FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common or serious side effects with Kanjinti are heart problems, reactions related to the Kanjinti infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.
Croatian: Najčešće ili ozbiljne nuspojave lijeka Kanjinti su problemi sa srcem, reakcije na infuziju lijeka Kanjinti, snižene razine krvnih stanica (posebno bijelih krvnih stanica), infekcije i problemi s plućima.
English: Because Kanjinti is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Kanjinti.
Croatian: Budući da je lijek Kanjinti biosličan lijek, ispitivanja djelotvornosti i sigurnosti trastuzumaba provedena za lijek Herceptin nije potrebno ponavljati za lijek Kanjinti.
English: Care should be taken if it is given to patients who already have heart problems or high blood pressure, and all patients need to be monitored during and after treatment to check their heart.
Croatian: Potrebno je pripaziti ako se lijek daje bolesnicima koji već imaju probleme sa srcem ili visoki krvni tlak, a stanje srca svih bolesnika treba pratiti tijekom i nakon liječenja.
English: Why is Kanjinti authorised in the EU?
Croatian: Zašto je lijek Kanjinti odobren u EU-u?
English: Kanjinti is a ‘biosimilar medicine'.
Croatian: Kanjinti je „biosličan lijek”.
English: An overview of Kanjinti and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Kanjinti i zašto je odobren u EU-u
English: Side effects reported with Kanjinti are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Kanjinti pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Croatian: Do povećane ekspresije HER2 dolazi kod otprilike četvrtine slučajeva raka dojke i petine slučajeva raka želudca.
English: It must not be used in patients whose advanced cancer causes serious breathing problems even when resting, or who need oxygen therapy.
Croatian: Lijek se ne smije primjenjivati u bolesnika koji zbog uznapredovalog raka imaju ozbiljnih poteškoća s disanjem, čak i u mirovanju, ili kojima je potrebno liječenje kisikom.
English: The reference medicine for Kanjinti is Herceptin.
Croatian: Referentni lijek za Kanjinti je Herceptin.
English: Kanjinti 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: Lijek Kanjinti izdaje se samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u primjeni lijekova protiv raka.
English: • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Croatian: • ranog raka dojke (raka koji se proširio unutar dojke ili do žlijezda ispod pazuha, ali ne i na ostale dijelove tijela) nakon kirurškog zahvata, kemoterapije (lijekovi za liječenje raka) i radioterapije (liječenje zračenjem), ako su provedeni.
English: What are the risks associated with Kanjinti?
Croatian: Koji su rizici povezani s lijekom Kanjinti?
English: Kanjinti must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Croatian: Kanjinti se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na trastuzumab, mišje bjelančevine ili bilo koji drugi sastojak lijeka.
English: In addition, one study involving 696 patients with early breast cancer that overexpressed HER2 showed that Kanjinti was effective in treating the condition.
Croatian: Nadalje, u jednom ispitivanju na 696 bolesnika s ranim rakom dojke s povećanom ekspresijom HER2 utvrđena je djelotvornost lijeka Kanjinti u liječenju toga stanja.
English: For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Kanjinti is used before surgery in combination with chemotherapy and then again after surgery on its own;
Croatian: Kod karcinoma koji su lokalno uznapredovali (uključujući upalne karcinome) ili su širi od 2 cm, lijek Kanjinti primjenjuje se u kombinaciji s kemoterapijom prije kirurškog zahvata i potom nakon kirurškog zahvata kao monoterapija;
English: • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).
Croatian: • metastatskog raka želudca, u kombinaciji s cisplatinom zajedno s ili kapecitabinom ili fluorouracilom (drugi lijekovi protiv raka).
English: After treatment of up to a year, 48% of those given Kanjinti (172 of 358) and 41% of those given the reference medicine Herceptin (137 of 338) had no invasive cancer cells in the breasts or surrounding lymph nodes.
Croatian: Nakon liječenja u trajanju do godine dana, stanice invazivnog raka u dojci ili okolnim limfnim čvorovima nisu bile prisutne u 48 % bolesnika koji su primali lijek Kanjinti (172 od 358) i u 41 % bolesnika koji su primali referentni lijek Herceptin (137 od 338).
English: Kanjinti can only be used when the cancer ‘overexpresses HER2': this means that the cancer produces a protein called HER2 in large quantities on the cancer cells.
Croatian: Primjena lijeka Kanjinti moguća je samo ako rak pokazuje „povećanu ekspresiju HER2”, što znači da rak proizvodi velike količine bjelančevina pod nazivom HER2 na površini tumorskih stanica.
English: As for all medicines, data on the use of Kanjinti are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Kanjinti kontinuirano se prate.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kanjinti 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 Kanjinti nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Laboratory studies comparing Kanjinti with Herceptin have shown that the active substance in Kanjinti is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Kanjinti i Herceptin pokazala su da je djelatna tvar u lijeku Kanjinti vrlo slična djelatnoj tvari u lijeku Herceptin u pogledu strukture, čistoće i biološke aktivnosti.
English: In the light of all the data provided the difference was not assessed to be relevant and it was concluded that Kanjinti would behave in the same way as Herceptin in its approved indications.
Croatian: Na temelju svih dostavljenih podataka ocijenjeno je da ta razlika nije relevantna te je zaključeno da će se lijek Kanjinti za odobrene indikacije ponašati na isti način kao lijek Herceptin.
English: The dose depends on the patient's body weight, on the condition being treated and on whether Kanjinti is given every week or every 3 weeks.
Croatian: Doza lijeka Kanjinti ovisi o tjelesnoj težini bolesnika, o bolesti koja se liječi i o tome primjenjuje li se jedanput tjedno ili svaka tri tjedna.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Kanjinti has been shown overall 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, utvrđeno da lijek Kanjinti posjeduje kakvoću, sigurnost i učinkovitost usporedivu s lijekom Herceptin.
English: For more information about using Kanjinti, see the package leaflet or contact a doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Kanjinti pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Other information about Kanjinti
Croatian: Ostale informacije o lijeku Kanjinti
English: Kanjinti contains the active substance trastuzumab.
Croatian: Kanjinti sadrži djelatnu tvar trastuzumab.
English: Therefore, the Agency's view was that, as for Herceptin, the benefit of Kanjinti outweighs the identified risk and it can be authorised.
Croatian: Stoga je stav Agencije da korist od lijeka Kanjinti, kao i od lijeka Herceptin, nadmašuje identificirani rizik te da lijek može biti odobren.
English: How is Kanjinti used?
Croatian: Kako se Kanjinti koristi?
English: Studies have also shown that giving Kanjinti produces similar levels of the active substance in the body to giving Herceptin.
Croatian: Ispitivanja su pokazala i da primjena lijeka Kanjinti dovodi do slične razine djelatne tvari u tijelu kao i primjena lijeka Herceptin.
English: What benefits of Kanjinti have been shown in studies?
Croatian: Koje su koristi od lijeka Kanjinti utvrđene u ispitivanjima?
English: The active substance in Kanjinti, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein.
Croatian: Djelatna tvar u lijeku Kanjinti, trastuzumab, monoklonsko je protutijelo (vrsta bjelančevine) namijenjeno prepoznavanju bjelančevine HER2 i vezivanju za njega.
English: How does Kanjinti work?
Croatian: Kako djeluje Kanjinti?
English: Compatibility with other concentrations is unknown.
Croatian: Kompatibilnost s drugim koncentracijama nije poznata.
English: >R (Resistant)
Croatian: >R (Rezistentni)
English: Frequency not known (cannot be estimated from available data)
Croatian: Učestalost nepoznata (ne može se procijeniti iz dostupnih podataka)
English: However, some may be serious and need medical attention.
Croatian: Međutim, neke od njih mogu biti ozbiljne te zahtijevati liječničku pomoć.
English: These precautions are also applicable to children.
Croatian: Ove mjere opreza vrijede također i za djecu.
English: These results are relevant to other populations and routes of administration.
Croatian: Ti su rezultati važni i za druge populacije i puteve primjene.
English: • You have had an allergic reaction to other azoles.
Croatian: • ako ste imali alergijsku reakciju na druge azole.
English: For example, 15-20 % of Asian populations may be expected to be poor metabolisers.
Croatian: Primjerice, može se očekivati da će 15-20% azijske populacije biti spori metabolizatori.
English: Clinical Experience Successful outcome in this section is defined as complete or partial response.
Croatian: Kliničko iskustvo Pozitivan ishod u ovom je odjeljku definiran kao potpun ili djelomičan odgovor.
English: Osmolality: 500± 50 mOsm/kg
Croatian: Osmolalnost: 500 ± 50 mOsm/kg
English: Plasma protein binding is estimated to be 58 %.
Croatian: Procjenjuje se da vezanje na proteine plazme iznosi 58%.
English: Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
Croatian: Do sada dostupni podaci opisani su u dijelovima 4.8 i 5.1, ali ne mogu se dati preporuke za doziranje.
English: However, this reduced response was not correlated with elevated MICs.
Croatian: Međutim, ovaj smanjeni odgovor nije bio povezan s povećanim vrijednostima MIK-a.
English: Insufficient evidence
Croatian: Nedovoljno podataka
English: Therefore, every attempt should be made to identify Candida to species level.
Croatian: Stoga svakako treba učiniti napor da se Candida identificira do razine vrste.
English: No clinically significant differences were seen when the safety data were analysed by age, race, or gender.
Croatian: Nisu uočene klinički značajne razlike kada su sigurnosni podaci analizirani vezano uz dob, rasu ili spol.
English: It works by killing or stopping the growth of the fungi that cause infections.
Croatian: Djeluje tako da uništava ili zaustavlja rast gljivica koje uzrokuju infekcije.
English: Dosage adjustment (Adults)
Croatian: Prilagodba doze (odrasli)
English: • You are suffering from, or have ever suffered from liver disease.
Croatian: • ako bolujete ili ste ikada imali bolest jetre.
English: Prophylaxis should be initiated on the day of transplant and may be administered for up to 100 days.
Croatian: Profilaksu je potrebno započeti na dan transplantacije i smije se davati najviše 100 dana.
English: Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent the infection from returning.
Croatian: Bolesnicima s oslabljenim imunološkim sustavom ili onima s teškim infekcijama možda će biti potrebno dulje liječenje kako bi se spriječio povratak infekcije.
English: The recommended dose for adults (including elderly patients) is as follows:
Croatian: Preporučena doza za odrasle (uključujući starije bolesnike) je kako slijedi:
English: Medicinal product [Mechanism of Interaction]
Croatian: Lijek [Mehanizam interakcije]
English: However, as there were only 9 cases available for EUCAST analysis, there is currently insufficient evidence to set clinical breakpoints for C. krusei.
Croatian: Međutim, s obzirom da je bilo samo 9 slučajeva dostupnih za EUCAST analizu, za sada nema dovoljno podataka za utvrđivanje graničnih vrijednosti za C. krusei.
English: Your doctor will determine your dose depending on your weight and the type of infection you have.
Croatian: Liječnik će odrediti dozu lijeka ovisno o Vašoj tjelesnoj težini i vrsti infekcije koju imate.
English: The recommended dose for children and teenagers is as follows:
Croatian: Preporučena doza za djecu i adolescente je kako slijedi:
English: As an evolution towards SCC has been reported, stringent measures for the photoprotection are warranted in this population of patients.
Croatian: Budući je prijavljen razvoj SCC-a, obavezne su stroge mjere fotozaštite u ovoj populaciji bolesnika.
English: This impurity should be considered a substance with carcinogenic potential in humans.
Croatian: To onečišćenje treba smatrati tvari s kancerogenim potencijalom u ljudi.
English: • Sinus bradycardia
Croatian: • sinusna bradikardija
English: This enzyme exhibits genetic polymorphism.
Croatian: Ovaj enzim iskazuje genetski polimorfizam.
English: Frequency categories are expressed as: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti izražene su kao: vrlo često (≥ 1/10), često (≥ 1/100 i <1/10), manje često (≥ 1 / 1000 i <1/100), rijetko (≥ 1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Depending upon your response to treatment, your doctor may increase or decrease the daily dose.
Croatian: Ovisno o Vašem odgovoru na liječenje, liječnik može povećati ili smanjiti dnevnu dozu.
English: It is used for the treatment of patients (adults and children over the age of 2) with:
Croatian: Koristi se za liječenje bolesnika (odraslih i djece starije od 2 godine) koji imaju:
English: From all patients 58% were subject to myeloablative conditions regimens.
Croatian: Od svih bolesnika, 58% podvrgnuto je mijeloablativnom postupku.
English: The majority (> 94 %) of the total radioactivity is excreted in the first 96 hours after both oral and intravenous dosing.
Croatian: Većina (> 94%) ukupne radioaktivnosti izluči se tijekom prvih 96 sati i nakon peroralne i nakon intravenske primjene.
English: Maximum increase in prothrombin time was approximately 2-fold
Croatian: Maksimalno produljenje protrombinskog vremena bilo je približno dvostruko.
English: • Existing symptomatic arrhythmias
Croatian: • postojeće simptomatske aritmije
English: The asterisk (*) indicates a two-way interaction.
Croatian: Zvjezdicom (*) je označena dvosmjerna interakcija.
English: Your doctor may change your dose depending upon your condition.
Croatian: Liječnik može promijeniti dozu ovisno o Vašem stanju.
English: (Please refer to the end of this leaflet for further information).
Croatian: (Dodatne informacije navedene su na kraju ove Upute o lijeku).
English: Treatment duration should be as short as possible depending on the patient's clinical and mycological response.
Croatian: Trajanje liječenja mora biti što kraće ovisno o kliničkom i mikološkom odgovoru bolesnika.
English: The mechanism of action is unknown, although the site of action is most likely to be within the retina.
Croatian: Mehanizam ovih reakcija nije poznat, iako je mjesto njihova nastanka najvjerojatnije u mrežnici.
English: The clinical efficacy data were supported by limited susceptibility data.
Croatian: Podaci o kliničkoj djelotvornosti bili su potkrijepljeni ograničenim podacima o osjetljivosti.
English: Difference in proportions and the 95% confidence interval (CI)
Croatian: Razlika u udjelima i 95%-tni interval pouzdanosti (CI)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {27 May 2015}
Croatian: Datum prvog odobrenja: 27 Svibanj 2015
English: Elevated liver enzymes were also observed more frequently in children.
Croatian: Povišeni jetreni enzimi zabilježeni su češće kod djece.
English: 1 Includes febrile neutropenia and neutropenia.
Croatian: 1 Uključuje febrilnu neutropeniju i neutropeniju.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83 and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
English: It may cause transient and reversible changes to vision, including blurring, altered/enhanced visual perception and/or photophobia.
Croatian: Može izazvati prolazne i reverzibilne promjene vida, uključujući zamagljen vid, promijenjenu/pojačanu vidnu percepciju i/ili fotofobiju.
English: - Reminds patients when and how to report relevant signs and symptoms of phototoxicity and skin cancer.
Croatian: - Podsjeća bolesnika kada i kako prijaviti značajne znakove i simptome fototoksičnosti i raka kože.
English: System Organ Class
Croatian: Klasa organskih sustava
English: Of these 7 patients, 3 had eye, 1 had sinus, and 3 had disseminated infection.
Croatian: Od 7 navedenih bolesnika, 3 su imala infekciju oka, 1 infekciju sinusa, a u 3 je bolesnika infekcija bila diseminirana.
English: Blood products and short-term infusion of concentrated solutions of electrolytes:
Croatian: Krvni pripravci i kratkotrajna infuzija koncentriranih otopina elektrolita:
English: The safety profile and plasma concentrations observed in male and female patients were similar.
Croatian: Sigurnosni profil i koncentracije u plazmi zabilježene u muških i ženskih bolesnika bili su podjednaki.
English: Common to < 1/10
Croatian: Često i < 1/10
English: The inter-individual variability of voriconazole pharmacokinetics is high.
Croatian: Interindividualna varijabilnost farmakokinetike vorikonazola je velika.
English: The recommended dosing regimen for prophylaxis is the same as for treatment in the respective age groups.
Croatian: Preporučen režim doziranja za profilaksu isti je kao i za liječenje u odgovarajućim dobnim skupinama.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Istraživanja na životinjama pokazala su reproduktivnu toksičnost (vidjeti dio 5.3.).
English: The median duration of study drug prophylaxis was 95.5 days in the MITT group.
Croatian: Medijan trajanja profilakse ispitivanim lijekom bio je 95,5 dana u skupini MITT.
English: Success was defined as the ability to continue study drug prophylaxis for 100 days after HSCT (without stopping for >14 days) and survival with no proven or probable IFI for 180 days after HSCT.
Croatian: Uspjeh je definiran kao sposobnost nastavljanja profilakse ispitivanim lijekom 100 dana nakon HSCT-a (bez prekida >14 dana) i preživljenje bez dokazane ili vjerojatne invazivne gljivične infekcije 180 dana nakon HSCT-a.
English: While affected, do not drive or operate any tools or machines.
Croatian: Ako to osjećate, nemojte voziti niti rukovati alatima ili strojevima.
English: Treatment should be as short as possible, however, if based on the benefit-risk assessment the treatment is continued (see section 4.2), monitoring frequency can be reduced to monthly if there are no changes in the liver function tests.
Croatian: Liječenje bi trebalo trajati što je kraće moguće, međutim ako se ono temelji na procjeni koristi i rizika, liječenje se nastavlja (vidjeti dio 4.2), a učestalost praćenja se može smanjiti na mjesečne provjere ako nema promjena u testovima funkcije jetre.
English: The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate sent to a reference laboratory.
Croatian: Testovi identifikacije i osjetljivosti na antimikrobne lijekove se na svakom takvom izolatu moraju ponoviti te se, ako se rezultati potvrde, izolat mora poslati u referentni laboratorij.
English: Successful response was seen in 24 patients (15 complete, 9 partial responses).
Croatian: Pozitivan odgovor postignut je u 24 bolesnika (u 15 potpun, a u 9 djelomičan).
English: For Caucasians and Blacks the prevalence of poor metabolisers is 3-5 %.
Croatian: Među pripadnicima bijele i crne rase prevalencija sporih metabolizatora iznosi 3-5%.
English: EU/1/15/1004/002
Croatian: EU/1/15/1004/001 EU/1/15/1004/002
English: In this analysis a successful response was seen in 41 % of patients in both treatment arms.
Croatian: U toj je analizi pozitivan odgovor na liječenje utvrđen u 41% bolesnika u obje skupine.
English: It is recommended to initiate the therapy with intravenous regimen, and oral regimen should be considered only after there is a significant clinical improvement.
Croatian: Preporučuje se započeti liječenje intravenskim režimom, a prelazak na peroralnu primjenu treba razmotriti tek kad dođe do značajnog kliničkog poboljšanja.
English: Prophylaxis in Adults and Children
Croatian: Profilaksa u odraslih i djece
English: If antifungal susceptibility testing is available, the MIC results may be interpreted using breakpoint criteria established by European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Croatian: Ako je dostupno ispitivanje osjetljivosti na antimikotike, rezultati MIK-a mogu se interpretirati pomoću kriterija graničnih vrijednosti utvrđenih od strane Europskog odbora za ispitivanje osjetljivosti na antimikrobne lijekove (EUCAST).
English: ≤S (Susceptible)
Croatian: ≤S (Osjetljivi)
English: The median treatment duration was 15 days in both treatment arms.
Croatian: Medijan trajanja liječenja u obje je terapijske skupine iznosio 15 dana.
English: This metabolite has minimal antifungal activity and does not contribute to the overall efficacy of voriconazole.
Croatian: Ovaj metabolit ima minimalno antifungalno djelovanje i kao takav ne pridonosi ukupnoj djelotvornosti vorikonazola.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton 1 (or 5) vials including blue box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjsko pakiranje s 1 (ili 5) bočicom(a) uključujući plavi okvir
English: However, tell your doctor or pharmacist if you think that a dose has been forgotten.
Croatian: Međutim, obavijestite liječnika ili ljekarnika ako mislite da ste propustili primiti dozu.
English: It is important to cover sun exposed areas of skin and use sunscreen with high sun protection factor (SPF), as an increased sensitivity of skin to the sun's UV rays can occur.
Croatian: Važno je da pokrijete područja kože izložena suncu i koristite sredstva za zaštitu od sunca s visokim zaštitnim faktorom (SPF) jer može doći do pojačane osjetljivosti kože na sunčeve UV zrake.
English: Currently there are insufficient data to allow dosing recommendations in this situation (see section 4.5).
Croatian: Trenutno nema dovoljno podataka da bi se mogle dati preporuke za doziranje u tom slučaju (vidjeti dio 4.5).