FrancophonIA/ELRC3.0 huggingface dataset:
English: - in combination with docetaxel (see section 5.1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Croatian: - u prvoj liniji liječenja uznapredovalog karcinoma želuca u kombinaciji s protokolom temeljenim na platini (vidjeti dio 5.1). - u kombinaciji s docetakselom (vidjeti dio 5.1) za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha citotoksične kemoterapije.
English: Oxaliplatin on Day 1, every 3 weeks Capecitabine oral twice daily for 2 weeks (followed by 1 week offtreatment)
Croatian: XELOX ili XELOX i bevacizumab oksaliplatin 130 mg/m2 intravenski 2 sata oksaliplatin prvog dana, svaka 3 tjedna kapecitabin oralno dvaput dnevno tijekom 2 tjedna (nakon čega slijedi jedan tjedan pauze)
English: Xeloda 150 mg film-coated tablets
Croatian: Xeloda 150 mg filmom obložene tablete
English: Following a mean duration of follow-up for the study population of 26.2 months, treatment responses were as shown below:
Croatian: Odgovori na liječenje nakon razdoblja praćenja studijske populacije u srednjem trajanju od
English: 24.6, 2.03 and 36.3.
Croatian: Vrijednosti AUC0-¥ u mg·sat/ml iznosile su 7,75; 7,24; 24,6; 2,03 i 36,3.
English: Xeloda is indicated for the treatment of: -for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
Croatian: - adjuvantno liječenje bolesnika nakon operacije karcinoma kolona stadija III (stadij C prema
English: 53% to 60% of all-grades HFS was observed in capecitabine monotherapy trials (comprising studies in adjuvant therapy in colon cancer, treatment of metastatic colorectal cancer, and treatment of breast cancer) and a frequency of 63% was observed in the capecitabine/docetaxel arm for the treatment of metastatic breast cancer.
Croatian: Za dozu kapecitabina od 1250 mg/m2 koja je primijenjena dvaput dnevno od 1. do 14. dana ciklusa svaka 3 tjedna učestalost od 53% do 60% svih stupnjeva sindroma šaka-stopalo uočena je u ispitivanjima monoterapije kapecitabinom (ispitivanjima adjuvantne terapije u bolesnika s karcinomom kolona, terapije bolesnika s metastatskim kolorektalnim karcinomom i terapije karcinoma dojke), a učestalost od 63% uočena je u skupini liječenoj kombinacijom kapecitabina i docetaksela zbog metastatskog karcinoma dojke.
English: • skin rash, hair loss (alopecia), skin reddening, dry skin, itching (pruritus), skin discolouration, skin loss, skin inflammation, nail disorder pain in the joints, or in the limbs (extremities), chest or back fever, swelling in the limbs, feeling ill
Croatian: • osip kože, gubitak kose (alopecija), crvenilo kože, suha koža, svrbež (pruritus), promjena boje kože, gubitak kože, upala kože, poremećaj noktiju
English: Hepatic failure (rare), Cholestatic hepatitis (rare)
Croatian: Poremećaji jetre i žuči hiperbilirubinemija, odstupanja u testovima jetrene funkcije žutica zatajenje jetre (rijetko), kolestatski hepatitis (rijetko)
English: Lacrimation increased, Conjunctivitis, Eye irritation
Croatian: • nadražaj oka, pojačano suzenje, crvenilo oka (konjunktivitis)
English: Data from a multicentre, randomised, controlled phase II study (AIO KRK 0604) supports the use of capecitabine at a starting dose of 800 mg/m2 for 2 weeks every 3 weeks in combination with irinotecan and bevacizumab for the first-line treatment of patients with metastatic colorectal cancer.
Croatian: podupiru primjenu kapecitabina u početnoj dozi od 800 mg/m2 tijekom 2 tjedna svaka 3 tjedna u kombinaciji s irinotekanom i bevacizumabom kao prve linije liječenja bolesnika s metastatskim kolorektalnim karcinomom.
English: Xeloda 500 mg film-caoted tablets
Croatian: Xeloda 500 mg filmom obložene tablete
English: Oxaliplatin on Day 1, every 2 weeks Leucovorin on Days 1 and 2, every 2 weeks
Croatian: 2 sata oksaliplatin prvog dana, svaka 2 tjedna leukovorin prvog i drugog dana, svaka 2 tjedna intravenski bolus/infuzija 5fluorouracila prvog i drugog dana, svaka 2 tjedna leukovorin 200 mg/m intravenski
English: Vascular disorders Lower limb oedema, Hypertension, +Embolism and thrombosis
Croatian: Krvožilni poremećaji edem donjih udova, hipertenzija, +embolija i tromboza crvenilo uz osjećaj vrućine,
English: Tablet core: anhydrous lactose, croscarmellose sodium, hypromellose (3 mPa.s), microcrystalline cellulose, magnesium stearate.
Croatian: Jezgra tablete bezvodna laktoza umrežena karmelozanatrij hipromeloza (3 mPa.s)
English: Xeloda 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine
Croatian: Xeloda 500 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 500 mg kapecitabina.
English: Japanese patients (n=18) had about 36% lower Cmax and 24% lower AUC for capecitabine than Caucasian patients (n=22).
Croatian: Faktori etničke pripadnosti: Nakon peroralne primjene 825 mg/m2 kapecitabina dvaput dnevno tijekom 14 dana, Japanci (n=18) su imali 36% niži Cmax i 24% niži AUC kapecitabina nego bijelci
English: Manufacturer:
Croatian: Njemačka Proizvođač
English: Table 4 lists ADRs associated with the use of capecitabine monotherapy based on a pooled analysis of safety data from three major studies including over 1900 patients (studies M66001, SO14695, and SO14796).
Croatian: U Tablici 4 nalazi se popis nuspojava povezanih s primjenom kapecitabina u monoterapiji koji se temelji na združenoj analizi sigurnosnih podataka iz tri glavna ispitivanja na više od 1900 bolesnika
English: Febrile neutropenia, Pancytopenia, Granulocytopenia, Thrombocytopenia, Leukopenia, Haemolytic anaemia, International Normalised Ratio (INR) increased/Prothrombin time prolonged
Croatian: Poremećaji krvi i limfnog sustava neutropenija, anemija febrilna neutropenija, pancitopenija, granulocitopenija, trombocitopenija, leukopenija, hemolitička anemija, povišen INR/produljeno protrombinsko vrijeme
English: The film-coated tablets are light peach tablets of biconvex, oblong shape with the marking ‘150' on the one side and ‘Xeloda' on the other side
Croatian: Filmom obložena tableta svijetle boje breskve, bikonveksna, duguljastog oblika s oznakom „150“ na jednoj i „Xeloda“ na drugoj strani.
English: Combination therapy with capecitabine and docetaxel in locally advanced or metastatic breast cancer Data from one multicentre, randomised, controlled phase III clinical trial support the use of capecitabine in combination with docetaxel for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Croatian: III podržavaju uporabu kapecitabina u kombinaciji s docetakselom u liječenju bolesnica s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspješne citotoksične kemoterapije, koja je uključivala antracikline.
English: The enzyme involved in the final conversion to 5-FU, thymidine phosphorylase (ThyPase), is found in tumour tissues, but also in normal tissues, albeit usually at lower levels.
Croatian: Enzim uključen u završnu konverziju u 5-FU, timidin fosforilaza (ThyPase),
English: Peach film-coated tablet of biconvex, oblong shape with the marking ‘500' on the one side and ‘Xeloda' on the other side.
Croatian: Filmom obložena tableta boje breskve, bikonveksna, duguljastog oblika s oznakom „500“ na jednoj i „Xeloda“ na drugoj strani.
English: weeks, a frequency of 22% to 30% of all-grade HFS was observed in capecitabine combination therapy.
Croatian: Za dozu kapecitabina od 1000 mg/m2 koja je primijenjena dvaput dnevno od 1. do 14. dana ciklusa svaka 3 tjedna učestalost od 22% do 30% svih stupnjeva sindroma šaka-stopalo uočena je u ispitivanjima kombinirane terapije kapecitabinom.
English: Radiotherapy: the MTD of capecitabine alone using the intermittent regimen is 3000 mg/m2 per day, whereas, when combined with radiotherapy for rectal cancer, the MTD of capecitabine is 2000 mg/m2
Croatian: MTD kapecitabina u monoterapiji i intermitentnom liječenju iznosi 3000 mg/m2 dnevno, a u kombinaciji s radioterapijom kod karcinoma rektuma MTD kapecitabina iznosi 2000 mg/m2 dnevno pri kontinuiranoj (svakodnevnoj) primjeni ili pri uzimanju tijekom 5 dana od ponedjeljka do petka, uz radioterapiju u trajanju od 6 tjedana.
English: The film-coated tablets are peach tablets of biconvex, oblong shape with the marking ‘500' on the one side and ‘Xeloda' on the other side.
Croatian: Filmom obložene tablete su bikonveksne, duguljaste tablete boje breskve, s oznakom ''500'' s jedne strane i ''Xeloda'' s druge strane.
English: Diarrhoea, Vomiting, Nausea, Stomatitis, Abdominal pain
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja, epistaksa, kašalj, rinoreja plućna embolija,
English: Intestinal obstruction, Ascites, Enteritis, Gastritis, Dysphagia, Abdominal pain lower, Oesophagitis, Abdominal discomfort,
Croatian: Poremećaji živčanog sustava glavobolja, letargija, omaglica, parestezija, disgeuzija afazija, oštećenje pamćenja, ataksija, sinkopa, poremećaj ravnoteže, poremećaji osjeta,
English: Pack size of 60 film-coated tablets (6 blisters of 10 tablets)
Croatian: Pakiranje sa 60 filmom obloženih tableta (6 blistera s 10 tableta) Xeloda 500 mg filmom obložene tablete
English: See table 6 for treatment regimens.
Croatian: Vidjeti uputu o lijeku za dodatne informacije.
English: 120 Patients were randomised to a modified XELIRI regimen with capecitabine 800 mg/m2 twice daily for two weeks followed by a 7-day rest period), irinotecan (200 mg/m2 as a 30 minute infusion on day 1 every
Croatian: protokolom, koji je obuhvaćao kapecitabin (u dozi od 800 mg/m2 dvaput dnevno tijekom dva tjedna, nakon čega slijedi pauza od 7 dana), irinotekan (200 mg/m2 kao 30-minutna infuzija 1. dana svaka 3 tjedna) i bevacizumab (7,5 mg/kg kao infuzija u trajanju od 30 do 90 minuta 1. dana svaka 3 tjedna).
English: XELOX or XELOX+ Bevacizumab
Croatian: intravenski 22 s ata placebo ili bevacizumab
English: Mucosal inflammation, Pain in limb, Pain, Chills, Chest pain, Influenza-like illness, +Fever, Infusion related reaction, Injection site reaction, Infusion site pain, Injection site pain
Croatian: reakcije na infuziju, reakcije na mjestu injiciranja, bol na mjestu davanja infuzije, bol na mjestu injiciranja
English: Pain in extremity, Back pain, Arthralgia
Croatian: • bol u zglobovima ili udovima (ekstremitetima), prsnom košu ili leđima
English: Sepsis, Urinary tract infection, Cellulitis, Tonsillitis,
Croatian: Infekcije i infestacije infekcija herpes virusom, nazofaringitis, infekcija donjeg dišnog sustava sepsa, infekcija mokraćnog sustava, celulitis, tonzilitis, upala ždrijela, oralna kandidijaza, gripa,
English: P value
Croatian: PPP IT T
English: Palmar-plantar erythrodysaesthesia syndrome**
Croatian: Poremećaji kože i potkožnog tkiva sindrom palmarnoplantarne eritrodizestezije**
English: Xeloda 150 mg film-coated tablets Xeloda 500 mg film-coated tablets capecitabine
Croatian: Xeloda 150 mg filmom obložene tablete kapecitabin
English: NAME OF THE MEDICINAL PRODUCT Xeloda 150 mg film-coated tablets Capecitabine
Croatian: Uputa o lijeku: Informacije za korisnika Xeloda 150 mg filmom obložene tablete Xeloda 500 mg filmom obložene tablete kapecitabin
English: Ventricular fibrillation (rare), QT prolongation (rare), Torsade de pointes (rare), Bradycardia (rare), Vasospasm (rare)
Croatian: • neke vrste aritmija (uključujući fibrilaciju klijetke, torsade de pointes i bradikardiju)
English: - ECF: epirubicin (50 mg/ m2 as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m2 as a two hour infusion on day 1 every 3 weeks) and 5-FU (200 mg/m2 daily given by continuous infusion via a central line).
Croatian: - ECF: epirubicin (50 mg/m2 kao bolus 1. dan, svaka 3 tjedna), cisplatin (60 mg/m2 kao dvosatna infuzija 1. dan, svaka 3 tjedna) i 5-FU (200 mg/m2 dnevno u obliku kontinuirane infuzije putem centralnog venskog katetera) - ECX: epirubicin (50 mg/m2 kao bolus 1. dan, svaka 3 tjedna), cisplatin (60 mg/m2 kao dvosatna infuzija 1. dan, svaka 3 tjedna) i kapecitabin (625 mg/m2 dvaput dnevno bez pauze) - EOF: epirubicin (50 mg/m2 kao bolus 1. dan, svaka 3 tjedna), oksaliplatin (130 mg/m2 kao dvosatna infuzija 1. dan, svaka 3 tjedna) i 5-FU (200 mg/m2 dnevno u obliku kontinuirane infuzije putem centralnog venskog katetera) - EOX: epirubicin (50 mg/m2 kao bolus 1. dan, svaka 3 tjedna), oksaliplatin (130 mg/m2 kao dvosatna infuzija 1. dan, svaka 3 tjedna) i kapecitabin (625 mg/m2 dvaput dnevno bez pauze)
English: Renal impairment
Croatian: Samo docetaksel
English: Anorexia
Croatian: Radioterapija
English: Do this only once.
Croatian: To napravite samo jedanput.
English: If this happens, you may be able to feel these pieces on your tongue.
Croatian: Ako se to dogodi, možete osjetiti ove komadiće na jeziku.
English: Tell your doctor immediately
Croatian: Odmah se javite svom liječniku
English: It will also help you to remember to use it.
Croatian: To će Vam također pomoći da ga se sjetite koristiti.
English: • Repeat steps 8, 9, 10 and 11.
Croatian: • Ponovite 8., 9., 10. i 11. korak.
English: If this happens:
Croatian: Ako se to dogodi:
English: Clean your inhaler once a week.
Croatian: Očistite svoj inhalator jedanput na tjedan.
English: Keep it dry.
Croatian: Držite ga suhim.
English: This makes breathing difficult.
Croatian: Ovo uzrokuje otežano disanje.
English: The side buttons should be facing left and right.
Croatian: Bočne tipke trebaju gledati lijevo i desno.
English: Treatment Dose (microgram)
Croatian: Doza (mikrogram)
English: Approximately 41% of patients had severe COPD.
Croatian: Približno 41% bolesnika imalo je teški KOPB.
English: Medical attention may be needed.
Croatian: Možda će Vam biti potrebna liječnička pomoć.
English: This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night.
Croatian: Time se osigurava uvijek dovoljno lijeka u tijelu koji Vam pomaže lakše disati tijekom dana i noći.
English: Use your inhaler at the same time each day, the effects last for 24 hours.
Croatian: Koristite inhalator u isto vrijeme svakog dana, učinci traju 24 sata.
English: An additional adverse reaction was tremor (common).
Croatian: Dodatne nuspojave bile su tremor (često).
English: Most people are able to empty the capsule with one or two inhalations.
Croatian: Većina ljudi može isprazniti kapsulu s jednom ili dvije inhalacije.
English: The dose should only be increased on medical advice.
Croatian: Doza se smije povećati samo prema liječničkoj preporuci.
English: • Hold your breath for at least 5-10 seconds or as long as you comfortably can while taking the inhaler out of your mouth.
Croatian: • Zadržite dah najmanje 5-10 sekundi ili koliko dugo možete dok vadite inhalator iz usta.
English: Do not inhale a double dose to make up for a forgotten dose.
Croatian: Nemojte udisati dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: The usual dose is to inhale the content of one capsule each day.
Croatian: Uobičajena doza je udisanje sadržaja jedne kapsule svakog dana.
English: The chances of the capsule shattering will be increased if the capsule is accidentally pierced more than once (step 6).
Croatian: Vjerojatnost da će se kapsula zdrobiti je veća ako se kapsula slučajno probuši više od jednog puta (6. korak).
English: Do not use more than your doctor tells you to use.
Croatian: Nemojte koristiti više nego što Vam je liječnik rekao.
English: The bronchodilator effect did not depend on the time of dosing, morning or evening.
Croatian: Učinak bronhodilatora nije ovisio o vremenu doziranja, ujutro ili navečer.
English: As long as the capsule is empty, you have received enough of your medicine.
Croatian: Dokle god je kapsula prazna, primili ste dovoljno svog lijeka.
English: Steady state was achieved within 12 to 14 days.
Croatian: Stanje dinamičke ravnoteže bilo je postignuto unutar 12 do 14 dana.
English: • Breathe in rapidly but steadily and as deeply as you can.
Croatian: • Udahnite brzo, ali postojano te što dublje možete.
English: If the capsule is empty, there is no need for concern.
Croatian: Ako je kapsula prazna, nemate razloga za brigu.
English: In case such effects occur, treatment may need to be discontinued.
Croatian: Ako se pojave ovi učinci, liječenje treba prekinuti.
English: Do not press the side buttons more than once.
Croatian: Nemojte pritisnuti bočne tipke više od jedanput.
English: You may notice that your heart is beating faster than usual, or you may have a headache, feel drowsy, feel nauseous or have to vomit.
Croatian: Možda ćete primijetiti da vaše srce kuca brže nego obično, ili možda imate glavobolju, osjećate se pospano, osjećate mučninu ili morate povraćati.
English: All these findings occurred at exposures sufficiently in excess of those anticipated in humans.
Croatian: Svi ovi nalazi javili su se pri izloženostima koje su bile više od onih očekivanih u ljudi.
English: Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it.
Croatian: Bolesnike koji ne osjete poboljšanje u disanju treba upitati gutaju li lijek umjesto da ga inhaliraju.
English: • if you get high levels of sugar in your blood (diabetes).
Croatian: • ako imate visoku razinu šećera u krvi (dijabetes).
English: Put the empty capsule in your household waste.
Croatian: Odbacite praznu kapsulu u svoj kućni otpad.
English: If you experience coughing briefly after inhaling the medicine, do not worry.
Croatian: Ako kašljete ubrzo nakon udisanja lijeka, nemojte brinuti.
English: The maximum dose is 300 microgram once daily.
Croatian: Najveća doza je 300 mikrograma jedanput na dan.
English: Within each system organ class, adverse reactions are ranked by frequency in descending order according to 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: Unutar svake skupine prema učestalosti, nuspojave su navedene u padajućem nizu prema sljedećem dogovoru: 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: Your doctor may tell you to use the 150 microgram capsule or the 300 microgram capsule depending on your condition and on how you respond to the treatment.
Croatian: Liječnik Vam može reći da koristite kapsulu od 150 mikrograma ili kapsulu od 300 mikrograma ovisno o Vašem stanju i kakav je Vaš odgovor na liječenje.
English: See “How to clean your inhaler”.
Croatian: Vidjeti „Kako čistiti svoj inhalator“.
English: • Hold the inhaler as shown in the picture.
Croatian: • Držite inhalator kako je prikazano na slici.
English: This medicine contains lactose (milk sugar).
Croatian: Ovaj lijek sadrži laktozu (mliječni šećer).
English: • Inhale the medicine again by repeating steps 8 and 9.
Croatian: • Ponovno udahnite lijek ponavljajući 8. i 9. korak.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete , obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: Check your inhaler to see if the capsule is empty and that you have received the full dose.
Croatian: Provjerite svoj inhalator da vidite je li kapsula prazna i jeste li primili punu dozu.
English: Children and adolescents Oslif Breezhaler should not be given to children or adolescents below the age of 18 years
Croatian: Djeca i adolescenti Oslif Breezhaler se ne smije davati djeci ili adolescentima mlađim od 18 godina.
English: • You should hear a “click” as the capsule is being pierced.
Croatian: • Trebate čuti „klik“ kada se probuši kapsula.
English: Please read the instructions at the end of this leaflet for more information about how to use the inhaler.
Croatian: Molimo Vas da pročitate upute na kraju ove upute o lijeku za više informacija o korištenju inhalatora.
English: Table 2 Symptom relief at 6 months treatment duration
Croatian: Tablica 2 Smanjenje simptoma tijekom 6 mjeseci liječenja
English: Oslif Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks.
Croatian: Oslif Breezhaler se može koristiti tijekom trudnoće samo ako je očekivana korist veća od mogućih rizika.
English: Date of first authorisation: 30 November 2009 Date of latest renewal: 18 September 2014
Croatian: Datum posljednje obnove odobrenja: 18. rujan 2014.
English: • swollen hands, ankles and feet (oedema)
Croatian: • otečene šake, gležnjevi i stopala (edem)
English: Always release the push buttons before inhalation.
Croatian: Uvijek oslobodite bočne tipke prije inhalacije.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet prije uzimanja bilo kojeg lijeka.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijekdefinirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: In isolated human bronchus, indacaterol has a rapid onset of action and a long duration of action.
Croatian: U izoliranom ljudskom bronhu indakaterol ima brz početak djelovanja i dugo trajanje djelovanja.
English: The in vitro human serum and plasma protein binding was 94.1-95.3% and 95.1-96.2%, respectively.
Croatian: In vitro vezanje na ljudske proteine seruma i plazme bilo je 94,1-95,3%, odnosno 95,1-96,2%.
English: Metabolic and transporter based interactions
Croatian: Metaboličke interakcije i interakcije temeljene na transporteru
English: Maximum plasma concentration and overall systemic exposure increase with age but no dose adjustment is required in elderly patients.
Croatian: Najveća koncentracija u plazmi i ukupna sistemska izloženost raste s dobi, ali nije potrebno prilagođavati dozu u starijih bolesnika.
English: Oslif Breezhaler should be administered at the same time of the day each day.
Croatian: Oslif Breezhaler treba primjenjivati svakog dana u isto vrijeme.
English: Mass balance was complete with ≥90% of the dose recovered in the excreta.
Croatian: Masena bilanca je bila potpuna uz ≥90% doze prikupljene u izlučevinama.
English: After you have finished taking your medicine:
Croatian: Kada završite primjenu svog lijeka:
English: Indacaterol was not embryotoxic or teratogenic in rats or rabbits.
Croatian: Indakaterol nije bio embriotoksičan niti teratogen u štakora i kunića.
English: • Then breathe out.
Croatian: • Zatim izdahnite.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako seone neće javiti kod svakoga.
English: You will experience a sweet flavour as the medicine goes into your lungs.
Croatian: Osjetit ćete slatki okus dok Vam lijek ulazi u pluća.
English: The mean age of patients was 64 years, with 48% of patients aged 65 years or older, and the majority (80%) was Caucasian.
Croatian: Prosječna starost bolesnika bila je 64 godine, od toga je 48% bolesnika imalo 65 godina ili više, a većina su bili bijelci (80%).
English: REMEMBER:
Croatian: ZAPAMTITE:
English: This helps open up the airways, making it easier to get air in and out.
Croatian: To pomaže otvaranju dišnih puteva, olakšavajući ulazak i izlazak zraka.
English: If a dose is missed the next dose should be taken at the usual time the next day.
Croatian: U slučaju propuštene doze, sljedeću dozu treba uzeti sljedećeg dana u isto vrijeme.