natgillin/translations-raw huggingface dataset:
Patients with a high tumour burden and/or high circulating lymphocyte count in CLL [> 25 x 109/L] may be at increased risk of severe IRRs.
Bolesnici s KLL-om koji imaju veliko tumorsko opterećenje i/ili velik broj limfocita u cirkulaciji (> 25 x 109/l) mogu imati povećan rizik od teških reakcija na infuziju.
No Grade 3-5 IRRs were reported beyond the first 1,000 mg infusions of Cycle 1.
Nakon infuzije prvih 1000 mg u 1. ciklusu nije prijavljena više niti jedna reakcija na infuziju 3.-5. stupnja.
· Use an effective method of contraception while being treated with Gazyvaro.
Zaštita od trudnoće · Koristite učinkovitu metodu sprječavanja trudnoće dok se liječite lijekom Gazyvaro.
The incidence of IRRs with subsequent infusions was 3% with the second 1,000 mg dose and 1% thereafter.
tijekom druge doze od 1000 mg te 1% nakon toga.
Difference in MRD rates, (95% CI) Event free survival
Razlika u stopama MRD-a (95% CI)
Gazyvaro infusions should not be administered as an intravenous push or bolus.
Gazyvaro se ne smije primijeniti brzom niti bolusnom intravenskom injekcijom.
Patients who experience neutropenia should be closely monitored with regular laboratory tests until resolution.
Bolesnike u kojih se pojavi neutropenija potrebno je pažljivo pratiti redovitim laboratorijskim pretragama sve do normalizacije krvne slike.
An enhanced pre and postnatal development (ePPND) toxicity study in pregnant cynomolgus monkeys showed no evidence of teratogenic effects.
Prošireno istraživanje toksičnih učinaka na prenatalni i postnatalni razvoj u skotnih ženki makaki majmuna nije ukazalo na teratogene učinke.
HBVscreening should be performed in all patients before initiation of treatment with Gazyvaro.
Prije početka liječenja lijekom Gazyvaro u svih bolesnika je potrebno napraviti probir na HBV.
Table 1 Premedication to be administered before Gazyvaro infusion to reduce the risk of IRRsin CLL and FL patients
Tablica 1 Premedikacija koju je potrebno primijeniti prije infuzije lijeka Gazyvaro radi smanjenja rizika od reakcija na infuziju u bolesnika s KLL-om i FL-om
Gazyvaro +Chemotherapy followed by Gazyvaro maintenance N=601
Gazyvaro + kemoterapija, nakon čega slijedi terapija održavanja lijekom Gazyvaro N=601
Table 7 Summary of efficacy from BO21004/CLL11 study Stage 1a
Tablica 7 Sažetak rezultata za djelotvornost iz ispitivanja BO21004/CLL11
Efficacy results for patients with previously untreated CLL are summarised in Table 7.
Rezultati za djelotvornost u bolesnika s prethodno neliječenom kroničnom limfocitnom leukemijom sažeto su prikazani u Tablici 7.
Patients were stratified according to region, iNHL subtype (follicular versus non-follicular), rituximab-refractory type (whether refractory to prior rituximab monotherapy or rituximab in combination with chemotherapy)
Bolesnici su bili stratificirani prema regiji, podtipu iNHL-a (folikularni ili nefolikularni), tipu refraktornosti na rituksimab (je li bolest bila refraktorna na prethodno liječenje rituksimabom u monoterapiji ili u kombinaciji s kemoterapijom) te broju prethodnih terapija (≤ 2 naspram > 2).
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.
dok su istoga dana koncentracije u mlijeku bile jako niske (manje od 0,5% odgovarajućih razina u serumu majke), što ukazuje na to da je do izloženosti mladunčadi moralo doći in utero.
A therapy choice for these patients should carefully consider the overall safety profile of Gazyvaro plus chemotherapy and the patient-specific situation.
Kod izbora terapije za ove bolesnike treba pažljivo razmotriti ukupni sigurnosni profil lijeka
No formal drug-drug interaction studies have been performed, although limited drug-drug interaction sub-studies have been undertaken for Gazyvaro with bendamustine, CHOP, fludarabine and cyclophosphamide (FC), and chlorambucil.
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena formalna ispitivanja interakcija s drugim lijekovima, ali su provedena ograničena podispitivanja interakcija lijeka Gazyvaro s bendamustinom, protokolom CHOP, fludarabinom i ciklofosfamidom (protokol FC) te klorambucilom.
Thrombocytopenia occurred more frequently in Cycle 1 in the Gazyvaro plus chemotherapy arm. Thrombocytopenia occurring during or 24 hours from end of infusion (acute thrombocytopenia) was more frequently observed in patients in the Gazyvaro plus chemotherapy arm than in the comparator arm.
Trombocitopenija koja je nastupila tijekom infuzije ili unutar 24 sata od njezina završetka (akutna trombocitopenija) češće je primijećena u bolesnika u skupini liječenoj lijekom Gazyvaro plus kemoterapijom nego u usporednoj skupini.
Cycles 2 - 6
2.-6. ciklus
For management of symptomatic adverse events (including IRRs), see paragraph below (Management of IRRs or section 4.4).
Za zbrinjavanje simptomatskih nuspojava (uključujući reakcije na infuziju), vidjeti odlomak u nastavku ('Zbrinjavanje reakcija na infuziju' ili dio 4.4).
Therapy with Gazyvaro should be withheld during the investigation of potential PML and permanently discontinued in case of confirmed PML.
Suzdržavanje od terapije lijekom Gazyvaro potrebno je dok se ne utvrdi boluje li bolesnik od PML-a, a ako se PML potvrdi, liječenje je potrebno trajno obustaviti.
Stage 1a compared Gazyvaro plus chlorambucil to chlorambucil alone in 356 patients and Stage 2 compared Gazyvaro plus chlorambucil to rituximab plus chlorambucil in 663 patients.
U stadiju 1a uspoređivana je kombinacija lijeka Gazyvaro i klorambucila s monoterapijom klorambucilom u 356 bolesnika, dok je u 2. stadiju
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.
utvrđeno je da su bolesnici u obje liječene skupine doživjeli klinički značajno poboljšanje simptoma povezanih s limfomom, koje se definiralo kao povećanje početnog rezultata na podljestvici za ocjenu limfoma za ≥ 3 boda, povećanje početnog rezultata indeksa ishoda ispitivanja (engl.
When these symptoms go away, or improve, the infusion can be continued.
Infuzija se može nastaviti nakon povlačenja ili poboljšanja simptoma.
The median estimated CrCl was 62 mL/min and 66% of all patients had a CrCl < 70 mL/min.
a 66% svih bolesnika imalo je CrCl < 70 ml/min.
Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or suitable alternative treatment such as urate oxidase (e.g. rasburicase), starting 12-24 hours prior to start of Gazyvaro infusion as per standard practice (see section 4.4).
Profilaksa bi se trebala sastojati od odgovarajuće hidracije i primjene urikostatika (npr. alopurinola) ili neke druge prikladne terapije, poput urat oksidaze (npr. razburikaze), započevši 12 - 24 sata prije početka infuzije lijeka Gazyvaro u skladu s uobičajenom praksom (vidjeti dio 4.4).
Bendamustine was given intravenously on Days 1 and 2 for all treatment cycles (Cycles 1-6) at 90 mg/m2/day when given in combination with Gazyvaro or 120 mg/m2/day when given alone.
Bendamustin se primjenjivao intravenski 1. i 2. dan u svim ciklusima liječenja (1. - 6. ciklus), u dozi od 90 mg/m2/dan kada se primjenjivao u kombinaciji s lijekom Gazyvaro ili u dozi od 120 mg/m2/dan kada se primjenjivao samostalno.
The adverse drug reactions (ADRs) described in this section were identified during induction, maintenance and follow up for indolent Non-Hodgkin lymphoma (iNHL) including FL; treatment and follow up for CLL in the three pivotal clinical studies: · BO21004/CLL11 (N=781): Patients with previously untreated CLL · BO21223/GALLIUM (N=1390): Patients with previously untreated iNHL (86% of the patients had FL) · GAO4753g/GADOLIN (N=392): Patients with iNHL (81% of the patients had FL) who had no response to or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
· BO21004/CLL11 (N = 781): bolesnici s prethodno neliječenim KLL-om · BO21223/GALLIUM (N=1390): bolesnici s prethodno neliječenim iNHL-om (86% bolesnika imalo je FL) · GAO4753g/GADOLIN (N = 392): bolesnici s iNHL-om (81% bolesnika imalo je FL) koji nisu odgovorili na prethodno liječenje rituksimabom ili protokolom koji je sadržavao rituksimab, ili su doživjeli progresiju tijekom ili do 6 mjeseci nakon takvog liječenja.
Bendamustine was given intravenously on Days 1 and 2 for all treatment cycles (Cycles 1-6) at 90 mg/m2/day when given in combination with Gazyvaro.
Bendamustin se primjenjivao intravenski 1. i 2. dan u svim ciklusima liječenja (1. - 6. ciklus) u dozi od 90 mg/m2/dan kada se primjenjivao u kombinaciji s lijekom Gazyvaro.
Prophylaxis and premedication for tumour lysis syndrome (TLS)
Profilaksa i premedikacija za sindrom lize tumora
Additional safety information from clinical studies experience
Dodatne informacije o sigurnosti iz kliničkih ispitivanja Progresivna multifokalna leukoencefalopatija
If you miss a Gazyvaro treatment
Ako propustite primiti Gazyvaro
A clear relationship between thrombocytopenia and haemorrhagic events has not been established.
Nije ustanovljena jasna veza između trombocitopenije i događaja krvarenja.
Patients in the CLL pivotal study BO21004/CLL11 were tested at multiple time-points for anti-therapeutic antibodies (ATA) to Gazyvaro.
U ključnom ispitivanju BO21004/CLL11 bolesnici s KLL-om testirani su u više navrata kako bi se utvrdila prisutnost protutijela na lijek Gazyvaro.
Before each infusion of Gazyvaro, you will be given medicines to lessen the chance of getting infusion related reactions or tumour lysis syndrome.
Lijekovi koje ćete primiti prije svake infuzije Prije svake infuzije lijeka Gazyvaro primit ćete lijekove koji će smanjiti vjerojatnost razvoja s infuzijom povezane reakcije ili sindroma lize tumora.
The Gazyvaro treatment
Liječenje lijekom Gazyvaro
Mitigation measures to reduce IRRs should be followed (see section 4.2).
Potrebno je primjenjivati navedene mjere kako bi se smanjio broj reakcija na infuziju (vidjeti dio 4.2).
How Gazyvaro works
Kako Gazyvaro djeluje
Respiratory, thoracic and mediastinal disorders Very common
Poremećaji dišnog sustava, prsišta i sredoprsja vrlo često kašalj§
Patients with a high tumour burden and/or a high circulating lymphocyte count (> 25 x 109/L) and/or renal impairment (CrCl < 70 mL/min) are considered at risk of TLS and should receive prophylaxis.
Bolesnici s velikim tumorskim opterećenjem i/ili velikim brojem cirkulirajućih limfocita (> 25 x 109/l) i/ili oštećenjem bubrežne funkcije (CrCl <70 ml/min) smatraju se rizičnima za razvoj sindroma lize tumora i stoga bi trebali primiti profilaksu.
· Tell your doctor or nurse straight away if you get any of the infusion related reactions listed at the start of section 4.
· Odmah obavijestite liječnika ili medicinsku sestru ako primijetite bilo koju od reakcija na infuziju navedenih na početku dijela 4. Reakcije na infuziju mogu se javiti tijekom infuzije ili do 24 sata nakon infuzije.
Induction (in combination with bendamustine2) Gazyvaro should be administered in six 28-day cycles in combination with bendamustine2.
Gazyvaro treba primjenjivati tijekom šest 28-dnevnih ciklusa u kombinaciji s bendamustinom2.
In patients with underlying cardiac disease, arrhythmias (such as atrial fibrillation and tachyarrhythmia), angina pectoris, acute coronary syndrome, myocardial infarction and heart failure have occurred when treated with Gazyvaro (see section 4.8).
(poput fibrilacije atrija i tahiaritmije), angina pektoris, akutni koronarni sindrom, infarkt miokarda te zatajenje srca (vidjeti dio 4.8).
Rate of infusion
Brzina infuzije
HR (95% CI) p-value (Log-Rank test, stratified*)
HR (95% CI) p-vrijednost (log-rang test, stratificiran*)
Day 8 (1,000 mg)
8. dan (1000 mg)
Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of Gazyvaro as outlined below.
Zbrinjavanje reakcija na infuziju (sve indikacije) Zbrinjavanje reakcija na infuziju može zahtijevati privremeni prekid primjene, smanjenje brzine infuzije ili obustavu liječenja lijekom Gazyvaro kako je navedeno u nastavku.
Hypotension may occur during Gazyvaro intravenous infusions.
Tijekom intravenskih infuzija lijeka Gazyvaro može se pojaviti hipotenzija.
For patients with FL, the recommended dose of Gazyvaro in combination with chemotherapy is shown in Table 3.
Preporučena doza lijeka Gazyvaro u kombinaciji s kemoterapijom za bolesnike s FL-om prikazana je u Tablici 3.
Administer at 50 mg/hr.
50 mg/h.
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 infuziju koja se primjenjuje 1. i 2. dan potrebno je pripremiti dvije infuzijske vrećice (100 mg za
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
Nakon razrjeđivanja, dokazane su kemijska i fizička stabilnost u otopini za injekciju 9 mg/ml (0,9%)
In the Gazyvaro plus chemotherapy arm, the incidence of Grade 1-4 neutropenia (50%) was higher relative to the comparator arm with an increased risk during the induction period.
Incidencija neutropenije 1. - 4. stupnja bila je veća u skupini liječenoj lijekom Gazyvaro plus kemoterapijom (50%) nego u usporednoj skupini, uz povećan rizik tijekom razdoblja uvodnog liječenja.
The metabolism of obinutuzumab has not been directly studied.
Nisu provedena izravna ispitivanja metabolizma obinutuzumaba.
Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or a suitable alternative such as a urate oxidate (e.g. rasburicase) starting 12-24 hours prior to the infusion of Gazyvaro as per standard practice (see section 4.2).
Profilaksa bi se trebala sastojati od odgovarajuće hidracije i primjene urikostatika (npr. alopurinola) ili neke druge prikladne terapije, poput urat oksidaze (npr. razburikaze), započevši 12 - 24 sata prije infuzije lijeka Gazyvaro u skladu s uobičajenom praksom (vidjeti dio 4.2).
Upper respiratory tract infection, sinusitis§, , urinary tract infection, pneumonia§ ,herpes zoster§
§, infekcija mokraćnih putova, pneumonija§, herpes zoster§
For patients with CLL the recommended dose of Gazyvaro in combination with chlorambucil is shown in Table 2.
Preporučena doza lijeka Gazyvaro u kombinaciji s klorambucilom za bolesnike s KLL-om prikazana je u Tablici 2.
Package leaflet: Information for the patient Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Uputa o lijeku: Informacije za bolesnika Gazyvaro 1000 mg koncentrat za otopinu za infuziju obinutuzumab
In CLL patients who received the combined measures for prevention of IRRs (adequate corticosteroid, oral analgesic/anti-histamine, omission of antihypertensive medicine in the morning of the first infusion, and the Cycle 1 Day 1 dose administered over 2 days) as described in section 4.2, a decreased incidence of IRRs of all Grades was observed.
bolesnika s KLL-om u kojih je na način opisan u dijelu 4.2. primijenjena kombinacija mjera za sprječavanje reakcija na infuziju (odgovarajući kortikosteroid, oralni analgetik/antihistaminik, izostavljanje antihipertenziva ujutro na dan prve infuzije i primjena 1. doze 1. ciklusa tijekom 2 dana)
In a phase III, open label, multicentre, randomised clinical study (GAO4753g/GADOLIN), 396 patients with iNHL who had no response during treatment or who progressed within 6 months following the last dose of rituximab or a rituximab-containing regimen (including rituximab monotherapy as part of induction or maintenance treatment) were evaluated.
(GAO4753g/GADOLIN) ocijenjeno je 396 bolesnika s iNHL-om koji nisu odgovorili na liječenje ili su doživjeli progresiju unutar 6 mjeseci nakon posljednje doze rituksimaba ili protokola koji je sadržavao rituksimab (uključujući monoterapiju rituksimabom u sklopu uvodnog liječenja ili terapije održavanja).
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.
Naime, u muškaraca je klirens u stanju dinamičke ravnoteže (CLss) bio 22% veći, a volumen distribucije 19% veći nego u žena.
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%).
Tijekom razdoblja terapije održavanja u ispitivanju GAO4753g/GADOLIN, najčešće nuspojave bile su kašalj (15%), infekcije gornjih dišnih putova (12%), neutropenija (11%), sinusitis (10%), proljev
Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of Gazyvaro as outlined below (see also section 4.4).
Zbrinjavanje reakcija na infuziju (sve indikacije) Zbrinjavanje reakcija na infuziju može zahtijevati privremeni prekid primjene, smanjenje brzine infuzije ili obustavu liječenja lijekom Gazyvaro kako je navedeno u nastavku (vidjeti i dio 4.4).
If no IRR occurred during the previous infusion, when the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
Ako se tijekom prethodne infuzije, kada je konačna brzina infuzije bila 100 mg/h ili viša, nije razvila reakcija na infuziju, infuzije je moguće započeti brzinom od 100 mg/h, a zatim povećavati za 100 mg/h svakih 30 minuta do maksimalno 400 mg/h.
It should be given as an intravenous infusion through a dedicated line after dilution.
Nakon razrjeđivanja primjenjuje se intravenskom infuzijom kroz poseban venski put.
Figure 8 IRC-assessed PFS by patient subgroup in FL *# (Study GAO4753g/GADOLIN)
Slika 8 PFS po podskupinama bolesnika s FL-om prema ocjeni neovisnog ocjenjivačkog povjerenstva*# (ispitivanje GAO4753g/GADOLIN)
Patient-reported Outcomes
Trial Outcome
How to store Gazyvaro
Kako primjenjivati Gazyvaro
NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion.
NAZIV LIJEKA Gazyvaro 1000 mg koncentrat za otopinu za infuziju.
Patients in the G+B arm who did not have disease progression (i.e. patients with a complete response (CR), partial response (PR) or stable disease (SD)) at the end of induction continued receiving Gazyvaro maintenance once every two months for two years or until disease progression (whichever occurred first).
Bolesnici u skupini liječenoj kombinacijom G+B koji nisu doživjeli progresiju bolesti (tj. bolesnici s potpunim odgovorom [CR], djelomičnim odgovorom [PR] ili stabilnom bolešću [engl. stable disease, SD]) na kraju razdoblja uvodnog liječenja, nastavili su primati
PML is a very rare and life-threatening brain infection that has been reported with Gazyvaro.
Progresivna multifokalna leukoencefalopatija PML je vrlo rijetka i po život opasna infekcija mozga prijavljena kod primjene lijeka Gazyvaro.
Day 15 (1,000 mg)
15. dan (1000 mg)
Co-administration with Gazyvaro had no effect on the pharmacokinetics of bendamustine, FC, chlorambucil or the individual components of CHOP.
Istodobna primjena s lijekom Gazyvaro nije utjecala na farmakokinetiku bendamustina, protokola FC,
Figure 7 Kaplan-Meier curve of OS in patients with FL # (Study GAO4753g/GADOLIN)
Slika 7 Kaplan-Meierova krivulja OS-a u bolesnika s FL-om# (ispitivanje GAO4753g/GADOLIN)
HistidineHistidine hydrochloride monohydrate Trehalose dihydrate
histidin histidinklorid hidrat trehaloza dihidrat poloksamer 188 voda za injekcije
Severe and life-threatening neutropenia including febrile neutropenia has been reported during treatment with Gazyvaro.
Tijekom liječenja lijekom Gazyvaro prijavljena je teška i po život opasna neutropenija, uključujući febrilnu neutropeniju.
IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Intervals, MRD: Minimal Residual Disease, NR = Not reached a Defined as the time from randomisation to the first occurrence of progression, relapse or death from any cause as assessed by the investigator b stratified by Binet stage at baseline c Includes 11 patients in the GClb arm with a complete response with incomplete marrow recovery d Blood and bone marrow combined e MRD negativity is defined as a result below 0.0001 f Includes MRD positive patients and patients who progressed or died before the end of treatment g Median observation time for overall survival (OS) data corresponds to 62.5 months median observation time in Stage 1a and to 59.4 months median observation time in Stage 2.
PFS (engl. progression-free survival): preživljenje bez progresije bolesti; HR (engl. hazard ratio): omjer hazarda; CI (engl. confidence intervals): intervali pouzdanosti; MRD (engl. minimal residual disease): minimalna ostatna bolest, ND = nije dostignuto a Definira se kao vrijeme od randomizacije do prvog nastupa progresije, relapsa ili smrti zbog bilo kojeg uzroka prema ocjeni ispitivača b Stratificirano prema stadiju bolesti po Binetovoj klasifikaciji na početku ispitivanja c
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.
ALT > 5 x GGN tijekom > 2 tjedna; bilirubin > 3 x GGN] i funkcijom bubrega (CrCl < 30 ml/min) nisu bili uključeni u ispitivanje.
Induction (in combination with chemotherapy2) Gazyvaro should be administered with chemotherapy as follows:
Gazyvaro treba primjenjivati s kemoterapijom na sljedeći način:
The most frequently observed adverse drug reactions (ADRs) in patients receiving Gazyvaro were IRRs, which occurred predominantly during infusion of the first 1,000 mg. IRRs may be related to cytokine release syndrome which has also been reported in Gazyvaro treated patients.
Najčešće primijećene nuspojave u bolesnika liječenih lijekom Gazyvaro bile su reakcije na infuziju, a javljale su se prvenstveno tijekom infuzije prvih 1000 mg.
Dose of Gazyvaro
Doza lijeka Gazyvaro
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Gazyvaro 1000 mg koncentrat za otopinu za infuziju obinutuzumab
In study GAO4753g/GADOLIN, patients in the bendamustine arm received 6 months of induction treatment only, whereas after the induction period, patients in the Gazyvaro plus bendamustine arm continued with Gazyvaro maintenance treatment.
U ispitivanju GAO4753g/GADOLIN, bolesnici u skupini liječenoj bendamustinom primili su samo
One vial of 40 mL concentrate contains 1,000 mg obinutuzumab, corresponding to a concentration before dilution of 25 mg/mL
Jedna bočica s 40 ml koncentrata sadrži 1000 mg obinutuzumaba, što odgovara koncentraciji od
Withdraw 40 mL of concentrate from the vial and dilute in polyvinyl chloride (PVC) or non-PVC polyolefin infusion bags containing sodium chloride 9 mg/mL (0.9%) solution for injection.
ili od poliolefina koje ne sadrže PVC, u kojima se nalazi otopina za injekcije 9 mg/ml (0,9%) natrijevog klorida.
Severe and life-threatening thrombocytopenia including acute thrombocytopenia (occurring within 24 hours after the infusion) has been observed during treatment with Gazyvaro.
Tijekom liječenja lijekom Gazyvaro primijećena je teška i po život opasna trombocitopenija, uključujući akutnu trombocitopeniju (koja se javlja unutar 24 sata nakon infuzije).