FrancophonIA/ELRC3.0 huggingface dataset:
English: Anaphylactic reactions following intravenous administration of free cytarabine have been rarely reported.
Icelandic: Bráðaofnæmisviðbrögð eftir gjöf á óbundnu cýtarabíni í bláæð hafa sjaldan verið tilgreind.
English: Mundipharma Pharmaceuticals Srl Tel: + 39.02.318288216
Icelandic: Mundipharma Pharmaceuticals Srl Tel: + 39.02. 318288216 Italy.InfoMedica@mundipharma.it
English: • Dizziness
Icelandic: • þróttleysi
English: If your side effects get worse or you notice any new side effects, tell your doctor.
Icelandic: Láttu lækninn vita ef aukaverkanir, sem þú finnur fyrir, versna eða þú finnur fyrir einhverjum nýjum aukaverkunum.
English: Consolidation therapy: 50 mg administered every 14 days for 3 doses (weeks 5, 7 and 9) followed by an additional dose of 50 mg at week 13.
Icelandic: 50 mg gefin á 14 daga fresti, þrisvar (í viku 5, 7 og 9) og 50 mg viðbótarskammtur í viku
English: Fertility
Icelandic: Tríóleín
English: See section 4..
Icelandic: Tafla 3:
English: Do not throw away any medicines via wastewater.
Icelandic: Lyfjum má ekki fleygja í frárennsli.
English: PC: {number} SN: {number} NN: {number}
Icelandic: SN: {númer} [serial number]
English: The CSF clearance rate of cytarabine is similar to the CSF bulk flow rate of 0.24 ml/min.
Icelandic: Hraði útskilnaðar úr heila- og mænuvökva er líkur heildarflæðihraða heila- og mænuvökva, 0,24 ml/mín.
English: • Shaking
Icelandic: • ringlun
English: The systemic exposure to free cytarabine following intrathecal treatment with DepoCyte was negligible.
Icelandic: Almenn dreifing á óbundnu cýtarabíni eftir innanbastsgjöf var óveruleg.
English: What DepoCyte looks like and contents of the pack
Icelandic: Útlit DepoCyte og pakkningastærðir
English: This leaflet was last revised in MM/YYYY
Icelandic: Þessi fylgiseðill var síðast uppfærður í {mánuður ÁÁÁÁ}.
English: No definite interactions between DepoCyte delivered intrathecally and other medicinal products have been established.
Icelandic: Milliverkanir milli DepoCyte, sem gefið er innan basts, og annarra lyfja hafa ekki verið staðfestar.
English: If left untreated, chemical arachnoiditis may be fatal.
Icelandic: Sé lyfjaorsökuð skúmbólga ekki meðhöndluð, getur hún verið banvæn.
English: For cell-cycle phase specific antimetabolites the duration of exposure of neoplastic cells to cytotoxic concentrations is an important determination of efficacy.
Icelandic: Tímalengdin, sem æxlisfrumur verða fyrir frumueyðandi þéttni andmetabólíta með sértæka fasaverkun í frumuhringnum, er mikilvæg til að ákvarða verkun.
English: Very common: diarrhoea, vomiting, nausea Very common: diarrhoea, vomiting, nausea
Icelandic: Mjög algengar: niðurgangur, uppköst, ógleði Mjög algengar: niðurgangur, uppköst, ógleði
English: Very common: vomiting, nausea Very common: vomiting, nausea Very common: vomiting, nausea
Icelandic: Mjög algengar: uppköst, ógleði Mjög algengar: uppköst, ógleði Mjög algengar: uppköst, ógleði
English: If you get any side effects, talk to your doctor or nurse.
Icelandic: Látið lækninn eða hjúkrunarfræðinginn vita um allar aukaverkanir.
English: Very common: pyrexia Common: pyrexia Very common: pyrexia *Cycle length was 2 weeks during which the patient received either 1 dose of DepoCyte or 4 doses of cytarabine or methotrexate.
Icelandic: *Lotulengd var 2 vikur þar sem sjúklingurinn fékk annað hvort 1 skammt af DepoCyte eða 4 skammta af cýtarabíni eða methotrexati.
English: An overdose with DepoCyte may be associated with severe arachnoiditis including encephalopathy.
Icelandic: DepoCyte getur tengst alvarlegri skúmbólgu ásamt heilakvilla.
English: Follow-up treatment: one vial of DepoCyte (50 mg) administered every 14 days for 3 doses (weeks 5, 7 and 9) followed by an additional dose at week 13.
Icelandic: Framhaldsmeðferð: gefið úr einu hettuglasi af DepoCyte (50 mg) á 14 daga fresti, þrisvar (þ.e. í viku 5, 7 og 9) og viðbótarskammtur í viku
English: Because these reactions are reported from a population of uncertain size, it is not possible to reliably estimate their frequency.
Icelandic: Ekki er hægt með áreiðanlegum hætti að meta tíðni þessara aukaverkana þar sem þær koma fram hjá hópi af óþekktri stærð.
English: DepoCyte should not be given to pregnant women as it may harm an unborn child. Women of childbearing potential should use a reliable contraceptive method to avoid pregnancy whilst being treated with DepoCyte.
Icelandic: Konur á frjósemisaldri ættu að nota örugga getnaðarvörn til að forðast þungun meðan þær fá meðferð með DepoCyte.
English: Cytarabine is a cell-cycle phase specific antineoplastic agent, affecting cells only during the S-phase of cell division.
Icelandic: Cýtarabín er efni sem verkar gegn krabbameinsfrumum, hefur sértæka fasaverkun í frumuhringnum og hefur einungis áhrif í S-fasa frumuskiptingar.
English: For Phase 1-4 studies in patients with lymphomatous meningitis receiving either DepoCyte or cytarabine adverse reactions are listed by MedDRA body system organ class and by frequency (Very common (≥1/10); and Common (≥1/100 to < 1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000)) in Table 1 below.
Icelandic: Mjög algengar (≥1/10), algengar (≥1/100 til <1/10), sjaldgæfar (≥1/1.000 til <1/100), mjög sjaldgæfar (≥1/10.000 til <1/1.000), koma örsjaldan fyrir (<1/10.000).
English: Systemic toxicity due to intravenous administration of cytarabine consists primarily of bone marrow suppression with leucopenia, thrombocytopenia and anaemia.
Icelandic: Almenn eiturverkun vegna cýtarabíngjafar í bláæð felst fyrst og fremst í beinmergsbælingu með hvítkornafæð, blóðflagnafæð og blóðleysi.
English: Very common: arachnoiditis, confusion, headache Very common: arachnoiditis, headache Common: confusion
Icelandic: Mjög algengar: skúmbólga, ringlun, höfuðverkur Mjög algengar: skúmbólga, höfuðverkur Algengar: ringlun
English: Mundipharma Pharmaceuticals B.V. Tel: +31 (0) 33 450 8270 info@mundipharma.nl
Icelandic: +31 (0) 33 450 8270 info@mundipharma.nl
English: Suspension for injection.
Icelandic: Upplýsingar fyrir notanda lyfsins
English: Marketing Authorisation Holder
Icelandic: OG SKILYRÐI MARKAÐSLEYFIS
English: Type I glass vial closed with a fluororesin faced butyl rubber stopper and sealed with an aluminium flip-off seal containing 50 mg cytarabine in 5 ml suspension.
Icelandic: I sem inniheldur 50 mg cýtarabín í 5 ml dreifu og er innsiglað með álhettu sem rífa má af með flipa.
English: DepoCyte 50 mg suspension for injection
Icelandic: DepoCyte 50 mg stungulyf, dreifa.
English: Blockage or reduction of CSF flow may result in increased free cytarabine concentrations in the CSF with increased risk of neurotoxicity.
Icelandic: Flæðishindrun eða skerðing á flæði heila- og mænuvökva getur leitt til aukinnar þéttni óbundins cýtarabíns í heila- og mænuvökva með aukinni hættu á eiturvirkni í taugakerfi.
English: DepoCyte is administered directly into the CSF via an intraventricular reservoir or by direct injection into the lumbar sac.
Icelandic: DepoCyte skal gefa beint í heila- og mænuvökva um lyfjabrunn í heilahólfi eða með beinni inngjöf við mænustungu.
English: Common: impaired bowel control
Icelandic: Algengar: skert stjórn á hægðum
English: Common: somnolence Common: somnolence
Icelandic: Algengar: svefnhöfgi Algengar: svefnhöfgi
English: Cytarabine is cytotoxic to a wide variety of proliferating mammalian cells in culture.
Icelandic: Cýtarabín er frumueyðandi fyrir margs konar spendýrafrumur sem fjölga sér í frumuræktun.
English: Common: cauda equina syndrome, convulsions, cranial nerve palsies, hypoesthesia, myelopathy, paresthesia, hemiplegia, numbness
Icelandic: Algengar: cauda equina heilkenni, krampar, heilataugalömun, minnkað snertiskyn, mænukvilli, náladofi, helftarlömun, doði Algengar: cauda equina heilkenni, krampar, heilataugalömun, minnkað snertiskyn, mænukvilli, náladofi, helftarlömun, doði
English: Responses were observed in 13/18 (72%, 95% confidence intervals: 47, 90) of DepoCyte patients versus 3/17 (18% patients, 95% confidence intervals: 4, 43) in the unencapsulated cytarabine arm. A statistically significant association between treatment and response was observed (Fisher's exact test p-value = 0.002).
Icelandic: DepoCyte á móti 3 af 17 (18% sjúklinga, 95% öryggismörk: 4, 13) sjúklingum sem fengu óhúðað cýtarabín.
English: Common: back pain, neck pain, neck stiffness Common: back pain, neck pain Uncommon: neck stiffness Common: back pain, neck pain, neck stiffness
Icelandic: Algengar: bakverkir, hálsverkir, hnakkastífleiki Algengar: bakverkir, hálsverkir Sjaldgæfar: hnakkastífleiki Algengar: bakverkir, hálsverkir, hnakkastífleiki
English: • Convulsion
Icelandic: • krömpum
English: Intrathecal treatment of lymphomatous meningitis.
Icelandic: LYFJAFORM Stungulyf, dreifa.
English: • Fever
Icelandic: • bakverk
English: Cytarabine was clastogenic to meiotic cells; a dose-dependent increase in sperm-head abnormalities and chromosomal aberrations occurred in mice given intraperitoneal (i.p.)
Icelandic: Cýtarabín var brotmyndandi hjá frumum í rýriskiptingu (meiosis); skammtaháð aukning á göllum í sáðfrumum og litningagallar komu fram hjá músum sem fengu cýtarabín í kviðarhol.
English: Blood and lymphatic system disorders
Icelandic: Dípalmitóýlfosfatídýlglýseról (DPPG)
English: Intrathecal use
Icelandic: INNIHALDSLÝSING
English: Very common: headache Common: convulsions, meningism
Icelandic: Mjög algengar: höfuðverkur Algengar: krampar, mengiserting
English: Adverse reactions are listed by MedDRA body system organ class and by frequency: Very common (_≥1/10); Common (≥1/100 to < 1/10); and Uncommon (≥ 1/1,000 to < 1/100).
Icelandic: (≥1/100 til <1/10), sjaldgæfar (≥1/1.000 til <1/100), mjög sjaldgæfar (≥1/10.000 til <1/1.000), koma örsjaldan fyrir (<1/10.000).
English: Common (experienced in less than 1 in 10 but more than 1 in 100 patients)
Icelandic: Algengar (koma fyrir hjá 1 til 10 af hverjum 100 notendum)
English: Intrathecal use.
Icelandic: Innleiðslumeðferð:
English: Similar changes (generally described as minimal to slight) were also observed in some animals receiving DepoFoam alone (DepoCyte vesicles without cytarabine) but not in sodium chloride solution control animals.
Icelandic: DepoFoam eingöngu (DepoCyte-blöðrur án cýtarabíns) en ekki í samanburðardýrum sem fengu saltlausn.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Icelandic: FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN
English: • Headaches
Icelandic: • heyrnartapi
English: Contents of the pack and other information What DepoCyte contains
Icelandic: DepoCyte Pakkningar og aðrar upplýsingar
English: Uncommon: meningism Very common: headache Common: convulsions, hydrocephalus acquired, meningism
Icelandic: Mjög algengar: höfuðverkur Algengar: krampar, áunnið vatnshöfuð, mengiserting
English: Tel : +420 222 318 221 office@mundipharma.cz
Icelandic: +40 751 121 222 office@mundipharma.ro
English: Infectious meningitis may be associated with intrathecal administration.
Icelandic: Heilahimnubólga af völdum sýkingar getur tengst innanbasts lyfjagjöf.
English: Not applicable.
Icelandic: <Á ekki við.>
English: Cholesterol Triolein Dioleoylphosphatidylcholine (DOPC) Dipalmitoylphosphatidylglycerol (DPPG) Sodium chloride Water for injections
Icelandic: HEITI LYFS DepoCyte 50 mg stungulyf, dreifa
English: VIAL LABEL
Icelandic: Meltingarfæri
English: The majority of DepoCyte patients went on beyond Induction to receive additional therapy.
Icelandic: DepoCyte héldu áfram eftir innleiðsluna og fengu framhaldsmeðferð.
English: − If you get any side effects, talk to your doctor.
Icelandic: − ef þú ert með sýkingu í heilahimnum.
English: Nervous system disorders
Icelandic: Styrkingarmeðferð:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX
Icelandic: SÉRSTAKAR VARÚÐARRÁÐSTAFANIR VIÐ FÖRGUN LYFJALEIFA
English: Common: urinary incontinence Common: urinary incontinence
Icelandic: Algengar: heyrnarleysi Algengar: heyrnarleysi
English: • Weakness
Icelandic: • skjálfta
English: There are no data for children < 7 months of age.
Icelandic: Engar upplýsingar liggja fyrir um börn < 7 mánaða.
English: (see section 5.1).
Icelandic: (sjá kafla 5.1).
English: These changes reversed after cessation of treatment.
Icelandic: Þessar breytingar gengu til baka eftir að meðferð var hætt.
English: You will then have a 2-week break where you will not be given the infusion.
Icelandic: Þú færð síðan 2 vikna hlé þar sem þú færð ekkert innrennsli.
English: Yes No
Icelandic: Já Nei
English: • Do not open the package.
Icelandic: Opnið ekki pakkninguna.
English: 5 years (2°C - 8°C)
Icelandic: 5 ár (2°C - 8°C)
English: These supplies are also required, but not included in the package
Icelandic: Einnig er þessi búnaður nauðsynlegur, en hann fylgir ekki með pakkningunni
English: BSA = body surface area
Icelandic: BSA = líkamsyfirborð (body surface area)
English: Currently available data in children are described in section 4.8 and 5.1.
Icelandic: Fyrirliggjandi upplýsingar um börn eru tilgreindar í kafla 4.8 og 5.1.
English: 6.1 months
Icelandic: 6,1 mánuðir
English: Your doctor will discuss with you how long your treatment will last.
Icelandic: Læknirinn ræðir við þig um það hversu lengi meðferðin muni standa.
English: Additionally, the side effects that happened more often in adolescents and children include:
Icelandic: Aukaverkanir sem komu oftar fyrir hjá unglingum og börnum eru:
English: ≥50% to <75%
Icelandic: ≥50% til <75%
English: You should not use BLINCYTO during pregnancy, unless your doctor thinks that it is the best medicine for you.
Icelandic: Þú skalt ekki nota BLINCYTO á meðgöngu nema læknirinn telji að það sé besta lyfið fyrir þig.
English: Do not try to restart your pump.
Icelandic: Ekki reyna að kveikja aftur á dælunni.
English: Your doctor will discuss with you if you can continue treatment at home after your initial hospital stay.
Icelandic: Læknirinn ræðir við þig hvort þú getir haldið meðferð áfram heima eftir fyrstu dvölina á sjúkrahúsi.
English: BLINCYTO should not be used in children below 1 year of age.
Icelandic: BLINCYTO á ekki að nota handa börnum yngri en 1 árs.
English: Days 29-42
Icelandic: Dagar 29-42
English: If you respond to this treatment, your doctor may decide to give you up to 3 additional cycles of treatment.
Icelandic: Ef þú svarar þessari meðferð, er hugsanlegt að læknirinn ákveði að gefa þér allt að 3 viðbótarlotur af meðferð.
English: Do not drive, use heavy machines, or engage in hazardous activities while you are being given BLINCYTO.
Icelandic: Ekki aka, nota þungar vélar eða taka þátt í hættulegum athöfnum meðan þú færð BLINCYTO.
English: The median time to onset was 7.5 days.
Icelandic: Miðgildi tíma þar til einkenni komu fram var 7,5 dagar.
English: The clinical significance of these imaging changes is unknown.
Icelandic: Klínískt vægi þessara breytinga á myndatökum er ekki þekkt.
English: The primary endpoint was overall survival (OS).
Icelandic: Aðalendapunktur var heildarlifun (OS).
English: ≥75% to <90%
Icelandic: ≥75% til <90%
English: Your doctor will check if you should have the vaccination.
Icelandic: Læknirinn athugar hvort þú ættir að fá bólusetninguna.
English: Special instructions to support accurate preparation
Icelandic: Sérstakar leiðbeiningar til að tryggja réttan undirbúning
English: Berkshire, SL1 4DX UK
Icelandic: Berkshire, SL1 4DX Bretland
English: The safety and efficacy of BLINCYTO in children < 1 year of age have not yet been established.
Icelandic: Ekki hefur enn verið sýnt fram á öryggi og verkun BLINCYTO hjá börnum < 1 árs.
English: The mean (SD) half-life was 2.11 (1.42) hours.
Icelandic: Meðal (staðalfrávik) helmingunartími var 2,11 (1,42) klst.
English: • if you think you may need any vaccinations in the near future, including those needed to travel to other countries.
Icelandic: ef þú telur að þú þurfir á bólusetningum að halda á næstunni, einnig þær sem nauðsynlegar eru vegna ferða til annarra landa.
English: The infusion rate may be faster or slower depending on how often the bag is changed.
Icelandic: Innrennslishraðinn kann að vera meiri eða minni eftir því hversu oft er skipt um poka.
English: - Do not freeze.
Icelandic: - Má ekki frjósa.
English: Patients may receive 2 cycles of treatment.
Icelandic: Sjúklingar kunna að fá 2 meðferðarlotur.
English: b MedDRA high level group terms (MedDRA version 18.1).
Icelandic: b MedDRA efsta flokkunarheiti (MedDRA útgáfa 18.1).
English: Store at 2°C - 8°C if not used immediately.
Icelandic: Geymið við 2°C - 8°C ef lyfið er ekki notað tafarlaust.
English: Contact your doctor or nurse immediately if:
Icelandic: Hafðu tafarlaust samband við lækninn eða hjúkrunarfræðinginn ef:
English: The median overall survival (OS) was 17.7 months (CI 3.1 - not estimable).
Icelandic: Miðgildi heildarlifunar var 17,7 mánuðir (CI:3,1 - ekki hægt að meta).
English: There is limited experience with BLINCYTO in patients ≥ 75 years of age.
Icelandic: Takmörkuð reynsla er af notkun BLINCYTO hjá sjúklingum ≥ 75 ára.
English: Forest plot of CR/CRh* rate during the first two cycles for study MT103-211 (primary analysis set)
Icelandic: Forest graf fyrir CR/CRh* svörun í fyrstu tveimur meðferðarlotum rannsóknar MT103-211 (frumgreiningarhópur)
English: Each pack of BLINCYTO contains:
Icelandic: Hver pakkning af BLINCYTO inniheldur:
English: Number of subjects at Risk
Icelandic: Fjöldi einstaklinga í áhættu
English: Some of these side effects may be serious.
Icelandic: Sumar þessara aukaverkana kunna að reynast alvarlegar.
English: Days 8-28 Days 29-42 Days 1-28 Days 29-42
Icelandic: Dagar 8-28 Dagar 29-42 Dagar 1-28 Dagar 29-42
English: [4.2 to 7.5 months]
Icelandic: [4,2 til 7,5 mánuðir]
English: *, 1 patient had progressive disease (OS 2.3 months) and 2 were non-responders (OS 1.1 months and 8.7 months, respectively).
Icelandic: *, 1 sjúklingur hafði framsækinn sjúkdóm (heildarlifun 2,3 mánuðir) og 2 svöruðu ekki meðferðinni (heildarlifun 1,1 mánuðir og 8,7 mánuðir, í þeirri röð).
English: [4.8 to 8.3 months]
Icelandic: [4,8 til 8,3 mánuðir]
English: Final interpretation of MRD results followed EuroMRD Consortium guidelines.
Icelandic: á MRD niðurstöðum var farið eftir leiðbeiningum EuroMRD Consortium.
English: Always use this medicine exactly as your doctor, pharmacist or nurse have told you.
Icelandic: Notið lyfið alltaf eins og læknirinn, lyfjafræðingur eða hjúkrunarfræðingurinn hefur sagt til um.
English: You may also be given medicines to reduce fever.
Icelandic: Hugsanlegt er að þú fáir einnig lyf sem lækka hita.
English: Your doctor will assess your nervous system and conduct tests before deciding if you should receive BLINCYTO.
Icelandic: Læknirinn metur taugakerfið og gerir próf áður en ákveðið verður hvort þú eigir að fá BLINCYTO.
English: Other instructions
Icelandic: Aðrar leiðbeiningar
English: Reconstituted solution:
Icelandic: Blönduð lausn:
English: Do not adjust the settings on the pump, even if there is a problem or the pump alarm sounds.
Icelandic: Ekki breyta stillingunum á dælunni, jafnvel þó vandamál komi upp eða viðvörunarhljóð heyrist í dælunni.
English: Cytokines including IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TNF-α and IFN-γ were measured and, IL-6, IL-10 and IFN-γ were most elevated.
Icelandic: Frumuboðar, þ.m.t. IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TNF-α og IFN-γ voru mældir og IL-6, IL-10 og IFN-γ höfðu hækkað mest.
English: If an interruption due to an adverse event is longer than 7 days, start a new cycle.
Icelandic: Ef hlé vegna aukaverkunar er lengra en 7 dagar skal hefja nýja lotu.
English: 7.5 months [4.0 to 11.8 months]
Icelandic: 7,5 mánuðir [4,0 til 11,8 mánuðir]
English: Because the health-related quality of life results are based on a post-hoc sensitivity analysis, the results should be interpreted with caution.
Icelandic: Vegna þess að niðurstöðurnar um heilsutengd lífsgæði eru byggðar á eftirá næmisgreiningu ber að túlka niðurstöðurnar með varúð.
English: Some vaccines must not be given within two weeks before, at the same time as or in the months after you receive treatment with BLINCYTO.
Icelandic: Sum bóluefni má ekki gefa síðustu tvær vikurnar fyrir, samtímis eða á næstu mánuðunum eftir að þú færð meðferð með BLINCYTO.
English: These may include corticosteroids (e.g. dexamethasone).
Icelandic: Þau geta m.a. verið barksterar (t.d. dexamethason).
English: Generally, safety was similar between elderly patients (≥ 65 years of age) and patients less than 65 years of age treated with BLINCYTO.
Icelandic: Almennt var öryggi svipað hjá öldruðum sjúklingum (≥ 65 ára) og sjúklingum yngri en 65 ára sem fengu meðferð með BLINCYTO.
English: Your doctor will determine when your BLINCYTO infusion bag will be changed, which may range from every day to every 4 days.
Icelandic: Læknirinn ákveður hvenær skipta þurfi um BLINCYTO innrennslispoka, en það getur verið allt frá daglega og upp í það að vera á 4 daga fresti.
English: Do not shake.
Icelandic: Ekki hrista.
English: This is particularly important when using an ambulatory infusion pump.
Icelandic: Þetta er einkum mikilvægt þegar verið er að nota innrennslisdælu utan sjúkrahúss.
English: • Do not refrigerate or freeze the package.
Icelandic: Setjið pakkninguna hvorki í kæli né látið frjósa.
English: - if you are breast-feeding.
Icelandic: - ef þú ert með barn á brjósti.
English: Results from an in vitro test in human hepatocytes suggest that blinatumomab did not affect CYP450 enzyme activities.
Icelandic: Niðurstöður úr in vitro prófi á lifrarfrumum úr mönnum gefa til kynna að blinatumomab hafi ekki áhrif á CYP450 ensímvirkni.
English: There is a possibility of a higher risk of neurologic events in this population.
Icelandic: Hugsanlega er meiri hætta á aukaverkunum á taugakerfi hjá þessum hópi.
English: • 21-23 gauge needle(s) (recommended)
Icelandic: 21-23 víddar nál(ar) (ráðlagt)
English: This was a two-part study, a dose-finding part to determine the appropriate dosing regimen, followed by a single-arm efficacy part using this regimen.
Icelandic: Þetta var tvíþætt rannsókn, skammtahluti (dose finding part) til að ákvarða viðeigandi skammtaáætlun og síðan einarma verkunarhluti með notkun á þeirri skammtaáætlun.
English: Kaplan-Meier curve of overall survival
Icelandic: Mynd 1. Kaplan-Meier ferill fyrir heildarlifun
English: The majority of patients who respond to blinatumomab achieve a response after 1 cycle (see section 5.1).
Icelandic: Meirihluti sjúklinga sem svara blinatumomabi ná fram svörun eftir 1 lotu (sjá kafla 5.1).
English: d. n1: number of patients who achieved MRD response and the respective remission status; n2: number of patients who achieved the respective remission status.
Icelandic: d. n1: fjöldi sjúklinga sem náði MRD svörun og viðkomandi sjúkdómshléi; n2: fjöldi sjúklinga sem náði viðkomandi sjúkdómshléi.
English: Months
Icelandic: Mánuðir
English: Body surface area (0.37 to 2.70 m2) influences the pharmacokinetics of blinatumomab.
Icelandic: Líkamsyfirborð (0,37 til 2,70 m2) hefur áhrif á lyfjahvörf blinatumomabs.
English: Action for patients less than 45 kg
Icelandic: Viðbrögð hjá sjúklingum sem eru léttari en 45 kg
English: - When refrigerated, the infusion bags must be used within 10 days of preparation.
Icelandic: - Þegar innrennslispokinn er geymdur í kæli þarf að nota hann innan 10 daga frá undirbúningi.
English: 3.8 months (1.9, 19.0)
Icelandic: 3,8 mánuðir (1,9; 19,0)
English: Additional information is provided in “Description of selected adverse reactions”.
Icelandic: Frekari upplýsingar er að finna í „Lýsing á völdum aukaverkunum“.
English: Do not shake the reconstituted solution.
Icelandic: Hristið ekki blandaða lausn.
English: Results suggest that age (7 months to 80 years) and gender do not influence the pharmacokinetics of blinatumomab.
Icelandic: Niðurstöður gefa til kynna að aldur (7 mánaða til 80 ára) og kyn hafi ekki áhrif á lyfjahvörf blinatumomabs.
English: Tell your doctor immediately if you get any of the following or combination of the following side effects:
Icelandic: Láttu lækninn vita tafarlaust ef þú færð einhverja eða fleiri en eina af eftirfarandi aukaverkunum:
English: BLINCYTO was also evaluated in an open-label, multicentre, single-arm phase II study of 189 patients.
Icelandic: BLINCYTO var einnig metið í opinni, fjölsetra einarma II. stigs rannsókn hjá 189 sjúklingum.