natgillin/translations-raw huggingface dataset:
The median time to onset in lenvatinib-treated patients was 16 days.
Medijan vremena do nastupa hipertenzije u bolesnika liječenih lenvatinibom iznosio je 16 dana.
Reactions of Grade 3 or 4 severity occurred in 5.0% of lenvatinibtreated vs 0 placebo-treated patients.
Nuspojave 3. ili 4. stupnja težine nastale su u 5,0% bolesnika liječenih lenvatinibom naspram 0 bolesnika koji su primali placebo.
Close monitoring of the overall safety is recommended in patients with mild or moderate hepatic impairment (see also sections 4.2 and 5.2).
U bolesnika s blagim ili umjerenim oštećenjem funkcije jetre preporučuje se pomno praćenje ukupnog sigurnosnog profila (vidjeti također dijelove 4.2 i 5.2).
• feeling very tired or weak
• osjećaj velikog umora ili slabosti
Patients with baseline hypertension had a higher incidence of Grade 3 or 4 hypertension, proteinuria, diarrhoea, and dehydration, and experienced more serious cases of dehydration, hypotension, pulmonary embolism, malignant pleural effusion, atrial fibrillation, and GI symptoms (abdominal pain, diarrhoea, vomiting).
Bolesnici s hipertenzijom na početku ispitivanja imali su višu incidenciju 3. ili 4. stupnja hipertenzije, proteinurije, proljeva i dehidracije te su imali ozbiljnije slučajeve dehidracije, hipotenzije, plućne embolije, malignog pleuralnog izljeva, atrijske fibrilacije i gastrointestinalnih simptoma (abdominalni bol, proljev, povraćanje).
Hypertension and proteinuria tend to occur early during lenvatinib treatment (see sections 4.4 and 4.8, Description of selected adverse reactions).
Hipertenzija i proteinurija imaju tendenciju nastajanja rano u tijeku liječenja lenvatinibom (vidjeti dijelove 4.4 i 4.8 Opis odabranih nuspojava).
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%).
Najvažnije ozbiljne nuspojave bile su zatajenje jetre (2,8%), hepatička encefalopatija (4,6%), krvarenje varikoziteta jednjaka (1,4%), cerebralno krvarenje (0,6%), arterijski tromboembolijski događaji (2,0%) uključujući infarkt miokarda (0,8%), moždani udar (0,4%) i cerebrovaskularni inzult (0,4%) te zatajenje/oštećenje funkcije bubrega (1,4%).
Electrolytes (magnesium, potassium and calcium) should be monitored periodically during treatment.
Tijekom liječenja potrebno je razmotriti potrebu povremenog praćenja elektrolita (magnezija, kalija i kalcija).
Asian patients had a higher incidence than Caucasian patients of proteinuria, decreased neutrophil count, decreased platelet count, decreased white blood count and PPE syndrome, while Caucasian patients had a higher incidence of fatigue, hepatic encephalopathy, acute kidney injury, anxiety, asthenia, nausea, thrombocytopenia and vomiting.
Kod bolesnika azijskog podrijetla postojala je veća incidencija nego kod bolesnika bijele rase što se tiče proteinurije, smanjenog broja neutrofila, smanjenog broja trombocita, smanjenog broja bijelih krvnih stanca i PPE sindroma, dok je kod bolesnika bijele rase bila veća incidencija umora, hepatičke encefalopatije, akutnog oštećenja bubrega, tjeskobe, astenije, mučnine, trombocitopenije i povraćanja.
Patients with baseline hepatic impairment had a higher incidence of hypertension and PPE, and a higher incidence of Grade 3 or 4 hypertension, asthenia, fatigue, and hypocalcaemia compared with patients with normal hepatic function.
Bolesnici s oštećenjem funkcije jetre na početku ispitivanja imali su višu incidenciju hipertenzije i PPE-a, kao i višu incidenciju 3. ili 4. stupnja hipertenzije, astenije, umora i hipokalcemije u usporedbi s bolesnicima s normalnom funkcijom jetre.
• changes in urine tests for protein (high) and urinary infections (increased frequency in urination and pain in passing urine)
• promjene u nalazu pretrage mokraće na bjelančevine (povišene) i mokraćne infekcije (povećana učestalost mokrenja i bolno mokrenje)
Hypomagnesaemia includes hypomagnesaemia and decreased blood magnesium.
Hipomagnezemija uključuje hipomagnezemiju i sniženi magnezij u krvi.
Adverse reactions that most commonly led to dose reductions (in ≥5% of patients) were hypertension, proteinuria, diarrhoea, fatigue, PPE, decreased weight, and decreased appetite.
Nuspojave koje su najčešće dovele do sniženja doze (u ≥5% bolesnika) bile su hipertenzija, proteinurija, proljev, umor, PPE, smanjena tjelesna težina i smanjeni apetit.
Consider resuming at reduced dose if resolves to Grade 0-1.
Ako se povuče na 0.-1. stupanj, razmisliti o nastavku primjene u sniženoj dozi.
Hazard ratio (95% CI)b,c
Omjer hazarda (95% CI)b,c
If urine dipstick proteinuria ≥2+ is detected, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Ako se urinskom test-trakom otkrije proteinurija ≥2+, može biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili prestati s primjenom (vidjeti dio 4.2).
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.
Nuspojave 3. ili višeg stupnja povezane s jetrom (uključujući jedan slučaj zatajenja jetre 5. stupnja) nastale su u 5,4% bolesnika liječenih lenvatinibom u usporedbi s 0,8% bolesnika koji su primali placebo.
CI, confidence interval; NE, not estimable; OS, overall survival; PFS, progression-free survival; RPSFT, rank preserving structural failure time model; VEGF/VEGFR, vascular endothelial growth factor / vascular endothelial growth factor receptor.
CI, interval pouzdanosti; NP, ne može se procijeniti; OS, ukupno preživljenje; PFS, preživljenje bez progresije bolesti; RPSFT model (engl.
LENVIMA 4 mg hard capsules LENVIMA 10 mg hard capsules lenvatinib
LENVIMA 4 mg tvrde kapsule LENVIMA 10 mg tvrde kapsule lenvatinib
Hazard ratio (99% CI)b,c P-valueb
Omjer hazarda (99% CI)b,c P-vrijednostb
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.
Nuspojave koje su najčešće dovele do prilagodbe doze (u ≥5% bolesnika) bile su smanjen apetit, proljev, proteinurija, hipertenzija, umor, PPE i smanjen broj trombocita.
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.
U mladih štakora također su bili opaženi zastoj u rastu, posljedično usporen fizički razvoj i lezije koje su se mogle pripisati farmakološkim učincima (sjekutići, femur [epifizna ploča rasta], bubrezi, nadbubrežne žlijezde i duodenum).
4 mg (one 4 mg capsule) orally every other day
4 mg (jedna kapsula od 4 mg) peroralno svaki drugi dan
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).
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), proljev je zabilježen u 38,7% bolesnika liječenih lenvatinibom (4,2% bilo je ≥3.stupnja).
Hazard ratio is for lenvatinib vs. sorafenib, based on a Cox model including treatment group as a factor.
Zaključni datum prikupljanja podataka: 13.11.2016. a Omjer hazarda za lenvatinib naspram sorafeniba, na temelju Coxovog modela koji uključuje terapijsku skupinu kao čimbenik.
Cardiac dysfunction (see section 4.4)
Srčana disfunkcija (vidjeti dio 4.4)
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.
Bolesnici s oštećenjem funkcije bubrega na početku ispitivanja imali su višu incidenciju 3. ili 4. stupnja hipertenzije, proteinurije, umora, stomatitisa, perifernog edema, trombocitopenije, dehidracije, produljenog QT intervala, hipotireoze, hiponatremije, povišenog tireotropina u krvi i pneumonije u usporedbi s ispitanicima s normalnom funkcijom bubrega.
(1 capsule of 10 mg and 1 capsule of 4 mg).
kapsula od 10 mg i 1 kapsula od 4 mg).
Management of adverse reactions may require dose interruption, adjustment, or discontinuation of lenvatinib therapy (see section 4.4).
Zbog zbrinjavanja nuspojava možda će biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili prestati s primjenom lenvatiniba (vidjeti dio 4.4).
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
Potrebno je provesti probir na varikozitete jednjaka u bolesnika s cirozom jetre i provesti naknadno liječenje u skladu sa standardnom skrbi prije početka primjene lenvatiniba.
Arterial thromboembolisms (see section 4.4)
Arterijska tromboembolija (vidjeti dio 4.4)
The dose is usually 12 mg once a day (3 capsules of 4 mg) if you weigh 60 kg or more and 8 mg once a day (2 capsules of 4 mg) if you weigh less than 60kg.
Doza je obično 12 mg jedanput dnevno (3 kapsule od 4 mg) ako težite 60 kg ili više i
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%).
Nuspojave čija je incidencija nastanka bila ≥0,75% viša od one kod placeba bile su: epistaksa (11,9%), hematurija (6,5%), kontuzija (4,6%), krvarenje iz desni (2,3%), hematohezija (2,3%), rektalno krvarenje (1,5%), hematom (1,1%), hemoroidalno krvarenje (1,1%), laringealno krvarenje (1,1%), petehije (1,1%) krvarenje intrakranijalnog tumora (0,8%).
• have a history of heart problems or stroke
• ste imali srčane tegobe ili moždani udar
In the pivotal Phase 3 SELECT trial (see section 5.1), 5.0% of patients developed renal failure and 1.9% developed renal impairment (3.1% of patients had a Grade ≥ 3 event of renal failure or impairment).
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1) 5,0% bolesnika razvilo je zatajenje bubrega, a 1,9% oštećenje funkcije bubrega (3,1% bolesnika imalo je zatajenje ili oštećenje funkcije bubrega ≥3. stupnja).
Chemotherapeutic agents
Kemoterapijski lijekovi
Hazard ratio (95% CI)b, e P-value b, e
Omjer hazarda (95% CI)b, e P-vrijednostb, e
PRES, also known as RPLS, has been reported in patients treated with lenvatinib (<1%; see section 4.8, Description of selected adverse reactions).
U bolesnika liječenih lenvatinibom zabilježen je PRES, poznat i kao RPLS (<1%; vidjeti dio 4.8, Opis odabranih nuspojava).
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.
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), produljenje QT/QTc intervala zabilježeno je u 8,8% bolesnika liječenih lenvatinibom i 1,5% bolesnika u skupini koja je primala placebo.
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).
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), proljev je zabilježen u 67,4% bolesnika u skupini liječenoj lenvatinibom (9,2% bilo je ≥3. stupnja) i u 16,8% bolesnika u skupini koja je primala placebo (nijedan slučaj ≥3. stupnja).
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.
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), proteinurija je bila zabilježena u 33,7% bolesnika liječenih lenvatinibom i 3,1% bolesnika u skupini koja je primala placebo.
In the Phase 3 REFLECT trial (see section 5.1), proteinuria was reported in 26.3% of lenvatinibtreated patients and Grade 3 reactions occurred in 5.9%.
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), proteinurija je zabilježena u 26,3% bolesnika liječenih lenvatinibom, a nuspojave 3. stupnja zabilježene su u 5,9%.
The median time to onset of liver reactions in lenvatinib-treated patients was 12.1 weeks.
Medijan vremena do nastupa jetrenih nuspojava u bolesnika liječenih lenvatinibom iznosio je 12,1 tjedana.
Posterior reversible encephalopathy syndrome Monoparesis Transient ischaemic attack
Poremećaji živčanog sustava omaglica glavobolja disgeuzija cerebrovaskularni inzult sindrom posteriorne reverzibilne encefalopatije monopareza tranzitorna ishemijska ataka
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).
U bolesnika liječenih lenvatinibom zabilježena je arterijska tromboembolija (cerebrovaskularni inzult, tranzitorna ishemijska ataka i infarkt miokarda) (vidjeti dio 4.8, Opis odabranih nuspojava).
No dose adjustments are required on the basis of renal function in patients with mild or moderate renal impairment.
Nije potrebna prilagodba doze na temelju funkcije bubrega u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
Adverse reactions that most commonly led to discontinuation of lenvatinib were hepatic encephalopathy, fatigue, increased blood bilirubin, proteinuria and hepatic failure.
Nuspojave koje su najčešće dovele do trajnog prekida liječenja lenvatinibom bile su hepatička encefalopatija, umor, povišene razine bilirubina u krvi, proteinurija i zatajenje jetre.
Each hard capsule contains 4 mg of lenvatinib (as mesylate).
Jedna tvrda kapsula sadrži 4 mg lenvatiniba (u obliku lenvatinibmesilata).
Adverse reactions that most commonly led to discontinuation of lenvatinib were proteinuria, asthenia, hypertension, cerebrovascular accident, diarrhoea, and pulmonary embolism.
Nuspojave koje su najčešće dovele do prestanka primjene lenvatiniba bile su proteinurija, astenija, hipertenzija, cerebrovaskularni inzult, proljev i plućna embolija.
Impaired wound healing has been reported in patients receiving lenvatinib.
Zabilježeno je smanjeno cijeljenje rana kod bolesnika koji primaju lenvatinib.
Hepatic encephalopathy occurred at more than twice the incidence in patients aged ≥75 years (17.2%) than in those <75 years (7.1%).
≥75 godina (17,2%) u odnosu na bolesnike u dobi
Renal impairment Increased blood creatinine Increased blood urea
oštećenje funkcije bubrega povišen kreatinin u krvi povišena ureja u krvi nefrotski sindrom
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.
Hemoragijski pojmovi koji su se javili u 5 ili više ispitanika sa DTC-om bili su: epistaksa, hemoptiza, hematurija, kontuzija, hematohezija, krvarenje iz desni, petehije, plućno krvarenje, rektalno krvarenje, prisutnost krvi u mokraći, hematom i vaginalno krvarenje.
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.
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), krvarenje je bilo zabilježeno u 34,9% bolesnika liječenih lenvatinibom (1,9% bilo je ≥3. stupnja) naspram 18,3% bolesnika koji su primali placebo (3,1% bilo je ≥3. stupnja).
In the Phase 3 REFLECT trial (see section 5.1), haemorrhage was reported in 24.6% of patients and 5.0% were Grade ≥ 3.
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), krvarenje je zabilježeno u 24,6% bolesnika, a 5,0% bilo je ≥3.stupnja.
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.
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), događaji arterijske tromboembolije zabilježeni su u 5,4% bolesnika liječenih lenvatinibom i 2,3% bolesnika u skupini koja je primala placebo.
Dose reduce and resume lenvatinib
Što poduzeti Sniženje doze i nastavak primjene lenvatiniba
Microcrystalline cellulose Hydroxypropylcellulose Low-substituted hydroxypropylcellulose Talc
Sadržaj kapsule kalcijev karbonat manitol celuloza, mikrokristalinična hidroksipropilceluloza hidroksipropilceluloza, nisko supstituirana talk
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.
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), događaji gastrointestinalne perforacije ili fistule zabilježeni su u 1,9% bolesnika liječenih lenvatinibom i 0,8% bolesnika u skupini koja je primala placebo.
In the Phase 3 REFLECT trial (see section 5.1), arterial thromboembolic events were reported in 2.3% of patients treated with lenvatinib.
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), arterijski tromboembolijski događaji zabilježeni su u 2,3% bolesnika liječenih lenvatinibom.
LENVIMA 4 mg hard capsules
LENVIMA 4 mg tvrde kapsule
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).
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), smanjena ejekcijska frakcija/zatajenje srca zabilježeno je u 6,5% bolesnika (1,5% bilo je ≥3. stupnja) u skupini liječenoj lenvatinibom i 2,3% u skupini liječenoj placebom (nijedan slučaj nije bio ≥3. stupnja).
Secondary efficacy outcome measures included overall response rate and overall survival.
Response Evaluation Criteria in Solid Tumours, RECIST) 1.1. Sekundarne mjere ishoda za djelotvornost uključivale su stopu ukupnog odgovora i ukupno preživljenje.
LENVIMA 10 mg hard capsules
LENVIMA 10 mg tvrde kapsule
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.
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), slučajevi gastrointestinalne perforacije ili fistule zabilježeni su u 1,9% bolesnika liječenih lenvatinibom.
Hypothyroidism Increased blood thyroid stimulating hormone ‡
Endokrini poremećaji hipotireoza povišen tireotropin u krvi‡
Lenvatinib impairs exogenous thyroid suppression (see section 4.8, Description of selected adverse reactions).
Lenvatinib narušava egzogenu supresiju štitnjače (vidjeti dio 4.8, Opis odabranih nuspojava).
Quartiles are estimated by the Kaplan-Meier method, and the 95% CIs are estimated with a generalized Brookmeyer and Crowley method f.
e Kvartili procijenjeni Kaplan-Meierovom metodom, a 95% CI procijenjeni su generaliziranom
Palmar-plantar erythrodysaesthesia syndrome Rash Alopecia
Poremećaji kože i potkožnog tkiva sindrom palmarno-plantarne eritrodizestezije osip alopecija hiperkeratoza
In the Phase 3 REFLECT trial (see section 5.1), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group.
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), zabilježen je 1 događaj PRES-a (2.stupnja) u skupini liječenoj lenvatinibom.
NE (16.8, NE)
NP (16,8, NP)
• feeling sick and being sick, constipation, diarrhoea, abdominal pain, indigestion
• mučnina i povraćanje, zatvor, proljev, bol u trbuhu, probavne tegobe
Hypocalcaemia‡ Hypokalaemia Decreased weight Decreased appetite
Poremećaji metabolizma i prehrane hipokalcemija‡ hipokalemija smanjena tjelesna težina smanjen apetit dehidracija hipomagnezemijab hiperkolesterolemijab
In the case of bleeding, dose interruptions, adjustments, or discontinuation may be required (see Section 4.2, Table 3).
U slučaju krvarenja može biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili trajno prekinuti primjenu (vidjeti dio 4.2, tablica 3).
Discontinue Do not resume
Trajno prekinuti
Patients with baseline renal impairment had a higher incidence of fatigue, hypothyroidism, dehydration, diarrhoea, decreased appetite, proteinuria and hepatic encephalopathy.
Bolesnici koji su na početku imali oštećenje bubrega imali su veću incidenciju umora, hipotireoze, dehidracije, proljeva, smanjenog apetita, proteinurije i hepatičke encefalopatije.
Hepatotoxicity (see section 4.4)
Hepatotoksičnost (vidjeti dio 4.4)
In patients with signs or symptoms of PRES, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
U bolesnika sa znakovima ili simptomima PRES-a može biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili trajno prekinuti primjenu (vidjeti dio 4.2).
Hypothyroidism has been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Hipotireoza je zabilježena u bolesnika liječenih lenvatinibom (vidjeti dio 4.8, Opis odabranih nuspojava).
Renal failure cases includes: acute prerenal failure, renal failure, renal failure acute, acute kidney injury and renal tubular necrosis.
Slučajevi zatajenja bubrega uključuju: akutno prerenalno zatajenje, zatajenje bubrega, akutno zatajenje bubrega, akutno oštećenje bubrega i bubrežnu tubularnu nekrozu.
Table 5 Adverse reactions reported in patients treated with lenvatinib System Organ
Tablica 5 Nuspojave zabilježene u bolesnika liječenih lenvatinibom Klasifikacija organskih sustava (MedDRA terminologija*)
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.
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1) hipokalcemija je bila zabilježena u 12,6% bolesnika liječenih lenvatinibom naspram nula slučajeva u skupini koja je primala placebo.
NAME OF THE MEDICINAL PRODUCT LENVIMA 4 mg hard capsules LENVIMA 10 mg hard capsules
NAZIV LIJEKA LENVIMA 4 mg tvrde kapsule LENVIMA 10 mg tvrde kapsule
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.
U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), zabilježen je 1 događaj PRES-a (2. stupnja) u skupini liječenoj lenvatinibom, a u skupini liječenoj placebom nije bilo takvih događaja.
Gastrointestinal perforation or fistulae have been reported in patients treated with lenvatinib (see section 4.8).
U bolesnika liječenih lenvatinibom zabilježeni su gastrointestinalna perforacija ili fistule (vidjeti dio 4.8).
• Not known
Nepoznato
Black iron oxide (E172) Potassium hydroxide Propylene glycol
Tinta za označavanje šelak željezov oksid, crni (E172) kalijev hidroksid propilenglikol
Non-Gastrointestinal fistulae (see section 4.4)
Fistule koje nisu gastrointestinalne (vidjeti dio 4.4)
chills, nausea and vomiting (splenic farction)
mučninom i povraćanjem (infarkt slezene)
• feeling unwell
• opće loše osjećanje
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
In the Phase 3 REFLECT trial (see section 5.1), 7.1% of lenvatinib-treated patients developed a renal failure/impairment event.
U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), u 7,1% bolesnika liječenih lenvatinibom došlo je do zatajenja/oštećenja funkcije bubrega.
8 mg (two 4 mg capsules) orally once daily
8 mg (dvije kapsule od 4 mg) peroralno jedanput dnevno
• have liver or kidney problems
• imate tegobe s jetrom ili bubrezima
What LENVIMA is
Što je LENVIMA
Non-Gastrointestinal fistula
Fistula koja nije gastrointestinalna
4 mg (one 4 mg capsule) orally once daily
4 mg (jedna kapsula od 4 mg) peroralno jedanput dnevno