FrancophonIA/ELRC3.0 huggingface dataset:
English: The Ellipta inhaler consists of a grey body, light green mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet.
Croatian: Ellipta inhalator se sastoji od sivog tijela, svijetlozelenog poklopca nastavka za usta i brojača doza, a zapakiran je u podložak od višeslojne folije koji sadrži vrećicu sa silika gelom kao sredstvom za sušenje.
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Incruse Ellipta inhaler:
Croatian: Ako se javi stezanje u prsima, kašalj, piskanje pri disanju ili nedostatak zraka neposredno nakon primjene lijeka Incruse:
English: If you stop using Incruse Ellipta
Croatian: Ako prestanete primjenjivati Incruse Ellipta
English: No dose adjustment is required in patients with renal impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrežne funkcije (vidjeti dio 5.2).
English: If you forget to use Incruse Ellipta
Croatian: Ako ste zaboravili primijeniti Incruse Ellipta
English: EU/1/14/922/002
Croatian: EU/1/14/922/001 EU/1/14/922/002
English: In-use shelf-life after opening the tray: 6 weeks.
Croatian: 2 godine Rok valjanosti nakon otvaranja podloška: 6 tjedana.
English: What Incruse Ellipta is and what it is used for
Croatian: Što je Incruse Ellipta i za što se koristi
English: The probability of having an exacerbation in patients receiving Incruse Ellipta at week 24 was 8.9% compared with 13.7% for placebo.
Croatian: Vjerojatnost pojave egzacerbacije nakon 24 tjedna iznosila je 8,9% u bolesnika liječenih lijekom Incruse Ellipta te 13,7% u onih koji su primali placebo.
English: In the 24-week study treatment with Incruse Ellipta, the mean (SD) change from baseline in the number of puffs of rescue salbutamol over the 24-week treatment period was -1.4 (0.20) for placebo and -1.7 (0.16) for Incruse Ellipta (Difference = -0.3; 95% CI: -0.8, 0.2, p=0.276).
Croatian: U 24-tjednom ispitivanju primjene lijeka Incruse, srednja (SD) promjena broja udisaja salbutamola za hitno ublažavanje simptoma tijekom 24-tjednog razdoblja liječenja u odnosu na početnu vrijednost iznosila je -1,4 (0,20) za placebo te -1,7 (0,16) za Incruse Ellipta (razlika = -0,3; 95% CI: -0,8; 0,2; p=0,276).
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 12 was greater for Incruse Ellipta 55 micrograms (44%) compared with placebo (26%) in the 12-week study.
Croatian: U 12-tjednom ispitivanju je udio bolesnika koji su nakon 12 tjedana postigli barem MCID u SGRQ rezultatu (definiran kao smanjenje za 4 boda od početne vrijednosti) bio veći kod primjene lijeka Incruse Ellipta od 55 mikrograma (44%) u usporedbi s primjenom placeba (26%).
English: These may affect up to 1 in 1,000 people:
Croatian: Mogu se javiti u do 1 na 1000 osoba: • bol u oku
English: At Week 52, a statistically significant improvement in the least-squares (LS) mean change from baseline in trough FEV1 was observed for FF/UMEC/VI compared with FF/VI (mean change: +94 mL vs. -3 mL; treatment difference: 97 mL; 95% CI: 85, 109; p<0.001).
Croatian: 52. tjedna, dobivene metodom najmanjih kvadrata opaženo je za FF/UMEC/VI u usporedbi s FF/VI, (srednja vrijednost promjene: +94 ml u odnosu na -3 ml; razlika između liječenja: 97 ml; 95% CI: 85, 109; p<0,001).
English: The inhaler will be in the ‘closed' position when it is first taken out of its sealed tray.
Croatian: Kada se inhalator prvi puta izvadi iz zatvorenog podloška, nalazit će se u „zatvorenom“ položaju.
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 12 was greater for Incruse Ellipta (38%) compared with placebo (15%) in the 12-week study.
Croatian: U 12-tjednom ispitivanju je udio bolesnika koji su nakon 12 tjedana odgovorili barem najmanjom klinički važnom razlikom (engl. minimum clinically important difference, MCID) od 1 boda u ukupnom TDI rezultatu bio veći kod primjene lijeka Incruse Ellipta (38%) u usporedbi s primjenom placeba (15%).
English: Incruse Ellipta demonstrated a statistically significant greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 12 compared with placebo (166 ml, p<0.001) in the 12week pivotal study.
Croatian: Incruse Ellipta je postigao statistički značajno veće poboljšanje ponderirane srednje vrijednosti FEV1 u razdoblju od 0 do 6 sati nakon primjene doze u odnosu na početne vrijednosti u usporedbi s placebom nakon 12 tjedana (166 ml, p<0,001) u 12-tjednom ključnom ispitivanju.
English: Your Incruse Ellipta inhaler carton contains
Croatian: Vaša kutija s Incruse Ellipta inhalatorom sadrži
English: Incruse Ellipta is for inhalation use.
Croatian: Incruse Ellipta namijenjen je za inhalacijsku primjenu.
English: NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited logo
Croatian: GlaxoSmithKline (Ireland) Limited logo
English: Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v.
Croatian: GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien
English: There is no relevant use of Incruse Ellipta in the paediatric population (under 18 years of age) in the indication for COPD.
Croatian: Nema relevantne primjene lijeka Incruse Ellipta u pedijatrijskoj populaciji (bolesnici mlađi od
English: Incruse Ellipta demonstrated a greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 24 compared with placebo (150 ml, p<0.001
Croatian: Incruse Ellipta je postigao veće poboljšanje ponderirane srednje vrijednosti FEV1 u razdoblju od 0 do 6 sati nakon primjene doze u odnosu na početne vrijednosti u usporedbi s placebom nakon 24 tjedna (150 ml, p<0,001*) u
English: Incruse Ellipta is for inhalation use only.
Croatian: Incruse Ellipta se primjenjuje isključivo putem inhalacije.
English: 2 years
Croatian: Treće tromjesečje
English: Similarly, a greater proportion of patients achieved at least the MCID for Incruse Ellipta at Week 24 (44%) compared with placebo (34%) in the 24-week study.
Croatian: Slično tome, u 24-tjednom ispitivanju je nakon 24 tjedna veći udio bolesnika ostvario barem MCID kod primjene lijeka Incruse Ellipta (44%) u usporedbi s primjenom placeba (34%).
English: Contents of the pack and other information Step-by-step instructions for use
Croatian: Kako čuvati Incruse Ellipta 6. Sadržaj pakiranja i druge informacije Upute za primjenu korak po korak
English: What is the inhaler?
Croatian: Kako koristiti inhalator
English: What Incruse Ellipta is used for
Croatian: Za što se Incruse Ellipta koristi
English: Similarly, a greater proportion of patients achieved 1 unit TDI focal score for Incruse Ellipta (53%) compared with placebo (41%) at Week 24 in the 24-week study.
Croatian: Slično tome, u 24-tjednom ispitivanju je nakon 24 tjedna veći udio bolesnika ostvario ukupan TDI rezultat od ≥1 boda kod primjene lijeka Incruse Ellipta (53%) u usporedbi s primjenom placeba (41%).
English: How to use Incruse Ellipta
Croatian: Kako primjenjivati Incruse Ellipta
English: • skin rash (hives) or redness
Croatian: • kožni osip (koprivnjača) ili crvenilo Česte nuspojave
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna primijenjena doza sadrži 55 mikrograma umeklidinija (što odgovara količini od 65 mikrograma umeklidinijeva bromida).
English: Incruse Ellipta also demonstrated a statistically significant improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 12 compared with placebo (-7.90 units, p<0.001) in the 12-week study.
Croatian: St. George's Respiratory Questionnaire, SGRQ), na što ukazuje smanjenje ukupnog SGRQ rezultata nakon 12 tjedana u usporedbi s placebom (-7,90 bodova, p<0,001) u 12-tjednom ispitivanju.
English: A greater improvement compared with placebo in the change from baseline in SGRQ total score at Week 24 was demonstrated for Incruse Ellipta (-4.69 units, p<0.001) in the 24-week study.
Croatian: Incruse Ellipta je doveo do većeg poboljšanja promjene ukupnog SGRQ rezultata u odnosu na početne vrijednosti u usporedbi s placebom nakon 24 tjedna (-4,69 bodova, p<0,001*) u 24-tjednom ispitivanju.
English: Table 1: Trough FEV1 (ml) at Week 12 and Week 24 (primary endpoint) Treatment with Incruse Ellipta 55 mcg
Croatian: Tablica 1: Najniža vrijednost FEV1 (ml) nakon 12 i 24 tjedna (primarna mjera ishoda)
English: NAME OF THE MEDICINAL PRODUCT Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed
Croatian: Incruse Ellipta 55 mikrograma prašak inhalata, dozirani
English: How to store Incruse Ellipta
Croatian: Kako čuvati Incruse Ellipta
English: Pivotal Efficacy Studies:
Croatian: Ključna ispitivanja djelotvornosti
English: Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
Croatian: Incruse Ellipta 55 mikrograma prašak inhalata, dozirani umeklidinij (umeklidinijev bromid)
English: In both of the pivotal 12-week and 24-week studies, Incruse Ellipta demonstrated statistically significant and clinically meaningful improvements in lung function (as defined by change from baseline trough FEV1 at Week 12 and Week 24 respectively, which was the primary efficacy endpoint in each study) compared with placebo (see Table 1).
Croatian: U oba ključna ispitivanja u trajanju od 12 tjedana i 24 tjedna Incruse Ellipta je postigao statistički značajna i klinički važna poboljšanja plućne funkcije (definirana promjenom najniže vrijednosti FEV1
English: METHOD AND ROUTE(S) OF ADMINISTRATION Once daily
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: Infections and infestations Nasopharyngitis Upper respiratory tract infection Urinary tract infection
Croatian: Infekcije i infestacije nazofaringitis infekcija gornjeg dišnog sustava infekcija mokraćnog sustava sinusitis faringitis često često često često manje često
English: • While holding the inhaler away from your mouth, breathe out as far as is comfortable.
Croatian: 3) Inhalirajte lijek • Držite inhalator dalje od usta i izdahnite koliko možete, do granice neugode.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics, ATC code: R03BB07
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: lijekovi za liječenje opstruktivnih bolesti dišnih putova, antikolinergici;
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street
Croatian: Glaxo Operations UK Ltd. (posluje pod nazivom Glaxo Wellcome Operations) Priory Street
English: NAME OF THE MEDICINAL PRODUCT Incruse Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide)
Croatian: Incruse Ellipta 55 μg prašak inhalata umeklidinij (umeklidinijev bromid)
English: week pivotal study.
Croatian: 24-tjednom ključnom ispitivanju.
English: In two 12-week, placebo controlled studies (200109 and 200110), the addition of Incruse Ellipta to fluticasone furoate/vilanterol (FF/VI) (92/22 micrograms) once daily in adult patients with a clinical diagnosis of COPD, resulted in statistically significant and clinically meaningful improvements in the primary endpoint of trough FEV1 at Day 85 compared to placebo plus FF/VI (124 mL 95% CI: 93, 154; p<0.001and 122 mL 95% CI: 91, 152; p<0.001).
Croatian: U dva 12-tjedna, placebom kontrolirana ispitivanja (200109 i 200110), dodavanje lijeka Incruse Ellipta kombinaciji flutikazonfuorat/vilanterol (FF/VI) (92/22 mikrograma) jedanput dnevno, u odraslih bolesnika s kliničkom dijagnozom KOPB-a, ishodilo je statistički značajnim i kliničkim bitnim
English: • eye pain
Croatian: • suha usta
English: Excipients
Croatian: EXP
English: NAME OF THE MEDICINAL PRODUCT Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
Croatian: Uputa o lijeku: Informacije za korisnika Incruse Ellipta 55 mikrograma prašak inhalata, dozirani umeklidinij (umeklidinijev bromid)
English: Tel: + 370 5 264 90 00 info.lt@gsk.com
Croatian: GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info.lt@gsk.com
English: What Incruse Ellipta looks like and contents of the pack Incruse Ellipta is an inhalation powder, pre-dispensed.
Croatian: Kako Incruse Ellipta izgleda i sadržaj pakiranja
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide.
Croatian: Jedna pojedinačna inhalacija osigurava primijenjenu dozu (doza koja izlazi iz nastavka za usta na inhalatoru) od 55 mikrograma umeklidinija (što odgovara količini od 65 mikrograma umeklidinijeva bromida).
English: Magyarország GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
Croatian: GlaxoSmithKline d.o.o. Tel: +385 1 6051999
English: INFORMATION IN BRAILLE incruse ellipta
Croatian: incruse ellipta
English: A statistically significant improvement compared with placebo in the TDI focal score at Week 24 was demonstrated for Incruse Ellipta (1.0 units, p<0.001) in the 24-week study.
Croatian: U 24-tjednom ispitivanju Incruse Ellipta je doveo do statistički značajnog poboljšanja ukupnog TDI rezultata nakon 24 tjedna u usporedbi s placebom (1,0 bod; p<0,001).
English: In the 12-week study, a statistically significant improvement compared with placebo in the TDI focal score at Week 12 was not demonstrated for Incruse Ellipta (1.0 units, p=0.05).
Croatian: Transitional Dyspnoea Index, TDI) nakon 12 tjedana u usporedbi s placebom (1,0 bod; p=0,05).
English: What Incruse Ellipta contains The active substance is umeclidinium bromide.
Croatian: Djelatna tvar je umeklidinijev bromid.
English: Magnesium stearate
Croatian: Poklopac podloška
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/922/003
Croatian: EU/1/14/922/001 EU/1/14/922/002 EU/1/14/922/003
English: Date of latest renewal: 24 June 2009
Croatian: Datum posljednje obnove: 24. lipnja 2009.
English: Talk to your doctor if you do not feel better after 2 months.
Croatian: Razgovarajte s liječnikom ako se ne budete osjećali bolje nakon 2 mjeseca.
English: ARICLAIM with food, drink and alcohol
Croatian: ARICLAIM s hranom, pićem i alkoholom
English: The difference in mean improvement between the two active treatment arms was not significant.
Croatian: Razlika u srednjem poboljšanju između dva aktivna načina liječenja nije bila značajna.
English: The following are reasons why ARICLAIM may not be suitable for you.
Croatian: U nastavku su navedeni razlozi zbog kojih ARICLAIM možda nije prikladan lijek za Vas.
English: Do not drive or use any tools or machines until you know how ARICLAIM affects you.
Croatian: Nemojte voziti niti rukovati alatima ili strojevima dok ne znate kako će ARICLAIM utjecati na Vas.
English: Other medicines and ARICLAIM
Croatian: Drugi lijekovi i ARICLAIM
English: Some patients who stop taking ARICLAIM suddenly have had symptoms such as:
Croatian: Neki bolesnici koji su naglo prekinuli uzimati ARICLAIM imali su simptome kao što su:
English: What ARICLAIM is and what it is used for
Croatian: Što je ARICLAIM i za što se koristi
English: ARICLAIM is indicated in adults.
Croatian: ARICLAIM je indiciran za odrasle.
English: Contents of the pack and other information What ARICLAIM contains
Croatian: Sadržaj pakiranja i druge informacije Što ARICLAIM sadrži
English: DO NOT take ARICLAIM if you:
Croatian: NEMOJTE uzimati ARICLAIM ako:
English: 7 Not statistically significantly different from placebo.
Croatian: 7 Ne razlikuje se statistički značajno od placeba.
English: If you take ARICLAIM near the end of your pregnancy, your baby might have some symptoms when it is born.
Croatian: Ako uzimate lijek ARICLAIM pred kraj trudnoće, Vaše dijete može imati neke simptome kada se rodi.
English: ARICLAIM may be taken with or without food.
Croatian: ARICLAIM se može uzimati s hranom ili bez nje.
English: To help you remember to take ARICLAIM, you may find it easier to take it at the same times every day.
Croatian: Možda ćete se lakše sjetiti uzeti ARICLAIM ako ga svakog dana budete uzimali u isto vrijeme.
English: Physicians should encourage patients to report any distressing thoughts or feelings or depressive symptoms at any time.
Croatian: Liječnici moraju potaknuti bolesnike da im prijave bilo kakve uznemirujuće misli ili osjećaje te simptome depresije u bilo koje vrijeme.
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Croatian: S obzirom da poboljšanje ne mora nastupiti tijekom prvih nekoliko tjedana liječenja ili dulje, bolesnike se mora pomno pratiti sve dok ne nastupi poboljšanje.
English: If your doctor has prescribed ARICLAIM for a patient under 18 and you want to discuss this, please go back to your doctor.
Croatian: Ako je liječnik propisao lijek ARICLAIM bolesniku mlađem od 18 godina i želite o tome razgovarati, vratite se svom liječniku.
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.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: In people with diabetic neuropathic pain it can take some weeks before you feel better.
Croatian: U osoba s boli kod dijabetičke neuropatije može biti potrebno nekoliko tjedana prije nego što se počnu osjećati bolje.
English: These effects are normally mild to moderate and often disappear after a few weeks.
Croatian: Te su nuspojave obično blage do umjerene i često nestaju nakon nekoliko tjedana.
English: You may be more likely to think like this if you: - have previously had thoughts about killing or harming yourself - are a young adult.
Croatian: Veća je vjerojatnost da će Vam se pojaviti takve misli ako: - ste prethodno razmišljali o samoubojstvu ili samoozljeđivanju - ste mlađa odrasla osoba.
English: Suicidal behaviour5,7
Croatian: Psihijatrijski poremećaji suicidalno ponašanje5,7
English: They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.
Croatian: Obično se javljaju unutar prvih nekoliko dana nakon prekida liječenja, ali je bilo i vrlo rijetkih prijava takvih simptoma u bolesnika koji su nehotično propustili dozu.
English: • menopausal symptoms, abnormal production of breast milk in men or women
Croatian: • simptomi menopauze, neuobičajeno stvaranje majčinog mlijeka u muškaraca ili žena
English: If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Croatian: Ako se, na temelju kliničke potrebe, ipak donese odluka o liječenju, bolesnika treba pažljivo pratiti kako bi se uočila moguća pojava suicidalnih simptoma.
English: • tinnitus (hearing sound in the ear when there is no external sound)
Croatian: • zvonjava u ušima (doživljaj zvuka u ušima kada nema vanjskog zvuka)
English: 8 Falls were more common in the elderly (≥65 years old).
Croatian: Padovi su bili češći u starijih osoba (≥ 65 godina starosti)
English: Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11 %).
Croatian: Hrana odgađa vrijeme do postizanja vršne koncentracije sa 6 na 10 sati te donekle smanjuje opseg apsorpcije (približno 11%).
English: What you need to know before you take ARICLAIM
Croatian: Što morate znati prije nego počnete uzimati ARICLAIM
English: Talk to your doctor before you take ARICLAIM if you:
Croatian: Obratite se svom liječniku prije nego uzmete ARICLAIM ako:
English: Keep this medicine out of the sight and reach of children.
Croatian: Ovaj Lijek čuvajte izvan pogleda i dohvata djece.
English: − are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
Croatian: − uzimate fluvoksamin koji se obično koristi za liječenje depresije, ciprofloksacin ili enoksacin koji se koriste za liječenje nekih infekcija
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking ARICLAIM.
Croatian: Morate obavijestiti liječnika ako se pojavi ili pogorša bilo koji od gore navedenih simptoma kad bolesnik mlađi od 18 godina uzima lijek ARICLAIM.
English: If your doctor thinks that you no longer need ARICLAIM he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Croatian: Ako liječnik smatra da više ne trebate ARICLAIM, uputit će Vas da dozu postupno smanjujete tijekom najmanje 2 tjedna prije nego što potpuno prestanete uzimati lijek.
English: ARICLAIM should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: ARICLAIM se u trudnoći smije primjenjivati samo ako moguća korist opravdava mogući rizik za plod.
English: • serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips, allergic reactions
Croatian: • ozbiljna alergijska reakcija koja uzrokuje teškoće pri disanju ili omaglicu s otečenim jezikom ili usnicama, alergijske reakcije
English: − are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
Croatian: − ste alergični na duloksetin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Croatian: Depresija je povezana s povećanim rizikom od suicidalnih misli, samoozljeđivanja i samoubojstva (događaja povezanih sa samoubojstvom).
English: The usual dose of ARICLAIM is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Croatian: Uobičajena doza lijeka ARICLAIM je 60 mg jednom na dan, no liječnik će Vam propisati dozu koja
English: If you take more ARICLAIM than you should
Croatian: Ako uzmete više lijeka ARICLAIM nego što ste trebali
English: ARICLAIM is available in 2 strengths: 30 mg and 60 mg.
Croatian: ARICLAIM je dostupan u 2 jačine: 30 mg i 60 mg.
English: • fast and/or irregular heart beat
Croatian: • ubrzani ili nepravilni otkucaji srca
English: Limited data suggest that the plasma levels of duloxetine are higher in these patients.
Croatian: Ograničeni podaci upućuju na to da su razine duloksetina u plazmi više u tih bolesnika.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove (EMA): http://www.ema.europa.eu
English: Stevens-Johnson Syndrome6
Croatian: Stevens-Johnsonov sindrom6
English: If while on ARICLAIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
Croatian: Ako se tijekom terapije lijekom ARICLAIM u bolesnika razviju agitacija ili simptomi depresije, treba zatražiti savjet liječnika specijalista jer je depresija ozbiljno medicinsko stanje.
English: There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain).
Croatian: Moguć je gubitak osjeta u zahvaćenom području ili osjeti poput dodira, topline, hladnoće ili pritiska mogu izazvati bol).
English: Taking a MAOI together with many prescription medicines, including ARICLAIM, can cause serious or even life-threatening side effects.
Croatian: Uzimanje MAOI zajedno s mnogim lijekovima na recept, uključujući ARICLAIM, može uzrokovati ozbiljne, čak i po život opasne nuspojave.