natgillin/translations-raw huggingface dataset:
Because testosterone is a male sex hormone, women who are taking Intrinsa should be monitored to see if they develop any ‘androgenic' side effects (development of male characteristics) such as hair growth on the face, deepening of the voice or hair loss.
Ker je testosteron moški spolni hormon, je treba ženske, ki uporabljajo zdravilo Intrinsa, spremljati, da bi ugotovili, ali se pri njih pojavljajo „androgeni“ neželeni učinki (pojavljanje moških značilnosti), kot so rast dlake na obrazu, znižanje glasu ali izpadanje las.
The most common side effects with Intrinsa (seen in more than 1 patient in 10) are hirsutism (increased hair growth, especially on the chin and upper lip) and reactions at the site of application of the patch (redness and itching).
Najpogostejši neželeni učinki zdravila Intrinsa (opaženi pri več kot 1 od 10 bolnic) so hirsutizem (povečana rast dlak, zlasti na bradi in nad zgornjo ustnico) in reakcije na mestu namestitve obliža (rdečica in srbenje).
It must not be used in women who have or have had breast cancer or another oestrogen-dependent cancer, or who have other conditions that mean that they cannot take oestrogen-containing medicines.
Ravno tako ga ne smejo uporabljati ženske, ki imajo ali so imele raka dojke ali katerega drugega od estrogena odvisnega raka oziroma katero drugo obolenje, zaradi katerega ne smejo prejemati zdravil, ki vsebujejo estrogen.
Intrinsa should not be used in people who may be hypersensitive (allergic) to testosterone or any of the other ingredients.
Zdravila Intrinsa ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) testosteron ali katero koli drugo sestavino zdravila.
Women should contact their doctor if they notice any of these effects.
Ženske, ki opazijo katerega od teh učinkov, se morajo posvetovati z zdravnikom.
Intrinsa releases testosterone through the skin into the bloodstream to produce testosterone levels that match the levels seen before removal of the womb and ovaries.
Zdravilo Intrinsa sprosti testosteron skozi kožo v krvni obtok, s čimer se vzpostavi raven testosterona, ki ustreza ravni, izmerjeni pred odstranitvijo maternice in jajčnikov.
It may take longer than a month for the patient to feel an improvement.
Bolnica utegne zaznati izboljšanje tudi šele po več kot enem mesecu.
Intrinsa is used to treat lack of sexual thoughts and desire that is causing distress in women who have had their womb and both ovaries removed.
Zdravilo Intrinsa se uporablja za zdravljenje pomanjkanja spolne želje in misli, ki povzroča čustveno stisko pri ženskah, ki so jim odstranili maternico in oba jajčnika.
What information is still awaited for Intrinsa?
Katere informacije o zdravilu Intrinsa še pričakujemo?
Intrinsa was compared with placebo (a patch containing no active substance).
Zdravilo Intrinsa so primerjali s placebom (obližem, ki ni vseboval zdravilne učinkovine).
Women using Intrinsa should also use oestrogens, but not of the type known as ‘conjugated oestrogens' because the combination of these with Intrinsa is not as effective as the combination of other types of oestrogen with Intrinsa.
Ženske, ki uporabljajo zdravilo Intrinsa, morajo prejemati tudi estrogen, vendar ne vrste estrogena, ki se imenuje „konjugirani estrogen“, ker ta v kombinaciji z zdravilom Intrinsa ni tako učinkovit kot druge vrste estrogena v kombinaciji z zdravilom Intrinsa.
The same place must not be used again until at least seven days later.
V naslednjih sedmih dneh se obliža ne sme namestiti na isto mesto.
When the results of the two studies were looked at together, the women who used Intrinsa had an average of 1.07 more satisfying sexual episodes than the women who used placebo over a four-week period.
Analiza skupnih rezultatov obeh študij je pokazala, da so ženske, ki so uporabljale zdravilo Intrinsa, v štiritedenskem obdobju imele v povprečju za 1,07 več zadovoljivih spolnih odnosov kot ženske, ki so uporabljale placebo.
What is the risk associated with Intrinsa?
Kakšna tveganja so povezana z zdravilom Intrinsa?
On average, women who had three satisfying sexual episodes in a four-week period before treatment had around five episodes over four weeks after using Intrinsa for six months.
V povprečju so ženske, ki so imele pred zdravljenjem povprečno tri zadovoljive spolne odnose v štiritedenskem obdobju, po šestmesečnem uporabljanju zdravila Intrinsa imele okoli pet zadovoljivih spolnih odnosov v štiritedenskem obdobju.
Why has Intrinsa been approved?
Zakaj je bilo zdravilo Intrinsa odobreno?
The company that makes Intrinsa will monitor some of the side effects of Intrinsa closely, such as its androgenic side effects.
Družba, ki proizvaja zdravilo Intrinsa, bo skrbno spremljala nekatere neželene učinke zdravila Intrinsa, kot so na primer njegovi androgeni neželeni učinki.
In women who have had their womb and ovaries removed, the amount of testosterone produced is halved.
Pri ženskah, ki so jim odstranili maternico in jajčnike, se raven proizvedenega testosterona zmanjša za polovico.
The full EPAR for Intrinsa can be found here.
Celotno evropsko javno poročilo o zdravilu (EPAR) za zdravilo Intrinsa je na voljo tukaj.
For the full list of all side effects reported with Intrinsa, see the
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Intrinsa, glejte navodilo za uporabo.
What is Intrinsa used for?
Za kaj se zdravilo Intrinsa uporablja?
How is Intrinsa used?
Kako se zdravilo Intrinsa uporablja?
How has Intrinsa been studied?
Kako je bilo zdravilo Intrinsa raziskano?
How does Intrinsa work?
Kako zdravilo Intrinsa deluje?
• Your female partner must also use a suitable method of contraception.
• Vaša partnerka mora prav tako uporabljati ustrezen način kontracepcije.
This is because it may harm an unborn baby.
Škoduje namreč lahko nerojenemu otroku.
Two highly effective and complementary forms of contraception are recommended.
Priporočljivi sta dve visoko učinkoviti in komplementarni obliki kontracepcije.
Post-hoc analysis.
Post hoc analiza.
It is important that you take the total recommended dose each day.
Pomembno je, da vsak dan vzamete celotni priporočeni odmerek.
See section 2 “Information on other ingredients in this medicine”.
Glejte poglavje 2 »Informacije o drugih sestavinah tega zdravila«.
You will have a blood test:
Preiskavo krvi boste imeli:
Pneumonitis is a serious condition that can often require hospital treatment.
Pnevmonitis je resno stanje, ki pogosto zahteva zdravljenje v bolnišnici.
However, the number of patients is too limited to make meaningful conclusions on the efficacy in this subgroup.
Vendar je bilo število bolnikov premajhno za dejanske zaključke o učinkovitosti v tej podskupini.
o bruising or bleeding for longer than usual if you hurt yourself
o podplutbe ali krvavitve, ki trajajo dlje kot po navadi, če se poškodujete,
Your doctor may prescribe a different dose if:
Zdravnik vam lahko predpiše drugačen odmerek:
Date of first authorisation: 16 December 2014 Date of last renewal:
Datum prve odobritve: 16. december 2014 Datum zadnjega podaljšanja:
For women with hormone dependent cancer, two non-hormonal contraceptive methods should be considered.
Pri ženskah s hormonsko odvisnim rakom je treba razmisliti o dveh nehormonskih načinih kontracepcije.
It is recommended that you record the date when the capsules are removed from refrigerator and the date after which they should be discarded.
Priporočamo vam, da si zabeležite datum, ko vzamete kapsule iz hladilnika, in datum, po katerem jih morate zavreči.
months 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 nolaparib nplacebo
meseci 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 nolaparib nplacebo
• every month for the first year of treatment
• vsak mesec med prvim letom zdravljenja,
June 2021
junija 2021
Your doctor may lower your dose or stop treatment, either for a short time or permanently.
Zdravnik vam lahko odmerek zmanjša ali zdravljenje prekine, bodisi za krajši čas bodisi trajno.
Based on stratified log-rank test.
Na podlagi stratificiranega log-rang testa.
Therefore, the specific dose recommendations for each formulation should be followed.
Zato je treba upoštevati specifična priporočila za odmerke za vsako posamezno obliko.
These changes were reversible within 4 weeks of cessation of dosing.
Te spremembe so bile reverzibilne v 4 tednih po prenehanju uporabe zdravila.
There were no confirmed responses in the comparator arm.
V primerjalni skupini ni bilo potrjenih odzivov.
Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Ne vzemite dvojnega odmerka (dva odmerka hkrati), če ste pozabili vzeti prejšnji odmerek.
These specific cancer cells can be identified by:
Te specifične rakave celice je mogoče prepoznati na podlagi:
Your doctor will tell you if there are any changes in your blood test that might need treatment.
Zdravnik vam bo povedal, ali imate v izvidih krvi kakšne spremembe, ki bi jih morda bilo treba zdraviti.
• a vaccine or a medicine that suppresses the immune system, as you may need to be closely monitored
• kakšno cepivo ali zdravilo, ki zavira imunski sistem, ker boste morda potrebovali skrbno spremljanje,
Exploratory analyses of TFST and TSST were also performed.
Izvedene so bile tudi eksplorativne analize TFST in TSST.
However, there was a slight reduction in embryofoetal survival.
Opazili pa so rahlo zmanjšanje embrio-fetalnega preživetja.
Uncommon side effects that may show up in blood tests: • increase in the size of red blood cells (not associated with any symptoms).
Občasni neželeni učinki, ki se lahko pokažejo na preiskavah krvi: • povečanje velikosti rdečih krvnih celic (to ni povezano z nobenimi simptomi).
HR= Hazard Ratio.
ROg = razmerje ogroženosti.
In particular, caution should be exercised if olaparib is administered in combination with any statin.
Še zlasti je previdnost potrebna, če se olaparib uporablja v kombinaciji s katerim koli statinom.
Chemotherapy n=97
kemoterapija n = 97
Confirmed responses (by BICR) were defined as a recorded response of either CR/PR, confirmed by repeat imaging not less than 4 weeks after the visit when the response was first observed.
Potrjeni odzivi (z BICR) so bili opredeljeni kot zabeležen CR ali PR, potrjen s ponovnim slikanjem ne prej kot 4 tedne po obisku, na katerem je bil odziv prvič opažen.
Other laboratory findings
Druge laboratorijske preiskave
• you have problems with your kidneys.
• če imate težave z ledvicami.
(events/patients)
(dogodki/bolnice)
Consistent results were observed in all predefined patient subgroups (see Figure 7).
Dosledne rezultate so opažali v vseh vnaprej določenih podskupinah bolnikov (glejte sliko 7).
months n-olaparib 74 n-placebo
meseci n-olaparib 74 n-placebo
• diarrhoea - if it gets severe, tell your doctor straight away.
• driska - če postane huda, morate to nemudoma povedati zdravniku.
INNER CARTON - with no blue box
NOTRANJA ŠKATLA - brez modrega okenca
(See previous paragraph: “Women of childbearing potential/contraception in females” for further information about birth control and pregnancy testing.)
(Za dodatne informacije o kontracepciji in testih nosečnosti glejte prejšnji odstavek “Ženske v rodni dobi/kontracepcija pri ženskah”.)
• if you are allergic to olaparib or any of the other ingredients of this medicine (listed in section 6)
• če ste alergični na olaparib ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
Seven patients, all stage IV, had no cytoreductive surgery.
Sedem bolnic, ki so vse imele stadij IV, ni imelo kirurške citoredukcije.
Antiemetic prophylaxis is not required.
Profilaksa z antiemetiki ni potrebna.
• Do not chew, crush, dissolve or divide the tablets as this may affect how quickly the medicine gets into your body.
• Tablet ne grizite, ne drobite, ne raztapljajte in ne lomite, ker lahko vse našteto vpliva na to, kako hitro zdravilo pride v telo.
Elimination Following a single dose of
Izločanje Po enkratnem odmerku
Study 19 (D0810C00019)
Študija 19 (D0810C00019)
Overall disease classification Metastatic
Celokupna klasifikacija bolezni Metastatska
If your blood count falls to a low level, you may need to have a blood transfusion (where you are given new blood or blood-based products from a donor).
Če se vam število krvnih celic preveč zmanjša, boste morda potrebovali transfuzijo krvi (pri kateri boste dobili novo kri ali krvne izdelke od krvodajalca).
Absence of fully functional HRR pathway is one of the key determinants of platinum sensitivity in ovarian and other cancers.
Odsotnost popolnoma funkcionalne poti HRR je eden ključnih dejavnikov občutljivosti na platino pri raku jajčnikov in drugih rakih.
ECOG performance status (%)
Stanje zmogljivosti po ECOG (%)
• increase in blood creatinine - this test is used to check how your kidneys are working.
• zvišanje kreatinina v krvi - ta preiskava se uporablja za preverjanje delovanja ledvic.
Many had also received other DNA damaging agents and radiotherapy.
Številne so prejemale tudi druga zdravila, ki okvarijo DNA, in radioterapijo.
Hard capsule 112 capsules
trda kapsula 112 kapsul
27.9 (22.6-NR)
27,9 (22,6-ND)
Number of patients at risk:
Število ogroženih bolnic:
Please tell your doctor if you are taking a hormonal contraceptive, as your doctor may recommend the addition of a non-hormonal contraceptive method.
Zdravnika morate obvestiti, če jemljete kakšen hormonski kontraceptiv: zdravnik vam bo morda svetoval, da dodatno uporabljate še nek nehormonski način kontracepcije.
• if you are breast-feeding (see section 2 below for more information).
• če dojite (za več informacij glejte poglavje 2, spodaj).
Any capsules that have been frozen must be discarded.
Kapsule, ki so bile zamrznjene, je treba zavreči.
Efficacy results are presented in Table 2 and Figures 1 and 2.
Rezultati učinkovitosti so prikazani v preglednici 2 in na slikah 1 in 2.
• Take one dose (8 capsules) of Lynparza by mouth with water, once in the morning and once in the evening.
• Zaužijte en odmerek (8 kapsul) zdravila Lynparza, z vodo, enkrat zjutraj in enkrat zvečer.
* Not controlled for multiplicity.
* Ni kontrolirano za večkratne primerjave.
• if you have low blood cell counts on testing.
• če imate na preiskavi majhno število krvnih celic.
Since it cannot be excluded that olaparib may reduce exposure to substrates of CYP2C9 through enzyme induction, the efficacy of some hormonal contraceptives may be reduced if co-administered with olaparib.
Ker ni mogoče izključiti, da olaparib zaradi indukcije encimov zmanjša izpostavljenost substratom CYP2C9, je možno, da se učinkovitost nekaterih hormonskih kontraceptivov med sočasno uporabo z olaparibom zmanjša.
Your doctor will test your blood every month for the first year of treatment and at regular intervals after that.
Zdravnik vam bo izvajal preiskave krvi vsak mesec prvo leto zdravljenja, pozneje pa v rednih presledkih.
• decrease in the number of platelets in blood (thrombocytopenia) - you may notice the following symptoms:
• zmanjšanje števila trombocitov v krvi (trombocitopenija) - opazite lahko naslednje simptome:
Do not take Lynparza:
Ne jemljite zdravila Lynparza:
• feeling short of breath, feeling very tired, pale skin or fast heart beat - these may be symptoms of a decrease in the number of red blood cells (anaemia).
• kratka sapa, občutek hude utrujenosti, bledica kože ali hitro bitje srca - to so lahko simptomi zmanjšanja števila rdečih krvnih celic (anemije).
The gBRCAm status of patients enrolled via local testing was confirmed retrospectively by central testing.
Status gBRCAm bolnic, vključenih z uporabo lokalnega testiranja, so retrospektivno potrdili s centralnim testiranjem.
• pain in the stomach area under the ribs (upper abdominal pain)
• bolečine v predelu želodca pod rebri (v zgornjem delu trebuha)
• allergic reactions (e.g. hives, difficulty breathing or swallowing, dizziness which are signs and symptoms of hypersensitivity reactions).
• alergijske reakcije (npr. koprivnica, težko dihanje ali požiranje, omotica, ki so znaki in simptomi preobčutljivostnih reakcij).
At the time of the PFS analysis, 1 patient had a confirmed partial response with a duration of response of 9.7 months in the olaparib arm.
Ob času analize PFS je imel 1 bolnik potrjen delen odziv s trajanjem odziva 9,7 meseca v skupini z olaparibom.
• You should not take Lynparza if you are pregnant or might become pregnant.
• Ne jemljite zdravila Lynparza, če ste noseči, ali če bi lahko zanosili.
Patients who had been treated with bevacizumab were excluded from the study, therefore there are no safety and efficacy data on olaparib patients who had previously received bevacizumab.
Bolnice, zdravljene z bevacizumabom, so bile izključene iz študije, zato podatkov o varnosti in učinkovitosti olapariba pri bolnicah, ki so predhodno prejemale bevacizumab, ni.
Genetic testing should be conducted by an experienced laboratory using a validated test.
Genetsko testiranje mora izvesti izkušen laboratorij z uporabo validiranega testa.
Lynparza should not be used during pregnancy.
Zdravila Lynparza se ne sme uporabljati med nosečnostjo.
NR (24.1-NR)
ND (24,1-ND)
This includes medicines obtained without a prescription and herbal medicines.
To velja tudi za zdravila, ki ste jih dobili brez recepta, in za zdravila rastlinskega izvora.
Instead, alternative and error-prone pathways are activated, such as the non-homologous end joining (NHEJ) pathway, leading to increased genomic instability.
Namesto tega se aktivirajo alternativne, napakam izpostavljene poti, npr. pot nehomolognega povezovanja koncev (NHEJ - non-homologous end joining), in to poveča genomsko nestabilnost.
The safety and efficacy of Lynparza in children and adolescents has not been established.
Varnost in učinkovitost zdravila Lynparza pri otrocih in mladostnikih nista bili dokazani.
Treatment with Lynparza should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Zdravljenje z zdravilom Lynparza mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
• Take Lynparza once in the morning and once in the evening.
• Zdravilo Lynparza vzemite enkrat zjutraj in enkrat zvečer.
Patients who experience these symptoms should observe caution when driving or using machines.
Bolniki, ki imajo takšne simptome, morajo biti previdni glede vožnje in upravljanja strojev.
Patients in the olaparib group continued to receive treatment longer than those in the placebo group.
Bolnice v skupini z olaparibom so nadaljevale zdravljenje dalj časa kot tiste v skupini s placebom.
The major primary target organ for toxicity in both species was the bone marrow, with associated changes in peripheral haematology parameters.
Glavni ciljni organ toksičnosti je bil pri obeh živalskih vrstah kostni mozeg; to so spremljale spremembe perifernih hematoloških vrednosti.
Rarely, these may be a sign of more serious problems with the bone marrow such as ‘myelodysplastic syndrome' (MDS) or ‘acute myeloid leukaemia' (AML).
Redko je to lahko znak resnejših težav s kostnim mozgom, na primer "mielodisplastičnega sindroma" (MDS) ali "akutne mieloične levkemije" (AML).
New metastatic breast cancer (%) Hormone receptor status (%) HR+
Lokalno napredovala Nov metastatski rak dojk (%) Stanje hormonskih receptorjev (%) HR+
If you notice any side effects not listed in this leaflet, please contact your doctor straight away.
Če opazite kakšen neželen učinek, ki ni naveden v tem navodilu, se takoj posvetujte z zdravnikom.
Depending on the test used and the international classification consensus, the BRCA1/2 mutations have been classified as deleterious/suspected deleterious or pathogenic/likely pathogenic.
Odvisno od uporabljenega testa in mednarodnega klasifikacijskega soglasja so bile mutacije genov BRCA1/2 opredeljene kot škodljive/domnevno škodljive ali patogene/verjetno patogene.
In the absence of BRCA1 or BRCA2 mutations, HRR pathway may be compromised by other mechanisms, although the causative aberrancy and penetrance are not fully elucidated.
V odsotnosti mutacij gena BRCA1 ali BRCA2 lahko pot HRR okrnejo drugi mehanizmi, čeprav vzročna anomalija in penetrantnost nista povsem pojasnjeni.
Lynparza capsules can be stored for up to 3 months below 30°C.
Kapsule zdravila Lynparza je mogoče do 3 mesece shranjevati pri temperaturi do 30 °C.
Lynparza tablets should be swallowed whole and not chewed, crushed, dissolved or divided.
Tablete zdravila Lynparza je treba pogoltniti cele in se jih ne sme gristi, drobiti, raztapljati ali lomiti.
Previous anthracycline and taxane treatment
Predhodno zdravljenje z antraciklinom in taksanom
This clastogenicity is consistent with the known pharmacology of olaparib and indicates potential for genotoxicity in man.
Klastogenost se sklada z znano farmakologijo olapariba in kaže na potencialno genotoksičnost pri človeku.
In repeat-dose toxicity studies of up to 6 months duration in rats and dogs, daily oral doses of olaparib were well-tolerated.
V študiji toksičnosti ponavljajočih se odmerkov v trajanju do 6 mesecev pri podganah in psih so živali dobro prenašale vsakodnevno peroralno uporabo olapariba.
Therefore, an additional non-hormonal contraceptive method should be considered during treatment (see section 4.5).
Zato je treba razmisliti o dodatni nehormonski kontracepciji med zdravljenjem (glejte poglavje 4.5).
Ninety three percent (93%) of patients were randomised within 8 weeks of their last dose of platinum-based chemotherapy.
Triindevetdeset odstotkov (93 %) bolnic je bilo randomiziranih v 8 tednih po njihovem zadnjem odmerku kemoterapije na osnovi platine.
PFS (DCO 30 June
PFS (DCO 30. junij
Patients with evidence of disease at 2 years, who in the opinion of the treating physician can derive further benefit from continuous treatment, can be treated beyond 2 years.
Bolnice, ki imajo po 2 letih znake bolezni in bi jim nadaljevanje zdravljenja po mnenju lečečega zdravnika dodatno koristilo, lahko zdravljenje prejemajo več kot 2 leti.
Consistent results were observed in the subgroups of patients by evidence of the disease at study entry.
Pri podskupinah bolnic glede na dokaze bolezni ob vstopu v študijo so opažali dosledne rezultate.
The incidence of MDS/AML cases was similar among gBRCA1m and gBRCA2m patients (1.7% and 1.4%, respectively).
Pojavnost primerov MDS/AML je bila pri bolnicah z gBRCA1m in gBRCA2m podobna (1,7 % pri prvih in 1,4 % pri drugih).
On multiple dosing there is no marked accumulation, with steady state exposures achieved within ~3 to 4 days.
Po večkratnem odmerjanju ni izrazitega kopičenja in izpostavljenost v stanju dinamičnega ravnovesja je dosežena v ~3 do 4 dneh.
Clinical studies of olaparib in combination with other anticancer medicinal products, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.
Klinične študije olapariba v kombinaciji z drugimi zdravili proti raku, vključno z zdravili, ki poškodujejo DNA, kažejo na okrepitev in podaljšanje mielosupresivne toksičnosti.
• looking for faulty DNA repair genes, such as BRCA (BReast CAncer) genes.
• ugotavljanja okvarjenih genov za popravo DNA, na primer genov BRCA (BReast CAncer).
The potential for olaparib to induce CYP2C9, CYP2C19 and P-gp can also not be excluded.
Prav tako ni mogoče izključiti možnosti, da olaparib inducira CYP2C9, CYP2C19 in P-gp.
PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage.
Zaviralci PARP lahko uničijo rakave celice, ki niso uspešne pri popravljanju okvare DNA.
• response to platinum chemotherapy, or
• odziva na kemoterapijo s platino ali
BOTTLE/LABEL
PLASTENKA/NALEPKA
The medicines listed here may not be the only ones that could affect Lynparza.
Tukaj našteta zdravila niso edina, ki lahko vplivajo na delovanje zdravila Lynparza.
Effect of olaparib on other medicinal products
Vpliv olapariba na druga zdravila
Therefore, olaparib upon co-administration may reduce the exposure to substrates of these metabolic enzymes and transport protein.
Zato lahko olaparib po sočasni uporabi zmanjša izpostavljenost substratom teh presnovnih encimov in prenašalne beljakovine.
The incidence of anaemia adverse reactions was 22.8% (CTCAE grade ≥3 7.4%).
Pojavnost neželenih učinkov z anemijo je bila 22,8 % (≥ 3. stopnje po CTCAE 7,4 %).