FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Nivestim is a biosimilar medicine the studies on effectiveness and safety of filgrastim carried out with Neupogen do not all need to be repeated for Nivestim.
Croatian: Budući da je lijek Nivestim biosličan lijek, ispitivanja učinkovitosti i sigurnosti primjene filgrastima provedena za lijek Neupogen nije potrebno ponavljati za lijek Nivestim.
English: Nivestim contains the active substance filgrastim.
Croatian: Nivestim sadrži djelatnu tvar filgrastim.
English: Nivestim is a ‘biosimilar' medicine.
Croatian: Nivestim je „biosličan lijek”.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Nivestim has a highly similar structure, purity and biological activity to Neupogen and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, utvrđeno da lijek Nivestim ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Neupogen te se u tijelu raspoređuje na isti način.
English: The patients who received Nivestim had severe neutropenia for a similar length of time as the patients who received Neupogen.
Croatian: Bolesnici koji su primali Nivestim imali su teški oblik neutropenije tijekom razdoblja sličnog trajanja kao i kod bolesnika koji su primali Neupogen.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and to prevent febrile neutropenia (neutropenia with fever) in cancer patients (excluding patients with chronic myeloid leukaemia or with myelodysplastic syndromes).
Croatian: • za smanjenje trajanja neutropenije (niska razina neutrofila, vrste bijelih krvnih stanica) i sprječavanje febrilne neutropenije (neutropenija praćena vrućicom) u bolesnika oboljelih od raka (s izuzetkom bolesnika s kroničnom mijeloičnom leukemijom ili s mijelodisplastičnim sindromom).
English: Neutropenia is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Croatian: Neutropenija je česta nuspojava liječenja raka i može uzrokovati osjetljivost bolesnika na infekcije;
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nivestim 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 Nivestim nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The safety of Nivestim has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neupogen.
Croatian: Ocijenjena je sigurnost primjene lijeka Nivestim i na temelju svih provedenih ispitivanja, nuspojave lijeka smatraju se usporedivima s onima za referentni lijek Neupogen.
English: The reference medicine for Nivestim is Neupogen.
Croatian: Referentni lijek za Nivestim je Neupogen.
English: For more information about using Nivestim, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Nivestim pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Nivestim can also be used in people who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Croatian: Lijek Nivestim može se davati i osobama koje će donirati matične krvne stanice za transplantaciju, kako bi se ove stanice odvojile od koštane srži.
English: As for all medicines, data on the use of Nivestim are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Nivestim kontinuirano se prate.
English: Other information about Nivestim
Croatian: Ostale informacije o lijeku Nivestim
English: Laboratory studies comparing Nivestim with Neupogen have shown that the active substance in Nivestim is highly similar to that in Neupogen in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Nivestim i Neupogen pokazala su da je djelatna tvar u lijeku Nivestim vrlo slična djelatnoj tvari u lijeku Neupogen u pogledu strukture, čistoće i biološke aktivnosti.
English: All these data were considered sufficient to conclude that Nivestim will behave in the same way as Neupogen in terms of effectiveness and safety in its authorised uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Nivestim za odobrene indikacije djelovati jednako kao lijek Neupogen u pogledu učinkovitosti i sigurnosti primjene.
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia;
Croatian: • za smanjenje trajanja neutropenije u bolesnika koji se liječe uništavanjem stanica koštane srži, nakon čega slijedi transplantacija koštane srži (primjerice u pojedinih bolesnika s leukemijom), ako su izloženi riziku od dugotrajne teške neutropenije;
English: How does Nivestim work?
Croatian: Kako djeluje Nivestim?
English: infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Croatian: • za liječenje perzistentne neutropenije u bolesnika s uznapredovalom infekcijom virusom humane imunodeficijencije (HIV) u svrhu smanjenja rizika od bakterijskih infekcija kad drugi načini liječenja nisu prikladni.
English: Therefore, the Agency's view was that, as for Neupogen, the benefits of Nivestim are greater than its risks and it can be authorised or use in the EU.
Croatian: Stoga je stav Agencije da koristi od lijeka Nivestim, kao i od lijeka Neupogen, nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: What benefits of Nivestim have been shown in studies?
Croatian: Koje su koristi od lijeka Nivestim utvrđene u ispitivanjima?
English: Studies have also shown that giving Nivestim produces similar levels of the active substance in the body to giving Neupogen.
Croatian: Ispitivanja su dokazala i da primjenom lijeka Nivestim proizvodi slična razina djelatne tvari u tijelu kao i primjenom lijeka Neupogen.
English: How is Nivestim used?
Croatian: Kako se Nivestim primjenjuje?
English: For the full list of side effects and restrictions with Nivestim, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s lijekom Nivestim potražite u uputi o lijeku.
English: Function.
Croatian: Organ Function.
English: The first European approval was in NL on 29 May 1981.
Croatian: Prvo je put odobren u Švedskoj 29. svibnja 1981.
English: The pregnancy section has been revised in line with the relevant guideline[9].
Croatian: Dio o trudnoći revidiran je u skladu s odgovarajućom smjernicom[9].
English: The text on breastfeeding has been amended accordingly.
Croatian: Shodno tome izmijenjen je tekst o dojenju.
English: This is particularly relevant when patients are treated in the curative setting (e.g. for testicular cancer).
Croatian: Ovo je posebno važno kada se bolesnici liječe u bolničkom okruženju (npr. kod raka testisa).
English: The safety and efficacy of Vepesid and associated names in children below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Vepesid i srodnih lijekova u djece mlađe od 18 godina nisu ustanovljene.
English: Based on data on bioavailability[1][2], the recommended oral dose is 100 to 200 mg/m2/day on day 1-5 in a cycle of 21 or 28 days; or 200 mg/m2/day on three days (most often days 1-3 or day 1, 3, and 5) in a cycle of 21 or 28 days.
Croatian: Na temelju podataka o biološkoj raspoloživosti[1][2], preporučena peroralna doza je 100 do 200 mg/m2/dan od 1. do 5. dana u ciklusu trajanja od 21 ili 28 dana ili doza od 200 mg/m2/dan primijenjena kroz tri dana (najčešće 1. do 3. dana ili 1., 3. i 5. dana) u ciklusu trajanja od 21 ili 28 dana.
English: The revised indications in section 4.1 of the Summary of Product Characteristics (SmPC) are:
Croatian: Revidirane indikacije iz dijela 4.1. sažetka opisa svojstava lijeka (SmPC) su:
English: - Acute myeloid leukaemia
Croatian: - akutna mijeloična leukemija
English: - Recurrent or refractory testicular cancer
Croatian: - ponovljeni ili refraktorni rak testisa
English: With regards to lactation, etoposide is excreted in the milk (Medications and Mothers' Milk: Thomas W. Hale) and it has been included as a contraindication.
Croatian: U pogledu dojenja, etopozid se izlučuje u mlijeko (Thomas W. Hale: Lijekovi i majčino mlijeko) te je to uvršteno kao kontraindikacija.
English: • The product information proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Croatian: • Informacije o lijeku koje je predložio nositelj odobrenja ocijenjene su na temelju dostavljene dokumentacije i znanstvene rasprave unutar Odbora.
English: In renal impairment (creatinine clearance (CrCl) 15-5 mL/min) a dose reduction of 25% is recommended.
Croatian: Kod oštećene funkcije bubrega (klirens kreatinina (CrCl) 15-5 mL/min) preporučuje se smanjenje doze za 25 %.
English: The following special warnings and precautions for use have been harmonised in section 4.4 where they were already included in some or most of the national SmPCs: within-patient variability, myelosuppression, secondary leukaemia, hypersensitivity, injection site reaction, low serum albumin, impaired renal and hepatic function, tumour lysis syndrome and mutagenic potential.
Croatian: Sljedeća posebna upozorenja i mjere opreza pri uporabi usklađeni su u dijelu 4.4., u koji su već bili uvršteni u nekim ili većini nacionalnih SmPC-ova: intraindividualna varijabilnost osjetljivosti, mijelosupresija, sekundarna leukemija, preosjetljivost, reakcija na mjestu primjene injekcije, niska razina serumskog albumina, oštećena funkcija bubrega i jetre, sindrom lize tumora i mutageni potencijal.
English: J Clin Oncol 1993;11:374-377 2 Johnson DH, Hainsworth JD, Hande KR, et al. Cancer 1999;67:231
Croatian: J Clin Oncol 1993;11:374Johnson D.H., Hainsworth J.D., Hande K.R., et al.
English: Lactation has been included as a contraindication, since breastfeeding women could replace breastfeeding by dairy products to feed their child.
Croatian: Dojenje je uvršteno kao kontraindikacija s obzirom na to da dojilje mogu zamijeniti dojenje mliječnim pripravcima pri hranjenju svog djeteta.
English: The available efficacy data for etoposide in the different indications are based for the most part on studies in which etoposide was used intravenously.
Croatian: Dostupni podatci o djelotvornosti etopozida kod različitih indikacija većinom se temelje na ispitivanjima u kojima se etopozid primjenjivao intravenozno.
English: - Ovarian cancer: non-epithelial ovarian cancer and platinum-resistant/refractory epithelial ovarian cancer
Croatian: - raj jajnika: ne-epitelijalni rak jajnika i rak jajnika otporan na platinu / refraktorni epitelijalni rak jajnika
English: In patients with renal impairment, the CHMP agreed not to recommend a dose reduction when creatinine clearance is > 50 mL/min as supported by available literature[3][4][5][6][7].
Croatian: Kod bolesnika s oštećenjem funkcije bubrega, CHMP se složio da se ne preporučuje smanjenje doze ako je klirens kreatinina > 50 mL/min što je potkrijepljeno u dostupnoj literaturi3][4][5][6][7].
English: The data in literature for patients with CrCl less than 15 mL/min and on dialysis strongly suggest that further dose reduction is required in these patients as reviewed by Inoue et al. (2004)[8].
Croatian: Na temelju podataka iz literature za bolesnike s CrCl-om manjim od 15 mL/min i na dijalizi snažno se preporučuje dodatno smanjenje doze prema reviziji koju su izradili Inoue i suradnici. (2004.)[8].
English: The CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Vepesid and associated names (see Annex I).
Croatian: CHMP je preporučio izmjene uvjeta za izdavanje odobrenja za stavljanje lijeka u promet, za koje su informacije o lijeku utvrđene u Prilogu III. za lijek Vepesid i srodne lijekove (vidjeti Prilog I.).
English: Vepesid is available as 50mg and 100 mg capsules for oral use.
Croatian: Lijek Vepesid dostupan je za peroralnu primjenu u obliku kapsula od 50 mg ili 100 mg.
English: For this reason, the CHMP agreed to include additional information in section 4.2 and 4.4 to inform physicians about the potential disadvantages of oral versus intravenous administration of etoposide.
Croatian: Iz tog razloga, CHMP se složio da uvrsti dodatne informacije u dijelove 4.2. i 4.4. radi obavještavanja liječnika o mogućim nedostatcima peroralne primjene etopozida u odnosu na njegovu intravenoznu primjenu.
English: The coefficient of variation is around 30% for oral administration, versus 10% for intravenous administration (between-patient variability is similar after intravenous or oral administration, i.e. 30-40%).
Croatian: Koeficijent varijacije je oko 30 % za peroralnu primjenu u odnosu na 10 % za intravenoznu primjenu (interindividualna varijabilnost je istovjetna nakon intravenozne ili peroralne primjene, tj. 30 do 40 %).
English: The MAH also discussed a dose reduction for patients with end stage renal disease (CrCl < 15mL/min).
Croatian: Podnositelj zahtjeva također je raspravljao o smanjenju doze za bolesnike u terminalnoj fazi bolesti bubrega (CrCl < 15mL/min).
English: Kintzel PE, Dorr RT. Anticancer drug reanl toxicity and elimination: dosing guidelines for altered renal function.
Croatian: Anticancer drug renal toxicity and elimination: dosing guidelines for altered renal function.
English: For this reason, it is critical that the advantages of the oral administration route are carefully weighed against the disadvantages of larger within-patient variability in exposure after oral administration, which should be evaluated on an individual basis.
Croatian: Iz tog razloga važno je da se prednosti peroralne primjene pažljivo odvagnu u odnosu na nedostatke veće intraindividualne varijabilnosti osjetljivosti nakon peroralne primjene koju je potrebno procijeniti na pojedinačnoj osnovi.
English: With regards to fertility, pregnancy and lactation, section 4.6 of the SmPC, information addressed to women of childbearing potential with regards to contraception in males and females was included.
Croatian: U pogledu plodnosti, trudnoće i dojenja, u dio 4.6. SmPC-a uvrštene su informacije koje se odnose na žene u reproduktivnoj dobi u pogledu kontracepcije kod muškaraca i žena.
English: The changes to the SmPC, when relevant for the user, have also been reflected in the PL and endorsed by the CHMP.
Croatian: Izmjene SmPC-a koje su relevantne za korisnike navedene su i u uputi o lijeku te ih je podržao CHMP.
English: Vepesid contains etoposide, a semi-synthetic derivative of podophyllotoxin which ruptures double strand DNA by means of an interaction with DNA-topoisomerase II, or by the formation of free radicals.
Croatian: Lijek Vepesid sadrži etopozid koji je polusintetički derivat podofilotoksina koji raskida dvolančanu DNK interakcijom s DNK-topoizomerazom tipa II ili stvarajući slobodne radikale.
English: • The Committee considered the divergences identified in the notification for Vepesid and associated names, as well as the remaining sections of the product information.
Croatian: • Odbor je u obzir uzeo utvrđene razlike u prijavi za lijek Vepesid i srodne lijekove, kao i u preostalim dijelovima informacija o lijeku.
English: As regards the posology, all 17 SmPCs state in section 4.2 that the oral dose of etoposide capsules is based on the recommended intravenous (IV) dose and mention the need to consider bioavailability when prescribing, since it varies from patient to patient.
Croatian: U pogledu doziranja i načina primjene, u svih 17 sažetaka opisa svojstava lijeka u dijelu 4.2. navodi se da se peroralna doza kapsula etopozida temelji na preporučenoj intravenoznoj dozi (IV) te se napominje da prilikom propisivanja lijeka treba uzeti u obzir biološku raspoloživost s obzirom na to da se ona razlikuje od bolesnika do bolesnika.
English: - Non-Hodgkin's lymphoma
Croatian: - ne-Hodgkinov limfom
English: In particular, for the concomitant use of live vaccines, immunosuppression is a common side effect of etoposide listed as very common in the SmPC.
Croatian: To se osobito odnosi na istodobnu primjenu živih cjepiva s obzirom na to da je imunosupresija uobičajena nuspojava etopozida koja se navodi kao vrlo česta u SmPC-u.
English: - Hodgkin's lymphoma
Croatian: - Hodgkinov limfom
English: Vepesid and associated names was included in the list of products for summary of product characteristics (SmPC) harmonisation, drawn up by the CMDh, in accordance with Article 30(2) of Directive 2001/83/EC.
Croatian: Lijek Vepesid i srodni lijekovi uvršteni su na popis lijekova za usklađivanje sažetaka opisa svojstava lijeka (SmPC), koji sastavlja Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), u skladu s člankom 30. stavkom 2. Direktive 2001/83/EZ.
English: The product was subsequently approved in AT, BE, DE, DK, EE, ES, FI, HR, IE, IT, LU, NO, RO, SE, SI and UK.
Croatian: Lijek je naknadno odobren u Austriji, Belgiji, Njemačkoj, Danskoj, Estoniji, Španjolskoj, Finskoj, Hrvatskoj, Irskoj, Italiji, Luksemburgu, Norveškoj, Rumunjskoj, Švedskoj, Sloveniji i Ujedinjenoj Kraljevini.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product, the European Commission therefore notified the CHMP/European Medicines Agency on 14 October 2015 of a referral under Article 30 of Directive 2001/83/EC for Vepesid and associated names, in order to resolve divergences amongst the nationally authorised product information and thus harmonise the product information across the EU.
Croatian: Zbog različitih odluka na nacionalnoj razini koje su donijele države članice u pogledu odobrenja za ovaj proizvod, Europska je komisija 14. listopada 2015. obavijestila CHMP / Europsku agenciju za lijekove o pokretanju službenog postupka upućivanja za lijek Vepesid i srodne lijekove u skladu s člankom 30.
English: The CHMP as a consequence, concluded that the benefit-risk balance of Vepesid and associated names remains favourable, subject to the agreed changes to the product information.
Croatian: CHMP slijedom toga zaključuje da omjer koristi i rizika za lijek Vepesid ostaje povoljan pod uvjetom da se u informacije o lijeku unesu dogovorene izmjene.
English: The adult dosing section contains details on monotherapy, combination therapy, an alternative dosing schedule, and dosing adjustments for a low neutrophil count.
Croatian: Dio koji se odnosi na doziranje kod odraslih opširnije opisuje monoterapiju, kombiniranu terapiju, alternativni raspored doziranja i prilagođeno doziranje kod niskog broja neutrofila.
English: Increased within-patient variability in exposure may lead to greater variability in the dose-response relationship, i.e., leading to greater variability in patients' sensitivity to experience treatment
Croatian: Povećana intraindividualna varijabilnost izloženosti može dovesti do veće varijabilnosti u odnosu doze i odgovora, tj. do povećane varijabilnosti u odnosu na osjetljivost bolesnika na toksičnost povezanu s liječenjem od ciklusa do ciklusa, te potencijalno utjecati na ukupnu djelotvornost liječenja kod nekih bolesnika.
English: • The Committee agreed on a harmonised product information for Vepesid and associated names.
Croatian: • Odbor se usuglasio oko usklađenih informacija o lijeku za lijek Vepesid i srodne lijekove.
English: It has been found that with oral administration, within-patient variability in exposure (i.e. between cycles) is notably larger than after intravenous administration.
Croatian: Utvrđeno je da je kod peroralne primjene znatno veća intraindividualna varijabilnost izloženosti (npr. između ciklusa) nego nakon intravenozne primjene.
English: Appendix 3 (EMEA/CHMP/203927/2005).
Croatian: Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labellingAppendix 3 (EMEA/CHMP/203927/2005).
English: • The committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
Croatian: • Odbor je ponovno pregledao sve podatke koje je u prilog predloženog usklađenja informacija o lijeku dostavio nositelj odobrenja za stavljanje lijeka u promet.
English: In section 4.3 of the SmPC Contraindications, the inclusions of hypersensitivity and concomitant use of live vaccines have been agreed as these are in line with the SmPC guidelines.
Croatian: Usuglašeno je dodavanje preosjetljivosti i istodobne primjene živih cjepiva u dio 4.3. SmPC-a „Kontraindikacije”, s obzirom da su u skladu sa smjernicama o SmPC-u.
English: 3 Kreusser W, Herrmann R, Tschope W, et al. Nephrological complications of cancer therapy.
Croatian: 3 Kreusser W., Herrmann R., Tschope W., et al.
English: Toffoli G, Corona G, Basso B et al. Pharmacokinetic Optimisation of Treatment with Oral Etoposide.
Croatian: Toffoli G., Corona G., Basso B. et al.
English: 7 Fissell WH, IV, Earl M. Pharmacokinetics of Anti-cancer Chemotherapy in Renal Insufficiency and Dialysis.
Croatian: Pharmacokinetics of Anti-cancer Chemotherapy in Renal Insufficiency and Dialysis.
English: 4 Arbuck SG, Douglass HO, Crom WR et al. Etoposide Pharmacokinetics in Patients With Normal and Abnormal Organ
Croatian: 4 Arbuck S.G., Douglass H.O., Crom W.R. et al.
English: 1 Hande KR, Krozely MG, Greco FA et al. Bioavailability of Low-Dose Oral Etoposide.
Croatian: 1 Hande K.R., Krozely M.G., Greco F.A. et al.
English: Treatment of S-LAM
Croatian: Liječenje S-LAM-a
English: Further information on Rapamune can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Rapamune možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was the number of treatment failures (rejection or loss of the new kidney, or death) after 6 months.
Croatian: Glavno mjerilo učinkovitosti bio je broj neuspješnih terapija (odbacivanje ili gubitak novog bubrega ili smrt) nakon šest mjeseci.
English: The most common side effects with Rapamune (which may affect more than 1 in 10 people) are infections, fever, slow wound healing, low counts of various blood cells, blood tests showing altered levels of various substances (including low potassium and phosphate; raised fats, cholesterol, glucose and markers for tissue breakdown and for liver and kidney function), diabetes, lymphocele (collection of lymph fluid usually in the lower belly), pain in various parts of the body, rapid heartbeat, raised blood pressure, problems affecting the gut, proteinuria (protein in the urine), menstrual disorders, oedema (swelling because of fluid build-up), rash and acne.
Croatian: Najčešće nuspojave povezane s lijekom Rapamune (koje se mogu javiti u više od 1 na 10 osoba) jesu infekcije, vrućica, sporo zacjeljivanje rana, niske razine različitih krvnih stanica, promijenjene razine različitih tvari na krvnim pretragama (uključujući nisku razinu kalija i fosfata, povišene razine masti, kolesterola, glukoze i markera za raspad tkiva i za funkciju jetre i bubrega), dijabetes, limfocele (nakupljanje limfne tekuće, najčešće u donjem dijelu trbuha), bol u raznim dijelovima tijela, ubrzani rad srca, povećani krvni tlak, problemi s crijevima, proteinurija (protein u mokraći), menstrualni poremećaji, edemi (oticanje zbog nakupljanja tekućine), osip i akne.
English: This overview was last updated in 07-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran: 7. 2018.