FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Ontruzant.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Ontruzant.
English: What are the risks associated with Ontruzant?
Croatian: Koji su rizici povezani s lijekom Ontruzant?
English: Because Ontruzant is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Ontruzant.
Croatian: Budući da je lijek Ontruzant biosličan lijek, ispitivanja učinkovitosti i sigurnosti trastuzumaba provedena za lijek Herceptin nije potrebno ponavljati za lijek Ontruzant.
English: Ontruzant is a ‘biosimilar medicine'.
Croatian: Ontruzant je „biosličan lijek”.
English: It is not intended to provide practical advice on how to use Ontruzant.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Ontruzant.
English: Ontruzant can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.
Croatian: Ontruzant se izdaje samo na liječnički recept, a liječenje treba započeti liječnik s iskustvom u primjeni lijekova protiv raka.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ontruzant has been shown to have a comparable quality, safety and effectiveness to Herceptin.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Ontruzant dokazao usporedivu kakvoću, sigurnost i učinkovitost kao i Herceptin.
English: The women received one or the other trastuzumab medicine before and after surgery, with other cancer medicines and radiotherapy according to standard practice.
Croatian: Žene su dobivale jedan ili drugi lijek koji sadržava trastuzumab prije i nakon kirurškog zahvata, s drugim lijekovima protiv raka i radioterapijom sukladno standardnoj praksi.
English: The recommended dose depends on the patient's body weight and depends on the condition to be treated and whether Ontruzant is given weekly or three-weekly.
Croatian: Preporučena doza ovisi o tjelesnoj težini bolesnika i o bolesti koja se liječi te o tome primjenjuje li se Ontruzant jedanput tjedno ili svaka tri tjedna.
English: Ontruzant can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells, which makes the tumour cells grow more quickly.
Croatian: Primjena lijeka Ontruzant moguća je samo ako tumor pokazuje „povećanu ekspresiju HER2”, što znači da rak proizvodi velike količine proteina pod nazivom HER2 na površini tumorskih stanica, zbog čega tumorske stanice brže rastu.
English: Why is Ontruzant approved?
Croatian: Zašto je lijek Ontruzant odobren?
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Croatian: Vezivanjem na HER2, trastuzumab aktivira djelovanje stanica imunosnog sustava, koje zatim ubijaju tumorske stanice.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ontruzant have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ontruzant nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: On the basis of all the data provided it was concluded that Ontruzant would behave in the same way as Herceptin in its approved indications.
Croatian: Na temelju svih dostavljenih podataka zaključeno je da će se Ontruzant za odobrene indikacije ponašati na isti način kao Herceptin.
English: • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or 5‑fluorouracil (other cancer medicines).
Croatian: • metastatski rak želuca, u kombinaciji s cisplatinom i kapecitabinom ili 5-fluorouracilom (drugi lijekovi protiv raka).
English: For more information about treatment with Ontruzant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Ontruzant pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Laboratory studies comparing Ontruzant with Herceptin have shown that the active substance in Ontruzant is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Ontruzant i Herceptin pokazala su da je djelatna tvar u lijeku Ontruzant vrlo slična djelatnoj tvari u lijeku Herceptin u pogledu strukture, čistoće i biološke aktivnosti.
English: For tumours that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Ontruzant is used before surgery in combination with chemotherapy and then again after surgery on its own;
Croatian: Kod tumora koji su lokalno uznapredovali (uključujući upalne tumore) ili širi od 2 cm, Ontruzant se primjenjuje u kombinaciji s kemoterapijom prije kirurškog zahvata i potom nakon kirurškog zahvata kao monoterapija;
English: Other information about Ontruzant
Croatian: Ostale informacije o lijeku Ontruzant
English: Therefore, the Agency's view was that, as for Herceptin, the benefit outweighs the identified risk and Ontruzant should be given marketing authorisation.
Croatian: Stoga je mišljenje Agencije da, kao i kod lijeka Herceptin, koristi nadmašuju utvrđene rizike te je preporučila davanje odobrenja za stavljanje lijeka Ontruzant u promet.
English: The active substance in Ontruzant, trastuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the HER2 protein, which is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Croatian: Djelatna tvar lijeka Ontruzant, trastuzumab, monoklonsko je protutijelo (vrsta proteina) namijenjeno prepoznavanju i vezivanju za protein HER2, čija je povećana ekspresija utvrđena kod otprilike četvrtine slučajeva raka dojke i petine slučajeva raka želuca.
English: How is Ontruzant used?
Croatian: Kako se Ontruzant koristi?
English: The study showed that 94% of women given Ontruzant and 93% of those given Herceptin survived without return or worsening of their disease when followed up for around 14 months.
Croatian: Ispitivanje je nakon praćenja od otprilike 14 mjeseci pokazalo preživljenje bez povratka ili pogoršanja bolesti u 94 % žena koje su primale lijek Ontruzant i u 93 % žena koje su primale lijek Herceptin.
English: For practical information about using Ontruzant, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Ontruzant bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: Studies have also shown that giving Ontruzant produces similar levels of the active substance in the body to giving Herceptin.
Croatian: Ispitivanja su dokazala i da se primjenom lijeka Ontruzant stvaraju slične razine djelatne tvari u tijelu kao i primjenom lijeka Herceptin.
English: What benefits of Ontruzant have been shown in studies?
Croatian: Koje su koristi lijeka Ontruzant utvrđene u ispitivanjima?
English: How does Ontruzant work?
Croatian: Kako djeluje Ontruzant?
English: Ontruzant contains the active substance trastuzumab.
Croatian: Ontruzant sadržava djelatnu tvar trastuzumab.
English: Elderly (≥ 65 years of age)
Croatian: Starije osobe (≥ 65 godina)
English: Date of first authorisation: 25 May 2000 Date of latest renewal: 25 May 2010
Croatian: Datum posljednje obnove odobrenja: 25. svibnja 2010.
English: PegIntron showed no genotoxic potential.
Croatian: PegIntron nije pokazao genotoksičan potencijal.
English: You must not use PegIntron if any of the conditions above should apply to you, or the child you are caring for.
Croatian: Ne smijete primjenjivati PegIntron ako se bilo što od gore navedenoga odnosi na Vas ili dijete za koje skrbite.
English: PegIntron is likely to also cause this effect.
Croatian: Vjerojatno i PegIntron ima ovaj učinak.
English: What PegIntron is and what it is used for
Croatian: Što je PegIntron i za što se koristi
English: PegIntron is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: PegIntron se smije koristiti tijekom trudnoće jedino ako moguća korist opravdava mogući rizik za plod.
English: For disposal instructions, see section 5 “How to store PegIntron”.
Croatian: Za upute o zbrinjavanju vidjeti dio 5 "Kako čuvati PegIntron".
English: While being treated with PegIntron, your doctor may advise to drink extra fluids to help prevent low blood pressure.
Croatian: Za vrijeme liječenja lijekom PegIntron liječnik Vam može savjetovati da pijete više tekućine kako bi se spriječio razvoj niskog krvnog tlaka.
English: No studies have been conducted in juvenile animals to examine the effects of treatment with PegIntron on growth, development, sexual maturation, and behaviour.
Croatian: Nisu provedena istraživanja na mladim životinjama kojima bi se utvrdili učinci liječenja lijekom PegIntron na rast, razvoj, spolno sazrijevanje i ponašanje.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of PegIntron therapy are:
Croatian: Prihvatljive početne vrijednosti koje se mogu koristiti kao smjernice prije početka liječenja lijekom PegIntron su sljedeće:
English: What PegIntron looks like and contents of the pack
Croatian: Kako PegIntron izgleda i sadržaj pakiranja
English: Patients may self-inject PegIntron if their physician determines that it is appropriate and with medical follow-up as necessary.
Croatian: Bolesnici si mogu samostalno injicirati PegIntron ako liječnik odredi da je to prikladno i po potrebi uz medicinsko praćenje.
English: What PegIntron contains
Croatian: Što PegIntron sadrži
English: What PegIntron is and what it is used for What you need to know before you use PegIntron How to use PegIntron
Croatian: Što je PegIntron i za što se koristi Što morate znati prije nego počnete primjenjivati PegIntron Kako primjenjivati PegIntron
English: Reduce only PegIntron dose (see note 2) if:
Croatian: Smanjiti samo dozu lijeka PegIntron (vidjeti napomenu 2) ako:
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of PegIntron therapy.
Croatian: Srčane aritmije (prvenstveno supraventrikularne) obično dobro reagiraju na konvencionalnu terapiju, ali mogu zahtijevati obustavu liječenja lijekom PegIntron.
English: Anaemia (hemoglobin < 9.4 g/dl) was reported in 12 % (23/194) of patients treated with PegIntron in combination with ribavirin.
Croatian: Anemija (hemoglobin < 9,4 g/dl) je prijavljena u 12% (23/194) bolesnika liječenih lijekom PegIntron u kombinaciji s ribavirinom.
English: Treatment with PegIntron in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Croatian: Liječenje lijekom PegIntron u kombinaciji s ribavirinom bilo je povezano sa smanjenjem apsolutnog broja CD4+ stanica u prva 4 tjedna, no bez smanjenja postotka CD4+ stanica.
English: ** For patients > 120 kg, the PegIntron dose should be calculated based on the individual patient weight.
Croatian: ** Za bolesnike teže od 120 kg dozu lijeka PegIntron treba izračunati na temelju tjelesne težine pojedinog bolesnika.
English: As adherence might be of importance for outcome of therapy, the dose of PegIntron and ribavirin should be kept as close as possible to the recommended standard dose.
Croatian: Budući da pridržavanje preporučenih doza može biti važno za ishod liječenja, potrebno je održavati dozu lijeka PegIntron i ribavirina što bliže preporučenoj standardnoj dozi.
English: If such a reaction develops during treatment with PegIntron, discontinue treatment and institute appropriate medical therapy immediately.
Croatian: Razvije li se takva reakcija tijekom liječenja lijekom PegIntron, treba odmah obustaviti liječenje i uvesti odgovarajuću terapiju.
English: dizziness), decrease in certain white blood cells (that makes you more susceptible to different infections), - pain in joints and muscles, muscle and bone pain.
Croatian: smanjenje broja određenih bijelih krvnih stanica (to Vas čini osjetljivijima na različite infekcije), - bolovi u zglobovima i mišićima, bol u mišićima i kostima.
English: PegIntron pre-filled pen is to be removed from the refrigerator before administration to allow the solvent to reach room temperature (not more than 25°C).
Croatian: PegIntron napunjenu brizgalicu treba prije primjene izvaditi iz hladnjaka kako bi otapalo dostiglo sobnu temperaturu (ne iznad 25°C).
English: Important information about some of the ingredients of PegIntron Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.
Croatian: Važne informacije o nekim sastojcima lijeka PegIntron Bolesnici s rijetkim nasljednim poremećajima nepodnošenja fruktoze, malapsorpcijom glukoze i galaktoze ili insuficijencijom saharaza-izomaltaza ne bi trebali uzimati ovaj lijek.
English: PegIntron increases the risk of hepatic decompensation and death in patients with cirrhosis.
Croatian: PegIntron povećava rizik od dekompenzacije jetre i smrti u bolesnika s cirozom.
English: Water for injection and PegIntron powder are provided in separate ampoules.
Croatian: Voda za injekcije i PegIntron prašak dolaze u odvojenim ampulama.
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm 3 was observed in 4 %
Croatian: U Ispitivanju 1 (vidjeti dio 5.1) smanjenje apsolutnog broja neutrofila na manje od 500 stanica/mm
English: Two pivotal trials have been conducted, one (C/I97-010) with PegIntron monotherapy; the other (C/I98-580) with PegIntron in combination with ribavirin.
Croatian: Provedena su dva pivotalna ispitivanja: u jednom (C/I97-010) se primjenjivao PegIntron u monoterapiji, a u drugom (C/I98-580) PegIntron u kombinaciji s ribavirinom.
English: These adverse reactions were common (≥1/100 to < 1/10) in clinical trials in patients treated with PegIntron monotherapy.
Croatian: * Ove su nuspojave bile česte (≥ 1/100 i < 1/10) u kliničkim ispitivanjima bolesnika liječenih lijekom PegIntron u monoterapiji.
English: PegIntron vials are for single use only.
Croatian: PegIntron bočice namijenjene su samo za jednokratnu uporabu.
English: Women of childbearing potential/contraception in males and females PegIntron is recommended for use in fertile women only when they are using effective contraception during the treatment.
Croatian: Žene generativne dobi/kontracepcija u muškaraca i žena Primjena lijeka PegIntron u plodnih žena preporučuje se samo ako tijekom liječenja koriste učinkovitu kontracepciju.
English: Interferon monotherapy, including PegIntron, is indicated mainly in case of intolerance or contraindication to ribavirin.
Croatian: Monoterapija interferonom, uključujući PegIntron, indicirana je uglavnom u slučaju nepodnošenja ribavirina ili kada je njegova primjena kontraindicirana.
English: This may require combinations of various PegIntron dose strengths and volumes.
Croatian: Za to će možda biti potrebna kombinacija različitih jačina i volumena lijeka PegIntron
English: In general, the adverse events seen in overdose cases involving PegIntron are consistent with the known safety profile for PegIntron; however, the severity of the events may be increased.
Croatian: Štetni događaji zabilježeni u slučajevima predoziranja općenito su u skladu s poznatim sigurnosnim profilom lijeka PegIntron, iako težina tih događaja može biti povećana.
English: The following instructions explain how to use the pre-filled pen to inject yourself.
Croatian: Sljedeće upute objašnjavaju kako koristiti napunjenu brizgalicu da biste si dali injekciju.
English: What you need to know before you use PegIntron
Croatian: Što morate znati prije nego počnete primjenjivati PegIntron
English: PegIntron should therefore not be used as long term maintenance monotherapy.
Croatian: Stoga se PegIntron ne smije primjenjivati u dugotrajnoj monoterapiji održavanja.
English: Table 5 Precautions for co-administration (PegIntron should be administered with care when co-administered with the following medicines)
Croatian: Tablica 5 Mjere opreza za istodobnu primjenu (PegIntron treba primjenjivati uz oprez kada se primjenjuje istodobno sa sljedećim lijekovima)
English: The use of PegIntron in combination with ribavirin had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Croatian: Uporaba lijeka PegIntron u kombinaciji s ribavirinom nije imala vidljivih negativnih učinaka na kontrolu viremije HIV-a tijekom liječenja ili praćenja bolesnika.
English: A clinically significant pharmacokinetic interaction was not observed between peginterferon alfa-2b (PegIntron) and tolbutamide, midazolam or dapsone; therefore, no dosing adjustment is necessary when peginterferon alfa-2b (PegIntron) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.
Croatian: Nije primijećena klinički značajna farmakokinetička interakcija između peginterferona alfa-2b (PegIntron) i tolbutamida, midazolama ili dapsona; stoga nije potrebna prilagodba doze kada se peginterferon alfa-2b (PegIntron) primjenjuje s lijekovima koji se metaboliziraju posredstvom CYP2C9, CYP3A4 i N-acetiltransferaze.
English: Do not inject PegIntron into an area where the skin is irritated, red, bruised, infected, or has scars, stretch marks, or lumps.
Croatian: Nemojte injicirati PegIntron na mjesta na kojima je koža nadražena, crvena, gdje su prisutne modrice, infekcija, ožiljci, strije ili izbočine.
English: PegIntron 1.5 micrograms/kg/week in combination with ribavirin capsules.
Croatian: PegIntron 1,5 mikrograma/kg na tjedan u kombinaciji s ribavirin kapsulama.
English: If you forget to take PegIntron
Croatian: Ako ste zaboravili primijeniti PegIntron
English: Mean (SD) PegIntron elimination half-life is approximately 40 hours (13.3 hours), with apparent clearance of 22.0 ml/hr/kg.
Croatian: Srednja vrijednost (SD) poluvremena eliminacije lijeka PegIntron iznosi oko 40 sati (13,3 sata), uz prividni klirens od 22,0 ml/h/kg.
English: If renal function decreases during treatment, PegIntron therapy should be discontinued.
Croatian: Ako tijekom liječenja bubrežna funkcija oslabi, liječenje lijekom PegIntron treba obustaviti.
English: Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of PegIntron in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Croatian: S obzirom da je prijavljeno da interferon alfa uzrokuje egzacerbaciju postojeće psorijaze i sarkoidoze, primjena lijeka PegIntron u bolesnika s psorijazom i sarkoidozom preporučuje se samo ako očekivana korist opravdava mogući rizik.
English: Table 8 Sustained virological response (% patients HCV negative) PegIntron monotherapy
Croatian: Tablica 8 Trajan virološki odgovor (% HCV-negativnih bolesnika) PegIntron u monoterapiji
English: The clinical incidence of neutralising factors in patients who received PegIntron 0.5 micrograms/kg is 1.1 %.
Croatian: Klinička incidencija neutralizirajućih čimbenika u bolesnika koji su primali PegIntron 0,5 mikrograma/kg iznosi 1,1%.
English: The relative non-toxicity of monomethoxy-polyethylene glycol (mPEG), which is liberated from PegIntron by metabolism in vivo has been demonstrated in preclinical acute and subchronic toxicity studies in rodents and monkeys, standard embryo-foetal development studies and in in vitro mutagenicity assays.
Croatian: Relativna netoksičnost monometoksipolietilenglikola (mPEG), koji se metabolizmom oslobađa iz lijeka PegIntron in vivo, dokazana je u pretkliničkim ispitivanjima akutne i subkronične toksičnosti u glodavaca i majmuna, u standardnim ispitivanjima embriofetalnog razvoja i testovima mutagenosti in vitro.
English: There were some cases of more severe neutropenia in patients treated with the recommended doses of PegIntron in combination with ribavirin (WHO grade 3: 39 of 186 [21 %]; and WHO grade 4: 13 of 186 [7 %]).
Croatian: Bilo je slučajeva teže neutropenije u bolesnika liječenih preporučenim dozama lijeka PegIntron u kombinaciji s ribavirinom (SZO stupnja 3 u 39 od 186 bolesnika [21%] i SZO stupnja 4 u 13 od 186 bolesnika [7%]).
English: PegIntron should be administered as a once weekly subcutaneous injection.
Croatian: PegIntron se primjenjuje supkutanom injekcijom jedanput na tjedan.
English: - Then insert the needle through the rubber top of the PegIntron vial.
Croatian: - Zatim ubodite iglu kroz gumeni vrh bočice lijeka PegIntron.
English: A large long-term follow-up study enrolled 567 patients after treatment in a prior study with PegIntron (with or without ribavirin).
Croatian: U veliko ispitivanje dugotrajnog praćenja uključeno je 567 bolesnika koji su završili liječenje u nekom od prethodnih ispitivanja lijeka PegIntron (sa ili bez ribavirina).
English: The safety and efficacy of PegIntron therapy has not been evaluated in patients with severe hepatic dysfunction, therefore PegIntron must not be used for these patients.
Croatian: Sigurnost i djelotvornost liječenja lijekom PegIntron nije ispitivana u bolesnika s teškim oštećenjem funkcije jetre te se stoga PegIntron ne smije primjenjivati u tih bolesnika.
English: Only 5 children and adolescents with Genotype 4 were treated in the PegIntron/ribavirin clinical trial.
Croatian: Samo je petero djece i adolescenata s genotipom 4 liječeno u kliničkom ispitivanju kombinacije PegIntron/ribavirin.
English: Concomitant administration of peginterferon alfa-2b (PegIntron) with caffeine or desipramine modestly increased the exposure of caffeine and desipramine.
Croatian: Istodobna primjena peginterferona alfa-2b (PegIntron) s kofeinom ili dezipraminom umjereno povećava izloženost kofeinu i dezipraminu.
English: The population enrolled mainly consisted of children with mild to moderate hepatitis C. Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of PegIntron with ribavirin needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Croatian: Populacija uključena u ispitivanje uglavnom se sastojala od djece s blagim do umjerenim hepatitisom C. Zbog nedostatka podataka u djece s teškom progresivnom bolešću i mogućih neželjenih učinaka u ovoj se populaciji mora pažljivo procijeniti omjer koristi i rizika liječenja kombinacijom lijeka PegIntron i ribavirina (vidjeti dijelove 4.1, 4.4 i 4.8).
English: Following single doses of PegIntron between 0.25 and 2.0 micrograms/kg/week, serum neopterin concentration was increased in a dose-related manner.
Croatian: Nakon primjene pojedinačnih doza lijeka PegIntron između 0,25 i 2,0 mikrograma/kg na tjedan, serumska koncentracija neopterina povećala se proporcionalno dozi.
English: PegIntron Cmax and AUC measurements increase in a dose-related manner.
Croatian: Vrijednosti Cmax i AUC lijeka PegIntron povećavaju se sukladno dozi.
English: Dose reduction of PegIntron in children and adolescents is accomplished by modifying the recommended dose in a two-step process from the original starting dose of 60 g/m 2/week, to 40 g/m 2/week, then to 20 g/m 2/week, if needed.
Croatian: Smanjivanje doze lijeka PegIntron u djece i adolescenata postiže se prilagodbom preporučene doze u dva koraka: od početne doze od 60 μg/m 2 na tjedan na 40 μg/m 2 na tjedan, a zatim na 20 μg/m 2 na tjedan, ako je potrebno.