FrancophonIA/ELRC3.0 huggingface dataset:
English: <The European Medicines Agency has waived the obligation to submit the results of studies with <{(Invented) Nname}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in all subsets of the paediatric population in {condition as per Ppaediatric Iinvestigation Pplan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Slovenian: <Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom {(izmišljeno) ime}> [ali za generična zdravila: <referenčno zdravilo, ki vsebuje {ime učinkovine(učinkovin)}>] za vse podskupine pediatrične populacije {pod pogoji, ki so za odobreno indikacijo zdravila navedeni v izvedbenem načrtu za pediatrično populacijo (PIP)} (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).>
English: 4.3 Contraindications <Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 <or {name of the residue(s)}>.>
Slovenian: 4.3 Kontraindikacije <Preobčutljivost na <učinkovino> <(učinkovineučinkovini> <učinkovine>(e)/-e) ali katero koli pomožno snov, navedeno v poglavju 6.1 <ali {imena ostankov topil}>.> 4.4 Posebna opozorila in previdnostni ukrepi <Sledljivost
English: <{tel}> <{fax}> <{e-mail}>
Slovenian: {Ime in naslov} <{tel.}> <{faks}> <{e-pošta}>
English: 6.6 Special precautions for disposal <and other handling> <Use in the paediatric population> <No special requirements <for disposal>.> <Any unused medicinal product or waste material should be disposed of in accordance with local requirements.>
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje <in ravnanje z zdravilom> <Uporaba pri pediatrični populaciji> <Ni posebnih zahtev <za odstranjevanje>.>
English: <The European Medicines Agency has deferred the obligation to submit the results of studies with <{(Invented) Nname}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in one or more subsets of the paediatric population in {condition, as per Ppaediatric Iinvestigation Pplan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Slovenian: <Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom {(izmišljeno) ime}> [ali za generična zdravila: <referenčno zdravilo, ki vsebuje {ime učinkovine(učinkovin)}>] za eno ali več podskupin pediatrične populacije {pod pogoji, ki so za odobreno indikacijo zdravila navedeni v izvedbenem načrtu za pediatrično populacijo (PIP)} (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).>
English: even if their signs of illness are the same as yours.> - If you get any side effects, talk to your <doctor> <,> <or> <pharmacist> <or nurse>.
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.> - Če opazite kateri koli neželeni učinek, se posvetujte <z>
 <zdravnikom><,> <ali>
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS> <Any unused medicinal product or waste material should be disposed of in accordance with local requirements.>
Slovenian: <Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.>
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER {Name and address}
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: <- This medicine has been prescribed for you only.
Slovenian: - <Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Danmark {Navn} <{Adresse} DK-0000 {by}>
Slovenian: Danmark {Navn} <{Adresse}
English: Do not <take> <use> X<:> - <if you are allergic to {active substance(s)} or any of the other ingredients of this medicine
Slovenian: Kaj morate vedeti, preden <boste vzeli> <boste uporabili> zdravilo X Ne <jemljite> <uporabljajte> zdravila X<:> - <če ste alergični na {učinkovino(-i/-e)} ali katero koli sestavino tega zdravila (navedeno v poglavju 6).>
English: <This medicinal product has been authorised under a so-called ‘conditional approval' scheme.
Slovenian: <Zdravilo je pridobilo tako imenovano „pogojno dovoljenje za promet“.
English: România {Nume} <{Adresă} {Oraş} {Cod poştal} - RO> Tel: + {Număr de telefon} <{e-mail}>
Slovenian: România {Nume} <{Adresă} {Oraş} {Cod poştal} - RO>
English: - If you have any further questions, ask your <doctor> <,> <or> <pharmacist> <or nurse>.
Slovenian: - Če imate dodatna vprašanja, se posvetujte <z>
 <zdravnikom><,> <ali> <farmacevtom> <ali medicinsko sestro>.
English: 5.2 Pharmacokinetic properties
Slovenian: 5.2 Farmakokinetične lastnosti <Absorpcija>
English: SK-000 00 {Mesto}> Tel: + {Telefónne číslo}
Slovenian: SK-000 00 {Mesto}> Tel: + {Telefónne číslo} <{e-mail}>
English: <Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.> <Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.> <Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:> <Environmental Rrisk Aassessment (ERA)>
Slovenian: <Neželeni učinki, ki jih v kliničnih študijah niso opaziliV kliničnih študijah niso opazili neželenih učinkov, opazili pa so jih v študijah na živalih pri stopnjah izpostavljenosti, ki so bile podobne stopnjam klinične izpostavljenosti in so morda pomembni za klinično uporabo, so.
English: <Medicinal product subject to medical prescription.> <Medicinal product not subject to medical prescription.> <Medicinal product subject to special medical prescription.> <Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).> <Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).>
Slovenian: <Predpisovanje in izdaja zdravila je le na recept.> <Izdaja zdravila je brez recepta.> <Predpisovanje in izdaja zdravila je le na posebni recept.> <Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).> <Predpisovanje in izdaja zdravila je le na poseben recept in le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).>
English: Other medicines and X <Tell your <doctor> <or> <pharmacist> if you are <taking> <using>, have recently <taken> <used> or might <take> <use> any other medicines.>
Slovenian: Druga zdravila in zdravilo X <Obvestite <zdravnika> <ali> <farmacevta>, če <jemljete> <uporabljate>, ste pred kratkim <jemali> <uporabljali> ali pa boste morda začeli <jemati> <uporabljati> katero koli drugo zdravilo.> Zdravilo X skupaj 
<z> <hrano> <in> <,> <pijačo> <in> <alkoholom> Nosečnost <in> <,> dojenje <in plodnost>
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION {(Invented) name strength pharmaceutical form} {Aactive substance(s)} {Route of administration}
Slovenian: IME ZDRAVILA IN POT(I) UPORABE {(Izmišljeno) ime jakost farmacevtska oblika} {učinkovina(-i/-e)} {pot uporabe}
English: NAME OF THE MARKETING AUTHORISATION HOLDER {Name}
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND>
Slovenian: A. <IZDELOVALPROIZVAJALEC (IZDELOVALPROIZVAJALCI) BIOLOŠKE
English: Tel: + {Numru tat-telefon} <{e-mail}>
Slovenian: Tel: + {Număr de telefon} <{e-mail}>
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.* [*For the printed material, please refer to the guidance of the annotated QRD template.]
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.*
English: X with <food> <and> <,> <drink> <and> <alcohol> Pregnancy <and> <,> breast-feeding <and fertility> <If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your <doctor> <or> <pharmacist> for advice before taking this medicine.> Driving and using machines <X contains {name the excipient(s)}>
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z <zdravnikom> <ali> <farmacevtom>, preden vzamete to zdravilo.> Vpliv na sposobnost upravljanja vozil in strojev <Zdravilo X vsebuje {ime pomožne(ih) snovi}>
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: What X contains - The active substance(s) is (are)… - The other <ingredient(s)> <(excipient(s))> is (are)...
Slovenian: - Učinkovina(-i/-e) je(sta/so) … - Druga(-i/-e) <sestavina(-i/-e) zdravila> <(pomožna(-i/-e) snov(-i))> je(sta/so)...
English: {(Invented) name strength pharmaceutical form} {Aactive substance(s)}
Slovenian: {(Izmišljeno) ime jakost farmacevtska oblika} {učinkovina(-i/-e)}
English: What you need to know before you <take> <use> X
Slovenian: Kaj je zdravilo X in za kaj ga uporabljamo Kaj morate vedeti, preden <boste vzeli> <boste uporabili> zdravilo X Kako <jemati> <uporabljati> zdravilo X Možni neželeni učinki
English: <{X} is contraindicated in children aged {x to y} <years> <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] <for the indication of...> (see section 4.3).> Method of administration <Precautions to be taken before handling or administering the medicinal product> <For instructions on <reconstitution> <dilution> of the medicinal product before administration, see section <6.6> <and> <12>.>
Slovenian: <Zdravilo {X} ni namenjeno za uporabo <pri pediatrični populaciji> <pri otrocih, starih {x do y} <let> <mesecev>, [ali drugi primerni skupini, npr. glede na telesno maso, dobo pubertete, spol] <za indikacijo...>.> <Zdravilo {X} je kontraindicirano pri otrocih, starih {x do y} <let> <mesecev>, [ali drugi primerni skupini, npr. glede na telesno maso, dobo pubertete, spol] <za indikacijo...> (glejte poglavje 4.3).>
English: NAME OF THE MEDICINAL PRODUCT {(Invented) name strength pharmaceutical form}
Slovenian: IME ZDRAVILA {(Izmišljeno) ime jakost farmacevtska oblika}
English: - You must talk to a doctor if you do not feel better or if you feel worse <after {number of}
Slovenian: - Če se znaki vaše bolezni poslabšajo ali ne izboljšajo <v {število} dneh>, se morate posvetovatiujte z zdravnikom.>
English: NAME OF THE MEDICINAL PRODUCT {(Invented) name strength pharmaceutical form} {Aactive substance(s)}
Slovenian: IME ZDRAVILA {(Izmišljeno) ime jakost farmacevtska oblika} {učinkovina(-i/-e)}
English: Hrvatska {Ime} <{Adresa} {Poštanski broj} {grad}> Tel: + {Telefonski broj} <{e-mail}>
Slovenian: Hrvatska {Ime} <{Adresa} {Poštanski broj} {grad}>
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu<, and on the website of {name of Member StateMS Agency (link)}>.
Slovenian: NAVODILA ZA PRIPRAVO RADIOFARMAKOV> <Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.> Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/<in na spletni strani {ime agencije v državi članici (povezava)}>.
English: <If you stop <taking> <using> X> <If you have any further questions on the use of this medicine, ask your <doctor> <,> <or> <pharmacist> <or nurse>.>
Slovenian: Če ste negotovi, se posvetujte <z>
 <zdravnikom> <ali> <farmacevtom>.> <Priporočeni odmerek je ...> <Pri <jemanju> <uporabi> tega zdravila natančno upoštevajte napotke v tem navodilu ali navodila <zdravnika> <,> <ali> <farmacevta> <ali medicinske sestre>.
English: 4.9 Overdose
Slovenian: 4.9 Preveliko odmerjanje <Pediatrična populacija>
English: • <Obligation to conduct post-authorisation measures> The MAH shall complete, within the stated timeframe, the below measures: Description
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
English: Warnings and precautions Talk to your doctor <or> <,> <pharmacist> <or nurse> before <taking> <using> X
Slovenian: Pred začetkom <jemanja> <uporabe> zdravila X se posvetujte <z> zdravnikom <ali><,> <farmacevtom> <ali medicinsko sestro>.
English: 4.4 Special warnings and precautions for use <Traceability
Slovenian: Opozorila in previdnostni ukrepi
English: <Always <take> <use> this medicine exactly as your doctor <or pharmacist> has told you.
Slovenian: Kako <jemati> <uporabljati> zdravilo X <Pri <jemanju> <uporabi> tega zdravila natančno upoštevajte navodila zdravnika <ali farmacevta>.
English: <The recommended dose is...>
Slovenian: Možen pomen za klinično uporabo je naslednji:>
English: 50 ampoules (multidose: 10 doses)
Slovenian: 50 ampul (večodmernih: 10 odmerkov)
English: 100 ampoules
Slovenian: 100 ampul
English: 28 May 2016
Slovenian: 28. maj 2016
English: March 2016 CMDh meeting
Slovenian: Zasedanje skupine CMDh marca 2016
English: Date of first authorisation: 31 October 2018
Slovenian: Datum prve odobritve: 31. oktober 2018
English: Your doctor will help you decide what is best for you and your child.
Slovenian: Zdravnik vam bo pomagal pri odločitvi, kaj je najboljše za vas in vašega otroka.
English: You may also notice that you do not get ill as often and/or that it is easier to gain weight.
Slovenian: Mogoče boste tudi opazili, da ne zbolite tako pogosto in/ali da se lažje zredite.
English: It is important to take this medicine regularly.
Slovenian: Pomembno je, da to zdravilo jemljete redno.
English: †Estimated event rate per year calculated using 48 weeks per year.
Slovenian: †Ocenjena pogostnost dogodkov na leto, izračunana z uporabo 48 tednov na leto.
English: #P value not statistically significant.
Slovenian: #Vrednost P statistično nesignifikantna.
English: As efficacy was a secondary objective for Study 3 there was no multiplicity adjustment.
Slovenian: Ker je bila v študiji 3 učinkovitost sekundaren cilj, ni bilo prilagoditve za večkratnost.
English: The potential relevance of these findings in humans is unknown.
Slovenian: Možen pomen teh ugotovitev za ljudi ni znan.
English: The recommended dose:
Slovenian: Priporočeni odmerek:
English: Just wait, and take your next tablet at the usual time.
Slovenian: Preprosto počakajte in vzemite naslednjo tableto ob običajnem času.
English: Your doctor may need to adjust your dose.
Slovenian: Mogoče vam bo zdravnik moral prilagoditi odmerek.
English: The next scheduled dose can be taken at the usual time.
Slovenian: Naslednji načrtovani odmerek lahko vzame ob običajnem času.
English: This is stamped with “V100”.
Slovenian: Ta ima vtisnjen napis “V100”.
English: Treatment of overdose consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Slovenian: Zdravljenje prevelikega odmerjanja predstavljajo splošni podporni ukrepi, vključno s spremljanjem vitalnih znakov in opazovanjem kliničnega stanja bolnika.
English: Take the tablets about 12 hours apart.
Slovenian: Tableti vzemite v presledku približno 12 ur.
English: If possible, take your medicine and this leaflet with you.
Slovenian: Če je le mogoče, vzemite zdravilo in to navodilo s seboj.
English: AUC0-24h or AUC0-12h
Slovenian: AUC0-24h ali AUC0-12h
English: You may start taking Symkevi on any day of the week.
Slovenian: Zdravilo Symkevi lahko začnete jemati kateri koli dan v tednu.
English: More than one dose of either tablet should not be taken at the same time.
Slovenian: Ni dovoljeno vzeti več kot en odmerek katere koli tablete ob istem času.
English: A91 P9KD
Slovenian: A91 P9KD Irska
English: Statistic
Slovenian: Statistika
English: • Do not take 2 tablets to make up for a missed dose.
Slovenian: • Ne vzemite 2 tablet, da bi nadomestili pozabljeni odmerek.
English: Tell your doctor straight away if you have any of these symptoms.
Slovenian: Nemudoma povejte zdravniku, če imate kakega od teh simptomov.
English: Meals or snacks that contain fat include those prepared with butter or oils or those containing eggs.
Slovenian: Obroki ali prigrizki, ki vsebujejo maščobe, so tisti, ki so pripravljeni z maslom ali olji, in tisti, ki vsebujejo jajca.
English: Assessments of transaminases (ALT or AST) are recommended for all patients prior to initiating treatment, every 3 months during the first year of treatment, and annually thereafter.
Slovenian: Meritve transaminaz (ALT ali AST) so priporočljive za vse bolnike pred uvedbo zdravljenja, vsake 3 mesece prvo leto zdravljenja, nato pa enkrat na leto.
English: • In the morning, take one yellow Symkevi tablet.
Slovenian: • Zjutraj vzemite eno rumeno tableto zdravila Symkevi.
English: • If more than 6 hours have passed, do not take the forgotten tablet.
Slovenian: • Če je preteklo že več kot 6 ur, ne vzemite pozabljene tablete.
English: • If you are allergic to tezacaftor, ivacaftor, or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na tezakaftor, ivakaftor ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Other medicinal products for which exposure may be increased include glimepiride and glipizide; these medicinal products should be used with caution.
Slovenian: Druga zdravila, pri katerih se utegne zvečati izpostavljenost, vključujejo glimepirid in glipizid; ta zdravila je treba previdno uporabljati.
English: If you have liver problems, either moderate or severe, your doctor may need to reduce the dose of your tablets, because your liver will not process the medicine as fast as usual.
Slovenian: Če imate težave z jetri, bodisi zmerne ali težke, vam bo zdravnik mogoče moral zmanjšati odmerek vaših tablet, ker vam jetra ne presnavljajo zdravila tako hitro, kot je običajno.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katera koli druga zdravila.
English: See the end of section 2 for important information about the contents of Symkevi.
Slovenian: Glejte konec poglavja 2 za pomembne podatke o vsebini zdravila Symkevi.
English: • Pregnancy: It may be better to avoid using this medicine during pregnancy.
Slovenian: • Nosečnost: Jemanju tega zdravila v nosečnosti se bi bilo bolje izogniti.
English: You may get side effects, including those mentioned in section 4 below.
Slovenian: Mogoče boste opazili neželene učinke, vključno s tistimi, ki so omenjeni v nadaljevanju v poglavju 4.
English: Your doctor will tell you how long you need to keep using Symkevi.
Slovenian: Zdravnik vam bo povedal, kako dolgo morate jemati zdravilo Symkevi.
English: You must keep using all your other medicines, unless your doctor tells you to stop.
Slovenian: Še naprej uporabljajte vsa druga zdravila, ki jih jemljete, razen če vam zdravnik naroči, da kako od njih prenehajte jemati.
English: • Talk to your doctor before starting treatment if you have received an organ transplant.
Slovenian: • Posvetujte se z zdravnikom, preden začnete z zdravljenjem, če ste imeli presaditev organa.
English: These may be a sign of liver problems:
Slovenian: Tole so lahko znaki težav z jetri:
English: Patients experiencing dizziness should be advised not to drive or use machines until symptoms abate.
Slovenian: Bolnikom, pri katerih se pojavi omotica, je treba svetovati, naj ne vozijo in upravljajo strojev, dokler simptomi ne izzvenijo.
English: Possible signs of liver problems
Slovenian: Možni znaki težav z jetri
English: Your doctor will consider the benefit of breast-feeding for the child and the benefit of treatment for you to help you decide whether to stop breast-feeding or to stop treatment.
Slovenian: Zdravnik bo pretehtal prednosti dojenja za otroka in prednosti zdravljenja za vas in vam pomagal, da se boste odločili, ali boste prenehali dojiti ali se boste prenehali zdraviti.
English: The magnitude of increase in exposure in these patients is unknown but is expected to be higher than that observed in patients with moderate hepatic impairment.
Slovenian: Velikost zvečanja izpostavljenosti pri teh bolnikih ni znana, pričakujemo pa, da bo večja kot tista, ki so jo ugotovili pri bolnikih z zmernimi okvarami jeter.
English: If you feel dizzy, do not drive, cycle or use machines unless you are not affected.
Slovenian: Če ste omotični, ne vozite, ne kolesarite in ne upravljajte strojev, razen če nimate težav.
English: Talk to your doctor, without taking the tablets, if this applies to you.
Slovenian: Posvetujte se z zdravnikom, še preden vzamete tablete, če to velja za vas.
English: ECG evaluation
Slovenian: Vrednotenje EKG
English: Less than 1% of the administered dose was excreted in urine as unchanged tezacaftor, showing that renal excretion is not the major pathway of tezacaftor elimination in humans.
Slovenian: Manj kot 1 % danega odmerka se je izločilo v urinu kot nespremenjeni tezakaftor, kar kaže, da izločanje skozi ledvice ni poglavitna pot izločanja tezakaftorja pri ljudeh.
English: • Ringing in the ears
Slovenian: • zvonjenje v ušesih,
English: • Pain or discomfort in the upper right area of the stomach (abdominal) area
Slovenian: • bolečina ali neugodje v zgornjem desnem predelu trebuha (abdomna),
English: There are no known risks due to overdose with Symkevi and there is no specific antidote available in the event of overdose.
Slovenian: Ni znanih tveganj zaradi prevelikega odmerka zdravila Symkevi in v primeru prevelikega odmerjanja ni na voljo specifičnega antidota.
English: See section 4.5 for interactions with ciclosporin or tacrolimus.
Slovenian: Glejte poglavje 4.5 za medsebojno delovanje s ciklosporinom in takrolimusom.
English: What Symkevi is and what it is used for 2.
Slovenian: Kaj je zdravilo Symkevi in za kaj ga uporabljamo 2.
English: What you need to know before you take Symkevi 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Symkevi 3.
English: • Cheese, whole milk, whole milk dairy products, yogurt, chocolate
Slovenian: • sir, neposneto mleko, mlečni izdelki iz neposnetega mleka, jogurt, čokolada;
English: Tezacaftor had no effects on fertility and reproductive performance indices in male and female rats at doses up to 100 mg/kg/day.
Slovenian: Tezakaftor ne vpliva na indekse plodnosti in reproduktivne uspešnosti pri samcih in samicah podgan v odmerkih do 100 mg/kg/dan.
English: Symkevi with food and drink
Slovenian: Zdravilo Symkevi skupaj s hrano in pijačo
English: Symkevi should only be prescribed by physicians with experience in the treatment of CF.
Slovenian: Zdravilo Symkevi naj predpisujejo le zdravniki, ki imajo izkušnje z zdravljenjem CF.
English: The tablets are for oral use.
Slovenian: Tablete so za peroralno uporabo.
English: Pharmacotherapeutic group: Other respiratory system products; ATC code: R07AX31
Slovenian: Farmakoterapevtska skupina: Druga zdravila za bolezni dihal; oznaka ATC: R07AX31.
English: • If you forget to take either your morning Symkevi or evening ivacaftor tablet, and you remember within 6 hours of the scheduled time you should have taken the tablet, take the forgotten tablet at once.
Slovenian: • Če pozabite vzeti bodisi jutranjo tableto zdravila Symkevi ali večerno tableto ivakaftorja in se tega spomnite v šestih urah po tistem, ko jo navadno vzamete, ali še prej, takoj vzemite pozabljeno tableto.
English: One patient (0.2%) on therapy and two patients (0.4%) on placebo permanently discontinued treatment for elevated transaminases.
Slovenian: En zdravljen bolnik (0,2 %) in dva bolnika (0,4 %) na placebu so zaradi zvišanih transaminaz trajno prenehali z zdravljenjem.
English: *Indicates statistical significance confirmed in the hierarchical testing procedure.
Slovenian: *Kaže, da je bila statistična signifikanca potrjena s hierarhičnim postopkom testiranja.