FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder (MAH) shall agree the details of the educational programme for Fabrazyme home infusion with the National Competent Authorities prior to implementing the programme nationally.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jaqbel mad-dettalji talprogramm edukattiv għal infużjoni ta' Fabrazyme d-dar mal-Awtoritajiet Kompetenti Nazzjonali qabel ma jimplimenta l-programm fuq skala nazzjonali.
English: Musculoskeletal and connective tissue disorders pain in extremity, myalgia, back pain, muscle spasms, arthralgia, muscle tightness, musculoskeletal stiffness musculoskeletal pain --
Maltese: uġigħ fl-għadam, uġigħ fid-dahar, spażmi muskolari, artralġja, tagħfis fil muskoli, ebusija muskolu-skeletriku uġigħ muskoluskeletrku
English: List of other side effects:
Maltese: Lista ta' effetti sekondarji oħrajn:
English: In clinical trials doses up to 3 mg/kg body weight were used.
Maltese: Fi studji kliniċi dożi sa 3 mg/kg piż tal-ġisem kienu użati.
English: Fabrazyme 5 mg powder for concentrate for solution for infusion agalsidase beta
Maltese: TAL-PRODOTT MEDIĊINALI Fabrazyme 5 mg, trab għall-konċentrat għal soluzzjoni għall-infużjoni agalsidase beta
English: Both baseline and 5-year kidney biopsies were obtained in a subset of 6 patients: in all, kidney capillary endothelium GL-3 scores were reduced to zero but highly variable effects were observed in podocyte GL-3, with a reduction in 3 patients.
Maltese: F'sottosett ta' 6 pazjenti nkisbu il-bijopsiji talkliewi kemm fil-linja bażi kif ukoll wara 5 snin: f'kollha, il-punteġġi GL-3 tal-endotiljum kapillari tal-kliewi tnaqqsu għal zero iżda ġew osservati effetti li jvarjaw ħafna fil-GL-3 tal-podoċiti, b'tnaqqis f'tliet pazjenti.
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of agalsidase beta in a clinically significant way.
Maltese: Għalhekk, indeboliment fil-funzjoni epatika mhux mistenni li jaffettwa l-farmakokinetika ta'agalsidase beta b'mod klinikament sinifikanti.
English: Gastrointestinal Disorders nausea, vomiting abdominal pain, abdominal pain upper, abdominal discomfort, stomach discomfort, hypoaesthesia oral, diarrhoea dyspepsia, dysphagia --
Maltese: Disturbi gastro-intestinali dardir, remettar uġigħ addominali, uġigħ addominali nnaħa ta' fuq, skonfort addominali, skumdita fl-istonku, ipoestesija orali, dijarea dispepsja,
English: • decreased mouth sensitivity
Maltese: • tnaqqis fis-sensittività għall-uġigħ
English: - The active substance is agalsidase beta, one vial contains 5 mg. - The other ingredients are:
Maltese: - Is-sustanza attiva hi agalsidase beta, kunjett wieħed fih 5 mg.
English: How to store Fabrazyme
Maltese: X'fih Fabrazyme
English: Reduced or absent αgalactosidase activity results in the accumulation of GL-3 in the lysosomes of many cell types including the endothelial and parenchymal cells, ultimately leading to life-threatening clinical deteriorations as a result of renal, cardiac and cerebrovascular complications.
Maltese: Tnaqqis jew l-assenza ta' l-attività α-galactosidase tirriżulta fl-akkumulazzjoni tal-GL-3 f'ħafna tipi ta' ċelluli inklużi ċelluli endotiljali u ċelluli parenkimali, li fl-aħħar mill-aħħar twassal għal deterjorazzjonijiet kliniċi li jistgħu ikunu ta' periklu għal ħajja bħala riżultat ta' komplikazzjonijiet renali, kardijaċi u ċerebrovaskulari.
English: Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Maltese: Irrikostitwixxi kull kunjett ta' Fabrazyme 35 mg b'7.2 ml ta' ilma għall-injezzjonijiet.
English: In the first placebo-controlled clinical trial, Fabrazyme was effective in clearing GL-3 from the vascular endothelium of the kidney after 20 weeks of treatment.
Maltese: Fl-ewwel prova klinika bi plaċebo bħala kontrolli, Fabrazyme kien effettiv fit-tneħħijja ta' GL-3 mill-endotilju vaskulari tal-kilwa wara 20 ġimgħa ta' kura.
English: The diluted solution can be held for up to 24 hours at 2°C - 8°C.
Maltese: Is-soluzzjoni dilwita biss tista' tinżamm sa 24 siegħa f'temperatura ta' bejn u 2 °C - 8 °C.
English: Fabrazyme is supplied as a white to off-white powder.
Maltese: Fabrazyme jiġi bħala trab ta' lewn bajdani jew off-white.
English: In an additional study, 21 male patients were enrolled to follow GL3 clearance in kidney and skin tissues at an alternative dosing regimen.
Maltese: Fi studju addizzjonali, 21 pazjent raġel kienu rekrutati biex isegwu t-tneħħija tal-GL3 mill-kliewi u t-tessuti tal-ġilda bi programm ta' dożi alternattivi.
English: Fabry disease is an inherited heterogeneous and multisystemic progressive disease, that affects both males and females.
Maltese: Il-marda Fabry hi marda eteroġena li tintiret u marda multisistematika progressiva, li taffettwa kemm l-irġiel u n-nisa.
English: Fabrazyme pharmacokinetics was also evaluated in two paediatric studies.
Maltese: Il-farmakokinetiċi ta' Fabrazyme kienu evalwati wkoll f'żewġ studji pedjatriċi.
English: • musculoskeletal stiffness
Maltese: • ebusija muskolskeletrika
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 5 VIALS, 10 VIALS)
Maltese: Id-daqsijiet tal-pakketti huma: 1, 5 u 10 kunjetti.
English: Since agalsidase beta (r-hαGAL) is a recombinant protein, the development of IgG antibodies is expected in patients with little or no residual enzyme activity.
Maltese: Billi agalsidase beta (r-hαGAL) hu proteina rikombinanti, l-iżvilupp ta' antikorpi għal IgG hu mistenni f'pazjenti bi ftit jew bla ebda attività residwa ta' enzimi.
English: • ear swelling
Maltese: Ż-ŻGĦAR EWLENIN
English: Excipients: mannitol sodium phosphate monobasic, monohydrate sodium phosphate dibasic, heptahydrate See the leaflet for further information.
Maltese: Sustanzi mhux attivi: mannitol sodium phosphate monobasic, monohydrate sodium phosphate dibasic, heptahydrate
English: • abdominal pain
Maltese: • skumdita addominali
English: These patients should be treated with caution when re-administering agalsidase beta (see section 4.8).
Maltese: Dawn il-pazjenti għandhom jiġu trattati b'kawtela meta jiġu mogħtija agalsidase beta mill-ġdid (ara sezzjoni 4.8).
English: Reconstitute each vial of Fabrazyme 5 mg with 1.1 ml water for injections.
Maltese: Irrikostitwixxi kull kunjett ta' Fabrazyme 5 mg b'1.1 ml ta' ilma għall-injezzjonijiet.
English: This clearance was achieved in 69% (20/29) of the Fabrazyme treated patients, but in none of the placebo patients (p<0.001).
Maltese: (20/29) tal-pazjenti trattati b'Fabrazyme, imma fl-ebda pazjent li ngħata l-plaċebo (p<0.001).
English: The safety and efficacy of Fabrazyme in children aged 0 to7 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Fabrazyme fit-tfal ta' età bejn 0 sa 7 snin għadhom ma ġewx stabbiliti.
English: The following information is intended for healthcare professionals only:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Genzyme Europe B.V.- NL Store in a refrigerator (2°C - 8°C)
Maltese: Aħżen fi friġġ (2 °C - 8 °C)
English: The majority of patients developed IgG antibodies to r-hαGAL, typically within 3 months of the first infusion with Fabrazyme.
Maltese: IgG għal r-hαGAL, ġeneralment fi żmien 3 xhur mill-ewwel infużjoni b'Fabrazyme.
English: Limited information from clinical trials suggests that the safety profile of Fabrazyme treatment in paediatric patients ages 5-7, treated with either 0.5 mg/kg every 2 weeks or 1.0 mg/kg every 4 weeks is similar to that of patients (above the age of 7) treated at 1.0 mg/kg every 2 weeks.
Maltese: Informazzjoni ristretta minn provi kliniċi tissuġerixxi li l-profil tas-sigurtà tat-trattament b'Fabrazyme f'pazjenti pedjatriċi b'etajiet minn 5-7 snin, ittrattati jew b'0.5 mg/kg kull ġimagħtejn jew 1.0 mg/kg kull 4 ġimgħat kien simili għal dak ta' pazjenti (li għandhom 'il fuq minn 7 snin) ittrattati b'1.0 mg/kg kull ġimagħtejn
English: The marketing authorisation holder (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.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: • muscle tightness
Maltese: • uġigħ muskolari
English: Sixty seven percent (67%) of the patients experienced at least one infusion-associated reaction.
Maltese: Sebgħa u sittin fil-mija (67%) tal-pazjenti kellhom ta' lanqas reazzjoni waħda assoċjata ma' l-infużjoni.
English: Adverse reactions were mostly mild to moderate in severity:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata sirdat,
English: Fabrazyme 5 mg powder for concentrate for solution for infusion Fabrazyme 5 mg is supplied in clear Type I glass 5 ml vials.
Maltese: Fabrazyme 5 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Fabrazyme 5 mg jiġi f'kunjetti tal-ħġieġ ċar ta' Tip 1 ta' 5 ml.
English: Summary of the safety profile Since agalsidase beta (r-hαGAL) is a recombinant protein, the development of IgG antibodies is expected in patients with little or no residual enzyme activity.
Maltese: Peress li agalsidase beta (r-hαGAL) hi proteina rikombinanti, hu mistenni li jiġu żviluppati antikorpi ta' l-IgG f'pazjenti bi ftit jew xejn attività ta' l-enżimi residwali.
English: This result was consistent across renal, cardiac and cerebrovascular events.
Maltese: Dan ir-riżultat kien konsistenti għal każijiet renali, kardijaċi u ċerebrovaskulari.
English: • hyperthermia
Maltese: • letarġija
English: • infusion site pain
Maltese: • skumdita fis-sider
English: In clinical trials, sixty seven percent (67 %) of the patients experienced at least one infusionassociated reaction (see section 4.8).
Maltese: Fil-provi kliniċi, sebgħa u sittin fil-mija (67%) tal-pazjenti kellhom ta' l-anqas reazzjoni waħda assoċjata ma' l-infużjoni (ara sezzjoni 4.8).
English: • itchy rash
Maltese: • raxx
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Fabrazyme 35 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Fabrazyme 5 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni
English: • muscle pain
Maltese: • spażmi muskolari
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 35 mg is supplied in clear Type I glass 20 ml vials.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Fabrazyme 35 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Fabrazyme 35 mg jiġi f'kunjetti tal-ħġieġ ċar ta' Tip 1 ta' 20 ml.
English: The reconstituted solution contains 5 mg agalsidase beta per ml, and appears as a clear colourless solution.
Maltese: Il-soluzzjoni rikostitwita fiha 5 mg agalsidase beta f'kull ml, u tidher bħala soluzzjoni ċara u bla kulur.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara r-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: EU/1/01/188/001 1 vial of powder for concentrate for solution for infusion EU/1/01/188/002 5 vials of powder for concentrate for solution for infusion EU/1/01/188/003 10 vials of powder for concentrate for solution for infusion
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/01/188/001 kunjett 1 ta' trab għall-konċentrat għal soluzzjoni għall-infużjoni EU/1/01/188/002 5 kunjetti ta' trab għall-konċentrat għal soluzzjoni għall-infużjoni EU/1/01/188/003 10 kunjetti ta' trab għall-konċentrat għal soluzzjoni għall-infużjoni
English: • low heart rate
Maltese: GĦAMLA KWALITATTIVA
English: Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency).
Maltese: Għadd żgħir ta' pazjenti kellhom reazzjonijiet suġġestivi ta' sensittività eċċessiva immedjata (Tip
English: As with any intravenous protein medicinal product, allergic-type hypersensitivity reactions are possible.
Maltese: Bħal kwalunkwe prodott mediċinali tal-proteina li jingħata minn ġol-vina, jista' jkun hemm reazzjonijiet ta' sensittività eċċessiva ta' tip allerġiku.
English: Fabrazyme is given through a drip into a vein (by intravenous infusion).
Maltese: Fabrazyme jingħata permezz ta' dripp ġol vina (b'infużjoni ġol-vina).
English: Based on its metabolism, agalsidase beta is an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Maltese: Meta wieħed iqies il-metaboliżmu tiegħu, mhux probabbli li jista' ikun hemm interazzjonijiet permezz taċ-ċitokromju P450 bejn l-agalsidase beta u mediċini oħra.
English: Fabry disease
Maltese: KLINIKU
English: Common (may affect up to 1 in 10 people): • chest pain
Maltese: Komuni ((jistgħu jaffettwaw sa persuna 1 minn kull 10)):
English: EU/1/01/188/004 1 vial of powder for concentrate for solution for infusion EU/1/01/188/005 5 vials of powder for concentrate for solution for infusion EU/1/01/188/006 10 vials of powder for concentrate for solution for infusion
Maltese: EU/1/01/188/006 Fabrazyme 5 mg 10 kunjetti ta' trab għall-konċentrat għal soluzzjoni għall infużjoni
English: One vial of powder contains 35 mg of agalsidase beta.
Maltese: Kunjett ta' trab fih 35 mg ta' agalsidase beta.
English: Agalsidase beta is a recombinant form of human α-galactosidase A and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture.
Maltese: agalsidase beta ma kinetx influwenzata mil-piż f'din il-popolazzjoni.
English: • vertigo
Maltese: • sturdament
English: Plasma GL-3 was cleared in a dose dependent manner, but was less consistent at the dose of 0.3 mg/kg.
Maltese: Ir-rata ta' tneħħija ta' GL-3 fil-plażma kienet tiddependi mid-doża, imma kienet inqas konsistenti meta d-doża kienet 0.3 mg/kg.
English: Renal function, as measured by glomerular filtration rate and serum creatinine, as well as proteinuria, remained stable in the majority of the patients.
Maltese: Il-funzjoni renali, kif imkejjel bir-rata ta' filtrazzjoni glomerulari u kreatinin fis-serum, kif ukoll proteinurja baqgħu stabbli fil-maġġoranza tal-pazjenti.
English: Ten (10) patients met per protocol dose increase criteria, two (2) had a dose increase to the recommended dose of 1.0 mg/kg every 2 weeks.
Maltese: Għaxar (10) pazjenti laħqu l-kriterja ta' żieda fiddoża skont il-protokoll, tnejn (2) kellhom żieda fid-doża sad-doża rrakkomandata ta' 1.0 mg kull ġimagħtejn.
English: • feeling hot
Maltese: • konġestjoni nażali
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Each vial of Fabrazyme contains a nominal value of 35 mg of agalsidase beta.
Maltese: Kull kunjett ta' Fabrazyme fih valur nominali ta' 35 mg ta' agalsidase beta.
English: Following an intravenous administration of agalsidase beta to adults at doses of 0.3 mg, 1 mg and 3 mg/kg body weight, the AUC values increased more than dose proportional, due to a decrease in clearance, indicating a saturated clearance.
Maltese: .2 Tagħrif farmakokinetiku Wara l-għoti ġol-vina ta' agalsidase beta lil adulti f'dożi ta' 0.3 mg, 1 mg u 3 mg/kg piż tal-ġisem,
English: Ear and labyrinth disorders tinnitus, vertigo auricular swelling, ear pain
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall
English: A reduction in GL-3 was observed in kidney, heart, skin and plasma at all doses.
Maltese: Kien hemm tnaqqis sinifikanti ta' GL-3 fil-kliewi, qalb, ġilda u plażma fid-dożi kollha.
English: Dilution
Maltese: Dilwazzjoni
English: In one of these studies, performed in adult male patients, after an initial dose of 1.0 mg/kg every 2 weeks for 6 months, 0.3 mg/kg every 2 weeks may maintain clearance of GL-3 in certain cell types in some patients; however, the long term clinical relevance of these findings has not been established (see section 5.1).
Maltese: F'wieħed minn dawn l-istudji, li sar f'pazjenti adulti irġiel, wara doża inizjali ta' 1.0 mg/kg kull ġimagħtejn għal 6 xhur, 0.3 mg/kg kull ġimagħtejn jistgħu jikkawżaw eliminazzjoni ta' GL-3 f'ċertu tipi ta' ċelloli f'xi pazjenti; madankollu ir-rilevanza klinika fuq perijodu ta' żmien twil ta' dawn ir-riżultati għadu ma ġiex stabbilit (ara sezzjoni 5.1).
English: • fatigue
Maltese: • urtikarja
English: White to off-white lyophilised cake or powder.
Maltese: Kejk jew trab abjad jew off-white lajofilizzat.
English: • difficulty in breathing
Maltese: Disturbi respiratorji,
English: Uncommon (may affect up to 1 in 100 people): • tremor
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100):
English: The recommended dose of Fabrazyme for children and adolescents 8 - 16 years is 1 mg/kg body weight, once every 2 weeks.
Maltese: Id-doża rakkomandata ta' Fabrazyme għat-tfal u adolexxenti minn 8 sa 16-il sena hi ta' 1 mg/kg ta'
English: The powder for concentrate for solution for infusion has to be reconstituted with water for injections, diluted with 0.9% sodium chloride intravenous solution and then administered by intravenous infusion.
Maltese: Imbagħad injetta bil-mod is-soluzzjoni rikostitwita fis-soluzzjoni intravenuża ta' 0.9% sodium chloride (mhux f'xi wiċċ li fadal ta' arja) għal konċentrazzjoni finali ta' bejn
English: The initial infusion rate should be no more than 0.25 mg/min (15 mg/hour) to minimise the potential occurrence of infusion-associated reactions.
Maltese: Ir-rata inizjali ta' l-infużjoni m'għandix tkun iżjed minn 0.25 mg/min (15 mg/siegħa) biex tnaqqas ir-riskju ta' xi reazzjonijiet relatati ma' l-infużjoni.
English: • muscle spasms
Maltese: • tħoss is-sħana
English: Adverse reaction terminology is based upon the Medical Dictionary for Regulatory Activities (MedDRA)
Maltese: Terminoloġija tar-reazzjonijiet avversi hi bażata fuq id-Dizzjunarju Mediku għal Attivitajiet
English: • lethargy
Maltese: • mnieħer iqattar
English: • sleepiness
Maltese: • sfurija
English: After intravenous infusion, agalsidase beta is rapidly removed from the circulation and taken up by vascular endothelial and parenchymal cells into lysosomes, likely through the mannose-6 phosphate, mannose and asialoglycoprotein receptors.
Maltese: doża waħda, effett tossiku minn dożi ripetuti u effett tossiku fuq l-embriju u l-fetu, ma juri l-ebda periklu speċjali għall-bnedmin.
English: Fertility
Maltese: disfaġja
English: Do not use this medicine after the expiry date which is stated on the label after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta wara ‘JIS'.
English: The recommended dose of Fabrazyme for adults is 1 mg/kg body weight, once every 2 weeks.
Maltese: Id-doża rrakkomandata ta' Fabrazyme għal adulti hi 1 mg/kg piż tal-ġisem darba kull ħmistax.
English: In an additional 5-year open-label paediatric study, 31 male patients aged 5 to 18 years were randomized prior to the onset of clinical symptoms involving major organs and treated with two lower dose regimens of agalsidase beta, 0.5 mg/kg every 2 weeks or 1.0 mg/kg every 4 weeks.
Maltese: F'studju pedjatriku open-label ieħor li dam 5 snin, ġew magħżula b'mod arbitrarju u qabel ma bdew is-sintomi kliniċi li jinvolvu l-organu maġġuri, 31 pazjent maskili ta' età minn 5 sa 18-il sena u ttrattati b'żewġ skedi baxxi ta' dożaġġi ta' agalsidase beta, 0.5 mg/kg kull ġimagħtejn jew
English: • ear pain
Maltese: • għajnejn ħomor
English: UAB „SANOFI-AVENTIS LIETUVA“ Tel. +370 5 275 5224
Maltese: France sanofi-aventis France Tél: 0 800 222 555
English: Investigations oxygen saturation decreased
Maltese: Disturbi fis sistema nervuża
English: Elderly
Maltese: KUNJETT
English: • chest discomfort
Maltese: • diffiċli tibla'
English: Anaphylactoid reactions have been reported in the postmarketing setting.
Maltese: Disturbi fil-ġilda u fit-tessuti ta'
English: • face oedema
Maltese: • rogħda
English: Over time, the majority of seropositive patients in clinical trials demonstrated either a downward trend in titers (based on a ≥ 4-fold reduction in titer from the peak measurement to the last measurement) (40% of the patients), tolerised (no detectable antibodies confirmed by 2 consecutive radioimmunoprecipitation (RIP) assays) (14% of the patients) or demonstrated a plateau (35% of the patients).
Maltese: Maż-żmien, il-biċċa l-kbira ta' pazjenti seropożittivi fil-provi kliniċi wrew jew xejra l-isfel fit-titri (fuq bażi ta' tnaqqis ta'≥ 4 darbiet fit-titru mill-kejl l-aktar għoli sa l-aħħar kejl) (40% tal-pazjenti), ittolerizzaw (l-ebda antikorpi intraċċati kkonfermati permezz ta' 2 assaġġi ta' radjuimmunopreċipitazzjoni (RIP) konsekuttivi) (14% tal-pazjenti) jew urew livellar (35%
English: Any clinical fracture (1)
Maltese: Kwalunkwe frattura klinika (1)
English: TEVA Gyógyszergyár Zrt.
Maltese: Magyarország Teva Gyógyszergyár Zrt Tel.:
English: This corresponds to a 28% reduction in the risk of all cause mortality (p=0.01).
Maltese: 28% fir-riskju ta' mortalità mill-kawżi kollha (p=0.01).
English: Clinical vertebral fracture (2)
Maltese: Frattura klinika tal-irkiekel (2)
English: Zoledronic acid (N = 1,065) event rate (%)
Maltese: Zoledronic acid (N=1,065) rata tal-każ
English: Luxembourg/Luxemburg Teva Pharma Belgium S.A. Tél: +32 3 820 73 73
Maltese: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Tél: +32 3 820 73 73
English: Teva Santé Tél: +33 1 55 91 7800
Maltese: Tél: +33 1 55 91 7800
English: It is supplied in packs sizes of 1, 5 and 10.
Maltese: Huwa jiġi f'daqsijiet tal-pakkett ta' 1, 5 u 10.
English: Clinical experience with acute overdose is limited.
Maltese: Esperjenza klinika b'doża eċċessiva akuta hija limitata.
English: Frequency cannot be estimated from available data.
Maltese: Mhuwiex possibbli li ssir stima tal-frekwenza mill-informazzjoni disponibbli. †
English: Solution for infusion multipack: 5 bags x 100 ml multipack: 10 bags x 100 ml
Maltese: U KONTENUT Soluzzjoni għall-infużjoni pakkett multiplu: 5 boroż x 100 ml pakkett multiplu: 10 boroż x 100 ml
English: After 6 months, zoledronic acid showed 96% (169/176) and 89% (156/176) response and serum alkaline phosphatase (SAP) normalisation rates compared to 74% (127/171) and 58% (99/171) for risedronate (all p<0.001).
Maltese: (169/176) u 89% (156/176) mqabbla ma' 74% (127/171) u 58% (99/171) għal risedronate (kollha kellhom p<0.
English: Five of the 6 patients had SAP within the normal range at month 6 (Last Observation Carried Forward, LOCF).
Maltese: Ħamsa mis6 pazjenti kellhom SAP fil-medda normali fis-6 xahar (L-Aħħar Osservazzjoni Rrappurtata, LOCF).
English: Zoledronic acid demonstrated a consistent effect over 3 years, resulting in a 41% reduction in the risk of hip fractures (95% CI, 17% to 58%).
Maltese: Zoledronic acid wera effett b'mod konsistenti fuq 3 snin, li wassal għal tnaqqis ta' 41% fir-riskju ta' fratturi fil-ġenbejn (95% CI, 17% sa 58%).
English: • in adult men at increased risk of fracture.
Maltese: • f'irġiel adulti li għandhom riskju ogħla ta' ksur.
English: Osteonecrosis of the jaw (ONJ)
Maltese: Osteonekrożi tax-xedaq (ONJ)
English: The incidence of delayed hip fracture healing was comparable between zoledronic acid (34 [3.2%]) and placebo (29 [2.7%]).
Maltese: L-inċidenza ta' dewmien fil-fejqan ta' fratturi fil-ġenbejn kienet komparabbli bejn zoledronic acid (34 [3.2%]) u l-plaċebo (29 [2.7%]).
English: Class effects:
Maltese: Effetti skont il-klassi:
English: Older people (≥ 65 years)
Maltese: Popolazzjoni anzjana (≥ 65 sena)
English: Cyclic Olefin Polymer (COP) plastic bottle, fitted with a chlorobutyl/butyl rubber stopper and aluminium cap fitted with violet plastic flip off disc.
Maltese: Flixkun tal-plastik tas-Cyclic Olefin Polymer (COP), b'tapp tal-lastku tal-chlorobutyl/butyl u għatu tal-aluminju b'diska tal-plastik vjola tat-tip flip off.
English: Not known** Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects)
Maltese: Osteonekrożi tax-xedaq (ara l-effetti skont il-klassi f'sezzjonijiet 4.4 u 4.8)