FrancophonIA/ELRC3.0 huggingface dataset:
English: • blood clot in the lung (pulmonary embolism) the symptoms of which may be sudden onset of shortness of breath or chest pain; nose bleed (epistaxis); blood clot in a deep vein (deep vein thrombosis); high blood pressure (hypertension); flushing;
Slovenian: • krvni strdek v pljučih (pljučna embolija), simptomi tega so lahko nenaden pojav kratke sape ali bolečine v prsih, krvavitev iz nosu (epistaksa), krvni strdek v globoki veni (globoka venska tromboza), visok krvni tlak (hipertenzija), zardevanje,
English: There is no clinical data to support dose adjustments in the elderly.
Slovenian: Kliničnih podatkov, ki bi podprli prilagoditev odmerka pri starejših, ni. Pediatrična populacija
English: loosening of the nails (onycholysis); ingrowing nail; excessive hair growth (hirsutism);
Slovenian: odstopanje nohtov (oniholiza), vraščanje nohta, čezmerna rast dlak (hirzutizem),
English: Activating mutations in the RAS genes occur frequently in a variety of human tumours and have been implicated in both oncogenesis and tumour progression.
Slovenian: Aktivacijske mutacije genov RAS so pogoste v različnih tumorjih pri človeku.
English: Panitumumab may impact the ability of a woman to become pregnant.
Slovenian: Panitumumab lahko vpliva na sposobnost ženske, da zanosi.
English: • low white blood numbers (leucopenia); low calcium levels in the blood (hypocalcaemia); low phosphates in the blood (hypophosphataemia); high glucose in the blood (hyperglycaemia);
Slovenian: • majhno število belih krvnih celic (levkopenija), nizka koncentracija kalcija v krvi (hipokalciemija), nizka koncentracija fosfatov v krvi (hipofosfatemija), visoka koncentracija glukoze v krvi (hiperglikemija),
English: If you are a woman of child bearing potential, you should use effective methods of contraception during treatment with Vectibix and for 2 months after the last dose.
Slovenian: Če ste ženska v rodni dobi, morate med zdravljenjem z zdravilom Vectibix in še 2 meseca po zadnjem odmerku uporabljati učinkovite metode kontracepcije.
English: For clinical management of infusion-related reactions, see section 4.4.
Slovenian: Za klinično obvladovanje z infundiranjem povezanih reakcij glejte poglavje 4.4.
English: Uncommon (≥ 1/1,000 to
Slovenian: Občasni (≥ 1/1.000 do < 1/100)
English: ORR (%)
Slovenian: ORR (%) (95 % IZ)
English: Vectibix must be administered using a low protein binding 0.2 or 0.22 micrometre in-line filter, through a peripheral line or indwelling catheter.
Slovenian: Zdravilo Vectibix morate aplicirati z 0,2- ali 0,22-mikrometrskim linijskim filtrom z majhno vezavo beljakovin, in sicer skozi periferen venski kanal ali stalni kateter.
English: Dermatological reactions (including nail effects), observed in patients treated with Vectibix or other EGFR inhibitors, are known to be associated with the pharmacologic effects of therapy.
Slovenian: Znano je, da so dermatološke reakcije (vključno z učinki na nohtih), ki so jih opažali pri bolnikih, zdravljenih z zdravilom Vectibix ali drugimi zaviralci EGFR, povezane s farmakološkimi učinki takšnega zdravljenja.
English: Vectibix must be administered as an intravenous infusion via an infusion pump, using a low protein binding 0.2 or 0.22 micrometre in-line filter, through a peripheral line or indwelling catheter.
Slovenian: Zdravilo Vectibix morate aplicirati v intravenski infuziji z infuzijsko črpalko in uporabo 0,2- ali 0,22-mikrometrskega linijskega filtra z majhno vezavo beljakovin, in sicer skozi periferen venski kanal ali stalni kateter.
English: Vectibix should not be administered in combination with IFL chemotherapy or with bevacizumabcontaining chemotherapy.
Slovenian: Zdravila Vectibix se ne sme uporabljati v kombinaciji s kemoterapijo IFL ali kemoterapijo, ki vključuje bevacizumab.
English: No clinical studies have been conducted to examine the pharmacokinetics of panitumumab in patients with renal or hepatic impairment.
Slovenian: Klinične študije za proučitev farmakokinetike panitumumaba pri bolnikih z okvaro ledvic ali jeter niso bile izvedene.
English: In a randomised, open-label, controlled clinical trial, chemotherapy (oxaliplatin or irinotecan) and bevacizumab were given with and without panitumumab in the first-line treatment of patients with metastatic colorectal cancer (n = 1,053 [n = 823 oxaliplatin cohort, n = 230 irinotecan cohort]).
Slovenian: V randomiziranem, odprtem, kontroliranem kliničnem preskušanju so v terapiji prve izbire pri bolnikih z metastatskim kolorektalnim rakom uporabljali kemoterapijo (oksaliplatin ali irinotekan) in bevacizumab s panitumumabom ali brez njega (n = 1.053 [n = 823 kohorta z oksaliplatinom, n = 230 kohorta z irinotekanom]).
English: Cetuximab (n = 500)
Slovenian: Cetuksimab (n = 500)
English: Also, dry skin, fissures (cracks in the skin) on the fingers or toes, fingernail bed or toenail bed infection (paronychia) or inflammation has been reported.
Slovenian: Poročali so tudi o suhi koži, fisurah (razpoke na koži) na prstih na rokah in na prstih na nogah, okužbi obnohtja na prstih na rokah in obnohtja na prstih na nogah (paronihija) ali vnetju.
English: Patients were randomised 1:1 to receive Vectibix at a dose of 6 mg/kg given once every two weeks plus best supportive care (not including chemotherapy) (BSC) or BSC alone.
Slovenian: Bolniki so bili v razmerju 1:1 randomizirani bodisi na zdravljenje z zdravilom Vectibix v odmerku 6 mg/kg enkrat na dva tedna in najboljšo podporno oskrbo (BSC - Best Supportive Care) (kar ni vključevalo kemoterapije) bodisi na samo BSC. Bolniki so bili zdravljeni, dokler se ni pojavilo napredovanje bolezni ali nesprejemljivi toksični učinki.
English: Dermatological reactions (including nail effects), observed in patients treated with Vectibix or other EGFR inhibitors, are known to be associated with the pharmacologic effects of therapy (with crossreference to sections 4.2 and 4.8).
Slovenian: Znano je, da so dermatološke reakcije (vključno z učinki na nohte), ki so jih opažali pri bolnikih, zdravljenih z zdravilom Vectibix ali drugimi zaviralci EGFR, povezane s farmakološkimi učinki takšnega zdravljenja (s sklicem na poglavji 4.2 in 4.8).
English: Vectibix plus BSC (n = 124)
Slovenian: zdravilo Vectibix in BSC (n = 124)
English: Vectibix should be inspected visually prior to administration.
Slovenian: Pred uporabo morate zdravilo Vectibix vizualno pregledati.
English: How to use Vectibix
Slovenian: Kako uporabljati zdravilo Vectibix
English: Median Duration of response (months) (95% CI)
Slovenian: Mediana trajanja odziva (meseci) (95 % IZ)
English: Severe (NCI-CTC grade 3) skin reactions were reported in 23% and life-threatening (NCI-CTC grade 4) skin reactions in < 1% of patients.
Slovenian: Poročali so o hudih kožnih reakcijah (3. stopnja po NCI-CTC) pri 23 % bolnikov in o življenjsko ogrožujočih kožnih reakcijah (4. stopnja po NCI-CTC) pri < 1 % bolnikov.
English: • The incidence of binding antibodies (excluding predose positive patients) was 1% as detected by the acid-dissociation ELISA and < 1% as detected by the Biacore assay;
Slovenian: • Incidenca protiteles, ki vežejo panitumumab (izključeni bolniki, pozitivni pred odmerkom in prehodno pozitivni bolniki) določena s kislinsko-disociacijskim testom ELISA je bila < 1 %, določena s preizkusom »Biacore« pa 3,8 %.
English: For patients with ECOG 2 performance status, assessment of benefit-risk is recommended prior to initiation of Vectibix in combination with chemotherapy for treatment of mCRC.
Slovenian: Pri bolnikih z zmogljivostnim stanjem 2 po ECOG je pred uvedbo zdravila Vectibix v kombinaciji s kemoterapijo za zdravljenje mKRR priporočljivo oceniti koristi in tveganje.
English: No pre- and post-natal development animal studies have been conducted with panitumumab.
Slovenian: Študije prenatalnega in postnatalnega razvoja pri živalih ob uporabi panitumumaba niso bile izvedene.
English: Severe (NCI-CTC grade 3) skin reactions were reported in 23% and life-threatening (NCI-CTC grade 4) skin reactions in < 1% of patients who received Vectibix monotherapy and in combination with chemotherapy (n = 2,224) (see section 4.8).
Slovenian: Poročali so o hudih kožnih reakcijah (3. stopnja po NCI-CTC) pri 23 % bolnikov in o življenjsko ogrožujočih kožnih reakcijah (4. stopnja po NCI-CTC) pri < 1 % bolnikov, ki so prejemali zdravilo Vectibix kot monoterapijo in v kombinaciji s kemoterapijo (n = 2.224) (glejte poglavje 4.8).
English: Each vial contains 400 mg of panitumumab.
Slovenian: Ena viala vsebuje 400 mg panitumumaba.
English: Vectibix plus BSC (n = 84)
Slovenian: zdravilo Vectibix in BSC (n = 84)
English: 20 mL of concentrate for solution for infusion.
Slovenian: 20 ml koncentrata za raztopino za infundiranje.
English: • as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Slovenian: • kot monoterapija po neuspehu shem kemoterapije, ki so vključevale fluoropirimidin,
English: All patients should be advised regarding the potential risk of panitumumab on pre- and post-natal development prior to initiation of Vectibix therapy.
Slovenian: Vsem bolnikom morate pred začetkom zdravljenja z zdravilom Vectibix pojasniti možno tveganje, ki ga panitumumab pomeni za prenatalni in postnatalni razvoj.
English: • spreading infection below the skin (cellulitis); hair follicle inflammation (folliculitis); localised infection; skin rash with pus-filled blisters (rash pustular); urinary tract infection;
Slovenian: • razširitev okužbe pod kožo (celulitis), vnetje lasnega mešička (folikulitis), lokalizirana okužba, kožni izpuščaj z gnojnimi mehurčki (pustulozen izpuščaj), okužba sečil,
English: Pulmonary complications
Slovenian: Zapleti na pljučih
English: • If you get any side effects talk to your doctor.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
English: The data in the table below describe adverse reactions reported from clinical studies in patients with mCRC who received panitumumab as a single agent or in combination with chemotherapy (n = 2,224) and spontaneous reporting.
Slovenian: Spodnja tabela opisuje neželene učinke, poročane v kliničnih študijah pri bolnikih z mKRR, ki so dobivali panitumumab kot edino zdravilo ali v kombinaciji s kemoterapijo (n = 2.224), in iz spontanih poročil v obdobju trženja zdravila.
English: No incompatibilities have been observed between Vectibix and sodium chloride 9 mg/mL (0.9%) solution for injection in polyvinyl chloride bags or polyolefin bags.
Slovenian: Inkompatibilnosti med zdravilom Vectibix in natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje v polivinilkloridnih ali poliolefinskih vrečkah niso ugotovili.
English: • Each mL of concentrate contains 20 mg panitumumab.
Slovenian: • En ml koncentrata vsebuje 20 mg panitumumaba.
English: Vectibix must not be administered as an intravenous push or bolus.
Slovenian: Zdravila Vectibix ne smete injicirati z intravenskim vbrizganjem ali v bolusu.
English: A positive benefitrisk balance has not been documented in patients with ECOG 2 performance status.
Slovenian: Pri bolnikih z zmogljivostnim stanjem 2 po ECOG pozitivno razmerje med koristnostjo in tveganjem ni bilo zabeleženo.
English: Doses higher than 1,000 mg should be diluted in 150 mL sodium chloride 9 mg/mL (0.9%) solution for injection (see section 4.2).
Slovenian: Odmerke, večje od 1.000 mg, morate razredčiti v 150 ml 9 mg/ml (0,9 %) natrijevega klorida raztopine za injiciranje (glejte poglavje 4.2).
English: It is recommended that women do not breast-feed during treatment with Vectibix and for 2 months after the last dose.
Slovenian: Priporočljivo je, da ženske med zdravljenjem z zdravilom Vectibix in še 2 meseca po zadnjem odmerku ne dojijo.
English: Median (months) (95% CI) Hazard ratio (95% CI) ORR n (%) (95% CI) Odds ratio (95% CI)
Slovenian: Mediana (meseci) (95 % IZ) Razmerje ogroženosti (95 % IZ) ORR n (%) (95 % IZ)
English: Across monotherapy and combination mCRC clinical studies (n = 2,224), infusion-related reactions (occurring within 24 hours of an infusion) were reported in Vectibix-treated patients, including severe infusion-related reactions (NCI-CTC grade 3 and grade 4).
Slovenian: V kliničnih študijah (n = 2.224) monoterapije in kombinirane terapije mKRR so pri bolnikih, zdravljenih z zdravilom Vectibix zabeležili z infundiranjem povezane reakcije (reakcije v 24 urah po infuziji), med njimi tudi hude (3. ali 4. stopnje po NCI-CTC).
English: Wear sunscreen and a hat if you are going to be exposed to sunlight.
Slovenian: Če boste izpostavljeni sončni svetlobi, kožo zaščitite s sredstvom za sončenje in nosite klobuk.
English: • diarrhoea; nausea; vomiting; abdominal pain; constipation; decreased appetite; decreased weight;
Slovenian: • driska, navzea, bruhanje, bolečine v trebuhu, zaprtost, zmanjšan apetit, zmanjšanje telesne mase,
English: • low red blood cell numbers (anaemia); low potassium levels in the blood (hypokalaemia); low magnesium levels in the blood (hypomagnesaemia);
Slovenian: • majhno število rdečih krvnih celic (anemija), nizka koncentracija kalija v krvi (hipokaliemija),
English: First-line combination with bevacizumab and oxaliplatin or irinotecan-based chemotherapy
Slovenian: Kombinacija s kemoterapijo na podlagi bevacizumaba in oksaplatina ali irinotekana v prvi liniji zdravljenja
English: The safety of Vectibix has not been studied in patients with renal or hepatic impairment.
Slovenian: Varnost zdravila Vectibix ni raziskana pri bolnikih z okvaro ledvic ali jeter.
English: Wild-type KRAS (exon 2) population
Slovenian: bolniki z divjim tipom KRAS (ekson 2)
English: KRAS (Kirsten rat sarcoma 2 viral oncogene homologue) and NRAS (Neuroblastoma RAS viral oncogene homologue) are highly related members of the RAS oncogene family.
Slovenian: KRAS (Kirstenov homolog virusnega onkogena podganjega sarkoma 2) in NRAS (nevroblastomski RAS homolog virusnega onkogena) sta izredno sorodna pripadnika družine onkogenov RAS. KRAS in NRAS gena kodirata majhne beljakovine, ki vežejo GTP in so vpletene v prenos signalov.
English: The safety and efficacy of Vectibix have not been studied in patients with renal or hepatic impairment.
Slovenian: Varnost in učinkovitost zdravila Vectibix pri bolnikih z okvaro ledvic ali jeter nista raziskani.
English: • keratitis (inflammation of the front part of the eye (cornea));
Slovenian: • keratitis (vnetje sprednjega dela očesa (roženice)),
English: A high incidence of severe diarrhoea was observed when panitumumab was administered in combination with IFL (see section 4.4), and increased toxicity and deaths were seen when panitumumab was combined with bevacizumab and chemotherapy (see sections 4.4 and 5.1).
Slovenian: Če je bil panitumumab uporabljen v kombinaciji z IFL (glejte poglavje 4.4), so opažali veliko incidenco hude driske, če je bil uporabljen v kombinaciji z bevacizumabom in kemoterapijo, pa so zabeležili večjo pogostnost toksičnih učinkov in smrti (glejte poglavji 4.4 in 5.1).
English: Mutant KRAS (exon 2) population
Slovenian: bolniki z mutantnim KRAS (ekson 2)
English: Please consult your doctor if you are unsure of your RAS tumour status.
Slovenian: Če ste glede stanja RAS svojega tumorja negotovi, se posvetujte z zdravnikom.
English: Cases of interstitial lung disease (ILD), both fatal and non-fatal, have been reported, mainly from the Japanese population.
Slovenian: Predvsem pri japonski populaciji so poročali o primerih intersticijske pljučne bolezni (ILD - Interstitial Lung Disease), in sicer s smrtnim izidom in brez njega.
English: For the mutant KRAS subset, the hazard ratio for PFS was 1.25 with 95% CI: 0.91-1.71.
Slovenian: V podskupini z mutantnim KRAS je bilo razmerje ogroženosti za preživetje brez napredovanja 1,25 s 95 % IZ: 0,91-1,71.
English: Modification of the dose of Vectibix may be necessary in cases of severe (≥ grade 3) dermatological reactions as follows:
Slovenian: V primeru hudih (≥ 3. stopnja) dermatoloških reakcij je lahko potrebna naslednja prilagoditev odmerka zdravila Vectibix:
English: Vectibix administered as a single agent or in combination with chemotherapy exhibits nonlinear pharmacokinetics.
Slovenian: Zdravilo Vectibix, aplicirano kot edino zdravilo ali v kombinaciji s kemoterapijo, ima nelinearno farmakokinetiko.
English: The most increased serious adverse events included diarrhoea in patients treated with Vectibix in combination with either FOLFOX or FOLFIRI, and dehydration and pulmonary embolism when patients were treated with Vectibix in combination with FOLFIRI.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Vectibix v kombinaciji s FOLFOX ali s FOLFIRI, se je najbolj povečala pojavnost resnega neželenega učinka diareje, pri bolnikih, ki so prejemali zdravilo Vectibix v kombinaciji s FOLFIRI pa dehidracija in pljučna embolija.
English: Hypocalcaemia Dehydration Hyperglycaemia Hypophosphataemia
Slovenian: Presnovne in prehranske motnje hipokaliemija hipomagneziemija zmanjšan apetit hipokalciemija dehidracija hiperglikemija hipofosfatemija
English: Infusion-related reactions
Slovenian: Z infuzijo povezane reakcije
English: • growth of eyelashes; flow of tears (lacrimation increased); redness of the eye (ocular hyperaemia); dry eye; itchy eyes (eye pruritus); eye irritation; eyelid inflammation (blepharitis);
Slovenian: • rast trepalnic, iztekanje solz (močnejše solzenje), pordelost očesa (očesna hiperemija), suho oko, srbenje oči (očesni pruritis), draženje oči, vnetje vek (blefaritis),
English: Ocular toxicities
Slovenian: Očesni toksični učinki
English: A greater frequency of pulmonary embolism, infections (predominantly of dermatologic origin), diarrhoea, electrolyte imbalances, nausea, vomiting and dehydration was also observed in the treatment arms using Vectibix in combination with bevacizumab and chemotherapy.
Slovenian: V terapevtskih skupinah z zdravilom Vectibix, uporabljenim v kombinaciji z bevacizumabom in kemoterapijo, so bile pogostejše tudi pljučna embolija, okužbe (pretežno dermatološkega izvora), driska, neravnovesje elektrolitov, navzea, bruhanje in dehidracija.
English: Doses higher than 1,000 mg should be diluted in 150 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Razredčite v skupni količini 100 ml. Odmerke, večje od 1.000 mg, morate razredčiti v 150 ml 9 mg/ml (0,9 %) natrijevega klorida raztopine za injiciranje.
English: • No evidence of an altered safety profile was found in patients who tested positive for antibodies to Vectibix.
Slovenian: • Pri bolnikih, ki so imeli pozitiven izvid protiteles proti zdravilu Vectibix, niso ugotovili spremenjenih varnostnih značilnosti.
English: Skin and subcutaneous tissue disorders1
Slovenian: Bolezni kože in podkožja1
English: • dry mouth; indigestion (dyspepsia); rectal bleeding (rectal haemorrhage); lip inflammation (cheilitis); heartburn (gastroesophageal reflux);
Slovenian: • suhost ust, prebavne motnje (dispepsija), krvavitev iz danke (rektalna krvavitev), vnetje ustnic (heilitis), zgaga (gastroezofagealni refluks),
English: Vectibix in combination with bevacizumab and chemotherapy regimens
Slovenian: Zdravilo Vectibix v kombinaciji z bevacizumabom in shemami kemoterapije
English: However, an increased number of serious adverse events were reported in elderly patients treated with Vectibix in combination with FOLFIRI (45% versus 32%) or FOLFOX (52% versus 37%) chemotherapy compared to chemotherapy alone (see section 4.4).
Slovenian: Vendar pa je bilo pri starejših bolnikih, ki so prejemali zdravilo Vectibix v kombinaciji s kemoterapijo FOLFIRI opisanih več resnih neželenih učinkov (45 %) kot pri tistih, ki so prejemali samo kemoterapijo (32 %); pri starejših bolnikih, ki so prejemali zdravilo Vectibix v kombinaciji s kemoterapijo FOLFOX je bilo ravno tako opisanih več resnih neželenih učinkov (52 %) kot pri tistih, ki so prejemali samo kemoterapijo (37 %) (glejte poglavje 4.4).
English: • chest pain; pain; chills; pain in the extremity; immune reaction (hypersensitivity); rapid heart rate (tachycardia);
Slovenian: • bolečine v prsih, bolečine, mrzlica, bolečine v okončini, imunska reakcija (preobčutljivost), hitro bitje srca (tahikardija),
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vectibix 20 mg/ml sterile concentrate panitumumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Vectibix 20 mg/ml sterilen koncentrat panitumumab i.v.
English: Package Leaflet: Information for the user Vectibix 20 mg/mL concentrate for solution for infusion panitumumab
Slovenian: Navodilo za uporabo: informacije za bolnike Vectibix 20 mg/ml koncentrat za raztopino za infundiranje panitumumab
English: Hypersensitivity reactions occurring more than 24 hours after infusion have also been reported in the post-marketing setting.
Slovenian: Med uporabo v obdobju trženja so bile opisane tudi preobčutljivostne reakcije, ki so se pojavile več kot 24 ur po infundiranju.
English: At the fourth occurrence
Slovenian: Ob četrtem pojavu prekinite uporabo
English: Stevens-Johnson syndrome4
Slovenian: Stevens-Johnsonov sindrom4 nekroza kože4 angioedem1 hirzutizem vraščanje nohta oniholiza
English: Vectibix contains sodium
Slovenian: Zdravilo Vectibix vsebuje natrij
English: The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown (see sections 4.3 and 5.1).
Slovenian: Kombinacija zdravila Vectibix s kemoterapijo, ki vključuje oksaliplatin, je kontraindicirana pri bolnikih z mKRR z mutantnim RAS ali pri katerih stanje RAS ni znano (glejte poglavji 4.3 in 5.1).
English: Withhold or discontinue Vectibix in the event of dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications.
Slovenian: Če se pojavi dermatološka toksičnost ali toksičnost mehkih tkiv, povezana s hudimi ali življenjsko ogrožujočimi vnetnimi ali infekcijskimi zapleti, zadržite ali prekinite zdravljenje z zdravilom Vectibix.
English: was < 1%;
Slovenian: »Biacore« pa < 1 %.
English: In women of childbearing potential, appropriate contraceptive measures must be used during treatment with Vectibix, and for 2 months following the last dose.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z zdravilom Vectibix in še 2 meseca po zadnjem odmerku uporabljati ustrezno kontracepcijsko zaščito.
English: • extreme tiredness (fatigue); fever or high temperature (pyrexia); lack or loss of strength
Slovenian: • skrajna izčrpanost (utrujenost), zvišana ali visoka telesna temperatura (pireksija), pomanjkanje ali izguba moči (astenija), kopičenje tekočine v okončinah (periferni edemi),
English: Efficacy results in patients with wild-type RAS mCRC and mutant RAS mCRC are shown in the below table.
Slovenian: Rezultati učinkovitosti pri bolnikih z mKRR z divjim tipom RAS in bolnikih z mKRR z mutantnim RAS so prikazani v spodnji tabeli.
English: • skin cell death (skin necrosis);
Slovenian: • odmiranje kožnih celic (nekroza kože),
English: It is not recommended to breast-feed your baby during treatment with Vectibix and for 2 months after the last dose.
Slovenian: Dojenje ni priporočljivo med zdravljenjem z zdravilom Vectibix in še 2 meseca po zadnjem odmerku.
English: Serious cases of keratitis and ulcerative keratitis have been rarely reported in the post-marketing setting.
Slovenian: Med uporabo v obdobju trženja so redko poročali o resnih primerih keratitisa in ulcerativnega keratitisa.
English: What Vectibix contains
Slovenian: Kaj vsebuje zdravilo Vectibix
English: NAME OF THE MEDICINAL PRODUCT Vectibix 20 mg/mL concentrate for solution for infusion.
Slovenian: IME ZDRAVILA Vectibix 20 mg/ml koncentrat za raztopino za infundiranje.
English: The efficacy of Vectibix in second-line in combination with irinotecan, 5-fluorouracil (5-FU) and leucovorin (FOLFIRI) was evaluated in a randomised, controlled trial of 1,186 patients with mCRC with the primary endpoints of OS and PFS. Other key endpoints included the ORR, time to response, TTP, and duration of response.
Slovenian: Učinkovitost zdravila Vectibix v drugi liniji zdravljenja v kombinaciji z irinotekanom, 5-fluorouracilom (5-FU) in levkovorinom (FOLFIRI) so ocenili v randomiziranem, kontroliranem preskušanju pri 1.186 bolnikih z mKRR, v katerem sta bila primarna opazovana dogodka OS in PFS.
English: Nail disorder
Slovenian: Razredčena raztopina