kunjett wieħed EU/1/16/1142/006 - 6 kunjetti EU/1/16/1142/007 - 12-il kunjett EU/1/16/1142/008 - 42 kunjett Parsabiv 10 mg soluzzjoni għall-injezzjoni EU/1/16/1142/009 - kunjett wieħed EU/1/16/1142/010 - 6 kunjetti EU/1/16/1142/011 - 12-il kunjett EU/1/16/1142/012 - 42 kunjett
English: Etelcalcetide is not metabolised by CYP450 enzymes.
Maltese: Etelcalcetide ma jiġix metabolizzat permezz tal-enzimi ta' CYP450.
English: 3 Paraesthesia includes preferred terms of paraesthesia and hypoaesthesia.
Maltese: 3 Parasteżija tinkludi termini ppreferuti ta' parasteżija u ipoesteżija.
English: -7.71 (2.16)b -1.31 (1.42) -9.63 (1.61)a -1.60 (1.42)
Maltese: -1.31 (1.42) -9.63 (1.61)a -1.60 (1.42)
English: The predominant biotransformation product (albumin bound) was minimally active in vitro.
Maltese: Il-prodott predominanti ta' bijotrasformazzjoni (marbut mal-albumina) kien attiv b'mod minimu in vitro.
English: Each mL contains 5 mg etelcalcetide.
Maltese: Kull mL fih 5 mg etelcalcetide.
English: < 7.5 mg/dL (1.88 mmol/L) or symptoms of hypocalcaemia
Maltese: < 7.5 mg/dL (1.88 mmol/L) jew sintomi ta' ipokalċimija
English: LIST OF EXCIPIENTS Sodium chloride, succinic acid, water for injections, hydrochloric acid, sodium hydroxide.
Maltese: TA' EĊĊIPJENTI Sodium chloride, succinic acid, ilma għall-injezzjonijiet, hydrochloric acid, sodium hydroxide.
English: The dose of Parsabiv could be titrated at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve target PTH levels ≤ 300 pg/mL while maintaining serum cCa concentrations.
Maltese: Id-doża ta' Parsabiv setgħet tiġi ttitrata f'ġimgħat 5, 9, 17, 25, 33, 41, u 49 sa doża massima ta' 15 mg biex jintlaħqu livelli mmirati ta' PTH ta' ≤ 300 pg/mL filwaqt li jinżammu lkonċentrazzjonijiet ta' cCa fis-serum.
English: In the studies total serum calcium was measured using Roche modular analysers.
Maltese: Fl-istudji kalċju totali fis-serum kien imkejjel blużu ta' Roche modular analysers.
English: * Total calcium was measured using Roche modular analyser.
Maltese: * Kalċju totali tkejjjel permezz tal-analizzatur modulari ta' Roche.
English: a p < 0.001 versus placebo b p = 0.003 versus placebo
Maltese: 84 (1.57)a -1.06 (1.42) a p < 0.001 kontra plaċebo b p = 0.003 kontra plaċebo
English: If PTH is below 100 pg/mL (10.6 pmol/L), the dose should be reduced or temporarily stopped.
Maltese: Jekk PTH ikun inqas minn 100 pg/mL (10.6 pmol/L), id-doża għandha titnaqqas jew titwaqqaf temporanjament.
English: What Parsabiv contains - The active substance is etelcalcetide.
Maltese: X'fih Parsabiv - Is-sustanza attiva hi etelcalcetide.
English: Adverse reactions are listed below 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); not known (cannot be estimated from the available data).
Maltese: Reazzjonijiet avversi huma elenkati hawn taħt skont il-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); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.
Maltese: Parsabiv huwa indikat għat-trattament ta' iperparatirojdiżmu sekondarju (SHPT - secondary hyperparathyroidism) f'pazjenti adulti b'marda kronika tal-kliewi (CKD - chronic kidney disease) fuq terapija ta' emodijalisi.
English: Placebo (N = 260)
Maltese: Plaċebo (N = 260)
English: There is no known risk of pharmacokinetic interaction with etelcalcetide.
Maltese: M'hemm l-ebda riskju magħruf ta' interazzjoni farmakokinetika ma' etelcalcetide.