FrancophonIA/ELRC3.0 huggingface dataset:
English: See LEMTRADA Health Care Professional Guide for more information, or read the summary of product characteristics available at the EMA website mentioned above.
Croatian: Za daljnje informacije pročitajte Vodič o lijeku LEMTRADA za zdravstvene radnike ili pročitajte sažetak opisa svojstava lijeka dostupan na prethodno navedenoj internetskoj stranici Europske agencije za lijekove.
English: Anti-GBM disease may lead to renal failure requiring dialysis and/or transplantation if not treated rapidly and can be life-threatening if left untreated.
Croatian: Anti-GBM bolest može uzrokovati zatajenje bubrega, zbog čega će biti potrebna dijaliza i/ili transplantacija ako se odmah ne liječi, te može biti opasna po život ako se ne liječi.
English: If you notice any of these signs or symptoms for bleeding or kidney disorders, call your doctor immediately to report the symptoms.
Croatian: Ako primijetite bilo koji od navedenih znakova ili simptoma poremećaja krvarenja ili bubrega, odmah nazovite svog liječnika kako biste mu prijavili simptome.
English: The observation of clinically significant changes from baseline in serum creatinine, unexplained haematuria, and/or proteinuria, should prompt further evaluation for nephropathies including immediate referral to a specialist.
Croatian: Ako se primijete klinički značajne promjene kreatinina u serumu u odnosu na početne vrijednosti, nerazjašnjena hematurija i/ili proteinurija, moraju se provesti dodatne pretrage za nefropatije, uključujući i trenutačno upućivanje bolesnika liječniku specijalistu.
English: Patients should be advised to seek immediate medical attention if any of these symptoms occur and be informed on the potential for delayed onset.
Croatian: Bolesnike treba savjetovati da potraže hitnu medicinsku pomoć ukoliko se pojavi bilo koji od simptoma i uputiti na mogućnost njihovog odgođenog nastanka.
English: Patients with Gadolinium enhancing lesions through Year 2
Croatian: Bolesnici s lezijama naglašenima gadolinijem tijekom 2. godine
English: • Urinalysis with microscopy (prior to treatment initiation and at monthly intervals thereafter)
Croatian: • Mikroskopska analiza mokraće (prije početka liječenja i u mjesečnim intervalima nakon toga)
English: The safety of immunisation with live viral vaccines following a course of LEMTRADA treatment has not been formally studied in controlled clinical trials in MS and should not be administered to MS patients who have recently received a course of LEMTRADA.
Croatian: Sigurnost imunizacije živim virusnim cjepivima nakon ciklusa liječenja lijekom LEMTRADA nije formalno ispitana u kontroliranim kliničkim ispitivanjima multiple skleroze, pa se takva cjepiva ne smiju primjenjivati u bolesnika s MS-om koji su nedavno primili terapiju lijekom LEMTRADA.
English: Serious endocrine events occurred in 4.4% of patients, with Basedow's disease (also known as Graves' disease), hyperthyroidism, hypothyroidism, autoimmune thyroiditis, and goitre occurring in more than 1 patient.
Croatian: Ozbiljni su se endokrini događaji javili u 4,4% bolesnika, a u više od 1 bolesnika javili su se Basedowljeva bolest (poznata i kao Gravesova bolest), hipertireoza, hipotireoza, autoimuni tireoiditis i gušavost.
English: After this period of time testing should be performed based on clinical findings suggestive of thyroid dysfunction or in case of pregnancy.
Croatian: Nakon tog razdoblja, pretrage treba provoditi na temelju kliničkih nalaza koji upućuju na poremećaj štitnjače ili u slučaju trudnoće.
English: Inject into 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Croatian: 100 ml otopine natrijevog klorida za infuziju od 9 mg/ml (0,9%) ili otopine glukoze za infuziju (5%).
English: It is recommended that the diluted product be administered immediately.
Croatian: Preporučuje se odmah primijeniti razrijeđeni lijek.
English: In the post-marketing setting several patients who developed biopsy proven AIH had previously developed autoimmune thyroid disorders.
Croatian: U razdoblju nakon stavljanja lijeka u promet, nekoliko bolesnika koji su razvili autoimuni hepatitis utvrđen biopsijom prethodno su razvili autoimune poremećaje štitnjače.
English: • A test of thyroid function, such as thyroid stimulating hormone level (prior to treatment initiation and every 3 months thereafter).
Croatian: • Pretraga funkcije štitnjače, kao što je razina hormona koji stimulira rad štitnjače (prije početka liječenja i svaka 3 mjeseca nakon toga)
English: The pharmacokinetics of alemtuzumab were evaluated in a total of 216 patients with RRMS who received intravenous infusions of either 12 mg/day or 24 mg/day on 5 consecutive days, followed by 3 consecutive days 12 months following the initial treatment course.
Croatian: Farmakokinetika alemtuzumaba ocijenjena je u ukupno 216 bolesnika s RRMS-om koji su primali intravenske infuzije u dozi od 12 mg/dan ili 24 mg/dan u 5 uzastopnih dana, te zatim tijekom 3 uzastopna dana 12 mjeseci nakon prvog ciklusa liječenja.
English: Serious reactions occurred in 3% of patients and included cases of headache, pyrexia, urticaria, tachycardia, atrial fibrillation, nausea, chest discomfort, and hypotension.
Croatian: U 3% bolesnika javile su se ozbiljne reakcije i uključivale su slučajeve glavobolje, pireksije, urtikarije, tahikardije, fibrilacije atrija, mučnine, nelagode u prsištu i hipotenzije.
English: In studies in mice, alterations in lymphocyte counts were observed in pups exposed to alemtuzumab during gestation at doses of 3 mg/kg/day for 5 consecutive days (AUC 0.6 times the human exposure at the recommended dose of 12 mg/day).
Croatian: U istraživanjima na miševima zabilježene su promjene broja limfocita u mladunaca koji su tijekom gestacije bili izloženi alemtuzumabu u dozama od 3 mg/kg na dan tijekom 5 uzastopnih dana (AUC 0,6 puta veći od izloženosti u ljudi pri preporučenoj dozi od 12 mg/dan).
English: Patients treated with LEMTRADA are also at a higher risk of developing listeria infection (a bacterial infection caused by ingestion of contaminated foods).
Croatian: Bolesnici liječeni lijekom LEMTRADA također imaju veći rizik od razvoja infekcije uzrokovane listerijom (bakterijska infekcija uzrokovana gutanjem zaražene hrane).
English: Liver inflammation can be diagnosed from the blood tests that you will be having regularly after LEMTRADA treatment.
Croatian: Upala jetre može se dijagnosticirati na temelju pretraga krvi koje ćete redovito provoditi nakon liječenja lijekom LEMTRADA.
English: • Administer LEMTRADA infusion solution via intravenous administration over approximately 4 hours.
Croatian: • Primijenite LEMTRADA otopinu za infuziju intravenskom infuzijom tijekom razdoblja od približno 4 sata.
English: The vast majority (approximately 80%) of patients who presented with a thyroid event after treatment were anti-TPO antibody negative at baseline.
Croatian: Velika većina (približno 80%) bolesnika koji su iskusili događaj štitnjače nakon liječenja bili su negativni na protutijela anti-TPO na početku ispitivanja.
English: If acute acalculous cholecystitis is suspected, evaluate and treat promptly.
Croatian: Ako postoji sumnja na akutni akalkulozni kolecistitis, potrebno je procijeniti stanje i odmah ga liječiti.
English: You should report to your doctor if you have symptoms such as stomach pain or discomfort, fever, nausea or vomiting.
Croatian: Morate prijaviti svom liječniku ako imate simptome kao što su bol ili nelagoda u trbuhu, vrućica, mučnina ili povraćanje.
English: • pain in ear
Croatian: • bol u uhu
English: After each infusion, the patient should be observed for 2 hours for infusion associated reactions.
Croatian: • Nakon svake infuzije bolesnika treba promatrati tijekom 2 sata zbog moguće pojave reakcija na infuziju.
English: A total of 1,486 patients treated with LEMTRADA (12 mg or 24 mg) constituted the safety population in a pooled analysis of MS clinical studies with a median follow-up of 6.1 years (maximum 12 years), resulting in 8,635 patient-years of safety follow-up.
Croatian: Ukupno je 1486 bolesnika liječenih lijekom LEMTRADA (12 mg ili 24 mg) sačinjavalo populaciju iz koje su prikupljeni podaci o sigurnosti primjene za objedinjenu analizu kliničkih ispitivanja multiple skleroze s medijanom praćenja od 6,1 godine (maksimalno 12 godina), u kojima je ukupno praćenje sigurnosti iznosilo 8635 bolesnik-godina.
English: Before initiation of therapy, evaluation of immune serostatus could be considered according to local guidelines.
Croatian: Prije početka terapije može se razmotriti provjera imunološkog serostatusa,
English: You will also have regular blood and urine tests to ensure that if you develop any of these conditions, they are treated promptly.
Croatian: Također ćete redovito morati obavljati pretrage krvi i mokraće kako bi se omogućilo pravodobno liječenje u slučaju pojave bilo kojega od navedenih stanja.
English: If a cytopenia is confirmed, appropriate medical intervention should be promptly initiated, including referral to a specialist.
Croatian: Ako se citopenija potvrdi, treba odmah započeti s odgovarajućom medicinskom intervencijom, uključujući upućivanje bolesnika liječniku specijalistu.
English: Uncommonly, patients have experienced autoimmune conditions involving red blood cells or white blood cells.
Croatian: U bolesnika su se manje često javile autoimune bolesti koje zahvaćaju crvene krvne stanice ili bijele krvne stanice.
English: Adverse reactions are listed by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT).
Croatian: Preferred Term, PT) Medicinskog rječnika za regulatorne poslove (MedDRA).
English: HR: 0.58 p-value: 0.0084
Croatian: p-vrijednost: 0,0084
English: Haemoptysis may also be indicative of ITP or acquired haemophilia A (see above), and an appropriate differential diagnosis has to be undertaken.
Croatian: Hemoptiza ujedno može biti indikacija za ITP ili stečenu hemofiliju A (vidjeti gore), te je potrebna odgovarajuća diferencijalna dijagnoza.
English: • constipation, acid reflex, dry mouth
Croatian: • zatvor, vraćanje kiseline, suha usta
English: The incidence of thyroid events was higher in patients with a medical history of thyroid disorders both in the LEMTRADA and interferon beta 1a (IFNB1a) treatment groups.
Croatian: Incidencija događaja štitnjače bila je veća u bolesnika s poremećajima štitnjače u povijesti bolesti u obje liječene skupine, onoj na lijeku LEMTRADA i onoj na interferonu beta 1a (IFNB-1a).
English: LEMTRADA may increase the risk of acute acalculous cholecystitis.
Croatian: LEMTRADA može povećati rizik od akutnog akalkuloznog kolecistitisa.
English: Each vial contains 12 mg alemtuzumab in 1.2 ml (10 mg/ml).
Croatian: Jedna bočica sadrži 12 mg alemtuzumaba u 1,2 ml (10 mg/ml).
English: Rarely, patients have experienced autoimmune related problems with their kidneys, such as antiglomerular basement membrane disease (anti-GBM disease).
Croatian: U bolesnika su se rijetko javile autoimune tegobe povezane s bubrezima, poput bolesti s protutijelima na glomerularnu bazalnu membranu (anti-GBM).
English: LEMTRADA is used if your MS is highly active despite that you have been treated with at least one other medicine for MS or if your MS is rapidly evolving.
Croatian: Lemtrada se koristi ako bolujete od multiple skleroze koja je jako aktivna unatoč tome što ste primili barem jedan lijek za multiplu sklerozu ili ako imate multiplu sklerozu koja brzo napreduje.
English: Acute acalculous cholecystitis
Croatian: Akutni akalkulozni kolecistitis
English: Neutropenia Cases of severe (including fatal) neutropenia have been reported within 2 months of LEMTRADA infusion.
Croatian: Prijavljeni su slučajevi teške (uključujući i smrtonosnu) neutropenije unutar 2 mjeseca nakon primjene infuzije lijeka LEMTRADA.
English: 1 Herpes virus infections include PTs: Oral herpes, Herpes simplex, Genital herpes, Herpes virus infection, Genital herpes simplex, Herpes dermatitis, Ophthalmic herpes simplex, Herpes simplex serology positive.
Croatian: 1 infekcije virusom herpesa uključuju preporučene pojmove: oralni herpes, herpes simplex, genitalni herpes, infekcija virusom herpesa, genitalni herpes simplex, dermatitis uzrokovan herpesom, očni herpes simplex, pozitivan serološki nalaz na herpes simplex.
English: The rate of thyroid adverse reactions was highest in year three and declined thereafter.
Croatian: Stopa nuspojava povezanih sa štitnjačom bila je najveća u trećoj godini nakon koje se smanjila.
English: • decreased weight, weight increase, red blood cell decrease, blood glucose increase, increase in red blood cell size
Croatian: • smanjenje tjelesne težine, povećanje tjelesne težine, smanjenje broja crvenih krvnih stanica, povećanje vrijednosti glukoze u krvi, povećane crvene krvne stanice
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Straße 65
Croatian: Boehringer Ingelheim Pharma GmBH & Co.
English: Infections that occurred more often in LEMTRADA -treated patients than IFNB 1a patients included nasopharyngitis, urinary tract infection, upper respiratory tract infection, sinusitis, oral herpes, influenza, and bronchitis.
Croatian: Infekcije, koje su se javljale češće u bolesnika liječenih lijekom LEMTRADA nego u bolesnika koji su primali IFNB-1a, uključivale su nazofaringitis, infekciju mokraćnih putova, infekciju gornjih dišnih puteva, sinusitis, oralni herpes, gripu i bronhitis.
English: Non-interventional post-authorisation safety study (PASS): In order to investigate the incidence of mortality in patients treated with Lemtrada compared to a relevant patient population, the MAH shall submit the results of a post-authorisation safety study
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon stavljanja u promet (PASS): Kako bi se istražila incidencija mortaliteta u bolesnika liječenih lijekom Lemtrada u odnosu na relevantnu populaciju bolesnika, nositelj odobrenja će dostaviti rezultate ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet koji uspoređuju lijek Lemtrada s odgovarajućom kontrolom.
English: Patients receiving LEMTRADA should be instructed to report symptoms of infections to a physician.
Croatian: Bolesnike koji primaju lijek LEMTRADA treba uputiti da prijave simptome infekcija liječniku
English: In controlled clinical studies, 0.2% of LEMTRADA-treated MS patients developed acute acalculous cholecystitis, compared to 0% of patients treated with INFB-1a.
Croatian: U kontroliranim kliničkim ispitivanjima 0,2% bolesnika s MS-om liječenih lijekom LEMTRADA razvilo je akutni akalkulozni kolecistitis u usporedbi s 0% bolesnika liječenih interferonom beta 1a.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL/VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA/BOČICA
English: One patient developed ITP that went unrecognised prior to implementation of monthly blood monitoring requirements and died from intracerebral haemorrhage.
Croatian: U jednog se bolesnika razvio ITP koji je prepoznat tek nakon uvođenja mjesečnih kontrola krvne slike.
English: The following information is intended for healthcare professionals only: Information on risk minimisation - autoimmune conditions
Croatian: Informacije o minimizaciji rizika - autoimuna stanja
English: Study name
Croatian: Naziv ispitivanja
English: The recommended dose of alemtuzumab is 12 mg/day administered by intravenous infusion for 2 initial treatment courses, with up to 2 additional treatment courses if needed.
Croatian: Preporučena doza alemtuzumaba je 12 mg/dan, a primjenjuje se intravenskom infuzijom u 2 ciklusa liječenja, te ako je potrebno mogu se primijeniti do 2 dodatna ciklusa liječenja.
English: Cases of acquired haemophilia A (anti-factor VIII antibodies) have been reported in both clinical trial and post-marketing setting.
Croatian: Slučajevi stečene hemofilije A (protutijela na faktor VIII) prijavljeni su i u kliničkim ispitivanjima i u razdoblju nakon stavljanja lijeka u promet.
English: Treatment with intravenous alemtuzumab at doses up to 10 mg/kg/day, administered for 5 consecutive days (AUC of 7.1 times the human exposure at the recommended daily dose) had no effect on fertility and reproductive performance in male huCD52 transgenic mice.
Croatian: Liječenje intravenskim alemtuzumabom u dozama do 10 mg/kg na dan tijekom 5 uzastopnih dana (AUC 7,1 puta veći od izloženosti u ljudi pri preporučenoj dnevnoj dozi) nije utjecalo na plodnost ni reproduktivnu sposobnost mužjaka transgeničnih miševa soja huCD52.
English: Cases of autoimmune hepatitis (including fatal cases and cases requiring liver transplantation) and hepatic injury related to infections have been reported in patients treated with LEMTRADA (see section 4.3).
Croatian: U bolesnika liječenih lijekom LEMTRADA prijavljeni su slučajevi autoimunog hepatitisa (uključujući smrtne slučajeve i slučajeve kod kojih je bila potrebna transplantacija jetre) i oštećenja jetre povezani s infekcijama (vidjeti dio 4.3).
English: No formal drug interaction studies have been conducted with LEMTRADA using the recommended dose in patients with MS.
Croatian: Nisu provedena službena ispitivanja interakcija drugih lijekova s lijekom LEMTRADA kod primjene preporučene doze u bolesnika s multiplom sklerozom.
English: Resources for the management of cytokine release syndrome, hypersensitivity and/or anaphylactic reactions should be available.
Croatian: Moraju biti dostupni osoblje i oprema za liječenje sindroma otpuštanja citokina, reakcija preosjetljivosti i/ili anafilaktičkih reakcija.
English: − if you have any of the following conditions: o other autoimmune disease besides multiple sclerosis o uncontrolled high blood pressure o history of tears in blood vessels supplying the brain o history of stroke o history of heart attack or chest pain o history of bleeding disorder
Croatian: o druge autoimune bolesti osim multiple skleroze o nekontroliran visok krvni tlak o rascjep krvnih žila koje opskrbljuju mozak u povijesti bolesti o moždani udar u povijesti bolesti o srčani udar ili bol u prsima u povijesti bolesti o poremećaj krvarenja u povijesti bolesti
English: In the subgroup of RRMS patients with 2 or more relapses in the prior year and at least 1 Gd-enhanced T1 lesion at baseline, the annualised relapse rate was 0.26 (95% CI: 0.20, 0.34) in the Lemtrada treated group (n
Croatian: U podskupini bolesnika s relapsno remitentnom multiplom sklerozom s 2 ili više relapsa u protekloj godini i najmanje 1 gadolinijem naglašenom T1 lezijom na početku ispitivanja, anualizirana stopa relapsa iznosila je 0,26 (95% CI: 0,20; 0,34) u skupini liječenoj lijekom LEMTRADA (n=205) i 0,51
English: Clinical examination and laboratory tests should be conducted at periodic intervals until at least 48 months following the last treatment course of LEMTRADA in order to monitor for early signs of autoimmune diseases:
Croatian: Najmanje do 48 mjeseci nakon posljednjeg ciklusa liječenja lijekom LEMTRADA, treba periodički provoditi kliničke preglede i laboratorijske pretrage, kako bi se pratila pojava ranih znakova autoimune bolesti:
English: Patients with active MS, defined as at least 2 relapses within the prior 2 years and 1 or more contrastenhancing lesions
Croatian: Bolesnici s aktivnom multiplom sklerozom, definiranom kao najmanje 2 relapsa unutar prethodne dvije godine i 1 ili više lezija naglašenih kontrastom
English: • trembling, loss of sensation, burning or prickling sensation
Croatian: • drhtanje, gubitak osjeta, osjećaj bockanja ili žarenja
English: Educate patients on the signs and symptoms of acquired haemophilia A and to seek immediate medical attention, if any of these symptoms are observed.
Croatian: Bolesnike treba educirati o znakovima i simptomima stečene hemofilije A te da potraže hitnu medicinsku pomoć ako primijete bilo koji od tih simptoma.
English: Additional course(s) of LEMTRADA were administered at 12 mg/day for 3 consecutive days (36 mg total dose) at least 12 months after the prior treatment course.
Croatian: Dodatni ciklus(i) liječenja lijekom LEMTRADA primijenjeni su u dozi od 12 mg/dan tijekom 3 uzastopna dana (ukupna doza od 36 mg) najmanje 12 mjeseci nakon prethodnog ciklusa liječenja.
English: Patients were treated with LEMTRADA 12 mg/day (N=108) or 24 mg/day (N=108) administered once per day for 5 days at month 0 and for 3 days at month 12 or subcutaneous IFNB-1a 44 µg (N=107) administered 3 times per week for 3 years.
Croatian: Bolesnici su liječeni lijekom LEMTRADA u dozi od 12 mg/dan (N=108) ili 24 mg/dan (N=108) primijenjenim jedanput dnevno tijekom 5 dana u 0. mjesecu i tijekom 3 dana u 12. mjesecu ili interferonom beta-1a (IFNB-1a) u dozi od 44 µg (N=107) primijenjenim supkutano triput tjedno tijekom 3 godine.
English: Continue to test the patient every month for autoimmune conditions, until 4 years after last infusion.
Croatian: Nastavite provoditi mjesečne pretrage za autoimune bolesti još 4 godine nakon posljednje infuzije.
English: In clinical trials, 74% of patients with positive anti-thyroid peroxidase (anti-TPO) antibodies at baseline developed a thyroid event compared with 38% of patients with a baseline negative status.
Croatian: U kliničkim ispitivanjima, 74% bolesnika koji su na početku ispitivanja bili pozitivni na protutijela protiv tiroidne peroksidaze (anti-TPO) razvili su događaj štitnjače u usporedbi s 38% bolesnika koji su na početku ispitivanja bili negativni.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek LEMTRADA Lijek čuvajte izvan pogleda i dohvata djece.
English: There is no relevant use of alemtuzumab in children aged from birth to less than 10 years for the treatment of multiple sclerosis.
Croatian: Nema relevantne primjene alemtuzumaba kod djece u dobi od rođenja do manje od 10
English: • pain in the back, the neck, or in arms or legs, muscle pain, muscle spasms, joint pain, painful mouth or throat
Croatian: • bol u leđima, vratu ili u rukama ili nogama, bol u mišićima, grčevi u mišićima, bol u zglobovima, bolna usta ili grlo • upala usta/desni/jezika
English: Annualised Relapse rate (ARR) (95% CI)
Croatian: Annualised Relapse rate, ARR) (95% CI) Omjer stopa (95% CI) Smanjenje rizika
English: Time to onset of symptoms ranged from less than 24 hours to 2 months after LEMTRADA infusion.
Croatian: Vrijeme do pojave simptoma kretalo se u rasponu od manje od 24 sata do 2
English: Your doctor will explain to you how LEMTRADA will be given.
Croatian: Liječnik će Vam objasniti kako ćete primati lijek LEMTRADA.
English: Supportive analyses from Study 2 (CAMMS32400507) showed that LEMTRADA 12 mg/day led to significantly fewer LEMTRADA -treated patients experiencing severe relapses (48% reduction, p=0.0121), and significantly fewer relapses that led to steroid treatment (56% reduction, p<0.0001) or to hospitalization (55% reduction, p=0.0045) compared to IFNB-1a.
Croatian: Suportivne analize iz Ispitivanja 2 (CAMMS32400507) pokazale su da je primjena lijeka LEMTRADA u dozi od 12 mg/dan značajno smanjila broja bolesnika liječenih lijekom LEMTRADA u kojih je došlo do ozbiljnih relapsa (smanjenje za 48%, p=0,0121) kao i broj relapsa koji iziskuju liječenje steroidima (smanjenje za 56% p<0,0001) ili hospitalizaciju (smanjenje za 55%, p=0,0045) u usporedbi s IFNB-1a.
English: LEMTRADA 12 mg/day led to significantly lower EDSS scores (improved compared to baseline) through 2 years of follow up, compared with IFNB-1a (p<0.0001).
Croatian: Lijek LEMTRADA u dozi od 12 mg/dan je tijekom 2 godine kontrolnog praćenja doveo do značajno nižeg EDSS rezultata (poboljšanje u odnosu na početne vrijednosti) u usporedbi s IFNB-1a (p<0,0001).
English: Varicella zoster virus antibody testing/vaccination
Croatian: Testiranje na protutijela na virus varičela zoster/cijepljenje
English: Symptomatic treatment can be initiated if needed - see SmPC.
Croatian: Po potrebi se može uvesti odgovarajuće simptomatsko liječenje - vidjeti sažetak opisa svojstava lijeka.
English: Patients with a history of angina pectoris or myocardial infarction.
Croatian: Bolesnici s anginom pektoris ili infarktom miokarda u povijesti bolesti.
English: Patients with a history of stroke.
Croatian: Bolesnici s moždanim udarom u povijesti bolesti.