FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Croatian: Poluvrijeme eliminacije vemurafeniba u populaciji procijenjeno populacijskom farmakokinetičkom analizom iznosi 51,6 sati (raspon od 5. do 95. percentile pojedinačnih procijenjenih poluvremena je 29,8 - 119,5 sati).
English: Management of QTc prolongation may require specific monitoring measures (see section 4.4).
Croatian: U liječenju produljenja QTc-intervala može biti potrebno primijeniti specifične mjere praćenja (vidjeti dio 4.4).
English: No specific studies with vemurafenib have been conducted in animals to evaluate the effect on fertility.
Croatian: Nisu provedena posebna ispitivanja vemurafeniba na životinjama kako bi se procijenio učinak na plodnost.
English: This test has CE marking and is used to assess the BRAF mutation status of DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumour tissue.
Croatian: Ovaj test ima oznaku CE i koristi se za procjenu statusa BRAF mutacije DNK izolirane iz tumorskog tkiva fiksiranog u formalinu i uklopljenog u parafin (engl. formalin-fixed,
English: ● Palmar plantar syndrome (i.e. redness, skin peeling or blisters on hands and feet)
Croatian: • palmarno-plantarni sindrom (tj. crvenilo, ljuštenje kože ili mjehurići na šakama i stopalima)
English: ● If you experience side effects, your doctor may decide to carry on your treatment but lower your dose.
Croatian: • Ako se pojave nuspojave, liječnik može odlučiti da nastavite s liječenjem, ali uz nižu dozu.
English: Of the specimens available from the non-clinical and clinical studies (n=920), that were mutation-positive by the cobas test and additionally analyzed by sequencing, no specimen was identified as being wild type by both Sanger and 454 sequencing.
Croatian: Niti za jedan od dostupnih uzoraka iz nekliničkih i kliničkih ispitivanja (n=920), za koje je cobas testom utvrđeno da su pozitivni na mutaciju i koji su dodatno analizirani sekvencioniranjem, nije utvrđeno da je divljeg tipa ni Sangerovom metodom ni "454" sekvencioniranjem.
English: Patients were randomised to treatment with vemurafenib (960 mg twice daily) or dacarbazine (1000 mg/m2 on day 1 every 3 weeks).
Croatian: Bolesnici su randomizirani na liječenje vemurafenibom (960 mg dvaput na dan) ili dakarbazinom (1000 mg/m2 prvog dana svaka 3 tjedna).
English: These lesions are usually removed by surgery and patients continue their treatment.
Croatian: Oni se obično kirurški odstrane i bolesnici nastavljaju s liječenjem.
English: • To grade 3
Croatian: • do 3. stupnja
English: Table 1: Dose modification schedule based on the grade of any Adverse Events (AEs)
Croatian: Tablica 1: Raspored prilagodbe doze na temelju stupnja bilo koje nuspojave Stupanj (CTC-AE)
English: ● Inflammation of the eye (uveitis)
Croatian: • upala oka (uveitis)
English: Within each frequency grouping, ADRs are presented in order of decreasing severity and were reported using NCI-CTCAE v 4.0 (common toxicity criteria) for assessment of toxicity.
Croatian: Unutar svake kategorije učestalosti nuspojave su navedene od težih prema lakšima i bile su prijavljene koristeći NCI-CTCAE verziju 4.0 (eng. common toxicity criteria) za procjenu toksičnosti.
English: - 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.
Croatian: - Prvu kohortu činili su prethodno neliječeni bolesnici (N = 90): bolesnici koji prethodno nisu primili liječenje za moždane metastaze; bila je dopuštena prethodna sistemska terapija za metastatski melanom uz izuzetak BRAF inhibitora i MEK inhibitora.
English: Patients with mild hepatic impairment due to liver metastases without hyperbilirubinaemia may be monitored according to the general recommendations.
Croatian: Bolesnici s blagim oštećenjem jetrene funkcije uslijed jetrenih metastaza, a bez hiperbilirubinemije, mogu se kontrolirati sukladno općim preporukama.
English: ● Decreased white blood cells (neutropenia).
Croatian: • smanjen broj bijelih krvnih stanica (neutropenija)
English: Aluminium/Aluminium perforated unit dose blisters.
Croatian: Aluminij/aluminij perforirani blisteri djeljivi na jedinične doze.
English: Older patients (≥ 65 years) may be more likely to experience adverse reactions, including cuSCC, decreased appetite, and cardiac disorders.
Croatian: Stariji bolesnici (≥ 65 godina) mogu imati veću vjerojatnost za razvoj nuspojava, uključujući planocelularni karcinom kože, smanjeni apetit i srčane poremećaje.
English: Most cases were cutaneous in nature but some cases involving visceral organs had fatal outcomes (see sections 4.5 and 4.8).
Croatian: Većina slučajeva zahvaćala je kožu, ali pojedini slučajevi koji su uključivali visceralne organe imali su smrtni ishod (vidjeti dijelove 4.5 i 4.8).
English: In addition ADRs originating from safety reports across all clinical trials and post-marketing sources are reported.
Croatian: Uz to, navode se nuspojave koje potječu iz izvješća o sigurnosti primjene iz svih kliničkih ispitivanja i izvora nakon stavljanja lijeka u promet.
English: In the majority of cases, patients received radiotherapy regimens greater than or equal to 2 Gy/day (hypofractionated regimens).
Croatian: U većini su slučajeva bolesnici primali radioterapijske protokole od 2 Gy ili više na dan (hipofrakcionirani protokoli).
English: There were no increases to Grade 4 ALT, alkaline phosphatase or bilirubin.
Croatian: Nije bilo povećanja odstupanja na stupanj 4 za vrijednosti ALT-a, alkalne fosfataze ili bilirubina.
English: ● Usually, this lesion appears on sun-damaged skin, remains local and can be cured by surgical removal.
Croatian: • To se oštećenje obično javlja na koži oštećenoj suncem, ne širi se i može se izliječiti kirurškim odstranjivanjem.
English: ● Shortness of breath, which may be accompanied by a cough, fever or chills (pneumonitis)
Croatian: ● nedostatak zraka koji može biti praćen kašljem, vrućicom ili zimicom (pneumonitis)
English: 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).
Croatian: U dva su se bolesnika (1,5%) razvile liječenjem uzrokovane apsolutne vrijednosti QTc-intervala > 500 ms (CTC Stupanj 3), a samo je jedan bolesnik (0,8%) imao promjenu QTc-intervala za > 60 ms u odnosu na početne vrijednosti (vidjeti dio 4.4).
English: Vemurafenib moderately inhibited CYP2C8 in vitro.
Croatian: Vemurafenib je umjereno inhibirao CYP2C8 in vitro.
English: ● Blockage of blood flow to part of the eye (retinal vein occlusion)
Croatian: • blokada dotoka krvi u dio oka (okluzija vene mrežnice)
English: Results from the phase II study (NP22657) in patients who failed at least one prior therapy
Croatian: Rezultati ispitivanja faze II (NP22657) u bolesnika koji nisu uspješno odgovorili na najmanje jednu liniju liječenja
English: - Cohort 2 with previously treated patients (N = 56): Patients who had been previously treated for their brain metastases and had progressed following this treatment.
Croatian: - Drugu kohortu činili su prethodno liječeni bolesnici (N = 56): bolesnici koji su prethodno primili liječenje za moždane metastaze i kojima je bolest uznapredovala nakon tog liječenja.
English: Based on preclinical data and the human mass balance study, major part of vemurafenib is eliminated via the liver.
Croatian: Na temelju podataka iz pretkliničkih ispitivanja i ispitivanja masene bilance u ljudi, najveći dio vemurafeniba eliminira se putem jetre.
English: The safety of vemurafenib in children and adolescents has not been established.
Croatian: Sigurnost vemurafeniba u djece i adolescenata nije ustanovljena.
English: ● Thickening of tissues underneath the palm of the hand which may cause tightening of the fingers inward; it can be disabling if severe
Croatian: • zadebljanje tkiva ispod dlana koje može uzrokovati zatezanje prstiju prema unutra; u teškim slučajevima može dovesti do onesposobljenosti
English: CuSCC usually occurred early in the course of treatment with a median time to the first appearance of 7 to 8 weeks.
Croatian: Planocelularni karcinom kože obično se javljao u ranoj fazi liječenja, s medijanom vremena do prve pojave od 7 do 8 tjedana.
English: For photosensitivity grade 2 (intolerable) or greater, dose modifications are recommended (see section
Croatian: Kod fotosenzitivnosti stupnja 2 (nepodnošljivo) ili višeg, preporučuje se prilagodba doze (vidjeti dio 4.2).
English: Alternative treatment with less inducing potential should be considered to maintain the efficacy of vemurafenib.
Croatian: Potrebno je razmotriti primjenu drugih lijekova s manjim indukcijskim potencijalom kako bi se održala djelotvornost vemurafeniba.
English: Results from the phase II study (MO25743) in patients with brain metastases
Croatian: Rezultati ispitivanja faze II (MO25743) u bolesnika s moždanim metastazama
English: ● Inflammation of hair's roots
Croatian: • upala korijena dlake
English: It is recommended that all patients receive a dermatologic evaluation prior to initiation of therapy and be monitored routinely while on therapy.
Croatian: U svih se bolesnika preporučuje dermatološka procjena prije započinjanja liječenja te rutinski nadzor tijekom terapije.
English: Liver enzymes (transaminases and alkaline phosphatase) and bilirubin should be measured before initiation of treatment and monitored monthly during treatment, or as clinically indicated.
Croatian: Vrijednosti jetrenih enzima (transaminaza i alkalne fosfataze) i bilirubina potrebno je odrediti prije započinjanja liječenja i kontrolirati jednom mjesečno tijekom liječenja, ili prema kliničkoj indikaciji.
English: Management of adverse drug reactions or QTc prolongation may require dose reduction, temporary interruption and/or treatment discontinuation (see tables 1 and 2).
Croatian: Liječenje nuspojava ili produljenja QTc-intervala može zahtijevati smanjenje doze, privremeni prekid i/ili trajnu obustavu liječenja (vidjeti tablice 1 i 2).
English: ● Weight loss
Croatian: • gubitak tjelesne težine
English: 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.
Croatian: Konstantno uzimanje vemurafeniba natašte moglo bi dovesti do značajno manje izloženosti u stanju dinamičke ravnoteže nego kada se lijek konstantno uzima uz obrok ili ubrzo nakon obroka.
English: In addition, patients should undergo a chest Computerised Tomography (CT) scan, prior to treatment and every 6 months during treatment.
Croatian: Osim toga, bolesnicima je potrebno napraviti kompjuteriziranu tomografiju (CT) prsnog koša prije te svakih 6 mjeseci tijekom liječenja.
English: 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.
Croatian: Ako tijekom liječenja QTc-interval premaši 500 ms, treba privremeno prekinuti liječenje vemurafenibom, korigirati poremećaje elektrolita (uključujući magnezij) te kontrolirati srčane čimbenike rizika za produljenje QT-intervala (npr. kongestivno zatajenje srca, bradiaritmije).
English: Vemurafenib may increase the plasma exposure of medicinal products that are P-gp substrates.
Croatian: Vemurafenib može povisiti plazmatsku izloženost lijekovima koji su supstrati P-gp-a.
English: Mutations in the BRAF gene result in constitutive activation of BRAF proteins, which can cause cell proliferation without associated growth factors.
Croatian: Mutacije u genu BRAF rezultiraju konstitutivnom aktivacijom BRAF proteina, što može uzrokovati proliferaciju stanica i kada nisu prisutni čimbenici rasta.
English: Grade 1 or Grade 2 (tolerable)
Croatian: Stupanj 2 (nepodnošljivo) ili
English: The co-primary efficacy endpoints of the study were overall survival (OS) and progression-free survival (PFS).
Croatian: Dvije primarne mjere ishoda djelotvornosti u ispitivanju bile su ukupno preživljenje (overall survival, OS) i preživljenje bez progresije bolesti (progression-free survival, PFS).
English: ● Types of kidney injury characterized by inflammation (acute interstitial nephritis) or damage to the tubules of the kidney (acute tubular necrosis).
Croatian: • vrste oštećenja tkiva bubrega koje karakterizira upala (akutni intersticijski nefritis) ili oštećenje bubrežnih tubula (akutna tubularna nekroza).
English: Electrocardiogram (ECG) and electrolytes (including magnesium) must be monitored in all patients before treatment with vemurafenib, after one month of treatment and after dose modification.
Croatian: U svih se bolesnika mora kontrolirati elektrokardiogram (EKG) i elektrolite (uključujući magnezij) prije započinjanja liječenja vemurafenibom, nakon mjesec dana liječenja kao i nakon promjene doze.
English: Symptoms of allergic reactions may include swelling of the face, lips or tongue, difficulty breathing, rash, or fainting sensation.
Croatian: Simptomi alergijske reakcije mogu obuhvaćati oticanje lica, usana ili jezika, otežano disanje, osip ili osjećaj da ćete se onesvijestiti.
English: ● Skin problems including warts
Croatian: • kožni problemi uključujući bradavice
English: The effects of P-gp and BCRP inhibitors that are not also strong CYP3A4 inhibitors are unknown.
Croatian: Učinci inhibitora P-gp-a i BCRP-a koji istovremeno nisu i snažni inhibitori CYP3A4 nisu poznati.
English: Based on mechanism of action, vemurafenib may cause progression of cancers associated with RAS mutations (see section 4.8).
Croatian: S obzirom na mehanizam djelovanja, vemurafenib može uzrokovati progresiju karcinoma povezanih s mutacijama RAS gena (vidjeti dio 4.8).
English: Table 4: Creatinine changes from baseline in the phase III study
Croatian: Tablica 4: Promjene razine kreatinina od početne vrijednosti u ispitivanju faze III
English: Acute kidney injury (h)
Croatian: Akutno oštećenje tkiva bubrega (h)
English: Mechanism of action and pharmacodynamic effects Vemurafenib is an inhibitor of BRAF serine-threonine kinase.
Croatian: Mehanizam djelovanja i farmakodinamički učinci Vemurafenib je inhibitor BRAF serin-treonin kinaze.
English: During clinical trials with vemurafenib, grade 3 adverse reactions reported more frequently in females than males were rash, arthralgia and photosensitivity.
Croatian: U kliničkim ispitivanjima vemurafeniba, nuspojave stupnja 3 prijavljene češće u žena nego u muškaraca bile su osip, artralgija i fotosenzitivnost.
English: Table 10: Efficacy of vemurafenib in patients with brain metastases
Croatian: Tablica 10: Djelotvornost vemurafeniba u bolesnika s moždanim metastazama
English: ● Change in liver tests results (ALT, alkaline phosphatase and bilirubin increase)
Croatian: • promjene rezultata testova jetrene funkcije (povišeni ALT, alkalna fosfataza i bilirubin)
English: This may affect the activity of Zelboraf.
Croatian: One mogu utjecati na djelovanje lijeka Zelboraf.
English: Anal examinations and pelvic examinations (for women) are recommended before and at the end of treatment or when considered clinically indicated.
Croatian: Preporučuje se izvršiti pregled anusa i zdjelice (u žena) prije i po završetku liječenja ili kada se smatra da je klinički indicirano.
English: ADRs which were reported in melanoma patients are listed below by MedDRA body system organ class, frequency and grade of severity.
Croatian: Nuspojave prijavljene u bolesnika s melanomom navedene su ispod prema MedDRA klasifikaciji organskih sustava, učestalosti i stupnju težine.
English: However, in repeat-dose toxicity studies in rats and dogs, no histopathological findings were noted in reproductive organs in males and females (see section 5.3).
Croatian: Međutim, u ispitivanjima toksičnosti ponovljenih doza na štakorima i psima nisu opažene histopatološke promjene u reproduktivnim organima mužjaka i ženki (vidjeti dio 5.3).
English: If co-administration cannot be avoided, it needs to be considered that vemurafenib may decrease plasma concentrations of CYP3A4 substrates and thereby their efficacy may be impaired.
Croatian: Ako se istodobna primjena ne može izbjeći, treba uzeti u obzir da vemurafenib može smanjiti plazmatske koncentracije supstrata CYP3A4 i tako narušiti njihovu djelotvornost.
English: 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%.
Croatian: U kliničkom je ispitivanju istodobna primjena jedne doze vemurafeniba od 960 mg s rifampicinom značajno smanjila izloženost vemurafeniba u plazmi, za približno 40%.
English: This is a precautionary measure in case a squamous cell carcinoma lesion would develop inside your body.
Croatian: To su mjere opreza u slučaju da se planocelularni karcinom razvije na unutarnjim organima.
English: ● Changes in the way things taste
Croatian: • promjene osjeta okusa
English: 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.
Croatian: Ako bolesnik povrati nakon primjene vemurafeniba, ne smije uzeti dodatnu dozu lijeka, već liječenje treba nastaviti prema uobičajenom rasporedu.
English: Taking too much Zelboraf may increase the likelihood and severity of side effects.
Croatian: Uzimanje prevelike količine lijeka Zelboraf može povećati vjerojatnost nuspojava i njihovu težinu.
English: 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.
Croatian: Bolesnicima je potrebno savjetovati da, dok uzimaju ovaj lijek, nose zaštitnu odjeću i koriste sredstvo za sunčanje i balzam za usne sa zaštitom protiv širokog spektra ultraljubičastih A i ultraljubičastih B (UVA/UVB) zraka (sa zaštitnim faktorom ≥ 30) pri boravku na otvorenom kako bi se zaštitili od sunčanih opeklina.
English: ● Types of skin cancers (basal cell carcinoma, new primary melanoma)
Croatian: • vrste raka kože (karcinom bazalnih stanica, novi primarni melanom)
English: ● Hair loss
Croatian: • opadanje kose
English: In cellular anti-proliferation assays the inhibitory concentration 50 (IC50) against V600 mutated cell lines (V600E, V600R, V600D and V600K mutated cell lines) ranged from 0.016 to 1.131 µM whereas the IC50 against BRAF wild type cell lines were 12.06 and 14.32 µM, respectively.
Croatian: U testovima stanične antiproliferacije, inhibitorna koncentracija koja postiže 50%-tni učinak (IC50) na staničnim linijama s mutacijom V600 (mutirane stanične linije V600E, V600R, V600D i V600K) kretala se u rasponu od 0,016 do 1,131 µM, dok je IC50 na staničnim linijama s divljim tipom gena BRAF iznosio 12,06 odnosno 14,32 µM.
English: The preclinical safety profile of vemurafenib was assessed in rats, dogs, and rabbits.
Croatian: Neklinički profil sigurnosti vemurafeniba ispitan je u štakora, pasa i kunića.
English: Based on its mechanism of action, vemurafenib could cause fetal harm when administered to a pregnant woman.
Croatian: S obzirom na mehanizam djelovanja, vemurafenib bi mogao naškoditi plodu kada se primjenjuje u trudnica.
English: 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.
Croatian: Ograničeni farmakokinetički podaci prikupljeni u šest adolescentnih bolesnika u dobi između 15 i 17 godina s melanomom stadija IIIC ili IV pozitivnim na BRAF mutaciju V600 ukazuju na to da su farmakokinetičke značajke vemurafeniba u adolescenata u načelu slične onima u odraslih.
English: Severe hypersensitivity reactions may include Stevens-Johnson syndrome, generalised rash, erythema or hypotension.
Croatian: Teške reakcije preosjetljivosti mogu uključivati Stevens-Johnsonov sindrom, generalizirani osip, eritem te hipotenziju.
English: ● Changes in electrical activity of the heart (QT prolongation)
Croatian: • promjene električne aktivnosti srca (produljenje QT-intervala)
English: Non-clinical and clinical studies with retrospective sequencing analyses have shown that the test also detects the less common BRAF V600D mutations and V600K mutations with lower sensitivity.
Croatian: Neklinička i klinička ispitivanja s retrospektivnim sekvencijskim analizama pokazala su da ovaj test s manjom osjetljivošću otkriva i manje česte BRAF mutacije V600D i V600K.
English: 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.
Croatian: Analiza centraliziranih EKG podataka iz otvorenog nekontroliranog podispitivanja faze II u kojem se ispitivao QT-interval u 132 bolesnika liječena vemurafenibom u dozi od 960 mg dvaput na dan (NP22657) pokazala je da dolazi do produljenja QTc-intervala proporcionalnog izloženosti lijeku.
English: 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.
Croatian: Većina je bolesnika bila muškog spola (61,6%) i bijele rase (92,5%), a medijan dobi iznosio je 54 godine (raspon: 26 do 83 godine); bolesnici su bili ravnomjerno raspodijeljeni između dvije kohorte.
English: In a clinical trial, co-administration of vemurafenib decreased the AUC of midazolam (CYP3A4 substrate) by an average 39% (maximum decrease up to 80%).
Croatian: U kliničkom je ispitivanju istodobna primjena vemurafeniba smanjila AUC midazolama (supstrata CYP3A4) za prosječno 39% (maksimalno smanjenje do 80%).
English: Serum creatinine elevations were mostly mild (>1-1.5x ULN) to moderate (>1.5-3x ULN) and observed to be reversible in nature (see table 4).
Croatian: Povišenja vrijednosti kreatinina u serumu uglavnom su bila blage (> 1 - 1,5 x GGN) do umjerene (> 1,5 - 3 x GGN) težine i reverzibilne prirode (vidjeti Tablicu 4).
English: The majority of the excised lesions reviewed by an independent central dermatopathology laboratory were classified as SCCkeratoacanthoma subtype or with mixed-keratoacanthoma features (52%).
Croatian: Većina kirurški odstranjenih lezija ispitanih u neovisnom središnjem dermatopatološkom laboratoriju klasificirana je kao planocelularni karcinom - podtip keratoakantom ili s miješanim osobinama keratoakantoma (52%).
English: With a median follow-up of 12.9 months (range, 0.6 to 20.1), the primary endpoint of confirmed best overall response rate (CR + PR) as assessed by an independent review committee (IRC) was 53% (95% CI: 44%, 62%).
Croatian: Uz medijan praćenja od 12,9 mjeseci (raspon od 0,6 do 20,1), primarna mjera ishoda - potvrđena najbolja stopa ukupnog odgovora na liječenje (potpun odgovor + djelomičan odgovor), prema procjeni neovisnog odbora za praćenje, iznosila je 53% (95% CI: 44%, 62%).
English: There is no information about the safety of Zelboraf in pregnant women.
Croatian: Nema podataka o sigurnosti primjene lijeka Zelboraf u trudnica.
English: In majority of the cases, vemurafenib was maintained and the event of sarcoidosis either resolved or persisted.
Croatian: U većini se slučajeva liječenje vemurafenibom nastavilo, a sarkoidoza se ili povukla ili je perzistirala.
English: Film-coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Croatian: Film ovojnica poli(vinilni alkohol) titanijev dioksid (E171) makrogol 3350 talk željezov oksid, crveni (E172)
English: Monitor patients routinely for ophthalmologic reactions.
Croatian: Bolesnika je potrebno rutinski nadzirati kako bi se uočile oftalmološke reakcije.