natgillin/translations-raw huggingface dataset:
Cases of prolonged neutropenia (2% in the Gazyvaro plus chlorambucil arm and 4% in the rituximab plus chlorambucil arm) and late onset neutropenia (16% in the Gazyvaro plus chlorambucil arm and 12% in the rituximab plus chlorambucil arm) were also reported (see section 4.4).
te odgođene neutropenije (16% u skupini liječenoj lijekom Gazyvaro i klorambucilom te 12% u skupini liječenoj rituksimabom i klorambucilom) (vidjeti dio 4.4).
In the pivotal studies (BO21223/GALLIUM, GAO4753g/GADOLIN) in iNHL, patients 65 years or older experienced more serious adverse events and adverse events leading to withdrawal or death than patients < 65 years of age.
Indolentni ne-Hodgkinov limfom, uključujući folikularni limfom U ključnim ispitivanjima kod iNHL-a (BO21223/GALLIUM, GAO4753g/GADOLIN), ozbiljne nuspojave i nuspojave koje su dovele do prekida liječenja ili smrti češće su se javljale u bolesnika u dobi od 65 ili više godina nego u onih mlađih od 65 godina.
How Gazyvaro is given
Kako se Gazyvaro primjenjuje
Prior to enrolment, patients had to have documented CD20+ CLL, and one or both of the following measures of coexisting medical conditions: comorbidity score (CIRS) of greater than 6 or reduced renal function as measured by CrCl < 70 mL/min.
Prije uključivanja u ispitivanje bolesnici su morali imali dokumentiran KLL pozitivan na CD20 te ispunjavati jedan ili oba uvjeta za istodobno postojeće bolesti: rezultat bodovanja komorbiditeta
Four percent of patients treated with Gazyvaro plus chlorambucil experienced acute thrombocytopenia (occurring within 24 hours after the Gazyvaro infusion) (see section 4.4).
Akutna trombocitopenija (koja se razvila unutar 24 sata nakon infuzije lijeka Gazyvaro) javila se u četiri posto bolesnika liječenih lijekom Gazyvaro i klorambucilom (vidjeti dio 4.4).
If the patient experienced an IRR during the previous infusion, start with administration at 25 mg/hr.
Ako se tijekom prethodne infuzije razvila reakcija na infuziju, primjenu treba započeti brzinom od 25 mg/h.
Figure 5 Kaplan-Meier curve of INV-assessed progression-free survival in patients with previously untreated FL (Study BO21223/GALLIUM)
‡ Kraj uvodnog liječenja = kraj razdoblja uvodnog liječenja, ne uključuje monoterapiju održavanja Slika 5 Kaplan-Meierova krivulja preživljenja bez progresije bolesti prema ocjeni ispitivača u bolesnika s prethodno neliječenim FL-om (ispitivanje BO21223/GALLIUM)
One vial of 40 mL concentrate contains 1,000 mg obinutuzumab, corresponding to a concentration before dilution of 25 mg/mL.
· Djelatna tvar je obinutuzumab: 1000 mg/40 ml po bočici, što odgovara koncentraciji od 25 mg/ml prije razrjeđivanja.
Grades 3-5† Gazyvaro + chemotherapy* (CLL, iNHL) followed by Gazyvaro maintenance (iNHL)
3.-5. stupanj† Gazyvaro + kemoterapija*
In the pivotal clinical study BO21004/CLL11, 91% (40 out of 44) of evaluable patients treated with Gazyvaro were B-cell depleted (defined as CD19+ B-cell counts < 0.07 x 109/L) at the end of treatment period and remained depleted during the first 6 months of follow up.
U ključnom kliničkom ispitivanju BO21004/CLL11, 91% (40 od 44) bolesnika dostupnih za procjenu koji su liječeni lijekom Gazyvaro imalo je depleciju B-stanica (koja se definira kao broj CD19+
Most frequently reported (≥ 5%) symptoms associated with an IRR were nausea, vomiting, diarrhoea, headache, dizziness, fatigue, chills, pyrexia, hypotension, flushing, hypertension, tachycardia, dyspnoea, and chest discomfort.
proljev, glavobolja, omaglica, umor, zimica, pireksija, hipotenzija, navale crvenila, hipertenzija, tahikardija, dispneja i nelagoda u prsištu.
In the small subgroup of patients with deletion 17p, only a positive trend was observed compared to Clb (HR=0.42, p=0.0892); no benefit was observed compared to RClb.
U svim je podskupinama rizik od progresije bolesti ili smrti bio smanjen u skupini koja je primala GClb u odnosu na onu koja je primala RClb i onu koja je primala Clb, osim u podskupini bolesnika s delecijom 17p. U malenoj podskupini bolesnika koji su imali deleciju 17p primijećen je samo pozitivan trend u odnosu na Clb (HR=0,42, p=0,0892); nije primijećena dobit u usporedbi s RClb.
Figure 6 Kaplan-Meier curve of IRC-assessed PFS in patients with FL # (Study GAO4753g/GADOLIN)
Slika 6 Kaplan-Meierova krivulja PFS-a u bolesnika s FL-om# prema ocjeni neovisnog ocjenjivačkog povjerenstva (ispitivanje GAO4753g/GADOLIN)
The safety of immunisation with live or attenuated viral vaccines following Gazyvaro therapy has not been studied and vaccination with live virus vaccines is not recommended during treatment and until B-cell recovery.
Cijepljenje Sigurnost cijepljenja živim ili atenuiranim virusnim cjepivima nakon terapije lijekom Gazyvaro nije ispitivana.
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.
Bolesnici su bili randomizirani u omjeru 1:1 za primanje lijeka Gazyvaro (n = 601 bolesnik) ili rituksimaba (n = 601 bolesnik) u kombinaciji s kemoterapijom
Day 1 (1,000 mg)
1. dan (1000 mg)
Cases of gastro-intestinal perforation have been reported in patients receiving Gazyvaro, mainly in iNHL.
U bolesnika liječenih lijekom Gazyvaro, uglavnom onih oboljelih od iNHL-a, prijavljeni su slučajevi gastrointestinalne perforacije.
Table 4 Chronic lymphocytic leukaemia: Standard infusion rate in the absence of IRRs/hypersensitivity and recommendations in case an IRR occurred with previous infusion
Tablica 4 Kronična limfocitna leukemija: Standardna brzina infuzije u odsustvu reakcija na infuziju/preosjetljivosti i preporuke u slučaju da je tijekom prethodne infuzije nastupila reakcija na infuziju
Tumour lysis syndrome, hypokalaemia
Sindrom lize tumora
No meaningful differences were seen between the arms in HRQOL or health status measures.
Nisu primijećene značajne razlike između skupina s obzirom na kvalitetu života vezanu uz zdravlje i mjerila zdravstvenog statusa.
Hazard ratio (95% CI) p-value (Log-Rank test, stratified b)
Omjer hazarda (95% CI) p-vrijednost (log-rang test, stratificiran b)
* Chemotherapy: Chlorambucil in CLL; bendamustine, CHOP, CVP in iNHL including FL § observed also during maintenance treatment with at least 2% higher incidence in Gazyvaro arm (BO21223)
*Kemoterapija: klorambucil kod KLL-a; bendamustin, CHOP, CVP kod iNHL-a, uključujući FL
Hypotension, as a symptom of IRRs, may occur during Gazyvaro intravenous infusions.
Tijekom intravenskih infuzija lijeka Gazyvaro može se pojaviti hipotenzija kao simptom reakcija na infuziju.
All Grades Gazyvaro + chemotherapy* (CLL, iNHL) followed by Gazyvaro maintenance (iNHL)
(KLL, iNHL) nakon čega slijedi terapija održavanja lijekom Gazyvaro (iNHL)
Patients who achieved a complete or partial response to induction treatment (i.e. the initial 6 treatment cycles) with Gazyvaro in combination with bendamustine or have stable disease should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
Bolesnici koji ostvare potpun ili djelomičan odgovor na uvodno liječenje (tj. na prvih 6 ciklusa liječenja) lijekom Gazyvaro u kombinaciji s bendamustinom ili koji imaju stabilnu bolest trebaju nastaviti primati monoterapiju lijekom Gazyvaro u dozi od 1000 mg kao terapiju održavanja jedanput svaka 2 mjeseca tijekom 2 godine ili do progresije bolesti (što god nastupi ranije).
Hazard ratio (95% CI) p-value (Log-Rank test, stratifiedb) Overall survival
Omjer hazarda (95% CI) p-vrijednost (log-rang test, stratificiran b) Ukupno preživljenje
MARKETING AUTHORISATION NUMBER(S)
Djelomičan odgovor (PR)
Infusion can be continued upon resolution of symptoms and, if the patient does not experience any IRR symptoms, the infusion rate escalation can resume at the increments and intervals as appropriate for the treatment dose (see Tables 4 and 5).
Ako se ne pojave simptomi reakcije na infuziju, njezinu brzinu je moguće nastaviti postupno povećavati u intervalima koji odgovaraju dozi (vidjeti Tablice 4 i 5).
Vaccination with live virus vaccines is not recommended during treatment and until B-cell recovery because of the immunosuppressive effect of obinutuzumab (see section 4.4).
Zbog imunosupresivnog učinka obinutuzumaba, cijepljenje živim virusnim cjepivima se ne preporučuje tijekom trudnoće niti prije normalizacije broja B stanica (vidjeti dio 4.4).
Patients who achieve a complete or partial response to induction treatment with Gazyvaro in combination with chemotherapy should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
Bolesnici koji ostvare potpun ili djelomičan odgovor na uvodno liječenje lijekom Gazyvaro u kombinaciji s kemoterapijom trebaju nastaviti primati terapiju održavanja samo lijekom Gazyvaro u dozi od 1000 mg jedanput svaka 2 mjeseca tijekom 2 godine ili do progresije bolesti (što god nastupi ranije).
· red eye · cold sores · depression, anxiety · night sweats · flu (influenza) · weight increase · lymph node pain · runny or blocked nose · eczema · nose or throat inflammation · pain in mouth or throat
· umor · omaglica · glavobolja · proljev · vrućica, navale crvenila ili zimica
The rate of infusion can be escalated in increments up to 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr.
Brzinu infuzije moguće je povećavati za 50 mg/h svakih 30 minuta do maksimalne brzine od 400 mg/h.
· muscle and bone pain in your chest · skin cancer (squamous cell carcinoma) · bone pain, pain in arms and legs · irregular heart beat (atrial fibrillation), heart failure · problems with urinating, urinary incontinence · high blood pressure · problems with digestion (e.g. heartburn), inflammation of the intestine, haemorrhoids · changes shown in blood tests:
· visok krvni tlak · probavne tegobe (žgaravica), upala crijeva, hemoroidi · promjene u krvnoj slici:
If you miss your appointment, make another one as soon as possible.
Ako propustite primiti dozu lijeka Gazyvaro, dogovorite novi termin što je prije moguće.
Patients who achieve a complete or partial response to induction treatment with Gazyvaro in combination with chemotherapy (CHOP or CVP or bendamustine) should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
Bolesnici koji ostvare potpun ili djelomičan odgovor na uvodno liječenje lijekom Gazyvaro u kombinaciji s kemoterapijom (protokolom CHOP ili CVP ili bendamustinom) trebaju nastaviti primati terapiju održavanja samo lijekom Gazyvaro u dozi od 1000 mg jedanput svaka 2 mjeseca tijekom 2 godine ili do progresije bolesti (što god nastupi ranije).
Table 5 Follicular lymphoma: Standard infusion rate in the absence of IRRs /hypersensitivity and recommendations in case an IRR occurred with previous infusion
Tablica 5 Folikularni limfom: Standardna brzina infuzije u odsustvu reakcija na infuziju/preosjetljivosti i preporuke u slučaju da je tijekom prethodne infuzije nastupila reakcija na infuziju
Patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen
Bolesnici s folikularnim limfomom koji nisu odgovorili na liječenje rituksimabom ili protokolom koji sadrži rituksimab, ili su doživjeli progresiju tijekom ili do 6 mjeseci nakon takvog liječenja
# Patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen
#Bolesnici s FL-om koji nisu odgovorili na liječenje rituksimabom ili protokolom koji sadrži rituksimab, ili su doživjeli progresiju tijekom ili do 6 mjeseci nakon takvog liječenja
The incidence of thrombocytopenia was higher in the Gazyvaro plus chlorambucil arm compared to the rituximab plus chlorambucil arm (16% vs. 7%) especially during the first cycle.
Incidencija trombocitopenije bila je viša u skupini liječenoj lijekom Gazyvaro i klorambucilom (16%)
If the patient experienced an IRR of Grade 2 or higher during the previous infusion administer at 50 mg/hr.
Ako se tijekom prethodne infuzije razvila reakcija na infuziju 2. ili višeg stupnja, ovu treba primijeniti brzinom od 50 mg/h.
● a hole in the stomach or intestines (gastrointestinal perforation, especially in cases where the cancer affects the gastrointestinal tubes)
Manje često (mogu se javiti u do 1 na 100 osoba) · probušenje stijenke želuca ili crijeva (gastrointestinalna perforacija, osobito u slučajevima u kojima rak zahvaća probavnu cijev)
Premedication to reduce the risk of IRRs is outlined in Table 1 (see also section 4.4).
Profilaksa i premedikacija za reakcije na infuziju Premedikacija radi smanjenja rizika od reakcija na infuziju opisana je u Tablici 1 (vidjeti i dio 4.4).
Your doctor may decide to stop treatment with Gazyvaro if you have a severe infusion related reaction.
Ako dobijete jaku reakciju na infuziju, liječnik može odlučiti prekinuti liječenje lijekom Gazyvaro.
You may be more likely to get an infection during and after treatment with Gazyvaro.
Tijekom i nakon liječenja lijekom Gazyvaro može postojati veća vjerojatnost da dobijete infekciju.
Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
D-79639 Grenzach-Wyhlen
Progressive multifocal leukoencephalopathy PML has been reported in patients treated with Gazyvaro (see section 4.4).
U bolesnika liječenih lijekom Gazyvaro prijavljen je PML (vidjeti dio 4.4).
Dose delays should be considered in case of severe or life-threatening neutropenia.
U slučaju teške i po život opasne neutropenije dolazi u obzir odgoda primjene doze.
Parenteral medicinal products should be inspected visually for particulates and discolouration prior to administration.
Lijekove za parenteralnu primjenu potrebno je prije primjene vizualno pregledati kako bi se utvrdila moguća prisutnost čestica ili promjena boje.
Fatal haemorrhagic events have also been reported in Cycle 1 in patients treated with Gazyvaro.
U bolesnika liječenih lijekom Gazyvaro su u 1. ciklusu prijavljeni i događaji smrtonosnih krvarenja.
Eye disorders Common
Poremećaji oka često očna hiperemija
Premedication
Primjena
If no IRR occurred during the previous infusion, administer at 50 mg/hr.
Ako se tijekom prethodne infuzije nije razvila reakcija na infuziju, ovu infuziju treba primijeniti brzinom od 50 mg/h.
NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Gazyvaro 1000 mg koncentrat za otopinu za infuziju obinutuzumab
Cycles 2-6 or 2-8 - this will be just one dose of Gazyvaro in the 28 or 21 days depending on which other cancer medicines are given together with Gazyvaro: · Day 1 - full dose (1,000 mg).
Od 2. do 6. ciklusa ili od 2. do 8. ciklusa - primjenjuje se samo jedna doza lijeka Gazyvaro u razdoblju od 28 ili 21 dana, ovisno o tome koji se drugi lijekovi za liječenje raka primjenjuju zajedno s lijekom
The incidence of IRRs was higher in the Gazyvaro plus chlorambucil arm compared to the rituximab plus chlorambucil arm.
Kronična limfocitna leukemija Incidencija reakcija na infuziju bila je veća u skupini liječenoj lijekom Gazyvaro i klorambucilom nego u skupini liječenoj rituksimabom i klorambucilom.
Key Endpoints
Ključne mjere ishoda
Oral herpes, rhinitis, pharyngitis, lung infection, influenza nasopharyngitis
često oralni herpes, rinitis, faringitis,
Primary Endpoint in FL population IRC-assessed PFS (PFS-IRC) Number (%) of patients with event Median time to event (months, 95% CI)
PFS prema ocjeni neovisnog ocjenjivačkog povjerenstva Broj (%) bolesnika s događajem
Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with anti-CD20 antibodies including Gazyvaro (see section 4.8).
U bolesnika liječenih anti-CD20 protutijelima, uključujući lijek Gazyvaro, može doći do reaktivacije virusa hepatitisa B (HBV), što u nekim slučajevima može rezultirati fulminantnim hepatitisom,
Clear, colourless to slightly brownish liquid.
Bistra, bezbojna do smećkasta tekućina.
Dose of Gazyvaro to be administered
Doza lijeka Gazyvaro za primjenu
Nervous system disorders Very common
Poremećaji živčanog sustava vrlo često glavobolja manje često glavobolja
Cough§
I DOHVATA
Patients with renal impairment (CrCl < 50 mL/min) are more at risk of neutropenia (see section 4.8).
Rizik od neutropenije veći je u bolesnika s oštećenjem funkcije bubrega (CrCl < 50 ml/min) (vidjeti dio 4.8).
Table 2 Dose of Gazyvaro to be administered during 6 treatment cycles each of 28 days duration for patients with CLL
Tablica 2 Doza lijeka Gazyvaro koju je potrebno primijeniti u bolesnika s KLL-om tijekom
Urinary tract infection, pneumonia, lung infection, upper respiratory tract infection, sinusitis, herpes zoster
Infekcije i infestacije vrlo često infekcija gornjih dišnih putova, sinusitis
No dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance [CrCl] 30-89 mL/min) (see section 5.2).
(klirens kreatinina [CrCl] 30-89 ml/min) (vidjeti dio 5.2).
The incidence of infection was 38% in the Gazyvaro plus chlorambucil arm and 37% in the rituximab plus chlorambucil arm (with Grade 3-5 events reported in 12% and 14%, respectively and fatal events reported in < 1% in both treatment arms).
(događaji 3.-5. stupnja prijavljeni su u 12% bolesnika liječenih lijekom Gazyvaro i klorambucilom i u 14% bolesnika koji su primali rituksimab i klorambucil, a incidencija smrtnih slučajeva u obje je liječene skupine bila manja od 1%).
Patients with renal impairment (CrCl < 50 mL/min) and patients with both Cumulative Illness Rating Scale (CIRS) > 6 and CrCl < 70 mL/min are more at risk of IRRs, including severe IRRs (see section 4.8).
Cumulative Illness Rating Scale, CIRS) iznosio > 6, a CrCl bio < 70 ml/min (vidjeti dio 4.8).
HR (95% CI) p-value (Log-Rank test, stratified*) Secondary Endpoints Investigator-assessed PFS (PFS-INV) Number (%) of patients with event Median time to event (months, 95% CI) HR (95% CI) p-value (Log-Rank test, stratified*)
Medijan vremena do događaja (mjeseci, 95% CI) HR (95% CI) p-vrijednost (log-rang test, stratificiran*) Najbolji ukupan odgovor (prema ocjeni neovisnog ocjenjivačkog povjerenstva)§ Broj bolesnika uključenih u analizu
and the number of prior therapies (≤ 2 versus > 2).
Uvodno liječenje (u kombinaciji s bendamustinom2)
Patients with previously untreated follicular lymphoma
Bolesnici s prethodno neliječenim folikularnim limfomom Uvodno liječenje (u kombinaciji s kemoterapijom2)
Figure 3 Kaplan-Meier curve of investigator assessed PFS from Stage 2 in patients with CLL (Study BO21004/CLL11)
Slika 3 Kaplan-Meierova krivulja PFS-a u stadiju 2 prema ocjeni ispitivača u bolesnika s KLL-om (ispitivanje BO21004/CLL11)
Figure 2 Kaplan-Meier curve of OS from Stage 1a in patients with CLL (Study BO21004/CLL11)
Slika 2 Kaplan-Meierova krivulja OS-a u stadiju 1a u bolesnika s KLL-om (ispitivanje BO21004/CLL11)
In a 26-week cynomolgus monkey study, hypersensitivity reactions were noted and attributed to the foreign recognition of the humanised antibody in cynomolgus monkeys (0.7-6 times the clinical exposure based on Cmax and AUC at steady state after weekly administration of 5, 25, and 50 mg/kg).
(izloženost 0,7-6 puta veća od kliničke izloženosti na temelju Cmax i AUC-a u stanju dinamičke ravnoteže nakon primjene tjednih doza od 5, 25 i 50 mg/kg).
Figure 4 Kaplan-Meier curve of OS from Stage 2 in patients with CLL (Study BO21004/CLL11)
Slika 4 Kaplan-Meierova krivulja OS-a u stadiju 2 u bolesnika s KLL-om (ispitivanje BO21004/CLL11)
Oral analgesic/anti-pyretic2 At least 30 minutes before Gazyvaro infusion
Intravenski kortikosteroid1,4 Završiti primjenu najmanje 1 sat prije infuzije lijeka Gazyvaro
Tumour lysis syndrome, hyperuricaemia, hypokalaemia
Poremećaji metabolizma i prehrane često sindrom lize tumora, hiperuricemija, hipokalijemija sindrom lize tumora, hipokalijemija manje često hiperuricemija
Patients with renal impairment (CrCl < 50 mL/min) are more at risk of thrombocytopenia (see section 4.8).
Rizik od trombocitopenije veći je u bolesnika s oštećenjem funkcije bubrega (CrCl < 50 ml/min) (vidjeti dio 4.8).
Figure 1 Kaplan-Meier curve of Investigator assessed PFS from Stage 1a in patients with CLL (Study BO21004/CLL11)
Slika 1 Kaplan-Meierova krivulja PFS-a u stadiju 1a prema ocjeni ispitivača u bolesnika s KLL-om (ispitivanje BO21004/CLL11)
No renal toxicity with a causal relationship to obinutuzumab has been observed in humans.
U ljudi nije primijećena toksičnost za bubrege koja bi bila posljedica primjene obinutuzumaba.
Prophylaxis and premedication for infusion related reactions (IRRs)
Profilaksa i premedikacija za reakcije na infuziju Premedikacija radi smanjenja rizika od reakcija na infuziju opisana je u Tablici 1.
No formal pharmacokinetic study has been conducted in patients with hepatic impairment.
U bolesnika s oštećenjem funkcije jetre nisu provedena formalna farmakokinetička ispitivanja.
The demographic data and baseline characteristics of the patient population were well balanced between the treatment arms; median age was 59 years, 81% were Caucasian, 53% were female, 79% had a FLIPI score of ≥ 2 and 7% had Stage II (bulky), 35% had Stage III and 57% had Stage IV disease, 44% had bulky disease (> 7 cm), 34% had at least one B-symptom at baseline and 97% had an ECOG performance status of 0-1 at baseline.
44% imalo je veliku tumorsku masu (> 7 cm), 34% bolesnika imalo je najmanje jedan B-simptom na početku ispitivanja, a njih 97% imalo je početni funkcionalni ECOG status 0 - 1.
Immunogenicity
Trombocitopenija
In the majority of patients, Gazyvaro was given intravenously as a 1,000 mg initial dose administered on Day 1, Day 8 and Day 15 of the first treatment cycle.
Većina je bolesnika Gazyvaro primila intravenski u početnoj dozi od 1000 mg primijenjenoj 1. dan,
Patients (CLL) with both CIRS > 6 and CrCl < 70 mL/min are more at risk of infections, including severe infections (see section 4.8).
rezultat > 6 i CrCl < 70 ml/min (vidjeti dio 4.8).
Patients who are considered to be at risk of TLS (e.g. 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]) should receive prophylaxis.
Bolesnici s velikim tumorskim opterećenjem i/ili velikim brojem cirkulirajućih limfocita (> 25 x 109/l) i/ili oštećenjem bubrežne funkcije (klirens kreatinina [CrCl] <70 ml/min) smatraju se rizičnima za razvoj sindroma lize tumora i stoga bi trebali primiti profilaksu.
No post-baseline HAHA (Human Anti-Human Antibody) were observed in patients with iNHL treated in study GAO4753g/GADOLIN.
U bolesnika s iNHL-om liječenih u ispitivanju GAO4753g/GADOLIN nisu pronađena humana antihumana protutijela (engl. human anti-human antibodies, HAHA) nakon početka liječenja.
Nasal congestion, rhinorrhoea, oropharyngeal pain
nazofaringitis infekcija mokraćnih putova, pneumonija, plućna infekcija,
Talk to your doctor or nurse before you are given Gazyvaro if: · you have an infection, or have had an infection in the past which lasted a long time or keeps coming back · you have ever taken, or been given, medicines which affect your immune system (such as chemotherapy or immunosuppressants) · you are taking medicines for high blood pressure or medicines used to thin your blood - your doctor might need to alter how you take these · you have ever had heart problems · you have ever had brain problems (such as memory problems, difficulty moving or feeling sensations in your body, eyesight problems) · you have ever had breathing problems or lung problems · you have ever had “hepatitis B” - a type of liver disease · you are due to have a vaccine or you know you may need to have one in the near future.
· ako uzimate lijekove za liječenje visokog krvnog tlaka ili lijekove koji se koriste za razrjeđivanje krvi - liječnik će možda morati promijeniti način na koji ih uzimate · ako ste ikada imali srčane tegobe