natgillin/translations-raw huggingface dataset:
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.
(razmerje ogroženosti = 0,42, p = 0,0892); v primerjavi s R-Clb pa koristi niso opazili.
· If you get any side effects, talk to your doctor or nurse.
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
· Chronic lymphocytic leukaemia (also called “CLL”) Gazyvaro is used in patients who have not had any treatment for CLL before and who have other illnesses which make it unlikely that they would be able to tolerate a full dose of a different medicine used to treat CLL called fludarabine.
Zdravilo Gazyvaro uporabljamo pri bolnikih, ki pred tem še niso prejemali nobenega zdravljenja za kronično limfocitno levkemijo in imajo pridružene bolezni, zaradi katerih je verjetno, da ne bi prenesli polnega odmerka drugega zdravila za zdravljenje kronične limfocitne levkemije, imenovanega fludarabin.
Stage 2
Slika 2.
Chronic lymphocytic leukaemia (CLL)
• Kronične limfocitne levkemije (KLL)
A population pharmacokinetic (PK) model was developed to analyse the PK data in 469 iNHL, 342 CLL and 130 diffuse large B-cell lymphoma (DLBCL) patients from Phase I, Phase II and Phase III studies who received obinutuzumab alone or in combination with chemotherapy.
Za analizo farmakokinetičnih podatkov pri 469 bolnikih z indolentnim ne-Hodgkinovim limfomom (iNHL), 342 bolnikih s KLL in 130 bolnikih z difuznim velikoceličnim limfomom B (DLBCL) v študijah I., II.
In Cycle 1, the overall incidence of IRRs was higher in patients receiving Gazyvaro plus chemotherapy compared to patients in the comparator arm.
Skupna incidenca reakcij, povezanih z infuzijo, je bila v 1. ciklu večja v skupini, ki je prejemala kombinacijo zdravila Gazyvaro in kemoterapije, kot v primerjalni skupini.
What you need to know before you are given Gazyvaro
Kaj morate vedeti, preden boste dobili zdravilo Gazyvaro Zdravila Gazyvaro ne smete dobiti:
3 e.g. 50 mg diphenhydramine
Npr. 1000 mg paracetamola Npr. 50 mg difenhidramina
Maintenance phase
Začetna faza
No Grade 3-5 IRRs were reported beyond the first 1,000 mg infusions of Cycle 1.
Po infundiranju prvih 1000 mg v 1. ciklu ni bilo več opisanih reakcij, povezanih z infuzijo od 3. do 5. stopnje.
The incidence of IRRs was higher in the Gazyvaro plus chlorambucil arm compared to the rituximab plus chlorambucil arm.
Incidenca reakcij, povezanih z infuzijo, je bila večja s kombinacijo zdravila Gazyvaro in klorambucila kot s kombinacijo rituksimaba in klorambucila.
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).
Bolniki z ledvično okvaro (očistek kreatinina < 50 ml/min) in bolniki, ki imajo hkrati kumulativno oceno bolezni po lestvici CIRS (Cumulative Illness Rating Scale) > 6 in očistek kreatinina < 70 ml/min, imajo večje tveganje za reakcije, povezane z infuzijo, vključno s hudimi reakcijami, povezanimi z infuzijo (glejte poglavje 4.8).
Hypotension may occur during Gazyvaro intravenous infusions.
Med intravenskim infundiranjem zdravila Gazyvaro se lahko pojavi hipotenzija.
· Six 21-day cycles in combination with cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP), followed by 2 additional cycles of Gazyvaro alone or · Eight 21-day cycles in combination with cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone (CVP).
• osem 21-dnevnih ciklov v kombinaciji s ciklofosfamidom, vinkristinom in prednizonom/prednizolonom/metilprednizolonom (CVP).
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*)
Vrednost p (stratificirani log-rang test*) Sekundarni opazovani dogodki PFS po raziskovalčevi oceni (PFS-INV) Število (%) bolnikov z dogodkom Mediani čas do dogodka (meseci, 95-% IZ) HR (95-% IZ)
Dose of Gazyvaro
Odmerek zdravila Gazyvaro
Cycle 1 - this will include three doses 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) · Day 8 - full dose (1,000 mg) · Day 15 - full dose (1,000 mg).
1. cikel - vključuje tri odmerke zdravila Gazyvaro v 28 ali 21 dneh, odvisno od tega, katera druga zdravila za zdravljenje raka boste prejeli skupaj z zdravilom Gazyvaro: • 1. dan - celoten odmerek (1000 mg)
CLL only - Cycle 1
Samo za 1. cikel KLL
Based on a subgroup analysis in previously untreated follicular lymphoma, the efficacy in FLIPI low risk (0-1) patients is currently inconclusive (see section 5.1).
O učinkovitosti pri bolnikih z nizkim tveganjem po točkovalniku FLIPI (0-1) na podlagi analize podskupin bolnikov s predhodno nezdravljenim folikularnim limfomom se trenutno ne more sklepati
Day 2 for CLL only
1. cikel: 2. dan samo pri KLL
(INV-assessed, CT) Responders (%) (CR, PR) Difference in response rate (%) [95% CI] p-value (Cochran-Mantel-Haenszel test) Complete Response (CR) Partial Response (PR)
(raziskovalčeva ocena, CT) Odzivni bolniki (%) (CR, PR) Razlika v deležu odgovora (%) [95-%
Severe and life-threatening neutropenia including febrile neutropenia has been reported during treatment with Gazyvaro.
Med zdravljenjem z zdravilom Gazyvaro so poročali o hudi in življenje ogrožajoči nevtropeniji, vključno s febrilno nevtropenijo.
Results of subgroup analyses (not adjusted for multiplicity) 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 (neprilagojeni glede multiplicitete) so se na splošno skladali z rezultati,
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.
V ključni klinični študiji BO21004/CLL11 je imelo 91 % (40 od 44) ocenljivih bolnikov, zdravljenih z zdravilom Gazyvaro, na koncu obdobja zdravljenja odsotnost celic B (opredeljeno kot število celic B
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).
Bolniki, ki dosežejo popolni ali delni odgovor na indukcijsko zdravljenje (tj. na prvih 6 ciklov zdravljenja) z zdravilom Gazyvaro v kombinaciji z bendamustinom ali imajo stabilno bolezen, morajo še naprej prejemati monoterapijo z zdravilom Gazyvaro 1.000 mg kot vzdrževalno zdravljenje enkrat na 2 meseca v obdobju 2 let ali do napredovanja bolezni (glede na to, kar se zgodi prej).
Patients with an IRR (Grade 1 or 2) with the previous infusion
Bolniki, ki so imeli med prejšnjim infundiranjem reakcijo, povezano z infuzijo, 1. ali 2. stopnje
· Continue to use effective contraception for 18 months after stopping treatment with Gazyvaro.
• Z uporabo učinkovitega načina kontracepcije nadaljujte še 18 mesecev po prejemu zadnjega odmerka zdravila.
Content of the pack and other information
Shranjevanje zdravila Gazyvaro Vsebina pakiranja in dodatne informacije
Patients with renal impairment (CrCl < 50 mL/min) are more at risk of neutropenia (see section 4.8).
Bolniki z ledvično okvaro (očistek kreatinina < 50 ml/min) imajo večje tveganje za nevtropenijo (glejte poglavje 4.8).
Due to the potential depletion of B-cells in infants of mothers who have been exposed to Gazyvaro during pregnancy, infants should be monitored for B-cell depletion and vaccinations with live virus vaccines should be postponed until the infant's B-cell count has recovered.
Zaradi možnega zmanjšanega števila celic B pri dojenčkih mater, ki so bile med nosečnostjo izpostavljene zdravilu Gazyvaro, je treba pri dojenčkih kontrolirati njihovo število.
HistidineHistidine hydrochloride monohydrate Trehalose dihydrate
histidin histidinijev klorid monohidrat trehaloza dihidrat poloksamer 188 voda za injekcije
Since human immunoglobulin G (IgG) is secreted in human milk and the potential for absorption and harm to the infant is unknown, women should be advised to discontinue breast-feeding during Gazyvaro therapy and for 18 months after the last dose of Gazyvaro.
Človeški imunoglobulin podvrste G (IgG) se izloča v materino mleko; možnost za absorpcijo in škodljivi vpliv pri dojenčku ni znan.
Gazyvaro was given by intravenous infusion as a dose of 1,000 mg on Days 1, 8 and 15 of Cycle 1, on Day 1 of subsequent cycles.
Zdravilo Gazyvaro so dajali v intravenski infuziji v odmerku 1000 mg 1., 8. in 15. dan cikla, 1. dan od
A clear relationship between thrombocytopenia and haemorrhagic events has not been established.
Jasne povezanosti med trombocitopenijo in krvavitvami niso ugotovili.
Severe and life-threatening thrombocytopenia including acute thrombocytopenia (occurring within 24 hours after the infusion) has been observed during treatment with Gazyvaro.
Med zdravljenjem z zdravilom Gazyvaro so opažali hudo in življenje ogrožajočo trombocitopenijo, vključno z akutno trombocitopenijo (ki se je pojavila znotraj 24 ur po infuziji).
What Gazyvaro is used for
Za kaj uporabljamo zdravilo Gazyvaro
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).
Gazyvaro in klorambucila 38-% in s kombinacijo rituksimaba in klorambucila 37-% (neželene učinke od 3. do 5. stopnje so zabeležili pri 12 % bolnikov v prvi skupini in 14 % v drugi skupini, učinkov s smrtnim izidom pa je bilo v obeh skupinah < 1 %).
· Follicular lymphoma (also called “FL”) Gazyvaro is used in patients who have not had any treatment for FL Gazyvaro is used in patients who have had at least one treatment with a medicine called rituximab before and whose FL has come back or got worse during or after this treatment.
Zdravilo Gazyvaro uporabljamo pri bolnikih, ki so pred tem prejemali vsaj eno zdravljenje z zdravilom, imenovanim rituksimab, a se je folikularni limfom med tem zdravljenjem ali po njem pri njih ponovil ali poslabšal.
Upper respiratory tract infection, sinusitis§, , urinary tract infection, pneumonia§ ,herpes zoster§
Infekcijske in parazitske bolezni zelo pogosti okužba zgornjih dihal, sinuzitis§, okužba sečil, pljučnica§, herpes zoster§
IRRs are very common during the first infusion of Gazyvaro, and patients experiencing infusion related symptoms should be advised not to drive or use machines until symptoms abate.
Bolnikom, pri katerih se pojavijo z infuzijo povezani simptomi, je treba naročiti, naj ne upravljajo vozil ali strojev, dokler simptomi ne minejo.
Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or suitable alternative such as a urate oxidase (e.g. rasburicase) starting 12-24 hours prior to start of Gazyvaro infusion as per standard practice.
To naj sestaljata ustrezna hidracija in dajanje urikostatika (npr. alopurinola) ali primernega alternativnega zdravljenja, kot je uratna oksidaza (npr. rasburikaza), ki se začne 12 do
Kaplan-Meier curves for progression-free survival (PFS) are shown in Figure 5.
Meierjevi krivulji preživetja brez napredovanja bolezni sta prikazani na sliki 5.
Cases of 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 4.4).
Med zdravljenjem z zdravilom Gazyvaro so se pojavili primeri motenj srčnega ritma (npr. atrijska fibrilacija in tahiaritmije), angine pektoris, akutnega koronarnega sindroma, akutnega miokardnega infarkta in srčnega popuščanja (glejte poglavje 4.4).
They will help you weigh up the benefit of continuing Gazyvaro against the risk to your baby.
Gazyvaro v primerjavi s tveganjem za otroka.
Cough, oropharyngeal pain
• herpetični mehurčki
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).
Bolniki, ki dosežejo popolni ali delni odgovor na indukcijsko zdravljenje z zdravilom Gazyvaro v kombinaciji s kemoterapijo, morajo še naprej prejemati monoterapijo z zdravilom Gazyvaro 1000 mg kot vzdrževalno zdravljenje enkrat na 2 meseca v obdobju 2 let ali do napredovanja bolezni (glede na to, kar se zgodi prej).
1See section 5.1 for information on chlorambucil dose
1 Za podatke o odmerku klorambucila glejte poglavje 5.1.
Median observation time 35 months
Mediani čas opazovanja
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 (nastala v 24 urah po infundiranju zdravila Gazyvaro) se je pojavila pri 4 % bolnikov, zdravljenih s kombinacijo zdravila Gazyvaro in klorambucila (glejte poglavje 4.4).
No renal toxicity with a causal relationship to obinutuzumab has been observed in humans.
Pri človeku niso opazili toksičnosti za ledvice, ki bi bila vzročno povezana z obinutuzumabom.
White blood cell count decreased, neutrophil count decreased, weight increased
Preiskave pogosti zmanjšanje števila belih krvnih celic, zmanjšanje števila nevtrofilcev, povečanje telesne mase zmanjšanje števila belih krvnih celic, zmanjšanje števila nevtrofilcev
The bag should be gently inverted to mix the solution in order to avoid excessive foaming.
Da bi preprečili pretirano penjenje raztopine, je treba vrečko za premešanje raztopine previdno obračati.
· The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, poloxamer 188 and water for injections.
• Druge sestavine zdravila so histidin, histidinijev klorid monohidrat, trehaloza dihidrat,
Fatal haemorrhagic events have also been reported in Cycle 1 in patients treated with Gazyvaro.
Pri bolnikih, zdravljenih z zdravilom Gazyvaro, so bili v 1. ciklu opisane tudi krvavitve s smrtnim izidom.
For each subsequent treatment cycle (Cycles 2 to 6), patients received Gazyvaro 1,000 mg on Day 1 only.
V vseh nadaljnjih ciklih zdravljenja (2. do 6. cikel) so bolniki dobili 1000 mg zdravila Gazyvaro samo 1. dan. Klorambucil so dobivali peroralno v odmerku 0,5 mg/kg telesne mase 1. in 15. dan v vseh ciklih zdravljenja (od 1. do 6.
· infection of upper airways (infection of nose, pharynx, larynx and sinuses), cough
• okužba zgornjih dihalnih poti (okužba nosu, žrela, grla in sinusov), kašelj Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
No. (%) of patients with event Median time to event (months)
Število (%) bolnikov z dogodkom 65 (55,1 %) Mediani čas do dogodka (meseci)
Administer at 50 mg/hr.
začnite s hitrostjo 50 mg/uro.
Patients with renal impairment (CrCl < 50 mL/min) are more at risk of thrombocytopenia (see section 4.8).
Bolniki z ledvično okvaro (očistek kreatinina < 50 ml/min) imajo večje tveganje za trombocitopenijo (glejte poglavje 4.8).
Hypotension, as a symptom of IRRs, may occur during Gazyvaro intravenous infusions.
Med intravenskim infundiranjem zdravila Gazyvaro se lahko kot simptom reakcij, povezanih z infuzijo, pojavi hipotenzija.
In the pivotal BO21004/CLL11 study, 27% (90 out of 336) of patients treated with Gazyvaro plus chlorambucil had moderate renal impairment (CrCl < 50 mL/min).
V ključni študiji BO21004/CLL11 je imelo zmerno ledvično okvaro (očistek kreatinina < 50 ml/min) 27 % (90 od 336) bolnikov, zdravljenih s kombinacijo zdravila Gazyvaro in klorambucila.
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).
Bolniki, ki dosežejo popolni ali delni odgovor na indukcijsko zdravljenje z zdravilom Gazyvaro v kombinaciji s kemoterapijo (CHOP, CVP ali bendamustin) nadaljujejo z monoterapijo z zdravilom Gazyvaro 1000 mg kot vzdrževalnim zdravljenjem enkrat na 2 meseca v obdobju 2 let ali do napredovanja bolezni (glede na to, kar se zgodi prej).
Median observation time: 20 months
Mediani čas opazovanja:
How to store Gazyvaro
Kako uporabljati zdravilo Gazyvaro Prejemanje zdravila Gazyvaro
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).
2. do 6. ali 2. do 8. cikel - vključujejo le en odmerek zdravila Gazyvaro v 28 ali 21 dneh, odvisno od tega, katera druga zdravila za zdravljenje raka boste prejeli skupaj z zdravilom Gazyvaro:
To prepare the 2 infusion bags, withdraw 40 mL of concentrate from the vial and dilute 4 mL into a 100 mL PVC or non-PVC polyolefin infusion bag and the remaining 36 mL in a 250 mL PVC or non-PVC polyolefin infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection.
Za zagotovitev razlikovanja obeh infuzijskih vrečk za začetni odmerek 1.000 mg je priporočljivo uporabiti različno veliki vrečki, da lahko razlikujete med 100-mg odmerkom za 1. dan 1. cikla in 900mg odmerkom za 1. dan 1. cikla (nadaljevanje) ali 2. dan. Za pripravo 2 infuzijskih vrečk potegnite iz viale 40 ml koncentrata in 4 ml razredčite v 100-ml PVC ali ne-PVC poliolefinski infuzijski vrečki, preostalih 36 ml pa v 250-ml PVC ali ne-PVC poliolefinski infuzijski vrečki, ki vsebujeta 0,9-% (9 mg/ml) raztopino natrijevega klorida za injekcije.
How Gazyvaro works
Kako deluje zdravilo Gazyvaro
Squamous cell carcinoma of skin Squamous cell carcinoma of skin Blood and lymphatic system disorders Very common
pogosti ploš čatocelični karcinom kože ploš čatocelični karcinom kože
Induction treatment of approximately six months (six treatment cycles of Gazyvaro, each of 28 day duration when combined with bendamustine, or eight treatment cycles of Gazyvaro, each of 21 day duration when combined with CHOP or CVP) followed by maintenance once every 2 months for 2 years or until disease progression (whichever occurs first).
Gazyvaro v kombinaciji z bendamustinom ali osem 21-dnevnih ciklov zdravljenja z zdravilom Gazyvaro v kombinaciji s CHOP ali CVP), ki mu sledi vzdrževalno zdravljenje enkrat na 2 meseca v obdobju 2 let ali do napredovanja bolezni (glede na to, kar se zgodi prej).
Thrombocytopenia and haemorrhagic events
Trombocitopenija in hemoragični dogodki
· You will be given 6 or 8 treatment cycles of Gazyvaro in combination with other medicines for cancer - each cycle lasts 28 or 21 days depending on which other cancer medicines are given together with Gazyvaro.
• Dobili boste 6 ali 8 ciklov zdravljenja z zdravilom Gazyvaro v kombinaciji z drugimi zdravili za zdravljenje raka.
Your doctor may decide to stop treatment with Gazyvaro if you have a severe infusion related reaction.
Če se vam pojavi huda reakcija, povezana z infuzijo, se zdravnik lahko odloči, da ukine zdravljenje z zdravilom Gazyvaro.
Urinary tract infection, pneumonia, lung infection, upper respiratory tract infection, sinusitis, herpes zoster
nazofaringitis okužba sečil, pljučnica, okužba pljuč, okužba zgornjih dihal,
Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen GERMANY
D-79639 Grenzach-Wyhlen Nemčija
2See section 5.1 for information on bendamustine dose
2 Za podatke o odmerku bendamustina glejte poglavje 5.1.
Figure 7 Kaplan-Meier curve of OS in patients with FL # (Study GAO4753g/GADOLIN)
Kaplan-Meierjeva krivulja celokupnega preživetja pri bolnikih s folikularnim limfomom# (študija GAO4753g/GADOLIN)
Nasopharyngitis, rhinitis, influenza, oral herpes
sinuzitis, herpes zoster občasni nazofaringitis, rinitis, gripa, herpes uste votline
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.
Če med predhodnim infundiranjem ni bilo reakcij, povezanih z infuzijo, ko je bila končna hitrost infundiranja 100 mg/uro ali več, je mogoče infundiranje začeti s hitrostjo 100 mg/uro in hitrost povečevati po 100 mg/uro vsakih 30 minut do največ 400 mg/uro.
GAO4753g/GADOLIN) that occurred at a higher incidence (difference of ≥ 2%) compared to the relevant comparator arm in at least one pivotal study in: · Patients with CLL receiving Gazyvaro plus chlorambucil compared with chlorambucil alone or rituximab plus chlorambucil (study BO21004/CLL11) · Patients with previously untreated iNHL receiving Gazyvaro plus chemotherapy (bendamustine, CHOP, CVP) followed by Gazyvaro maintenance in patients achieving a response, compared to rituximab plus chemotherapy followed by rituximab maintenance in patients achieving a response (study BO21223/GALLIUM) · Patients with iNHL who had no response to or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen receiving Gazyvaro plus bendamustine, followed by Gazyvaro maintenance in some patients, compared to bendamustine alone (study GAO4753g/GADOLIN) The incidences presented in Table 6 (all grades and Grades 3-5) are the highest incidence of that ADR reported from any of the three studies.
Poročana je samo največja pogostnost, opažena v preskušanjih (v študijah BO21004: predhodno nezdravljena KLL, BO21223: predhodno nezdravljen napredovali iNHL in GAO4753g: rituksimab pri refraktarnem iNHL) † Incidenca nobenega neželenega učinka 5. stopnje se med skupinama v študiji ni razlikovala za ≥ 2 % * Kemoterapija: klorambucil pri KLL; bendamustin, CHOP, CVP pri iNHL, vključno s FL § Opažen tudi med vzdrževalnim zdravljenjem z vsaj 2 % večjo incidenco v skupini, zdravljeni z zdravilom Gazyvaro (BO21223)
However, in patients with FL the addition of Gazyvaro to bendamustine delayed the time to worsening of health-related quality of life as measured by the FACT-Lym TOI score by 2.2 months (median 5.6 versus 7.8 months for B and G+B respectively HR = 0.83; 95% CI: 0.60, 1.13).
2,2 meseca (mediana 5,6 meseca z bendamustinom in 7,8 meseca z G + B; HR = 0,83, 95-% IZ: 0,60;
If you miss your appointment, make another one as soon as possible.
Če izpustite dajanje zdravila Gazyvaro, se čim prej dogovorite za drug termin.
For management of symptomatic adverse events (including IRRs), see paragraph below (Management of IRRs or section 4.4).
prosimo, glejte spodnji odstavek (Obvladovanje reakcij, povezanih z infuzijo, ali poglavje 4.4).
Neutropenia, thrombocytopenia
• depresija, tesnoba
System organ class Frequency
• povečanje telesne mase
Table 4 Chronic lymphocytic leukaemia: Standard infusion rate in the absence of IRRs/hypersensitivity and recommendations in case an IRR occurred with previous infusion
Kronična limfocitna levkemija: standardna hitrost infundiranja v primeru, da ni reakcij, povezanih z infuzijo/preobčutljivostjo, in priporočila, če se je reakcija, povezana z infuzijo, pojavila med predhodno infuzijo
The rate of infusion can be escalated in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.
Hitrost infundiranja je mogoče povečevati po 50 mg/uro vsakih 30 minut do največ 400 mg/uro.
Clear, colourless to slightly brownish liquid.
Bistra, brezbarvna do rjavkasta tekočina.
Figure 8 IRC-assessed PFS by patient subgroup in FL *# (Study GAO4753g/GADOLIN)
Preživetje brez napredovanja bolezni (po oceni IRC) po podskupinah bolnikov s folikularnim limfomom*# (študija GAO4753g/GADOLIN)
Cases of hepatitis B reactivation have been reported in patients treated with Gazyvaro (see section 4.4).
Pri bolnikih, zdravljenih z zdravilom Gazyvaro, so poročali o PML (glejte poglavje 4.4).