FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1059/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/006
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1059/006
English: A higher dose of these proton pump inhibitors may be required to obtain the desired clinical effect.
Slovenian: Mogoče bo potreben večji odmerek teh zaviralcev protonske črpalke, da bomo dosegli želeni klinični učinek.
English: (listed in section 6).
Slovenian: (glejte poglavje 4.2).
English: A higher dose of repaglinide may be required to obtain the desired clinical effect.
Slovenian: Mogoče bo potreben večji odmerek repaglinida, da bomo dosegli želeni klinični učinek.
English: Concomitant use of lumacaftor/ivacaftor with these anticonvulsants is not recommended.
Slovenian: Sočasne uporabe lumakaftorja/ivakaftorja s temi antikonvulzivi ne priporočajo.
English: • Redness in the throat*
Slovenian: • zatrdlina v dojki*.
English: Cellulose, microcrystalline
Slovenian: ketokonazol, vorikonazol
English: A higher dose of rifabutin may be required to obtain the desired clinical effect.
Slovenian: Mogoče bo potreben večji odmerek rifabutina, da bomo dosegli želeni klinični učinek.
English: During Trials 1 and 2, the incidence of combined menstrual abnormality events (amenorrhoea, dysmenorrhoea, menorrhagia, menstruation irregular, metrorrhagia, oligomenorrhoea, and polymenorrhoea) was 9.9 % in lumacaftor/ivacaftor-treated female patients and 1.7% in placebo-treated females.
Slovenian: (amenoreja, dismenoreja, menoragija, neredna menstruacija, metroragija, oligomenoreja in polimenoreja) 9,9 % pri bolnicah, zdravljenih z lumakaftorjem/ivakaftorjem, in 1,7 % pri ženskah, ki so prejemale placebo.
English: Number of pulmonary exacerbations through Week 24
Slovenian: Število pljučnih poslabšanj do vključno
English: A higher dose of fluconazole may be required to obtain the desired clinical effect.
Slovenian: Mogoče bo potreben večji odmerek flukonazola, da bomo dosegli želeni klinični učinek.
English: Lumacaftor/ivacaftor may alter the exposure of digoxin.
Slovenian: Lumakaftor/ivakaftor lahko spremeni izpostavljenost digoksinu.
English: Baseline BMI (kg/m2)‡ Absolute change from baseline in BMI (kg/m2)
Slovenian: Izhodiščni ITM (kg/m2)‡ 20,9 (2,8) Absolutna sprememba od izhodiščnega ITM (kg/m2)
English: Lumacaftor/ivacaftor may decrease the exposure of montelukast, which may reduce its efficacy.
Slovenian: Lumakaftor/ivakaftor lahko zmanjša izpostavljenost montelukastu, kar lahko zmanjša njegovo učinkovitost.
English: Sodium laurilsulfate
Slovenian: propilenglikol amonijev hidroksid
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
Slovenian: Navodilo za uporabo Orkambi 100 mg/125 mg zrnca v vrečici Orkambi 150 mg/188 mg zrnca v vrečici lumakaftor (lumacaftorum)/ivakaftor (ivacaftorum)
English: Antibiotics: clarithromycin, telithromycin
Slovenian: klaritromicin, telitromicin ↔ LUM
English: Frequency
Slovenian: razmerje pogostnosti
English: ↓ clarithromycin, telithromycin Due to induction of CYP3A by LUM
Slovenian: everolimus, sirolimus, takrolimus Zaradi indukcije CYP3A z LUM
English: Lumacaftor/ivacaftor may decrease the exposures of clarithromycin and telithromycin, which may reduce their efficacy.
Slovenian: Lumakaftor/ivakaftor lahko zmanjša izpostavljenost klaritromicinu in telitromicinu, kar lahko zmanjša njuno učinkovitost.
English: For patients aged 2 to 5 years and < 14 kg lumacaftor 200 mg + ivacaftor 250 mg
Slovenian: Za bolnike, stare 2 do 5 let in < 14 kg 200 mg lumakaftorja +
English: Multipacks containing 56 film-coated tablets (2 packs of 28 film-coated tablets).
Slovenian: Skupno pakiranje, ki vsebuje 56 filmsko obloženih tablet (2 pakiranji po 28 filmsko obloženih tablet).
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
Slovenian: V preskušanju 7 (glejte Klinična učinkovitost in varnost) pri bolnikih, homozigotnih za mutacijo F508del-CFTR, starih 6 do 11 let, je bila razlika zaradi zdravljenja (povprečje najmanjših kvadratov) kloridov v znoju za absolutno spremembo v 24. tednu v primerjavi s placebom -24,9 mmol/l (nominalna P < 0,0001).
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).
Slovenian: Petnajstega dne je bila razlika zaradi zdravljenja med lumakaftorjem 400 mg/ivakaftorjem 250 mg na 12 ur in placebom za povprečno absolutno spremembo (95 % IZ) ppFEV1 od izhodišča 2,51 odstotne točke v združenih preskušanjih 1 in 2 (P < 0,0001).
English: A higher dose of ibuprofen may be required to obtain the desired clinical effect.
Slovenian: Mogoče bo potreben večji odmerek ibuprofena, da bomo dosegli želeni klinični učinek.
English: • Ear congestion*
Slovenian: • kongestija obnosnih votlin*,
English: The exposures are similar between adults and the paediatric population based on population (PK) analyses as presented in Table 9.
Slovenian: Izpostavljenosti na podlagi populacijskih farmakokinetičnih (FK) analiz so bile pri pediatrični populaciji podobne kot pri odraslih, kot kaže preglednica 9 v nadaljevanju: Preglednica 9: Povprečna (SD) izpostavljenost lumakaftorju in ivakaftorju po starostnih skupinah
English: Lumacaftor
Slovenian: montelukast
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/007
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1059/007
English: Elevated transaminases have been reported commonly in patients with CF receiving lumacaftor/ivacaftor.
Slovenian: Pri bolnikih s CF, ki so prejemali lumakaftor/ivakaftor, so pogosto poročali o zvišanih transaminazah.
English: In Trial 7 (see Clinical efficacy and safety) in patients homozygous for the F508del-CFTR mutation aged 6 to 11 years.
Slovenian: V preskušanju 7 (glejte Klinična učinkovitost in varnost) pri bolnikih, homozigotnih za mutacijo
English: Lumacaftor/ivacaftor may decrease the exposures of methylprednisolone and prednisone, which may reduce their efficacy.
Slovenian: Lumakaftor/ivakaftor lahko zmanjša izpostavljenost metilprednizolonu in prednizonu, kar lahko zmanjša njuno učinkovitost.
English: For patients aged 2 to 5 years and ≥ 14 kg lumacaftor 300 mg + ivacaftor 376 mg
Slovenian: Za bolnike, stare 2 do 5 let in ≥ 14 kg 300 mg lumakaftorja +
English: Your child's doctor may perform some eye examinations prior to and during treatment with Orkambi.
Slovenian: Mogoče bo otrokov zdravnik pred zdravljenjem z zdravilom Orkambi in med njim naredil nekatere očesne preiskave.
English: • Vomiting
Slovenian: • vetrovi,
English: LUM 400 mg q12h/IVA 250 mg q12h (n = 369)
Slovenian: 12 ur/IVA 250 mg na 12 ur (n = 369)
English: Cases of non-congenital lens opacities without impact on vision have been reported in paediatric patients treated with lumacaftor/ivacaftor and ivacaftor monotherapy.
Slovenian: Pri pediatričnih bolnikih, zdravljenih z lumakaftorjem/ivakaftorjem in z monoterapijo z ivakaftorjem, so poročali o primerih ne-prirojenih motnjav leče brez vpliva na vid.
English: Orkambi 200 mg/125 mg film-coated tablets Each film-coated tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor.
Slovenian: Orkambi 200 mg/125 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 200 mg lumakaftorja (lumacaftorum) in 125 mg ivakaftorja (ivacaftorum).
English: BATCH NUMBER Lot
Slovenian: UGT z LUM
English: Baseline for the lumacaftor 400 mg q12h/ivacaftor 250 mg q12h group was the Trial 1 and 2 baseline.
Slovenian: Izhodišče za skupino, ki je prejemala lumakaftor 400 mg/12 h/ivakaftor 250 mg/12 h, je bilo izhodišče preskušanja 1 in 2.
English: • Nipple changes or pain*
Slovenian: • zvečanje prsi*, • spremembe bradavice ali bolečina v bradavici*.
English: Increased blood pressure has been observed in some patients treated with lumacaftor/ivacaftor.
Slovenian: Pri nekaterih bolnikih, zdravljenih z lumakaftorjem/ivakaftorjem, so opazili zvišan krvni tlak.
English: ‡ Baseline for the placebo transitioned to lumacaftor 400 mg q12h/ivacaftor 250 mg q12h group was the Trial 3 baseline.
Slovenian: ‡ Izhodišče za skupino, ki je prejemala placebo in nato prešla na lumakaftor 400 mg/12 h/ivakaftor 250 mg/12 h, je bilo izhodišče preskušanja 3.
English: • Multipacks containing 56 film-coated tablets (2 packs of 28 film-coated tablets).
Slovenian: • skupna pakiranja, ki vsebujejo po 56 filmsko obloženih tablet (2 pakiranji po 28 filmsko obloženih tablet);
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg film-coated tablets Orkambi 200 mg/125 mg film-coated tablets
Slovenian: Orkambi 100 mg/125 mg filmsko obložene tablete Orkambi 200 mg/125 mg filmsko obložene tablete
English: Lumacaftor/ivacaftor may decrease the exposures of these proton pump inhibitors, which may reduce their efficacy.
Slovenian: Lumakaftor/ivakaftor lahko zmanjša izpostavljenost tem zaviralcem protonske črpalke, kar lahko zmanjša njihovo učinkovitost.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec
English: STATEMENT OF ACTIVE SUBSTANCE Each sachet of granules contains 150 mg of lumacaftor and 188 mg of ivacaftor.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena vrečica zrnc vsebuje 150 mg lumakaftorja in 188 mg ivakaftorja.
English: Concomitant use of lumacaftor/ivacaftor with St. John's wort is not recommended.
Slovenian: Sočasne uporabe lumakaftorja/ivakaftorja s šentjanževko ne priporočajo.
English: • Multipacks containing 112 film-coated tablets (4 packs of 28 film-coated tablets).
Slovenian: • skupna pakiranja, ki vsebujejo po 112 filmsko obloženih tablet (4 pakiranja po 28 filmsko obloženih tablet).
English: For patients aged 6 to 11 years 300 mg lumacaftor + 375 mg ivacaftor
Slovenian: Za bolnike, stare 6 do 11 let 300 mg lumakaftorja +
English: Transaminase elevations uncommon Cholestatic hepatitis‡
Slovenian: Bolezni jeter, žolčnika in žolčevodov pogosti zvišane transaminaze občasni holestatični hepatitis‡
English: The dose of lumacaftor/ivacaftor should be reduced to one tablet daily for the first week of treatment when initiating lumacaftor/ ivacaftor in patients currently taking clarithromycin or telithromycin.
Slovenian: Odmerek lumakaftorja/ivakaftorja je treba zmanjšati na eno tableto na dan za prvi teden zdravljenja, kadar uvajamo lumakaftor/ivakaftor pri bolnikih, ki trenutno jemljejo klaritromicin ali telitromicin.
English: A higher dose of bupropion may be required to obtain the desired clinical effect.
Slovenian: Mogoče bo potreben večji odmerek bupropiona, da bomo dosegli želeni klinični učinek.
English: Lumacaftor/ivacaftor may decrease the exposure of rifabutin, which may reduce its efficacy.
Slovenian: Lumakaftor/ivakaftor lahko zmanjša izpostavljenost rifabutinu, kar lahko zmanjša njegovo učinkovitost.
English: Patients aged 12 to less than 18 years lumacaftor 400 mg/ivacaftor 250 mg every 12 hours
Slovenian: Bolniki, stari 12 do manj kot 18 let lumakaftor 400 mg/ivakaftor
English: Orkambi 200 mg/125 mg film-coated tablets
Slovenian: Orkambi 200 mg/125 mg filmsko obložene tablete
English: Lumacaftor/ivacaftor may decrease the exposure of fluconazole, which may reduce its efficacy.
Slovenian: Lumakaftor/ivakaftor lahko zmanjša izpostavljenost flukonazolu, kar lahko zmanjša njegovo učinkovitost.
English: Lumacaftor/ivacaftor may decrease the exposure of erythromycin, which may reduce its efficacy.
Slovenian: Lumakaftor/ivakaftor lahko zmanjša izpostavljenost eritromicinu, kar lahko zmanjša njegovo učinkovitost.
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Slovenian: natrijev lavrilsulfat magnezijev stearat Filmska obloga polivinilalkohol titanov dioksid (E171)
English: Due to inhibition of CYP3A by erythromycin
Slovenian: CYP3A z eritromicinom ↓ eritromicin
English: You may start taking Orkambi on any day of the week.
Slovenian: Zdravilo ORKAMBI lahko začnete jemati kateri koli dan v tednu.
English: For patients aged 12 years and older 800 mg lumacaftor + 500 mg ivacaftor
Slovenian: Za bolnike, stare 12 let ali več 800 mg lumakaftorja +
English: Lumacaftor/ivacaftor may decrease the exposure of ibuprofen, which may reduce its efficacy.
Slovenian: Lumakaftor/ivakaftor lahko zmanjša izpostavljenost ibuprofenu, kar lahko zmanjša njegovo učinkovitost.
English: Mild hepatic impairment (Child-Pugh Class A)
Slovenian: Child-Pughovi lestvici)
English: No dose adjustment is necessary when CYP3A inhibitors are initiated in patients currently taking Orkambi.
Slovenian: Kadar uvajamo zaviralce CYP3A pri bolnikih, ki trenutno jemljejo zdravilo Orkambi, prilagoditev odmerka ni potrebna.
English: The dose of lumacaftor/ivacaftor should be reduced to one sachet daily for the first week of treatment when initiating lumacaftor/ivacaftor in patients currently taking clarithromycin or telithromycin.
Slovenian: Odmerek lumakaftorja/ivakaftorja je treba zmanjšati na eno vrečico na dan za prvi teden zdravljenja, kadar uvajamo lumakaftor/ivakaftor pri bolnikih, ki trenutno jemljejo klaritromicin ali telitromicin.
English: Absolute change from baseline in body mass index (BMI)
Slovenian: Absolutna sprememba indeksa telesne mase (ITM) od izhodišča n = 57
English: Talk to your child's doctor or pharmacist before taking Orkambi.
Slovenian: Pred začetkom dajanja zdravila Orkambi se posvetujte z otrokovim zdravnikom ali farmacevtom.
English: NAME OF THE MEDICINAL PRODUCT Orkambi 200 mg/125 mg film-coated tablets lumacaftor/ivacaftor
Slovenian: IME ZDRAVILA Orkambi 200 mg/125 mg filmsko obložene tablete lumacaftorum/ivacaftorum
English: Placebo (n = 371)
Slovenian: (n = 371)
English: Orkambi 100 mg/125 mg granules in sachet:
Slovenian: Orkambi 100 mg/125 mg zrnca v vrečici:
English: Orkambi 100 mg/125 mg film-coated tablets
Slovenian: Orkambi 100 mg/125 mg filmsko obložene tablete
English: Respiratory Domain Score (points)‡
Slovenian: Izhodiščni rezultat respiracijske domene
English: ↓ esomeprazole, lansoprazole, omeprazole Due to induction of CYP3A/2C19 by LUM
Slovenian: ↔ LUM, IVA ↓ ibuprofen Zaradi indukcije CYP3A/2C8/2C9 z
English: Liver function decompensation, including liver failure leading to death, has been reported in CF patients with preexisting cirrhosis with portal hypertension receiving lumacaftor/ivacaftor.
Slovenian: Pri bolnikih s CF, ki so imeli že od prej cirozo s portalno hipertenzijo in so prejemali lumakaftor/ivakaftor, so poročali o dekompenzaciji funkcije jeter, vključno z odpovedjo jeter, ki je povzročila smrt.
English: Due to induction of CYP3A by antimycobacterials
Slovenian: Zaradi indukcije CYP3A z zdravili za zdravljenje infekcij z mikobakterijami
English: Dose
Slovenian: Podalj.
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
Slovenian: Navodilo za uporabo Orkambi 100 mg/125 mg filmsko obložene tablete Orkambi 200 mg/125 mg filmsko obložene tablete lumakaftor (lumacaftorum)/ivakaftor (ivacaftorum)
English: • Cough with sputum
Slovenian: • kašelj z izmečkom,
English: STATEMENT OF ACTIVE SUBSTANCE Each sachet of granules contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Slovenian: NAVEDBA UČINKOVINE Ena vrečica zrnc vsebuje 100 mg lumakaftorja in 125 mg ivakaftorja.
English: Each sachet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Slovenian: Ena vrečica vsebuje 100 mg lumakaftorja in 125 mg ivakaftorja.
English: Dose adjustment of fexofenadine may be required to obtain the desired clinical effect.
Slovenian: Mogoče bo potrebna prilagoditev odmerka feksofenadina, da bomo dosegli želeni klinični učinek.
English: Hepatic impairment
Slovenian: občasni hepatična encefalopatija†
English: Baseline CFQ-R
Slovenian: Absolutna sprememba rezultata CFQ-R
English: Lumacaftor/ivacaftor may alter the exposure of fexofenadine.
Slovenian: Lumakaftor/ivakaftor lahko spremeni izpostavljenost feksofenadinu.
English: The dose of lumacaftor/ivacaftor should be reduced to one tablet daily for the first week of treatment when initiating lumacaftor/ ivacaftor in patients currently taking these antifungals.
Slovenian: Odmerek lumakaftorja/ivakaftorja je treba zmanjšati na eno tableto na dan za prvi teden zdravljenja, kadar uvajamo lumakaftor/ivakaftor pri bolnikih, ki trenutno jemljejo te antimikotike.
English: Orkambi 100 mg/125 mg film-coated tablets and Orkambi 200 mg/125 mg film-coated tablets: The other ingredients are:
Slovenian: Orkambi 100 mg/125 mg filmsko obložene tablete in Orkambi 200 mg/125 mg filmsko obložene tablete:
English: INFORMATION IN BRAILLE Orkambi 200 mg, 125 mg
Slovenian: Orkambi 200 mg, 125 mg
English: For patients aged 12 years and older 400 mg lumacaftor + 250 mg ivacaftor or a reduced daily dose
Slovenian: Za bolnike, stare 12 let ali več 400 mg lumakaftorja +
English: • Tablet core: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate;
Slovenian: Druge sestavine zdravila so: • jedro tablete: mikrokristalna celuloza; premreženi natrijev karmelozat; hipromeloza acetat sukcinat; povidon (K30); natrijev lavrilsulfat; in magnezijev stearat;
English: Concomitant use of lumacaftor/ivacaftor with these anti-mycobacterials is not recommended.
Slovenian: Sočasne uporabe lumakaftorja/ivakaftorja s temi antimikotiki ne priporočajo.
English: LUM 400 mg q12h/IVA 250 mg q12h (n = 187)
Slovenian: 12 ur/IVA 250 mg na 12 ur (n = 187)
English: For patients aged 12 years and older 2 tablets of 200 mg/125 mg in the morning +
Slovenian: 2 tableti po 200 mg/125 mg zjutraj +
English: Lumacaftor/ivacaftor may decrease the exposure of repaglinide, which may reduce its efficacy.
Slovenian: Lumakaftor/ivakaftor lahko zmanjša izpostavljenost repaglinidu, kar lahko zmanjša njegovo učinkovitost.
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.
Slovenian: Orkambi 100 mg/125 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg lumakaftorja (lumacaftorum) in 125 mg ivakaftorja (ivacaftorum).
English: The dose of lumacaftor/ivacaftor should be reduced to one sachet daily for the first week of treatment when initiating lumacaftor/ivacaftor in patients currently taking these antifungals.
Slovenian: Odmerek lumakaftorja/ivakaftorja je treba zmanjšati na eno vrečico na dan za prvi teden zdravljenja, kadar uvajamo lumakaftor/ivakaftor pri bolnikih, ki trenutno jemljejo te antimikotike.
English: Multipacks containing 112 film-coated tablets (4 packs of 28 film-coated tablets).
Slovenian: Pakiranje, ki vsebuje 112 filmsko obloženih tablet (4 pakiranja po 28 filmsko obloženih tablet).
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg granules in sachet lumacaftor/ivacaftor
Slovenian: IME ZDRAVILA Orkambi 100 mg/125 mg zrnca v vrečici lumacaftorum/ivacaftorum
English: • Antibiotic medicines (used for the treatment of bacterial infections) for example: telithromycin, clarithromycin, rifampicin, rifabutin, rifapentine, erythromycin
Slovenian: telitromicin, klaritromicin, rifampicin, rifabutin, rifapentin, eritromicin;
English: • Breast inflammation*
Slovenian: zatrdlina v dojki*
English: Relative change in ppFEV1 at Week 24
Slovenian: Relativna sprememba ppFEV1 v
English: Lumacaftor/ivacaftor has not been studied in patients with CF who have undergone organ transplantation.
Slovenian: Pri bolnikih s CF, ki so imeli presaditev organa, lumakaftorja/ivakaftorja niso proučevali.
English: Concomitant use of lumacaftor/ivacaftor with these immunosuppressants is not recommended.
Slovenian: Sočasne uporabe lumakaftorja/ivakaftorja s temi zdravili za zaviranje imunske odzivnosti ne priporočajo.
English: Lumacaftor/ivacaftor may decrease the exposure of bupropion, which may reduce its efficacy.
Slovenian: Lumakaftor/ivakaftor lahko zmanjša izpostavljenost bupropionu, kar lahko zmanjša njegovo učinkovitost.
English: Flatulence, vomiting
Slovenian: esomeprazol, lansoprazol, omeprazol
English: Dose adjustment of ranitidine may be required to obtain the desired clinical effect.
Slovenian: Mogoče bo potrebna prilagoditev odmerka ranitidina, da bomo dosegli želeni klinični učinek.
English: LUM 400 mg q12h/ IVA 250 mg q12h (n = 182)
Slovenian: 12 ur/ IVA 250 mg na 12 ur (n = 182)
English: INFORMATION IN BRAILLE Orkambi 100 mg, 125 mg
Slovenian: Orkambi 100 mg, 125 mg
English: Placebo (n = 101)
Slovenian: (n = 101)
English: Number of Pulmonary exacerbations (events) ** † *** Number of events per patient- year (95% CI) (rate per 48 wks)
Slovenian: Število dogodkov na bolnika leto (95 % IZ) (pogostnost na 48 tednov)
English: Appropriate clinical monitoring should be employed when co-administered with lumacaftor/ivacaftor.
Slovenian: Pri sočasni uporabi z lumakaftorjem/ivakaftorjem je potrebno ustrezno klinično spremljanje.
English: For patients aged 6 to 11 years 200 mg lumacaftor + 250 mg ivacaftor or a reduced daily dose
Slovenian: Za bolnike, stare 6 do 11 let 200 mg lumakaftorja +
English: Absolute change from baseline in stature (cm)
Slovenian: Absolutna sprememba telesne višine (cm) od izhodišča n = 57
English: OTHER Morning Evening
Slovenian: peroralna uporaba zjutraj zvečer
English: Herbals:
Slovenian: Antimikotiki:
English: What you need to know before your child takes Orkambi 3.
Slovenian: Kaj morate vedeti, preden bo vaš otrok vzel zdravilo Orkambi Kako dajati zdravilo Orkambi
English: No effects on male or female fertility and reproductive performance indices were observed at ≤ 100 mg/kg/day
Slovenian: Pri odmerku ≤ 100 mg/kg/dan niso ugotovili učinkov na indekse plodnosti in reproduktivne uspešnosti pri samcih in samicah podgan (glejte poglavje 5.3).
English: Coating
Slovenian: Dojenje
English: ↓ repaglinide Due to induction of CYP3A/2C8 by LUM
Slovenian: Zaradi indukcije CYP3A/2C8 z
English: Lumacaftor/ivacaftor may alter the exposure of ranitidine.
Slovenian: Lumakaftor/ivakaftor lahko spremeni izpostavljenost ranitidinu.
English: 1 tablet of 100 mg/125 mg in the evening (12 hours later) or a reduced daily dose
Slovenian: 1 tableto po 100 mg/125 mg zvečer (12 ur pozneje)
English: Each film-coated tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor.
Slovenian: Ena tableta vsebuje 200 mg lumakaftorja in 125 mg ivakaftorja.
English: Changes in ppFEV1 in response to lumacaftor alone or in combination with ivacaftor were also evaluated in the double-blind, placebo-controlled, Phase 2 trial in patients with CF age 18 years and older.
Slovenian: V dvojno slepem, s placebom kontroliranem preskušanju faze 2 pri bolnikih s CF, starih 18 let ali več, so ovrednotili tudi spremembe ppFEV1 v odzivu na lumakaftor sam ali v kombinaciji z ivakaftorjem.
English: Placebo (n = 184)
Slovenian: (n = 184)
English: Lumacaftor/ivacaftor may alter the exposure of warfarin.
Slovenian: Lumakaftor/ivakaftor lahko spremeni izpostavljenost varfarinu.
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg film-coated tablets lumacaftor/ivacaftor
Slovenian: Orkambi 100 mg/125 mg filmsko obložene tablete lumacaftorum/ivacaftorum
English: • Enlargement of the breast*
Slovenian: • vnetje dojke*,
English: Due to potential induction or inhibition of CYP2C9 by LUM
Slovenian: ↑ ali ↓ varfarin Zaradi možne indukcije ali zaviranja CYP2C9
English: • Diarrhoea
Slovenian: • bruhanje,
English: Carmine (E120)
Slovenian: makrogol 3350 smukec karmin (E120)
English: Other forms of this medicine (granules in a sachet) are more suitable for children under 6 years of age, ask your doctor or pharmacist.
Slovenian: (zrnca v vrečici) so primernejše za otroke, mlajše od 6 let.
English: Each film-coated tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Slovenian: Ena tableta vsebuje 100 mg lumakaftorja in 125 mg ivakaftorja.
English: P value Mean (SD)
Slovenian: Izhodiščni in končni povprečje (SD)
English: NAME OF THE MEDICINAL PRODUCT Orkambi 200 mg/125 mg tablets lumacaftor/ivacaftor
Slovenian: Orkambi 200 mg/125 mg tablete lumacaftorum/ivacaftorum