natgillin/translations-raw huggingface dataset:
A predefined retrospective subset analysis of 641 patients of the 656 patients with wild-type KRAS (exon 2) mCRC was performed.
Opravljena je bila vnaprej opredeljena retrospektivna analiza podskupine 641 od 656 bolnikov z mKRR z divjim tipom KRAS (ekson 2).
If a severe or life-threatening reaction occurs during an infusion or at any time post-infusion [e.g. presence of bronchospasm, angioedema, hypotension, need for parenteral treatment, or anaphylaxis], Vectibix should be permanently discontinued (see sections 4.3 and 4.8).
Če se kadarkoli med ali po infundiranju pojavi huda ali smrtno nevarna reakcija (npr. z bronhospazmom, angioedemom, hipotenzijo, potrebo po parenteralnem zdravljenju ali anafilaksijo), je treba uporabo zdravila Vectibix za stalno prekiniti (glejte poglavje 4.3 in 4.8).
Hypersensitivity reactions occurring more than 24 hours after infusion have been reported including a fatal case of angioedema that occurred more than 24 hours after the infusion.
Poročali so o preobčutljivostnij reakcijah, ki so se pojavile več kot 24 ur po infundiranju, vključno s smrtnim primerom angioedema, ki se je pojavil več kot 24 ur po infundiranju.
Vectibix will be administered in a healthcare facility under the supervision of a doctor experienced in the use of anti-cancer medicines.
Zdravilo Vectibix boste dobili v zdravstveni ustanovi, pod nadzorstvom zdravnika, izkušenega z uporabo zdravil za zdravljenje raka.
For patients whose sera tested positive in either screening immunoassay, an in vitro biological assay was performed to detect neutralising antibodies.
Pri bolnikih, ki so imeli pozitiven izvid enega ali drugega imunskega preizkusa, so opravili in vitro biološki preizkus za odkritje nevtralizacijskih protiteles.
Skin-related reactions are likely to occur in approximately 94 out of 100 people who take Vectibix and are usually mild to moderate.
Reakcije, povezane s kožo, se predvidoma pojavijo pri približno 94 od 100 bolnikov, ki uporabljajo zdravilo Vectibix in so navadno blage do zmerne.
If you experience a severe skin reaction, your doctor may recommend an adjustment of the dose of Vectibix.
Če se vam pojavi kakšna huda kožna reakcija, lahko zdravnik svetuje prilagoditev odmerka zdravila Vectibix.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema anemija levkopenija
Each mL of concentrate contains 0.150 mmol sodium, which is 3.45 mg sodium.
En mililiter koncentrata vsebuje 0,150 mmol natrija, kar je 3,45 mg natrija.
The study was retrospectively analysed by wild-type KRAS (exon 2) status versus mutant KRAS (exon 2) status.
Študijo so retrospektivno analizirali po stanju divjega tipa KRAS (ekson 2) v primerjavi z mutantnim tipom KRAS (ekson 2).
Electrolyte disturbances
Elektrolitske motnje
If ILD is diagnosed, Vectibix should be permanently discontinued and the patient should be treated appropriately.
Če diagnosticirate ILD, morate zdravljenje z zdravilom Vectibix za stalno prekiniti in bolnika ustrezno zdraviti.
The diluted solution should be mixed by gentle inversion, do not shake.
Razredčeno raztopino premešajte s previdnim obračanjem; ne stresajte je.
The efficacy of Vectibix was also evaluated in an open-label trial in patients with wild-type KRAS (exon 2) mCRC.
Učinkovitost zdravila Vectibix so ocenili tudi v odprtem preskušanju pri bolnikih z mKRR z divjim tipom KRAS (ekson 2).
Paronychial inflammation was associated with swelling of the lateral nail folds of the toes and fingers.
Obnohtno vnetje je spremljala oteklost lateralnih nohtnih gub prstov na nogah in rokah.
Human IgG is known to cross the placental barrier, and panitumumab may therefore be transmitted from the mother to the developing foetus.
Znano je, da humani IgG prehajajo skozi placentno pregrado, tako da bi panitumumab lahko prešel od matere v razvijajoči se plod.
Shortened progression-free survival time and increased deaths were observed in the patients receiving Vectibix in combination with bevacizumab and chemotherapy.
Krajši čas preživetja brez napredovanja in več smrti so opazili med bolniki, ki so dobivali zdravilo Vectibix v kombinaciji z bevacizumabom in kemoterapijo.
Other medicines and Vectibix
Druga zdravila in zdravilo Vectibix
In the post-marketing setting, serious cases of keratitis and ulcerative keratitis have been rarely reported (see section 4.4).
Med uporabo v obdobju trženja so bili redko poročani resni primeri keratitisa in ulcerativnega keratitisa (glejte poglavje 4.4).
An additional analysis of efficacy data by KRAS (exon 2) status did not identify a subset of patients who benefited from panitumumab in combination with oxaliplatin- or irinotecan based chemotherapy and bevacizumab.
Dodatna analiza podatkov o učinkovitosti glede na stanje KRAS (ekson 2) ni odkrila bolnikov, ki bi jim bil koristil panitumumab v kombinaciji s kemoterapijo na podlagi oksaliplatina ali irinotekana ter bevacizumab.
The hazard ratio for overall survival was 1.43 (95% CI: 1.11, 1.83).
Razmerje ogroženosti za celokupno preživetje je bilo 1,43 (95 % IZ: 1,11, 1,83).
If a patient develops dermatologic reactions that are grade 3 (CTCAE v 4.0) or higher, or that are considered intolerable, see the recommendation for dose modification in section 4.2.
Če se pri bolniku pojavijo dermatološke reakcije 3. ali višje stopnje (po CTCAE verzija 4.0) ali dermatološke reakcije, ocenjene kot neznosne, glejte priporočilo za prilagoditev odmerka v poglavju 4.2.
If a diagnosis of ulcerative keratitis is confirmed, treatment with Vectibix should be interrupted or discontinued.
Če je potrjena diagnoza ulcerativnega keratitisa, je treba zdravljenje z zdravilom Vectibix začasno ali trajno prekiniti.
Panitumumab is a recombinant, fully human IgG2 monoclonal antibody that binds with high affinity and specificity to the human EGFR.
Panitumumab je rekombinantno, povsem humano monoklonsko protitelo IgG2, ki se z veliko afiniteto in specifičnostjo veže na humani EGFR.
Treatment and management of dermatologic reactions should be based on severity and may include a moisturiser, sun screen (SPF > 15 UVA and UVB), and topical steroid cream (not stronger than 1% hydrocortisone) applied to affected areas, and/or oral antibiotics (e.g. doxycycline).
Zdravljenje in obvladovanje dermatoloških reakcij mora temeljiti na izrazitosti le-teh in lahko vključuje vlažilno sredstvo, sredstvo za zaščito pred soncem (zaščitni faktor UVA in UVB > 15) in lokalno steroidno kremo (ne močnejšo kot 1 % hidrokortizon), nanešene na prizadete predele, in/ali peroralne antibiotike (npr. doksiciklin).
• in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
• v drugi liniji zdravljenja v kombinaciji s FOLFIRI pri bolnikih, ki so v prvi liniji zdravljenja prejemali kemoterapijo, ki je vključevala fluoropirimidin (vendar ni vključevala irinotekana),
Among patients with wild-type RAS mCRC, PFS, OS, and ORR were improved for subjects receiving panitumumab plus chemotherapy (FOLFOX or FOLFIRI) compared with those receiving chemotherapy alone.
Med bolniki z mKRR z divjim tipom RAS so bili PFS, OS in ORR pri prejemnikih panitumumaba in kemoterapije (FOLFOX ali FOLFIRI) izboljšani v primerjavi s tistimi, ki so prejemali samo kemoterapijo.
Moreover, panitumumab treatment was associated with improved PFS compared to BSC in patients with wild-type RAS tumours (HR = 0.38 [95% CI: 0.27, 0.56]), but not in patients with tumours harbouring a RAS mutation (HR = 0.98 [95% CI: 0.73, 1.31]).
Poleg tega je bilo zdravljenje s panitumumabom v primerjavi z najboljšo standardno oskrbo pri bolnikih s tumorjem z divjim tipom RAS povezano z boljšim PFS (razmerje ogroženosti = 0,38 [95 % IZ: 0,27, 0,56]), pri bolnikih s tumorjem z mutacijo RAS pa ne (razmerje ogroženosti = 0,98 [95 % IZ: 0,73, 1,31]).
Vectibix is administered intravenously (into a vein) with an infusion pump (a device that gives a slow injection).
Zdravilo Vectibix se daje intravensko (v veno) z infuzijsko črpalko (napravo, ki omogoča počasno injiciranje).
Wild-type RAS population PFS
Populacija z divjim tipom RAS PFS
It is recommended that you limit sun exposure whilst receiving Vectibix and if you are experiencing skin reactions as sunlight can worsen these.
Priporočljivo je, da med zdravljenjem z zdravilom Vectibix omejite izpostavljenost soncu; prav tako izpostavljenost soncu omejite, če se vam pojavijo kožne reakcije, saj jih sončna svetloba lahko poslabša.
The addition of panitumumab to radiation, chemotherapy or other targeted therapeutic agents, in animal studies resulted in an increase in antitumour effects compared to radiation, chemotherapy or targeted therapeutic agents alone.
Dodatek panitumumaba obsevanju, kemoterapiji ali drugim ciljanim terapevtskim sredstvom je v študijah na živalih povečal protitumorske učinke v primerjavi z uporabo obsevanja, kemoterapije ali ciljanih terapevtskih sredstev samih.
Non-serious cases of keratitis have been observed in 0.3% of clinical trial patients.
Pri 0,3 % bolnikov v kliničnih preskušanjih so zabeležili primere keratitisa, ki niso bili resni.
• severe skin reaction with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome);
• huda kožna reakcija z mehurji na koži, v ustih, na očeh in spolovilih (Stevens-Johnsonov sindrom),
For clinical management of skin reactions, including dose modification recommendations, see section 4.4.
Za klinično obvladovanje kožnih reakcij, vključno s priporočili za prilagoditev odmerka, glejte poglavje 4.4.
In patients experiencing a mild or moderate (CTCAE v 4.0 grades 1 and 2) infusion-related reaction the infusion rate should be reduced for the duration of that infusion.
Bolnikom, ki se jim pojavi blaga ali zmerna (1. in 2. stopnja po CTCAE verzija 4.0) z infundiranjem povezana reakcija, je treba hitrost infundiranja za čas te infuzije zmanjšati.
Panitumumab has been shown to cause foetal abortions and/or foetal deaths in cynomolgus monkeys when administered during the period of organogenesis at doses approximately equivalent to the recommended human dose.
Dokazano je, da panitumumab povzroča splave plodov in/ali smrt plodov, če je pri opicah cynomolgus uporabljen med obdobjem organogeneze v odmerkih, približno enakovrednih priporočenemu odmerku za človeka.
Patients receiving Vectibix in combination with the IFL regimen [bolus 5-fluorouracil (500 mg/m2), leucovorin (20 mg/m2) and irinotecan (125 mg/m2)] experienced a high incidence of severe diarrhoea (see section 4.8).
Bolniki, ki so dobivali zdravilo Vectibix v kombinaciji z IFL shemo [bolus 5-fluorouracila (500 mg/m2), levkovorina (20 mg/m2) in irinotekana (125 mg/m2)], so zelo pogosto dobili hudo drisko
The recommended dose of Vectibix is 6 mg/kg (milligrams per kilogram of body weight) given once every two weeks.
Priporočeni odmerek zdravila Vectibix je 6 mg/kg (miligramov na kilogram telesne mase) enkrat na dva tedna.
Vectibix is used in the treatment of metastatic colorectal cancer (cancer of the bowel) for adult patients with a certain type of tumour known as a “Wild-type RAS tumour”.
Zdravilo Vectibix se uporablja za zdravljenje metastatskega kolorektalnega raka (raka debelega črevesa) pri odraslih bolnikih, ki imajo določen tip tumorja, ki je znan kot »tumor z divjim tipom RAS«.
Prior to infusion, Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection to a final concentration not to exceed 10 mg/mL (for preparation instructions see section 6.6).
Pred infundiranjem je treba zdravilo Vectibix razredčiti z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje na končno koncentracijo; ta ne sme preseči 10 mg/ml (navodila za pripravo so navedena v poglavju 6.6).
Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
Bolnike, ki se jim med prejemanjem zdravila Vectibix pojavijo znaki in simptomi, ki kažejo na keratitis, kot so akutni pojav ali poslabšanje: vnetja očesa, solzenja, občutljivosti na svetlobo, zamegljenega vida, bolečine v očesu in/ali rdečih oči, je priporočljivo takoj napotiti k specialistu oftalmologu.
Diarrhoea when reported was mainly mild or moderate in severity.
Driska, o kateri so poročali, je bila v glavnem blaga ali zmerno izrazita.
Do not use needle-free devices (e.g. vial adapters) to withdraw vial contents.
Da bi izvlekli vsebino iz viale, ne smete uporabljati pripomočkov brez igle (npr. adapterjev za vialo).
A predefined retrospective subset analysis of 586 patients of the 597 patients with wild-type KRAS (exon 2) mCRC was performed, where tumour samples from these patients were tested for additional RAS and BRAF mutations as previously described.
Opravljena je bila vnaprej opredeljena retrospektivna analiza podskupine 586 od 597 bolnikov z mKRR z divjim tipom KRAS (ekson 2), pri kateri so vzorce tumorja teh bolnikov testirali glede dodatnih mutacij RAS in BRAF, kot je bilo predhodno opisano.
Overall, panitumumab treatment combined with chemotherapy and bevacizumab is associated with an unfavourable benefit-to-risk profile irrespective of tumour KRAS mutational status.
V celoti je zdravljenje s panitumumabom v kombinaciji s kemoterapijo in bevacizumabom povezano z neugodnim profilom koristi in tveganja, ne glede na mutacijsko stanje KRAS tumorja.
The infusion line should be flushed with sodium chloride solution before and after Vectibix administration to avoid mixing with other medicinal products or intravenous solutions.
Infuzijsko linijo morate pred aplikacijo zdravila Vectibix in po njej sprati z raztopino natrijevega klorida, da boste preprečili mešanje z drugimi zdravili ali intravenskimi raztopinami.
In the post-marketing setting, rare cases of skin necrosis, Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.4) have been reported.
V obdobju trženja so bili poročani redki primeri nekroze kože, Stevens-Johnsonovega sindroma in toksične epidermalne nekrolize (glejte poglavje 4.4).
In the event of acute onset or worsening pulmonary symptoms, Vectibix treatment should be interrupted and a prompt investigation of these symptoms should occur.
Zato morate v primeru akutnega nastanka ali poslabšanja pljučnih simptomov zdravljenje z zdravilom Vectibix prekiniti in simptome takoj raziskati.
Doses up to 9 mg/kg have been tested in clinical trials.
V kliničnih preskušanjih so testirali odmerke do 9 mg/kg.
Vectibix should not be used in combination with bevacizumab (another monoclonal antibody used in cancer of the bowel) or with a chemotherapy combination known as “IFL”.
Zdravilo Vectibix se ne sme uporabljati v kombinaciji z bevacizumabom (drugo monoklonsko protitelo, ki se uporablja pri raku debelega črevesa) ali v kombinaciji s kemoterapijo, znano kot »IFL«.
Panitumumab binds to the ligand binding domain of EGFR and inhibits receptor autophosphorylation induced by all known EGFR ligands.
Panitumumab se veže na predel EGFR za vezavo liganda in zavre avtofosforilacijo receptorja, ki jo sprožijo vsi znani ligandi EGFR.
Your doctor may decide to reduce the rate of your infusion or discontinue your treatment with Vectibix.
Vaš zdravnik se lahko odloči, da zmanjša pogostnost odmerjanja vaših infuzij ali prekine vaše zdravljenje z zdravilom Vectibix.
Median overall survival was 19.4 (95% CI: 18.4, 20.8) and 24.5 (95% CI: 20.4, 24.5) in the panitumumab arm and the non-panitumumab arm.
Mediana celokupnega preživetja v kraku s panitumumabom je bilo 19,4 (95 % IZ: 18,4, 20,8) in v kraku brez panitumumaba 24,5 (95 % IZ: 20,4, 24,5).
• in combination with oxaliplatin-based chemotherapy, if your RAS test shows that you have mutant RAS tumour, or if your RAS tumour status is unknown.
• v kombinaciji s kemoterapijo na podlagi oksaliplatina, če preiskava RAS pokaže, da imate tumor z mutantnim RAS oz. če stanje RAS vašega tumorja ni znano.
There have been reports of acute renal failure in patients who develop diarrhoea and dehydration (see section 4.4).
Poročali so o primerih akutne odpovedi ledvic pri bolnikih, ki se jim pojavi driska in dehidracija (glejte poglavje 4.4).
In the post-marketing setting, serious infusion-related reactions have been reported, including rare post-marketing reports with a fatal outcome.
Med uporabo v obdobju trženja so poročali tudi o resnih z infundiranjem povezanih reakcijah, vključno z redkimi primeri s smrtnim izidom.
• The other ingredients are sodium chloride, sodium acetate trihydrate, acetic acid (glacial) and water for injections.
• Druge sestavine zdravila so natrijev klorid, natrijev acetat trihidrat, koncentrirana ocetna kislina (ledocet) in voda za injekcije.
Acute renal failure has been observed in patients who develop severe diarrhoea and dehydration.
Opisana je akutna odpoved ledvic pri bolnikih, ki se jim pojavi huda driska in dehidracija.
Sodium chloride, sodium acetate trihydrate, acetic acid (glacial), water for injections.
Natrijev klorid, natrijev acetat trihidrat, koncentrirana ocetna kislina (ledocet), voda za injekcije.
Formal male fertility studies have not been conducted; however, microscopic evaluation of male reproductive organs from repeat-dose toxicity studies in cynomolgus monkeys at doses up to approximately 5-fold the human dose on a mg/kg basis, revealed no differences compared to control male monkeys.
Vendar mikroskopski pregled reproduktivnih organov samcev opic cynomolgus v študijah ponavljajočih se odmerkov z odmerki, ki so bili do približno 5-kratnik odmerka za človeka na podlagi mg/kg, ni pokazal razlik v primerjavi s kontrolnimi samci.
Vectibix should not be administered in combination with bevacizumab containing chemotherapy (see sections 4.5 and 5.1).
Zdravila Vectibix se ne sme uporabljati v kombinaciji s kemoterapijo, ki vključuje bevacizumab (glejte poglavji 4.5 in 5.1).
If you develop a severe infection or fever as a result of skin reactions, your doctor may stop your treatment with Vectibix.
Če zaradi kožne reakcije pride do hude infekcije ali povišane telesne temperature, lahko zdravnik prekine vaše zdravljenje z zdravilom Vectibix.
The skin rash and diarrhoea observed in monkeys are considered related to the pharmacological action of panitumumab and are consistent with the toxicities observed with other anti-EGFR inhibitors.
Izpuščaj na koži in driska, opažena pri opicah, veljata za povezana s farmakološkim delovanjem panitumumaba in se skladata s toksičnimi učinki, ugotovljenimi z drugim zaviralci anti-EGFR.
These reactions are related to the pharmacologic effects of Vectibix, and the majority are mild to moderate in nature with 23% severe (grade 3 NCI-CTC) and < 1% life-threatening (grade 4 NCI-CTC).
Te reakcije so povezane s farmakološkimi učinki zdravila Vectibix in so večinoma blage do zmerne, 23 % je hudih (3. stopnja po NCI-CTC) in < 1 % je življensko ogrožujočih (4. stopnja po NCI-CTC).
In the final analysis, the hazard ratio for PFS was 1.27 (95% CI: 1.06, 1.52).
Končna analiza je pokazala razmerje ogroženosti za PFS 1,27 (95 % IZ: 1,06, 1,52).
Panitumumab is a fully human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
Panitumumab je popolnoma humano monoklonsko protitelo IgG2, pridobljeno na sesalski celični liniji (CHO) s tehnologijo rekombinantne DNA.
Patients who have severe dermatologic reactions or soft tissue toxicity or who develop worsening reactions whilst receiving Vectibix should be monitored for the development of inflammatory or infectious sequelae (including cellulitis and necrotising fasciitis), and appropriate treatment promptly initiated.
Bolnike s hudimi dermatološkimi reakcijami ali toksičnostjo mehkih tkiv ali poslabšanjem reakcij med uporabo zdravila Vectibix morate spremljati zaradi možnih vnetnih ali infekcijskih posledic (vključno s celulitisom in nekrotizirajočim fasciitisom) ter jim ob pojavu le teh nemudoma uvesti ustrezno zdravljenje.
Patients with additional RAS mutations beyond KRAS exon 2 were unlikely to benefit from the addition of panitumumab to FOLFIRI and a detrimental effect was seen with the addition of panitumumab to FOLFOX in these patients.
Pri bolnikih, ki so imeli poleg KRAS eksona 2 dodatne mutacije RAS, ni bilo verjetno, da bi jim dodatek panitumumaba poleg FOLFIRI koristil, po dodatku panitumumaba poleg FOLFOX pa so pri teh bolnikih opažali škodljiv učinek.
Data from an interaction study involving Vectibix and irinotecan in patients with mCRC indicated that the pharmacokinetics of irinotecan and its active metabolite, SN-38, are not altered when the medicinal products are co-administered.
Podatki študije o medsebojnem delovanju zdravil, ki je vključevala zdravili Vectibix in irinotekanom, pri bolnikih z mKRR kažejo, da se med sočasno uporabo zdravil farmakokinetika irinotekana in njegovega aktivnega metabolita SN-38 ne spremeni.
Patients with ECOG 2 performance status treated with Vectibix in combination with chemotherapy
Bolniki z zmogljivostnim stanjem 2 po ECOG, zdravljeni z zdravilom Vectibix v kombinaciji s kemoterapijo
Based on an analysis of all mCRC clinical trial patients receiving Vectibix monotherapy and in combination with chemotherapy (n = 2,224), the most commonly reported adverse reactions are skin reactions occurring in approximately 94% of patients.
Na podlagi analize vseh bolnikov z mKRR v kliničnih preskušanjih, ki so prejemali monoterapijo z zdravilom Vectibix in zdravilo Vectibix v kombinaciji s kemoterapijo (n = 2.224), so najpogosteje poročani neželeni učinki kožne reakcije; pojavijo se pri približno 94 % bolnikov.
In combination with irinotecan- or oxaliplatin-based chemotherapy:
V kombinaciji s kemoterapijo na podlagi irinotekana ali oksaliplatina:
In vitro assays and in vivo animal studies have shown that panitumumab inhibits the growth and survival of tumour cells expressing EGFR.
Preizkusi in vitro in študije na živalih in vivo so pokazali, da panitumumab zavre rast in preživetje tumorskih celic z eksprimiranim EGFR.
Your doctor will also check your blood levels of magnesium and calcium periodically during your treatment, and for up to 8 weeks after you have finished your treatment.
Zdravnik vam bo v rednih časovnih presledkih tudi med zdravljenjem in še do 8 tednov po koncu zdravljenja preverjal koncentraciji magnezija in kalcija v krvi.
• eye inflammation (conjunctivitis);
• vnetje oči (konjunktivitis),
If you experience blistering, you should notify your doctor immediately.
Če se vam pojavijo mehurji, morate nemudoma obvestiti svojega zdravnika.
Very rarely, serious allergic (hypersensitivity) reactions involving symptoms similar to an infusion reaction (see “Infusion reactions”) have occurred more than 24 hours after treatment and resulted in a fatal outcome.
Zelo redko so se po več kot 24 urah po zdravljenju pojavile resne alergijske (preobčutljivostne) reakcije, ki so vključevale podobne simptome kot pri z infuzijo povezanih reakcijah (glejte poglavje »Z infuzijo povezane reakcije«) in se končale s smrtnim izidom.
In clinical studies, subsequent to the development of severe dermatologic reactions (including stomatitis), infectious complications including sepsis and necrotising fasciitis, in rare cases leading to death, and local abscesses requiring incisions and drainage were reported.
V kliničnih študijah so po pojavu hudih dermatoloških reakcij (vključno s stomatitisom) zabeležili infekcijske zaplete, vključno s sepso in nekrotizirajočim fasciitisom, ki so v redkih primerih povzročili smrt, ter lokalne abscese, ki so potrebovali incizijo in drenažo.
Progressively decreasing serum magnesium levels leading to severe (grade 4) hypomagnesaemia have been observed in some patients.
Pri nekaterih bolnikih so opažali napredujoče zniževanje koncentracije magnezija v serumu, ki je povzročilo hudo hipomagneziemijo (4. stopnje).
The incidence of these additional RAS mutations in the wild-type KRAS exon 2 population was approximately 16%.
Incidenca teh dodatnih mutacij RAS v populaciji z divjim tipom KRAS ekson 2 je bila približno 16 %.