FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effect with Cufence (which may affect up to 1 in 10 people) is nausea (feeling sick), especially when starting treatment.
Croatian: Najčešća nuspojava lijeka Cufence (koja se može javiti u manje od 1 na 10 osoba) jest mučnina (slabost), posebice u početku terapije.
English: How does Cufence work?
Croatian: Kako djeluje Cufence?
English: Cufence (trientine dihydrochloride)
Croatian: Cufence (trientindiklorid)
English: Cufence is used in patients who cannot take D-penicillamine, another medicine for this condition.
Croatian: Cufence se primjenjuje u bolesnika koji ne mogu uzimati D-penicilamin, drugi lijek za liječenje te bolesti.
English: Cufence can only be obtained with a prescription and treatment should be started by a specialist with experience in the management of Wilson's disease.
Croatian: Cufence se izdaje samo na recept, a liječenje mora započeti liječnik s iskustvom u liječenju Wilsonove bolesti.
English: What benefits of Cufence have been shown in studies?
Croatian: Koje su koristi od lijeka Cufence utvrđene u ispitivanjima?
English: Duodenitis (inflammation of the duodenum, the part of the gut leading out of the stomach) and severe colitis (inflammation in the large bowel causing pain and diarrhoea) have also been reported.
Croatian: Prijavljeni su i duodenitis (upala dvanaesnika, dijela crijeva koji izlazi iz želudca) te teški kolitis (upala debelog crijeva koja uzrokuje bol i proljev).
English: Cufence contains the active substance trientine dihydrochloride.
Croatian: Cufence sadrži djelatnu tvar trientindiklorid.
English: Although Dpenicillamine is the main treatment for this condition, trientine is effective at improving the symptoms of liver and neurological disease in patients who cannot take this medicine.
Croatian: Premda se ova bolest uglavnom liječi D-penicilaminom, trientin je djelotvoran u poboljšanju simptoma bolesti jetre i neuroloških simptoma u bolesnika koji ne mogu uzimati ovaj lijek.
English: The company that markets Cufence will conduct a study to further characterise the effectiveness of trientine in the treatment of Wilson's disease, including its effect on the associated liver, neurological or psychiatric symptoms and what the dose should be during early treatment.
Croatian: Tvrtka koja stavlja lijek Cufence u promet provest će ispitivanje u svrhu dodatnog opisivanja učinkovitosti trientina u liječenju Wilsonove bolesti, uključujući učinak lijeka na simptome bolesti jetre te neurološke i psihijatrijske simptome povezane s tom bolešću, kao i jačinu doze u početku terapije.
English: The active substance in Cufence, trientine, has been shown to improve symptoms of liver and neurological disease in patients with Wilson's disease who could no longer take D-penicillamine.
Croatian: Dokazano je da trientin, djelatna tvar lijeka Cufence, poboljšava simptome bolesti jetre i neurološke bolesti u bolesnika oboljelih od Wilsonove bolesti koji više ne mogu uzimati D-penicilamin.
English: The active substance in Cufence, trientine, is a chelating agent.
Croatian: Djelatna tvar lijeka Cufence, trientin, kelacijsko je sredstvo.
English: For the full list of side effects and restrictions of Cufence, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Cufence potražite u uputi o lijeku.
English: How is Cufence used?
Croatian: Kako se Cufence primjenjuje?
English: Improved (< grade 3)
Croatian: Poboljšan (< stupnja 3)
English: This leaflet was last revised in
Croatian: Ova uputa je zadnji puta revidirana u .
English: Date of latest renewal: 15 January 2015
Croatian: Datum posljednje obnove odobrenja: 15. siječanj 2015.
English: Difference (months)
Croatian: Razlika (mjeseci)
English: It is important to tell your doctor if you are pregnant; think you may be pregnant; or plan to get pregnant.
Croatian: Važno je reći liječniku ako ste trudni, mislite da bi mogli biti trudni, ili planirate zatrudnjeti.
English: Do not administer Vectibix if its appearance is not as described above.
Croatian: Nemojte primjenjivati Vectibix ako ne izgleda kako je gore opisano.
English: Please consult your doctor if you are unsure of your RAS tumour status.
Croatian: Molimo obratite se Vašem liječniku ukoliko niste sigurni u Vaš RAS status tumora.
English: Ulcerative keratitis1,4 Keratitis1
Croatian: Ulcerozni keratitis1,4 Keratitis1
English: Occurrence of skin symptom(s): ≥ grade 31
Croatian: Pojava kožnih simptoma: ≥ stupanj 31
English: The diluted solution must not be frozen.
Croatian: Razrijeđenu otopinu ne smije se zamrzavati.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
Croatian: Molimo obavijestite svoga liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta i biljne lijekove.
English: Wear sunscreen and a hat if you are going to be exposed to sunlight.
Croatian: Koristite kremu za sunčanje i nosite šešire ako ćete biti izloženi suncu.
English: There was no difference in overall survival (OS) seen in either group.
Croatian: Nije bilo razlike u ukupnom preživljenju (OS, engl. overall survival) između dvije skupine.
English: At the fourth occurrence
Croatian: Kod četvrte pojave
English: The elimination half-life was approximately 7.5 days (range: 3.6 to 10.9 days).
Croatian: Poluvrijeme eliminacije iznosilo je približno 7,5 dana (raspon: 3,6 do 10,9 dana).
English: Vectibix is intended for single use only.
Croatian: Vectibix je namijenjen samo za jednokratnu uporabu.
English: It is recommended to maintain this lower infusion rate in all subsequent infusions.
Croatian: Preporučuje se održavanje te male brzine infuzije u svim sljedećim primjenama.
English: If the first infusion is tolerated, then subsequent infusions may be administered over 30 to 60 minutes.
Croatian: Ukoliko se prva infuzija dobro tolerirala, sljedeće se infuzije mogu primijeniti tijekom 30 do 60 minuta.
English: 1 Greater than or equal to grade 3 is defined as severe or life-threatening Special populations
Croatian: 1 veći ili jednak stupnju 3 se definira kao težak ili opasan po život
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should be no longer than 24 hours at 2°C - 8°C.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika i normalno ne bi smjeli biti duži od 24 sata na temperaturi od 2°C - 8°C.
English: Patients were treated until disease progression or unacceptable toxicity occurred.
Croatian: Bolesnici su liječeni do trenutka napredovanja bolesti ili do neprihvatljive toksičnosti.
English: However, at doses above 2 mg/kg, the AUC of panitumumab increases in an approximately dose-proportional manner.
Croatian: Međutim, pri dozama većim od 2 mg/kg, AUC panitumumaba se povećava približno proporcionalno dozi.
English: Prolonged exposure to the sun can make the rash worse.
Croatian: Produljeno izlaganje suncu može pogoršati osip.
English: Vectibix could affect your unborn baby or ability to stay pregnant.
Croatian: Vectibix može utjecati na Vaše nerođeno dijete ili Vašu sposobnost da ostanete trudni.
English: Contact lens use is also a risk factor for keratitis and ulceration.
Croatian: Primjena kontaktnih leća također je faktor rizika za keratitis i ulceraciju.
English: An exploratory analysis showed similar results to those in the previous table.
Croatian: Eksplorativna analiza pokazala je rezultate slične ovima u prethodnoj tablici.
English: Pain in extremity
Croatian: Bol u ekstremitetima
English: No new toxicities or worsening of previously recognised toxicities beyond the expected additive effects were observed.
Croatian: Nisu zabilježene nove toksičnosti ili pogoršanja prethodno poznatih toksičnosti u mjeri većoj od očekivanih aditivnih učinaka.
English: During or following treatment you may experience an infusion reaction.
Croatian: Tijekom ili nakon liječenja možete razviti infuzijsku reakciju.
English: Dilute in a total volume of 100 mL.
Croatian: Razrijedite u ukupnom volumenu od 100 ml.
English: Based on your age (older than 65 years) or general health, your doctor will discuss with you your ability to tolerate taking Vectibix with your chemotherapy treatment.
Croatian: Ovisno o Vašoj dobi (preko 65 godina) ili općem zdravlju, liječnik će razgovarati s Vama o Vašoj sposobnosti podnošenja primjene lijeka Vectibix uz liječenje kemoterapijom.
English: 3 See section 4.4 Pulmonary complications
Croatian: 3 Vidjeti dio 4.4 Plućne komplikacije
English: Adverse reactions seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Croatian: Nuspojave zapažene u životinja pri razinama ekspozicije sličnim razinama kliničke ekspozicije i s mogućom relevantnošću za kliničku primjenu bile su sljedeće:
English: The final concentration should not exceed 10 mg/mL.
Croatian: Konačna koncentracija otopine ne smije biti veća od 10 mg/ml.
English: EGFR has been implicated in the control of prenatal development and may be essential for normal organogenesis, proliferation, and differentiation in the developing embryo.
Croatian: EGFR je bio impliciran u kontroli prenatalnog razvoja i može biti neophodan za normalnu organogenezu, proliferaciju i diferencijaciju tijekom razvoja embrija.
English: It is important to tell your doctor if you plan to breast-feed.
Croatian: Važno je reći liječniku ako planirate dojiti.
English: Stevens-Johnson syndrome4
Croatian: Stevens-Johnsonov sindrom4
English: • if you are allergic to panitumumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na panitumumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The detection of antibody formation is dependent on the sensitivity and specificity of the assay.
Croatian: Otkrivanje formiranja protutijela ovisno je o osjetljivosti i specifičnosti testa.
English: The potential for absorption and harm to the infant after ingestion is unknown.
Croatian: Nisu poznate mogućnosti apsorpcije i štetnost za dojenče nakon ingestije.
English: Other electrolyte disturbances, including hypokalaemia, have also been observed.
Croatian: Također su primijećeni ostali poremećaji elektrolita, uključujući hipokalijemiju.
English: What Vectibix is and what it is used for
Croatian: Što je Vectibix i za što se koristi
English: The recommended infusion time is approximately 60 minutes.
Croatian: Preporučeno vrijeme trajanja infuzije je oko 60 minuta.
English: The median time to first symptom of dermatologic reaction was 10 days, and the median time to resolution after the last dose of Vectibix was 31 days.
Croatian: Medijan vremena do pojave prvih simptoma dermatološke reakcije bio je 10 dana, a medijan vremena povlačenja nakon posljednje doze lijeka Vectibix iznosilo je 31 dan.
English: The product should be used immediately after dilution.
Croatian: Lijek treba primijeniti odmah nakon razrjeđenja.
English: KRAS (Kirsten rat sarcoma 2 viral oncogene homologue) and NRAS (Neuroblastoma RAS viral oncogene homologue) are highly related members of the RAS oncogene family.
Croatian: KRAS (Kirsten rat sarkoma 2 viral oncogene homologue) i NRAS (Neuroblastoma RAS viral oncogene homologue) visoko su srodni članovi skupine onkogena RAS.
English: See section 2 “Vectibix contains sodium”.
Croatian: Vidjeti dio 2 „Vectibix sadrži natrij“.
English: The treatment will usually be given over a period of approximately 60 minutes.
Croatian: Lijek će se obično primjenjivati u trajanju od približno 60 minuta.
English: Monoclonal antibodies are proteins, which specifically recognise and attach (bind) to other unique proteins in the body.
Croatian: Monoklonska protutijela su proteini koji specifično prepoznaju i vežu se na druge jedinstvene proteine u tijelu.
English: Doses up to 9 mg/kg have been tested in clinical trials.
Croatian: Doze do 9 mg/kg ispitane su u kliničkim ispitivanjima.
English: This is equivalent to 0.017% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 0,017% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: As monotherapy:
Croatian: Kao monoterapija:
English: RAS mutational status should be determined using a validated test method by an experienced laboratory (see section 4.2).
Croatian: Mutacijski status RAS mora se odrediti korištenjem validirane metode testiranja u iskusnom laboratoriju (vidjeti dio 4.2).
English: For these ADRs the maximum frequency category was estimated from the upper limit of 95% confidence interval for the point estimate based on regulatory guidelines for estimation of the frequency of adverse reactions from spontaneous reporting.
Croatian: Za ove nuspojave je kategorija najveće učestalosti procijenjena na osnovi gornje granice 95% intervala pouzdanosti za točku procjene na temelju regulatornih smjernica za procjenu učestalosti nuspojava kod spontanog prijavljivanja.
English: Overall, the safety profile of panitumumab was similar to that of cetuximab, in particular regarding skin toxicity.
Croatian: Sveukupno, profil sigurnosti panitumumaba bio je sličan onome cetuksimaba, osobito u odnosu na kožnu toksičnost.
English: The RAS/BRAF ascertainment was 85% (1,014 of 1,186 randomised patients).
Croatian: RAS/BRAF su utvrđeni u 85% (1014 od 1186 randomiziranih bolesnika).
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC08
Croatian: Farmakoterapijska skupina: antineoplastici, monoklonska protutijela, ATK oznaka: L01XC08
English: Panitumumab + FOLFIRI Wild-type RAS (n = 69)
Croatian: Panitumumab + FOLFIRI Divlji tip RAS (n = 69)
English: If patients experience treatment-related symptoms affecting their vision and/or ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Croatian: Ukoliko bolesnici dožive simptome povezane s liječenjem, koji utječu na vid i/ili sposobnost koncentracije i reagiranja, preporučuje im se da ne voze niti rade sa strojevima dok se simptomi ne povuku.
English: Magnesium repletion is recommended, as appropriate.
Croatian: Preporučuje se odgovarajuća nadoknada magnezija.
English: These can be mild or moderate (likely to occur in approximately 5 out of 100 people who take Vectibix), or severe (likely to occur in 1 out of 100 people who take Vectibix).
Croatian: Može biti blaga ili umjerena (vjerojatnost nastanka u približno 5 na 100 osoba koje primaju Vectibix) ili teška (vjerojatnost nastanka u 1 na 100 osoba koje primaju Vectibix).
English: As with all therapeutic proteins, there is potential for immunogenicity.
Croatian: Kao i kod svih terapijskih proteina, i kod panitumumaba postoji potencijal za imunogenost.
English: The primary endpoint was OS.
Croatian: Primarni ishod bio je OS.
English: Secondary endpoints included PFS and objective response rate (ORR).
Croatian: Sekundarni ishodi su uključivali PFS i stopu objektivnog odgovora (ORR).
English: The diluted solution should be mixed by gentle inversion, do not shake.
Croatian: Razrijeđenu otopinu mora se miješati nježnim okretanjem, ne tresti.
English: Angioedema1
Croatian: Angioedem1
English: Once treatment is withheld or discontinued, the skin reactions will generally resolve.
Croatian: Nakon što se liječenje privremeno ili trajno prekine, kožne se reakcije općenito povuku.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg/5 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 100 mg/5 ml
English: Skin-related reactions are likely to occur in approximately 94 out of 100 people who take Vectibix and are usually mild to moderate.
Croatian: Reakcije koje zahvaćaju kožu vjerojatno će nastati u približno 94 od 100 osoba koje uzimaju Vectibix i obično su blage do umjerene.
English: When prepared according to the instructions given in section 6.6, the final panitumumab concentration should not exceed 10 mg/mL.
Croatian: Kad je lijek pripremljen prema uputama navedenim u dijelu 6.6, konačna koncentracija panitumumaba ne smije biti viša od 10 mg/ml.
English: What Vectibix looks like and contents of the pack
Croatian: Kako Vectibix izgleda i sadržaj pakiranja
English: What Vectibix is and what it is used for What you need to know before you use Vectibix How to use Vectibix
Croatian: Što je Vectibix i za što se koristi Što morate znati prije nego počnete primjenjivati Vectibix Kako primjenjivati Vectibix
English: Vectibix will be stored in the healthcare facility where it is used.
Croatian: Vectibix će biti čuvan u zdravstvenoj ustanovi u kojoj se primjenjuje.
English: Patients should be informed of the possibility of a late onset reaction and instructed to contact their physician if symptoms of a hypersensitivity reaction occur.
Croatian: Bolesnike se mora upozoriti na mogućnost pojave kasnih reakcija i uputiti ih da se obrate svom liječniku u slučaju pojave simptoma reakcije preosjetljivosti.
English: Vectibix may have a minor influence on the ability to drive and use machines.
Croatian: Lijek Vectibix može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: There is no relevant use of Vectibix in the paediatric population in the indication treatment of colorectal cancer.
Croatian: Nema relevantne primjene lijeka Vectibix u pedijatrijskoj populaciji u indikaciji liječenja kolorektalnog karcinoma.
English: Withhold 1 or 2 doses
Croatian: Izostaviti 1 ili 2 doze
English: Vectibix is a colourless liquid that may contain visible particles and is supplied in a glass vial.
Croatian: Vectibix je bezbojna tekućina koja može sadržavati vidljive čestice, a dolazi u staklenoj bočici.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 December 2007
Croatian: Datum prvog odobrenja: 3. prosinac 2007.
English: Other medicines and Vectibix
Croatian: Drugi lijekovi i Vectibix
English: If Vectibix is used during pregnancy or if the patient becomes pregnant while receiving this medicinal product, she should be advised of the potential risk for loss of the pregnancy or potential hazard to the foetus.
Croatian: Ako se Vectibix primjenjuje tijekom trudnoće ili ako bolesnica zatrudni tijekom primjene ovoga lijeka, mora biti upoznata s mogućim rizikom od gubitka trudnoće te mogućim štetnim učincima na plod.
English: Studies to evaluate the mutagenic and carcinogenic potential of panitumumab have not been performed.
Croatian: Ispitivanja kojima bi se utvrdio mutageni i karcinogeni potencijal panitumumaba nisu provedena.
English: • Compared with patients who did not develop antibodies, no relationship between the presence of anti-panitumumab antibodies and pharmacokinetics, efficacy and safety has been observed.
Croatian: • Uspoređujući s bolesnicima koji nisu razvili protutijela nije primijećena veza između prisutnosti protutijela na panitumumab i farmakokinetike te djelotvornosti i sigurnosti lijeka.
English: The maximum frequency estimated from the upper limit of 95% confidence interval for the point estimate, i.e., 3/2,224 (or 0.13%).
Croatian: Najveća učestalost procijenjena je na osnovi gornje granice 95% intervala pouzdanosti za točku procjene, tj. 3/2224 (ili 0,13%).
English: What you need to know before you use Vectibix
Croatian: Što morate znati prije nego počnete primjenjivati Vectibix
English: Vectibix has not been tested in pregnant women.
Croatian: Vectibix nije ispitivan na trudnicama.
English: If you experience any of these symptoms, you should notify your doctor immediately.
Croatian: Ako osjetite bilo koji od ovih simptoma, morate odmah obavijestiti liječnika.
English: In some cases, it may cause infected sores requiring medical and/or surgical treatment, or cause severe skin infections that in rare cases could be fatal.
Croatian: U nekim slučajevima to može dovesti do inficiranih ranica, koje je potrebno liječiti lijekovima i/ili kirurški, ili može prouzročiti teške kožne infekcije koje u rijetkim slučajevima mogu imati smrtni ishod.
English: Doses higher than 1,000 mg should be infused over approximately 90 minutes.
Croatian: Doze iznad 1000 mg moraju biti primijenjene tijekom približno 90 minuta.
English: Some rashes have been associated with redness, itching and flaking of the skin which can become severe.
Croatian: Neki su osipi povezani s crvenilom, svrbežom i perutanjem kože, koji mogu postati teški.
English: Your doctor will also check your blood levels of magnesium and calcium periodically during your treatment, and for up to 8 weeks after you have finished your treatment.
Croatian: Vaš liječnik će obavljati pretragu razine magnezija i kalcija periodično tijekom liječenja, te do 8 tjedana po završetku liječenja.
English: Pulmonary complications
Croatian: Plućne komplikacije
English: Vectibix does not contain any antimicrobial preservative or bacteriostatic agent.
Croatian: Vectibix ne sadrži nikakve antimikrobne konzervanse ili bakteriostatska sredstva.
English: • No evidence of an altered safety profile was found in patients who tested positive for antibodies to Vectibix.
Croatian: • Nije utvrđena promjena sigurnosnog profila kod bolesnika koji su bili pozitivni na protutijela na Vectibix.
English: 427 (92%) patients were evaluable for KRAS status of which 184 had mutations.
Croatian: Od 427 (92%) bolesnika u kojih je ispitivan status KRAS gena, njih 184 imalo je mutacije.
English: The efficacy results for the study are presented in the table below.
Croatian: Rezultati djelotvornosti ispitivanja su prikazani u tablici ispod.
English: Non-serious cases of keratitis have been observed in 0.3% of clinical trial patients.
Croatian: Slučajevi keratitisa, koji nisu ocijenjeni ozbiljnima, primijećeni su u 0,3% bolesnika u kliničkim ispitivanjima.
English: There have been reports of overdose at doses up to approximately twice the recommended therapeutic dose (12 mg/kg).
Croatian: Bilo je izvješća o predoziranju u slučajevima kada su primjenjivane otprilike dvostruko veće doze od onih preporučenih (12 mg/kg).
English: Cases of interstitial lung disease (ILD), both fatal and non-fatal, have been reported, mainly from the Japanese population.
Croatian: Prijavljeni su slučajevi intersticijske plućne bolesti, sa smrtnim ili bez smrtnog ishoda, uglavnom u japanskoj populaciji.
English: Common (≥ 1/100 to < 1/10)
Croatian: Često (≥ 1/100 i < 1/10)
English: • extreme tiredness (fatigue); fever or high temperature (pyrexia); lack or loss of strength
Croatian: • iznimna iscrpljenost (umor); vrućica ili visoka temperatura (pireksija); manjak ili gubitak snage
English: This medicine contains 3.45 mg sodium (main component of cooking/table salt) in each mL unit.
Croatian: Ovaj lijek sadrži 3,45 mg natrija (glavni sastojak kuhinjske soli) u jednom ml.
English: If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered.
Croatian: Ukoliko je keratitis dijagnosticiran, moraju se pažljivo razmotriti koristi i rizici nastavka liječenja.
English: Tumour samples obtained from the primary resection of colorectal cancer were analysed for the presence of the seven most common activating mutations in the codon 12 and 13 of the KRAS gene.
Croatian: U uzorcima tumora dobivenih primarnom resekcijom kolorektalnog karcinoma ispitivano je pojavljivanje sedam najčešćih aktivirajućih mutacija unutar kodona 12 i 13 gena KRAS.
English: These events consisted predominantly of rash and dermatitis acneiform and were mostly mild to moderate in severity.
Croatian: Ovi događaji obuhvaćaju pretežno osip i akneiformni dermatitis i uglavnom su bili blagi do umjereni.
English: • headache; dizziness; anxiety.
Croatian: • glavobolja; omaglica; tjeskoba.
English: KRAS and NRAS genes encode small, GTP-binding proteins involved in signal transduction.
Croatian: Geni KRAS i NRAS kodiraju male GTP-vezujuće proteine koji su uključeni u prijenos signala kroz stanicu.