FrancophonIA/ELRC3.0 huggingface dataset:
English: • infection at the injection site
Slovenian: • okužba na mestu injiciranja.
English: The effects of epoprostenol on platelet aggregation is dose-related when between 2 and 16 nanograms/kg/min is administered intravenously, and significant inhibition of aggregation induced by adenosine diphosphate is observed at doses of 4 nanograms/kg/min and above.
Slovenian: Učinki intravensko uporabljenega epoprostenola na agregacijo trombocitov so v odmerkih od 2 do 16 nanogramov/kg/min odvisni od odmerka; pri odmerkih 4 nanograme/kg/min in več je opazno pomembno zavrtje agregacije, povzročene z adenozindifosfatom.
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.
Slovenian: Bolnikom, ki prejemajo digoksin, se lahko po uvedbi zdravljenja z zdravilom Flolan pojavi zvišanje koncentracije digoksina.
English: Other common intravenous fluids are unsatisfactory for the dilution of the concentrated solution as the required pH is not attained.
Slovenian: Druge pogoste intravenske tekočine za razredčenje koncentrirane raztopine niso primerne, ker ni dosežen potrebni pH. Raztopine zdravila Flolan so pri nizkem pH manj stabilne.
English: • 1.5 mg epoprostenol sodium.
Slovenian: • 1,5 mg natrijevega epoprostenolata.
English: Skin and Subcutaneous Tissue Disorders Common
Slovenian: Bolezni kože in podkožja Pogosti izpuščaj
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).
Slovenian: V razponu 12 tednov so ugotovili statistično značilno razliko (p < 0,001) v spremembi 6-minutnega testa hoje v primerjavi z izhodiščem med skupino, ki je prejemala epoprostenol in konvencionalno zdravljenje, in skupino, ki je prejemala le konvencionalno zdravljenje (mediana: 63,5 v prim.
English: Flolan is injected into a vein.
Slovenian: Zdravilo Flolan se injicira v veno.
English: Infusion rates for a concentration of 5,000 nanograms/mL
Slovenian: Hitrosti infundiranja za koncentracijo 5.000 nanogramov/ml
English: Flolan is a potent inhibitor of platelet aggregation, therefore, an increased risk for haemorrhagic complications should be considered, particularly for patients with other risk factors for bleeding (see section 4.5).
Slovenian: Zato je treba upoštevati večje tveganje za zaplete zaradi krvavitve, zlasti pri bolnikih, ki imajo še druge dejavnike tveganja za krvavitev (glejte poglavje 4.5).
English: infusions may be used until central access is established.
Slovenian: Dokler ni nameščen centralni dostop, je mogoče uporabiti začasno periferno intravensko infuzijo.
English: Nineteen patients received 51 heparin dialyses and 19 received 44 epoprostenol dialyses in major controlled studies.
Slovenian: V velikih kontroliranih študijah je 19 bolnikov opravilo 51 dializ s heparinom, 19 pa 44 dializ z epoprostenolom.
English: 10 mL concentrated solution + 40 mL sodium chloride 0.9% w/v solution.
Slovenian: 10 ml koncentrirane raztopine + 40 ml 0,9 % (m/v) raztopine natrijevega klorida Dobljena koncentracija = 2.000 nanogramov zdravila Flolan/ml:
English: Store Flolan in a dry place.
Slovenian: Zdravilo Flolan shranjujte na suhem mestu.
English: EXP Read the package leaflet for the shelf-life of the reconstituted/diluted product
Slovenian: EXP Glede roka uporabnosti pripravljenega/razredčenega zdravila preberite navodilo za uporabo
English: Epoprostenol 1.5mg Powder for Solution for Infusion:
Slovenian: Epoprostenol 1,5 mg prašek za raztopino za infundiranje:
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.
Slovenian: Če 0,5 mg zdravila Flolan pripravite s 50 ml vehikla, ima končna raztopina za injiciranje pH približno 10,5 in vsebuje približno 56 mg natrijevih ionov.
English: Initially, a pack containing solvent must be used.
Slovenian: Uvodoma je treba uporabiti pakiranje, ki vsebuje vehikel.
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).
Slovenian: Zaradi možnosti smrtnega preobratnega učinka ("rebound") se zdravila Flolan ne sme nenadoma prenehati uporabljati; prav tako se ne sme nenadoma močno zmanjšati hitrosti infundiranja (glejte poglavje 4.4).
English: It is possible to refrigerate Flolan reconstituted solutions, before they are used at room temperature, ranging between 2°C and 8°C and without exceeding 40 hour storage.
Slovenian: Pripravljeno raztopino zdravila Flolan je mogoče pred uporabo pri sobni temperaturi shranjevati v hladilniku pri temperaturi od 2 do 8 °C; takšno shranjevanje ne sme trajati več kot 40 ur.
English: While you are being treated with Flolan it is important that you check the injection area.
Slovenian: Pomembno je, da med zdravljenjem z zdravilom Flolan preverjate mesto injiciranja.
English: Because of the high pH of the final infusion solutions, care should be taken to avoid extravasation during their administration and consequent risk of tissue damage.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi pH končne raztopine za infundiranje je visok, zato je treba paziti, da med dajanjem ne pride do ekstravazacije in posledične okvare tkiva.
English: Withdraw approximately 10 mL of the solvent into a sterile syringe, inject it into the vial containing 0.5 mg freeze-dried Flolan powder and shake gently until the powder has dissolved.
Slovenian: Izvlecite približno 10 ml vehikla v sterilno brizgo, vbrizgajte ga v vialo, ki vsebuje 0,5 mg liofiliziranega praška zdravila Flolan, in nežno pretresajte, dokler se prašek ne raztopi.
English: • You have fevers or chills.
Slovenian: • Imate zvišano telesno temperaturo ali mrzlico.
English: The pack suitable for use in renal dialysis contains 0.5 mg freeze-dried Flolan plus 50 mL solvent.
Slovenian: Pakiranje, primerno za uporabo pri ledvični dializi, vsebuje 0,5 mikrograma liofiliziranega zdravila Flolan in 50 ml vehikla.
English: Kidney dialysis You will be given an infusion of Flolan for the duration of your dialysis.
Slovenian: Ledvična dializa Infuzijo zdravila Flolan boste dobili, medtem ko bo potekala dializa.
English: The active substance is epoprostenol sodium.
Slovenian: Zdravilna učinkovina je natrijev epoprostenolat.
English: Very common side effects These may affect more than 1 in 10 people:
Slovenian: Zelo pogosti neželeni učinki Ti se lahko pojavijo pri več kot 1 od 10 oseb:
English: Flolan contains Sodium.
Slovenian: Zdravilo Flolan vsebuje natrij.
English: This is where the pressure is high in the blood vessels in the lungs.
Slovenian: Pri tej bolezni je tlak v pljučnem ožilju previsok.
English: Each vial contains epoprostenol sodium equivalent to 0.5 mg epoprostenol.
Slovenian: Ena viala vsebuje natrijev epoprostenolat, kolikor ga ustreza 0,5 mg epoprostenola.
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).
Slovenian: Pri bolnikih, ki so stalno prejemali intravenski epoprostenol obenem s konvencionalnim zdravljenjem (n = 52) 8 ali 12 tednov, so v primerjavi z bolniki, ki so prejemali le konvencionalno zdravljenje (n = 54) zabeležili statistično značilno izboljšanje obremenitvene zmogljivosti (p = 0,001), merjene s 6-minutnim testom hoje (kombinirana sprememba od izhodišča za 8. in 12. teden - mediana: 49 v prim.
English: Sterile technique must be adhered to in preparing the drug and in the care of the catheter.
Slovenian: Pri pripravi zdravila in oskrbi katetra je treba upoštevati sterilen postopek.
English: Looking after the injection line
Slovenian: Skrb za injekcijski kateter
English: Nervous System Disorders Very common Headache Cardiac Disorders Common
Slovenian: Bolezni živčevja Zelo pogosti glavobol
English: The median baseline value for the conventional therapy group and epoprostenol plus conventional therapy group was 240 meters and 270 meters, respectively.
Slovenian: Izhodiščna mediana vrednost 6-minutnega testa hoje je bila v skupini s konvencionalnim zdravljenjem 240 metrov in v skupini s kombinacijo konvencionalnega zdravljenja in epoprostenola 270 metrov.
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.
Slovenian: • Ena viala s sterilnim liofiliziranim zdravilom Flolan, kolikor ustreza 1,5 mg zdravila Flolan, z eno ali dvema 50-ml vialama vehikla in filtrirno enoto.
English: Each vial contains epoprostenol sodium equivalent to 1.5 mg epoprostenol.
Slovenian: Ena viala vsebuje natrijev epoprostenolat, kolikor ga ustreza 1,5 mg epoprostenola.
English: If you get any side effects , talk to your doctor or pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: Dispense the concentrated solution directly into the chosen infusion solution using firm but not excessive pressure; the typical time taken for filtration of 50 mL of concentrated solution is 70 seconds.
Slovenian: Koncentrirano raztopino dajte neposredno v izbrano raztopino za infundiranje z odločnim, a ne premočnim pritiskom; običajni čas za filtriranje 50 ml koncentrirane raztopine je 70 sekund.
English: Draw up the resulting Flolan solution into the syringe, re-inject it into the remaining volume of the solvent and mix thoroughly.
Slovenian: Nastalo raztopino zdravila Flolan potegnite v brizgo in jo ponovno injicirajte v preostalo količino vehikla ter temeljito premešajte.
English: Dispense the concentrated solution directly into the solvent using firm but not excessive pressure; the typical time taken for filtration of 50 mL of concentrated solution is 70 seconds.
Slovenian: Koncentrirano raztopino dajte neposredno v vehikel z odločnim, a ne premočnim pritiskom; običajni čas za filtriranje 50 ml koncentrirane raztopine je 70 sekund.
English: • pain at the injection site
Slovenian: • bolečina na mestu injiciranja.
English: What Flolan contains
Slovenian: Kaj vsebuje zdravilo Flolan
English: Keep dry.
Slovenian: Shranjujte na suhem mestu.
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.
Slovenian: Kronično stalno infundiranje epoprostenola pri bolnikih z idiopatsko ali dedno PAH so raziskali v 2 prospektivnih, odprtih randomiziranih preskušanjih, ki sta trajali 8 tednov (n = 25) in 12 tednov (n = 81).
English: Breast-feeding should be discontinued during treatment with Flolan.
Slovenian: Med zdravljenjem z zdravilom Flolan je treba dojenje prekiniti.
English: • 0.5 mg epoprostenol sodium
Slovenian: • 0,5 mg natrijevega epoprostenolata ali
English: Contact the hospital immediately for advice if the area becomes sore, painful or swollen or you notice any blistering or shedding.
Slovenian: Če se mesto injiciranja vname, boli ali oteče, ali če opazite mehurje ali lupljenje, se za nasvet nemudoma obrnite na bolnišnico.
English: No statistical difference in survival over 12 weeks was observed in PAH/SSD patients treated with epoprostenol as compared to those receiving conventional therapy alone.
Slovenian: Primerjava bolnikov s PAH/SSD, zdravljenih z epoprostenolom in zdravljenih s konvencionalnim zdravljenjem samim, v 12 tednih ni pokazala statistične razlike glede preživetja.
English: Example For Dosing Using a Concentration of 5,000 nanograms/mL Dosage (nanograms/ kg/ min)
Slovenian: Primer za odmerjanje z uporabo koncentracije 5.000 nanogramov/ml Odmerek (nanogramo v/kg/min)
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.
Slovenian: Prozorne steklene viale (iz stekla tipa 1) z zamaški iz sintetične butilne gume z aluminijsko obrobo in snemnim pokrovčkom.
English: In general, dose selection for an elderly patient should be made carefully, reflecting the greater frequency of decreased hepatic, renal (in the case of pulmonary arterial hypertension) or cardiac function and of concomitant disease or other medicine therapy.
Slovenian: Specifičnih informacij o uporabi zdravila Flolan pri ledvični dializi ali pljučni arterijski hipertenziji pri bolnikih, starejših od 65 let, ni. Na splošno je treba odmerek za starejše bolnike določiti skrbno, upoštevaje večjo pogostnost zmanjšanega delovanja jeter, ledvic (v primeru pljučne arterijske hipertenzije) ali srca ter sočasne bolezni ali uporabo drugih zdravil.
English: There are four packs available for use in the treatment of pulmonary arterial hypertension, as follows:
Slovenian: Za zdravljenje pljučne arterijske hipertenzije so na voljo naslednja štiri pakiranja:
English: • heart beating faster
Slovenian: • hitrejši srčni utrip,
English: Flolan may be used either as concentrated solution or in a diluted form for the treatment of pulmonary arterial hypertension.
Slovenian: Zdravilo Flolan se za zdravljenje pljučne arterijske hipertenzije lahko uporablja kot koncentrirana raztopina ali v razredčeni obliki.
English: This solution is now referred to as the concentrated solution and contains 10,000 nanograms/mL Flolan.
Slovenian: Nastalo raztopino imenujemo koncentrirana raztopina in vsebuje 10.000 nanogramov zdravila Flolan/ml.
English: One ml of reconstituted concentrate solution contains epoprostenol (as epoprostenol sodium) 10 000 nanogram.
Slovenian: En mililiter pripravljenega koncentrata raztopine vsebuje 10.000 nanogramov epoprostenola (kot natrijevega epoprostenolata).
English: • feeling agitated
Slovenian: • vznemirjenost,
English: None of the dialyses using heparin and 5% (n=32) of dialyses using epoprostenol had minor clotting.
Slovenian: Manj pomembno strjevanje se ni pojavilo pri nobeni dializi s heparinom in pri 5 % (n = 32) dializ z epoprostenolom.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Each vial contains 0.5mg epoprostenol (as epoprostenol sodium) Each vial contains 1.5mg epoprostenol (as epoprostenol sodium)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Ena viala vsebuje 0,5 mg epoprostenola (kot natrijevega epoprostenolata)
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.
Slovenian: V velikih kontroliranih študijah je (vse dialize skupaj za vsako zdravljenje - heparin ali epoprostenol) imelo v enakih časovnih obdobjih več prejemnikov heparina kot prejemnikov epoprostenola krvavitev dan pred dializo (n = 13/17 v prim.
English: Only the 0.5 mg pack is suitable for use in renal dialysis.
Slovenian: Ledvična dializa Za uporabo pri ledvični dializi je primerno samo pakiranje 0,5 mg.
English: Sodium chloride 0.9% w/v solution must not be used when Flolan is to be used for the treatment of pulmonary arterial hypertension.
Slovenian: Če je zdravilo Flolan uporabljeno za zdravljenje pljučne arterijske hipertenzije, se ne sme uporabljati 0,9 % (m/v) raztopine natrijevega klorida.
English: • redness of your face (flushing)
Slovenian: • pordelost obraza (zardevanje).
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.
Slovenian: funkcijskem razredu po NYHA (New York Heart Association), so bili vsi bolniki v III. ali IV. funkcijskem razredu.
English: • One 1.5 mg powder vial.
Slovenian: • ena viala z 1,5 mg praška.
English: • One vial containing sterile, freeze-dried Flolan equivalent to 0.5 mg Flolan supplied alone.
Slovenian: • Ena viala s sterilnim liofiliziranim zdravilom Flolan, kolikor ustreza 0,5 mg zdravila Flolan, samim.
English: • diarrhoea
Slovenian: • oteklost,
English: Seek urgent medical attention if you think you have used or been given too much Flolan.
Slovenian: Če menite, da ste uporabili ali da ste dobili preveč zdravila Flolan, nemudoma poiščite zdravniško pomoč.
English: You should stop breastfeeding your child during treatment with Flolan.
Slovenian: Med zdravljenjem z zdravilom Flolan morate nehati dojiti.
English: 2 Tachycardia has been reported as a response to Flolan at doses of 5 nanograms/kg/min and below.
Slovenian: 2 Kot odziv na zdravilo Flolan v odmerkih 5 nanogramov/kg/min in manj je bila opisana tahikardija.
English: Flolan 0.5 mg powder for solution for infusion Flolan 1.5 mg powder for solution for infusion Intravenous use
Slovenian: Flolan 0,5 mg prašek za raztopino za infundiranje Flolan 1,5 mg prašek za raztopino za infundiranje intravenska uporaba epoprostenol
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.
Slovenian: Pri bolnikih, ki so kronično prejemali epoprostenol, so v primerjavi z bolniki, ki ga niso prejemali, po 12 tednih zdravljenja ugotovili statistično značilno povečanje CI ter statistično značilno zmanjšanje PAPm, RAPm, PVR in SAPm .
English: Even brief interruptions in the delivery of Flolan may result in rapid symptomatic deterioration.
Slovenian: Simptomi se lahko hitro poslabšajo že po kratki prekinitvi dajanja zdravila Flolan.
English: MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING LABEL for solvent vial
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNI OVOJNINI NALEPKA za vialo z vehiklom
English: • One 0.5 mg powder vial.
Slovenian: • Ena viala z 0,5 mg praška
English: • One vial containing sterile, freeze-dried Flolan equivalent to 1.5 mg Flolan supplied alone.
Slovenian: • Ena viala s sterilnim liofiliziranim zdravilom Flolan, kolikor ustreza 1,5 mg zdravila Flolan, samim.
English: Very rare side effects These may affect up to 1 in 10,000 people:
Slovenian: Zelo redki neželeni učinki Pojavijo se lahko pri največ 1 od 10.000 oseb:
English: Only the solvent provided may be used for the further dilution of reconstituted Flolan.
Slovenian: Za nadaljnje razredčenje pripravljenega zdravila Flolan se sme uporabiti le priloženi vehikel.
English: Abdominal colic, sometimes reported as abdominal discomfort
Slovenian: Pogosti trebušne kolike; bolniki jih včasih opisujejo kot nelagodje v trebuhu
English: Blood pressure and heart rate should be monitored during administration of Flolan.
Slovenian: Med dajanjem zdravila Flolan je treba kontrolirati bolnikov krvni tlak in srčno frekvenco.
English: Store between 2 and 8oC for the full administration period.
Slovenian: Med celotnim obdobjem dajanja shranjujte pri temperaturi med 2 in 8 oC.
English: Summary of product characteristics, labelling and package leaflet
Slovenian: Priloga III Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo
English: Higher infusion rates, and therefore, more concentrated solutions may be necessary with long-term administration of Flolan.
Slovenian: Med dolgotrajno uporabo zdravila Flolan je lahko potrebna večja hitrost infundiranja in zaradi tega bolj koncentrirane raztopine.
English: Hyperthyroidism Psychiatric Disorders Common
Slovenian: Zelo redki hipertiroidizem Psihiatrične motnje Pogosti anksioznost, živčnost
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
Slovenian: Hitrost pretoka v ml/h Hitrosti infundiranja za koncentracijo 15.000 nanogramov/ml
English: INSTRUCTIONS ON USE [To be completed nationally] INFORMATION IN BRAILLE [To be completed nationally]
Slovenian: PODATKI V BRAILLOVI PISAVI [Izpolni država članica]
English: 0.5 mg vial powder for solution for infusion, 1 vial of solvent and 1 filter unit 0.5 mg vial powder for solution for infusion, 2 vials of solvent and 1 filter unit
Slovenian: Prašek in vehikel za raztopino za infundiranje Prašek za raztopino za infundiranje Vehikel za parenteralno uporabo viala z 0,5 mg praška za raztopino za infundiranje, 1 viala vehikla in 1 filtrirna enota viala z 0,5 mg praška za raztopino za infundiranje, 2 viali vehikla in 1 filtrirna enota viala z 1,5 mg praška za raztopino za infundiranje, 1 viala vehikla in 1 filtrirna enota viala z 1,5 mg praška za raztopino za infundiranje, 2 viali vehikla in 1 filtrirna enota
English: Rare side effects
Slovenian: Pogosti neželeni učinki
English: Store the solvent below 25°C.
Slovenian: Viale shranjujte pri temperaturi do 25 °C.
English: • dry mouth
Slovenian: • suha usta.
English: Hypotension
Slovenian: Dojenje
English: GENERAL CLASSIFICATION FOR SUPPLY Medicine subject to medicinal prescription
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Infusion rate (mL/min) = concentration of solution (nanogram/mL)
Slovenian: = koncentracija raztopine (nanogramov/ml)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Epoprostenol 0.5mg Powder for Solution for Infusion:
Slovenian: Epoprostenol 0,5 mg prašek za raztopino za infundiranje:
English: The vasodilator effects of Flolan may augment or be augmented by concomitant use of other vasodilators.
Slovenian: Vazodilatacijski učinki zdravila Flolan lahko povečajo učinek sočasno uporabljenih vazodilatatorjev in obratno.
English: Flolan must not be administered with other parenteral solutions or medications when used for pulmonary arterial hypertension.
Slovenian: Če se zdravilo Flolan uporablja za zdravljenje pljučne arterijske hipertenzije, se ga ne sme uporabljati z drugimi parenteralnimi raztopinami ali zdravili.
English: The hypotensive effect of Flolan may be enhanced by the use of acetate buffer in the dialysis bath during renal dialysis.
Slovenian: Uporaba acetatnega pufra v dializni kopeli med ledvično dializo lahko poveča hipotenzivni učinek zdravila Flolan.
English: Bradycardia associated with a considerable fall in systolic and diastolic blood pressure has followed i.v.
Slovenian: 30 nanogramom/kg/min, je pri zdravih prostovoljcih, ki so bili pri zavesti, sledila bradikardija, povezana z občutnim padcem sistoličnega in diastoličnega krvnega tlaka.
English: Use only the solvent provided for reconstitution.
Slovenian: Za pripravo uporabljajte le priloženi vehikel.
English: • One 0.5 mg powder vial and one or two solvent vials and a filter unit.
Slovenian: • eno vialo z 0,5 mg praška, eno ali dve viali z vehiklom in filtrirno enoto,
English: Its use is forbidden in the presence of a discoloration or particles.
Slovenian: Ne sme se je uporabiti, če je spremenjene barve ali so v njej delci.
English: Flolan 0.5 mg Powder and Solvent for Solution for Infusion Flolan 1.5 mg Powder and Solvent for Solution for Infusion
Slovenian: Flolan 0,5 mg prašek in vehikel za raztopino za infundiranje Flolan 1,5 mg prašek in vehikel za raztopino za infundiranje
English: Each vial contains epoprostenol sodium equivalent to 1.5 mg epoprostenol One ml of reconstituted concentrate solution contains epoprostenol (as epoprostenol ) 30 000 nanogram.
Slovenian: En mililiter pripravljenega koncentrata raztopine vsebuje 30.000 nanogramov epoprostenola (kot natrijevega epoprostenolata).
English: • One 1.5 mg powder vial and one or two solvent vials and a filter unit.
Slovenian: • eno vialo z 1,5 mg praška, eno ali dve viali z vehiklom in filtrirno enoto,
English: How to store Flolan
Slovenian: Shranjevanje zdravila Flolan