natgillin/translations-raw huggingface dataset:
In patients with detectable EGFR protein expression (indicated patient population), overall survival was statistically significantly improved in the Portrazza+GC Arm as compared to the GC Arm with an estimated reduction in risk of death of 21% (hazard ratio [HR] = 0.79 [0.69, 0.92]; p = 0.002) and a median OS of 11.7 months in the Portrazza+GC Arm and 10.0 months in the GC Arm. A statistically significant improvement in progression-free survival was also observed (HR = 0.84 [0.72, 0.97]; p = 0.018), with a median PFS of 5.7 months in the Portrazza+GC Arm and 5.5 months in the GC Arm.
Pri bolnikih z izraženostjo beljakovine EGFR (zadevna populacija bolnikov) se je celokupno preživetje statistično pomembno izboljšalo v skupini Portrazza+GC v primerjavi s skupino GC z ocenjenim zmanjšanjem tveganja smrti za 21 % (razmerje tveganja [HR] = 0,79 [0,69; 0,92]; p = 0,002) in mediano celokupnega preživetja 11,7 mesecev v skupini Portrazza+GC in 10,0 mesecev v skupini GC.
There are no data on the effect of necitumumab on human fertility.
Ni podatkov o vplivu necitumumaba na plodnost pri človeku.
- Cardiorespiratory disorders
- Kardiorespiratorna obolenja
There have been no studies performed with other routes of administration.
Študij uporabe zdravila z drugimi potmi uporabe niso opravili.
No dose adjustments are required in patients with mild or moderate renal impairment (see section 5.2).
Pri bolnikih z blago ali zmerno okvaro levic prilagajanja odmerkov niso potrebna (glejte poglavje 5.2).
Women of childbearing potential have to use effective contraception during necitumumab treatment and up to 3 months after last administration of necitumumab treatment.
Ženske v rodni dobi morajo med zdravljenjem z necitumumabom in še do 3 mesece po zadnjem odmerku necitumumaba uporabljati učinkovito kontracepcijo.
Symptoms may include swelling, pain and tenderness of the limb, difficulty breathing, chest pain, or an abnormal heartbeat and discomfort.
Simptomi lahko vključujejo otekanje, bolečine in občutljivost uda, težave z dihanjem, bolečine v prsih ali nenormalen srčni utrip in občutek nelagodja.
The addition of necitumumab did not improve the efficacy outcome over pemetrexed and cisplatin alone in advanced non-squamous NSCLC.
Dodajanje necitumumaba ni izboljšalo izida učinkovitosti pri napredovalem neskvamoznem NSCLC v primerjavi s pemetreksedom in cisplatinom v monoterapiji.
Overall survival Number of events (n) Median - months (95 % CIa) Hazard ratio (95 % CI)b, c Two-sided log-rank p-valuec 1-year Overall survival rate (%)
Celokupno preživetje Število dogodkov (n) Mediana - meseci (95-% IZa) Razmerje tveganja (95-%
The European Medicines Agency has waived the obligation to submit the results of studies with Portrazza in all subsets of the paediatric population in non-small cell lung cancer (see section 4.2 for information on paediatric use).
Portrazza za vse podskupine pediatrične populacije za nedrobnocelični rak pljuč (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
You may be given medicines to reduce the risk of an infusion-related reaction or a skin reaction before you receive Portrazza.
Preden boste prejeli zdravilo Portrazza, boste morda prejeli zdravila za zmanjšanje tveganja za reakcijo, povezano z infuzijo, ali za kožno reakcijo.
Management recommendations (any occurrence) Grades 1 and 2 • No dose adjustment necessary Grade 3
Stopnji 1 in 2 • Prilagajanje odmerka ni potrebno.
GC Arm N=548
Skupina z GC N = 548
Management recommendations (any occurrence)
Priporočila za obravnavanje
Portrazza infusions should not be administered or mixed with glucose solutions.
Infuzij zdravila Portrazza ne smete dajati z raztopinami glukoze ali jih mešati z njimi.
After dilution When prepared as directed, infusion solutions of Portrazza contain no antimicrobial preservatives.
Raztopine za infundiranje Portrazza, ki so pripravljene po navodilih, ne vsebujejo antimikrobnih konzervansov.
There has been limited experience with necitumumab overdose in human clinical trials.
Izkušnje s prevelikim odmerjanjem necitumumaba v kliničnih preskušanjih pri ljudeh so omejene.
Skin reactions were reported with necitumumab (see section 4.8).
Pri uporabi necitumumaba so poročali o kožnih reakcijah (glejte poglavje 4.8).
STATEMENT OF ACTIVE SUBSTANCE(S) One vial of 50 mL contains 800 mg necitumumab (16 mg/mL).
Ena viala s 50 ml vsebuje 800 mg necitumumaba (16 mg/ml).
Patients should be instructed to seek medical care if they develop symptoms of thromboembolism 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 trombembolije, kot so kratka sapa, bolečine v prsih, otekanje rok ali nog.
Common Arterial thromboembolic events
Pogosti arterijski trombembolični dogodki
Toxicity in the elderly or in patients with ECOG PS 2
Toksičnost pri starejših ali pri bolnikih z oceno stanja zmogljivosti 2 po ECOG Klinično pomembne toksičnosti pri starejših in bolnikih z oceno stanja zmogljivosti 2 po ECOG
Women of childbearing potential should be advised to avoid becoming pregnant while on necitumumab.
Ženskam v rodni dobi je treba svetovati, naj se izogibajo zanositvi med zdravljenjem z necitumumabom.
Infusion-related reactions may occur during treatment with Portrazza.
Med zdravljenjem z zdravilom Portrazza lahko pride do reakcij, povezanih z infuzijo.
Portrazza has no known influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Portrazza nima znanega vpliva na sposobnost vožnje in upravljanja s stroji.
In a clinical trial in advanced non-squamous NSCLC, patients experienced an increased rate of serious thromboembolic events (including fatal events) in the necitumumab plus pemetrexed and cisplatin arm as compared to the pemetrexed and cisplatin arm (see also section 4.8).
V kliničnem preskušanju z napredovalim neskvamoznim NSCLC so pri bolnikih zabeležili povečano stopnjo resnih trombemboličnih dogodkov (vključno s smrtnimi primeri) v skupini zdravljenja z necitumumabom in pemetreksedom ter cisplatinom v primerjavi s skupino s pemetreksedom in cisplatinom (glejte tudi poglavje 4.8).
Portrazza is administered in addition to gemcitabine and cisplatin-based chemotherapy for up to 6 cycles of treatment followed by Portrazza as a single agent in patients whose disease has not progressed, until disease progression or unacceptable toxicity.
Zdravilo Portrazza se daje kot dodatek gemcitabinu in cisplatinu največ 6 ciklov zdravljenja, ki jim sledi dajanje zdravila Portrazza v obliki monoterapije, do napredovanja bolezni ali nesprejemljive toksičnosti pri bolnikih, pri katerih bolezen ni napredovala.
Effective contraception has to be used during necitumumab treatment and up to 3 months after last administration of necitumumab treatment.
Med zdravljenjem z necitumumabom in še do 3 mesece po zadnjem odmerku necitumumaba je treba uporabljati učinkovito kontracepcijo.
An increased frequency of cardiorespiratory arrest or sudden death was observed with necitumumab.
Pri uporabi necitumumaba so opazili povečano pogostnost kardiorespiratornega zastoja ali nenadne smrti.
Severe skin rections were reported in approximately 6 % of patients while 1.7 % of patients discontinued due to skin reactions.
medtem ko je 1,7 % bolnikov zaradi kožnih reakcij prekinilo zdravljenje.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Parenteral medicines should be inspected visually for particulate matter prior to administration.
Parenteralna zdravila je treba pred uporabo vizualno pregledati, da ne vsebujejo trdnih delcev.
Each 50 mL vial contains 800 mg of necitumumab.
Ena 50-mililitrska viala vsebuje 800 mg necitumumaba.
In patients who have experienced a previous Grade 1-2 hypersensitivity or infusion-related reaction to Portrazza, premedication with a corticosteroid and an antipyretic in addition to an antihistamine is recommended.
Pri bolnikih, pri katerih je v preteklosti že nastopila preobčutljivostna reakcija stopnje 1-2 ali z infuzijo povezana reakcija na zdravilo Portrazza, je priporočena premedikacija s kortikosteroidom in antipiretikom kot dodatkom antihistaminiku.
This medicine is given as an intravenous (into a vein) infusion via a drip.
To zdravilo se daje v obliki intravenske (v veno) kapalne infuzije.
A similar observation was made in a clinical trial investigating necitumumab in combination with pemetrexed and cisplatin versus pemetrexed and cisplatin alone as the first-line therapy in patients with advanced non-squamous NSCLC.
Do podobnih ugotovitev so prišli v kliničnem preskušanju, v katerem so preučevali necitumumab v kombinaciji s pemetreksedom in cisplatinom v primerjavi s pemetreksedom in cisplatinom samima kot zdravljenje prve izbire pri bolnikih z napredovalim neskvamoznim nedrobnoceličnim pljučnim rakom.
Each millilitre of the concentrate for solution for infusion contains 16 mg of necitumumab.
En mililiter koncentrata za raztopino za infundiranje vsebuje 16 mg necitumumaba.
In patients who have experienced a previous Grade 1 or 2 hypersensitivity or infusion related reaction to Portrazza, premedication with a corticosteroid and an antipyretic in addition to an antihistamine is recommended.
Pri bolnikih, pri katerih je v preteklosti že nastopila preobčutljivostna reakcija stopnje 1 ali 2 ali z infuzijo povezana reakcija na zdravilo Portrazza, je priporočena premedikacija s kortikosteroidom in antipiretikom kot dodatkom antihistaminiku.
Cardiorespiratory disorders
Kardiorespiratorna obolenja
See also section 2 under “Warnings and precautions”.
Glejte tudi poglavje 2 pod naslovom
Albumin-corrected hypocalcaemiac
Zelo pogosti za albumin korigirana hiperkalciemijac
• Stop the infusion; when the reaction has resolved to Grade ≤ 1, resume infusion at a 50 % decreased infusion rate.b
• Ustavite infuzijo; ko se reakcija izboljša do stopnje ≤ 1,
Symptoms may include difficulty breathing, chest pain, or an abnormal heartbeat and discomfort.
Simptomi lahko vključujejo težave z dihanjem, bolečine v prsih ali nenormalen srčni utrip in občutek nelagodja.
Blood clots can also lead to a blockage in the blood vessels of the lung.
Krvni strdki lahko povzročijo tudi zamašitev krvnih žil v pljučih.
Venous thromboembolic events (VTEs) were reported in approximately 8 % of patients and mainly present as pulmonary embolism and deep vein thrombosis.
O venskih trombemboličnih dogodkih so poročali pri približno 8 % bolnikov in so večinoma predstavljali pljučno embolijo in globoko vensko trombozo.
Dose dependent reversible skin toxicity was observed in the 26-week monkey study.
V 26-tedenski študiji na opicah so opazili reverzibilno kožno toksičnost, povezano z odmerkom.
• If symptoms do not worsen at 400 mg for at least 1 treatment cycle, the dose may be increased to 600 mg If symptoms worsen at 600 mg, temporarily withhold, for a maximum of 6 weeks following Day 1 of the most recent treatment cycle, until symptoms resolve to Grade ≤ 2.
Če se simptomi pri odmerku 600 mg poslabšajo, začasno prekinite zdravljenje za največ 6 tednov po 1. dnevu zadnjega cikla zdravljenja, dokler se simptomi ne izboljšajo do stopnje ≤ 2.
Appropriate medical resources for the treatment of severe infusion reactions should be available during necitumumab infusions.
Med infuzijami necitumumaba morajo biti na voljo ustrezna medicinska oprema in osebje za zdravljenje hudih alergičnih reakcij na infuzijo.
There are no data regarding necitumumab administration in patients with moderate or severe hepatic impairment (see section 5.2).
Okvara jeter Ni podatkov o dajanju necitumumaba bolnikom z zmerno ali hudo okvaro jeter (glejte poglavje 5.2).
50 mL solution in a vial (Type I glass) with a chlorobutyl elastomer stopper, an aluminium seal and a polypropylene cap.
6.5 Vrsta ovojnine in vsebina 50 ml raztopine v viali (iz stekla tipa I) z zamaškom iz klorobutilnega elastomera, aluminijasto zaporko in polipropilenskim pokrovčkom.
There are no data regarding necitumumab administration in patients with severe renal impairment.
Ni podatkov o dajanju necitumumaba bolnikom s hudo okvaro ledvic.
- Blood levels of magnesium, calcium, potassium and phosphate During treatment, your doctor will check your blood periodically for levels of several substances such as magnesium, calcium, potassium and phosphate.
Zdravnik bo v času vašega zdravljenja periodično preverjal ravni različnih snovi, kot so magnezij, kalcij, kalij in fosfati v vaši krvi.
There is no known antidote for necitumumab overdose.
Antidot za preveliko odmerjanje necitumumaba ni znan.
Necitumumab exhibits concentration-dependent clearance.
Očistek necitumumaba je odvisen od koncentracije zdravila.
Portrazza is administered as an intravenous infusion.
Zdravilo Portrazza se daje v obliki intravenske infuzije.
Arterial thromboembolic events (ATEs) were reported in approximately 4 % of patients and mainly present as stroke and myocardial infarction.
O arterijskih trombemboličnih dogodkih so poročali pri približno 4 % bolnikov in so večinoma predstavljali kap in miokardni infarkt.
There was no premedication for Portrazza mandated by the study.
Študija ni predvidevala obvezne premedikacije za uporabo zdravila Portrazza.
• Permanently discontinue if patients experience Grade 3 skin induration/fibrosis.
lahko odmerek povečate na 800 mg. • Trajno prekinite zdravljenje, če se pri bolnikih pojavijo kožne zatrdline/fibroza stopnje 3.
During each infusion, your doctor or nurse will check for side effects.
Vaš zdravnik ali medicinska sestra bosta med vsako infuzijo pozorna na neželene učinke.
Very common
Zelo pogosti stomatitis
Only use sodium chloride 9 mg/mL (0.9 %) solution for injection as a diluent.
Kot redčilo uporabljajte le natrijev klorid 9 mg/ml (0,9 %) raztopino za injiciranje.
Discontinuation of necitumumab in patients who experience a VTE or ATE should be considered after a thorough benefit risk assessment for the individual patient.
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.
In a clinical trial in advanced non-squamous NSCLC, venous thromboembolic events (VTEs) were reported in approximately 11 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 8 % in the pemetrexed and cisplatin alone arm) and mainly presented as pulmonary embolism and deep vein thrombosis.
V kliničnih preskušanjih z napredovalim neskvamoznim NSCLC so o venskih trombemboličnih dogodkih poročali pri približno 11 % bolnikov, zdravljenih z necitumumabom v kombinaciji s pemetreksedom in cisplatinom (v primerjavi z 8 % v skupini s pemetreksedom in cisplatinom) in so večinoma predstavljali pljučno embolijo in globoko vensko trombozo.
There was no relationship between immunogenicity and IRRs or treatment emergent adverse events.
Povezanosti med imunogenostjo in preobčutljivostnimi reakcijami/reakcijami, povezanimi z infuzijo ali neželenimi učinki zaradi zdravljenja ni bilo.
Eyelash trichomegaly Isolated cases of Grade 1 trichomegaly have been reported in patients treated with necitumumab.
Pri bolnikih, zdravljenih z necitumumabom, so poročali o osamljenih primerih trihomegalije stopnje 1.
Common Phlebitis
Pogosti flebitis
Do not freeze or shake the infusion solution.
NE ZAMRZUJTE IN NE PRETRESAJTE raztopine za infundiranje.
DO NOT FREEZE OR SHAKE the infusion solution.
Ne zamrzujte in ne pretresajte raztopine za infundiranje.
This medicine contains 76 mg sodium per dose.
Zdravilo Portrazza vsebuje natrij To zdravilo vsebuje 76 mg natrija na odmerek.
Necitumumab recognises and binds specifically to a protein on the surface of some cancer cells.
Necitumumab prepozna beljakovino, ki jo najdemo na površini nekaterih rakastih celic, in se veže specifično nanjo.
Seek medical help immediately if you experience any of the following:
Če opazite katerega od spodaj naštetih učinkov, morate takoj poiskati zdravniško pomoč:
Dose and administration
Odmerek in dajanje
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Portrazza 800 mg sterile concentrate necitumumab
IME ZDRAVILA IN POT(I) UPORABE Portrazza 800 mg sterilni koncentrat necitumumab
Common (≥1/100 to <1/10)
Pogosti (≥ 1/100 do < 1/10) Občasni (≥ 1/1.000 do < 1/100)
The relative risk of VTE or ATE was approximately three-fold higher in patients with a reported history of VTE or ATE.
Relativno tveganje venskih trombemboličnih dogodkov ali arterijskih trombemboličnih dogodkov je bilo približno trikrat višje pri bolnikih, ki so poročali o anamnezi venskih trombemboličnih dogodkov ali arterijskih trombemboličnih dogodkov.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Med zdravilom Portrazza in gemcitabinom/cisplatinom niso opazili medsebojnega delovanja.
Cardiorespiratory arrest or sudden death was reported in 2.8% (15/538) of patients treated with necitumumab in combination with gemcitabine and cisplatin compared to 0.6% (3/541) of patients treated with chemotherapy alone.
zdravljenih z necitumumabom v kombinaciji z gemcitabinom in cisplatinom v primerjavi z 0,6 % (3/541) bolnikov, ki so bili zdravljeni le s kemoterapijo.
NAME OF THE MEDICINAL PRODUCT Portrazza 800 mg concentrate for solution for infusion
IME ZDRAVILA Portrazza 800 mg koncentrat za raztopino za infundiranje
Thromboprophylaxis should be considered after careful assessment of a patient's risk factors (including the increased risk of serious bleeding in patients with tumour cavitation or tumour involvement of large central blood vessels).
Po natančni oceni bolnikovih dejavnikov tveganja (vključno s povečanim tveganjem za resno krvavitev pri bolnikih s kavitacijo tumorja ali prepletenostjo tumorja z velikimi osrednjimi krvnimi žilami) je treba razmisliti o tromboprofilaksi.
Adverse drug reactions (ADRs) which were reported in patients with squamous non-small cell lung cancer are listed below in MedDRA body system organ class, frequency and grade of severity.
Tabelarični seznam neželenih učinkov Neželeni učinki zdravila, o katerih so poročali pri bolnikih s skvamoznim nedrobnoceličnim pljučnim rakom, so navedeni spodaj po organskih sistemih, pogostnosti in resnosti glede na podatkovno bazo MedDRA. Pogostnost je navedena v skladu z naslednjim dogovorom:
Clinically relevant toxicities with respect to the elderly and those patients with Eastern Cooperative Oncology Group (ECOG) performance status score 2 (ECOG PS2) were similar to the overall population in patients receiving necitumumab plus chemotherapy consisting of gemcitabine and cisplatin.
(Eastern Cooperative Oncology Group) (ECOG PS2) so bile podobne kot v celokupni populaciji bolnikov, ki so prejemali necitumumab in kemoterapijo, sestavljeno iz gemcitabina in cisplatina.
Based on population pharmacokinetic approach (PopPK), the mean volume of distribution at steady state (Vss) for necitumumab was 6.97 L (CV
Po načelih populacijske farmakokinetike (PopPK) je povprečni porazdelitveni volumen za necitumumab v stanju dinamičnega ravnovesja (Vss) znašal
See section 4 for more details about infusion-related reactions which may occur during or after the infusion.
povezanih z infuzijo, ki se lahko pojavijo med infuzijo ali po njej.
Sodium citrate dihydrate (E331) Citric acid anhydrous (E330) Sodium chloride Glycine (E640)
6.1 Seznam pomožnih snovi natrijev citrat dihidrat (E331) brezvodna citronska kislina (E330) natrijev klorid glicin (E640) manitol (E421) polisorbat 80 (E433) voda za injekcije
Patients received a maximum of six cycles of chemotherapy in each arm; patients in the Portrazza+GC arm who had no progression continued to receive single-agent Portrazza until disease progression, unacceptable toxicity, or withdrawal of consent.
Bolniki so v vsaki od skupin prejeli največ šest ciklov kemoterapije; bolniki v skupini Portrazza+GC, pri katerih bolezen ni napredovala,
Vascular disorders Common Venous thromboembolic events
Pogosti venski trombembolični dogodki
Table 1 - Management recommendations for hypersensitivity/infusion-related reactions
Preobčutljivostne reakcije/reakcije, povezane z infuzijo Preglednica 1 - Priporočila za obravnavanje preobčutljivostnih reakcij/reakcij, povezanih z infuzijo
Common Hypersensitivity reactions/infusionrelated reactions
Pogosti preobčutljivostne reakcije/reakcije, povezane z infuzijo
Name and address of the manufacturer(s) responsible for batch release Lilly, S.A.
Ime in naslov izdelovalca (izdelovalcev), odgovornega za sproščanje serij
Common (may affect up to 1 in 10 people) - headache - coughing up blood (haemoptysis) - nosebleed (epistaxis) - strange tastes; metallic taste (dysgeusia) - eye inflammation (conjunctivitis) - blood clots in the arteries - urinary tract infection (bladder and/or kidneys) - pain when passing urine (dysuria) - difficulty in swallowing (dysphagia) - muscle spasms - inflammation of veins in the legs (phlebitis) - allergic reactions - pain in your mouth and throat (oropharyngeal pain)
- glavobol - izkašljevanje krvi (hemoptiza) - krvavitev iz nosu (epistaksa) - nenavadni okusi v ustih; kovinski okus (disgevzija)
Portrazza may also cause changes in the results of blood tests.
- bolečina v vaših ustih in grlu (orofaringealna bolečina) Zdravilo Portrazza lahko povzroči tudi spremembe v krvnih testih.
Monitor patients during and following the infusion for signs of hypersensitivity and infusion-related reactions with resuscitation equipment and appropriate medical resources readily available.
Med infundiranjem in po njem morate bolnike spremljati in biti pozorni na znake preobčutljivostnih reakcij in reakcij,
Common Dysuria
Pogosti disgevzija
Hypersensitivity/infusion-related reactions (IRRs) were reported with necitumumab.
Preobčutljivostne reakcije/reakcije, povezane z infuzijo Pri uporabi necitumumaba so poročali o preobčutljivostnih reakcijah/reakcijah, povezanih z infuzijo.
Severe VTEs were reported in approximately 4 % of patients.
O hudih venskih trombemboličnih dogodkih so poročali pri približno 4 % bolnikov.
Pre-emptive skin treatment including skin moisturiser, sun screen, topical steroid cream (1 % hydrocortisone) and an oral antibiotic (e.g. doxycycline) may be useful in the management of dermatologic reactions as clinically appropriate.
Profilaktično zdravljenje kože, vključno s sredstvom za vlaženje kože, sredstvom za zaščito kože pred soncem, topikalno steroidno kremo (1 % hidrokortizon) in peroralnim antibiotikom (npr.
BATCH NUMBER Lot
Dvostranska p vrednost testa log-rankc
Portrazza must not be administered as an intravenous bolus or push.
Zdravila Portrazza ne smete dajati v obliki intravenskega bolusa ali hitre intravenske injekcije.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
A separate infusion line must be used and the line must be flushed with sodium chloride 9 mg/mL (0.9%) solution for injection at the end of the infusion.
Za infuzijo morate uporabiti ločeno infuzijsko linijo, ki jo morate ob koncu infundiranja sprati z natrijevim kloridom 9 mg/ml (0,9%) raztopino za injiciranje.
How to store Portrazza
Shranjevanje zdravila Portrazza
Cardiovascular comorbidities, performance status and the likely tolerability to chemotherapy with add-on necitumumab should therefore be thoroughly evaluated prior to the initiation of treatment in patients above 70 years of age.
Zato je treba pred začetkom zdravljenja pri bolnikih, starejših od 70 let, natančno oceniti sočasna srčno-žilna obolenja, stanja zmogljivosti in verjetnost prenašanja kemoterapije z dodatkom necitumumaba.
Excipient with known effect Each 50 mL vial contains approximately 76 mg sodium.
Ena 50-mililitrska viala vsebuje približno 76 mg natrija.
Posology adjustments
Prilagajanje odmerjanja
What you need to know before you are given Portrazza
Kaj morate vedeti, preden boste prejeli zdravilo Portrazza Zdravila Portrazza ne smete prejeti: