natgillin/translations-raw huggingface dataset:
The blister pack should be returned into the carton immediately after use and the carton should be stored out of the sight and reach of children. 
Preostale blistre je treba takoj po dajanju vrniti v škatlo; škatlo pa shranjevati nedosegljivo otrokom.
The veterinary medicinal product has immediate and persistent tick killing activity for at least 5 weeks. 
To zdravilo za uporabo v veterinarski medicini ima takojšnjo in trajno aktivnost ubijanja klopov najmanj 5 tednov.
The blister pack should then be returned into the carton immediately after use and the carton should be stored out of the sight and reach of children. 
Preostale pretisne omote je treba takoj po dajanju vrniti v škatlo, škatlo pa shranjevati nedosegljivo otrokom.
For the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus). 
Zdravljenje infestacij s klopi (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus in
MiPet Easecto 5 mg chewable tablets for dogs 1.3-2.5 kg MiPet Easecto 10 mg chewable tablets for dogs >2.5-5 kg MiPet Easecto 20 mg chewable tablets for dogs >5-10 kg MiPet Easecto 40 mg chewable tablets for dogs >10-20 kg MiPet Easecto 80 mg chewable tablets for dogs >20-40 kg MiPet Easecto 120 mg chewable tablets for dogs >40-60 kg 
MiPet Easecto 5 mg žvečljive tablete za pse 1,3 - 2,5 kg MiPet Easecto 10 mg žvečljive tablete za pse >2,5-5 kg MiPet Easecto 20 mg žvečljive tablete za pse >5-10 kg MiPet Easecto 40 mg žvečljive tablete za pse >10-20 kg MiPet Easecto 80 mg žvečljive tablete za pse >20-40 kg MiPet Easecto 120 mg žvečljive tablete za pse >40-60 kg
MiPet Easecto 5 mg chewable tablets for dogs 1.3-2.5 kg MiPet Easecto 10 mg chewable tablets for dogs >2.5-5 kg MiPet Easecto 20 mg chewable tablets for dogs >5-10 kg MiPet Easecto 40 mg chewable tablets for dogs >10-20 kg MiPet Easecto 80 mg chewable tablets for dogs >20-40 kg MiPet Easecto 120 mg chewable tablets for dogs >40-60 kg sarolaner 
MiPet Easecto 5 mg žvečljive tablete za pse 1,3 - 2,5 kg MiPet Easecto 10 mg žvečljive tablete za pse >2,5-5 kg MiPet Easecto 20 mg žvečljive tablete za pse >5-10 kg MiPet Easecto 40 mg žvečljive tablete za pse >10-20 kg MiPet Easecto 80 mg žvečljive tablete za pse >20-40 kg MiPet Easecto 120 mg žvečljive tablete za pse >40-60 kg sarolaner
for dogs 1.3-2.5 kg for dogs >2.5-5 kg for dogs >5-10 kg for dogs >10-20 kg for dogs >20-40 kg for dogs >40-60 kg 
za pse 1,3-2,5 kg za pse >2,5-5 kg za pse >5-10 kg za pse >10-20 kg za pse >20-40 kg za pse >40-60 kg
4.7 Use during pregnancy, lactation or lay 
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Varnost zdravila v obdobju brejosti, laktacije in pri psih za vzrejo ni bila ugotovljena.
Glucose, liquid (81.5% solids) Spray dried pork liver powder Hydrolysed vegetable protein Gelatin type A 
6.1 Seznam pomožnih snovi hipromeloza acetat sukcinat, srednje stopnje laktoza monohidrat natrijev karboksimetilškrob silicijev dioksic, koloidni, brezvodni magnezijev stearat koruzni škrob saharoza glukoza, tekoča (81,5 % trdne snovi) aroma svinjskih jeter hidrolizirani rastlinski protein želatina tip A pšenični kalčki kalcijev hidrogenfosfat, brezvodni
Calcium hydrogen phosphate anhydrous 
Rhipicephalus sanguineus).
Confectioner's sugar 
PODATKI NA ZUNANJI OVOJNINI
Ref. EMEA/CHMP/384876/2008 
EMEA/CHMP/674499/2008
London, 02 December 2008 Doc. 
London, 2. decembra 2008 Sklic na dok.
Efexor depot, 37.5 mg, 75 mg, 150 mg, hard prolonged-release capsules, is an antidepressant, indicated for the treatment of major depressive episodes, for the prevention of recurrence of major depressive episodes, for the treatment of social anxiety disorder, panic disorders with or without agoraphobia, and generalized anxiety disorder. 
Zdravilo Efexor depot, 37,5 mg, 75 mg, 150 mg, trde kapsule s podaljšanim sproščanjem, je antidepresiv, namenjen za zdravljenje hudih epizod depresije, za preprečevanje njihovega ponovnega pojava, zdravljenje socialnih anksioznih motenj, paničnih motenj z agorafobijo ali brez nje in generaliziranih anksioznih motenj.
On 3 May 2007, the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Efexor depot. 
Komisija je dne 3. maja 2007 agenciji EMEA predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, da bi uskladila na nacionalni ravni odobrene povzetke glavnih značilnosti zdravila (SPC), označevanja in navodila za uporabo zdravila Efexor depot.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Efexor depot approved across EU Member States, with respect to the treatment of major depressive episodes, the prevention of recurrence of major depressive episodes, the treatment of social anxiety disorder, panic disorders with or without agoraphobia, and generalized anxiety disorder. 
Podlaga za napotitev so bila razhajanja med povzetki glavnih značilnosti zdravila (SPC) Efexor depot, ki so bili odobreni v državah članicah EU v zvezi z zdravljenjem hudih epizod depresije, preprečevanjem njihovega ponovnega pojava, zdravljenjem socialnih anksioznih motenj, paničnih motenj z agorafobijo ali brez nje in generaliziranih anksioznih motenj.
The CHMP gave a positive opinion on 24 July 2008 with a subsequent revision on 25 September 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Efexor depot. 
CHMP je dne 24. julija 2008 izdal pozitivno mnenje, temu pa je dne 25. septembra 2008 sledila revizija, na podlagi katere se priporoča 2008 uskladitev povzetkov glavnih značilnosti zdravila (SPC), označevanj in navodil za uporabo zdravila Efexor depot.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Efexor depot and associated names International Non-Proprietary Name (INN): venlafaxine 
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA ZDRAVILO Efexor depot in z njim povezana imena
Further information on Ziextenzo can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo. 
Več informacij o zdravilu Ziextenzo je na voljo na spletni strani agencije: https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo.
What measures are being taken to ensure the safe and effective use of Ziextenzo? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ziextenzo?
This means that Ziextenzo is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU. 
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
An overview of Ziextenzo and why it is authorised in the EU 
Pregled zdravila Ziextenzo in zakaj je odobreno v EU
What benefits of Ziextenzo have been shown in studies? 
Kakšne koristi zdravila Ziextenzo so se pokazale v študijah?
What is Ziextenzo and what is it used for? 
Kaj je zdravilo Ziextenzo in za kaj se uporablja?
The most common side effect with Ziextenzo (which may affect more than 1 in 10 people) is pain in the bones. 
Najpogostejši neželeni učinek zdravila Ziextenzo (ki se lahko pojavi pri več kot 1 bolniku od 10) je bolečina v kosteh.
Why is Ziextenzo authorised in the EU? 
Zakaj je bilo zdravilo Ziextenzo odobreno v EU?
As for all medicines, data on the use of Ziextenzo are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ziextenzo stalno spremljajo.
Side effects reported with Ziextenzo are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Ziextenzo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Other information about Ziextenzo 
Druge informacije o zdravilu Ziextenzo
Ziextenzo can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders. 
Predpisovanje in izdaja zdravila Ziextenzo je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem rakavih obolenj ali krvnih bolezni.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ziextenzo have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ziextenzo upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What are the risks associated with Ziextenzo? 
Kakšna tveganja so povezana z zdravilom Ziextenzo?
Ziextenzo is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines). 
Zdravilo Ziextenzo se daje v obliki enkratnega 6-miligramskega odmerka, ki se injicira pod kožo vsaj 24 ur po koncu vsakega ciklusa kemoterapije (zdravljenja z zdravili proti raku).
For more information about using Ziextenzo, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Ziextenzo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The reference medicine for Ziextenzo is Neulasta. 
Referenčno zdravilo za zdravilo Ziextenzo je zdravilo Neulasta.
The active substance in Ziextenzo, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF). 
Učinkovina zdravila Ziextenzo, pegfilgrastim, je oblika filgrastima, ki je zelo podoben človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G-CSF).
All these data were considered sufficient to conclude that Ziextenzo will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses. 
Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Ziextenzo pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Neulasta.
The safety of Ziextenzo has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta. 
Varnost zdravila Ziextenzo je bila ocenjena in na podlagi vseh izvedenih študij so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila Neulasta.
Because Ziextenzo is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Ziextenzo. 
Zdravilo Ziextenzo je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti pegfilgrastima, izvedenih z zdravilom Neulasta, z zdravilom Ziextenzo ni treba ponavljati.
In addition, two studies involving 624 patients who had chemotherapy before or after surgery for breast cancer showed that Ziextenzo was as effective as Neulasta in reducing the duration of neutropenia. 
Poleg tega so v dveh študijah, ki sta vključevali 624 bolnic, ki so se s kemoterapijo zdravile pred kirurškim posegom zaradi raka dojk ali po njem, dokazali, da je zdravilo Ziextenzo pri skrajševanju trajanja nevtropenije enako učinkovito kot zdravilo Neulasta.
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. 
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.
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). 
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).
For the full list of side effects and restrictions with Ziextenzo, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Ziextenzo glejte navodilo za uporabo.
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. 
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.
How does Ziextenzo work? 
Kako zdravilo Ziextenzo deluje?
Ziextenzo is a ‘biosimilar medicine'. 
Zdravilo Ziextenzo je „podobno biološko zdravilo“.
In Ziextenzo, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol). 
V zdravilu Ziextenzo je filgrastim „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
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. 
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.
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. 
Agencija je menila, da koristi zdravila Ziextenzo enako kot pri zdravilu Neulasta odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
How is Ziextenzo used? 
Kako se zdravilo Ziextenzo uporablja?
Studies have also shown that giving Ziextenzo produces similar levels of the active substance in the body to giving Neulasta. 
Študije so pokazale tudi, da zdravilo Ziextenzo vzpostavi podobne ravni učinkovine v telesu kot zdravilo Neulasta.
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. 
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.
The medicine was also shown to have an acceptable safety profile. 
Poleg tega je bilo ugotovljeno, da ima zdravilo sprejemljiv varnostni profil.
Lung function was measured after 4 weeks and 8 weeks of treatment. 
Delovanje pljuč je bilo izmerjeno po štirih in osmih tednih zdravljenja.
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. 
Opozorila je tudi, da so o dolgoročnih učinkih zdravila na voljo le omejeni podatki in da mora podjetje priskrbeti dodatne informacije.
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. 
FEV1 je največja količina zraka, ki jo lahko oseba izdihne v eni sekundi, in je merilo delovanja pljuč.
What measures are being taken to ensure the safe and effective use of Kalydeco? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kalydeco?
Kalydeco received a marketing authorisation valid throughout the EU on 23 July 2012. 
Za zdravilo Kalydeco je bilo 23. julija 2012 izdano dovoljenje za promet, veljavno po vsej EU.
Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu308556. 
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/en/medicines/human/orphan-designations/eu308556.
They should be mixed with 5 ml of soft food or liquid to make a suspension to be taken by mouth. 
Treba jih je zmešati s 5 ml tekoče hrane ali tekočine, da se pripravi suspenzija, ki jo je treba vzeti peroralno.
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. 
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.
Further information on Kalydeco can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/kalydeco. 
Nadaljnje informacije za zdravilo Kalydeco so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/kalydeco.
One of the studies was in patients aged over 12 years, while the other was in patients aged between 6 and 11 years. 
Ena od študij je bila izvedena pri bolnikih, starejših od 12 let, medtem ko je druga vključevala bolnike, stare od šest do 11 let.
As for all medicines, data on the use of Kalydeco are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Kalydeco stalno spremljajo.
Other information about Kalydeco 
Druge informacije o zdravilu Kalydeco
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. 
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.
Kalydeco is available as tablets (150 mg) and as granules (25, 50, and 75 mg) in a sachet. 
Zdravilo Kalydeco je na voljo v obliki tablet (150 mg) in zrnc (25 mg, 50 mg in 75 mg) v vrečicah.
What is Kalydeco and what is it used for? 
Kaj je zdravilo Kalydeco in za kaj se uporablja?
Why is Kalydeco authorised in the EU? 
Zakaj je bilo zdravilo Kalydeco odobreno v EU?
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. 
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.
What benefits of Kalydeco have been shown in studies? 
Kakšne koristi zdravila Kalydeco so se pokazale v študijah?
An overview of Kalydeco and why is it authorised in the EU 
Pregled zdravila Kalydeco in zakaj je odobreno v EU
The mutations reduce the number of CFTR proteins on the cell surface or affect the way the protein works. 
Mutacije zmanjšujejo število beljakovin CFTR na celični površini ali pa vplivajo na način delovanja beljakovine.
Side effects reported with Kalydeco are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Kalydeco, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
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. 
Predpiše ga lahko samo zdravnik, ki ima izkušnje z zdravljenjem cistične fibroze, in sicer samo bolnikom, ki imajo potrjene zgoraj navedene mutacije.
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. 
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.
This makes mucus and digestive juices less thick, thereby helping to relieve symptoms of the disease. 
Tako se sluz in prebavni sokovi razredčijo, kar ublaži simptome bolezni.
Cystic fibrosis is rare, and Kalydeco was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 July 2008. 
Cistična fibroza je redka bolezen, zato je bilo zdravilo Kalydeco 8. julija 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
The tablets are used in adults and children aged 6 years and above and weighing 25 kg or more. 
Tablete se uporabljajo pri odraslih in otrocih, starejših od šest let, s telesno maso 25 kg ali več.
What are the risks associated with Kalydeco? 
Kakšna tveganja so povezana z zdravilom Kalydeco?
For more information about using Kalydeco, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Kalydeco glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Serious side effects include abdominal pain and increased liver enzymes. 
Resni neželeni učinki vključujejo bolečine v trebuhu in zvišane vrednosti jetrnih encimov.
For infants and children aged 6 months and above and weighing 5 to 25 kg, the granules should be used. 
Pri otrocih, starih šest mesecev ali več, s telesno maso od 5 kg do 25 kg je treba uporabiti zrnca.
The main measure of effectiveness was based on improvement in patients' FEV1. 
Glavno merilo učinkovitosti je bilo izboljšanje bolnikove vrednosti FEV1.
The study found that Kalydeco granules resulted in increased bodyweight and a decreased amount of chloride contained in sweat. 
Ugotovili so, da je jemanje zrnc zdravila Kalydeco privedlo do višje telesne mase in manjše količine kloridov v znoju.
Cystic fibrosis affects the cells that produce mucus and digestive juices. 
Cistična fibroza prizadene celice, ki proizvajajo sluz in prebavne sokove.
The doses may also need to be adjusted in patients with reduced liver function. 
Prav tako je treba odmerke včasih zmanjšati pri bolnikih z okvaro jeter.
The dose and frequency depends on whether Kalydeco is used alone or together with tezacaftor / ivacaftor. 
Odmerek in pogostnost jemanja zdravila Kalydeco sta odvisna od tega, ali se zdravilo jemlje samostojno ali skupaj s tezakaftorjem in ivakaftorjem.
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. 
Kalydeco je zdravilo, ki se uporablja za zdravljenje cistične fibroze, tj. dedne bolezni, ki ima resne učinke na pljuča, prebavila in druge organe.
The main measure of effectiveness in these studies was based on improvements in patients' FEV1. 
V teh študijah je bilo glavno merilo učinkovitosti izboljšanje bolnikove vrednosti FEV1.
In the studies, Kalydeco was compared with placebo (a dummy treatment). 
V teh študijah so zdravilo Kalydeco primerjali s placebom (zdravilom brez učinkovine).
The active substance in Kalydeco, ivacaftor, increases the activity of the defective CFTR protein. 
Učinkovina v zdravilu Kalydeco, ivakaftor, povečuje delovanje okvarjene beljakovine CFTR.
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). 
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).