natgillin/translations-raw huggingface dataset:
Patients received either Arzerra as monthly intravenous infusions (cycle 1: 300 mg on day 1 and 1000 mg on day 8; subsequent cycles: 1000 mg on day 1 every 28 days) in combination with chlorambucil (10 mg/m2 orally on days 1-7 every 28 days) or chlorambucil alone (10 mg/m orally on days 1-7 every 
Bolniki so prejemali ali zdravilo Arzerra v intravenskih infuzijah vsak mesec (1. ciklus: 300 mg 1. dan in 1.000 mg 8. dan; nadaljnji ciklusi: 1.000 mg 1. dan vsakih 28 dni) v kombinaciji s klorambucilom (10 mg/m peroralno od 1. do 7. dne vsakih 28 dni) ali samo klorambucil
Marketing Authorisation Holder Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR United Kingdom 
Imetnik dovoljenja za promet z zdravilom Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR Velika Britanija
Talk to your doctor or nurse before you are given Arzerra: 
Pred začetkom prejemanja zdravila Arzerra se posvetujte z zdravnikom ali medicinsko sestro:
Very common symptoms of an infusion-related reaction (may affect more than 1 in 10 people): 
Zelo pogosti simptomi z infundiranjem povzane reakcije (pojavijo se lahko pri več kot 1 od 10 oseb):
Figure 2 Kaplan-Meier estimates of PFS in relapsed CLL 
Slika 2 Kaplan-Meierjeva ocena preživetja brez napredovanja bolezni pri bolnikih s ponovitvijo KLL
Arzerra is available in packs of 1 vial. 
Zdravilo Arzerra je na voljo v pakiranjih po 1 vialo.
Agranulocytosis, coagulopathy, red cell aplasia, lymphopenia 
Bolezni krvi in limfatičnega sistema agranulocitoza, koagulopatija, aplazija eritrocitov, limfopenija
Arzerra is available in packs of 3 vials. 
Zdravilo Arzerra je na voljo v pakiranjih po 3 viale.
It is recommended that patients have electrolytes such as potassium and magnesium measured prior to and during the administration of ofatumumab. 
Pred uporabo in med uporabo ofatumumaba je bolnikom priporočljivo izmeriti elektrolite, npr. kalij in magnezij.
Relapsed CLL 
Ponovitev KLL
Median time to progression was longer for the OFA+FC arm versus FC (42.1 months versus 26.8 months; HR: 0.63; 95% CI: 0.45-0.87). 
Mediani čas do napredovanja bolezni je bil v skupini OFA+FC daljši kot v skupini FC (42,1 meseca v primerjavi s 26,8 meseca; razmerje ogroženosti: 0,63; 95% IZ: 0,45-0,87).
1000 mg dose - Use one 1000 mg/50 ml vial (50 ml total, 50 ml per vial): 
Odmerek 1.000 mg - Uporabite eno vialo s 1.000 mg/50 ml (skupaj 50 ml, 50 ml na vialo):
• frequent infections, fever, chills, sore throat or mouth ulcers due to infections 
• pogoste okužbe, zvišana telesna temperatura, mrazenje, vneto grlo oziroma žrelo ali razjede v
Cases of progressive multifocal leukoencephalopathy (PML) resulting in death have been reported in CLL patients receiving cytotoxic pharmacotherapy, including ofatumumab. 
Pri bolnikih s KLL, ki so dobivali citotoksično farmakoterapijo, vključno z ofatumumabom so poročali o primerih progresivne multifokalne levkoencefalopatije (PML), ki so se končali s smrtjo.
The infusion rate can continue to be increased according to standard procedures, to physician discretion and to patient tolerance (not to exceed increasing the rate every 30 minutes). 
Hitrost infundiranja je mogoče še naprej povečevati v skladu s standardnimi postopki, glede na zdravnikovo presojo in bolnikovo prenašanje (hitrosti se ne sme povečevati prejkot vsakih 30 minut).
2000 mg dose - Use two 1000 mg/50 ml vials (100 ml total, 50 ml per vial): 
Odmerek 2.000 mg - Uporabite dve viali s 1.000 mg/50 ml (skupaj 100 ml, 50 ml na vialo):
The infusion rate can continue to be increased according to standard procedures, to physician discretion and to patient tolerance (not to exceed doubling the rate every 30 minutes). 
Hitrost infundiranja je mogoče še naprej povečevati v skladu s standardnimi postopki, zdravnikovo presojo in bolnikovim prenašanjem (hitrosti se ne sme podvojevati prej kot na vsakih 30 minut).
Do not use the Arzerra concentrate if there is discolouration. 
Če je koncentrat zdravila Arzerra obarvan, ga ne uporabite.
Ofatumumab may cause foetal B-cell depletion based on findings from animal studies and on its mechanism of action (see section 5.1). 
Po podatkih iz študij na živalih in na osnovi mehanizma delovanja ofatumumaba lahko to zdravilo povzroči znižanje števila celic B pri plodu (glejte poglavje 5.1).
If a diagnosis of PML is suspected Arzerra should be discontinued and referral to a neurologist should be considered. 
V primeru suma na PML je treba zdravljenje z zdravilom Arzerra prekiniti; v poštev pride napotitev bolnika k nevrologu.
Median creatinine clearance (CrCl), assessed with the use of the Cockroft-Gault formula, was 70 ml/min and 48% of patients had a CrCl of <70 ml/min. 
Mediani očistek kreatinina (CrCl), ocenjen po Cockroft-Gaultovi formuli, je bil 70 ml/min in 48 % bolnikov je imelo očistek kreatinina < 70 ml/min.V študijo so bili vključeni bolniki s stanjem zmogljivosti od 0 do 2 po ECOG (Eastern Cooperative Oncology Group) in 91 % bolnikov je imelo stanje zmogljivosti 0 ali 1 po ECOG.
2) How to dilute the solution for infusion 
2) Redčenje raztopine za infundiranje
One ml of concentrate contains 20 mg of ofatumumab. 
En ml koncentrata vsebuje 20 mg ofatumumaba.
• blue discolouration of the lips and extremities (possible symptoms of hypoxia) 
• pomodrelost ustnic in okončin (možni znaki slabe oskrbe s kiskom).
4.8 Undesirable effects 
Zelo pogosti neželeni učinki
• throat pain or irritation 
• bolečine ali draženje v žrelu,
You should be tested for hepatitis B (a liver disease) before starting Arzerra treatment. 
Pred začetkom zdravljenja z zdravilom Arzerra morate opraviti testiranje za hepatitis B (bolezen jeter).
PFS based on local (investigator) assessment was consistent with the primary endpoint and resulted in a ~11-month improvement in median PFS (OFA+FC 27.2 months versus 16.8 months for FC; HR=0.66 (95% CI: 0.51, 0.85, p=0.0009). 
Lokalno ocenjeno preživetje brez napredovanja bolezni po oceni raziskovalca se je ujemalo s primarnim opazovanim dogodkom in je pokazalo podaljšanje mediane preživetja brez napredovanja bolezni za približno 11 mesecev (27,2 meseca v skupini OFA+FC v primerjavi s 16,8 meseca v skupini FC; razmerje ogroženosti 0,66 (95% IZ: 0,51, 0,85, p = 0,0009).
Each vial contains 100 mg ofatumumab in 5 ml. 
Vsaka viala vsebuje 100 mg ofatumumaba v 5 ml.
Study OMB110911 (randomised, open-label, parallel-arm, multicentre) evaluated the efficacy of Arzerra in combination with chlorambucil compared with chlorambucil alone in 447 patients with previously untreated CLL considered inappropriate for fludarabine-based treatment (e.g. due to advanced age or presence of co-morbidities), with active disease and indicated for treatment. 
Primerjala je učinkovitost zdravila Arzerra v kombinaciji s klorambucilom z učinkovitostjo samega klorambucila pri 447 bolnikih s predhodno nezdravljeno KLL, ki niso bili primerni za zdravljenje na podlagi fludarabina (npr. zaradi visoke starosti ali komorbidnih stanj) ter so imeli aktivno bolezen in indikacijo za zdravljenje.
• Withdraw 5 ml of ofatumumab from each of the three 100 mg vials and inject into the 1000 ml bag; 
• Potegnite 5 ml ofatumumaba iz vsake od treh vial s 100 mg in ga injicirajte v 1.000-ml vrečko.
Risk factors for TLS include a high tumour burden, high concentrations of circulating cells (≥25,000/mm hypovolaemia, renal insufficiency, elevated pre-treatment uric acid levels and elevated lactate dehydrogenase levels. 
Med dejavniki tveganja za sindrom lize tumorja so veliko tumorsko breme, velika koncentracija celic v obtoku (≥25.000/mm
Musculoskeletal and connective tissue disorders General disorders and administration site conditions syndrome*, chills (including rigors)*, hyperhidrosis* 
sindrom sproščanja citokinov*, mrzlica (vključno z drgetanjem)*, hiperhidroza*
For patients who show evidence of prior (HBsAg negative, anti-HBc positive) hepatitis B infection, physicians with expertise in managing hepatitis B should be consulted regarding monitoring and initiation of HBV antiviral therapy. 
Če ima bolnik izvid, ki dokazuje predhodno okužbo s hepatitisom B (HBsAg-negativen, anti-HBc-pozitiven), se je treba glede nadziranja in glede uvedbe protivirusnega zdravljenja proti HBV posvetovati z zdravnikom, ki ima izkušnje z zdravljenjem hepatitisa B. Zdravljenja z zdravilom Arzerra se ne sme začeti pri bolnikih z izvidom, ki dokazuje trenutno okužbo s hepatitisom B (HBsAg-pozitiven), dokler okužba ni ustrezno zdravljena.
Each vial contains 1000 mg ofatumumab in 50 ml. 
Vsaka viala vsebuje 1.000 mg ofatumumaba v 50 ml.
Hypersensitivity to ofatumumab or to any of the excipients listed in section 6.1. 
Preobčutljivost za ofatumumab ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
There was a rapid and sustained depletion of CD20 
+, s čimer se je zmanjšalo število celic CD20
Arzerra 100 mg concentrate for solution for infusion 300 mg dose: Use 3 vials (15 ml total, 5 ml per vial) - Withdraw and discard 15 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; - Withdraw 5 ml of ofatumumab from each of 3 vials and inject into the 1000 ml bag; - Do not shake; mix diluted solution by gentle inversion. 
Arzerra 100 mg koncentrat za raztopino za infundiranje Odmerek 300 mg: Uporabite 3 viale (skupaj 15 ml, 5 ml na vialo) - Iz 1.000-ml vrečke 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje potegnite 15 ml
Uncommon symptoms of an infusion-related reaction (may affect up to 1 in 100 people): 
Občasni simptomi z infundiranjem povezanih reakcij (pojavijo se lahko pri največ 1 od 100 oseb):
The primary endpoint of progression-free survival (PFS), as assessed by a blinded independent review committee (IRC) using the updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008), was prolonged in the ofatumumab plus fludarabine-cyclophosphamide (OFA+FC) arm compared to the fludarabine-cyclophosphamide (FC) arm (28.9 months versus 18.8 months; HR: 0.67; 95% CI: 0.51-0.88, p=0.0032) resulting in a 10-month improvement in median PFS (see Figure 2). 
V skupini z ofatumumabom skupaj s fludarabinom in ciklofosfamidom (OFA+FC) je bilo preživetje brez napredovanja bolezni daljše kot v skupini s fludarabinom in ciklofosfamidom (FC) (28,9 meseca v primerjavi z 18,8 meseca; razmerje ogroženosti: 0,67; 95% IZ: 0,51-0,88, p = 0,0032), kar pomeni podaljšanje medianega preživetja brez napredovanja bolezni za 10 mesecev (glejte sliko 2).
Common symptoms of an infusion-related reaction (may affect up to 1 in 10 people): 
Pogosti simptomi z infundiranjem povezane reakcije (pojavijo se lahko pri največ 1 od 10 oseb):
Age was not found to be a significant factor for ofatumumab pharmacokinetics in a cross-study population pharmacokinetic analysis of patients ranging in age from 21 to 87 years of age. 
Farmakokinetična analiza populacije več študij (bolniki v starosti od 21 do 87 let) je pokazala, da starost ni pomemben dejavnik farmakokinetike ofatumumaba.
Nervous system disorders Metabolism and nutrition disorders 
Bolezni živčevja Presnovne in prehranske motnje sindrom lize tumorja
• diarrhoea 
• zardevanje
If you get any side effects, talk to your doctor or nurse. 
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
No dose adjustment is recommended for mild to moderate renal impairment (creatinine clearance >30 ml/min). 
Bolnikom z blago do zmerno okvaro ledvic (očistek kreatinina > 30 ml/min) odmerka ni treba prilagoditi.
Hepatitis B virus (HBV) infection and reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has occurred in patients treated with medicinal products classified as CD20directed cytolytic antibodies, including Arzerra. 
Pri bolnikih, zdravljenih z zdravili, ki se uvrščajo med citolitična protitelesa, usmerjena proti CD20 (vključno z zdravilom Arzerra), se je pojavila okužba z virusom hepatitisa B (HBV) ali njena reaktivacija, v nekaterih primerih s posledičnim fulminantnim hepatitisom, odpovedjo jeter in smrtjo.
Arzerra 1000 mg concentrate for solution for infusion 1000 mg dose: Use 1 vial (50 ml total, 50 ml per vial) - Withdraw and discard 50 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; - Withdraw 50 ml of ofatumumab from the vial and inject into the 1000 ml bag; - Do not shake; mix diluted solution by gentle inversion. 
Arzerra 1000 mg koncentrat za raztopino za infundiranje Odmerek 1.000 mg: Uporabite 1 vialo (skupaj 50 ml, 50 ml na vialo) - Iz 1.000-ml vrečke 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje potegnite 50 ml
• Withdraw 50 ml of ofatumumab from the 1000 mg vial and inject into the 1000 ml bag 
• Potegnite 50 ml ofatumumaba iz viale s 1.000 mg in ga injicirajte v 1.000-ml vrečko.
The overall response rate (ORR) including complete response (CR) was also assessed by an IRC using the 2008 IWCLL guidelines. 
IRC je po smernicah IWCLL 2008 ocenil tudi celokupni delež odziva (ORR - overall response rate), vključno s popolnim odzivom (CRcomplete response).
Diluted infusion solution 
Razredčena raztopina za infundiranje
Infusion schedule 
Razpored infuzij
Bradycardia* 
Srčne bolezni bradikardija*
2000 mg dose: Use 2 vials (100 ml total, 50 ml per vial) - Withdraw and discard 100 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; - Withdraw 50 ml of ofatumumab from each of 2 vials and inject into the 1000 ml bag; - Do not shake; mix diluted solution by gentle inversion. 
Odmerek 2.000 mg: Uporabite 2 viali (skupaj 100 ml, 50 ml na vialo) - Iz 1.000-ml vrečke 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje potegnite 100 ml
Arzerra 100 mg concentrate for solution for infusion Arzerra 1000 mg concentrate for solution for infusion 
Arzerra 100 mg koncentrat za raztopino za infundiranje Arzerra 1000 mg koncentrat za raztopino za infundiranje
Cardiovascular 
Srčno-žilni
• shaking or shivering 
• tresenje ali drgetanje,
Respiratory, thoracic and mediastinal disorders oropharyngeal pain*, nasal congestion* 
Bolezni dihal, prsnega koša in mediastinalnega prostora nelagodje v prsih*,
For the first infusion, administer over 4.5 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below: 
Prvo infuzijo je treba dati v 4,5 ure (glejte poglavje 4.2) po periferni liniji ali stalnem katetru in po naslednjem časovnem razporedu:
• allergic reactions, sometimes severe where symptoms include raised and itchy rash (hives), 
• alergijske reakcije, včasih hude, s simptomi, ki vključujejo dvignjen srbeč izpuščaj, oteklost obraza ali ust (angioedem), ki povzroči težave z dihanjem in nenaden padec krvnega tlaka,
If the first infusion was completed without a severe adverse reaction, the remaining infusions of 1000 mg should be administered over 4 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below. 
Če je bila prva infuzija dokončana brez hudih neželenih reakcij, je treba preostale infuzije po 1.000 mg dati v 4 urah (glejte poglavje 4.2) po periferni liniji ali stalnem katetru in po naslednjem časovnem razporedu.
• Withdraw 50 ml of ofatumumab from each of the two 1000 mg vials and inject into the 1000 ml bag; 
• Potegnite 50 ml ofatumumaba iz vsake od obeh vial s 1.000 mg in ga injicirajte v 1.000-ml
Clear Type I glass vial with a bromobutyl rubber stopper and aluminium over-seal, containing 50 ml of concentrate for solution for infusion. 
Viala iz prozornega stekla tipa I z zamaškom iz brombutilne gume in s prekrivno zaporo iz aluminija; viala vsebuje 50 ml koncentrata za raztopino za infundiranje.
Clear Type I glass vial with a bromobutyl rubber stopper and aluminium over-seal, containing 5 ml of concentrate for solution for infusion. 
Viala iz prozornega stekla tipa I z zamaškom iz brombutilne gume in s prekrivno zaporo iz aluminija; viala vsebuje 5 ml koncentrata za raztopino za infundiranje.
Arzerra 100 mg concentrate for solution for infusion Arzerra 1000 mg concentrate for solution for infusion ofatumumab 
Arzerra 100 mg koncentrat za raztopino za infundiranje Arzerra 1000 mg koncentrat za raztopino za infundiranje ofatumumab
Very common side effects These may affect more than 1 in 10 people: 
Pogosti neželeni učinki Pojavijo se lahko pri največ 1 od 10 oseb:
Concentrate for solution for infusion. 
Koncentrat za raztopino za infundiranje
These reactions may result in temporary interruption or withdrawal of treatment. 
Ofatumumab, ki se daje intravensko, je bil povezan z reakcijami, ki so povezane z infundiranjem in lahko povzročijo začasno ali dokončno prekinitev zdravljenja.
3) How to administer the diluted solution 
3) Dajanje razredčene raztopine
Dose modification and reinitiation of therapy after infusion-related ADRs In the event of a mild or moderate ADR, the infusion should be interrupted and restarted at half of the infusion rate at the time of interruption once the patient's condition is stable. 
V primeru blagega ali zmernega neželenega učinka je treba infundiranje prekiniti in ga po tem, ko se bolnikovo stanje stabilizira, znova začeti s polovično hitrostjo infundiranja v času prekinitve.
Complete resolution of constitutional symptoms (fever, night sweats, fatigue, weight loss) defined as the presence of any symptoms at baseline, followed by no symptoms present. 
Pri bolnikih z manjkajočimi izhodiščnimi podatki so bili na izhodišče preneseni zadnji presejalni podatki/podatki dobljeni zunaj časovnega b Popolno izginotje simptomov (zvišane telesne temperature, nočnega znojenja, utrujenosti, hujšanja), opredeljeno kot prisotnost kateregakoli simptoma izhodiščno, ki mu je sledila c Limfadenopatija, merjena z vsoto zmnožkov največjih premerov (SPD), ocenjenih s
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE 
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE
Sepsis (including neutropenic sepsis and septic shock) herpes viral infection, urinary tract 
Infekcijske in parazitske bolezni okužbe spodnjih dihal (vključno s sepsa (vključno z nevtropenično sepso in septičnim šokom),
If the second infusion was completed without a severe adverse reaction, the remaining infusions (3-12) should be administered over 4 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below. 
Če se je drugo infundiranje končalo brez hude reakcije, je treba preostale infuzije (3-12) dati v 4 urah (glejte poglavje 4.2) po perifernem kanalu ali stalnem katetru in po naslednjem časovnem razporedu.
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja urtikarija*, srbenje*,
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 were enrolled into the study and 91% had an ECOG performance status of 0 or 1. 
93 % bolnikov je imelo oceno stanja zmogljivosti ECOG 0 ali 1.
• feeling sick (nausea) 
• siljenje na bruhanje (navzea),
Arzerra 1000 mg concentrate for solution for infusion 
Arzerra 1000 mg koncentrat za raztopino za infundiranje
Arzerra should be discontinued in patients who experience serious or life-threatening cardiac arrhythmias. 
Če se pri bolniku pojavijo resne ali smrtno nevarne motnje srčnega ritma, je treba uporabo zdravila Arzerra prekiniti.
If any infusion-related adverse reactions are observed, infusion should be interrupted and restarted when the patient's condition is stable (see section 4.2 for further information). 
Če pride do kakršnih koli neželenih učinkov, povezanih z infundiranjem, je treba infundiranje prekiniti in ga znova začeti, ko je bolnikovo stanje stabilno (za več informacij glejte poglavje 4.2).
Cytopenias, including prolonged and late-onset neutropenia, have been reported during ofatumumab therapy. 
Med zdravljenjem z ofatumumabom so bile opisane citopenije, vključno z dolgotrajno in pozno nastalo nevtropenijo.
Arzerra 100 mg concentrate for solution for infusion 
Arzerra 100 mg koncentrat za raztopino za infundiranje
Arzerra 1000 mg concentrate for solution for infusion ofatumumab 
Arzerra 1000 mg koncentrat za raztopino za infundiranje ofatumumab
If the first infusion was completed without a severe adverse reaction, the remaining infusions of 1000 mg should be administered over 4 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below. 
Če je bila prva infuzija dokončana brez hudih neželenih reakcij, je treba preostale infuzije po 1.000 mg dati v 4 urah (glejte poglavje 4.2 povzetka glavnih značilnosti zdravila) po periferni liniji ali stalnem katetru in po naslednjem časovnem razporedu.
Arzerra 100 mg concentrate for solution for infusion ofatumumab 
Arzerra 100 mg koncentrat za raztopino za infundiranje ofatumumab
Check the Arzerra concentrate for particulate matter and discolouration prior to dilution. 
Pred redčenjem morate preveriti, da koncentrat zdravila Arzerra ne vsebuje delcev in ni obarvan.
• Withdraw and discard 100 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; 
• Iz 1.000-ml vrečke 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje potegnite 100 ml
• Withdraw and discard 15 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; 
• Iz 1.000-ml vrečke 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje potegnite 15 ml
Refractory CLL 
Refraktarna KLL
If any infusion-related ADRs are observed, infusion should be interrupted and restarted when the patient's condition is stable (see section 4.2). 
Če pride do kakršnihkoli z infundiranjem povezanih neželenih učinkov zdravila, je treba infundiranje prekiniti in ga znova začeti, ko je bolnikovo stanje stabilno (glejte poglavje 4.2).
For the first and second infusion, administer over 6.5 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below: 
Prvo in drugo infundiranje zdravila morata trajati 6,5 ure (glejte poglavje 4.2); infuziji je treba dati po perifernem kanalu ali stalnem katetru in po naslednjem časovnem razporedu:
ORR (%) 95% CI P value p<0.001 
Vrednost p p < 0,001
• Withdraw and discard 50 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; 
• Iz 1.000-ml vrečke 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje potegnite 50 ml
For the first infusion, administer over 4.5 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below: 
Prvo infuzijo je treba dati v 4,5 ure (glejte poglavje 4.2 povzetka glavnih značilnosti zdravila) po periferni liniji ali stalnem katetru in po naslednjem časovnem razporedu:
(Primary) endpoint 
(Primarni) opazovani dogodek
Ask your doctor for advice if you are planning to become pregnant after this period. 
Če želite po tem obdobju zanositi, se posvetujte z zdravnikom.
Chlorambuci + Chl 
Limfadenopatija c
Small intestinal obstruction 
• mišični krči.
Immune system disorders 
Redčenje raztopine za infundiranje
Chlorambucil 
Zapora črevesa
If any infusion-related adverse reactions are observed, infusion should be interrupted and restarted when the patient's condition is stable (see section 4.2 of the SmPC). 
Če pride do kakršnih koli neželenih učinkov, povezanih z infundiranjem, je treba infundiranje prekiniti in ga znova začeti, ko je bolnikovo stanje stabilno (glejte poglavje 4.2 povzetka glavnih značilnosti zdravila).
For the first and second infusion, administer over 6.5 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below: 
Prvo in drugo infundiranje zdravila morata trajati 6,5 ure (glejte poglavje 4.2 povzetka glavnih značilnosti zdravila); infuziji je treba dati po perifernem kanalu ali stalnem katetru in po naslednjem časovnem razporedu:
All responses were confirmed after 4 weeks. 
Vsi odzivi so bili potrjeni po 4 tednih.
31 May 2022 
31. maj 2022
It should only be used, if other medicinal products are not efficacious. 
Uporablja se lahko le, če druga zdravila niso učinkovita.
No additional deaths or transformations occurred in the ITT population. 
V populaciji ITT ni prišlo do dodatnih smrti ali transformacij.