FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy and safety of the recommended dose of trametinib (2 mg once daily) in combination with dabrafenib (150 mg twice daily) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation was studied in two Phase III trials and one supportive Phase I/II study.
Maltese: L-effikaċja u s-sigurtà tad-doża rrakkomandata ta' trametinib (2 mg darba kuljum) flimkien ma' dabrafenib (150 mg darbtejn kuljum) għall-kura ta' pazjenti adulti b'melanoma metastatika jew li ma tistax titneħħa b'mutazzjoni BRAF V600 ġew studjati f'żewġ provi tal-Fażi III u fi studju ta' sostenn wieħed tal-Fażi I/II.
English: Dabrafenib is an inhibitor of RAF kinases.
Maltese: Dabrafenib huwa inibitur ta' kinases RAF.
English: The primary endpoint of the study was intracranial response in Cohort A, defined as the percentage of patients with a confirmed intracranial response assessed by the investigator using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Maltese: L-endpoint primarju tal-istudju kien ir-rispons intrakranjali f'Koħort A, iddefinit bil-persentaġġ ta' pazjenti b'rispons intrakranjali kkonfermat evalwat mill-investigatur billi ntużat verżjoni 1.1. talKriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi (RECIST).
English: • Cohort C: patients with BRAFV600D/K/R mutant melanoma with asymptomatic brain metastases, with or without prior local brain-directed therapy and ECOG performance status of 0 or 1.
Maltese: • Koħort Ċ: pazjenti b'melanoma għall-mutazzjoni BRAFV600D/K/R b'metatesi fil-moħħ asintomatika, li ngħataw minn qabel jew le terapija lokalizzata diretta fil-moħħ u bil-qagħda talpunteġġ ta' prestazzjoni ECOG 0 jew 1.
English: Patients should be evaluated for signs and symptoms of infection (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu evalwati għal sinjali u sintomi ta' infezzjoni (ara sezzjoni 4.4).
English: Cutaneous malignancies
Maltese: TAL-PRODOTT MEDIĊINALI
English: Dabrafenib is an inducer of metabolising enzymes which may lead to loss of efficacy of many commonly used medicinal products (see examples in section 4.5).
Maltese: Dabrafenib huwa induttur ta' enzimi metabolizzanti li jista' jwassal għal tnaqqis fl-effikaċja ta' prodotti mediċinali użati b'mod komuni (ara l-eżempji fis-sezzjoni 4.5).
English: The primary endpoint of the study was overall intracranial response rate (OIRR) in the V600E patient population, as assessed by investigators.
Maltese: Il-punt ta' tmiem primarju tal-istudju kienet ir-rata globali ta' rispons intrakranjali (OIRR) filpopolazzjoni ta' pazjenti V600E, kif ivvalutat mill-investigaturi.
English: Concomitant use of dabrafenib with medicinal products that are sensitive substrates of certain metabolising enzymes or transporters (see section 4.5) should generally be avoided if monitoring for efficacy and dose adjustment is not possible.
Maltese: L-użu konkomitanti ta' dabrafenib ma' prodotti mediċinali li huma substrati sensittivi ta' ċertu enzimi metabolizzanti jew trasportaturi (ara sezzjoni 4.5) għandu ġeneralment jiġi evitati jekk ma jkunx possibbli li jsir monitoraġġ għall-effikaċja u aġġustament tad-doża.
English: Bronchoalveolar inflammation of the lungs was observed in several dogs at ≥20 mg/kg/day (≥9 times human clinical exposure based on AUC) and was associated with shallow and/or laboured breathing.
Maltese: Kienet osservata infjammazzjoni bronkoalveolari tal-pulmuni f'diversi klieb b'doża ta' ≥ 20 mg/kg/jum (≥ 9 darbiet l-esponiment kliniku tal-bniedem abbażi tal-AUC) u kienet assoċjata ma' nifs qasir u mgħaġġel u/jew teħid tan-nifs bit-tbatija.
English: In the integrated safety population for dabrafenib in combination with trametinib, 2% of patients developed cuSCC and the events occurred later than with dabrafenib monotherapy with a median time to onset of 18-31 weeks.
Maltese: Fil-popolazzjoni ta' sigurtà integrata għal dabrafenib flimkien ma' trametinib, 2% tal-pazjenti żviluppaw cuSCC u l-avvenimenti seħħew aktar tard milli bil-monoterapija b'dabrafenib bi żmien medjan għall-bidu ta' 18-31 ġimgħa.
English: Any prior systemic anti-cancer treatment, including radiotherapy, was not allowed.
Maltese: Kwalunkwe trattament sistemiku mogħti minn qabel għal kontra l-kanċer, inkluż radjuterapija, ma kienx permess.
English: The recommended dose of dabrafenib, either used as monotherapy or in combination with trametinib, is 150 mg (two 75 mg capsules) twice daily (corresponding to a total daily dose of 300 mg).
Maltese: Id-doża rakkomandata ta' dabrafenib, użata bħala monoterapija jew inkella flimkien ma' trametinib, hija ta' 150 mg (żewġ kapsuli ta' 75 mg) darbtejn kuljum (li jikkorrispondu għal doża totali ta' kuljum ta' 300 mg).
English: In the adjuvant treatment of melanoma trial, pancreatitis was reported in <1% (1/435) of patients receiving dabrafenib in combination with trametinib, and no patients receiving placebo.
Maltese: Fit-trattament adjuvanti tal-prova talmelanoma, kienet irrappurtata pankreatite f'<1 % (1/435) tal-pazjenti li kienu qed jirċievu dabrafenib flimkien ma' trametinib, u l-ebda pazjent ma rċieva plaċebo.
English: Neutropenia Anaemia
Maltese: Disturbi vaskulari
English: Overall survival estimate, % (95% CI)
Maltese: Stima tassopravivenza globali, % (95% CI)
English: • medicines to treat seizures (epilepsy), such as phenytoin, phenobarbital, primidone, valproic acid or carbamazepine
Maltese: • mediċini għall-kura tal-aċċessjonijiet (epilessija), bħal phenytoin, phenobarbital, primidone,
English: Fatigue
Maltese: Dispnea
English: • Inflammation of the mucosa
Maltese: • Infjammazzjoni tal-mukosa
English: How to take Tafinlar
Maltese: X'fih Tafinlar
English: Dabrafenib exposure (Cmax and AUC) increased in a dose proportional manner between 12 and 300 mg following single-dose administration, but the increase was less than dose-proportional after repeat twice daily dosing.
Maltese: L-espożizzjoni ta' dabrafenib (Cmax u AUC) żdiedet b'mod proporzjonali mad-doża bejn 12 u 300 mg wara l-għoti ta' doża waħda, iżda ż-żieda kienet anqas minn proporzjonali għad-doża wara dożaġġ ta' kuljum ripetut darbtejn.
English: Animal studies have shown that the active substance dabrafenib may permanently reduce male fertility.
Maltese: Studji f'annimali wrew li s-sustanza attiva dabrafenib tista' tnaqqas b'mod permanenti l-fertilità flirġiel.
English: Treatment Number of deaths (%)
Maltese: N (%)
English: Tafinlar 50 mg hard capsules
Maltese: Tafinlar 50 mg kapsuli ibsin
English: Improvements were also observed for overall response rate (ORR) and a longer duration of response (DoR) was observed in the combination arm compared to dabrafenib monotherapy (Table 7).
Maltese: Deher ukoll titjib fir-rata tar-rispons globali (ORR) u kien osservat ukoll rispons (DoR) fuq medda itwal ta' żmien fil-fergħa tal-kombinazzjoni mqabbel mal-monoterapija b'dabrafenib (Tabella 7).
English: Hazard Ratio (95% CI)
Maltese: Rata ta' sena (95% CI)
English: NR = Not reached, NA = Not applicable
Maltese: NR = Ma ntlaħaqx, NA = Mhux applikabbli
English: Pyrexia Fatigue Chills Asthenia
Maltese: Jekk tinsa tieħu Tafinlar
English: Median OS and estimated 1-year, 2-year, 3-year, 4 year and 5-year survival rates are presented in Table 8.
Maltese: L-OS medjana u r-rati ta' sopravivenza stmati għal sena, sentejn, 3 snin, 4 snin u 5 snin huma ppreżentati f'Tabella 8.
English: If uveitis does not respond to local ocular therapy, withhold dabrafenib until resolution of ocular inflammation and then restart dabrafenib reduced by one dose level (see section 4.4).
Maltese: Ma hemm l-ebda dejta klinika fuq individwi b'indeboliment renali sever u ma tistax tiġi determinata lħtieġa potenzjali għal aġġustament tad-doża (ara sezzjoni 5.2).
English: • Increase in some substances (enzymes) produced by the liver
Maltese: • Żieda f'xi sustanzi (enzimi) prodotti mill-fwied
English: Based on the population pharmacokinetic analysis, age had no significant effect on dabrafenib pharmacokinetics.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni, l-età ma kellha l-ebda effett sinifikanti fuq ilfarmakokinetika ta' dabrafenib.
English: Duration of intracranial response, median, months (95% CI)
Maltese: Dewmien tar-rispons intrakranjali, medjan, xhur (95% CI)
English: These met the statistical significance to reject the null hypothesis that the ORR of dabrafenib in combination with trametinib for this NSCLC population was less than or equal to 30%.
Maltese: Dawn laħqu punt statistikament sinifikanti biex tiġi rrifjutata l-ipoteżi nulla li l-ORR ta' dabrafenib flimkien ma' trametinib għal din il-popolazzjoni b'NSCLC kien ugwali għal 30% jew anqas.
English: Overall intracranial response rate,% (95% CI)
Maltese: Rata ġenerali ta' rispons intrakranjali, % (95 % CI)
English: • Cohort B: patients with BRAFV600E mutant melanoma with asymptomatic brain metastases with prior local brain-directed therapy and ECOG performance status of 0 or1.
Maltese: • Koħort B: pazjenti b'melanoma għall-mutazzjoni BRAFV600E b'metatesi fil-moħħ asintomatika li ngħataw minn qabel terapija lokalizzata diretta fil-moħħ u bil-qagħda talpunteġġ ta' prestazzjoni ECOG 0 jew 1.
English: For dabrafenib monotherapy in study MEK115306, cutaneous squamous cell carcinomas (including those classified as keratoacanthoma or mixed keratoacanthoma subtype) occurred in 10% of patients and approximately 70% of the events occurred within the first 12 weeks of treatment with a median time to onset of 8 weeks.
Maltese: Għal monoterapija b'dabrafenib fl-istudju MEK115306, karċinomi taċ-ċelluli skwamużi tal-ġilda (inkluż dawk ikklassifikati bħala keratoakantoma jew sottotip imħallat ta' keratoakantoma) seħħew f'10 % tal-pazjenti u madwar 70% tal-avvenimenti seħħew fl-ewwel 12-il ġimgħa tal-kura bi żmien medjan għall-bidu ta' 8 ġimgħat.
English: Survival estimates at 1 and 2 years from randomisation were 97% and 91% in the combination arm and 94% and 83% in the placebo arm, respectively).
Maltese: Is-sopravivenza stmata f'sena u f'sentejn mir-randomizzazzjoni kienet 97% u 91% fil-grupp mogħti t-taħlita u 94% u 83% fil-grupp mogħti lplaċebo, rispettivament.
English: The majority of subjects had BRAF V600E mutation-positive melanoma (89%).
Maltese: Il-maġġoranza tal-individwi kellhom melanoma pożittiva għal mutazzjoni BRAF V600E (89 %).
English: Renal failure, acute renal failure Nephritis
Maltese: Insuffiċjenza renali, insuffiċjenza renali akuta
English: • If you are a woman who could become pregnant you must use a reliable birth control method while you are taking Tafinlar and for at least 2 weeks after you stop taking it and for at least 16 weeks following the last dose of trametinib when given in combination with Tafinlar.
Maltese: • Jekk inti mara li tista' tinqabad tqila, inti għandek tuża metodu affidabbli ta' kontroll tat-twelid waqt li tkun qiegħda tieħu Tafinlar u għal mill-inqas ġimagħtejn wara li tieqaf tieħdu u għal mill-inqas 16-il ġimgħa wara l-aħħar doża ta' trametinib meta dan jingħata flimkien ma' Tafinlar.
English: Severe cutaneous adverse reactions
Maltese: Reazzjonijiet avversi gravi fil-ġilda
English: Progression-free survival, median, months (95% CI)
Maltese: Sopravivenza mingħajr progressjoni, medjan, xhur (95% CI)
English: New primary melanomas have been reported in clinical trials with dabrafenib as monotherapy and in combination with trametinib in melanoma studies.
Maltese: Melanomi primarji ġodda kienu rrapportata fi provi kliniċi b'dabrafenib bħala monoterapija u flimkien ma' trametinib fl-istudji dwar il-melanoma.
English: Pancreatitis has been reported in <1% of patients treated with dabrafenib as monotherapy and in combination with trametinib in unresectable or metastatic melanoma clinical trials and about 4% of patients treated with dabrafenib in combination with trametinib in the NSCLC clinical trial.
Maltese: Pankreatite kienet irrapportata f'< 1 % tal-pazjenti kkurati b'dabrafenib bħala monoterapija u flimkien ma' trametinib fi provi kliniċi ta' melanoma li ma tistax titneħħa b'intervent kirurġiku jew metastatika u madwar 4% tal-pazjenti kkurati b'dabrafenib flimkien ma' trametinib fil-prova klinika ta' NSCLC.
English: Dry skin Pruritus Rash Erythema h
Maltese: Ma sarux studji dwar il-fertilità tar-raġel b'dabrafenib.
English: Two of these patients had a QTcB Grade 3 increase (>500 msec) that was also an increase >60 msec from baseline.
Maltese: Tnejn minn dawn il-pazjenti kellhom żieda tal-QTcB fil-Grad 3 (> 500 msek) li kienet ukoll żieda ta' > 60 msek mil-linja bażi.
English: nd line plus
Maltese: F'sena 3
English: Each hard capsule contains dabrafenib mesilate equivalent to 50 mg or 75 mg of dabrafenib.
Maltese: Kull pillola iebsa fiha dabrafenib mesilate ekwivalenti għal 50 mg jew 75 mg ta' dabrafenib.
English: Due to small sample size reflected by wide 95% CIs, the results in Cohorts B, C, and D should be interpreted with caution.
Maltese: Minħabba d-daqs żgħir talkampjun rifless b'95% CIs wiesa', ir-riżultati f'Koħorti B, Ċ, u D għandhom jiġu interpretati b'kawtela.
English: % (95% CI) ORR difference (95% CI)
Maltese: Differenza tal-ORR (95 % CI)
English: Rare side effects (may affect up to 1 in 1000 people) • A hole (perforation) in the stomach or intestines
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 minn kull 1000)
English: CI = Confidence Interval NR = Not reached
Maltese: CI = Intrevall ta' Fiduċja NR = Ma ntlaħaqx
English: The European Medicines Agency has deferred the obligation to submit the results of studies with dabrafenib in one or more subsets of the paediatric population in melanoma and solid malignant tumours (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'dabrafenib f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-melanoma u tumuri malinni solidi (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Animal studies have shown reproductive toxicity and embryo-foetal developmental toxicities, including teratogenic effects (see section 5.3).
Maltese: Studji fuq l-annimali wrew tossiċità riproduttiva u tossiċitajiet fl-iżvilupp embrijofetali, inkluż effetti teratoġeniċi (ara sezzjoni 5.3). Dabrafenib ma għandux jingħata lil nisa tqal sakemm il-benefiċċju potenzjali lill-omm ma jegħlibx irriskju possibbli lill-fetu.
English: • Take Tafinlar twice daily and take trametinib once daily.
Maltese: • Ħu Tafinlar darbtejn kuljum u ħu trametinib darba kuljum.
English: Median OS Months (95% CI)
Maltese: Rata ta' sentejn (95% CI)
English: Please see trametinib SmPC (see section 4.6) when used in combination with trametinib.
Maltese: Jekk jogħġbok irreferi għall-SmPC (ara sezzjoni 4.4) ta' trametinib għal tagħrif addizzjonali.
English: The transport protein Pgp may also be induced as well as other transporters, e.g. MRP-2.
Maltese: Il-proteina ta' trasport Pgp tista' tiġi indotta wkoll kif ukoll trasportaturi oħra, eż MRP-2.
English: • feeling lightheaded
Maltese: • Tnaqqis fl-aptit
English: Cutaneous squamous cell carcinoma
Maltese: Karċinoma taċ-ċelluli skwamużi tal-ġilda
English: Dabrafenib has not been studied in patients with renal insufficiency (defined as creatinine >1.5 x ULN) therefore caution should be used in this setting (see section 5.2).
Maltese: Dabrafenib ma ġiex studjat f'pazjenti b'insuffiċjenza tal-kliewi (definita bħala kreatinina > 1.5 x ULN), għalhekk, għandha tintuża kawtela f'dan il-kuntest (ara sezzjoni 5.2).
English: • Cohort A: Monotherapy (dabrafenib 150 mg twice daily), 84 patients enrolled.
Maltese: • Grupp A: Monoterapija (dabrafenib 150 mg darbtejn kuljum), 84 pazjent irreġistrati. 78 pazjent kienet ingħatgħatilhom kura sistemika preċedenti għall-mard metastatiku tagħhom.
English: The incidence and severity of pyrexia are increased with combination therapy.
Maltese: L-inċidenza u s-severità tad-deni jiżdiedu bit-terapija ta' kombinazzjoni.
English: Median (months) (95% CI)
Maltese: Medjan (95% CI)
English: Dabrafenib in combination with trametinib has been reported to decrease LVEF (see section 4.8).
Maltese: Mhija disponibbbli l-ebda dejta f'individwi b'indeboliment renali qawwi (ara s-Sezzjoni 4.2).
English: Carboxy-dabrafenib is excreted in bile and urine.
Maltese: Carboxy-dabrafenib jitneħħa mis-sistema biljari u l-awrina.
English: Monitoring should continue for 6 months following discontinuation of dabrafenib or until initiation of another anti-neoplastic therapy.
Maltese: Il-monitoraġġ għandu jkompli għal 6 xhur wara li dabrafenib jitwaqqaf jew sakemm tinbeda terapija anti-neoplastika oħra.
English: Renal failure has been identified in <1% of patients treated with dabrafenib alone and in ≤1% of patients treated with dabrafenib in combination with trametinib.
Maltese: Insuffiċjenza tal-kliewi ġiet identifikata f'< 1 % tal-pazjenti kkurati b'dabrafenib waħdu u f'≤ 1 % talpazjenti kkurati b'dabrafenib flimkien ma' trametinib.
English: P-value is obtained from the two-sided stratified logrank test (stratification factors were disease stage - IIIA vs. IIIB vs. IIIC - and BRAF V600 mutation type - V600E vs. V600K) NE = not estimable
Maltese: L-endpoint primarju tal-istudju kien sopravivenza mingħajr progressjoni (PFS), b'endpoint sekondarju ewlieni ta' sopravivenza globali (OS). L-individwi kienu stratifikati b'livell ta' lactate dehydrogenase (LDH) (> il-limitu massimu tan-normal (ULN) versus  ULN) u mutazzjoni BRAF (V600E versus V600K).
English: Nervous system disorders
Maltese: Disturbi tas-sistema nervuża Komuni ħafna
English: The population pharmacokinetic analysis showed no significant differences in the pharmacokinetics of dabrafenib between Asian and Caucasian patients.
Maltese: L-analiżi tal-farmakokinetika tal-popolazzjoni ma wriet l-ebda differenza sinifikanti fil-farmakokinetika ta' dabrafenib bejn il-pazjenti Asjatiċi u Kawkasi.
English: Muscle pain
Maltese: Uġigħ fil-muskoli
English: These include:
Maltese: Taqsiriet:
English: Median DoR Months (95% CI)
Maltese: DoR Medjan Xhur (95% CI)
English: Nasopharyngitis
Maltese: Iperidrożi
English: Some people taking Tafinlar may also notice that new melanomas have appeared.
Maltese: Xi persuni li jkunu qed jieħdu Tafinlar jistgħu jinnotaw ukoll li tfaċċaw melanomi ġodda.
English: • Heart rate that is lower than the normal range and/or a decrease in heart rate
Maltese: • Rata tat-taħbit tal-qalb iżjed baxxa mill-medja normali u/jew tnaqqis fir-rata tal-qalb
English: Decreased LVEF has been reported in 6% (65/1076) of patients in the integrated safety population of dabrafenib in combination with trametinib.
Maltese: Tnaqqis fl-LVEF/Disfunzjoni ventrikulari tax-xellug Ġie rrapportat tnaqqis fl-LVEF f'6% (65/1076) tal-pazjenti fil-popolazzjoni ta' sigurtà integrata ta' dabrafenib flimkien ma' trametinib .
English: • Cohort A: patients with BRAFV600E mutant melanoma with asymptomatic brain metastases without prior local brain-directed therapy and ECOG performance status of 0 or 1.
Maltese: • Koħort A: pazjenti b'melanoma għall-mutazzjoni BRAFV600E b'metatesi fil-moħħ asintomatika li ma ngħatawx minn qabel terapija lokalizzata diretta fil-moħħ u bil-qagħda talpunteġġ ta' prestazzjoni ECOG 0 jew 1.
English: The efficacy and safety of dabrafenib in combination with trametinib in patients with BRAF mutant-positive melanoma that has metastasised to the brain was studied in a non-randomised, open-label, multicentre, Phase II study (COMBI-MB study).
Maltese: Is-sigurtà u l-effikaċja ta' meta dabrafenib u trametinib jingħataw flimkien lil pazjenti b'melanoma pożittiva għall-mutazzjoni BRAF V600 li kellha metatesi fil-moħħ ġew studjati waqt studju mhux randomizzat, open-label, multiċentriku f'Fażi II (studju COMBI-MB).
English: Constipation Diarrhoea Nausea Vomiting
Maltese: Infezzjoni fl-apparat tal-awrina Ċellulite
English: Previously untreated patients (results from the Phase III study [BREAK-3]) The efficacy and safety of dabrafenib were evaluated in a Phase III randomised, open-label study [BREAK 3] comparing dabrafenib to dacarbazine (DTIC) in previously untreated patients with BRAF V600E mutation positive advanced (unresectable Stage III) or metastatic (Stage IV) melanoma.
Maltese: III [BREAK-3] fejn dabrafenib tqabbel ma' dacarbazine (DTIC) f'pazjenti b'melanoma avvanzata (Stadju III li ma tistax titneħħa) jew metastatika (Stadju IV) pożittiva għall-mutazzjoni BRAF V600E li ma ġewx ikkurati qabel.
English: Date of latest renewal: 21 March 2007
Maltese: Data ta' l-aħħar tiġdid: 21 ta' Marzu 2007
English: Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
Maltese: Fondaparinux ma jinibixxix CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 jew CYP3A4) in vitro.
English: Picture A
Maltese: Figura A
English: Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.
Maltese: Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, Franza.
English: Excretion/Elimination
Maltese: Eskrezzjoni/ Eliminazzjoni
English: Rare: non-protein-nitrogen (Npn) 2 increased
Maltese: Rari: żieda fin-nitroġenu mhux minn proteini (Npn)2
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 March 2002
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 21 ta' Marzu 2002
English: Sodium chloride Water for injections Hydrochloric acid Sodium hydroxide
Maltese: Sodium Chloride Ilma għal injezzjonijiet Hydrochloric acid Sodium hydroxide
English: Picture E
Maltese: Figura E
English: The active substance is:
Maltese: Sustanza(i):
English: Quixidar contains a synthetic substance called fondaparinux sodium.
Maltese: Quixidar fih sustanza sintetika msemmija fondaparinux sodium.
English: Prevention of VTE following Surgery
Maltese: Prevenzjoni ta' VTE wara l-kirurġija
English: Rare: other bleeding (hepatic, retroperitoneal, intracranial/intracerebral), thrombocythaemia
Maltese: Rari: fsada oħra (epatika, retroperitonjali, intrakranja/intraċerebrali), tromboċitemija
English: Undesirable effects in patients treated for VTE1
Maltese: Effetti mhux mixtieqa f'pazjenti fuq trattament għal VTE1
English: Picture C
Maltese: Figura C
English: Incidences in non-primary PCI in UA/NSTEMI were 1.0% vs 0.3% (fondaparinux vs. enoxaparin) and in primary PCI in STEMI were 1.2% vs 0% (fondaparinux vs. control).
Maltese: L-inċidenzi f'PCI mhux primarju f'UA/NSTEMI kienu ta' 1.0% kontra 0.3% (fondaparinux kontra enoxaparin) u f'PCI primarju f'STEMI kienu ta' 1.2% kontra 0% (fondaparinux kontra l-kontroll).
English: The corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.3% (13/559), 4.6% (17/368), 9.7% (14/145) and 11.1% (2/18) respectively, and in patients receiving the recommended regimen of unfractionated heparin in the treatment of PE were 6.9% (36/523), 3.1% (11/352), 11.1% (18/162) and 10.7% (3/28), respectively.
Maltese: Meta maqsumin f'gruppi fl-istess mod, il-każi f'pazjenti li jieħdu d-dożaġġ rakkomandat ta' enoxaparin fit-trattament ta' DVT kienu ta' 2.3% (13/559), 4.6% (17/368), 9.7% (14/145) u 11.1% (2/18), rispettivament, u l-każi f'pazjenti li jieħdu d-dożaġġ rakkomandat ta' eparina mhux frazzjonata fit-trattament ta' PE kienu ta' 6.9% (36/523), 3.1% (11/352), 11.1% (18/162) and 10.
English: In a pooled analysis of these studies, the recommended dose regimen of fondaparinux versus enoxaparin was associated with a significant decrease (54% - 95% CI, 44 %; 63%) in the rate of VTE evaluated up to day 11 after surgery, irrespective of the type of surgery performed.
Maltese: F'ġabra ta' analiżi ta' dawn l-istudji, ir-reġimen tad-doża rakkomandata ta' fondaparinux kontra enoxaparin ġiet assoċjata ma' nuqqas sinifikattiv (54 % - 95 % CI, 44 %; 63 %) fir-rata ta' VTE evalwata sa jum 11 wara l-kirurġija, irrispettivament mit-tip ta' kirurġija li tkun saret.
English: The incidence of symptomatic DVT was similar between treatment groups: 6 patients (0.4%) in the fondaparinux group vs 5 patients (0.3%) in the dalteparin group.
Maltese: L-inċidenza ta' DVT sintomatiku kien simili bejn il-gruppi ta' trattamenti: 6 pazjenti (0.4%) fil-grupp ta' fondaparinux meta mqabbel ma' 5 pazjenti (0.3%) fil-grupp ta' dalteparin.