natgillin/translations-raw huggingface dataset:
The use of Kalydeco monotherapy or in combination with tezacaftor/ivacaftor in patients with severe hepatic impairment is therefore not recommended unless the benefits outweigh the risks (see Table 2 in section 4.2 and section 4.4).
Uporaba monoterapije z zdravilom Kalydeco ali v kombinaciji s tezakaftorjem/ivakaftorjem pri bolnikih s težko okvaro jeter zato ni priporočljiva, razen če pričakovana korist odtehta tveganja (glejte preglednico 2 v poglavju 4.2 in poglavje 4.4).
6- to 11-year-olds † (≥ 25 kg)
6 do 11 let stari otroci (≥ 25 kg)
• Talk to your doctor if you have liver problems, or have previously had them.
• Posvetujte se z zdravnikom, če imate ali ste kdaj prej imeli težave z jetri.
Concomitant use of CYP3A inhibitors
Sočasna uporaba zaviralcev CYP3A
There was negligible urinary excretion of ivacaftor as unchanged parent.
Ivakaftor kot nespremenjena izhodna snov se je izločal v urinu v zanemarljivih količinah.
Food or drink containing grapefruit or Seville oranges should be avoided during treatment with Kalydeco (see section 4.2).
Med zdravljenjem z zdravilom Kalydeco se je treba izogibati hrani in pijači, ki vsebujeta grenivke ali grenke pomaranče (glejte poglavje 4.2).
During the 48-week placebo-controlled studies 1 and 2 of ivacaftor monotherapy in patients aged 6 years and older, the incidence of maximum transaminase (ALT or AST) > 8, > 5 or > 3 x ULN was 3.7%, 3.7% and 8.3% in ivacaftor-treated patients and 1.0%, 1.9% and 8.7% in placebo-treated patients, respectively.
Med študijama 1 in 2 monoterapije z ivakaftorjem, kontroliranima s placebom, ki sta trajali 48 tednov, pri bolnikih, starih 6 let ali več, je bila pogostnost najvišje transaminaze (ALT ali AST) > 8, > 5 oziroma > 3 x ULN, 3,7 %, 3,7 % oziroma 8,3 % pri bolnikih, zdravljenih z ivakaftorjem, in 1,0 %, 1,9 % oziroma 8,7 % pri bolnikih, ki so prejemali placebo.
Caution is recommended for patients with severe renal impairment or end-stage renal disease (see section 5.2).
Pri bolnikih s težko okvaro ledvic ali boleznijo ledvic v končnem stadiju je priporočljiva previdnost (glejte poglavje 5.2).
• Rash
• driska
At the follow-up visit 4 weeks after ivacaftor dosing had ended, the mean (SD) absolute change in percent predicted FEV1 from part 2 week 16 was -5.9% (9.4%).
Pri kontrolnem pregledu 4 tedne po koncu odmerjanja z ivakaftorjem je bila povprečna (SD) absolutna sprememba v odstotkih napovedanega FEV1 iz 16. tedna drugega dela -5,9 % (9,4 %).
Kalydeco 75 mg granules in sachet are white to off-white granules.
Kalydeco 75 mg zrnca v vrečici so bela do belkasta zrnca.
At the follow up visit 4 weeks after ivacaftor dosing had ended, the mean (SD) absolute change in percent predicted FEV1 from part 2 week 16 was -7.4% (5.5%).
Pri kontrolnem pregledu 4 tedne po koncu odmerjanja ivakaftorja je bila povprečna (SD) absolutna sprememba napovedanega FEV1 v odstotkih od 16. tedna drugega dela -7,4 % (5,5 %).
Based on these results, a modified regimen of Kalydeco monotherapy is recommended for patients with moderate hepatic impairment (see Table 2 in section 4.2).
Na podlagi teh rezultatov pri bolnikih z zmerno okvaro jeter priporočajo spremenjeno shemo monoterapije z zdravilom Kalydeco (glejte preglednico 2 v poglavju 4.2).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHETS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
The mean absolute change from baseline through week 16 in percent predicted FEV1 (primary efficacy endpoint) was 1.5 percentage points in the ivacaftor group and -0.2 percentage points in the placebo group.
Povprečna absolutna sprememba od izhodišča do 16. tedna v odstotkih napovedanega FEV1 (cilj študije glede učinkovitosti) je bila 1,5 odstotne točke v skupini z ivakaftorjem in -0,2 odstotne točke v skupini s placebom.
Use of ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/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).
Uporaba ivakaftorja, bodisi samega bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem, pri bolnikih s težkimi okvarami jeter ni priporočljiva, razen če pričakujemo, da bodo koristi odtehtale tveganja (glejte poglavji 4.2 in 5.2).
Mean absolute change from baseline in body weight (kg)
Povprečna absolutna sprememba telesne mase (kg) od izhodišča
Respiratory, thoracic and mediastinal disorders
Bolezni jeter, žolčnika in žolčevodov zvišanja transaminaz zelo pogosti
Based on these results, a modified regimen for Kalydeco in a combination regimen with tezacaftor/ivacaftor is recommended for patients with moderate hepatic impairment (see Table 2 in section 4.2).
Na podlagi teh rezultatov pri bolnikih z zmerno okvaro jeter priporočajo spremenjeno shemo zdravila Kalydeco v kombinirani shemi s tezakaftorjem/ivakaftorjem (glejte preglednico 2 v poglavju 4.2).
The use of Kalydeco in patients with severe hepatic impairment is therefore not recommended unless the benefits outweigh the risks (see section 4.2 and section 4.4).
Uporaba zdravila Kalydeco pri bolnikih s težko okvaro jeter zato ni priporočljiva, razen če pričakovana korist odtehta tveganja (glejte poglavji 4.2 in 4.4).
Caution is recommended when administering ivacaftor, either as monotherapy or in combination with tezacaftor, 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).
Priporočljiva je previdnost, kadar dajemo ivakaftor, bodisi kot monoterapijo bodisi v kombinaciji s tezakaftorjem, 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).
Kalydeco can make you dizzy.
Zdravilo Kalydeco lahko povzroči omotico.
After oral administration of ivacaftor150 mg every 12 hours for 7 days in healthy volunteers in a fed state, the mean (± SD) apparent volume of distribution was 353 (122) L.
Po peroralni aplikaciji 150 mg ivakaftorja vsakih 12 ur 7 dni dolgo zdravim prostovoljcem po obroku hrane je bilo povprečje (± SD) navideznega porazdelitvenega volumna 353 (122) l.
Tezacaftor 100 mg/ ivacaftor 150 mg tablet Ivacaftor 150 mg tablet
Jutranji odmerek tableta tezakaftorja 100 mg/ ivakaftorja 150 mg tableta ivakaftorja 150 mg
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj zelo pogosti
Kalydeco 50 mg granules in sachet are white to off-white granules.
Kalydeco 50 mg zrnca v vrečici so bela do belkasta zrnca.
Table 5: Effect of ivacaftor on percent predicted FEV1 in study 4 Original study and treatment group
Preglednica 5: Vpliv ivakaftorja na spremembe v odstotkih napovedanega FEV1 v študiji 4
Table 6: Effect of ivacaftor on percent predicted FEV1 in study 4 Original study and treatment group
Preglednica 6: Vpliv ivakaftorja na spremembe v odstotkih napovedanega FEV1 v študiji 4
Contact your doctor straight away if you get any of these.
Če dobite katerega od teh, se takoj obrnite na svojega zdravnika.
• Redness inside the ear
• rdečica v ušesu
PHARMACEUTICAL FORM AND CONTENTS
FARMACEVTSKA OBLIKA IN VSEBINA 7 tablet
Kalydeco 25 mg granules in sachet are white to off-white granules.
Kalydeco 25 mg zrnca v vrečici so bela do belkasta zrnca.
• If your child gets any side effects, talk to your child's doctor or pharmacist.
• Če opazite pri otroku kateri koli neželeni učinek, se posvetujte z otrokovim zdravnikom ali farmacevtom.
After oral administration of ivacaftor 150 mg every 12 hours for 7 days in healthy volunteers in a fed state, the mean (± SD) apparent volume of distribution was 353 (122) L.
Po peroralni aplikaciji ivakaftorja v odmerku 150 mg vsakih 12 ur 7 dni dolgo zdravim prostovoljcem po obroku hrane je bilo povprečje (± SD) navideznega porazdelitvenega volumna 353 (122) l.
If your child gets any side effects, talk to your child's doctor or pharmacist.
Če opazite katerega koli od neželenih učinkov pri svojem otroku, se posvetujte z otrokovim zdravnikom ali farmacevtom.
Upper respiratory tract infection very common
Infekcijske in parazitske bolezni okužbe zgornjih dihal zelo pogosti nazofaringitis zelo pogosti rinitis pogosti
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).
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).
Based on these results, a modified regimen of Kalydeco monotherapy is recommended for patients with moderate hepatic impairment (see section 4.2)
Na podlagi teh rezultatov pri bolnikih z zmerno okvaro jeter priporočajo spremenjeno shemo monoterapije z zdravilom Kalydeco (glejte poglavje 4.2).
What you need to know before your child takes Kalydeco Do not take Kalydeco
Kaj morate vedeti, preden bo vaš otrok vzel zdravilo Kalydeco
Kalydeco 75 mg granules in sachet: The active substance is ivacaftor.
Kalydeco 75 mg zrnca v vrečici: Učinkovina je ivakaftor.
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).
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
12 months to less than 24 months (7 kg to < 14 kg)
12 mesecev do manj kot 24 mesecev (7 kg do < 14 kg)
• 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).
• 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.
Kalydeco 150 mg film-coated tablets ivacaftor
Kalydeco 150 mg filmsko obložene tablete ivacaftorum
6 months to less than 12 months (7 kg to < 14 kg)
6 mesecev do manj kot 12 mesecev (7 kg do < 14 kg)
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).
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).
• Bottle containing 56 film-coated tablets
• plastenka, ki vsebuje 56 filmsko obloženih tablet.
Please refer to Kalydeco tablets Package Leaflet
Upoštevajte Navodilo za uporabo tablet Kalydeco.
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).
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).
Common side effects (may affect up to 1 in 10 people)
Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov)
There is no experience of the use of Kalydeco monotherapy or in combination with tezacaftor/ivacaftor in patients with severe hepatic impairment.
Pri bolnikih s težkimi okvarami jeter ni izkušenj z uporabo niti samo zdravila Kalydeco niti zdravila Kalydeco v kombinaciji s tezakaftorjem/ivakaftorjem.
If so, contact your doctor or pharmacist to ask for advice.
Če jih boste dobili, se obrnite za nasvet na zdravnika ali farmacevta.
≥ 14 kg to < 25 kg 75 mg granules taken orally every 12 hours with fat-containing food
≥ 14 kg do < 25 kg 75 mg zrnc peroralno vsakih 12 ur z obrokom hrane, ki vsebuje maščobe
How to store Kalydeco
Shranjevanje zdravila Kalydeco
Kalydeco 50 mg granules in sachet: The active substance is ivacaftor.
Kalydeco 50 mg zrnca v vrečici: Učinkovina je ivakaftor.
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).
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).
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.
Kadar dajemo zdravilo Kalydeco (bodisi samo bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem) z zmernimi ali šibkimi spodbujevalci CYP3A, prilagajanje odmerka ni priporočljivo.
≥ 7 kg to < 14 kg 50 mg granules taken orally every 12 hours with fat-containing food
≥ 7 kg do < 14 kg 50 mg zrnc peroralno vsakih 12 ur z obrokom hrane, ki vsebuje maščobe
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).
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).
No dose adjustment is recommended when Kalydeco is used with moderate or weak CYP3A inducers.
Kadar dajemo zdravilo Kalydeco z zmernimi ali šibkimi spodbujevalci CYP3A, prilagajanje odmerka ni priporočljivo.
• Blister pack containing 56 film-coated tablets
• pretisni omot, ki vsebuje 56 filmsko obloženih tablet,
Each sachet of granules contains 75 mg of ivacaftor.
Kalydeco 75 mg zrnca v vrečici Ena vrečica vsebuje 75 mg ivakaftorja (ivacaftorum).
• Talk to your doctor if you have kidney problems, or have previously had them.
• Posvetujte se z zdravnikom, če imate ali ste kdaj prej imeli težave z ledvicami.
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).
Kadar zdravilo Kalydeco dajemo skupaj z močnimi zaviralci CYP3A, večernega odmerka zdravila Kalydeco ne smemo dati (glejte poglavji 4.4 in 4.5).
≥5 kg to < 7 kg 25 mg granules taken orally every 12 hours with fat-containing food
≥ 5 kg do < 7 kg 25 mg zrnc peroralno vsakih 12 ur z obrokom hrane, ki vsebuje maščobe
Cmin, ss (ng/mL) AUCτ,ss (ng*h/mL)
Ivakaftor povprečje (SD) AUCτ,ss (ng∙h/ml)
Each sachet contains 25 mg of ivacaftor.
Ena vrečica vsebuje 25 mg ivakaftorja.
Caution is recommended while using ivacaftor in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
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).
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).
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).
14 kg to less than 25 kg One sachet of 75 mg granules taken orally every 12 hours with fat-containing food
14 kg do manj kot 25 kg ena 75-miligramska vrečica zrnc peroralno vsakih 12 ur z obrokom hrane, ki vsebuje maščobe
Through week 24 Through week 48
Obdobje do 48. tedna
Kalydeco 150 mg film-coated tablets
IME ZDRAVILA Kalydeco 150 mg filmsko obložene tablete
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
PODATKI NA PRIMARNI OVOJNINI NALEPKA NA PLASTENKI
5 kg to less than 7 kg One sachet of 25 mg granules taken orally every 12 hours with fat-containing food
5 kg do manj kot 7 kg ena 25-miligramska vrečica zrnc peroralno vsakih 12 ur z obrokom hrane, ki vsebuje maščobe
Kalydeco 25 mg granules in sachet Each sachet contains 25 mg of ivacaftor.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Kalydeco 25 mg zrnca v vrečici Ena vrečica vsebuje 25 mg ivakaftorja (ivacaftorum).
7 kg to less than 14 kg One sachet of 50 mg granules taken orally every 12 hours with fat-containing food
7 kg do manj kot 14 kg ena 50-miligramska vrečica zrnc peroralno vsakih 12 ur z obrokom hrane, ki vsebuje maščobe
Each sachet of granules contains 50 mg of ivacaftor.
Kalydeco 50 mg zrnca v vrečici Ena vrečica vsebuje 50 mg ivakaftorja (ivacaftorum).
Kalydeco 50 mg granules ivacaftor
Kalydeco 50 mg zrnca ivacaftorum peroralna uporaba
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).
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).
Each sachet contains 75 mg of ivacaftor.
Ena vrečica vsebuje 75 mg ivakaftorja.
Kalydeco 75 mg granules in sachet ivacaftor
IME ZDRAVILA Kalydeco 75 mg zrnca v vrečici ivacaftorum
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,
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.
Kalydeco 50 mg granules in sachet
Kalydeco 25 mg zrnca v vrečici:
Medicinal products affected by ivacaftor
Zdravila, na katera vpliva ivakaftor
One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily
ena tableta ivakaftorja 150 mg enkrat na dan ena tableta tezakaftorja 100 mg/ivakaftorja 150 mg enkrat na dan
Each sachet contains 50 mg of ivacaftor.
Ena vrečica vsebuje 50 mg ivakaftorja.
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.
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
Oropharyngeal pain very common
Bolezni živčevja glavobol zelo pogosti omotica zelo pogosti
Abdominal pain very common
Bolezni prebavil bolečine v trebuhu zelo pogosti driska zelo pogosti
7 tablets
tabletah in zrncih.
Duration of ivacaftor treatment (weeks)
Trajanje zdravljenja z ivakaftorjem
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).
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
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.
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.
Hepatobiliary disorders
Monoterapija z ivakaftorjem
Package leaflet: Information for the patient Kalydeco 150 mg film-coated tablets ivacaftor
Navodilo za uporabo Kalydeco 150 mg filmsko obložene tablete ivakaftor (ivacaftorum)
Through week 8
do 8. tedna v 8. tednu do 8. tedna
DATE OF REVISION OF THE TEXT
Skupni dnevni odmerek
No dose adjustment is necessary for patients with mild hepatic impairment (Child-Pugh Class A).
Pri bolnikih z blago okvaro jeter (razred A po Child-Pughovi lestvici) ni potrebno prilagajanje odmerjanja.
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).
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,
• Enlargement of the breast in males
• zvečanje prsi pri moških
Ivacaftor should be administered with fat-containing food.
Ivakaftor je treba jemati skupaj s hrano, ki vsebuje maščobe.
Kalydeco contains the active ingredient ivacaftor.
Zdravilo Kalydeco vsebuje učinkovino ivakaftor.
Kalydeco 25 mg granules in sachet ivacaftor
IME ZDRAVILA Kalydeco 25 mg zrnca v vrečici ivacaftorum
Each sachet contains 109.8 mg of lactose (as monohydrate) For the full list of excipients, see section 6.1.
Pomožna snov z znanim učinkom Ena vrečica vsebuje 109,8 mg laktoze (v obliki monohidrata).
Package leaflet: Information for the patient Kalydeco 25 mg granules in sachet
PODATKI V BRAILLOVI PISAVI Kalydeco 25 mg zrnca
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.
Zato je treba bolnikom, ki so omotični, svetovati, naj ne vozijo ali upravljajo strojev, dokler simptomi ne izzvenijo.
Kalydeco 50 mg granules in sachet ivacaftor
IME ZDRAVILA Kalydeco 50 mg zrnca v vrečici ivacaftorum
Adults (≥ 18 years old) n = 389
Vsi bolniki (N = 39)
Silica, colloidal anhydrous Croscarmellose sodium Hypromellose acetate succinate Lactose monohydrate Magnesium stearate Mannitol
6.1 Seznam pomožnih snovi koloidni brezvodni silicijev dioksid premreženi natrijev karmelozat hipromeloza acetat sukcinat laktoza monohidrat magnezijev stearat manitol sukraloza natrijev lavrilsulfat (E487)
Kalydeco 75 mg granules
PODATKI V BRAILLOVI PISAVI Kalydeco 75 mg zrnca
If so, contact your child's doctor or pharmacist to ask for advice.
Če jih bo dobil, se obrnite za nasvet na otrokovega zdravnika ali farmacevta.
Mean absolute change from baseline in BMI (kg/m2)
Povprečna absolutna sprememba indeksa telesne mase (ITM) (kg/m2) od izhodišča V 24. tednu
Each sachet of granules contains 25 mg of ivacaftor.
NAVEDBA UČINKOVINE Ena vrečica zrnc vsebuje 25 mg ivakaftorja.
Each sachet contains 36.6 mg of lactose (as monohydrate) Kalydeco 50 mg granules in sachet Each sachet contains 50 mg of ivacaftor.
Pomožna snov z znanim učinkom Ena vrečica vsebuje 36,6 mg laktoze (v obliki monohidrata).
− Blister card pack containing 28 film-coated tablets
PRETISNA ZGIBANKA - PAKIRANJE Z 28 TABLETAMI