natgillin/translations-raw huggingface dataset:
The most important serious adverse reactions were hepatic failure (2.8%), hepatic encephalopathy (4.6%), oesophageal varices haemorrhage (1.4%), cerebral haemorrhage (0.6%), arterial thromboembolic events (2.0%) including myocardial infarction (0.8%), cerebral infarction (0.4%) and cerebrovascular accident (0.4%) and renal failure/impairment events (1.4%).
Najpomembnejši resni neželeni učinki so bili jetrna odpoved (2,8 %), jetrna encefalopatija (4,6 %), krvavitev iz ezofagealnih varic (1,4 %), možganska krvavitev (0,6 %), arterijski tromboembolični dogodki (2,0 %), vključno z miokardnim infarktom (0,8 %), cerebralni infarkt (0,4 %) in cerebrovaskularni insult (0,4 %) ter dogodki ledvične odpovedi/okvare (1,4 %).
Resolves to less than 2 g / 24 hours.
Izboljša se na manj kot 2 g/24 ur nefrotični sindrom ------
In the Phase 3 REFLECT trial (see section 5.1), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group.
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) je bil en dogodek PRES (stopnje 2) v skupini, zdravljeni z lenvatinibom.
Cardiac dysfunction Grade 3
Zdravljenja ne začnite znova disfunkcija srca stopnja 3
Excluding laboratory abnormalities judged to be nonlife-threatening, which should be managed as Grade 3.
Razen pri nepravilnostih laboratorijskih vrednosti, za katere sodimo, da niso življenjsko nevarne, ki jih lahko obravnavamo kot resne neželene učinke stopnje 3.
The printing ink contains shellac, black iron oxide (E172), potassium hydroxide, propylene glycol.
Tiskarsko črnilo vsebuje šelak, črni železov oksid (E172), kalijev hidroksid, propilenglikol.
Adverse reactions that most commonly led to discontinuation of lenvatinib were hepatic encephalopathy, fatigue, increased blood bilirubin, proteinuria and hepatic failure.
Neželeni učinki, ki so najpogosteje privedli do ukinitve zdravljenja z lenvatinibom, so bila jetrna encefalopatija, utrujenost, povečan bilirubin v krvi, proteinurija in jetrna odpoved.
Progression-Free Survival (PFS)a Number of progressions or deaths (%) Median PFS in months (95% CI)
Preživetje brez napredovanja bolezni (PFS)a število napredovanj ali smrti (%) mediano PFS v mesecih (95 % IZ)
Asian patients had a higher incidence than Caucasian patients of peripheral oedema, hypertension, fatigue, PPE, proteinuria, thrombocytopenia, and increased blood thyroid stimulating hormone.
Bolniki azijske rase so imeli večjo incidenco perifernih edemov, hipertenzije, utrujenosti, PPE, proteinurije, trombocitopenije in zvišanega tirotropnega hormona v krvi kot bolniki bele rase.
One subject (0.2%) discontinued lenvatinib due to hypertension.
Pri 1 bolniku (0,2 %) je hipertenzija povzročila trajno ukinitev zdravljenja z lenvatinibom.
In the pivotal Phase 3 SELECT trial (see section 5.1), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group and no reports in the placebo group.
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) je bil en dogodek PRES (stopnje 2) v skupini, zdravljeni z lenvatinibom, v skupini s placebom pa niso poročali o nobenem primeru.
<60 kg BW 8 mg (two 4 mg capsules orally once daily)
< 60 kg TM 8 mg (dve 4 mg kapsuli peroralno enkrat na dan)
Capsule shell Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Ovojnica kapsule hipromeloza, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172).
Liver cancer
Rak ščitnice
Patients of age ≥75 years were more likely to experience Grade 3 or 4 hypertension, proteinuria, decreased appetite, and dehydration.
Pri bolnikih, starih ≥ 75 let, so bile verjetnejše hipertenzija, proteinurija, zmanjšan apetit in dehidracija stopnje 3 ali 4.
Management of adverse reactions may require dose interruption, adjustment, or discontinuation of lenvatinib therapy (see section 4.4).
Zaradi obvladovanja neželenih učinkov utegnejo biti potrebne prekinitev odmerjanja, prilagoditev odmerka ali ukinitev zdravljenja z lenvatinibom (glejte poglavje 4.4).
Cases of fistula formation or enlargement that involve areas of the body other than stomach or intestines were observed in clinical trials and in post-marketing experience (e.g. tracheal, tracheo-oesophageal, oesophageal, cutaneous, female genital tract fistulae).
V kliničnih preskušanjih in izkušnjah po prihodu zdravila na trg so opazili primere nastanka ali zvečanja fistul, ki so zajeli druge dele telesa, ne želodca ali črevesja (npr. trahealne, traheo-ezofagealne, ezofagealne, kožne fistule in fistule ženskih spolovil).
Liver-related reactions of Grade 3 or higher (including 1 Grade 5 case of hepatic failure) occurred in 5.4% of lenvatinib-treated patients compared with 0.8% in placebo-treated patients.
Z jetri povezani neželeni učinki stopnje 3 ali višje stopnje (vključno z 1 primerom odpovedi jeter stopnje 5) so nastopili pri 5,4 % bolnikov, zdravljenih z lenvatinibom, in pri 0,8 % bolnikov, ki so prejemali placebo.
In the pivotal Phase 3 SELECT trial (see section 5.1), QT/QTc interval prolongation was reported in 8.8% of lenvatinib-treated patients and 1.5% of patients in the placebo group.
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o podaljšanju intervala QT/QTc pri 8,8 % bolnikov, zdravljenih z lenvatinibom, in pri 1,5 % bolnikov v skupini s placebom.
Grade 4 (despite medical management)
Izboljša se na stopnjo 0-1 ali v izhodišče stopnja 4 (kljub medicinski obravnavi)
Hypothyroidism Increased blood thyroid stimulating hormone ‡
Bolezni endokrinega sistema hipotiroidizem zvišan tirotropni hormon v krvi‡
If urine dipstick proteinuria ≥2+ is detected, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Če z urinskim testnim lističem odkrijemo proteinurijo ≥ 2+, bodo morda potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2).
In the Phase 3 -REFLECT trial (see section 5.1), hypertension (including hypertension, increased blood pressure, increased diastolic blood pressure and orthostatic hypertension) was reported in 44.5% of lenvatinib-treated patients and Grade 3 hypertension occurred in 23.5%.
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o hipertenziji (vključno s hipertenzijo, zvišanim krvnim tlakom, zvišanim diastoličnim krvnim tlakom in ortostatsko hipertenzijo) pri 44,5 % bolnikov, zdravljenih z lenvatinibom.
LENVIMA
Driska
Lenvatinib should be discontinued following an arterial thrombotic event.
Po arterijskem trombotičnem dogodku je treba lenvatinib ukiniti.
Reactions that occurred at an incidence of ≥ 0.75% above placebo were: epistaxis (11.9%), haematuria (6.5%), contusion (4.6%), gingival bleeding (2.3%), haematochezia (2.3%), rectal haemorrhage (1.5%), haematoma (1.1%), haemorrhoidal haemorrhage (1.1%), laryngeal haemorrhage (1.1%), petechiae (1.1%), and intracranial tumour haemorrhage (0.8%).
Neželeni učinki, ki so se pojavili z incidenco, za ≥ 0,75 % večjo kot pri placebu, so bili: epistaksa (11,9 %), hematurija (6,5 %), kontuzija (4,6 %), gingivalna krvavitev (2,3 %), hematohezija (2,3 %), rektalna krvavitev (1,5 %), hematom (1,1 %), krvavitev iz hemoroidov (1,1 %), laringealna krvavitev (1,1 %), petehije (1,1 %) in krvavitev v znotrajlobanjski tumor (0,8 %).
In the Phase 3 REFLECT trial (see section 5.1), haemorrhage was reported in 24.6% of patients and 5.0% were Grade ≥ 3.
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o krvavitvah pri 24,6 %, in 5,0 % jih je bilo stopnje ≥ 3.
The available data do not allow for a dosing recommendation for patients with HCC and severe renal impairment.
Razpoložljivi podatki pri bolnikih s HCC in hudo okvaro ledvic ne zadostujejo za priporočilo glede odmerjanja.
Adverse reactions that most commonly led to dose modifications (in ≥5% of patients) were decreased appetite, diarrhoea, proteinuria, hypertension, fatigue, PPE and decreased platelet count.
Neželeni učinki, ki so najpogosteje privedli do sprememb odmerka (pri ≥ 5 % bolnikov), so bili zmanjšan apetit, driska, proteinurija, hipertenzija, utrujenost, PPE in zmanjšano število trombocitov.
LENVIMA 4 mg hard capsules LENVIMA 10 mg hard capsules lenvatinib
LENVIMA 4 mg trde kapsule LENVIMA 10 mg trde kapsule lenvatinib
Hazard ratioa, b (95% CI)
Razmerje ogroženostia, b (95-odstotni IZ)
Patients with baseline renal impairment had a higher incidence of Grade 3 or 4 hypertension, proteinuria, fatigue, stomatitis, oedema peripheral, thrombocytopenia, dehydration, prolonged QT, hypothyroidism, hyponatraemia, increased blood thyroid stimulating hormone, pneumonia compared with subjects with normal renal function.
Bolniki z izhodiščno okvaro ledvic so imeli večjo incidenco hipertenzije, proteinurije, utrujenosti, stomatitisa, perifernih edemov, trombocitopenije, dehidracije, podaljšanega intervala QT, hipotiroidizma, hiponatriemije, zvišanega tirotropnega hormona v krvi in pljučnice stopnje 3 ali 4 v primerjavi s preiskovanci z normalno funkcijo ledvic.
Across clinical studies in which 1,327 patients received lenvatinib monotherapy in indications other than HCC, Grade ≥ 3 or greater haemorrhage was reported in 2% of patients, 3 patients (0.2%) had a Grade 4 haemorrhage and 8 patients (0.6%) had a Grade 5 reaction including arterial haemorrhage, haemorrhagic stroke, intracranial haemorrhage, intracranial tumour haemorrhage, haematemesis, melaena, haemoptysis and tumour haemorrhage.
Med 1166 bolniki, zdravljenimi z lenvatinibom v monoterapiji za druge indikacije kot HCC, so poročali o krvavitvi stopnje ≥ 3 ali višje stopnje pri 2 % bolnikov, 3 bolniki (0,2 %) so imeli krvavitve stopnje 4, 8 bolnikov (0,6 %) pa je imelo neželeni učinek stopnje 5, vključno z arterijsko krvavitvijo, hemoragično možgansko kapjo, znotrajlobansko krvavitvijo, krvavitvijo v znotrajlobanski tumor, hematemezo, meleno, hemoptizo in krvavitvijo v tumor.
In the Phase 3 REFLECT trial (see section 5.1), diarrhoea was reported in 38.7% of patients treated with lenvatinib (4.2% were Grade ≥ 3).
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o driski pri 38,7 % bolnikov, zdravljenih z lenvatinibom (4,2 % jih je bilo stopnje ≥ 3).
The majority of cases recovered following dose interruption or reduction, which occurred in 3.6% and 3.4% of patients respectively.
V večini primerov je prišlo do okrevanja po prekinitvi ali zmanjšanju odmerjanja, kar se je zgodilo pri 3,6 % oziroma 3,4 % bolnikov.
Adverse reactions that most commonly led to discontinuation of lenvatinib were proteinuria, asthenia, hypertension, cerebrovascular accident, diarrhoea, and pulmonary embolism.
Neželeni učinki, ki so najpogosteje povzročili ukinitev lenvatiniba, so bili proteinurija, astenija, hipertenzija, cerebrovaskularni insult, driska in pljučna embolija.
The majority of cases had an outcome of recovered or resolved following dose interruption or reduction, which occurred in 16.9% and 10.7% of patients, respectively.
V večini primerov je prišlo do ozdravitve ali okrevanja po prekinitvi ali zmanjšanju odmerka, kar se je zgodilo pri 16,9 % oziroma 10,7 % bolnikov.
In the pivotal Phase 3 SELECT trial (see section 5.1), decreased ejection fraction/cardiac failure was reported in 6.5% of patients (1.5% were Grade ≥ 3) in the lenvatinib treated group, and 2.3% in the placebo group (none were Grade ≥ 3).
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o zmanjšani iztisni frakciji/popuščanju srca pri 6,5 % bolnikov (1,5 % jih je bilo stopnje ≥ 3) v skupini, zdravljeni z lenvatinibom, in pri 2,3 % v skupini s placebom (nobeden ni bil stopnje ≥ 3).
24 mg orally once daily Two 10 mg capsules plus one 4 mg capsule
24 mg peroralno enkrat na dan dve 10 mg kapsuli in ena 4 mg kapsula
The majority of cases recovered following dose interruption or reduction, which occurred in 6.9% and 2.5% of patients respectively.
V večini primerov je prišlo do okrevanja po prekinitvi ali zmanjšanju odmerka, kar se je zgodilo pri 6,9 % oziroma 2,5 % bolnikov.
• feeling sick and being sick, constipation, diarrhoea, abdominal pain, indigestion
• slabost in bruhanje, zaprtje, driska, bolečina v trebuhu, prebavne motnje,
Table 3 Adverse reactions requiring dose modification of lenvatinib in DTC and HCC Adverse reaction Severity
Preglednica 3 Neželeni učinki pri DTC in HCC, pri katerih je potrebna sprememba odmerka lenvatiniba Neželeni učinek Resnost
In the Phase 3 REFLECT trial (see section 5.1), events of gastrointestinal perforation or fistula were reported in 1.9% of lenvatinib-treated patients.
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o dogodkih gastrointestinalne perforacije ali fistule pri 1,9 % bolnikov, zdravljenih z lenvatinibom.
Quartiles are estimated by the Kaplan-Meier method, and the 95% CIs are estimated with a generalized Brookmeyer and Crowley method f.
e Kvartili so ocenjeni s Kaplan-Meierjevo metodo; 95-odstotni IZ so bili ocenjeni s posplošeno
Interrupt until resolved to Grade 0-1 or baselined
prekinite, dokler se ne izboljša na stopnjo 0-1 ali izhodiščed
Haemorrhage terms that occurred in 5 or more subjects with DTC were: epistaxis, haemoptysis, haematuria, contusion, haematochezia, gingival bleeding, petechial, pulmonary haemorrhage, rectal haemorrhage, blood urine present, haematoma and vaginal haemorrhage.
Izrazi za krvavitev, ki so se pojavili pri 5 ali več preiskovancih z DTC, so bili: epistaksa, hemoptiza, hematurija, kontuzija, hematohezija, krvavitev iz dlesni, petehije, krvavitev v pljučih, rektalna krvavitev, prisotnost krvi v urinu, hematom in vaginalna krvavitev.
4 mg (one 4 mg capsule) orally every other day
4 mg (ena 4 mg kapsula) peroralno vsak drugi dan
In the pivotal Phase 3 SELECT trial (see section 5.1), diarrhoea was reported in 67.4% of patients in the lenvatinib-treated group (9.2% were Grade ≥ 3) and in 16.8% of patients in the placebo group (none were Grade ≥ 3).
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o driski pri 67,4 % bolnikov v skupini, zdravljeni z lenvatinibom (9,2 % jih je bilo stopnje ≥ 3), in pri 16,8 % bolnikov v skupini s placebom (nobeden ni bil stopnje ≥ 3).
LENVIMA 4 mg hard capsules
LENVIMA 4 mg trde kapsule
In the pivotal Phase 3 SELECT trial (see section 5.1), haemorrhage was reported in 34.9% (1.9% were Grade ≥ 3) of lenvatinib-treated patients versus 18.3% (3.1% were Grade ≥ 3) of placebo-treated patients.
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o krvavitvah pri 34,9 % (1,9 % jih je bilo stopnje ≥ 3) bolnikov, zdravljenih z lenvatinibom, in pri 18,3 % (3,1 % jih je bilo stopnje ≥ 3) bolnikov, ki so prejemali placebo.
LENVIMA 10 mg hard capsules
LENVIMA 10 mg trde kapsule
In the Phase 3 REFLECT trial (see section 5.1), 7.1% of lenvatinib-treated patients developed a renal failure/impairment event.
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) se je pri 7,1 % bolnikov, zdravljenih z lenvatinibom, pojavil dogodek odpovedi ali okvare ledvic.
In the pivotal Phase 3 SELECT trial (see section 5.1), arterial thromboembolic events were reported in 5.4% of lenvatinib-treated patients and 2.3% of patients in the placebo group.
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o arterijskih trombemboličnih dogodkih pri 5,4 % bolnikov, zdravljenih z lenvatinibom, in pri 2,3 % bolnikov v skupini s placebom.
Growth retardation, secondary delay of physical development, and lesions attributable to pharmacologic effects (incisors, femur [epiphyseal growth plate], kidneys, adrenals, and duodenum) were also observed in juvenile rats.
Pri mladih podganah so opazili tudi upočasnitev rasti, sekundarno zakasnitev telesnega razvoja in lezije, ki jih lahko pripišemo farmakološkim učinkom (sekalci, stegnenica [epifizna rastna plošča], ledvice, nadledvičnice in dvanajstnik).
• feeling dizzy
• okvara jeter
Any grade
katera koli stopnja prekinite
In the pivotal Phase 3 SELECT trial (see section 5.1), events of gastrointestinal perforation or fistula were reported in 1.9% of lenvatinib-treated patients and 0.8% of patients in the placebo group.
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o dogodkih gastrointestinalne perforacije ali fistule pri 1,9 % bolnikov, zdravljenih z lenvatinibom, in pri 0,8 % bolnikov v skupini s placebom.
Lenvatinib impairs exogenous thyroid suppression (see section 4.8, Description of selected adverse reactions).
Lenvatinib oslabi eksogeno supresijo ščitnice (glejte poglavje 4.8 Opis izbranih neželenih učinkov).
In the pivotal Phase 3 SELECT trial (see section 5.1), proteinuria was reported in 33.7% of lenvatinibtreated patients and 3.1% of patients in the placebo-treated group.
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o proteinuriji pri 33,7 % bolnikov, zdravljenih z lenvatinibom, in pri 3,1 % bolnikov v skupini, ki je prejemala placebo.
The majority of cases recovered or resolved following dose interruption or reduction, which occurred in 13.0% and 13.4% of patients, respectively.
V večini primerov je prišlo do ozdravitve ali okrevanja po prekinitvi ali zmanjšanju odmerjanja, kar se je zgodilo pri 13,0 % oziroma 13,4 % bolnikov.
Arterial thromboembolisms (see section 4.4)
Arterijske trombembolije (glejte poglavje 4.4)
Renal impairment Increased blood creatinine Increased blood urea
okvara ledvic zvišan kreatinin v krvi zvišana sečnina v krvi nefrotični sindrom
Initiate medical management for nausea, vomiting, or diarrhoea prior to interruption or dose reduction.
Pred prekinitvijo ali zmanjšanjem odmerka uvedite ukrepe za obvladovanje navzee, bruhanja ali driske.
The median time to first onset in lenvatinib-treated patients was 10.1 weeks.
Mediani čas do prvega nastopa pri bolnikih, zdravljenih z lenvatinibom, je bil 10,1 tedna.
PRES, also known as RPLS, has been reported in patients treated with lenvatinib (<1%; see section 4.8, Description of selected adverse reactions).
O sindromu posteriorne reverzibilne encefalopatije (PRES, znan tudi kot RPLS) so poročali pri bolnikih, zdravljenih z lenvatinibom (< 1 %; glejte poglavje 4.8, Opis izbranih neželenih učinkov).
10 mg orally once dailya One 10mg capsule a:
10 mg peroralno enkrat na dana ena 10 mg kapsula a:
In the case of a gastrointestinal perforation or fistula, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
V primeru gastrointestinalne perforacije ali fistule bodo morda potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2).
The median time to onset of liver reactions in lenvatinib-treated patients was 12.1 weeks.
Mediani čas do nastopa z jetri povezanih neželenih učinkov pri bolnikih, zdravljenih z lenvatinibom, je bil 12,1 tedna.
8 mg (two 4 mg capsules) orally once daily
8 mg (dve 4 mg kapsuli) peroralno enkrat na dan
The median time to first onset in lenvatinibtreated patients was 11.1 weeks.
Mediani čas do prvega nastopa pri bolnikih, zdravljenih z lenvatinibom, je bil 11,1 tedna.
Oral inflammation includes: aphthous stomatitis, aphthous ulcer, gingival erosion, gingival ulceration, oral mucosal blistering, stomatitis, glossitis, mouth ulceration, and mucosal inflammation.
Vnetje v ustih vključuje: aftozni stomatitis, aftozni ulkus, gingivalno erozijo, razjede dlesni, mehurje na ustni sluznici, stomatitis, glositis, razjede v ustih in vnetje sluznice.
In patients with signs or symptoms of PRES, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Pri bolnikih z znaki ali simptomi PRES bodo morda potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2).
• loss of appetite or weight loss
• izguba teka ali hujšanje,
• have a history of heart problems or stroke
• ste v preteklosti imeli težave s srcem ali ste doživeli možgansko kap;
Discontinue Do not resume
Zdravljenja ne začnite znova
Arterial thromboembolisms (cerebrovascular accident, transient ischaemic attack, and myocardial infarction) have been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Pri bolnikih, zdravljenih z lenvatinibom, so poročali o arterijskih trombembolijah (cerebrovaskularni insult, tranzitorna ishemična ataka (TIA) in miokardni infarkt) (glejte poglavje 4.8, Opis izbranih neželenih učinkov).
In the patient populations enrolled in the HCC study no dose adjustments were required on the basis of hepatic function in those patients who had mild hepatic impairment (Child-Pugh A).
V populacijah bolnikov z blago jetrno okvaro (Child-Pugh A), vključenih v študijo HCC, prilagoditev odmerka na podlagi jetrne funkcije ni bila potrebna.
In the case of hepatotoxicity, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
V primeru hepatotoksičnosti bodo morda potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2).
In patients with severe (Child-Pugh C) hepatic impairment, the recommended starting dose is 14 mg taken once daily.
Pri bolnikih s hudo (Child-Pugh C) okvaro jeter je priporočeni začetni odmerek 14 mg enkrat na dan. Na podlagi prenašanja posameznega bolnika utegnejo biti potrebne nadaljnje prilagoditve odmerka.
In the pivotal Phase 3 SELECT trial (see section 5.1), hypocalcaemia was reported in 12.6% of lenvatinib-treated patients vs. no cases in the placebo arm.
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o hipokalciemiji pri 12,6 % bolnikov, zdravljenih z lenvatinibom, in pri nobenem bolniku v kraku s placebom.
4 mg (one 4 mg capsule) orally once daily
4 mg (ena 4 mg kapsula) peroralno enkrat na dan
Reactions of Grade 3 or 4 severity occurred in 5.0% of lenvatinibtreated vs 0 placebo-treated patients.
Neželeni učinki stopnje 3 ali 4 so nastopili pri 5,0 % bolnikov, zdravljenih z lenvatinibom, in pri nobenem od bolnikov, ki so prejemali placebo.
• liver damage
• težave s celjenjem ran
In the case of bleeding, dose interruptions, adjustments, or discontinuation may be required (see Section 4.2, Table 3).
V primeru krvavitve bodo mogoče potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2, preglednica 3).
Proteinuria‡
Bolezni sečil proteinurija‡
In the Phase 3 REFLECT trial (see section 5.1), arterial thromboembolic events were reported in 2.3% of patients treated with lenvatinib.
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o arterijskih trombemboličnih dogodkih pri 2,3 % bolnikov, zdravljenih z lenvatinibom.
Lenvatinib should be discontinued in the event of nephrotic syndrome.
V primeru nefrotičnega sindroma je treba lenvatinib ukiniti.
Pneumothorax
pnevmotoraks
Dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Morda bodo potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2).
Baseline hypertension
Izhodiščna hipertenzija
Patients may be at increased risk for the development of fistulae when treated with lenvatinib.
Kadar se bolniki zdravijo z lenvatinibom, se lahko pri njih zveča tveganje nastanka fistul.
Hypothyroidism has been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Pri bolnikih, zdravljenih z lenvatinibom, so poročali o hipotiroidizmu (glejte poglavje 4.8, Opis izbranih neželenih učinkov).
Myocardial infarctionc,†
Srčne bolezni miokardni infarktc,†
In the Phase 3 REFLECT trial (see section 5.1), hypocalcaemia was reported in 1.1% of patients, with grade 3 reactions occurring in 0.4%.
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o hipokalciemiji pri 1,1 % bolnikov.
Screening for and subsequent treatment of oesophageal varices in patients with liver cirrhosis should be performed as per standard of care before starting treatment with lenvatinib
Pred začetkom zdravljenja bolnikov z jetrno cirozo z lenvatinibom je treba v skladu s standardom oskrbe opraviti pregled glede prisotnosti ezofagealnih varic in njihovo zdravljenje.
Figure 2
DRUGI PODATKI
Per independent radiology review retrospective analysis.
Odziv (popolni ali delni odziv) g Glede na retrospektivno analizo neodvisnega radiološkega pregleda.
Name and address of the manufacturer responsible for batch release Eisai Manufacturing Ltd
Ime in naslov proizvajalca, odgovornega za sproščanje serij