natgillin/translations-raw huggingface dataset:
The incidence and severity of infusion related symptoms decreased substantially after the first 1,000 mg was infused, with most patients having no IRRs during subsequent administrations of Gazyvaro (see section 4.8).
Incidenca in izrazitost simptomov reakcij, povezanih z infuzijo, se je bistveno zmanjšala po infundiranju prvih 1000 mg in večina bolnikov med nadaljnjo uporabo zdravila Gazyvaro reakcij, povezanih z infuzijo, ni imela (glejte poglavje 4.8).
All subsequent infusions for CLL and FL
Vsa nadaljnja infundiranja pri KLL in FL
If a planned dose of Gazyvaro is missed, it should be administered as soon as possible; do not wait until the next planned dose.
V primeru, da bolnik načrtovani odmerek zdravila Gazyvaro izpusti, mu ga je treba dati čim prej; ne čakajte do naslednjega načrtovanega odmerka.
No Grade 5 events of thrombocytopenia were reported.
O dogodkih trombocitopenije 5. stopnje niso poročali.
Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, assay robustness to quantities of Gazyvaro/antibody in the circulation, sample handling, timing of sample collection, concomitant medicines and underlying disease.
Rezultati preizkusov imunogenosti so zelo odvisni od številnih dejavnikov, vključno s senzitivnostjo in specifičnostjo preizkusa, metodologijo preizkusa, robustnostjo preizkusov za količino zdravila Gazyvaro v obtoku, ravnanjem z vzorcem, časom odvzema vzorca, sočasnimi zdravili in osnovno boleznijo.
· PML is a very rare and life-threatening brain infection that has been reported in very few patients having treatment with Gazyvaro.
• Progresivna multifokalna levkoencefalopatija (PML) je zelo redka in smrtno nevarna okužba možganov, o kateri so poročali pri zelo majhnem številu bolnikov, zdravljenih z zdravilom Gazyvaro.
B-cell counts returned to normal levels in the offspring, and immunologic function was restored within 6 months of birth.
Število celic B se je pri potomstvu normaliziralo in imunološko delovanje obnovilo v 6 mesecih po rojstvu.
Overall, 3% of patients experienced an infusion related reaction leading to discontinuation of Gazyvaro.
Skupno je imelo 3 % bolnikov reakcijo, povezano z infuzijo, ki je vodila k prekinitvi zdravljenja z zdravilom Gazyvaro.
The clearance of obinutuzumab was approximately 0.11 L/day in CLL patients and 0.08 L/day in iNHL patients with a median elimination t½ of 26.4 days in CLL patients and 36.8 days in iNHL patients.
Očistek obinutuzumaba je bil približno 0,11 l/dan pri bolnikih s KLL in 0,08 l/dan pri bolnikih z iNHL, mediani eliminacijski t1/2 pa 26,4 dneva pri bolnikih s KLL in 36,8 dneva pri bolnikih z iNHL.
It is strongly recommended that patients with severe neutropenia lasting more than 1 week receive antimicrobial prophylaxis throughout the treatment period until resolution to Grade 1 or 2.
Za bolnike s hudo nevtropenijo, daljšo od 1 tedna, je zelo priporočljivo dajanje protibakterijske profilakse med zdravljenjem, dokler se nevtropenija ne izboljša na stopnjo 1 ali 2.
Results of subgroup analyses were in general consistent with the results seen in the FL population, supporting the robustness of the overall result.
Rezultati analiz podskupin Rezultati analiz podskupin so se na splošno skladali z rezultati v populaciji s FL; to potrjuje robustnost skupnega rezultata.
Findings included acute anaphylactic or anaphylactoid reactions and an increased prevalence of systemic inflammation and infiltrates consistent with immune-complex mediated hypersensitivity reactions, such as arteritis/periarteritis, glomerulonephritis, and serosal/adventitial inflammation.
Izsledki so obsegali akutne anafilaktične in anafilaktoidne reakcije in večjo prevalenco sistemskega vnetja in infiltratov, kar se sklada s preobčutljivostnimi reakcijami, posredovanimi z imunskimi kompleksi, npr. arteritisom/periarteritisom, glomerulonefritisom in vnetjem seroze/adventicije.
Cases of gastro-intestinal perforation have been reported in patients receiving Gazyvaro, mainly in iNHL.
Pri bolnikih, zdravljenih z zdravilom Gazyvaro, so poročali o primerih gastrointestinalnih perforacij, večinoma pri iNHL.
The B-cell counts returned to normal levels, and immunologic function was restored within 6 months post-partum.
Število celic B se je normaliziralo in imunološko delovanje se je obnovilo v 6 mesecih po porodu.
Gazyvaro infusions should not be administered as an intravenous push or bolus.
Infuzij zdravila Gazyvaro se ne sme dati v obliki hitre intravenske infuzije ali kot bolus.
After dilution, chemical and physical stability have been demonstrated in sodium chloride 9 mg/mL (0.9%) solution for injection at concentrations of 0.4 mg/mL to 20 mg/mL for 24 hours at 2°C to 8°C
Po razredčenju sta kemijska in fizikalna stabilnost dokazani v 0,9-% (9 mg/ml) raztopini natrijevega klorida za injiciranje v koncentracijah od 0,4 mg/ml do 20 mg/ml za 24 ur pri temperaturi od 2 do
For storage conditions of the infusion bags see section 6.3.
Za pogoje shranjevanja infuzijskih vrečk glejte poglavje 6.3.
Patients who experience neutropenia should be closely monitored with regular laboratory tests until resolution.
Bolnike, pri katerih se razvije nevtropenija, je treba skrbno nadzirati z rednimi laboratorijskimi kontrolami krvne slike, dokler ne mine.
If a hypersensitivity reaction is suspected during or after an infusion, the infusion must be stopped and treatment permanently discontinued.
Pri sumu na preobčutljivostno reakcijo med infundiranjem ali po njem je treba infundiranje prekiniti in zdravljenje trajno končati.
In animal models obinutuzumab mediates potent B-cell depletion and antitumour efficacy.
V živalskih modelih obinutuzumab močno zmanjša število celic B in deluje protitumorsko.
Serious bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of Gazyvaro therapy.
Med zdravljenjem z zdravilom Gazyvaro in po njem se lahko pojavijo resne bakterijske, glivične in nove ali reaktivirane virusne okužbe.
The incidence of haemorrhagic events was similar across all treatment arms.
Incidenca hemoragičnih dogodkov je bila med zdravljenima skupinama podobna.
The infusion must be stopped and therapy permanently discontinued if the patient experiences a second occurrence of a Grade 3 IRR.
Infundiranje je treba ustaviti in zdravljenje trajno končati, če se bolniku še drugič pojavi z infuzijo povezana reakcija 3. stopnje.
Of these patients, none experienced anaphylactic or hypersensitivity reactions that were considered related to ATA, nor was clinical response affected.
Nobeden od teh bolnikov ni imel anafilaktične ali preobčutljivostne reakcije, ki bi bila ocenjena kot povezana s protiterapevtskimi protitelesi; tudi klinični odziv ni bil spremenjen.
At the start of treatment for FL, Gazyvaro is used together with other medicines for cancer.
Na začetku zdravljenja folikularnega limfoma zdravilo Gazyvaro uporabljamo skupaj z drugimi zdravili za zdravljenje raka.
Day of treatment
Dan zdravljenja
However, weekly obinutuzumab dosing from post-coitum day 20 to delivery resulted in complete depletion of B-cells in infant monkeys at weekly intravenous obinutuzumab doses of 25 and 50 mg/kg (2-5 times the clinical exposure based on Cmax and AUC).
Toda vsakotedenska uporaba od 20. postkoitalnega dne do poroda je pri opičjih mladičih povzročila popolno odsotnost celic B ob tedenskih intravenskih odmerkih obinutuzumaba od 25 do 50 mg/kg (to je od 2- do 5-kratnik klinične izpostavljenosti na podlagi Cmax in AUC).
In repeat-dose toxicity studies in cynomolgus monkeys obinutuzumab had no adverse effects on male and female reproductive organs.
V študijah toksičnosti ponavljajočih se odmerkov obinutuzumab pri opicah cynomolgus ni imel škodljivega vpliva na reproduktivne organe samcev in samic.
Completed at least 1 hour prior to Gazyvaro infusion
Dokončano vsaj 1 uro pred infundiranjem zdravila Gazyvaro
Overall Survival (not yet mature) No. (%) of patients with event Median time to event (months)
Celokupno preživetje (še ni doseženo) Število (%) bolnikov z dogodkom Mediani čas do dogodka (meseci)
· Do not use this medicine after the expiry date which is stated on the carton after EXP.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
· Grade 1-2 (mild to moderate): The infusion rate must be reduced and symptoms treated.
• 1. do 2. stopnja (blage do zmerne): Hitrost infundiranja je treba zmanjšati in zdraviti simptome.
Patients were randomised 1:1 to receive either bendamustine (B) alone (n = 202) or Gazyvaro in combination with bendamustine (G+B) (n = 194) for 6 cycles, each of 28 days duration.
Bolnike so v razmerju 1:1 randomizirali na prejemanje bodisi samega bendamustina (B) (n = 202) bodisi zdravila Gazyvaro v kombinaciji z bendamustinom (G + B) (n = 194) za 6 28-dnevnih ciklov.
Tell your doctor or nurse if you notice any of the side effects listed above.
Zdravniku ali medicinski sestri povejte, če opazite katerega koli od zgoraj navedenih neželenih učinkov.
Cycles 2, 3, 4, 5 and 6 this will be just one dose of Gazyvaro in the 28 days: · Day 1 - full dose (1,000 mg).
2., 3., 4., 5. in 6. cikel - vključujejo le en odmerek zdravila Gazyvaro v 28 dneh: • 1. dan - celoten odmerek (1000 mg).
During the follow-up phase, Grade 3-5 infections are observed more in patients who received Gazyvaro plus bendamustine in the induction phase.
Med obdobjem spremljanja so dokumentirali več okužb 3. do 5. stopnje pri bolnikih, ki so v fazi indukcije prejemali zdravilo Gazyvaro v kombinaciji z bendamustinom.
Progressive multifocal leukoencephalopathy (also called “PML”)
Progresivna multifokalna levkoencefalopatija (imenovana tudi PML)
Pharmacokinetics of obinutuzumab in patients with mild creatinine clearance (CrCl 50-89 mL/min, n=464) or moderate (CrCl 30 to 49 mL/min, n=106) renal impairment were similar to those in patients with normal renal function (CrCl ³ 90 mL/min, n=383).
Farmakokinetika obinutuzumaba je bila pri bolnikih z blago (očistek kreatinina 50-89 ml/min, n = 464) ali zmerno (očistek kreatinina 30-49 ml/min, n = 106) ledvično okvaro podobna kot pri bolnikih z normalnim delovanjem ledvic (očistek kreatinina ≥ 90 ml/min,
A reproduction study in cynomolgus monkeys showed no evidence of embryofoetal toxicity or teratogenic effects but resulted in a complete depletion of B-lymphocytes in offspring.
Študija sposobnosti razmnoževanja na opicah cynomolgus ni pokazala znakov embriofetalne toksičnosti ali teratogenih učinkov, ugotovila pa je popolno odsotnost (zmanjšanje števila) limfocitov B pri potomstvu.
Concentrations in infant serum on day 28 post-partum were in the range of concentrations in maternal serum, whereas concentrations in milk on the same day were very low (less than 0.5% of the corresponding maternal serum levels) suggesting that exposure of infants must have occurred in utero.
28. dan po porodu je bila v razponu koncentracije v materinem serumu, koncentracija v mleku isti dan pa je bila zelo nizka (manj kot 0,5 % ustrezne koncentracije v materinem serumu); to kaže, da je moralo do izpostavljenosti priti in utero.
For treatment of TLS, correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated.
Med zdravljenjem sindroma razpada tumorja je treba odpraviti nepravilnosti elektrolitov, preverjati delovanje ledvic in ravnovesje tekočin ter uporabiti podporno oskrbo, vključno z dializnim zdravljenjem, kot je indicirano.
In the population pharmacokinetic analysis, gender was found to be a covariate which explains some of the inter-patient variability, with a 22% greater steady state clearance (CLss) and a 19% greater volume of distribution (V) in males.
Razmerje farmakokinetika/farmakodinamika V analizi populacijske farmakokinetike se je spol izkazal kot sospremenljivka, ki pojasni del variabilnosti med bolniki: pri moških je očistek v stanju dinamičnega ravnovesja (CLss) za 22 % večji,
Patients with known hypersensitivity to obinutuzumab must not be treated (see section 4.3).
Bolnikov, ki imajo znano preobčutljivost za obinutuzumab, se z njim ne sme zdraviti (glejte poglavje 4.3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Common
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
Table 6 summarises the ADRs of the pivotal studies (BO21004/CLL11, BO21223/GALLIUM
Preglednica 6 povzema neželene učinke iz ključnih študij (BO21004/CLL11, BO21223/GALLIUM,
The storage details are as follows: · Keep this medicine out of the sight and reach of children.
Podrobnosti o shranjevanju so: • Zdravilo shranjujte nedosegljivo otrokom!
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Navodila za razredčenje
The median OS was not yet reached for either arm.
Mediana celokupnega preživetja še ni bilo dosežena v nobeni skupini.
Corticosteroid premedication is recommended for patients with FL and mandatory for CLL patients in the first cycle (see Table 1).
Premedikacija s kortikosteroidom je v prvem ciklu za bolnike s FL priporočljiva, za bolnike s KLL pa obvezna (glejte preglednico 1).
Women of childbearing potential must use effective contraception during and for 18 months after treatment with Gazyvaro.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 18 mesecev po zaključku zdravljenja z zdravilom Gazyvaro.
In study BO21223/GALLIUM, 1/565 patient (0.2% of patients with a post-baseline assessment) developed HAHA at induction completion.
V študiji BO21223/GALLIUM so se pri 1 bolniku od 565 bolnikov (0,2 % od testiranih po začetku zdravljenja) razvila protitelesa HAHA po zaključku indukcije.
Following Cycles 6-8, in combination with chemotherapy, responding patients received Gazyvaro maintenance therapy every 2 months until disease progression or for up to 2 years.
Po 6. ali 8. ciklu v kombinaciji s kemoterapijo so odzivni bolniki prejeli vzdrževalno zdravljenje z zdravilom Gazyvaro vsaka 2 meseca do napredovanja bolezni ali največ 2 leti.
Beyond Cycle 1 the incidence of IRRs in subsequent infusions was comparable between the Gazyvaro and the relevant comparator arms.
V nadaljnjih infundiranjih po 1. ciklu je bila incidenca reakcij, povezanih z infuzijo, med zdravilom Gazyvaro in ustreznim primerjalnim zdravilom primerljiva.
The safety and efficacy of Gazyvaro has not been established in patients with severe renal impairment (CrCl < 30 mL/min) (see sections 4.8 and 5.2).
Varnost in učinkovitost zdravila Gazyvaro pri bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/min) nista ugotovljeni (glejte poglavji 4.8 in 5.2).
Patients with inadequate liver function (National Cancer Institute - Common Terminology Criteria for Adverse Events Grade 3 liver function tests (AST, ALT > 5 x ULN for > 2 weeks; bilirubin > 3 x ULN) and renal function (CrCl < 30 mL/min) were excluded.
Cancer Institute - Common Terminology Criteria for Adverse Events (AST, ALT > 5 x zgornje normalne meje > 2 tedna; bilirubin > 3 x zgornje normalne meje) in delovanjem ledvic (očistek kreatinina < 30 ml/min) so bili izključeni.
A total of 781 patients were randomised 2:2:1 to receive Gazyvaro plus chlorambucil, rituximab plus chlorambucil or chlorambucil alone.
V celoti so 781 bolnikov v razmerju 2 : 2 : 1 randomizirali na prejemanje kombinacije zdravila Gazyvaro in klorambucila, kombinacije rituksimaba in klorambucila ali samega klorambucila.
No formal pharmacokinetic study has been conducted in patients with hepatic impairment.
Formalnih farmakokinetičnih študij pri bolnikih z jetrno okvaro niso izvedli.
The population pharmacokinetic analysis of obinutuzumab showed that creatinine clearance does not affect pharmacokinetics of obinutuzumab.
Populacijska farmakokinetična analiza obinutuzumaba je pokazala, da očistek kreatinina ne vpliva na farmakokinetiko obinutuzumaba.
Two infusion bags should be prepared for the infusion on Days 1 and 2 (100 mg for Day 1 and 900 mg for Day 2).
Za infundiranje 1. in 2. dan je treba pripraviti dve infuzijski vrečki (100 mg za 1. dan in 900 mg za
Results of the progression free survival (PFS) subgroup analysis (i.e. sex, age, Binet stages, CrCl, CIRS score, beta2-microglobulin, IGVH status, chromosomal abnormalities, lymphocyte count at baseline) were consistent with the results seen in the overall Intent-to-Treat population.
Rezultati analize preživetja brez napredovanja bolezni (PFS) po podskupinah (tj. spol, starost, stadij po Binetu, očistek kreatinina, ocena CIRS, beta2-mikroglobulin, stanje IGVH, kromosomske nepravilnosti, izhodiščno število limfocitov) so se skladali z rezultati, ugotovljenimi v celotni populaciji z-namenom-zdravljenja.
· If you had any of these symptoms before treatment with Gazyvaro, tell your doctor straight away if you notice any changes in them.
• Če ste imeli kateri koli opisani simptom že pred zdravljenjem z zdravilom Gazyvaro, zdravniku takoj povejte, če opazite kakršno koli spremembo teh simptomov.
Do not use other diluents such as glucose (5%) solution.
Ne uporabljajte drugih raztopin za redčenje, npr. 5-% raztopine glukoze.
· Keep the container in the outer carton in order to protect from light.
• Vsebnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
The observed HRs by chemotherapy subgroup were as follows; CHOP (n = 398): HR 0.77 (95% CI: 0.50, 1.20), CVP (n = 118): HR 0.63 (95% CI: 0.32, 1.21), and bendamustine (n = 686): HR 0.61 (95% CI: 0.43, 0.86).
(95-% IZ: 0,50; 1,20), CVP (n = 118): RO 0,63 (95-% IZ: 0,32; 1,21) in bendamustin (n = 686): RO 0,61 (95-% IZ: 0,43; 0,86).
After dilution
Po razredčenju
The number of fatal haemorrhagic events was balanced between the treatment arms; however, all of the events in patients treated with Gazyvaro were reported in Cycle 1.
Število krvavitev s smrtnim izidom je bilo med skupinama uravnoteženo, a vsi dogodki med prejemniki zdravila Gazyvaro so se pojavili v 1. ciklu.
Before each infusion of Gazyvaro, you will be given medicines to lessen the chance of getting infusion related reactions or tumour lysis syndrome.
Pred vsakim infundiranjem zdravila Gazyvaro boste dobili zdravila, ki pomagajo zmanjšati možnost nastanka reakcij, povezanih z infuzijo, ali sindroma razpada tumorja.
Common (may affect up to 1 in 10 people)
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov)
At least 30 minutes before Gazyvaro infusion
Vsaj 30 minut pred infundiranjem zdravila Gazyvaro
Patients were randomised to 1:1 to receive either Gazyvaro (n=601 patients) or rituximab (n=601 patients) in combination with chemotherapy (bendamustine, CHOP or CVP), followed by Gazyvaro or rituximab maintenance in patients achieving a complete or partial response.
Bolnike so randomizirali v razmerju 1:1 na prejemanje zdravila Gazyvaro (n = 601 bolnikov) ali rituksimaba (n = 601 bolnikov) v kombinaciji s kemoterapijo (bendamustin, CHOP ali CVP), čemur je pri bolnikih s popolnim ali delnim odgovorom sledilo vzdrževalno zdravljenje z zdravilom Gazyvaro ali rituksimabom.
· If you have any further questions, ask your doctor or nurse.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom ali medicinsko sestro.
18.7 months median observation time g
18,7 meseca g
At baseline, 22% of patients had Binet Stage A, 42% had Binet Stage B and 36% had Binet Stage C.
Izhodiščno je imelo 22 % stadij A po Binetu, 42 % stadij B po Binetu in 36 % stadij C po Binetu.
If you had any of these symptoms before treatment with Gazyvaro, tell your doctor straight away if you notice any changes in them.
Če ste imeli katere koli simptome že pred zdravljenjem z zdravilom Gazyvaro, zdravniku takoj povejte, če opazite kakršno koli spremembo teh simptomov.
Serum concentrations of obinutuzumab in offspring were similar to those in the mothers on day 28 post-partum, whereas concentrations in milk on the same day were very low, suggesting that obinutuzumab crosses the placenta (see section 5.3).
Koncentracija obinutuzumaba v serumu pri potomcih 28. dan po porodu je bila podobna kot pri materah, koncentracija v mleku istega dne pa je bila zelo majhna, kar kaže, da obinutuzumab prehaja skozi placento (glejte poglavje 5.3).
In patients with FLIPI score 0-1 (low risk), no difference between Gazyvaro plus chemotherapy and rituximab plus chemotherapy was observed (INV-assessed PFS HR 1.17 (95%CI 0.63;2.19, 40 PFS events).
Pri bolnikih z rezultatom točkovalnika FLIPI 0-1 (nizko tveganje) niso opazili razlik med skupino, ki je prejemala zdravilo Gazyvaro in kemoterapijo, ter skupino, ki je prejemala rituksimab in kemoterapijo (PFS po raziskovalčevi oceni z RO 1,17 (95-% IZ 0,63; 2,19, 40 primerov PFS).
A Phase III international, multicentre, open label, randomised, two-stage, three-arm clinical study (BO21004/CLL11) investigating the efficacy and safety of Gazyvaro plus chlorambucil (GClb) compared to rituximab plus chlorambucil (RClb) or chlorambucil (Clb) alone was conducted in patients with previously untreated CLL with comorbidities.
Mednarodna, multicentrična, odprta, randomizirana, dvostopenjska klinična študija faze III s tremi skupinami (BO21004/CLL11) za preučitev učinkovitosti in varnosti kombinacije zdravila Gazyvaro in klorambucila (G-Clb) v primerjavi s kombinacijo rituksimaba in klorambucila (R-Clb) ter s klorambucilom (Clb) je bil izvedena pri bolnikih s še nezdravljeno KLLin komorbidnimi stanji.
During the maintenance period in study GAO4753g/GADOLIN, the most common adverse reactions were cough (15%), upper respiratory infections (12%), neutropenia (11%), sinusitis (10%), diarrhoea (8%), IRRs (8%), nausea (8%), fatigue (8%), bronchitis (7%), arthralgia (7%), pyrexia (6%), nasopharyngitis (6%), and urinary tract infections (6%).
V obdobju vzdrževalnega zdravljenja v študiji GAO4753g/GADOLIN so bili najbolj pogosti neželeni učinki kašelj (15 %), okužba zgornjih dihal (12 %), nevtropenija (11 %), sinuzitis (10 %), diareja (8 %), reakcije, povezane z infuzijo (8 %), navzea (8 %), utrujenost (8 %), bronhitis (7 %), artralgija (7 %), zvišana telesna temperatura (6 %), nazofaringitis (6 %) in okužbe sečil (6 %).
The studies BO21223/GALLIUM and GAO4753g/GADOLIN enrolled patients with iNHL including FL.
V študijah BO21223/GALLIUM in GAO4753g/GADOLIN so bili vključeni bolniki z iNHL,
Based on the FACT-Lym questionnaire collected during treatment and follow-up phases, patients in both treatment arms experienced clinically meaningful improvements in lymphoma-related symptoms as defined by a ³ 3 point increase from baseline in the Lymphoma subscale, a ³ 6 point increase from baseline in the FACT Lym TOI and a ³ 7 point increase from baseline in the FACT Lym Total score.
Izidi po navedbi bolnika Na podlagi vprašalnika FACT-Lym, uporabljenega med zdravljenjem in obdobjem spremljanja, so se pri bolnikih iz obeh zdravljenih skupin simptomi, povezani z limfomom, klinično pomembno izboljšali, kot določa zvečanje za ≥ 3 točke od izhodišča na podlestvici za limfome, zvečanje za ≥ 6 točk od izhodiščne ocene FACT-Lym TOI in zvečanje za ≥ 7 točk od izhodiščne skupne ocene FACT-Lym.
The incidences presented in the following sections if referring to iNHL are the highest incidence of that ADR reported from either pivotal study (BO21223/GALLIUM, GAO4753g/GADOLIN).
V spodnjih poglavjih navedene incidence, ki se nanašajo na iNHL, so najvišje incidence neželenih učinkov, ki so jih poročali ali iz ene ali iz druge ključne študije (BO21223/GALLIUM, GAO4753g/GADOLIN).
In addition, there were no apparent effects of bendamustine, FC, chlorambucil or CHOP on the pharmacokinetics of Gazyvaro.
Dodatno ni bilo vidnih učinkov bendamustina, FC, klorambucila ali CHOP na farmakokinetiko zdravila Gazyvaro.
A type of liver disease called “hepatitis B” has also been reported to reoccur in patients who have had hepatitis B in the past.
Pri bolnikih, ki so imeli v preteklosti vrsto jetrne bolezni, imenovane hepatitis B, je bila opisana ponovitev hepatitisa B.
1100 mg prednisone/prednisolone or 20 mg dexamethasone or 80 mg methylprednisolone.
1 100 mg prednizona/prednizolona ali 20 mg deksametazona ali 80 mg metilprednizolona.