natgillin/translations-raw huggingface dataset:
Effects on male and female fertility have not been evaluated within formal animal studies (see section 5.3).
Učinkov na plodnost pri moških in ženskah niso ugotavljali v formalnih študijah na živalih (glejte poglavje 5.3).
Cases of interstitial lung disease (ILD), including fatal cases, have been reported, with the majority of patients from the Japanese population.
Poročali so o primerih intersticijske pljučne bolezni (IPB), med katerimi so bili tudi smrtni primeri, pri čemer je bila večina bolnikov pripadnikov japonske populacije.
• chest pain (a symptom of side effects on your heart) If such symptoms occur, speak to a doctor immediately.
• bolečine v prsnem košu (znak neželenih učinkov na srce) Če se pojavijo taki simptomi, se nemudoma pogovorite z zdravnikom.
If you have heart problems, your doctor will discuss with you whether you can receive Erbitux in combination with other anticancer medicines, especially if you are 65 years of age or older.
Če imate težave s srcem, se bo vaš zdravnik z vami pogovoril, ali lahko prejemate zdravilo Erbitux v kombinaciji z drugimi zdravili proti raku, zlasti, če ste stari 65 let ali več.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
• a certain type of cancer of the head and neck (squamous cell cancer).
• Določenega tipa raka glave in vratu (raka skvamoznih celic).
If you notice other extensive skin alterations, please inform your doctor as soon as possible because the Erbitux dose or the time between infusions may need to be changed.
Če opazite drugo obsežno kožno spremembo, morate čim prej obvestiti zdravnika, saj bo morda treba spremeniti odmerek zdravila Erbitux ali čas med infundiranji.
Your doctor will decide whether treatment has to be stopped if skin reactions reappear after several dose reductions.
Vaš zdravnik se bo odločil, ali bo treba z zdravljenjem prenehati, če se kožna reakcija ponovno pojavi po večkratnih zmanjšanjih odmerka.
In these patients cetuximab should be administered only after a careful assessment of benefit/risk, including alternative treatments, and only under close supervision of well trained personnel with resuscitation equipment ready.
Pri teh bolnikih je treba dati cetuksimab samo po skrbni oceni koristi in tveganj, vključno z alternativnim zdravljenjem, in le pod skrbnim nadzorom dobro usposobljenega osebja in pripravljeno opremo za oživljanje.
If such symptoms occur, please inform your doctor as soon as possible.
Če se pojavijo tovrstni učinki, morate čim prej obvestiti zdravnika.
It is strongly recommended that Erbitux be given during pregnancy or to any woman not employing adequate contraception only if the potential benefit for the mother justifies a potential risk to the foetus.
Močno priporočamo, da zdravilo Erbitux uporabljate med nosečnostjo ali pri katerikoli ženski brez ustrezne kontracepcije samo, če njegova pričakovana korist za mater upraviči morebitno tveganje za plod.
• inflammation of the lining of the intestine, mouth, and nose (in some cases severe), which may lead to nose bleeding in some patients
• vnetje sluznice črevesa, ust in nosu (v nekaterih primerih resno), ki lahko pri nekaterih bolnikih povzroči krvavitev iz nosu
If the severe skin reaction occurred for the first time, treatment may be resumed without any change in dose level.
Če se je huda kožna reakcija pojavila prvič, lahko z zdravljenjem nadaljujete brez kakršnekoli spremembe velikosti odmerka.
Electrolyte repletion is recommended, as appropriate.
Po potrebi se priporoča nadomeščanje elektrolitov.
Once opened, Erbitux is intended for immediate use.
Po odprtju je zdravilo Erbitux namenjeno za takojšnjo uporabo.
Treatment may only be resumed if the reaction has resolved to grade 2.
Z zdravljenjem smete nadaljevati le, če se je reakcija izboljšala do 2. stopnje.
They usually disappear over time after the end of Erbitux therapy.
Ponavadi sčasoma izginejo po koncu zdravljenja z zdravilom Erbitux.
KRAS mutational status was available for 2072 patients.
Mutacijski status KRAS so lahko določili pri 2072 bolnikih.
In clinical studies with doses up to 700 mg/m 2 given every 2 weeks the safety profile was consistent with that described in section 4.8.
V kliničnih študijah z odmerki do 700 mg/m², ki so se dajali vsaka dva tedna, je bil varnostni profil skladen s profilom, opisanim v poglavju 4.8.
Talk to your doctor before using Erbitux, if any of the following information is not clear.
Pred začetkom uporabe zdravila Erbitux se posvetujte z zdravnikom, če vam katera od naslednjih informacij ni jasna.
Treatment with Erbitux must then be stopped.
Zdravljenje z zdravilom Erbitux je treba takrat ustaviti.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/06/2004
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 29/06/2004 Datum zadnjega podaljšanja: 29/06/2009
The majority of skin reactions develop within the first three weeks of therapy.
Večina kožnih reakcij se pojavi v prvih treh tednih zdravljenja.
The infusion rate must not exceed 10 mg/min.
Hitrost infuzije ne sme preseči 10 mg/min.
Animal data revealed no evidence of teratogenicity.
Podatki pri živalih niso pokazali dokazov o teratogenosti.
Do not use Erbitux if you have ever had a severe hypersensitivity (allergic) reaction to cetuximab.
Ne uporabljajte zdravila Erbitux, če ste imeli kdaj hudo preobčutljivostno (alergijsko) reakcijo na cetuksimab.
If during the first infusion, an infusion-related reaction occurs within the first 15 minutes, the infusion should be stopped.
Če se med prvim infundiranjem v prvih 15 minutah pojavi reakcija, povezana z infundiranjem, je treba infundiranje ustaviti.
If patients experience treatment-related symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Če ima bolnik simptome, povezane z zdravljenjem, ki vplivajo na njegovo zbranost in reakcijsko sposobnost, priporočamo, naj ne vozi ali upravlja strojev, dokler vpliv zdravila ne preneha.
Hypomagnesaemia (see section 4.4).
hipomagneziemija (glejte poglavje 4.4).
continue slow infusion and immediately administer treatment for symptoms c) Grade 3 and 4:
nadaljujte s počasnim infundiranjem in takoj dajte zdravilo za simptome c) 3. in 4. stopnja:
According to clinical practice guidelines prophylactic use of oral tetracyclines (6 - 8 weeks) and topical application of 1% hydrocortisone cream with moisturiser should be considered.
Glede na smernice klinične prakse je treba razmisliti o preventivni uporabi peroralnih tetraciklinov (6-8 tednov) in dermalna uporaba 1-% hidrokortizonske kreme z vlažilcem.
A careful benefit/risk assessment should be undertaken including consideration whether the patient may have preformed IgE antibodies before a subsequent infusion is given.
Opraviti je treba skrbno oceno koristi in tveganj, vključno z upoštevanjem, ali so se pri bolniku pojavila protitelesa proti IgE, preden se da naslednjo infuzijo.
Therefore, please make sure that you also read the package leaflet for the other medicines.
Zato morate prebrati tudi navodilo za uporabo drugih zdravil.
Bevacizumab plus FOLFIRI
Bevacizumab in FOLFIRI
The efficacy and safety of cetuximab have not been documented in patients with tumours where EGFR was not detected.
Učinkovitost in varnost cetuksimaba še nista bili dokumentirani pri bolnikih s tumorji, pri katerih EGFR niso odkrili.
The initial dose should be given slowly and speed of infusion must not exceed 5 mg/min (see section 4.4).
Začetni odmerek je treba dati počasi in hitrost infundiranja ne sme preseči 5 mg/min (glejte poglavje 4.4).
The first dose should be administered slowly and the speed must not exceed 5 mg/min whilst all vital signs are closely monitored for at least two hours.
Prvi odmerek je treba dati počasi, hitrost pa ne sme preseči 5 mg/min, ob tem pa je treba vsaj 2 uri skrbno spremljati vse vitalne znake.
Treatment may only be resumed at a lower dose level (200 mg/m² after the second occurrence and 150 mg/m² after the third occurrence), if the reaction has resolved to grade 2.
Z zdravljenjem lahko nadaljujete le z manjšim odmerkom (200 mg/m² po drugem pojavu reakcije in 150 mg/m² po tretjem pojavu reakcije) in le, če se je reakcija izboljšala do 2. stopnje.
In addition, hypokalaemia may develop as a consequence of diarrhoea.
Poleg tega se lahko pojavi hipokaliemija kot posledica driske.
Progressively decreasing serum magnesium levels occur frequently and may lead to severe hypomagnesaemia.
Pogosto se pojavi progresivno zniževanje nivoja magnezija v serumu, ki lahko povzroči hudo hipomagneziemijo.
The main undesirable effects of cetuximab are skin reactions, which occur in more than 80% of patients, hypomagnesaemia which occurs in more than 10% of patients and infusion-related reactions, which occur with mild to moderate symptoms in more than 10% of patients and with severe symptoms in more than 1% of patients.
Glavni neželeni učinki cetuksimaba so kožne reakcije, ki se pojavijo pri več kot 80 % bolnikov, hipomagneziemija, ki se pojavi pri več kot 10 % bolnikov, in reakcije, povezane z infundiranjem, ki se z blagimi do zmernimi simptomi pojavijo pri več kot 10 % bolnikov, s hudimi simptomi pa pri več kot 1 % bolnikov.
It is recommended that women do not breast-feed during treatment with Erbitux and for 2 months after the last dose, because it is not known whether cetuximab is excreted in breast milk.
Priporočamo tudi, naj ženske ne dojijo med zdravljenjem z zdravilom Erbitux in še 2 meseca po zadnjem odmerku, ker ni znano, ali se cetuksimab izloča v materino mleko.
In about 15 out of 100 patients these skin reactions are likely to be severe.
Pri približno 15 od 100 bolnikov bodo te kožne reakcije verjetno hude.
Erbitux does not contain any antimicrobial preservative or bacteriostatic agent.
Zdravilo Erbitux ne vsebuje nikakršnih protimikrobnih konzervansov ali bakteriostatikov.
stop infusion immediately, treat symptoms vigorously and contraindicate further use of cetuximab
takoj ustavite infundiranje, aktivno zdravite simptome in kontraindicirajte nadaljnjo uporabo cetuksimaba
During each infusion and for at least 1 hour afterwards, your condition will be checked regularly for early signs of a possible infusion-related side effect.
Med vsako infuzijo in še najmanj eno uro po njej bodo redno spremljali vaše stanje, da ugotovijo zgodnje znake morebitnega neželenega učinka, povezanega z infundiranjem.
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC06
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC06
You are more likely to experience severe allergic reactions if you are allergic to red meat, tick bites or had positive results for certain antibodies (seen in a test).
Bolj verjetno je, da boste doživeli hudo alergijsko reakcijo, če ste alergični na rdeče meso, ugrize klopa ali imate pozitivne rezultate na nekatera protitelesa (kot pokažejo testi).
It further induces the internalisation of EGFR, which can lead to downregulation of EGFR.
Potem sproži obrat EGFR navznoter, kar bi lahko vodilo do efektivnega zmanjšanja števila EGFR.
It is recommended to maintain this lower infusion rate in all subsequent infusions.
Priporočljivo je, da ostane hitrost infundiranja na nižji vrednosti tudi pri vseh naslednjih infuzijah.
There is no relevant use of Erbitux in children and adolescents.
Zdravilo Erbitux ni primerno za uporabo pri otrocih in mladostnikih.
With respect to the KRAS status, tumour samples were only available from 23% of the patients (300 of 1298).
Glede na KRAS status so bili vzorci tumorja na voljo za samo 23 % bolnikov (300 od 1.298).
The mean Cmax ( standard deviation) was 18555 microgram per mL.
Srednja vrednost Cmax (± standardna deviacija) je bila 185 ± 55 mikrogramov/ml.
Several pathways have been described that may contribute to the metabolism of antibodies.
Opisali so več presnovnih poti, ki bi lahko prispevale k presnovi protiteles.
Analyses on the RAS wild-type population are required to appropriately evaluate these data
Za ustrezno ocenitev teh podatkov so potrebne analize populacije nemutiranega tipa RAS
Main adverse reactions of cetuximab are skin reactions which may become severe, especially in combination with chemotherapy.
Glavni neželeni učinek cetuksimaba so kožne reakcije, ki lahko postanejo resne, zlasti v kombinaciji s kemoterapijo.
These reactions are commonly associated with bronchospasm and urticaria.
Te reakcije so pogosto povezane z bronhospazmom in urtikarijo.
Cetuximab has not been studied in patients presenting with one or more of the following laboratory parameters:
Cetuksimaba niso raziskovali pri bolnikih, ki so imeli katerega od naslednjih laboratorijskih parametrov:
In some studies association with age ≥ 65 years or performance status has been observed.
V nekaterih študijah so opazili povezavo s starostjo ≥ 65 let ali indeksom zmogljivosti.
In all studies, cetuximab was administered as described in section 4.2.
Pri vseh študijah se je cetuksimab dajal tako, kot je opisano v poglavju 4.2.
In very rare cases (may affect up to 1 in 10,000 people) patients may experience blistering or peeling of the skin, which may indicate a severe skin reaction called “Stevens-Johnson syndrome”.
V zelo redkih primerih (pojavijo se lahko pri do 1 od 10.000 bolnikov) se lahko pri bolnikih pojavijo mehurji ali luščenje kože, ki lahko kažejo na hudo kožno reakcijo, imenovano „Stevens-Johnsonov sindrom“.
Occurrence of a severe infusion-related reaction requires immediate and permanent discontinuation of cetuximab therapy and may necessitate emergency treatment.
Pojav hude reakcije, povezane z infundiranjem, zahteva takojšnjo in stalno ukinitev terapije s cetuksimabom, lahko pa je potrebno tudi urgentno zdravljenje.
Do not use this medicine after the expiry date which is stated on the label and the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake "Uporabno do".
To recognise early signs of such effects, your condition will be checked regularly while you receive each infusion of Erbitux and for at least 1 hour afterwards.
Da bi lahko prepoznali zgodnje znake teh učinkov, bodo vaše stanje redno preverjali med prejemanjem vsake infuzije zdravila Erbitux in še najmanj eno uro po infuziji.
Your doctor will decide whether treatment has to be stopped.
Vaš zdravnik se bo odločil, ali bo treba z zdravljenjem prenehati.
• in combination with irinotecan-based chemotherapy,
• v kombinaciji s kemoterapijo na osnovi irinotekana;
In addition, significantly fewer patients treated with cetuximab received second-line therapy.
Posledično je pomembno manj bolnikov, zdravljenih s cetuksimabom, prejelo sekundarno zdravljenje.
Symptoms may occur during the first infusion and for up to several hours afterwards or with subsequent infusions.
Simptomi se lahko pojavijo med prvo infuzijo in do nekaj ur po koncu ali pri naslednjih infundiranjih.
These signs may indicate a skin infection, which may have serious consequences including life-threatening conditions.
Ti znaki lahko kažejo na kožno okužbo, ki ima lahko resne posledice, vključno s smrtno nevarnimi stanji.
Most of these side effects develop within the first three weeks of treatment.
Večina neželenih učinkov se pojavi v prvih treh tednih zdravljenja.
The appearance of HACA did not correlate with the occurrence of hypersensitivity reactions or any other undesirable effect to cetuximab.
Pojav HAHP ni bil v korelaciji s pojavom preobčutljivostnih reakcij ali katerega drugega neželenega učinka cetuksimaba.
If a diagnosis of ulcerative keratitis is confirmed, treatment with cetuximab should be interrupted or discontinued.
Če je diagnoza ulcerativnega keratitisa potrjena, je treba zdravljenje s cetuksimabom prekiniti ali ukiniti.
The combination of cetuximab with irinotecan compared to cetuximab alone reduced the overall risk of disease progression by 46% and significantly increased objective response rate.
Kombinacija cetuksimaba in irinotekana je v primerjavi s samostojnim cetuksimabom zmanjšala skupno tveganje napredovanja bolezni za 46 % in pomembno povečala objektivno stopnjo odgovora.
Cetuximab has a long elimination half-life with values ranging from 70 to 100 hours at the target dose.
Cetuksimab ima dolgo razpolovno dobo izločanja z vrednostmi od 70 do 100 ur pri ciljnem odmerku.
Non-clinical data on genotoxicity and local tolerance including accidental administration by routes other than the intended infusion revealed no special hazard for humans.
Predklinični podatki o genotoksičnosti in lokalni toleranci, vključno z nenamernim dajanjem po drugih poteh (tj. ne z infuzijo), ne kažejo posebnega tveganja za človeka.
(5.8, NE)
(5,8; NMO)
Hypocalcaemia may also occur; in particular in combination with platinum-based chemotherapy the frequency of severe hypocalcaemia may be increased.
Lahko se pojavi hipokalciemija; zlasti v kombinaciji s kemoterapijo na osnovi platine se lahko pogostnost hude hipokalciemije poveča.
Detailed instructions for your doctor or your nurse on how to prepare the Erbitux infusion are included at the end of this package leaflet (see 'Handling instructions').
Na koncu tega navodila so dodana podrobna navodila za zdravnika ali medicinsko sestro o tem, kako pripraviti infuzijo zdravila Erbitux (glejte poglavje "Navodila za pripravo").
• leukocyte count < 3000/mm³
• število levkocitov < 3.000/mm³
Take an appropriate sterile syringe (minimum 50 mL) and attach a suitable needle.
Vzemite ustrezno sterilno brizgo (najmanj 50 ml) in nanjo pritrdite primerno iglo.
• inflammation of the eye lid or the front part of the eye
• vnetje očesne veke ali sprednjega dela očesa
Conjunctivitis.
konjunktivitis.
Dehydration, in particular secondary to diarrhoea or mucositis; hypocalcaemia (see section 4.4); anorexia which may lead to weight decrease.
dehidracija, zlasti zaradi driske ali mukozitisa; hipokalcemija (glejte poglavje 4.4); anoreksija, ki lahko povzroči zmanjšanje telesne mase.
Your doctor will discuss with you whether you may need any particular supervision (see also 'Side effects in combination with other anticancer treatments' in section 4).
Vaš zdravnik se bo z vami pogovoril, ali morda potrebujete posebni nadzor (glejte tudi "Neželeni učinki pri kombinaciji z drugimi oblikami zdravljenja proti raku" v poglavju 4).
• absolute neutrophil count < 1500/mm³
• absolutno število nevtrofilcev < 1.500/mm³
Set and control the rate as explained in section 4.2.
Nastavite in nadzorujte hitrost, kot je razloženo v poglavju 4.2.
Therefore, if you experience general signs of infection such as fever and tiredness, please speak to a doctor immediately.
Zato, če opazite splošne znake okužbe, kot sta zvišana telesna temperatura in utrujenost, se nemudoma pogovorite z zdravnikom.
The efficacy of cetuximab in paediatric patients below the age of 18 years has not been established.
Učinkovitost cetuksimaba pri pediatričnih bolnikih, starih do 18 let, ni bila dokazana.
The mean clearance was 0.022 L/h per m² body surface area.
Srednja vrednost očistka je bila 0,022 l/h/m² telesne površine.
Prior to the first infusion, patients must receive premedication with an antihistamine and a corticosteroid at least 1 hour prior to administration of cetuximab.
Pred prvo infuzijo mora bolnik prejeti premedikacijo z antihistaminikom in kortikosteroidom najmanj 1 uro pred uporabo cetuksimaba.
Please tell your doctor, if you have acute or worsening eye problems such as blurred vision, eye pain, red eyes and/or severe dry eye, if you have had such problems in the past or if you use contact lenses.
Obvestite zdravnika, če imate akutne težave z očmi ali težave z očmi, ki se slabšajo, na primer zamegljen vid, bolečine v očesu, pordelost očesa in/ali zelo suhe oči, če ste imeli take težave v preteklosti ali če uporabljate kontaktne leče.
Your doctor will therefore monitor your blood and general condition for signs of infection (see also 'Side effects in combination with other anticancer treatments' in section 4).
Zdravnik bo zato nadzoroval vašo kri in splošno stanje zaradi znakov okužbe (glejte tudi "Neželeni učinki pri kombinaciji z drugimi oblikami zdravljenja proti raku" v poglavju 4).
However, dependent on the dose, an increased incidence of abortion was observed (see section 5.3).
Opazili pa so povečano incidenco abortusov, odvisno od odmerka (glejte poglavje 5.3).
• in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.
• v kombinaciji s kemoterapijo na osnovi platine za ponavljajočo se in/ali metastatsko bolezen.
In combination with capecitabine and oxaliplatin (XELOX) the frequency of severe diarrhoea may be increased.
V kombinaciji s kapecitabinom in oksaliplatinom (zdravilo XELOX) se lahko pogostnost hude driske poveča.
No dose adjustment is required in older people, but the experience is limited in patients 75 years of age and above.
Pri starejših bolnikih prilagoditev odmerka ni potrebna, izkušnje pri bolnikih, starih 75 let ali več, pa so skope.
EGFR is involved in foetal development.
EGFR sodeluje pri razvoju ploda.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8ºC, unless opening has taken place in controlled and validated aseptic conditions.
Običajno naj čas do uporabe zdravila po odpiranju ne bi presegal 24 ur pri temperaturi shranjevanja med 2 in 8 °C, razen če je bilo odpiranje opravljeno v kontroliranih in validiranih aseptičnih pogojih.
Cetuximab binds to the EGFR with an affinity that is approximately 5- to 10-fold higher than that of endogenous ligands.
Cetuksimab se veže na EGFR z afiniteto, ki je približno 5 do 10-krat večja od afinitete endogenih ligandov.
Limited observations in animals are indicative of a placental transfer of cetuximab, and other IgG1 antibodies have been found to cross the placental barrier.
Omejena opažanja pri živalih kažejo na placentni prenos cetuksimaba, za druga IgG1 protitelesa pa so prav tako ugotovili, da prehajajo prek placentne pregrade.
Contact lens use is also a risk factor for keratitis and ulceration.
Tudi kontaktne leče so dejavnik tveganja za keratitis in razjedo.
Combination with other anticancer treatments
Kombinacija z drugimi oblikami zdravljenja proti raku
Following disease progression, treatment with EGFR-targeting agents was initiated in 50% of patients in the irinotecan-alone arm.
Po napredovanju bolezni so zdravljenje z zdravili, ki delujejo na EGFR, začeli pri 50 % bolnikov v skupini, ki je prejemala samo irinotekan.
Deep vein thrombosis.
globoka venska tromboza.
If an infusion-related reaction develops later during the infusion or at a subsequent infusion further management will depend on its severity:
Če se kasneje med infundiranjem ali pri naslednjih infuzijah pojavi reakcija, povezana z infundiranjem, je nadaljnja obravnava odvisna od resnosti:
Side effects of which the frequency is not known (cannot be estimated from the available data) • inflammation of the lining of the brain (aseptic meningitis)
Neželeni učinki z neznano pogostnostjo (ni mogoče oceniti iz razpoložljivih podatkov) • vnetje možganske ovojnice (aseptični meningitis)
A cytokine release syndrome (CRS) typically occurs within one hour after infusion and is less commonly associated with bronchospasm and urticaria.
Sindrom sproščanja citokinov se običajno pojavi v eni uri od infundiranja in je manj pogosto povezan z bronhospazmom in urtikarijo.
The use of cetuximab in combination with chemo-radiotherapy has so far not been adequately investigated.
Uporaba cetuksimaba v kombinaciji s kemoterapijo in radioterapijo doslej še ni bila primerno raziskana.
Pharmacokinetics in special populations
Farmakokinetika v posebnih skupinah bolnikov
Pulmonary embolism; interstitial lung disease, which may be fatal (see section 4.4).
pljučna embolija; intersticijska pljučna bolezen, ki ima lahko za posledico smrt (glejte poglavje 4.4).