FrancophonIA/ELRC3.0 huggingface dataset:
English: Eligibility criteria permitted enrolment of patients with a documented ALK rearrangement based on a validated test, ECOG Performance Status of 0-2, and prior chemotherapy.
Slovenian: Vključitveni kriteriji so dopuščali vključevanje bolnikov z dokumentirano preureditvijo ALK na podlagi validiranega testa, stanja zmogljivost ECOG 0-2 in predhodne kemoterapije.
English: Grade 4 hypertension (life threatening consequences, urgent intervention indicated)
Slovenian: Hipertenzija stopnje 4 (z življenjsko ogrožajočimi posledicami, potrebno je bilo nujno posredovanje)
English: The median time to onset for CPK elevations was 27 days.
Slovenian: Mediani čas za pojav zvišanja CPK je bil 27 dni.
English: Alunbrig has not been studied in children or adolescents.
Slovenian: Zdravilo Alunbrig ni bilo raziskano pri otrocih ali mladostnikih.
English: Treatment with Alunbrig is not recommended in persons under 18 years of age.
Slovenian: Zdravljenje z zdravilom Alunbrig ni priporočljivo pri osebah, mlajših od 18 let.
English: Alunbrig has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Alunbrig ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: • reduced number of red blood cells (anaemia)
Slovenian: • zmanjšano število rdečih krvnih celic (anemija)
English: In the event of an overdose, monitor the patient for adverse reactions (see section 4.8) and provide appropriate supportive care.
Slovenian: V primeru prevelikega odmerka spremljajte bolnika zaradi neželenih učinkov (glejte poglavje 4.8) in zagotovite ustrezno podporno oskrbo.
English: The MAH shall ensure that in each Member State where Alunbrig is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use Alunbrig have access to/are provided with the following educational package:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer je zdravilo Alunbrig na trgu, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali oz. uporabljali zdravilo Alunbrig, imeli dostop/prejeli naslednje izobraževalno gradivo:
English: Efficacy results from ALTA analysis are summarised in Table 4. and the Kaplan-Meier (KM) curve for investigator-assessed PFS is shown in Figure 1.
Slovenian: Rezultati učinkovitosti iz analize ALTA so povzeti v preglednici 4 in krivulja Kaplan Meier (KM) za preiskovano ocenjeno PFS je prikazana na sliki 1.
English: The limited data on the safety and efficacy of Alunbrig in patients aged 65 years and older suggest that a dose adjustment is not required in elderly patients (see section 4.8).
Slovenian: Omejeni podatki o varnosti in učinkovitosti zdravila Alunbrig pri bolnikih, starih 65 let ali več, kažejo, da prilagoditev odmerka pri starejših bolnikih ni potrebna (glejte poglavje 4.8).
English: The incidence of Grade 3-4 elevations of CPK was 13.6%.
Slovenian: Pojav zvišanja CPK na stopnjo 3-4 je bil 13,6%.
English: What Alunbrig is and what it is used for
Slovenian: Kaj je zdravilo Alunbrig in za kaj ga uporabljamo
English: (27.7, NE)
Slovenian: (27,7; NO)
English: Ask your doctor about the birth control methods that may be right for you.
Slovenian: Posvetujte se s svojim zdravnikom o metodah kontracepcije, ki so za vas ustrezne.
English: The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity) and not a clastogenic effect on chromosomes.
Slovenian: Mehanizem indukcije mikronukleusov je bila nenormalna segregacija kromosoma (anevgenost) in ne klastogeni učinek na kromosome.
English: • pain in arms and legs
Slovenian: • bolečine v rokah in nogah
English: Patients should be advised to report any visual symptoms.
Slovenian: Bolnikom je treba svetovati, naj poročajo o kakršnih koli simptomih motenj vida.
English: Alunbrig with food and drink
Slovenian: Zdravilo Alunbrig skupaj s hrano in pijačo
English: Increased age and shorter interval (less than 7 days) between the last dose of crizotinib and the first dose of Alunbrig were independently associated with an increased rate of these pulmonary adverse reactions.
Slovenian: Višja starost in kratek interval (manj kot 7 dni) med zadnjim odmerkom krizotiniba in prvim odmerkom zdravila Alunbrig sta bila neodvisno povezana s povečano stopnjo teh neželenih učinkov na pljuča.
English: (peripheral neuropathy)
Slovenian: (periferna nevropatija)
English: (18.2, NE)
Slovenian: (18,2; NO)
English: The median duration of peripheral neuropathy adverse reactions was 4.5 months, with a maximum duration of 28.7 months.
Slovenian: Mediano trajanje neželenih učinkov povezanih s periferno nevropatijo je bilo 4,5 meseca, največ 28,7 meseca.
English: Grade 3 hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg, medical intervention indicated, more than one anti-hypertensive medicinal product, or more intensive therapy than previously used indicated)
Slovenian: Hipertenzija stopnje 3 (SBP ≥160 mmHg ali DBP ≥100 mmHg, potreben je bil medicinski poseg, več kot eno antihipertenzivno zdravilo ali bolj intenzivno zdravljenje, kot je bilo že ustaljeno)
English: The most common sites of extra-thoracic metastasis included 69% brain (of whom 62% had received prior radiation to the brain), 39% bone, and 26% liver.
Slovenian: Najpogostejša mesta ekstratorakalnih metastaz so vključevala 69% možganov (od katerih jih je 62% predhono opravilo obsevanje možganov), 39% kosti in 26% jeter.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporaba tega zdravila posvetujte s svojim zdravnikom.
English: Do not crush or dissolve the tablets.
Slovenian: Tablete ne smete zdrobiti ali raztopiti.
English: Alunbrig may also induce other enzymes and transporters (e.g., CYP2C, P-gp) via the same mechanisms responsible for induction of CYP3A (e.g., pregnane X receptor activation).
Slovenian: Zdravilo Alunbrig lahko inducira tudi druge encime in transporte (npr. CYP2C, P-gp) preko enakih mehanizmov, ki so odgovorni za indukcijo CYP3A (npr. aktivacija pregnanskega X receptorja).
English: Intracranial disease control rate
Slovenian: Stopnja kontrole intrakranialne bolezni
English: Of these, three Grade 3 adverse reactions (2.7%) including macular oedema and cataract were reported.
Slovenian: Od tega so poročali o neželenih učinkih stopnje 3 (2,7%), vključno z makularnim edemom in katarakto.
English: • The active substance is brigatinib.
Slovenian: • Učinkovina je brigatinib.
English: Treatment with Alunbrig should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Slovenian: Zdravljenje z zdravilom Alunbrig mora uvesti in nadzorovati zdravnik z izkušnjami pri uporabi zdravil za zdravljenje raka.
English: • change in sense of taste
Slovenian: • sprememba okusa
English: • If you vomit after taking Alunbrig, do not take any more tablets until your next scheduled dose.
Slovenian: • Če po zaužitju zdravila Alunbrig bruhate, ne vzemite dodatnih tablet do naslednjega načrtovanega odmerka.
English: reduce to 60 mg once daily permanently discontinue not applicable
Slovenian: zmanjšanje na 60 mg enkrat na dan trajno prenehanje navedba smiselno ni potrebna
English: Adverse reactions reported in ALTA and Study 101 at the recommended dosing regimen are presented in Table 3 and are listed by system organ class, preferred term and frequency.
Slovenian: Neželeni učinki, o katerih so poročali v študiji ALTA in študiji 101 pri priporočenem režimu odmerjanja, so predstavljeni v preglednici 3 in so navedeni glede na organske sisteme, prednostne izraze in pogostnost.
English: After a single dose and at steady state, systemic exposure was dose proportional over the dose range of 60-240 mg once daily.
Slovenian: Po enkratnem odmerku in v stanju dinamičnega ravnovesja je bila sistemska izpostavljenost sorazmerna odmerku v razponu odmerkov 60-240 mg enkrat na dan.
English: Study 101: An open-label multicentre phase 1/2 dose escalation/expansion trial in patients with advanced malignancies.
Slovenian: Študija 101: Multicentrično, odprto preskušanje stopnjevanja/razširjanja odmerka faze 1/2 pri bolnikih z napredovalimi malignimi boleznimi.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale toksičnost za sposobnost razmnoževanja (glejte poglavje 5.3).
English: Median (months) 95% CI
Slovenian: Povprečno (mesecev) 95% IZ
English: Unchanged brigatinib was the major circulating radioactive component (92%) along with AP26123 (3.5%), the primary metabolite also observed in vitro.
Slovenian: Nespremenjeni brigatinib je bil glavna krožeča radioaktivna komponenta (92%) skupaj z AP26123 (3,5%), primarnim presnovkom, ki je bil opažen tudi in vitro.
English: • symptoms such as numbness, tingling, prickling sensation, weakness or pain in hands or feet
Slovenian: • simptomi, kot so odrevenelost, mravljinčenje, zbadanje, šibkost ali bolečina v rokah ali nogah
English: Macrogol Polyvinyl alcohol Titanium dioxide
Slovenian: Obloga tablete smukec makrogol polivinilalkohol titanov dioksid
English: • reduced number of white blood cells, called neutrophils and lymphocytes, in blood tests
Slovenian: • zmanjšano število belih krvnih celic, imenovanih nevtrofilci in limfociti, pri preiskavah krvi
English: Adverse reactions† all grades
Slovenian: Neželeni učinki† vse stopnje
English: • carbamazepine: a medicine to treat epilepsy, euphoric/depressive episodes and certain pain conditions
Slovenian: • karbamazepin: zdravilo za zdravljenje epilepsije, evforične/depresivne epizode in nekaterih bolečinskih stanj
English: Early pulmonary adverse reactions also occurred in a dose escalation study in patients (N = 137) (Study 101) including three fatal cases (hypoxia, acute respiratory distress syndrome and pneumonia).
Slovenian: Zgodnji neželeni učinki na pljuča so se prav tako pojavili v študiji stopnjevanja odmerka pri bolnikih (N = 137) (študija 101), vključno s tremi smrtnimi primeri (hipoksija, sindrom akutne respiratorne stiske in pljučnica).
English: The effect of gemfibrozil on the pharmacokinetics of brigatinib is not clinically meaningful and the underlying mechanism for the decreased exposure of brigatinib is unknown.
Slovenian: Učinek gemfibrozila na farmakokinetiko brigatiniba ni klinično pomemben in osnovni mehanizem za zmanjšano izpostavljenost brigatinibu ni znan.
English: Dose reduction levels First
Slovenian: Ravni zmanjšanja odmerka prvič drugič tretjič
English: • abnormal electrical activity of the heart (prolonged electrocardiogram QT interval)
Slovenian: • nenormalna električna aktivnost srca (podaljšan interval QT na elektrokardiogramu)
English: bpm = beats per minute; CPK = Creatine Phosphokinase; DBP = diastolic blood pressure; HR = heart rate; SBP = systolic blood pressure; ULN = upper limit of normal *Graded per National Cancer Institute Common Terminology Criteria for Adverse Events.
Slovenian: CPK = kreatin fosfokinaza; DBP = diastolični krvni tlak; HR = srčni utrip; SBP = sistolični krvni tlak; ULN = zgornja meja normalne vrednosti *Razvrščeni po nacionalnem kriteriju nacionalnega inštituta za rak za neželene učinke.
English: This effect was observed at approximately five fold the human exposure at the 180 mg once daily dose.
Slovenian: Ta učinek so opazili pri približno petkratni izpostavljenosti človeka pri odmerku 180 mg enkrat na dan.
English: Given that brigatinib exhibits high solubility and high permeability, inhibition of P-gp and BCRP is not expected to result in a clinically meaningful change in the systemic exposure of brigatinib.
Slovenian: Glede na to da brigatinib izkazuje visoko topnost in visoko prepusnost, ne pričakujemo, da bi inhibicija P-gp in BCRP povzročila klinično pomembno spremembo sistemske izpostavljenosti brigatinibu.
English: The abnormal gene produces a protein known as a kinase that stimulates the growth of the cancer cells.
Slovenian: Nenormalni gen proizvaja protein, ki se imenuje kinaza in spodbuja rast rakavih celic.
English: Baseline demographics and disease characteristics in ALTA were median age 54 years old (range 18 to 82; 23% 65 and over), 67% White and 31% Asian, 57% female, 36% ECOG PS 0 and 57% ECOG PS 1, 7% ECOG PS2, 60% never smoker, 35% former smoker, 5% current smoker, 98% Stage IV, 97% adenocarcinoma, and 74% prior chemotherapy.
Slovenian: Osnovna demografija in značilnosti bolezni pri študiji ALTA so bile: mediana starost 54 let (razpon od 18 do 82, 23% 65 let in več), 67% belcev in 31% Azijcev, 57% žensk, 36% stanje zmogljivosti 0 po ECOG in 57% stanje zmogljivosti 1 po ECOG, 7% stanje zmogljivosti 2 po ECOG, 60% oseb, ki ni nikoli kadilo, 35% bivših kadilcev, 5% trenutnih kadilcev, 98% IV. stopnja, 97% adenokarcinom in 74% s predhodno izvedeno kemoterapijo.
English: Your doctor may need to adjust your treatment or stop Alunbrig temporarily or permanently.
Slovenian: Vaš zdravnik bo morda moral prilagoditi zdravljenje, začasno prekiniti ali trajno ukiniti uporabo zdravila Alunbrig.
English: Alunbrig is not recommended during pregnancy unless the benefit outweighs the risk to the baby.
Slovenian: Zdravila Alunbrig ni priporočeno jemati med nosečnostjo, razen če korist odtehta tveganje za dojenčka.
English: Adverse reactions seen in animals at exposure levels similar to clinical exposure levels with possible relevance to clinical use were as follows: gastrointestinal system, bone marrow, eyes, testes, liver, kidney, bone, and heart.
Slovenian: Neželeni učinki, ki so jih opazili pri živalih, pri ravneh izpostavljenosti, podobnih stopnjam klinične izpostavljenosti, ki so lahko pomembni za klinično uporabo, so bili na: gastrointestinalni sistem, kostni mozeg, oči, moda, jetra, ledvice, kosti in srce.
English: Of these, 19 patients had an investigator-assessed confirmed objective response (76%; 95% CI: 55, 91) and the KM estimate median duration of response among the 19 responders was 26.1 months (95% CI: 7.9, 26.1).
Slovenian: Od tega je za 19 bolnikov raziskovalec ocenil potrjen objektivni odziv (76%, 95% IZ: 55; 91) in KM oceno mediane trajanja odziva med 19 odzivi je bila 26,1 meseca (95% IZ: 7,9; 26,1).
English: IRC assessments of intracranial ORR and duration of intracranial response in patients from ALTA with measurable brain metastases (≥ 10 mm in longest diameter) at baseline are summarised in Table 5.
Slovenian: Ocene IRC intrakranialnega ORR in trajanje intrakranialnega odziva pri bolnikih v študiji ALTA z merljivimi metastazami v možganih (≥10 mm v najdaljšem premeru) so na začetku opisane v preglednici 5.
English: Brigatinib is a tyrosine kinase inhibitor that targets ALK, c-ros oncogene 1 (ROS1), and insulin-like growth factor 1 receptor (IGF-1R).
Slovenian: Brigatinib je zaviralec tirozin-kinaze, ki cilja na ALK, c-ros onkogen 1 (ROS1) in receptorje insulinu podobnega rastnega dejavnika 1 (IGF-1R).
English: In ALTA, 13.5% of patients ≥ 65 years of age experienced an early pulmonary adverse reaction compared with 4.2% of patients < 65 years of age.
Slovenian: V študiji ALTA se je pri 13,5% bolnikih, starih ≥65 let, pojavil zgodnji neželeni učinek na pljuča v primerjavi s 4,2% bolnikov, mlajših od 65 let.
English: The safety and efficacy of Alunbrig in patients less than 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Alunbrig pri bolnikih, mlajših od 18 let, nista bili dokazani.
English: Alunbrig may cause visual disturbances, dizziness or tiredness.
Slovenian: Zdravilo Alunbrig lahko povzroči motnje vida, omotico ali utrujenost.
English: • inflammation of the mouth and lips (stomatitis)
Slovenian: • vnetje ustne votline in ustnic (stomatitis)
English: Clinical drug-drug interaction studies with CYP3A sensitive substrates have not been conducted.
Slovenian: Klinične študije interakcij med zdravili in substrati, občutljivimi na CYP3A, niso bile izvedene.
English: In monkeys, findings included reduced size of testes along with microscopic evidence of hypospermatogenesis; these effects were reversible during the recovery period.
Slovenian: Pri opicah so ugotovitve vključevale zmanjšano velikost mod skupaj z mikroskopskimi dokazi o hipospermatogenezi; ti učinki so med obdobjem okrevanja izginili.
English: If Alunbrig is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previously tolerated dose.
Slovenian: Če jemanje zdravila Alunbrig prekinete za 14 dni ali dlje iz drugega razloga kot so neželeni učinki, je treba zdravljenje nadaljevati z odmerkom 90 mg enkrat na dan za obdobje 7 dni, preden odmerek povečate na predhodno toleriran odmerek.
English: Tell your doctor if you are feeling very thirsty, need to urinate more than usual, feeling very hungry, sick to your stomach, weak or tired, or confused.
Slovenian: Obvestite svojega zdravnika, če se pojavi občutek hude žeje, če urinirate več kot običajno, se počutite zelo lačne, občutite slabost, ste šibki, utrujeni ali zmedeni.
English: Evidence of pneumonitis in any patient with worsening respiratory symptoms should be promptly investigated.
Slovenian: Bolnike, pri katerih so se pojavili znaki pnevmonitisa s poslabšanimi simptomi bolezni dihal, je treba nemudoma pregledati.
English: Population pharmacokinetic analyses showed that race and gender had no impact on the pharmacokinetics of brigatinib.
Slovenian: Analize populacijske farmakokinetike so pokazale, da rasa in spol nista vplivala na farmakokinetiko brigatiniba.
English: Brigatinib can be administered with or without food.
Slovenian: Brigatinib se lahko odmerja s hrano ali brez nje.
English: If you take more Alunbrig than you should
Slovenian: Če ste vzeli večji odmerek zdravila Alunbrig, kot bi smeli
English: Alunbrig should not be used during pregnancy unless the clinical condition of the mother requires treatment.
Slovenian: Zdravila Alunbrig ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva zdravljenje.
English: The KM median PFS was 16.3 months (95% CI: 9.2, NE) and the 12-month probability of overall survival was 84.0% (95% CI: 62.8, 93.7).
Slovenian: Povprečje KM za PFS je 16,3 meseca (95% IZ: 9,2; NO) in 12-mesečna verjetnost skupnega preživetja je bila 84,0% (95% IZ: 62,8; 93,7).
English: Alunbrig should be permanently discontinued if patient is unable to tolerate the 60 mg once daily dose.
Slovenian: Zdravljenje z zdravilom Alunbrig je potrebno ukiniti, če bolnik ne prenaša odmerka 60 mg enkrat na dan.
English: In Study 101, the QT interval prolongation potential of Alunbrig was assessed in 123 patients with advanced malignancies following once daily brigatinib doses of 30 mg to 240 mg.
Slovenian: V študiji 101 je bil potencial podaljšanja QT intervala zdravila Alunbrig ocenjen pri 123 bolnikih z napredovalimi malignimi boleznimi, ki so enkrat dnevno prejemali odmerke brigatiniba od 30 mg do 240 mg.
English: Overall, these effects on the male reproductive organs in rats and monkeys occurred at exposures ≥ 0.2-times the AUC observed in patients at the 180 mg once daily dose.
Slovenian: Na splošno so se ti učinki na moške reproduktivne organe pri podganah in opicah pojavili pri izpostavljenosti ≥ 0,2-kratni vrednosti AUC, opaženi pri bolnikih z odmerkom 180 mg enkrat na dan.
English: Do not drive or use machines during treatment if such signs occur.
Slovenian: Ob pojavu teh znakov med zdravljenjem ne vozite in ne uporabljajte strojev.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Alunbrig in all subsets of the paediatric population in lung carcinoma (small cell and non-small cell carcinoma) (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Alunbrig za vse podskupine pediatrične populacije pri zdravljenju karcinoma pljuč (drobnocelični ali nedrobnocelični karcinom) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: At the beginning of your treatment with Alunbrig your doctor may prescribe a treatment initiation pack.
Slovenian: Na začetku zdravljenja z zdravilom Alunbrig vam lahko zdravnik predpiše uvajalno pakiranje.
English: Table 1: Recommended Alunbrig dose reduction levels Dose
Slovenian: Preglednica 1: Priporočene ravni zmanjšanja odmerka zdravila Alunbrig Odmerjanje
English: No patients had dose reductions due to elevation of ALT or AST.
Slovenian: Pri nobenem bolniku ni bilo potrebno znižati odmerka zaradi zvišanja vrednosti ALT ali AST.
English: Safety pharmacology studies with brigatinib identified potential for pulmonary effects (altered respiration rate; 1-2 times the human Cmax), cardiovascular effects (altered heart rate and blood pressure; at 0.5 times the human Cmax), and renal effects (reduced renal function; at 1-2.5 times the human Cmax), but did not indicate any potential for QT prolongation or neurofunctional effects.
Slovenian: Farmakološke študije varnosti z brigatinibom so odkrile potencialne učinke na pljuča (spremenjeno stopnjo dihanja; 1-2-kratnik Cmax pri ljudeh), kardiovaskularne učinke (spremenjeni srčni utrip in krvni tlak; 0,5-kratnik Cmax pri ljudeh) in učinke na ledvica (poslabšano delovanje ledvic; 1-2,5-kratnik Cmax pri ljudeh), vendar niso pokazale potenciala podaljšanja intervala QT ali nevrofunkcijskih učinkov.
English: The most common serious adverse reactions (≥ 2%) reported in patients treated with Alunbrig at the recommended dosing regimen other than events related to neoplasm progression were pneumonitis, pneumonia, and dyspnoea.
Slovenian: Najpogostejši resni neželeni učinki (≥2%), o katerih so poročali pri bolnikih, zdravljenih z zdravilom Alunbrig pri priporočenem režimu odmerjanja, razen pri učinkih, povezanih z napredovanjem neoplazme, so bili pnevmonitis, pljučnica in dispneja.
English: For elevations to Grade 3 and 4, the incidences for ALT and AST were 5.5% and 3.6%, respectively.
Slovenian: Zvišanje na stopnjo 3 in 4 se je pojavilo za ALT v 5,5% in za AST v 3,6%.
English: • rifabutin, rifampicin: medicines to treat tuberculosis or certain other infections
Slovenian: • rifabutin, rifampicin: zdravila za zdravljenje tuberkuloze ali nekaterih drugih okužb
English: Some patients experienced pneumonitis later in treatment with Alunbrig.
Slovenian: Nekateri bolniki so zaradi pnevmonitisa zboleli kasneje med zdravljenjem z zdravilom Alunbrig.
English: • pravastatin, rosuvastatin: medicines to lower elevated cholesterol levels
Slovenian: • pravastatin, rosuvastatin: zdravila za znižanje zvišane ravni holesterola
English: Brigatinib is a substrate of the transporter proteins P-gp and BCRP.
Slovenian: Brigatinib je substrat transportnih proteinov P-gp in BCRP.
English: Figure 1: Investigator-Assessed Systemic Progression-Free Survival: ITT Population by Treatment Arm (ALTA)
Slovenian: Slika 1: Sistemsko preživetje brez napredovanja bolezni, glede na oceno preiskovalca: Populacija ITT za posamezni krak zdravljenja (ALTA)
English: Outer Carton: PC:
Slovenian: Zunanja ovojnina: PC:
English: Prior to launch of Alunbrig in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj Pred prihodom zdravila Alunbrig na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načinom razdeljevanja in vsemi ostalimi vidiki programa.
English: Lung problems, some severe, are more frequent within the first 7 days of treatment.
Slovenian: • težave s pljuči ali dihanjem Težave s pljuči, nekatere resnejše, so pogostejše v prvih 7 dneh zdravljenja.
English: They are convex on the upper and lower side.
Slovenian: Tablete so konveksne na zgornji in spodnji strani.
English: It is unknown whether Alunbrig is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Alunbrig izloča v materino mleko.