FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution, each dose of 71.4 microlitre contains 100 micrograms parathyroid hormone.
Maltese: Wara r-rikostituzzjoni, kull doża ta' 71.4 mikrolitru fiha 100 mikrogrammi ta' ormon tal-paratirojde.
English: Diarrhoea
Maltese: Anoreksja
English: Injection site irritation
Maltese: Irritazzjoni fil-post ta' l-injezzjoni
English: Dizziness
Maltese: ġurnata.
English: In a large phase III clinical study, antibodies to parathyroid hormone were detected in 3% of women receiving Preotact compared to 0.2% of women receiving placebo.
Maltese: III, antikorpi għall-ormon tal-paratirojde ġew rilevati fi 3% tan-nisa li rċevew Preotact meta mqabbel ma' 0.2% tan-nisa li rċevew plaċebo.
English: The combination was effective regardless of age, baseline rate of bone turnover, or baseline BMD.
Maltese: It-taħlita kienet effettiva irrispettivament mill-età, irrata tal-linja bażi ta' l-immudellar mill-ġdid ta' l-għadam, jew BMD tal-linja bażi.
English: Each pre-filled pen contains 1.61 mg of parathyroid hormone as powder and 1.13 ml of solvent.
Maltese: L-ewwel kompartiment fih 1.61 mg ta' trab u t-tieni kompartiment fih 1.13 ml ta' solvent.
English: Hypercalcemia and/or hypercalciuria reflect the known pharmacodynamic actions of parathyroid hormone in the gastrointestinal tract, the kidney, and the bone.
Maltese: L-iperkalċimja u/jew l-iperkalċurja jirriflettu l-azzjonijiet farmakodinamiċi magħrufa ta' l-ormon tal-paratirojde fl-apparat gastro-intestinali, il-kliewi, u l-għadam.
English: Reconstituted solution: chemical and physical in-use stability has been demonstrated for 28 days at 28°C.
Maltese: Soluzzjoni rikostitwita: stabbilità kimika u fiżika waqt l-użu dehret għal 28 ġurnata f'temperatura ta'
English: No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min).
Maltese: (tneħħija tal-kreatinina ta' 30 sa 80 ml/min).
English: This includes any possible side
Maltese: Effetti sekondarji possibbli
English: • You can store the unmixed pre-filled pen at temperatures between 2-25°C.
Maltese: • Taħżinx f'temperatura 'l fuq minn 25°C.
English: • with metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism
Maltese: • b'mard metaboliku ta' l-għadam differenti minn osteoporożi primarja (fosthom iperparatirojdiżmu u l-marda ta' l-għadam ta' Paget)
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity, toxicity to fertility and general reproduction, and local tolerance.
Maltese: Tagħrif ta' qabel l-użu kliniku, ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku fuq il-ġeni, effett tossiku fuq il-fertilità u r-riproduzzjoni ġenerali, u tolleranza lokali, ma turi l ebda periklu speċjali għall-bnedmin.
English: Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
Maltese: It-tabib tiegħek jista' jagħtik parir biex tieħu kalċju u vitamina D supplimentari.
English: These carboxy-terminal fragments are thought to play a role in the regulation of parathyroid hormone activity.
Maltese: Dawn il-frammenti carboxy-terminali huma maħsuba li għandhom rwol fir-regolazzjoni ta' l-attività ta' l-ormon tal-paratirojde.
English: In the pivotal study, Preotact increased BMD in the lumbar spine after 18 months treatment by 6.5% compared with -0.3% for placebo (p<0.001).
Maltese: 6% għall-plaċebo (p<0.001).
English: Preotact has not been studied in patients with active urolithiasis.
Maltese: Preotact ma ġiex studjat f'pazjenti b'urolitjasis attiva.
English: Serum calcium concentrations reach a maximum between 6 and 8 hours post dose and normally return to baseline by 20 to 24 hours after each administration of parathyroid hormone.
Maltese: Il-konċentrazzjonijiet talkalċju fis-serum jilħqu l-massimu bejn 6 u 8 sigħat wara doża u normalment jirritornaw għal-linja bażi fi żmien 20 sa 24 siegħa wara kull għoti ta' ormon tal-paratirojde.
English: Blood alkaline phosphatase increased Anorexia
Maltese: Żieda ta' alkaline phosphatase fiddemm
English: Dosage
Maltese: Indiċi
English: • You can store the mixed pre-filled pen for up to 7 days outside the refrigerator (below 25°C)
Maltese: • Tista' żżomm il-pinna mimlija għal-lest sa 7 ijiem barra mill-friġġ (taħt temperatura ta' 25°C)
English: Effects on serum calcium concentrations
Maltese: Effetti fuq il-konċentrazzjonijiet ta' kalċju fis-serum
English: • with unexplained elevations of bone-specific alkaline phosphatase
Maltese: • żieda fil-livell ta' alkaline phosphatase fid-demm,
English: 4.3 Contraindications
Maltese: 4.3 Kontra-indikazzjonijiet Preotact huwa kontra-indikat f'pazjenti
English: Press the yellow release button to release the blue injection button.
Maltese: Agħfas il-buttuna tager-rilaxx safra biex tirrilaxxa l-buttuna tal-injezzjoni blu.
English: • The medicine should not be used for more than 28 days after it has been mixed.
Maltese: • Il-mediċina m'għandiex tintuża għal aktar minn 28 jum wara li tkun ġiet imħallta.
English: There is no specific antidote for Preotact.
Maltese: M'hemmx antidotu speċifiku għal Preotact.
English: Preotact is available in a pack with 2 pre-filled pens.
Maltese: Preotact huwa disponibbli f'pakketti ta' 2 pinen mimlijin għal-lest.
English: Transient elevations in parathyroid hormone levels after subcutaneous injection of Preotact stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity.
Maltese: (perjosteali u/jew endosteali) bi stimulazzjoni preferenzjali ta' l-attività osteoblastika fuq l-attività osteoklastika.
English: The table below gives an overview of the ADRs where the incidence is at least 0.5% higher in the parathyroid hormone group compared to placebo.
Maltese: It-tabella ta' hawn isfel tagħti ħarsa ġenerali ta' l-ADRs fejn l-inċidenza hija mill-anqas 0.5% ogħla fil-grupp ta' l-ormon tal-paratirojde meta mqabbel mal-plaċebo.
English: The volume of distribution at steady-state following intravenous administration is approximately 5.4 l. Interindividual variability in the volume of distribution of parathyroid hormone is about 40%.
Maltese: Il-varjabilità bejn individwu u ieħor fil-volum tad-distribuzzjoni ta' l-ormon tal-paratirojde hija madwar 40%.
English: The following adverse reaction (ADR) data are based on two placebo-controlled studies involving 2,642 postmenopausal osteoporotic women of whom 1,341 received parathyroid hormone.
Maltese: L-informazzjoni segwenti dwar ir-reazzjonijiet avversi (ADR) hija bbażata fuq żewġ studji kkontrollati bil-plaċebo li kienu jinvolvu 2,642 mara ta' wara l-menopawsa b'osteoporożi li minnhom
English: The pivotal study was an 18-month double-blind, placebo-controlled, phase III study (TOP) of the effect of Preotact on fracture incidence in women with postmenopausal osteoporosis.
Maltese: III, tat-tip double-blind ikkontrollat bil-plaċebo, mifrux fuq 18-il xahar (TOP) dwar l-effett ta' Preotact fuq l-inċidenza tal-ksur f'nisa b'osteoporożi ta' wara lmenopawsa.
English: In monkeys receiving daily subcutaneous doses for 6 months, there was an increased occurrence of renal tubular mineralization at exposure levels below clinical exposure levels.
Maltese: Fix-xadini li rċevew dożi taħt il-ġilda kuljum għal 6 xhur, kien hemm okkorrenza akbar ta' mineralizzazzjoni tubulari renali f'livelli ta' espożizzjoni ta ħt il-livelli ta' l-espożizzjoni kliniku.
English: • The frequency of Preotact dosing should be changed to 100 micrograms every other day
Maltese: • L-għoti supplimentari ta' kalċju u vitamina D għandu jiġi mwaqqaf • Il-frekwenza tad-dożaġġ ta' Preotact għandha tinbidel għal 100 mikrogramm ġurnata iva u oħra le
English: It was managed during the clinical programme by monitoring laboratory values and the use of a pre-specified management algorithm (see sections 4.3 and 4.4).
Maltese: Matul il-programm kliniku hija kienet ġestita bil monitoraġġ tal-valuri tal-laboratorju u l-użu ta' proċeduri ta' ġestjoni stabbiliti minn qabel (ara sezzjoni 4.3 u 4.4).
English: Renal and urinary disorders Very common
Maltese: Popolazzjonijiet speċjali Indeboliment renali
English: Pinch a skin fold in the abdomen and take the injection in a 90° degree angle as you have been instructed by your doctor or nurse.
Maltese: Oqros parti mill-ġilda fl-addome u ħu linjezzjoni f'angolu ta' grad ta' 90° skont listruzzjonijiet li ngħatajt mit-tabib jew infermier tiegħek.
English: In the second year of the study women in the original Preotact group were randomly assigned to receive either alendronate or matching placebo, and women in the other two groups received alendronate.
Maltese: Preotact ġew magħżula b'mod każwali biex jirċievu jew alendronate jew plaċebo simili, u n-nisa fiżżewġ gruppi l-oħra rċevew alendronate.
English: • if you suffer from severe kidney problems;
Maltese: • KONDIZZJONIJIET OĦRA TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FISSUQ
English: Muscle cramp
Maltese: Qabel tħallat
English: Injection site erythema
Maltese: Buttuna tal-injezzjoni
English: The skeletal effects of parathyroid hormone depend upon the pattern of systemic exposure.
Maltese: L-effetti skeletali ta' l-ormon tal-paratirojde jiddependu fuq il-mudell ta' l-espożizzjoni sistemiku.
English: What Preotact contains -The active substance is parathyroid hormone.
Maltese: Is-sustanza attiva hija l-ormon tal-paratirojde.
English: Furthermore, parathyroid hormone is not protein bound and has a low volume of distribution.
Maltese: Barra minn hekk, l-ormon tal-paratirojde ma jaqbadx mal-proteini u għandu volum ta' distribuzzjoni baxx.
English: Do not store above 25°C.
Maltese: 2-8°C.
English: Posology The recommended dose is 100 micrograms of parathyroid hormone administered once-daily
Maltese: Pożoloġija Id-doża rakkomandata hija 100 mg ta' ormon tal-paratirojde mogħtija darba kuljum.
English: Of the 2,532 randomised intention-to-treat (ITT) patients, a total of 59 patients experienced at least one new vertebral fracture, placebo: 42 (3.37%) - Preotact: 17 (1.32%), p=0.001.
Maltese: Mill-2,532 pazjent magħżula b'mod każwali bl-intenzjoni ta' kura (ITT), total ta' 59 pazjent esperjenzaw mill-anqas ksur vertebrali ġdid, plaċebo:
English: • reddening of the skin (erythema) at injection site,
Maltese: • ħmura (eritema) fuq il-ġilda fil-post tal-injezzjoni,
English: EXPIRY DATE EXP
Maltese: It-trab fih
English: THE PRE-FILLED PEN
Maltese: Żieda fil-proporzjon ta'
English: Fatigue
Maltese: Labra
English: Due to the relatively short duration of the pharmacological activity of Preotact further measures should not be necessary.
Maltese: Minħabba t-tul relattivament qasir ta' l-attività farmakoloġika ta'
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton (2 Pre-filled pens)
Maltese: Kartuna ta' barra (2 pinen mimlijin għal-lest)
English: Effect on bone mineral density (BMD)
Maltese: GĦAMLA KWALITATTIVA
English: Pain in extremity
Maltese: Uġigħ fl-estremità
English: • Let it sit for about one minute until the medicine is completely mixed.
Maltese: • Ħalliha toqgħod għal madwar minuta sakemm il-mediċina tkun tħalltet kompletament.
English: It has not been shown that Preotact reduces the risk of breaking your hip.
Maltese: Intwera li Preotact inaqqas ir-riskju ta' ksur għal ġenbejk.
English: Preotact is supplied in a pre-filled pen containing a cartridge.
Maltese: Kif jidher Preotact u l-kontenut tal-pakkett
English: The occurrence of osteosarcoma only occurred at doses that produced systemic exposures > 27-times higher than that observed in humans at the 100 micrograms dose.
Maltese: (ara sezzjoni 5.3). L-okkorrenza ta' osteosarkoma seħħet biss f'dożi li pproduċew espożizzjonijiet sistemiċi > 27 darba ogħla minn dawk osservati fil-bniedem bid-doża ta' 100 mikrogramma.
English: 6.3 Shelf life
Maltese: Is-solvent fih
English: In general, serum calcium levels return to baseline levels 24 hours after dosing.
Maltese: Ġeneralment, il-livelli tal-kalċju fis-serum jerġgħu jura fil-livelli tal-linja bażi 24 siegħa wara d-doża.
English: This leaflet was last approved in MM/YYYY
Maltese: Żomm l-prodott protett mid-dawl.
English: The needle pre-filled pen is full number of index outer needle cover needle inner needle cover
Maltese: Fit-tieni sena ta' l-istudju n-nisa fil-grupp oriġinali ta'
English: It is available as tablets (2.5 mg, 5 mg).
Maltese: Jiġi bħala pilloli (2.5 mg, 5 mg).
English: Further information on Eliquis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Aktar informazzjoni fuq Eliquis tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Eliquis received a marketing authorisation valid throughout the EU on 18 May 2011.
Maltese: Eliquis ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-18 ta' Mejju 2011.
English: Other information about Eliquis
Maltese: Informazzjoni oħra dwar Eliquis
English: The active substance in Eliquis, apixaban, is a ‘factor Xa inhibitor'.
Maltese: Is-sustanza attiva f'Eliquis, apissaban, hija “inibitur tal-fattur Xa”.
English: The most frequent side effects with Eliquis (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haemorrhage (bleeding), haematoma (a collection of blood under the skin), contusion (bruising), nausea (feeling sick), low blood pressure (hypotension), epistaxis (nose bleeds), haematuria (blood in urine), low blood platelet counts (thrombocytopenia), blood tests showing alanine aminotransferase and gamma-glutamyltransferase increase and skin rash.
Maltese: L-aktar effetti sekondarji frekwenti b'Eliquis (li dehru f'bejn pazjent 1 u 10 minn 100) huma anemija (numru baxx ta' ċelloli ħomor fid-demm, emorraġija (fsada), ematoma (ġbir ta' demm taħt il-ġilda), kontużjoni (tbenġil), nawżea (tħossok marid), pressjoni tad-demm baxxa (ipotensjoni), epistassi (fsada fl-imnieħer), ematurija (demm fl-awrina), għadd baxx ta' pjastrini fid-demm (tromboċitopenja) testijiet tad-demm li juru żieda fl-alanina aminotransferażi u fil-gamma-glutamyltransferase u raxx.
English: This overview was last updated in 09-2014.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar fi: 09-2014.
English: Eliquis contains the active substance apixaban.
Maltese: Eliquis fih is-sustanza attiva apissaban.
English: In patients undergoing a knee replacement, the corresponding numbers were 15% (147 out of 976) for Eliquis compared with 24% (243 out of 997) for enoxaparin.
Maltese: F'pazjenti li kienu qed jagħmlu intervent kirurġiku ta' sostituzzjoni ta' rkoppa, in-numru korrispondenti kien 15 % (147 minn 976) għal Eliqiuis meta mqabbel ma' 24 % (243 minn 997) għal enossaparina.
English: As for all medicines, data on the use of Eliquis are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Eliquis tiġi ssorveljata kontinwament.
English: What are the risks associated with Eliquis?
Maltese: X'inhuma r-riskji assoċjati ma' Eliquis?
English: Eliquis was also shown to be effective in preventing strokes and arterial blood clots in patients with atrial fibrillation in two main studies: the first (in 18,201 patients) compared Eliquis with another medicine, warfarin, while the second (in 5,598 patients) compared Eliquis with aspirin.
Maltese: Eliquis intwera wkoll li huwa effettiv fil-prevenzjoni ta' attakki ta' puplesija u emboli tad-demm arterjali f'pazjenti b'fibrillazzjoni atrijali f'żewġ studji ewlenin: tal-ewwel (fi 18,201 pazjent) qabbel Eliquis ma' mediċina oħra, warfarina, filwaqt li t-tieni (f'5,598 pazjent) qabbel Eliquis ma' aspirina.
English: 2.3% of patients taking Eliquis (2.5 mg twice a day) experienced a clot or died, compared with 9.3% of patients taking placebo.
Maltese: 2.3 % tal-pazjenti li jieħdu Eliquis (2.5 mg darbtejn kuljum) esperjenzaw embolu tad-demm jew mietu, meta mqabbel ma' 9.3 % tal-pazjenti li kienu qed jieħdu plaċebo.
English: The yearly rates in the second study were 1.6% for patients taking Eliquis and 3.6% for patients taking aspirin.
Maltese: Ir-rati annwali fit-tieni studju kienu 1.6 % għall-pazjenti li jieħdu Eliquis u 3.6 % għall-pazjenti li jieħdu aspirina.
English: In the study comparing Eliquis with warfarin, 1.3 % of the patients taking Eliquis had a stroke or clotting event every year compared with 1.6% of the patients taking warfarin.
Maltese: Fl-istudju li qabbel Eliquis ma' warfarina, 1.3 % tal-pazjenti li jieħdu Eliquis kull sena kellhom attakk ta' puplesija jew avveniment ta' koagulazzjoni meta mqabbel ma' 1.6 % talpazjenti li jieħdu warfarina.
English: The recommended dose is one 2.5 mg tablet taken by mouth twice a day, usually for over one month (32 to 38 days) after a hip replacement or for 10 to 14 days after a knee replacement.
Maltese: Id-doża rakkomandata hija ta' pillola ta' 2.5 mg li tittieħed mill-ħalq darbtejn kuljum, normalment fuq medda ta' xahar (bejn 32 sa 38 jum) wara sostituzzjoni ta' ġenb jew minn 10 ijiem sa 14-il jum wara sostituzzjoni ta' rkoppa.
English: Eliquis is a medicine used to prevent venous thromboembolism (blood clots in the veins) in adults following a hip or knee replacement operation.
Maltese: Eliquis huwa mediċina li tintuża biex tipprevjeni t-tromboemboliżmu vaskulari (emboli tad-demm filvini) fl-adulti wara operazzjoni ta' sostituzzjoni ta' ġenb jew irkoppa.
English: In patients undergoing a hip replacement, 1.4% of the patients who completed treatment with Eliquis (27 out of 1,949) had a clotting event or died from any cause, compared with 3.9% (74 out of 1,917) of the patients taking enoxaparin.
Maltese: F'pazjenti li kienu qed jagħmlu intervent kirurġiku ta' sostituzzjoni ta' ġenb, 1.4 % tal-pazjenti li lestew il-kura b'Eliquis (27 minn 1,949) kellhom avveniment ta' koagulazzjoni jew mietu minħabba kwalunkwe kawża, meta mqabbel ma' 3.9 % (74 minn 1,917) tal-pazjenti li jieħdu l-enossaparina.
English: 2.3% of patients treated with Eliquis had a clot or died, compared with 2.7% of patients treated with enoxaparin plus warfarin, showing that Eliquis was as effective as the comparator treatment.
Maltese: 2.3 % tal-pazjenti kkurati b'Eliquis kellhom embolu tad-demm jew mietu, meta mqabbel ma' 2.7 % tal-pazjenti kkurati b'enossaparina flimkien ma' warfarina, li juri li Eliquis kien effettiv daqs il-kura tal-komparatur.
English: To prevent deep vein thrombosis and pulmonary embolism from reoccurring, the recommended dose is 2.5 mg twice a day.
Maltese: Biex tiġi pprevenuta r-rikorrenza tat-trombożi tal-vini fondi u l-emboliżmu pulmonari, id-doża rakkomandata hi ta' 2.5 mg darbtejn kuljum.
English: In the prevention study in 2,482 patients, Eliquis was compared with placebo (a dummy treatment) and its effectiveness was measured by looking at the number of patients who either had problems related to clotting in the veins or who died of any cause during treatment.
Maltese: Fl-istudju ta' prevenzjoni f'2,482 pazjent, Eliquis tqabbel ma' plaċebo (kura finta) u l-effettività tiegħu ġiet imkejla billi ġie osservat in-numru ta' pazjenti li jew kellhom problemi relatati ma' koagulazzjoni fil-vini jew li mietu bi kwalunkwe kawża matul il-kura.
English: The company that markets Eliquis will provide educational material for healthcare professionals expected to prescribe Eliquis that addresses the risk of bleeding during treatment.
Maltese: Il-kumpanija li tqiegħed Eliquis fis-suq se tipprovdi materjal edukattiv għall-professjonisti fil-qasam talkura li mistennija jippreskrivu Eliquis li jindirizza r-riskju ta' fsada matul il-kura.
English: Eliquis was effective at preventing blood clots in the veins following a hip or knee replacement in two main studies involving a total of 8,464 patients.
Maltese: Eliquis kien effettiv fil-prevenzjoni ta' emboli tad-demm fil-vini wara sostituzzjoni ta' ġenb jew irkoppa f'żewġ studji ewlenin li kienu jinvolvu total ta' 8,464 pazjent.
English: For patients who have had a hip or knee replacement, treatment with Eliquis should be started 12 to 24 hours after the operation.
Maltese: Għal pazjenti li jkunu għamlu operazzjoni tas-sostituzzjoni ta' ġenb jew irkoppa, il-kura b'Eliquis għandha tinbeda minn 12 sa 24 siegħa wara l-operazzjoni.
English: By blocking factor Xa, it reduces the levels of thrombin in the blood, which reduces the risk of blood clots forming in the arteries and veins.
Maltese: Billi timblokka l-fattur Xa, tnaqqas il-livelli ta' trombina fid-demm, li jnaqqas ir-riskju li fl-arterji u fil-vini jiffirumaw l-emboli tad-demm.
English: In both studies, Eliquis was compared with enoxaparin (another medicine used to prevent blood clots).
Maltese: Fiż-żewġ studji, Eliquis ġie mqabbel ma' enossaparina (mediċina oħra użata għall-prevenzjoni tal-emboli tad-demm).
English: The medicine must also not be used in patients with conditions putting them at risk of major bleeding, such as an ulcer in the gut, or in patients being treated with other anticoagulant medicines except in specific circumstances (see summary of product characteristics).
Maltese: Barra minn hekk, il-mediċina ma għandhiex tintuża fuq pazjenti b'kundizzjonijiet li jqegħduhom f'riskju ta' fsada maġġuri, bħal ulċera flimsaren, jew fuq pazjenti li jkunu qed jiġu trattati b'mediċini antikoagulanti oħra ħlief f'ċirkostanzi speċifiċi (ara s-sommarju tal-karatteristiċi tal-prodott).
English: Additionally, Eliquis is used to prevent stroke (caused by blood clots in the brain) and blood clots in other organs in adults with atrial fibrillation (irregular rapid contractions of the upper chambers of the heart).
Maltese: Barra minn hekk, Eliquis jintuża biex jipprevjeni attakki ta' puplesija (ikkawżati minn emboli tad-demm fil-moħħ) u emboli tad-demm f'organi oħrajn f'adulti b'fibrillazzjoni atrijali (kontrazzjonijiet rapidi u irregolari fil-kompartimenti ta' fuq tal-qalb).
English: What measures are being taken to ensure the safe and effective use of Eliquis?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Eliquis?
English: Eliquis was also effective at treating deep vein thrombosis and pulmonary embolism and preventing their reoccurrence in two main studies.
Maltese: Eliquis kien effettiv ukoll biex jikkura t-trombożi f'vini fondi u l-emboliżmu pulmonari u biex jipprevjeni r-rikorrenza tagħhom fiż-żewġ studji ewlenin.
English: For the full list of side effects and restrictions with Eliquis, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Eliquis, ara l-fuljett ta' tagħrif.
English: For patients with atrial fibrillation at risk of stroke or blood clots, the recommended dose is 5 mg taken twice a day.
Maltese: Għal pazjenti b'fibrillazzjoni atrijali li jkunu f'riskju ta' attakk ta' puplesija jew ta' emboli tad-demm, id-doża rakkomandata hija ta' 5 mg darbtejn kuljum.
English: How does Eliquis work?
Maltese: Kif jaħdem Eliquis?
English: Some of these side effects are not seen with all the uses of Eliquis.
Maltese: Uħud minn dawn l-effetti sekondarji ma jidhrux fl-użi kollha ta' Eliquis.
English: It is used in patients who have one or more risk factors, such as having had a previous stroke, having high blood pressure, diabetes, heart failure or being 75 years old or over.
Maltese: Jintuża f'pazjenti li għandhom fattur ta' riskju wieħed jew aktar, bħal dawk li diġà kellhom attakk ta' puplesija, pressjoni tad-demm għolja, dijabete, insuffiċjenza kardijaka jew dawk li għandhom 75 sena jew aktar.
English: The full EPAR for Faslodex 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: This summary was last updated in 01-2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'01-2018.
English: Faslodex contains the active substance fulvestrant.
Maltese: Faslodex fih is-sustanza attiva fulvestrant.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Faslodex on 10 March 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Faslodex fl-10 ta' Marzu 2004.