FrancophonIA/ELRC3.0 huggingface dataset:
English: The one-stage clotting assay for Factor VIII is recommended as it has been used in determination of the potency of OBIZUR and the mean recovery rate (see section 4.4 and 5.2).
Maltese: L-assaġġ tal-fsada ta' fażi waħda għal Fattur VIII huwa rrakkomandat minħabba li ntuża fid-determinazzjoni tal-potenza ta' OBIZUR u r-rata ta' rkupru medja (ara sezzjoni 4.4 u 5.2).
English: There is a lack of clinical information on the development of inhibitory antibodies to OBIZUR following repeated administration.
Maltese: Hemm nuqqas ta' informazzjoni klinika dwar l-iżvilupp ta' antikorpi inibitorji għal OBIZUR wara għoti ripetut.
English: Inhibitory antibodies against OBIZUR were measured using a modification of the Nijmegen variation of the Bethesda assay method.
Maltese: L-antikorpi inibitorji kontra OBIZUR tkejlu permezz ta' modifika tal-varjazzjoni ta' Nijmegen tal-metodu ta' assaġġ ta' Bethesda.
English: Place the vial adapter over the OBIZUR powder vial and firmly push the filter spike of the vial adapter through the centre of the OBIZUR powder vial's rubber circle until the clear plastic cap snaps onto the vial (Figure F).
Maltese: Poġġi l-adapter tal-kunjett fuq il-kunjett ta' trab ta' OBIZURu agħfas sew il-ponta tal-filtru tal-adapter tal-kunjett miċ-ċentru taċ-ċirku tal-lastku tal-kunjett ta' trab ta' OBIZUR sakemm l-għatu tal-plastik trasparenti jfaqqa' fil-kunjett (Figura F).
English: 6.6 Special precautions for disposal and other handling After reconstitution, the solution is clear, colourless, free from particles and has a pH of 6.8 to 7.2.
Maltese: Wara r-rikostituzzjoni, is-soluzzjoni hija ċara, bla kulur, mingħajr frak u għandha pH ta' 6.8 sa 7.2.
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation Factor VIII, porcine sequence.
Maltese: Kategorija farmakoterapewtika: antiemorraġiċi, Fattur VIII ta' koagulazzjoni tad-demm, sekwenza tal-porċini.
English: Inhibitory antibodies against porcine Factor VIII (measured using a modification of the Nijmegen variation of the Bethesda assay) were detected before and after exposure to OBIZUR.
Maltese: Antikopri inibitorji kontra l-Fattur VIII tal-porċini (imkejlin permezz ta' modifika tal-varjazzjoni ta' Nijmegen tal-assaġġ ta' Bethesda) ġew rilevati qabel u wara l-espożizzjoni għal OBIZUR.
English: Obizur is a recombinant, B-domain deleted, porcine sequence Factor VIII (susoctocog alfa).
Maltese: OBIZUR huwa Fattur VIII ta' sekwenza tal-porċini, imħassar mill-qasam B, rikombinanti (susoctocog alfa).
English: The dose, frequency, and duration of the therapy with OBIZUR depend on the location, extent and severity of the bleeding episode, target Factor VIII activity, and on the patient´s clinical condition.
Maltese: Id-doża, il-frekwenza, u d-durata tat-terapija b'OBIZUR jiddependu fuq il-post, il-firxa u s-severità tal-episodju ta' fsada, l-attività fil-mira tal-Fattur VIII, u fuq il-kundizzjoni klinika tal-pazjent.
English: Name and batch number
Maltese: NUMRU TAL-LOTT
English: The mean half-life of OBIZUR in nine evaluable subjects in the bleeding state was (about) 10 hours (range 2.6 to 28.6 hours).
Maltese: Il-half-life medju ta' OBIZUR f'disa' individwi evalwabbli fl-istat ta' fsada kienet (madwar) 10 sigħat (medda ta' 2.6 sa 28.6 siegħa).
English: Do not use OBIZUR: - if you are allergic to susoctocog alfa or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to hamster proteins (trace amounts may be present in Obizur arising from the manufacturing process)
Maltese: Tużax OBIZUR: - jekk inti allerġiku għal susoctocog alfa jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6) - jekk inti allerġiku għall-proteini tal-ħamster (jistgħu jkunu preżenti traċċi f'OBIZUR li jirriżultaw mill-proċess ta' manifattura)
English: No interactions of OBIZUR with other medicinal products have been reported.
Maltese: L-ebda interazzjonijiet ta' OBIZUR ma' prodotti mediċinali oħra ma ġew irrapportati.
English: Each powder vial contains nominally 500 Units of B domain deleted antihaemophilic Factor VIII (recombinant), porcine sequence, susoctocog alfa.
Maltese: Unità ta' Fattur VIII antiemofiliku (rikombinanti) imħassar tal-qasam B, sekwenza tal-porċini, susoctocog alfa.
English: Do not to touch the luer lock (tip) in the centre of the vial adapter.
Maltese: Tmissx il-luer lock (ponta) fiċ-ċentru tal-adapter tal-kunjett.
English: The potency (U) is determined using the one-stage coagulation assay (OSCA).
Maltese: Il-qawwa (U) hija ddeterminata permezz ta' assaġġ tal-koagulazzjoni fi stadju wieħed (OSCA).
English: The median dose per injection to successfully treat the primary bleed was 133 U/kg and the median total dose was 1523 U/kg for a median of 6 days.
Maltese: Id-doża medjana għal kull injezzjoni biex tiġi kkurata b'suċċess il-fsada primarja kienet 133 U/kg u d-doża totali medjana kienet 1523 U/kg għal medjan ta' 6 ijiem.
English: The total volume of reconstituted OBIZUR should be administered at a rate of 1 to 2 mL per minute.
Maltese: Il-volum totali ta' OBIZUR rikostitwit għandu jingħata b'rata ta' 1 sa 2 mL fil-minuta.
English: Allergic type hypersensitivity reactions are possible with OBIZUR.
Maltese: Reazzjonijiet ta' sensittività eċċessiva ta' tip allerġiku huma possibbli b'OBIZUR.
English: OBIZUR contains sodium This medicine contains 4.4 mg sodium per milliliter once it is made up.
Maltese: OBIZUR fih is-sodju Din il-mediċina fiha 4.4 mg sodju għal kull millilitru ladarba tkun ġiet imsawwra.
English: Mild and moderate superficial muscle / no neurovascular compromise and joint bleeding
Maltese: Fsada ħafifa għal moderata minn muskolu superfiċjali/l-ebda kompromess newrovaskulari jew fsada fil-ġogi
English: Immediately after release in the patient's circulation, Factor VIII binds to von Willebrand factor (vWF).
Maltese: Immedjatament wara r-rilaxx fiċ-ċirkolazzjoni tal-pazjent, il-Fattur VIII jeħel mal-fattur von Willebrand (vWF).
English: The recommended initial dose is 200 U per kilogram bodyweight, given by injection.
Maltese: Id-doża inizjali rrakkomandata hija 200 U għal kull kilogramma ta' piż tal-ġisem, li tingħata b'injezzjoni.
English: Known anaphylactic reactions to the active substance, hamster protein, or to any of the excipients listed in section 6.1.
Maltese: Reazzjonijiet anafilattiċi magħrufin għas-sustanza attiva, għall-proteini tal-ħamster, jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: The European Medicines Agency has waived the obligation to submit the results of studies with OBIZUR in all subsets of the paediatric population in treatment of acquired haemophilia (see section 4.2 for information on paediatric use).
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Maltese: Il-pazjenti għandhom jiġu infurmati dwar is-sinjali bikrija ta' reazzjonijiet ta' sensittività eċċessiva li jinkludu ħorriqija, urtikarja ġeneralizzata, għafis tas-sider, tħarħir, pressjoni baxxa, u anafilassi.
English: Administer the reconstituted OBIZUR intravenously at a rate of 1 to 2 mL per minute.
Maltese: Agħti s-soluzzjoni rikostitwita ta' OBIZUR ġol-vina b'rata ta' 1 sa 2 mL fil-minuta.
English: • Do not administer OBIZUR in the same tubing or container with other medicinal products for injection.
Maltese: • Tagħtix OBIZUR fl-istess tubu jew kontenitur ma' prodotti mediċinali oħrajn għal injezzjoni.
English: Circulating antibodies (inhibitors) targeted against human Factor VIII have minimal or no cross reactivity against OBIZUR.
Maltese: L-antikorpi (inibituri) li jiċċirkolaw li huma mmirati kontra l-Fattur VIII tal-bniedem għandhom reattività inkroċjata minima jew ebda reattività inkroċjata kontra OBIZUR.
English: For intravenous injection only!
Maltese: Għal injezzjoni ġol-vina biss!
English: Intravenous use.
Maltese: Użu ġol-vina.
English: Titrate subsequent doses based on clinical response and to maintain target Factor VIII trough activity
Maltese: Ittitra dożi sussegwenti abbażi tar-rispons kliniku u biex iżżomm l-attività l-aktar baxxa fil-mira għall-Fattur VIII
English: What OBIZUR looks like and contents of the pack One pack contains 1, 5 or 10 of the following: - glass vial of OBIZUR 500 U white, friable powder with a rubber stopper and a flip-off seal - pre-filled glass syringe of 1 ml sterilised water for injections with a rubber tip cap and a Luer
Maltese: U b'tapp tal-lastku u siġill li jinfetaħ billi tgħollih. - siringa tal-ħġieġ mimlija għal-lest ta' 1 ml ilma sterilizzat għall-injezzjonijiet b'għatu b'ponta tal-lastku u adapter Luer Lock - apparat għat-trasferiment tal-fluwidu b'ponta tal-plastik integrali
English: It is recommended that treatment should be based on clinical judgement and not based on detection of inhibitory antibodies by the Bethesda assay.
Maltese: Huwa rrakkomandat li l-kura għandha tkun ibbażata fuq ġudizzju kliniku u mhux abbażi tas-sejba ta' antikorpi inibitorji mill-assaġġ ta' Bethesda.
English: When treatment was required beyond 24 hours, a median total dose of 1050 U/kg were utilized with a median of 10.5 infusions (median dose 100 U/kg) to control a bleeding episode.
Maltese: 5 infużjonijiet (doża medjana ta' 100 U/kg) biex jiġi kkontrollat episodju ta' fsada.
English: Usually, the replacement therapy with OBIZUR is a temporary treatment until bleeding is resolved or the antibodies against your own Factor VIII are eradicated.
Maltese: Ġeneralment, it-terapija ta' sostituzzjoni b'OBIZUR hija kura temporanja sakemm il-fsada tieqaf jew l-antikopri kontra l-Fattur VIII tiegħek stess jiġu eredikati.
English: The one-stage assay is recommended because it has been used in determination of the potency and the mean recovery rate of OBIZUR (see sections 4.2 and 5.2).
Maltese: L-assaġġ ta' stadju wieħed huwa rrakkomandat minħabba li ntuża fid-determinazzjoni tal-qawwa u r-rata ta' rkupru medja ta' OBIZUR (ara s-sezzjonijiet 4.2 u 5.2).
English: Other medicines and OBIZUR
Maltese: Mediċini oħra u OBIZUR
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION OBIZUR 500 U powder for solution for injection Susoctocog alfa
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna, fuq il-kunjett u fuq is-siringa mimlija għal-lest wara
English: How to use OBIZUR
Maltese: U L-UŻU
English: Gently swirl (in a circular motion) the OBIZUR powder vial without removing the syringe until all of the powder is fully dissolved /reconstituted (Figure G).
Maltese: Ħawwad bil-mod (b'moviment ċirkolari) il-kunjett ta' trab ta' OBIZUR mingħajr ma tneħħi s-siringa sakemm it-trab kollu jkun inħall/rikostitwit (Figura G).
English: Diabetic ketoacidosis a,
Maltese: Ketoaċidosi Dijabetika a,
English: Pruritus (generalised)
Maltese: FOLJI (perforati)
English: • cimetidine, a medicine used to treat stomach problems.
Maltese: • cimetidine, mediċina użata biex tikkura problemi tal-istonku.
English: Annex IV
Maltese: Tabella 4:
English: derived from postmarketing experience see section 4.4
Maltese: a derivata mill-esperjenza ta' wara t-tqegħid fis-suq b ara sezzjoni 4.4
English: • a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034,
Maltese: • tnaqqis sinifikanti tar-riskju assolut ta' kwalunkwe kumplikazzjoni relatata mad-dijabete fil-grupp ikkurat b'metformin (29.8 avveniment/1,000 sena ta' pazjenti) versus kura b'dieta biss (43.3 avveniment/1,000 sena ta' pazjenti), p = 0.0023, u kontra l-gruppi kkurati b'monoterapija kombinata ta' sulphonylurea u insulina (40.1 avveniment/1,000 sena ta' pazjenti), p = 0.0034,
English: Table 8 Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with metformin
Maltese: Tabella 8: Riżultati tal-effikaċja f'Ġimgħat 18 u 78 fi studju kkontrollat bi plaċebo ta' empagliflozin bħala terapija addizzjonali mal-insulina bażali u metformin
English: respectively, were total cholesterol 5.0% and 5.2% versus 3.7%; HDL-cholesterol 4.6% and 2.7% versus -0.5%; LDL-cholesterol 9.1% and 8.7% versus 7.8%; triglycerides 5.4% and 10.8% versus
Maltese: LDL-kolesterol 9.1% u 8.7% meta mqabbla ma' 7.8%; trigliċeridi 5.4% u 10.
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Urinary tract infection
Maltese: Monilijasi vaġinali, vulvovaġinite, balanite u infezzjoni ġenitali oħra
English: Table 2 Adverse reactions reported in placebo-controlled studies System organ class
Maltese: Tabella 2: Reazzjonijiet avversi rapportati fi studji kkontrollati bi plaċebo.
English: Table 3: Efficacy results of 24 week placebo-controlled studies Add-on to metformin therapy
Maltese: Tabella 3: Riżultati ta' effikaċja fi studji ta' 24 ġimgħa kkontrollati bi plaċeboa Terapija aġġuntiva ma' metformin Plaċebo
English: Cationic medicinal products
Maltese: Prodotti mediċinali katjoniċi
English: Comparison vs. met (95% CI)
Maltese: Proporzjon ta' periklu vs. plaċebo (95% CI) valur−p
English: Synjardy is contraindicated in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3.
Maltese: Metformin huwa kontraindikat f'pazjenti b'GFR <30 mL/min u għandu jitwaqqaf temporanjament filpreżenza ta' kundizzjonijiet li jibdlu l-funzjoni renali, ara sezzjoni 4.3).
English: Complicated urinary tract infections (including serious urinary infections, pyelonephritis or urosepsis) occurred at a similar frequency in patients treated with empagliflozin compared to placebo.
Maltese: Infezzjonijiet kkumplikati tal-passaġġ urinarju (inkluż infezzjonijiet serji tal-passaġġ urinarju, pijelonefrite jew urosepsis) ġiet osservata bi frekwenza simili f'pazjenti kkurati b'empagliflozin meta mqabbel ma' plaċebo.
English: Erythema Urticaria
Maltese: Eritema Urtikarja
English: Major hypoglycaemia (events requiring assistance) The overall frequency of patients with major hypoglycaemic events was low (<1%) and similar for empagliflozin and placebo as add-on to metformin, and for the combination of empagliflozin with metformin in drug-naïve patients compared to those treated with empagliflozin and metformin as individual components, and as adjunct to standard care therapy.
Maltese: Il-frekwenza globali ta' pazjenti b'avvenimenti ipogliċemiċi maġġuri kienet baxxa (< 1%) u simili għal empagliflozin u plaċebo bħala terapija aġġuntiva ma' metformin, u għall-kombinazzjoni ta' empagliflozin ma' metformin f'pazjenti li qatt ma ngħataw kura qabel mqabbla ma' dawk ikkurati b'empagliflozin u metformin bħala komponenti individwali, u bħala żieda ma' terapija ta' kura standard.
English: Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post marketing in patients treated with SGLT2 inhibitors, including empagliflozin.
Maltese: Każijiet rari ta' ketoaċidosi dijabetika (DKA, diabetic ketoacidosis) inklużi każijiet ta' periklu għall-ħajja, ġew irrapportati minn provi kliniċi u wara t-tqegħid fis-suq f'pazjenti kkurati b'inibituri ta' SGLT2, inkluż empagliflozin.
English: Glycaemic efficacy and cardivascular outcomes have been assessed in a total of 10,366 patients with type 2 diabetes who were treated in 9 double-blind, placebo or active-controlled clinical studies of at least 24 weeks duration, of which 2950 patients received empagliflozin 10 mg and 3701 received empagliflozin 25 mg as add-on to metformin therapy.
Maltese: L-effikaċja gliċemika u r-riżultati kardjovskulari ġew ivvalutati b'kollox f'10,366 pazjent b'dijabete ta' tip 2 li kienu kkurati f' 9 studji kliniċi double blind, ikkontrollati bi plaċebo jew b'mod attiv li damu tal-anqas 24 ġimgħa, li minnhom 2,950 pazjent ingħataw empagliflozin 10 mg u 3,701 pazjent ngħataw empagliflozin 25 mg bħala terapija aġġuntiva ma' metformin.
English: Body Mass Index
Maltese: Sistema tal-klassifika tal-organi
English: Metformin The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Maltese: Metformin Studju randomised prospettiv (UKPDS) stabbilixxa l-benefiċċju fit-tul ta' kontroll intensiv tal-glukosju fid-demm fid-dijabete ta' tip 2.
English: Time to first event of CV death, non-fatal MI, or non-fatal stroke) N (%) Hazard ratio vs. placebo (95.02% CI) p−value for superiority CV Death N (%) Hazard ratio vs. placebo (95% CI) p-value Non-fatal MI N (%) Hazard ratio vs. placebo (95% CI) p−value Non-fatal stroke N (%) Hazard ratio vs. placebo (95% CI) p−value All-cause mortality N (%) Hazard ratio vs. placebo (95% CI) p-value Non-CV mortality N (%) Hazard ratio vs. placebo (95% CI) CV = cardiovascular, MI = myocardial infarction Treated set (TS), i.e. patients who had received at least one dose of study drug Pooled doses of empagliflozin 10 mg and 25 mg Since data from the trial were included in an interim analysis, a two-sided 95.02% confidence interval applied which corresponds to a p-value of less than 0.0498 for significance.
Maltese: CV = kardjovaskulari, MI = infart mijokardijaku Sett trattat (TS), jiġifieri pazjenti li rċievew għallinqas doża waħda tal-mediċina tal-istudju Dożi miġburin ta' empagliflozin 10 mg u 25 mg Minħabba li d-data mill-prova ġiet inkluża f'analiżi interim, applika intervall ta' fiduċja ta' 95.
English: • redness of the skin (erythema) or an itchy rash (hives)
Maltese: • diffikultà biex tieħu n-nifs
English: Lactic acidosis Vitamin B12 deficiency
Maltese: Defiċjenza ta' vitamina
English: • a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021),
Maltese: 6 avveniment/1,000 sena ta' pazjenti, (p = 0.011), u kontra dawk b' monoterapija kombinata ta' sulphonylurea u insulina 18.9 avveniment/1,000 sena ta' pazjenti (p = 0.021),
English: Synjardy 5 mg/850 mg film-coated tablets are yellowish white, oval, biconvex.
Maltese: Synjardy 5 mg/850 mg pilloli miksijin b'ritahuma ovali, ta' lewn abjad fl-isfar, mżaqqa fuq żewġ naħat.
English: HbA1c (%) Baseline (mean) Change from baseline Comparison vs. empa (95% CI)
Maltese: Mortalita b'kull kawża N (%) Proporzjon ta' periklu vs. plaċebo (95% CI) valur−p
English: Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see section 2, ‘Warnings and precautions'): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Maltese: Dawn huma s-sinjali ta' ketoaċidosi dijabetika (ara sezzjoni 2, ‘Twissijiet u prekawzjonijiet'): - żieda fil-livelli ta' “korpi ketaċoniċi” fl-awrina jew fid-demm tiegħek - telf malajr fil-piż - tħossok ma tiflaħx jew tkun ma tiflaħx - uġigħ fl-istonku - ikollok ħafna għatx - in-nifs ikun mgħaġġel u fil-fond - konfużjoni - ngħas jew għeja mhux tas-soltu - in-nifs jinxtamm ħelu, togħma ħelwa jew metallika f'ħalqek jew riħa differenti tal-awrina jew l għaraq.
English: The PRAC also considered that additional information on amputation events should be collected through appropriate case report forms (CRFs) for clinical trials, follow-up questionnaires for postmarketing cases, use of common MedDRA preferred term (PT) lists for amputation preceding events, and appropriate meta-analyses of large studies including cardiovascular outcome studies.
Maltese: • Il-PRAC ikkunsidra wkoll li għandha tinġabar informazzjoni addizzjonali dwar avvenimenti ta' amputazzjoni permezz ta' formoli ta' rapporti ta' każijiet (CRFs, case report forms) xierqa għal provi kliniċi, kwestjonarji ta' segwitu għal każijiet ta' wara t-tqegħid fis-suq, l-użu ta' listi komuni ta' termini ppreferuti (PT, preferred term) ta' MedDRA għal avvenimenti ta' qabel amputazzjoni, u metaanaliżi ta' studji kbar inkluż studji ta' eżitu kardjovaskulari.
English: Of these, a total of 794 patients received empagliflozin as add-on to metformin plus insulin, of which 266 patients were treated with empagliflozin 10 mg and 264 with empagliflozin 25 mg.
Maltese: Minn dawn, 266 jew 264 pazjent kienu kkurati b'empagliflozin 10 mg jew 25 mg bħala terapija aġġuntiva ma' metoformin flimkien mal-insulina, rispettivament.
English: (PT at Risk)
Maltese: (PT f'Riskju)
English: AND ≥ 75,000
Maltese: U ≥ 75,000
English: Over 99% of patients had an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Maltese: Iktar minn 99% tal-pazjenti kellhom stat ta' prestazzjoni ECOG (Eastern Cooperative Oncology Group) ta' 0 jew 1.
English: Abbreviations: ANC=Absolute Neutrophil Count; WBC=white blood cell
Maltese: ANC = Għadd Assolut tan-Newtrofili (ANC=Absolute Neutrophil Count); WBC=għadd ta' ċelluli bojod (WBC=white blood cell)
English: OR < 100,000
Maltese: JEW < 100,000
English: 26.5 [18.98, 34.05] (n = 132) 13.2 [7.54, 18.93] (n = 136) 0.006a
Maltese: 26.5 [18.98, 34.05] (n = 132) 13.2 [7.54, 18.93] (n = 136) 0.006
English: • Depression, sleep problems
Maltese: • Dipressjoni, problemi ta' rqad
English: Dose of carboplatin (AUC mg•min/mL)1
Maltese: Doża ta' carboplatin (AUC mg•min/mL)
English: Date of first authorisation: 11 January 2008 Date of latest renewal: 14 January 2013
Maltese: Data tal-aħħar tiġdid: 14 ta' Jannar 2013
English: Alopecia was observed in >80% of the patients treated with Abraxane.
Maltese: Alopeċja kienet osservata f'> 80% ta` pazjenti kkurati b'Abraxane.
English: Figure 1: Kaplan-Meier curve of overall survival (intent-to-treat population)
Maltese: Stampa 1: Kurva ta' Kaplan-Meier ta' sopravivenza globali (popolazzjoni b'intenzjoni li tiġi kkurata)
English: Lactation (see section 4.6).
Maltese: Treddigħ (ara sezzjoni 4.6).
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1000 sa <1/100), rari (≥1/10,000 sa <1/1000), rari ħafna (<1/10,000).
English: OR < 50,000
Maltese: JEW < 50,000
English: Response rate [95% CI] (%)
Maltese: Rata ta' rispons [95% CI] (%)
English: • A disorder of the electrical conduction system of the heart (atrioventricular block)
Maltese: • Disturb tas-sistema ta' konduzzjoni elettrika tal-qalb (imblokk atrijoventrikulari)
English: The median relative dose intensity of Abraxane was 81%.
Maltese: Il-medjan tal-intensità taddoża relattiva ta' Abraxane kienet ta' 81%.
English: For patients with normal baseline CA 19-9 levels the survival HR was 1.07 (95% CI 0.692, 1.661).
Maltese: Għal pazjenti b'linja bażi normali tal-livelli ta' CA 19-9, is-sopravivenza HR kienet ta' 1.07 (95% CI 0.692, 1.661).
English: Abraxane (100 mg/m2/week) + carboplatin (N=521)
Maltese: Abraxane (100 mg/m2/ġimgħa) + carboplatin (N=521)
English: The reconstituted suspension has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg.
Maltese: Is-suspensjoni rikostitwita għandha pH ta' 6-7.5 u osmolalità ta' 300-360 mOsm/kg.
English: P-value (chi-square test)
Maltese: Chi-squared test b
English: At the clinical dose range of 80 to 300 mg/m2, the mean plasma clearance of paclitaxel ranges from 13 to 30 L/h/m2, and the mean terminal half-life ranges from 13 to 27 hours.
Maltese: Fil-medda klinika tad-doża ta' 80 sa 300 mg/m2, it-tneħħija medja ta' paclitaxel mill-plażma tvarja minn 13 sa 30 L/h/m2, u l-medja tal-half-life terminali tvarja minn 13 sa 27 siegħa.