natgillin/translations-raw huggingface dataset:
For more information about treatment with Aldurazyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Aldurazyme pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
It is produced by a method known as ‘recombinant DNA technology': the enzyme is made by cells into which a gene (DNA) has been introduced that makes them able to produce laronidase.
Proizvodi se metodom poznatom kao „tehnologija rekombinantne DNK”: enzim tvore stanice u koje je unesen gen (DNK) koji im omogućuje proizvodnju laronidaze.
Aldurazyme is used in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; α L iduronidase deficiency) to treat the non-neurological symptoms of the disease (symptoms that are not connected with the brain or nerves).
Aldurazyme se koristi u bolesnika s potvrđenom dijagnozom mukopolisaharidoze I (MPS I; deficijencija -L-iduronidaze) za liječenje simptoma bolesti koji nisu neurološki (simptomi koji nisu povezani s mozgom ni živcima).
MPS I is a rare, inherited disease, in which the level of α L iduronidase enzyme activity is much lower than normal.
MPS I je rijetka, nasljedna bolest u koje je razina aktivnosti enzima -Liduronidaze mnogo niža od normalne.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aldurazyme.
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Aldurazyme.
What is the risk associated with Aldurazyme?
Koji su rizici povezani s lijekom Aldurazyme?
The non-neurological symptoms of MPS I can be an enlarged liver, stiff joints that make moving more difficult, reduced lung volume, heart disease and eye disease.
Simptomi bolesti MPS I koji nisu neurološki mogu biti povećana jetra, ukočeni zglobovi koji otežavaju kretanje, smanjen obujam pluća, bolest srca i bolest oka.
The most common side effects in patients over the age of five years (seen in more than 1 patient in 10) are headache, nausea (feeling sick), abdominal pain (stomach ache), rash, arthropathy (damage to the joints), arthralgia (joint pain), back pain, pain in the extremities (hands and feet), flushing, pyrexia (fever) and reactions at the site of the infusion.
Najčešće nuspojave u bolesnika starijih od pet godina (zapažene u više od 1 na 10 bolesnika) su glavobolja, mučnina (osjećaj slabosti), abdominalna bol (trbobolja), osip, artropatija (oštećenje zglobova), artralgija (bol u zglobovima), bol u leđima, bol u ekstremitetima (šakama i stopalima), crvenilo, pireksija (vrućica) i reakcije na mjestu infuzije.
Why has Aldurazyme been approved?
Zašto je Aldurazyme odobren?
The active substance in Aldurazyme, laronidase, is a copy of the human enzyme α L iduronidase.
Djelatna tvar u lijeku Aldurazyme, laronidaza, kopija je humanog enzima -L-iduronidaze.
Aldurazyme treatment should be supervised by a doctor who has experience in the management of patients with MPS I or other inherited metabolic diseases.
Liječenje lijekom Aldurazyme mora nadzirati liječnik s iskustvom u liječenju bolesnika oboljelih od MSP I ili drugih nasljednih metaboličkih bolesti.
Aldurazyme is a solution for infusion (drip) into a vein that contains the active substance laronidase.
Aldurazyme je otopina za infuziju (drip) u venu koja sadrži djelatnu tvar laronidazu.
In patients under five years of age, the most common side effects (seen in more than 1 patient in 10) are increased blood pressure, decreased oxygen saturation (a measure of how well the lungs are working), tachycardia (rapid heart rate), pyrexia and chills.
U bolesnika mlađih od pet godina najčešće nuspojave (zapažene u više od 1 na 10 bolesnika) su povišeni krvni tlak, smanjena saturacija kisika (mjerilo kvalitete funkcioniranja pluća), tahikardija (brz rad srca), pireksija i zimica.
Most of the side effects seen with Aldurazyme are reactions caused by the infusion procedure rather than the medicine itself.
Većina nuspojava zapaženih pri primjeni lijeka Aldurazyme reakcije su prouzročene postupkom infuzije, a nesamim lijekom.
What is Aldurazyme?
Što je Aldurazyme?
Laronidase is used as ‘enzyme replacement therapy', which means that it replaces the enzyme that is missing in patients with MPS I. This controls the symptoms of MPS I, improving the patient's quality of life.
Laronidaza se upotrebljava kao „enzimska nadomjesna terapija”, što znači da zamjenjuje enzim koji nedostaje u bolesnika s MPS I.
What benefit has Aldurazyme shown during the studies?
Koje su koristi lijeka Aldurazyme utvrđene u ispitivanjima?
The CHMP decided that Aldurazyme gives effective control of the symptoms of MPS I. The Committee decided that Aldurazyme's benefits are greater than its risks and recommended that Aldurazyme be given marketing authorisation.
Odbor je odlučio da koristi lijeka Aldurazyme nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka Aldurazyme u promet.
For the full list of all side effects reported with Aldurazyme, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Aldurazyme potražite u uputi o lijeku.
What is Aldurazyme used for?
Za što se Aldurazyme koristi?
How does Aldurazyme work?
Kako Aldurazyme djeluje?
Aldurazyme has been compared with placebo (a dummy treatment) in 45 patients aged six years and over with a confirmed diagnosis of MPS I. The main measure of effectiveness was the forced vital capacity (FVC, a measure of how well the lungs are working) and the distance the patients could walk over six minutes.
Aldurazyme je uspoređen s placebom (prividnim liječenjem) u 45 bolesnika u dobi od šest godina i više s potvrđenom dijagnozom bolesti MPS I.
How has Aldurazyme been studied?
Kako je Aldurazyme ispitivan?
How is Aldurazyme used?
Kako se Aldurazyme koristi?
Content (concentration)
Put primjene Unutarnje pakiranje Sadržaj (koncentracija)
Immediate packaging
Veličina pakiranja
Skin reactions are seen in more than 80% of patients.
Kožne reakcije uočene su u više od 80% bolesnika.
Erbitux is given once a week.
Erbitux se daje jednom na tjedan.
Patients must also be closely observed for any signs of allergic reaction for at least one hour after the end of the infusion.
Bolesnici se moraju također pažljivo promatrati kako bi se uočili bilo kakvi znakovi alergijskih reakcija najmanje jedan sat nakon završetka infuzije.
This summary was last updated in 12-2013.
Sažetak je posljednji put ažuriran: 12.2013.
Erbitux is given in the following ways:
Erbitux se primjenjuje na sljedeće načine:
Between 79 and 89% of colorectal cancers and more than 90% of squamous cell cancers of the head and neck have EGFR on their cell surfaces.
Između 79 i 89% kolorektalnih karcinoma i više od 90% karcinoma skvamoznih stanica vrata i glave imaju EGFR na površini svojih stanica.
The following infusions are 250 mg/m2 given over one hour.
Naredne infuzije daju se u dozi od 250 mg/m2 tijekom jednog sata.
The full EPAR for Erbitux can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Erbitux nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Erbitux on 29 June 2004.
Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Erbitux vrijedi na prostoru Europske unije od 29. lipnja 2004.
The first infusion is given at a dose of 400 mg per square metre body surface area (calculated using the patient's height and weight) over two hours.
Prva se infuzija daje u dozi od 400 mg po metru kvadratnom tjelesne površine (izračunato pomoću visine i tjelesne težine bolesnika) tijekom razdoblja od dva sata.
All of the studies looked at how long the patients lived without their cancer getting worse or how long they survived.
Sva su ispitivanja istražila koliko su dugo bolesnici živjeli, a da se karcinom nije pogoršao ili koliko su dugo preživjeli.
Erbitux can be associated with severe reactions during the infusion, so the patients must be monitored carefully while the medicine is being given.
Erbitux se može povezati s ozbiljnim reakcijama tijekom infuzije, tako da se bolesnici moraju pažljivo pratiti tijekom davanja lijeka.
Other information about Erbitux
Ostale informacije o lijeku Erbitux
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Erbitux.
Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Erbitux.
Before receiving Erbitux, the patient must be given an antihistamine and a corticosteroid to prevent an allergic reaction.
Prije nego što primi Erbitux, bolesniku se mora dati antihistamin i kortikosteroid kako bi se spriječila alergijska reakcija.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Monoklonalno protutijelo je protutijelo (tip protein) koje je dizajnirano kako bi prepoznalo i vezalo se na posebne strukture (naziva antigen) u tijelu.
When it is used with radiotherapy, Erbitux is started one week before the radiotherapy starts and continued until the radiotherapy has finished.
Ako se koristi s radioterapijom, s primjenom lijeka Erbitux treba započeti jedan tjedan prije početka radioterapije i nastaviti sve dok se radioterapija ne završi.
This is a summary of the European public assessment report (EPAR) for Erbitux.
Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Erbitux.
For more information about treatment with Erbitux, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Erbitux pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
• on its own when previous treatment containing oxaliplatin and irinotecan has failed and the patient cannot receive irinotecan.
• samostalno u slučajevima kada prethodna terapija koja je sadržavala oksaliplatin i irinotekan nije bila uspješna i bolesnici ne mogu uzimati irinotekan.
The most common side effects with Erbitux (seen in more than 1 patient in 10) are skin reactions such as rash, hypomagnesaemia (low blood magnesium levels), mild or moderate reactions linked to the infusion (such as fever, chills, dizziness and difficulty breathing), mucositis (inflammation of the lining of the mouth) and raised levels of some liver enzymes.
Najčešće nuspojave lijeka Erbitux (kod više od 1 na 10 osoba) su kožne reakcije poput osipa, hipomagnezemije (niskih razina magnezija u krvi), blagih ili umjerenih reakcija povezanih s infuzijom (poput groznice, drhtavice, vrtoglavice i otežanog disanja), mukozitisa (upale sluznice usta) i povišenih razina enzima jetre.
• together with anticancer treatments containing irinotecan;
• zajedno s antineoplastičkim terapijama koje sadrže irinotekan;
EPAR summary for the public cetuximab
EPAR, sažetak za javnost cetuksimab
Erbitux is used in patients whose tumour cells have a protein on their surface called epidermal growth factor receptor (EGFR) and contain ‘wild-type' (non-mutated) versions of a family of genes called ‘RAS'.
Erbitux se koristi u bolesnika čije tumorske stanice sadrže protein na površini naziva receptor za epidermalni faktor rasta (EGFR) i sadrži verzije „divljeg (nemutiranog) tipa” obitelji gena naziva „RAS”.
In locally advanced cancer (when the tumour has grown but has not spread), Erbitux is given in combination with radiotherapy (treatment with radiation).
U slučaju karcinoma koji su se lokalno razvili (u slučaju kada je tumor narastao, no nije se raširio), Erbitux se primjenjuje u kombinaciji s radioterapijom (liječenjem zračenjem).
EGFR is involved in switching on genes called RAS that are involved in the growth of cells; by attaching to EGFR, cetuximab prevents this from happening in the tumour cells and helps stop them growing.
EGFR je uključen u aktiviranje gena naziva RAS koji su uključeni u rast stanica; vezivanjem na EGFR, cetuksimab sprječava da se to dogodi u tumorskim stanicama te pomaže pri zaustavljanju njihova rasta.
The CHMP decided that Erbitux's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je odlučio da koristi od lijeka Erbitux nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
• together with the oxaliplatin-containing treatment FOLFOX in patients who have not been treated before;
• zajedno s liječenjem koje sadrži oksaliplatin FOLFOX u bolesnika koji nisu prethodno liječeni;
These types of cancer affect the cells of the lining of the mouth or the throat, or of organs such as the larynx (voice box).
Ovi tipovi karcinoma utječu na stanice sluznice usta ili grla ili organa poput larinksa (grkljana).
One of the studies also looked at the results separately in patients whose tumours carried wild-type forms of all RAS genes and patients with mutated forms of any RAS gene.
Jedno od ispitivanja je također zasebno istražilo rezultate prikupljene u bolesnika čiji su tumori nosili oblike divljega tipa svih RAS gena i bolesnika s mutiranim oblicima bilo kojeg RAS gena.
• two studies involved 1,535 patients who had not received chemotherapy before, looking at the effects of adding Erbitux to a treatment combination containing either irinotecan or oxaliplatin (FOLFOX); a third study looked also at the effects of adding Erbitux to two treatment combinations containing oxaliplatin (one of which was similar to FOLFOX) in 1,630 patients.
• dva su ispitivanja obuhvatila 1 535 bolesnika koji ranije nisu primili kemoterapiju, te je istraženo djelovanje dodavanja lijeka Erbitux u terapijsku kombinaciju koja je sadržavala irinotekan ili oksaliplatin (FOLFOX); treće je ispitivanje istražilo djelovanje dodavanja lijeka Erbitux u dvije terapijske kombinacije koje su sadržavale oksaliplatin (od kojih je jedna slična FOLFOX-u) u 1 630 bolesnika.
Cetuximab has been designed to attach to EGFR, which can be found on the surface of some tumour cells.
Cetuksimab je dizajniran za vezanje na EGFR, koji se nalazi na površini pojedinih tumorskih stanica.
• three studies involved 2,199 patients whose disease had got worse while they were on previous treatment including irinotecan, oxaliplatin or both, or who could not receive these medicines.
• tri su ispitivanja obuhvatila 2 199 bolesnika čija se bolest pogoršala tijekom ranije terapije irinotekanom, oksaliplatinom ili obama lijekovima, ili bolesnike koji nisu mogli primiti ove lijekove.
Erbitux must not be used with oxaliplatin-containing chemotherapy for metastatic colorectal cancer in patients with mutated RAS or for whom RAS status is unknown.
Erbitux se ne smije koristiti zajedno s kemoterapijom koja sadrži oksaliplatin za metastatski kolorektalni karcinom u bolesnika s mutiranim RAS-om ili za koje status RAS-a nije poznat.
In cancer that is recurrent (when it has come back after previous treatment) or metastatic, Erbitux is used with a ‘platinum-based' anticancer medicine combination (including medicines such as cisplatin or carboplatin).
U slučaju rekurentnog karcinoma (ako se vratio nakon prethodnog liječenja) ili metastatskog karcinoma, Erbitux se koristi kao kombinacija antineoplastičkih lijekova „baziranih na platini” (uključujući lijekove poput ciplastina ili karboplatina).
For cancers of the head and neck, Erbitux was investigated in two main studies:
U slučaju karcinoma glave i vrata, Erbitux je ispitan u dva glavna ispitivanja:
Erbitux is also used to treat ‘squamous cell' cancers of the head and neck.
Erbitux se također koristi za liječenje karcinoma „skvamoznih stanica” glave i vrata.
What is the risk associated with Erbitux?
Koji su rizici povezani s lijekom Erbitux?
Erbitux should only be given under the supervision of a doctor who has experience in the use of anticancer medicines in a setting where facilities for resuscitation are available.
Erbitux se mora primijeniti pod nadzorom liječnika iskusnog u primjeni antineoplastičkih lijekova u okruženju u kojem je dostupna opreme za oživljavanje.
The active substance in Erbitux, cetuximab, is a monoclonal antibody.
Djelatna stvar u lijeku Erbitux, cetuksimab, je monoklonalno protutijelo.
Most of the studies looked at the results separately in patients whose tumours had wildtype KRAS (one of the types of RAS genes) and patients whose tumours had mutated KRAS.
Većina je ispitivanja analizirala rezultate zasebno u bolesnika čiji su tumori imali divlji tip KRAS (jedan od tipova RAS gena) i u bolesnika čiji su tumori imali mutirani KRAS.
In the studies of cancer of the colon or rectum, Erbitux was shown overall to increase the time patients lived without their cancer getting worse or how long they survived:
U ispitivanjima karcinoma kolona ili rektuma, načelno je dokazano da lijek Erbitux produžava vrijeme tijekom kojeg su bolesnici živjeli bez pogoršanja raka ili vrijeme preživljenja:
• the first study involved 424 patients with locally advanced cancer, looking at the effects of adding Erbitux to radiotherapy;
• prvim su ispitivanjem obuhvaćena 424 bolesnika s lokalno uznapredovanim karcinomom, te je istraženo djelovanje dodavanja lijeka Erbitux u radioterapiju;
However, in the third study, patients with wild-type KRAS only survived overall for 16.3 months when Erbitux was added to the another oxaliplatin-based treatment similar to FOLFOX, compared with 18.2 months when the oxaliplatin-based treatment was used alone.
No, u trećem ispitivanju, bolesnici samo s KRAS-om divljeg tipa živjeli su ukupno 16,3 mjeseci dulje nakon što je Erbitux dodan drugom liječenju temeljenom na oksaliplatinu koje je slično lijeku FOLFOX, u usporedbi s 18,2 mjeseca u slučaju liječenja kada je korišteno samo liječenje temeljeno na oksaliplatinu.
When it is used on its own or with other anticancer medicines, Erbitux is continued for as long as the patient responds.
Ako se koristi kao monoterapija ili s drugim antineoplastičkim lijekovima, Erbitux treba nastaviti davati tako dugo dok postoje odgovori bolesnika.
Why has Erbitux been approved?
Zašto je Erbitux odobren?
What is Erbitux?
Što je Erbitux?
For metastatic cancer of the colon or rectum, Erbitux was studied in six main studies:
U slučaju metastatskog karcinoma crijeva ili rektuma, Erbitux se ispitivao u šest glavnih ispitivanja:
Erbitux is a solution for infusion (drip into a vein) that contains the active substance cetuximab.
Erbitux je otopina za infuziju (drip u venu) koja sadrži djelatnu tvar cetuksimab.
In recurrent or metastatic head and neck cancer, survival was longer when Erbitux was added to a platinum-based anticancer medicine combination (10.1 months compared with 7.4 months, on average).
U slučaju rekurentnog ili metastatskog karcinoma glave i vrata, preživljenje je bilo duže ako se Erbitux dodao u kombinaciju protutumorskih lijekova baziranih na platini (prosječno 10,1 mjesec u odnosu na 7,4 mjeseci).
In patients receiving Erbitux in combination with oxaliplatin-containing chemotherapy (FOLFOX) patients with wild-type RAS lived for longer without their disease getting worse compared with patients on FOLFOX alone (12.0 months compared with 5.8 months, on average).
U bolesnika koji su primali lijek Erbitux u kombinaciji s kemoterapijom koja je sadržavala oksaliplatin (FOLFOX), bolesnici s RAS-om divljeg tipa živjeli su dulje, a da se njihova bolest nije pogoršala, u usporedbi s bolesnicima samo na lijeku FOLFOX (prosječno 12,0 mjeseci u usporedbi s 5,8 mjeseci).
• the second study involved 442 patients with recurrent or metastatic cancer, looking at the effects of adding Erbitux to a platinum-based anticancer medicine combination.
• drugim su ispitivanjem obuhvaćena 442 bolesnika s rekurentnim ili metastatskim karcinomom, te je istraženo djelovanje dodavanja lijeka u Erbitux kombinaciju protutumorskih lijekova baziranih na platini.
Patients who had failed both oxaliplatin and irinotecan treatment lived for an average of 3.6 months without their disease getting worse with Erbitux, compared with 1.9 months in those receiving best supportive care alone (the treatment of symptoms but not the cancer itself).
Bolesnici kod kojih liječenje oksaliplatinom i irinotekanom nije bilo uspješno živjeli su prosječno 3,6 mjeseci, a da se njihova bolest nije pogoršala, s lijekom Erbitux, u usporedbi s 1,9 mjeseci u bolesnika koji su primali samo najbolju potpornu skrb (liječenje simptoma, no ne i samog karcinoma).
• in patients who had not received chemotherapy before, patients who had wild-type KRAS in their tumours lived for longer without their disease getting worse when they received Erbitux in addition to chemotherapy including irinotecan (9.9 months compared with 8.4 months, on average).
• u bolesnika koji nisu prethodno primili kemoterapiju, bolesnici koji su imali KRAS divljeg tipa u svojim tumorima živjeli su dulje, a da se njihova bolest nije pogoršala, nakon što su primili lijek Erbitux uz kemoterapiju koja je uključivala irinotekan (prosječno 9,9 mjeseci u usporedbi s 8,4 mjeseci).
When RAS genes (such as KRAS) are mutated they can stimulate the tumour cells to grow without being switched on by EGFR, so Erbitux would not be expected to be of much help.
KRAS-a) mutiraju, oni mogu stimulirati stanice tumora da rastu, a da ih ne aktivira EGFR, tako da se ne može očekivati velika pomoć od lijeka Erbitux.
What benefit has Erbitux shown during the studies?
Koje su koristi lijeka Erbitux dokazane u ispitivanjima?
In locally advanced head and neck cancers, the patients lived for longer without their disease getting worse when Erbitux was added to radiotherapy (24.4 months compared with 14.9 months, on average).
U slučaju karcinoma koji su napredovali lokalno u području glave i vrata, bolesnici su živjeli dulje, a da se njihova bolest nije pogoršala, ako se radioterapiji dodao lijek Erbitux (prosječno 24,4 mjeseca u usporedbi sa 14,9 mjeseci).
What is Erbitux used for?
Za što se Erbitux koristi?
Patients who had failed oxaliplatin treatment lived for an average of 4.0 months without their disease getting worse with Erbitux plus irinotecan, compared with 2.6 months in those receiving irinotecan alone.
Bolesnici u kojih liječenje oksaliplatinom nije bilo uspješno živjeli su prosječno 4,0 mjeseci, a da se njihova bolest nije pogoršala, s lijekom Erbitux i irinotekanom, u usporedbi s 2,6 mjeseci u onih koji su primali samo irinotekan.
For the full list of all side effects reported with Erbitux, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Erbitux potražite u uputi o lijeku.
How is Erbitux used?
Kako se Erbitux koristi?
‘Metastatic' means that the cancer has spread to other parts of the body.
Erbitux se koristi za metastatskog karcinoma crijeva ili rektuma (debelog crijeva). „Metastatski” znači da se karcinom proširio na druge dijelove tijela.
How has Erbitux been studied?
Kako se Erbitux ispitivao?
How does Erbitux work?
Kako djeluje Erbitux?
• the first study in patients who had taken chemotherapy before did not look at RAS mutations, but in the other two studies, patients with wild-type KRAS in their tumours lived for longer without their disease getting worse when Erbitux was added to their treatment.
No, u druga dva ispitivanja bolesnici s KRAS-om divljeg tipa u tumorima živjeli su dulje, a da se njihova bolest nije pogoršala, nakon što je lijek Erbitux dodan njihovom liječenju.
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