natgillin/translations-raw huggingface dataset:
36 patients had a normal karyotype and chromosomal aberrations were detected in 174 patients; there were 47 patients with 17p deletion, 73 patients with 11q deletion, 23 patients with trisomy 12q, and 31 patients with 13q deletion as the sole aberration.
36 bolnikov je imelo normalen kariotip in kromosomske aberacije so odkrili pri 174 bolnikih: 47 bolnikov je imelo delecijo 17p, 73 bolnikov delecijo 11q, 23 bolnikov trisomijo 12q in 31 bolnikov delecijo 13q kot edino nepravilnost.
Patients should be closely monitored during administration of ofatumumab for the onset of infusionrelated reactions, including cytokine release syndrome, particularly during the first infusion.
Bolnike je treba med dajanjem ofatumumaba skrbno nadzirati glede nastopa z infundiranjem povezanih reakcij, vključno s sindromom sproščanja citokinov, posebno med prvo infuzijo.
No studies on the effects of Arzerra on the ability to drive and use machines have been performed.
Študij o vplivu zdravila Arzerra na sposobnost vožnje in upravljanja s stroji niso izvedli.
If you think you have had such a reaction before, tell your doctor before you are given Arzerra.
Če mislite, da ste imeli tako reakcijo že kdaj prej, morate to povedati zdravniku, preden dobite zdravilo Arzerra.
Study OMB115991 evaluated the efficacy of Arzerra in combination with bendamustine in 44 patients with previously untreated CLL considered inappropriate for fludarabine-based treatment.
Študija OMB115991 je ocenila učinkovitost zdravila Arzerra v kombinaciji z bendamustinom pri 44 bolnikih s predhodno nezdravljeno KLL, ki niso bili primerni za zdravljenje na podlagi fludarabina.
Seven percent of patients had ≥Grade 3 infusion-related reactions at any time during treatment.
Sedem odstotkov bolnikov je imelo kadar koli med zdravljenjem z infundiranjem povezane reakcije  3. stopnje.
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuremberg, Nemčija
Ofatumumab is a human monoclonal antibody produced in a recombinant murine cell line (NS0).
Ofatumumab je humano monoklonsko protitelo, pridobljeno v rekombinantni liniji mišjih celic (NS0).
These patients also experienced comparable clinical improvement, in terms of the efficacy endpoints and haematological parameters detailed above, to patients refractory to both fludarabine and alemtuzumab.
Bolniki so doživeli tudi primerljivo klinično izboljšanje, kar zadeva končne točke učinkovitosti in hematološke parametre, navedene zgoraj, kakor bolniki, pri katerih je bolezen neodzivna na zdravljenje s fludarabinom in alemtuzumabom.
There were no fatal infusionrelated reactions (see section 4.4).
Z infundiranjem povezanih reakcij s smrtnim izidom ni bilo (glejte poglavje 4.4).
Formation of anti-ofatumumab antibodies was observed for less than 0.5% of patients with CLL after treatment with ofatumumab.
Tvorbo protiteles proti ofatumumabu so po zdravljenju z ofatumumabom opažali pri manj kot 0,5 % bolnikov s KLL.
The results of this study demonstrated that Arzerra in combination with bendamustine is an effective therapy providing an ORR of 95% (95% CI: 85, 99) and a CR of 43%.
Rezultati te študije so pokazali, da je zdravilo Arzerra v kombinaciji z bendamustinom učinkovito zdravljenje s celokupnim deležem odziva 95 % (95 % IZ: 85, 99) in 43 % popolnega odziva.
Management of TLS includes correction of electrolyte abnormalities, monitoring of renal function, maintenance of fluid balance and supportive care.
Obvladovanje sindroma lize tumorja vključuje odpravo elektrolitskih motenj, kontrolo delovanja ledvic, vzdrževanje ravnovesja tekočin in podporno oskrbo.
Patients with evidence of prior HBV infection should be monitored for clinical and laboratory signs of hepatitis or HBV reactivation during treatment with and for 6-12 months following the last infusion of Arzerra.
Bolnike z izvidi, ki dokazujejo predhodno okužbo s HBV, je treba kontrolirati glede kliničnih in laboratorijskih znakov hepatitisa ali reaktivacije HBV, in sicer med zdravljenjem z zdravilom Arzerra in še 6 do 12 mesecev po zadnji infuziji tega zdravila.
Number at risks at
Število izpostavljenih tveganju Risk:
These may include anti-histamines, steroids and pain relievers.
Med njimi so lahko antihistaminiki, steroidi in zdravila proti bolečinam.
• 2000 mg every 28 days for 4 doses (infusions 9 to 12)
• 2.000 mg vsakih 28 dni (štirje odmerki, kar je 9. do 12. infuzija).
It is not known whether the ingredients in Arzerra pass into human milk.
Ni znano, ali sestavine zdravila Arzerra pri človeku prehajajo v materino mleko.
Of these 223 patients, 95 patients were refractory to fludarabine and alemtuzumab therapy (defined as failure to achieve at least a partial response with fludarabine or alemtuzumab treatment or disease progression within 6 months of the last dose of fludarabine or alemtuzumab).
Od teh 223 bolnikov je bilo 95 neodzivnih na zdravljenje s fludarabinom in alemtuzumabom (neodzivnost je bila opredeljena kot nedoseganje vsaj delnega odziva na zdravljenje s fludarabinom ali alemtuzumabom ali napredovanje bolezni v 6 mesecih po zadnjem odmerku fludarabina ali alemtuzumaba).
HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive.
Reaktivacija HBV je opredeljena kot nenadno povečanje replikacije HBV, ki se kaže s hitrim zvišanjem ravni HBV DNA v serumu ali s pojavom HBsAg pri predhodno HBsAg-negativni in antiHBc-pozitivni osebi.
Driving and using machines Arzerra is unlikely to affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Arzerra vplivalo na vašo sposobnost vožnje in upravljanja s stroji.
• Subsequent cycles (until best response or a maximum of 12 cycles): 1000 mg on day 1 every
• nadaljnji ciklusi (do najboljšega odziva oziroma največ 12 ciklusov) 1.000 mg na 1. dan vsakih
cells available for the antibody to bind at subsequent infusions.
+, ki so bile na voljo za vezavo protitelesa po nadaljnjih infuzijah.
• low levels of white blood cells (neutropenia)
• majhno število belih krvnih celic (nevtropenija),
The antibody in Arzerra recognises a substance on the surface of lymphocytes and causes the lymphocyte to die.
Protitelo v zdravilu Arzerra prepozna določeno snov na površini limfocitov in povzroči, da limfociti odmrejo.
PFS benefit with the addition of Arzerra was observed in all patients, including those with poor-risk biological features (such as 17p or 11q deletion, unmutated IGHV, β2M >3500 μg/l, and ZAP-70 expression).
Korist za preživetje brez napredovanja so z dodatkom zdravila Arzerra opazili pri vseh bolnikih, vključno s tistimi, ki so imeli biološke značilnosti, povezane z izrazitejšim tveganjem (npr. delecijo 17p ali 11q, nemutiran IGHV, β2M > 3.500 μg/l in ekspresijo ZAP-70).
First and second infusions
Prvo in drugo infundiranje
268 (23%) of the 1,168 patients experienced ≥Grade 3 infections.
Pri 268 (23 %) od 1.168 bolnikov so se pojavile okužbe ≥ 3. stopnje.
Glaxo Operations UK Ltd. Harmire Road Barnard Castle Durham, DL12 8DT United Kingdom
Glaxo Operations UK Ltd. Harmire Road Barnard Castle Durham, DL12 8DT Velika Britanija
Arzerra concentrate for solution for infusion does not contain a preservative; therefore dilution should be carried out under aseptic conditions.
Zdravilo Arzerra koncentrat za raztopino za infundiranje ne vsebuje konzervansov, zato mora biti redčenje opravljeno v aseptičnih pogojih.
The median progression-free survival was 5.5 months (95% CI: 4.6, 6.4) and the median overall survival was 17.4 months (95% CI: 15.0, 24.0).
Mediani čas brez napredovanja je bil 5,5 meseca (95 % IZ: 4,6, 6,4) in mediana celokupnega preživetja 17,4 meseca (95 % IZ: 15,0, 24,0).
This includes 643 patients treated with ofatumumab as monotherapy (in patients with relapsed or refractory CLL) and 525 patients treated with ofatumumab in combination with chemotherapy (chlorambucil or bendamustine or fludarabine and cyclophosphamide).
To vključuje 643 bolnikov, zdravljenih z ofatumumabom v monoterapiji (pri bolnikih z recidivno ali refraktarno KLL), in 525 bolnikov, zdravljenih z ofatumumabom v kombinaciji s kemoterapijo (s klorambucilom ali bendamustinom ali fludarabinom in ciklofosfamidom).
If the coadministration is judged unavoidable, the risks and benefits of vaccinating patients during therapy with ofatumumab should be considered (see section 4.4).
Če je sočasna uporaba ocenjena za nujno, je treba pretehtati tveganja in koristi cepljenja bolnikov med zdravljenjem z ofatumumabom (glejte poglavje 4.4).
Breast-feeding should be discontinued during treatment with Arzerra and for 12 months following treatment.
Dojenje je treba prekiniti med zdravljenjem z zdravilom Arzerra in v obdobju 12 mesecev po zdravljenju.
In addition, the binding of ofatumumab allows the recruitment of natural killer cells allowing the induction of cell death through antibody-dependent cell-mediated cytotoxicity.
Poleg tega vezava ofatumumaba omogoča okrepitev naravnih celic ubijalk, kar omogoči indukcijo celične smrti s celično posredovano, od protiteles odvisno citotoksičnostjo.
Patients should receive the following pre-medication medicinal products 30 minutes to 2 hours prior to each Arzerra infusion according to the following dosing schedules:
Bolniki morajo od 30 minut do 2 uri pred vsakim infundiranjem zdravila Arzerra dobiti naslednja premedikacijska zdravila po naslednji shemi:
It is unknown whether Arzerra is excreted in human milk, however human IgG is secreted in human milk.
Ni znano, ali se zdravilo Arzerra izloča v materinem mleku, se pa v materinem mleku izloča človeški IgG.
Store and transport refrigerated (2 C - 8C).
Zdravilo shranjujte in prevažajte na hladnem (2 °C - 8 °C).
There is a potential for immunogenicity with therapeutic proteins such as ofatumumab.
Pri terapevtskih beljakovinah, kot je ofatumumab, obstaja možnost imunogenosti.
Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, County Durham, DL12 8DT, United Kingdom Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, County Durham, DL12 8DT, Velika Britanija Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Velika Britanija
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALCI ODGOVORNI ZA SPROŠČANJE SERIJ
There are limited pharmacokinetic data in patients with severe renal impairment (creatinine clearance <30 ml/min).
Na voljo je malo farmakokinetičnih podatkov za bolnike s hudo okvaro ledvic (očistek kreatinina < 30 ml/min).
The overall response rate in this group was 63% (95.3% CI: 35, 85).
Celotni delež odziva v tej skupini je bil 63 % (95,3 % IZ: 35, 85).
If an anaphylactic reaction occurs, Arzerra should be immediately and permanently discontinued and appropriate medical treatment should be initiated.
Če pride do anafilaktične reakcije, je treba zdravilo Arzerra takoj in dokončno ukiniti in začeti z ustreznim zdravljenjem.
At the end of organogenesis (day 48 of gestation), the ofatumumab exposure (AUCinf) corresponded to 0.46 to 3.6 times the human exposure after the eighth infusion of the maximum recommended human dose (MRHD) of 2000 mg. At day 100 of gestation, depletion of B-cells relating to the pharmacological activity of ofatumumab were observed in foetal cord blood and foetal splenic tissues.
Ob koncu organogeneze (48. dan gestacije) je izpostavljenost ofatumumabu (AUCinf) ustrezala 0,46 do 3,6-kratni vrednosti izpostavljenosti pri ljudeh po osmi infuziji najvišjega priporočenega odmerka za človeka 2.000 mg. Na 100. dan gestacije so v fetalni popkovnični krvi in vraničnem tkivu ugotovili zmanjšanje števila celic B, povezano s farmakološkim delovanjem ofatumumaba.
Ofatumumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzymes.
Ofatumumab je beljakovina, katere pričakovana presnovna pot je razgradnja v majhne peptide in posamezne aminokisline s povsod prisotnimi proteolitičnimi encimi.
Uncommon side effects that may show up in your blood tests:
Občasni neželeni učinki, ki se lahko pokažejo na preiskavah krvi:
Arzerra and chlorambucil (N=221)
Arzerra in klorambucil (N = 221)
Therefore Arzerra is not recommended for use in children and adolescents.
Zato zdravila Arzerra pri otrocih in mladostnikih ni priporočljivo uporabljati.
• sore throat, feeling of pressure or pain in the cheeks and forehead, infections of the ear, nose or throat.
• vnetje žrela oziroma grla, občutek pritiska v predelu lic in čela, okužbe ušes, nosu ali žrela.
Overall response rate Responders, n (%) 95.3% CI (%) Response rate in patients with prior rituximab therapy Responders, n (%) 95% CI (%) Response rate in patients with chromosomal abnormality 17p deletion Responders, n (%) 95% CI (%) 11q deletion Responders, n (%) 95% CI (%) Median overall survival Months 95% CI Progression-free survival Months 95% CI Median duration of response Months 95% CI Median time to next CLL therapy Months 95% CI The overall response was assessed by an Independent Response Committee using the 1996 NCI-WG guidelines for CLL.
Celotni delež odziva Odzivni bolniki, n (%) 95,3 % IZ (%) Delež odziva pri bolnikih, predhodno zdravljenih z rituksumabom Odzivni bolniki, n (%) 95 % IZ (%) Delež odziva pri bolnikih s kromosomsko nenormalnostjo Delecija 17p Odzivni bolniki, n (%) 95 % IZ (%) Delecija 11q Odzivni bolniki, n (%) 95 % IZ (%) Mediano celokupno preživetje Meseci 95 % IZ Preživetje brez napredovanja Meseci 95 % IZ Mediano trajanje odziva Meseci 95 % IZ Mediani čas do naslednjega zdravljenja KLL Meseci 95 % IZ Celotni odziv je ocenil neodvisni Odbor za oceno na podlagi smernic NCI-WG (National Cancer Institute Working Group) za KLL iz leta 1996.
If you have been previously treated for CLL you will usually have a course of 12 infusions.
Če ste se že zdravili zaradi KLL, boste praviloma dobili ciklus 12 infuzij.
Your doctor will weigh up the benefit to you against the risk to your baby of taking Arzerra while you're pregnant.
Zdravnik bo pretehtal koristi zdravljenja z zdravilom Arzerra med nosečnostjo za vas v primerjavi s tveganjem za vašega otroka.
This dose will be increased, usually to 1000 mg or 2000 mg, for the remaining infusions.
Ta odmerek se za preostala infundiranja poveča, po navadi do 1.000 mg ali 2.000 mg.
Abbreviations: β2M = beta-2-microglobulin, CI = confidence interval; CIRS-G = Cumulative Illness Rating Scale for Geriatrics, CLL = chronic lymphocytic leukaemia, CrCl = creatinine clearance, ECOG = Eastern Cooperative Oncology Group, IGHV = Immunoglobulin Heavy Chain Variable Region, IRC = Independent Review Committee, N = number, NR = not reached, PFS = progression-free survival, ZAP-70 = zeta-chain-associated protein kinase 70.
Okrajšave: β2M = beta-2-mikroglobulin, IZ = interval zaupanja, CIRS-G = lestvica kumulativne ocene bolezni za geriatrične bolnike (Cumulative Illness Rating Scale for Geriatrics), KLL = kronična limfocitna levkemija, CrCl = očistek kreatinina, ECOG = Eastern Cooperative Oncology Group, IGHV = variabilna regija težke verige imunoglobulina, IRC = neodvisni odbor za pregled, N = število, ND = ni doseženo, PFS = preživetje brez napredovanja bolezni, ZAP-70 = z verigo zeta povezana protein-kinaza 70.
CR (%) CR with MRD negativity (% of CR) Median duration of response, all patients, months 95% CI P value p<0.001
Popolni odziv (%) Popolni odziv z negativno MRD (% popolnega odziva) Mediano trajanje odziva, vsi bolniki, meseci 95 % IZ Vrednost p p < 0,001
Pulmonary oedema*, hypoxia*
pljučni edem*, hipoksija*
Monitoring
Nadziranje
Increases above 5 msec were observed in the median/mean QT/QTc intervals in the pooled analysis.
V tej kumulativni analizi so opažali podaljšanje medianega/povprečnega intervala QT/QTc nad 5 msec.
Administer using an intravenous infusion pump.
Uporabite intravensko infuzijsko črpalko.
Administration of live vaccines to neonates and infants exposed to ofatumumab in utero should be avoided until B-cell recovery occurs (see sections 4.4 and 4.5).
Pri novorojenčkih in dojenčkih, ki so bili in utero izpostavljeni ofatumumabu, se je treba izogibati uporabi živih cepiv, dokler se število celic B ne normalizira (glejte poglavji 4.4 in 4.5).
Study OMB110913 (randomised, open-label, parallel-arm, multicentre trial) evaluated the efficacy of ofatumumab in combination with fludarabine and cyclophosphamide compared with fludarabine and cyclophosphamide in 365 patients with relapsed CLL (defined as a patient who has received at least one prior CLL therapy and previously achieved a complete or partial remission/response, but after a period of six or more months demonstrated evidence of disease progression).
V študiji OMB110913 (randomizirani, odprti, vzporedni multicentrični študiji) so ocenjevali učinkovitost ofatumumaba v kombinaciji s fludarabinom in ciklofosfamidom v primerjavi z učinkovitostjo fludarabina in ciklofosfamida pri 365 bolnikih s ponovitvijo KLL (ki so bili opredeljeni kot bolniki, ki so prejeli najmanj eno predhodno zdravljenje KLL in so predhodno že dosegli popolno/delno remisijo oziroma popolni/delni odziv, vendar so se pri njih po šestih ali več mesecih pokazali znaki napredovanja bolezni).
Clear to opalescent, colourless to pale yellow liquid.
Bistra do opalescentna, brezbarvna do svetlo rumena tekočina.
Arzerra contains ofatumumab, which belongs to a group of medicines called monoclonal antibodies.
Zdravilo Arzerra vsebuje ofatumumab, ki spada v skupino zdravil, imenovanih monoklonska protitelesa.
As ofatumumab is a monoclonal antibody, genotoxicity and carcinogenicity studies have not been conducted with ofatumumab.
Ofatumumab je monoklonsko protitelo, zato z njim niso bile opravljene študije genotoksičnosti in kancerogenosti.
Since ofatumumab may cause foetal B-cell depletion, effective contraception (methods that result in less than 1% pregnancy rates) has to be used during Arzerra therapy and for 12 months after the last Arzerra dose.
Ofatumumab lahko povzroči znižanje števila celic B pri plodu, zato morajo ženske uporabljati učinkovito kontracepcijo (metodo, ki zagotavlja manj kot 1-odstotno stopnjo zanositve) v času zdravljenja z zdravilom Arzerra in še namanj 12 mesecev po zadnjem odmerku tega zdravila.
Arzerra was administered as monotherapy to 223 patients with refractory CLL (study Hx-CD20-406).
Zdravilo Arzerra je bilo uporabljeno v monoterapiji pri 223 bolnikih z refrektarno KLL (študija HxCD20-406).
• If you do become pregnant during treatment with Arzerra, tell your doctor.
• Če med zdravljenjem z zdravilom Arzerra zanosite, morate o tem obvestiti zdravnika.
The initial rate of the first and second infusion of Arzerra should be 12 ml/hour.
Začetna hitrost prvega in drugega infundiranja zdravila Arzerra mora biti 12 ml/uro.
• yellow skin and eyes, nausea, loss of appetite, dark urine (possible symptoms of an infection or reactivation of hepatitis B virus)
• porumenela koža in oči, občutek slabosti, izguba apetita, temno obarvan urin (možni simptomi nove ali ponovno aktivirane okužbe z virusom hepatitisa B)
Lymphadenopathy 50% improvement Complete resolution Splenomegaly 50% improvement Complete resolution Hepatomegaly 50% improvement Complete resolution Haemoglobin <11 g/dl at baseline to >11 g/dl post baseline Platelet counts ≤100x10 increase or >100x10 Neutrophils <1x10
 50 % izboljšanje Popolno izginotje Splenomegalija  50 % izboljšanje Popolno izginotje Hepatomegalija  50 % izboljšanje Popolno izginotje Hemoglobin < 11 g/dl izhodiščno do > 11 g/dl poizhodiščno Število trombocitov ≤ 100 x 10 do > 50 % povečanje ali > 100 x 10 poizhodiščno
In the event of a severe infusion-related reaction, the infusion of Arzerra must be interrupted immediately and symptomatic treatment instituted (see section 4.2).
V primeru hude z infundianjem povezane reakcije je treba infundiranje zdravila Arzerra nemudoma prekiniti in uporabiti simptomatsko zdravljenje (glejte poglavje 4.2).
Infusions 3* to 12 Infusion rate (ml/hour)
* do 12. infuzija hitrost infundiranja (ml/uro)
Your doctor may treat you if any electrolyte imbalance is detected.
Če bo zdravnik pri vas odkril kakršnokoli neravnovesje elektrolitov, vas bo morda zdravil.
Overall, the pharmacokinetics of ofatumumab were consistent across the indications, whether given as a single agent or in combination with fludarabine and cyclophosphamide or chlorambucil.
V celoti je bila farmakokinetika ofatumumaba približno enaka pri vseh indikacijah ne glede na to, ali je šlo za samostojno uporabo ali uporabo v kombinaciji s fludarabinom in ciklofosfamidom ali s klorambucilom.
In patients with CLL, tumour lysis syndrome (TLS) may occur with use of Arzerra.
Pri bolnikih s KLL se lahko med uporabo zdravila Arzerra pojavi sindrom lize tumorja (TLS - tumor lysis syndrome).
Very common side effects that may show up in your blood tests:
Zelo pogosti neželeni učinki, ki se lahko pokažejo na preiskavah krvi:
No data comparing Arzerra in combination with bendamustine or with chlorambucil versus a rituximab based regimen such as rituximab with chlorambucil is available.
Na voljo ni podatkov, ki bi primerjali zdravilo Arzerra v kombinaciji z bendamustinom ali s klorambucilom proti na rituksimabu temelječem režimu, kot na primer rituksimab s klorambucilom.
Treatment with Arzerra (when given as 4 once-weekly infusions), led to a 50% objective response rate in the highest dose group (1st dose: 500 mg; 2nd, 3rd and 4th dose: 2,000 mg) and included 12 partial remissions and one nodular partial remission.
Zdravljenje z zdravilom Arzerra (uporabljenim kot 4 infuzije enkrat na teden) je v skupini z največjim odmerkom povzročilo 50 % objektivni delež odziva (1. odmerek: 500 mg, 2., 3. in 4. odmerek: 2.000 mg) ter je vključevalo 12 delnih odzivov in en nodularni delni odziv.
These included improvements associated with constitutional symptoms, lymphadenopathy, organomegaly, or cytopenias (see Table 4).
To je obsegalo izboljšanje glede konstitutivnih simptomov, limfadenopatije, povečanja organov in citopenij (glejte preglednico 4).
Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of complement defence molecules.
Dokazano je, da ofatumumab izzove občutno lizo celic z visoko izraženostjo obrambnih molekul komplementa.
The primary endpoint was median progression-free survival (PFS) as assessed by a blinded Independent Review Committee (IRC) using the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008).
Primarni opazovani dogodek je bilo mediano preživetje brez napredovanja (PFS - progression-free survival), kot ga je ocenil slepljeni neodvisni odbor za pregled (IRC - Independent Review Committee) z uporabo smernic NCI-WG (National Cancer Institute-sponsored Working Group) v posodobitvi IWCLL (Workshop for Chronic Lymphocytic Leukaemia) (2008).
Intravenous and subcutaneous administration to monkeys resulted in the expected depletion of peripheral and lymphoid tissue B-cell counts with no associated toxicological findings.
Intravenska oziroma subkutana uporaba je pri opicah povzročila pričakovano zmanjšanje števila perifernih celic B in celic B v limfatičnem tkivu, brez spremljajočih toksikoloških ugotovitev.
Vaccination and Arzerra
Cepljenja in zdravilo Arzerra
Patients who had prior rituximab therapy, either as monotherapy or in combination with other medicinal products, responded to treatment with Arzerra at a similar rate to those who had not had prior rituximab therapy.
Med bolniki, ki so predhodno dobivali rituksimab v monoterapiji ali v kombinaciji z drugimi zdravili, je bil delež odziva na zdravljenje z zdravilom Arzerra podoben kot med bolniki, ki predhodno niso dobivali rituksimaba.
• fluid in the lungs (pulmonary oedema) causing breathlessness
• tekočina v pljučih (pljučni edem), ki povzroča zasoplost