natgillin/translations-raw huggingface dataset:
See also section 2, “Warnings and precautions”.
Također pogledajte dio 2 "Upozorenja i mjere opreza".
See also the beginning of section 4.
Pogledajte također početak dijela 4.
Version 4.0 (NCI CTCAE v4).
Verzija 4.0 (NCI CTCAE v4).
Alunbrig with food and drink
Alunbrig s hranom i pićem
If you take more Alunbrig than you should
Ako uzmete više Alunbriga nego što ste trebali
Symptoms may be similar to symptoms from lung cancer.
Simptomi mogu biti slični simptomima raka pluća.
• sensitivity to sunlight
• osjetljivost na sunčevo svjetlo
They are convex on the upper and lower side.
Konveksne su s gornje i donje strane.
There are no available data on patients over 85 years of age.
Za bolesnike starije od 85 godina nema dostupnih podataka.
Your doctor may adjust your dose according to your needs and this may require use of a 30 mg tablet to achieve the new recommended dose.
Vaš liječnik može prilagoditi dozu prema Vašim potrebama, a to može zahtijevati uporabu tablete od 30 mg kako bi se postigla nova, preporučena doza.
The median duration of follow-up was 22.9 months.
Medijan trajanja praćenja bio je 22,9 mjeseci.
The tablets should be swallowed whole and with water.
Tablete treba progutati cijele i s vodom.
• Swallow the tablets whole, with a glass of water.
• Tablete progutajte cijele, s čašom vode.
Treatment should continue as long as clinical benefit is observed.
Liječenje treba nastaviti sve dok postoji klinička korist.
• Take Alunbrig once daily at the same time each day.
• Alunbrig uzimajte jedanput dnevno, uvijek u isto vrijeme.
Day 8 to Day 28
Dan 8 do Dan 28
Talk to your doctor before taking Alunbrig or during treatment if you have:
Obratite se svom liječniku prije nego uzmete Alunbrig ili za vrijeme liječenja ako imate:
Frequency categories are very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Kategorije učestalosti su vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10) i manje često (≥ 1/1000 do < 1/100).
Study 101
Ispitivanje 101
Age, body weight, and albumin concentrations
Dob, tjelesna težina i koncentracije albumina
• increased blood clotting time shown by test of activated partial thromboplastin time
• povećano vrijeme zgrušavanja krvi utvrđeno testom aktiviranog parcijalnog tromboplastinskog vremena
Thereafter, monitoring should be performed periodically.
Nakon toga je potrebno periodičko praćenje.
Hypertension should be treated according to standard guidelines to control blood pressure.
Hipertenziju treba liječiti prema standardnim smjernicama kako bi se kontrolirao krvni tlak.
Do not drive or use machines during treatment if such signs occur.
Ne smijete voziti ili koristiti strojeve ako se jave takvi znakovi za vrijeme liječenja.
Alunbrig blocks the action of this protein and thus slows down the growth and spread of the cancer.
Alunbrig blokira djelovanje tog proteina i tako usporava rast i širenje raka.
Alunbrig has not been studied in children or adolescents.
Alunbrig nije ispitan u djece ili adolescenata.
Your doctor may need to adjust your treatment or stop Alunbrig temporarily or permanently.
Vaš liječnik će možda trebati prilagoditi liječenje ili ga privremeno ili trajno prekinuti.
The MAH shall complete, within the stated timeframe, the below measures:
Nositelj odobrenja dužan je, unutar navedenog vremenskog roka provesti niže navedene mjere:
The median duration of peripheral neuropathy adverse reactions was 4.5 months, with a maximum duration of 28.7 months.
Medijan trajanja periferne neuropatije bio je 4,5 mjeseci, uz maksimalno trajanje od 28,7 mjeseci.
What Alunbrig is and what it is used for What you need to know before you take Alunbrig How to take Alunbrig
Što je Alunbrig i za što se koristi Što morate znati prije nego počnete uzimati Alunbrig Kako uzimati Alunbrig
Tell your doctor or pharmacist right away if you have taken more tablets than recommended.
Odmah obavijestite liječnika ili ljekarnika ako ste uzeli više tableta nego što je preporučeno.
Do not change the dose without talking to your doctor.
Ne smijete mijenjati dozu bez savjetovanja sa liječnikom.
What Alunbrig is and what it is used for
Što je Alunbrig i za što se koristi
The blood-to-plasma concentration ratio is 0.69.
Omjer koncentracije u krvi i plazmi iznosi 0,69.
If you are pregnant or think you may be pregnant or are planning to have a baby, talk to your doctor to discuss the risks of taking Alunbrig during pregnancy.
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, razgovarajte sa svojim liječnikom o rizicima uzimanja lijeka Alunbrig tijekom trudnoće.
Avoid any grapefruit products during treatment as they may change the amount of brigatinib in your body.
Za vrijeme liječenja izbjegavajte sve proizvode s grejpom jer oni mogu izmijeniti količinu brigatiniba u tijelu.
Available data cannot exclude potential excretion in human milk.
Dostupni podaci ne mogu isključiti mogućnost izlučivanja u majčino mlijeko.
90 mg once daily (first 7 days)
90 mg jedanput dnevno (prvih 7 dana)
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107.(c) stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
These effects were generally reversible during the non-dosing recovery period; however, effects in the eyes and testes were notable exceptions due to lack of recovery.
Ovi učinci općenito su bili reverzibilni za vrijeme razdoblja oporavka bez primjene doze; ipak, učinci na oči i testise bili su značajne iznimke zbog nedostatka oporavka.
• inflammation of pancreas which may cause severe and persistent stomach pain, with or without nausea and vomiting (pancreatitis)
• upala gušterače koja može uzrokovati tešku i stalnu bol u trbuhu, sa ili bez mučnine i povraćanja (pankreatitis)
Additionally, patients with central nervous system (CNS) metastases were included, provided they were neurologically stable and did not require an increasing dose of corticosteroids.
uključeni su bolesnici s metastazama u središnjem živčanom sustavu (CNS), pod uvjetom da su bili neurološki stabilni i nisu trebali povećanu dozu kortikosteroida.
Randomisation was stratified by brain metastases (present, absent) and best prior response to crizotinib therapy (complete or partial response, any other response/unknown).
Randomizacija je stratificirana po metastazama na mozgu (prisutne, odsutne) i najboljem prethodnom odgovoru na liječenje krizotinibom (kompletan ili djelomičan odgovor, bilo koji drugi odgovor/nepoznato).
Ask your doctor about the birth control methods that may be right for you.
Posavjetujte se sa svojim liječnikom o metodama kontrole začeća koje su najbolje za Vas.
Median (months)
Ukupno preživljenje Medijan (mjeseci)
Of these, three Grade 3 adverse reactions (2.7%) including macular oedema and cataract were reported.
Među njima su prijavljene tri nuspojave 3. stupnja (2,7 %) uključujući makularni edem i kataraktu.
Antihyperglycaemic treatment should be initiated or optimised as needed.
Po potrebi, treba započeti ili optimizirati antihiperglikemijsko liječenje.
Day 1 to Day 7
Dan 1 do Dan 7
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).
Alunbrig također može inducirati druge enzime i transportere (npr. CYP2C, P-gp) putem istih mehanizama odgovornih za induciranje CYP3A (npr. aktiviranje pregnan X receptora).
What Alunbrig looks like and contents of the pack
Kako Alunbrig izgleda i sadržaj pakiranja
It is unknown if brigatinib passes into breast milk and could potentially harm the baby.
Nije poznato izlučuje li se brigatinib u majčino mlijeko i može li potencijalno naškoditi bebi.
reduce to 60 mg once daily permanently discontinue not applicable
smanjiti na 60 mg jedanput dnevno trajno prekinuti nije primjenjivo
• reduced number of red blood cells (anaemia)
• smanjen broj crvenih krvnih stanica (anemija)
Heart rate and blood pressure should be monitored regularly.
Srčana frekvencija i krvni tlak se moraju redovito pratiti.
Most pulmonary adverse reactions were observed within the first 7 days of treatment.
Većina nuspojava na plućima opažena je tijekom prvih 7 dana liječenja.
Bradycardia with life-threatening consequences, urgent intervention indicated
Bradikardija s po život opasnim posljedicama, indicirana hitna intervencija
• pain in arms and legs
• bol u rukama i nogama
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.
Najčešća mjesta ekstratorakalnih metastaza uključuju 69 % mozak (od kojih je 62 % prethodno imalo zračenje mozga), 39 % kosti i 26 % jetru.
The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity) and not a clastogenic effect on chromosomes.
Mehanizam indukcije mikronukleusa bio je abnormalna segregacija kromosoma (aneugenost), a ne klastogeni učinak na kromosome.
Table 4: Efficacy results in ALTA (ITT population) Efficacy parameter
Tablica 4: Rezultati djelotvornosti u ispitivanju ALTA (ITT populacija) Parametar djelotvornosti
Treatment with Alunbrig is not recommended in persons under 18 years of age.
Liječenje lijekom Alunbrig se ne preporučuje u osoba mlađih od 18 godina.
Alunbrig may cause visual disturbances, dizziness or tiredness.
Alunbrig može uzrokovati smetnje vida, omaglicu ili umor.
The median time to onset for CPK elevations was 27 days.
Medijan vremena do pojave porasta razine CPK bio je 27 dana.
Alunbrig should not be used during pregnancy unless the clinical condition of the mother requires treatment.
Alunbrig se ne smije koristiti tijekom trudnoće, osim ako kliničko stanje majke ne zahtijeva liječenje.
Other medicines and Alunbrig
Drugi lijekovi i Alunbrig
• The tablets can be taken with or without food.
• Tablete možete uzeti s hranom ili bez nje.
Brigatinib was moderately bound (91%) to human plasma proteins and binding was not concentration-dependent.
Brigatinib se umjereno vezivao (91 %) za proteine u ljudskoj plazmi, a vezivanje nije ovisilo o koncentraciji.
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.
Nuspojave opažene u životinja pri razinama izloženosti sličnima kliničkim izloženostima s mogućom povezanosti s kliničkom uporabom bile su sljedeće: gastrointestinalni sustav, koštana srž, oči, testisi, jetra, bubrezi, kost i srce.
(27.7, NE)
(27,7; NP)
The incidence of Grade 3-4 elevations of CPK was 13.6%.
Incidencija porasta razina CPK 3.-4. stupnja bila je 13,6 %.
Do not stop taking Alunbrig before talking to your doctor.
Ne smijete prestati uzimati Alunbrig prije savjetovanja sa liječnikom.
Grade 4 hypertension (life threatening consequences, urgent intervention indicated)
Hipertenzija 4. stupnja (posljedice opasne po život, indicirana hitna intervencija)
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.
Prije stavljanja u promet lijeka Alunbrig u svakoj državi članici nositelj odobrenja će s nadležnim nacionalnim tijelom dogovoriti sadržaj i oblik edukacijskih materijala, uključujući oblik komunikacije, način distribucije i sve druge aspekte programa.
Alunbrig has minor influence on the ability to drive and use machines.
Alunbrig malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
ALK-positive NSCLC status should be known prior to initiation of Alunbrig therapy.
ALK pozitivni status NSCLC-a mora biti poznat prije početka liječenja lijekom Alunbrig.
Brigatinib can be administered with or without food.
Brigatinib se može primjenjivati s hranom ili bez nje.
Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitors, ATC code: L01XE43
Farmakoterapijska skupina: antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE43
Carcinogenicity studies have not been performed with brigatinib.
Ispitivanja kancerogenosti s brigatinibom nisu provedena.
The major outcome measure was confirmed objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1) as evaluated by investigator.
Glavna mjera ishoda bila je potvrđena stopa objektivnog odgovora (engl. objective response rate, ORR) prema Kriterijima za procjenu odgovora kod solidnih tumora (RECIST v1.1) prema procjeni ispitivača.
Unchanged brigatinib was the major circulating radioactive component (92%) along with AP26123 (3.5%), the primary metabolite also observed in vitro.
Nepromijenjeni brigatinib bio je glavni cirkulirajući radioaktivni sastojak (92 %) zajedno sa AP26123 (3,5 %), primarnim metabolitom također opaženim in vitro.
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).
Ograničeni podaci o sigurnosti i djelotvornosti lijeka Alunbrig u bolesnika u dobi od 65 i više godina ukazuju na to da nije potrebna prilagodba doze u starijih bolesnika (vidjeti dio 4.8).
Macrogol Polyvinyl alcohol Titanium dioxide
Poli(vinilni alkohol) Titanijev dioksid
Thirty percent of patients had resolution of all peripheral neuropathy adverse reactions.
Kod trideset posto bolesnika povukle su se sve nuspojave periferne neuropatije.
12-month survival probability (%)
Vjerojatnost preživljenja 12 mjeseci
Patients should be advised to report any visual symptoms.
Bolesnike treba savjetovati da prijave sve poremećaje vida.
Alunbrig is not recommended during pregnancy unless the benefit outweighs the risk to the baby.
Alunbrig se ne preporučuje tijekom trudnoće osim ako je korist od liječenja veća od rizika za bebu.
Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised.
Testiranje za ALK pozitivni NSCLC se mora provoditi u laboratoriju koji je dokazano stručan u korištenju odabrane tehnologije ispitivanja.
Unchanged brigatinib represented 41% and 86% of the total radioactivity in faeces and urine, respectively, the remainder being metabolites.
Nepromijenjeni brigatinib predstavljao je 41 % i 86 % ukupne radioaktivnosti u fecesu, odnosno urinu, a ostatak su bili metaboliti.
Alunbrig should be permanently discontinued if patient is unable to tolerate the 60 mg once daily dose.
Liječenje lijekom Alunbrig se mora trajno prekinuti ako bolesnik ne može tolerirati dozu od 60 mg jedanput dnevno.
The following medicines can affect or be affected by Alunbrig:
Sljedeći lijekovi mogu utjecati na Alunbrig ili Alunbrig može utjecati na njih:
Eye disorders Very common Visual disturbancee Common
Poremećaji oka Vrlo često Poremećaj vidae Često
At the beginning of your treatment with Alunbrig your doctor may prescribe a treatment initiation pack.
Na početku Vašeg liječenja lijekom Alunbrig, liječnik vam može prepisati početno pakiranje.
Some patients experienced pneumonitis later in treatment with Alunbrig.
Neki bolesnici su dobili pneumonitis kasnije tijekom liječenja lijekom Alunbrig.
There are no clinical data on the use of Alunbrig in pregnant women.
Nema kliničkih podataka o primjeni Alunbriga u trudnica.
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:
Nositelj odobrenja mora osigurati da u svakoj državi članici gdje je Alunbrig na tržištu svi zdravstveni radnici i bolesnici/skrbnici za koje se očekuje da će propisivati i primjenjivati Alunbrig dobiju sljedeći edukacijski paket:
Very common AST increased ALT increased
Vrlo često Povišeni AST Povišeni ALT
The median time to onset for amylase elevations and lipase elevations was 17 days and 29 days, respectively.
Medijan vremena za pojavu porasta razina amilaze i lipaze bio je 17 dana, odnosno 29 dana.
Do not use this medicine after the expiry date which is stated on either the bottle label or blister and carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice ili na blisteru i kutiji iza oznake „EXP“.
This effect was observed at approximately five fold the human exposure at the 180 mg once daily dose.
Ovaj je učinak opažen na približno pet puta većoj izloženosti od one u ljudi pri dnevnoj dozi od 180 mg jedanput dnevno.
• symptoms such as numbness, tingling, prickling sensation, weakness or pain in hands or feet
• simptomi kao što su utrnulost, bockanje, peckanje, slabost ili bol u šakama ili stopalima
Alunbrig is available as a treatment initiation pack.
Alunbrig je dostupan kao početno pakiranje.
Modest accumulation was observed upon repeated dosing (geometric mean accumulation ratio: 1.9 to 2.4).
Umjerena akumulacija lijeka zabilježena je nakon opetovane primjene (akumulacijski omjer geometrijskih sredina: 1,9 do 2,4).
In the event of an overdose, monitor the patient for adverse reactions (see section 4.8) and provide appropriate supportive care.
U slučaju predoziranja, bolesnika je potrebno pažljivo nadzirati zbog nuspojava (vidjeti dio 4.8) i pružiti mu odgovarajuću suportivnu skrb.
(3.7, NE)
(3,7; NP)
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.
Početne demografske karakteristike te karakteristike bolesti u ispitivanju ALTA bile su medijan dobi od 54 godine (raspon od 18 do 82; 23 % u dobi od 65 i više), 67 % bijelaca i 31 % Azijata, 57 % žena, 36 % ECOG PS 0 i 57 % ECOG PS 1, 7 % ECOG PS2, 60 % nikada pušača, 35 % bivših pušača, 5 % trenutnih pušača, 98 % 4. stadij, 97 % adenokarcinom i 74 % prethodna kemoterapija.
However, caution should be exercised when driving or operating machines as patients may experience visual disturbance, dizziness, or fatigue while taking Alunbrig.
Međutim, potreban je oprez prilikom vožnje ili upravljanja strojevima jer bolesnici mogu iskusiti smetnje vida, omaglicu ili umor dok uzimaju lijek Alunbrig.
• The active substance is brigatinib.
• Djelatna tvar je brigatinib.
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.
Starija dob i kraće razdoblje (kraće od 7 dana) između posljednje doze krizotiniba i prve doze lijeka Alunbrig bile su svaka za sebe povezane s povećanom stopom nuspojava na plućima.
After a single dose and at steady state, systemic exposure was dose proportional over the dose range of 60-240 mg once daily.
Nakon jednokratne doze i u stanju dinamičke ravnoteže, sistemska izloženost bila je proporcionalna dozi u rasponu od 60240 mg jedanput dnevno.
• abnormal electrical activity of the heart (prolonged electrocardiogram QT interval)
• poremećena električna aktivnost srca (produljeni QT interval u elektrokardiogramu)
Evidence of pneumonitis in any patient with worsening respiratory symptoms should be promptly investigated.
Znakove pneumonitisa treba odmah istražiti u svih bolesnika s pogoršanim respiratornim simptomima.
Adverse reactions† all grades
Nuspojave† svih stupnjeva
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.
Učinak gemfibrozila na farmakokinetiku brigatiniba nije klinički značajan, a temeljni mehanizam smanjene izloženosti brigatinibu nije poznat.
(peripheral neuropathy)
(periferna neuropatija)
In ALTA, 69% of patients experienced hyperglycaemia.
U ispitivanju ALTA, 69 % bolesnika imalo je hiperglikemiju.
Treatment with Alunbrig should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Liječenje lijekom Alunbrig mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova za liječenje raka.
Outer Carton: PC:
Vanjska kutija: PC:
Population pharmacokinetic analyses showed that race and gender had no impact on the pharmacokinetics of brigatinib.
Populacijska farmakokinetička analiza pokazala je da rasa i spol nisu imali utjecaja na farmakokinetiku brigatiniba.
Interstitial lung disease (ILD)/pneumonitis
Intersticijska bolest pluća (IBP)/pneumonitis
• If you vomit after taking Alunbrig, do not take any more tablets until your next scheduled dose.
• Ako povratite nakon uzimanja lijeka Alunbrig, nemojte uzeti dodatne tablete prije sljedeće planirane doze.
Study 101: An open-label multicentre phase 1/2 dose escalation/expansion trial in patients with advanced malignancies.
Ispitivanje 101: otvoreno multicentrično ispitivanje faze s 1/2 povišenja/proširenja doze u bolesnika s uznapredovalim zloćudnim bolestima.
The abnormal gene produces a protein known as a kinase that stimulates the growth of the cancer cells.
Izmijenjeni gen proizvodi protein kinazu koji potiče rast stanica raka.
There is no specific antidote for overdose with Alunbrig.
Nema specifičnog antidota za predoziranje lijekom Alunbrig.
• rifabutin, rifampicin: medicines to treat tuberculosis or certain other infections
• rifabutin, rifampicin: lijekovi za liječenje tuberkuloze ili određenih drugih infekcija
• carbamazepine: a medicine to treat epilepsy, euphoric/depressive episodes and certain pain conditions
• karbamazepin: lijek za liječenje epilepsije, euforičnih/depresivnih stanja i određenih bolnih stanja
Common Dry skin Photosensitivity reaction
Suha koža Reakcija fotoosjetljivosti
• cold-like symptoms (upper respiratory tract infection)
• simptomi slični prehladi (infekcija gornjih dišnih puteva)
The safety and efficacy of Alunbrig in patients less than 18 years of age have not been established.
Sigurnost i djelotvornost lijeka Alunbrig u bolesnika mlađih od 18 godina nisu još ustanovljene.
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.
Uključni kriteriji dozvolili su uključenje bolesnika s dokumentiranim mutacijama preslagivanja ALKa temeljem validiranog testa, ECOG funkcionalnog statusa 0-2, i prethodno liječenih kemoterapijom.
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).
KM medijan PFSa bio je 16,3 mjeseca (95 % CI: 9,2; NP), a 12 -mjesečna vjerojatnost ukupnog preživljenja bila je 84,0 % (95 % CI: 62,8; 93,7).
In patients, at steady state, the plasma AUC of AP26123 was < 10% of brigatinib exposure.
U bolesnika u stanju dinamičke ravnoteže, AUC AP26123 u plazmi iznosio je < 10 % izloženosti brigatinibu.