natgillin/translations-raw huggingface dataset:
Renal cell carcinoma Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Karcinom ledvičnih celic Nexavar je indiciran za zdravljenje bolnikov z napredovalim karcinomom ledvičnih celic, pri katerih je bilo predhodno zdravljenje z interferonom alfa in interlevkinom- 2 neuspešno ali za katere je ocenjeno, da tako zdravljenje za njih ni primerno.
Nexavar treatment should be supervised by a physician experienced in the use of anticancer therapies.
Zdravljenje z Nexavarom mora nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
The recommended dose of Nexavar in adults is 400 mg (two tablets of 200 mg) twice daily (equivalent to a total daily dose of 800 mg).
Priporočen odmerek Nexavara za odrasle je 400 mg (dve tableti po 200 mg) dvakrat na dan (kar ustreza skupnemu dnevnemu odmerku 800 mg).
It is recommended that sorafenib should be administered without food or with a low or moderate fat meal.
Sorafenib je priporočeno jemati brez hrane ali z malo oziroma zmerno mastno hrano.
If the patient intends to have a high-fat meal, sorafenib tablets should be taken at least 1 hour before or 2 hours after the meal.
Če bolnik uživa mastno hrano, mora zdravilo vzeti najmanj eno uro pred obrokom hrane ali dve uri po njem.
The tablets should be swallowed with a glass of water.
Tablete je treba pogoltniti in popiti kozarec vode.
Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Zdravljenje traja tako dolgo, dokler je opaziti njegovo klinično koristnost oziroma dokler neželeni učinki zdravljenja niso prekomerno izraženi.
Management of suspected adverse drug reactions may require temporary interruption or dose reduction of Nexavar therapy.
Prilagoditev odmerjanja Ob sumu pojava neželenih učinkov zdravila je treba zdravljenje začasno prekiniti ali zmanjšati odmerek Nexavara.
When dose reduction is necessary, the Nexavar dose should be reduced to two tablets of 200 mg once daily (see section 4.4).
Kadar je odmerek zdravila treba zmanjšati, je zmanjšani odmerek Nexavara dve tableti po 200 mg enkrat na dan (glejte poglavje 4. 4).
The safety and efficacy in children and adolescents (< 18 years) have not been studied.
Varnosti in učinkovitosti uporabe zdravila pri otrocih in mladostnikih (< 18 let) niso preučevali.
Nexavar is not recommended for use in children and adolescents due to a lack of data on safety and efficacy (see section 5.3).
Uporaba Nexavara zaradi pomanjkanja podatkov o njegovi varnosti in učinkovitosti pri otrocih in mladostnikih zato ni priporočljiva (glejte poglavje 5. 3).
No dose adjustment is required in the elderly (patients above 65 years of age).
Starejšim bolnikom (starim več kot 65 let) odmerka zdravila ni treba prilagajati.
No dose adjustment is required in patients with mild, moderate or severe renal impairment.
Za bolnike, ki potrebujejo dializo, ni podatkov (glejte poglavje 5. 2)
Monitoring of fluid balance and electrolytes in patients at risk of renal dysfunction is advised.
2 Pri bolnikih s tveganjem za moteno ledvično delovanje se priporoča spremljanje ravnotežja med tekočino in elektroliti.
No dose adjustment is required in patients with Child Pugh A and B (mild to moderate) hepatic impairment.
Bolnikom z blago do zmerno hudo jetrno okvaro (Child Pugh A in B) odmerka zdravila ni treba prilagajati.
No data is available on patients with Child Pugh C (severe) hepatic impairment (see section 4.4 and 5.2).
Podatkov za bolnike s hudo jetrno okvaro (Child Pugh C) ni (glejte poglavji 4. 4 in 5. 2).
Hypersensitivity to the active substance or to any of the excipients.
preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov
Dermatological toxicities:
Dermatološka toksičnost:
Hand-foot skin reaction (palmar-plantar erythrodysaesthesia) and rash represent the most common adverse drug reactions with Nexavar.
Najpogostejši neželeni učinki zdravljenja z Nexavarom so kožne reakcije na rokah in nogah (palmarno- plantarna eritrodisestezija) in izpuščaji.
Rash and hand-foot skin reaction are usually CTC (Common Toxicity Criteria) Grade 1 and 2 and generally appear during the first six weeks of treatment with Nexavar.
Po CTC (Common Toxicitiy Criteria) so 1. in 2. stopnje in se ponavadi pojavijo v prvih šestih tednih zdravljenja z Nexavarom.
Management of dermatological toxicities may include topical therapies for symptomatic relief, temporary treatment interruption and/ or dose modification of Nexavar, or in severe or persistent cases, permanent discontinuation of Nexavar (see section 4.8).
Te kožne spremembe se simptomatsko lahko lajšajo z lokalnim zdravljenjem, začasno prekinitvijo zdravljenja in/ ali spremembo odmerka Nexavara, v hudih in trdovratnih primerih pa je treba zdravljenje z Nexavarom trajno prenehati (glejte poglavje 4. 8).
An increased incidence of arterial hypertension was observed in Nexavar-treated patients.
Pri bolnikih, ki so se zdravili z Nexavarom, so opazili zvečano incidenco arterijske hipertenzije.
Hypertension was usually mild to moderate, occurred early in the course of treatment, and was amenable to management with standard antihypertensive therapy.
Ponavadi je bila blaga do zmerno huda, pojavila se je na začetku zdravljenja z Nexavarom, njeno zdravljenje pa je bilo učinkovito s standardnimi antihipertenzivi.
In cases of severe or persistent hypertension, or hypertensive crisis despite institution of antihypertensive therapy, permanent discontinuation of Nexavar should be considered (see section 4.8).
V primeru hude ali trdovratne hipertenzije oziroma kadar hipertenzijska kriza traja kljub ustreznemu antihipertenzijskemu zdravljenju, je treba zdravljenje z Nexavarom trajno prenehati (glejte poglavje 4. 8).
Haemorrhage:
Krvavitve:
An increased risk of bleeding may occur following Nexavar administration.
Med zdravljenjem z Nexavarom se lahko zveča nevarnost krvavitev.
If any bleeding event necessitates medical intervention it is recommended that permanent discontinuation of Nexavar should be considered (see section 4.8).
Če je zaradi krvavitve potrebno medicinsko ukrepanje, je priporočeno zdravljenje z Nexavarom trajno prenehati (glejte poglavje 4. 8).
Cardiac ischaemia and/ or infarction:
Srčna ishemija in/ ali infarkt:
In a randomised, placebo-controlled, double-blind study (study 1, see section 5.1) the incidence of treatment-emergent cardiac ischaemia/ infarction events was higher in the Nexavar group (2.9%) compared with the placebo group (0.4%).
V randomizirani, s placebom kontrolirani, dvojno slepi študiji (študija 1, glejte poglavje 5. 1) je bila incidenca med zdravljenjem nastale srčne ishemije/ infarkta v skupini bolnikov, ki so se zdravili z Nexavarom, večja (2, 9%) kot pri bolnikih, ki so prejemali placebo (0, 4%).
In study 3 (see section 5.1), the incidence of treatment-emergent cardiac ischaemia/ infarction events was 2.7% in Nexavar patients compared with 1.3% in the placebo group.
V študiji 3 (glejte poglavje 5. 1) je bila incidenca med zdravljenjem nastale srčne ishemije/ infarkta 2, 7% pri bolnikih, ki so dobivali Nexavar, in 1, 3% pri bolnikih, ki so prejemali placebo.
Patients with unstable coronary artery disease or recent myocardial infarction were excluded from these studies.
Ti študiji nista vključili bolnikov z nestabilno boleznijo koronarnih arterij ali nedavnim miokardnim infarktom.
Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischaemia and/ or infarction (see section 4.8).
O začasnem ali trajnem prenehanju zdravljenja z Nexavarom je treba premisliti pri bolnikih, pri katerih se pojavi srčna ishemija in/ ali infarkt (glejte poglavje 4. 8).
Gastrointestinal perforation:
Perforacija prebavil:
Gastrointestinal perforation is an uncommon event and has been reported in less than 1% of patients taking sorafenib.
Občasno pride do perforacije prebavil; dogodek je opisan pri manj kot 1% bolnikov, ki jemljejo sorafenib.
In some cases this was not associated with apparent intra- abdominal tumor.
V nekaterih primerih ni bila povezana s prisotnim intraabdominalnim tumorjem.
Sorafenib therapy should be discontinued (see section 4.8).
Zdravljenje s sorafenibom je treba prekiniti (glejte poglavje 4. 8).
No data is available on patients with Child Pugh C (severe) hepatic impairment.
Podatkov o bolnikih s hudo jetrno okvaro (Child Pugh C) ni.
Since sorafenib is mainly eliminated via the hepatic route exposure might be increased in patients with severe hepatic impairment (see section 4.2 and 5.2).
Ker se sorafenib izloča predvsem skozi jetra, se pri bolnikih s hudo jetrno okvaro lahko zveča njihova izpostavljenost učinkovini (glejte poglavji 4. 2 in 5. 2).
Warfarin co-administration:
Sočasna uporaba varfarina:
Infrequent bleeding events or elevations in the International Normalised Ratio (INR) have been reported in some patients taking warfarin while on Nexavar therapy.
Pri nekaterih bolnikih, ki so jemali varfarin, se je med zdravljenjem z Nexavarom redko pojavila krvavitev ali se jim je zvečalo internacionalno normalizirano razmerje (INR).
Patients taking concomitant warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, INR or clinical bleeding episodes (see sections 4.5 and 4.8).
Pri bolnikih, ki sočasno jemljejo varfarin ali fenprokumon, je treba redno spremljati spremembe protrombinskega časa, vrednosti INR in epizode kliničnih krvavitev (glejte poglavji 4. 5 in 4. 8).
3 Wound healing complications:
3 Zapleti pri celjenju ran:
No formal studies of the effect of sorafenib on wound healing have been conducted.
Uradnih študij o vplivu sorafeniba na celjenje ran ni.
Temporary interruption of Nexavar therapy is recommended for precautionary reasons in patients undergoing major surgical procedures.
Zaradi previdnostnih razlogov je priporočena začasna prekinitev zdravljenja z Nexavarom pri bolnikih z načrtovanim obsežnim kirurškim posegom.
There is limited clinical experience regarding the timing of reinitiation of therapy following major surgical intervention.
Klinične izkušnje glede tega, kdaj po obsežnem kirurškem posegu spet začeti zdravljenje, so omejene.
Therefore, the decision to resume Nexavar therapy following a major surgical intervention should be based on clinical judgement of adequate wound healing.
Odločitev o tem, kdaj po obsežnem kirurškem posegu spet začeti zdravljenje z Nexavarom, mora temeljiti na klinični oceni ustreznosti celjenja ran.
The experience with the use of Nexavar in elderly patients is limited.
Izkušnje o uporabi Nexavara pri starejših bolnikih so omejene.
Cases of renal failure have been reported.
Poročali so o primerih ledvične odpovedi.
Monitoring of renal function should be considered.
Priporočena je kontrola ledvične funkcije.
Renal cell carcinoma:
Karcinom ledvičnih celic:
High Risk Patients, according to MSKCC (Memorial Sloan Kettering Cancer Center) prognostic group, were not included in the phase III clinical study in renal cell carcinoma (see study 1 in section 5.1); and benefit-risk in these patients has not been evaluated.
V klinično študijo III. faze pri karcinomu ledvičnih celic (glejte študijo 1 v poglavju 5. 1) niso bili vključeni bolniki z velikim tveganjem glede na prognostično skupino po MSKCC (Memorial Sloan Kettering Cancer Center), zato korist in tveganje pri teh bolnikih nista bila ocenjena.
Drug-drug interactions:
Medsebojno delovanje zdravil:
Caution is recommended when administering Nexavar with compounds that are metabolised/ eliminated predominantly by the UGT1A1 (e. g. irinotecan) or UGT1A9 pathways (see section 4.5).
Previdnost je potrebna pri sočasni uporabi Nexavara in učinkovin, ki se presnavljajo/ izločajo predvsem prek UGT1A1 (npr. irinotekan) ali UGT1A9 (glejte poglavje 4. 5).
Caution is recommended when sorafenib is co-administered with docetaxel (see section 4.5).
Previdnost je potrebna pri sočasni uporabi sorafeniba in docetaksela (glejte poglavje 4. 5).
Administration of rifampicin for 5 days before administration of a single dose of sorafenib resulted in an average 37% reduction of sorafenib AUC.
Induktorji presnovnih encimov: uporaba rifampicina 5 dni pred uporabo enkratnega odmerka sorafeniba zmanjša AUC sorafeniba za 37%.
John’ s wort, phenytoin, carbamazepine, phenobarbital, and dexamethasone) may also increase metabolism of sorafenib and thus decrease sorafenib concentrations.
Drugi induktorji aktivnosti CYP3A4 ali glukuronidacije (na primer Hypericum perforatum, imenovan tudi šentjanževka, fenitoin, karbamazepin, fenobarbital in deksametazon), ali obojega, lahko zvečajo presnovo sorafeniba in tako zmanjšajo njegovo koncentracijo.
Ketoconazole, a potent inhibitor of CYP3A4, administered once daily for 7 days to healthy male volunteers did not alter the mean AUC of a single 50 mg dose of sorafenib.
Ketokonazol, močan zaviralec CYP3A4, ki so ga zdravi moški prostovoljci prejemali sedem dni enkrat na dan, ni vplival na srednjo AUC enkratnega 50- miligramskega odmerka sorafeniba.
These data suggest that clinical pharmacokinetic interactions of sorafenib with CYP3A4 inhibitors are unlikely.
Ti podatki nakazujejo, da so klinične farmakokinetične interakcije med sorafenibom in zaviralci CYP3A4 malo verjetne.
CYP2C9 substrates:
Substrati CYP2C9:
Sorafenib inhibited CYP2C9 in vitro.
Sorafenib je zaviral CYP2C9 in vitro.
It cannot be excluded that sorafenib may increase the concentrations of concomitantly administered substrates of CYP2C9.
Možnosti zvečanja koncentracij s sorafenibom sočasno predpisanih substratov CYP2C9 ni možno izključiti.
The concomitant treatment with Nexavar and warfarin, a CYP2C9 substrate, did not result in changes in mean PT-INR compared to placebo.
Med sočasnim zdravljenjem z Nexavarom in varfarinom, substratom CYP2C9, se srednja vrednost PT- INR v primerjavi s placebom ni spremenila.
However, patients taking warfarin or phenprocoumon should have their INR checked regularly (see section 4.4).
Vseeno pa je treba pri bolnikih, ki jemljejo varfarin ali fenprokumon, redno preverjati njihov INR (glejte poglavje 4. 4).
CYP2B6 and CYP2C8 substrates:
Substrati CYP2B6 in CYP2C8:
Sorafenib inhibited CYP2B6 and CYP2C8 in vitro, but the clinical relevance of this inhibition has not been evaluated.
Sorafenib je zaviral CYP2B6 in CYP2C8 in vitro, vendar klinični pomen tega delovanja ni bil ovrednoten.
It cannot be excluded that sorafenib may increase the concentrations of concomitantly administered substrates of CYP2B6 (e. g. bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone) and CYP2C8 (e. g. paclitaxel, amodiaquine, repaglinide).
Možnosti zvečanja koncentracij sočasno predpisanih substratov CYP2B6 (na primer bupropion, ciklofosfamid, efavirenz, ifosfamid, metadon) in CYP2C8 (na primer paklitaksel, amodiakvin, repaglinid) ni možno izključiti.
UGT1A1 and UGT1A9 substrates:
Substrati UGT1A1 in UGT1A9:
The clinical relevance of this finding is unknown (see below and section 4.4).
Klinični pomen te ugotovitve ni znan (glejte nadaljevanje in poglavje 4. 4).
CYP isoforms selective substrates:
Selektivni substrati izoform CYP:
Concomitant administration of sorafenib and midazolam, dextromethorphan or omeprazole, which are substrates for cytochromes CYP3A4, CYP2D6 and CYP2C19 respectively, did not alter the exposure of these agents.
Sočasna uporaba sorafeniba in midazolama, dekstrometorfana ali omeprazola, ki so substrati citokroma CYP3A4, CYP2D6 in CYP2C19, ne vpliva na izpostavljenost tem snovem.
4 In vitro studies of CYP enzyme induction:
In vitro študije o indukciji encima CYP:
CYP1A2 and CYP3A4 activities were not altered after treatment of cultured human hepatocytes with sorafenib, indicating that sorafenib is unlikely to be an inducer of CYP1A2 and CYP3A4.
Aktivnost CYP1A2 in CYP3A4 se po uporabi sorafeniba in vitro na gojenih človeških jetrnih celicah ni spremenila, kar nakazuje, da je malo verjetno, da bi sorafenib induciral CYP1A2 in CYP3A4.
P-gp-substrates:
4 P- gp- substrati:
In vitro, sorafenib has been shown to inhibit the transport protein p-glycoprotein (P- gp).
Sorafenib je in vitro pokazal, da zavira prenos beljakovine p- glikoprotein (P- gp).
Increased plasma concentrations of P-gp substrates such as digoxin cannot be excluded with concomitant treatment with sorafenib.
Pri sočasni uporabi sorafeniba, zvečanja plazemske koncentracije P- gp substrata, kot je digoksin, ni možno izključiti.
Combination with other anti-neoplastic agents:
Sočasno jemanje z drugimi antineoplazemskimi učinkovinami:
In clinical studies Nexavar has been administered with a variety of other anti-neoplastic agents at their commonly used dosing regimens including gemcitabine, oxaliplatin, doxorubicin, and irinotecan.
V kliničnih študijah so Nexavar uporabljali sočasno z več drugimi antineoplazemskimi učinkovinami (gemcitabin, oksaliplatin, doksorubicin in irinotekan), v običajnih odmerkih.
Sorafenib had no effect on the pharmacokinetics of gemcitabine or oxaliplatin.
Sorafenib ni vplival na farmakokinetiko gemcitabina in oksaliplatina.
Concomitant treatment with Nexavar resulted in a 21% increase in the AUC of doxorubicin.
Med sočasnim zdravljenjem z Nexavarom in doksorubicinom se je AUC slednjega zvečala za 21%.
When administered with irinotecan, whose active metabolite SN-38 is further metabolised by the UGT1A1 pathway, there was a 67 - 120% increase in the AUC of SN-38 and a 26 - 42% increase in the AUC of irinotecan.
Med sočasno uporabo irinotekana, čigar aktivni presnovek SN- 38 se nato presnovi prek UGT1A1, se AUC SN- 38 zveča za 67 do 120%, AUC irinotekana pa za 26 do 42%.
The clinical significance of these findings is unknown (see section 4.4).
Klinični pomen teh ugotovitev ni znan (glejte poglavje 4. 4).
Docetaxel (75 or 100 mg/ m2 administered once every 21 days) when co-administered with sorafenib (200 mg twice daily or 400 mg twice daily administered on Days 2 through 19 of a 21-day cycle with a 3-day break in dosing around administration of docetaxel) resulted in a 36-80% increase in docetaxel AUC and a 16-32% increase in docetaxel Cmax.
Sočasna uporaba docetaksela (75 ali 100 mg/ m2 v enkratnem odmerku vsakih 21 dni) in sorafeniba (200 mg dvakrat na dan ali 400 mg dvakrat na dan od 2. do 19. dne enaindvajset dnevnega ciklusa s tridnevnim premorom pred uporabo docetaksela) zveča AUC docetaksela za 36 - 80% in njegov Cmax za 16 - 32%.
Caution is recommended when sorafenib is co-administered with docetaxel (see section 4.4).
Previdnost je potrebna pri sočasni uporabi sorafeniba in docetaksela (glejte poglavje 4. 4).
There are no data on the use of sorafenib in pregnant women.
Ni podatkov o uporabi sorafeniba pri nosečnicah.
Studies in animals have shown reproductive toxicity including malformations (see section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja in pojav malformacij (glejte 5. 3).
In rats, sorafenib and its metabolites were demonstrated to cross the placenta and sorafenib is anticipated to cause harmful effects on the foetus.
Sorafenib in njegovi presnovki pri podganah prehajajo skozi placento; pričakovati je, da sorafenib škodljivo deluje na plod.
Nexavar should not be used during pregnancy unless clearly necessary, after careful consideration of the needs of the mother and the risk to the foetus.
Nexavara se ne sme uporabljati med nosečnostjo, razen če je to nujno potrebno in po skrbnem pretehtanju nujnosti zdravljenja za mater in tveganja za plod.
Results from animal studies further indicate that sorafenib can impair male and female fertility (see section 5.3).
V študijah pri živalih so ugotovili, da lahko Nexavar zmanjša reprodukcijsko sposobnost tako pri samcih kot samicah (glejte poglavje 5. 3).
It is not known whether sorafenib is excreted in human milk.
Ni znano, ali se sorafenib pri človeku izloča v materino mleko.
In animals, sorafenib and/ or its metabolites were excreted in milk.
Pri živalih so se sorafenib in/ ali njegovi presnovki izločali v mleko.
Because sorafenib could harm infant growth and development (see section 5.3), women must not breast-feed during sorafenib treatment.
Ker lahko sorafenib škoduje otrokovi rasti in razvoju (glejte poglavje 5. 3), ženske med zdravljenjem s sorafenibom ne smejo dojiti.
There is no evidence that Nexavar affects the ability to drive or to operate machinery.
Dokazov o vplivu Nexavara na sposobnost vožnje ali dela s stroji ni.
The most common adverse reactions were diarrhoea, rash, alopecia and hand-foot syndrome (corresponds to palmar plantar erythrodysaesthesia syndrome in MedDRA).
Najpogostejši neželeni učinki so bili driska, osip, alopecija in sindrom dlani in podplatov (ta ustreza sindromu palmarno- plantarne eritrodisestezije po MedDRA).
Adverse reactions reported in at least 5% of patients in any treatment group – study 11213 in renal cell carcinoma (see study 1 in section 5.1).
Neželeni učinki, opisani pri vsaj 5% bolnikov v katerikoli terapevtski skupini – študija 11213 pri karcinomu ledvičnih celic (glejte študijo 1 v poglavju 5. 1).
System organ
Organski
Nexavar N=451
Nexavar, n = 451
Placebo N=451
Placebo, n = 451
class Metabolism and
sistem Presnovne in
all grades grade 3 grade 4 all grades grade 3 grade 4
stopnje 3. stopnja 4. stopnja
nutrition disorders Nervous system
Bolezni prebavil
anorexia
driska
disorders
Bolezni kože in podkožja
headache
< 1% < 1%
Vascular disorders Gastrointestinal disorders
pruritus rdečina suha koža kožna
hypertension flushing diarrhoea nausea vomiting constipation
0% 0% 0%
12% 2% < 1% 1% < 1% 6% 0% 0% 2% 0% 38% 2% 0% 9% < 1% 16% < 1% 0% 12% < 1% 10% < 1% 0% 6% < 1% 6% 0% 0% 3% 0%
0% 0% 0%
Skin and subcutaneous tissue disorders
2%
rash alopecia hand foot syndrome**
0%
pruritus erythema dry skin skin exfoliation
3%
Musculoskeletal and connective
sistema in vezivnega tkiva
arthralgia
okončinah
tissue disorders General disorders and
Splošne težave in spremembe na
pain in extremity fatigue
utrujenost
6 Table 2:
6 Preglednica 2:
Adverse reactions reported in at least 5% of patients in any treatment group – study 100554 in hepatocellular carcinoma (see study 3 in section 5.1).
Neželeni učinki, opisani pri vsaj 5% bolnikov v katerikoli terapevtski skupini – študija 100554 pri karcinomu jetrnih celic (glejte študijo 3 v poglavju 5. 1).
Nexavar N= 297
Nexavar n = 297
Placebo N= 302
Placebo n = 302
class Metabolism and
Organski
term
Neželeni
all grades
Vse
grade 3
3.
grade 4 all grades grade 3
stopnje
grade 4
4. stopnja
gastrointestinal disorders
Bolezni prebavil
diarrhoea nausea abdominal
driska navzeja bolečine v
pain
trebuhu
Skin and
Bolezni kože in
vomiting hand foot
bruhanje sindrom
subcutaneous
podkožja
syndrome**
dlani in podplatov **
alopecia rash pruritus dry skin
alopecija
14% 11% 8% 8%
14%
General disorders and
osip srbenje suha koža
fatigue
0% < 1% 0%
< 1% 13% 3%
< 1%
administration site conditions
aplikacije
< 1% 2% < 1%
< 1%
weight
zmanjšanje
decreased
telesne mase
Adverse reactions reported in multiple clinical trials are listed below in Table 3, by system organ class (in MedDRA) and frequency.
Neželeni učinki, ki so se pojavili v več kliničnih preskušanjih, so našteti v spodnji preglednici 3 po organskih sistemih (po MedDRA) in pogostosti.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100).
Pogostost je definirana kot: zelo pogosto (≥ 1/ 10), pogosto (≥ 1/ 100 do < 1/ 10), občasno (≥ 1/ 1000 do < 1/ 100).
7 Table 3:
7 Preglednica 3:
All adverse reactions reported in patients in multiple clinical trials
Vsi neželeni učinki, o katerih so poročali pri bolnikih v različnih kliničnih preskušanjih
Infections and infestations
Organski sistem Infekcijske in parazitske bolezni
≥ 1/ 10
Zelo pogosto ≥ 1/ 10
≥ 1/ 100, < 1/ 10
Pogosto ≥ 1/ 100, < 1/ 10
≥ 1/ 1,000, < 1/ 100 folliculitis infection
Občasno ≥ 1/ 1000, < 1/ 100 folikulitis okužbe
lymphopenia
limfopenija
leucopenia neutropenia anaemia thrombocytopenia
levkopenija nevtropenija anemija trombocitopenija
Immune system disorders
Bolezni imunskega sistema Bolezni endokrinega sistema
hypersensitivity reactions (including skin reactions and urticaria)
preobčutljivostne reakcije (tudi kožne reakcije in koprivnica) hipotiroidizem hiponatriemija
Endocrine disorders
Presnovne in prehranske motnje
hypothyroidism
hipofosfatemija