natgillin/translations-raw huggingface dataset:
Therefore, in patients receiving dasatinib, coadministration of a potent CYP3A4 inhibitor is not recommended (see section 4.5).
Pri bolnikih, ki se zdravijo z dasatinibom, sočasnega zdravljenja z močnimi zaviralci CYP3A4 ne priporočamo (glejte poglavje 4.5).
Not known hepatitis B reactivation
Neznana pogostnost reaktivacija hepatitisa B Bolezni krvi in limfatičnega sistema
SPRYCEL 20 mg film-coated tablets
SPRYCEL 20 mg filmsko obložene tablete
Table 1: Dosage of SPRYCEL tablets for paediatric patients with Ph+ CML-CP or Ph+ ALL Body weight (kg)a
Odmerjanje zdravila SPRYCEL v obliki tablet pri pediatričnih bolnikih s Ph+ KML-KO ali Ph+ ALL
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.
Vsi bolniki Bolniki, odporni na imatinib a Rezultati pri uporabi priporočenega začetnega odmerka 100 mg enkrat na dan. b Kriteriji hematološkega odziva (vsi odzivi potrjeni po 4 tednih): Popoln hematološki odziv (CHR) (KML v kroničnem obdobju): število belih krvnih celic ≤ zgornje meje referenčnih vrednosti, trombociti < 450.000/mm3, brez blastov ali promielocitov v periferni krvi, < 5% mielocitov in metamielocitov v periferni krvi, < 20% bazofilcev v periferni krvi in brez ekstramedularne vpletenosti.
SPRYCEL 50 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS” debossed on one side and “528” on the other side.
SPRYCEL 50 mg: bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako “BMS” na eni in “528” na drugi strani.
SPRYCEL 80 mg: the film-coated tablet is white to off-white, biconvex, triangular with “BMS 80” debossed on one side and “855” on the other side.
SPRYCEL 80 mg: bele do sivobele, bikonveksne in trikotne filmsko obložene tablete z oznako “BMS 80” na eni in “855” na drugi strani.
By 3 years 24%, p<.0013
V 3 letih p<0,0013
Rare anaphylactic shock Endocrine disorders Uncommon hypothyroidism
Redki anafilaktični šok Bolezni endokrinega sistema
Allow a washout period of approximately 1 week after the inhibitor is stopped before reinitiating SPRYCEL.
Pred ponovno uvedbo zdravljenja z zdravilom SPRYCEL naj obdobje izpiranja po prekinitvi zdravljenja z zaviralcem traja približno 1 teden.
SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS 100” debossed on one side and “852” on the other side.
SPRYCEL 100 mg: bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako “BMS 100” na eni in “852” na drugi strani.
CHR Cytogenetic responsec (%) (95% CI)
Citogenetski odzivc (%) (95% IZ)
White to off-white, biconvex, oval film-coated tablet with "BMS 100" debossed on one side and "852" on the other side.
Bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako "BMS 100" na eni in "852" na drugi strani.
SPRYCEL 70 mg film-coated tablets dasatinib
SPRYCEL 70 mg filmsko obložene tablete dasatinib
Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Ena filmsko obložena tableta vsebuje 70 mg dasatiniba (v obliki monohidrata).
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 filmsko obloženih tablet (pretisni omoti) EU/1/06/363/007 - 60 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/001 - 60 filmsko obloženih tablet (plastenka)
Table 11: Efficacy in phase II SPRYCEL single-arm clinical studiesa Chronic (n= 387)
Učinkovitost zdravila SPRYCEL v enoskupinskih (“single-arm”) kliničnih preskušanjih II fazea
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 filmsko obloženih tablet (pretisni omoti) EU/1/06/363/008 - 60 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/002 - 60 filmsko obloženih tablet (plastenka)
Cardiac adverse reactions
Neželeni učinki za srce
PROPORTION RESPONDERS
RAZMERJE
SPRYCEL 50 mg film-coated tablets dasatinib
SPRYCEL 50 mg filmsko obložene tablete dasatinib
Notably, 22% of patients reported a complete cytogenetic response (CCyR) in the dasatinib arm while only 8% achieved a CCyR in the imatinib arm. With longer treatment and follow-up (median of 24 months), MCyR was achieved in 53% of the dasatinib-treated patients (CCyR in 44%) and 33% of the imatinib-treated patients (CCyR in 18%) prior to crossover.
Pri daljšem zdravljenju in spremljanju (v povprečju 24 mesecev) je bil dober citogenetski odziv dosežen pri 53% bolnikov, ki so se zdravili z dasatinibom (popoln citogenetski odziv pri 44%), in 33% bolnikov, ki so se zdravili z imatinibom (popoln citogenetski odziv pri 18%) pred zamenjavo zdravljenja.
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 filmsko obloženih tablet (pretisni omoti) EU/1/06/363/009 - 60 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/003 - 60 filmsko obloženih tablet (plastenka)
White to off-white, biconvex, triangular film-coated tablet with "BMS 80" debossed on one side and "855" on the other side.
Bele do sivobele, bikonveksne in trikotne filmsko obložene tablete z oznako "BMS 80" na eni in "855" na drugi strani.
The mean Cmax and AUC of dasatinib adjusted for the 70 mg dose were decreased by 47% and 8%, respectively, in subjects with moderate hepatic impairment compared to subjects with normal hepatic function.
V primerjavi z osebami z normalnim delovanjem jeter sta bili pri osebah z zmerno okvaro jeter srednji vrednosti Cmax in AUC dasatiniba, prilagojeni na 70 mg odmerek dasatiniba, manjši, in sicer Cmax za 47%, AUC pa za 8%.
Not known fatal gastrointestinal haemorrhage* Hepatobiliary disorders
Neznana pogostnost usodna gastrointestinalna krvavitev* Bolezni jeter, žolčnika in žolčevodov
Haematologic response rateb (%) (95% CI)
Delež hematološkega odzivab (%) (95% IZ)
Table 10: Dasatinib patients with BCR-ABL ≤ 10% and > 10% at 3 months
Bolniki, ki so se zdravili z dasatinibom, in so imeli v 3. mesecu vrednost BCR-ABL ≤ 10% in > 10%
Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weak heart muscle, high blood pressure, increased blood pressure in the lungs, cough Digestive problems: appetite disturbances, taste disturbance, bloated or distended tummy (abdomen), inflammation of the colon, constipation, heartburn, mouth ulceration, weight increase, weight decrease, gastritis
Srce in pljuča: razbijanje srca, motnje srčnega ritma, kongestivno srčno popuščanje, oslabelost srčne mišice, visok krvni tlak, zvišan krvni tlak v pljučih in kašelj.
CHR (advanced CML/Ph+ ALL): WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Popoln hematološki odziv (KML v napredovalem obdobju/Ph+ ALL): število belih krvnih celic ≤ zgornje meje referenčnih vrednosti, absolutno število nevtrofilcev ≥ 1.000/mm3, trombociti ≥ 100.000/mm3, brez blastov ali promielocitov v periferni krvi, blasti v kostnem mozgu ≤ 5%, < 5% mielocitov in metamielocitov v periferni krvi, < 20% bazofilcev v periferni krvi in brez ekstramedularne vpletenosti.
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 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/014 - 30 filmsko obloženih tablet (plastenka)
SPRYCEL 20 mg film-coated tablets dasatinib
SPRYCEL 20 mg filmsko obložene tablete dasatinib
White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "527" on the other side.
Bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako "BMS" na eni in "527" na drugi strani.
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 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/010 - 30 filmsko obloženih tablet (plastenka)
Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Ena filmsko obložena tableta vsebuje 20 mg dasatiniba (v obliki monohidrata).
SPRYCEL contains sucrose
Zdravilo SPRYCEL vsebuje saharozo
Dasatinib is extensively metabolised in humans with multiple enzymes involved in the generation of the metabolites.
Pri nastanku presnovkov so vključeni številni encimi.
By 4 years 73%, p<.0021
V 4 letih p<0,0021
Imatinib-intolerant patients 100% (100, 100) 95% (88, 100)
SMRTI / Št. zajetih bolnikov MEDIANA (95% IZ) RAZMERJE OGROŽENOSTI (95% IZ)
j Conjunctival oedema, eye oedema, eye swelling, eyelid oedema, face oedema, lip oedema, macular oedema, oedema mouth, orbital oedema, periorbital oedema, swelling face.
ij Edem veznic, očesni edem, oteklina oči, edem očesnih vek, edem obraza, edem ustnic, makularni edem, edem ust,
Guidelines for dose modifications in paediatric patients with CML-CP are summarised in Table 3.Guidelines for paediatric patients with Ph+ ALL treated in combination with chemotherapy are in a separate paragraph following the table.
Smernice za pediatrične bolnike s Ph+ ALL, ki se zdravijo v kombinaciji s kemoterapijo, so navedene v ločenem odstavku, ki sledi preglednicam.
Common weight decreased, weight increased
Pogosti zmanjšanje telesne mase, povečanje telesne mase
Forty-two percent of the imatinib-resistant patients with no prior MCyR to imatinib (n= 188) achieved a MCyR with dasatinib.
Pri uporabi dasatiniba je bil dober citogenetski odziv dosežen pri 42% bolnikov, odpornih na imatinib, pri katerih dober citogenetski odziv na zdravljenje z imatinibom (n = 188) ni bil dosežen.
White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "524" on the other side.
Bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako "BMS" na eni in "524" na drugi strani.
CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Popoln hematološki odziv (CHR): število belih krvnih celic ≤ zgornje meje referenčnih vrednosti, absolutno število nevtrofilcev ≥ 1.000/mm3, trombociti ≥ 100.000/mm3, brez blastov ali promielocitov v periferni krvi, blasti v kostnem mozgu ≤ 5%, < 5% mielocitov in metamielocitov v periferni krvi, < 20% bazofilcev v periferni krvi in brez ekstramedularne vpletenosti.
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 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/012 - 30 filmsko obloženih tablet (plastenka)
Pain: pain in the muscles (during or after discontinuing treatment), tummy (abdominal) pain Tests may show: low blood platelet count, low white blood cells count (neutropaenia), anaemia, fluid around the lungs
Preiskave lahko pokažejo: zmanjšano število trombocitov, zmanjšano število belih krvnih celic (nevtropenija), anemijo in tekočino okrog pljuč.
Escalation
Povečanje
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.
Popoln hematološki odziv (KML v kroničnem obdobju): število belih krvnih celic ≤ zgornje meje referenčnih vrednosti, trombociti < 450.000/mm3, brez blastov ali promielocitov v periferni krvi, < 5% mielocitov in metamielocitov v periferni krvi, < 20% bazofilcev v periferni krvi in brez ekstramedularne vpletenosti.
One-level dose reduction
Odmerek, zmanjšan za eno stopnjo
Four single-arm, uncontrolled, open-label Phase II clinical studies were conducted to determine the safety and efficacy of dasatinib in patients with CML in chronic, accelerated, or myeloid blast phase, who were either resistant or intolerant to imatinib.
Za določitev varnosti in učinkovitosti dasatiniba pri bolnikih s KML v kroničnem obdobju, obdobju pospešenega poteka ali obdobju mieloblastne preobrazbe, ki se na zdravljenje z imatinibom niso odzvali ali ga niso prenašali, so bile izvedene štiri enoskupinske (“single-arm”), nenadzorovane, odprte klinične študije II.
Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Ena filmsko obložena tableta vsebuje 50 mg dasatiniba (v obliki monohidrata).
SPRYCEL must be administered orally.
Zdravilo SPRYCEL je namenjeno za peroralno uporabo.
White to off-white, biconvex, oval film-coated tablet with "BMS" debossed on one side and "528" on the other side.
Bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako "BMS" na eni in "528" na drugi strani.
Prior imatinib (N = 46)b a Patients from Phase II paediatric study of newly diagnosed CML-CP receiving oral tablet formulation b Patients from Phase I and Phase II paediatric studies of imatinib-resistant or intolerant CML-CP receiving oral tablet formulation
Predhodno imatinib (N = 46)b a Bolniki iz pediatričnih študij II.
Not known thrombotic microangiopathy Respiratory, thoracic and mediastinal disorders Very common pleural effusion*, dyspnoea
Neznana pogostnost trombotična mikroangiopatija Bolezni dihal, prsnega koša in mediastinalnega prostora
An open-label, single-arm, multicentre study was conducted in patients intolerant or resistant to imatinib.
Pri bolnikih, ki imatiniba niso prenašali ali so bili nanj odporni, je bila izvedena odprta, enoskupinska (“single-arm”), multicentrična študija.
The majority of SPRYCEL-treated patients experienced adverse reactions at some time.
V določenem času so se neželeni učinki pojavili pri večini z zdravilom SPRYCEL zdravljenih bolnikov.
Progression-free survivalb
Preživetje brez napredovanja boleznib
achieved in 93% of the overall patient population.
Predhodni popolni hematološki odziv na imatinib je bil dosežen pri 93% vseh bolnikov.
You cannot be sure you will receive the correct dose if you crush, cut, chew or disperse the tablets.
Če zdrobite, razpolovite, žvečite ali raztopite tablete, ne morete vedeti zagotovo, če boste prejeli pravi odmerek.
CHR (95% CI) NEL (95% CI)
MaHRb (95% IZ) CHRb (95% IZ) NELb (95% IZ) MCyRc (95% IZ) CCyR (95% IZ)
By 1 year 46%, p<.0001
V 1 letu p<0,0001
Very common haemorrhage*d Common hypertension, flushing Uncommon hypotension, thrombophlebitis, thrombosis
Občasni hipotenzija, tromboflebitis, tromboza
By 2 years 64%, p<.0001
V 2 letih p<0,0001
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.
V vseh časovnih točkah po odmerku na 8. dan so bile srednje spremembe od izhodišča v intervalu QTcF 4 -6 milisekund, s pridruženimi zgornjimi 95-odstotnimi intervali zaupanja < 7 milisekund.
Dasatinib should be administered with caution to patients who have or may develop prolongation of QTc.
Pri bolnikih s podaljšanim intervalom QTc oziroma bolnikih, pri katerih bi se podaljšanje intervala QTc lahko pojavilo, je potrebna previdnost pri predpisovanju dasatiniba.
Median duration of treatment on dasatinib was 3 months with 2% treated for > 24 months to date.
Zdravljenje z dasatinibom je v povprečju trajalo 3 mesece, pri 2% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev.
Common asthenia, pain, chest pain, generalised oedema*k, chills Uncommon malaise, other superficial oedemal
Pogosti astenija, bolečina, bolečina v prsih, generalizirani edem*k, mrzlica
b Includes central nervous system haemorrhage, cerebral haematoma, cerebral haemorrhage, extradural haematoma, haemorrhage intracranial, haemorrhagic stroke, subarachnoid haemorrhage, subdural haematoma, and subdural haemorrhage.
b Vključuje krvavitve v osrednjem živčevju, cerebralni hematom, cerebralno krvavitev, ekstraduralni hematom,
NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg film-coated tablets dasatinib
SPRYCEL 140 mg filmsko obložene tablete dasatinib
Other secondary endpoints included duration of MCyR, PFS, and overall survival.
Drugi sekundarni opazovani dogodki so vključevali trajanje dobrega citogenetskega odziva, preživetje brez progresije bolezni (PFS - “progression-free survival”) in skupno preživetje.
An open-label, single-arm, multicentre study was conducted in patients with lymphoid blast phase CML or Ph+ ALL who were resistant or intolerant to prior imatinib therapy.
Pri bolnikih s KML v obdobju limfoblastne preobrazbe ali s Ph+ ALL, ki imatiniba niso prenašali ali pa so bili na predhodno zdravljenje z imatinibom odporni, je bila izvedena odprta, enoskupinska (“single-arm”), multicentrična študija.
Prior complete haematologic response (CHR) to imatinib was
Popoln hematološki odziv (CHR)
Ninety-three percent of patients in the dasatinib arm and 82% of patients in the imatinib arm achieved a CHR prior to crossover.
V skupini, ki je prejemala dasatinib, je bil pred prehodom v skupino z alternativnim zdravljenjem popolni hematološki odziv dosežen pri 93% bolnikov, v skupini, ki je prejemala imatinib, pa pri 82% bolnikov.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
Ena filmsko obložena tableta vsebuje 140 mg dasatiniba (v obliki monohidrata).
However, SPRYCEL should be used with caution in patients with hepatic impairment (see section 5.2).
Pri bolnikih z blago, zmerno ali s hudo okvaro jeter se zdravljenje lahko uvede s priporočenim začetnim odmerkom, vendar pa je pri bolnikih z okvaro jeter kljub temu potrebna previdnost pri uporabi zdravila SPRYCEL (glejte poglavje 5.2).
• spread to other parts of the body or cannot be removed by surgery.
• se je razširila na druge dele telesa ali je ni mogoče kirurško odstraniti.
They may be taken with or without food.
Lahko se jemljejo skupaj s hrano ali brez.
Specific inducers of these enzymes have not been studied and may result in a loss of efficacy.
Specifični induktorji teh encimov se niso preučevali in lahko povzročijo izgubo učinkovitosti.
These data show that the efficacy of the combination would be lower in these patients.
Ti podatki kažejo, da je učinkovitost uporabe te kombinacije pri teh bolnikih nižja.
Then continue taking your tablets at regular times as usual.
Nato tablete jemljite redno kot običajno.
EU/1/18/1315/001 84 film-coated tablets EU/1/18/1315/002 168 film-coated tablets
EU/1/18/1315/001 84 filmsko obloženih tablet EU/1/18/1315/002 168 filmsko obloženih tablet
PFS as assessed by investigators (investigator assessment) was a supportive analysis.
PFS, kot so ga ocenili raziskovalci (ocenjevanje raziskovalcev), je predstavljal podporno analizo.
All events occurred in the setting of new or progressive brain metastases.
Vsi dogodki so se zgodili v primeru novih ali napredujočih metastaz v možganih.
If necessary, your doctor may interrupt your treatment or stop it altogether.
Po potrebi zdravnik lahko prekine zdravljenje ali ga v celoti preneha izvajati.
Confirmed overall responses
Potrjeni skupni odzivi
Patients should be assessed at each visit for symptoms of new or worsening visual disturbances.
Bolnike je treba ob vsakem obisku pregledati za simptome novih ali poslabšanih motenj vida.
LVEF should be evaluated every 2 weeks.
LVEF je treba oceniti vsaka 2 tedna.
Mektovi is not recommended for children and adolescents under 18 years of age.
Zdravilo Mektovi se ne priporoča za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
Visual impairment was generally reversible.
Okvara vida je bila večinoma reverzibilna.
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 razlike so v obsegu variabilnosti, ki so jo opazili za te parametre pri obeh kohortah te študije (od 25 % do 49 %), in variabilnosti, ki so jo predhodno opazili pri bolnikih v kliničnih študijah, zato ni verjetno, da so te razlike klinično pomembne.
• a particular change (mutation) in a gene responsible for producing a protein called BRAF, and
• pri kateri je prišlo do posebne spremembe (mutacije) gena, ki proizvaja protein z imenom BRAF, ter
• red or black stools that look like tar
• rdeče ali črno blato, ki je videti kot katran,
Dose modifications recommendations in case of adverse reactions are presented below and in Tables 1 and 2.
Priporočene spremembe odmerka v primeru neželenih učinkov so navedene spodaj in v preglednicah 1 in 2.
The safety and efficacy of binimetinib in children and adolescents have not yet been established.
Varnost in učinkovitost zdravila binimetinib pri otrocih in mladostnikih še nista bili dokazani.
Mektovi can be taken with food or between meals.
Zdravilo Mektovi se lahko jemlje skupaj s hrano ali med obroki.
You will also receive treatment with another medicine, encorafenib.
Zdravili se boste še z enim zdravilom, enkorafenibom.
As a precaution, drink plenty of fluids during treatment.
Kot previdnostni ukrep med zdravljenjem pijte veliko tekočin.
Genital examinations (for women) and anal examinations are also recommended before the initiation and at the end of your treatment.
Pregledi spolovil (za ženske) in analni pregledi se prav tako priporočajo pred začetkom zdravljenja in na koncu zdravljenja.
Similar results were observed per Investigator assessment.
Podobni rezultati so se pokazali tudi pri posameznih ocenah raziskovalca.
The efficacy results based on investigator assessment were consistent with the independent central assessment.
Rezultati učinkovitosti po oceni raziskovalcev so se ujemali z rezultati neodvisnega centralnega ocenjevanja.
Each pack contains either 84 or 168 tablets.
Eno pakiranje vsebuje 84 ali 168 tablet.
Binimetinib is more distributed in plasma than blood.
Binimetinib je bolj porazdeljen v plazmi kot v krvi.
Table 4 and Figure 1 summarise the PFS and other efficacy results based on central review of the data by a blinded independent radiology committee.
preglednici 4 in na sliki 1 je povzetek vrednosti PFS in drugih rezultatov učinkovitosti glede na centralni pregled podatkov, ki ga je izvedel neodvisni slepi radiološki odbor.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V vsaki skupini pogostnosti so neželeni učinki razvrščeni padajoče po resnosti.
• unusual vaginal bleeding
• nenavadno vaginalno krvavenje.
What you need to know before you take Mektovi 3.
Kaj morate vedeti, preden boste vzeli zdravilo Mektovi 3.
Updated analysis, cut-off date: 07 November 2017
Posodobljena analiza, končni datum: 7. november 2017
If you miss a dose of Mektovi, take it as soon as you remember.
Če pozabite vzeti odmerek zdravila Mektovi, ga vzemite takoj, ko se spomnite.
There is no specific treatment of overdose.
Za preveliko odmerjanje ni specifičnega zdravljenja.
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.
Zdravnik vam bo kožo pregledal pred začetkom zdravljenja in na vsaka 2 meseca med zdravljenjem, preglede pa bo izvajal tudi do 6 mesecev po tem, ko prenehate jemati ta zdravila, da bi preveril nastanek morebitnega novega kožnega raka.
If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
V primeru prevelikega odmerjanja moramo bolnika zdraviti s potrebnimi podpornimi ukrepi in ga ustrezno spremljati.
In urine, 6.5 % of the radioactivity was excreted as binimetinib.
V urinu je bilo 6,5 % radioaktivnosti izločene kot binimetinib.