natgillin/translations-raw huggingface dataset:
Some of these cases have progressed to acute hepatic failure, resulting in discontinuation of pomalidomide.
Neki od tih slučajeva napredovali su u akutno zatajenje funkcije jetre, što je rezultiralo prekidom primjene pomalidomida.
Very Common Pneumonia
Vrlo često pneumonija
Febrile neutropenia (FN) was reported in 3.2-6.7% of patients and was serious in 1.8-4.0% of patients (see section 4.2 and 4.4).
Febrilna neutropenija zabilježena je u 3,2 - 6,7% bolesnika, a bila je ozbiljna u 1,8 - 4,0% bolesnika (vidjeti dijelove 4.2 i 4.4).
Survival Time (weeks)
vrijeme preživljenja (tjedni)
Patients with a history of severe rash associated with lenalidomide or thalidomide should not receive pomalidomide (see section 4.4).
Bolesnici s anamnezom teškog osipa koji je povezan s liječenjem lenalidomidom ili talidomidom ne smiju primati pomalidomid (vidjeti dio 4.4).
Other serious adverse reactions reported included pyrexia (4.0%), lower respiratory tract infection (2.9%), pulmonary embolism (2.9%), influenza (2.9%), and acute kidney injury (2.9%).
Ostale ozbiljne nuspojave uključivale su pireksiju (4,0%), infekciju donjih dišnih puteva (2,9%), plućnu emboliju (2,9%), influencu (2,9%) i akutno oštećenje bubrega (2,9%).
Frequencies for Pom+Btz+Dex (any grade) are defined in accordance with current guidance, as: very common (≥1/10), common (≥1/100 to <1/10); and uncommon (≥1/1,000 to <1/100).
Učestalosti nuspojava u skupini Pom+Btz+Dex (svi stupnjevi) definirane su u skladu s važećom smjernicom kao: vrlo česte (≥1/10), česte (≥1/100 i <1/10) i manje česte (≥1/1000 i <1/100).
Dispensing of pomalidomide to women of childbearing potential should occur within 7 days of the prescription.
Do izdavanja pomalidomida ženama reproduktivne dobi treba doći unutar 7 dana od propisivanja.
Co-administration of multiple doses of up to 4 mg pomalidomide with 20 mg to 40 mg dexamethasone (a weak to moderate inducer of several CYP enzymes including CYP3A) to patients with multiple myeloma had no effect on the pharmacokinetics of pomalidomide compared with pomalidomide administered alone.
Istodobna primjena višestrukih doza do 4 mg pomalidomida i 20 mg do 40 mg deksametazona (slabog do umjerenog induktora nekoliko CYP enzima uključujući CYP3A) bolesnicima s multiplim mijelomom nije imala učinka na farmakokinetiku pomalidomida u usporedbi s onom kad se pomalidomid primjenjivao sam.
• He understands that if his female partner becomes pregnant whilst he is taking pomalidomide or 7 days after he has stopped taking pomalidomide, he should inform his treating physician immediately and that it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
• shvaćaju da, ako njihova partnerica zatrudni dok uzimaju pomalidomid ili 7 dana nakon što su prestali uzimati pomalidomid, trebaju odmah obavijestiti nadležnog liječnika te da se preporučuje uputiti partnericu liječniku specijalistu ili liječniku s iskustvom u teratologiji radi pregleda i savjeta.
95% CI about the median.
95% CI za medijan c
However, patients with hepatic impairment should be carefully monitored for adverse reactions and dose reduction or interruption of pomalidomide should be used as needed.
Ipak, bolesnike s oštećenjem funkcije jetre treba pozorno pratiti zbog mogućih nuspojava i, prema potrebi, smanjiti dozu ili prekinuti primjenu pomalidomida.
Women of childbearing potential must use at least one effective method of contraception for at least 4 weeks before therapy, during therapy, and until at least 4 weeks after pomalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Žene reproduktivne dobi moraju primjenjivati barem jednu djelotvornu metodu kontracepcije najmanje 4 tjedna prije terapije, tijekom i najmanje 4 tjedna nakon liječenja pomalidomidom čak i u slučaju prekida liječenja, osim ako se bolesnica obveže na apsolutnu i neprekidnu apstinenciju koja se će se potvrđivati mjesečno.
Alanine aminotransferase increased Weight decreased
Često povišena alanin aminotransferaza smanjena težina
Pomalidomide doses as high as 50 mg as a single dose in healthy volunteers, and 10 mg as once-daily multiple doses in multiple myeloma patients have been studied without reported serious adverse reactions related to overdose.
U zdravih dobrovoljaca ispitane su doze pomalidomida od čak 50 mg kao jednokratna doza, a u bolesnika s multiplim mijelomom doze od 10 mg kao višekratne doze primjenjivane jedanput na dan, bez zabilježenih ozbiljnih nuspojava povezanih s predoziranjem.
According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL must be performed for women of childbearing potential as outlined below.
U skladu s lokalnom praksom, žene reproduktivne dobi moraju se, pod liječničkim nadzorom, podvrgnuti testovima na trudnoću, osjetljivosti od najmanje 25 mIU/ml, kako je to opisano u nastavku.
ANC** < 0.5 x 109/l or febrile neutropenia (fever ≥38.5°C and ANC <1 x 109/l)
9/l ili febrilna neutropenija (vrućica ≥38,5°C i ABN <1 x 109/l)
Patients with ongoing ≥ Grade 2 peripheral neuropathy were excluded from clinical studies with pomalidomide.
Bolesnici s prisutnom perifernom neuropatijom ≥2. stupnja bili su isključeni iz kliničkih ispitivanja s pomalidomidom.
• Safety advice for men o The need to avoid foetal exposure o The need to use condoms if sexual partner is pregnant or a WCBP and has no contraception (even if man has had a vasectomy) ▪ During pomalidomide treatment ▪ For one week following final dose o That he should not donate semen or sperm during therapy (including during dose interruptions) and for 7 days after discontinuation of pomalidomide treatment o That if his partner becomes pregnant whilst he is taking pomalidomide or shortly after he has stopped taking pomalidomide he should inform his treating doctor immediately
• Sigurnosni savjeti za muškarce o potreba za izbjegavanjem fetalne izloženosti o potreba za uporabom prezervativa ako je partnerica trudna ili u reproduktivnoj dobi i bez kontracepcije (čak i ako se muški partner podvrgnuo vazektomiji) ▪ tijekom liječenja pomalidomidom ▪ tjedan dana nakon zadnje doze o ne smije donirati sjeme ili spermu tijekom liječenja (uključujući privremene prekide liječenja) i još 7 dana nakon prestanka liječenja pomalidomidom o ako njegova partnerica zatrudni dok on uzima pomalidomid ili ubrzo nakon prestanka uzimanja pomalidomida, odmah treba obavijestiti svog liječnika.
Frequencies are defined in accordance with current guidance, as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); and uncommon (≥ 1/1,000 to < 1/100).
Učestalosti su definirane u skladu s važećom smjernicom kao: vrlo česte (≥1/10), česte (≥1/100 i <1/10) i manje česte (≥1/1000 i
The primary efficacy endpoint was progression free survival by International Myeloma Working Group (IMWG criteria).
Primarni ishod djelotvornosti bilo je preživljenje bez progresije bolesti prema kriterijima Međunarodne radne skupine za mijelom (IMWG).
ANC return to ≥ 1 x 109/l
Oporavak ABN na ≥1 x 109/l
These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Te testove na trudnoću treba provoditi na dan propisivanja lijeka ili 3 dana prije posjete liječniku koji propisuje lijek.
A medically supervised pregnancy test should be performed during the consultation, when pomalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Test na trudnoću pod liječničkim nadzorom treba provesti tijekom konzultacija kada se propisuje pomalidomid ili 3 dana prije posjeta liječniku koji propisuje lijek kada bolesnica primjenjuje djelotvornu kontracepciju najmanje 4 tjedna.
Overall Survival: ITT Population
Tablica 12: Ukupno preživljenje: analiza ITT populacije
• The need to stop pomalidomide immediately upon suspicion of pregnancy
• potreba za prekidom uzimanja pomalidomida odmah nakon sumnje na trudnoću
• The need to contact their doctor immediately upon suspicion of pregnancy
• potreba da se obrate svom liječniku odmah nakon sumnje na trudnoću.
How to take Imnovid Imnovid must be given to you by a doctor with experience in treating multiple myeloma.
Imnovid Vam mora propisati liječnik s iskustvom u liječenju multiplog mijeloma.
Dizziness and confusional state have been reported with pomalidomide.
Omaglica i konfuzno stanje zabilježeni su uz pomalidomid.
• That if his partner becomes pregnant he should inform his treating doctor immediately
• ako partnerica zatrudni, bolesnik treba odmah obavijestiti svog liječnika
• She understands the need to commence the treatment as soon as pomalidomide is dispensed following a negative pregnancy test
• shvaća potrebu da se s liječenjem započne odmah po izdavanju pomalidomida, a nakon negativnog testa na trudnoću
In patients receiving combination therapy with pomalidomide in clinical studies, infection occurred in 55.0-80.2% of patients (24.0-30.9% Grade 3 or 4).
U bolesnika koji su u kliničkim ispitivanjima primali kombiniranu terapiju s pomalidomidom infekcija se razvila u 55,0 - 80,2% bolesnika (24,0 - 30,9% 3. ili 4. stupnja).
• He understands the need for the use of a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception, throughout treatment duration, during dose interruption and for 7 days after dose interruptions and/or cessation of treatment.
• shvaćaju potrebu za uporabom prezervativa u slučaju spolne aktivnosti s trudnicom ili ženom reproduktivne dobi koja ne koristi učinkovitu kontracepciju tijekom trajanja liječenja, tijekom prekida doze i 7 dana nakon prekida primjene i/ili prestanka liječenja.
Exposure-adjusted rates were comparable across treatment arms.
Stope prilagođene za izloženost bile su slične u svim terapijskim skupinama.
Pomalidomide has direct anti-myeloma tumoricidal activity, immunomodulatory activities and inhibits stromal cell support for multiple myeloma tumour cell growth.
Pomalidomid je izravno citotoksičan za mijelomske stanice, ima imunomodulatorno djelovanje i inhibira stromalnu potporu tumorskim stanicama multiplog mijeloma.
Consider dose interruption or discontinuation of pomalidomide treatment.
Razmisliti o privremenom prekidu primjene ili prestanku liječenja pomalidomidom.
Common Weight decreased
Često smanjena težina
4.5 Interaction with other medicinal products and other forms of interaction Effect of pomalidomide on other medicinal products
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija
Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day.
U idealnom slučaju testiranje na trudnoću trebalo bi obaviti isti dan kada i propisivanje i izdavanje lijeka.
• Obligations of the health care professional in relation to the prescribing of pomalidomide o Need to provide comprehensive advice and counselling to patients o That patients should be capable of complying with the requirements for the safe use of pomalidomide o Need to provide patients with appropriate patient educational brochure and patient card
• obveze zdravstvenih radnika u vezi s propisivanjem pomalidomida o potreba za iscrpnim objašnjenjima i savjetovanjem bolesnika o bolesnici trebaju biti sposobni pridržavati se zahtjeva za sigurnu primjenu pomalidomida o potreba da bolesnici dobiju odgovarajuće edukacijske knjižice i kartice za bolesnike.
Cardiac failure Atrial fibrillation Myocardial infarction
Često srčano zatajenje fibrilacija atrija infarkt miokarda
Very Common Pneumonia (bacterial, viral and fungal infections, including opportunistic infections)
Infekcije i infestacije Vrlo često pneumonija (bakterijske, virusne i gljivične infekcije, uključujući oportunističke infekcije)
The 1-year event free rate was 52.6% (± 5.72%) for the Pom + LD-Dex arm and 28.4% (± 7.51%) for the HD-Dex arm.
Jednogodišnja stopa bez događaja iznosila je 52,6% (±5,72%) u skupini Pom+LD-Dex i 28,4% (±7,51%) u skupini HD-Dex.
If the patient forgets to take a dose of pomalidomide on one day, then the patient should take the normal prescribed dose as scheduled on the next day.
Ako bolesnik jedan dan zaboravi uzeti dozu pomalidomida, sljedeći dan ne smije uzeti veću dozu kako bi nadoknadio propuštenu, nego uobičajenu propisanu dozu prema rasporedu za taj dan.
Haemorrhagic events have included epistaxis, intracranial haemorrhage and gastrointestinal haemorrhage.
Hemoragijski događaji uključuju epistaksu, intrakranijalno krvarenje i gastrointestinalno krvarenje.
In the rat embryofoetal developmental toxicity study, malformations of absence of urinary bladder, absence of thyroid gland, and fusion and misalignment of lumbar and thoracic vertebral elements (central and/or neural arches) were observed at all dosage levels (25, 250, and 1000 mg/kg/day).
U ispitivanju toksičnosti za embriofetalni razvoj kod štakora, opažene su malformacije u vidu odsutnosti mokraćnog mjehura, odsutnosti štitne žlijezde i fuzije i neporavnatosti lumbalnih i torakalnih kralježaka (centralni i/ili neuralni lukovi) pri primjeni svih razina doza (25, 250 i 1000 mg/kg na dan).
Thrombocytopenia was Grade 3 or 4 in 20.7-27.3% of patients, led to pomalidomide discontinuation in 0.7% of patients and was serious in 0.4-1.7% of patients (see sections 4.2 and 4.4).
Trombocitopenija je bila 3. ili 4. stupnja u 20,7 - 27,3% bolesnika, dovela je do prestanka primjene pomalidomida u 0,7% bolesnika, a bila je ozbiljna u 0,4 - 1,7% bolesnika (vidjeti dijelove 4.2 i 4.4).
System Organ Class/ Preferred Term
Klasifikacija organskih sustava/ preporučeni pojam
Neutropenia and thrombocytopenia tended to occur more frequently within the first 2 cycles of treatment with pomalidomide.
Neutropenija i trombocitopenija obično su se češće pojavile u prva 2 ciklusa terapije pomalidomidom.
• Itchy skin.
• svrbež kože
The mean increases in exposure to pomalidomide in each of these impairment groups are not of a magnitude for which adjustments in schedule or dose are required (see section 4.2).
Srednje vrijednosti povećanja izloženosti pomalidomidu u svakoj od ovih skupina s oštećenjem funkcije jetre nisu takvog raspona da bi zahtijevale prilagodbu rasporeda primjene ili doze (vidjeti dio 4.2).
Pomalidomide has a mean total body clearance (CL/F) of approximately 7-10 L/hr.
Ukupni prosječni klirens pomalidomida iz organizma (CL/F) približno 7 - 10 l/h.
Other ≥ Grade 3 pomalidomide-related adverse events
Drugi štetni događaji ≥3. stupnja povezani s pomalidomidom
(E133), and white ink.
(E133) i bijelu tintu.
Do not use while pregnant or breast-feeding.
Ne primjenjivati u trudnoći ili u razdoblju dojenja.
Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis (see sections 4.6 and 5.3).
Otkriveno je da je pomalidomid teratogen u štakora i kunića kad se primjenjuje tijekom razdoblja glavne organogeneze (vidjeti dijelove 4.6 i 5.3).
• Changes in the way things taste.
• promjene osjeta okusa
Pomalidomide interruption or discontinuation should be considered for Grade 2-3 skin rash.
O prekidu ili ukidanju primjene pomalidomida treba razmisliti u slučaju osipa na koži 2. do 3. stupnja.
• That pomalidomide may cause thrombocytopenia and the need for regular blood tests
• da pomalidomid može prouzročiti trombocitopeniju te potrebu za redovitim krvnim pretragama
Uncommon Cerebrovascular accident
Manje često cerebrovaskularni incident
Additionally, pomalidomide inhibits the proliferation of lenalidomide-resistant multiple myeloma cell lines and synergises with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumour cell apoptosis.
Uz to, inhibira proliferaciju staničnih linija multiplog mijeloma rezistentnih na lenalidomid i sinergistički djeluje s deksametazonom inducirajući apoptozu tumorskih stanica u staničnim linijama osjetljivim i onima rezistentnim na lenalidomid.
• Requirements in the event of pregnancy o Instructions to stop pomalidomide immediately upon suspicion of pregnancy if female patients o Need to refer to physician specialised or experienced in dealing with teratology and its diagnosis for evaluation and advice o Local contact details for reporting of any suspected pregnancy o Pregnancy reporting form
• Zahtjevi u slučaju trudnoće o upute za prekid uzimanja pomalidomida odmah nakon sumnje na trudnoću u bolesnica o potreba da se uputi na pregled i savjetovanje liječniku specijaliziranom ili iskusnom u liječenju i dijagnosticiranju teratogenih učinaka/poremećaja o lokalni kontakt podaci za prijavljivanje svake sumnje na trudnoću o obrazac za prijavu trudnoće.
• Numbness, tingling or burning sensation to the skin, pains in hands or feet (peripheral sensory neuropathy).
• utrnulost, trnci ili osjećaj žarenja kože, bolovi u šakama ili stopalima (periferna senzorna neuropatija)
• Pomalidomide in combination with bortezomib and dexamethasone The most commonly reported blood and lymphatic system disorders were neutropenia (46.8%), thrombocytopenia (36.7%) and anaemia (28.4%).
• Pomalidomid u kombinaciji s bortezomibom i deksametazonom Najčešće zabilježeni poremećaji krvi i limfnog sustava bili su neutropenija (46,8%), trombocitopenija (36,7%) i anemija (28,4%).
When Imnovid is used with dexamethasone, in people who have had at least two other treatments, it can stop multiple myeloma getting worse:
Kada se Imnovid primjenjuje s deksametazonom u osoba koje su primile najmanje dvije druge terapije, može zaustaviti pogoršanje multiplog mijeloma:
31 August 2023
31. kolovoza
Median OS time for the HD-Dex arm was 34 weeks (95% CI: 23.4, 39.9).
Medijan razdoblja ukupnog preživljenja u skupini koja je primala HD-Dex iznosio je 34 tjedna (95% CI: 23,4; 39,9).
What Imnovid is and what it is used for What you need to know before you take Imnovid How to take Imnovid
Što je Imnovid i za što se koristi Što morate znati prije nego počnete uzimati Imnovid Kako uzimati Imnovid
• Low blood levels of magnesium (hypomagnesaemia), which may cause tiredness, generalised weakness, muscle cramps, irritability and may result in low blood levels of calcium (hypocalcaemia), which may cause numbness and, or tingling of hands, feet, or lips, muscle cramps, muscle weakness, light-headedness, confusion.
• niske razine magnezija u krvi (hipomagnezijemija) što može prouzročiti umor, opću slabost, grčeve u mišićima i razdražljivost te može rezultirati niskim razinama kalcija (hipokalcijemija), što može prouzročiti utrnulost i trnce u šakama, stopalima ili usnama, grčeve u mišićima, slabost u mišićima, ošamućenost, smetenost
The No Observed Adverse Effect Level (NOAEL) was 0.1 mg/kg/day (0.5-fold exposure ratio relative to a 4 mg clinical dose).
No Observed Adverse Effect Level, NOAEL) iznosila je 0,1 mg/kg na dan (0,5 puta veći omjer izloženosti u odnosu na kliničku dozu od 4 mg).
(E172) and white ink.
(E172) i bijelu tintu.
Common (may affect up to 1 in 10 people):
Često (mogu se pojaviti u do 1 na 10 osoba):
Common Depression Insomnia
Često depresija nesanica
• She understands the need for effective contraception, without interruption, at least 4 weeks before starting treatment, throughout the entire duration of treatment, and at least 4 weeks after the end of treatment
• razumije potrebu za djelotvornom kontracepcijom, bez prekida, najmanje 4 tjedna prije početka liječenja te kroz cjelokupno trajanje liječenja kao i najmanje 4 tjedna nakon završetka liječenja
• Brochure for women patients of childbearing potential and their partners
• knjižice za bolesnice u reproduktivnoj dobi i njihove partnere
• High blood level of calcium (hypercalcaemia), which may cause slowing reflexes and skeletal muscle weaknesses.
• visoka razina kalcija u krvi (hiperkalcijemija) što može prouzročiti usporene reflekse i slabost mišića
Thalidomide is a known human teratogen that causes severe life-threatening birth defects.
Talidomid je poznati teratogen za ljude koji uzrokuje teške životno ugrožavajuće prirođene anomalije.
• Safety advice relevant to all patients o Description and management of thrombocytopenia including incidence rates from clinical studies o Description and management of cardiac failure o Disposal of unwanted medicine o Local country specific arrangements for a prescription for pomalidomide to be dispensed
• Sigurnosni savjeti koji vrijede za sve bolesnike o opis i zbrinjavanje trombocitopenije, uključujući stope incidencije iz kliničkih ispitivanja o opis i zbrinjavanje zatajenja srca o zbrinjavanje lijeka koji više nije potreban o specifični lokalni zahtjevi za propisivanjem i izdavanjem pomalidomida
Neutrophil count decreased White blood cell count decreased Platelet count decreased Alanine aminotransferase increased
Često snižen broj neutrofila snižen broj bijelih krvnih stanica snižen broj trombocita povišena alanin aminotransferaza
Uncommon Decreased appetite
Manje često smanjen apetit
st relapse and approximately 73% of patients received bortezomib as prior treatment.
U približno 40% bolesnika to je bio prvi recidiv, a oko 73% bolesnika primalo je bortezomib kao prethodnu terapiju.
The MAH should agree the final text of the Direct Healthcare Professional Communication and the physician information pack contents with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
3. Nositelj odobrenja treba se dogovoriti s nacionalnim nadležnim tijelom pojedine države članice o konačnom tekstu pisma zdravstvenim radnicima te sadržaju paketa s informacijama za liječnika te osigurati da materijali sadrže ključne elemente opisane u nastavku.
• High blood levels of potassium, which may cause abnormal heart rhythm.
• visoke razine kalija u krvi koje mogu prouzročiti abnormalan srčani ritam
In rats, chronic administration of pomalidomide at doses of 50, 250, and 1000 mg/kg/day for 6 months was well tolerated.
Štakori su dobro podnosili kroničnu primjenu pomalidomida u dozama od 50, 250 i 1000 mg/kg na dan tijekom 6 mjeseci.
Haematological events Neutropenia was the most frequently reported Grade 3 or 4 haematological adverse reaction in patients with relapsed/refractory multiple myeloma, followed by anaemia and thrombocytopenia.
Neutropenija je bila najčešće zabilježena hematološka nuspojava 3. ili 4. stupnja kod bolesnika s relapsnim/refraktornim oblikom multiplog mijeloma nakon koje su slijedile anemija i trombocitopenija.
• Disposal of unwanted medicine
• zbrinjavanje lijeka koji više nije potreban
Very Common Muscular weakness Back pain
Vrlo često mišićna slabost bol u leđima
Pomalidomide is administered in combination with bortezomib and dexamethasone, as shown in Table 1.
Pomalidomid se primjenjuje u kombinaciji s bortezomibom i deksametazonom, kako je prikazano u tablici 1.
In a second study to evaluate the contribution of a CYP1A2 inhibitor alone to metabolism changes, co-administration of fluvoxamine alone with pomalidomide increased mean exposure to pomalidomide by 125% with a 90% confidence interval [98% to 157%] compared to pomalidomide alone.
U drugom ispitivanju, u kojem je procijenjen doprinos samo inhibitora CYP1A2 na promjene metabolizma, istodobna primjena samog fluvoksamina s pomalidomidom povećala je srednju vrijednost izloženosti pomalidomidu za 125% uz 90%-tni interval pouzdanosti [98% do 157%] u usporedbi sa samim pomalidomidom.
In a fertility and early embryonic development study in rats, pomalidomide was administered to males and females at dosages of 25, 250, and 1000 mg/kg/day.
Tijekom ispitivanja učinaka na plodnost i rani embrionalni razvoj štakora, pomalidomid je bio primjenjivan na mužjacima i ženkama u dozama od 25, 250 i 1000 mg/kg na dan.
No adverse findings were noted up to 1000 mg/kg/day (175-fold exposure ratio relative to a 4 mg clinical dose).
Nije bilo zabilježenih štetnih učinaka pri dozama do 1000 mg/kg na dan (175 puta veći omjer izloženosti u odnosu na kliničku dozu od 4 mg).
Interstitial lung disease (ILD)
Intersticijska bolest pluća (IBP)