FrancophonIA/ELRC3.0 huggingface dataset:
English: - Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
Croatian: - Jedna bočica od 5 ml sadrži nusinersennatrij što odgovara 12 mg nusinersena.
English: 1CS3B was stopped following positive statistical analysis on the primary endpoint at interim analysis (statistically significantly greater percentage of patients achieved the definition of a motor milestone responder in the Spinraza group (41%) compared to the sham-control group (0%), p<0.0001) 2At the final analysis, event-free survival and overall survival were assessed using the Intent to Treat population (ITT Spinraza n=80; Sham-control n=41).
Croatian: 1Ispitivanje CS3B bilo je zaustavljeno nakon pozitivne statističke analize mjere primarnog ishoda u interim analizi (statistički značajno veći postotak bolesnika zadovoljio je definiciju odgovora na liječenje s obzirom na postignute ključne točke motoričkog razvoja u skupini koja je primala lijek Spinraza (41%) nego u kontrolnoj skupini u kojoj je proveden placebo postupak (0%), p<0,0001).
English: Spinraza 12 mg solution for injection
Croatian: NAZIV LIJEKA Spinraza 12 mg otopina za injekciju
English: What you need to know before you or your child are given Spinraza Spinraza must not be given:
Croatian: Što morate znati prije nego što Vi ili Vaše dijete počnete primati lijek Spinraza
English: It is recommended that the volume of cerebral spinal fluid (CSF), equivalent to the volume of Spinraza to be injected, is removed prior to administration of Spinraza.
Croatian: Prije primjene lijeka Spinraza preporučuje se izvući volumen cerebrospinalnog likvora koji odgovara volumenu lijeka Spinraza koji će se ubrizgati.
English: Intrathecal use
Croatian: Intratekalno
English: 4Assessed at the later of Day 183, Day 302, and Day 394 Study Visit 5According to Hammersmith Infant Neurological Examination (HINE) section 2: ≥2 point increase [or maximal score] in ability to kick, OR ≥1 point increase in the motor milestones of head control, rolling, sitting, crawling, standing or walking, AND improvement in more categories of motor milestones than worsening, defined as a responder for this primary analysis.
Croatian: Hammersmith Infant Neurological Examination, HINE): za ovu primarnu analizu, odgovor na liječenje bio je definiran kao povećanje za ≥2 boda [ili maksimalni broj bodova] u sposobnosti udaranja nožicama, ILI povećanje za ≥1 bod za ključne točke motoričkog razvoja u pogledu kontrole glave, prevrtanja, sjedenja, puzanja, stajanja ili hodanja, I poboljšanje u više kategorija ključnih točki motoričkog razvoja nego pogoršanje.
English: Some of these patients had needed to have a device called a ventriculo-peritoneal shunt implanted to treat the hydrocephalus.
Croatian: Za liječenje hidrocefalusa, nekima od tih bolesnika trebala je biti ugrađena naprava koja se naziva ventrikuloperitonealni drenažni sustav.
English: No cases of overdose associated with adverse reactions were reported in clinical studies.
Croatian: U kliničkim ispitivanjima nije bio zabilježen nijedan slučaj predoziranja povezan s nuspojavama.
English: Of these patients, stabilization or improvement in mean HFMSE (1.4; SD 4.02) and RULM (2.1; SD 2.56) scores were observed from baseline to Study Day 265 in Study CS11.
Croatian: U tih bolesnika u razdoblju od početka do 265. dana ispitivanja CS11 primijećeni su stabilizacija ili poboljšanja srednjih vrijednosti HFMSE (1,4; SD 4,02) i RULM rezultata (2,1; SD 2,56).
English: An additional clinical study, CS7 (EMBRACE) was opened for patients not eligible for participation in Study CS3B or Study CS4 due to screening age or SMN2 copy number.
Croatian: Za bolesnike koji nisu ispunjavali uvjete za sudjelovanje u ispitivanju CS3B ili ispitivanju CS4 zbog dobi kod probira ili broja kopija SMN2, otvoreno je dodatno kliničko ispitivanje CS7 (EMBRACE).
English: How to store Spinraza
Croatian: Kako čuvati lijek Spinraza
English: Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.
Croatian: Spinraza je indicirana za liječenje spinalne mišićne atrofije uzrokovane mutacijom na kromosomu 5q. 4.2 Doziranje i način primjene
English: How Spinraza is given
Croatian: Kako se daje lijek Spinraza
English: Submission of study results:
Croatian: Podnošenje rezultata ispitivanja: drugo tromjesečje
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet Biogen (Denmark) Manufacturing ApS
English: Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat natrijev klorid kalijev klorid kalcijev klorid dihidrat magnezijev klorid heksahidrat natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH) voda za injekcije
English: Each dose of Spinraza contains less than 1 mmol (23 mg) sodium.
Croatian: Jedna doza lijeka Spinraza sadrži manje od 1 mmol (23 mg) natrija, tj. sadrži zanemarive količine natrija, pa se može primjenjivati u osoba s ograničenjem unosa natrija.
English: At the final analysis, a statistically significant greater percentage of patients achieved the definition of a motor milestone responder in the Spinraza group (51%) compared to the sham-control group (0%) (p<0.0001).
Croatian: Spinraza (51%) nego u kontrolnoj skupini u kojoj je proveden placebo postupak (0%) (p<0,0001).
English: Infantile onset
Croatian: Početak u dojenačkoj dobi
English: In these patients, a mean improvement of 28.6 meters (SD 47.22, n=12) at Day 253 and 86.5 metres (SD 40.58, n=8) at Day 1050.
Croatian: (SD 47,22, n=12) na 253. dan i 86,5 metara (SD 40,58, n=8) na 1050. dan.
English: - The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate,
Croatian: - Drugi sastojci su natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat, natrijev klorid,
English: Adverse reactions associated with the administration of Spinraza by lumbar puncture have been observed.
Croatian: Opažene su nuspojave povezane s primjenom lijeka Spinraza putem lumbalne punkcije.
English: Further improvement in mean total motor milestone (HINE-Section 2) (2.1; SD 4.36; n=22) and CHOP INTEND (4.68; SD 3.993, n=22) scores were observed from baseline to Study Day 304 in Study CS11.
Croatian: Od početka do 304. dana ispitivanja CS11 uočena su dodatna poboljšanja srednje vrijednosti rezultata za cjelokupne ključne točke motoričkog razvoja (HINE - 2. dio) (2,1; SD 4,36; n = 22) i CHOP INTEND (4,68; SD 3,993; n
English: HFMSE score
Croatian: Hidrocefalus
English: 4.7 Effects on ability to drive and use machines
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Spinraza ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Kontrola(N=42)
English: Aseptic technique should be used when preparing Spinraza solution for intrathecal administration.
Croatian: Pripremu otopine lijeka Spinraza za intratekalnu primjenu potrebno je izvoditi aseptičkom tehnikom.
English: Adverse reactions have been identified during post-approval use of Spinraza.
Croatian: Nuspojave lijeka Spinraza zabilježene su tijekom njegove primjene nakon dobivanja odobrenja za stavljanje lijeka u promet.
English: Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica od 5 ml sadrži nusinersennatrij što odgovara 12 mg nusinersena.
English: Proportion with improvement in total motor milestone score Proportion with worsening in total motor milestone score p<0.0001
Croatian: Udio s poboljšanjem ukupnog rezultata ocjene ključnih točki motoričkog razvoja Udio s pogoršanjem ukupnog rezultata ocjene ključnih točki motoričkog razvoja
English: Biogen Belgium N.V./S.A.
Croatian: Biogen Netherlands B.V.
English: Your doctor will tell you how long you or your child need to receive Spinraza.
Croatian: Vi ili Vaše dijete trebate primati lijek Spinraza.
English: 3.9 (95% CI: 3.0, 4.9) p=0.0000001
Croatian: 3,9 (95% CI: 3,0; 4,9)
English: Tel.: +386 1 511 02 90
Croatian: Biogen Pharma d.o.o. Tel.: +386 1 511 02 90
English: The assessment of undesirable effects is based on the following frequency data:
Croatian: Ocjena nuspojava temelji se na sljedećim podacima o učestalosti: vrlo često (≥1/10)
English: A sustained improvement was seen in patients with Type II SMA who experienced a mean improvement from baseline HFMSE score of 5.1 (SD 4.05, n=11) at Day 253, and 9.1(SD 6.61, n=9) at Day 1050.
Croatian: rezultata od 5,1 (SD 4,05; n=11) na 253. dan i 9,1 (SD 6,61, n=9) na 1050. dan.
English: Tel: +420 255 706 200
Croatian: Česká republika Biogen (Czech Republic) s.r.o. Tel: +420 255 706 200
English: 4.2(95% CI: 3.4, 5.0) p=0.00000016
Croatian: 4,2 (95% CI: 3,4; 5,0)
English: The Spinraza vial should be inspected for particles prior to administration.
Croatian: Prije primjene, bočicu lijeka Spinraza potrebno je pregledati da ne sadrži čestice.
English: Tel: +370 52 14 02 60
Croatian: Ewopharma AG Atstovybė Tel: +370 52 14 02 60
English: What you need to know before you or your child are given Spinraza 3.
Croatian: Vi ili Vaše dijete počnete primati lijek Spinraza 3.
English: Further information on Gefitinib Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Gefitinib Mylan možete nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that it blocks specific enzymes known as tyrosine kinases.
Croatian: To znači da blokira određene enzime poznate pod nazivom tirozin kinaze.
English: Gefitinib Mylan is available as 250 mg tablets to be taken by mouth.
Croatian: Gefitinib Mylan dostupan je u obliku tableta od 250 mg koje se uzimaju na usta.
English: EGFR is involved in the growth and spread of cancer cells.
Croatian: EGFR sudjeluje u razvoju i širenju stanica raka.
English: By blocking EGFR, Gefitinib Mylan helps to slow down the growth and spread of the cancer.
Croatian: Blokiranjem EGFR-a Gefitinib Mylan pomaže u usporavanju razvoja i širenja raka.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Iressa, and do not need to be repeated for Gefitinib Mylan.
Croatian: Ispitivanja koristi i rizika djelatne tvari u odobrenoj primjeni već su provedena s referentnim lijekom Iressa i stoga ih nije potrebno ponavljati za lijek Gefitinib Mylan.
English: This means that Gefitinib Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Iressa.
Croatian: To znači da Gefitinib Mylan sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Iressa.
English: What measures are being taken to ensure the safe and effective use of Gefitinib Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Gefitinib Mylan?
English: Gefitinib Mylan can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience with anticancer treatments.
Croatian: Lijek Gefitinib Mylan izdaje se samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u liječenju raka.
English: Side effects reported with Gefitinib Mylan are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Gefitinib Mylan pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gefitinib Mylan have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Gefitinib Mylan nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Gefitinib Mylan is used to treat adults who have non-small cell lung cancer that is locally advanced or metastatic (when cancer cells have spread from the original site to other parts of the body).
Croatian: Gefitinib Mylan lijek je protiv raka koji se primjenjuje za liječenje odraslih s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica (kada se stanice raka prošire s primarnog žarišta na druge dijelove tijela).
English: What is Gefitinib Mylan and what is it used for?
Croatian: Što je Gefitinib Mylan i za što se koristi?
English: Because Gefitinib Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Gefitinib Mylan generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: What are the benefits and risks of Gefitinib Mylan?
Croatian: Koje su koristi i rizici od lijeka Gefitinib Mylan?
English: It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal growth factor receptor (EGFR).
Croatian: Primjenjuje se u bolesnika u kojih stanice raka imaju mutaciju u genima koji proizvode bjelančevinu naziva „receptor epidermalnog faktora rasta” (EGFR).
English: An overview of Gefitinib Mylan and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Gefitinib Mylan i zašto je odobren u EU-u
English: The European Medicines Agency concluded that, in accordance with EU requirements, Gefitinib Mylan has been shown to have comparable quality and to be bioequivalent to Iressa.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, lijek Gefitinib Mylan dokazao usporedivu kakvoću te da je bioekvivalentan s lijekom Iressa.
English: Other information about Gefitinib Mylan
Croatian: Ostale informacije o lijeku Gefitinib Mylan
English: For more information about using Gefitinib Mylan, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Gefitinib Mylan potražite u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: These enzymes can be found on the surface of cancer cells, such as EGFR on the surface of non-small cell lung cancer cells.
Croatian: Ti se enzimi nalaze na površini stanica raka, na primjer EGFR-a koji se nalazi na površini stanica raka pluća nemalih stanica.
English: The tablet can be dispersed in water for patients who have difficulty swallowing.
Croatian: Za bolesnike koji imaju teškoća s gutanjem tableta se može rastopiti u vodi.
English: The active substance in Gefitinib Mylan, gefitinib, is a protein tyrosine kinase inhibitor.
Croatian: Djelatna tvar lijeka Gefitinib Mylan, gefitinib, inhibitor je protein-tirozin kinaze.
English: As for every medicine, the company provided studies on the quality of Gefitinib Mylan.
Croatian: Kao za svaki lijek, tvrtka je dostavila podatke o ispitivanjima kakvoće za lijek Gefitinib Mylan.
English: Gefitinib Mylan works only in non-small cell lung cancer cells that have a mutation in their EGFR.
Croatian: Gefitinib Mylan djeluje samo na stanice raka pluća nemalih stanica koje imaju mutaciju EGFR-a.
English: As for all medicines, data on the use of Gefitinib Mylan are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Gefitinib Mylan kontinuirano se prate.
English: Why is Gefitinib Mylan authorised in the EU?
Croatian: Zašto je lijek Gefitinib Mylan odobren u EU-u?
English: Therefore, the Agency's view was that, as for Iressa, the benefit of Gefitinib Mylan outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka Gefitinib Mylan, kao i od lijeka Iressa, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: Gefitinib Mylan contains the active substance gefitinib and is a ‘generic medicine'.
Croatian: Gefitinib Mylan sadrži djelatnu tvar gefitinib te je „generički lijek”.
English: How is Gefitinib Mylan used?
Croatian: Kako se Gefitinib Mylan koristi?
English: How does Gefitinib Mylan work?
Croatian: Kako djeluje Gefitinib Mylan?
English: How has Gefitinib Mylan been studied?
Croatian: Kako je Gefitinib Mylan ispitivan?
English: MA (EU) Number
Croatian: Broj (EU) odobrenja (Zaštićeno) Ime
English: Adopted at the 6-9 June 2016 PRAC
Croatian: Usvojeno na sjednici PRAC-a održanoj 6.-9. lipnja 2016.
English: Interim results showed an increased risk of mortality and serious adverse events in subjects receiving riociguat compared to those receiving
Croatian: Rezultati interim analize pokazali su da postoji povećani rizik od smrtnosti i ozbiljnih štetnih događaja u ispitanika koji primaju riocigvat u usporedbi s onima koji primaju placebo.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/400813/2016
Croatian: Novi tekst informacija o lijeku - izvadci iz preporuka PRAC-a vezanih uz signale EMA/PRAC/424154/2016
English: Section 2 - What you need to know before you take Adempas Do NOT take Adempas: - If you have increased pressure in your pulmonary circulation associated with scarring of the lungs, of unknown cause (idiopathic pulmonary pneumonia).
Croatian: - Što morate znati prije nego počnete uzimati Adempas NEMOJTE uzimati Adempas: - ako imate povišen tlak u plućnoj cirkulaciji koji je povezan sa stvaranjem ožiljaka na plućima nepoznatog uzroka (idiopatska pneumonija).
English: Riociguat - Increased mortality and serious adverse events (SAEs) in patients with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) in a single clinical trial (EPITT no 18681)
Croatian: Riocigvat - povećana smrtnost i ozbiljni štetni događaji u bolesnika s plućnom hipertenzijom (PH) povezanom s idiopatskim intersticijskim pneumonijama (IIP) u jednom kliničkom ispitivanju (EPITT br. 18681)
English: The available data do not indicate a clinically significant benefit from riociguat treatment in these patients.
Croatian: značajnu korist od liječenja riocigvatom u tih bolesnika.
English: A randomised, double blind, placebo-controlled phase II study (RISE-IIP) to evaluate the efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) was terminated early.
Croatian: Bolesnici s plućnom hipertenzijom povezanom s idiopatskim intersticijskim pneumonijama (PH-IIP) Randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze II (RISE-IIP) u kojem su se ocjenjivale djelotvornost i sigurnost riocigvata u bolesnika sa simptomatskom plućnom hipertenzijom povezanom s idiopatskim intersticijskim pneumonijama (PH-IIP) prekinuto je ranije.
English: Section 4.3 - Contraindications - Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) (see Section 5.1)
Croatian: Dio 4.3. - Kontraindikacije - Bolesnici s plućnom hipertenzijom povezanom s idiopatskim intersticijskim pneumonijama (PH-IIP) (vidjeti dio 5.1.)
English: Riociguat is therefore contraindicated in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (see section 4.3).
Croatian: Stoga je riocigvat kontraindiciran u bolesnika s plućnom hipertenzijom povezanom s idiopatskim intersticijskim pneumonijama (vidjeti dio 4.3.).
English: Macrogol 400
Croatian: makrogol 400
English: (cannot be estimated from the available data)
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka)
English: What Levitra is and what it is used for
Croatian: Što je Levitra i za što se koristi
English: Tell your doctor if you think Levitra is too strong or too weak.
Croatian: Obavijestite svog liječnika ako mislite da je Levitra prejaka ili preslaba.
English: It can interfere with the usual effect of the medicine.
Croatian: Može utjecati na uobičajeni učinak tog lijeka.
English: It may be risky for you to have sex.
Croatian: Za Vas spolni odnos može biti rizičan.
English: Effect on QTc interval
Croatian: Utjecaj na QTc interval
English: Do not take Levitra more than once a day.
Croatian: Nemojte uzimati lijek Levitra više od jedanput na dan.
English: Levitra will only work when you are sexually stimulated.
Croatian: Levitra će djelovati samo kad ste seksualno stimulirani.
English: - Alcoholic drink can make erection difficulties worse.
Croatian: - Alkoholna pića mogu pogoršati tegobe s erekcijom.
English: This was not associated with any muscle or neurological toxicity.
Croatian: To nije bilo povezano s mišićnom ili neurološkom toksičnošću.
English: Use in adult men
Croatian: Primjena u odraslih muškaraca
English: Most of the men who experienced these side effects had heart problems before taking this medicine.
Croatian: Većina muškaraca koji su imali ove nuspojave imala je srčane probleme prije uzimanja ovog lijeka.
English: When using the individual correction formulae, none of the values were out of the limit.
Croatian: Kad su se koristile individualizirane korekcijske formule (QTci), niti jedna vrijednost nije bila izvan granice.
English: Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Croatian: Molimo obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: Of these, 900 patients have been treated for one year or longer.
Croatian: Među njima, 900 bolesnika se liječilo godinu dana ili dulje.
English: Other medicines and Levitra
Croatian: Drugi lijekovi i Levitra
English: The combination should be avoided (see section 4.5).
Croatian: Ova se kombinacija treba izbjegavati (vidjeti dio 4.5).
English: Moxifloxacin (400 mg) was included as an active internal control.
Croatian: Moksifloksacin (400 mg) je bio uključen kao aktivna interna kontrola.
English: - Swallow one tablet with a glass of water.
Croatian: Progutajte jednu tabletu uz čašu vode.
English: At least one in ten men has trouble getting or keeping an erection at some time.
Croatian: Najmanje jedan na deset muškaraca ponekad ima poteškoća s postizanjem ili održavanjem erekcije.
English: If you have a bleeding disorder (such as haemophilia).
Croatian: Pomoćne tvari:
English: The mean absolute oral bioavailability is 15%.
Croatian: Prosječna apsolutna oralna bioraspoloživost je 15%.
English: Date of first authorisation: 6 March 2003 Date of latest renewal: 6 March 2008
Croatian: Datum posljednje obnove odobrenja: 6. ožujka 2008.
English: What Levitra looks like and contents of the pack
Croatian: Kako Levitra izgleda i sadržaj pakiranja
English: The clinical relevance of this finding is unknown and cannot be generalised to all patients under all circumstances, as it will depend on the individual risk factors and susceptibilities that may be present at any time in any given patient.
Croatian: Klinička važnost ovog nalaza nije poznata i ne može se generalizirati na sve bolesnike u svim situacijama, jer će to ovisiti o rizičnim čimbenicima individualnog bolesnika i osjetljivosti koja se može razviti u bilo kojem trenu.
English: The maximum recommended dosing frequency is once per day.
Croatian: Maksimalna preporučena učestalost doziranja je jedanput na dan.
English: Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
Croatian: Većina bolesnika u kojih su zabilježeni navedeni događaji već je imala postojeće čimbenike kardiovaskularnog rizika.
English: Most of the effects are mild or moderate.
Croatian: Nuspojave su većinom blage ili umjerene.
English: The actual clinical impact of these QT changes is unknown.
Croatian: Stvarni klinički učinak ovih promjena QT intervala nije poznat.