FrancophonIA/ELRC3.0 huggingface dataset:
English: The main active substance in Teysuno, tegafur, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the ‘anti-metabolites' group.
Croatian: Glavna djelatna tvar lijeka Teysuno, tegafur, je citotoksičan lijek (lijek koji ubija stanice koje se dijele, poput stanica raka) koji se ubraja u grupu „antimetabolita“.
English: The company presented data from two studies involving a total of 43 patients with advanced gastric cancer or other tumours, in which Teysuno was used in combination with oxaliplatin and other cancer medicines.
Croatian: Tvrtka je dostavila podatke iz dva ispitivanja koja su obuhvatila ukupno 43 bolesnika s uznapredovanim gastričnim rakom ili drugim tumorima, u kojih se Teysuno koristio u kombinaciji s oksaliplatinom i drugim lijekovima protiv raka.
English: The company informed the CHMP that there are no consequences for patients in clinical trials or compassionate use programmes.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja ili programe milosrdnog davanja lijekova.
English: Teysuno is a cancer medicine that is used to treat adults with advanced gastric (stomach) cancer.
Croatian: Teysuno je lijek za liječenje raka koji se koristi u odraslih osoba s uznapredovanim gastričnim rakom (rakom želuca).
English: In particular very limited data were provided on the combination of Teysuno with oxaliplatin and no data were provided on the use with carboplatin.
Croatian: Dostavljeni su vrlo ograničeni podaci posebice za kombinaciju lijeka Teysuno s oksaliplatinom te nisu dostavljeni podaci za uporabu s carboplatinom.
English: What is happening with Teysuno for the treatment of patients with advanced gastric cancer in combination with cisplatin?
Croatian: Što se događa s lijekom Teysuno kada je riječ o liječenju bolesnika s uznapredovanim gastričnim rakom u kombinaciji sa cisplatinom?
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it withdrew the application because, in its preliminary assessment report, the CHMP considered that the data provided were insufficient to conclude that the benefits outweigh the risks when Teysuno is used in combination with other platinum-based cancer medicines.
Croatian: U dopisu tvrtke kojim se obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela kako je povukla zahtjev zato što je u svojem preliminarnom izvještaju o ocijeni, CHMP zaključio da dostavljeni podaci nisu dostatni kako bi se zaključilo da koristi nadmašuju rizike u slučajevima kada se Teysuno koristi u kombinaciji s drugim lijekovima protiv raka temeljenima na platini.
English: Data from published studies on the use of Teysuno in combination with platinum-based medicines were also provided.
Croatian: Dostavljeni su također podaci iz objavljenih ispitivanja o primjeni lijeka Teysuno u kombinaciji s lijekovima temeljenima na platini.
English: Teysuno was also expected to be used in combination with platinum-based cancer medicines other than cisplatin, such as oxaliplatin.
Croatian: Teysuno se trebao koristiti u kombinaciji s lijekovima protiv raka temeljenima na platini, a koji nisu cisplatin, poput primjerice oksaliplatina.
English: The change concerned extending the use of Teysuno to treat advanced gastric cancer in combination with platinum-based cancer medicines other than cisplatin.
Croatian: Promjena se odnosila na proširenje primjene lijeka Teysuno na liječenje uznapredovanog gastričnog raka u kombinaciji s lijekovima protiv raka temeljenima na platini, a koji nisu cisplatin.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Teysuno could not have been approved for the treatment of advanced gastric cancer in combination with platinumbased medicines other than cisplatin.
Croatian: Na temelju pregleda podataka te odgovora tvrtke na popis pitanja CHMP-a, u trenutku povlačenja, CHMP je smatrao da postoje problemi te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za Teysuno za liječenje uznapredovanog gastričnog raka u kombinaciji s lijekovima temeljenima na platini, a koji nisu cisplatin.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the data provided were too scarce to allow adequate evaluation of the benefits and risks of Teysuno in combination with platinumbased medicines other than cisplatin in patients with advanced gastric cancer.
Croatian: Stoga, u trenutku povlačenja, CHMP je smatrao da su dostavljeni podaci nedovoljno čvrsti kako bi omogućili primjerenu ocjenu koristi i rizika lijeka Teysuno u kombinaciji s lijekovima temeljenim na platini, a koji nisu cisplatin u bolesnika s uznapredovanim gastričnim rakom.
English: The data provided were too limited to allow a benefit-risk evaluation of Teysuno in combination with other platinum-based medicines in patients with advanced gastric cancer.
Croatian: Dostavljeni podaci su bili previše ograničeni da bi omogućili ocjenu omjera koristi i rizika lijeka Teysuno u kombinaciji s drugim lijekovima koji se temelje na platini u bolesnika s uznapredovanim gastričnim rakom.
English: Send a question via our website www.ema.europa.eu/contact the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Croatian: U tijelu, 5-FU uzima mjesto pirimidina i interferira s enzimima uključenima u proizvodnju novog DNK.
English: Long term effects are not yet known.
Croatian: Dugoročni učinci nisu još poznati.
English: This difference was not statistically significant.
Croatian: Razlika nije bila statistički značajna.
English: Long term safety
Croatian: Dugoročna sigurnost
English: What Kepivance is and what it is used for
Croatian: Što je Kepivance i za što se koristi
English: Do not freeze
Croatian: Ne zamrzavati.
English: Generally, dissolution of Kepivance takes less than 5 minutes.
Croatian: U pravilu, otapanje lijeka Kepivance traje manje od 5 minuta.
English: Date of latest renewal: 23 September 2010
Croatian: Datum posljednje obnove odobrenja: 23. rujna 2010.
English: Kepivance is not recommended in children (0 to 18 years).
Croatian: Kepivance se ne preporučuje za djecu (0 do 18 godina).
English: 5550 Airport Boulevard Boulder, Colorado 80301 United States of America
Croatian: 5550 Airport Boulevard Boulder, Colorado 80301
English: The potential risk to the human embryo or foetus is unknown.
Croatian: Potencijalni rizici za ljudski embrij ili fetus nisu poznati.
English: It is important to tell your doctor if you: - are pregnant; - think you may be pregnant; or - plan to have a baby.
Croatian: - ste trudni - mislite da biste mogli biti trudni ili - planirate imati dijete.
English: What you need to know before you use Kepivance
Croatian: Što morate znati prije nego počnete primati Kepivance
English: Please inform your doctor if you are receiving or have recently received heparin.
Croatian: Obavijestite svog liječnika ako primate ili ste nedavno primali heparin.
English: Systemic exposure did not appear to increase with the dose.
Croatian: Sustavno izlaganje nije se povećalo s dozom.
English: The safety and efficacy of Kepivance in children aged 0 to 18 years have not been established.
Croatian: Sigurnost i djelotvornost Kepivancea u djece u dobi od 0 do 18 godina nije ustanovljena.
English: Palifermin (60 micrograms/kg/day) n = 106
Croatian: Palifermin (60 mikrograma/kg/dan) n = 106
English: Kepivance should only be used in adults over the age of 18 years.
Croatian: Kepivance smiju uzimati samo odrasle osobe starije od 18 godina.
English: For information on preparation and administration of Kepivance, please see information for healthcare professionals at the end of this leaflet.
Croatian: Za informacije o pripremi i primjeni Kepivancea pročitajte informacije za zdravstvene djelatnike na kraju ove upute.
English: If you are pregnant you should not use Kepivance unless clearly necessary.
Croatian: Ako ste trudni, ne smijete primati Kepivance, osim ako je to neophodno.
English: Once reconstituted, store in a refrigerator and use within 24 hours.
Croatian: Nakon pripreme za primjenu, čuvati u hladnjaku i primijeniti unutar 24 sata.
English: These events were consistent with those observed at the recommended dose but were generally more severe.
Croatian: Te nuspojave odgovaraju onima primijećenim pri preporučenoj dozi, ali su općenito bile ozbiljnije.
English: Studies in animals have shown reproductive and developmental toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu i razvojnu toksičnost (vidjeti dio 5.3).
English: These reactions were primarily mild to moderate in severity and were reversible.
Croatian: Te reakcije bile su uglavnom blage do umjerene i reverzibilne.
English: Adverse reactions from clinical trials and spontaneous reporting
Croatian: Nuspojave iz kliničkih ispitivanja i spontanog prijavljivanja
English: • increase in lipase and amylase levels (digestive enzymes) in the blood (which do not require treatment and usually return to normal after stopping treatment with Kepivance).
Croatian: • povišene razine lipaze i amilaze (probavnih enzima) u krvi (koje ne zahtijevaju liječenje i obično se vrate na normalnu razinu po završetku liječenja Kepivanceom).
English: Based on these limited data no recommendation on dose adjustment can be
Croatian: Na temelju ovih ograničenih podataka nije moguće dati preporuku za prilagodbu doze.
English: Peri- and postnatal development has not been studied.
Croatian: Nisu provedena ispitivanja peri- i postnatalnog razvoja.
English: Kepivance will be given to you by a doctor or nurse with experience in cancer treatment.
Croatian: Kepivance će Vam dati liječnik ili medicinska sestra s iskustvom u liječenju raka.
English: Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment, ATC code: V03A F08.
Croatian: Farmakoterapijska skupina: Detoksikacijsko sredstvo pri liječenju antineoplastičnim lijekovima, ATK oznaka: V03A F08.
English: Safety and efficacy has not been evaluated in older people.
Croatian: Starije osobe Sigurnost i djelotvornost u starijih osoba nije procijenjena.
English: In this study, 212 patients were randomised and received either palifermin or placebo.
Croatian: U ovom ispitivanju 212 bolesnika je randomizirano i primilo ili palifermin, ili placebo.
English: Although palifermin was safe at all doses tested the incidence of skin reactions increased with the dose.
Croatian: Iako je palifermin bio siguran pri svim ispitivanim dozama, incidencija kožnih reakcija povećavala se s dozom.
English: Other medicines and Kepivance
Croatian: Drugi lijekovi i Kepivance
English: As a protein therapeutic, the risk for Kepivance to interact with other medicinal products is low.
Croatian: Budući da se radi o terapijskom proteinu, rizik od interakcije Kepivancea s drugim lijekovima je nizak.
English: After reconstitution: 24 hours at 2 °C - 8 °C, protected from light.
Croatian: Nakon pripreme za primjenu: 24 sata na temperaturi 2°C-8°C, zaštićen od svjetlosti.
English: Kepivance might interact with a medicine called heparin.
Croatian: Može doći do interakcije lijeka Kepivance s lijekom koji se zove heparin.
English: Anaphylactic reaction/Hypersensitivity
Croatian: Anafilaktička reakcija/preosjetljivost
English: Each pack contains 6 vials.
Croatian: Svako pakiranje sadrži 6 bočica.
English: There are no adequate data from the use of Kepivance in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni Kepivancea u trudnica.
English: Blood amylase increased and Lipase Increased1
Croatian: Povišena amilaza u krvi i povišena lipaza1
English: Palifermin is a 140 amino acid protein with a molecular weight of 16.3 kilodaltons.
Croatian: Palifermin je protein koji se sastoji od 140 aminokiselina i ima molekularnu težinu od 16,3 kilodaltona.
English: However, the administration of palifermin did not affect heparin´s anticoagulant effect in the experimental conditions (single dose, subtherapeutic dose regimen).
Croatian: Međutim, primjena palifermina nije utjecala na antikoagulacijski učinak heparina u eksperimentalnim uvjetima (jednokratna doza, primjena supterapijske doze).
English: Very common: Common:
Croatian: Vrlo često:
English: Neither of the two dosing regimens demonstrated statistically significant results versus placebo.
Croatian: U niti jednom od dva protokola doziranja nisu utvrđeni statistički značajni rezultati u usporedbi s placebom.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Palifermin should not be used in association with myeloablative chemotherapy-only conditioning.
Croatian: Palifermin se ne smije upotrebljavati pri kondicioniranju samo mijeloablativnom kemoterapijom.
English: A phase I dose escalation study was conducted in paediatric patients aged 1-16 years.
Croatian: Ispitivanje faze I s povišenjem doze provedeno je u pedijatrijskih bolesnika u dobi od 1 do 16 godina.
English: In a study to assess potential carcinogenicity in transgenic rasH2 mice, no treatment related increases in the incidence of neoplastic lesions were observed.
Croatian: U ispitivanju provedenom radi procjene potencijalne kancerogenosti u transgeničnih rasH2 miševa nije došlo do povećanja incidencije neoplastičnih lezija povezanih s liječenjem.
English: Kepivance should be reconstituted with 1.2 ml water for injections.
Croatian: Kepivance treba pripremiti za primjenu pomoću 1,2 ml vode za injekcije.
English: One of the side effects of these treatments is oral mucositis.
Croatian: Jedna od nuspojava tih liječenja je oralni mukozitis.
English: Lack of efficacy and risk of infection with high dose melphalan conditioning regimen
Croatian: Nedostatna djelotvornost i rizik od infekcije u slučaju protokola kondicioniranja visokom dozom melfalana
English: Inter-subject variability is high with a CV% of about 50% for CL and 60% for Vss.
Croatian: Varijabilnost među ispitanicima bila je visoka, s koeficijentom varijacije od oko 50% za klirens i 60% za volumen Vss.
English: Visual acuity was not affected at 6 or 12 months in either treatment group.
Croatian: Oštrina vida nije se u 6 ili 12 mjeseci pogoršala niti u jednoj od skupina.
English: The usual dose of Kepivance is 60 micrograms of Kepivance per kilogram of bodyweight per day.
Croatian: Uobičajena doza Kepivancea je 60 mikrograma po kilogramu tjelesne težine dnevno.
English: Median time to onset was approximately 6 days following the first of 3 consecutive daily doses of Kepivance, with a median duration of approximately 5 days.
Croatian: Medijan vremena do pojave bio je oko 6 dana nakon prve od 3 uzastopne dnevne doze Kepivancea s medijanom trajanja od oko 5 dana.
English: 1 Kepivance may cause increased lipase and amylase levels in some patients with or without symptoms of abdominal pain or backache.
Croatian: 1 Kepivance može uzrokovati povišene razine lipaze i amilaze u nekih bolesnika s ili bez simptoma boli u trbuhu ili leđima.
English: - The active substance is palifermin.
Croatian: - Djelatna tvar je palifermin.
English: Face oedema, oedema mouth
Croatian: Edem lica, edem usne šupljine
English: The long-term safety of Kepivance has not been fully evaluated with respect to overall survival, progression free survival and secondary malignancies.
Croatian: Dugoročna sigurnost Kepivancea s obzirom na ukupno preživljenje, preživljenje bez progresije bolesti i sekundarne maligne bolesti još nije u potpunosti istražena.
English: The contents should be swirled gently during dissolution.
Croatian: Sadržaj je tijekom otapanja potrebno lagano miješati.
English: Kepivance should not be administered subcutaneously due to poor local tolerability.
Croatian: Kepivance se ne smije primjenjivati supkutano zbog loše lokalne podnošljivosti lijeka.
English: Dysgeusia Paraesthesia oral
Croatian: Dizgeuzija Oralne parestezije
English: The pharmacodynamic effect of palifermin, as measured by the change in Ki67 expression, tended to be lower when administered with heparin but the clinical relevance of this finding is unclear.
Croatian: Farmakodinamički učinak palifermina, mjeren promjenama u ekspresiji antigena Ki67, bio je manji kada se primjenjivao s heparinom, no klinički značaj ove pojave nije jasan.
English: For information on dose limiting toxicities see section 4.8.
Croatian: Za informacije o toksičnosti ovisnoj o dozi vidjeti dio 4.8.
English: In addition, there was a higher incidence of infections in patients administered palifermin pre- and post-chemotherapy (49.5%) compared with patients who received placebo (24.6%).
Croatian: Osim toga, incidencija infekcija bila je veća u bolesnika koji su palifermin primili prije i poslije kemoterapije (49,5%) u usporedbi s bolesnicima koji su primali placebo (24,6%).
English: In-vitro and in-vivo data suggest that palifermin binds to unfractionated as well as low molecular weight heparins.
Croatian: In vitro i in vivo podaci pokazuju da se palifermin veže za nefrakcionirani heparin kao i za heparine niske molekularne mase.
English: A single dose of 250 micrograms/kg has been administered intravenously to 8 healthy volunteers without severe or serious adverse effects.
Croatian: Jednokratna doza od 250 mikrograma/kg primijenjena je intravenski u 8 zdravih dobrovoljaca bez teških ili ozbiljnih nuspojava.
English: In this Phase 3 clinical study, palifermin treated patients demonstrated significant benefits in patient-reported outcomes of mouth and throat soreness and its impact on swallowing, drinking, eating and talking.
Croatian: U ovom kliničkom ispitivanju faze 3 bolesnici liječeni paliferminom prijavili su značajno poboljšanje po pitanju nadraženosti usne šupljine i grla i njenog utjecaja na gutanje, pijenje, jedenje i pričanje.
English: In two studies in healthy volunteers, co-administration of Kepivance and heparin resulted in approximately 5 times higher systemic exposure to palifermin, due to a lower volume of distribution.
Croatian: U dva ispitivanja provedena na zdravim dobrovoljcima, istovremena primjena Kepivancea i heparina dovela je do približno 5 puta većeg sustavnog izlaganja paliferminu zbog smanjenog volumena raspodjele.
English: The main efficacy endpoint of the study was the number of days during which patients experienced severe oral mucositis (grade 3/4 on the World Health Organisation (WHO) scale).
Croatian: Primarni ishod ispitivanja bio je broj dana tijekom kojih su bolesnici imali težak oblik oralnog mukozitisa (stupnja 3/4 prema ljestvici Svjetske zdravstvene organizacije (SZO)).
English: Do not use Kepivance if you are breast
Croatian: Nemojte primjenjivati Kepivance ako dojite.
English: Kepivance is a sterile but unpreserved product and is intended for single use only.
Croatian: Kepivance je sterilan lijek, ali ne sadrži konzervanse te je namijenjen za jednokratnu uporabu.
English: The most commonly reported adverse drug reactions (reported in > 1/10 patients) are reactions consistent with the pharmacologic action of Kepivance on skin and oral epithelium, e.g. oedema, including peripheral oedema, and hypertrophia of oral structures.
Croatian: Najčešće nuspojave na lijek (u >1/10 bolesnika) su reakcije koje odgovaraju farmakološkom djelovanju Kepivancea na kožu i oralni epitel, npr. edem, uključujući periferni edem i hipertrofiju oralnih struktura.
English: • darkening of an area of skin (hyperpigmentation);
Croatian: • trnci u usnoj šupljini; • tamnjenje dijela kože (hiperpigmentacija);
English: Currently available data are described in section 5.2 but no recommendation on dose adjustment can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.2, međutim nije moguće dati preporuku o doziranju.
English: However, patients treated with chemotherapy and/or radiotherapy are at higher risk of developing secondary tumours some of which may express KGF receptors, and theoretically, be stimulated by KGF receptor ligands.
Croatian: Međutim, u bolesnika liječenih kemoterapijom i/ili radioterapijom postoji veći rizik od razvoja sekundarnih tumora od kojih neki mogu izražavati receptore za čimbenike rasta keratinocita i teoretski mogu biti stimulirani ligandima receptora za čimbenike rasta keratinocita.
English: Common (affects 1 to 10 users in 100) side effects are:
Croatian: Često (mogu se javiti u 1 do 10 osoba na 100 osoba):
English: Treatment with these doses was also associated with maternal effects (clinical signs and/or changes in body weight/food consumption), suggesting that palifermin was not selectively toxic to development in either species.
Croatian: Liječenje ovim dozama također je bilo povezano s učincima na majku (klinički pokazatelji i/ili promjene tjelesne težine/uzimanja hrane), što znači da u tim vrstama palifermin nije bio selektivno toksičan za razvoj.
English: There was an imbalance in age distribution with more elderly (> 65 years) patients in the palifermin group.
Croatian: Skupine su bile dobno neuravnotežene, s više starijih ispitanika (> 65 godina) u skupini koja je primala palifermin.
English: Due to limited data in patients, heparins should be used with care in patients receiving palifermin and appropriate blood coagulation tests should be carried out to monitor their treatment.
Croatian: Zbog ograničenih podataka u bolesnika, heparine treba upotrebljavati oprezno u bolesnika koji primaju palifermin te treba provoditi odgovarajuće testove zgrušavanja krvi radi praćenja liječenja.
English: Palifermin stimulates the growth of specific cells called epithelial cells that form the tissue lining of your mouth and digestive tract, as well as other tissues such as skin.
Croatian: Palifermin potiče rast posebnih stanica koje se nazivaju epitelne stanice, a oblikuju tkivo kojim su obložena Vaša usta i probavna cijev, kao i druga tkiva poput kože.
English: Salient findings in toxicology studies in rat and monkey were generally attributable to the pharmacological activity of palifermin, specifically, proliferation of epithelial tissues.
Croatian: Glavni rezultati toksikoloških ispitivanja na štakorima i majmunima uglavnom su bili u skladu s farmakološkom aktivnošću palifermina, osobito proliferacijom epitelnog tkiva.
English: Compared with the placebo group, the pre/post-chemotherapy group had a higher incidence of herpes virus infection (9% vs 0%), oral fungal infection (7% vs 2%) and sepsis/septic shock (12% vs 2%).
Croatian: U usporedbi sa skupinom koja je primala placebo, u skupini koja je lijek primila prije i poslije kemoterapije bila je viša incidencija infekcija virusom herpesa (9% naspram 0%), oralnih gljivičnih infekcija (7% naspram 2%) i sepse/septičkog šoka (12% naspram 2%).
English: ** WHO Oral Mucositis Scale: Grade 1 = soreness/erythema; Grade 2 = erythema, ulcers, can eat solids; Grade 3 = ulcers, requires liquid diet only; Grade 4 = alimentation not possible
Croatian: ** Ljestvica SZO-a za oralni mukozitis: stupanj 1 = osjetljivost/crvenilo; stupanj 2 = crvenilo, ulkusi, može jesti krutu hranu; stupanj 3 = ulkusi, samo tekuća hrana; stupanj 4 = nije moguće uzimanje hrane
English: MARKETING AUTHORISATION HOLDER Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm
Croatian: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Švedska
English: To treat your blood cancer you may be receiving chemotherapy, radiotherapy and autologous hematopoietic stem cell transplantation (cells from your own body that produce blood cells).
Croatian: Za liječenje raka krvi možete primati kemoterapiju, zračenje ili presađivanje vlastitih krvotvornih matičnih stanica (stanice iz Vašeg tijela koje proizvode druge krvne stanice).
English: Before injection‚ Kepivance may be allowed to reach room temperature for a maximum of 1 hour but should be protected from light.
Croatian: Prije injiciranja, Kepivance se može ostaviti maksimalno 1 sat da postigne sobnu temperaturu, ali ga je potrebno zaštititi od svjetlosti.
English: Vaginal oedema and vulvovaginal erythema
Croatian: Vaginalni edem i vulvovaginalni eritem