natgillin/translations-raw huggingface dataset:
Based on non-clinical findings, male fertility may be compromised by treatment with Farydak (see section 5.3).
Na temelju nekliničkih nalaza, liječenje Farydakom moglo bi smanjiti mušku plodnost (vidjeti dio 5.3).
The efficacy and safety of panobinostat in combination with bortezomib and dexamethasone were evaluated in a randomised, double-blind, placebo-controlled, multicentre phase III study in patients with relapsed or relapsed and refractory multiple myeloma who had received 1-3 prior lines of therapies.
Djelotvornost i sigurnost panobinostata u kombinaciji s bortezomibom i deksametazonom bile su ocjenjivane u randomiziranom, dvostruko slijepom, placebom kontroliranom multicentričnom ispitivanju faze III u bolesnika s rekurentnim ili rekurentnim i refraktornim multiplim mijelomom koji su prethodno primili 1-3 linije terapije.
At the first sign of abdominal cramping, loose stools or onset of diarrhoea, it is recommended that the patient be treated with anti-diarrhoeal medicinal product (e.g. loperamide) or any additional treatment in accordance with local treatment guidelines.
Na prvi znak grčeva u abdomenu, mekih stolica ili nastupa proljeva preporučuje se liječiti bolesnika antidijaroikom (npr. loperamidom) ili bilo kojom dodatnom terapijom u skladu s lokalnim smjernicama za liječenje.
If patients experience thrombocytopenia, panobinostat may need to be temporarily withheld and the subsequent dose may need to be reduced (see Table 3).
Ako se u bolesnika pojavi trombocitopenija, možda će biti potrebno privremeno prekinuti primjenu panobinostata te smanjiti narednu dozu (vidjeti Tablicu 3).
Given panobinostat's cytostatic/cytotoxic mode of action, the potential risk to the foetus is high.
S obzirom na citostatični/citotoksični način djelovanja panobinostata, potencijalni rizik za fetus je visok.
If a diagnosis of invasive systemic fungal infection is made, panobinostat should be discontinued and appropriate anti-fungal therapy instituted.
Ako se utvrdi dijagnoza invazivne sistemske gljivične infekcije, treba prekinuti primjenu panobinostata te uvesti odgovarajuću terapiju antimikoticima.
• vomiting blood, black or bloody stools, passage of fresh blood through the anus, usually in or with stools (signs of gastrointestinal bleeding)
• povraćanje krvi, crna ili krvava stolica, prolaz svježe krvi kroz anus, obično u stolici ili uz stolicu (znakovi krvarenja u probavnom sustavu)
Dose adjustments
Prilagođavanja doze
Fatigue and asthenia were reported in 41.2% and 22.0% of patients, respectively.
Umor i astenija bili su prijavljeni u 41,2% odnosno 22,0% bolesnika.
• severe headache, feeling weak or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (potential signs of nervous system problems such as bleeding or swelling in the skull or brain)
• teška glavobolja, osjećaj slabosti ili paraliza udova ili lica, poteškoće u govoru, iznenadni gubitak svijesti (potencijalni znakovi problema sa živčanim sustavom kao što su krvarenje ili oticanje u lubanji ili mozgu)
• feeling thirsty, high urine output, increased appetite with weight loss (signs of a high level of sugar in the blood)
• osjećaj žeđi, velika proizvodnja mokraće, povećani apetit uz gubitak tjelesne težine (znakovi visoke razine šećera u krvi)
Colitis, haematemesis, gastrointestinal pain
Kolitis, hematemeza, gastrointestinalna bol
Grade 3 asthenia was observed in 9.4% of the patients, with no patients experiencing asthenia at CTC grade 4.
Astenija 3. stupnja bila je uočena u 9,4% bolesnika, pri čemu nijedan bolesnik nije imao asteniju 4. stupnja prema CTC-u.
SGOT = serum glutamic oxaloacetic transaminase; AST = aspartate aminotransferase
SGOT = serumska glutamat-oksaloacetat transaminaza; AST = aspartat aminotransferaza GGN = gornja granica normalnog raspona
Repeated dose toxicity studies
Ispitivanja toksičnosti ponovljenih doza
Co-administration of a single 20 mg panobinostat dose with ketoconazole, a strong CYP3A inhibitor, increased the Cmax and AUC of panobinostat by 1.6- and 1.8-fold, respectively, compared to when panobinostat was given alone.
Istodobna primjena jednokratne doze panobinostata od 20 mg s ketokonazolom, snažnim CYP3A inhibitorom, povećala je Cmax i AUC panobinostata za 1,6 odnosno 1,8 puta, u usporedbi s panobinostatom samim.
Resume at reduced dose
Nastaviti u smanjenoj dozi
Dizziness may occur following administration of Farydak (see section 4.8).
Može se pojaviti omaglica nakon primjene Farydaka (vidjeti dio 4.8).
Liver function should be monitored prior to treatment and regularly during treatment as clinically indicated, especially in patients with hepatic impairment (see section 4.4).
Jetrenu funkciju potrebno je pratiti prije liječenja te redovito tijekom liječenja prema kliničkim indikacijama, osobito u bolesnika s oštećenjem jetre (vidjeti dio 4.4).
Mild hypothyroidism was reported in patients treated with panobinostat + bortezomib + dexamethasone in Study D2308; some patients required treatment (see section 4.4).
Blagi hipotireoidizam bio je zabilježen u bolesnika liječenih panobinostatom + bortezomibom + deksametazonom u Ispitivanju D2308; neki bolesnici su trebali liječenje (vidjeti dio 4.4).
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Unutar svake skupine učestalosti, nuspojave na lijek su prikazane od najozbiljnijih prema manje ozbiljnima.
Modification of panobinostat starting dose
Modifikacija početne doze panobinostata
The most common adverse events (AEs) leading to treatment discontinuation were diarrhoea (4.5%), asthenia and fatigue (2.9% each) and pneumonia (1.3%).
Najčešći štetni događaji koji su doveli do prekida liječenja bili su proljev (4,5%), astenija i umor (2,9% svaki) te pneumonija (1,3%).
Platelet transfusions may be required as clinically indicated (see sections 4.2 and 4.8).
Transfuzije trombocita mogle bi biti potrebne prema kliničkim indikacijama (vidjeti dijelove 4.2 i 4.8).
Regardless of events chronology, syncope was reported in 9% of patients with ST-T depression and 7.2% of patients with T wave change and 4.9% of patients with neither of these ECG abnormalities.
Bez obzira na kronologiju događaja, sinkopa je bila prijavljena u 9% bolesnika s depresijom ST-T segmenta, u 7,2% bolesnika s promjenom u T valu te u 4,9% bolesnika s nijednom od tih abnormalnosti na EKG-u.
Tabulated list of adverse drug reactions from clinical studies
Tablični popis nuspojava iz kliničkih ispitivanja
In patients with CTC grade 3 thrombocytopenia (platelet count <50 x 109/l with bleeding) panobinostat may need to be temporarily withheld and/or the subsequent dose may need to be reduced.
U bolesnika s trombocitopenijom 3. stupnja prema CTC-u (broj trombocita <50 x 109/l uz krvarenje) primjenu panobinostata će možda trebati privremeno prekinuti i/ili smanjiti narednu dozu.
Gastrointestinal
Gastrointestinalne
What Farydak is used for
Za što se Farydak koristi
How long to take Farydak
Koliko dugo uzimati Farydak
Panobinostat is administered in combination with bortezomib and dexamethasone, as shown in Tables 1 and 2.
Panobinostat se primjenjuje u kombinaciji s bortezomibom i deksametazonom, kako je prikazano u Tablicama 1 i 2.
Complete blood counts should be frequently monitored during treatment (in particular before each injection of bortezomib, i.e. on days 1, 4, 8 and 11 of cycles 1 to 8 and on days 1 and 8 of cycles 9 to 16), especially for thrombocytopenia (see section 4.4).
Kompletnu krvnu sliku treba učestalo pratiti tijekom liječenja (osobito prije svake injekcije bortezomiba, tj. 1., 4., 8. i 11. dana 1. do 8. ciklusa te 1. i 8. dana od 9. do 16. ciklusa), osobito radi otkrivanja trombocitopenije (vidjeti dio 4.4).
Plasma exposure of panobinostat is not altered in cancer patients with mild to severe renal impairment.
Izloženost panobinostata u plazmi ne mijenja se u bolesnika oboljelih od raka s blagim do teškim oštećenjem bubrega.
• generally feeling unwell
• opće loše osjećanje
• increased blood levels of the liver enzymes alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP).
• povećane razine jetrenih enzima alanin aminotransferaze (ALT), aspartat aminotransferaze
Clinical judgement on how to continue the treatment should be exercised when a patient experiences an adverse drug reaction.
Potrebno je upotrijebiti kliničku prosudbu o načinu nastavka liječenja kada u bolesnika dođe do nuspojave na lijek.
• oral thrush (yeast infection of the mouth)
• oralna kandidijaza (gljivična infekcija ustiju)
Likewise ischaemic heart disease (including myocardial infarction and ischaemia) were reported in 4.5% of patients with ST-T depression and 4.8% of patients with T wave change and 2.7% of patients with neither of these ECG abnormalities.
Također, ishemijska bolest srca (uključujući infarkt miokarda i ishemiju) bila je prijavljena u 4,5 % bolesnika s depresijom ST-T segmenta, u 4,8% bolesnika s promjenom u T valu te u 2,7% bolesnika s nijednom od tih abnormalnosti na EKG-u.
Panobinostat has not been studied in patients with end-stage renal disease (ESRD) or patients on dialysis (see section 5.2).
Panobinostat nije bio ispitivan u bolesnika sa završnom fazom bubrežne bolesti (eng. end-stage renal disease, ESRD) ili u bolesnika na dijalizi (vidjeti dio 5.2).
Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.
Farydak, u kombinaciji s bortezomibom i deksametazonom, indiciran je za liječenje odraslih bolesnika s recidivirajućim i/ili refraktornim multiplim mijelomom koji su primili najmanje dva prethodna režima uključujući bortezomib i imunomodulator.
In the event of grade 3 or 4 neutropenia, physicians should consider the use of growth factors (e.g.
U slučaju neutropenije 3. ili 4. stupnja, liječnici trebaju razmotriti primjenu čimbenika rasta (npr. G-CSF) u skladu s lokalnim smjernicama.
• difficulty in breathing or swallowing, swelling of the face, lips, tongue or throat, severe itching of the skin, with a red rash or raised bumps (potential signs of an allergic reaction)
• poteškoće u disanju ili gutanju, oticanje lica, usana, jezika ili grla, teški svrbež kože, s crvenim osipom ili izdignutim kvržicama (potencijalni znakovi alergijske reakcije)
Modification of bortezomib starting dose
Modifikacija početne doze bortezomiba
Very common Decreased appetite, hypophosphataemia a, hyponatraemia a, hypokalaemia a
Smanjeni apetit, hipofosfatemija a, hiponatrijemija a, hipokalijemija a
Paediatric population Panobinostat was not evaluated in multiple myeloma patients under 18 years of age.
Pedijatrijska populacija Panobinostat nije ispitivan u bolesnika s multiplim mijelomom mlađih od 18 godina.
Severe nausea, diarrhoea, constipation and vomiting, sometimes requiring the use of anti-emetic and anti-diarrhoeal medicinal products, have been reported in patients treated with Farydak (see section 4.8).
Gastrointestinalni poremećaji Teška mučnina, proljev, konstipacija i povraćanje, koji ponekad zahtijevaju primjenu antiemetika i antidijaroika, prijavljeni su u bolesnika liječenih Farydakom (vidjeti dio 4.8).
When panobinostat is administered together with dexamethasone, which is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters, the risk for reduced efficacy of hormonal contraceptives needs to be considered.
Kada se panobinostat primjenjuje zajedno s deksametazonom, za koji je poznato da je slabi do umjereni induktor CYP3A4 kao i drugih enzima i transportera, mora se uzeti u obzir rizik od smanjene djelotvornosti hormonskih kontraceptiva.
Patients should be advised to contact their physician to discuss the use of any laxative product.
Bolesnike treba uputiti da se obrate svom liječniku i razgovaraju o primjeni laksativa.
In addition, when panobinostat is administered together with dexamethasone, which is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters, the risk for reduced efficacy of contraceptives needs to be considered.
Uz to, kada se panobinostat primjenjuje zajedno s deksametazonom, za koji se zna da je slab do umjeren induktor CYP3A4 kao i drugih enzima i transportera, rizik od smanjenja djelotvornosti kontraceptiva treba uzeti u obzir.
Due to the nature of multiple myeloma and the known haematotoxicity for panobinostat and its combination agent bortezomib, thrombocytopenia, often severe, has been frequently observed.
Zbog prirode multiplog mijeloma i poznate hematotoksičnosti za panobinostat i tvar s kojom se kombinira, bortezomib, trombocitopenija, često teška, bila je učestalo uočena.
For adverse drug reactions that are related to bortezomib or dexamethasone treatment, please refer to the relevant SmPC.
Za nuspojave koje su povezane s liječenjem bortezomibom ili deksametazonom, molimo pogledajte odgovarajući Sažetak opisa svojstava lijeka.
- if you notice any signs of a heart problem.
- ako primijetite bilo kakve znakove problema s jetrom. - ako primijetite bilo kakve znakove infekcije. - ako primijetite bilo kakve znakove srčanih problema.
• fast breathing, feeling dizzy
• ubrzano disanje, osjećaj omaglice
In patients with platelet count <50 x 109/l (complicated by bleeding) or <25 x 109/l, Farydak therapy should be withheld and resumed at a reduced dose upon recovery to platelet count ≥50 x 109/l.
U bolesnika s brojem trombocita <50 x 109/l (zakomplicirano krvarenjem) ili <25 x 109/l, terapiju Farydakom treba privremeno prekinuti te nastaviti smanjenom dozom nakon oporavka do broja trombocita ≥50 x 109/l.
Platelet counts should be monitored prior to each dose of bortezomib (i.e. on days 1, 4, 8 and 11 of cycles 1-8, see Table 1, and on days 1 and 8 of cycles 9-16, see Table 2).
Broj trombocita potrebno je pratiti prije svake doze bortezomiba (tj. 1., 4., 8. i 11. dana 1.-8. ciklusa, vidjeti Tablicu 1, te 1. i 8. dana 9.-16. ciklusa, vidjeti Tablicu 2).
Petechiae
Petehije
CTC grade 3 or 4 haemorrhage was reported in 4.2% of patients, including cases of gastrointestinal and pulmonary haemorrhage with fatal outcomes.
Krvarenje 3. ili 4. stupnja prema CTC-u prijavljeno je u 4,2% bolesnika, uključujući slučajeve gastrointestinalnog i plućnog krvarenja sa smrtnim ishodima.
≤1.0 x ULN >ULN Reduce panobinostat dose to 15 mg in the first treatment cycle.
≤1,0 x GGN >GGN Smanjiti dozu panobinostata na 15 mg u prvom ciklusu liječenja.
Agents that are predicted to decrease panobinostat concentrations
Tvari za koje se predviđa da smanjuju koncentracije panobinostata
>1.0 x ULN and ≤1.5 x ULN
>1,0 x GGN i ≤1,5 x GGN
• inflamed ear, nose bleed or bleeding in the white of the eye, bruising, inflamed skin caused by infection (rash, red skin, which is also known as erythema)
• upaljeno uho, krvarenje iz nosa ili krvarenje u bjeloočnici, stvaranje modrica, upaljena koža uzrokovana infekcijom (osip, crvenilo kože, što se naziva eritem)
Patients received panobinostat (20 mg taken orally once a day, three times per week, on a 2 weeks on and 1 week off dosing regimen), in combination with bortezomib (1.3 mg/m2 injected intravenously) and dexamethasone (20 mg).
Bolesnici su primali panobinostat (20 mg peroralno jedanput na dan, triput na tjedan, u režimu doziranja s 2 tjedna primanja terapije i 1 tjednom bez), u kombinaciji s bortezomibom (1,3 mg/m2 injicirano intravenski) i deksametazonom (20 mg).
Hyperglycaemia, dehydration, hypoalbuminaemia, fluid retention, hyperuricaemia, hypocalcaemia, hypomagnesaemia
Hiperglikemija, dehidracija, hipoalbuminemija, zadržavanje tekućine, hiperurikemija, hipokalcijemija, hipomagnezijemija
quinidine, propafenone or sotalol.
disopiramid, prokainamid, kvinidin, propafenon ili sotalol.
PAN= panobinostat PBO= placebo BTZ= bortezomib Dex = dexamethasone
PAN= panobinostat PBO= placebo BTZ= bortezomib Dex = deksametazon
Clinical efficacy in patients with bortezomib-refractory multiple myeloma (Study DUS71Panorama 2)
Klinička djelotvornost u bolesnika s multiplim mijelomom refraktornim na bortezomib (Ispitivanje DUS71 - Panorama 2)
Septic shock, urinary tract infection, viral infection, oral herpes, Clostridium difficile colitis, otitis media, cellulitis, sepsis, gastroenteritis, lower respiratory tract infection, candidiasis
Septički šok, infekcija mokraćnog sustava, virusna infekcija, oralni herpes, Clostridium difficile kolitis, upala srednjeg uha, celulitis, sepsa, gastroenteritis, infekcija donjeg dijela dišnog sustava, kandidijaza
The safety data of panobinostat have been assessed from a total of 451 patients with multiple myeloma treated with panobinostat in combination with bortezomib and dexamethasone and from a total of 278 patients treated with panobinostat as a single agent.
Sigurnosni podaci o panobinostatu procijenjeni su na ukupno 451 bolesniku s multiplim mijelomom liječenom panobinostatom u kombinaciji s bortezomibom i deksametazonom te na ukupno 278 bolesnika liječenih samim panobinostatom.
Study DUS71 was a two-stage, single-arm, open-label multicentre phase II study of oral panobinostat (20 mg) in combination with bortezomib (1.3 mg/m2) and dexamethasone (20 mg) in 55 patients with relapsed and refractory multiple myeloma, who were bortezomib-refractory and had received at least two prior lines of therapy.
Ispitivanje DUS71 bilo multicentrično, otvoreno ispitivanje faze II u dvije etape i s jednom skupinom, u kojem se ispitivao oralni panobinostat (20 mg) u kombinaciji s bortezomibom (1,3 mg/m2) i deksametazonom (20 mg) u 55 bolesnika s rekurentnim i refraktornim multiplim mijelomom, koji su bili refraktorni na bortezomib i primili najmanje dvije prethodne linije terapije.
• sudden bleeding or bruising underneath the skin (signs of low level of blood platelets)
• iznenadno krvarenje ili podljevi ispod kože (znakovi niske razine trombocita u krvi)
Women using hormonal contraceptives should additionally use a barrier method of contraception.
Žene koje koriste hormonske kontraceptive trebaju uz to koristiti kontracepcijsku metodu barijere.
Haematological adverse drug reactions, including severe thrombocytopenia, neutropenia and anaemia (CTC grade 3 to 4) were reported in patients treated with panobinostat.
Hematološke nuspojave, uključujući tešku trombocitopeniju, neutropeniju i anemiju (3. do 4. stupnja prema CTC-u) prijavljene su u bolesnika liječenih panobinostatom.
• feeling thirsty, low urine output, weight loss, dry flushed skin, irritability (signs of dehydration)
• osjećaj žeđi, mala proizvodnja mokraće, gubitak tjelesne težine, suha užarena koža, razdražljivost (znakovi dehidracije)
Hypertension, haematoma, orthostatic hypotension
Hipertenzija, hematom, ortostatska hipotenzija
The effect of hepatic impairment on the pharmacokinetics of panobinostat was evaluated in a phase I study, in 24 patients with solid tumours and with varying degrees of hepatic impairment.
Učinak oštećenja jetre na farmakokinetiku panobinostata ocijenjen je u ispitivanju faze I, u 24 bolesnika sa solidnim tumorima i s različitim stupnjevima oštećenja jetre.
Thyroid and pituitary function should be monitored by measuring hormone levels (e.g. free T4 and TSH) as clinically indicated.
Funkciju štitnjače i hipofize treba pratiti mjerenjem razina hormona (npr. slobodnog T4 i TSH-a) prema kliničkim indikacijama.
- For women taking Farydak
• Za žene koje uzimaju Farydak
The most common non-haematological adverse reactions were diarrhoea, fatigue, nausea and vomiting.
Najčešće ne-hematološke nuspojave bile su proljev, umor, mučnina i povraćanje.
Due to the potential risk of death or malformation to the foetus, Farydak should not be taken during:
Trudnoća i dojenje Zbog potencijalnog rizika od smrti ili anomalije fetusa Farydak se ne smije uzimati tijekom:
On-treatment deaths not due to the study indication (multiple myeloma) were reported in 6.8% of panobinostat + bortezomib + dexamethasone-treated patients versus 3.2% of placebo + bortezomib + dexamethasone-treated patients.
Smrt tijekom liječenja koja nije bila uzrokovana ispitivanom indikacijom (multiplim mijelomom) bila je prijavljena u 6,8% bolesnika liječenih panobinostatom + bortezomibom + deksametazonom u usporedbi s 3,2% bolesnika liječenih placebom + bortezomibom + deksametazonom.
Based on findings in animals, the likelihood of panobinostat increasing the risk of both foetal death and developmental skeletal abnormalities when administered to pregnant women is predicted to be high.
Na temelju nalaza u životinja, predviđa se da je velika vjerojatnost da će panobinostat povećati rizik od fetalne smrti i razvojnih skeletalnih poremećaja kada se primjenjuje u trudnica.
The platelet count should be ≥100 x 109/l and the absolute neutrophil count ≥1.0 x 109/l prior to initiation of treatment.
Broj trombocita treba biti ≥100 x 109/l, a apsolutni broj neutrofila ≥1,0 x 109/l prije početka liječenja.
Figure 1 Median platelet counts over time (Study D2308, Safety set, cycles 1-8)
Slika 1 Medijan broja trombocita tijekom vremena (Ispitivanje D2308, Sigurnosna skupina,
• feeling tired (fatigue), pale skin.
• osjećaj umora, blijeda koža.
It is recommended to monitor patients over 65 years of age more frequently, especially for thrombocytopenia and gastrointestinal toxicity (see section 4.8 and section 4.2).
Preporučuje se učestalije pratiti bolesnike starije od 65 godina, osobito radi trombocitopenije i gastrointestinalne toksičnosti (vidjeti dio 4.8 i dio 4.2).
• coughing up blood, oozing of bloody fluid from the nose (signs of bleeding in the lungs)
• iskašljavanje krvi, curenje tjelesnih tekućina iz nosa (znakovi krvarenja u plućima)
• increased blood level of uric acid
• povećana razina mokraćne kiseline u krvi
The safety data reported below are based on the phase III clinical study (Panorama 1) in 381 patients with multiple myeloma treated with 20 mg panobinostat once a day three times per week, on a 2 weeks on and 1 week off dosing regimen in combination with bortezomib and dexamethasone.
Sigurnosni podaci navedeni u nastavku temelje se na kliničkom ispitivanju faze III (Panorama 1) na 381 bolesniku s multiplim mijelomom liječenom s 20 mg panobinostata jedanput na dan tri puta tjedno, prema režimu doziranja 2 tjedna primanja terapije, 1 tjedan bez terapije, u kombinaciji s bortezomibom i deksametazonom.
• fever, chest pain, increased heart rate, decreased blood pressure, shortness of breath or rapid breathing (signs of blood poisoning, which is also known as sepsis)
• vrućica, bol u grudima, povećana srčana frekvencija, sniženi krvni tlak, nedostatak zraka ili ubrzano disanje (znakovi trovanja krvi, koje se naziva i sepsa)
Possible side effects
Druge moguće nuspojave
• fast weight gain, swelling of hands, ankles, feet or face (signs of water retention)
• brzi porast tjelesne težine, oticanje šaka, gležnjeva, stopala ili lica (znakovi zadržavanja tekućine)
Table 7 Panobinostat adverse drug reactions observed in multiple myeloma patients in the phase III study
Tablica 7 Nuspojave na panobinostat uočene u bolesnika s multiplim mijelomom u ispitivanju faze III
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
Platelet transfusions may be required, if clinically indicated (see section 4.4).
Mogle bi biti potrebne transfuzije trombocita, ako je to klinički indicirano (vidjeti dio 4.4).
Grade 3
Neutropenija 3. stupnja
• fever, sore throat, or mouth ulcers due to infections (signs of a low level of white blood cells)
• vrućica, grlobolja ili čirevi u ustima uzrokovani infekcijama (znakovi niske razine bijelih krvnih stanica)
- medicines used to treat cough, such as dextromethorphan.
- lijekove koji se koriste za liječenje kašlja, kao što je dekstrometorfan.
Grade 3-4 events more frequently observed in patients included the following (percentages presented for patients <65 years, 65-75 years and ≥75 years of age, respectively): thrombocytopenia (60%, 74%, and 91%), anaemia (16%, 17% and 29%), diarrhoea (21%, 27% and 47%), and fatigue (18%, 28% and 47%).
<65 godina, 65-75 godina i ≥75 godina): trombocitopenija (60%, 74% i 91%), anemija (16%, 17% i