FrancophonIA/ELRC3.0 huggingface dataset:
English: United Kingdom sanofi-aventis Cyprus Ltd.
Croatian: Κύπρος sanofi-aventis Cyprus Ltd.
English: After this period of time, testing should be performed based on clinical findings suggestive of nephropathies.
Croatian: Nakon tog razdoblja moraju se provesti testiranja na temelju kliničkih nalaza koji upućuju na nefropatije.
English: Suspected autoimmune cytopenias such as neutropenia, haemolytic anaemia and pancytopenia have been infrequently reported in clinical trials in MS.
Croatian: Suspektne autoimune citopenije, poput neutropenije, hemolitičke anemije i pancitopenije, nisu često prijavljene u kliničkim ispitivanjima multiple skleroze.
English: These can be diagnosed from the blood tests that you will be having regularly after LEMTRADA treatment.
Croatian: One se mogu dijagnosticirati na temelju pretraga krvi koje ćete redovito provoditi nakon liječenja lijekom LEMTRADA.
English: • potassium dihydrogen phosphate (E340)
Croatian: • kalijev dihidrogenfosfat (E340)
English: • ITP (bleeding disorders), (common - may affect up to 1 in 10 people): may show as small scattered red, pink or purple spots on your skin; easy bruising; bleeding from a cut that is harder to stop; heavier, longer or more frequent menstrual periods than normal; bleeding between menstrual periods; bleeding from your gums or nose that is new or takes longer than usual to stop; or coughing up blood.
Croatian: na 100 osoba): može se manifestirati kao spontano stvaranje modrica, krvarenja iz nosa, bolni ili otečeni zglobovi, druge vrste krvarenja ili krvarenje iz posjekotine kojem treba dulje nego obično da se zaustavi. • ITP (poremećaj krvarenja) (često - može se javiti u manje od 1 na 10 osoba): može se manifestirati kao male, mjestimične crvene, ružičaste ili ljubičaste točkice na koži, lako stvaranje modrica; krvarenje iz posjekotine koje se teško zaustavlja; obilnije, dulje ili češće mjesečnice nego obično; krvarenje između mjesečnica; krvarenje iz desni ili nosa koje je novo ili treba dulje nego obično da se zaustavi; ili iskašljavanje krvi.
English: Study 4, was a Phase 3, multicenter, open-label, rater-blinded, efficacy and safety extension study for patients with RRMS who participated in Study 1, 2, or 3 (prior phase 3 and 2 studies) to assess long-term efficacy and safety of LEMTRADA.
Croatian: Podaci o dugoročnoj djelotvornosti Ispitivanje 4 bilo je multicentrični, otvoreni nastavak ispitivanja djelotvornosti i sigurnosti faze 3 u kojem ocjenjivači nisu znali koji bolesnik prima koji lijek u bolesnika s relapsno-remitentnom multiplom sklerozom koji su sudjelovali u Ispitivanjima 1, 2 i 3 (prethodna ispitivanja faze 3 i 2) kako bi se procijenila dugoročna djelotvornost i sigurnost lijeka LEMTRADA.
English: Prophylaxis with an oral anti-herpes agent should be initiated starting on the first day of LEMTRADA treatment and continuing for a minimum of 1 month following each course of treatment.
Croatian: Profilaksa peroralnim lijekom protiv herpesa mora se uvesti prvoga dana liječenja lijekom LEMTRADA i primjenjivati najmanje mjesec dana nakon svakog ciklusa liječenja.
English: For these reasons, comparison of the incidence of antibodies to LEMTRADA with the incidence of antibodies to other products may be misleading.
Croatian: Zbog toga usporedba incidencije protutijela na lijek LEMTRADA s incidencijom protutijela na druge lijekove može odvesti na krivi trag.
English: In the majority of cases time to onset was within 1-3 days of the LEMTRADA infusion.
Croatian: U većini slučajeva vrijeme do pojave nuspojava bilo je unutar 1-3 dana nakon primjene lijeka LEMTRADA.
English: • Patients should be premedicated with corticosteroids immediately prior to LEMTRADA infusion for the first 3 days on any treatment course.
Croatian: • Bolesnici moraju primiti premedikaciju kortikosteroidima neposredno prije primjene infuzije lijeka LEMTRADA tijekom prva 3 dana svakog ciklusa liječenja.
English: Your doctor can also prescribe a medicine for cold sores (see section 2: What you need to know before you are administered LEMTRADA - Infections).
Croatian: Liječnik Vam također može propisati lijek za herpes (pogledajte dio 2.: Što morate znati prije nego počnete primjenjivati lijek LEMTRADA
English: Uncommonly, patients developed a bleeding disorder caused by antibodies that work against factor VIII (a protein needed for normal clotting of blood), called acquired hemophilia A. This condition must be diagnosed and treated immediately.
Croatian: Bolesnici su manje često razvili poremećaj krvarenja uzrokovan protutijelima koja su usmjerena protiv faktora VIII (protein potreban za normalno zgrušavanje krvi) koji se zove stečena hemofilija A.
English: Positive samples were further evaluated for evidence of in vitro inhibition using a flow cytometry assay.
Croatian: Pozitivni uzorci dodatno su ocijenjeni testom protočne citometrije, s ciljem pronalaženja dokaza moguće inhibicije in vitro.
English: Relapse Rate1
Croatian: Onesposobljenost1
English: • kidney stones, excretion of ketone bodies in urine, kidney disease
Croatian: • bubrežni kamenci, izlučivanje ketonskih tijela u mokraći, bolest bubrega
English: Before treatment, patients must be informed about the risks and benefits, and the need to commit to follow-up from treatment initiation until at least 48 months after the last infusion of the second LEMTRADA treatment course.
Croatian: Bolesnici prije liječenja moraju biti informirani o rizicima i koristima te o nužnosti da pristanu na praćenje od početka liječenja do najmanje 48 mjeseci nakon posljednje infuzije u drugom ciklusu liječenja lijekom LEMTRADA.
English: • Infections: airway infections such as colds and sinus infections, urinary tract infections, herpes infections
Croatian: • Infekcije: infekcije dišnih puteva, kao što su prehlade i infekcije sinusa, infekcije mokraćnih putova, infekcije herpesom
English: LEMTRADA treatment should only be initiated and supervised by a neurologist experienced in the treatment of patients with multiple sclerosis in a hospital with ready access to intensive care.
Croatian: Liječenje lijekom LEMTRADA smije započeti i nadgledati samo neurolog koji ima iskustva u liječenju bolesnika s multiplom sklerozom u bolnici s dostupnim pristupom intenzivnoj njezi.
English: The study was declared successful if at least one of the two coprimary endpoint was met. 2 CDW was defined as an increase of at least 1 point on the expanded disability status scale (EDSS) from a baseline EDSS score ≥1.0 (1.5 point increase for patients with baseline EDSS of 0) that was sustained for 6 months.
Croatian: 2 CDW je definiran kao povećanje od najmanje 1 boda na ljestvici proširenja stupnja onesposobljenosti (engl. expanded disability status scale, EDSS) u odnosu na početni rezultat na EDSS ljestvici ≥ 1,0 (povećanje od 1,5 boda u bolesnika u kojih je početni rezultat na EDSS ljestvici iznosio 0) koje se održalo tijekom 6 mjeseci.
English: Weight decreased, weight increased, red blood cell count decreased, bacterial test positive, blood glucose increased, mean cell volume increase
Croatian: povećanje tjelesne težine, smanjen broj crvenih krvnih stanica, pozitivan test na bakterije, povišena vrijednost glukoze u krvi,
English: The diluted solution should be administered by intravenous infusion over a period of approximately 4 hours.
Croatian: Razrijeđena otopina primjenjuje se intravenskom infuzijom tijekom razdoblja od približno 4 sata.
English: Cytokine release syndrome*, hypersensitivity including anaphylaxis*
Croatian: Poremećaji imunološkog sustava sindrom otpuštanja citokina*, preosjetljivost uključujući anafilaksiju*
English: In some patients there was increased blood pressure from baseline before the haemorrhage.
Croatian: Neki bolesnici su prije hemoragije imali povišen krvni tlak u odnosu na početnu vrijednost.
English: Screening patients at high risk of HBV and/or HCV infection before initiation of LEMTRADA should be considered and caution should be exercised in prescribing LEMTRADA to patients identified as carriers of HBV and/or HCV as these patients may be at risk of irreversible liver damage relative to a potential virus reactivation as a consequence of their pre-existing status.
Croatian: Nužan je oprez pri propisivanju lijeka LEMTRADA bolesnicima za koje se utvrdilo da su nositelji HBV-a i/ili HCV-a, jer ti bolesnici mogu biti izloženi riziku od ireverzibilnog oštećenja jetre povezanog s mogućom reaktivacijom virusa kao posljedicom svog postojećeg stanja.
English: Patients had an EDSS from 0-3.0, at least 2 clinical episodes of MS in the prior 2 years, and ≥1 gadolinium-enhancing lesion at study entry.
Croatian: U trenutku uključivanja u ispitivanje bolesnici su imali EDSS rezultat 0-3,0, najmanje 2 kliničke epizode multiple skleroze tijekom prethodne 2 godine i ≥ 1 lezije naglašene gadolinijem.
English: o Immune Thrombocytopenic Purpura (ITP)
Croatian: o Imuna trombocitopenijska purpura (ITP)
English: What you need to know before you are administered LEMTRADA 3.
Croatian: Što morate znati prije nego počnete primjenjivati lijek LEMTRADA
English: There is little or no CD52 detected on neutrophils, plasma cells, or bone marrow stem cells.
Croatian: CD52 nije uopće prisutan ili je prisutan u vrlo maloj mjeri na neutrofilima, stanicama plazme ili matičnim stanicama u koštanoj srži.
English: LEMTRADA treatment should only be initiated and supervised by a neurologist experienced in the treatment of patients with multiple sclerosis (MS) in a hospital with ready access to intensive care.
Croatian: Liječenje lijekom LEMTRADA smije započeti i nadgledati samo neurolog koji ima iskustva u liječenju bolesnika s multiplom sklerozom (MS) u bolnici s dostupnim pristupom intenzivnoj njezi.
English: If you experience multiple symptoms such as fever, swollen glands, bruising, or skin rash, contact your doctor immediately.
Croatian: Ako doživite više simptoma kao što su vrućica, otečene žlijezde, pojava modrica ili osip na koži, odmah se obratite svom liječniku.
English: Therefore, breast-feeding should be discontinued during each course of treatment with LEMTRADA and for 4 months following the last infusion of each treatment course.
Croatian: Stoga dojenje treba prekinuti tijekom svakog ciklusa liječenja lijekom LEMTRADA i 4 mjeseca nakon posljednje infuzije u sklopu svakog ciklusa liječenja.
English: In clinical trials, infusion associated reactions (IARs) were defined as any adverse event occurring during or within 24 hours of LEMTRADA infusion.
Croatian: U kliničkim ispitivanjima, reakcije povezane s infuzijom opisuju se kao bilo koja nuspojava koja se pojavi tijekom infuzije lijeka LEMTRADA ili unutar 24 sata nakon nje.
English: IARs may occur in patients despite pretreatment.
Croatian: Reakcije povezane s infuzijom mogu se javiti u bolesnika unatoč premedikaciji.
English: LEMTRADA 12 mg sterile concentrate alemtuzumab
Croatian: LEMTRADA 12 mg sterilni koncentrat alemtuzumab i.v.
English: HLH is characterized by fever, hepatomegaly and cytopenias.
Croatian: HLH je karakterizirana vrućicom, hepatomegalijom i citopenijama.
English: Each vial contains 12 mg alemtuzumab in 1.2 ml.
Croatian: Jedna bočica sadrži 12 mg alemtuzumaba u 1,2 ml.
English: Information about some specific conditions that have been seen in MS patients who have been treated with LEMTRADA is provided below.
Croatian: Informacije o nekim specifičnim bolestima koje su primijećene u oboljelih od multiple skleroze liječenih lijekom LEMTRADA navedene su u nastavku.
English: The frequency of PML in BCLL patients treated with alemtuzumab is no greater than the background frequency.
Croatian: Učestalost PML-a u bolesnika s B-KLL-om liječenih alemtuzumabom nije veća od osnovne učestalosti.
English: Immune Thrombocytopenic Purpura (ITP)
Croatian: Imuna trombocitopenijska purpura (ITP)
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
English: How to store LEMTRADA
Croatian: Kako čuvati lijek LEMTRADA
English: • disodium phosphate dihydrate (E339)
Croatian: • natrijev hidrogenfosfat dihidrat (E339)
English: MRI Endpoints (0-2 years)
Croatian: MRI ishodi (0-2 godine) Medijan % promjene volumena
English: Non-interventional post-authorisation safety study (PASS): In order to assess compliance with the therapeutic indication and effectiveness of measures to minimise the risk of cardiovascular and cerebrovascular adverse events in close temporal association with Lemtrada infusion and immune-mediated adverse reactions, the MAH shall submit the results of a drug utilisation study.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon stavljanja u promet (PASS): Kako bi se procijenila usklađenost s terapijskom indikacijom i učinkovitost mjera za minimizaciju rizika od kardiovaskularnih i cerebrovaskularnih štetnih događaja usko vremenski povezanih s infuzijom lijeka
English: Potassium chloride (E508) Potassium dihydrogen phosphate (E340) Polysorbate 80 (E433) Sodium chloride
Croatian: 6.1 Popis pomoćnih tvari natrijev hidrogenfosfat dihidrat (E339) dinatrijev edetat kalijev klorid (E508) kalijev dihidrogenfosfat (E340) polisorbat 80 (E433) natrijev klorid voda za injekcije
English: Patients should be informed about the signs and symptoms and on the time to onset of the events.
Croatian: Bolesnike treba uputiti da obrate pažnju na znakove i simptome i o vremenu do nastanka tih nuspojava.
English: In controlled clinical trials two MS patients accidentally received up to 60 mg LEMTRADA (i.e. total dose for initial treatment course) in a single infusion and experienced serious reactions (headache, rash, and either hypotension or sinus tachycardia).
Croatian: 60 mg lijeka LEMTRADA (tj. ukupnu dozu za početni ciklus liječenja) u jednoj infuziji te su se u njih javile ozbiljne reakcije (glavobolja, osip i hipotenzija ili sinusna tahikardija).
English: As with other immunomodulating therapies, potential combined effects on the patient's immune system should be taken into account when considering administration of LEMTRADA.
Croatian: potencijalni kombinirani učinak na imunološki sustav bolesnika mora se uzeti u obzir kada se razmatra primjena lijeka LEMTRADA.
English: During post-marketing use, additional cases of acute acalculous cholecystitis have been reported in LEMTRADA-treated patients.
Croatian: Nakon stavljanja lijeka u promet, prijavljeni su dodatni slučajevi akutnog akalkuloznog kolecistitisa u bolesnika liječenih lijekom LEMTRADA.
English: Autoimmune events reported in alemtuzumab-treated patients include neutropenia, haemolytic anaemia (including a fatal case), acquired haemophilia, anti-GBM disease, and thyroid disease.
Croatian: Autoimuni događaji prijavljeni u bolesnika liječenih alemtuzumabom uključuju neutropeniju, hemolitičku anemiju (uključujući smrtni slučaj), stečenu hemofiliju, anti-GBM bolest i bolest štitnjače.
English: The incidence of IARs was higher in course 1 than in subsequent courses.
Croatian: Incidencija reakcija povezanih s infuzijom bila je viša u prvom ciklusu nego u narednim ciklusima.
English: There is 1 vial in each carton.
Croatian: Jedno pakiranje sadrži 1 bočicu.
English: • red and white blood cells disorders (uncommon - may affect up to 1 in 100 people): diagnosed from your blood tests.
Croatian: • poremećaji crvenih i bijelih krvnih stanica (manje često - mogu se javiti u manje od 1 na 100
English: Missed LEMTRADA doses
Croatian: Propuštena doza lijeka LEMTRADA
English: In female mice dosed with intravenous alemtuzumab up to 10 mg/kg/day (AUC of 4.7 times the human exposure at the recommended daily dose) for 5 consecutive days prior to cohabitation with wild-type male mice, the average number of corpora lutea and implantation sites per mouse were significantly reduced as compared to vehicle treated animals.
Croatian: U ženki miševa, koje su primale intravenski alemtuzumab u dozama do 10 mg/kg na dan (AUC 4,7 puta veći od izloženosti u ljudi pri preporučenoj dnevnoj dozi) tijekom 5 uzastopnih dana prije kohabitacije s mužjacima miševa divljeg tipa, prosječan broj žutih tijela i mjesta usadnje po ženki bio je značajno manji nego u životinja koje su primale vehikulum.
English: Remind the patient to remain vigilant for symptoms related to autoimmune conditions, and to seek medical help if they have any concerns.
Croatian: Podsjetite bolesnika da pripazi na pojavu simptoma povezanih s autoimunim stanjima i da potraži liječničku pomoć u slučaju bilo kakvih pitanja.
English: Treatment with LEMTRADA may increase the risk for autoimmune conditions.
Croatian: Liječenje lijekom LEMTRADA može povećati rizik od razvoja autoimunih bolesti.
English: Treatment-naïve patients Patients with inadequate response to prior therapy*
Croatian: Bolesnici koji nisu dovoljno dobro reagirali na prethodno liječenje*
English: It is unknown whether alemtuzumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se alemtuzumab u majčino mlijeko u ljudi.
English: Patients with a history of arterial dissection of the cervicocephalic arteries.
Croatian: Bolesnici s arterijskom disekcijom cervikocefaličnih arterija u povijesti bolesti.
English: Most patients treated with LEMTRADA will experience side-effects at the time of the infusion or within 24 hours after the infusion.
Croatian: U većine bolesnika liječenih lijekom LEMTRADA javit će se nuspojave tijekom infuzije ili unutar 24 sata nakon nje.
English: While not observed in clinical trials, alveolar haemorrhage manifested as haemoptysis may occur with anti-GBM disease.
Croatian: Iako nije zabilježeno u kliničkim ispitivanjima, uz anti-GBM bolest može se javiti alveolarno krvarenje u obliku hemoptize.
English: Pneumonitis has been reported in patients who received LEMTRADA infusions.
Croatian: Pneumonitis je prijavljen u bolesnika koji su primili infuziju lijeka LEMTRADA.
English: Most cases occurred within 2 months of alemtuzumab dosing.
Croatian: Najviše slučajeva pojavilo se unutar 2 mjeseca od početka liječenja alemtuzumabom.
English: Thyroid function tests, such as thyroid stimulating hormone levels, should be obtained prior to initiation of treatment and every 3 months thereafter until 48 months following the last infusion.
Croatian: Pretrage funkcije štitnjače, poput određivanja razine hormona koji stimulira štitnjaču, treba provesti prije početka liječenja i svaka tri mjeseca nakon toga, sve do 48 mjeseci nakon posljednje infuzije.
English: − if you are allergic to alemtuzumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na alemtuzumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako ste zaraženi virusom humane imunodeficijencije (HIV) - ako bolujete od ozbiljne infekcije
English: • acne, redness of the skin, excessive sweating, skin discoloration, skin lesion, dermatitis
Croatian: • akne, crvenilo kože, prekomjerno znojenje, promjena boje kože, oštećenje kože, dermatitis
English: Summary of tests you will have for autoimmune conditions: Test
Croatian: Sažetak pretraga koje ćete obavljati radi otkrivanja autoimunih bolesti:
English: Patients treated with LEMTRADA are at a higher risk of getting a serious infection (see section 4infections).
Croatian: U bolesnika liječenih lijekom LEMTRADA postoji veći rizik od razvoja ozbiljne infekcije (vidjeti dio 4. - infekcije).
English: These are the side effects that you may experience:
Croatian: Nuspojave koje se mogu javiti su sljedeće:
English: Most patients treated with LEMTRADA in clinical trials in MS experienced mild to moderate IARs during and/or up to 24 hours after LEMTRADA 12 mg administration.
Croatian: U većine bolesnika liječenih lijekom LEMTRADA u kliničkim ispitivanjima multiple skleroze javile su se blage do umjerene reakcije povezane s infuzijom tijekom i/ili unutar 24 sata nakon primjene lijeka LEMTRADA u dozi od 12 mg.
English: Symptoms of acquired hemophilia A are described in section 4.
Croatian: Simptomi stečene hemofilije A opisani su u dijelu 4.
English: In alignment with the effect on relapse rate, supportive analyses from Study 1 (CAMMS323) showed that LEMTRADA 12 mg/day led to significantly fewer LEMTRADA -treated patients experiencing severe relapses (61% reduction, p=0.0056) and signficantly fewer relapses that led to steroid treatment (58%
Croatian: U skladu s učinkom na stopu relapsa, suportivne analize iz Ispitivanja 1 (CAMMS323) pokazale su da je primjena lijeka LEMTRADA u dozi od 12 mg/dan značajno smanjila broj bolesnika liječenih lijekom LEMTRADA u kojih je došlo do teških relapsa (smanjenje za 61%, p=0,0056) kao i broj relapsa koji iziskuju liječenje steroidima (smanjenje za 58%, p<0,0001) u usporedbi s primjenom IFNB-1a.
English: Severe anaphylaxis and other hypersensitivity reactions, including anaphylactic shock and angioedema have also been reported.
Croatian: Također su prijavljeni teška anafilaksija i druge reakcije preosjetljivosti,
English: Contact details of the prescriber of LEMTRADA
Croatian: Podatke za kontakt osobe koja je propisala lijek LEMTRADA
English: Lymphopenia, leukopenia, including neutropenia
Croatian: Pojava citopenije, uključujući neutropeniju,
English: 2 Herpes zoster infections include PTs: Herpes zoster, Herpes zoster cutaneous disseminated, Ophthalmic herpes zoster, Herpes ophthalmic, Herpes zoster infection neurological, Herpes zoster meningitis.
Croatian: 2 infekcije uzrokovane herpes zosterom uključuju preporučene pojmove: herpes zoster, diseminirani kožni herpes zoster, očni herpes zoster, neurološka infekcija uzrokovana herpes zosterom, meningitis uzrokovan herpes zosterom
English: • nose bleeds, bruises
Croatian: • krvarenja iz nosa, modrice
English: Whereas
Croatian: Međutim,
English: Cognitive, physical, and sexual development of pups exposed to alemtuzumab during lactation were not affected at doses up to 10 mg/kg/day alemtuzumab.
Croatian: Doze alemtuzumaba do 10 mg/kg na dan nisu utjecale na kognitivni, tjelesni ni seksualni razvoj mladunaca koji su alemtuzumabu bili izloženi tijekom laktacije.
English: • Thyroid disorders such as over-active or under-active thyroid gland
Croatian: • Poremećaji štitnjače kao npr. prekomjerno aktivna ili premalo aktivna štitnjača.
English: Name and address of the manufacturers responsible for batch release
Croatian: NJEMAČKA Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
English: The bag should be inverted gently to mix the solution.
Croatian: Nježno preokrenite infuzijsku vrećicu kako biste promiješali otopinu.
English: • Pre-infusion evaluations: o Obtain a baseline ECG and vital signs, including heart rate and blood pressure measurement.
Croatian: Potrebno je utvrditi početne vrijednosti EKG i vitalnih znakova, uključujući mjerenja pulsa i tlaka.
English: o coagulopathy, on antiplatelet or anti-coagulant therapy o concomitant autoimmune diseases other than multiple sclerosis.
Croatian: Bolesnici s poznatom koagulopatijom, na terapiji antitrombocitnim lijekovima ili antikoagulansima Bolesnici s istodobnim drugim autoimunim bolestima (osim multiple skleroze).
English: Blister, night sweats, swelling face, eczema
Croatian: • mjehurići, noćno znojenje, oticanje lica, ekcem
English: Thyroid disorders could be harmful to the baby (see section 2 Warnings and precautions - autoimmune conditions).
Croatian: Poremećaji štitnjače mogu biti štetni za dijete (pogledajte dio 2.
English: Forty-six patients received a third course of LEMTRADA treatment at 12 mg/day or 24 mg/day for 3 days at month 24.
Croatian: LEMTRADA u dozi od 12 mg/dan ili 24 mg/dan tijekom tri dana u 24. mjesecu.
English: This medicine contains less than 1 mmol potassium (39 mg) per infusion, i.e. it is essentially ‘potassiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (39 mg) kalija po infuziji, tj. zanemarive količine kalija.
English: • bleeding in lungs
Croatian: • krvarenje u plućima • srčani udar
English: Show the Patient Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
Croatian: Pokažite Karticu za bolesnika i ovu Uputu o lijeku svakom liječniku koji sudjeluje u Vašem liječenju,