FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the administration of radiolabelled epoprostenol to humans, the urinary and faecal recoveries of radioactivity were 82% and 4%, respectively.
Maltese: Wara l-għoti ta' epoprostenol radjutikkettat lill-bnedmin, l-irkupru tar-radjuattività mill-awrina u millippurgar kien ta' 82% u 4%, rispettivament.
English: Many of the actions of epoprostenol are exerted via the stimulation of adenylate cyclase, which leads to increased intracellular levels of cyclic adenosine 3'5' monophosphate (cAMP).
Maltese: Ħafna mill-azzjonijiet ta' epoprostenol isiru permezz tal-istimulu ta' adenylate cyclase, li jwassal għal żieda fil-livelli intraċellulari ta' adenosine 3'5' monophosphate ċikliku (cAMP).
English: A sequential stimulation of adenylate cyclase, followed by activation of phosphodiesterase, has been described in human platelets.
Maltese: Stimulu sekwenzjali ta' adenylate cyclase, segwit mill-attivazzjoni ta' phosphodiesterase, ġie spjegat fil-plejtlits tal-bniedem.
English: It may be diluted with sodium chloride 0.9% w/v solution, provided a ratio of 6 volumes of sodium chloride 0.9% w/v solution to 1 volume of concentrated solution is not exceeded e.g. 50 mL of concentrated solution further diluted with a maximum of 300 mL sodium chloride 0.9% w/v solution.
Maltese: Hija tista' tiġi ddilwita b'soluzzjoni ta' sodium chloride 0.9% w/v, bil-kundizzjoni li ma jinqabiżx il-proporzjon ta' 6 volumi ta' soluzzjoni ta' sodium chloride 0.9% w/v ma' volum 1 ta' soluzzjoni kkonċentrata eż. 50 mL ta' soluzzjoni kkonċentrata tiġi ddilwita aktar b'massimu ta' 300 mL ta' soluzzjoni ta' sodium chloride 0.9% w/v.
English: Each vial contains epoprostenol sodium equivalent to 0.5 mg epoprostenol.
Maltese: Kull kunjett fih epoprostenol sodium ekwivalenti għal 0.5 mg epoprostenol.
English: Abrupt withdrawal of Flolan or sudden large reductions in infusion rates should be avoided due to the risk of potential fatal rebound effect (see section 4.4).
Maltese: Twaqqif ta' Flolan f'daqqa jew tnaqqis kbir f'daqqa waħda fir-rati tal-infużjoni għandu jiġi evitat minħabba r-riskju possibbli ta' effett rebound fatali (ara sezzjoni 4.4).
English: Flolan is indicated for:
Maltese: Flolan huwa indikat għal:
English: • One 1.5 mg powder vial.
Maltese: • Kunjett wieħed ta' 1.5 mg ta' trab.
English: • feeling anxious, feeling nervous
Maltese: • tħossok anzjuż, tħossok nervuż
English: Chronic continuous infusions of epoprostenol in patients with PAH/SSD were studied in a prospective, open, randomised trial of 12 weeks' duration comparing epoprostenol plus conventional therapy (N = 56) to conventional therapy alone (N = 55).
Maltese: Infużjonijiet kroniċi kontinwi ta' epoprostenol f'pazjenti b'PAH/SSD ġew studjati fi prova prospettiva, open, fejn il-pazjenti ntagħżlu b'mod każwali li damet 12-il ġimgħa li qabblet epoprostenol u terapija konvenzjonali (N = 56) ma' terapija konvenzjonali waħedha (N = 55).
English: One ml of reconstituted concentrate solution contains epoprostenol (as epoprostenol sodium) 10 000 nanogram.
Maltese: Millilitru wieħed ta' konċentrat tas-soluzzjoni rikostitwita fih 10,000 nanogramma epoprostenol (bħala epoprostenol sodium).
English: Each vial contains epoprostenol sodium equivalent to 1.5 mg epoprostenol.
Maltese: Kull kunjett fih epoprostenol sodium ekwivalenti għal 1.5 mg epoprostenol.
English: • build up of fluid in the lungs (pulmonary oedema)
Maltese: • akkumulazzjoni ta' ilma fil-pulmun (edima fil-pulmun)
English: Sodium Hydroxide (for pH adjustment)
Maltese: Sodium Hydroxide (għall-aġġustament tal-pH)
English: Sepsis, septicaemia (mostly related to delivery system for Flolan)1 Blood and Lymphatic System Disorders Common
Maltese: Sepsis, settiċemija (l-aktar marbuta mas-sistema ta' kif jingħata Flolan)1
English: Epoprostenol 1.5mg Powder for Solution for Infusion:
Maltese: Epoprostenol 1.5 mg Trab għal Soluzzjoni għall-Infużjoni:
English: Where a pack containing 1.5 mg Flolan is reconstituted with 50 mL solvent the resultant concentration is 30,000 nanograms/mL.
Maltese: Fejn pakkett li fih 1.5 mg ta' Flolan jiġi rrikkostitwir b'50 mL ta' solvent il-konċentrazzjoni li tinkiseb tkun ta' 30,000 nanogramma/mL.
English: A statistically significant increase in CI, and statistically significant decreases in PAPm, RAPm, PVR, and SAPm after 12 weeks of treatment were observed in patients who received epoprostenol chronically compared to those who did not.
Maltese: Żieda sinifikanti b'mod statistiku fil-CI, u tnaqqis sinifikanti b'mod statistiku fil-PAPm, RAPm, PVR, u SAPm wara 12-il ġimgħa ta' kura kienu osservati f'pazjenti li rċivew epoprostenol b'mod kroniku meta mqabbla ma' dawk li ma ħaduhx.
English: Except for 2 New York Heart Association (NYHA) functional Class II patients, all patients were either functional Class III or Class IV. As results were similar in the 2 studies, the pooled results are described.
Maltese: Ħlief għal 2 pazjenti li kienu fil-Klassi ta' funzjoni II tal-Assoċjazzjoni talQalb ta' New York (NYHA-New York Heart Association), il-pazjenti kollha kienu jew fil-Klassi ta' funzjoni III jew inkella fil-Klassi ta' funzjoni IV.
English: Other medicines and Flolan
Maltese: Mediċini oħra u Flolan
English: Pallor
Maltese: TIKKETTAR
English: Example For Dosing Using a Concentration of 5,000 nanograms/mL Dosage (nanograms/ kg/ min)
Maltese: Eżempju għal Għoti ta' Doża bl-Użu ta' Konċentrazzjoni ta' 5,000 nanogramma/mL Doża (nanogramm i/kg/min)
English: Calculation of infusion rate:
Maltese: Kalkolu tar-rata tal-infużjoni:
English: • infection of the blood (septicaemia)
Maltese: • infezzjoni fid-demm (settiċemija)
English: Dilution:
Maltese: Dilwizzjoni:
English: Solvent for parenteral use: glycine, sodium chloride, sodium hydroxide (for pH adjustment), water for injection
Maltese: Solvent għal użu parentrali: glycine, sodium chloride, sodium hydroxide (għall-aġġustament tal-pH), ilma għall-injezzjonijiet
English: Hyperthyroidism Psychiatric Disorders Common
Maltese: Ipertirojdiżmu Disturbi psikjatriċi Komuni
English: Reconstitution, dilution and calculation of infusion rate:
Maltese: Rikostituzzjoni, dilwizzjoni u kalkolu tar-rata tal-infużjoni:
English: When used in renal dialysis Flolan may be administered as the concentrated solution (a) or in diluted form (b).
Maltese: Meta jintuża fid-dijalisi tal-kliewi Flolan jista' jingħata bħala soluzzjoni kkonċentrata (a) jew fil-forma ddilwita (b). a.
English: At the end of the treatment period, 4 of 56 (7%) patients receiving epoprostenol died, whereas 5 of 55 (9%) patients receiving conventional therapy alone died.
Maltese: Fl-aħħar tal-perjodu ta' kura, 4 mill-56 (7%) pazjent li kienu qed jirċievu epoprostenol mietu, filwaqt li 5 mill-55 (9%) pazjent li kienu qed jirċievu terapija konvenzjonli waħedha mietu.
English: Unlike many other prostaglandins, epoprostenol is not metabolised during passage through the pulmonary circulation.
Maltese: B'kuntrast ma' prostaglandins oħra, epoprostenol ma jiġix metabolizzat waqt li jkun għaddej miċċirkulazzjoni tal-pulmun.
English: 2 Tachycardia has been reported as a response to Flolan at doses of 5 nanograms/kg/min and below.
Maltese: 2 Takikardija ġiet irrappurtata bħala rispons għal Flolan b'dożi ta' 5 nanogrammi/kg/min u inqas.
English: Decreased platelet count, bleeding at various sites (e.g. pulmonary, gastrointestinal, epistaxis, intracranial, post-procedural, retroperitoneal)
Maltese: Tnaqqis fl-għadd tal-plejtlits, ħruġ ta' demm minn postijiet differenti (eż. mill-pulmuni, gastrointestinali, faġra mill-imnieħer, ġol-kranju, wara xi proċedura, minn wara l-peritonew)
English: Flow rates in mL/h
Maltese: Rati ta' fluss f'mL/siegħa
English: During dialysis: 4 nanograms/kg/min into the arterial inlet of the dialyser
Maltese: Waqt id-dijalisi: 4 nanogrammi/kg/min ġo mnejn l-apparat tad-dijalisi jidħol fl-arterja
English: Preparation of Flolan intravenous injectable solution:
Maltese: Preparazzjoni ta' soluzzjoni ta' Flolan biex tiġi injettata fil-vina:
English: Pack sizes:
Maltese: Mekkaniżmu ta' azzjoni
English: This solution is now referred to as the concentrated solution and contains either 10,000 (for the 0.5 mg strength) or 30,000 nanogram per mL Flolan (for the 1.5 mg strength).
Maltese: Din is-soluzzjoni issa hija magħrufa bħala s-soluzzjoni kkonċentrata u jkun fiha jew 10,000 (għall-qawwa ta' 0.5 mg) jew inkella 30,000 nanogramma f'kull mL ta' Flolan (għall-qawwa ta' 1.5 mg).
English: Statistically significant improvement was observed in exercise capacity (p=0.001), as measured by the 6MWT in patients receiving continuous intravenous epoprostenol plus conventional therapy (N=52) for 8 or 12 weeks compared to those receiving conventional therapy alone (N=54) (combined week 8 and 12 change from baseline - median: 49 vs. -4 meters; mean: 55 vs. -4 meters).
Maltese: Titjib sinifikanti b'mod statistiku ġie osservat fil-ħila tal-eżerċizzju (p=0.001), kif tkejjel permezz tas-6MWT f'pazjenti li kienu qed jirċievu epoprostenol kontinwu mill-vina flimkien ma' terapija konvenzjonali (N=52) għal 8 jew 12-il ġimgħa meta mqabbel ma' dawk li kienu qed jirċievu terapija konvenzjonali waħedha (N=54) (tibdil mill-linja bażi għall-ġimgħat 8 u 12 flimkien- medjan:
English: Reproductive studies in animals have shown no effects on fertility (see section 5.3).
Maltese: Studji dwar riproduzzjoni flannimali ma wrew l-ebda effetti fuq il-fertilità (ara Sezzjoni 5.3).
English: Except for 5 NYHA functional Class II patients, all patients were either functional Class III or Class IV.
Maltese: Ħlief għal 5 pazjenti li kienu fil-Klassi ta' funzjoni II ta' NYHA, il-pazjenti l-oħra kollha kienu jew fil-Klassi ta' funzjoni III jew inkella fil-Klassi ta' funzjoni IV.
English: However, 9 of 27 epoprostenol dialyses were unsuccessful following multiple attempts.
Maltese: Madankollu, 9 minn 27 dijalisi b'epoprostenol ma rnexxewx wara ħafna attentati.
English: Twelve patients at very high risk of haemorrhage received 35 epoprostenol dialyses and 11 patients received 28 heparin dialyses in major controlled studies.
Maltese: Tnax-il pazjent b'riskju kbir ta' emorraġija rċivew 35 dijalisi b'epoprostenol u 11-il pazjent irċivew 28 dijalisi b'heparin fl-istudji kbar ikkontrollati.
English: Flolan is a potent pulmonary and systemic vasodilator.
Maltese: Flolan huwa vażodilatatur tal-pulmun u sistemiku qawwi.
English: Infusion rate (mL/min) = concentration of solution (nanogram/mL)
Maltese: = konċentrazzjoni tas-soluzzjoni (nanogramma/mL)
English: The following schedule of infusion has been found effective in adults: Prior to dialysis: 4 nanograms/kg/min intravenously for 15 mins
Maltese: Qabel id-dijalisi: 4 nanogrammi/kg/min fil-vini għal 15-il minuta
English: • overactive thyroid gland
Maltese: • ħalq xott
English: Patients on digoxin may show elevations of digoxin concentrations after initiation of therapy with Flolan, which although transient, may be clinically significant in patients prone to digoxin toxicity.
Maltese: Pazjenti fuq digoxin jistgħu juru livelli ogħla ta' konċentrazzjonijiet ta' digoxin wara l-bidu ta' terapija bi Flolan, li għalkemm temporanji, jistgħu jkunu ta' sinifikat kliniku f'pazjenti b'tendenza ta' tossiċità minn digoxin.
English: Flolan is indicated for the treatment of pulmonary arterial hypertension (PAH) (idiopathic or heritable PAH and PAH associated with connective tissue diseases) in patients with WHO Functional Class III-IV symptoms to improve exercise capacity (see section 5.1).
Maltese: Flolan huwa indikat għall-kura ta' pressjoni għolja fl-arterji tal-pulmun (PAH - pulmonary arterial hypertension) (PAH idjopatika jew li tintiret u PAH assoċjata ma' mard tat-tessuti konnettivi) f'pazjenti b'sintomi tal-Klassi ta' Funzjoni III-IV tal-WHO biex titjieb il-ħila għall-eżerċizzju (ara sezzjoni 5.1).
English: catheter*, lassitude, chest tightness
Maltese: TAL-PRODOTT, TIKKETTAR U FULJETT TA' TAGĦRIF
English: Infusion rates for a concentration of 5,000 nanograms/mL
Maltese: Rati tal-infużjoni għal konċentrazzjoni ta' 5,000 nanogramma/mL
English: Major clotting (dialysis permanently suspended, or requiring changing of artificial kidney) occurred in approximately 9% (n=56) of all epoprostenol dialyses and in <1% (n=1) of heparin dialyses in major controlled studies and emergency studies.
Maltese: Tagħqid kbir tad-demm (id-dijalisi twaqqfet b'mod permanenti, jew kellha tinbidel il-kilwa artifiċjali) seħħ f'madwar 9% (n=56) tad-dijalisi kollha b'epoprostenol u f'<1% (n=1) tad-dijalisi b'heparin fl-istudji prinċipali kkontrollati u fl-istudji t'emerġenza.
English: Blood glucose increased * Associated with the delivery system for Flolan 1 Catheter-related infections caused by organisms not always considered pathogenic (including micrococcus) have been reported.
Maltese: Mhux magħruf Żieda fil-glucose fid-demm * Assoċjati mas-sistema ta' kif jingħata Flolan 1 Ġew irrappurtati infezzjonijiet marbuta mal-kateter ikkawżati minn organiżmi li mhux dejjem huma meqjusa bħala patoġeniċi (inkluż mikrokokkus).
English: Effects on platelets have been found to disappear within 2 hours of discontinuing the infusion, and haemodynamic changes due to epoprostenol to return to baseline within 10 minutes of termination of 60 minutes infusion at 1 to 16 nanograms/kg/min.
Maltese: L-effetti fuq il-plejtlits instabu li jitilqu fi żmien sagħtejn minn meta titwaqqaf l-infużjoni, u l-bidliet emodinamiċi minħabba epoprostenol instabu li jirritornaw lura għal-linja bażi fi żmien 10 minuti minn meta titwaqqaf infużjoni ta' 60 minuta b'doża ta' bejn 1 u 16-il nanogramma/kg/min.
English: When all dialyses were combined, slightly more epoprostenol patients appeared to bleed during the predialysis (N=12/25 vs. 8/32), dialysis (23/44 vs. 14/51) and postdialysis (8/34 vs. 5/44) days compared to heparin patients during the same periods.
Maltese: Meta d-dijalisi kollha ġew ikkombinati, xi ftit aktar pazjenti li kienu qed jieħdu epoprostenol dehru li kellhom ħruġ ta' demm fil-jiem ta' qabel id-dijalisi (N=12/25 vs. 8/32), tad-dijalisi (23/44 vs. 14/51) u ta' wara d-dijalisi (8/34 vs. 5/44) meta mqabbla ma' pazjenti li kienu qed jieħdu heparin fl-istess perjodi ta' żmien.
English: Pulmonary Arterial Hypertension
Maltese: Artralġja
English: In major controlled studies, when all dialyses were combined for each treatment (heparin or epoprostenol), more heparin patients bled during the day prior to dialysis (N=13/17 vs. 8/23), dialysis day (N=25/28 vs. 16/35) and the day following dialysis (N=16/24 vs. 5/24) than epoprostenol patients during the same time periods.
Maltese: Fi studji prinċipali kkontrollati, meta d-dijalisi kollha kienu kkombinati għal kull waħda mill-kuri (heparin jew epoprostenol), kien hemm aktar pazjenti fuq heparin li kellhom ħruġ ta' demm fil-jum ta'qabel id-dijalisi (N=13/17 vs. 8/23), fil-jum tad-dijalisi (N=25/28 vs. 16/35) u fil-jum ta' wara d-dijalisi (N=16/24 vs. 5/24) milli pazjenti fuq epoprostenol waqt l-istess perijodi ta' żmien.
English: • tenderness
Maltese: • sensittività
English: • stinging
Maltese: • tingiż
English: Powder for solution for infusion: Store vials below 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25oC.
English: The effects of epoprostenol on mean pulmonary artery pressure (PAPm) in patients with PPH were variable and minor.
Maltese: L-effetti ta' epoprostenol fuq il-pressjoni medja tal-arterja tal-pulmun (PAPm- mean pulmonary artery pressure) f'pazjenti b'PPH kienu varjabbli u ħfief.
English: • jaw pain
Maltese: Dawn jinkludu:
English: Eight of 40 (20%) patients receiving conventional therapy alone died, whereas none of the 41 patients receiving epoprostenol died (p=0.003).
Maltese: Tmienja mill-40 (20%) pazjent li kienu qed jirċievu terapija konvenzjonali waħedha mietu, filwaqt li ma miet l-ebda pazjent mill-41 li kienu qed jirċievu epoprostenol (p=0.003).
English: 15,000 nanograms/mL - 1.5 mg Flolan reconstituted and diluted to a total volume of 100mL in solvent.
Maltese: • 15,000 nanogramma/mL - 1.5 mg ta' Flolan irrikostitwit u ddilwit fis-solvent għall-volum totali ta' 100mL.
English: Chronic continuous infusions of epoprostenol in patients with idiopathic or heritable PAH were studied in 2 prospective, open, randomised trials of 8 and 12 weeks' duration (N=25 and N=81, respectively) comparing epoprostenol plus conventional therapy to conventional therapy alone.
Maltese: Infużjonijiet kroniċi kontinwi ta' epoprostenol f'pazjenti b'PAH idjopatika jew li tintiret ġew studjati f'żewġ provi, prospettivi, open, bil-pazjenti magħżula b'mod każwali li damu sejrin 8 ġimgħat u 12-il ġimgħa (N=25 u N=81, rispettivament) li qabblu epoprostenol u terapija konvenzjonali ma' terapija konvenzjonali waħedha.
English: Store Flolan in a dry place.
Maltese: Aħżen Flolan f'post xott.
English: Flolan is given by slow infusion (drip) into a vein.
Maltese: Flolan jingħata permezz ta' infużjoni bil-mod (dripp) fil-vina.
English: Flolan Injection comes in different strengths.
Maltese: L-injezzjoni ta' Flolan tiġi f'qawwiet differenti.
English: • One 0.5 mg powder vial.
Maltese: • Kunjett wieħed ta' 0.5 mg ta'trab.
English: Epoprostenol is only indicated for continuous infusion by intravenous route.
Maltese: Epoprostenol huwa indikat biss għal infużjoni kontinwa permezz tar-rotta fil-vina.
English: As reported with other prostaglandin analogues, Flolan may reduce the thrombolytic efficacy of tissue plasminogen activator (t-PA) by increasing hepatic clearance of t-PA.
Maltese: Bħal ma ġie rrappurtat għal analogi oħrajn ta' prostaglandin, Flolan jista' jnaqqas l-effikaċja trombolitika talattivatur tal-plasminogen fit-tessuti (t-PA - tissue plasminogen activator) billi jżid it-tneħħija ta' t-PA millfwied.
English: • One vial containing sterile, freeze-dried Flolan equivalent to 0.5 mg Flolan supplied alone.
Maltese: • Kunjett wieħed li fih Flolan sterili, imnixxef permezz tal-iffriżar ekwivalenti għal 0.5 mg ta' Flolan,
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Epoprostenol 0.5mg Powder for Solution for Infusion:
Maltese: U KWANTITATTIVA Epoprostenol 0.5 mg Trab għal Soluzzjoni għall-Infużjoni:
English: Bodyweight (kg)
Maltese: Piż tal-ġisem(kg)
English: In use shelf life reconsititued/solvent solution for infusion:
Maltese: Trab u Solvent għal soluzzjoni għall-infużjoni:
English: • with congestive heart failure arising from severe left ventricular dysfunction.
Maltese: • b'insuffiċjenza konġestiva tal-qalb ġejja minn funzjoni ħażina ħafna tal-ventrikulu tax-xellug.
English: Flow rates in mL/h Infusion rates for a concentration of 15,000 nanograms/mL Example For Dosing Using a Concentration of 15,000 nanograms/mL
Maltese: Rati tal-infużjoni għal konċentrazzjoni ta' 15,000 nanogramma/mL
English: Six heparin-controlled studies and five emergency studies explored the place of epoprostenol in the general management of renal dialysis, using different techniques.
Maltese: Sitt studji kkontrollati b'heparin u ħames studji ta' emerġenza esploraw post epoprostenol fl-immanniġġar ġenerali tad-dijalisi tal-kliewi, bl-użu ta' tekniċi differenti.
English: Dosage adjustments:
Maltese: Kategorija farmakoterapewtika:
English: You will start with an infusion of Flolan.
Maltese: Inti se tibda b'infużjoni ta' Flolan.
English: Store between 2 and 8oC for the full administration period.
Maltese: Aħżen f'temperatura bejn 2 u 8oC għall-perjodu kollu tal-għoti.
English: The pack suitable for use in renal dialysis contains 0.5 mg freeze-dried Flolan plus 50 mL solvent.
Maltese: Il-pakkett adattat biex jintuża fid-dijalisi tal-kliewi fih 0.5 mg ta' Flolan imnixxef permezz tal-iffriżar flimkien ma' 50 mL ta' solvent.
English: Temporary peripheral i.v.
Maltese: Informazzjoni għall-utent
English: • One vial containing sterile, freeze-dried Flolan equivalent to 1.5 mg Flolan, supplied with one or two 50 mL vials of solvent and a filter unit.
Maltese: • Kunjett wieħed li fih Flolan sterili, imnixxef permezz tal-iffriżar ekwivalenti għal 1.5 mg ta' Flolan, fornut b'kunjett wieħed jew żewġ kunjetti ta' 50 mL ta' solvent u komponent biex jiffiltra.
English: How to store Flolan
Maltese: Tihux Flolan
English: Most epoprostenol dialyses (67%) that required replacement of artificial kidney were completed subsequently with epoprostenol without clotting.
Maltese: Il-biċċa l-kbira tad-dijalisi b'epoprostenol (67%) fejn kien jeħtieġ li tinbidel il-kilwa artifiċjali sussegwentement intemmu b'epoprostenol mingħajr taqgħid tad-demm.
English: Arthralgia
Maltese: Sfurija
English: Flolan is infused continuously through a permanent indwelling central venous catheter via a small, portable infusion pump.
Maltese: Flolan jingħata bħala infużjoni kontinwa minn katater imqiegħed b'mod permanenti ġo vina ċentrali permezz ta' pompa tal-infużjoni żgħira li tista' tinġarr.
English: Sodium Hydroxide (for pH adjustment) Water for Injection
Maltese: Sodium Chloride Sodium Hydroxide (għall-aġġustament tal-pH)
English: N=4/25).
Maltese: 49 vs. -4 metri; medja: 55 vs. -4 metri).
English: Mix well.
Maltese: Żomm xott.
English: Nervous System Disorders Very common Headache Cardiac Disorders Common
Maltese: Disturbi fis-sistema endokrinarja Rari ħafna
English: During chronic Flolan therapy the final concentration of solution may be increased by the addition of a further 0.5 mg or 1.5 mg vial of freezedried Flolan.
Maltese: Waqt terapija kronika bi Flolan ilkonċentrazzjoni finali tas-soluzzjoni tista' tiżdied biż-żieda ta' kunjett ieħor ta' 0.5 mg jew 1.5 mg ta' Flolan imnixxef permezz tal-iffriżar.
English: When 0.5 mg Flolan powder is reconstituted with 50 mL of the solvent, the final injection has a pH of approximately 10.5 and a sodium ion content of approximately 56 mg.
Maltese: Meta 0.5 mg ta' trab ta' Flolan għal infużjoni fil-vina jiġi rrikostitwit b'50 mL ta' solvent, l-injezzjoni finali jkollha pH ta' madwar 10.5 u kontenut ta' joni ta' sodium ta' madwar 56 mg.
English: Bleeding severity worsened during only 1 dialysis day with epoprostenol (N=1/16) whereas severity worsened during 5 dialysis days (N=5/25) and 2 predialysis days (N=2/13) with heparin.
Maltese: Il-qawwa tal-ħruġ tad-demm mar għall-agħar waqt jum 1 biss ta' dijalisi b'epoprostenol (N=1/16) filwaqt li b'heparin il-qawwa marret għall-agħar għal 5 ijem ta' dijalisi (N=5/25) u għal jumejn qabel id-dijalisi (N=2/13).
English: Dosage decreases should be made gradually in 2 nanograms/kg/min decrements every 15 min or longer until the dose-limiting effects resolve.
Maltese: Tnaqqis fiddoża għandu jsir bil-mod bi tnaqqis ta' 2 nanogrammi/kg/min kull 15-il minuta jew aktar sakemm imorru leffetti li jillimitaw id-doża.
English: Powder for solution for infusion: Clear (type 1) glass vials with synthetic butyl rubber stoppers and an aluminium collar with a snap-off top.
Maltese: Kunjetti tal-ħġieġ trasparenti (tat-tip 1) b'tappijiet tal-gomma butyl sintetika u kullar tal-aluminju bil-parti ta' fuq titqaċċat.
English: Flolan 0.5 mg Powder and Solvent for Solution for Infusion Flolan 1.5 mg Powder and Solvent for Solution for Infusion
Maltese: Flolan 0.5 mg Trab u Solvent għal Soluzzjoni għall-Infużjoni Flolan 1.5 mg Trab u Solvent għal Soluzzjoi għall-Infużjoni
English: • 15,000 nanogram/mL - One vial containing 1.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
Maltese: • 15,000 nanogramma/mL - Kunjett wieħed li fih 1.5 mg ta' Flolan irrikostitwit u ddilwit fis-solvent għall-volum totali ta' 100mL.
English: Over 12 weeks, a statistical difference (p<0.001) in the change from baseline for the 6MWT was observed in the group receiving epoprostenol and conventional therapy as compared to the group receiving conventional therapy alone (median: 63.5 vs. -36.0 meters; mean: 42.9 vs. -40.7 meters).
Maltese: Fuq perjodu ta' 12-il xahar, differenza statistika (p<0.001) fil-bidla mil-linja bażi għas-6MWT kienet osservata fil-grupp li kien qed jirċievi epoprostenol u terapija konvenzjonali meta mqabbel mal-grupp li kien qed jirċievi terapija konvenzjonali waħedha (medjan: 63.5 vs.
English: • 5,000 nanogram/mL - One vial containing 0.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
Maltese: • 5,000 nanogramma/mL - Kunjett wieħed li fih 0.5 mg ta' Flolan irrikostitwit u ddilwit fis-solvent għall-volum totali ta' 100 mL.