FrancophonIA/ELRC3.0 huggingface dataset:
English: • Antibiotic medicines (used for the treatment of bacterial infections) for example: telithromycin, clarithromycin, rifampicin, rifabutin, rifapentine, erythromycin
Croatian: telitromicin, klaritromicin, rifampicin, rifabutin, rifapentin, eritromicin • antikonvulzivi (primjenjuju se za liječenje napadaja [epileptičkih napadaja]), primjerice:
English: Due to inhibition of CYP3A by fluconazole
Croatian: ↔ LUM ↑ IVA zbog inhibicije CYP3A flukonazolom
English: NAME OF THE MEDICINAL PRODUCT Orkambi 150 mg/188 mg granules in sachet lumacaftor/ivacaftor
Croatian: Orkambi 150 mg/188 mg granule u vrećici lumacaftorum/ivacaftorum
English: What Orkambi looks like and contents of the pack Orkambi 100 mg/125 mg film-coated tablets (tablets) are pink, oval-shaped tablets (dimensions 14 × 7.6 × 4.9 mm) printed with “1V125” in black ink on one side.
Croatian: Orkambi 100 mg/125 mg filmom obložene tablete (tablete) ružičaste su ovalne tablete (dimenzija 14 × 7,6 × 4,9 mm) s otisnutom oznakom “1V125” crnom tintom s jedne strane.
English: What Orkambi looks like and contents of the pack Orkambi 100 mg/125 mg granules in sachet are white to off-white granules.
Croatian: Orkambi 100 mg/125 mg granule u vrećici bijele su do gotovo bijele granule.
English: Give the missed dose with fat-containing food if less than 6 hours have passed since the time your child missed the dose.
Croatian: Ako je od vremena kada je Vaše dijete trebalo uzeti dozu prošlo manje od 6 sati, dajte mu propuštenu dozu s hranom koja sadrži masti.
English: Orkambi 200 mg/125 mg film-coated tablets 4 years
Croatian: Orkambi 200 mg/125 mg filmom obložene tablete 4 godine
English: Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene (see sections 4.2, 4.4 and 5.1).
Croatian: Orkambi tablete indicirane su za liječenje cistične fibroze (CF) u bolesnika u dobi od 6 i više godina koji su homozigoti za mutaciju F508del gena CFTR (engl.
English: Due to induction of CYP3A by antimycobacterials
Croatian: ↔ LUM ↓ IVA zbog indukcije CYP3A antimikobakterijskim lijekovima
English: • Breast mass*
Croatian: • omaglica*
English: In Trial 7 (see Clinical efficacy and safety) in patients homozygous for the F508del-CFTR mutation aged 6 to 11 years, the treatment difference (LS mean) in sweat chloride for the absolute change at
Croatian: U ispitivanju 7 (vidjeti Klinička djelotvornost i sigurnost) u bolesnika u dobi od 6 do 11 godina koji su bili homozigoti za mutaciju F508del gena CFTR, terapijska razlika (srednja vrijednost dobivena metodom najmanjih kvadrata [LS]) između liječenja i placeba u apsolutnoj promjeni koncentracije klorida u znoju u 24. tjednu iznosila je -24,9 mmol/L (nominalni P < 0,0001).
English: • Multipacks containing 56 film-coated tablets (2 packs of 28 film-coated tablets).
Croatian: • Višestruko pakiranje od 56 filmom obloženih tableta (2 pakiranja po 28 filmom obloženih tableta).
English: A higher dose of repaglinide may be required to obtain the desired clinical effect.
Croatian: Može biti potrebna viša doza repaglinida da bi se postigao željeni klinički učinak.
English: Due to potential induction or inhibition of P-gp
Croatian: ↑ ili ↓ dabigatran zbog moguće indukcije ili inhibicije P-gp-a
English: Lumacaftor is a strong inducer of CYP3A and ivacaftor is a weak inhibitor of CYP3A when given as monotherapy.
Croatian: Kada se daju kao monoterapija, lumakaftor je jaki induktor CYP3A, a ivakaftor slabi inhibitor CYP3A.
English: Active substance name Effect
Croatian: Skupina istodobno primijenjenog lijeka: Naziv djelatne tvari
English: A higher dose of these antidepressants may be required to obtain the desired clinical effect.
Croatian: Može biti potrebna viša doza antidepresiva da bi se postigao željeni klinički učinak.
English: • Shortness of breath
Croatian: • nedostatak zraka
English: Tell your child's doctor straight away if your child has any of these symptoms, which may be a sign of liver problems:
Croatian: Ako Vaše dijete ima neki od ovih simptoma, koji mogu biti znak poremećaja jetre, odmah o tome obavijestite djetetovog liječnika:
English: Substrates of CYP3A
Croatian: Supstrati CYP3A
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Orkambi 100 mg/125 mg granules lumacaftor/ivacaftor
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Orkambi 100 mg/125 mg granule lumacaftorum/ivacaftorum
English: Your doctor will decide whether to recommend that you stop breast-feeding or for you to stop lumacaftor/ivacaftor therapy.
Croatian: Liječnik će odlučiti hoće li Vam preporučiti da prekinete dojenje ili da prekinete terapiju lumakaftorom/ivakaftorom, uzimajući u obzir korist dojenja za dijete i korist liječenja za Vas.
English: Important information about the contents of Orkambi This medicine contains less than 1 mmol sodium (23 mg) per dose, so it is essentially ‘sodium-free'.
Croatian: Natrij Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Respiration abnormal, oropharyngeal pain, sinus congestion*, rhinorrhoea, pharyngeal erythema*
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja vrlo često kongestija nosa, dispneja, produktivni kašalj, pojačan sputum često poremećeno disanje, orofaringealna bol, kongestija sinusa*, rinoreja, faringealni eritem*
English: Multipacks containing 56 film-coated tablets (2 packs of 28 film-coated tablets).
Croatian: Višestruka pakiranja s 56 filmom obloženih tableta (2 pakiranja po 28 filmom obloženih tableta).
English: Lumacaftor/ivacaftor will decrease the exposure of these immunosuppressants, which may reduce the efficacy of these immunosuppressants.
Croatian: Lumakaftor/ivakaftor će smanjiti izloženost ovim imunosupresivima, što može oslabiti njihovu djelotvornost.
English: • Dark urine
Croatian: • tamna boja mokraće
English: • Multipacks containing 112 film-coated tablets (4 packs of 28 film-coated tablets).
Croatian: • Višestruko pakiranje od 112 filmom obloženih tableta (4 pakiranja po 28 filmom obloženih tableta).
English: Concomitant use of CYP3A inhibitors
Croatian: Istodobna primjena inhibitora CYP3A
English: Due to inhibition of CYP3A by clarithromycin, telithromycin
Croatian: ↔ LUM ↑ IVA zbog inhibicije CYP3A klaritromicinom,
English: ↓ erythromycin Due to induction of CYP3A by LUM
Croatian: ↓ eritromicin zbog indukcije CYP3A lumakaftorom
English: A higher dose of rifabutin may be required to obtain the desired clinical effect.
Croatian: Može biti potrebna viša doza rifabutina da bi se postigao željeni klinički učinak.
English: Concomitant use of lumacaftor/ivacaftor with these anticonvulsants is not recommended.
Croatian: Ne preporučuje se istodobna primjena lumakaftora/ivakaftora s ovim antikonvulzivima.
English: From Week 4, the change in mean heart rate at pre-dose ranged from 1 to 2 bpm below baseline among patients treated with lumacaftor/ivacaftor.
Croatian: Od 4. tjedna, promjena u srednjoj vrijednosti frekvencije srca prije doziranja u bolesnika liječenih lumakaftorom/ivakaftorom kretala se u rasponu od 1 do 2 otkucaja po minuti ispod početne vrijednosti.
English: Tell your doctor straight away if you have any of the following symptoms:
Croatian: Ako imate neki od sljedećih simptoma, odmah se obratite liječniku:
English: A higher dose of ibuprofen may be required to obtain the desired clinical effect.
Croatian: Može biti potrebna viša doza ibuprofena da bi se postigao željeni klinički učinak.
English: Lumacaftor/ivacaftor may decrease the exposure of ibuprofen, which may reduce its efficacy.
Croatian: Lumakaftor/ivakaftor može smanjiti izloženost ibuprofenu, što može oslabiti njegovu djelotvornost.
English: Lumacaftor/ivacaftor may decrease the exposure of rifabutin, which may reduce its efficacy.
Croatian: Lumakaftor/ivakaftor može smanjiti izloženost rifabutinu, što može oslabiti njegovu djelotvornost.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Orkambi 100 mg/125 mg granules in sachet Each sachet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Croatian: Orkambi 100 mg/125 mg granule u vrećici Jedna vrećica sadrži 100 mg lumakaftora (lumacaftorum) i 125 mg ivakaftora (ivacaftorum).
English: For patients aged 6 to 11 years 2 tablets of 100 mg/125 mg in the morning + 1 tablet of 100 mg/125 mg in the evening (12 hours later)
Croatian: 2 tablete od 100 mg/125 mg ujutro + 1 tableta od 100 mg/125 mg navečer (12 sati kasnije)
English: A higher dose of fluconazole may be required to obtain the desired clinical effect.
Croatian: Može biti potrebna viša doza flukonazola da bi se postigao željeni klinički učinak.
English: Orkambi 200 mg/125 mg film-coated tablets Each film-coated tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor.
Croatian: Orkambi 200 mg/125 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 200 mg lumakaftora (lumacaftorum) i 125 mg ivakaftora (ivacaftorum).
English: Package leaflet: Information for the patient Orkambi 100 mg/125 mg granules in sachet Orkambi 150 mg/188 mg granules in sachet lumacaftor/ivacaftor
Croatian: Orkambi 100 mg/125 mg granule u vrećici Orkambi 150 mg/188 mg granule u vrećici lumakaftor/ivakaftor (lumacaftorum/ivacaftorum)
English: Orkambi 200 mg/125 mg film-coated tablets
Croatian: Orkambi 200 mg/125 mg filmom obložene tablete
English: Concomitant use of lumacaftor/ivacaftor with these anti-mycobacterials is not recommended.
Croatian: Ne preporučuje se istodobna primjena lumakaftora/ivakaftora s ovim antimikobakterijskim lijekovima.
English: Dose adjustment of ranitidine may be required to obtain the desired clinical effect.
Croatian: Može biti potrebna prilagodba doze ranitidina da bi se postigao željeni klinički učinak.
English: LUM 400 mg q12h/IVA 250 mg q12h (n = 369)
Croatian: LUM 400 mg svakih 12 h/IVA 250 mg svakih 12 h (n = 369)
English: • Corticosteroid medicines (used to treat inflammation): methylprednisolone, prednisone
Croatian: • kortikosteroidi (primjenjuju se za liječenje upale), primjerice: metilprednizolon, prednizon
English: ↓ ciclosporin, everolimus, sirolimus, tacrolimus
Croatian: ↓ ciklosporin, everolimus, sirolimus, takrolimus zbog indukcije CYP3A lumakaftorom
English: • Breast inflammation*
Croatian: • upala dojki*
English: Lumacaftor/ivacaftor may decrease the exposures of these antidepressants, which may reduce their efficacy.
Croatian: Lumakaftor/ivakaftor može smanjiti izloženost tim antidepresivima, što može oslabiti njihovu djelotvornost.
English: Concomitant medicinal product class:
Croatian: • biljni lijekovi, primjerice:
English: Take the missed dose with fat-containing food if less than 6 hours have passed since the time you missed the dose.
Croatian: Ako je od vremena kada ste trebali uzeti dozu prošlo manje od 6 sati, uzmite propuštenu dozu s hranom koja sadrži masti.
English: Lumacaftor/ivacaftor may decrease the exposure of fluconazole, which may reduce its efficacy.
Croatian: Lumakaftor/ivakaftor može smanjiti izloženost flukonazolu, što može oslabiti njegovu djelotvornost.
English: Respiratory Domain Score (points)‡
Croatian: Početni rezultat CFQ-R u respiratornoj domeni (bodovi)‡
English: The absolute change from predose at 4 to 6 hours post-dose was -7.7 on Day 1 and -1.3 on Day 15 in lumacaftor/ivacaftor patients.
Croatian: U bolesnika liječenih lumakaftorom/ivakaftorom apsolutna promjena vrijednosti od one prije doze do vrijednosti 4-6 sati nakon doze iznosila je 1. dana -7,7 i 15. dana -1,3.
English: Orkambi 100 mg/125 mg film-coated tablets
Croatian: Orkambi 100 mg/125 mg filmom obložene tablete
English: Multipacks containing 112 film-coated tablets (4 packs of 28 film-coated tablets).
Croatian: Višestruka pakiranja sa 112 filmom obloženih tableta (4 pakiranja po 28 filmom obloženih tableta).
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg film-coated tablets Orkambi 200 mg/125 mg film-coated tablets
Croatian: Orkambi 100 mg/125 mg filmom obložene tablete Orkambi 200 mg/125 mg filmom obložene tablete
English: STATEMENT OF ACTIVE SUBSTANCE Each sachet of granules contains 150 mg of lumacaftor and 188 mg of ivacaftor.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna vrećica s granulama sadrži 150 mg lumakaftora i 188 mg ivakaftora.
English: Lumacaftor/ivacaftor may decrease the exposure of erythromycin, which may reduce its efficacy.
Croatian: Lumakaftor/ivakaftor može smanjiti izloženost eritromicinu, što može oslabiti njegovu djelotvornost.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet of granules contains 150 mg of lumacaftor and 188 mg of ivacaftor.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna vrećica s granulama sadrži 150 mg lumakaftora i 188 mg ivakaftora.
English: Abnormal blood tests of the liver have been commonly seen in some people receiving Orkambi.
Croatian: Orkambi često su opaženi poremećeni rezultati krvnih pretraga funkcije jetre.
English: No dose adjustment is necessary when CYP3A inhibitors are initiated in patients currently taking Orkambi.
Croatian: Kada se započinje liječenje inhibitorima CYP3A u bolesnika koji već uzimaju Orkambi, nije potrebna prilagodba doze.
English: At Day 15, the treatment difference between lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo for the mean absolute change (95% CI) in ppFEV1 from baseline was 2.51 percentage points in the pooled Trials 1 and 2 (P < 0.0001).
Croatian: U objedinjenim ispitivanjima 1 i 2, terapijska razlika između lumakaftora 400 mg/ivakaftora 250 mg svakih 12 sati i placeba za srednju vrijednost apsolutne promjene (95% CI) u ppFEV1 iznosila je 15. dana u odnosu na početnu vrijednost 2,51 postotnih bodova (P < 0,0001).
English: Number of Pulmonary exacerbations (events) ** † *** Number of events per patient- year (95% CI) (rate per 48 wks)
Croatian: Broj događaja po bolesnik-godini (95% CI) (stopa na 48 tjedana)
English: LUM 400 mg q12h/IVA 250 mg q12h (n = 187)
Croatian: LUM 400 mg svakih 12 h/IVA 250 mg svakih 12 h (n = 187)
English: A higher dose of bupropion may be required to obtain the desired clinical effect.
Croatian: Može biti potrebna viša doza bupropiona da bi se postigao željeni klinički učinak.
English: Final CSR December 2021
Croatian: Konačno izvješće kliničkog ispitivanja u prosincu 2021.
English: What Orkambi contains
Croatian: Kako Orkambi izgleda i sadržaj pakiranja
English: Lumacaftor/ivacaftor may decrease the exposures of methylprednisolone and prednisone, which may reduce their efficacy.
Croatian: Lumakaftor/ivakaftor može smanjiti izloženosti metilprednizolonu i prednizonu, što može oslabiti njihovu djelotvornost.
English: See Orkambi tablets SmPC for further details
Croatian: Za daljnje informacije vidjeti sažetak opisa svojstava lijeka za Orkambi tablete
English: • Enlargement of the breast*
Croatian: • povećanje dojki*
English: Orkambi 100 mg/125 mg film-coated tablets and Orkambi 200 mg/125 mg film-coated tablets: The other ingredients are:
Croatian: Orkambi 100 mg/125 mg filmom obložene tablete i Orkambi 200 mg/125 mg filmom obložene tablete:
English: Package leaflet: Information for the patient Orkambi 100 mg/125 mg film-coated tablets Orkambi 200 mg/125 mg film-coated tablets lumacaftor/ivacaftor
Croatian: Orkambi 100 mg/125 mg filmom obložene tablete Orkambi 200 mg/125 mg filmom obložene tablete lumakaftor/ivakaftor (lumacaftorum/ivacaftorum)
English: LUM 400 mg q12h/ IVA 250 mg q12h (n = 182)
Croatian: LUM 400 mg svakih 12 h/IVA 250 mg svakih 12 h (n = 182)
English: Increased blood pressure has been observed in some patients treated with lumacaftor/ivacaftor.
Croatian: U nekih bolesnika liječenih lumakaftorom/ivakaftorom opažen je povišen krvni tlak.
English: Two lumacaftor 100 mg/ivacaftor 125 mg tablets every 12 hours lumacaftor 400 mg/ ivacaftor 500 mg
Croatian: 6-11 godina dvije tablete lumakaftor 100 mg/ ivakaftor 125 mg svakih 12 sati lumakaftor 400 mg/ ivakaftor 500 mg
English: Lumacaftor/ivacaftor may decrease the exposure of repaglinide, which may reduce its efficacy.
Croatian: Lumakaftor/ivakaftor može smanjiti izloženost repaglinidu, što može oslabiti njegovu djelotvornost.
English: Lumacaftor/ivacaftor may alter the exposure of fexofenadine.
Croatian: Lumakaftor/ivakaftor može promijeniti izloženost feksofenadinu.
English: NAME OF THE MEDICINAL PRODUCT Orkambi 200 mg/125 mg tablets lumacaftor/ivacaftor
Croatian: NAZIV LIJEKA Orkambi 200 mg/125 mg tablete lumacaftorum/ivacaftorum
English: Lumacaftor/ivacaftor may alter the exposure of warfarin.
Croatian: Lumakaftor/ivakaftor može promijeniti izloženost varfarinu.
English: • Nausea
Croatian: • mučnina
English: • Common cold*
Croatian: • obična prehlada*
English: Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating treatment with lumacaftor/ivacaftor.
Croatian: U pedijatrijskih bolesnika koji započinju liječenje lumakaftorom/ivakaftorom, preporučuju se oftalmološki pregledi na početku liječenja i tijekom praćenja.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/005
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1059/001
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet of granules contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna vrećica s granulama sadrži 100 mg lumakaftora i 125 mg ivakaftora.
English: Dose adjustment of dabigatran may be required to obtain the desired clinical effect.
Croatian: Može biti potrebna prilagodba doze dabigatrana kako bi se postigao željeni klinički učinak.
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg tablets lumacaftor/ivacaftor
Croatian: NAZIV LIJEKA Orkambi 100 mg/125 mg tablete lumacaftorum/ivacaftorum
English: Lumacaftor/ivacaftor may decrease the exposures of these antifungals, which may reduce their efficacy.
Croatian: Lumakaftor/ivakaftor može smanjiti izloženost ovim antimikoticima, što može oslabiti njihovu djelotvornost.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1059/007
English: • If your child gets any side effects, talk to your child's doctor or pharmacist.
Croatian: • Ako primijetite bilo koju nuspojavu kod svog djeteta, potrebno je obavijestiti djetetovog liječnika ili ljekarnika.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/006
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1059/006
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Orkambi 100 mg/125 mg film-coated tablets Each film-coated tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Croatian: Orkambi 100 mg/125 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg lumakaftora (lumacaftorum) i 125 mg ivakaftora (ivacaftorum).
English: Tablet core
Croatian: Omjer stope
English: There was negligible urinary excretion of ivacaftor as unchanged drug.
Croatian: Mokraćom se izlučila zanemariva količina ivakaftora u neizmijenjenom obliku.
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg granules in sachet lumacaftor/ivacaftor
Croatian: Orkambi 100 mg/125 mg granule u vrećici lumacaftorum/ivacaftorum
English: Mean lumacaftor (SD) AUCss
Croatian: (μg/mL*sati) lumakaftora
English: 1 tablet of 200 mg/125 mg in the evening (12 hours later)
Croatian: 1 tableta od 200 mg/125 mg ujutro + 1 tableta od 200 mg/125 mg navečer (12 sati kasnije)
English: Lumacaftor/ivacaftor may decrease the exposure of bupropion, which may reduce its efficacy.
Croatian: Lumakaftor/ivakaftor može smanjiti izloženost bupropionu, što može oslabiti njegovu djelotvornost.
English: • Antifungal medicines (used for the treatment of fungal infections) for example: fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole
Croatian: flukonazol, ketokonazol, itrakonazol, posakonazol, vorikonazol
English: STATEMENT OF ACTIVE SUBSTANCE Each sachet of granules contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna vrećica s granulama sadrži 100 mg lumakaftora i 125 mg ivakaftora.
English: Lumacaftor 400 mg q12h/ Ivacaftor 250 mg q12h (n = 369)†
Croatian: Lumakaftor 400 mg/ ivakaftor 250 mg svakih 12 sati (n = 369)†
English: ↓ posaconazole Due to induction of UGT by LUM
Croatian: ↓ posakonazol zbog indukcije UGT-a lumakaftorom
English: Trial 8: Safety and tolerability study in pediatric patients with CF aged 2 to 5 years homozygous for the F508del mutation in the CFTR gene
Croatian: Ispitivanje 8: Ispitivanje sigurnosti i podnošljivosti primjene u pedijatrijskih bolesnika s cističnom fibrozom u dobi od 2 do 5 godina koji su bili homozigoti za F508del mutaciju gena CFTR U ispitivanju 8 procijenjeno je 60 bolesnika koji su na probiru bili u dobi od 2 do 5 godina (srednja vrijednost dobi na početku bila je 3,7 godina).
English: Concomitant use of lumacaftor/ivacaftor with St. John's wort is not recommended.
Croatian: Ne preporučuje se istodobna primjena lumakaftora/ivakaftora s gospinom travom.
English: For patients aged 2 to 5 years and < 14 kg lumacaftor 100 mg + ivacaftor 125 mg For patients aged 2 to5 years and ≥ 14 kg lumacaftor 150 mg + ivacaftor 188 mg
Croatian: Za bolesnike u dobi od 2 do 5 godina i ≥ 14 kg 150 mg lumakaftora + 188 mg ivakaftora
English: ‡ Baseline for the placebo transitioned to lumacaftor 400 mg q12h/ivacaftor 250 mg q12h group was the Trial 3 baseline.
Croatian: ‡ Početni podaci za skupinu koja je s placeba prebačena na lumakaftor 400 mg/ivakaftor 250 mg svakih 12 sati bili su početni podaci u ispitivanju
English: Appropriate clinical monitoring should be employed, as is reasonable, when co-administered with lumacaftor/ivacaftor.
Croatian: Kada se primjenjuje zajedno s lumakaftorom/ivakaftorom, nužno je odgovarajuće kliničko praćenje.
English: Orkambi dose
Croatian: Doza lijeka Orkambi
English: Odds ratio
Croatian: Omjer izgleda
English: Baseline for the lumacaftor 400 mg q12h/ivacaftor 250 mg q12h group was the Trial 1 and 2 baseline.
Croatian: 3. Početni podaci za skupinu koja je primala lumakaftor 400 mg/ivakaftor 250 mg svakih 12 sati bili su početni podaci iz ispitivanja 1 i 2.
English: Presentation of the lumacaftor 400 mg q12h/ivacaftor 250 mg q12h dose group is consistent with recommended posology.
Croatian: Primjena terapije u skupini koja je primala dozu lumakaftora 400 mg/ivakaftora 250 mg svakih 12 sati bila je sukladna preporučenom doziranju.
English: For patients aged 6 to 11 years 300 mg lumacaftor + 375 mg ivacaftor
Croatian: Za bolesnike u dobi od 6 do 11 godina 300 mg lumakaftora
English: • Passing gas
Croatian: • puštanje vjetrova
English: Dose adjustment of fexofenadine may be required to obtain the desired clinical effect.
Croatian: Može biti potrebna prilagodba doze feksofenadina da bi se postigao željeni klinički učinak.
English: EU/1/15/1059/001 EU/1/15/1059/002 EU/1/15/1059/003 EU/1/15/1059/005
Croatian: EU/1/15/1059/002
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 100 mg lumakaftora i 125 mg ivakaftora.
English: For patients aged 12 years and older 800 mg lumacaftor + 500 mg ivacaftor
Croatian: Za bolesnike u dobi od 12 i više godina 800 mg lumakaftora
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu kod djeteta, potrebno je obavijestiti djetetovog liječnika ili ljekarnika.
English: NAME OF THE MEDICINAL PRODUCT Orkambi 200 mg/125 mg film-coated tablets lumacaftor/ivacaftor
Croatian: Orkambi 200 mg/125 mg filmom obložene tablete lumacaftorum/ivacaftorum
English: Dose
Croatian: Poč.
English: ↔ LUM
Croatian: Nast.
English: Posology
Croatian: Lumakaftor
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg film-coated tablets lumacaftor/ivacaftor
Croatian: Orkambi 100 mg/125 mg filmom obložene tablete lumacaftorum/ivacaftorum
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 200 mg lumakaftora i 125 mg ivakaftora.
English: Hepatic impairment
Croatian: Menstrualni poremećaji
English: ↓ clarithromycin, telithromycin Due to induction of CYP3A by LUM
Croatian: telitromicin zbog indukcije CYP3A lumakaftorom
English: • Increase in sputum
Croatian: • pojačan iskašljaj