natgillin/translations-raw huggingface dataset:
Treatment must not be started if the absolute neutrophil count is < 1.5 ×109/L, if the platelet counts are < 75× 109/L, or if the patient has an unresolved Grade 3 or 4 non-haematological clinically relevant toxicity from prior therapies.
Liječenje se ne smije započeti ako je apsolutni broj neutrofila (ABN) < 1,5 × 109/L, ako je broj trombocita < 75 × 109/L, ili ako bolesnik ima klinički značajnu neriješenu nehematološku toksičnost 3. ili 4. stupnja od prethodnih terapija.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama Plana.
If the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Lonsurf.
Ako se gore navedeno odnosi na Vas (ili ako niste sigurni), razgovarajte sa svojim liječnikom ili ljekarnikom prije uzimanja lijeka Lonsurf.
In the Phase III clinical trials, treatment-related infections occurred more frequently in Lonsurf-treated patients (5.8%) compared to those receiving placebo (1.8%).
U kliničkim ispitivanjima faze III infekcije povezane s liječenjem češće su zabilježene kod bolesnika liječenih Lonsurfom (5,8%) u usporedbi s placebom (1,8%).
The cytotoxic activity of trifluridine/tipiracil hydrochloride against several human tumour xenografts correlated highly with the amount of trifluridine incorporated into DNA, suggesting this as the primary mechanism of action.
Citotoksična aktivnost trifluridina/tipiracilklorida kod nekoliko ljudskih tumorskih ksenograftova visoko korelira s količinom ugrađenog trifluridina u DNA, sugerirajući to kao primarni mehanizam djelovanja.
Common: may affect up to 1 in 10 people:
Često: mogu se javiti u do 1 na 10 osoba:
The protein binding of trifluridine in human plasma was over 96% and trifluridine bound mainly to human serum albumin.
Trifluridin se vezao više od 96% za proteine u ljudskoj plazmi, i to uglavnom za albumin.
Dysgeusia Neuropathy peripheral
Disgeuzija Periferna neuropatija
• The other ingredients are: - Tablet core: lactose monohydrate, starch pregelatinised (Maize) and stearic acid.
• Drugi sastojci su: - Jezgra tablete: laktoza hidrat, škrob, prethodno geliran (kukuruzni) i stearatna kiselina.
There is no known antidote for an overdose of Lonsurf.
Nema specifičnog antidota za predoziranje Lonsurfom.
This is because zidovudine may not work as well if you are taking Lonsurf.
To je zbog toga što zidovudin možda neće imati isti učinak ako se istodobno liječite lijekom Lonsurf.
In vitro studies indicated that trifluridine is a substrate for the nucleoside transporters CNT1, ENT1 and ENT2.
In vitro ispitivanja ukazuju da je trifluridin supstrat za nukleozidne prijenosnike CNT1, ENT1 i ENT2.
In the event of haematological and/or non-haematological toxicities patients should follow the dose interruption, resumption and reduction criteria stated in Table 2, Table 3 and Table 4.
U slučaju hematološke i/ili nehematološke toksičnosti kod bolesnika potrebno je pratiti kriterije za privremeni prekid primjene, nastavak primjene te smanjenje doze navedene u Tablici 2, Tablici 3 i Tablici 4.
Tipiracil hydrochloride was the major component and 6-hydroxymethyluracil was the major metabolite consistently in human plasma, urine, and faeces.
Tipiracilklorid je bio glavna komponenta a 6-hidroksimetiluracil je bio glavni metabolit koji se dosljedno nalazio u ljudskoj plazmi, urinu i fecesu.
Lonsurf contains lactose
Lonsurf sadrži laktozu
Dry eye
Suho oko
• increased liver enzymes
• povećane vrijednosti jetrenih enzima
Within each frequency group, adverse drug reactions are presented in order of decreasing seriousness.
Unutar svake skupine po učestalosti, nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
Breast-feeding should be discontinued during treatment with Lonsurf.
Dojenje treba prekinuti za vrijeme liječenja lijekom Lonsurfom.
50a a At a total daily dose of 50 mg, patients should take 1 x 20 mg/8.19 mg tablet in the morning and 2 x 15 mg/6.14 mg tablets in the evening.
50a a Kod ukupne dnevne doze od 50 mg, bolesnici trebaju uzeti jednu tabletu od 20 mg/8,19 mg ujutro i 2 tablete od 15/6,14 mg mg navečer.
Trifluridine was mainly eliminated by metabolism via TPase to form an inactive metabolite, FTY.
Trifluridin se većinom eliminirao metabolizmom putem TPaze u inaktivni metabolit FTY.
Based on findings in animals, trifluridine may cause foetal harm when administered to pregnant women.
Na temelju ispitivanja na životinjama, trifluridin može izazvati oštećenja fetusa kada se primjeni u trudnica.
Trifluridine is a substrate of TPase, but is not metabolised by cytochrome P450 (CYP).
Trifluridin je supstrat TPaze, ali se ne metabolizira putem citokroma P450 (CYP).
Lonsurf has minor influence on the ability to drive and use machines.
Lonsurf malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Toxicology assessment of trifluridine/tipiracil hydrochloride was performed in rats, dogs and monkeys.
Ispitivanje toksičnosti trifluridina i tipiracilklorida je napravljeno u štakora, pasa i majmuna.
Men with a partner of child-bearing potential must use effective contraception during treatment and for up to 6 months after discontinuation of treatment.
Muškarci s partnericama u generativnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja te do šest mjeseci nakon prekida liječenja.
The adverse drug reactions reported in association with overdoses were consistent with the established safety profile.
Opažene nuspojave povezane s predoziranjem u skladu su sa utvrđenim sigurnosnim profilom lijeka.
Studies in animals have shown excretion of trifluridine, tipiracil hydrochloride and/or their metabolites in milk (see section 5.3).
Ispitivanja na životinjama pokazala su da se trifluridin, tipiracilklorid i/ili njihovi metaboliti izlučuju u mlijeko (vidjeti dio 5.3).
Lonsurf caused an increase in the incidence of gastrointestinal toxicities including nausea, vomiting and diarrhoea.
Lonsurf uzrokuje povećanu incidenciju gastrointestinalne toksičnosti uključujući mučninu, povraćanje i proljev.
The absorbed trifluridine was metabolised, and excreted into urine as FTY and trifluridine glucuronide isomers.
Apsorbirani trifluridin se metabolizirao i izlučivao urinom kao FTY i izomeri trifluridin glukuronida.
Fatigue, dizziness or malaise may occur during treatment (see section 4.8).
Umor, omaglica ili malaksalost se mogu javiti tijekom liječenja (vidjeti dio 4.8).
However, trifluridine is rapidly degraded by TPase and readily metabolised by a first-pass effect following oral administration, hence the inclusion of the TPase inhibitor, tipiracil hydrochloride.
Međutim, trifluridin se brzo degradira TPazom i odmah metabolizira prvim prolaskom kroz jetru nakon oralne primjene, te je stoga u kombinaciji sa inhibitorom TPaze, tipiracilkloridom.
Dose in mg (2x daily)
Doza u mg (2x dnevno)
It is not known whether Lonsurf changes your ability to drive or use machines.
Nije poznato utječe li Lonsurf na Vašu sposobnost vožnje ili upravljanja strojevima.
Post-marketing experience in patients with unresectable advanced or recurrent colorectal cancer
Iskustvo nakon stavljanja lijeka na tržište u bolesnika s neresektabilnim uznapredovalim ili rekurentnim kolorektalnim karcinomom
Plasma protein binding of tipiracil hydrochloride was below 8%.
Tipiracilklorid se vezao manje od 8% za proteine plazme.
Musculoskeletal pain Muscular weakness Muscle spasms Pain in extremity
Mišićno-koštana bol Slabost mišića Spazam mišića Bolovi u ekstremitetima
Thus it is unlikely to cause an interaction with other medicinal products, at recommended doses, due to inhibition of OCT2 and MATE1.
Prema tome, nije vjerojatno da će pri primjeni preporučenih doza uzrokovati interakciju s drugim lijekovima zbog inhibicije OCT2 i MATE1.
• Dose reductions are permitted to a minimum dose of 20 mg/m2/dose twice daily.
• Smanjenja doze su dozvoljena do minimalne doze od 20 mg/m2/dozi primjenjeno dva puta dnevno.
a Kaplan-Meier estimates b Methodology of Brookmeyer and Crowley c Stratified log-rank test (strata: region, ECOG status at baseline, prior ramucirumab treatment)
a Procijenjeno pomoću Kaplan-Meierove metode b Brookmeyerovom i Crowleyjevom metodom c Stratificirani log-rang test (strata: regija, ECOG status na početku, ranije liječenje ramucirumabom)
Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy (see section 4.8).
Preporučuje se praćenje proteinurije pomoću laboratorijskih trakica prije početka i tijekom liječenja (vidjeti dio 4.8).
• blood clots, e.g. in the brain or legs
• krvni ugrušci, npr. u mozgu ili nogama
LIST OF EXCIPIENTS Contains lactose monohydrate, see leaflet for further information.
POPIS POMOĆNIH TVARI Sadrži laktozu hidrat, za dodatne informacije vidjeti uputu o lijeku.
The specific dosing schedule is as follows:
Specifična shema uzimanja lijeka je:
Uncommon: may affect up to 1 in 100 people
Manje često: mogu se javiti u do 1 u 100 osoba
• high blood sugar (hyperglycaemia), increased salt, urea, creatinine and potassium in your blood
• visoka vrijednost šećera u krvi (hiperglikemija), povećana vrijednost soli, kreatinina ili kalija u krvi
Results of animal studies did not indicate an effect of Lonsurf on male or female fertility (see section 5.3).
Ispitivanja na životinjama nisu ukazala na učinke Lonsurfa na plodnost u mužjaka ili ženki (vidjeti dio 5.3).
• The active substances are trifluridine and tipiracil.
• Djelatne tvari su trifluridin i tipiracil.
The DCR (complete response or partial response or stable disease) was significantly higher in patients treated with Lonsurf (44% vs 16%, p < 0.0001).
Stopa kontrole bolesti (DCR, bolesnici s potpunim odgovorom, djelomičnim odgovorom ili stabilnom bolesti) je bila značajno viša u bolesnika liječenih Lonsurfom (44% naspram 16%, p < 0,0001).
The most serious observed adverse drug reactions in patients receiving Lonsurf are bone marrow suppression and gastrointestinal toxicity (see section 4.4).
Najozbiljnije nuspojave zabilježene u bolesnika koji su primali Lonsurf su supresija koštane srži i gastrointestinalna toksičnost (vidjeti dio 4.4).
Given that the majority were reported in the context of bone marrow suppression, the patient's condition should be monitored closely, and appropriate measures, such as antimicrobial agents and granulocyte-colony stimulating factor (G-CSF), should be administered as clinically indicated.
Budući da se većina slučajeva prijavila u smislu supresije koštane srži, bolesnika se treba pažljivo pratiti, te se trebaju poduzeti potrebne mjere u slučaju kliničke indikacije kao što su primjena antimikrobnih lijekova te stimulirajućeg faktora kolonija granulocita (G-CSF).
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1096/001-006
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1096/001-006
Neither trifluridine nor tipiracil hydrochloride was an inhibitor of or substrate for human uptake and efflux transporters based on in vitro studies, except for OCT2 and MATE1.
Niti trifluridin niti tipiracilklorid ne inhibiraju ljudske transportne proteine za unos i efluks niti su njihovi supstrati, što se temelji na in vitro ispitivanjima, osim OCT2 i MATE1.
The most frequently observed adverse drug reactions (≥ 30%) in patients receiving Lonsurf are neutropenia (53% [34% ≥ Grade 3]), nausea (34% [1% ≥ Grade 3]), fatigue (32% [4% ≥ Grade 3]), anaemia (32% [12% ≥ Grade 3]).
Najčešće opažene nuspojave (≥ 30%) u bolesnika koji su primali Lonsurf su neutropenija (53% [34% ≥ 3. stupanj]), mučnina (34% [1% ≥ 3. stupanj]), umor (32% [4% ≥ 3. stupanj]), anemija (32% [12% ≥ 3. stupanj]).
• low levels of phosphates, sodium, potassium or calcium in your blood
• niske vrijednosti fosfata, natrija, kalija ili kalcija u krvi
The OS and PFS benefit was observed consistently, in all relevant pre-specified subgroups, including race, geographic region, age (< 65; ≥ 65), sex, ECOG PS, KRAS status, time since diagnosis of first metastasis, number of metastatic sites, and primary tumour site.
Korist u smislu OS i PFS je konzistentno zabilježena u svih relevantnih, prethodno specificiranih, podskupina, uključujući rasu, geografsku regiju, starost (< 65; ≥ 65), spol, ECOG PS, KRAS status, vrijeme od dijagnoze prve metastaze, broj metastatskih sijela i mjesto primarnog tumora.
• Week 2 - take the dose 2 times a day for 5 days - then have 2 days off - no medicine
• 2. tjedan - uzmite dozu dva puta dnevno tijekom 5 dana - dva dana ne uzimajte lijek - stanka
Table 3 - Recommended dose modifications for Lonsurf in case of haematological and non-haematological adverse reactions
Tablica 3 - Preporučene prilagodbe doze za lijek Lonsurf u slučaju hematoloških ili nehematoloških nuspojava
How to take Lonsurf
Kako uzimati Lonsurf
Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease (see section 5.1).
Lonsurf je indiciran kao monoterapija za liječenje odraslih bolesnika s metastatskim karcinomom želuca uključujući adenokarcinom gastroezofagealnog spoja koji su prethodno bili liječeni s najmanje dva režima sistemskog liječenja uznapredovale bolesti (vidjeti dio 5.1).
The ORR (complete response + partial response) was not significantly higher in patients treated with Lonsurf (4.5% vs 2.1 %, p-value = 0.2833) but the DCR (complete response or partial response or stable disease) was significantly higher in patients treated with Lonsurf (44.1% vs 14.5%, p < 0.0001).
Ukupna stopa odgovora (eng. overall response rate, ORR) (potpuni odgovor + djelomični odgovor) nije bio značajno veći u bolesnika liječenih Lonsurfom (4,5% naspram 2,1%, p-vrijednost = 0,2833), ali je DCR (potpuni odgovor ili djelomični odgovor ili stabilna bolest) bio značajno veći u bolesnika liječenih Lonsurfom (44,1% naspram 14,5%, p <0,0001).
A maximum of 3 dose reductions are permitted to a minimum dose of 20 mg/m2 twice daily.
Smanjenje doze dozvoljeno je najviše 3 puta do najmanje doze od 20 mg/m2 dva puta dnevno.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Ako Vam je liječnik rekao da imate poremećaj nepodnošenja nekih šećera, prije nego što počnete uzimati ovaj lijek posavjetujete se sa svojim liječnikom.
• Week 1 - take the dose 2 times a day for 5 days - then have 2 days off - no medicine
• 1. tjedan - uzmite dozu dva puta dnevno tijekom 5 dana - dva dana ne uzimajte lijek - stanka
0.0003 (1-sided), 0.0006 (2-sided)
0,0003 (1-strano), 0,0006 (2-strano)
Haematocrit decreased a. Different MedDRA preferred terms that were considered clinically similar have been grouped into a single term.
Različiti MedDRA preporučeni pojmovi koji su smatrani klinički sličnim svedeni su pod jedan pojam.
Blood alkaline phosphatase increased Weight decreased
Povišena alkalna fosfataza u krvi Smanjenje tjelesne težine
• passing out (syncope)
• nesvjestica (sinkopa)
Women should avoid becoming pregnant while taking Lonsurf and for up to 6 months after ending treatment.
Žene trebaju izbjegavati trudnoću tijekom liječenja Lonsurfom kao i do 6 mjeseci nakon prekida liječenja.
The primary efficacy endpoint was overall survival (OS), and supportive efficacy endpoints were progression-free survival (PFS), overall response rate (ORR) and disease control rate (DCR).
Primarni ishod za djelotvornost bilo je ukupno preživljenje (eng. overall survival, OS), a dodatni ishodi za djelotvornost su bili preživljenje bez progresije (eng. progression free survival, PFS), ukupna stopa odgovora (eng. overall response rate, ORR) i stopa kontrole bolesti (eng. disease control rate, DCR).
No adjustment of the starting dose is required in patients ≥ 65 years old (see sections 4.8, 5.1 and 5.2).
Nije potrebno prilagoditi početnu dozu u bolesnika starih ≥ 65 godina (vidjeti dijelove 4.8, 5.1 i 5.2).
Treatment-related proteinuria occurred more frequently in Lonsurf-treated patients (1.8%) compared to those receiving placebo (0.9%), all of which were Grade 1 or 2 in severity (see section 4.4).
Proteinurija povezana s liječenjem češće je zabilježena kod bolesnika liječenih Lonsurfom (1,8%) u usporedbi s placebom (0,9%), a po težini su sve bile 1. ili 2. stupnja (vidjeti dio 4.4).
The signs include difficulty in breathing, shortness of breath, with cough or fever.
Znakovi bolesti uključuju otežano disanje, nedostatak zraka, s kašljem ili vrućicom.
• dry eyes
• suhe oči
Of the 533 patients in the RECOURSE study who received Lonsurf, 306 (57%) patients had normal renal function (CrCl ≥ 90 mL/min), 178 (33%) patients had mild renal impairment (CrCl 60 to 89 mL/min), and 47 (9%) had moderate renal impairment (CrCl 30 to 59 mL/min), with data missing for 2 patients.
Od 533 bolesnika uključenih u RECOURSE ispitivanje koji su primili Lonsurf, 306 (57%) bolesnika je imalo normalnu funkciju bubrega (CrCl ≥90 mL/min), 178 (33%) bolesnika je imalo blago oštećenu funkciju bubrega (CrCl 60 - 89 mL/min), a 47 (9%) bolesnika umjereno oštećenu funkciju bubrega (CrCl 30 - 59 mL/min), podaci su nedostajali za 2 bolesnika.
In vitro evaluation of trifluridine and tipiracil hydrochloride was conducted using human uptake and efflux transporters (trifluridine with MDR1, OATP1B1, OATP1B3 and BCRP; tipiracil hydrochloride with OAT1, OAT3, OCT2, MATE1, MDR1 and BCRP).
In vitro ispitivanja trifluridina i tipiracilklorida su provedena upotrebom ljudskih transportnih proteina za unos u stanice i efluks transportnih proteina (trifluridin s MDR1, OATP1B1, OATP1B3 i BCRP; tipiracilklorid s OAT1, OAT3, OCT2, MATE1, MDR1 i BCRP).
Lonsurf is not recommended for use in patients with severe renal impairment or end-stage renal disease (creatinine clearance [CrCl] < 30 mL/min or requiring dialysis, respectively), as Lonsurf has not been studied in these patients (see section 5.2).
Primjena Lonsurfa se ne preporučuje kod bolesnika s teškim oštećenjem bubrega ili s terminalnom fazom bubrežne bolesti (klirens kreatinina [CrCl] < 30 ml/min ili potrebna dijaliza), jer Lonsurf nije ispitivan kod tih bolesnika (vidjeti dio 5.2).
In nonclinical studies, trifluridine/tipiracil hydrochloride demonstrated antitumour activity against both 5-fluorouracil (5-FU) sensitive and resistant colorectal cancer cell lines.
U nekliničkim je ispitivanjima trifluridin/tipiracilklorid pokazao antitumorsku aktivnost i na staničnim linijama kolorektalnog karcinoma koje su osjetljive na 5-fluorouracil (5-FU) i na onim rezistentnim.
• swelling of mucous membranes - this could be inside the nose, mouth, throat, eyes, vagina, lungs or gut
• oticanje sluznica - to može biti sluznica u nosu, ustima, grlu, očima, rodnici, plućima ili crijevima
Tipiracil hydrochloride was an inhibitor of OCT2 and MATE1 in vitro, but at concentrations substantially higher than human plasma Cmax at steady state.
Tipiracilklorid je bio inhibitor OCT2 i MATE1 in vitro, ali pri koncentracijama značajno većim nego je Cmax u stanju dinamičke ravnoteže.
This medicine does not require any special storage conditions.
Ovaj lijek nema posebnih uvjeta čuvanja.
The signs include feeling short of breath, tiredness or looking pale (see section 2).
Znaci uključuju osjećaj nedostatka zraka, umora ili bljedilo kože (pogledajte dio 2).
No peri/post-natal developmental toxicity studies have been performed.
Nisu provedena ispitivanja toksičnosti pre- i postnatalnog razvoja.
• pain or inflammation in upper or lower part of digestive tract
• bol ili upala u gornjem ili donjem dijelu probavnog trakta
• increased lactate dehydrogenase level in your blood
• povišene vrijednosti laktat dehidrogenaze u krvi
OS appeared more favourable in the high AUC group compared to the low AUC group (median OS of 9.3 vs. 8.1 months, respectively).
Ukupno preživljenje je bilo povoljnije u skupini s visokim AUCom u usporedbi sa skupinom s niskim AUC-om (medijan OS je bio 9,3 u usporedbi s 8,1 mjeseci).
Based on a population PK analysis, the exposure of Lonsurf in patients with mild renal impairment (CrCl = 60 to 89 mL/min) was similar to those in patients with normal renal function (CrCl ≥ 90 mL/min).
Temeljem analize populacijske PK, izloženost Lonsurfu u bolesnika s blago oštećenom funkcijom bubrega (CrCl 60 - 89 mL/min) je bila slična izloženosti u bolesnika s normalnom bubrežnom funkcijom (CrCl ≥90 mL/min).
No long term studies evaluating the carcinogenic potential of trifluridine/tipiracil hydrochloride in animals have been performed.
Na životinjama nisu provedena dugoročna ispitivanja kancerogenosti trifluridin/tipiracilklorida.
Table 1 - Starting dose calculation according to body surface area (BSA)
Tablica 1 - Izračun početne doze prema površini tijela (PT)
The signs include intense stomach or abdominal pain that can be associated with vomiting, blocked or partly blocked bowel, fever or swelling of the abdomen.
Znaci uključuju snažne bolove u želucu ili trbuhu koji mogu biti povezani s povraćanjem, potpuna ili djelomična opstrukcija crijeva, vrućica ili nadutost trbuha.
In a dose finding study (15 to 35 mg/m2 twice daily), the AUC from time 0 to 10 hours (AUC0-10) of trifluridine tended to increase more than expected based on the increase in dose; however, oral clearance (CL/F) and apparent volume of distribution (Vd/F) of trifluridine were generally constant at the dose range of 20 to 35mg/m2.
U ispitivanju doziranja (15 do 35 mg/m2 dva puta dnevno), AUC trifluridina od vremena 0 do 10 sati (AUC0-10) je naginjala većem povećanju od onog očekivanog na temelju povećanja doze; ipak, klirens (CL/F) i prividni volumen distribucije (Vd/F) trifluridina su bili generalno konstantni kod raspona doze od 20 do 35 mg/m2.
The clinical efficacy and safety of Lonsurf were evaluated in an international, randomised, doubleblind, placebo-controlled Phase III study (RECOURSE) in patients with previously treated metastatic colorectal cancer.
Klinička djelotvornost i sigurnost Lonsurfa je ispitivana u internacionalnom, randomiziranom, dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju faze III (RECOURSE) u bolesnika s prethodno liječenim metastatskim kolorektalnim karcinomom.
• swelling in your hands or legs or feet
• oticanje u Vašim rukama ili nogama ili stopalima
Each film-coated tablet contains 90.735 mg of lactose monohydrate.
Svaka filmom obložena tableta sadrži 90,735 mg laktoze hidrata.
Titanium dioxide (E171) Magnesium stearate
Titanijev dioksid (E171) Magnezijev stearat
40 film-coated tablets
40 filmom obloženih tableta
Table 2 - Dose interruption and resumption criteria for haematological toxicities related to myelosuppression
Tablica 2: Kriteriji za privremeni prekid primjene i nastavak primjene u slučaju hematološke toksičnosti povezane s mijelosupresijom
• Moderate or severe hepatic impairment
• Umjereno ili teško oštećenje jetre