natgillin/translations-raw huggingface dataset:
Liver enzymes (transaminases and alkaline phosphatase) and bilirubin should be measured before initiation of treatment and monitored monthly during treatment, or as clinically indicated.
Pred uvedbo zdravljenja je treba izmeriti jetrne encime (transaminaze in alkalno fosfatazo) ter bilirubin in jih spremljati mesečno med zdravljenjem oz. kot je klinično indicirano.
In addition ECG monitoring every month during the first three months is recommended.
Prav tako je vsak mesec, prve 3 mesece zdravljenja priporočljivo opraviti EKG pregled.
Zelboraf is an anticancer medicine that contains the active substance vemurafenib.
Zdravilo Zelboraf je zdravilo za zdravljenje raka, ki vsebuje učinkovino vemurafenib.
In the majority of cases, patients received radiotherapy regimens greater than or equal to 2 Gy/day (hypofractionated regimens).
V večini primerov so bolniki prejeli protokole obsevanja z 2 Gy/dan ali več (hipofrakcionirane protokole).
Based on mechanism of action, vemurafenib may cause progression of cancers associated with RAS mutations (see section 4.8).
Glede na mehanizem delovanja lahko vemurafenib povzroči napredovanje rakov, povezanih z mutacijo RAS (glejte poglavje 4.8).
In a phase III clinical trial (MO25515, N= 3219), a higher incidence of potentiation of radiation toxicity was reported when vemurafenib patients received radiation prior to and during vemurafenib therapy (9.1%) compared to those patients who received radiation and vemurafenib concomitantly (5.2 %) or to those whose radiation treatment was prior to vemurafenib (1.5%).
V kliničnem preskušanju faze III (MO25515, n = 3219) so poročali o večji incidenci povečanja toksičnosti obsevanja, ko so bolniki prejemali obsevanje pred in med zdravljenjem z vemurafenibom (9,1 %), v primerjavi s tistimi, ki so obsevanje in vemurafenib prejemali sočasno (5,2 %) ali tistimi, ki so obsevanje prejemali pred vemurafenibom (1,5 %).
The majority of patients were male (61.6%), and Caucasian (92.5%), and the median age was 54 years (range 26 to 83 years), similarly distributed between the two cohorts.
Večina bolnikov je bila moških (61,6 %) in belcev (92,5 %), mediana starost je bila 54 let (v razponu od 26 do 83 let), po starosti so bili bolniki enakomerno porazdeljeni med obe skupini.
Severe hypersensitivity reactions may include Stevens-Johnson syndrome, generalised rash, erythema or hypotension.
Hude preobčutljivostne reakcije lahko vključujejo Stevens-Johnsonov sindrom, generaliziran izpuščaj, eritem ali hipotenzijo.
It is important to keep taking Zelboraf for as long as your doctor prescribes it for you.
Pomembno je, da zdravilo Zelboraf jemljete toliko časa, kot vam je predpisal zdravnik.
Results from the phase II study (MO25743) in patients with brain metastases
Rezultati študije faze II (MO25743) pri bolnikih z zasevki v možganih
Zelboraf is not recommended for children and adolescents.
Jemanje zdravila Zelboraf ni priporočljivo pri otrocih in mladostnikih.
The safety of vemurafenib in children and adolescents has not been established.
Varnost vemurafeniba pri otrocih in mladostnikih ni bila dokazana.
In the phase II study, AUC0-8h and Cmax at day 1 were 22.1 ± 12.7 µg⋅h/mL and 4.1 ± 2.3 µg/mL.
V študiji faze II sta bili AUC0-8h in Cmax na dan 1 22,1 ± 12,7 µg⋅h/ml in 4,1 ± 2,3 µg/ml.
Serum creatinine should be measured before initiation of treatment and monitored during treatment as clinically indicated (see sections 4.2 and 4.8).
Serumski kreatinin je treba izmeriti pred začetkom zdravljenja in ga med zdravljenjem spremljati, kot je klinično indicirano (glejte poglavji 4.2 in 4.8).
Patients were randomised to treatment with vemurafenib (960 mg twice daily) or dacarbazine (1000 mg/m2 on day 1 every 3 weeks).
Bolnike so randomizirali na zdravljenje z vemurafenibom (960 mg dvakrat na dan) ali z dakarbazinom (1000 mg/m2 1. dan vsake 3 tedne).
Amongst these patients, 3 had a PR, 3 had SD, 2 had PD and one was not evaluable.
Med temi bolniki so 3 dosegli delni odziv, 3 so imeli stabilno bolezen, pri 2 je bolezen napredovala, pri enem bolniku pa ocena ni bila mogoča.
PFS - brain only Median (months)e
PFS - le v možganih mediana (meseci)e
Consistent intake of vemurafenib on an empty stomach may lead to significantly lower steady state exposure than consistent intake of vemurafenib with or a short time after a meal.
Redno jemanje vemurafeniba na prazen želodec lahko povzroči signifikantno nižjo izpostavljenost v stanju dinamičnega ravnovesja kot redno jemanje vemurafeniba z obrokom ali kmalu po njem.
There are no data regarding the use of vemurafenib in pregnant women.
Podatkov o uporabi vemurafeniba pri nosečnicah ni.
The effects of P-gp and BCRP inhibitors that are not also strong CYP3A4 inhibitors are unknown.
Vplivi zaviralcev P-gp in BCRP, ki niso tudi močni zaviralci CYP3A4, niso znani.
● If it is less than 4 hours before your next dose, skip the missed dose.
• Če je do naslednjega odmerka manj kot 4 ure, pozabljeni odmerek izpustite.
In the phase III study, ninety-four (28%) of 336 patients with unresectable or metastatic melanoma treated with vemurafenib were ≥ 65 years.
V študiji faze III je bilo 94 bolnikov (28 %) od 336 z neresektabilnim ali metastatskim melanomom, zdravljenih z vemurafenibom, starih 65 let ali več.
• To grade 4
• do stopnje 4
Therefore an effect of vemurafenib on the foetus cannot be excluded.
Tako vpliv vemurafeniba na zarodek ne more biti izključen.
Re-initiation of treatment should occur once the QTc decreases below 500 ms and at a lower dose as described in table 2.
Zdravljenje se sme znova začeti, ko se interval QTc skrajša pod 500 ms; uporabiti je treba manjši odmerek, tako kot je opisano v preglednici 2.
- Cohort 2 with previously treated patients (N = 56): Patients who had been previously treated for their brain metastases and had progressed following this treatment.
- 2. skupina: predhodno zdravljeni bolniki (n = 56) - bolniki, katerih zasevke v možganih so že zdravili in jim je bolezen po tem zdravljenju napredovala.
● Difficulty breathing
• težko dihanje,
Most cases were cutaneous in nature but some cases involving visceral organs had fatal outcomes (see sections 4.5 and 4.8).
Večina primerov je bila po naravi kožnih, a nekaj primerov, ki je vključevalo visceralne organe, je imelo smrtni izid (glejte poglavji 4.5 in 4.8).
Initiation of treatment with vemurafenib is not recommended in patients with QTc>500 milliseconds (ms).
Zdravljenja z vemurafenibom ni priporočljivo uvesti pri bolnikih, ki imajo interval QTc > 500 milisekund (ms).
The preclinical safety profile of vemurafenib was assessed in rats, dogs, and rabbits.
Predklinični varnostni profil vemurafeniba so ocenili pri podganah, psih in kuncih.
Variability in exposure may also occur due to differences in gastro-intestinal fluid content, volumes, pH, motility and transition time and bile composition.
Variabilnost v izpostavljenosti se lahko pojavi tudi zaradi razlik v vsebini gastrointestinalne tekočine, volumnu, pH, gibljivosti in času prehoda gastrointestinalnega trakta ter sestavi žolča.
Worsening of radiation treatment side effects can occur in patients who are treated with radiation before, during, or after Zelboraf treatment.
Neželeni učinki zdravljenja z obsevanjem se lahko poslabšajo pri bolnikih, zdravljenih z obsevanjem pred, med ali po zdravljenju z zdravilom Zelboraf.
Symptoms of allergic reactions may include swelling of the face, lips or tongue, difficulty breathing, rash, or fainting sensation.
Simptomi alergijske reakcije lahko vključujejo oteklost obraza, ust ali jezika, težko dihanje, kožni izpuščaj ali omedlevico.
● Types of kidney injury characterized by inflammation (acute interstitial nephritis) or damage to the tubules of the kidney (acute tubular necrosis).
• vrsti ledvičnih poškodb, za kateri je značilno vnetje (akutni intersticijski nefritis) ali poškodovani ledvični tubuli (akutna tubulna nekroza).
The geometric mean ratios between the fed and fasted states for Cmax and AUC were 2.5 and 4.6 to 5.1 fold, respectively.
Povprečno geometrično razmerje za Cmax in AUC med jemanjem na tešče in s hrano, je bilo 2,5 in 4,6 do 5,1.
The primary efficacy objective of the study was best overall response rate (BORR) in the brain of metastatic melanoma patients with previously untreated brain metastases, as assessed by an independent review committee (IRC).
Primarni cilj učinkovitosti študije je bil delež najboljšega celokupnega odziva (BORR, best overall response rate) v možganih bolnikov z metastatskim melanomom, katerih zasevkov v možganih še niso zdravili, po oceni odbora za neodvisni pregled (IRC).
Limited pharmacokinetic data from six adolescent patients aged between 15 and 17 years with stage IIIC or IV BRAF V600 mutation positive melanoma suggest that vemurafenib pharmacokinetic characteristics in adolescents are generally similar to those in adults.
Omejeni farmakokinetični podatki šestih mladostnikov, starih med 15 in 17 let, z melanomom v stadiju IIIC ali IV s pozitivno mutacijo BRAF V600 kažejo, da so farmakokinetične značilnosti vemurafeniba pri mladostnikih v splošnem podobne tistim pri odraslih.
Of the patients who experienced cuSCC, approximately 33% experienced > 1 occurrence with median time between occurrences of 6 weeks.
Med bolniki, pri katerih se je pojavil ploščatocelični karcinom kože, je bilo približno 33 % takšnih, pri katerih se je pojavil več kot enkrat; mediana časa med pojavi je bila 6 tednov.
New primary melanomas have been reported in clinical trials.
V kliničnih preskušanjih so poročali o novih primarnih melanomih.
Two patients (1.5%) developed treatment-emergent absolute QTc values >500 ms (CTC Grade 3), and only one patient (0.8%) exhibited a QTc change from baseline of >60 ms (see section 4.4).
Pri dveh bolnikih (1,5 %) so se pojavile med zdravljenjem nastale absolutne vrednosti intervala QTc > 500 ms (stopnje 3 po CTC) in le enemu bolniku (0,8 %) se je interval QTc od izhodišča spremenil za > 60 ms (glejte poglavje 4.4).
The mean QTc effect remained stable between 12-15 ms beyond the first month of treatment, with the largest mean QTc prolongation (15.1 ms; upper 95% CI: 17.7 ms) observed within the first 6 months (n=90 patients).
Povprečni učinek na interval QTc je ostal po prvem mesecu zdravljenja stabilen med 12 in 15 ms, z najdaljšim povprečnim podaljšanjem intervala QTc (15,1 ms, zgornja meja 95-% intervala zaupanja: 17,7 ms), ugotovljenim v prvih 6 mesecih (n = 90 bolnikov).
Due to the long half-life of vemurafenib, the full inhibitory effect of vemurafenib on a concomitant medicinal product might not be observed before 8 days of vemurafenib treatment.
Zaradi dolge razpolovne dobe vemurafeniba je mogoče, da popolnega zaviralnega učinka vemurafeniba na sočasno dajano zdravilo ne opazimo, dokler ne mine 8 dni zdravljenja z vemurafenibom.
In a clinical study, co-administration of a single dose 960 mg of vemurafenib with rifampicin, significantly decreased the plasma exposure of vemurafenib by approximately 40%.
V klinični študiji je sočasna uporaba enkratnega 960-mg odmerka vemurafeniba z rifampicinom značilno zmanjšala izpostavljenost vemurafenibu v plazmi za približno 40 %.
Based on the population PK analysis, age has no statistically significant effect on vemurafenib pharmacokinetics.
Populacijska farmakokinetična analiza kaže, da starost nima pomembnega vpliva na farmakokinetiko vemurafeniba.
CYP3A4 is the primary enzyme responsible for the metabolism of vemurafenib in vitro.
CYP3A4 je primarni encim, ki je odgovoren za presnavljanje vemurafeniba in vitro.
● If you forget a dose and it is more than 4 hours before your next dose, just take your dose as soon as you remember it. Take the next dose at the usual time.
• Če ste pozabili vzeti odmerek, naslednjega pa naj bi vzeli več kot čez 4 ure, preprosto vzemite odmerek takoj, ko se spomnite.
Vemurafenib might decrease the efficacy of hormonal contraceptives (see section 4.5).
Vemurafenib lahko zmanjša učinkovitost hormonskih kontraceptivov (glejte poglavje 4.5).
The population elimination half-life estimated by the population PK analysis for vemurafenib is 51.6 hours (the 5th and 95th percentile range of the individual half-life estimates is 29.8 - 119.5 hours).
Populacijski eliminacijski razpolovni čas, ocenjen s populacijsko farmakokinetično analizo za vemurafenib, je 51,6 ure (razpon od 5. do 95. percentila eliminacijskega časa, ocenjenega individualno, je od 29,8 do 119,5 ure).
● Blockage of blood flow to part of the eye (retinal vein occlusion)
• zaviranje pretoka krvi v dele očesa (zapora mrežnice vene),
Your doctor will also do some blood tests to check your liver and kidney functions before you start taking Zelboraf and during treatment.
Zdravnik bo opravil tudi določene preiskave krvi, s katerimi bo preveril delovanje jeter in ledvic pred začetkom zdravljenja in med zdravljenjem z zdravilom
Based on preclinical data and the human mass balance study, major part of vemurafenib is eliminated via the liver.
Kot kažejo predklinični podatki in raziskava masnega ravnovesja pri človeku, se večji del vemurafeniba odstrani skozi jetra.
Although transient tumour regressions were seen, the best overall response rate (BORR) was 0% (95% CI: 0%, 46%) based on confirmed responses.
Čeprav so opazili prehodna zmanjšanja tumorjev, je bil glede na potrjene odzive delež najboljšega celokupnega odziva (BORR) 0 % (95-% IZ: 0 %, 46 %).
● A type of severe skin reaction characterised by rash accompanied by fever and inflammation of internal organs such as liver and kidney
• vrsta hude kožne reakcije, za katero je značilen izpuščaj, povezan z zvišano telesno temperaturo in vnetjem notranjih organov, kot so jetra in ledvice,
• To grade 3
• do stopnje 3
Monitoring should continue for 6 months following discontinuation of vemurafenib or until initiation of another anti-neoplastic therapy.
Nadzor se mora nadaljevati še 6 mesecev po prenehanju zdravljenja z vemurafenibom ali do uvedbe drugega antineoplastičnega zdravljenja.
Other malignancies
Druge malignosti
Table 6: Kinase inhibitory activity of vemurafenib against different BRAF kinases Kinase
Preglednica 6: Inhibitorna kinazna aktivnost vemurafeniba pri različnih BRAF kinazah
● Film-coating: iron oxide red, macrogol 3350, polyvinyl alcohol, talc and titanium dioxide.
• filmska obloga: rdeči železov oksid, makrogol 3350, polivinilalkohol, smukec, titanov dioksid.
If during treatment the QTc exceeds 500 ms, vemurafenib treatment should be temporarily interrupted, electrolyte abnormalities (including magnesium) should be corrected, and cardiac risk factors for QT prolongation (e.g. congestive heart failure, bradyarrhythmias) should be controlled.
Če se interval QTc med zdravljenjem podaljša prek 500 ms, je treba zdravljenje z vemurafenibom začasno prekiniti, odpraviti nepravilnosti elektrolitov (vključno z magnezijem) in obvladati srčne dejavnike tveganja za podaljšanje intervala QT (npr. kongestivno srčno popuščanje, bradiaritmije).
Table 3: ADRs occurring in patients treated with vemurafenib in the phase II or phase III study and events originating from safety reports across all trials(1) and post-marketing sources(2).
Preglednica 3: Neželeni učinki, ki so se pojavili pri bolnikih, zdravljenih z vemurafenibom v študiji faze II in III in dogodki iz varnostnih poročil vseh preskušanj(1) in obdobja po prihodu zdravila na trg(2)
Cases of sarcoidosis have been reported in patients treated with vemurafenib, mostly involving the skin, lung and eye.
Pri bolnikih, zdravljenih z vemurafenibom, so poročali o primerih sarkoidoze, ki so večinoma vključevali kožo, pljuča in oči.
Secondary objectives included an evaluation of the efficacy of vemurafenib using BORR in the brain of previously treated patients, duration of response (DOR), progression-free survival (PFS) and overall survival (OS) in patients with melanoma metastatic to the brain (see table 10).
Sekundarni cilji so vključevali oceno učinkovitosti vemurafeniba glede na BORR v možganih predhodno zdravljenih bolnikov, trajanje odziva (DOR, duration of response), preživetje brez napredovanja bolezni (PFS) in celokupno preživetje (OS) pri bolnikih z melanomom, ki je zaseval v možgane (glejte preglednico 10).
In case of vomiting after vemurafenib administration the patient should not take an additional dose of the medicinal product but the treatment should be continued as usual.
Če bolnik po zaužitju vemurafeniba bruha, ne sme vzeti dodatnega odmerka zdravila, ampak mora z zdravljenjem normalno nadaljevati.
Number of crossover patients (%)
Število bolnikov, ki je prešlo na vemurafenib (%)
Table 10: Efficacy of vemurafenib in patients with brain metastases
Preglednica 10: Učinkovitost vemurafeniba pri bolnikih z zasevki v možganih
Concomitant administration of strong CYP3A4 inhibitors or inducers or inhibitors/inducer of transport protein activity may alter vemurafenib concentrations.
Sočasno dajanje močnih zaviralcev/induktorjev CYP3A4 ali zaviralcev/induktorjev aktivnosti prenašalnih beljakovin lahko spremeni koncentracije vemurafeniba.
Vemurafenib may increase the plasma exposure of medicinal products that are P-gp substrates.
Vemurafenib lahko poveča plazemsko izpostavljenost zdravilom, ki so substrati P-gp.
The co-primary efficacy endpoints of the study were overall survival (OS) and progression-free survival (PFS).
Primarna opazovana dogodka učinkovitosti v študiji sta bila celokupno preživetje (OS, overall survival) in preživetje brez napredovanja bolezni (PFS, progression-free survival).
Side effects are listed below by frequency:
Spodaj so glede na pogostnost navedeni neželeni učinki:
Dupuytren's contracture and plantar fascial fibromatosis Dupuytren's contracture and plantar fascial fibromatosis have been reported with vemurafenib.
Dupuytrenova kontraktura in fibromatoza plantarne fascije Pri jemanju vemurafeniba so poročali o Dupuytrenovi kontrakturi in fibromatozi plantarne fascije.
Vemurafenib has minor influence on the ability to drive and use machines.
Vemurafenib ima blag vpliv na sposobnost vožnje in upravljanja strojev.
● Cough.
• kašelj.
Any suspicious skin lesions should be excised, sent for dermatopathologic evaluation and treated as per local standard of care.
Vsako sumljivo spremembo je treba izrezati, poslati na histopatološko oceno in jo zdraviti v skladu z lokalnimi smernicami.
Vemurafenib should not be administered to pregnant women unless the possible benefit to the mother outweighs the possible risk to the foetus.
Nosečnice ne smejo prejemati vemurafeniba, razen če možne koristi za mater odtehtajo možna tveganja za plod.
Interrupt treatment until grade 0 - 1.
Prekinite zdravljenje, dokler se neželeni dogodek ne zniža na stopnjo 0 do 1.
Although metabolism does not appear to result in a relevant amount of metabolites in plasma, the importance of metabolism for excretion cannot be excluded.
Zdi se, da pri presnavljanju ne pride do pomembnih količin presnovkov v plazmi, čeprav pomembnosti presnove pri izločanju ne moremo izključiti.
● Types of skin cancers (basal cell carcinoma, new primary melanoma)
• vrste kožnega raka (bazalnocelični karcinom, novi primarni melanom),
Kidney or liver problems
Težave z ledvicami ali jetri
Although limited by the low number of patients, efficacy analyses among these patients with V600K-positive tumours suggested similar treatment benefit of vemurafenib in terms of OS, PFS and confirmed best overall response.
Kljub omejenemu številu bolnikov analize učinkovitosti med temi bolniki z V600K pozitivnimi tumorji kažejo dobrobit zdravljenja z vemurafenibom glede na celokupno preživetje, preživetje brez napredovanja bolezni in potrjen najboljši celokupni odziv.
Analysis of centralised ECG data from an open-label uncontrolled phase II QT sub-study in 132 patients dosed with vemurafenib 960 mg twice daily (NP22657) showed an exposure-dependent QTc prolongation.
Analiza centraliziranih podatkov o EKG iz podštudije intervala QT v odprti, nekontrolirani študiji faze II pri 132 bolnikih, ki so prejemali 960 mg vemurafeniba dvakrat na dan (NP22657), je pokazala od izpostavljenosti odvisno podaljšanje intervala QTc.
Older patients (≥ 65 years) may be more likely to experience adverse reactions, including cuSCC, decreased appetite, and cardiac disorders.
Pri starejših bolnikih (≥ 65 let) je možna večja verjetnost neželenih učinkov, vključno s ploščatoceličnim karcinomom kože, zmanjšanjem teka in motnjami srčnega ritma.
Vemurafenib is for oral use.
Vemurafenib je namenjen peroralni uporabi.
Women of childbearing potential / Contraception in females Women of childbearing potential have to use effective contraception during treatment and for at least 6 months after treatment.
Ženske v rodni dobi morajo med zdravljenjem in vsaj še 6 mesecev po zdravljenju uporabljati učinkovito kontracepcijsko zaščito.
● Change in liver tests results (GGT increase)
• spremembe v izvidih jetrnih testov (zvišanje GGT),
- Cohort 1 with previously untreated patients (N = 90): Patients who had not received previous treatment for brain metastases; prior systemic therapy for metastatic melanoma was allowed, excluding BRAF inhibitors and MEK inhibitors.
- 1. skupina: predhodno nezdravljeni bolniki (n = 90) - bolniki, katerih zasevkov v možganih še niso zdravili; predhodno sistemsko zdravljenje metastatskega melanoma brez zaviralcev BRAF in MEK je bilo dovoljeno.
(95% CI)d
(95-% IZ)
● Thickening of tissues underneath the palm of the hand which may cause tightening of the fingers inward; it can be disabling if severe
• zadebelitev tkiv pod dlanjo, ki lahko povzroči, da zategnjene prste vleče proti dlani; če je huda,
Maintain vemurafenib at a dose of 960 mg twice daily.
Ohranite odmerek vemurafeniba 960 mg dvakrat na dan.
Very common ≥ 1/10
Zelo pogosti: ≥ 1/10
The overall survival rate at 6 months was 77% (95% CI: 70%, 85%) and at 12 months was 58% (95% CI: 49%,
Delež 6-mesečnega preživetja je bil 77 % (95-% interval zaupanja: 70 %; 85 %), delež 12-mesečnega preživetja pa je bil 58 % (95-% interval zaupanja: 49 %; 67 %).
The efficacy and safety of vemurafenib in patients with tumours expressing rare BRAF V600 mutations other than V600E and V600K have not been convincingly established (see section 5.1).
Dokazi o učinkovitosti in varnosti vemurafeniba pri bolnikih s tumorji z izraženo redko BRAF V600 mutacijo, ki ni V600E ali V600K, niso prepričljivi (glejte poglavje 5.1).
A risk for increased exposure in patients with severe renal impairment cannot be excluded.
Pri bolnikih s hudo okvaro ledvic tveganja za povečano izpostavljenost ne moremo izključiti.
Pinkish white to orange white, oval, biconvex film-coated tablets of approximately 19 mm, with ‘VEM' engraved on one side.
Rožnatobele do oranžnobele, ovalne, bikonveksne filmsko obložene tablete, približno 19 mm v premeru, z oznako VEM, vtisnjeno na eni strani.
If you stop taking Zelboraf
Če ste prenehali jemati zdravilo Zelboraf
While taking the medicinal product, patients should be advised to wear protective clothing and use a broad spectrum Ultraviolet A (UVA)/Ultraviolet B (UVB) sunscreen and lip balm (Sun Protection Factor ≥ 30) when outdoors to help protect against sunburn.
Bolnikom je treba svetovati, naj med jemanjem zdravila za preprečitev sončnih opeklin nosijo zaščitna oblačila in uporabljajo širokospektralno ultravijolično A (UVA)/ultravijolično B (UVB) sredstvo za sončenje in mazilo za ustnice (zaščitni faktor SPF ≥ 30), kadar so na prostem.
Heart disorder
Motnje delovanja srca
● medicines for bacterial infections (e.g. azithromycin, clarithromycin)
• zdravila proti bakterijskim okužbam (npr. azitromicin, klaritromicin),
Film-coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Filmska obloga polivinilalkohol titanov dioksid (E171) makrogol 3350 smukec rdeči železov oksid (E172)
No signs of genotoxicity were identified in in vitro assays (bacterial mutation [AMES Assay], human lymphocyte chromosome aberration) nor in the in vivo rat bone marrow micronucleus test conducted with vemurafenib.
Znakov genotoksičnosti niso ugotovili ne v preizkusih in vitro (bakterijskih mutacij [preizkus AMES], kromosomskih aberacij človeških limfocitov), niti v mikrojedrnem testu kostnega mozga podgan in vivo, opravljenih z vemurafenibom.