natgillin/translations-raw huggingface dataset:
Common gastrointestinal bleeding*, colitis (including neutropaenic colitis), gastritis, mucosal inflammation (including mucositis/stomatitis), dyspepsia, abdominal distension, constipation, oral soft tissue disorder
Često gastrointestinalno krvarenje*, kolitis (uključujući neutropenijski kolitis), gastritis, upala sluznica (uključujući mukozitis/stomatitis), dispepsija, distenzija abdomena, konstipacija, poremećaji mekih tkiva usne šupljine Manje često pankreatitis (uključujući akutni pankreatitis), ulkus u gornjem dijelu gastrointestinalnog trakta, ezofagitis, ascites*, analna fisura, disfagija, gastroezofagealna refluksna bolest
Biochemistry
Biokemijske pretrage
Improvements in haemodynamic and clinical parameters have been observed in patients with PAH following discontinuation of dasatinib.
Nakon prekida primjene dasatiniba u bolesnika s PAH-om opažena su poboljšanja hemodinamskih i kliničkih parametara.
SPRYCEL 70 mg film-coated tablets dasatinib
SPRYCEL 70 mg filmom obložene tablete dasatinib
SPRYCEL 20 mg film-coated tablets
SPRYCEL 20 mg filmom obložene tablete
Table 8: CTC grades 3/4 haematological laboratory abnormalities in clinical studies in patients with resistance or intolerance to prior imatinib therapya
CTC stupnja u kliničkim ispitivanjima u bolesnika koji nisu podnosili prethodnu terapiju imatinibom ili su otporni na imatiniba
Tell your doctor if you are taking medicines to thin the blood or prevent clots.
Ako uzimate lijekove za razrjeđivanje krvi ili sprječavanje stvaranja krvnih ugrušaka, obavijestite o tome liječnika.
SPRYCEL 50 mg film-coated tablets dasatinib
SPRYCEL 50 mg filmom obložene tablete dasatinib
Adverse reaction
S ODGOVOROM
EU/1/06/363/004 - 56 film-coated tablets (blisters) EU/1/06/363/007 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/001 - 60 film-coated tablets (bottle)
EU/1/06/363/004 - 56 filmom obloženih tableta (blisteri) EU/1/06/363/007 - 60 x 1 filmom obložena tableta (blisteri djeljivi na jedinične doze) EU/1/06/363/001 - 60 filmom obloženih tableta (boca)
Imatinib-intolerant patients
bolesnici otporni na imatinib
Improvements in haemodynamic and clinical parameters have been observed in dasatinib-treated patients with PAH following cessation of dasatinib therapy.
Nakon prestanka terapije dasatinibom u bolesnika s PAH-om koji su primali dasatinib opažena su poboljšanja hemodinamskih i kliničkih parametara.
White to off-white, biconvex, oval film-coated tablet with "BMS 100" debossed on one side and "852" on the other side.
Bijela do gotovo bijela, bikonveksna ovalna filmom obložena tableta s oznakom "BMS 100" utisnutom s jedne i oznakom"852" s druge strane.
EU/1/06/363/005 - 56 film-coated tablets (blisters) EU/1/06/363/008 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/002 - 60 film-coated tablets (bottle)
EU/1/06/363/005 - 56 filmom obloženih tableta (blisteri) EU/1/06/363/008 - 60 x 1 filmom obložena tableta (blisteri djeljivi na jedinične doze) EU/1/06/363/002 - 60 filmom obloženih tableta (boca)
k Fluid overload, fluid retention, gastrointestinal oedema, generalised oedema, peripheral swelling, oedema, oedema due to cardiac disease, perinephric effusion, post procedural oedema, visceral oedema.
k Preopterećenje tekućinom, zadržavanje tekućine, gastrointestinalni edem, generalizirani edem, periferno oticanje, edem,
EU/1/06/363/006 - 56 film-coated tablets (blisters) EU/1/06/363/009 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/003 - 60 film-coated tablets (bottle)
EU/1/06/363/006 - 56 filmom obloženih tableta (blisteri) EU/1/06/363/009 - 60 x 1 filmom obložena tableta (blisteri djeljivi na jedinične doze) EU/1/06/363/003 - 60 filmom obloženih tableta (boca)
At all post-dose time points on day 8, the mean changes from baseline in QTcF interval were 4 - 6 msec, with associated upper 95% confidence intervals < 7 msec. Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received SPRYCEL in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction.
Produženja QTc intervala bila su prijavljena kao nuspojava u 15 (1%) od 2182 bolesnika koji ne podnose ili su otporni na prethodnu terapiju imatinibom, a koji su primali dasatinib u kliničkim ispitivanjima.
White to off-white, biconvex, triangular film-coated tablet with "BMS 80" debossed on one side and "855" on the other side.
Bijela do gotovo bijela, bikonveksna trokutasta filmom obložena tableta s oznakom "BMS 80" utisnutom s jedne i oznakom"855" s druge strane.
Median duration of treatment on dasatinib was 3 months with 7% of patients treated for > 24 months to date.
Medijan trajanja liječenja dasatinibom iznosio je 3 mjeseca s time da je 7% bolesnika do tada bilo liječeno >24 mjeseca.
White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "527" on the other side.
Bijela do gotovo bijela, bikonveksna okrugla filmom obložena tableta s oznakom "BMS" utisnutom s jedne i oznakom"527" s druge strane.
EU/1/06/363/015 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/014 - 30 film-coated tablets (bottle)
EU/1/06/363/015 - 30 x 1 filmom obložena tableta (blisteri djeljivi na jedinične doze) EU/1/06/363/014 - 30 filmom obloženeihtableta (boca)
White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "524" on the other side.
Bijela do gotovo bijela, bikonveksna okrugla filmom obložena tableta s oznakom "BMS" utisnutom s jedne i oznakom"524" s druge strane.
SPRYCEL 20 mg film-coated tablets dasatinib
SPRYCEL 20 mg filmom obložene tablete dasatinib
CHR Cytogenetic responsec (%) (95% CI)
Citogenetski odgovorc (%) (95% CI)
If you are breast-feeding, tell your doctor.
Ako dojite, obavijestite o tome liječnika.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
2. NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 140 mg dasatiniba (u obliku hidrata).
EU/1/06/363/011 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/010 - 30 film-coated tablets (bottle)
EU/1/06/363/011 - 30 x 1 filmom obložena tableta (blisteri djeljivi na jedinične doze) EU/1/06/363/010 - 30 filmom obloženih tableta (boca)
EU/1/06/363/013 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/012 - 30 film-coated tablets (bottle)
EU/1/06/363/013 - 30 x 1 filmom obložena tableta (blisteri djeljivi na jedinične doze) EU/1/06/363/012 - 30 filmom obloženihtableta (boca)
What SPRYCEL looks like and contents of the pack SPRYCEL 20 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “527” on the other side.
SPRYCEL 20 mg: filmom obložena tableta bijele do gotovo bijele boje, bikonveksna, okrugla, s oznakom “BMS” utisnutom s jedne i oznakom “527” s druge strane.
All patients
UDIO BOLESNIKA
With the bottle in an upright position, insert the tip of the syringe firmly into the bottle adapter.
Postavite bocu uspravno i gurnite vrh štrcaljke čvrsto u nastavak za bocu.
Inflammation of the lungs
Oštećenje funkcije bubrega
NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg tablets dasatinib
SPRYCEL 140 mg tablete dasatinib
e Includes drug eruption, erythema, erythema multiforme, erythrosis, exfoliative rash, generalised erythema, genital rash, heat rash, milia, miliaria, pustular psoriaisis, rash, rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, skin exfoliation, skin irritation, toxic skin eruption, urticaria vesiculosa, and vasculitic rash.
genitalni osip, toplinski osip, milia, milijariju, pustuloznu psorijazu, osip, eritematozni osip, folikularni osip, generalizirani osip, makularni osip, makulopapulozni osip, papulozni osip, pruritički osip, pustulozni osip, vezikularni osip, ljuštenje kože, nadraženost kože, toksičnu kožnu erupciju, vezikularnu urtikariju i vaskulitični osip. f Nakon stavljanja lijeka u promet prijavljeni su pojedinačni slučajevi Stevens-Johnson sindroma.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
2. NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 100 mg dasatiniba (u obliku hidrata).
n/a = not applicable; CI = confidence interval; ULN = upper limit of normal range.
MCyR (0%-35%) obuhvaća i potpuni i djelomični odgovor. n/p = nije primjenjivo CI = raspon pouzdanosti; GGN = gornja granica normalnog raspona.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
2. NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 80 mg dasatiniba (u obliku hidrata).
Reproductive system and breast disorders Uncommon gynecomastia, menstrual disorder General disorders and administration site conditions Very common peripheral oedemai, fatigue, pyrexia, face oedemaj
Poremećaji reproduktivnog sustava i dojki Manje često ginekomastija, menstrualni poremećaj Opći poremećaji i reakcije na mjestu primjene
b Includes central nervous system haemorrhage, cerebral haematoma, cerebral haemorrhage, extradural haematoma, haemorrhage intracranial, haemorrhagic stroke, subarachnoid haemorrhage, subdural haematoma, and subdural haemorrhage.
intrakranijalno krvarenje, hemoragijski moždani udar, subarahnoidalno krvarenje, subduralni hematom i subduralno krvarenje.
See the package leaflet for further information.
Za dodatne informacije pročitajte uputu o lijeku.
Active substances that may increase dasatinib plasma concentrations In vitro studies indicate that dasatinib is a CYP3A4 substrate.
In vitro ispitivanja pokazuju da je dasatinib supstrat enzima CYP3A4.
White to off-white, biconvex, oval film-coated tablet with "BMS" debossed on one side and "528" on the other side.
Bijela do gotovo bijela, bikonveksna ovalna filmom obložena tableta s oznakom "BMS" utisnutom s jedne i oznakom"528" s druge strane.
Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating dasatinib therapy.
Nakon povlačenja tih znakova i simptoma, a prije nastavka liječenja dasatinibom, mora se izvršiti procjena srčane funkcije.
Progression-free survivalb
Preživljenje bez progresije bolestib
These reactions are presented by system organ class and by frequency.
Nuspojave su prikazane prema klasifikaciji organskih sustava i učestalosti.
In patients with lymphoid blast phase CML treated with the 140 mg once daily regimen, the median duration of MaHR was 5 months, the median PFS was 5 months, and the median overall survival was 11 months.
U bolesnika s KML u mijeloidnoj blastnoj krizi liječenih dozom od 140 mg jedanput dnevno, medijan trajanja
Pyrexia
CCyRb
Median duration of treatment on dasatinib was 3 months with 2% treated for > 24 months to date.
Medijan trajanja liječenja dasatinibom iznosio je 3 mjeseca, s time da je do tada 2% bolesnika bilo liječeno >24 mjeseca.
b Haematologic response criteria (all responses confirmed after 4 weeks): Complete haematologic response (CHR) (chronic CML): WBC ≤ institutional ULN, platelets <450,000/mm3, no blasts or promyelocytes in peripheral blood, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <20%, and no extramedullary involvement.
CHR (kronična KML): Potpuni hematološki odgovor (CHR) (kronična KML): broj leukocita ≤ GGN za laboratorij, trombociti < 450 000/mm3, bez blasta ili promijelocita u perifernoj krvi, < 5% mijelocita plus metamijelociti u perifernoj krvi, bazofili u perifernoj krvi < 20%, i bez ekstramedularne bolesti.
Hepatic and renal impairment
Infekcije i infestacije
NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg film-coated tablets dasatinib
SPRYCEL 140 mg filmom obložene tablete dasatinib
Make sure you take SPRYCEL for as long as it is prescribed.
Uzimajte SPRYCEL onoliko dugo koliko je propisano.
Prior complete haematologic response (CHR) to imatinib was
Potpuni hematološki odgovor (CHR - engl. complete haematologic response) na prethodno liječenje imatinibom postiglo je 93% svih bolesnika.
CHR (chronic CML): WBC ≤ institutional ULN, platelets < 450,000/mm3, no blasts or promyelocytes in peripheral blood, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
broj leukocita ≤ GGN za laboratorij, trombociti < 450 000/mm3, bez blasta ili promijelocita u perifernoj krvi, < 5% mijelocita plus metamijelociti u perifernoj krvi, bazofili u perifernoj krvi < 20%, i bez ekstramedularne bolesti.
The mutations detected among the dasatinib-treated patients were T315I, F317I/L and V299L.
Mutacije T315I, F317I/L i V299L otkrivene su među bolesnicima liječenim dasatinibom dok je u skupini bolesnika liječenih imatinibom otkriven drugačiji spektar mutacija.
SPRYCEL is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.
SPRYCEL je indiciran u liječenju odraslih bolesnika kod: novodijagnosticirane kronične mijeloične leukemije (KML) s pozitivnim Philadelphia kromosomom (Ph+) u kroničnoj fazi. kronične faze, faze ubrzanja ili faze blastne krize KML uz nepodnošenje ili otpornost na prethodnu terapiju, uključujući imatinib.
Table 4: Dose adjustments for neutropaenia and thrombocytopaenia in paediatric patients with Ph+ CML-CP
Tablica 4: Prilagodbe doze zbog neutropenije i trombocitopenije u pedijatrijskih bolesnika s
Blood and lymphatic system disorders
Oštećenje funkcije jetre i bubrega
Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in paediatric patients with Ph+ CML-CP
Tablica 3: Prilagodbe doze zbog neutropenije i trombocitopenije u pedijatrijskih bolesnika s
If you are sick
Ako ste bolesni
Talk to your doctor if you are not sure you can drive.
Obratite se liječniku ako niste sigurni možete li voziti.
Specific inducers of these enzymes have not been studied and may result in a loss of efficacy.
Specifični induktori ovih enzima nisu proučavani i mogu dovesti do smanjenja djelotvornosti.
These data show that the efficacy of the combination would be lower in these patients.
Ovi podaci ukazuju da će djelotvornost te kombinacije biti smanjena u ovih bolesnika.
Gilbert's syndrome
Gilbertov sindrom
EU/1/18/1315/001 84 film-coated tablets EU/1/18/1315/002 168 film-coated tablets
EU/1/18/1315/001 84 filmom obložene tablete EU/1/18/1315/002 168 filmom obložene tablete
Mektovi can be taken with food or between meals.
Lijek Mektovi može se uzeti s hranom ili između obroka.
It may cause permanent harm or birth defects to an unborn baby.
Može uzrokovati trajno oštećenje ili prirođene mane u nerođenog djeteta.
• red or black stools that look like tar
• crvenu ili crnu stolicu koja izgleda poput katrana
As a precaution, drink plenty of fluids during treatment.
Kao mjeru opreza, pijte puno tekućine tijekom liječenja.
Mektovi is not recommended for children and adolescents under 18 years of age.
Lijek Mektovi ne preporučuje se djeci i adolescentima mlađim od 18 godina.
PVC/PVDC/Alu blister containing 12 tablets.
PVC/PVDC/Al blister sadrži 12 tablete.
• vomit containing blood or that looks like “coffee grounds”
• povraćanje koje sadrži krv ili izgleda kao „talog kave”
a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
Cancer Institute Common Terminology Criteria for Adverse Events, NCI CTCAE) verzija 4.03
The tablets are to be swallowed whole with water.
Tablete treba progutati cijele s vodom.
If you miss a dose of Mektovi, take it as soon as you remember.
Ako propustite dozu lijeka Mektovi, uzmite je čim se sjetite.
Women of childbearing potential/Contraception in females
Žene u reproduktivnoj dobi / Kontracepcija u žena
Each pack contains either 84 or 168 tablets.
Svako pakiranje sadrži 84 ili 168 tablete.
Then continue taking your tablets at regular times as usual.
Zatim nastavite s uzimanjem tableta po uobičajenom rasporedu.
(11.1, NE)
(11,1; NP)
If you vomit at any time after taking Mektovi, do not take an additional dose.
Ako budete povraćali u bilo kojem trenutku nakon uzimanja lijeka Mektovi, nemojte uzimati dodatnu dozu.
In particular, tell your doctor if you are taking anything in this list or any other medicines:
Posebno, obavijestite svojeg liječnika ako uzimate bilo koji lijek s ove liste ili bilo koji drugi lijek:
Visual impairment was generally reversible.
Poremećaj vida uglavnom je bio reverzibilan.
You will also receive treatment with another medicine, encorafenib.
Također ćete biti liječeni i drugim lijekom, enkorafenibom.
There is no specific treatment of overdose.
Nema specifičnog liječenja predoziranja.
These differences were within the variability observed for these parameters in both cohorts of this study (25 % - 49 %) and the variability previously observed in patient clinical studies, hence these differences are unlikely to be clinically relevant.
Te su razlike bile unutar varijabilnosti primijećene za te parametre u objema skupinama ovog ispitivanja (25% - 49%) i varijabilnosti prethodno primijećene u kliničkim ispitivanjima bolesnika, stoga te razlike vjerojatno nisu klinički relevantne.
LVEF should be evaluated every 2 weeks.
Treba procijeniti LVEF svaka 2 tjedna.
Tell your doctor immediately if you have any of the following serious side effects, either for the first time or if they get worse (see also section 2).
Odmah obavijestite svog liječnika ako primijetite bilo koju od sljedećih ozbiljnih nuspojava po prvi put ili ako se nuspojave pogoršaju (vidjeti također dio 2).
If you take more Mektovi than you should
Ako uzmete više lijeka Mektovi nego što ste trebali
• heart problems
• srčane probleme
• bleeding problems or if you are taking medicines that may cause bleeding
• probleme s krvarenjem ili ako uzimate lijekove koji mogu uzrokovati krvarenje
Therapy should be discontinued if the patient is not able to tolerate 30 mg orally twice daily.
Terapija se mora prekinuti ako bolesnik ne može tolerirati 30 mg peroralno dvaput na dan.
Treatment continued until disease progression or unacceptable toxicity.
Liječenje se nastavilo do progresije bolesti ili do neprihvatljive toksičnosti.
Before starting treatment your doctor will check for BRAF mutation.
Prije početka liječenja, Vaš će liječnik provjeriti prisustvo BRAF mutacije.
The efficacy results based on investigator assessment were consistent with the independent central assessment.
Rezultati djelotvornosti temeljeni na ocjeni ispitivača bili su u skladu s neovisnom središnjom procjenom.
Tell your doctor right away if you have any unusual bleeding or signs of bleeding, including:
Odmah obavijestite svog liječnika ako imate bilo kakve neobična krvarenja ili znakove krvarenja, uključujući i sljedeće:
Prior treatment with BRAF/MEK inhibitors was not allowed.
Prethodno liječenje s BRAF/MEK inhibitorima nije bilo dozvoljeno.
In humans, the blood-to-plasma ratio is 0.718.
U ljudi, taj omjer između krvi i plazme je 0,718.
What Mektovi is and what it is used for
Što je lijek Mektovi i za što se koristi
The safety and efficacy of binimetinib in children and adolescents have not yet been established.
Sigurnost i djelotvornost binimetiniba u djece i adolescenata nije još ustanovljena.
LVD was generally reversible following dose reduction or dose interruption.
LVD je općenito bio reverzibilan nakon smanjenja ili obustavljanja doze.
Mutations in the BRAF gene can produce proteins that cause the melanoma to grow.
Mutacije u BRAF genu mogu stvoriti proteine koji prouzrokuju rast melanoma.
If you get serious side effects (such as heart, eye or skin problems) your doctor may lower the dose or stop treatment temporarily or permanently.
Ako dobijete ozbiljne nuspojave (poput srčanih, problema s očima ili problema s kožom), liječnik može smanjiti dozu ili privremeno odnosno trajno prekinuti liječenje.
What you need to know before you take Mektovi
Što morate znati prije nego počnete uzimati lijek Mektovi
Adverse reactions are listed below by MedDRA body system organ class and the following frequency convention: 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).
Nuspojave su navedene ispod prema MedDRA klasifikaciji organskih sustava i sljedećim kategorijama učestalosti: 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).
This is a precaution in case a squamous cell carcinoma develops inside your body.
Ovo je mjera opreza za slučaj nastanka tvorbe planocelularnog karcinoma unutar Vašeg tijela.
In melanoma and other cancers, this pathway is often activated by mutated forms of BRAF which activates MEK.
Kod melanoma i drugih vrsta raka taj put često aktiviraju mutirani oblici BRAF-a koji aktivira MEK.
Binimetinib is more distributed in plasma than blood.
Binimetinib se više distribuira u plazmi nego u krvi.
Your doctor will check your skin before initiation of treatment, every 2 months during treatment, and for up to 6 months after you stop taking these medicines to look for any new skin cancer.
Liječnik će provjeriti vašu kožu prije početka liječenja, potom svaka 2 mjeseca tijekom liječenja te do 6 mjeseci nakon što prestanete uzimati te lijekove da bi provjerio eventualnu pojavu bilo kakvog novog raka kože.
• unusual vaginal bleeding
• neuobičajeno vaginalno krvarenje
Do not take Mektovi if you are allergic to binimetinib or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati lijek Mektovi ako ste alergični na binimetinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
LVEF should be evaluated every 2 weeks until recovery.
Treba procijeniti LVEF svaka 2 tjedna do oporavka.
All events occurred in the setting of new or progressive brain metastases.
Svi događaji su se dogodili kod bolesnika s pojavom novih ili progresijom postojećih metastaza na mozgu.
• Heart problems: Mektovi can make your heart work less well, or make existing heart problems worse.
• Srčani problemi: lijek Mektovi može učiniti da Vaše srce slabije radi ili pogoršati postojeće srčane probleme.
If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Ako dođe do predoziranja, bolesnika se mora liječiti potpornim mjerama uz odgovarajući nadzor prema potrebi.
In the small group of patients aged ≥ 75 years (n=15), patients were more likely to experience serious adverse events and adverse events leading to discontinuation of treatment.
≥ 75 godina (n=15), bolesnici su imali veću šansu doživjeti ozbiljne štetne događaje i štetne događaje koje dovode do trajne obustave liječenja.
CI = confidence interval; CR = complete response; DCR = disease control rate (CR+PR+SD+NonCR/Non-PD; Non-CR/Non-PD applies only to patients without a target lesion who did not achieve CR or have PD); HR = hazard ratio; NE = not estimable; PFS = progression-free survival; PR = partial response; SD = stable disease.
CI (confidence interval) = interval pouzdanosti; CR (complete response) = potpuni odgovor; DCR (disease control rate) = stopa kontrole bolesti (CR+PR+SD+Ne-CR/Ne-PD; Ne-CR/Ne-PD odnosi se samo na bolesnike bez ciljne lezije koji nisu ostvarili CR ili imali progresivno oboljenje); HR (hazard ratio) = omjer hazarda; NP = ne može se procijeniti; PFS (progression-free survival) = preživljenje bez progresije; PR (partial response) = djelomični odgovor; SD (stable disease) = stabilna bolest.
Frequency (All grades)
Učestalost (svi stupnjevi)
If you are a woman who could become pregnant, you must use reliable contraception while you are taking Mektovi, and you must continue to use reliable contraception at least 1 month after taking your last dose.
Ako ste žena koja bi mogla zatrudnjeti, morate koristiti pouzdanu kontracepciju dok uzimate lijek Mektovi i morate nastaviti s pouzdanom kontracepcijom najmanje 1 mjesec nakon uzimanja zadnje doze.
• Recurrent or intolerable Grade 2 adverse reactions
• Ponovljene ili nepodnošljive nuspojave stupnja 2
• Symptomatic RPED (Grade 4) associated with reduced visual acuity (Grade 4)
• Simptomatski RPED (stupanj 4) povezan sa smanjenom vidnom oštrinom (stupanj 4)