FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
Croatian: • Mikroinjekcijski sustav za primjenu u kožu sastoji se od napunjene štrcaljke s mikroiglom
English: HOW TO USE IDflu
Croatian: Vidjeti također dio 3. KAKO PRIMJENJIVATI IDflu
English: Remove the needle cap from the
Croatian: Uklonite zatvarač igle s mikroinjekcijskog sustava
English: Package leaflet: Information for the user
Croatian: Sadržaj pakovanja i dodatne informacije
English: b. Tabulated summary of adverse reactions
Croatian: • Periodička izvješća o neškodljivosti
English: * Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species.
Croatian: * Relativna potencija (test potencije na miševima) u usporedbi s referentnim cjepivom koje je pokazalo djelotvornost u ciljnih vrsta životinja
English: EU/2/14/178/001 Zulvac SBV --1 Suspension for injection
Croatian: EU/2/14/178/001 Zulvac SBV --1
English: Inactivated Schmallenberg virus, strain BH80/11-4: ≥ 1 RP*/2 ml (for cows) or ≥ 1 RP*/ml (for sheep).
Croatian: Inaktivirani virus Schmallenberg, soj BH80/11-4: ≥ 1 RP*/2 ml (za krave) ili ≥ 1 RP*/ml (za ovce).
English: Intramuscular use or subcutaneous use.
Croatian: Goveda i ovce Intramuskularna ili supkutana upotreba
English: Vial (HDPE) 50 ml
Croatian: 50 ml
English: The Agency issued its opinion on 17 October 2019.
Croatian: Agencija je objavila mišljenje 17. listopada 2019.
English: Vanflyta was compared with other
Croatian: Vanflyta je uspoređen s drugim
English: What is Vanflyta and what was it intended to be used for?
Croatian: Što je Vanflyta i za što se trebao koristiti?
English: The company that applied for authorisation, Daiichi Sankyo Europe GmbH, may ask for re-examination of the opinion within 15 days of receiving the opinion.
Croatian: Tvrtka koja je podnijela zahtjev za izdavanje odobrenja, Daiichi Sankyo Europe GmbH, može zatražiti preispitivanje mišljenja u roku od 15 dana od primitka ovog mišljenja.
English: Further information on the orphan designation can be found on the Agency's website: ema.europa.eu/medicines/human/orphan-designations/eu309622.
Croatian: Dodatne informacije o uvrštenju lijekova za rijetke bolesti dostupne su na internetskim stranicama Agencije: ema.europa.eu/medicines/human/orphan-designations/eu309622.
English: What were the main reasons for refusing the marketing authorisation?
Croatian: Koji su bili glavni razlozi za odbijanje odobrenja za stavljanje lijeka u promet?
English: How does Vanflyta work?
Croatian: Kako djeluje Vanflyta?
English: 18 October 2019 EMA/559309/2019 EMEA/H/C/004468
Croatian: EMA/559309/2019 EMEA/H/C/004468
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, speak with your clinical trial doctor.
Croatian: Ako sudjelujete u kliničkom ispitivanju ili programu milosrdnog davanja lijekova te vam je potrebno više informacija o liječenju, obratite se liječniku koji vas liječi.
English: cancer medicines and the main measure of effectiveness was overall survival (how long patients lived) after being given Vanflyta or the comparator medicines.
Croatian: lijekovima protiv raka, a glavno mjerilo učinkovitosti bilo je ukupno preživljenje (koliko su dugo bolesnici živjeli) nakon primjene lijeka Vanflyta ili usporednih lijekova.
English: Does this refusal affect patients in clinical trials or compassionate use programmes?
Croatian: Ima li ovo odbijanje zahtjeva posljedice za bolesnike u kliničkim ispitivanjima ili u programima milosrdnog davanja lijekova?
English: Refusal of the marketing authorisation for Vanflyta (quizartinib) EMA/559309/2019
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Vanflyta (kvizartinib) EMA/559309/2019
English: The company presented the results of a study in 367 patients with FLT3-ITD positive AML whose disease did not respond to treatment or came back after treatment.
Croatian: Tvrtka je dostavila rezultate ispitivanja provedenog na 367 bolesnika s AML-om pozitivnim na FLT3-ITD u kojih bolest nije reagirala na liječenje ili se vratila nakon liječenja.
English: Therefore, the Agency's opinion was that the benefits of Vanflyta did not outweigh its risks and it recommended refusing marketing authorisation.
Croatian: Stoga je Agencija smatrala da koristi od lijeka Vanflyta ne nadmašuju s njim povezane rizike te je preporučila odbijanje izdavanja odobrenja za stavljanje lijeka u promet.
English: Vanflyta contains the active substance quizartinib and was to be available as tablets.
Croatian: Vanflyta sadrži djelatnu tvar kvizartinib i trebao je biti dostupan u obliku tableta.
English: Vanflyta was to be used in adult patients whose disease had come back or did not respond to previous treatments and for continuation of treatment after the patient had undergone a haematopoietic stem cell transplant (HSCT, a transplant of cells that can develop into different types of blood cells).
Croatian: Vanflyta se trebao primjenjivati u odraslih bolesnika čija se bolest vratila ili nije reagirala na prethodna liječenja te za nastavak liječenja nakon što je bolesnik prošao transplantaciju hematopoetskih matičnih stanica (HSCT, transplantaciju stanica koje se mogu razviti u različite vrste krvnih stanica).
English: Although the results from the main study indicated a marginal improvement in overall survival for patients given Vanflyta, the study had important limitations which meant that the effectiveness of Vanflyta could not be sufficiently demonstrated.
Croatian: Iako su rezultati iz glavnog ispitivanja ukazivali na neznatno poboljšanje ukupnog preživljenja u bolesnika koji su primili lijek Vanflyta, ispitivanje je imalo značajna ograničenja zbog kojih se učinkovitost lijeka Vanflyta nije mogla utvrditi na zadovoljavajući način.
English: Refusal of the marketing authorisation for Vanflyta (quizartinib)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Vanflyta (kvizartinib)
English: The European Medicines Agency has recommended the refusal of the marketing authorisation for Vanflyta, a medicine intended for the treatment of adults with acute myeloid leukaemia (AML) (a cancer of the white blood cells).
Croatian: Europska agencija za lijekove preporučila je odbijanje odobrenja za stavljanje u promet lijeka Vanflyta, namijenjenog liječenju odraslih osoba s akutnom mijeloičnom leukemijom (AML) (rak bijelih krvnih stanica).
English: Vanflyta was developed as a cancer medicine for the treatment of a type of AML called ‘FLT3-ITD positive' (when the cancer cells have a certain change in the gene for a protein called FLT3).
Croatian: Lijek Vanflyta razvijen je kao lijek protiv raka za liječenje vrste AML-a naziva „FLT3-ITD pozitivan” (kada stanice raka imaju određenu promjenu na genu za bjelančevinu naziva FLT3).
English: By blocking FLT3, quizartinib is expected to stop cancer cells from multiplying and thus slow down the progression of the disease.
Croatian: Očekuje se da će kvizartinib blokiranjem gena FLT3 zaustaviti umnožavanje stanica raka i na taj način usporiti razvoj bolesti.
English: The company informed the Agency that there are no consequences for patients in clinical trials or in compassionate use programmes with Vanflyta.
Croatian: Tvrtka je obavijestila Agenciju da nema posljedica za bolesnike koji su uključeni u klinička ispitivanja ili programe milosrdnog davanja lijekova u kojima se koristi lijek Vanflyta.
English: The active substance in Vanflyta, quizartinib, is a ‘receptor tyrosine kinase inhibitor'.
Croatian: Djelatna tvar u lijeku Vanflyta, kvizartinib, inhibitor je tirozinske kinaze.
English: It works by blocking FLT3, a protein involved in cell growth and proliferation.
Croatian: Djeluje blokiranjem FLT3, gena za bjelančevinu uključenu u rast i širenje stanica.
English: Vanflyta was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 March 2009 for the treatment of AML.
Croatian: Lijek Vanflyta dobio je status lijeka za rijetke bolesti dana 23. ožujka 2009. za liječenje AML-a.
English: The protocols, abstracts and final study reports shall be submitted in the format set out in Annex III of Commission Implementing Regulation (EC) No 520/2012.
Croatian: Protokoli, sažeci i konačna izvješća istraživanja moraju se predati u obliku zadanom u Dodatku III dokumenta Commission Implementing Regulation (EU) br. 520/2012.
English: The MAH shall conduct a non-interventional post-authorisation safety study (PASS) to evaluate the safety of Targocid in adults with Gram-positive infections who are exposed to the higher loading dose of 12mg/kg twice a day (24 mg/kg/day).
Croatian: Sigurnosno istraživanje nakon izdavanja odobrenja (PASS) Nositelj odobrenja mora provesti neintervencijsko sigurnosno istraživanje nakon izdavanja odobrenja (PASS) kako bi se ocijenila sigurnost davanja viših početnih doza Targocida (12 mg/kg dvaput dnevno = 24 mg/kg/dnevno) odraslima s gram-pozitivnim infekcijama.
English: The study protocol shall be entered in the EU electronic register of post-authorisation studies (EU PAS Register) before the start of data collection.
Croatian: Protokol ovoga istraživanja mora se unijeti u elektronički registar istraživanja nakon izdavanja odobrenja EU-a (engl. EU PAS Register), a prije početka sakupljanja podataka.
English: The protocol of this non-interventional PASS shall be submitted within 2 months of the Commission Decision.
Croatian: Spomenuti protokol ovog neintervencijskog PASS-a mora se predati unutar 2 mjeseca od Odluke povjerenstva.
English: Risk management plan The MAH shall submit a RMP within 6 months of the Commission Decision.
Croatian: Plan upravljanja rizicima Nositelj odobrenja mora predati RMP unutar 6 mjeseci od Odluke povjerenstva.
English: This is a long-term treatment, possibly lasting for months or years.
Croatian: Ovo je dugoročno liječenje, koje može potrajati mjesecima ili godinama.
English: This will help you to remember to take your medicine.
Croatian: To će Vam pomoći prisjetiti se uzeti svoj lijek.
English: 22 August 2017
Croatian: 22. kolovoza 2017.
English: This leaflet was last revised in
Croatian: Ova uputa je zadnju puta revidirana u
English: • A treatment cycle lasts 28 days.
Croatian: • Ciklus liječenja traje 28 dana.
English: You may take it with or without food.
Croatian: Možete ga uzeti s hranom ili bez nje.
English: Ask your doctor about options for effective contraception.
Croatian: Upitajte svog liječnika o mogućnostima učinkovite kontracepcije.
English: It is very important to follow your doctor's instructions.
Croatian: Vrlo je važno da slijedite upute svog liječnika.
English: Your doctor, pharmacist or nurse will tell you exactly how many tablets to take and which days to take them on.
Croatian: Vaš će Vam liječnik, ljekarnik ili medicinska sestra reći koliko točno tableta trebate uzeti i u koje dane ih trebate uzimati.
English: This includes in particular:
Croatian: To naročito uključuje:
English: • If you have any problems with your liver or have previously had any type of liver disease.
Croatian: • Ako imate bilo kakve tegobe s jetrom ili ste prije imali bilo koju vrstu bolesti jetre.
English: This includes patients:
Croatian: To uključuje bolesnice:
English: Mark off circle for every tablet you take.
Croatian: Označite krug za svaku tabletu koju uzmete.
English: Overall survival, NSAI subgroup
Croatian: Ukupno preživljenje, NSAI podgrupa
English: Ask your doctor or pharmacist if you are not sure if your medicine is one of the medicines listed above.
Croatian: Upitajte svog liječnika ili ljekarnika ako niste sigurni je li Vaš lijek jedan od gore navedenih lijekova.
English: Number of patients still at risk
Croatian: Broj bolesnica još pod rizikom
English: Instead, wait until it is time for your next dose and then take your usual dose.
Croatian: Umjesto toga pričekajte dok ne dođe vrijeme za Vašu sljedeću dozu i potom uzmite svoju uobičajenu dozu.
English: Effect of age, weight, gender and race
Croatian: Učinak dobi, težine, spola i rase
English: • Reduced appetite
Croatian: • Smanjeni apetit
English: Do not exceed the recommended dose prescribed by your doctor.
Croatian: Nemojte prekoračiti preporučenu dozu koju Vam je propisao Vaš liječnik.
English: Kisqali with food and drink
Croatian: Kisqali s hranom i pićem
English: Anticipated interactions
Croatian: Očekivane interakcije
English: Blocking these proteins can slow down the growth of cancer cells and delay the progression of your cancer.
Croatian: Blokiranje ovih proteina može usporiti rast stanica raka i odgoditi napredovanje Vašeg raka.
English: Increases in transaminases were observed.
Croatian: Bile su opažene povišene vrijednosti transaminaza.
English: 34.1% of patients were de novo.
Croatian: 34,1% bolesnica bilo je de novo.
English: In 6 healthy male subjects, following a single oral dose of [
Croatian: U 6 zdravih muških ispitanika, nakon jednokratne peroralne doze [
English: • Strange taste in the mouth (dysgeusia)
Croatian: • Čudan okus u ustima (disgeuzija)
English: Children and adolescents Kisqali is not to be used in children and adolescents under 18 years of age.
Croatian: Djeca i adolescenti Kisqali se ne smije koristiti u djece i adolescenata mlađih od 18 godina.
English: - PFS based on investigator radiological assessment
Croatian: - PFS na temelju ispitivačeve radiološke procjene
English: No Kisqali this week.
Croatian: Bez Kisqalija ovaj tjedan.
English: All patients had an ECOG performance status of 0 or 1.
Croatian: Sve su bolesnice imale ECOG funkcionalno stanje 0 ili 1.
English: In vitro interaction data
Croatian: In vitro podaci o interakcijama
English: ) with clinically meaningful treatment effect.
Croatian: ) s klinički važnim terapijskim učinkom.
English: The treatment should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs.
Croatian: Liječenje je potrebno nastaviti dokle god bolesnica ima kliničke koristi od terapije ili dok ne dođe do neprihvatljive toksičnosti.
English: Grade 3* febrile neutropenia**
Croatian: Stupanj 3* febrilne neutropenije**
English: Kisqali should not be used during pregnancy since it may harm your unborn baby.
Croatian: Kisqali se ne smije primjenjivati tijekom trudnoće, jer može naškoditi Vašem nerođenom djetetu.
English: Data on differences in pharmacokinetics due to race are too limited to draw conclusions.
Croatian: Podaci o razlici u farmakokinetici uzrokovani rasom preograničeni su da bi se mogli izvući zaključci.
English: Your doctor will discuss with you the potential risks of taking Kisqali during pregnancy.
Croatian: Liječnik će razgovarati s Vama o mogućim rizicima uzimanja Kisqalija tijekom trudnoće.
English: Patients should be instructed to avoid grapefruit or grapefruit juice.
Croatian: Bolesnice treba uputiti da izbjegavaju grejp ili sok od grejpa.
English: Take your dose once a day for 3 weeks followed by a 1-week break.
Croatian: Uzimajte dozu jedanput na dan tijekom 3 tjedna, nakon čega slijedi stanka od 1 tjedan.
English: Do not stop taking Kisqali unless your doctor tells you to.
Croatian: Nemojte prestati uzimati Kisqali, osim ako Vam to ne kaže Vaš liječnik.
English: There was no evidence of embryo-foetal mortality.
Croatian: Nije bilo dokaza embriofetalnog mortaliteta.
English: In the event of an overdose, symptoms such as nausea and vomiting may occur.
Croatian: U slučaju predoziranja mogu se pojaviti simptomi poput mučnine i povraćanja.
English: Patients should be instructed to report any fever promptly.
Croatian: Bolesnice treba uputiti da bez odlaganja prijave svaku vrućicu.
English: The next prescribed dose should be taken at the usual time.
Croatian: Sljedeću propisanu dozu potrebno je uzeti u uobičajeno vrijeme.
English: • Shortness of breath, difficulty breathing
Croatian: • Nedostatak zraka, teškoće s disanjem
English: Overall response rate (ORR)
Croatian: Stopa ukupnog odgovora (ORR)
English: 200 mg*/day * If further dose reduction below 200 mg/day is required, the treatment should be permanently discontinued.
Croatian: 200 mg*/dan * Ako je potrebno daljnje smanjenje doze ispod 200 mg/dan, liječenje treba trajno prekinuti.
English: Dose interruption until recovery to grade ≤2.
Croatian: Prekid doziranja do oporavka na stupanj ≤2.
English: Kisqali may increase or decrease your blood levels of some other medicines.
Croatian: Kisqali može povisiti ili sniziti razinu nekih drugih lijekova u Vašoj krvi.
English: General supportive care should be initiated in all cases of overdosage as necessary.
Croatian: Općenito je potrebno započeti suportivno liječenje u svim slučajevima predoziranja prema potrebi.
English: Besides the atrophic changes seen in the testes, which showed a trend towards reversibility, all other changes were fully reversible after a 4-week treatment-free period.
Croatian: Pored atrofijskih promjena opaženih u testisima, koje su pokazivale trend ka reverzibilnosti, sve druge promjene bile su u potpunosti reverzibilne nakon 4 tjedna bez liječenja.
English: Critical visceral disease
Croatian: Kritična visceralna bolest
English: • with uncontrolled or significant cardiac disease, including recent myocardial infarction,
Croatian: • s nekontroliranom ili značajnom srčanom bolešću, što uključuje nedavni infarkt miokarda,
English: Hazard ratio is based on unstratified Cox model.
Croatian: Omjer hazarda je baziran na nestratificiranom Cox modelu.
English: CYP3A4 substrates
Croatian: CYP3A4 supstrati
English: Kisqali should be taken orally once daily with or without food.
Croatian: Kisqali se uzima peroralno jedanput na dan, uz hranu ili bez nje.
English: There is also potential to induce incidences of premature ventricular contractions (PVCs) at elevated exposures (approximately 5-fold the anticipated clinical Cmax).
Croatian: Također postoji potencijal induciranja slučajeva preuranjenih ventrikularnih kontrakcija (PVC) pri povišenim izloženostima (otprilike 5 puta većim od predviđenog kliničkog Cmax).
English: Kisqali may have minor influence on the ability to drive and use machines.
Croatian: Kisqali može imati mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: • Reduced level of calcium in the blood, which may sometimes lead to cramps
Croatian: • Snižena razina kalcija u krvi, koja ponekad može dovesti do grčeva
English: There were no reported cases of torsade de pointes.
Croatian: Nije bilo prijavljenih slučajeva torsade de pointes.
English: Ribociclib 334 294 277 257 240 227 207 196 188 176 164 132 97 46 Placebo 334 279 265 239 219 196 179 156 138 124 110 93
Croatian: Ribociklib 334 294 277 257 240 227 207 196 188 176 164 132 97 46 Placebo 334 279 265 239 219 196 179 156 138 124 110 93
English: Overall survival, overall study population
Croatian: Ukupno preživljenje, cjelokupna ispitivana populacija
English: If dose reduction is required, the recommended dose reduction guidelines are listed in Table 1.
Croatian: Ako je potrebno smanjiti dozu, smjernice za smanjenje preporučene doze navedene su u Tablici 1.
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
Croatian: Uz to, odgovarajuća kategorija učestalosti za svaku nuspojavu temelji se na sljedećoj konvenciji (CIOMS III): vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) or PA/alu/PVC (polyamide/aluminium/polyvinylchloride) blisters containing 14 or 21 film-coated tablets.
Croatian: PVC/PCTFE (polivinilklorid/poliklorotrifluoroetilen) ili PA/Al/PVC (poliamid/aluminij/polivinilklorid) blisteri koji sadrže 14 ili 21 filmom obloženu tabletu.
English: Take the next dose at your usual time.
Croatian: Uzmite sljedeću dozu u uobičajeno vrijeme.
English: Do not take this medicine if you notice any damage to the packaging or if there are any signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakvo oštećenje na pakiranju ili ako postoje znakovi neovlaštenog otvaranja.
English: The apparent volume of distribution at steady state (Vss/F) was 1090 L based on population pharmacokinetic analysis.
Croatian: Prividni volumen distribucije u stanju dinamičke ravnoteže (Vss/F) bio je 1090 l na temelju populacijske farmakokinetičke analize.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Croatian: Vaše stanje kako bi provjerio ima li terapija željeni učinak.
English: • Reduced level of phosphate in the blood
Croatian: • Snižena razina fosfata u krvi
English: Other side effects include the following listed below.
Croatian: Druge nuspojave uključuju niže navedene sljedeće nuspojave.
English: Patients should be encouraged to take their dose at approximately the same time each day, preferably in the morning.
Croatian: Bolesnicama treba savjetovati da uzimaju svoju dozu u otprilike isto vrijeme svakoga dana, po mogućnosti ujutro.
English: Event-free probability (%)
Croatian: Vjerojatnost izostanka događaja (%)
English: Reproductive toxicity/Fertility
Croatian: Reproduktivna toksičnost/plodnost
English: Enter weekdays starting with the 1st day of treatment.
Croatian: Upišite dane u tjednu počevši od prvog dana liječenja.
English: • Swollen hands, ankles or feet (peripheral oedema)
Croatian: • Oteknute ruke, gležnjevi ili stopala (periferni edem)
English: Therefore, Kisqali is unlikely to affect substrates of these enzymes.
Croatian: Stoga je malo vjerojatno da će Kisqali utjecati na supstrate tih enzima.
English: levofloxacin and azithromycin.
Croatian: levofloksacin i azitromicin.
English: What Kisqali is and what it is used for What you need to know before you take Kisqali How to take Kisqali
Croatian: Što je Kisqali i za što se koristi Što morate znati prije nego počnete uzimati Kisqali Kako uzimati Kisqali
English: Your heart activity will also be monitored before and during treatment with Kisqali with a test called an electrocardiogram (ECG).
Croatian: Također će se pratiti aktivnost Vašeg srca, prije i poslije liječenja Kisqalijem, pomoću pretrage koja se zove elektrokardiogram (EKG).
English: c p-values are obtained from one-sided Cochran-Mantel-Haenszel chi-square test
Croatian: c p-vrijednosti dobivene su iz jednostranog Cochran-Mantel-Haenszelovog hi-kvadrat testa
English: Before you take Kisqali, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines or supplements obtained without a prescription, because these may influence the effect of Kisqali.
Croatian: Prije nego što uzmete Kisqali, obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove ili dodatke prehrani dobivene bez recepta, jer oni mogu utjecati na učinak Kisqalija.
English: If you take more Kisqali than you should
Croatian: Ako uzmete više Kisqalija nego što ste trebali
English: The cyclin D-CDK4/6 complex regulates cell cycle progression through phosphorylation of the retinoblastoma protein (pRb).
Croatian: Kompleks ciklin DCDK4/6 regulira progresiju staničnog ciklusa putem fosforilacije retinoblastoma proteina (pRb).
English: Log-rank p-value = 0.00973
Croatian: Log-rang p-vrijednost = 0,00973
English: You should not eat grapefruits or drink grapefruit juice during your treatment with Kisqali.
Croatian: Ne biste smjeli jesti grejpfrut ili piti sok od grejpfruta tijekom svog liječenja Kisqalijem.
English: Kisqali works by blocking proteins called cyclin-dependent kinases 4 and 6, which are important for the growth and division of cells.
Croatian: Kisqali djeluje tako da blokira proteine zvane ciklin-ovisne kinaze 4 i 6, koji su važni za rast i diobu stanica.