FrancophonIA/ELRC3.0 huggingface dataset:
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Slovenian: Če opazite katerega koli od neželenih učinkov pri svojem otroku, se posvetujte z otrokovim zdravnikom ali farmacevtom.
English: Upper respiratory tract infection very common
Slovenian: Infekcijske in parazitske bolezni okužbe zgornjih dihal zelo pogosti nazofaringitis zelo pogosti rinitis pogosti
English: However, caution is recommended when administering ivacaftor to patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end-stage renal disease (see sections 4.2 and 4.4).
Slovenian: Priporočljiva pa je previdnost, kadar dajemo ivakaftor bolnikom s težko okvaro ledvic (očistek kreatinina največ 30 ml/min) ali z boleznijo ledvic v končnem stadiju (glejte poglavji 4.2 in 4.4).
English: Based on these results, a modified regimen of Kalydeco monotherapy is recommended for patients with moderate hepatic impairment (see section 4.2)
Slovenian: Na podlagi teh rezultatov pri bolnikih z zmerno okvaro jeter priporočajo spremenjeno shemo monoterapije z zdravilom Kalydeco (glejte poglavje 4.2).
English: What you need to know before your child takes Kalydeco Do not take Kalydeco
Slovenian: Kaj morate vedeti, preden bo vaš otrok vzel zdravilo Kalydeco
English: Kalydeco 75 mg granules in sachet: The active substance is ivacaftor.
Slovenian: Kalydeco 75 mg zrnca v vrečici: Učinkovina je ivakaftor.
English: A reduction of the Kalydeco dose is recommended for co-administration with strong CYP3A inhibitors, such as ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin and clarithromycin (see sections 4.2 and 4.4).
Slovenian: Za sočasno uporabo z močnimi zaviralci CYP3A, kot so npr. ketokonazol, itrakonazol, posakonazol, vorikonazol, telitromicin in klaritromicin, priporočajo zmanjšanje odmerka zdravila Kalydeco (glejte poglavji 4.2 in
English: 12 months to less than 24 months (7 kg to < 14 kg)
Slovenian: 12 mesecev do manj kot 24 mesecev (7 kg do < 14 kg)
English: • Abnormality of the eye lens (cataract) without any effect on vision has been noted in some children and adolescents treated with Kalydeco (alone or in combination with tezacaftor/ivacaftor).
Slovenian: • Pri nekaterih otrocih in mladostnikih, zdravljenih z zdravilom Kalydeco (bodisi samim bodisi v kombinaciji s tezakaftorjem/ivakaftorjem), so opazili nenormalnost očesne leče (katarakta) brez vpliva na vid.
English: Kalydeco 150 mg film-coated tablets ivacaftor
Slovenian: Kalydeco 150 mg filmsko obložene tablete ivacaftorum
English: 6 months to less than 12 months (7 kg to < 14 kg)
Slovenian: 6 mesecev do manj kot 12 mesecev (7 kg do < 14 kg)
English: Therefore, monitoring of the international normalised ratio (INR) is recommended during co-administration of warfarin with Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor).
Slovenian: Zato med sočasnim dajanjem varfarina z zdravilom Kalydeco (bodisi samim bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem) priporočajo spremljanje mednarodnega normaliziranega razmerja (international normalised ratio-INR).
English: • Bottle containing 56 film-coated tablets
Slovenian: • plastenka, ki vsebuje 56 filmsko obloženih tablet.
English: Please refer to Kalydeco tablets Package Leaflet
Slovenian: Upoštevajte Navodilo za uporabo tablet Kalydeco.
English: Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating ivacaftor treatment, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor (see section 5.3).
Slovenian: Pri pediatričnih bolnikih, ki začenjajo zdravljenje z ivakaftorjem, bodisi samim bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem, priporočajo izhodiščne in kontrolne oftalmološke preiskave (glejte poglavje 5.3).
English: Common side effects (may affect up to 1 in 10 people)
Slovenian: Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov)
English: There is no experience of the use of Kalydeco monotherapy or in combination with tezacaftor/ivacaftor in patients with severe hepatic impairment.
Slovenian: Pri bolnikih s težkimi okvarami jeter ni izkušenj z uporabo niti samo zdravila Kalydeco niti zdravila Kalydeco v kombinaciji s tezakaftorjem/ivakaftorjem.
English: If so, contact your doctor or pharmacist to ask for advice.
Slovenian: Če jih boste dobili, se obrnite za nasvet na zdravnika ali farmacevta.
English: ≥ 14 kg to < 25 kg 75 mg granules taken orally every 12 hours with fat-containing food
Slovenian: ≥ 14 kg do < 25 kg 75 mg zrnc peroralno vsakih 12 ur z obrokom hrane, ki vsebuje maščobe
English: How to store Kalydeco
Slovenian: Shranjevanje zdravila Kalydeco
English: Kalydeco 50 mg granules in sachet: The active substance is ivacaftor.
Slovenian: Kalydeco 50 mg zrnca v vrečici: Učinkovina je ivakaftor.
English: Caution is recommended while using ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor, in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Slovenian: Pri uporabi ivakaftorja, bodisi samega bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem, pri bolnikih s težkimi okvarami ledvic ali z boleznijo ledvic v končnem stadiju je priporočljiva previdnost (glejte poglavji 4.2 in 5.2).
English: No dose adjustment is recommended when Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) is used with moderate or weak CYP3A inducers.
Slovenian: Kadar dajemo zdravilo Kalydeco (bodisi samo bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem) z zmernimi ali šibkimi spodbujevalci CYP3A, prilagajanje odmerka ni priporočljivo.
English: ≥ 7 kg to < 14 kg 50 mg granules taken orally every 12 hours with fat-containing food
Slovenian: ≥ 7 kg do < 14 kg 50 mg zrnc peroralno vsakih 12 ur z obrokom hrane, ki vsebuje maščobe
English: OTHER
Slovenian: N
English: Use of ivacaftor is not recommended in patients with severe hepatic impairment unless the benefits are expected to outweigh the risks (see sections 4.2 and 5.2).
Slovenian: Uporaba ivakaftorja pri bolnikih s težkimi okvarami jeter ni priporočljiva, razen če pričakujemo, da bodo koristi odtehtale tveganja (glejte poglavji 4.2 in 5.2).
English: No dose adjustment is recommended when Kalydeco is used with moderate or weak CYP3A inducers.
Slovenian: Kadar dajemo zdravilo Kalydeco z zmernimi ali šibkimi spodbujevalci CYP3A, prilagajanje odmerka ni priporočljivo.
English: • Blister pack containing 56 film-coated tablets
Slovenian: • pretisni omot, ki vsebuje 56 filmsko obloženih tablet,
English: Each sachet of granules contains 75 mg of ivacaftor.
Slovenian: Kalydeco 75 mg zrnca v vrečici Ena vrečica vsebuje 75 mg ivakaftorja (ivacaftorum).
English: • Talk to your doctor if you have kidney problems, or have previously had them.
Slovenian: • Posvetujte se z zdravnikom, če imate ali ste kdaj prej imeli težave z ledvicami.
English: Kalydeco in a combination regimen with tezacaftor/ivacaftor When co-administered with strong inhibitors of CYP3A, the Kalydeco evening dose should not be administered (see sections 4.4 and 4.5).
Slovenian: Kadar zdravilo Kalydeco dajemo skupaj z močnimi zaviralci CYP3A, večernega odmerka zdravila Kalydeco ne smemo dati (glejte poglavji 4.4 in 4.5).
English: ≥5 kg to < 7 kg 25 mg granules taken orally every 12 hours with fat-containing food
Slovenian: ≥ 5 kg do < 7 kg 25 mg zrnc peroralno vsakih 12 ur z obrokom hrane, ki vsebuje maščobe
English: Cmin, ss (ng/mL) AUCτ,ss (ng*h/mL)
Slovenian: Ivakaftor povprečje (SD) AUCτ,ss (ng∙h/ml)
English: Each sachet contains 25 mg of ivacaftor.
Slovenian: Ena vrečica vsebuje 25 mg ivakaftorja.
English: Caution is recommended while using ivacaftor in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Slovenian: Pri uporabi ivakaftorja pri bolnikih s težkimi okvarami ledvic ali z boleznijo ledvic v končnem stadiju je priporočljiva previdnost (glejte poglavji 4.2 in 5.2).
English: A reduction of the Kalydeco dose (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) is recommended for patients taking concomitant moderate CYP3A inhibitors, such as fluconazole and erythromycin (see sections 4.2 and 4.4).
Slovenian: Za bolnike, ki sočasno jemljejo zmerne zaviralce CYP3A, kakršna sta flukonazol in eritromicin, priporočajo zmanjšanje odmerka zdravila Kalydeco (bodisi samega bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem) (glejte poglavji 4.2 in 4.4).
English: 14 kg to less than 25 kg One sachet of 75 mg granules taken orally every 12 hours with fat-containing food
Slovenian: 14 kg do manj kot 25 kg ena 75-miligramska vrečica zrnc peroralno vsakih 12 ur z obrokom hrane, ki vsebuje maščobe
English: Through week 24 Through week 48
Slovenian: Obdobje do 48. tedna
English: Kalydeco 150 mg film-coated tablets
Slovenian: IME ZDRAVILA Kalydeco 150 mg filmsko obložene tablete
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA NA PLASTENKI
English: 5 kg to less than 7 kg One sachet of 25 mg granules taken orally every 12 hours with fat-containing food
Slovenian: 5 kg do manj kot 7 kg ena 25-miligramska vrečica zrnc peroralno vsakih 12 ur z obrokom hrane, ki vsebuje maščobe
English: Kalydeco 25 mg granules in sachet Each sachet contains 25 mg of ivacaftor.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Kalydeco 25 mg zrnca v vrečici Ena vrečica vsebuje 25 mg ivakaftorja (ivacaftorum).
English: 7 kg to less than 14 kg One sachet of 50 mg granules taken orally every 12 hours with fat-containing food
Slovenian: 7 kg do manj kot 14 kg ena 50-miligramska vrečica zrnc peroralno vsakih 12 ur z obrokom hrane, ki vsebuje maščobe
English: Each sachet of granules contains 50 mg of ivacaftor.
Slovenian: Kalydeco 50 mg zrnca v vrečici Ena vrečica vsebuje 50 mg ivakaftorja (ivacaftorum).
English: Kalydeco 50 mg granules ivacaftor
Slovenian: Kalydeco 50 mg zrnca ivacaftorum peroralna uporaba
English: Food or drink containing grapefruit or Seville oranges should be avoided during treatment with Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor, see section 4.2).
Slovenian: Med zdravljenjem z zdravilom Kalydeco (bodisi samim bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem) se je treba izogibati hrani in pijači, ki vsebujeta grenivke ali grenke pomaranče (glejte poglavje 4.2).
English: Each sachet contains 75 mg of ivacaftor.
Slovenian: Ena vrečica vsebuje 75 mg ivakaftorja.
English: Kalydeco 75 mg granules in sachet ivacaftor
Slovenian: IME ZDRAVILA Kalydeco 75 mg zrnca v vrečici ivacaftorum
English: Kalydeco tablets are also indicated in a combination regimen with tezacaftor 100 mg/ivacaftor 150 mg tablets for the treatment of adults and adolescents aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E,
Slovenian: Tablete Kalydeco so indicirane tudi v kombinirani shemi s tabletami tezakaftorja 100 mg/ivakaftorja 150 mg za zdravljenje odraslih in mladostnikov, starih 12 let ali več, s cistično fibrozo (CF), ki so homozigotni za mutacijo F508del ali ki so heterozigotni za mutacijo F508del in imajo eno od naslednjih mutacij v genu CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G ali 3849+10kbC→T.
English: Kalydeco 50 mg granules in sachet
Slovenian: Kalydeco 25 mg zrnca v vrečici:
English: Medicinal products affected by ivacaftor
Slovenian: Zdravila, na katera vpliva ivakaftor
English: One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily
Slovenian: ena tableta ivakaftorja 150 mg enkrat na dan ena tableta tezakaftorja 100 mg/ivakaftorja 150 mg enkrat na dan
English: Each sachet contains 50 mg of ivacaftor.
Slovenian: Ena vrečica vsebuje 50 mg ivakaftorja.
English: Kalydeco tablets are indicated for the treatment of adults, adolescents and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have one of the following gating mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
Slovenian: Tablete Kalydeco so indicirane za zdravljenje odraslih, mladostnikov in otrok, starih 6 let ali več in s telesno maso 25 kg ali več s cistično fibrozo (CF), ki imajo eno od naslednjih mutacij spreminjanja prehodnosti kanalčkov celične membrane (skupina III) v genu CFTR (cystic fibrosis transmembrane conductance regulator): G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N ali
English: Oropharyngeal pain very common
Slovenian: Bolezni živčevja glavobol zelo pogosti omotica zelo pogosti
English: Abdominal pain very common
Slovenian: Bolezni prebavil bolečine v trebuhu zelo pogosti driska zelo pogosti
English: 7 tablets
Slovenian: tabletah in zrncih.
English: Duration of ivacaftor treatment (weeks)
Slovenian: Trajanje zdravljenja z ivakaftorjem
English: Only patients with CF who had a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R gating (class III), G970R or R117H mutation in at least one allele of the CFTR gene were included in studies 1, 2, 5 and 6 (see section 5.1).
Slovenian: V študije 1, 2, 5 in 7 so bili vključeni samo bolniki s CF, ki so imeli mutacijo spreminjanja prehodnosti G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N ali S549R (skupina
English: Cases of non-congenital lens opacities without impact on vision have been reported in paediatric patients treated with ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor.
Slovenian: Pri pediatričnih bolnikih, zdravljenih z ivakaftorjem, bodisi samim bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem, so poročali o primerih ne-prirojenih motnjav leče brez vpliva na vid.
English: Hepatobiliary disorders
Slovenian: Monoterapija z ivakaftorjem
English: Package leaflet: Information for the patient Kalydeco 150 mg film-coated tablets ivacaftor
Slovenian: Navodilo za uporabo Kalydeco 150 mg filmsko obložene tablete ivakaftor (ivacaftorum)
English: Through week 8
Slovenian: do 8. tedna v 8. tednu do 8. tedna
English: DATE OF REVISION OF THE TEXT
Slovenian: Skupni dnevni odmerek
English: No dose adjustment is necessary for patients with mild hepatic impairment (Child-Pugh Class A).
Slovenian: Pri bolnikih z blago okvaro jeter (razred A po Child-Pughovi lestvici) ni potrebno prilagajanje odmerjanja.
English: Kalydeco granules are indicated for the treatment of infants aged at least 6 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1).
Slovenian: Zrnca Kalydeco so indicirana za zdravljenje dojenčkov, starih najmanj 6 mesecev, malčkov in otrok s telesno maso 5 kg do manj kot 25 kg, s cistično fibrozo (CF), ki imajo eno od naslednjih mutacij spreminjanja prehodnosti kanalčkov celične membrane (skupina III) v genu CFTR (cystic fibrosis transmembrane conductance regulator): G551D, G1244E, G1349D, G178R, G551S, S1251N,
English: • Enlargement of the breast in males
Slovenian: • zvečanje prsi pri moških
English: Ivacaftor should be administered with fat-containing food.
Slovenian: Ivakaftor je treba jemati skupaj s hrano, ki vsebuje maščobe.
English: Kalydeco contains the active ingredient ivacaftor.
Slovenian: Zdravilo Kalydeco vsebuje učinkovino ivakaftor.
English: Kalydeco 25 mg granules in sachet ivacaftor
Slovenian: IME ZDRAVILA Kalydeco 25 mg zrnca v vrečici ivacaftorum
English: Each sachet contains 109.8 mg of lactose (as monohydrate) For the full list of excipients, see section 6.1.
Slovenian: Pomožna snov z znanim učinkom Ena vrečica vsebuje 109,8 mg laktoze (v obliki monohidrata).
English: Package leaflet: Information for the patient Kalydeco 25 mg granules in sachet
Slovenian: PODATKI V BRAILLOVI PISAVI Kalydeco 25 mg zrnca
English: Ivacaftor may cause dizziness (see section 4.8) and, therefore, patients experiencing dizziness should be advised not to drive or use machines until symptoms abate.
Slovenian: Zato je treba bolnikom, ki so omotični, svetovati, naj ne vozijo ali upravljajo strojev, dokler simptomi ne izzvenijo.
English: Kalydeco 50 mg granules in sachet ivacaftor
Slovenian: IME ZDRAVILA Kalydeco 50 mg zrnca v vrečici ivacaftorum
English: Adults (≥ 18 years old) n = 389
Slovenian: Vsi bolniki (N = 39)
English: Silica, colloidal anhydrous Croscarmellose sodium Hypromellose acetate succinate Lactose monohydrate Magnesium stearate Mannitol
Slovenian: 6.1 Seznam pomožnih snovi koloidni brezvodni silicijev dioksid premreženi natrijev karmelozat hipromeloza acetat sukcinat laktoza monohidrat magnezijev stearat manitol sukraloza natrijev lavrilsulfat (E487)
English: Kalydeco 75 mg granules
Slovenian: PODATKI V BRAILLOVI PISAVI Kalydeco 75 mg zrnca
English: If so, contact your child's doctor or pharmacist to ask for advice.
Slovenian: Če jih bo dobil, se obrnite za nasvet na otrokovega zdravnika ali farmacevta.
English: Mean absolute change from baseline in BMI (kg/m2)
Slovenian: Povprečna absolutna sprememba indeksa telesne mase (ITM) (kg/m2) od izhodišča V 24. tednu
English: Each sachet of granules contains 25 mg of ivacaftor.
Slovenian: NAVEDBA UČINKOVINE Ena vrečica zrnc vsebuje 25 mg ivakaftorja.
English: Each sachet contains 36.6 mg of lactose (as monohydrate) Kalydeco 50 mg granules in sachet Each sachet contains 50 mg of ivacaftor.
Slovenian: Pomožna snov z znanim učinkom Ena vrečica vsebuje 36,6 mg laktoze (v obliki monohidrata).
English: − Blister card pack containing 28 film-coated tablets
Slovenian: PRETISNA ZGIBANKA - PAKIRANJE Z 28 TABLETAMI
English: In study 4 patients who completed treatment in studies 1 and 2 with placebo were switched to ivacaftor while patients on ivacaftor continued to receive it for a minimum of 96 weeks, i.e., the length of treatment with ivacaftor was at least 96 weeks for patients in the placebo/ivacaftor group and at least 144 weeks for patients in the ivacaftor/ivacaftor group.
Slovenian: dolžina zdravljenja z ivakaftorjem je bila pri bolnikih v skupini s placebom in ivakaftorjem vsaj 96 tednov, v skupini z ivakaftorjem in ivakaftorjem pa vsaj 144 tednov.
English: common
Slovenian: Zmerne
English: Always take this medicine exactly as your doctor has told you to.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika.
English: Kalydeco granules are indicated for the treatment of babies and children aged 6 months and older and weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have one of the following gating mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
Slovenian: Zrnca Kalydeco so namenjena zdravljenju dojenčkov in otrok, starih 6 mesecev ali starejših, s telesno maso 5 kg do manj kot 25 kg, s cistično fibrozo (CF), ki imajo eno od naslednjih mutacij spreminjanja prehodnosti kanalčkov celične membrane na genu CFTR: G551D, G1244E, G1349D, G178R,
English: CYP3A inhibitors
Slovenian: Spodbujevalci CYP3A
English: Placebo
Slovenian: FEV1
English: MA (EU) number (Invented) name
Slovenian: Številka postopka EMA (Izmišljeno) ime
English: --¹ After reconstitution, 1 dose (0.5 ml) contains 50 micrograms of gE antigen1 adjuvanted with AS01B2.
Slovenian: --1 Po rekonstituciji 1 odmerek (0,5 ml) vsebuje 50 mikrogramov antigena gE1 z adjuvansom AS01B2.
English: 1 vial (powder) + 1 vial (suspension)
Slovenian: 1 viala (prašek) + 1 viala (suspenzija)
English: 10 vials (powder) + 10 vials (suspension)
Slovenian: 10 vial (prašek) + 10 vial (suspenzija)
English: 2 AS01B Adjuvant System is composed of the plant extract Quillaja saponaria Molina, fraction 21 (QS-21) (50 micrograms) and 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota (50 micrograms)
Slovenian: 1 glikoprotein E (gE) virusa varicella zoster, pridobljen iz celic jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA 2 AS01B adjuvansni sistem je sestavljen iz rastlinskega izvlečka Quillaja saponaria Molina, frakcija 21 (QS-21) (50 mikrogramov) in 3-O-dezacil-4'monofosforillipida A (MPL) iz Salmonella minnesota (50 mikrogramov)
English: In certain cases treatment should be permanently stopped.
Slovenian: V določenih primerih je treba zdravljenje trajno ukiniti.
English: This overview was last updated in 06-2018.
Slovenian: Povzetek je bil nazadnje posodobljen 06-2018.
English: Further information on Alecensa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Alecensa so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Alecensa (alectinib)
Slovenian: Alecensa (alektinib)
English: Alecensa received a marketing authorisation valid throughout the EU on 16 February 2017.
Slovenian: Zdravilo Alecensa je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 16. februarja 2017.
English: The medicine is available as capsules (150 mg).
Slovenian: Zdravilo je na voljo v obliki kapsul (150 mg).
English: The European Medicines Agency decided that Alecensa's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Alecensa večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Response was maintained for an average of 14.9 months in the first study, and 15.2 months in the second study.
Slovenian: V prvi študiji je odziv trajal povprečno 14,9 meseca, v drugi pa 15,2 meseca.
English: In the second study, the complete or partial response rate at the time of analysis was 51% (62 out of 122 patients).
Slovenian: V drugi študiji je bil delež popolnega ali delnega odziva v času analize 51 % (62 od 122 bolnikov).
English: What measures are being taken to ensure the safe and effective use of Alecensa?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Alecensa?
English: As for all medicines, data on the use of Alecensa are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Alecensa stalno spremljajo.
English: The recommended usual dose is 4 capsules taken twice a day with food (1,200 mg in total).
Slovenian: Priporočeni običajni odmerek je štiri kapsule dvakrat na dan s hrano (skupaj 1 200 mg).
English: Response to treatment was assessed using body scans and standardised criteria for solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Slovenian: Odziv na zdravljenje so ocenjevali s slikanjem telesa in standardiziranimi merili za čvrste tumorje; popoln odziv je pri tem pomenil, da bolnik nima nikakršnih preostalih znakov raka.
English: Genetic defects affecting ALK (‘ALK-positive' status) should be confirmed in advance by appropriate methods.
Slovenian: Genske okvare, ki vplivajo na anaplastično limfomsko kinazo (ALK-pozitivno stanje), je treba predhodno potrditi z ustreznimi metodami.
English: The most common side effects with Alecensa (which may affect more than 2 in 10 people) are constipation, muscle pain and oedema (swelling) including of the ankles and feet, the face, the eyelids and the area around the eyes.
Slovenian: Najpogostejši neželeni učinki zdravila Alecensa (ki se lahko pojavijo pri več kot 2 bolnikih od 10) so zaprtje, bolečine v mišicah in edem (otekanje), vključno z otekanjem gležnjev in stopal, obraza ter vek in predelov okrog oči.
English: Two main studies involved a total of 225 patients in whom the disease progressed despite previous treatment with Xalkori (crizotinib).
Slovenian: Dve glavni študiji sta skupaj vključevali 225 bolnikov, pri katerih je bolezen napredovala kljub predhodnemu zdravljenju z zdravilom Xalkori (krizotinib).
English: The safety profile of Alecensa was considered acceptable and in line with that of other ALK inhibitors.
Slovenian: Varnostni profil zdravila Alecensa je bil sprejemljiv in v skladu z drugimi ALK-zaviralci.