natgillin/translations-raw huggingface dataset:
Women of childbearing potential must use two forms of reliable contraception before starting Lynparza treatment, during therapy and for 1 month after receiving the last dose of Lynparza.
Ženske v rodni dobi morajo pred začetkom zdravljenja z zdravilom Lynparza, med zdravljenjem in še 1 mesec po zadnjem odmerku zdravila Lynparza uporabljati dve obliki zanesljive kontracepcije.
If you feel dizzy, weak or tired while taking Lynparza, do not drive or use tools or machines.
Ne upravljajte vozil ali strojev, če ste med jemanjem zdravila omotični, šibki ali utrujeni.
Median time (months) (95% CI) HR (95% CI)
Mediani čas (meseci) (95 % IZ) ROg (95 % IZ)
Patients with HR+ (ER and/or PgR positive) tumours must have received and progressed on at least one endocrine therapy (adjuvant or metastatic) or had disease that the treating physician believed to be inappropriate for endocrine therapy.
Delež preživelih bolnic hormonskim zdravljenjem (adjuvantnim ali metastatskim), ali imeti bolezen, ki je bila po mnenju lečečega zdravnika neprimerna za hormonsko zdravljenje.
If a strong CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 100 mg (one 100 mg tablet) taken twice daily (equivalent to a total daily dose of 200 mg).
Če je treba sočasno uporabiti močen zaviralec CYP3A, je priporočeno zmanjšanje odmerka zdravila Lynparza na 100 mg (ena 100-mg tableta) dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 200 mg).
The following adverse reactions have been identified in clinical trials with patients receiving Lynparza monotherapy where patient exposure is known.
Pri bolnicah, ki so v kliničnih preizkušanjih prejemale monoterapijo z zdravilom Lynparza (kjer je izpostavljenost bolnic znana), so zabeležili naslednje neželene učinke.
• colchicine - used to treat gout
• kolhicin - uporablja se za zdravljenje protina,
Figure 2 SOLO1: Kaplan-Meier plot of OS in newly diagnosed patients with BRCA1/2m advanced ovarian cancer (21% maturity)
SOLO1: Kaplan-Meierjeva krivulja celokupnega preživetja pri na novo diagnosticiranih bolnicah z napredovalim rakom jajčnikov in BRCA1/2m (21 % zrelost)
If a moderate CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 200 mg taken twice daily (equivalent to a total daily dose of 400 mg) (see sections 4.4 and 4.5).
Če je treba sočasno uporabiti zmeren zaviralec CYP3A, pa je priporočeno zmanjšanje odmerka zdravila Lynparza na 200 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 400 mg) (glejte poglavji 4.4 in 4.5).
Each film-coated tablet contains 150 mg of olaparib.
Ena filmsko obložena tableta vsebuje 150 mg olapariba.
PAES: In order to further confirm the efficacy of olaparib in patients with platinum sensitive relapsed BRCA mutated high grade serous ovarian cancer, the MAH should submit the results of study D0816C00002, a phase III randomised double-blind placebo-controlled multicentre study.
Študija učinkovitosti po izdaji dovoljenje za promet (PAES): Za dodatno potrditev učinkovitosti olapariba pri bolnicah z recidivom na platino občutljivega slabo diferenciranega seroznega raka jajčnikov in mutacijo gena BRCA, mora imetnik dovoljenja za promet predložiti rezultate študije D0816C00002, randomizirane dvojno slepe, s placebom kontrolirane multicentrične študije III. faze.
• maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
• vzdrževalno zdravljenje odraslih bolnic, pri katerih je prišlo do ponovitve epitelijskega raka visokega gradusa z izvorom v jajčnikih, jajcevodih ali peritoneju, občutljivega na platino, ki so v popolnem ali delnem odzivu na kemoterapijo na osnovi platine.
The study met its primary objective demonstrating a statistically significant improvement in PFS for olaparib compared with placebo in the overall population with a HR of 0.35 (95% CI 0.25-0.49; p<0.00001; median 8.4 months olaparib vs 4.8 months placebo).
Študija je dosegla svoj primarni cilj in je dokazala statistično značilno izboljšanje preživetja brez napredovanja bolezni z olaparibom v primerjavi s placebom v celotni populaciji (ROg 0,35; 95 % IZ: 0,25 do 0,49, p < 0,00001, mediana 8,4 meseca z olaparibom in 4,8 meseca s placebom).
Yellow to dark yellow, oval, bi-convex tablet, debossed with ‘OP100' on one side and plain on the other side.
Rumena do temno rumena, ovalna, bikonveksna tableta z vtisnjeno oznako "OP100" na eni strani in brez oznak na drugi strani.
• You must not donate sperm while taking Lynparza and for 3 months after taking the last dose.
• Med jemanjem zdravila Lynparza in še 3 mesece po zadnjem odmerku ne smete darovati sperme.
If a further dose reduction is required, then reduction to 100 mg twice daily (equivalent to a total daily dose of 200 mg) is recommended.
Če je potrebno še dodatno zmanjšanje odmerka, je priporočljivo zmanjšanje na 100 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 200 mg).
In the HR+ patient subgroup the confirmed ORR was 57% (46/81) in the olaparib arm and 33% (11/33) in the comparator arm. bd Twice daily; CI Confidence interval; DOR Duration of response; DCO Data cut off; HR Hazard ratio; HR+ Hormone receptor positive, ORR Objective response rate; OS overall survival; PFS progression-free survival; PFS2 Time to second progression or death, TNBC triple negative breast cancer.
2x/dan = dvakrat na dan, IZ = interval zaupanja, DCO = datum zamejitve podatkov, Rog = razmerje ogroženosti, HR+ = s pozitivnimi hormonskimi receptorji, ORR = delež objektivnega odziva, PFS = preživetje brez napredovanja bolezni, PFS2 = čas do drugega napredovanja bolezni ali do smrti, TNBC = trojno negativen rak dojk.
CYP3A4/5 are the isozymes predominantly responsible for the metabolic clearance of olaparib.
Za presnovni očistek olapariba so pretežno odgovorni izoencimi CYP3A4/5.
The incidence of dose interruptions, reductions and discontinuations due to an adverse event was 34.6%, 25.7% and 5.9%, respectively.
Večina bolnic je ostala na začetnem odmerku 400 mg olapariba dvakrat na dan. Pojavnost prekinitev uporabe je bila 34,6 %, zmanjšanj odmerka 25,7 % in prenehanj zaradi neželenega učinka 5,9 %.
The incidence of dose interruptions, reductions, discontinuations due to an adverse event was 45.1%, 25.1% and 10.8%, respectively.
Večina bolnic je ostala na začetnem odmerku 300 mg olapariba dvakrat na dan. Pojavnost prekinitev uporabe je bila 45,1 %, zmanjšanj odmerka 25,1 % in prenehanj zaradi neželenega učinka 10,8 %.
In the absence of functional BRCA1 or 2, DNA DSBs cannot be repaired via HRR.
Če funkcionalnih genov BRCA 1 ali 2 ni, homologno popravljanje z rekombinacijo ne more popraviti dvoverižnih prekinitev DNA.
Olaparib 400 mg bd Placebo
olaparib 400 mg dvakrat na dan placebo
If a moderate CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 150 mg (one 150 mg tablet) taken twice daily (equivalent to a total daily dose of 300 mg) (see sections 4.4 and 4.5).
Če je treba sočasno uporabiti zmeren zaviralec CYP3A, pa je priporočeno zmanjšanje odmerka zdravila Lynparza na 150 mg (ena 150-mg tableta) dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 300 mg) (glejte poglavji 4.4 in 4.5).
The safety and efficacy of olaparib as a maintenance therapy in the treatment of platinum-sensitive relapsed (PSR) high grade serous ovarian, including fallopian tube or primary peritoneal cancer patients, following treatment with two or more platinum-containing regimens, were studied in a Phase II randomised, double-blind, placebo-controlled trial (study 19).
Varnost in učinkovitost olapariba kot vzdrževalnega zdravljenja bolnic z recidivom na platino občutljivega (PSR - platinum-sensitive relapsed) slabo diferenciranega seroznega raka jajčnikov, vključno z jajcevodi ali primarno peritonealnega raka po zdravljenju z dvema ali več shemama na osnovi platine, so raziskali v randomiziranem, dvojno slepem, s placebom kontroliranem preskušanju II.
Silica, colloidal anhydrous Mannitol
Jedro tablete kopovidon koloidni brezvodni silicijev dioksid manitol natrijev stearilfumarat
Number of events: Total number of patients (%) 99:260 (38) Median time (months)
Število dogodkov: celotno število bolnic (%) Mediani čas (meseci)
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets olaparib
Lynparza 100 mg filmsko obložene tablete Lynparza 150 mg filmsko obložene tablete olaparib
Lynparza dose adjustment is recommended for patients with moderate renal impairment (see section 4.2).
Pri bolnikih z zmerno okvaro ledvic se priporoča prilagoditev odmerka zdravila Lynparza (glejte poglavje 4.2).
Lynparza 50 mg hard capsules olaparib
Lynparza 50 mg trde kapsule olaparib
If a strong CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 150 mg taken twice daily (equivalent to a total daily dose of 300 mg).
Če je treba sočasno uporabiti močen zaviralec CYP3A, je priporočeno zmanjšanje odmerka zdravila Lynparza na 150 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 300 mg).
gBRCA1/2-mutated HER2-negative metastatic breast cancer OlympiAD (Study D0819C00003)
OlympiAD (študija D0819C00003)
Green to green/grey, oval, bi-convex tablet, debossed with ‘OP150' on one side and plain on the other side.
Zelena do zeleno-siva, ovalna, bikonveksna tableta z vtisnjeno oznako "OP150" na eni strani in brez oznak na drugi strani.
• Each Lynparza 150 mg film-coated tablet contains 150 mg olaparib.
• Ena filmsko obložena tableta zdravila Lynparza 150 mg vsebuje 150 mg olapariba.
What Lynparza is used for
Za kaj uporabljamo zdravilo Lynparza
Lynparza 150 mg film-coated tablets Each film-coated tablet contains 150 mg olaparib.
Lynparza 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg olapariba.
Table 2 Summary of key efficacy findings for patients with BRCA-mutated PSR ovarian cancer in Study 19
Povzetek ključnih izsledkov o učinkovitosti pri PSR bolnicah z rakom jajčnikov in mutacijo gena BRCA v študiji 19
The safety and efficacy of olaparib as a maintenance therapy in the treatment of PSR ovarian, including fallopian tube or primary peritoneal cancer patients, following treatment with two or more platinum-containing regimens, were studied in a large Phase II randomised, double-blind, placebo-controlled trial (Study 19).
Varnost in učinkovitost olapariba kot vzdrževalnega zdravljenja bolnic, ki imajo na platino občutljive ponovitve (PSR) raka jajčnikov, vključno z jajcevodom ali primarnim peritonealnim rakom po zdravljenju z dvema ali več shemami s platino, so raziskali v obsežnem randomiziranem, dvojno slepem, s placebom kontroliranem preizkušanju II.
Women of childbearing potential must use two forms of reliable contraception before starting Lynparza treatment, during therapy and for 1 month after receiving the last dose of Lynparza (see section 4.6).
Ženske v rodni dobi morajo pred začetkom zdravljenja z zdravilom Lynparza, med zdravljenjem in še 1 mesec po zadnjem odmerku zdravila Lynparza uporabljati dve obliki zanesljive kontracepcije (glejte poglavje 4.6).
Table 4 Summary of key secondary objective outcomes for patients with gBRCA1/2m PSR ovarian cancer in SOLO2
Povzetek izidov ključnih sekundarnih ciljev pri PSR bolnicah z rakom jajčnikov in gBRCA1/2m v študiji SOLO2
Figure 1 SOLO1: Kaplan-Meier plot of PFS in newly diagnosed patients with BRCA1/2m advanced ovarian cancer (51% maturity - investigator assessment)
SOLO1: Kaplan-Meierjev prikaz preživetja brez napredovanja bolezni pri na novo diagnosticiranih bolnicah z napredovalim rakom jajčnikov in BRCA1/2m (51 % zrelostraziskovalčeva ocena)
The recommended dose of Lynparza is 300 mg (two 150 mg tablets) taken twice daily, equivalent to a total daily dose of 600 mg.
Priporočeni odmerek zdravila Lynparza je 300 mg (dve 150-mg tableti) dvakrat na dan; to ustreza celotnemu dnevnemu odmerku 600 mg. 100-mg tablete so na voljo za zmanjšanje odmerka.
Figure 2 Study 19: Kaplan-Meier plot of OS in BRCA-mutated patients (73% maturity)
Slika 2 Študija 19: Kaplan Meierjevi krivulji celokupnega preživetja pri bolnicah z mutacijo gena BRCA (73 % zrelost)
A summary of the primary objective outcome for patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19 is presented in Table 4 and for all patients in Study 19 in Table 5 and Figure 4.
Povzetek izida primarnega cilja za vse bolnice in PSR bolnice z rakom jajčnikov in z mutacijo gena BRCA1/2 in BRCA1/2 wt/VUS v študiji 19 je prikazan v preglednici 5 ter za vse bolnice v študiji 19 v preglednici 5 in na sliki 4.
• Each Lynparza 100 mg film-coated tablet contains 100 mg olaparib.
• Ena filmsko obložena tableta zdravila Lynparza 100 mg vsebuje 100 mg olapariba.
In the olaparib and placebo arms, 17% and 20% of patients had prior bevacizumab, respectively.
Bevacizumab je predhodno prejemalo 17 % bolnic v skupini z olaparibom in 20 % bolnic v skupini s placebom.
Mechanism of action and pharmacodynamic effects Olaparib is a potent inhibitor of human poly (ADP-ribose) polymerase enzymes (PARP-1, PARP-2 and PARP-3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo either as a standalone treatment or in combination with established chemotherapies.
Mehanizem delovanja in farmakodinamični učinki Olaparib je močan zaviralec humanih encimov poli(ADP-riboza)polimeraze (PARP-1, PARP-2 in PARP-3).
The investigator assessment of PFS was supported with a blinded independent central radiological (BICR) review of PFS. At the time of PFS analysis, interim OS data were immature (21%), with HR 0.95 (95% CI 0.60, 1.53; p-value=0.9).
V času analize PFS vmesni podatki o celokupnem preživetju niso bili dozoreli (21 %); ROg je bilo 0,95 (95 % IZ 0,60 do 1,53; vrednost p = 0,9).
Table 6 Summary of key secondary objective outcomes for all patients and patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19
Povzetek izidov ključnih sekundarnih ciljev za vse bolnice in za PSR bolnice z rakom jajčnikov z mutacijo gena BRCA1/2 in BRCA1/2 wt/VUS v študiji 19
Figure 1 Study 19: Kaplan-Meier plot of PFS in BRCA-mutated patients (53% maturity-investigator assessment)
Slika 1 Študija 19: Kaplan-Meierjevi krivulji preživetja brez napredovanja bolezni pri bolnicah z mutacijo gena BRCA (53 % zrelost - raziskovalčeva ocena)
No Lynparza dose adjustment is required for patients with mild or moderate hepatic impairment (see section 4.2).
Bolnikom z blago ali zmerno okvaro jeter odmerka zdravila Lynparza ni treba prilagoditi (glejte poglavje 4.2).
Warnings and precautions Talk to your doctor, pharmacist or nurse before or during treatment with Lynparza:
Pred začetkom zdravljenja z zdravilom Lynparza ali med zdravljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
DOR - DCO 09 December 2016
Trajanje odziva - DCO 09. december 2016
The most common histological type was serous (96%), endometrioid histology was reported in 2% of the patients.
Najpogostejša histološka vrsta je bila serozna (96 %),
Lynparza is used for the treatment of:
Za kaj uporabljamo zdravilo Lynparza Zdravilo Lynparza uporabljamo za zdravljenje:
How to store Lynparza
Shranjevanje zdravila Lynparza
In the olaparib and placebo arms, 6% and 5% of patients had prior bevacizumab, respectively.
Bevacizumab je predhodno prejemalo 6 % bolnic v skupini z olaparibom in 5 % bolnic v skupini s placebom.
Distribution The in vitro plasma protein binding is approximately 82% at 10 µg/mL which is approximately Cmax.
Porazdelitev Ob koncentraciji 10 µg/ml, ki je približna vrednost Cmax, je vezava na beljakovine in vitro približno
Anaemia includes preferred terms (PTs) of anaemia, anaemia macrocytic, erythropenia, haematocrit decreased, haemoglobin decreased, normochromic anaemia, normochromic normocytic anaemia, normocytic anaemia and red blood cell count decreased; Neutropenia includes PTs of agranulocytosis, febrile neutropenia, granulocyte count decreased, granulocytopenia, idiopathic neutropenia, neutropenia, neutropenic infection, neutropenic sepsis and neutrophil count decreased; Thrombocytopenia includes PTs of platelet count decreased, platelet production decreased, plateletcrit decrease and thrombocytopenia; Leukopenia includes PTs of leukopenia and white blood cell count decreased;
Anemija obsega prednostne izraze (Preferred Terms) anemija, makrocitna anemija, eritropenija, znižanje hematokrita, znižanje hemoglobina, normokromna anemija, normokromna normocitna anemija, normocitna anemija in zmanjšano število eritrocitov.
The primary endpoint was PFS based on investigator assessment using RECIST 1.0.
Primarni cilj študije je bilo preživetje brez napredovanja bolezni (PFS) na podlagi raziskovalčeve ocene in z uporabo RECIST 1.0.
Patient-reported outcome (PRO) data indicate no difference for the olaparib-treated patients as compared to placebo as measured by improvement and worsening rates in the TOI and FACT-O total.
Podatki o izidu po navedbi bolnic (PRO) merjeni z deleži izboljšanja oziroma poslabšanja indeksa TOI lestvice FACT-O ne kažejo razlik med prejemnicami olapariba in prejemnicami placeba.
Lynparza 100 mg film-coated tablets
Lynparza 100 mg filmsko obložene tablete
Do not breast-feed if you are taking Lynparza and for 1 month after taking the last dose of Lynparza.
Med jemanjem zdravila Lynparza in še en mesec po vzetju zadnjega odmerka zdravila Lynparza ne smete dojiti.
Lynparza 150 mg film-coated tablets
Lynparza 150 mg filmsko obložene tablete
Do not eat preferably for up to 2 hours after taking Lynparza.
Potem, ko ste vzeli zdravilo Lynparza, po možnosti do 2 uri ne jejte.
Olaparib 300 mg bd
olaparib 300 mg 2x/dan kemoterapija
Lynparza 100 mg film-coated tablets olaparib
Lynparza 100 mg filmsko obložene tablete olaparib
Uncommon Increase in blood creatinine
Preiskave pogosti zvišanje kreatinina v krvi občasni povečanje povprečnega volumna eritrocitov občasni zvišanje kreatinina v krvi
Patients must have confirmation of a deleterious or suspected deleterious breast cancer susceptibility gene (BRCA) mutation (either germline or tumour) before Lynparza treatment is initiated.
Pred uvedbo zdravljenja z zdravilom Lynparza morajo imeti bolnice potrjeno škodljivo ali domnevno škodljivo mutacijo gena BRCA (gen dovzetnosti za raka dojk), bodisi germinalno bodisi v tumorju.
Lynparza 150 mg film-coated tablets olaparib
Lynparza 150 mg filmsko obložene tablete olaparib
Table 5 Summary of primary objective outcome for all patients and patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19
Povzetek izida primarnega cilja za vse bolnice in PSR bolnice z rakom jajčnikov z mutacijo gena BRCA1/2 in BRCA1/2 wt/VUS v študiji 19
Tabulated list of adverse reactions
Seznam neželenih učinkov v preglednici Neželeni učinki
You will be asked to take 200 mg (2 x 100 mg tablets)
Jemati boste morali 200 mg (dve 100 mg tableti) dvakrat na danskupaj 4 tablete vsak dan,
Table 3 Summary of primary objective outcome for patients with gBRCA1/2m PSR ovarian cancer in SOLO2
Povzetek izida primarnega cilja pri PSR bolnicah z rakom jajčnikov in gBRCA1/2m v študiji SOLO2.
• You must use a condom when having sex with a female partner, even if she is pregnant, while taking Lynparza and for 3 months after taking the last dose.
• Medtem ko jemljete zdravilo Lynparza in še 3 mesece po uporabi zadnjega odmerka tega zdravila morate med spolnimi odnosi s partnerko uporabljati kondom, in sicer tudi če je partnerka noseča.
Placebo Olaparib 400 mg capsule bd
olaparib kapsule 400 mg dvakrat na dan placebo olaparib kapsule 400 mg dvakrat na dan olaparib kapsule 400 mg dvakrat na dan placebo
The recommended dose reduction is to 200 mg twice daily (equivalent to a total daily dose of 400 mg).
V primeru potrebe po zmanjšanju odmerka je priporočeno zmanjšanje odmerka na 200 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 400 mg).
Lymphopenia includes PTs of B-lymphocyte count decreased, lymphocyte count decreased, lymphopenia and T-lymphocyte count decreased; Cough includes PTs of cough and productive cough; Rash includes PTs of exfoliative rash, generalised erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular and rash pruritic; Hypersensitivity includes PTs of drug hypersensitivity and hypersensitivity; Dermatitis includes PTs of dermatitis, dermatitis allergic and dermatitis exfoliative.
Izpuščaj obsega prednostne izraze eksfoliativni izpuščaj, generaliziran eritem, izpuščaj, eritematozen izpuščaj, generaliziran izpuščaj, makularen izpuščaj, makulo-papulozen izpuščaj, papulozen izpuščaj in pruritičen izpuščaj.
PAES: In order to further define the efficacy of olaparib in patients with platinum sensitive relapsed (PSR) non-germline BRCA mutated high grade ovarian cancer in the maintenance setting and investigate predictive biomarkers within this patient group, the MAH should submit the results of study D0816C00020 (OPINION), a phase IIIb single-arm, open-label, multicentre study of maintenance therapy in PSR non-germline BRCA mutated ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.
PAES: Za dodatno opredelitev učinkovitosti olapariba med vzdrževalnim zdravljenjem bolnic z recidivom slabo diferenciranega raka jajčnikov, občutljivega za platino (PSR), z negerminalno mutacijo gena BRCA ter za proučitev napovednih bioloških označevalcev v tej skupini bolnic mora imetnik dovoljenja za promet z zdravilom predložiti rezultate študije D0816C00020 (OPINION).
The primary endpoint was PFS determined by investigator assessment using RECIST 1.1.
Primarni cilj študije je bilo preživetje brez napredovanja bolezni (PFS) po raziskovalčevi oceni na podlagi meril RECIST 1.1.
o A test is used to find out whether you have BRCA-mutated ovarian cancer.
o Za ugotavljanje tega, ali imate raka jajčnikov z mutacijo gena BRCA, se uporablja posebna preiskava.
Preplanned subgroup analysis identified patients with BRCA1/2-mutated ovarian cancer (n=136,
Vnaprej načrtovana analiza podskupin je pokazala, da je vzdrževalna monoterapija z olaparibom klinično najbolj koristila podskupini bolnic z rakom jajčnikov in z mutacijo gena BRCA1/2 (n = 136, 51,3 %, vključno z 20 bolnicami z identificirano somatsko tumorsko mutacijo gena BRCA1/2).
Tablet coating
Izpuščeni odmerek
Common Lymphopenia
PODATKI NA ZUNANJI OVOJNINI
Gastrointestinal toxicities
Toksični učinki na prebavilih
Vomiting, Diarrhoea, Nausea, Dyspepsia, Upper abdominal pain
Bolezni živčevja zelo pogosti omotica, glavobol, spremenjen okus občasni omotica, glavobol
bd Twice daily; NR not reached; CI confidence interval; PFS2 time from randomisation to second progression or death;
ND = ni doseženo, IZ = interval zaupanja, PFS2 = čas od randomizacije do drugega napredovanja bolezni, TSST = čas od randomizacije do začetka drugega nadaljnjega zdravljenja ali smrti.
It can affect the way the medicine works.
Grenivkin sok namreč lahko vpliva na delovanje tega zdravila.
14 Capsules
14 kapsul
Blister(Alu/Alu)
Pretisni omot (Alu/Alu)
200 mg Powder for concentrate for solution for infusion
EU/1/15/1036/001 Zdravilo Cresemba 200 mg Prašek za koncentrat za raztopino za infundiranje
Intravenous use vial (glass)
Intravenska uporaba viala (steklena) 10 ml
100 mg Capsule, hard Oral use
EU/1/15/1036/002 Zdravilo Cresemba 100 mg Kapsula, trda
If it is taken with food, it may take longer to work.
Če se zdravilo jemlje s hrano, bo morda preteklo več časa, preden bo delovalo.
What measures are being taken to ensure the safe and effective use of Spedra?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Spedra?
The European Commission granted a marketing authorisation valid throughout the European Union for Spedra on 21 June 2013.
Evropska komisija je dovoljenje za promet z zdravilom Spedra, veljavno po vsej Evropski uniji, izdala 21. junija 2013.
Spedra may be taken with or without food.
Zdravilo Spedra se lahko jemlje s hrano ali brez nje.