FrancophonIA/ELRC3.0 huggingface dataset:
English: Since the risk of serious bleeding is considerable in this situation, the dosage of Refludan should be substantially reduced.
Slovenian: Ker je v takih primerih tveganje za pojav hude krvavitve precejšnje, je treba odmerek Refludana bistveno zmanjšati.
English: If you have the impression that the effect of Refludan is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če imate občutek, da je učinek Refludana premočan ali prešibak, se pogovorite z vašim zdravnikom ali farmacevtom.
English: One anti-thrombin unit (ATU) is the amount of hirudin that neutralises one unit of WHO preparation 89/588 of thrombin.
Slovenian: Ena antitrombinska enota (ATe) je količina hirudina, ki nevtralizira eno enoto WHO preparata trombina 89/588.
English: Adverse events reported on Refludan are shown in the table below:
Slovenian: Neželeni učinki Refludana, o katerih so poročali, so prikazani v spodnji tabeli:
English: - With other reagents, the upper limit of the therapeutic aPTT window should be reduced to 2.5 fold prolongation of the normal control value.
Slovenian: - Pri ostalih reagentih mora biti zgornja meja terapevtskega okna aPTT zmanjšana na 2,5kratno podaljšanje normalnih kontrolnih vrednosti.
English: - In general, an infusion rate of 0.21 mg/kg/hour should not be exceeded without checking for coagulation abnormalities which might be preventing an appropriate aPTT response.
Slovenian: - Na splošno pa hitrost infundiranja ne sme presegati 0,21 mg/kg/h brez predhodnega ugotavljanja morebitnih koagulacijskih nepravilnosti, ki bi lahko preprečevale ustrezen odgovor aPTT.
English: The polypeptide composed of 65 amino acids has a molecular weight of 6979.5 Dalton.
Slovenian: Polipeptid, ki ga sestavlja 65 aminokislin, ima molekulsko maso 6979,5 daltonov.
English: Lepirudin is a highly specific direct inhibitor of thrombin.
Slovenian: Lepirudin je visoko specifičen neposredni zaviralec trombina.
English: - For injection only polypropylene syringes may be used.
Slovenian: - Za injiciranje se smejo uporabljati le polipropilenske brizge.
English: - The perfusor syringe must be changed at least every 12 hours after the start of the infusion.
Slovenian: - Brizgo perfuzorja je treba zamenjati vsaj vsakih 12 ur po začetku infuzije.
English: Distribution is essentially confined to extra-cellular fluids and is characterised by an initial half-life of approximately 10 minutes.
Slovenian: Porazdelitev je v glavnem omejena na zunajcelično tekočino, začetna razpolovna doba pa znaša približno 10 minut.
English: As lepirudin is almost exclusively excreted and metabolised renally (see also section 5.2), the patient's renal function should be considered prior to administration.
Slovenian: Ker se lepirudin izloča in presnavlja skoraj izključno preko ledvic (glejte tudi poglavje 5.2), je treba pred dajanjem upoštevati bolnikovo ledvično funkcijo.
English: - If the confirmed aPTT value is below the target range, the infusion speed should be increased by 20 %.
Slovenian: - Če je potrjena vrednost aPTT pod ciljnim območjem, je treba hitrost infundiranja povečati za 20 %.
English: Mutagenicity Lepirudin was not mutagenic or clastogenic in standard assays for such effects.
Slovenian: Mutagenost Lepirudin ni bil mutagen ali klastogen v standardnih testih teh učinkov.
English: Allergic Skin Reactions (including rash) Pruritus
Slovenian: Alergijske kožne reakcije (vključno z izpuščajem) Pruritus
English: - Anaphylaxis: Refludan may cause allergic reactions including anaphylaxis and shock (see section 4.8).
Slovenian: - Anafilaksa: Refludan lahko povzroči alergijske reakcije, vključno z anafilakso in šokom (glejte poglavje 4.8).
English: In female patients the systemic clearance is about 25 % lower as compared to male patients.
Slovenian: Pri ženskih bolnicah je sistemski očistek za približno 25 % nižji kot pri moških.
English: INFORMATION IN BRAILLE
Slovenian: PODATKI V V BRAILLOVI PISAVI
English: Anemia or drop in the haemoglobin value without obvious source of bleeding Haematoma
Slovenian: Anemija ali padec vrednosti hemoglobina brez očitnih izvorov krvavitve Hematom
English: Date of first authorisation: 13-03-1997 Date of last renewal: 05-03-2007
Slovenian: Datum zadnjega podaljšanja: 05-03-2007
English: Whenever available, dose adjustments should be based on creatinine clearance values as obtained from a reliable method (24 h urine sampling).
Slovenian: Kadarkoli je mogoče, mora prilagajanje odmerka temeljiti na vrednostih očistka kreatinina, ki so bile izmerjene z zanesljivo metodo (24-urno zbiranje urina).
English: Injection volume [ml]
Slovenian: Injekcijski volumen [ml]
English: Currently, no specific antidote against lepirudin is available.
Slovenian: Specifičnega antidota proti lepirudinu do sedaj še nimamo.
English: There is currently no information available on the use of Refludan during lactation.
Slovenian: Zaenkrat ni na voljo podatkov o uporabi Refludana v obdobju dojenja.
English: The following dosage recommendations are based on single-dose studies in a small number of patients with renal impairment.
Slovenian: Priporočila za odmerjanje, ki so navedena v nadaljevanju, temeljijo na študijah enkratnega odmerjanja pri majhnem številu bolnikov z okvaro ledvic.
English: Single and repeat-dose toxicity studies in mice, rats and monkeys showed the adverse responses that could be expected from an exaggerated pharmacodynamic impact of lepirudin.
Slovenian: Študije toksičnosti po enkratnem in večkratnem odmerku pri miših, podganah in opicah so pokazale neželene odzive, ki bi jih lahko pričakovali ob pretiranem farmakodinamičnem učinku lepirudina.
English: In patients with a body weight exceeding 110 kg the dosage should not be increased beyond the 110 kg body weight dose (see also tables 2 and 3, below).
Slovenian: Pri bolnikih, katerih telesna masa presega 110 kg, odmerjanja ne smemo povečevati nad mejo, ki je določena za odmerek pri telesni masi 110 kg (glejte tudi preglednici 2 in 3 spodaj).
English: Dose modifications: - Any aPTT value out of the target range is to be confirmed at once before drawing conclusions with respect to dose modifications, unless there is a clinical need to react immediately.
Slovenian: Prilagajanje odmerka: - Vsako vrednost aPTT izven ciljnega območja je treba pred odločitvijo glede spremembe odmerka najprej potrditi, razen v primeru, ko obstajajo klinični razlogi za takojšnje ukrepanje.
English: Refludan is an antithrombotic medicine.
Slovenian: Refludan je antitrombotično zdravilo.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Slovenian: Podrobne informacije o tem proizvodu najdete na spletni strani Evropske agencije za zdravila (European Medicines Agency - EMEA): http://www.emea.europa.eu
English: Life-threatening bleeding events (including intracranial bleeding) were uncommonly reported (≥1/1,000 to <1/100) in patients with acute coronary syndrome included in clinical studies.
Slovenian: O življenjsko nevarnih krvavitvah (vključno z intrakranialnimi krvavitvami) so poročali občasno (>1/1.000 do < 1/100) pri bolnikih z akutnim koronarnim sindromom, ki so bili vključeni v klinične študije.
English: The intended maintenance dose should be started with no loading dose.
Slovenian: Z nameravanim vzdrževalnim odmerkom je treba pričeti brez predhodnega začetnega odmerka.
English: One molecule of hirudin binds to one molecule of thrombin and thereby blocks the thrombogenic activity of thrombin.
Slovenian: Ena molekula hirudina se veže na eno molekulo trombina in tako blokira trombogeni učinek trombina.
English: In case of overdose the risk of bleeding may be increased.
Slovenian: V primeru prevelikega odmerjanja se lahko poveča tveganje zapletov s krvavitvami.
English: No evidence of a neutralisation of lepirudin or of an allergic reaction associated with the positive antibody test results was found.
Slovenian: Ni dokazov za nevtralizacijo lepirudina ali za alergijsko reakcijo, povezano s pozitivnimi rezultati testiranja na protitelesa.
English: The physician should carefully weigh the risk of Refludan administration versus its anticipated benefit, taking into account possible measures to control bleeding.
Slovenian: Zdravnik mora skrbno pretehtati tveganje ob uporabi Refludana v primerjavi s pričakovanimi koristmi ter pri tem upoštevati možne ukrepe za obvladovanje krvavitev.
English: The clinical information on HIT type II in this SPC is based upon the data of two prospective trials comprising a total of 198 HIT type II patients treated with Refludan.
Slovenian: Klinični podatki o HIT tipa II, ki so navedeni v tem povzetku glavnih značilnosti zdravila (SPC), temeljijo na izsledkih dveh prospektivnih preskušanj, ki sta vključili skupno 198 bolnikov s HIT tipa II, zdravljenih z Refludanom.
English: Recommendations for use in patients scheduled for a switch to oral anticoagulation
Slovenian: Priporočila za uporabo pri bolnikih, za katere je načrtovan prehod na peroralno antikoagulacijsko zdravljenje
English: - Known hypersensitivity to lepirudin, to hirudins or to any of the excipients - Pregnancy and lactation (see section 4.6)
Slovenian: - znana preobčutljivost za lepirudin, hirudine ali za katero od pomožnih snovi - nosečnost in dojenje (glejte poglavje 4.6)
English: - If the confirmed aPTT value is above the target range, the infusion should be stopped for two hours.
Slovenian: - Če potrjena vrednost aPTT presega ciljno območje, je treba infundiranje za 2 uri prekiniti.
English: Elimination follows a first order process and is characterised by a terminal half-life of about 1.3 hours in young healthy volunteers.
Slovenian: Izločanje poteka po kinetiki prvega reda; končna razpolovna doba pri zdravih mladih prostovoljcih je približno 1,3 ure.
English: Severe bleeding may lead to decreased volume of circulating blood, low blood pressure, shock, and their clinical sequelae.
Slovenian: Huda krvavitev lahko privede do zmanjšanja količine krvi v obtoku, padca krvnega tlaka, šoka in s temi pojavi povezanih kliničnih posledic.
English: Lepirudin ([Leu1, Thr2]-63-desulfohirudin) is a recombinant hirudin derived from yeast cells.
Slovenian: Lepirudin ([Leu1, Thr2]-63-desulfohirudin) je rekombinantni hirudin, pridobljen iz celic kvasovk).
English: You should also inform your doctor if you have ever received Refludan, hirudin or a hirudin analogue.
Slovenian: Svojega zdravnika morate obvestiti tudi, če ste že kdaj dobivali Refludan, hirudin ali kak hirudinski analog.
English: In any case, the bolus dose must be reduced to 0.2 mg / kg body weight.
Slovenian: V vsakem primeru je treba bolusni odmerek zmanjšati na 0,2 mg/kg telesne mase.
English: The systemic clearance of lepirudin decreases in proportion to the existing glomerular filtration rate.
Slovenian: Sistemski očistek lepirudina pada sorazmerno s stopnjo prisotne glomerularne filtracije.
English: Initial intravenous bolus:
Slovenian: Začetni intravenski bolus:
English: Treatment with Refludan should be initiated under the guidance of a physician with experience in coagulation disorders.
Slovenian: Zdravljenje z Refludanom se mora pričeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem koagulacijskih motenj.
English: It may result in a too low number of blood platelets and/or clots in your blood vessels (thrombosis).
Slovenian: Posledica je lahko premajhno število trombocitov in/ali strdki v krvnih žilah (tromboza).
English: - The first aPTT determination should be done 4 hours after start of Refludan therapy.
Slovenian: - Prvo določanje vrednosti aPTT se mora opraviti 4 ure po začetku zdravljenja z Refludanom.
English: avoid or STOP infusion !
Slovenian: izogibajte se uporabi ali PREKINITE infundiranje*
English: Injection vial:
Slovenian: Injekcijska viala:
English: Rare (less than 1 in 1,000 people affected) - Allergic skin reactions (including rash), itching, hot flushes, fever, chills.
Slovenian: Redki (pojavijo se pri manj kot 1 od 1000 bolnikov) - alergijske kožne reakcije (vključno z izpuščajem), srbečica, navali vročine, zvišana telesna temperatura, mrzlica.
English: Pharmacotherapeutic group: Antithrombotic agent - direct thrombin inhibitor, ATC Code: B01AE02
Slovenian: Farmakoterapevtska skupina: Antitrombotiki - direktni zaviralci trombina, oznaka ATC: B01AEO2
English: Additional aPTT monitoring is mandatory.
Slovenian: Obvezno je dodatno spremljanje vrednosti aPTT.
English: Please inform your doctor if you suffer from reduced kidney function or liver cirrhosis (advanced disease of the liver) for he will then reduce the dosage.
Slovenian: Prosimo, obvestite svojega zdravnika, če imate zmanjšano delovanje ledvic ali jetrno cirozo (napredovalo jetrno bolezen), ker vam bo ustrezno zmanjšal odmerek zdravila.
English: In elderly patients the systemic clearance of lepirudin is about 25 % lower as compared to younger patients.
Slovenian: Pri starejših bolnikih je sistemski očistek lepirudina približno 25 % nižji kot pri mlajših bolnikih.
English: Severe bleeding and, in particular, intracranial bleeding may be fatal.
Slovenian: Hude krvavitve, zlasti pa možganske, so lahko usodne.
English: Concomitant use with - antiplatelet agents other than acetylsalicylic acid, such as ticlopidine or clopidogrel, - GpIIb/IIIa receptor antagonists such as eptifibatide, tirofiban, or abciximab, - other thrombin inhibitors such as low molecular weight heparins has not been assessed.
Slovenian: Sočasna uporaba z - zaviralci agregacije trombocitov (razen acetilsalicilne kisline), kot so tiklopidin ali klopidogrel, - antagonisti receptorjev GpIIb/IIIa, kot so eptifibatid, tirofiban ali abciksimab, - drugimi zaviralci trombina, kot so nizkomolekularni heparini, ni bila ocenjena.
English: 3 minutes.
Slovenian: minutah.
English: Refludan, once reconstituted with an appropriate solvent, will be administered into a vein, by injection and then by infusion.
Slovenian: Ko Refludan rekonstituirajo z ustreznim topilom, ga vnesejo v žilo s pomočjo injekcije in nato z infuzijo.
English: Hot flushes Shock including fatal shock
Slovenian: Šok, vključno s šokom s smrtnim izidom
English: Further dilution is necessary prior to use.
Slovenian: Pred uporabo je potrebno dodatno redčenje.
English: In the indication HIT type II with thromboembolic disease (125 patients) the overall mortality during the study period was approximately 9 % while amputations and new thromboembolic complications were recorded in 6 % and 10 %, respectively.
Slovenian: Pri indikaciji HIT tipa II s tromboembolijo (125 bolnikov) je skupna umrljivost v času raziskave znašala približno 9 %, medtem ko so amputacije zabeležili pri 6 %, nove tromboembolične zaplete pa pri 10 % bolnikov.
English: This may result in an enhanced anticoagulant effect of lepirudin, possibly due to delayed renal elimination of active lepirudin-antihirudin complexes.
Slovenian: To lahko privede do povečanega antikoagulacijskega učinka lepirudina, verjetno zaradi podaljšanega izločanja aktivnih kompleksov lepirudin-antihirudin.
English: Antibodies against hirudin which appeared in several of the treated monkeys resulted in prolongation of the terminal half-life and an increase in systemic exposure to lepirudin.
Slovenian: Protitelesa proti hirudinu, ki so se pojavila pri mnogih opicah, ki so prejemale zdravilo, so imela za posledico podaljšanje končne razpolovne dobe in povečanje sistemske izpostavljenosti lepirudinu.
English: Only if aPTT values have fallen below the lower therapeutic limit (see Monitoring: target range), further intravenous bolus doses of 0.1 mg / kg body weight may be considered every other day.
Slovenian: Samo v primeru, če so se vrednosti aPTT zmanjšale pod spodnjo terapevtsko mejo (glejte Spremljanje in nadzor: ciljno območje), je dovoljena nadaljnja uporaba intravenskih bolusnih odmerkov po 0,1 mg/kg telesne mase vsak drugi dan.
English: Infusion speed [ml/h]
Slovenian: Infuzijska hitrost [ml/h]
English: The infusion rate must be reduced according to table 1.
Slovenian: Hitrost infundiranja je treba zmanjšati, kot je navedeno v preglednici 1.
English: Antithrombotics are medicines to prevent formation of blood clots (thrombosis).
Slovenian: Antitrombotiki so zdravila, ki preprečujejo nastajanje krvnih strdkov (trombozo).
English: - The preparation should be warmed to room temperature before administration.
Slovenian: - Pred uporabo je treba zdravilo ogreti do sobne temperature.
English: At restart, the infusion speed should be decreased by 50 % (no additional intravenous bolus should be administered).
Slovenian: Po ponovnem začetku infundiranja je treba hitrost infundiranja zmanjšati za 50 % (brez dajanja dodatnega i.v.
English: Where there is active bleeding or bleeding tendency it is generally not advisable to administer Refludan.
Slovenian: V primeru akutne krvavitve ali nagnjenosti h krvavitvam uporaba Refludana običajno ni priporočljiva.
English: Medicines given to break up clots or tablets to prevent clot formation (coumarins) may increase the risk of bleeding when given at the same time.
Slovenian: Zdravila, ki so namenjena raztapljanju strdkov, ali tablete za preprečevanje njihovega nastajanja (kumarini) lahko povečajo tveganje krvavitev, kadar se dajejo sočasno.
English: As these reactions are immune-mediated, patients with recent exposure to hirudin or hirudin analog may be at an increased risk.
Slovenian: Ker so te reakcije imunsko pogojene, obstaja povečano tveganje pri bolnikih, ki so bili pred nedavnim izpostavljeni hirudinu ali analogu hirudina.
English: Treatment initiation with Refludan should be undertaken only in a setting where medical assistance is readily available and where there is access to treatment for anaphylactic reactions.
Slovenian: Zdravljenje z Refludanom se mora začeti v ustanovi, kjer je v vsakem trenutku na voljo zdravniška pomoč in kjer je dostopno vse potrebno za zdravljenje anafilaktičnih reakcij.
English: Table 1: Reduction of infusion rate in patients with renal impairment
Slovenian: Preglednica 1: Zmanjšanje hitrosti infundiranja pri bolnikih z okvaro ledvic
English: Fatal anaphylactic reactions have been reported in patients re-exposed to Refludan in a second or subsequent treatment course.
Slovenian: Poročajo o usodnih anafilaktičnih reakcijah pri bolnikih, ki so bili ob drugem ali nadaljnjih terapevtskih ciklusih ponovno izpostavljeni Refludanu.
English: Therefore, alternative treatment options must be considered before the decision to re-expose a patient to Refludan.
Slovenian: Zato je pred odločitvijo za ponovno izpostavitev bolnika Refludanu treba upoštevati možnost drugih načinov zdravljenja.
English: Concomitant treatment with thrombolytics (e.g. rt-PA or streptokinase) may - increase the risk of bleeding complications - considerably enhance the effect of Refludan on aPTT prolongation.
Slovenian: Sočasno zdravljenje s trombolitiki (npr. rt-PA ali streptokinazo) lahko: - poveča tveganje zapletov s krvavitvami - značilno poveča učinek Refludana na podaljšanje aPTT.
English: Serious liver injury (e.g. liver cirrhosis) may enhance the anticoagulant effect of lepirudin due to coagulation defects secondary to reduced generation of vitamin K-dependent coagulation factors.
Slovenian: Resna okvara jeter (npr. jetrna ciroza) lahko poveča antikoagulacijski učinek lepirudina zaradi koagulacijskih defektov, ki so posledica zmanjšane tvorbe od vitamina K odvisnih koagulacijskih faktorjev.
English: - if you are pregnant or breast-feeding.
Slovenian: Refludan - če ste noseči ali dojite.
English: As a result all thrombin dependent coagulation assays are affected, e.g. the aPTT values increase in a dose-dependent fashion.
Slovenian: To vpliva na vse od trombina odvisne koagulacijske teste; vrednosti aPTT se npr. povečajo sorazmerno z odmerkom.
English: The diagnosis should be confirmed by the HIPAA (heparin induced platelet activation assay) or an equivalent test.
Slovenian: Diagnoza mora biti potrjena s testom aktivacije trombocitov s heparinsko indukcijo (HIPAA) ali z drugim enakovrednim testom.
English: In a standard embryo-foetal toxicity trial, decreased pup and maternal survival was observed.
Slovenian: V standardnem preskušanju toksičnosti za zarodek in plod je bilo ugotovljeno zmanjšano preživetje zaroda in matere.
English: Moreover, in rats slight to moderate sinushistiocytosis of the regional lymph nodes and decreased haemosiderin deposits in the spleen were observed.
Slovenian: Poleg tega so pri podganah opazili blago do zmerno histiocitozo regionalnih bezgavk in zmanjšane zaloge hemosiderina v vranici.
English: - Target range (therapeutic window) for the aPTT: - Using "Actin FS" or "Neothromtin" on automated coagulometers the target range for the aPTT is 1.5 fold to 3 fold prolongation of the normal control value.
Slovenian: - Ciljno območje (terapevtsko okno) za aPTT: - Ob uporabi reagentov »Actin FS« ali »Neothromtin« na avtomatiziranih merilcih koagulacije je bilo ciljno območje za aPTT od 1,5- do 3-krat daljši od normalnih kontrolnih vrednosti.
English: - There is no experience with lepirudin in patients with significant liver impairment.
Slovenian: - Ni poročil o izkušnjah z lepirudinom pri bolnikih s pomembno okvaro jeter.
English: - Elderly: Patients of advanced age have an increased risk of bleeding complications with anticoagulation.
Slovenian: - Starostniki: Pri starejših bolnikih je tveganje zapletov s krvavitvami zaradi antikoagulacijske terapije večje.
English: In patients with terminal renal insufficiency prolonged elimination half-lives of about 2 days were observed.
Slovenian: Pri bolnikih z zadnjim stadijem ledvične insuficience opažajo, da se razpolovna doba podaljša na približno 2 dni.
English: In monkeys retinal haemorrhages occurred.
Slovenian: Pri opicah so se pojavile mrežnične krvavitve.
English: - Experience of combined therapy with thrombolytic agents in patients with HIT type II is very limited.
Slovenian: - Izkušenj s kombinirano terapijo s trombolitičnimi zdravili pri bolnikih s HIT tipa II je zelo malo.
English: Recommendations for use in patients with renal impairment
Slovenian: Priporočila za uporabo pri bolnikih z okvaro ledvic
English: Both, excretion and metabolism take place in the kidney, and about 45 % of the dose administered is detectable in the urine.
Slovenian: Tako izločanje kot presnova potekata v ledvicah in približno 45 % apliciranega odmerka prehaja v urin.
English: - Injection site reactions, including pain.
Slovenian: - reakcije na mestu injiciranja, vključno z bolečino.
English: * In haemodialysis patients or in case of acute renal failure (creatinine clearance below 15 ml/min or creatinine value above 60 mg/l [530 mol/l]), infusion of Refludan is to be avoided or stopped.
Slovenian: * Pri bolnikih na hemodializi ali v primeru akutne odpovedi ledvic (očistek kreatinina pod 15 ml/min ali vrednost kreatinina nad 60 mg/l [530 (mol/l]) se je treba infundiranju Refludana izogibati ali ga prekiniti.
English: The safety of Refludan for use in human pregnancy or lactation has not been established.
Slovenian: Varnosti Refludana med nosečnostjo ali v obdobju dojenja pri ljudeh niso ugotavljali.
English: Colourless glass vial (glass type I) sealed with bromobutyl rubber infusion stopper, plastic flip-off cap and aluminium cap.
Slovenian: Brezbarvna steklena viala (steklo tipa I), zaprta s klorbutilnim infuzijskim zamaškom iz gume, plastično zaščitno zaporko in aluminijastim pokrovčkom.
English: - To obtain specific and exact aPTT limits, the laboratory equipment / test reagent used may be calibrated by spiking standardised human plasma with 0.15 g/ml lepirudin (lower limit) and 1.5 g/ml lepirudin (upper limit).
Slovenian: - Da bi dobili specifične in točne mejne vrednosti aPTT, se lahko laboratorijsko opremo / uporabljeni testni reagent kalibrira tako, da se standardizirano humano plazmo obdela z 0,15 g/mL lepirudina (spodnja meja) in 1,5 g/mL lepirudina (zgornja meja).
English: What Refludan is and what it is used for Before you use Refludan How to use Refludan Possible side effects 5 How to store Refludan Further information
Slovenian: Kaj je Refludan in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili Refludan Kako uporabljati zdravilo Refludan Možni neželeni učinki