natgillin/translations-raw huggingface dataset:
Population pharmacokinetic analysis suggested age, gender, and race had no effect on the pharmacokinetics of necitumumab, while CL and volume of distribution had a less than proportional positive correlation with body weight.
Posebne skupine bolnikov Analiza populacijske farmakokinetike je nakazala, da starost, spol in rasa niso vplivali na farmakokinetiko necitumumaba, očistek (CL) in porazdelitveni volumen pa sta imela manj kot sorazmerno pozitivno korelacijo s telesno maso.
The most common adverse reactions were skin reactions, venous thromboembolic events and laboratory abnormalities (hypomagnesaemia and albumin-corrected hypocalcaemia).
Najpogostejši neželeni učinki so bili kožne reakcije, venski trombembolični dogodki in nenormalni izvidi laboratorijskih preiskav (hipomagneziemija in za albumin korigirana hipokalciemija).
Cases of cardiorespiratory disorders and unexplained death were observed in patients treated with Portrazza in combination with gemcitabine and cisplatin and in patients treated with gemcitabine and cisplatin alone.
Primere kardiorespiratornih obolenj in nepojasnjeno smrt so opazili pri bolnikih, zdravljenih z zdravilom Portrazza v kombinaciji z gemcitabinom in cisplatinom, in pri bolnikih, ki so bili zdravljeni samo z gemcitabinom in cisplatinom.
The number of infusions that you receive will depend on how and for how long you respond to treatment with Portrazza.
Število infuzij, ki jih boste prejeli, bo odvisno od vašega odziva na zdravljenje z zdravilom Portrazza in od trajanja tega odziva.
Elderly No dose reductions other than those recommended for all patients are necessary (see sections 4.4 and
Zmanjšanja odmerkov z izjemo zmanjšanj, priporočenih za vse bolnike, niso potrebna (glejte poglavji
Excipients: sodium citrate dihydrate, citric acid anhydrous, sodium chloride, glycine, mannitol, polysorbate 80 and water for injections.
Pomožne snovi: natrijev citrat dihidrat, brezvodna citronska kislina, natrijev klorid, glicin, manitol, polisorbat 80 in voda za injekcije.
The recommended dose of Portrazza is 800 mg (flat dose) administered as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle.
Priporočeni odmerek zdravila Portrazza je 800 mg (fiksen odmerek), ki se daje v obliki intravenske infuzije v 60 minutah 1. in 8. dan vsakega 3-tedenskega cikla.
Human IgG1 is known to cross the placenta; therefore, necitumumab has the potential to be transmitted from the mother to the developing foetus.
Za humano protitelo IgG1 je znano, da prehaja skozi placento, zato ima necitumumab potencial za placentni prenos z matere na razvijajoči se plod.
Before starting treatment you must tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se morate posvetovati z zdravnikom, preden začnete z zdravljenjem.
The important side effects of Portrazza are skin reactions and blood clots in the veins.
Pomembni neželeni učinki zdravila Portrazza so kožne reakcije in krvni strdki v venah.
The following table provides the frequency and severity of ADRs based on results from SQUIRE, a global, multicenter, two-arm, randomized Phase 3 study in adult patients with squamous NSCLC randomised to treatment with necitumumab in combination with gemcitabine/cisplatin or gemcitabine/cisplatin.
V naslednji preglednici pogostnost in resnost neželenih učinkov zdravila temeljita na izidih študije SQUIRE, globalne, multicentrične, randomizirane študije 3. faze z dvema skupinama zdravljenja pri odraslih bolnikih s skvamoznim NSCLC, ki so bili randomizirani v skupino za zdravljenje z necitumumabom v kombinaciji z gemcitabinom/cisplatinom ali pa v skupino za zdravljenje z gemcitabinom/cisplatinom.
The incidence of fatal ATEs was 0.6% in the experimental arm versus 0.2% in the control arm (see also section 4.4).
Incidenca smrtnih arterijskih trombemboličnih dogodkov je bila 0,6 % v skupini eksperimentalnega zdravljenja v primerjavi z 0,2 % v kontrolni skupini (glejte tudi poglavje
Specific animal studies to test necitumumab for carcinogenic potential or potential to impair fertility have not been performed.
Specifičnih študij na živalih, v katerih bi testirali karcinogeni potencial necitumumaba ali potencial necitumumaba za škodljivo delovanje na plodnost, niso izvedli.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 800 mg/ 50 mL
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 800 mg/50 ml
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 s preteklo hudo ali življenjsko nevarno preobčutljivostjo na zdravilno učinkovino ali na katero koli pomožno snov, navedeno v poglavju 6.1.
If not used immediately, the prepared necitumumab dosing solution must be stored at 2°C to 8°C for a duration not to exceed 24 hours, or may be held at 9°C to 25°C for up to 4 hours.
Če pripravljene raztopine necitumumaba za odmerjanje ne uporabimo takoj, jo je treba shraniti pri 2 ºC 8 ºC za največ 24 ur, ali pa jo hraniti pri temperaturi od 9°C do 25°C največ 4 ure.
Portrazza and gemcitabine were administered on days 1 and 8 of each 3-week treatment cycle, and cisplatin was administered on day 1 of each 3-week treatment cycle.
Bolniki so prejeli zdravilo Portrazza in gemcitabin 1. in 8. dan vsakega 3tedenskega cikla zdravljenja, cisplatin pa 1. dan vsakega 3-tedenskega cikla zdravljenja.
Any grade
Vseh stopenj
Based on the results of the population pharamacokinetic analysis, there was no impact of age on necitumumab exposure.
Na podlagi rezultatov analize populacijske farmakokinetike ni bilo vpliva starosti na izpostavljenost necitumumabu.
Portrazza is for intravenous use only.
Zdravilo Portrazza je namenjeno le za intravensko uporabo.
See also section 4 for the symptoms of blood clots.
Za simptome krvnih strdkov glejte tudi poglavje 4.
For management and dose adjustments, see section 4.2.
Za obravnavo in prilagajanje odmerka glejte poglavje 4.2.
o Instruction for healthcare professionals to read the materials in conjunction with the SmPC.
o Navodilo za zdravstvene delavce, naj preberejo gradiva v povezavi s Povzetkom glavnih značilnosti zdravila.
In patients with no detectable EGFR protein expression, no improvement in overall survival (hazard ratio [HR] = 1.52 [0.74, 3.12]) or progression free survival (hazard ratio [HR] = 1.33 [0.65, 2.70] was observed.
Pri bolnikih brez izražene beljakovine EGFR ni bilo opaziti izboljšanja celokupnega preživetja (razmerje tveganja [HR] = 1,52 [0,74; 3,12]) ali preživetja brez napredovanja bolezni (razmerje tveganja [HR] = 1,33 [0,65, 2,70]).
What Portrazza looks like and contents of the pack Portrazza 800 mg concentrate for solution for infusion (sterile concentrate) is a clear to slightly opalescent and colourless to slightly yellow liquid in a glass vial with a rubber stopper.
Izgled zdravila Portrazza in vsebina pakiranja Portrazza 800 mg koncentrat za raztopino za infundiranje (sterilni koncentrat) je bistra ali rahlo opalescentna in brezbarvna ali nekoliko rumenkasta tekočina v stekleni viali z gumijastim zamaškom.
Do not administer the solution if you notice any particulate matter or discoloration.
Ne dajajte raztopine, če opazite v njej delce ali obarvanost.
Inspect the contents of the vials for particulate matter and discolouration.
Preglejte vsebino vial in bodite pozorni na trdne delce in obarvanost.
Animal reproduction studies have not been conducted with necitumumab.
Študije razmnoževanja pri živalih z necitumumabom niso bile opravljene.
How you are given Portrazza
Kako boste prejeli zdravilo Portrazza
There are no data from the use of necitumumab in pregnant women.
Nosečnost V zvezi z uporabo necitumumaba pri nosečnicah ni podatkov.
The concentrate for solution for infusion must be clear to slightly opalescent and colourless to slightly yellow prior to dilution.
Koncentrat za raztopino za infundiranje mora biti pred redčenjem bister do rahlo opalescenten in brezbarven do nekoliko rumenkast.
- The other ingredients are sodium citrate dihydrate (E331), citric acid anhydrous (E330), sodium chloride (see section 2 “Portrazza contains sodium”), glycine (E640), mannitol (E421), polysorbate 80 (E433) and water for injections.
- Druge sestavine zdravila so natrijev citrat dihidrat (E331), brezvodna citronska kislina (E330), natrijev klorid (glejte poglavje 2 "Zdravilo Portrazza vsebuje natrij"), glicin (E640), manitol (E421), polisorbat 80 (E433) in voda za injekcije.
Very common (may affect more than 1 in 10 people): - itching; dry skin; scaling; nail disorders (skin reactions) - vomiting - fever or high temperature (pyrexia) - decreased weight - mouth ulcers and cold sores (stomatitis)
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - srbečica; suha koža; luščenje kože; bolezni nohtov (kožne reakcije)
They can lead to a blockage of a blood vessel in the leg.
Povzročijo lahko zamašitev krvne žile v nogi.
If you have a severe skin reaction, your doctor may recommend adjusting the dose of Portrazza, or stop your treatment with Portrazza.
Če se bodo pri vas pojavile hude kožne reakcije, bo vaš zdravnik morda predlagal prilagoditev odmerka zdravila Portrazza, ali pa prekinil vaše zdravljenje z zdravilom Portrazza.
Following the dose regimen of 800 mg necitumumab on day 1 and day 8 of a 21 day schedule, the geometric mean of necitumumab Cmin was 98.5 μg/mL (Coefficient of Variation 80 %) in serum from patients with squamous NSCLC after five cycles of treatment in combination with gemcitabine and cisplatin.
Ob upoštevanju režima odmerjanja 800 mg necitumumaba 1. in 8. dan 21-dnevnega cikla so bile dosežene geometrične srednje vrednosti necitumumaba Cmin 98,5 μg/ml (koeficient variacije 80 %) v serumu bolnikov s skvamoznim NSCLC po petih ciklih zdravljenja v kombinaciji z gemcitabinom in cisplatinom.
ADRs reported in ≥ 1 % of necitumumab treated patients in SQUIRE
Neželeni učinki, o katerih so poročali pri ≥ 1 % bolnikov, zdravljenih z necitumumabom v študiji SQUIRE
o The need to carefully consider use of necitumumab in patients with a history of thromboembolic events or pre-existing risk factors for thromboembolic events o Information on relative risk of VTE or ATE in patients with a history of VTE or ATE o Advice that necitumumab should not be administered to patients with multiple risk factors for thromboembolic events unless the benefits outweigh the risks to the patient o The need to consider thromboprophylaxis after careful assessment of a patient's risk factors o Discontinuation of necitumumab in patients who experience a VTE or ATE should be considered after a thorough benefit risk assessment for the individual patient.
o Potreba po natančnem razmisleku o uporabi necitumumaba pri bolnikih s trombemboličnimi dogodki v anamnezi ali obstoječimi faktorji tveganja za trombembolične dogodke o Informacije o relativnem tveganju venskih trombemboličnih dogodkov ali arterijskih trombemboličnih dogodkov pri bolnikih z venskimi trombemboličnimi dogodki ali arterijskimi trombemboličnimi dogodki v anamnezi o Priporočilo, da se necitumumaba ne sme dati bolnikom z več dejavniki tveganja za trombembolične dogodke, razen če koristi odtehtajo tveganja za bolnika o Potreba po razmisleku o tromboprofilaksi po natančni oceni bolnikovih dejavnikov tveganja o Pri bolnikih, pri katerih se pojavijo venski trombembolični dogodki in arterijski trombembolični dogodki, je treba po natančni oceni koristi in tveganj za posameznega bolnika razmisliti o prekinitvi zdravljenja z necitumumabom.
Administration of necitumumab should be carefully considered in those patients with a history of thromboembolic events (such as pulmonary embolism, deep vein thrombosis, myocardial infarction, stroke) or preexisting risk factors for thromboembolic events (such as advanced age, patients with prolonged periods of immobilisation, severely hypovolemic patients, patients with acquired or inherited thrombophilic disorders).
O dajanju necitumumaba je treba natančno razmisliti pri bolnikih s trombemboličnimi dogodki v anamnezi (npr. pljučna embolija, globoka venska tromboza, miokardni infarkt, kap) ali obstoječimi faktorji tveganja za trombembolične dogodke (npr. višja starost, bolniki z daljšimi obdobji imobilizacije, bolniki s hudo hipovolemijo, bolniki s pridobljenimi ali podedovanimi trombofilnimi stanji).
Twelve of the fifteen patients died within 30 days of the last dose of necitumumab and had comorbid conditions including history of coronary artery disease (n=3), hypomagnesemia (n=4), chronic obstructive pulmonary disease (n=7), and hypertension (n=5).
dneh po zadnjem odmerku necitumumaba in je imelo sočasna obolenja, vključno s koronarno arterijsko boleznijo (n = 3), hipomagneziemijo (n = 4), kronično obstruktivno pljučno boleznijo (n = 7) in hipertenzijo (n = 5) v anamnezi.
An improvement was observed in subgroups for OS and PFS including the pre-specified stratification factors [ECOG PS score (0-1 vs. 2) and geographic region (North America, Europe, and Australia vs. South America, South Africa, and India vs. Eastern Asia)]; in patients age 70 and over, the hazard ratio for overall survival was 1.03 (0.75, 1.42) (see Figure 2).
vključno z vnaprej določenimi faktorji stratifikacije (ocena stanja zmogljivosti po ECOG [0-1 v primerjavi z 2] in geografsko regijo [Severna Amerika, Evropa in Avstralija v primerjavi z Južno Ameriko, Južno Afriko in Indijo v primerjavi z Vzhodno Azijo]); pri bolnikih, starih 70 let in več, je bilo razmerje tveganja za celokupno preživetje 1,03 (0,75; 1,42) (glejte Sliko 2).
Necitumumab hinders other proteins from binding to the EGFR and thus prevents the cancer cell from growth and division.
Necitumumab drugim beljakovinam onemogoča vezavo na EGFR in na ta način preprečuje rast in delitev rakave celice.
The recommended dose of Portrazza is 800 mg on days 1 and 8 of each 3-week cycle.
Priporočeni odmerek zdravila Portrazza je 800 mg 1. in 8. dan vsakega 3-tedenskega cikla.
The onset of events usually occurred after the first or second administration of necitumumab.
Ti dogodki so običajno nastopili po prvem ali drugem infundiranju necitumumaba.
Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.
Zdravilo Portrazza je v kombinaciji s kemoterapijo z gemcitabinom in cisplatinom indicirano za zdravljenje odraslih bolnikov z lokalno napredovalim ali metastatskim skvamoznim nedrobnoceličnim rakom pljuč z ekspresijo receptorjev za epidermalni rastni dejavnik (EGFR-epidermal growth factor receptor), ki za to bolezen še niso prejeli predhodne kemoterapije.
Overall, there was a low incidence of both treatment-emergent anti-drug antibodies and neutralizing antibodies among necitumumab-treated patients, and no correlation with safety outcomes in these patients.
Skupno je bila med bolniki, zdravljenimi z necitumumabom, incidenca protiteles na zdravilo zaradi zdravljenja in nevtralizirajočih protiteles nizka, korelacije z varnostnimi izidi pri teh bolniki ni bilo.
Patients may be advised to apply moisturiser, sunscreen and topical steroid cream to face, hands, feet, neck, back and chest.
Bolnikom lahko svetujete, naj nanesejo sredstvo za vlaženje kože, sredstvo za zaščito kože pred soncem ali topikalno steroidno kremo na obraz, dlani, stopala, vrat, hrbet in prsi.
The ECOG PS was 0 for 31.5 %, 1 for 59.7 %, and 2 for 9 % of patients; over 50 % had metastatic disease at more than 2 sites.
in 2 pri 9 % bolnikov; več kot 50 % bolnikov je imelo metastatsko bolezen na več kot 2 mestih.
In case of previous hypersensitivity or infusion-related reaction, recommendations for management of hypersensitivity/infusion-related reactions should be followed, as for Table 1.
V primeru preobčutljivostne reakcije ali reakcije, povezane z infuzijo, je treba upoštevati priporočila za obravnavo preobčutljivostne reakcije/reakcije, povezane z infuzijo, kot je navedeno v Preglednici 1.
• If symptoms do not worsen at 600 mg for another treatment cycle, the dose may be further increased to 800 mg.
• Če se simptomi pri odmerku 400 mg ne poslabšajo vsaj 1 cikel zdravljenja, lahko odmerek povečate na 600 mg.
Necitumumab is a recombinant human IgG1 monoclonal antibody that binds with high affinity and specificity to the human epidermal growth factor receptor 1 (EGFR) and blocks the ligand binding site, blocking activation by all known ligands and inhibiting relevant biological consequences in vitro.
Mehanizem delovanja Necitumumab je rekombinantno humano monoklonsko protitelo IgG1, ki se z visoko afiniteto in specifičnostjo veže na humani receptor 1 za epidermalni rastni dejavnik (EGFR) in zavira mesto vezave liganda, pri tem pa zavira z znanimi ligandi stimulirano aktivacijo receptorja in zavira pomembne biološke posledice in vitro.
No other formal interaction studies with necitumumab have been performed in humans.
Drugih formalnih študij medsebojnega delovanja z necitumumabom pri ljudeh niso opravili.
Portrazza may cause side effects involving the skin.
Zdravilo Portrazza lahko povzroči neželene učinke, ki vključujejo kožo.
If you have a severe infusion-related reaction, your doctor may recommend adjusting the dose of Portrazza, or stop your treatment with Portrazza.
Če se bodo pri vas pojavile hude reakcije, povezane z infuzijo, bo vaš zdravnik morda predlagal prilagoditev odmerka zdravila Portrazza, ali pa prekinil vaše zdravljenje z zdravilom Portrazza.
Patients were randomised to receive first-line Portrazza at 800 mg plus chemotherapy consisting of gemcitabine at 1,250 mg/m2 and cisplatin at 75 mg/m2 (Portrazza+GC Arm), or gemcitabine-cisplatin chemotherapy alone (GC Arm).
Bolniki so bili randomizirani v skupino zdravljenja prve izbire z zdravilom Portrazza v odmerku 800 mg in kemoterapijo, sestavljeno iz gemcitabina v odmerku 1250 mg/m2 in cisplatina v odmerku 75 mg/m2 (skupina Portrazza+GC), ali kemoterapijo s gemcitabinom in cisplatinom (skupina GC).
- Blood clots in the arteries or the veins
Krvni strdki v arterijah ali venah
Portrazza contains the active substance necitumumab, which belongs to a group of substances called monoclonal antibodies.
Zdravilo Portrazza vsebuje zdravilno učinkovino necitumumab, ki spada v skupino zdravilnih učinkovin, imenovanih monoklonska protitelesa.
Concentrate for solution for infusion (sterile concentrate).
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilen koncentrat)
Avoid getting pregnant while receiving this medicine and for at least 3 months after the last dose of Portrazza as this medicine may potentially cause harm to your unborn child. Talk to your doctor about the best contraception for you.
Med prejemanjem tega zdravila in še najmanj 3 mesece po prejemu zadnjega odmerka zdravila Portrazza se morate izogibati zanositvi, saj bi to zdravilo lahko škodovalo vašemu nerojenemu otroku.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 800 mg/50 mL
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 800 mg/50 ml
In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone as the first-line therapy in patients with Stage IV metastatic squamous NSCLC, an increased rate of infections was observed early after start of treatment, which led to subsequent infectious complications such as pneumonia and/or sepsis.
V kliničnem preskušanju 2. faze, v katerem so preučevali necitumumab v kombinaciji s paklitakselom in karboplatinom v primerjavi s paklitakselom in karboplatinom samima kot zdravljenje prve izbire pri bolnikih z metastatskim skvamoznim nedrobnoceličnim pljučnim rakom v IV. stadiju, so kmalu po začetku zdravljenja opazili povečano stopnjo okužb, ki so povzročile posledične zaplete, kot so pljučnica in/ali sepsa.
Based on the results of the population pharmacokinetic analysis, there was no impact of renal function as assessed by creatinine clearance [CrCl] on the pharmacokinetics of necitumumab.
Na podlagi rezultatov analize populacijske farmakokinetike ni bilo vpliva delovanja ledvic, ocenjenega s pomočjo očistka kreatinina [CrCl], na farmakokinetiko necitumumaba.
o Description of cardiorespiratory disorders including incidence rates from clinical trials o Information that the incremental risk of cardiopulmonary arrest or sudden death in patients with a history of coronary artery disease, congestive heart failure, or arrhythmias as compared to those without these comorbid conditions is not known.
o Opis kardiorespiratornih obolenj, vključno s stopnjami incidence iz kliničnih preskušanj o Informacije o prirastnem tveganju za kardiopulmonarni zastoj ali nenadno smrt pri bolnikih z boleznijo koronarnih arterij, kongestivnim srčnim popuščanjem ali aritmijami v anamnezi v primerjavi z bolniki, ki teh sočasnih stanj nimajo, niso znane.
- Infusion-related reaction
- Reakcija, povezana z infuzijo
Discard any unused portion of necitumumab left in a vial, as the product contains no antimicrobial preservatives.
Morebitno neuporabljeno učinkovino necitumumab, ki ostane v viali, zavrzite, saj izdelek ne vsebuje antimikrobnih konzervansov.
Vials contain 800 mg as a 16 mg/mL solution of necitumumab; one 50 mL vial contains the complete dose.
Viale vsebujejo 800 mg v obliki raztopine necitumumaba 16 mg/ml; ena 50-mililitrska viala vsebuje celoten odmerek.
Breast-feeding should be discontinued during treatment with Portrazza and for at least 4 months after the last dose.
Ženske morajo med zdravljenjem z zdravilom Portrazza prekiniti dojenje in ne smejo dojiti še vsaj 4 mesece po zadnjem odmerku.
Symptoms may include swelling, pain and tenderness of the limb.
Simptomi lahko vključujejo otekanje, bolečine in občutljivost uda.
The incremental risk of cardiopulmonary arrest or sudden death in patients with a history of coronary artery disease, congestive heart failure, or arrhythmias as compared to those without these comorbid conditions is not known.
Prirastno tveganje za kardiopulmonarni zastoj ali nenadno smrt pri bolnikih z boleznijo koronarnih arterij, kongestivnim srčnim popuščanjem ali aritmijami v anamnezi v primerjavi z bolniki, ki teh sočasnih stanj nimajo, ni znano.
Distribution of Portrazza follow a biphasic decline.
Porazdelitev zdravila Portrazza kaže dvofazni upad.
Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Bolnikom je treba dati navodila, naj poiščejo zdravniško pomoč, če se pri njih razvijejo simptomi, kot so kratka sapa, bolečine v prsih, otekanje rok ali nog.
You must not be given Portrazza - if you have ever had a severe allergic reaction to necitumumab or any of the other ingredients of this medicine (listed in section 6).
- če ste že kdaj imeli hudo alergično reakcijo na necitumumab ali katero koli sestavino tega zdravila
Patients should be carefully monitored for serum electrolytes, including serum magnesium, potassium, and calcium, prior to each necitumumab administration and after completion of necitumumab treatment, until within normal limits.
Bolnike je treba pred vsakim dajanjem necitumumaba in po zaključku zdravljenja z necitumumabom natančno spremljati glede serumskih elektrolitov, vključno z magnezijem, kalijem in kalcijem v serumu, dokler se ne vrnejo na normalne vrednosti.