FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ziextenzo has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Ziextenzo po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Neulasta in da se po telesu enako prenaša.
English: Ziextenzo is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Slovenian: Zdravilo Ziextenzo ni namenjeno uporabi pri bolnikih s krvnim rakom, tj. kronično mieloično levkemijo ali mielodisplastičnimi sindromi (boleznimi, pri katerih nastajajo velike količine nenormalnih krvnih celic, ki se lahko razvijejo v levkemijo).
English: For the full list of side effects and restrictions with Ziextenzo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Ziextenzo glejte navodilo za uporabo.
English: Ziextenzo is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Slovenian: Ziextenzo je zdravilo, ki se uporablja pri bolnikih z rakom za pomoč pri nevtropeniji (zmanjšanem številu nevtrofilcev, vrste belih krvnih celic), ki je pogost neželeni učinek pri zdravljenju raka, zaradi katerega pa so bolniki dovzetnejši za okužbe.
English: How does Ziextenzo work?
Slovenian: Kako zdravilo Ziextenzo deluje?
English: Ziextenzo is a ‘biosimilar medicine'.
Slovenian: Zdravilo Ziextenzo je „podobno biološko zdravilo“.
English: In Ziextenzo, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Slovenian: V zdravilu Ziextenzo je filgrastim „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
English: In addition, studies in breast cancer patients undergoing chemotherapy have shown that the effectiveness of Ziextenzo is equivalent to that of Neulasta in reducing the duration of neutropenia.
Slovenian: Poleg tega so v študiji pri bolnicah z rakom dojke, ki so se zdravile s kemoterapijo, dokazali, da je učinkovitost zdravila Ziextenzo pri skrajševanju trajanja nevtropenije enakovredna učinkovitosti zdravila Neulasta.
English: Therefore, the Agency's view was that, as for Neulasta, the benefit of Ziextenzo outweighs the identified risk and it can be authorised for use in the EU.
Slovenian: Agencija je menila, da koristi zdravila Ziextenzo enako kot pri zdravilu Neulasta odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: How is Ziextenzo used?
Slovenian: Kako se zdravilo Ziextenzo uporablja?
English: Studies have also shown that giving Ziextenzo produces similar levels of the active substance in the body to giving Neulasta.
Slovenian: Študije so pokazale tudi, da zdravilo Ziextenzo vzpostavi podobne ravni učinkovine v telesu kot zdravilo Neulasta.
English: Laboratory studies comparing Ziextenzo with Neulasta have shown that the active substance in Ziextenzo is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Ziextenzo primerjali z zdravilom Neulasta, so pokazale, da je učinkovina zdravila Ziextenzo po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Neulasta.
English: The medicine was also shown to have an acceptable safety profile.
Slovenian: Poleg tega je bilo ugotovljeno, da ima zdravilo sprejemljiv varnostni profil.
English: Lung function was measured after 4 weeks and 8 weeks of treatment.
Slovenian: Delovanje pljuč je bilo izmerjeno po štirih in osmih tednih zdravljenja.
English: The Agency also noted, however, that there were limited data on the longer-term effects of the medicine and that further data should be provided by the company.
Slovenian: Opozorila je tudi, da so o dolgoročnih učinkih zdravila na voljo le omejeni podatki in da mora podjetje priskrbeti dodatne informacije.
English: FEV1 is the maximum amount of air a person can breathe out in one second and is a measure of how well the lungs work.
Slovenian: FEV1 je največja količina zraka, ki jo lahko oseba izdihne v eni sekundi, in je merilo delovanja pljuč.
English: What measures are being taken to ensure the safe and effective use of Kalydeco?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kalydeco?
English: Kalydeco received a marketing authorisation valid throughout the EU on 23 July 2012.
Slovenian: Za zdravilo Kalydeco je bilo 23. julija 2012 izdano dovoljenje za promet, veljavno po vsej EU.
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu308556.
Slovenian: Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/en/medicines/human/orphan-designations/eu308556.
English: They should be mixed with 5 ml of soft food or liquid to make a suspension to be taken by mouth.
Slovenian: Treba jih je zmešati s 5 ml tekoče hrane ali tekočine, da se pripravi suspenzija, ki jo je treba vzeti peroralno.
English: The European Medicines Agency therefore decided that the benefits of Kalydeco are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Kalydeco večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: Further information on Kalydeco can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/kalydeco.
Slovenian: Nadaljnje informacije za zdravilo Kalydeco so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/kalydeco.
English: One of the studies was in patients aged over 12 years, while the other was in patients aged between 6 and 11 years.
Slovenian: Ena od študij je bila izvedena pri bolnikih, starejših od 12 let, medtem ko je druga vključevala bolnike, stare od šest do 11 let.
English: Kalydeco (ivacaftor)
Slovenian: Kalydeco (ivakaftor)
English: As for all medicines, data on the use of Kalydeco are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Kalydeco stalno spremljajo.
English: Other information about Kalydeco
Slovenian: Druge informacije o zdravilu Kalydeco
English: The company that markets Kalydeco is conducting a study in children who were aged 2 to 5 years at the start of treatment to assess long-term effects of early treatment.
Slovenian: Podjetje, ki trži zdravilo Kalydeco, trenutno izvaja študijo pri otrocih, ki so bili ob začetku zdravljenja stari od dve do pet let, da bi ocenilo dolgoročne učinke zgodnjega zdravljenja.
English: Kalydeco is available as tablets (150 mg) and as granules (25, 50, and 75 mg) in a sachet.
Slovenian: Zdravilo Kalydeco je na voljo v obliki tablet (150 mg) in zrnc (25 mg, 50 mg in 75 mg) v vrečicah.
English: What is Kalydeco and what is it used for?
Slovenian: Kaj je zdravilo Kalydeco in za kaj se uporablja?
English: Why is Kalydeco authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Kalydeco odobreno v EU?
English: The most common side effects with Kalydeco (which may affect more than 1 in 10 people) are headache, sore throat, upper respiratory tract infection (nose and throat infection), nasal congestion, abdominal (belly) pain, nasopharyngitis (inflammation of the nose and throat), diarrhoea, dizziness, rash, bacteria in sputum (phlegm) and an increase in certain liver enzymes.
Slovenian: Najpogostejši neželeni učinki zdravila Kalydeco (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so glavobol, vneto žrelo, okužba zgornjih dihal (okužba nosu in žrela), zamašen nos, bolečine v trebuhu, nazofaringitis (vnetje nosu in žrela), driska, omotica, izpuščaj, bakterije v izpljunku (sluzi) in zvišane vrednosti nekaterih jetrnih encimov.
English: What benefits of Kalydeco have been shown in studies?
Slovenian: Kakšne koristi zdravila Kalydeco so se pokazale v študijah?
English: An overview of Kalydeco and why is it authorised in the EU
Slovenian: Pregled zdravila Kalydeco in zakaj je odobreno v EU
English: The mutations reduce the number of CFTR proteins on the cell surface or affect the way the protein works.
Slovenian: Mutacije zmanjšujejo število beljakovin CFTR na celični površini ali pa vplivajo na način delovanja beljakovine.
English: Side effects reported with Kalydeco are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Kalydeco, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: It should only be prescribed by a doctor with experience in the treatment of cystic fibrosis, and only in patients confirmed to have the mutations mentioned above.
Slovenian: Predpiše ga lahko samo zdravnik, ki ima izkušnje z zdravljenjem cistične fibroze, in sicer samo bolnikom, ki imajo potrjene zgoraj navedene mutacije.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kalydeco have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Kalydeco upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: This makes mucus and digestive juices less thick, thereby helping to relieve symptoms of the disease.
Slovenian: Tako se sluz in prebavni sokovi razredčijo, kar ublaži simptome bolezni.
English: Cystic fibrosis is rare, and Kalydeco was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 July 2008.
Slovenian: Cistična fibroza je redka bolezen, zato je bilo zdravilo Kalydeco 8. julija 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: The tablets are used in adults and children aged 6 years and above and weighing 25 kg or more.
Slovenian: Tablete se uporabljajo pri odraslih in otrocih, starejših od šest let, s telesno maso 25 kg ali več.
English: What are the risks associated with Kalydeco?
Slovenian: Kakšna tveganja so povezana z zdravilom Kalydeco?
English: For more information about using Kalydeco, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Kalydeco glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Serious side effects include abdominal pain and increased liver enzymes.
Slovenian: Resni neželeni učinki vključujejo bolečine v trebuhu in zvišane vrednosti jetrnih encimov.
English: For infants and children aged 6 months and above and weighing 5 to 25 kg, the granules should be used.
Slovenian: Pri otrocih, starih šest mesecev ali več, s telesno maso od 5 kg do 25 kg je treba uporabiti zrnca.
English: The main measure of effectiveness was based on improvement in patients' FEV1.
Slovenian: Glavno merilo učinkovitosti je bilo izboljšanje bolnikove vrednosti FEV1.
English: The study found that Kalydeco granules resulted in increased bodyweight and a decreased amount of chloride contained in sweat.
Slovenian: Ugotovili so, da je jemanje zrnc zdravila Kalydeco privedlo do višje telesne mase in manjše količine kloridov v znoju.
English: Cystic fibrosis affects the cells that produce mucus and digestive juices.
Slovenian: Cistična fibroza prizadene celice, ki proizvajajo sluz in prebavne sokove.
English: The doses may also need to be adjusted in patients with reduced liver function.
Slovenian: Prav tako je treba odmerke včasih zmanjšati pri bolnikih z okvaro jeter.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Slovenian: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
English: The dose and frequency depends on whether Kalydeco is used alone or together with tezacaftor / ivacaftor.
Slovenian: Odmerek in pogostnost jemanja zdravila Kalydeco sta odvisna od tega, ali se zdravilo jemlje samostojno ali skupaj s tezakaftorjem in ivakaftorjem.
English: Kalydeco is a medicine used to treat cystic fibrosis, an inherited disease that has severe effects on the lungs, the digestive system and other organs.
Slovenian: Kalydeco je zdravilo, ki se uporablja za zdravljenje cistične fibroze, tj. dedne bolezni, ki ima resne učinke na pljuča, prebavila in druge organe.
English: The main measure of effectiveness in these studies was based on improvements in patients' FEV1.
Slovenian: V teh študijah je bilo glavno merilo učinkovitosti izboljšanje bolnikove vrednosti FEV1.
English: In the studies, Kalydeco was compared with placebo (a dummy treatment).
Slovenian: V teh študijah so zdravilo Kalydeco primerjali s placebom (zdravilom brez učinkovine).
English: The active substance in Kalydeco, ivacaftor, increases the activity of the defective CFTR protein.
Slovenian: Učinkovina v zdravilu Kalydeco, ivakaftor, povečuje delovanje okvarjene beljakovine CFTR.
English: Kalydeco is used on its own to treat cystic fibrosis in patients aged 6 months and above who have one of nine mutations (changes) in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator' (CFTR).
Slovenian: Zdravilo Kalydeco se uporablja samostojno za zdravljenje cistične fibroze pri bolnikih, starejših od šest mesecev, ki imajo eno od devetih oblik mutacije (spremembe) v genu za beljakovino, imenovano regulator transmembranske prevodnosti pri cistični fibrozi (CFTR).
English: Patients with cystic fibrosis have low bodyweight due to problems with digestion of food and high levels of chloride in sweat due to CFTR not working properly.
Slovenian: Telesna masa bolnikov s cistično fibrozo je zaradi težav pri prebavi hrane nizka, poleg tega pa imajo ti bolniki zaradi nepravilnega delovanja beljakovine CFTR tudi visoke ravni kloridov v znoju.
English: For the full list of side effects and restrictions with Kalydeco, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Kalydeco glejte navodilo za uporabo.
English: Two of the studies involved 219 patients with cystic fibrosis who had the G551D mutation.
Slovenian: Dve študiji sta vključevali 219 bolnikov s cistično fibrozo, ki so imeli mutacijo G551D.
English: The two medicines are used in patients who have inherited the F508del mutation from both parents and therefore have the mutation in both copies of the CFTR gene.
Slovenian: Zdravili se uporabljata pri bolnikih, ki so mutacijo F508del podedovali od obeh staršev, zato je ta prisotna v obeh kopijah gena CFTR.
English: Another study investigated Kalydeco granules in 34 patients aged between 2 and 5 years of age who had cystic fibrosis due to a G551D or S549N mutation.
Slovenian: V še eni študiji so proučevali zrnca zdravila Kalydeco pri 34 bolnikih, starih od dveh do pet let, ki so imeli cistično fibrozo zaradi oblik mutacij G551D ali S549N.
English: The second study involved 248 patients with cystic fibrosis who have inherited the F508del mutation from one parent and who also have another CFTR mutation.
Slovenian: V drugo študijo je bilo vključenih 248 bolnikov s cistično fibrozo, ki so podedovali mutacijo F508del od enega starša in so imeli še eno mutacijo CFTR.
English: The fourth study involved 69 patients aged 6 years and above with cystic fibrosis who had the R117H mutation.
Slovenian: Četrta študija je vključevala 69 bolnikov s cistično fibrozo, starejših od šest let, ki so imeli mutacijo R117H.
English: Kalydeco is also used on its own to treat patients with cystic fibrosis aged 18 years and above who have the R117H mutation in the CFTR gene.
Slovenian: Zdravilo Kalydeco se samostojno uporablja tudi za zdravljenje bolnikov s cistično fibrozo, starejših od 18 let, ki imajo v genu CFTR mutacijo R117H.
English: How does Kalydeco work?
Slovenian: Kako zdravilo Kalydeco deluje?
English: The doses of Kalydeco may need to be adjusted if the patient is also taking a type of medicine called a ‘moderate or strong CYP3A inhibitor', such as certain antibiotics or medicines for fungal infections.
Slovenian: „zmeren ali močan zaviralec CYP3A“, kot so nekateri antibiotiki ali zdravila proti glivičnim okužbam.
English: The third study involved 39 patients over 6 years of age with cystic fibrosis due to several mutations other than G551D.
Slovenian: V tretjo študijo je bilo vključenih 39 bolnikov, starejših od šest let, s cistično fibrozo zaradi drugih oblik mutacij, ki niso mutacija G551D.
English: Similar results were seen in patients aged between 6 and 11 years, where Kalydeco treatment led to an improvement of 12.5 percentage points more than with placebo.
Slovenian: Podobni rezultati so bili opaženi pri bolnikih, starih od šest do 11 let, pri katerih se je zaradi zdravljenja z zdravilom Kalydeco vrednost FEV1 izboljšala za 12,5 odstotne točke več kot pri jemanju placeba.
English: They are also used in patients who have inherited the F508del mutation from one parent and also have one of the following mutations in CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, or 3849+10kbC→T.
Slovenian: Prav tako se uporabljata pri bolnikih, ki so mutacijo F508del podedovali od enega starša in imajo tudi eno od naslednjih mutacij 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 used on its own or together with tezacaftor / ivacaftor has been shown to improve lung function in patients with specific mutations.
Slovenian: Dokazano je bilo, da samostojna uporaba zdravila Kalydeco ali njegova uporaba v kombinaciji s tezakaftorjem in ivakaftorjem izboljšujeta delovanje pljuč pri bolnikih z določenimi mutacijami.
English: How is Kalydeco used?
Slovenian: Kako se zdravilo Kalydeco uporablja?
English: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H mutations
Slovenian: Mutacije G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H
English: Patients who took Kalydeco and tezacaftor / ivacaftor had an average increase in FEV1 of 6.5 percentage points compared with an increase of 4.4 percentage points in patients who took Kalydeco alone and a reduction of 0.3 percentage points in patients who took placebo.
Slovenian: Pri bolnikih, ki so jemali zdravilo Kalydeco v kombinaciji s tezakaftorjem in ivakaftorjem, se je vrednost FEV1 povprečno povečala za 6,5 odstotne točke, medtem ko se je pri bolnikih, ki so jemali samo zdravilo Kalydeco, povečala za 4,4 odstotne točke, pri bolnikih, ki so jemali placebo, pa zmanjšala za 0,3 odstotne točke.
English: Kalydeco can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Kalydeco je le na recept.
English: Kalydeco is also used together with another cystic fibrosis medicine containing the active substances tezacaftor and ivacaftor to treat patients with cystic fibrosis aged 12 years and above who have a mutation called F508del in the CFTR gene.
Slovenian: Zdravilo Kalydeco se uporablja tudi skupaj z drugim zdravilom za zdravljenje cistične fibroze, ki vsebuje učinkovini tezakaftor in ivakaftor, in sicer za zdravljenje bolnikov s cistično fibrozo, starejših od 12 let, ki imajo v genu CFTR mutacijo F508del.
English: However, when analysing the subset of patients aged 18 years and above alone, an average improvement of around 5.0 percentage points was seen in patients who took Kalydeco compared with patients who took placebo.
Slovenian: Kljub temu je bilo pri analizi samo podskupine bolnikov, starejših od 18 let, pri bolnikih, ki so jemali zdravilo Kalydeco, opaziti povprečno izboljšanje za približno 5,0 odstotne točke več kot pri tistih, ki so jemali placebo.
English: F508del mutation from both parents or F508del mutation from one parent and P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G or 3849+10kbC→T mutations
Slovenian: Mutacija F508del, podedovana od obeh staršev, ali mutacija F508del, podedovana od enega starša, in mutacije P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G ali 3849+10kbC→T
English: The mutations are: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N and S549R (also known as gating mutations).
Slovenian: Te oblike mutacij so: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N in S549R (znane kot mutacije spreminjanja prehodnosti kanalčkov celične membrane).
English: Kalydeco, taken with tezacaftor / ivacaftor, was compared with Kalydeco taken alone and with placebo.
Slovenian: Zdravilo Kalydeco v kombinaciji s tezakaftorjem in ivakaftorjem so primerjali z zdravilom Kalydeco kot samostojnim zdravilom in placebom.
English: Kalydeco, taken with tezacaftor / ivacaftor, was compared with placebo.
Slovenian: Zdravilo Kalydeco v kombinaciji s tezakaftorjem in ivakaftorjem so primerjali s placebom.
English: After 8 weeks of treatment patients who took Kalydeco had an average improvement of 10.7 percentage points more than those who took placebo.
Slovenian: Po osmih tednih zdravljenja se je vrednost FEV1 pri bolnikih, ki so jemali zdravilo Kalydeco, povprečno izboljšala za 10,7 odstotne točke več kot pri bolnikih, ki so jemali placebo.
English: Positive results have also been shown with Kalydeco granules in a study involving 19 children aged 1 to 2 years and 11 children aged 6 months to 1 year.
Slovenian: V študiji, v katero je bilo vključenih 19 otrok, starih od enega do dveh let, in 11 otrok, starih od šest mesecev do enega leta, so bili opaženi pozitivni rezultati pri uporabi zrnc zdravila Kalydeco.
English: After 24 weeks of treatment, patients aged 12 years and older who took Kalydeco had an average improvement in FEV1 of 10.6 percentage points more than those who took placebo.
Slovenian: Po 24 tednih zdravljenja se je vrednost FEV1 pri bolnikih, starih 12 let ali več, ki so jemali zdravilo Kalydeco, povprečno izboljšala za 10,6 odstotne točke več kot pri bolnikih, ki so jemali placebo.
English: No difference was seen between placebo and Kalydeco for children aged 6 years and above.
Slovenian: Pri otrocih, starejših od šest let, niso opazili razlike med jemanjem placeba in zdravila Kalydeco.
English: After 24 weeks of treatment, patients who took the medicines had an average increase in FEV1 of 3.4 percentage points compared with a reduction of 0.6 percentage points in patients who took placebo.
Slovenian: Po 24 tednih zdravljenja se je vrednost FEV1 pri bolnikih, ki so jemali zdravilo Kalydeco v kombinaciji s tezakaftorjem in ivakaftorjem, povprečno povečala za 3,4 odstotne točke, pri bolnikih, ki so jemali placebo, pa se je zmanjšala za 0,6 odstotne točke.
English: Kalydeco contains the active substance ivacaftor.
Slovenian: Zdravilo Kalydeco vsebuje učinkovino ivakaftor.
English: Kalydeco was shown to be effective at improving lung function in 4 main studies involving patients with cystic fibrosis who had various mutations.
Slovenian: V štirih glavnih študijah pri bolnikih s cistično fibrozo, ki so imeli različne mutacije, je bilo dokazano, da je zdravilo Kalydeco učinkovito pri izboljševanju delovanja pljuč.
English: Kalydeco taken together with tezacaftor / ivacaftor was shown to be effective at improving lung function in two main studies of patients with cystic fibrosis aged 12 years and above with the the F508del mutation.
Slovenian: V dveh glavnih študijah pri bolnikih s cistično fibrozo z mutacijo F508del, starejših od 12 let, se je pokazalo, da zdravilo Kalydeco v kombinaciji s tezakaftorjem in ivakaftorjem učinkovito izboljšuje delovanje pljuč.
English: Invented nameStrength Pharmaceutical Form Route of Administration
Slovenian: Izmišljeno ime Jakost
English: Information on how to do this has been included in the product information.
Slovenian: Informacije o tem, kako to storiti, so vključene v informacije o zdravilu.