FrancophonIA/ELRC3.0 huggingface dataset:
English: At the end of organogenesis (day 48 of gestation), the ofatumumab exposure (AUCinf) corresponded to 0.46 to 3.6 times the human exposure after the eighth infusion of the maximum recommended human dose (MRHD) of 2000 mg. At day 100 of gestation, depletion of B-cells relating to the pharmacological activity of ofatumumab were observed in foetal cord blood and foetal splenic tissues.
Icelandic: Við lok líffæramyndunar (dagur 48 á meðgöngu) samsvaraði útsetning fyrir ofatumumabi (AUCinf) til 0,46 til 3,6 sinnum útsetningar hjá mönnum eftir áttunda innrennslið af ráðlögðum hámarksskammti fyrir menn sem er 2000 mg.
English: If an infusion-related ADR is observed during infusion, see below section “Dose modification and reinitiation of therapy after infusion-related ADRs”.
Icelandic: Komi innrennslistengd aukaverkun fram meðan á innrennsli stendur, þá sjá kaflann „Skammtabreyting og meðferð hafin að nýju eftir innrennslistengdar aukaverkanir“ hér fyrir neðan.
English: Infusion schedule
Icelandic: Innrennslisáætlun
English: Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, County Durham, DL12 8DT, United Kingdom Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Icelandic: UK Limited (undir heitinu Glaxo Wellcome Operations), Harmire Road, Barnard Castle, County Durham, DL12 8DT, Bretland
English: Probability of Progression-free Survival
Icelandic: Líkur á lifun án versnunar sjúkdóms
English: Intravenous ofatumumab has been associated with infusion-related reactions.
Icelandic: Ofatumumab, gefið í bláæð, hefur tengst innrennslistengdum viðbrögðum.
English: Sodium acetate (E262)
Icelandic: Natríumasetat (E262) Natríumklóríð
English: Arzerra contains ofatumumab, which belongs to a group of medicines called monoclonal antibodies.
Icelandic: Arzerra inniheldur ofatumumab, sem tilheyrir flokki lyfja sem kallast einstofna mótefni.
English: 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).
Icelandic: Miðgildistími að versnun sjúkdóms var lengri fyrir hópinn sem fékk OFA+FC en fyrir hópinn sem fékk FC (42,1 mánuður á móti 26,8 mánuðum; áhættuhlutfall: 0,63; 95% CI: 0,45-0,87).
English: Small intestinal obstruction
Icelandic: hægur hjartsláttur
English: 1000 mg dose - Use one 1000 mg/50 ml vial (50 ml total, 50 ml per vial):
Icelandic: - Notið eitt 1000 mg/50 ml hettuglas (50 ml alls, 50 ml í hverju hettuglasi):
English: There is a potential for immunogenicity with therapeutic proteins such as ofatumumab.
Icelandic: Mótefnamyndun vegna lyfjapróteina eins og ofatumumabs er hugsanleg.
English: • fluid in the lungs (pulmonary oedema) causing breathlessness
Icelandic: vökvi í lungum (lungnabjúgur) sem getur valdið mæði
English: Baseline disease characteristics and prognostic markers were balanced between treatment arms and representative of a relapsed CLL population.
Icelandic: Einkenni sjúkdóms í upphafi og lífmerki sem spá fyrir um batahorfur voru í jafnvægi milli meðferðarhópa og dæmigerð fyrir sjúklinga sem voru með endurkomið langvinnt eitilfrumuhvítblæði.
English: First infusion
Icelandic: Fyrsta innrennsli
English: Arzerra contains sodium
Icelandic: Arzerra inniheldur natríum
English: If a diagnosis of PML is suspected Arzerra should be discontinued and referral to a neurologist should be considered.
Icelandic: Ef greining leiðir til gruns um ágenga fjölhreiðra innlyksuheilabólgu skal notkun Arzerra hætt og tilvísun til taugasérfræðings íhuguð.
English: The median progression-free survival was 5.5 months (95% CI: 4.6, 6.4) and the median overall survival was 17.4 months (95% CI: 15.0, 24.0).
Icelandic: 4,6, 6,4) og miðgildi heildarlifunar 17,4 mánuðir (95% CI:
English: The main pharmacokinetic parameters of ofatumumab as a single agent or in combination are summarised in Table 5.
Icelandic: Aðal lyfjahvarfabreytur ofatumumabs gefið eitt og sér eða í samsetningu eru teknar saman í töflu 5.
English: Arzerra 100 mg sterile concentrate ofatumumab
Icelandic: Arzerra 100 mg sæft þykkni ofatumumab i.v.
English: • Use a reliable method of contraception to avoid becoming pregnant while you are being treated with Arzerra, and for 12 months after your last dose of Arzerra.
Icelandic: Notið öruggar getnaðarvarnir til að forðast þungun meðan á meðferð með Arzerra stendur og í að minnsta kosti 12 mánuði eftir síðasta skammtinn af Arzerra.
English: • Withdraw 50 ml of ofatumumab from each of the two 1000 mg vials and inject into the 1000 ml bag;
Icelandic: Dragið 50 ml af ofatumumabi úr hvoru 1000 mg hettuglasinu og dælið inn í 1.000 ml pokann;
English: Efficacy endpoint or haematological parameter a
Icelandic: Endapunktur verkunar eða blóðgildi a
English: 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.
Icelandic: Áhættuþættir vegna æxlislýsuheilkennis eru m.a. mikil æxlisbyrði, há þéttni frumna í blóðrás (≥25.000/mm
English: You should be tested for hepatitis B (a liver disease) before starting Arzerra treatment.
Icelandic: Áður en meðferð með Arzerra er hafin skal gera hjá þér próf fyrir lifrarbólgu B (lifrarsjúkdómur).
English: Intravenous corticosteroid (prednisolone or equivalent)
Icelandic: Barksterar í bláæð (prednisólón eða jafngildi þess)
English: Arzerra 1000 mg sterile concentrate ofatumumab
Icelandic: Arzerra 1000 mg sæft þykkni ofatumumab i.v.
English: Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in those who are hepatitis B core antibody (anti-HBc) positive but HBsAg negative.
Icelandic: Greint hefur verið frá tilvikum hjá sjúklingum sem eru jákvæðir gagnvart yfirborðsmótefnavaka lifrarbólgu B (HBsAg) og einnig þeim sem eru jákvæðir gagnvart kjarnamótefni lifrarbólgu
English: Common symptoms of an infusion-related reaction (may affect up to 1 in 10 people):
Icelandic: Algeng innrennslistengd viðbrögð (geta komið fyrir hjá allt að 1 af 10 einstaklingum):
English: Cases of progressive multifocal leukoencephalopathy (PML) resulting in death have been reported in CLL patients receiving cytotoxic pharmacotherapy, including ofatumumab.
Icelandic: (PML) sem leiddu til dauðsfalla hjá sjúklingum með langvinnt eitilfrumuhvítblæði sem fá frumudrepandi lyf, þ.m.t. ofatumumab.
English: Arzerra 100 mg concentrate for solution for infusion Arzerra 1000 mg concentrate for solution for infusion
Icelandic: Arzerra 100 mg innrennslisþykkni, lausn Arzerra 1000 mg innrennslisþykkni, lausn
English: Arzerra should be permanently discontinued in patients who develop an anaphylactic reaction to the medicinal product.
Icelandic: Hætta skal endanlega notkun Arzerra hjá sjúklingum sem fá bráðaofnæmisviðbrögð við lyfinu.
English: Intravenous and subcutaneous administration to monkeys resulted in the expected depletion of peripheral and lymphoid tissue B-cell counts with no associated toxicological findings.
Icelandic: Gjöf í bláæð og undir húð hjá öpum leiddi til fækkunar B-frumna í útæðum og eitlavef eins og búist var við, án neinna tengdra eiturverkana.
English: Table 1 Summary of PFS with Arzerra in combination with chlorambucil compared with chlorambucil in previously untreated CLL
Icelandic: Yfirlit yfir aðrar niðurstöður fyrir notkun Arzerra ásamt klórambúcíli samanborið við klórambúcíl, gegn áður ómeðhöndluðu langvinnu eitilfrumuhvítblæði
English: 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.
Icelandic: Ef um er að ræða vægar eða miðlungsalvarlegar aukaverkanir, skal gera hlé á innrennslinu og það hafið að nýju á helmingi þess innrennslishraða sem var þegar hlé var gert á innrennslinu, þegar ástand sjúklings er orðið stöðugt.
English: Uncommon symptoms of an infusion-related reaction (may affect up to 1 in 100 people):
Icelandic: Mjög sjaldgæf innrennslistengd viðbrögð (geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum)
English: Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of complement defence molecules.
Icelandic: örvar umtalsvert sundrun frumna með verulega mikla tjáningu komplement-varnarsameinda.
English: 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.
Icelandic: - Dragið upp og fargið 100 ml úr 1.000 ml poka af 9 mg/ml (0,9%) natríumklóríðlausn fyrir stungulyf; - Dragið 50 ml af ofatumumabi úr hvoru af hettuglösunum 2 og dælið inn í 1.000 ml pokann; - Ekki hrista.
English: Subsequent infusions*
Icelandic: Síðari innrennsli*
English: • blocked nose.
Icelandic: stíflað nef
English: In addition, the binding of ofatumumab allows the recruitment of natural killer cells allowing the induction of cell death through antibody-dependent cell-mediated cytotoxicity.
Icelandic: Að auki gerir binding ofatumumabs nýliðun náttúrlegra drápsfrumna mögulega, sem örvar frumudauða fyrir tilstilli mótefnaháðra, frumumiðlaðra eiturverkana á frumur.
English: Patients received 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 intravenous bendamustine 90 mg/m on days 1 and 2 every 28 days.
Icelandic: 1000 mg á degi 1 á 28 daga fresti) ásamt bendamústíní í bláæð, 90 mg/m daga 1 og 2 á 28 daga fresti.
English: It is recommended that patients have electrolytes such as potassium and magnesium measured prior to and during the administration of ofatumumab.
Icelandic: Mælt er með því að blóðsölt, svo sem kalíum og magnesíum, séu mæld hjá sjúklingum fyrir og meðan á meðferð með ofatumumabi stendur.
English: • difficulty in breathing, shortness of breath, chest tightness, cough
Icelandic: öndunarörðugleikar, mæði, þyngsli fyrir brjósti, hósti
English: • fever, coughing, difficulty breathing, wheezing, possible symptoms of infections of the lungs or airways (respiratory tract) including pneumonia
Icelandic: • hiti, hósti, öndunarerfiðleikar, hvæsandi öndun, hugsanlega einkenni sýkingar í lungum eða
English: 28 days).
Icelandic: 42 dögum eftir síðustu meðferð).
English: Nervous system disorders Metabolism and nutrition disorders
Icelandic: Klórambúcíl Ofatumumab og klórambúcíl
English: The overall response rate (ORR) including complete response (CR) was also assessed by an IRC using the 2008 IWCLL guidelines.
Icelandic: Heildarsvörunarhlutfall, þ.m.t. fullkomin svörun, var einnig metin af óháðri matsnefnd samkvæmt IWCLL-leiðbeiningum frá árinu 2008.
English: Even with premedication, severe reactions, including cytokine release syndrome, have been reported following use of ofatumumab.
Icelandic: Þrátt fyrir undirbúningslyfjameðferð hefur verið greint frá alvarlegum aukaverkunum, þ.m.t. cýtókínlosunarheilkenni, við notkun ofatumumabs.
English: Reactivation of HBV replication is often followed by hepatitis, i.e. increase in transaminase levels and, in severe cases, increase in bilirubin levels, liver failure, and death.
Icelandic: Lifrarbólga, þ.e, hækkun á þéttni transamínasa og í alvarlegum tilvikum hækkuð þéttni bilírúbíns, lifrarbilun og dauðsföll, koma oft fram í kjölfar endurvirkjunar á afritun lifrarbólguveiru B.
English: Arzerra 100 mg concentrate for solution for infusion Arzerra 1000 mg concentrate for solution for infusion ofatumumab
Icelandic: Arzerra 100 mg innrennslisþykkni, lausn Arzerra 1000 mg innrennslisþykkni, lausn ofatumumab
English: Treatment with Arzerra (when given as 4 once-weekly infusions), led to a 50% objective response rate in the highest dose group (1st dose: 500 mg; 2nd, 3rd and 4th dose: 2,000 mg) and included 12 partial remissions and one nodular partial remission.
Icelandic: 500 mg; 2., 3., og 4. skammtur: 2000 mg) og fól í sér 12 hlutasvaranir og eina hlutasvörun með hnútum (nodular partial response).
English: Abbreviations: CI = confidence interval, CLL = chronic lymphocytic leukaemia, CR = complete response, IRC = Independent Review Committee, MRD = minimal residue disease, N = number, ORR = overall response rate
Icelandic: CI = öryggisbil, CR = fullkomin svörun, MRD = lágmarkssjúkdómsleifar, N = fjöldi, ORR = heildarsvörunarhlutfall
English: • increase in potassium, phosphate and uric acid in the blood that can cause kidney problems (tumour lysis syndrome) The symptoms of this condition include:
Icelandic: hækkun kalíums, fosfats og þvagsýru í blóði sem getur valdið nýrnavandamálum
English: If you notice these symptoms, contact your doctor as soon as possible.
Icelandic: Leitaðu til læknisins eins fljótt og unnt er ef þú færð þessi einkenni.
English: Arzerra is administered by intravenous infusion; therefore, absorption is not applicable.
Icelandic: Arzerra er gefið með innrennsli í bláæð; því er ekki um frásog að ræða.
English: Each vial contains 100 mg ofatumumab in 5 ml.
Icelandic: Hvert hettuglas inniheldur 100 mg ofatumumab í 5 ml.
English: For the highest dose group, the median time to progression was 15.6 weeks (95% CI: 15,22.6) in the full analysis population, and 23 weeks (CI: 20,31) in responders.
Icelandic: Í hópnum sem fékk hæstu skammtana var miðgildi tíma að versnun sjúkdóms 15,6 vikur (95% CI:
English: Relapsed CLL (ofatumumab + FC)
Icelandic: Endurkomið langvinnt eitilfrumuhvítblæði (ofatumumab + flúdarabín og cyclofosfamíð)
English: 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.
Icelandic: - Dragið upp og fargið 50 ml úr 1.000 ml poka af 9 mg/ml (0,9%) natríumklóríðlausn fyrir stungulyf; - Dragið 50 ml af ofatumumabi úr hettuglasinu og dælið inn í 1.000 ml pokann; - Ekki hrista.
English: • If you do become pregnant during treatment with Arzerra, tell your doctor.
Icelandic: Láttu lækninn vita ef þú verður barnshafandi meðan á meðferð með Arzerra stendur.
English: How to store Arzerra
Icelandic: á Arzerra
English: Table 4 Summary of clinical improvement with a minimum duration of 2 months in refractory patients with abnormalities at baseline
Icelandic: Kaplan-Meier-áætlanir fyrir lifun án versnunar sjúkdóms hjá sjúklingum með endurkomið langvinnt eitilfrumuhvítblæði
English: • Withdraw 5 ml of ofatumumab from each of the three 100 mg vials and inject into the 1000 ml bag;
Icelandic: Dragið 5 ml af ofatumumabi úr hverju þriggja 100 mg hettuglasanna og dælið inn í 1.000 ml
English: Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of adult patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.
Icelandic: Langvinnt eitilfrumuhvítblæði (CLL) sem ekki hefur verið meðhöndlað áður Arzerra, ásamt klórambúcíli eða bendamústíni, er ætlað til meðferðar hjá fullorðnum sjúklingum með langvinnt eitilfrumuhvítblæði, sem hafa ekki fengið meðferð áður, þegar meðferð sem byggir á flúdarabíni á ekki við.
English: 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:
Icelandic: Fyrsta og annað innrennsli skulu gefin á 6,5 klst. (sjá kafla 4.2), um útæðalínu eða uppsettan æðalegg, samkvæmt eftirfarandi áætlun:
English: Neutropenia
Icelandic: Frásog
English: • producing less urine than normal
Icelandic: • minni þvagmyndun en venjulega • vöðvakrampar
English: • Withdraw 50 ml of ofatumumab from the 1000 mg vial and inject into the 1000 ml bag
Icelandic: Dragið 50 ml af ofatumumabi úr 1000 mg hettuglasinu og dælið inn í 1.000 ml pokann;
English: Dilution
Icelandic: Lyfhrif
English: • Subsequent cycles (until best response or a maximum of 12 cycles): 1000 mg on day 1 every
Icelandic: Síðari lotur (þar til bestu svörun eða hámarkinu, 12 lotum, er náð):
English: • fever or, alternatively, a very low body temperature, chest pain, shortness of breath or rapid breathing, shaking, chills, confusion, dizziness, decreased urination and rapid pulse, (possible symptoms of blood infection)
Icelandic: ringlun, sundl, minnkuð þvaglát og hraður hjartsláttur (hugsanlega einkenni blóðsýkingar)
English: Respiratory, thoracic and mediastinal disorders oropharyngeal pain*, nasal congestion*
Icelandic: (þ.m.t. lungnabólga), efri öndunarfærasýking daufkyrningafæðar og blóðsýkingarlost), herpesveirusýking, þvagfærasýking
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Lýsing á útliti Arzerra og pakkningastærðir
English: Each vial contains 100 mg of ofatumumab in 5 ml.
Icelandic: Hvert hettuglas inniheldur 100 mg af ofatumumabi í 5 ml.
English: 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.
Icelandic: Ef seinna innrennslinu var lokið án alvarlegra aukaverkana, skal gefa innrennslin sem eftir eru (3-12) á 4 klst. (sjá kafla 4.2), um útæðalínu eða uppsettan æðalegg, samkvæmt eftirfarandi áætlun.
English: • Withdraw and discard 100 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
Icelandic: Dragið upp og fargið 100 ml úr 1.000 ml poka af 9 mg/ml (0,9%) natríumklóríðlausn fyrir
English: 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.
Icelandic: Ef fyrsta innrennslinu var lokið án alvarlegra aukaverkana skal gefa innrennslin sem eftir eru með 1000 mg á 4 klst. (sjá kafla 4.2), um útæðalínu eða uppsettan æðalegg, samkvæmt eftirfarandi áætlun.
English: Each vial contains 1000 mg of ofatumumab in 50 ml.
Icelandic: Hvert hettuglas inniheldur 1000 mg ofatumumab í 50 ml.
English: • allergic reactions, sometimes severe where symptoms include raised and itchy rash (hives),
Icelandic: • ofnæmisviðbrögð, stundum veruleg þegar einkenni geta m.a. verið upphleypt útbrot með kláða
English: Vascular disorders
Icelandic: Glaxo Operations
English: Infusion reactions
Icelandic: Innrennslisviðbrögð
English: Clear Type I glass vial with a bromobutyl rubber stopper and aluminium over-seal, containing 50 ml of concentrate for solution for infusion.
Icelandic: I, með brómóbútýlgúmmítappa og álhettu, sem innihalda 50 ml af innrennslisþykkni, lausn.
English: Clear Type I glass vial with a bromobutyl rubber stopper and aluminium over-seal, containing 5 ml of concentrate for solution for infusion.
Icelandic: I, með brómóbútýlgúmmítappa og álhettu, sem innihalda 5 ml af innrennslisþykkni, lausn.
English: • skin rash
Icelandic: • andlitsroði
English: 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.
Icelandic: B skal leita ráða hjá sérfræðingum í meðferð lifrarbólgu B, varðandi eftirlit og byrjun veiruhamlandi meðferðar gegn lifrarbólguveiru B. Ekki skal hefja meðferð með Arzerra hjá sjúklingum með vísbendingar um yfirstandandi sýkingu af völdum lifrarbólguveiru
English: Hypersensitivity*
Icelandic: Ofnæmi*
English: • throat pain or irritation
Icelandic: verkur eða erting í hálsi
English: Clear to opalescent, colourless to pale yellow liquid.
Icelandic: Tær til skýjaður, litlaus til fölgulur vökvi.
English: 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:
Icelandic: Fyrsta innrennsli skal gefa á 4,5 klst. (sjá kafla 4.2), um útæðalínu eða uppsettan æðalegg, samkvæmt eftirfarandi áætlun:
English: • Withdraw and discard 50 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
Icelandic: Dragið upp og fargið 50 ml úr 1.000 ml poka af 9 mg/ml (0,9%) natríumklóríðlausn fyrir
English: Ofatumumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzymes.
Icelandic: Ofatumumab er prótein og umbrotsferillinn sem gert er ráð fyrir er sundrun í lítil peptíð og einstakar amínósýrur, fyrir tilstilli próteinsundrandi ensíma sem eru alls staðar.
English: Relapsed CLL
Icelandic: HEITI LYFS
English: 1 vial
Icelandic: 1. innrennsli
English: • Withdraw and discard 15 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
Icelandic: Dragið upp og fargið 15 ml úr 1.000 ml poka af 9 mg/ml (0,9%) natríumklóríðlausn fyrir
English: CR (%) CR with MRD negativity (% of CR) Median duration of response, all patients, months 95% CI P value p<0.001
Icelandic: CR (%) CR með neikvæðu MRD (% af CR)
English: 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.
Icelandic: Ef fyrsta innrennslinu var lokið án alvarlegra aukaverkana, skal gefa innrennslin sem eftir eru með 1000 mg á 4 klst. (sjá kafla 4.2 í samantekt á eiginleikum lyfsins), um útæðalínu eða uppsettan æðalegg, samkvæmt eftirfarandi áætlun.
English: (Primary) endpoint
Icelandic: (Megin)endapunktur
English: 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).
Icelandic: Ef fram koma aukaverkanir tengdar innrennsli skal stöðva innrennslið og hefja aftur þegar ástand sjúklingsins er orðið stöðugt (sjá frekari upplýsingar í kafla 4.2).
English: If any infusion-related ADRs are observed, infusion should be interrupted and restarted when the patient's condition is stable (see section 4.2).
Icelandic: Ef einhverjar innrennslistengdar aukaverkanir sjást skal gera hlé á innrennslinu og hefja að nýju þegar ástand sjúklingsins er stöðugt (sjá kafla 4.2).
English: B-cells after the first ofatumumab infusion, leaving a reduced number of CD20
Icelandic: Hröð og stöðug fækkun CD20+ B-frumna varð eftir fyrsta innrennsli ofatumumabs, sem skildi eftir færri CD20+-frumur fyrir mótefnið til að bindast við í innrennslunum sem á eftir komu.
English: Administer using an intravenous infusion pump.
Icelandic: Gefa skal lyfið með dælu fyrir innrennsli í bláæð.
English: 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:
Icelandic: Fyrsta og annað innrennsli skulu gefin á 6,5 klst. (sjá kafla 4.2 í samantekt á eiginleikum lyfsins), um útæðalínu eða uppsettan æðalegg, samkvæmt eftirfarandi áætlun:
English: 268 (23%) of the 1,168 patients experienced ≥Grade 3 infections.
Icelandic: 1.168 sjúklingum fengu sýkingar af stigi ≥3.65 (6%) af þessum
English: IRC-assessed primary and subgroup analyses of PFS, months
Icelandic: Megin- og undirhópagreiningar á lifun án versnunar sjúkdóms samkvæmt mati óháðrar nefndar (IRC), mánuðir
English: Common side effects that may show up in your blood tests: • low levels of platelets in the blood (cells that help blood to clot).
Icelandic: • fækkun blóðflagna í blóðinu (frumur sem stuðla að blóðstorknun).
English: How Arzerra is given
Icelandic: Arzerra inniheldur
English: Hepatic impairment
Icelandic: Höfuðverkur*
English: Arzerra 1000 mg concentrate for solution for infusion ofatumumab
Icelandic: Arzerra 1000 mg innrennslisþykkni, lausn ofatumumab