natgillin/translations-raw huggingface dataset:
Adverse events observed included skin toxicity, diarrhoea, dehydration and fatigue and were consistent with the safety profile at the recommended dose.
Opaženi neželeni učinki, med katerimi so toksični učinki na koži, driska, dehidracija in utrujenost, so se skladali z varnostnimi značilnostmi ob priporočenem odmerku.
The study was prospectively analysed by tumour KRAS (exon 2) status which was evaluable in 93% of the patients.
Študija je bila prospektivno analizirana po stanju KRAS tumorja (ekson 2), ki so ga ocenili pri 93 % bolnikov.
Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies.
Zdravilo Vectibix kot učinkovino vsebuje panitumumab, ki spada v skupino zdravil, imenovanih monoklonska protitelesa.
The incidence of these additional RAS mutations (KRAS exons 3, 4 and NRAS exons 2, 3, 4) in the wild-type KRAS (exon 2) population was approximately 19%.
Incidenca teh dodatnih mutacij RAS (KRAS eksonov 3 in 4 in NRAS eksonov 2, 3 in 4) v populaciji z divjim tipom KRAS (ekson 2) je bila približno 19 %.
For instructions on dilution of the medicinal product before administration, see section 6.6.
Za navodila o redčenju zdravila pred uporabo glejte poglavje 6.6.
The study was prospectively analysed by tumour KRAS (exon 2) status which was evaluable in 91% of the patients.
Študija je bila prospektivno analizirana po stanju KRAS tumorja (ekson 2), ki so ga ocenili pri 91 % bolnikov.
The efficacy of Vectibix as monotherapy in patients with metastatic colorectal cancer (mCRC) who had disease progression during or after prior chemotherapy was studied in open-label, single-arm trials (585 patients) and in two randomised controlled trials versus best supportive care (463 patients) and versus cetuximab (1,010 patients).
Učinkovitost zdravila Vectibix v monoterapiji pri bolnikih z metastatskim kolorektalnim rakom (mKRR), ki jim je bolezen napredovala med predhodno kemoterapijo ali po njej, so raziskali v odprtih preskušanjih z eno skupino (585 bolnikov) in v dveh randomiziranih kontroliranih preskušanjih v primerjavi z najboljšo podporno oskrbo (463 bolnikov) v primerjavi s cetuksimabom (1.010 bolnikov).
Patients should be periodically monitored for hypomagnesaemia and accompanying hypocalcaemia prior to initiating Vectibix treatment, and periodically thereafter for up to 8 weeks after the completion of treatment (see section 4.8).
Bolnike je treba pred uvedbo zdravljenja, med zdravljenjem in še 8 tednov po končanem zdravljenju z zdravilom Vectibix, redno spremljati glede hipomagneziemije in spremljajoče hipokalciemije (glejte poglavje 4.8).
Each vial contains either 100 mg of panitumumab in 5 mL, or 400 mg of panitumumab in 20 mL.
Ena viala vsebuje 100 mg panitumumaba v 5 ml ali 400 mg panitumumaba v 20 ml.
Across all clinical trials, skin reactions occurred in approximately 94% of patients receiving Vectibix as monotherapy or in combination with chemotherapy (n = 2,224).
V vseh kliničnih preskušanjih so se kožne reakcije pojavile pri približno 94 % bolnikov, ki so prejemali zdravilo Vectibix v monoterapiji ali v kombinaciji s kemoterapijo (n = 2.224).
• blue colouration of the skin and mucous membranes (cyanosis);
• modro obarvanje kože in sluznic (cianoza),
A shortened progression-free survival (PFS) and overall survival (OS) time were observed in patients with mutant KRAS (exon 2) tumours and additional RAS mutations (KRAS [exons 3 and 4] or NRAS [exons 2, 3, 4]) who received panitumumab in combination with infusional 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) versus FOLFOX alone (see section 5.1).
Ugotovili so krajše preživetje brez napredovanja (PFS - Progression Free Survival) in krajše celokupno preživetje (OS - Overall Survival) pri tistih bolnikih s tumorjem z mutantnim KRAS (ekson 2) in dodatnimi mutacijami RAS (KRAS [eksona 3 in 4] ali NRAS [eksoni 2, 3, 4]), ki so dobivali panitumumab v kombinaciji z infuzijo 5-fluorouracila, levkovorina in oksaliplatina (FOLFOX), kot pri tistih, ki so dobivali samo FOLFOX (glejte poglavje 5.1).
Subsequent to the development of severe skin and subcutaneous reactions, infectious complications including sepsis, in rare cases leading to death, cellulitis and local abscesses requiring incisions and drainage were reported.
Po pojavu hudih kožnih in podkožnih reakcij so zabeležili infekcijske zaplete, vključno s sepso, ki so v redkih primerih povzročili smrt, celulitis in lokalne abscese, ki so potrebovali incizijo in drenažo.
The most serious side effects and main side effects for Vectibix are listed below:
Spodaj so navedeni najresnejši neželeni učinki in glavni neželeni učinki za zdravilo Vectibix:
Clinical efficacy as monotherapy
Klinična učinkovitost v monoterapiji
Your doctor may ask you to use a moisturiser, sun screen (SPF > 15), topical steroid, and/or oral antibiotics which may help in the management of skin toxicities that can be associated with the use of Vectibix.
Zdravnik vam bo morda svetoval uporabo vlažilnega sredstva, sredstva za zaščito pred soncem (zaščitni faktor > 15), lokalnega steroida in/ali peroralnih antibiotikov; vse to vam lahko pomaga obvladovati toksične učinke na koži, ki lahko spremljajo uporabo zdravila Vectibix.
Skin rash most commonly occurred on the face, upper chest, and back, but could extend to the extremities.
Izpuščaj na koži se je najpogosteje pojavil na obrazu, zgornjem delu prsnega koša in hrbtu, vendar se je lahko razširil na ude.
The recommended dose of Vectibix is 6 mg/kg of bodyweight given once every two weeks.
Priporočeni odmerek zdravila Vectibix je 6 mg/kg telesne mase enkrat na dva tedna.
What Vectibix looks like and contents of the pack
Izgled zdravila Vectibix in vsebina pakiranja
Colourless, pH 5.6 to 6.0 solution that may contain translucent to white, visible amorphous, proteinaceous panitumumab particles.
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Brezbarvna raztopina s pH od 5,6 do 6,0, ki lahko vsebuje prosojne do bele vidne amorfne beljakovinske delce panitumumaba.
Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC):
Zdravilo Vectibix je indicirano za zdravljenje odraslih bolnikov z metastatskim kolorektalnim rakom (mKRR) z divjim tipom RAS:
Median PFS was 10.0 (95% CI: 8.9, 11.0) and 11.4 (95% CI: 10.5, 11.9) months in the panitumumab and the non-panitumumab arm, respectively.
Mediana PFS je bila v kraku s panitumumabom 10,0 (95 % IZ: 8,9, 11,0) in v kraku brez panitumumaba 11,4 (95 % IZ: 10,5, 11,9) mesecev.
Other toxicities that were observed with a greater frequency relative to monotherapy included hypomagnesaemia, diarrhoea, and stomatitis.
Drugi toksični učinki, ki so bili pogostejši kot med monoterapijo, so bili hipomagneziemija, driska in stomatitis.
A population pharmacokinetic analysis was performed to explore the potential effects of selected covariates on panitumumab pharmacokinetics.
Za proučitev možnih učinkov izbranih sospremenljivk na farmakokinetiko panitumumaba je bila narejena analiza populacijske farmakokinetike.
Severe diarrhoea (NCI-CTC grade 3 and 4) was reported in 2% of patients treated with Vectibix as a monotherapy and in 16% of patients treated with Vectibix in combination with chemotherapy.
O hudi (3. in 4. stopnja po NCI-CTC) driski so poročali pri 2 % bolnikov, zdravljenih z zdravilom Vectibix v monoterapiji, in pri 16 % bolnikov, zdravljenjih z zdravilom Vectibix v kombinaciji s kemoterapijo.
A trend for OS favouring the control arm was observed in the wild-type KRAS subset of the oxaliplatin cohort (hazard ratio = 1.89; 95% CI: 1.30, 2.75).
V podskupini z divjim tipom KRAS je bil v oksaliplatinski kohorti opazen trend k boljšemu OS v kontrolnem kraku (razmerje ogroženosti = 1,89; 95 % IZ: 1,30, 2,75).
• skin ulcer; scab; excess hair growth (hypertrichosis); redness and swelling of palms of hands or soles of feet (hand-foot syndrome); excess sweating (hyperhidrosis); skin reaction (dermatitis);
• kožna razjeda, krasta, čezmerna rast dlak (hipertrihoza), pordelost in otekanje dlani ali podplatov (sindrom dlani in podplatov), prekomerno znojenje (hiperhidroza), kožna reakcija (dermatitis),
Vectibix (n = 499)
Zdravilo Vectibix (n = 499)
Your doctor may decide to treat the rash, adjust the dose or discontinue your treatment with Vectibix.
Zdravnik se lahko odloči, da zdravi izpuščaj, prilagodi odmerek ali prekine vaše zdravljenje z zdravilom Vectibix.
The efficacy of Vectibix in first-line in combination with FOLFIRI was evaluated in a single-arm study of 154 patients with the primary endpoint of objective response rate (ORR).
Učinkovitost zdravila Vectibix v prvi liniji zdravljenja v kombinaciji s FOLFIRI so ocenili v študiji z eno samo skupino pri 154 bolnikih, primarni opazovani dogodek pa je bil objektivni delež odziva (ORR).
The safety profile of Vectibix in combination with chemotherapy consisted of the reported adverse reactions of Vectibix (as a monotherapy) and the toxicities of the background chemotherapy regimen.
Varnostne značilnosti zdravila Vectibix v kombinaciji s kemoterapijo so obsegale poročila o neželenih učinkih zdravila Vectibix (kot monoterapije) in toksičnosti osnovne sheme kemoterapije.
Deep vein thrombosis Hypotension Hypertension Flushing
Žilne bolezni globoka venska tromboza hipotenzija hipertenzija zardevanje
A variety of stimuli, including that from the EGFR activate KRAS and NRAS which in turn stimulate other intracellular proteins to promote cell proliferation, cell survival and angiogenesis.
KRAS in NRAS nato stimulirata druge znotrajcelične beljakovine za spodbudo proliferacije celic, preživetja celic in angiogeneze.
Vectibix treatment should be supervised by a physician experienced in the use of anti-cancer therapy.
Zdravljenje z zdravilom Vectibix mora spremljati zdravnik z izkušnjami pri zdravljenju raka.
Vectibix in combination with irinotecan, bolus 5-fluorouracil, and leucovorin (IFL) chemotherapy
Zdravilo Vectibix v kombinaciji s kemoterapijo z irinotekanom, bolusnim 5-fluorouracilom in levkovorinom (IFL)
Across monotherapy and combination mCRC clinical studies (n = 2,224), infusion-related reactions (occurring within 24 hours of any infusion), which may include symptoms/signs such as chills, fever or dyspnoea, were reported in approximately 5% of Vectibix-treated patients, of which 1% were severe (NCI-CTC grade 3 and grade 4).
V kliničnih študijah (n = 2.224) monoterapije mKRR in terapije mKRR s kombinacijo zdravil so z infundiranjem povezane reakcije (pojavijo se v 24 urah po katerikoli infuziji), ki lahko vključujejo simptome/znake, kot so mrzlica, povišana telesna temperatura ali dispneja, zabeležili pri približno 5 % bolnikov, zdravljenih z zdravilom Vectibix, 1 % teh reakcij je bilo hudih (3. ali 4. stopnje po NCI-CTC).
The incidence of BRAF exon 15 mutation in the wild-type KRAS (exon 2) population was approximately 8%.
Incidenca mutacije BRAF eksona 15 je bila v populaciji z divjim tipom KRAS (ekson 2) približno 8 %.
Secondary endpoints included PFS and objective response rate (ORR).
Primarni opazovani dogodek je bilo OS. Sekundarna opazovana dogodka sta obsegala PFS in objektivni delež odziva (ORR - Objective Response Rate).
Vectibix must be administered as an intravenous infusion via an infusion pump.
Zdravilo Vectibix morate aplicirati v intravenski infuziji z infuzijsko črpalko.
It is also recommended that patients experiencing rash/dermatological toxicities wear sunscreen and hats and limit sun exposure as sunlight can exacerbate any skin reactions that may occur.
Priporočljivo je tudi, da bolniki, pri katerih se pojavi izpuščaj/dermatološki toksični učinki kožo zavarujejo s sredstvi za sončenje, nosijo klobuke in omejijo izpostavljenost soncu.
• 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;
• 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,
There is no clinical data to support dose adjustments in the elderly.
Kliničnih podatkov, ki bi podprli prilagoditev odmerka pri starejših, ni. Pediatrična populacija
loosening of the nails (onycholysis); ingrowing nail; excessive hair growth (hirsutism);
odstopanje nohtov (oniholiza), vraščanje nohta, čezmerna rast dlak (hirzutizem),
Activating mutations in the RAS genes occur frequently in a variety of human tumours and have been implicated in both oncogenesis and tumour progression.
Aktivacijske mutacije genov RAS so pogoste v različnih tumorjih pri človeku.
Panitumumab may impact the ability of a woman to become pregnant.
Panitumumab lahko vpliva na sposobnost ženske, da zanosi.
• low white blood numbers (leucopenia); low calcium levels in the blood (hypocalcaemia); low phosphates in the blood (hypophosphataemia); high glucose in the blood (hyperglycaemia);
• majhno število belih krvnih celic (levkopenija), nizka koncentracija kalcija v krvi (hipokalciemija), nizka koncentracija fosfatov v krvi (hipofosfatemija), visoka koncentracija glukoze v krvi (hiperglikemija),
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.
Če ste ženska v rodni dobi, morate med zdravljenjem z zdravilom Vectibix in še 2 meseca po zadnjem odmerku uporabljati učinkovite metode kontracepcije.
For clinical management of infusion-related reactions, see section 4.4.
Za klinično obvladovanje z infundiranjem povezanih reakcij glejte poglavje 4.4.
Uncommon (≥ 1/1,000 to
Občasni (≥ 1/1.000 do < 1/100)
ORR (%)
ORR (%) (95 % IZ)
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.
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.
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.
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.
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.
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.
Vectibix should not be administered in combination with IFL chemotherapy or with bevacizumabcontaining chemotherapy.
Zdravila Vectibix se ne sme uporabljati v kombinaciji s kemoterapijo IFL ali kemoterapijo, ki vključuje bevacizumab.
No clinical studies have been conducted to examine the pharmacokinetics of panitumumab in patients with renal or hepatic impairment.
Klinične študije za proučitev farmakokinetike panitumumaba pri bolnikih z okvaro ledvic ali jeter niso bile izvedene.
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]).
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]).
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.
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.
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.
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.
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).
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).
Vectibix plus BSC (n = 124)
zdravilo Vectibix in BSC (n = 124)
Vectibix should be inspected visually prior to administration.
Pred uporabo morate zdravilo Vectibix vizualno pregledati.
How to use Vectibix
Kako uporabljati zdravilo Vectibix
Median Duration of response (months) (95% CI)
Mediana trajanja odziva (meseci) (95 % IZ)
Severe (NCI-CTC grade 3) skin reactions were reported in 23% and life-threatening (NCI-CTC grade 4) skin reactions in < 1% of patients.
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.
• 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;
• 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 %.
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.
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.
No pre- and post-natal development animal studies have been conducted with panitumumab.
Študije prenatalnega in postnatalnega razvoja pri živalih ob uporabi panitumumaba niso bile izvedene.
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).
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).
Each vial contains 400 mg of panitumumab.
Ena viala vsebuje 400 mg panitumumaba.
Vectibix plus BSC (n = 84)
zdravilo Vectibix in BSC (n = 84)
20 mL of concentrate for solution for infusion.
20 ml koncentrata za raztopino za infundiranje.
• as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
• kot monoterapija po neuspehu shem kemoterapije, ki so vključevale fluoropirimidin,
All patients should be advised regarding the potential risk of panitumumab on pre- and post-natal development prior to initiation of Vectibix therapy.
Vsem bolnikom morate pred začetkom zdravljenja z zdravilom Vectibix pojasniti možno tveganje, ki ga panitumumab pomeni za prenatalni in postnatalni razvoj.
• spreading infection below the skin (cellulitis); hair follicle inflammation (folliculitis); localised infection; skin rash with pus-filled blisters (rash pustular); urinary tract infection;
• razširitev okužbe pod kožo (celulitis), vnetje lasnega mešička (folikulitis), lokalizirana okužba, kožni izpuščaj z gnojnimi mehurčki (pustulozen izpuščaj), okužba sečil,
Pulmonary complications
Zapleti na pljučih
• If you get any side effects talk to your doctor.
• Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
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.
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.
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.
Inkompatibilnosti med zdravilom Vectibix in natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje v polivinilkloridnih ali poliolefinskih vrečkah niso ugotovili.
• Each mL of concentrate contains 20 mg panitumumab.
• En ml koncentrata vsebuje 20 mg panitumumaba.
Vectibix must not be administered as an intravenous push or bolus.
Zdravila Vectibix ne smete injicirati z intravenskim vbrizganjem ali v bolusu.
A positive benefitrisk balance has not been documented in patients with ECOG 2 performance status.
Pri bolnikih z zmogljivostnim stanjem 2 po ECOG pozitivno razmerje med koristnostjo in tveganjem ni bilo zabeleženo.
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).
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).
It is recommended that women do not breast-feed during treatment with Vectibix and for 2 months after the last dose.
Priporočljivo je, da ženske med zdravljenjem z zdravilom Vectibix in še 2 meseca po zadnjem odmerku ne dojijo.
Median (months) (95% CI) Hazard ratio (95% CI) ORR n (%) (95% CI) Odds ratio (95% CI)
Mediana (meseci) (95 % IZ) Razmerje ogroženosti (95 % IZ) ORR n (%) (95 % IZ)
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).
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).
Wear sunscreen and a hat if you are going to be exposed to sunlight.
Če boste izpostavljeni sončni svetlobi, kožo zaščitite s sredstvom za sončenje in nosite klobuk.
• diarrhoea; nausea; vomiting; abdominal pain; constipation; decreased appetite; decreased weight;
• driska, navzea, bruhanje, bolečine v trebuhu, zaprtost, zmanjšan apetit, zmanjšanje telesne mase,
• low red blood cell numbers (anaemia); low potassium levels in the blood (hypokalaemia); low magnesium levels in the blood (hypomagnesaemia);
• majhno število rdečih krvnih celic (anemija), nizka koncentracija kalija v krvi (hipokaliemija),
First-line combination with bevacizumab and oxaliplatin or irinotecan-based chemotherapy
Kombinacija s kemoterapijo na podlagi bevacizumaba in oksaplatina ali irinotekana v prvi liniji zdravljenja
The safety of Vectibix has not been studied in patients with renal or hepatic impairment.
Varnost zdravila Vectibix ni raziskana pri bolnikih z okvaro ledvic ali jeter.
Wild-type KRAS (exon 2) population
bolniki z divjim tipom KRAS (ekson 2)