natgillin/translations-raw huggingface dataset:
Patients with interstitial pneumonitis or pulmonary fibrosis (see section 4.4).
Bolniki z intersticijskim pnevmonitisom ali pljučno fibrozo (glejte poglavje 4.4).
Monoclonal antibodies are proteins, which specifically recognise and attach (bind) to other unique proteins in the body.
Monoklonska protitelesa so beljakovine, ki specifično prepoznajo druge edinstvene beljakovine v telesu in se vežejo nanje.
The treatment will usually be given over a period of approximately 60 minutes.
Dajanje zdravila ponavadi traja približno 60 minut.
• local or widespread rash which may be bumpy (with or without spots), itchy, red or flaky;
• lokalen ali razširjen izpuščaj, ki je lahko bunčičast (z ali brez peg), srbeč, rdeč ali luskast,
There is no relevant use of Vectibix in the paediatric population in the indication treatment of colorectal cancer.
Uporaba zdravila Vectibix v pediatrični populaciji za indikacijo zdravljenja kolorektalnega raka ni relevantna.
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC08
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC08
The efficacy results from an analysis adjusting for potential bias from unscheduled assessments are shown in the table below.
Rezultati učinkovitosti iz analize, ki je uporabila korekcijo možne pristranosti zaradi nenačrtovanih ocenjevanj, so prikazani v tabeli spodaj.
Some rashes have been associated with redness, itching and flaking of the skin which can become severe.
Nekateri izpuščaji so bili povezani z rdečino, srbenjem in luščenjem kože in lahko postanejo hudi.
Binding of panitumumab to EGFR results in internalisation of the receptor, inhibition of cell growth, induction of apoptosis, and decreased interleukin 8 and vascular endothelial growth factor production.
Vezava panitumumaba na EGFR povzroči internalizacijo receptorja, zavrtje celične rasti, indukcijo apoptoze ter manjše nastajanje interlevkina 8 in žilnega endotelijskega rastnega faktorja.
These toxicities infrequently led to discontinuation of Vectibix or of chemotherapy.
Ti toksični učinki so redko povzročili prenehanje uporabe zdravila Vectibix ali kemoterapije.
Additional mutations in KRAS and NRAS at exon 3 (codon 59) were subsequently identified (n = 7).
V nadaljevanju so bile ugotovljene dodatne mutacije KRAS in NRAS v eksonu 3 (kodon 59) (n = 7).
Studies to evaluate the mutagenic and carcinogenic potential of panitumumab have not been performed.
Študije za oceno mutagenosti in kancerogenosti panitumumaba niso bile izvedene.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg/5 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 mg/5 ml
Do not use Vectibix:
Ne uporabljajte zdravila Vectibix:
Doses higher than 1,000 mg should be infused over approximately 90 minutes (for handling instructions, see section 6.6).
Odmerke nad 1.000 mg je treba infundirati približno 90 minut (za navodila za ravnanje glejte poglavje 6.6).
It is important to tell your doctor if you plan to breast-feed.
Pomembno je, da zdravniku poveste, če nameravate dojiti.
What you need to know before you use Vectibix
Kaj morate vedeti, preden boste uporabili zdravilo Vectibix
However, infusion reactions were more frequent with cetuximab (13% versus 3%) but electrolyte disturbances were more frequent with panitumumab, especially hypomagnesaemia (29% versus 19%).
Infuzijske reakcije so bile pogostejše pri cetuksimabu (13 % pri cetuksimabu v primerjavi s 3 % pri panitumumabu), vendar so bile elektrolitske motnje pogostejše pri panitumumabu, še posebej hipomagnezemija (29 % pri panitumumabu v primerjavi z 19 % pri cetuksimabu).
Monitoring as above and repletion as appropriate of these electrolytes is also recommended.
Priporočljivo je spremljanje, kot je opisano zgoraj, in dodajanje teh elektrolitov, kot je ustrezno.
No overall differences in safety or efficacy were observed in elderly patients (≥ 65 years of age) treated with Vectibix monotherapy.
V celoti niso ugotovili razlik v varnosti ali učinkovitosti med starejšimi bolniki (starimi ≥ 65 let), ki so prejemali monoterapijo z zdravilom Vectibix.
If Vectibix is used during pregnancy or if the patient becomes pregnant while receiving this medicinal product, she should be advised of the potential risk for loss of the pregnancy or potential hazard to the foetus.
Če zdravilo Vectibix uporabite med nosečnostjo ali če bolnica med zdravljenjem s tem zdravilom zanosi, jo morate seznaniti z možnim tveganjem za splav in možno nevarnostjo za plod.
A total of 1,010 patients refractory to chemotherapy were randomised 1:1 to receive Vectibix or cetuximab to test whether Vectibix is non-inferior to cetuximab.
Skupno 1.010 bolnikov, odpornih proti kemoterapiji, so v razmerju 1:1 randomizirali na prejemanje zdravila Vectibix ali cetuksimaba, da bi ugotovili, ali je zdravilo Vectibix neinferiorno cetuksimabu.
If Vectibix is to be used in combination with FOLFOX then it is recommended that mutational status be determined by a laboratory that participates in a RAS External Quality Assurance programme or wild-type status be confirmed in a duplicate test.
Če je predvidena uporaba zdravila Vectibix v kombinaciji s FOLFOX, je priporočljivo, da mutacijsko stanje določi laboratorij, ki sodeluje v programu Eksterno zagotavljanje kakovosti RAS (RAS External Quality Assurance programme), ali da se stanje divjega tipa potrdi s ponovitvijo testa.
Panitumumab binds onto the EGFR and prevents the cancer cell from receiving the messages it needs for growth and division.
Panitumumab se veže na EGFR in tako rakavi celici prepreči, da bi sprejela sporočila, potrebna za rast in delitev.
Results from a cross-study comparison indicated that irinotecan-containing regimens (IFL or FOLFIRI) have no effect on the pharmacokinetics of panitumumab.
Rezultati primerjave v navzkrižni študiji so pokazali, da sheme z irinotekanom (IFL ali FOLFIRI) ne vplivajo na farmakokinetiko panitumumaba.
Results suggest that age (21-88), gender, race, hepatic function, renal function, chemotherapeutic agents, and EGFR membrane staining intensity (1+, 2+, 3+) in tumour cells had no apparent impact on the pharmacokinetics of panitumumab.
Rezultati kažejo, da starost (21 - 88 let), spol, rasa, delovanje jeter, delovanje ledvic, zdravila za kemoterapijo in intenzivnost membranskega barvanja EGFR (1+, 2+, 3+) na tumorskih celicah nimajo opaznega vpliva na farmakokinetiko panitumumaba.
These events consisted predominantly of rash and dermatitis acneiform and were mostly mild to moderate in severity.
Ti učinki so obsegali predvsem izpuščaj in akneiformen dermatitis ter so bili večinoma blagi do zmerni.
Patients with a history of, or evidence of, interstitial pneumonitis or pulmonary fibrosis were excluded from clinical studies.
Bolniki z anamnezo ali znaki intersticijskega pnevmonitisa ali pljučne fibroze so bili izključeni iz kliničnih študij.
Tell your doctor if you use contact lenses and/or have a history of eye problems such as severe dry eye, inflammation of the front part of the eye (cornea) or ulcers involving the front part of the eye.
Povejte svojemu zdravniku, če uporabljate kontaktne leče in/ali če ste kdaj imeli težave z očmi, kot so zelo suhe oči, vnetje sprednjega dela očesa (roženice) ali razjede, ki so vključevale sprednji del očesa.
Very commonly reported adverse reactions occurring in ≥ 20% of patients were gastrointestinal disorders [diarrhoea (46%), nausea (39%), vomiting (26%), constipation (23%) and abdominal pain (23%)]; general disorders [fatigue (35%), pyrexia (21%)]; metabolism and nutrition disorders [decreased appetite (30%)]; infections and infestations [paronychia (20%)]; and skin and subcutaneous disorders [rash (47%), dermatitis acneiform (39%), pruritus (36%), erythema (33%) and dry skin
Zelo pogosto opisani neželeni učinki, ki so se pojavili pri ≥ 20 % bolnikov, so bile bolezni prebavil [driska (46 %), navzea (39 %), bruhanje (26 %), zaprtost (23 %) in bolečine v trebuhu (23 %)], splošne težave [utrujenost (35 %), pireksija (21 %)]; presnovne in prehranske motnje [zmanjšan apetit (30 %)]; infekcijske in parazitske bolezni [paronihija (20 %)] ter bolezni kože in podkožja [izpuščaj (47 %), akneiformni dermatitis (39 %), srbenje (36 %), eritem (33 %) in suha koža (21 %)].
In rare cases patients may experience blistering of the skin, mouth, eyes and genitals, which may indicate a severe skin reaction called “Stevens-Johnson syndrome” or blistering of the skin, which may indicate a severe skin reaction called “toxic epidermal necrolysis”.
V redkih primerih se bolnikom lahko pojavijo mehurji na koži, v ustih, na očeh in spolovilih, ki so lahko znak hude kožne reakcije, imenovane "Stevens-Johnsonov sindrom", ali mehurji na koži, ki so lahko znak hude kožne reakcije, imenovane "toksična epidermalna nekroliza".
Mutational status should be determined by an experienced laboratory using validated test methods for detection of KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4) mutations.
Mutacijsko stanje mora ugotoviti izkušen laboratorij z uporabo validiranih testnih metod za detekcijo mutacij KRAS (eksoni 2, 3 in 4) in NRAS (eksoni 2, 3 in 4).
Doses higher than 1,000 mg should be infused over approximately 90 minutes.
Odmerke, večje od 1.000 mg, je treba infundirati približno 90 minut.
Panitumumab treatment was discontinued due to a statistically significant reduction in PFS in patients receiving panitumumab observed in an interim analysis.
Zdravljenje s panitumumabom so prekinili, ker je bilo na vmesni analizi ugotovljeno statistično značilno skrajšanje PFS med bolniki, ki so dobivali panitumumab.
Clinical efficacy in combination with chemotherapy
Klinična učinkovitost v kombinaciji s kemoterapijo
Anaphylactic reaction2
anafilaktična reakcija2
Vectibix has not been tested in pregnant women.
Zdravilo Vectibix ni preizkušeno pri nosečnicah.
The fatal event occurred after re-exposure following a prior episode of angioedema; both episodes occurred greater than 24 hours after administration (see sections 4.3 and 4.4).
Bolnik je umrl po ponovni izpostavljenosti zdravilu, ki je sledila predhodnemu angioedemu; obe epizodi sta se pojavili več kot 24 ur po uporabi (glejte poglavji 4.3 in 4.4).
Animal studies have shown reversible effects on the menstrual cycle and reduced female fertility in monkeys (see section 5.3).
Študije na živalih so pokazale reverzibilne učinke na menstruacijski ciklus in manjšo plodnost opičjih samic (glejte poglavje 5.3).
You may experience skin reactions or severe swelling and tissue damage, if these worsen or become intolerable please tell your doctor or nurse immediately.
Pojavijo se vam lahko kožne reakcije ali hudo otekanje in poškodba tkiva; če se poslabšajo ali postanejo nevzdržni, nemudoma obvestite zdravnika ali medicinsko sestro.
This medicine contains 3.45 mg sodium (main component of cooking/table salt) in each mL unit.
To zdravilo vsebuje 3,45 mg natrija (glavne sestavine kuhinjske soli) na ml.
Panitumumab recognises and binds specifically to a protein known as epidermal growth factor receptor (EGFR), which is found on the surface of some cancer cells.
Panitumumab prepozna in se specifično veže na beljakovino, imenovano receptor za epidermalni rastni dejavnik (EGFR), ki se nahaja na površini nekaterih rakavih celic.
Vectibix is used alone or in combination with other anti-cancer medicines.
Zdravilo Vectibix se uporablja samostojno ali v kombinaciji z drugimi zdravili proti raku.
Because human IgG is secreted into human milk, panitumumab might also be secreted.
Ker se v materino mleko izločajo humani IgG, bi se lahko izločal tudi panitumumab.
These can be mild or moderate (likely to occur in approximately 5 out of 100 people who take Vectibix), or severe (likely to occur in 1 out of 100 people who take Vectibix).
Te reakcije so lahko blage ali zmerne (predvidoma se pojavijo pri približno 5 od 100 bolnikov, ki uporabljajo zdravilo Vectibix), ali hude (predvidoma se pojavijo pri 1 od 100 bolnikov, ki uporabljajo zdravilo Vectibix).
Symptoms may include headache, rashes, itching or hives, flushing, swelling (face, lips, mouth, around the eyes, and throat area), rapid and irregular heartbeat, fast pulse, sweating, nausea, vomiting, dizziness, difficulty breathing or swallowing, or a decrease in blood pressure that may be severe or life-threatening and, very rarely, may lead to death.
Simptomi lahko vključujejo glavobol, izpuščaje, srbenje ali koprivnico, rdečico, oteklino (obraza, ustnic, ust, predela okoli oči in grla), hitro in neredno bitje srca, hiter srčni utrip, potenje, navzeo, bruhanje, omotico, težave z dihanjem ali s požiranjem, ali znižanje krvnega tlaka, in so lahko hudi ali življensko nevarni in zelo redko tudi smrtni.
The skin rash commonly resembles acne and often involves the face, upper chest and back, but can affect any area of the body.
Kožni izpuščaj je pogosto podoben aknam, pogosto vključuje obraz, zgornji del prsnega koša in hrbta, lahko pa prizadene kateri koli drug predel na telesu.
• if you have previously had or have evidence of interstitial pneumonitis (swelling of the lungs causing coughing and difficulty breathing) or pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).
• če ste kdaj imeli ali imate intersticijsko pljučnico (otekanje pljuč, ki povzroči kašelj in težko dihanje) ali pljučno fibrozo (brazgotinjenje in zadebelitve v pljučih, ki povzročijo kratko sapo),
Fertility studies conducted in female cynomolgus monkeys showed that panitumumab may produce prolonged menstrual cycle and/or amenorrhea and reduced pregnancy rate which occurred at all doses evaluated.
Študije plodnosti pri samicah opic cynomolgus so pokazale, da lahko panitumumab povzroči podaljšan menstruacijski ciklus in/ali amenorejo ter zmanjša delež nosečnosti, kar se je dogajalo pri vseh ocenjevanih odmerkih.
Patients may be advised to apply moisturiser and sunscreen to face, hands, feet, neck, back and chest every morning during treatment, and to apply the topical steroid to face, hands, feet, neck, back and chest every night during treatment.
Bolnikom se lahko svetuje, naj v času zdravljenja vsako jutro na obraz, roke, noge, vrat, hrbet in prsi nanesejo vlažilno sredstvo in sredstvo za zaščito pred soncem ter vsak večer na obraz, roke, noge, vrat, hrbet in prsi nanesejo lokalni steroid.
The potential for absorption and harm to the infant after ingestion is unknown.
Možnost absorpcije in škodljivega delovanja na dojenčka po zaužitju nista znana.
When growth factors (other body proteins) attach to the EGFR, the cancer cell is stimulated to grow and divide.
Ko se na EGFR vežejo rastni dejavniki (določene druge telesne beljakovine), to rakavo celico spodbudi, da raste in se deli.
Upon disease progression BSC alone patients were eligible to crossover to a companion study and receive Vectibix at a dose of 6 mg/kg given once every two weeks.
Po napredovanju bolezni so bolniki, ki so prejemali samo BSC, lahko prešli v spremljajočo študijo in dobivali zdravilo Vectibix v odmerku 6 mg/kg enkrat na dva tedna.
You should speak with your doctor before driving or using machines, as some side effects may impair your ability to do so safely.
Preden vozite ali upravljate stroje, se morate posvetovati z zdravnikom, kajti nekateri neželeni učinki lahko poslabšajo sposobnost za varno izvajanje teh opravil.
Animal studies are insufficient with respect to embryo-foetal development since foetal panitumumab exposure levels were not examined.
Študije na živalih niso zadostne, kar zadeva razvoj zarodka in ploda, ker raven izpostavljenosti ploda panitumumabu ni raziskana.
Mutant RAS population PFS
Populacija z mutantnim RAS PFS
Following a single-dose administration of panitumumab as a 1-hour infusion, the area under the concentration-time curve (AUC) increased in a greater than dose-proportional manner and clearance (CL) of panitumumab decreased from 30.6 to 4.6 mL/day/kg as the dose increased from 0.75 to 9 mg/kg.
Po uporabi posamičnega odmerka panitumumaba v 1-urni infuziji se je površina pod krivuljo koncentracije po času (AUC) povečala bolj kot sorazmerno odmerku, očistek (Cl) panitumumaba pa se je ob povečanju odmerka od 0,75 na 9 mg/kg zmanjšal s 30,6 na 4,6 ml/dan/kg.
Vectibix is a colourless liquid that may contain visible particles and is supplied in a glass vial.
Zdravilo Vectibix je brezbarvna tekočina, ki lahko vsebuje vidne delce, in je na voljo v steklenih vialah.
Other key endpoints included the PFS, time to response, TTP, and duration of response.
Med drugimi ključnimi opazovanimi dogodki so bili PFS, čas do odziva, TTP in trajanje odziva.
CI = confidence interval a In patients that crossed over to panitumumab after progression on BSC alone (95% CI)
IZ = interval zaupanja a Pri bolnikih, ki so po napredovanju ob uporabi samo BSC prešli v skupino s panitumumabom (95 % IZ)
The solution should be colourless and may contain visible translucent-to-white, amorphous, proteinaceous particulates (which will be removed by in-line filtration).
Raztopina mora biti brezbarvna in lahko vsebuje vidne prosojne do bele amorfne beljakovinske delce (ki bodo odstranjeni z linijsko filtracijo).
Patients who experience severe diarrhoea should be instructed to consult a healthcare professional urgently.
Bolnikom, ki se jim pojavi huda driska, je treba naročiti, da se takoj posvetujejo z zdravnikom.
• in first-line in combination with FOLFOX or FOLFIRI.
• v prvi liniji zdravljenja v kombinaciji s FOLFOX ali FOLFIRI,
The mean (± SD) AUC0-tau and CL were 1,306 ± 374 mcg•day/mL and 4.9 ± 1.4 mL/kg/day, respectively.
Povprečna (± SD) AUC0-tau je bila 1.306 ± 374 mcg•dan/ml, povprečni (± SD) očistek pa 4,9 ± 1,4 ml/kg/dan.
BRAF mutations were not predictive of the outcome for panitumumab treatment in combination with FOLFOX or FOLFIRI.
Mutacije BRAF niso bile napovednik izida zdravljenja s panitumumabom v kombinaciji s FOLFOX ali FOLFIRI.
Therefore administration of Vectibix in combination with IFL should be avoided (see section 4.5).
Zato se je treba uporabi zdravila Vectibix v kombinaciji z IFL izogibati (glejte poglavje 4.5).
The observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medicinal products and underlying disease, therefore, comparison of the incidence of antibodies to other products may be misleading.
Na ugotovljeno incidenco pozitivnih izvidov za protitelesa z določenim preizkusom lahko vpliva več dejavnikov, med drugim metodologija preizkusa, ravnanje z vzorcem, čas odvzema vzorca, sočasno uporabljana zdravila in osnovna bolezen, zato je lahko primerjava incidence protiteles z drugimi zdravili zavajajoča.
If you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision and/or sensitivity to light, please tell your doctor or nurse immediately as you may need urgent treatment (see “Possible side effects” below).
Če se vam akutno pojavijo ali poslabšajo pordelost in bolečina v očesu, povečano solzenje, zamegljenost vida in/ali občutljivost na svetlobo, morate to nemudoma povedati zdravniku ali medicinski sestri, saj boste mogoče potrebovali takojšnje zdravljenje (glejte poglavje »Možni neželeni učinki« spodaj).
3 See section 4.4 Pulmonary complications
3 Glejte poglavje 4.4 Zapleti na pljučih.
What Vectibix is and what it is used for What you need to know before you use Vectibix How to use Vectibix
Kaj je zdravilo Vectibix in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Vectibix Kako uporabljati zdravilo Vectibix Možni neželeni učinki
Patients with a history of severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Bolniki z anamnezo hude ali smrtno nevarne preobčutljivosti na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte poglavje 4.4).
A case of fatal angioedema occurred in a patient with recurrent and metastatic squamous cell carcinoma of the head and neck treated with Vectibix in a clinical trial.
Opisan je primer smrtnega angioedema pri bolniku z recidivnim in metastatskim ploščatoceličnim karcinomom glave in vratu, ki je v kliničnem preskušanju dobival zdravilo Vectibix.
Occurrence of skin symptom(s): ≥ grade 31
Pojav kožnih simptomov: ≥ 3. stopnje1
• severe skin reaction with blistering of the skin (toxic epidermal necrolysis);
• huda kožna reakcija z mehurji na koži (toksična epidermalna nekroliza),
Using only a 21-gauge or smaller diameter hypodermic needle, withdraw the necessary amount of Vectibix for a dose of 6 mg/kg.
Z uporabo hipodermične igle, ki je lahko le velikosti 21 ali manjšega premera, izvlecite potrebno količino zdravila Vectibix za odmerek 6 mg/kg.
In an exploratory analysis of banked tumour specimens from this study, 11 of 72 patients (15%) with wild-type RAS tumours receiving panitumumab had an objective response compared to only 1 of 95 patients (1%) with mutant RAS tumour status.
V eksplorativni analizi shranjenih vzorcev tumorjev iz te študije je objektivni odziv doseglo 11 od 72 bolnikov (15 %) s tumorji z divjim tipom RAS, ki so prejemali panitumumab, pa le 1 od 95 bolnikov (1 %), ki so imeli tumor z mutiranim statusom RAS.
In patients with a history of interstitial pneumonitis or pulmonary fibrosis, the benefits of therapy with panitumumab versus the risk of pulmonary complications must be carefully considered.
Pri bolnikih z anamnezo intersticijskega pnevmonitisa ali pljučne fibroze je potrebno skrbno razmisliti o koristih zdravljenja s panitumumabom v primerjavi s tveganjem za zaplete na pljučih.
• inflammation of the lungs (interstitial lung disease).
• vnetje pljuč (intersticijska pljučna bolezen).
PHARMACEUTICAL FORM AND CONTENTS 5 mL of concentrate for solution for infusion.
FARMACEVTSKA OBLIKA IN VSEBINA 5 ml koncentrata za raztopino za infundiranje.
• inability to sleep (insomnia);
• nespečnost (insomnija),
A multinational, randomised, controlled trial was conducted in 463 patients with EGFR-expressing metastatic carcinoma of the colon or rectum after confirmed failure of oxaliplatin and irinotecancontaining regimens.
Narejeno je bilo multinacionalno, randomizirano, kontrolirano preskušanje 463 bolnikov z metastatskim karcinomom na kolonu ali rektumu in eksprimiranim EGFR, po potrjenem neuspehu shem z oksaliplatinom in irinotekanom.
Vectibix should be used with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye.
Zdravilo Vectibix morate uporabljati previdno pri bolnikih z anamnezo keratitisa, ulcerativnega keratitisa ali zelo suhih oči.
Patient tumour samples with wild-type KRAS exon 2 (codons 12/13) status were tested for additional RAS mutations in KRAS exon 3 (codons 61) and exon 4 (codons 117/146) and NRAS exon 2 (codons 12/13), exon 3 (codon 61), and exon 4 (codons 117/146) and BRAF exon 15 (codon 600).
Vzorce tumorjev bolnikov z divjim tipom KRAS ekson 2 (kodoni 12/13) so testirali za dodatne mutacije RAS v KRAS eksonu 3 (kodoni 61) in eksonu 4 (kodoni 117/146) ter NRAS eksonu 2 (kodoni 12/13), eksonu 3 (kodoni 61) in eksonu 4 (kodoni 117/146) in BRAF eksonu 15 (kodon 600).
There was an increase in mortality in the panitumumab arm.
Umrljivost v kraku s panitumumabom se je povečala.
Data on the development of anti-panitumumab antibodies has been evaluated using two different screening immunoassays for the detection of binding anti-panitumumab antibodies (an ELISA which detects high-affinity antibodies, and a Biosensor Immunoassay which detects both high and low-affinity antibodies).
Pojav protiteles proti panitumumabu so ovrednotili z dvema različnima presejalnima imunskima preizkusoma za odkrivanje protiteles, ki vežejo panitumumab (ELISA, ki odkrije visokoafinitetna protitelesa, in Biosensor Immunoassay, ki odkrije visoko- in nizkoafinitetna protitelesa).
This medicinal product contains 3.45 mg sodium per mL, equivalent to 0.017% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
To zdravilo vsebuje 3,45 mg natrija na ml, kar je enako 0,017 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.