FrancophonIA/ELRC3.0 huggingface dataset:
English: Trazimera intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
Icelandic: Lyfjaform Trazimera til gjafar í bláæð er ekki ætlað til notkunar undir húð og ætti einungis að gefa með innrennsli í bláæð.
English: • allergic reactions
Icelandic: • bráðaofnæmisviðbrögð
English: • leg cramps
Icelandic: • fótkrampar
English: Detection of HER2 overexpression or HER2 gene amplification in breast cancer Trastuzumab should only be used in patients whose tumours have HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Icelandic: Trastuzúmab á einungis að nota hjá sjúklingum sem hafa æxli sem yfirtjá HER2 eða hafa HER2 genamögnun sem ákvörðuð er með nákvæmri og gildaðri mæliaðferð.
English: Glomerulonephropathy
Icelandic: Lungnavanþroski
English: Breast inflammation/mastitis
Icelandic: LYFJAFORM OG INNIHALD
English: Table 14 Population Predicted Cycle 1 PK Exposure Values (median with 5th - 95th Percentiles) for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients Regimen
Icelandic: Tafla 14 Spáð þýðisgildi fyrir útsetningu í meðferðarlotu 1 (miðgildi með 5. - 95. Hundraðshlutabili) hjá sjúklingum með MBC, EBC og AGC sem fá trastuzúmab í æð samkvæmt mismunandi skömmtunaráætlunum
English: If left ventricular ejection fraction (LVEF) percentage drops ≥10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
Icelandic: Ef útfallsbrot vinstri slegils (LVEF) fellur um ≥10 prósentustig frá grunnlínu
English: Table 15 Population Predicted Steady State PK Exposure Values (median with 5th - 95th Percentiles) for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients
Icelandic: Tafla 15 Spáð þýðisgildi fyrir útsetningu við jafnvægi (miðgildi með 5. - 95. Hundraðshlutabili) hjá sjúklingum með MBC, EBC og AGC sem fá trastuzúmab í æð samkvæmt mismunandi skömmtunaráætlunum
English: Due to nonlinear elimination, total clearance increased with decreasing concentration.
Icelandic: Vegna ólínulegs brotthvarfs jókst heildarúthreinsun með minnkandi þéttni.
English: Trastuzumab plus paclitaxel
Icelandic: +Berkjukrampi
English: Hazard Ratio vs AC→D (95% CI) p-value
Icelandic: Áhættuhlutfall á móti AC→D (95% CI) p-gildi
English: Subsequent Trazimera maintenance doses (weekly regimen:2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.
Icelandic: 2 mg/kg; þriggja vikna áætlun: 6 mg/kg) eins fljótt og auðið er.
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Icelandic: Stungulyf skal skoða m.t.t. agna og upplitunar áður en þau eru gefin.
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab At median duration of follow up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs. AC→P
Icelandic: 1,8 ár fyrir sjúklinga í AC→P hópnum og 2,0 ár fyrir sjúklinga í AC→PH hópnum p-gildi fyrir heildarlifun fór ekki yfir fyrir fram skilgreind tölfræðileg mörk fyrir samanburð á AC→PH og AC→P
English: - intravenous push doxorubicin, at 60 mg/m 2, given every 3 weeks for 4 cycles.
Icelandic: - doxorúbicín með inndælingu í bláæð, 60 mg/m 2, 4 lotur á 3 vikna fresti.
English: Summary of the safety profile
Icelandic: Miðgildi lifunar öryggismörk)
English: Patients are eligible for Trazimera treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Icelandic: Sjúklingar eru ákjósanlegir fyrir Trazimera meðferð ef þeir yfirtjá HER2 eins og lýst er við stig 3+ skv.
English: • difficulty in breathing when lying flat
Icelandic: • óeðlilega lítill vökvi sem umlykur fóstur í legi
English: Trazimera 420 mg powder for concentrate for solution for infusion
Icelandic: Trazimera 420 mg stofn fyrir innrennslisþykkni, lausn.
English: • based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight:
Icelandic: á grundvelli hleðsluskammts sem nemur 4 mg af trastuzúmab/kg líkamsþyngdar eða eftirfylgjandi vikulegum skammti sem nemur 2 mg af trastuzúmab/kg líkamsþyngdar:
English: In patients with EBC eligible for neoadjuvant-adjuvant treatment, Trazimera should be used concurrently with anthracyclines only in chemotherapy-naive patients and only with low-dose anthracycline regimens i.e. maximum cumulative doses of doxorubicin 180 mg/m2 or epirubicin
Icelandic: Hjá sjúklingum með brjóstakrabbamein án meinvarpa sem þykja ákjósanlegir fyrir formeðferð og viðbótarmeðferð ætti eingöngu að nota Trazimera samhliða antracýklínum hjá sjúklingum sem hafa ekki fengið lyfjameðferð áður og eingöngu með litlum skömmtum af antracýklínum, þ.e. hámarks uppsafnaðir skammtar:
English: PHARMACEUTICAL FORM AND CONTENTS
Icelandic: Formeðferð og viðbótarmeðferð
English: Cmin,ss* (µg/mL)
Icelandic: N Cmin,ss
English: PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) T : +357 22 817690
Icelandic: PFIZER EΛΛAΣ A.E. Τηλ.: +30 210 67 85 800
English: Recurrence-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Icelandic: - Fjöldi sjúklinga án tilviks P-gildi borið saman við eftirlit
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Icelandic: Ítarlegar upplýsingar um lyfið eru birtar á vef Lyfjastofnunar Evrópu http://www.ema.europa.eu/ Þessi fylgiseðill er birtur á vef Lyfjastofnunar Evrópu á tungumálum allra ríkja Evrópska efnahagssvæðisins.
English: Pulmonary oedema
Icelandic: +Lungnabólga
English: Acute pulmonary oedema
Icelandic: +Bráður lungnabjúgur
English: Stomatitis
Icelandic: Vanlíðan
English: which was followed by
Icelandic: sem fylgt var eftir af:
English: Febrile neutropenia
Icelandic: brjóstabólga þunglyndi
English: Respiratory distress
Icelandic: Hjartaflökt
English: • Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section
Icelandic:  Ofnæmi fyrir trastuzúmabi, músapróteinum eða einhverju hjálparefnanna sem talin eru upp í kafla 6.1.
English: Trazimera 150 mg powder for concentrate for solution for infusion
Icelandic: Trazimera 150 mg stofn fyrir innrennslisþykkni, lausn.
English: For instructions on reconstitution of Trazimera intravenous formulation before administration, see section 6.6.
Icelandic: Sjá leiðbeiningar í kafla 6.6 um blöndun Trazimera til notkunar í æð fyrir gjöf.
English: The reconstituted Trazimera results in a colourless to pale brownish-yellow transparent solution and should be essentially free of visible particulates.
Icelandic: Þegar búið er að blanda verður Trazimera litlaus eða föl gulbrún, gegnsæ lausn, og nauðsynlegt er að hún sé laus við sjáanlegar smáagnir.
English: Cardiac dysfunction
Icelandic: Óreglulegur hjartsláttur
English: White blood cell count decreased/leukopenia
Icelandic: Fækkun hvítra blóðkorna/hvítfrumnafæð Mjög algengar Blóðflagnafæð
English: Study H0649g: IHC3+ patient subset
Icelandic: IHC3+ hlutmengi
English: Ejection fraction decreased
Icelandic: Eftirfylgni að miðgildislengd
English: Placental transfer of trastuzumab during the early (days 20-50 of gestation) and late (days 120-150 of gestation) foetal development period was observed.
Icelandic: Degi þungunar) og síðkomnum stigum fósturþroska (120. Til 150.
English: Trazimera and anthracyclines should not be given concurrently in combination in the MBC setting.
Icelandic: Ekki ætti að gefa Trazimera og antracýklín samhliða í samsettri meðferð við brjóstakrabbameini með meinvörpum.
English: • dry eyes
Icelandic: ofnæmisviðbrögð þurr augu
English: Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxylpaclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or 4 mg/kg intravenous loading dose followed by 6 mg/kg q3w or 2 mg/kg q1w intravenous dose, respectively).
Icelandic: 6-α hýdroxýl-paclitaxel, POH og doxórúbicínóli, DOL) væri óbreytt í návist trastuzúmabs (8 mg/kg hleðsluskammtur í bláæð og síðan 6 mg/kg í bláæð á þriggja vikna fresti eða 4 mg/kg hleðsluskammtur í bláæð og síðan 2 mg/kg í bláæð einu sinni í viku).
English: Haemorrhoids
Icelandic: Daufkyrningafæð
English: What you need to know before you are given Trazimera
Icelandic: Áður en byrjað er að nota Trazimera
English: Bronchospasm
Icelandic: Vöðvaþrautir
English: Breast cancer
Icelandic: Lifrarbólga
English: Response rate (95% CI) Median duration of response (months) (range) Median TTP (months) (95% CI)
Icelandic: Svörunarhlutfall öryggismörk) Miðgildi svörunarlengdar (mánuðir) (á bilinu) Miðgildi TTP (mánuðir)
English: • asthma
Icelandic: • nýrnakvillar astmi
English: PC: SN: NN:
Icelandic: FP+H:
English: Pulmonary hypoplasia
Icelandic: Blóðkalíumhækkun
English: Muscle tightness
Icelandic: Trazimera hettuglas
English: Heart beat irregular
Icelandic: lungu fósturs þroskast ekki eðlilega
English: Rhinorrhoea
Icelandic: Lungnakvilli
English: Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Icelandic: öflugur milliliður mótefnaháðra frumu-milliliða frumudráps (ADCC).
English: Tumour cell cluster with a faint ⁄ barely perceptible membranous reactivity irrespective of percentage of tumour cells stained
Icelandic: Æxlisfrumnaþyrping með daufri/naumlega merkjanlegri himnuvirkni, hver svo sem hundraðshluti litaðra æxlisfrumna er
English: At 8 years, the diseasefree survival rate was estimated to be 77.2% (95% CI: 75.4, 79.1) in the AC→PH arm, an absolute benefit of 11.8% compared with the AC→P arm.
Icelandic: 75,4, 79,1) í AC→PH hópnum, sem er heildarávinningur sem nemur 11,8% í samanburði við AC^-P hópinn.
English: • acute accumulation of fluid in the lungs
Icelandic: +Íferðir í lungum
English: Nasopharyngitis
Icelandic: Nefrennsli
English: use after reconstitution and dilution
Icelandic: Til notkunar í æð eftir blöndun og þynningu.
English: Malignant neoplasm progression
Icelandic: Brjóstakrabbamein án meinvarpa (viðbótarmeðferð)
English: Ataxia
Icelandic: Ofsabjúgur
English: AGC 274
Icelandic: EBC AGC
English: p-value
Icelandic: p-g ildi
English: Strong complete membrane staining is detected in >10% of the tumour cells.
Icelandic: Dauf/naumlega merkjanleg himnuvirkni í > 10% æxlisfrumna.
English: Wheezing
Icelandic: Heyrnarleysi
English: Table 11 Post-Hoc Exploratory Analysis Results from the Joint Analysis NSABP B-31/NCCTG N9831* and BCIRG006 Clinical Studies Combining DFS Events and Symptomatic Cardiac Events AC→PH (vs. AC→P) (NSABP B-31 and NCCTG N9831)
Icelandic: AC→PH (vs. AC→P) (NSABP B-31 og NCCTG B9831)
English: C.
Icelandic: N
English: Pneumonitis
Icelandic: öndunarbilun
English: Alopecia
Icelandic: Heimakoma
English: Immune system disorders Hypersensitivity
Icelandic: Framrás illkynja æxlismyndunar
English: The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Icelandic: 95% sjúklinganna muni ná þéttni <1 μg/ml (u.þ.b.
English: Concentration after reconstitution - 21 mg/mL
Icelandic: Styrkur eftir blöndun er 21 mg/ml.
English: Trazimera contains the active substance trastuzumab, which is a monoclonal antibody.
Icelandic: Trazimera inniheldur virka efnið trastuzúmab, sem er einstofna mótefni.
English: Early breast cancer (adjuvant setting)
Icelandic: Afturkræfni alvarlegrar hjartabilunar (skilgreind sem a.m.k.
English: Neoplasm progression
Icelandic: bráð þrenging
English: • inflammation of the liver
Icelandic: • máttleysi í vöðvum
English: Anaphylactic reaction
Icelandic: +Bráðaofnæmisviðbrögð
English: Acute respiratory distress syndrome
Icelandic: +Brátt andnauðarheilkenni
English: • heartburn (dyspepsia)
Icelandic: • nábítur (meltingartruflanir)
English: 4 pre-filled pens
Icelandic: 4 áfylltir lyfjapennar
English: 4 pre-filled pens + 1 needle
Icelandic: 4 áfylltir lyfjapennar + 1 nál
English: 12 (3 x 4) prefilled pens (multipack)
Icelandic: 12 (3 x 4) áfylltir lyfjapennar (fjölpakkning)
English: 4 single-dose kits (1 vial + 1 prefilled syringe + 1 vial connector + 2 needles)
Icelandic: 4 stakskammta einingar (búnaður) (1 hettuglas + 1 áfyllt sprauta + 1 millistykki fyrir hettuglas + 2 nálar)
English: 12 (3 x 4) prefilled pens + 3 needles (multipack)
Icelandic: 12 (3 x 4) áfylltir lyfjapennar + 3 nálar (fjölpakkning)
English: 12 (3 x 4) singledose kits (1 vial + 1 pre-filled syringe + 1 vial connector + 2 needles) (multipack)
Icelandic: 12 (3 x 4) stakskammta einingar (búnaður) (1 hettuglas + 1 áfyllt sprauta + 1 millistykki fyrir hettuglas + 2 nálar)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/982/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/982/001
English: You will take Viekirax for either 12 or 24 weeks.
Icelandic: Viekirax skal taka í annaðhvort 12 eða 24 vikur.
English: • Anaemia (low number of red blood cells).
Icelandic: Blóðleysi (lítill fjöldi rauðra blóðkorna).
English: If you do miss a dose and it is:
Icelandic: Ef skammtur gleymist og það eru;
English: Arm B 24 Weeks N = 32
Icelandic: Armur B 24 vikur N = 32
English: NA Decrease amlodipine dose by 50% and monitor patients for clinical effects.
Icelandic: Á ekki við Minnkið amlodipin-skammt um 50% og fylgist með klínískri verkun á sjúklinga.
English: • If you have severe liver problems other than hepatitis C.
Icelandic: ef þú ert með alvarleg vandamál tengd lifur önnur en lifrarbólgu C.
English: Genotype 1a N=67
Icelandic: Arfgerð 1a N=67
English: ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4)
Icelandic: ALT >5-20 × ULN* (gráða 3) >20 × ULN (gráða 4)
English: ALPHA 1-ADRENORECEPTOR ANTAGONIST Alfuzosin
Icelandic: ALFA 1-ADRENALÍNVIÐTAKAHEMLAR Alfuzosin
English: Table 15 shows SVR rates for these subjects.
Icelandic: Tafla 15 sýnir SVR tíðni fyrir þessa einstaklinga.
English: • amiodarone
Icelandic: • amiodaron
English: 25 mg once daily administered in the morning, with food
Icelandic: 25 mg einu sinni á sólarhring, gefið að morgni með mat
English: The frequency of these events is unknown.
Icelandic: Tíðni þessara aukaverkana er ekki þekkt.
English: A 10 kg change in body weight from 76 kg (median weight in the Phase 3 studies) would results in <10% change in ombitasvir exposures, and no change in paritaprevir exposures.
Icelandic: Breyting á þyngd um 10 kg frá 76 kg (miðgildisþyngd í 3. stigs rannsóknunum) myndi leiða af sér < 10% breytingu á útsetningu ombitasvirs og enga breytingu á útsetningu paritaprevirs.
English: Haemoglobin <100-80 g/L (grade 2) <80-65 g/L (grade 3) <65 g/L (Grade 4)
Icelandic: Hemóglóbín (blóðrauði) <100-80 g/l (gráða 2) <80-65 g/l (gráða 3) <65 g/L (gráða 4)
English: If an HIV protease inhibitor is added (atazanavir, darunavir), rilpivirine exposure may increase even further and is therefore not recommended.
Icelandic: Ef HIV próteasa hemli er bætt við (atazanaviri, darunaviri) getur útsetning fyrir rilpivirini aukist enn frekar og er því ekki ráðlagt.
English: Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Icelandic: Tíðni er skilgreind á eftirfarandi hátt: mjög algengar (≥ 1/10), algengar (≥ 1/100 til < 1/10), sjaldgæfar (≥ 1/1.000 til < 1/100), mjög sjaldgæfar (≥
English: AbbVie Ltd Maidenhead SL6 4UB United Kingdom
Icelandic: AbbVie Ltd Maidenhead SL6 4UB Bretland
English: ALT elevations were typically asymptomatic, generally occurred during the first 4 weeks of treatment (mean time 20 days, range 8-57 days) and most resolved with ongoing therapy.
Icelandic: Hækkað ALT er yfirleitt einkennalaust og kemur vanalega fram á fyrstu 4 vikum meðferðar (meðaltími 20 dagar, frá 8-57 dögum) og flest tilvikin ganga til baka við áframhaldandi meðferð.
English: ↓ carbamaze pine 10, 11epoxide ombitasvir
Icelandic: ↓ carbamaze pin 10, 11epoxid ombitasvir
English: The majority of these ALT elevations were transient and assessed as drug-related.
Icelandic: Meirihluti hækkana ALT voru skammvinnar og metnar sem lyfjatengdar.
English: Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
Icelandic: HCV RNA gildi í plasma voru mæld í klínískum rannsóknum þar sem stuðst var við COBAS TaqMan HCV próf (útgáfu 2.0), til notkunar ásamt High Pure System.
English: Overall, 72 of 79 treatment-naive subjects (45 of 52 GT1a and 27 of 27 GT1b) and 40 of 45 treatment-experienced subjects (21 of 26 GT1a and 19 of 19 GT1b) achieved SVR12 after 12 weeks of treatment.
Icelandic: (45 af 52 GT1a og 27 af 27 GT1b) og 40 af 45 sjúklingum sem höfðu áður fengið meðferð (21 af 26 GT1a og 19 af 19 GT1b)
English: If you accidentally take more than the recommended dose, you should contact your doctor or go to the nearest hospital straight away.
Icelandic: Ef tekinn er stærri skammtur en mælt er fyrir um Ef tekinn er fyrir slysni stærri skammtur en ráðlagður er skal hafa samband við lækni eða fara á næsta sjúkrahús tafarlaust.
English: • Swallow the tablets whole.
Icelandic: Gleypið töflurnar í heilu lagi.
English: ↑ pravastatin 1.37
Icelandic: ↑ amlodipin 1,26
English: The dose of ribavirin was left to the discretion of the investigator, with most patients receiving 600 to 800 mg per day as a starting dose, and most patients also receiving 600 to 800 mg per day at the end of treatment.
Icelandic: Skammtur ribavirins var ákveðinn á einstaklingsgrundvelli af rannsakanda, en flestir sjúklinganna fengu 600 til 800 mg sem upphafsskammt og flestir sjúklinganna fengu einnig 600 til 800 mg á sólarhring við lok meðferðar.
English: 33 out of the 34 subjects (97.1%) achieved SVR12 (96.6% in subjects with genotype 1a infection and 100% in subjects with genotype 1b infection).
Icelandic: 33 af 34 einstaklingum (97,1%) voru með SVR12 (96,6% hjá einstaklingum með sýkingu af arfgerð 1a og 100% hjá einstaklingum með sýkingu af arfgerð 1b).
English: ↑ quinidine ↑ ranolazine
Icelandic: ↑ quinidin ↑ ranolazin
English: Patients with severe hepatic impairment (Child-Pugh C) (see section 5.2).
Icelandic: Sjúklingar með alvarlega skerta lifrarstarfsemi (Child-Pugh C) (sjá kafla 5.2).
English: Rilpivirine exposure is substantially increased (3-fold) when rilpivirine is given in combination with Viekirax and dasabuvir, with a consequent potential for QT-prolongation.
Icelandic: Útsetning fyrir rilpivirini eykst verulega (3-falt) þegar rilpivirin er gefið samhliða Viekirax og dasaburviri, sem getur leitt til hugsanlegrar lengingar QT-bilsins.
English: Three interrupted Viekirax and dasabuvir for one to seven days, including one on ethinylestradiol.
Icelandic: Þrír gerðu hlé á notkun Viekirax og dasabuviri í einn til sjö daga, þar af einn sem tók etinýlestradíól.
English: Atazanavir can be used in combination with Viekirax and dasabuvir, if administered at the same time.
Icelandic: Atazanavir má nota samhliða Viekirax og dasaburviri, ef gefið á sama tíma.
English: As the incidence of such elevations was 26% among women taking a concomitant ethinylestradiol-containing medicinal product, such medicinal products are contraindicated with Viekirax with or without dasabuvir.
Icelandic: Þar sem tíðni slíkrar hækkunar var 26% hjá konum sem tóku samhliða lyf sem innihéldu etinýlestradíól má ekki nota slík lyf með Viekirax, með eða án dasabuviri.
English: Rare: may affect up to 1 in 1,000 people
Icelandic: Geta komið fyrir hjá 1 af hverjum 1.000 einstaklingum
English: Viekirax and dasabuvir + ribavirin 12 or 24 weeks N = 380 n (%)
Icelandic: Viekirax og dasabuvir + ribavirin 12 eða 24 vikur N = 380 n (%)
English: Although buprenorphine and zolpidem are also metabolized by CYP3A, drug interaction studies indicate that no dose adjustment is needed when co-administering these medicinal products with Viekirax with or without dasabuvir (see Table 2).
Icelandic: Þó buprenorphin og zolpidem umbrotni einnig fyrir tilstilli CYP3A, hafa rannsóknir á milliverkunum gefið til kynna að engrar skammtaaðlögunar sé þörf þegar þessi lyf eru gefin samhliða Viekirax, með eða án dasabuviri (sjá töflu 2).
English: 0.035/0.25 mg once daily
Icelandic: 0,035/0,25 mg einu sinni á sólarhring
English: ALT elevations were asymptomatic and generally occurred during the first 4 weeks of treatment, without concomitant elevations of bilirubin, and declined within approximately two weeks of onset with continued dosing of Viekirax and dasabuvir with or without ribavirin.
Icelandic: Hækkanir ALT voru einkennalausar og komu vanalega fram á fyrstu 4 vikum meðferðar, án samhliða hækkunar bílirúbíns og lækkaði innan u.þ.b. tveggja vikna frá upphafi hækkunar með áframhaldandi notkun Viekirax og dasabuvirs, með eða án ribavirins.
English: 5 of 6 subjects with compensated cirrhosis in each arm achieved SVR12.
Icelandic: 5 af 6 einstaklingum með einkennalausa skorpulifur í hvorum armi voru með SVR12.
English: • enzalutamide
Icelandic: • enzalutamid
English: In Phase 3 clinical trials, 91.5% of subjects did not require ribavirin dose adjustments during therapy.
Icelandic: Í klínískum 3.stigs rannsóknum þurftu 91,5% einstaklinga ekki skammtaaðlögun ribavirins meðan á meðferð stóð.
English: When starting coadministration with Viekirax, administer 0.5 mg tacrolimus once every week.
Icelandic: Þegar byrjað er að gefa lyfið samhliða Viekirax skal gefa 0,5 mg af tacrolimus einu sinni í viku.
English: HCV ANTIVIRALS Sofosbuvir
Icelandic: HCV VEIRUHAMLANDI LYF Sofosbuvir
English: Hydrocodone (as given in a fixed-dose hydrocodone/ paracetamol)
Icelandic: Hydrocodon (sem hluti af föstum skammti hydrocodon/par acetamol)
English: Ombitasvir is an inhibitor of HCV NS5A which is essential for viral replication.
Icelandic: Ombitasvir er HCV NS5A hemill sem er nauðsynlegur fyrir veirueftirmyndun.
English: ↑ naloxone
Icelandic: ↑ naloxon
English: How much to take The recommended dose is two tablets taken together in the morning.
Icelandic: Ráðlagður skammtur er tvær töflur teknar saman að morgni.
English: Elevations in ALT were generally not associated with bilirubin elevations.
Icelandic: Hækkað ALT var almennt ekki tengt hækkun á bílirúbíni.
English: The assay had a lower limit of quantification (LLOQ) of 25 IU per mL.
Icelandic: Prófið hafði lægri magngreiningarmörkin (LLOQ, lower limit of quantification) 25 a.e./ml.
English: No increase in incidence of ALT elevations was observed with other types of estrogens commonly used for hormone replacement therapy (e.g. estradiol and conjugated estrogens).
Icelandic: Ekki kom fram aukin tíðni hækkaðs ALT með öðrum gerðum estrógena sem algengt er að notuð séu í hormónauppbótarmeðferð (t.d. estradíól og samtengd estrógen).
English: Co-administration of efavirenz (enzyme inducer) based regimens with paritaprevir /ritonavir + dasabuvir resulted in ALT elevations and therefore, early discontinuation of the study.
Icelandic: Samhliðagjöf byggð á efavirenz (ensímvirkir) meðferðaráætlun með paritapreviri/ritonaviri + dasabuviri leiddi til hækkunar á ALT og því var rannsókninni hætt snemma.
English: In subjects who received the recommended regimen, 97% achieved SVR overall (among which 181 subjects with compensated cirrhosis achieved 97% SVR), while 0.5% experienced virologic breakthrough and 1.2% experienced post-treatment relapse.
Icelandic: Hjá einstaklingum sem fengu ráðlagða meðferð voru 97% með SVR í heildina (þar á meðal voru 181 einstaklingar með einkennalausa skorpulifur með 97% SVR), jafnframt því að 0,5% fengu fyrstu einkenni af veirufræðilegu ónæmi og 1,2% fengu bakslag eftir meðferð.
English: Subjects were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir or raltegravir, coadministered with a backbone of tenofovir plus emtricitabine or lamivudine.
Icelandic: Þátttakendur fylgdu stöðugri veiruhemlandi HIV-1-meðferðaráætlun (ART) sem fól í sér ritonavirörvað atazanavir eða raltegravir með stuðningi tenofovirs auk emtricitabins eða lamivudins.