FrancophonIA/ELRC3.0 huggingface dataset:
English: If life-threatening bleeding occurs and excessive plasma levels of lepirudin are suspected, the following recommendations should be followed: - Immediately STOP Refludan administration - Determine aPTT and other coagulation parameters as appropriate - Determine haemoglobin and prepare for blood transfusion - Follow the current guidelines for shock-therapy.
Slovenian: Ob pojavu življenjsko nevarne krvavitve in sumu na prevelike koncentracije lepirudina v plazmi je treba ukrepati v skladu z naslednjimi priporočili: - takoj PREKINITE z dajanjem Refludana; - določite aPTT in druge ustrezne koagulacijske parametre; - določite hemoglobin in pripravite vse potrebno za transfuzijo krvi; - upoštevajte navodila za terapijo šoka.
English: The pharmacokinetic properties of lepirudin following intravenous administration are well described by a two-compartment model.
Slovenian: Farmakokinetične lastnosti lepirudina po intravenskem dajanju dobro ponazarja dvofazni fugativnostni model porazdelitve.
English: To avoid prothrombotic effects when initiating coumarin, continue parenteral anticoagulation for 4 to 5 days (see oral anticoagulant package insert for information).
Slovenian: Da ob uvedbi kumarina ne bi prišlo do protrombotičnega učinka, je treba s peroralnim antikoagulacijskim zdravljenjem nadaljevati še 4 do 5 dni (glejte navodila, ki so priložena peroralnemu antikoagulantu).
English: Table 3: Examples for standard infusion speed according to body weight
Slovenian: Preglednica 3: Primeri standardnih infuzijskih hitrosti glede na telesno maso
English: Concomitant treatment with coumarin derivatives (vitamin K antagonists) and drugs that affect platelet function may also increase the risk of bleeding.
Slovenian: Sočasno zdravljenje s kumarinskimi derivati (antagonisti vitamina K) in zdravili, ki vplivajo na delovanje trombocitov, lahko tudi povečajo tveganje za pojav krvavitev.
English: CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Germany
Slovenian: CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Nemčija
English: HOW TO USE REFLUDAN
Slovenian: KAKO UPORABLJATI ZDRAVILO REFLUDAN
English: Bleeding from puncture sites
Slovenian: Krvavitev iz mesta punkcije Epistaksa
English: (Lepirudin is a recombinant DNA product derived from yeast cells)
Slovenian: (Lepirudin je rekombinantni produkt DNA, pridobljen iz celic kvasovk)
English: Reported bleeding events include: anaemia or drop in the haemoglobin value without obvious source of bleeding, bruising, bleeding from puncture sites, nose bleeding, blood in urine, gastrointestinal bleeding, vaginal bleeding, rectal bleeding, pulmonary haemorrhage, bleeding into chest space and around the heart following surgery, bleeding into the brain.
Slovenian: Krvavitve, o katerih poročajo, vključujejo: anemijo ali padec vrednosti hemoglobina brez očitnega izvora krvavitve, podplutbe, krvavitve iz punkcijskih mest, krvavitve iz nosu, kri v urinu, krvavitve iz prebavil, vaginalne krvavitve, rektalne krvavitve, pljučno hemoragijo, krvavitev v prsno votlino in okolico srca po operaciji, možganske krvavitve.
English: - Formation of anti-hirudin antibodies was observed in about 40 % of HIT type II patients and have been reported especially with a treatment period exceeding five days.
Slovenian: - Pri 40 % bolnikov s HIT tipa II so opazili tvorbo protiteles proti hirudinu, poročila pa jih omenjajo zlasti v povezavi z zdravljenjem, ki je trajalo dlje kot 5 dni.
English: The rate of infusion must be reduced in case of known or suspected renal insufficiency (see sections 4.2, and 5.2).
Slovenian: V primeru potrjene ledvične insuficience ali suma na okvaro ledvic je treba zmanjšati hitrost infundiranja (glejte poglavji 4.2 in 5.2).
English: Therefore, the treating physician should carefully weigh the risk of administration versus its anticipated benefit.
Slovenian: Zdravnik mora skrbno pretehtati tveganje uporabe v primerjavi s pričakovanimi koristmi.
English: With respect to lepirudin dosage the potential of renal impairment in elderly patients is to be taken into account.
Slovenian: Pri odmerjanju lepirudina je treba pri starejših bolnikih upoštevati možnost morebitne okvare ledvic.
English: This leaflet was last approved on {date}
Slovenian: Navodilo je bilo odobreno {MM/LL}
English: If a patient is scheduled to receive coumarin derivatives (vitamin K antagonists) for oral anticoagulation after Refludan therapy, the following should apply: Coumarin derivatives should be initiated only when platelet counts are normalising.
Slovenian: Če se pri bolniku po zdravljenju z Refludanom načrtuje uvedba peroralnega antikoagulacijskega zdravljenja s kumarinskimi derivati (antagonisti vitamina K), je treba upoštevati naslednje: kumarinski derivati se lahko začnejo uvajati šele takrat, ko je dosežena normalizacija števila trombocitov.
English: Its activity is measured in a chromogenic assay.
Slovenian: Njegovo aktivnost merijo s pomočjo kromogenskega testa.
English: Table 2: Examples for standard injection volume according to body weight
Slovenian: Preglednica 2: Primeri standardnih injekcijskih volumnov glede na telesno maso
English: Natural hirudin is produced in trace amounts as a family of highly homologous iso-polypeptides by the leech Hirudo medicinalis.
Slovenian: Naravni hirudin iz družine visoko homolognih izo-polipeptidov se v sledeh izloča v slini pijavke Hirudo medicinalis.
English: Intravenous infusion:
Slovenian: Intravenska infuzija:
English: - Anaphylactic/oid reactions including urticaria, difficulty in breathing (e.g. consisting of spasms), cough, sharp sound when breathing, build-up of water in the body and in the inner wall of a vessel (including: face oedema, tongue oedema, throat oedema).
Slovenian: - anafilaktične/anafilaktoidne reakcije, vključno s koprivnico, težave z dihanjem (npr. spastični napadi), kašelj, hropenje, nabiranje vode v telesu in v notranjih stenah žil (vključno z edemom obraza, jezika in grla).
English: Like all medicines, Refludan can have side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Refludan neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Additionally, individual case reports and in-vitro data suggest that either haemofiltration or haemodialysis (using high flux dialysis membranes with a cut-off point of 50,000 Dalton) may be useful in this situation.
Slovenian: Nadalje je iz posameznih prikazov primerov in in vitro podatkov razvidno, da je lahko v tem primeru koristna hemofiltracija ali hemodializa (ob uporabi visokopretočnih membran z mejno vrednostjo 50.000 daltonov).
English: VIAL LABEL: 50 mg
Slovenian: OZNAKA NA VIALI: 50 mg
English: It may be necessary to exclude patients with renal impairment from treatment with lepirudin regimen.
Slovenian: Bolnike z okvaro ledvic bo morda potrebno izključiti iz zdravljenja z lepirudinom.
English: Do not use Refludan after the expiry date which is stated on the carton and the vial after EXP.
Slovenian: Zdravila Refludan ne smete uporabljati po datumu izteka uporabnosti, ki je naveden na ovojnini in na viali po oznaki EXP.
English: Creatinine clearance [ml/min]
Slovenian: Očistek kreatinina [ml/min]
English: - For rapid, complete reconstitution, inject 1 ml of diluent into the vacuum vial and shake it gently.
Slovenian: - Za hitro in popolno rekonstitucijo vbrizgajte 1 mL vehikla v vakuumsko vialo in rahlo pretresite.
English: Refludan should therefore not be administered to pregnant women or nursing mothers.
Slovenian: Refludana se zato ne sme dajati nosečnicam in doječim materam.
English: Do not use Refludan - if you are allergic (hypersensitive) to lepirudin, to hirudins or any of the other ingredients of
Slovenian: Ne uporabljajte zdravila Refludan: - če ste alergični na (preobčutljivi za) na lepirudin, hirudine ali katerokoli sestavino zdravila
English: - In case of renal impairment relative overdose may occur even under a standard dosage regimen.
Slovenian: - V primeru ledvične okvare lahko pride do relativnega prevelikega odmerka tudi ob standardni shemi odmerjanja.
English: On reconstitution a clear, colourless solution is usually obtained within less than
Slovenian: Ob rekonstituciji dobite prozorno, brezbarvno raztopino običajno v manj kot 3
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: Če katerikoli stranski učinek postane resen ali če opazite kakršenkoli neželen učinek, ki ni omenjen v tem navodilu, vas prosimo, da o tem obvestite svojega zdravnika ali farmacevta.
English: Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom
Slovenian: Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, Velika Britanija
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koţa in mediastinalnega prostora
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: • POGOJI IN OMEJITVE ZA VARNO IN UČINKOVITO UPORABO ZDRAVILA Navedba smiselno ni potrebna.
English: This particularly includes the following situations with increased bleeding risk: - Recent puncture of large vessels or organ biopsy - Anomaly of vessels or organs - Recent cerebrovascular accident, stroke, or intracerebral surgery - Severe uncontrolled hypertension - Bacterial endocarditis - Advanced renal impairment - Haemorrhagic diathesis - Recent major surgery - Recent bleeding (e.g. intracranial, gastrointestinal, intraocular, pulmonary) - Overt signs of bleeding - Recent active peptic ulcer - Age > 65 years.
Slovenian: To velja še zlasti za naslednja stanja s povečanim tveganjem krvavitve: - nedavna punkcija večjih žil ali biopsija organov - nepravilnosti ožilja ali organov - nedavni cerebrovaskularni insult, kap ali možganska operacija - huda neobvladana hipertenzija - bakterijski enodkarditis - napredovala okvara ledvic - hemoragična diateza - nedavni večji operativni poseg - nedavna krvavitev (npr. intrakranialna, gastrointestinalna, intraokularna, pljučna) - prikriti znaki krvavitve - nedavno aktivna želodčna razjeda - starost > 65 let.
English: - 0.4 mg / kg body weight intravenously as a bolus dose - followed by 0.15 mg / kg body weight / hour as a continuous intravenous infusion for 2 - 10
Slovenian: - 0,4 mg / kg telesne mase intravensko v obliki bolusa - temu sledi 0,15 mg / kg telesne mase / uro v obliki neprekinjene intravenske infuzije, ki traja 2
English: Refludan should not be administered to pregnant women or nursing mothers.
Slovenian: Refludana se ne sme dajati nosečnicam in doječim materam.
English: - For rapid, complete reconstitution, inject 0.4 ml of diluent into the vacuum vial and shake it gently.
Slovenian: - Za hitro in popolno rekonstitucijo vbrizgajte 0,4 mL vehikla v vakuumsko vialo in rahlo pretresite.
English: EU/1/97/035/003 REFLUDAN - 20 mg - Powder for solution for injection or infusion - 1 vial EU/1/97/035/004 REFLUDAN - 20 mg - Powder for solution for injection or infusion - 10 vials
Slovenian: EU/1/97/035/003 REFLUDAN - 20 mg - prašek za raztopino za injiciranje ali infundiranje - 1 viala EU/1/97/035/004 REFLUDAN - 20 mg - prašek za raztopino za injiciranje ali infundiranje - 10 vial
English: Any unused solution must be discarded appropriately.
Slovenian: Vso neuporabljeno raztopino je treba ustrezno zavreči.
English: Injection site reactions including pain.
Slovenian: Reakcije na mestu injiciranja, vključno z bolečino.
English: Manufacturer CSL Behring GmbH, Emil-von-Behring-Straße 76, 35041 Marburg, Germany.
Slovenian: Izdelovalec CSL Behring GmbH, Emil-von-Behring-Straße 76, 35041 Marburg, Nemčija.
English: If you have a bleeding tendency, your doctor will weigh the risk of Refludan administration against its benefit.
Slovenian: Bodite posebej pozorni pri uporabi zdravila Refludan Če ste nagnjeni h krvavitvam, bo vaš zdravnik pretehtal tveganje, povezano z uporabo Refludana, v primerjavi z njegovimi koristmi.
English: EU/1/97/035/001 REFLUDAN - 50 mg - Powder for solution for injection or infusion - 1 vial EU/1/97/035/002 REFLUDAN - 50 mg - Powder for solution for injection or infusion - 10 vials
Slovenian: EU/1/97/035/003 REFLUDAN - 50 mg - prašek za raztopino za injiciranje ali infundiranje - 1 viala EU/1/97/035/004 REFLUDAN - 50 mg - prašek za raztopino za injiciranje ali infundiranje - 10 vial
English: For continuous intravenous infusion, a solution with a concentration of 2 mg/ml is needed.
Slovenian: Za neprekinjeno intravensko infuzijo potrebujemo raztopino v koncentraciji 2 mg/ml.
English: Anaphylactic/oid reactions
Slovenian: Anafilaktične/anafilaktoidne reakcije
English: The other ingredients are mannitol (E421) and sodium hydroxide for pH adjustment.
Slovenian: Ostale snovi so manitol (E421) in natrijev hidroksid za uravnavanje PH.
English: In case of renal impairment relative overdose might occur even under standard dosage regimen.
Slovenian: V primeru ledvične okvare lahko pride do prevelikega odmerka tudi ob standardni shemi odmerjanja.
English: VIAL LABEL: 20 mg
Slovenian: NALEPKA NA VIALI: 20 mg
English: Also contains: mannitol, sodium hydroxide.
Slovenian: Ostale sestavine: manitol, natrijev hidroksid
English: - Any unused solution must be discarded appropriately.
Slovenian: - Vso neuporabljeno raztopino je treba ustrezno zavreči.
English: The speed of the perfusor automate [ml per hour] is to be set in a body weight dependent fashion.
Slovenian: Hitrost perfuzorja [mL na uro] je treba nastaviti glede na telesno maso.
English: Once reconstituted Refludan is to be used immediately.
Slovenian: Rekonstituirano raztopino je treba takoj uporabiti.
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost voţnje in upravljanja s stroji Navedba smiselno ni potrebna.
English: Refludan is used for anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease requiring injected antithrombotic medicines.
Slovenian: Refludan se uporablja za antikoagulacijo pri odraslih bolnikih, ki imajo s heparinom izzvano trombocitopenijo (HIT) tipa II in tromboembolijo, ki zahteva zdravljenje z injekcijami antitrombotikov.
English: Angio-oedema (including: face oedema, tongue oedema, larynx oedema)
Slovenian: Angioedem (vključno z: edemom obraza, edemom jezika, edemom grla)
English: Gastrointestinal bleeding
Slovenian: Gastrointestinalna krvavitev Vaginalna krvavitev Rektalna krvavitev Pljučna hemoragija
English: Dosing adjustments are based on renal function, weight, and aPTT (see section 4.2).
Slovenian: Specifičnih prilagoditev odmerjanja za starejše bolnike ni. Odmerjanje se prilagaja glede na delovanje ledvic, telesno maso in aPTT (glejte poglavje 4.2).
English: Thus, please tell your doctor if you have or have had: - Recent puncture of large vessels or organs - Anomaly of vessels or organs - Recent stroke, accident or surgery involving the brain - High blood pressure - Inflammation of the inner membrane of the heart - Advanced kidney disease - Advanced bleeding tendency - Recent major surgery
Slovenian: Prosimo, povejte svojemu zdravniku, če imate ali ste imeli kaj od spodaj naštetega: - pred kratkim punkcijo večjih žil ali organov - nepravilnosti ožilja ali organov - pred nedavnim kap, nesrečo ali operacijo možganov - visok krvni tlak - vnetje osrčnika (notranje srčeve ovojnice) - napredovalo bolezen ledvic - večjo nagnjenost h krvavitvam - pred kratkim večji operativni poseg - pred kratkim krvavitev (npr. v možganih, želodcu, črevesu, očeh, pljučih)
English: Marketing Authorisation Holder Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, Združeno kraljestvo
English: In clinical trials, Refludan was not therapeutically administered to HIT type II patients with significant renal impairment.
Slovenian: V kliničnih preskušanjih bolniki z HIT tipa II in pomembno okvaro ledvic niso bili zdravljeni z Refludanom.
English: Anticoagulation in adult patients with HIT type II and thromboembolic disease:
Slovenian: Začetni odmerek Antikoagulacija pri odraslih bolnikih s HIT tipa II in tromboembolijo:
English: Its mode of action is independent of antithrombin III.
Slovenian: Njegov način delovanja je neodvisen od antitrombina III. Trombocitni faktor 4 ne zavira lepirudina.
English: - Do not use solutions which are cloudy or contain particles.
Slovenian: - Ne uporabljajte raztopine, če je kalna ali če vsebuje delce.
English: In intensified post-marketing surveillance in HIT type II, fatal bleeding was reported in 1 % and intracranial bleeding in 0.2 % of patients.
Slovenian: V intenzivnem postmarketinškem spremljanju bolnikov s HIT tipa II so poročali o pojavu usodnih krvavitev pri 1 % in o pojavu intrakranialnih krvavitev pri 0,2 % bolnikov.
English: What Refludan contains The active substance is lepirudin, a recombinant DNA product derived from yeast cells.
Slovenian: Aktivna učinkovina je lepirudin, rekombinantni produkt DNA, pridobljen iz celic kvasovk.
English: Therefore, the bolus dose and infusion rate must be reduced in case of known or suspected renal insufficiency (creatinine clearance below 60 ml/min or creatinine value above 15 mg/l [133 mol/l]).
Slovenian: Zato je treba v primeru potrjene ledvične insuficience ali suma na okvaro ledvic (očistek kreatinina < 60 ml/min ali vrednost kreatinina > 15 mg/l [133 mol/l]) bolusni odmerek in hitrost infundiranja ustrezno zmanjšati.
English: Do not use Refludan - if you are allergic (hypersensitive ) to lepirudin, to hirudins or any of the other ingredients of
Slovenian: Ne uporabljajte zdravila Refludan: - če ste alergični na (preobčutljivi za) lepirudin, hirudine ali katerokoli sestavino zdravila Refludan - če ste noseči ali dojite.
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKE DOVOLJENJA (DOVOLJENJ) ZA PROMET
English: For intravenous bolus injection, a solution with a concentration of 5 mg/ml is needed.
Slovenian: Za injekcijo intravenskega bolusa potrebujemo raztopino v koncentraciji 5 mg/ml.
English: - Recent bleeding (e.g. in brain, stomach/intestine, eye, lung) - Obvious signs of bleeding - Recent active peptic ulcer - Age > 65 years
Slovenian: - očitne znake krvavitve - pred kratkim aktivno želodčno razjedo - starost nad 65 let.
English: - Mannitol - Sodium hydroxide for adjustment to pH 7
Slovenian: 6.1 Seznam pomoţnih snovi - manitol - natrijev hidroksid za prilagoditev vrednosti pH na 7 6.2 Inkompatibilnosti
English: Liver cirrhosis may also affect the renal excretion of lepirudin.
Slovenian: Jetrna ciroza lahko vpliva tudi na izločanje lepirudina preko ledvic.
English: Anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease mandating parenteral antithrombotic therapy.
Slovenian: Antikoagulacija pri odraslih bolnikih, ki imajo s heparinom inducirano trombocitopenijo (HIT) tipa II in tromboembolijo, ki zahteva parenteralno antitrombotično zdravljenje.
English: Do not use solutions which are cloudy or contain particles.
Slovenian: Ne uporabljajte raztopine, če je kalna ali če vsebuje delce.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRVE PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve: 13-03-1997
English: Urticaria
Slovenian: Serija
English: Powder for solution for injection or infusion.
Slovenian: Prašek za raztopino za injiciranje ali infundiranje.
English: 1 vial contains 50 mg lepirudin.
Slovenian: 1 viala vsebuje 50 mg lepirudina.
English: 1 vial contains 20 mg lepirudin.
Slovenian: 1 viala vsebuje 20 mg lepirudina.
English: Refludan.
Slovenian: bolusa).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: Izgled zdravila Refludan in vsebina pakiranja
English: General Disorders and Administration Site Conditions
Slovenian: Splošne teţave in spremembe na mestu aplikacije
English: Presentations: - Pack with 1 vial - Pack with 10 vials Not all pack sizes may be marketed.
Slovenian: Oprema: - škatla z 1 vialo - škatla z 10 vialami
English: Dosage 0.2 mg / kg body weight
Slovenian: Odmerek 0,1 mg/kg telesne mase /h
English: What Refludan looks like and contents of the pack Refludan is a white powder for solution for injection or infusion supplied in a vial containing 50 mg lepirudin.
Slovenian: Refludan je bel prašek za raztopino za injiciranje ali infundiranje v viali, ki vsebuje 50 mg lepirudina.
English: What Refludan looks like and contents of the pack Refludan is a white powder for solution for injection or infusion supplied in a vial containing 20 mg lepirudin.
Slovenian: Refludan je bel prašek za raztopino za injiciranje ali infundiranje v viali, ki vsebuje 20 mg lepirudina.
English: OUTER CARTON: 50 mg x 1 VIAL
Slovenian: ZUNANJA ZLOŢENKA: 50 mg x 1 viala
English: 10 x 1 vial of powder for solution for injection or infusion.
Slovenian: 10 x 1 viala s praškom za raztopino za injiciranje ali infundiranje
English: Dosage 0.15 mg / kg body weight / h Dosage 0.1 mg / kg body weight / h
Slovenian: Odmerek 0,15 mg/kg telesne mase /h
English: Reconstitute one vial (20 mg of lepirudin) with 0.4 ml of either water for injections or sodium chloride 9 mg/ml (0.9 %) solution.
Slovenian: Eno vialo (20 mg lepirudina) rekonstituirajte z 0,4 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/mL (0,9 %).
English: OUTER CARTON: 20 mg x 1 VIAL
Slovenian: ZUNANJA ZLOŢENKA: 20 mg x 1 viala
English: - For reconstitution water for injections or sodium chloride 9 mg/ml (0.9 %) solution are to be used.
Slovenian: - Za rekonstitucijo se uporablja voda za injekcije ali raztopina natrijevega klorida 9 mg/mL (0,9
English: BEFORE YOU USE REFLUDAN
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO REFLUDAN
English: - For further dilution sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solutions are suitable.
Slovenian: - Za nadaljnje redčenje je primerna raztopina natrijevega klorida 9 mg/mL (0,9 %) ali raztopina 5
English: CLINICAL PARTICULARS
Slovenian: Ţilne bolezni
English: Chills
Slovenian: Hematurija
English: Do not use Refludan if the reconstituted solution is cloudy or contains particles.
Slovenian: Če je rekonstituirana raztopina Refludana motna ali če vsebuje delce, je ne uporabite.
English: Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ml (0.9 %) solution.
Slovenian: Eno vialo (50 mg lepirudina) rekonstituirajte z 1 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/mL (0,9 %).
English: Fever
Slovenian: Navali vročine
English: Refludan 50 mg powder for solution for injection or infusion
Slovenian: Refludan 50 mg prašek za raztopino za injiciranje ali infundiranje
English: Refludan 20 mg powder for solution for injection or infusion
Slovenian: Refludan 20 mg prašek za raztopino za injiciranje ali infundiranje
English: - If any of the side effects gets serious, or if you notice side effects not listed in this leaflet,
Slovenian: - Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: 1 vial of powder for solution for injection or infusion.
Slovenian: 1 viala s praškom za raztopino za injiciranje ali infundiranje.
English: Epistaxis
Slovenian: Urtikarija
English: HOW TO STORE REFLUDAN
Slovenian: SHRANJEVANJE ZDRAVILA REFLUDAN
English: Preparation of a Refludan solution with a concentration of 2 mg/ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ml is needed: - Reconstitute two vials (each containing 20 mg of lepirudin) with 0.4 ml each using either water for injections or sodium chloride 9 mg/ml (0.9 %) solution.
Slovenian: Priprava raztopine Refludana v koncentraciji 2 mg/ml Za neprekinjeno intravensko infuzijo potrebujemo raztopino v koncentraciji 2 mg/ml: - Uporabite dve viali s po 20 mg lepirudina; vsako od njih rekonstituirajte z 0,4 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/mL (0,9 %).