natgillin/translations-raw huggingface dataset:
Therapy with Gazyvaro should be withheld during the investigation of potential PML and permanently discontinued in case of confirmed PML. 
Med preiskovanjem suma na PML je treba zdravljenje z zdravilom Gazyvaro prekiniti, če je PML potrjena, pa ga je treba trajno končati.
No meaningful differences were seen between the arms in HRQOL or health status measures. 
Med zdravljenima skupinama niso opazili pomembnih razlik v zdravstveni kakovosti življenja ali merilih zdravstvenega statusa.
One vial of 40 mL concentrate contains 1,000 mg obinutuzumab, corresponding to a concentration before dilution of 25 mg/mL. 
Ena viala s 40 ml koncentrata vsebuje 1000 mg obinutuzumaba; to ustreza koncentraciji pred razredčenjem 25 mg/ml.
Table 9 Summary of efficacy in patients with FL# from GAO4753g/GADOLIN study 
Povzetek o učinkovitosti pri bolnikih s FL# iz študije GAO4753g/GADOLIN
Tell your doctor or nurse straight away if you get any of the following symptoms during your infusion or up to 24 hours after having your infusion: 
Zdravniku ali medicinski sestri morate takoj povedati, če se vam med infundiranjem ali v 24 urah po njem pojavi kar koli od spodaj navedenega:
Induction (in combination with chemotherapy2) Gazyvaro should be administered with chemotherapy as follows: 
Indukcija (v kombinaciji s kemoterapijo2) Zdravilo Gazyvaro apliciramo v kombinaciji s kemoterapijo, kot je opisano spodaj:
Patients with no IRR during the previous infusion 
Bolniki, ki med prejšnjim infundiranjem niso imeli reakcije, povezane z infuzijo
Injury, poisoning and procedural complications Very common 
Poškodbe, zastrupitve in zapleti postopkov zelo pogosti reakcije, povezane z infuzijo reakcije, povezane z infuzijo
Cycles 2-6 or 2-8 
2. do 6. cikel ali 2. do 8. cikel
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. 
Bolniki z velikim tveganjem za sindrom razpada tumorja (npr. bolniki z velikim tumorskim bremenom in/ali velikim številom limfocitov v periferni krvi [> 25 x 109/l]) in/ali ledvično okvaro (očistek kreatinina < 70 ml/min) morajo prejeti profilakso.
Poloxamer 188 
poloksamer 188 in voda za injekcije.
IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Interval * Stratification factors were chemotherapy regimen, FLIPI risk group for follicular lymphoma, geographic region Significance level at this efficacy interim analysis: 0.012 ¶ Data Not Yet Mature. 
* Stratifikaciski dejavniki so bili: režim kemoterapije, rizična skupina FLIPI za folikularni limfom, geografska regija § Stopnja značilnosti pri tej vmesni analizi učinkovitosti: 0,012
Figure 5 Kaplan-Meier curve of INV-assessed progression-free survival in patients with previously untreated FL (Study BO21223/GALLIUM) 
Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po raziskovalčevi oceni pri bolnikih s predhodno nezdravljenim FL (študija BO21223/GALLIUM)
METHOD OF ADMINISTRATION For intravenous use after dilution 
POSTOPEK UPORABE Za intravensko uporabo po razredčenju
Keep the vial in the outer carton in order to protect from light 
Ne zamrzujte Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
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). 
Po izginotju simptomov je infundiranje mogoče nadaljevati in če se bolniku ne pojavi noben simptom reakcije, povezane z infuzijo, je mogoče hitrost infundiranja povečevati v korakih in presledkih, ki ustrezajo uporabljenemu odmerku (glejte preglednici 4 in 5).
STATEMENT OF ACTIVE SUBSTANCE(S) 
Popolni odgovor (CR) Delni odgovor (PR)
Progressive multifocal leukoencephalopathy (PML) has been reported in patients treated with Gazyvaro (see section 4.8). 
Pri bolnikih, zdravljenih z zdravilom Gazyvaro, je bila opisana progresivna multifokalna levkoencefalopatija (PML) (glejte poglavje 4.8).
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). 
Zaradi imunosupresivnega učinka obinutuzumaba cepljenje z živimi virusnimi cepivi ni priporočljivo med zdravljenjem in do okrevanja celic B (glejte poglavje 4.4).
In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded (or stated) in the patient file. 
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Za izboljšanje sledljivosti bioloških zdravil je treba zaščiteno ime in številko serije uporabljenega zdravila jasno zabeležiti (ali navesti) v bolnikovi dokumentaciji.
No dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance [CrCl] 30-89 mL/min) (see section 5.2). 
Bolnikom z blago do zmerno ledvično okvaro (očistek kreatinina 30-89 ml/min) odmerka ni treba prilagoditi (glejte poglavje 5.2).
Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of 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. 
Zdravilo Gazyvaro je v kombinaciji z bendamustinom ter s poznejšo vzdrževalno uporabo zdravila Gazyvaro indicirano za zdravljenje bolnikov s folikularnim limfomom (FL), ki se na zdravljenje z rituksimabom ali shemo, ki je vključevala rituksimab, niso odzvali ali jim je bolezen med ali v 6 mesecih po takšnem zdravljenju napredovala.
Gazyvaro + chlorambucil N= 238 
zdravilo Gazyvaro + klorambucil n = 238
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1,000 mg/40 mL 
koncentrat za raztopino za infundiranje 1000 mg/40 ml
Patients (CLL) with both CIRS > 6 and CrCl < 70 mL/min are more at risk of infections, including severe infections (see section 4.8). 
Bolniki (KLL), ki imajo hkrati CIRS > 6 in očistek kreatinina < 70 ml/min, imajo večje tveganje za okužbe, vključno s hudimi okužbami (glejte poglavje 4.8).
In order to reduce the rate of infusion related reactions in patients, an amendment was implemented and 140 patients received the first Gazyvaro dose administered over 2 days (Day 1 [100 mg] and Day 2 [900 mg]) (see section 4.2 and 4.4). 
Za zmanjšanje deleža reakcij, povezanih z infuzijo, je bila sprejeta sprememba in 140 bolnikov je dobilo prvi odmerek zdravila Gazyvaro v 2 dneh (1. dan
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) 
Bolnike so stratificirali glede na regijo, podvrsto iNHL (folikularni ali nefolikularni), vrsto refraktarnosti na rituksimab (refraktaren na predhodno monoterapijo z rituksimabom ali na rituksimab v kombinaciji s kemoterapijo) in število predhodnih zdravljenj (≤ 2 ali > 2).
Chronic Lymphocytic Leukaemia 
Kronična limfocitna levkemija
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. 
Večina bolnikov je zdravilo Gazyvaro dobila intravensko kot začetni odmerek 1000 mg, uporabljen 1., 8. in 15. dan prvega cikla zdravljenja.
The incidence of IRRs was 66% with the infusion of the first 1,000 mg of Gazyvaro (20% of patients experiencing a Grade 3-4 IRR). 
med infundiranjem prvih 1000 mg zdravila Gazyvaro (20 % bolnikov je imelo reakcijo, povezano z infuzijo od 3. do 4. stopnje).
No post-baseline HAHA (Human Anti-Human Antibody) were observed in patients with iNHL treated in study GAO4753g/GADOLIN. 
Pri nobenem bolniku z iNHL se po začetku zdravljenja v študiji GAO4753g/GADOLIN niso razvila protitelesa HAHA (Human Anti-Human Antibody).
For patients with FL, the recommended dose of Gazyvaro in combination with chemotherapy is shown in Table 3. 
Za bolnike s FL je priporočeni odmerek zdravila Gazyvaro v kombinaciji s kemoterapijo prikazan v preglednici 3.
Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each Gazyvaro infusion and for the first hour after administration. 
Zato je treba začasno prekiniti uporabo antihipertenzivnih zdravil v obdobju 12 ur pred infundiranjem zdravila Gazyvaro, med celotnim infundiranjem in še prvo uro po koncu dajanja zdravila.
From the population PK model, after the Cycle 6 Day 1 infusion in CLL patients, the estimated median Cmax value was 465.7 μg/mL and AUC(τ) value was 8961 μg•d/mL and in iNHL patients the estimated median Cmax value was 
Na podlagi populacijskega farmakokinetičnega modela je bila pri bolnikih s KLL po infuziji 1. dan 6. cikla ocenjena mediana Cmax 465,7 µg/ml in AUC(τ)
In the non-FL population the HR for IRC-assessed PFS was 0.94 [95% CI: 0.49, 1.90]. 
V populaciji, ki ni imela FL, je bilo razmerje ogroženosti po oceni IRC 0,94 [95-% interval zaupanja:
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). 
Pri bolnikih z obstoječo srčno boleznijo so se med zdravljenjem z zdravilom Gazyvaro pojavile motnje srčnega ritma (npr. atrijska fibrilacija in tahiaritmija), angina pektoris, akutni koronarni sindrom, akutni miokardni infarkt in srčno popuščanje (glejte poglavje 4.8).
What Gazyvaro is and what it is used for 
Kaj je zdravilo Gazyvaro in za kaj ga uporabljamo Kaj je zdravilo Gazyvaro
Gazyvaro +Chemotherapy followed by Gazyvaro maintenance N=601 
Zdravilo Gazyvaro + kemoterapija, nato vzdrževalno zdravljenje z zdravilom Gazyvaro n = 601
Cycles 2 - 6 
2. do 6. cikel
Gazyvaro + chlorambucil N= 333 
zdravilo Gazyvaro + klorambucil n = 333
If no IRR occurred during the previous infusion, administer at 50 mg/hr. 
Če med predhodnim infundiranjem ni bilo reakcij, povezanih z infuzijo, začnite s hitrostjo 50 mg/uro.
No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3). 
V študijah toksičnosti ponavljajočih se odmerkov, ki so jih opravili na opicah cynomolgus, niso ugotovili neželenih učinkov na reproduktivne organe samcev in samic (glejte poglavje 5.3).
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). 
Bolnikom, zdravljenim s protitelesi proti CD20 (vključno z zdravilom Gazyvaro), se lahko pojavi reaktivacija virusa hepatitisa B (HBV), v nekaterih primerih s posledičnim fulminantnim hepatitisom, jetrno odpovedjo in smrtjo (glejte poglavje 4.8).
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. 
Izvedli pa so nekaj podštudij medsebojnega delovanja med zdravili za zdravilo Gazyvaro z bendamustinom, CHOP, fludarabinom in ciklofosfamidom (FC) in klorambucilom.
To ensure differentiation of the two infusion bags for the initial 1,000 mg dose, it is recommended to utilise bags of different sizes to distinguish between the 100 mg dose for Cycle 1 Day 1 and the 900 mg dose for Cycle 1 Day 1 (continued) or Day 2. 
Za zagotovitev razlikovanja obeh infuzijskih vrečk za začetni odmerek 1000 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,
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. 
Faza 1a je primerjala kombinacijo zdravila Gazyvaro in klorambucila s samim klorambucilom pri 356
The overall incidence of haemorrhagic events was similar in the Gazyvaro treated arm and in the rituximab treated arm. 
Celotna incidenca krvavitev je bila v skupini z zdravilom Gazyvaro podobna kot v skupini z rituksimabom.
Follicular versus non-follicular was also a stratification factor for the study but is not applicable in the subgroup analysis of patients with FL. § Best response within 12 months of start of treatment 
Stratifikacijski dejavnik v študiji je bila tudi folikularna bolezen v primerjavi z nefolikularno, vendar ta dejavnik ne pride v poštev za analizo podskupin bolnikov s folikularnim limfomom.
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. 
Trombocitopenijo, ki se je pojavila med ali v 24-ih urah po končanem infundiranju (akutno trombocitopenijo), so bolj pogosto opazili v skupini bolnikov, zdravljeni z zdravilom Gazyvaro in kemoterapijo, kot v primerjalni skupini.
PML is a very rare and life-threatening brain infection that has been reported with Gazyvaro. 
Progresivna multifokalna levkoencefalopatija (PML) PML je zelo redka in smrtno nevarna okužba možganov, opisana med uporabo zdravila Gazyvaro.
Gazyvaro is given under the supervision of a doctor experienced in such treatment. 
Zdravilo Gazyvaro boste prejeli pod nadzorom zdravnika z izkušnjami za zdravljenje raka.
Respiratory, thoracic and mediastinal disorders Very common 
Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti kašelj§
Chronic lymphocytic leukaemia · You will be given 6 treatment cycles of Gazyvaro in combination with another medicine for cancer called chlorambucil. 
• Dobili boste 6 ciklov zdravljenja z zdravilom Gazyvaro v kombinaciji z drugim zdravilom za zdravljenje raka, imenovanim klorambucil.
Dyspepsia, colitis, haemorrhoids Diarrhoea, colitis 
pogosti dispepsija, kolitis, hemoroidi diareja, kolitis občasni zaprtost, hemoroidi
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