FrancophonIA/ELRC3.0 huggingface dataset:
English: DARZALEX infusion should be interrupted for IRRs of any severity and medical management/supportive treatment for IRRs should be instituted as needed.
Icelandic: Stöðva skal innrennsli með DARZALEX ef fram koma viðbrögð tengd innrennsli, af hvaða stigi sem er, og hefja læknismeðferð/stuðningsmeðferð við viðbrögðum tengdum innrennsli eftir þörfum.
English: Serious adverse reactions were pneumonia, bronchitis, upper respiratory tract infection, pulmonary oedema, influenza, pyrexia, dehydration, diarrhoea and atrial fibrillation.
Icelandic: Alvarlegar aukaverkanir voru lungnabólga, berkjubólga, sýkingar í efri öndunarvegi, lungnabjúgur, inflúensa, hiti, vessaþurrð, niðurgangur og gáttatif.
English: Following dilution the DARZALEX infusion should be intravenously administered at the initial infusion rate presented in Table 5 below.
Icelandic: DARZALEX innrennsli í bláæð með upphaflegum innrennslishraða eins og sýnt er í töflu 5 hér á eftir.
English: A Mantel-Haenszel estimate of the common odds ratio for stratified tables is used.
Icelandic: Mantel-Haenszel mat á almennu líkindahlutfalli fyrir lagskiptar töflur er notað.
English: • build up of fluid in the lungs making you short of breath
Icelandic: vökvasöfnun í lungum sem veldur mæði
English: Rare (may affect up to 1 in 1,000 people):
Icelandic: Koma örsjaldan fyrir (geta komið fyrir hjá allt að 1 af 1.000 einstaklingum):
English: 20 mL concentrate in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 400 mg of daratumumab.
Icelandic: I með gúmmítappa og álinnsigli með smelluloki, sem inniheldur 400 mg af daratumumabi.
English: Table 1: DARZALEX dosing schedule in combination with lenalidomide (4-week cycle dosing regimen) and monotherapy
Icelandic: Skammtaáætlun fyrir DARZALEX í samsettri meðferð með lenalidomidi (4-vikna meðferðarlotur) og einlyfjameðferð
English: Dosing schedule in combination with bortezomib, thalidomide and dexamethasone (4-week cycle regimens) for treatment of newly diagnosed patients eligible for autologous stem cell transplant (ASCT):
Icelandic: Skammtaáætlun við samsetta meðferð með bortezomibi, talidomidi og dexametasoni (4-vikna meðferðarlotur) hjá nýgreindum sjúklingum þegar samgena stofnfrumuígræðsla á við:
English: Study MMY3007, an open-label, randomised, active-controlled Phase III study, compared treatment with DARZALEX 16 mg/kg in combination with bortezomib, melphalan and prednisone (D-VMP), to treatment with VMP in patients with newly diagnosed multiple myeloma.
Icelandic: stigs rannsókn með virkum samanburði bar saman meðferð með DARZALEX 16 mg/kg í samsettri meðferð með bortezomibi, melphalani og prednisoni (D-VMP) og meðferð með VMP hjá sjúklingum með nýgreint mergæxli.
English: Stringent complete response (sCR) [n(%)] 63 (18.0) Complete response (CR) [n(%)] Very good partial response (VGPR) [n(%)] 100 (28.6) Partial response (PR) [n(%)]
Icelandic: Ströng alger svörun (sCR) [n (%)]) Alger svörun (CR) [n(%)] Mjög góð hlutasvörun (VGPR) [n(%)] Hlutasvörun (Partial response (PR)) [n(%)] MRD neikvætt gildi (95% CI)
English: Median Time to Response [months (range)]
Icelandic: Miðgildi lifunar án versnunar - mánuðir
English: It should be recognised that daratumumab bound to RBCs may mask detection of antibodies to minor antigens in the patient's serum.
Icelandic: Hafa þarf í huga að daratumumab bundið við rauð blóðkorn getur valdið því að ekki mælast mótefni gegn vægum mótefnavökum í sermi sjúklingsins.
English: Severe reactions have occurred, including bronchospasm, hypoxia, dyspnoea, hypertension, laryngeal oedema and pulmonary oedema.
Icelandic: Alvarleg viðbrögð hafa komið fram, þ.á m. berkjukrampi, súrefnisskortur, mæði, háþrýstingur, bjúgur í barkakýli og lungnabjúgur.
English: Dilution volume
Icelandic: Stigaukning hraða
English: The rates of engraftment and haematopoietic reconstitution was similar among the transplanted subjects in the D-VTd and VTd arms (D-VTd: 99.8%; VTd: 99.6%; as measured by the recovery of neutrophils > 0.5 x 10
Icelandic: Tíðni frumuígræðslu og enduruppbyggingar blóðfrumnamyndunar var svipuð hjá þeim sem fengu ígræðslu í D-VTd hópnum og VTd hópnum (D-VTd: 99,8%; VTd:
English: Bortezomib was administered by SC injection or IV infusion at a dose of 1.3 mg/m2 body surface area twice weekly for two weeks (Days 1, 4, 8, and 11)
Icelandic: Bortezomib var gefið með inndælingu undir húð eða í innrennsli í bláæð í skammti 1,3 mg/m2 líkamsyfirborð tvisvar sinnum í viku í tvær vikur (dagar 1, 4, 8 og 10) í endurteknum 21 dags (3-vikna) meðferðarlotum, í samtals 8 lotur.
English: A total of 1085 patients were randomized: 543 to the D-VTd arm and 542 to the VTd arm.
Icelandic: 543 í D-VTd hópinn og 542 í VTd hópinn.
English: • muscle spasms
Icelandic: • lágt blóðkalsíumgildi
English: Table 7: Additional efficacy results from Study MMY3008
Icelandic: Viðbótarniðurstöður verkunar úr rannsókn MMY3008
English: Additional efficacy results from Study MMY3003 are presented in Table 11 below.
Icelandic: Viðbótarniðurstöður verkunar úr rannsókn MMY3003 eru sýndar í töflu 11 hér á eftir.
English: Severe infusion-related reactions included bronchospasm, dyspnoea, laryngeal oedema, pulmonary oedema, hypoxia, and hypertension.
Icelandic: Alvarleg viðbrögð tengd innrennsli voru m.a. berkjukrampi, mæði, bjúgur í barkakýli, lungnabjúgur, súrefnisskortur og háþrýstingur.
English: • bronchitis
Icelandic: • bakverkur
English: The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 4.
Icelandic: Ráðlagður skammtur er DARZALEX 16 mg/kg líkamsþyngdar gefið í innrennsli í bláæð samkvæmt eftirfarandi skammtaáætlun í töflu 2.
English: DARZALEX will be given to you by a doctor or nurse.
Icelandic: Læknir eða hjúkrunarfræðingur mun gefa þér DARZALEX.
English: The pharmacokinetics (PK) of daratumumab following intravenous administration of daratumumab monotherapy were evaluated in patients with relapsed and refractory multiple myeloma at dose levels from 0.1 mg/kg to 24 mg/kg.
Icelandic: Lyfjahvörf daratumumabs eftir lyfjagjöf með daratumumabi sem einlyfjameðferð í bláæð voru metin hjá sjúklingum með endurkomið mergæxli sem svaraði ekki meðferð við skammtagildi frá 0,1 mg/kg að 24 mg/kg.
English: Pre- and post-infusion medications should be administered to reduce the risk of infusion-related reactions (IRRs) with daratumumab.
Icelandic: Gefa skal lyf fyrir og eftir innrennsli til að minnka hættuna á viðbrögðum tengdum innrennsli með daratumumabi.
English: First dose of the every-2-week dosing schedule is given at Week 9 First dose of the every-4-week dosing schedule is given at Week 25
Icelandic: 9 Fyrsti skammtur í 4-vikna skammtaáætluninni er gefinn í viku 25
English: • Visually inspect parenteral medicinal products for particulate matter and discolouration prior to administration.
Icelandic: Skoðið lyf til inndælingar með tilliti til agna og mislitunar fyrir lyfjagjöf.
English: One mL of concentrate contains 20 mg daratumumab.
Icelandic: Einn ml af þykkni inniheldur 20 mg daratumumab.
English: Overall response (sCR+CR+VGPR+PR) n(%) p-value
Icelandic: Heildarsvörun (sCR+CR+VGPR+PR) n(%) p-gildi
English: The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 3.
Icelandic: Ráðlagður skammtur er DARZALEX 16 mg/kg líkamsþyngdar gefið í innrennsli í bláæð samkvæmt eftirfarandi skammtaáætlun í töflu
English: Summary of the safety profile
Icelandic: Virkniniðurstöður fyrir rannsókn
English: Combination treatment with bortezomib, thalidomide and dexamethasone (VTd) in patients eligible for autologous stem cell transplant (ASCT):
Icelandic: Samsett meðferð með bortezomibi, talidomidi og dexametasoni (VTd) þegar samgena stofnfrumuígræðsla á við:
English: Due to the high affinity to a unique epitope on CD38, daratumumab is not anticipated to alter drug-metabolising enzymes.
Icelandic: Ekki er búist við að daratumumab, sem hefur mikla sækni í einstakan mótefnavísi á CD38, breyti ensímum sem eiga þátt í lyfjaumbroti.
English: Study MMY3008, an open-label, randomized, active-controlled Phase III study, compared treatment with DARZALEX 16 mg/kg in combination with lenalidomide and low-dose dexamethasone (DRd) to treatment with lenalidomide and low-dose dexamethasone (Rd) in patients with newly diagnosed multiple myeloma.
Icelandic: stigs rannsókn með virkum samanburði bar saman meðferð með DARZALEX 16 mg/kg í samsettri meðferð með lenalidomidi og lágskammta dexametasoni (DRd) og meðferð með lenalidomidi og lágskammta dexametasoni (Rd) hjá sjúklingum með nýgreint mergæxli.
English: Study MMY3003 demonstrated an improvement in PFS in the DRd arm as compared to the Rd arm; the median PFS had not been reached in the DRd arm and was 18.4 months in the Rd arm (HR=0.37; 95% CI: 0.27, 0.52; p<0.0001), representing 63% reduction in the risk of disease progression or death in patients treated with DRd (see Figure 3).
Icelandic: DRd arminum og var 18,4 mánuðir í Rd arminum (áhættuhlutfall=0,37, 95% CI: 0,27; 0,52, p<0,0001), sem táknar 63% minni hættu á versnun sjúkdóms eða dauðsfalli hjá sjúklingum sem fengu meðferð með DRd (sjá mynd 3).
English: Infections and infestations Pneumonia
Icelandic: LYFJAFORM OG INNIHALD
English: Newly diagnosed multiple myeloma
Icelandic: Fjöldi sjúklinga með metanlega svörun
English: MRD negative rate (95% CI)
Icelandic: Rd (95% CI)
English: Table 6: Adverse reactions in multiple myeloma patients treated with DARZALEX
Icelandic: Aukaverkanir hjá sjúklingum með mergæxli sem fengu meðferð með DARZALEX
English: • in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
Icelandic: • í samsettri meðferð með bortezomibi, talidomidi og dexametasoni til meðferðar hjá fullorðnum sjúklingum með nýgreint mergæxli þegar samgena stofnfrumuígræðsla á við.
English: 5 mL concentrate in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 100 mg of daratumumab.
Icelandic: I með gúmmítappa og álinnsigli með smelluloki, sem inniheldur 100 mg af daratumumabi.
English: Kaplan-Meier Curve of Primary Analysis of PFS in Study MMY3007
Icelandic: Kaplan-Meier graf yfir aðalgreiningu á lifun án versnunar í rannsókn MMY3007
English: Relapsed/refractory patient studies: DVd: 21%, Vd: 19%; DRd: 27%, Rd: 23%; DPd: 28% Newly diagnosed patient studies: D-VMP: 23%, VMP: 15%; DRd: 32%, Rd: 23%; D-VTd: 22%, VTd: 20%.
Icelandic: 32%, Rd: 23%; D-VTd:
English: Tabulated list of adverse reactions
Icelandic: Hlutfall lifunar án versnunar
English: Common (may affect up to 1 in 10 people):
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af 10 einstaklingum):
English: d.o.o.
Icelandic: D-VMP
English: Odds ratio with 95% CI p-value
Icelandic: Líkindahlutfall með 95% CI P-gildi
English: Odds ratio with 95% CI P-value
Icelandic: Líkindahlutfall með 95% CI p-gildi
English: Lenalidomide (25 mg once daily orally on Days 1-21 of repeated 28-day [4-week] cycles) was given with low dose oral or intravenous dexamethasone 40 mg/week (or a reduced dose of 20 mg/week for patients >75 years or body mass index [BMI] <18.5).
Icelandic: [4-vikna] meðferðarlotum) var gefið með lágskammta dexametasoni, til inntöku eða í bláæð, 40 mg/viku (eða minni skammtur 20 mg/viku fyrir sjúklinga >75 ára eða með líkamsþyngdarstuðul [BMI] <18,5).
English: NK cells are known to express high levels of CD38 and are susceptible to daratumumab mediated cell lysis.
Icelandic: Þekkt er að náttúrulegar drápsfrumur tjá há gildi af CD38 og eru næmar fyrir daratumumab-miðlaðri sundrun frumu.
English: Study MMY3003, an open-label, randomised, active-controlled Phase III trial, compared treatment with DARZALEX 16 mg/kg in combination with lenalidomide and low-dose dexamethasone (DRd) to treatment with lenalidomide and low-dose dexamethasone (Rd) in patients with relapsed or refractory multiple myeloma who had received at least one prior therapy.
Icelandic: stigs rannsókn með virkum samanburði, bar saman meðferð með DARZALEX 16 mg/kg ásamt lenalidomidi og lágskammta dexametasoni (DRd) við meðferð með lenalidomidi og lágskammta dexametasoni (Rd) hjá sjúklingum með endurkomið mergæxli eða mergæxli sem svaraði ekki fyrri meðferð, sem fengið höfðu a.m.k. eina fyrri meðferð.
English: Immune system disorders Anaphylactic reaction b Rare Metabolism and nutrition Decreased appetite Very Common 12
Icelandic: Bráðaofnæmisviðbrögð b Mjög sjaldgæfar
English: The median duration of response had not been reached in the DRd group and was 34.7 months (95% CI: 30.8, not estimable) in the Rd group.
Icelandic: DRd hópnum og var 34,7 mánuðir (95% CI:
English: Study MMY3004, an open-label, randomised, active-controlled Phase III trial, compared treatment with DARZALEX 16 mg/kg in combination with bortezomib and dexamethasone (DVd), to treatment with bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma who had received at least one prior therapy.
Icelandic: stigs rannsókn með virkum samanburði, bar saman meðferð með DARZALEX 16 mg/kg ásamt bortezomibi og dexametasoni (DVd) við meðferð með bortezomibi og dexametasoni (Vd) hjá sjúklingum með endurkomið mergæxli eða mergæxli sem svaraði ekki fyrri meðferð, sem höfðu fengið a.m.k. eina fyrri meðferð.
English: Option 2 (Split dose infusion) Week 1 Day 1 (8 mg/kg)
Icelandic: Vika 1 dagur 1 (8 mg/kg)
English: Figure 4: Kaplan-Meier Curve of PFS in Study MMY3004
Icelandic: Kaplan-Meier graf yfir lifun án versnunar í rannsókn MMY3004
English: • low number of a type of blood cell called platelets which help to clot blood (thrombocytopenia)
Icelandic: lítill fjöldi tegundar blóðfrumna sem eru kallaðar blóðflögur og hjálpa við storknun blóðs
English: Musculoskeletal and connective tissue disorders
Icelandic: Truflun á rafdrætti sermispróteina og mótefnalitun
English: Four population PK analyses were performed to describe the PK characteristics of daratumumab and to evaluate the influence of covariates on the disposition of daratumumab in patients with multiple myeloma; Analysis 1 (n=223) in patients receiving DARZALEX monotherapy while Analysis 2 (n=694), Analysis 3 (n=352) and Analysis 4 (n=355) were conducted in patients with multiple myeloma that received daratumumab combination therapies.
Icelandic: DARZALEX einlyfjameðferð en greining 2 (n=694), greining 3 (n=352) og greining 4 (n=355) voru gerðar á sjúklingum með mergæxli sem fengu daratumumab í samsettri meðferð.
English: Decreased blood cell counts
Icelandic: Blóðsykurshækkun Algengar Blóðkalsíumlækkun
English: When DARZALEX dosing was interrupted in the setting of ASCT (Study MMY3006) for a median of 3.75 (range: 2.4; 6.9) months, upon re-initiation of DARZALEX the incidence of IRRs was 11% at first infusion following ASCT.
Icelandic: 2,4; 6,9) var tíðni innrennslistengdra viðbragða 11% við fyrsta innrennsli þegar notkun DARZALEX var hafin á ný eftir samgena stofnfrumuígræðsluna.
English: Study MMY3008 showed an improvement in Progression Free Survival (PFS) in the DRd arm as compared to the Rd arm; the median PFS had not been reached in the DRd arm and was 31.9 months in the Rd arm (hazard ratio [HR]=0.56; 95% CI: 0.43, 0.73; p<0.0001), representing 44% reduction in the risk of disease progression or death in patients treated with DRd.
Icelandic: DRd arminum og var 31,9 mánuðir í Rd arminum (áhættuhlutfall=0,56, 95% CI: 0,43; 0,73, p<0,0001), sem táknar 44% minni hættu á versnun sjúkdóms eða dauðsfalli hjá sjúklingum sem fengu meðferð með DRd.
English: st
Icelandic: o
English: 95% CI (%) Odds ratio with 95% CI p-value
Icelandic: MRD neikvætt gildi (95% CI) Líkindahlutfall með 95% CI P-gildi
English: Figure 3: Kaplan-Meier Curve of PFS in Study MMY3003
Icelandic: Kaplan-Meier graf yfir lifun án versnunar í rannsókn MMY3003
English: Treatment phase
Icelandic: Meðferðarfasi
English: No dose reductions of DARZALEX are recommended.
Icelandic: DARZALEX er ekki ráðlögð.
English: HBV screening should be performed in all patients before initiation of treatment with DARZALEX.
Icelandic: Áður en DARZALEX meðferð er hafin á að skima fyrir lifrarbólguveiru B hjá öllum sjúklingum.
English: 95% CI (%) Odds ratio with 95% CI MRD negativity in combination with CR or better c n(%)
Icelandic: MRD neikvætt gildi ásamt CR eða betra n(%)
English: • irregular heart beat (atrial fibrillation)
Icelandic: • óreglulegur hjartsláttur (gáttatif)
English: An odds ratio > 1 indicates an advantage for D-VMP. p-value from Fisher's exact test.
Icelandic: Líkindahlutfall > 1 sýnir ávinning fyrir D-VMP.
English: However, the employed assay has limitations in detecting anti-daratumumab antibodies in the presence of high concentrations of daratumumab.
Icelandic: Mæliaðferðin sem notuð er hefur þó takmarkanir við greiningu and-daratumumab mótefna við háa þéttni daratumumabs.
English: • Do not infuse DARZALEX concomitantly in the same intravenous line with other agents.
Icelandic: DARZALEX með innrennsli samhliða öðrum lyfjum í sömu bláæðaslöngu.
English: Figure 1: Kaplan-Meier Curve of PFS in Study MMY3008
Icelandic: Kaplan-Meier graf yfir lifun án versnunar sjúkdóms í rannsókn MMY3008
English: Each vial of 20 mL concentrate contains 400 mg of daratumumab (20 mg/mL).
Icelandic: Hvert 20 ml hettuglas með þykkni inniheldur 400 mg af daratumumabi (20 mg/ml).
English: Pre-infusion medication
Icelandic: Lyfjagjöf fyrir innrennsli
English: On DARZALEX infusion days, the dexamethasone dose was given as a pre-infusion medication.
Icelandic: DARZALEX var dexametason skammturinn gefinn sem forlyf fyrir innrennsli.
English: • itchy, runny or blocked nose
Icelandic: • kláði í nefi, nefrennsli eða stífla
English: Each vial of 5 mL concentrate contains 100 mg of daratumumab (20 mg/mL).
Icelandic: Hvert 5 ml hettuglas með þykkni inniheldur 100 mg af daratumumabi (20 mg/ml).
English: Fertility
Icelandic: Hrvatska
English: Constipation Nausea Vomiting Pancreatitis
Icelandic: Berkjubólga Sýking í efri öndunarvegi Þvagfærasýking
English: • Grade 3 (severe): Once reaction symptoms resolve, restarting of the infusion may be considered at no more than half the rate at which the reaction occurred.
Icelandic: Þegar einkenni viðbragða hjaðna má íhuga að hefja aftur innrennsli með a.m.k. helmingi minni hraða en þegar viðbrögðin tengd innrennsli komu fram.
English: st infusion), and the mean (SD) ratio of Cmax at steady-state to Cmax after the first dose was 1.6 (0.5).
Icelandic: Miðað við þýðisgreiningu lyfjahvarfa fyrir daratumumab einlyfjameðferð (greining 1) nær daratumumab jafnvægi á u.þ.b. 5 mánuðum með 4-vikna skammtatímabili (við 21. innrennslið) og meðal (staðalfrávik) hlutfall Cmax við jafnvægi og Cmax eftir fyrsta skammtinn var 1,6 (0,5).
English: Janssen Sciences Ireland UC Tel: +353 1 800 709 122
Icelandic: Johnson & Johnson România SRL Tel: +40 21 207 1800
English: DARZALEX is for intravenous use.
Icelandic: DARZALEX er ætlað til notkunar í bláæð.
English: Chills
Icelandic: flensa
English: Table 10: IRC assessed efficacy results for study MMY2002 Efficacy endpoint
Icelandic: MMY2002 metnar af IRC
English: Most cases occurred within 2 months of alemtuzumab dosing.
Icelandic: Flest tilvik komu fram innan 2 mánaða eftir gjöf alemtuzumabs.
English: EMA/PRAC/595696/2018
Icelandic: EMA/PRAC/667056/2018 Corr2
English: Adopted at the 3-6 September 2018 PRAC
Icelandic: Samþykkt á fundi PRAC 3.-6. september 2018
English: Talk to your doctor before taking [product]:
Icelandic: Leitið ráða hjá lækninum áður en [lyfjaheiti] er notað:
English: Rare side effects (may affect up to 1 in 1000 people)
Icelandic: Mjög sjaldgæfar aukaverkanir (geta komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum)
English: Talk to your doctor <or> <pharmacist> <or> <nurse> before <taking> <using> X
Icelandic: <,> <lyfjafræðingi> <eða hjúkrunarfræðingnum> áður en X er notað
English: Tell your doctor right away if you have symptoms of infection such as fever or swollen glands.
Icelandic: Segðu lækninum strax frá því ef þú færð einkenni um sýkingu svo sem hita eða bólgna kirtla.
English: In clinical trials, a single dose of infliximab 5 mg/kg was added unless contraindicated.
Icelandic: Í klínískum rannsóknum var stökum skammti af infliximab 5 mg/kg bætt við, nema um frábendingu væri að ræða.
English: Protect your skin from sun exposure and UV rays while <taking> <using> X 4.
Icelandic: Þú skalt vernda húðina22 gegn sólarljósi og UV geislum á meðan þú <tekur> <notar> X
English: A cumulative doseresponse relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Icelandic: 1,7-2,6) sem jókst upp17 í OR 3,9 (3,0-4,9) við mikla notkun18 (~25.000 mg) og OR 7,7 (5,7-10,5) fyrir stærsta uppsafnaðan skammt19 (~100.000 mg) (sjá einnig kafla 4.4).
English: - if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Icelandic: - ef þú færð húðkrabbamein eða óvænta húðskemmd meðan á meðferð stendur.
English: High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.23-1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
Icelandic: Mikil notkun hydrochlorothiazids (≥50.000 mg uppsafnað)13 tengdist leiðréttu líkindahlutfalli (adjusted odds ratio (OR))14 sem var 1,29 (95% CI: 1,23-1,35) fyrir grunnfrumukrabbamein og15 3,98 (95% CI: 3,68-4,31) fyrir flöguþekjukrabbamein.
English: One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively.
Icelandic: Ein rannsókn11 tók til hóps sem náði yfir 71.533 tilvik um grunnfrumukrabbamein og 8.629 flöguþekjukrabbamein parað við 1.430.833 og 172.462 einstaklinga í viðmiðunarþýði12, talið í sömu röð.
English: Infections
Icelandic: Aukaverkanir
English: Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer).
Icelandic: Meðferð með hydrochlorothiazidi, einkum við langtímanotkun21 stórra skammta, getur aukið hættu á sumum gerðum af húð- eða varakrabbameini (húðkrabbamein sem ekki er sortuæxli).
English: Possible side effects Uncommon side effects These may affect up to 1 in 100 people: - reduction in blood platelets
Icelandic: Þessar geta komið fram hjá allt 1 af hverjum 100 einstaklingum: - fækkun blóðflagna
English: - if you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular EhlersDanlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).
Icelandic: - ef þú hefur fjölskyldusögu um ósæðargúlp eða ósæðarrof eða aðra áhættuþætti eða ástand sem eykur hættu á slíku (t.d. bandvefskvilla svo sem Marfans-heilkenni, eða æðaafbrigði Ehlers Danlos heilkennis eða æðakvilla svo sem Takayasu slagæðabólgu, risafrumu slagæðarbólgu, Behcet sjúkdóm, háan blóðþrýsting eða þekkta æðakölkun).
English: Fluoroquinolones for systemic and inhaled use2 - Aortic aneurysm and dissection (EPITT no 18651)
Icelandic: Flúorókínólónar til altækrar notkunar og til innöndunar3Ósæðargúlpur og ósæðarrof (EPITT nr. 18651)
English: Coughing, wheezing and shortness of breath which may be accompanied by a high temperature
Icelandic: Hósti, önghljóð og mæði sem fylgt getur hár hiti.
English: Infliximab must not be used if gastrointestinal perforation or sepsis is suspected (see the Summary of Product Characteristics for infliximab).
Icelandic: Ekki má nota infliximab ef grunur leikur á rofi í meltingarvegi eða sýklasótt(sjá upplýsingar í samantekt á eiginleikum lyfs fyrir infliximab).
English: Diarrhoea or colitis occurring after initiation of ipilimumab must be promptly evaluated to exclude infectious or other alternate etiologies.
Icelandic: Niðurgang eða ristilbólgu sem kemur fram eftir að meðferð með ipilimumabi er hafin verður að meta strax til þess að útiloka sýkingar eða aðrar orsakir.