natgillin/translations-raw huggingface dataset:
For cancers of the head and neck, Erbitux was investigated in two main studies:
Pri raku glave in vratu so zdravilo Erbitux proučevali v dveh glavnih študijah:
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).
Ta vrsta raka prizadene celice sluznice ustne votline ali žrela oziroma organov, kot je grlo (govorni aparat).
• together with the oxaliplatin-containing treatment FOLFOX in patients who have not been treated before;
• skupaj s terapijo FOLFOX, ki vsebuje oksaliplatin, pri bolnikih, ki predhodno še niso bili zdravljeni;
• on its own when previous treatment containing oxaliplatin and irinotecan has failed and the patient cannot receive irinotecan.
• samostojno, kadar predhodno zdravljenje raka z zdravili, ki vsebujejo oksaliplatin in irinotekan, ni bilo uspešno in bolnik ne more več prejemati irinotekana.
For the full list of all side effects reported with Erbitux, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Erbitux, glejte navodilo za uporabo.
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.
V eni študiji so ločeno analizirali tudi rezultate pri bolnikih, katerih tumorji so vsebovali divje tipe vseh genov RAS, in pri bolnikih z mutiranimi oblikami katerega koli gena RAS.
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:
V študijah raka kolona ali danke je bilo na splošno dokazano, da zdravilo Erbitux podaljša čas življenja bolnikov brez poslabšanja njihove bolezni ali čas njihovega preživetja:
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).
Pri ponavljajočem (ki se ponovi po predhodnem zdravljenju) ali metastatskem raku se zdravilo Erbitux uporablja v kombinaciji z zdravili za zdravljenje raka na osnovi platine (vključno z zdravili, kot je cisplatin ali karboplatin).
What is the risk associated with Erbitux?
Kakšna tveganja so povezana z zdravilom Erbitux?
The active substance in Erbitux, cetuximab, is a monoclonal antibody.
Zdravilna učinkovina v zdravilu Erbitux, cetuksimab, je monoklonsko protitelo.
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.
Kadar so geni RAS (kot je npr. gen KRAS) mutirani, lahko tumorske celice spodbudijo k rasti, ne da bi k njihovi aktivaciji pripomogel receptor za epidermalni rastni faktor, zato se ne pričakuje, da bi bilo zdravilo Erbitux koristno.
• 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.
• v dve študiji je bilo vključenih 1 535 bolnikov, ki predhodno še niso bili zdravljeni s kemoterapijo, v njej pa so proučevali učinkovitost dodajanja zdravila Erbitux kemoterapevtskemu zdravljenju s kombinacijo zdravil, ki so vsebovala irinotekan ali oksaliplatin (FOLFOX); v tretji študiji so pri 1 630 bolnikih proučevali tudi učinke dodajanja zdravila Erbitux dvema zdravljenjema s kombinacijo zdravil, ki so vsebovale oksaliplatin (eno je bilo podobno zdravljenju FOLFOX);
• 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.
• v drugo študijo je bilo vključenih 442 bolnikov s ponavljajočim se ali metastatskim rakom, v njej pa so proučevali učinke dodajanja zdravila Erbitux kombinaciji zdravil proti raku na osnovi platine.
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.
Vendar pa je bilo v tretji študiji celokupno preživetje bolnikov z divjim tipom gena KRAS le 16,3 meseca, kadar je bilo zdravilo Erbitux dodano zdravljenju z oksaliplatinom, podobnemu zdravljenju FOLFOX, v primerjavi s 18,2 meseca, če je bilo zdravljenje z oksaliplatinom uporabljeno samostojno;
When it is used on its own or with other anticancer medicines, Erbitux is continued for as long as the patient responds.
Kadar se zdravilo Erbitux uporablja samostojno ali skupaj z drugimi zdravili proti raku, se bolniku daje tako dolgo, dokler se nanj odziva.
Why has Erbitux been approved?
Zakaj je bilo zdravilo Erbitux odobreno?
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).
Pri ponavljajočem se ali metastatskem raku glave in vratu je bil čas preživetja daljši, kadar se je zdravilo Erbitux dodajalo kombinaciji zdravil proti raku na osnovi platine (povprečno 10,1 meseca v primerjavi s 7,4 meseca).
For metastatic cancer of the colon or rectum, Erbitux was studied in six main studies:
Pri metastatskem raku kolona ali danke so zdravilo Erbitux proučevali v šestih glavnih študijah:
Erbitux is also used to treat ‘squamous cell' cancers of the head and neck.
Zdravilo Erbitux se uporablja tudi za zdravljenje ploščatoceličnega raka glave in vratu.
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.
Zdravilo Erbitux se ne sme uporabljati skupaj s kemoterapijo, ki vsebuje oksaliplatin, pri bolnikih z metastatskim rakom kolona ali danke z mutiranim genom RAS ali tistih, pri katerih stanje gena RAS ni znano.
Erbitux is used to treat metastatic cancer of the colon or rectum (large intestine).
Zdravilo Erbitux se uporablja za zdravljenje metastatskega raka kolona ali danke (debelega črevesa).
When it is used with radiotherapy, Erbitux is started one week before the radiotherapy starts and continued until the radiotherapy has finished.
Kadar se uporablja skupaj z obsevanjem, se začne zdravilo dajati en teden pred začetkom obsevanja in se daje vse do konca obsevanja.
Erbitux is a solution for infusion (drip into a vein) that contains the active substance cetuximab.
Zdravilo Erbitux je raztopina za infundiranje (kapalno infuzijo v veno), ki vsebuje zdravilno učinkovino cetuksimab.
• 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.
• v prvi študiji, izvedeni pri bolnikih, ki so predhodno že prejemali kemoterapijo, niso opazovali mutacij gena RAS, v drugih dveh študijah pa je pri bolnikih s tumorji z divjim tipom gena KRAS, ki so prejemali zdravilo Erbitux kot dodatek k zdravljenju, do poslabšanja bolezni prišlo pozneje.
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).
Pri bolnikih, pri katerih zdravljenje z oksaliplatinom in irinotekanom ni bilo uspešno, se bolezen ni poslabšala povprečno 3,6 meseca pri bolnikih, ki so prejemali zdravilo Erbitux, v primerjavi z 1,9 meseca pri bolnikih, ki so prejemali samo podporno nego (zdravljenje simptomov, a ne samega raka).
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).
Bolniki z divjim tipom gena RAS, ki so prejemali zdravilo Erbitux v kombinaciji s kemoterapijo, ki je vsebovala oksaliplatin (FOLFOX), so živeli dlje brez poslabšanja bolezni v primerjavi z bolniki, ki so prejemali samo zdravljenje FOLFOX (v povprečju 12,0 meseca v primerjavi s 5,8 meseca).
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.
V večini študij so rezultate za bolnike s tumorji z divjim tipom gena KRAS (eno od vrste genov RAS) in za bolnike s tumorji z mutiranim genom KRAS analizirali ločeno.
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).
Pri lokalno napredovalem raku glave in vratu je bil čas do poslabšanja bolezni daljši pri bolnikih, ki so prejemali zdravilo Erbitux kot dodatek k obsevanju (povprečno 24,4 meseca v primerjavi s 14,9 meseca).
• 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).
• pri bolnikih, ki predhodno niso bili zdravljeni s kemoterapijo, in bolnikih s tumorji z divjim tipom gena KRAS so tisti, ki so prejemali zdravilo Erbitux kot dodatek h kemoterapiji, vključno z irinotekanom, živeli dlje brez poslabšanja bolezni (v povprečju 9,9 meseca v primerjavi z 8,4 meseca).
Cetuximab has been designed to attach to EGFR, which can be found on the surface of some tumour cells.
Zdravilna učinkovina cetuksimab je bila zasnovana tako, da se veže na receptor za epidermalni rastni faktor, ki ga najdemo na površini nekaterih tumorskih celic.
What is Erbitux used for?
Za kaj se zdravilo Erbitux uporablja?
How has Erbitux been studied?
Kako je bilo zdravilo Erbitux raziskano?
• the first study involved 424 patients with locally advanced cancer, looking at the effects of adding Erbitux to radiotherapy;
• v prvo študijo, v kateri so proučevali učinke dodajanja zdravila Erbitux med obsevanjem, je bilo vključenih 424 bolnikov z lokalno napredovalnim rakom;
What is Erbitux?
Kaj je zdravilo Erbitux?
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.
V skupini bolnikov, pri katerih zdravljenje z oksaliplatinom ni bilo uspešno, do poslabšanja ni prišlo povprečno 4,0 meseca pri bolnikih, ki so prejemali zdravilo Erbitux in irinotekan, in 2,6 meseca pri bolnikih, ki so prejemali samo irinotekan.
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.
Cetuksimab z vezavo na receptor za epidermalni rastni faktor preprečuje, da se to zgodi v tumorskih celicah, in pomaga zavirati njihovo rast.
How does Erbitux work?
Kako zdravilo Erbitux deluje?
How is Erbitux used?
Kako se zdravilo Erbitux uporablja?
Valproate Magnesium 10000mg/100 Ml
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280 tablet (skupno pakiranje)
The initial daily dose of Ucedane should be 100 mg per kilogram body weight, but up to 250 mg/kg can be used if necessary.
Začetni dnevni odmerek zdravila Ucedane naj bo 100 mg na kilogram telesne mase, če pa je treba, se lahko daje do 250 mg/kg.
What measures are being taken to ensure the safe and effective use of Ucedane?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ucedane?
It is not intended to provide practical advice on how to use Ucedane.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Ucedane carglumic acid
Ucedane kargluminska kislina
The full EPAR for Ucedane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ucedane je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What is Ucedane and what is it used for?
Kaj je zdravilo Ucedane in za kaj se uporablja?
Ucedane is available as dispersible tablets (200 mg) that are to be dispersed (mixed) in a small amount of water.
Zdravilo Ucedane je na voljo v obliki disperzibilnih tablet (200 mg), ki jih je treba dispergirati (zmešati) v majhni količini vode.