FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection/infusion contains 50 mg idarucizumab.
Maltese: U KWANTITATTIVA Kull mL ta' soluzzjoni għall-injezzjoni/infużjoni fih 50 mg idarucizumab.
English: NAME OF THE MEDICINAL PRODUCT Praxbind 2.5 g/50 mL solution for injection/infusion
Maltese: Praxbind 2.5 g/50 mL soluzzjoni għall-injezzjoni/infużjoni
English: Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT).
Maltese: Il-parametri ta' koagulazzjoni relevanti huma l-Ħin tat-Thromboplastin Parzjali Attivat (aPTTactivated Partial Thromboplastin Time), il-Ħin ta' Thrombin dilwit (dTT - diluted Thrombin Time), jew il-Ħin ta' Koagulazzjoni tal-Ecarin (ECT - Ecarin Clotting Time).
English: The recommended dose is 5 g (2 vials of 50 mL).
Maltese: Id-doża rakkomandata hija 5 g (2 kunjetti ta' 50 mL).
English: Immediately after the administration of idarucizumab, the plasma concentrations of unbound dabigatran were reduced by more than 99 %, resulting in levels with no anticoagulant activity.
Maltese: Minnufih wara l-għoti ta' idarucizumab, il-konċentrazzjonijiet fil-plasma ta' dabigatran mhux marbut tnaqqsu b'aktar minn 99%, u dan irriżulta f'livelli mingħajr ebda attività antikoagulanti.
English: In a subset of patients, recurrence of plasma levels of unbound dabigatran and concomitant elevation of clotting tests was observed, possibly due to re-distribution of dabigatran from the periphery.
Maltese: F'numru limitat ta' pazjenti, kienu osservati okkorrenza mill-ġdid ta' livelli fil-plażma ta' dabigatran mhux marbut u żieda fl-istess ħin tat-testijiet ta' koagulazzjoni tad-demm, possibbilment dovuti għal ridistribuzzjoni ta' dabigatran mill-periferija.
English: Restoration of haemostasis was achieved in 80.3% of evaluable patients who had serious bleeding and normal haemostasis was observed in 93.4% of patients who required an urgent procedure.
Maltese: It-treġġigħ lura ta' emostażi ntlaħaq fi 80.3% tal-pazjenti evalwabbli li kellhom fsada serja u ġiet osservata emostażi normali fi 93.4% tal-pazjenti li kellhom bżonn ta' proċedura urġenti.
English: In these studies the doses of idarucizumab ranged from 20 mg to 8 g and the infusion times ranged from 5 minutes to 1 hour.
Maltese: F'dawn l-istudji, id-dożi ta' idarucizumab varjaw minn 20 mg għal 8 g u l-ħinijiet ta' infużjoni varjaw minn 5 minuti għal 1 siegħa.
English: • coagulation factor concentrates, such as prothrombin complex concentrates (PCCs, e.g. 3 factor and
Maltese: • konċentrati ta' fatturi ta' koagulazzjoni, bħal kumplessi konċentrati ta' prothrombin (PCC, eż.
English: What Praxbind contains - The active substance is idarucizumab.
Maltese: X'fih Praxbind - Is-sustanza attiva hi idarucizumab.
English: No adverse reactions have been identified.
Maltese: Ma ġew identifikati ebda reazzjonijiet avversi.
English: Figure 3 - Reversal of dabigatran-induced clotting time prolongation determined by aPTT in patients from the RE-VERSE AD study (N=486)
Maltese: Figura 3 - Qlib lura tat-titwil tal-ħin ta' koagulazzjoni indott minn dabigatran determinat minn aPTT f'pazjenti mill-istudju RE-VERSE AD (N=486)
English: LIST OF EXCIPIENTS Excipients: Sodium acetate trihydrate, acetic acid, sorbitol, polysorbate 20, water for injection.
Maltese: Triidrat tal-aċetat tas-sodju, aċidu tal-aċetat, sorbitol, polisorbat 20, ilma għall-injezzjonijiet.
English: The majority of the patients showed sustained reversal of dabigatran plasma concentrations up to 12 hours (≥90%).
Maltese: Il-maġġoranza tal-pazjenti urew treġġigħ lura sostnut ta' konċentrazzjonijiet fil-plażma ta' dabigatran għal sa 12-il siegħa (≥ 90%).
English: This medicinal product contains 50 mg sodium per dose, equivalent to 2.5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 50 mg sodium f'kull doża, ekwivalenti għal 2.5 % tal-ammont massimu rakkomandat mill-WHO ta' 2 g sodium li għandu jittieħed kuljum minn adult.
English: Restarting Antithrombotic Therapy
Maltese: Bidu mill-Ġdid ta' Kura Antitrombotika
English: This is equivalent to 2.5 % of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 2.5 % tal-ammont massimu rakkomandat ta' sodium li għandu jittieħed kuljum mad-dieta minn adult.
English: The pharmacodynamics of idarucizumab after administration of dabigatran etexilate were investigated in 141 subjects in Phase I studies, of which data for a representative subgroup of 6 healthy subjects aged 45 to 64 years receiving a dose of 5 g as intravenous infusion are presented.
Maltese: Il-farmakodinamika ta' idarucizumab wara l-għoti ta' etessilat tad-dabigatran ġiet investigata f'141 suġġett fi studji ta' Fażi I, li għalihom qiegħda tiġi ppreżentata dejta għal subgrupp rappreżentattiv ta' 6 suġġetti b'saħħithom ta' bejn 45 u 64 sena li rċevew doża ta' 5 g bħala infużjoni ġol-vini.
English: Idarucizumab effectively and rapidly reversed the life-threatening bleeding within 15 min after the injection.
Maltese: Idarucizumab qeleb b'mod effettiv u rapidu l-fsada ta' theddida għall-ħajja fi żmien 15-il minuta wara l-injezzjoni.
English: What Praxbind is
Maltese: X'inhu Praxbind
English: The pharmacokinetics of idarucizumab were investigated in 224 subjects in Phase I studies, of which data for a representative subgroup of 6 healthy subjects aged 45 to 64 years receiving a dose of 5 g as intravenous infusion are presented.
Maltese: Il-farmakokinetika ta' idarucizumab ġiet investigata f'224 suġġett fi studji ta' Fażi I, li għalihom qiegħda tiġi ppreżentata dejta għal subgrupp rappreżentattiv ta' 6 suġġetti b'saħħithom ta' bejn 45 u 64 sena li rċevew doża ta' 5 g bħala infużjoni ġol-vini.
English: PHARMACEUTICAL FORM AND CONTENTS solution for injection/infusion 2 vials of 50 mL each
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT soluzzjoni għall-injezzjoni/infużjoni 2 kunjetti ta' 50 mL kull wieħed
English: The transient proteinuria is a physiologic reaction to renal protein overflow after bolus/short term application of 5g idarucizumab intravenously.
Maltese: Il-proteinurja temporanja hija reazzjoni fiżjoloġika għal fluss eċċessiv ta' proteina fil-kliewi wara applikazzjoni bolus/għal żmien qasir ta' 5 g idarucizumab mogħti ġol-vini.
English: Studies to assess the potential reproductive effects of idarucizumab have not been performed.
Maltese: Ma sarux studji li jivvalutaw l-effetti riproduttivi potenzjali ta' idarucizumab.
English: No formal interaction studies with Praxbind and other medicinal products have been performed.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni formali ta' Praxbind u prodotti mediċinali oħrajn.
English: Figure 1 - Reversal of dabigatran-induced clotting time prolongation determined by dTT in patients from the RE-VERSE AD study (N=487)
Maltese: Figura 1 - Qlib lura tat-titwil tal-ħin ta' koagulazzjoni indott minn dabigatran determinat minn dTT f'pazjenti mill-istudju RE-VERSE AD (N=487)
English: No incompatibilities between Praxbind and polyvinyl chloride, polyethylene or polyurethane infusion sets or polypropylene syringes have been observed.
Maltese: Ma ġiet osservata ebda inkompatibilità bejn Praxbind u s-settijiet ta' infużjoni ta' klorur tal-polivinil, polietilen jew poliuretan jew siringi tal-polipropilen.
English: From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product shall be used immediately after opening.
Maltese: Minn lat mikrobijoloġiku, sakemm il-metodu ta' ftuħ ma jipprekludix ir-riskju ta' kontaminazzjoni mikrobijali, il-prodott għandu jintuża minnufih wara l-ftuħ.
English: Pradaxa (dabigatran etexilate) treatment can be re-initiated 24 hours after administration of Praxbind, if the patient is clinically stable and adequate haemostasis has been achieved.
Maltese: Il-kura bi Pradaxa (dabigatran etexilate) tista' terġa' tinbeda 24 siegħa wara l-għoti ta' Praxbind, jekk il-pazjent ikun klinikament stabbli u tkun inkisbet emostażi adegwata.
English: In a phase III trial the safety of Praxbind has been evaluated in 503 patients, who had uncontrolled bleeding or required emergency surgery or procedures and were under treatment with Pradaxa (dabigatran etexilate), as well as in 224 volunteers in phase I trials.
Maltese: III, is-sigurtà ta' Praxbind ġiet evalwata f'503 pazjenti, li kellhom fsada mhux ikkontrollata jew li kellhom bżonn ta' kirurġija jew proċeduri ta' emerġenza u kienu taħt kura bi Pradaxa (dabigatran etexilate), kif ukoll f'224 voluntier fi provi ta' Fażi I.
English: For storage conditions after opening of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara l-ewwel ftuħ tal-prodott mediċinali, ara sezzjoni 6.3.
English: Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required:
Maltese: Praxbind huwa aġent riversiv speċifiku għal dabigatran u huwa indikat f'pazjenti adulti kkurati b'Pradaxa (dabigatran etexilate) meta jkun meħtieġ qlib lura rapidu tal-effetti antikoagulanti tiegħu:
English: Read all of this leaflet carefully, because it contains important information for you.
Maltese: Id-data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: Thrombotic events were reported in 34 patients (23 out of the 34 patients were not on antithrombotic therapy at the time of the event) and in each of these cases, the thrombotic event could be attributed to the underlying medical condition of the patient.
Maltese: Episodji trombotiċi ġew irrapportati f'34 pazjent, (23 mill-34 pazjent ma kinux fuq terapija antitrombotika fil-ħin tal-episodju) u f'kull wieħed mill-każijiet, l-avveniment trombotiku seta' jiġi attribwit għall-kundizzjoni medika bażi tal-pazjent.
English: This medicine contains 50 mg sodium (main component of cooking/table salt) per dose.
Maltese: Din il-mediċina fiha 50 mg sodium (il-komponent prinċipali tal-melħ tat-tisjir / li jintuża mal-ikel) f'kull doża.
English: In patients with hereditary fructose intolerance there is a risk for serious adverse reactions, which must be weighed against the benefit of an emergency treatment with Praxbind.
Maltese: F'pazjenti b'intolleranza ereditarja għall-fruttożju, hemm ir-riskju għal reazzjonijiet avversi serji, li jista' jiġi mwieżen kontra l-benefiċċju ta' kura ta' emerġenza bi Praxbind.
English: • Intravenous administration as two consecutive infusions over 5 to 10 min each or as bolus injections
Maltese: • Għoti ġol-vini bħala żewġ infużjonijiet konsekuttivi għal 5 sa 10 minuti kull waħda jew bħala injezzjonijiet bolus.
English: Therefore, in patients with hereditary fructose intolerance the risk of treatment with Praxbind must be weighed against the potential benefit of such an emergency treatment.
Maltese: Għaldaqstant, f'pazjenti b'intolleranza ereditarja għall-fruttożju, ir-riskju ta' kura bi Praxbind għandu jiġi mwieżen kontra l-benefiċċju potenzjali ta' kura ta' emerġenza bħal din.
English: Package leaflet: Information for the patient and user Praxbind 2.5 g/50 mL solution for injection/infusion idarucizumab
Maltese: Informazzjoni għall-pazjent u għall-utent Praxbind 2.5 g/50 mL soluzzjoni għall-injezzjoni/infużjoni idarucizumab
English: Based on population pharmacokinetic analyses, sex, age, and race do not have a clinically meaningful effect on the pharmacokinetics of idarucizumab.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni, is-sess, l-eta u r-razza ma għandhomx effett li jagħmel sens klinikament fuq il-farmakokinetika ta' idarucizumab.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Praxbind in one or more subsets of the paediatric population in the prevention and treatment of dabigatran associated haemorrhage (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati r-riżultati tal-istudji bi Praxbind f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-prevenzjoni u kura ta' emorraġija assoċjata ma' dabigatran (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Praxbind may be used during pregnancy, if the expected clinical benefit outweighs the potential risks.
Maltese: Praxbind jista' jintuża waqt it-tqala, jekk il-benefiċċju kliniku mistenni jkun akbar mir-riskji potenzjali.
English: Absence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition.
Maltese: In-nuqqas ta' kura antitrombotika jista' jesponi lil pazjenti għar-riskju trombotiku tal-marda jew kundizzjoni bażi tagħhom.
English: The remaining part of the dose is assumed to be eliminated via protein catabolism, mainly in the kidney.
Maltese: Huwa ssoponut li l-parti li jifdal tad-doża tiġi eliminata permezz ta' kataboliżmu tal-proteina, prinċipalment fil-kliewi.
English: Effect of idarucizumab on the exposure and anticoagulant activity of dabigatran
Maltese: Effett ta' idarucizumab fuq l-espożizzjoni u l-attività antikoagulanti ta' dabigatran
English: A complete and sustained reversal of dabigatran-induced clotting time prolongation was observed immediately after the idarucizumab infusion, lasting over the entire observation period of at least 24 h.
Maltese: Qlib komplet u sostenibbli ta' titwil tal-ħin ta' koagulazzjoni indott minn dabigatran ġie osservat minnufih wara l-infużjoni ta' idarucizumab, u dan dam tul il-perjodu ta' osservazzjoni kollu ta' mill-inqas 24 siegħa.
English: Based on pharmacokinetic data from 12 patients with liver disease, the AUC of idarucizumab was increased by 10% as compared to patients without liver disease.
Maltese: Ibbażat fuq data farmakokinetika minn 12-il pazjent b'mard tal-fwied, lAUC ta' idarucizumab żdiedet b'10% meta mqabbla ma' pazjenti mingħajr mard tal-fwied.
English: Preclinical pharmacodynamics
Maltese: GĦAMLA FARMAĊEWTIKA
English: Of the total 503 patients, 101 patients died; each of these deaths could be attributed either as a complication of the index event or associated with co-morbidities.
Maltese: Minn total ta' 503 pazjenti, 101 pazjent mietu; kull waħda minn dawn l-imwiet setgħet tiġi attribwita għal kumplikazzjoni tal-avveniment indiċi jew assoċjata ma' komorbiditajiet.
English: Sodium content
Maltese: Linja Bażi
English: 50 mL solution in a glass vial (type I glass), with a butyl rubber stopper, an aluminium cap and a label with integrated hanger.
Maltese: 50 mL soluzzjoni f'kunjett tal-ħġieġ (ħġieġ tat-tip I) b'tapp tal-gomma tal-butil, kappa tal-aluminju u tikketta b'maqbad minn fejn jiddendel integrat.
English: All pigs survived at idarucizumab doses of approximately 2.5 and 5 g. Without idarucizumab, the mortality in the anticoagulated group was 100 %.
Maltese: Mingħajr idarucizumab, il-mortalità fil-grupp antikoagulat kienet ta' 100%.
English: Pregnancy
Maltese: Idarucizumab
English: To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate (see section 4.2).
Maltese: Biex jitnaqqas dan ir-riskju, it-tkomplija mill-ġdid tal-kura antikoagulanti għandha tiġi kkunsidrata malli jkun medikament xieraq (ara sezzjoni 4.2).
English: Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises their anticoagulant effect.
Maltese: Idarucizumab jeħel bis-saħħa u speċifikament ma' dabigatran u mal-metaboliti tiegħu u jinnewtralizza l-effetti antikoagulanti tagħhom.
English: Figure 2 - Reversal of dabigatran-induced clotting time prolongation determined by ECT in patients from the RE-VERSE AD study (N=487)
Maltese: 2 - Qlib lura tat-titwil tal-ħin ta' koagulazzjoni indott minn dabigatran determinat minn ECT f'pazjent mill-istudju RE-VERSE AD (N=487)
English: The primary endpoint was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, based on central laboratory determination of dilute thrombin time (dTT) or ecarin clotting time (ECT).
Maltese: Il-punt ta' tmiem primarju kien it-treġġigħ lura perċentwali massimu tal-effett antikoagulanti ta' dabigatran fi żmien 4 sigħat wara l-għoti ta' idarucizumab, abbażi ta' determinazzjoni tal-laboratorju ċentrali tal-ħin ta' thrombin dilwit (dTT) jew il-ħin ta' koagulazzjoni ecarin (ECT) Punt ta' tmiem sekondarju ewlieni kien it-treġġigħ lura ta' emostażi.
English: Figure 5 - Reversal of dabigatran-induced clotting time prolongation determined by dTT in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h)
Maltese: Figura 5 - Qlib tat-titwil tal-ħin ta' koagulazzjoni indotta minn dabigatran determinat minn dTT fil-grupp rappreżentattiv ta' suġġetti b'saħħithom (għoti ta' idarucizumab jew plaċebo f'0 h)
English: Subjects with a creatinine clearance below 44 mL/min have not been studied in Phase I. Depending on the degree of renal impairment the total clearance was reduced compared to healthy subjects, leading to an increased exposure of idarucizumab.
Maltese: Suġġetti b'eliminazzjoni tal-kreatinina inqas minn 44 mL/mL/min ma ġewx studjati fil-Fażi I.
English: A maximum daily dose has not been investigated.
Maltese: Doża massima ta' kuljum ma ġietx investigata.
English: The risk of using Praxbind in patients with known hypersensitivity (e.g. anaphylactoid reaction) to idarucizumab or to any of the excipients needs to be weighed cautiously against the potential benefit of such an emergency treatment.
Maltese: Ir-riskju li jintuża Praxbind f'pazjenti b'sensittività eċċessiva magħrufa (eż. reazzjoni anafilaktojde) għal idarucizumab jew għal kwalunkwe eċċipjent ieħor jeħtieġ li jiġi peżat b'attenzjoni kontra l-benefiċċju potenzjali ta' kura ta' emerġenza bħal din.
English: Re-administration of dabigatran etexilate
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Praxbind is used in adults in emergency situations where your doctor decides that rapid inactivation of the effect of Pradaxa is required - For emergency surgery/urgent procedures - In life-threatening or uncontrolled bleeding.
Maltese: Praxbind jintuża f'adulti f'sitwazzjonijiet ta' emerġenza fejn it-tabib tiegħek jiddeċiedi li tkun meħtieġa inattivazzjoni rapida tal-effett ta' Pradaxa - Għal kirurġija ta' emerġenza/proċeduri urġenti - Fi fsada ta' theddida għall-ħajja jew mhux ikkontrollata.
English: The idarucizumab-dabigatran complex is characterised by a rapid on-rate and extremely slow off-rate resulting in a very stable complex.
Maltese: Il-kumpless ta' idarucizumab-dabigatran huwa kkaratterizzat minn on-rate rapida u minn off-rate bil-mod ħafna li tirriżulta f'kumpless stabbli ħafna.
English: 61.5% of patients in Group A and 62.4% of patients in Group B had been treated with dabigatran 110 mg twice daily.
Maltese: L-eta medjana kienet ta' 78 sena u l-eliminazzjoni medjana tal-kreatinina kienet 52.6 mL/min. 61.5% tal-pazjenti fi Grupp A u 62.4% tal-pazjenti fi Grupp B ġew ikkurati b'dabigatran 110 mg darbtejn kuljum.
English: After administration of Praxbind, other antithrombotic therapy (e.g. low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate haemostasis has been achieved.
Maltese: Wara l-għoti ta' Praxbind, tista' tinbeda kura antitrombotika oħra (eż. eparina b'piż molekulari baxx) fi kwalunkwe ħin, jekk il-pazjent ikun klinikament stabbli u tkun inkisbet emostażi adegwata.
English: An impact of hepatic impairment, assessed by hepatic injury as determined by elevated liver function tests, on the pharmacokinetics of idarucizumab has not been observed.
Maltese: Ma kienx osservat impatt ta' indeboliment tal-fwied, stmat minn korriment fil-fwied kif determinat minn testijiet tal-funzjoni tal-fwied elevati, fuq il-farmakokinetika ta' idarucizumab.
English: Preclinical investigations with idarucizumab have shown no interactions with
Maltese: Struzzjonijiet dwar l-immaniġġjar:
English: PHARMACEUTICAL FORM AND CONTENTS 2 vials of 50 mL solution for injection/infusion each
Maltese: U KONTENUT 2 kunjetti ta' 50 mL soluzzjoni għall-injezzjoni/infużjoni kull wieħed
English: After opening the vial, chemical and physical in-use stability of idarucizumab has been demonstrated for 6 hours at room temperature.
Maltese: Wara l-ftuħ tal-kunjett, l-istabilita kimika u fiżika ta' idarucizumab waqt l-użu ntweriet għal 6 sigħat f'temperatura ambjentali.
English: Idarucizumab has been studied in 58 patients with varying degrees of hepatic impairment.
Maltese: Idarucizumab ġie studjat fi 58 pazjent bi gradi varji ta' indeboliment tal-fwied.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Praxbind is a reversal agent specific for dabigatran (Pradaxa), a blood thinner medicine that blocks a substance in the body, which is involved in blood clot formation.
Maltese: Praxbind huwa aġent riversiv speċifiku għal dabigatran (Pradaxa), mediċina li traqqaq id-demm li timblokka sustanza fil-ġisem, li hija involuta fil-formazzjoni tal-koagulazzjoni tad-demm.
English: -1 Porcine circovirus type 2 ORF2 subunit antigen: ≥ 1,436 AU* per 0.2 ml * Antigenic units as determined in the in vitro potency test (antigenic mass assay).
Maltese: -1 Porcine circovirus tip 2 ORF2 subjunit antiġen: ≥ 1,436 AU* per 0.2 ml Tajter ta' unit antiġeniċi miksub minn testijiet ta' potenza in vitro (antigenic mass assay).
English: EU (MA) Number Invented name
Maltese: EU (MA) Numru Isem ivvintat
English: Pfizer Manufacturing Deutschland GmbH Betriebsstӓtte Freiburg Mooswaldallee 1
Maltese: Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee 1
English: No adverse drug reactions were reported with an absolute difference of ≥15%.
Maltese: Lebda reazzjonijiet avversi tal-mediċina ma ġew irrappurtati b'differenza assoluta ta' ≥15%.
English: Hypophosphataemia (6%)
Maltese: Ipofosfatemija (6%)
English: Study 1001 N=53a
Maltese: Studju 1001 N=53a
English: There were 6 complete responses and 32 partial responses for an ORR of 72% (95% CI: 58%, 83%).
Maltese: Kien hemm 6 risponsi kompleti u 32 risponsi parzjali għal ORR ta' 72% (95% CI: 58%, 883%).
English: Rash (13%)
Maltese: Raxx (13%)
English: XALKORI as monotherapy is indicated for:
Maltese: XALKORI bħala monoterapija huwa indikat:
English: Oesophagitisk (2%) Dyspepsia (8%)
Maltese: Esofaġitek (2%) Dispepsja (8%)
English: • Quinidine, digoxin, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, verapamil,
Maltese: • Quinidine, digoxin, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, verapamil, diltiazem użati għal problemi fil-qalb.
English: • Rifabutin, rifampicin, used to treat tuberculosis.
Maltese: • Rifabutin, rifampicin, użati għat-trattament tat-tuberkulożi.
English: • Ketoconazole, itraconazole, posaconazole, voriconazole, used to treat fungal infections.
Maltese: • Ketoconazole, itraconazole, posaconazole, voriconazole, użati għat-trattament ta' infezzjonijiet fungali.
English: XALKORI 250 mg hard capsules EU/1/12/793/003
Maltese: XALKORI 250 mg kapsuli ibsin EU/1/12/793/003
English: Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation with Grade ≤1 total bilirubin
Maltese: Alanine aminotransferase (ALT) ta' Grad 3 jew 4 jew żieda ta' aspartate aminotransferase (AST) b'bilirubin totali ta' Grad ≤1
English: Capsule content: colloidal anhydrous silica, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate (Type A), magnesium stearate.
Maltese: Kontenut tal-kapsula: silica, colloidal anhydrous, cellulose, microcrystalline, calcium hydrogen phosphate, anhydrous, sodium starch glycolate (Type A), magnesium stearate.
English: d. Updated based on final OS analysis.
Maltese: d. Aġġornat abbażi ta' analiżi OS finali.
English: Grade 2, 3 Bradycardiad,e Symptomatic, may be severe and medically significant, medical intervention indicated
Maltese: Bradikardija ta' Grad 2, 3d,e Bis-sintomi, tista' tkun severa u medikament sinifikanti, indikat intervent mediku
English: Crizotinib is an inhibitor of OCT1 and OCT2 in vitro.
Maltese: Crizotinib hu inibitur ta' OCT1 and OCT2 in vitro.