FrancophonIA/ELRC3.0 huggingface dataset:
English: It is available as tablets (150 mg aliskiren and 5 mg amlodipine; 150 mg aliskiren and 10 mg amlodipine; 300 mg aliskiren and 5 mg amlodipine; 300 mg aliskiren and 10 mg amlodipine).
Croatian: Dostupan je kao tablete (150 mg aliskirena i 5 mg amlodipina; 150 mg aliskirena i 10 mg amlodipina; 300 mg aliskirena i 5 mg amlodipina; 300 mg aliskirena i 10 mg amlodipina).
English: Rasilamlo in combination with an ACE inhibitor or an ARB must not be used in patients with diabetes, or moderate or severe kidney impairment.
Croatian: Rasilamlo u kombinaciji s inhibitorom ACE-a ili ARB-om ne smije se koristiti u bolesnika s dijabetesom te umjerenim ili ozbiljnim oštećenjem funkcije bubrega.
English: What benefit has Rasilamlo shown during the studies?
Croatian: Koje su koristi lijeka Rasilamlo dokazane u ispitivanjima?
English: In the first study, patients taking Rasilamlo 300/10 mg and 300/5 mg had a fall in their sitting diastolic blood pressure of 13.1 mmHg and 10.5 mmHg, respectively, compared with a fall of 5.8 mmHg in patients taking aliskiren 300 mg.
Croatian: U prvom ispitivanju, u bolesnika koji su uzimali Rasilamlo 300/10 mg i 300/5 mg zabilježeno je sniženje dijastoličkog krvnog tlaka u sjedećem položaju od 13,1 mmHg, odnosno 10,5 mmHg, u usporedbi sa sniženjem od 5,8 mmHg u bolesnika koji su uzimali aliskiren u dozi od 300 mg.
English: Rasilamlo contains two active substances, aliskiren and amlodipine.
Croatian: Rasilamlo sadrži dvije djelatne tvari, aliskiren i amlodipin.
English: It must not be used in patients with a history of angioedema (swelling beneath the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, severe hypotension, shock, narrowing of the aortic heart valve or in patients with heart failure after a heart attack.
Croatian: Ne smije se koristiti u bolesnika s anamnezom angioedema (oticanja ispod kože) pri primjeni aliskirena, nasljednim angioedemom ili angioedemom bez očitog razloga, ozbiljnom hipotenzijom, šokom,
English: What is Rasilamlo used for?
Croatian: Za što se Rasilamlo koristi?
English: Rasilamlo is a medicine that contains the active substances aliskiren and amlodipine.
Croatian: Rasilamlo je lijek koji sadrži djelatne tvari aliskiren i amlodipin.
English: Rasilamlo is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.
Croatian: Rasilamlo se koristi za liječenje esencijalne hipertenzije (visokog krvnog tlaka) u odraslih osoba čiji krvni tlak nije odgovarajuće kontroliran monoterapijom aliskirena ili amlodipina. „Esencijalno” znači da ne postoji očiti uzrok hipotenzije.
English: The third study showed a fall in blood pressure of 8.5 mmHg with Rasilamlo 150/5 mg compared with 8.0 mmHg and 4.8 mmHg with amlodipine 10 mg and 5 mg, respectively.
Croatian: Treće je ispitivanje pokazalo sniženje u krvnom tlaku od 8,5 mmHg pri primjeni lijeka Rasilamlo 150/5 mg u usporedbi s 8,0 mmHg s amlodipinom od 10 mg, odnosno 4,8 mmHg s amlodipinom od 5 mg.
English: In the second study the falls in blood pressure were 11.0 mmHg and 9.0 mmHg with Rasilamlo 300/10 mg and 150/10mg, respectively, compared with 7.2mmHg with amlodipine 10 mg.
Croatian: U drugom su ispitivanju sniženja u krvnom tlaku bila 11,0 mmHg s dozom od 300/10 mg, odnosno 9,0 mmHg s dozom od 150/10mg, u odnosu na 7,2 mmHg s amlodipinom od 10 mg.
English: How has Rasilamlo been studied?
Croatian: Kako je Rasilamlo ispitivan?
English: How does Rasilamlo work?
Croatian: Kako djeluje Rasilamlo?
English: For the full list of all side effects reported with Rasilamlo, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Rasilamlo potražite u uputi o lijeku.
English: How is Rasilamlo used?
Croatian: Kako se Rasilamlo koristi?
English: What is Rasilamlo?
Croatian: Što je Rasilamlo?
English: (Best response rates)
Croatian: (Najbolje stope odgovora)
English: - Do not take a double dose to make up a forgotten dose.
Croatian: - Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: • Difficulty in sleeping (insomnia).
Croatian: • otežano spavanje (nesanica).
English: For CML, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment.
Croatian: Za KML, liječnik Vam može propisati višu ili nižu dozu, ovisno o tome kako reagirate na liječenje.
English: The expiry date refers to the last day of that month.
Croatian: Datum isteka roka valjanosti odnosi se na posljednji dan u mjesecu.
English: Date of first authorization: 01 July 2013 Date of latest renewal: 19th April 2018
Croatian: Datum posljednje obnove odobrenja: 19. travnja 2018
English: However, always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Međutim, uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarnik.
English: % of patients (CI95%)
Croatian: % bolesnika (CI95%)
English: Your doctor has prescribed Imatinib Accord because you suffer from a serious condition.
Croatian: Vaš liječnik je propisao Imatinib Accord jer patite od ozbiljnog stanja.
English: After 42 months of follow-up, 11 patients experienced a confirmed loss (within 4 weeks) of their cytogenetic response.
Croatian: Nakon 42 mjeseca praćenja, 11 bolesnika doživjelo je potvrđeni gubitak (unutar 4 tjedna) njihovog citogenetskog odgovora.
English: The safety database for children and adolescents with Ph+ALL is very limited though no new safety concerns have been identified.
Croatian: Baza sigurnosnih podataka za djecu i adolescente s Ph+ALL vrlo je ograničena iako nisu uočena nikakva nova sigurnosna pitanja.
English: Similar findings were found based on a 18-months landmark analysis.
Croatian: Slični nalazi su nađeni i na temelju analize pokazatelja nakon 18 mjeseci.
English: The amount of Imatinib Accord given will depend on your child's condition, body weight and height.
Croatian: Količina Imatinib Accorda koju je potrebno dati ovisiti će o stanju djeteta, tjelesnoj težini i visini.
English: Talk to your doctor before taking Imatinib Accord: - if you have or have ever had a liver, kidney or heart problem.
Croatian: Obratite se svom liječniku prije nego uzmete Imatinib Accord: - ako imate, ili ste ikada imali, problema s jetrom, bubrezima ili srcem.
English: • Decreased or increased skin sensitivity.
Croatian: • smanjena ili povećana osjetljivost kože.
English: Imatinib Accord may do the same to some other medicines.
Croatian: Imatinib Accord može to isto napraviti nekim drugim lijekovima.
English: 8 to 10 g (single dose): Vomiting and gastrointestinal pain have been reported.
Croatian: 8 do 10 g (jednokratna doza): zabilježeni su povraćanje i gastrointestinalni bolovi.
English: • Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Croatian: • ponovna pojava (reaktivacija) infekcije virusom hepatitisa B ako ste u prošlosti imali hepatitis B (infekciju jetre).
English: If you have any questions about how Imatinib Accord works or why this medicine has been prescribed for you, ask your doctor.
Croatian: Ako imate bilo kakvih pitanja o tome na koji način djeluje Imatinib Accord, ili zašto je taj lijek Vama propisan, obratite se svom liječniku.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use only as directed by a doctor.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Primjenjivati isključivo prema uputama liječnika.
English: Imatinib Accord can reduce the number of white blood cells, so you might get infections more easily.
Croatian: Imatinib Accord može smanjiti broj bijelih krvnih stanica, pa možete lakše dobiti infekciju.
English: Imatinib Accord can help you to fight this condition.
Croatian: Imatinib Accord Vam može pomoći u borbi protiv tog stanja.
English: Some children and adolescents taking Imatinib Accord may have slower than normal growth.
Croatian: Kod neke djece i adolescenata koji uzimaju Imatinib Accord rast može biti sporiji od normalnog.
English: Dosing for children and adolescents should be on the basis of body surface area (mg/m2).
Croatian: U djece i adolescenata doziranje se treba temeljiti na veličini površine tijela (mg/m2).
English: Complete CyR n (%) Partial CyR n (%)
Croatian: Potpuni CyR n (%) Djelomični CyR n (%)
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John's Wort).
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate , nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove dobivene bez recepta (poput paracetamola) i biljne pripravke (poput gospine trave).
English: Other side effects may include
Croatian: Druge nuspojave mogu uključivati
English: If you are unable to swallow the tablets, you can dissolve them in a glass of still water or apple juice:
Croatian: Ako niste u mogućnosti progutati tablete, možete ih otopiti u čaši negazirane vode ili soka od jabuke:
English: • Do not use any pack that is damaged or shows signs of tampering.
Croatian: • Ne koristiti pakiranje koje je oštećeno ili na kojem su vidljivi znakovi otvaranja.
English: A complete haematological response was achieved in 95% of patients.
Croatian: Potpuni je hematološki odgovor postignut u 95% bolesnika.
English: The current estimate of the median survival of the previously untreated and treated patients was 7.7 and 4.7 months, respectively.
Croatian: Trenutna procjena medijana preživljenja prethodno neliječenih i liječenih bolesnika iznosila je 7,7, odnosno 4,7 mjeseci.
English: Imatinib pharmacokinetics have not been specifically studied in elderly.
Croatian: Farmakokinetika imatiniba nije specifično ispitivana u starijih osoba.
English: What Imatinib Accord is and what it is used for What you need to know before you take Imatinib Accord How to take Imatinib Accord Possible side effects
Croatian: Što je Imatinib Accord i za što se koristi Što morate znati prije nego počnete uzimati Imatinib Accord Kako uzimati Imatinib Accord Moguće nuspojave
English: No new target organs were identified in the rat juvenile development toxicology study (day 10 to 70 postpartum) with respect to the known target organs in adult rats.
Croatian: Nisu bili uočeni novi ciljni organi u toksikološkom ispitivanju juvenilnog razvoja u štakora (10 do 70 dana nakon okota) u odnosu na poznate ciljne organe u odraslih štakora.
English: Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (~10% of a therapeutic dose).
Croatian: Uzimajući u obzir kombiniranu koncentraciju imatiniba i metabolita i maksimalni dnevni unos majčinog mlijeka od strane dojenčeta, očekuje se da je ukupna izloženost niska (~10% terapijske doze).
English: • Stir with a spoon until the tablets have completely dissolved.
Croatian: • Miješajte žlicom sve dok se tablete potpuno ne otope.
English: While you are taking Imatinib Accord, your doctor will regularly check whether the medicine is working.
Croatian: Dok uzimate Imatinib Accord, liječnik će redovito pratiti da li lijek djeluje.
English: 5 patients responded, 3 completely and 2 partially.
Croatian: 5 bolesnika je imalo odgovor, 3 potpuni i 2 djelomični.
English: Middlesex, HA1 4HF United Kingdom
Croatian: Middlesex, HA1 4HF Ujedinjeno Kraljevstvo
English: For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of mineral water or apple juice.
Croatian: Bolesnicima koji ne mogu progutati filmom obložene tablete, tablete se mogu dispergirati u čaši mineralne vode ili soka od jabuke.
English: You may become more sensitive to the sun while taking Imatinib Accord.
Croatian: Možete postati osjetljiviji na sunce tijekom uzimanja Imatinib Accord.
English: Chronic phase, Interferon failure
Croatian: Kronična faza, neuspjeh interferona
English: Traces of the dissolved tablets may be left behind in the glass.
Croatian: Ostaci otopljenih tableta mogu ostati u čaši.
English: If you take more Imatinib Accord than you should
Croatian: Ako uzmete više Imatinib Accorda nego što ste trebali
English: Ki values in human liver microsomes were 27, 7.5 and 7.9 mol/l, respectively.
Croatian: Ki vrijednosti u jetrenim mikrosomima čovjeka bile su 27, 7,5, odnosno 7,9 mol/l.
English: Tell your doctor straight away if you get any of the following
Croatian: Odmah obavijestite liječnika ako se kod Vas javi bilo što od sljedećeg:
English: Study 0109 40.5-month data Accelerated phase (n=235)
Croatian: Studija 0109 40,5-mjesečni podaci Ubrzana faza (n=235)
English: There is no experience in children with CML below 2 years of age and with Ph+ ALL below 1 year of age (see section 5.1).
Croatian: Ne postoji iskustvo kod djece s KML-om koja su mlađa od 2 godine i s Ph+ALL mlađe od 1 godine (vidjeti dio 5.1).
English: 532 adult patients were treated at a starting dose of 400 mg.
Croatian: 532 odrasla bolesnika liječena su s početnom dozom od 400 mg.
English: 4.7 Effects on ability to drive and use machines
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sastrojevima
English: Considering the limited safety database, the adverse events thus far reported in children and adolescents are consistent with the known safety profile in adult patients with Ph+ ALL.
Croatian: Imajući na umu ograničenost baze podataka o sigurnosti primjene, dosad prijavljeni štetni događaji u djece i adolescenata odgovaraju poznatome sigurnosnom profilu u odraslih bolesnika s Ph+ ALL.
English: The degree of cytogenetic response and molecular response had a clear effect on long-term outcomes in patients on Imatinib.
Croatian: Stupanj citogenetskog odgovora i molekularnog odgovora imao je jasan učinak na dugotrajne ishode u bolesnika na Imatinibu.
English: This is because Imatinib Accord could cause hepatitis B to become active again, which can be fatal in some cases.
Croatian: To je potrebno jer Imatinib Accord može uzrokovati ponovnu aktivaciju hepatitisa B što u nekim slučajevima može rezultirati smrtnim ishodom.
English: They may increase or decrease the effect of Imatinib Accord, either leading to increased side effects or making Imatinib Accord less effective.
Croatian: Oni mogu povećati ili smanjiti učinak Imatinib Accorda bilo povećanjem nuspojava ili smanjenjem učinka Imatinib Accorda.
English: 11 Fatal cases have been reported in patients with advanced disease, severe infections, severe neutropenia and other serious concomitant conditions.
Croatian: 11 Smrtni slučajevi zabilježeni su u bolesnika s uznapredovalom bolešću, teškim infekcijama, teškom neutropenijom i drugim ozbiljnim popratnim stanjima.
English: This includes any possible side effects not listed in this leaflet.
Croatian: To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.Pogledajte dio
English: Do not stop taking Imatinib Accord unless your doctor tells you to.
Croatian: Nemojte prestati uzimati Imatinib Accord, osim ako Vam to ne kaže liječnik.
English: • Dry mouth, dry skin or dry eye.
Croatian: • suha usta, suhoća kože ili suho oko.
English: During treatment with Imatinib Accord, tell your doctor straight away if you put on weight very quickly.
Croatian: Tijekom liječenja Imatinib Accordom odmah obavijestite svog liječnika ako vrlo brzo dobivate na težini.
English: In all clinical studies 38-40% of patients were > 60 years of age and 10-12% of patients were > 70 years of age.
Croatian: U svim kliničkim ispitivanjima 38-40% bolesnika bilo je u dobi ≥60 godina, a 10-12% bolesnika bilo je u dobi ≥70 godina.
English: Total bilirubin: > 3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Croatian: Ukupni bilirubin: > 3-10 GGN AST: bilo koja vrijednost GGN = institucionalna gornja granica normale AST = aspartat-aminotransferaza
English: • Pain in your hips or difficulty walking.
Croatian: • bol u kukovima ili otežano hodanje.
English: Frequency categories are defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti se definiraju kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Imatinib Accord will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Croatian: Imatinib Accord Vam može propisati jedino liječnik koji ima iskustva s lijekovima za liječenje raka krvi ili solidnih tumora.
English: Severe elevation of transaminases (< 5%) or bilirubin (< 1%) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Croatian: Veliko povišenje vrijednosti transaminaza (< 5%) ili bilirubina (< 1%) uočeno je u bolesnika s KML-om i obično je liječeno smanjenjem doze ili prekidom terapije (medijan trajanja tih epizoda bio je približno tjedan dana).
English: Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
Croatian: Prednizolon 200 mg peroralno, 5 danana mjesec tijekom 13 mjeseci Svi režimi liječenja uključuju primjenu steroida radi CNS profilakse.
English: Dermatofibrosarcoma protuberans (DFSP).
Croatian: - Dermatofibrosarkoma protuberans (DFSP).
English: In clinical trials, there was an increased incidence of these events in elderly and those with a prior history of cardiac disease.
Croatian: U kliničkim je ispitivanjima zabilježena povećana incidencija tih događaja u starijih osoba te u onih koji su ranije bolovali od bolesti srca.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitor, ATC code: L01XE01
Croatian: Farmakoterapijska skupina: antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE01
English: Alu/Alu blisters
Croatian: Alu/Alu blisteri
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTERE
English: A limited number of patients were enrolled in phase I studies (n=10).
Croatian: U ispitivanjima faze I uključen je ograničeni broj bolesnika (n=10).
English: Non-neoplastic lesions not identified in earlier preclinical studies were the cardiovascular system, pancreas, endocrine organs and teeth.
Croatian: Neneoplastičke lezije koje nisu identificirane u prethodnim pretkliničkim ispitivanjima javile su se kod kardiovaskularnog sustava, gušterače, endokrinih organa i zuba.
English: However, some of these reactions may be serious or life-threatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure.
Croatian: No, neke od tih reakcija mogu biti ozbiljne ili opasne po život, pa je nekoliko bolesnika s blastičnom krizom umrlo s kompleksnom kliničkom anamnezom pleuralnog izljeva, kongestivnog zatajenja srca i zatajenja bubrega.
English: Patients should be tested for HBV infection before initiating treatment with Imatinib Accord.
Croatian: Bolesnike je potrebno testirati na infekciju HBV-om prije početka liječenja Imatinib Accord.
English: The yearly rates of progression of any type for Imatinib also decreased over time.
Croatian: Kod Imatiniba su se godišnje stope progresije bilo koje vrste također smanjivale s vremenom.
English: Disease-free survival (DFS) and overall survival (OS) constantly exceeded 1 year and were superior to historical control (DFS p<0.001; OS p<0.0001) in two studies (AJP01 and AUS01).
Croatian: Preživljenje bez bolesti (DFS) i ukupno preživljenje (OS) stalno su premašivali1 godinu te su bili superiorni povijesnojkontroli (DFS p<0,001; OS p<0,0001) u dva ispitivanja (AJP01 i AUS01).
English: • Blood clots in small blood vessels (thrombotic microangiopathy).
Croatian: • krvni ugrušci u malim krvnim žilama (trombotična mikroangiopatija).
English: Other medicines and Imatinib Accord
Croatian: Drugi lijekovi i Imatinib Accord
English: Your doctor will discuss with you the possible risks of taking Imatinib Accord during pregnancy.
Croatian: Liječnik će Vam objasniti moguće rizike od uzimanja Imatinib Accorda tijekom trudnoće.
English: The median duration of second-line treatment with Imatinib was 64 months.
Croatian: Medijan trajanja druge linije liječenja za Imatinib bio je 64 mjeseca.
English: The rate ofresponse was also higher in the patients treated at 600 mg (33%) as compared to the patients treated at 400 mg (16%, p=0.0220).
Croatian: Stopa odgovora također je bila viša u bolesnika koji su liječeni s dozom od 600 mg (33%) u usporedbi s bolesnicima koji su liječeni s 400 mg (16%, p=0,0220).
English: The doctor will tell you how many tablets of Imatinib Accord to give to your child.
Croatian: Liječnik će Vam reći koliko tableta Imatinib Accorda trebate dati djetetu.
English: Healthcare professionals are asked to report any suspected adverse reactionsvia the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: Keep taking Imatinib Accord every day for as long as your doctor tells you.
Croatian: Imatinib Accord nastavite uzimati svaki dan onoliko dugo koliko Vam je liječnik rekao.
English: As expected on the basis of the study design, no difference was observed in remission duration, disease-free survival or overall survival, although patients with complete molecular response and remaining in minimal residual disease had a better outcome in terms of both remission duration (p=0.01) and disease-free survival (p=0.02).
Croatian: Kao što se očekivalo na temelju dizajna studije, nije uočena razlika u trajanju remisije, preživljenju bez bolesti ili ukupnom preživljenju, premda su bolesnici s potpunim molekularnim odgovorom i s minimalnom rezidualnom bolešću imali bolji ishod u smislu dužine remisije (p=0,01) i preživljenja bez bolesti (p=0,02).
English: - Take Imatinib Accord with a meal.
Croatian: - Imatinib Accord uzimajte uz obrok.
English: Patients had received a median of 14 months of prior IFN therapy at doses ≥ 25 x 106 IU/week and were all in late chronic phase, with a median time from diagnosis of 32 months.
Croatian: Bolesnici su prethodno primali IFN terapiju u medijanu trajanja od 14 mjeseci u dozama ≥ 25 x 106 IU/tjedan i svi su bili u završnoj kroničnoj fazi, sa medijanom vremena od postavljanja dijagnoze od 32 mjeseca.
English: If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Imatinib Accord should not be resumed.
Croatian: Ako su anti-ADAMTS13-protutijela povišena istodobno sa sniženom ADAMTS13 aktivnosti, liječenje Imatinib Accordom se ne smije nastaviti.
English: This will help protect you from stomach problems when taking Imatinib Accord.
Croatian: To će Vam pomoći u zaštiti od želučanih problema prilikom uzimanja Imatinib Accorda.
English: • Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
Croatian: • iznenadno oticanje i crvenilo kože (znakovi kožne infekcije zvane celulitis).
English: Patients with Severe renal impairment should be treated with caution.
Croatian: Bolesnike s teškim oštećenjem bubrega treba liječiti s oprezom.
English: The percentage of some adverse reactions was higher in the 40 patients in whom the dose was increased to 800 mg daily compared to the population of patients before dose increase (n=551).
Croatian: Postotak nekih nuspojava bio je viši u 40 bolesnika u kojih je doza povećana na 800 mg na dan, u usporedbi s populacijom bolesnika prije povećanja doze (n=551).