FrancophonIA/ELRC3.0 huggingface dataset:
English: Ara-C 2x 2 g/m2 i.v.
Icelandic: Ara-C 2x 2 g/m2 i.v. (3 klst., með 12 klst. millibili), dag 5
English: Anaphylactic shock* Blood and lymphatic system disorders
Icelandic: Æxlisblæðing/æxlisdrep*.
English: The starting dose is 100 mg, to be taken as one capsule of 100 mg once a day.
Icelandic: Upphafsskammturinn er 100 mg, en þá er tekið eitt 100 mg hylki einu sinni á sólarhring.
English: Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) only erythromycin (IC50 50 μM) and fluconazole (IC50 118 μM) showed inhibition of imatinib metabolism which could have clinical relevance.
Icelandic: sýndu einungis erytromycin (IC50 50 μM) og fluconazol (IC50 118 μM) hömlun á umbrotum imatinibs sem gæti haft klíníska þýðingu.
English: Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP) Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and
Icelandic: Handa- og fótaheilkenni (palmoplantar erythrodysesthesia syndrome)*, hornlagsskæningur (lichenoid keratosis)*, flatskæningur*, eitrunardreplos húðþekju*, lyfjaútbrot ásamt rauðkyrningageri og altækum einkennum (DRESS)
English: Dizziness, paraesthesia, taste disturbance, hypoaesthesia Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage Increased intracranial pressure, convulsions, optic neuritis
Icelandic: Ógleði, uppköst, niðurgangur, útbrot, roðaþot, bjúgur, þroti, þreyta, vöðvakrampar, blóðflagnafæð, blóðfrumnafæð, kviðverkir, höfuðverkur, skert matarlyst.
English: Croatia
Icelandic: Hrvatska
English: Description of selected adverse reactions:
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Mjög algengar:
English: Hyperkalaemia, hypomagnesaemia
Icelandic: Brjóstverkur, lasleiki.
English: Methotrexate (5 g/m2 over 24 hours, IV): day 1
Icelandic: MTX (5 g/m2 á 24 klst., i.v.): dagur 1
English: Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction,
Icelandic: Hjartsláttaróregla, gáttatif, hjartastopp, hjartadrep, hjartaöng, gollurshússvökvi.
English: MTX 15 mg intrathecal, day 1; Methylprednisolone 40 mg intrathecal, day 1
Icelandic: Methylprednisolon 40 mg í mænuvökva, dag 1
English: What Imatinib Teva B.V. looks like and contents of the pack Imatinib Teva B.V. 400 mg film-coated tablets are dark yellow to brownish orange oblong film-coated tablets with a score line on one side.
Icelandic: 400 mg filmuhúðaðar töflur eru dökkgular til brún appelsínugular, ílangar, filmuhúðaðar töflur deiliskoru á annarri hliðinni.
English: If your daily dose is 800 mg (2 tablets), you should take one tablet in the morning and a second
Icelandic: Ef sólarhringsskammturinn er 800 mg (2 töflur), skal taka eina töflu að morgni og aðra töflu að kvöldi.
English: The usual starting dose is 600 mg to be taken as one capsule of 400 mg plus 2 capsules of 100 mg
Icelandic: Venjulegur upphafsskammtur 600 mg, en þá er tekið eitt 400 mg hylki og tvö 100 mg hylki einu sinni á sólarhring.
English: Your doctor may decide to increase the dose to 400 mg, to be taken as one tablet of 400 mg once a day, depending on how you respond to treatment.
Icelandic: Vera má að læknirinn auki skammtinn í 400 mg, en þá er tekið eitt 400 mg hylki einu sinni á sólarhring, eftir því hver svörun við meðferðinni er.
English: Imatinib Teva B.V. 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate).
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur imatinib 100 mg (sem mesilat).
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis,
Icelandic: Munnbólga, munnsæri, blæðing í meltingarfærum7, ropi, sortusaur, vélindabólga, skinuholsvökvi, magasár, blóðug uppköst, varaþroti, kyngingartregða, brisbólga.
English: Hypertension, haematoma, subdural haematoma, peripheral coldness,
Icelandic: Sundl, dofi/náladofi, truflanir á bragðskyni, minnkað snertiskyn.
English: Study AAU02 Induction therapy (de novo Ph+ ALL) Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16;
Icelandic: Innleiðslumeðferð (de novo Ph+ ALL) Daunorubicin 30 mg/m2 i.v., daga 1-3, 15-16; VCR 2 mg heildarskammtur i.v., daga 1, 8, 15, 22;
English: VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8;
Icelandic: MTX 500 mg/m2 i.v. (24 klst.), daga 1, 15; 6-MP 25 mg/m2 til inntöku, daga 1-20
English: (3 h), days 1-4; Mitoxantrone 10 mg/m2 i.v.
Icelandic: Ara-C 1,000 mg/m2/12 klst i.v. (3 klst.), daga 1-4; Mitoxantron 10 mg/m2 i.v. daga 3-5;
English: Increased hepatic enzymes
Icelandic: Endurvirkjun lifrarbólgu
English: Imatinib Teva B.V. 100 mg film-coated tablets Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Icelandic: - Hver Imatinib Teva B.V. filmuhúðuð tafla inniheldur 100 mg af imatinibi (sem mesilat).
English: - Each film-coated tablet of Imatinib Teva B.V. contains 400 mg imatinib (as mesilate).
Icelandic: - Hver Imatinib Teva B.V. filmuhúðuð tafla inniheldur 400 mg af imatinibi (sem mesilat).
English: What you need to know before you take Imatinib Teva B.V.
Icelandic: Áður en byrjað er að nota Imatinib Teva B.V.
English: Colitis, ileus, inflammatory bowel disease
Icelandic: Lifur og gall Algengar:
English: Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP) Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and
Icelandic: Bráð daufkyrningahúðsótt með sótthita (Sweets heilkenni), mislitun nagla, ofsabjúgur, útbrot með blöðrum, regnbogaroðaþot, ofnæmisæðabólga, Stevens-Johnson heilkenni, bráð almenn bóluútbrot (AGEP).
English: Imatinib Teva B.V. 400 mg hard capsules Each hard capsule contains 400 mg of imatinib (as mesilate).
Icelandic: VIRK(T) EFNI Hvert hart hylki inniheldur imatinib 400 mg (sem mesilat).
English: - The tablet coating is made of polyvinyl alcohol partially hydrolysed, macrogol, iron oxide yellow
Icelandic: - Filmuhúðin er úr polývínýl alkóhóli (að hluta til vatnsrofið), makrógóli, gulu járnoxíði (E172),
English: Iron oxide, red (E172) Printing ink Shellac
Icelandic: Gult járnoxíð (E172) Talkúm
English: MTX 12 mg intrathecal, day 1 DEX 10 mg/m2 oral, days 6-7, 13-16;
Icelandic: DEX 10 mg/m2 til inntöku, daga 6-7, 13-16; VCR 1 mg i.v., daga 7, 14;
English: If your daily dose is 800 mg (8 capsules), you should take 4 capsules in the morning and 4
Icelandic: Ef sólarhringsskammturinn er 800 mg (8 hylki), skal taka 4 hylki að morgni og 4 hylki að kvöldi.
English: Study AUS01 Induction-consolidation therapy Hyper-CVAD regimen: CP 300 mg/m2 i.v.
Icelandic: Ofur-CVAD-skömmtun (hyper-CVAD regimen):
English: Anorexia
Icelandic: Ostravská
English: Ara-C 75 mg/m2 i.v.
Icelandic: CP 750 mg/m2 i.v., daga 1, 8;
English: Imatinib vs placebo
Icelandic: Upplýsingar um Imatinib
English: Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of imatinib (see
Icelandic: Mælt er með að bætt sé úr klínískt marktækum vökvaskorti og að há þvagsýra sé meðhöndluð áður en meðferð er hafin með imatinibi vegna hugsanlegrar myndunar æxlislýsuheilkennis (tumour lysis syndrome) (sjá kafla 4.8).
English: VCR 1 mg i.v., days 7, 14;
Icelandic: CP 1 g/m2 i.v. (1 klst.), daga 26, 46;
English: The starting dose is 400 mg, to be taken as one tablet once a day.
Icelandic: Upphafsskammturinn er 400 mg, en þá eru tekin 1 tafla einu sinni á sólarhring.
English: Therefore, close monitoring of growth in children under imatinib treatment is recommended (see section
Icelandic: Því er mælt með að haft sé náið eftirlit með vexti barna á meðferð með imatinibi (sjá kafla 4.8).
English: The starting dose is 400 mg, to be taken as one capsule once a day.
Icelandic: Upphafsskammturinn er 400 mg, en þá er tekið 1 hylki einu sinni á sólarhring.
English: Imatinib Teva B.V. is a treatment for: - Chronic myeloid leukaemia (CML).
Icelandic: Kyrningabráðafasi (myeloid blast crisis):
English: The starting dose is 100 mg, to be taken as one capsule once a day.
Icelandic: Upphafsskammturinn er 100 mg, en þá er tekið eitt hylki einu sinni á sólarhring.
English: Imatinib Teva B.V. 400 mg film-coated tablets Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Icelandic: VIRK(T) EFNI Hver filmuhúðuð tafla inniheldur imatinib 400 mg (sem mesilat).
English: Triple IT therapy (age-adjusted): days 1 and 22 VP-16 (100 mg/m2/day, IV): days 22-26
Icelandic: VP-16 (100 mg/m2/sólarhring, i.v.): dagar 22-26
English: DEX (6 mg/m2/day, PO): days 1-5; 29-33
Icelandic: VP-16 (100 mg/m2, i.v.): dagar 29-33
English: imatinib teva b.v. 400 mg hard capsules
Icelandic: 400 mg hörð hylki imatinib
English: It may harm them,
Icelandic: Það getur valdið þeim skaða.
English: You will take Exviera for either 12 or 24 weeks.
Icelandic: Exviera skal taka í annaðhvort 12 eða 24 vikur.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/983/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/983/001
English: 67061 Ludwigshafen GERMANY
Icelandic: 67061 Ludwigshafen ÞÝSKALAND
English: NA Decrease in 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 been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Icelandic: Ef læknirinn hefur sagt að þú hafir óþol fyrir sumum sykurtegundum skal hafa samband við hann áður en þetta lyf er notað.
English: Expected: ↓ esomeprazole, lansoprazole
Icelandic: Áætlað: ↓ esomeprazol, lansoprazol
English: Peg-IFN + RBV, n (%) Baseline albumin, median g/L
Icelandic: Peg-IFN + RBV, n (%) Upphafsgildi albumins, miðgildi g/l
English: Exviera film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blister packs.
Icelandic: Exviera filmuhúðaðar töflur eru í PVC/PE/PCTFE álþynnupakkningum.
English: Do not take Exviera:
Icelandic: Ekki má nota Exviera:
English: Arm A 12 Weeks N = 31
Icelandic: Armur A 12 vikur N = 31
English: The direction of the arrow indicates the direction of the change in exposures (Cmax, and AUC) in the paritaprevir, ombitasvir, dasabuvir and the co-administered medicinal product (↑= increase more than 20%, ↓ = decrease more than 20%, ↔ = no change or change less than 20%).
Icelandic: Stefna örvarinnar gefur til kynna breytingu útsetningar (Cmax og AUC) fyrir paritapreviri, ombitasviri, dasabuviri og lyfjum sem notuð eru samhliða (↑ = aukning (yfir 20%), ↓ = minnkun (um meira en 20%), ↔ = engin breyting eða breyting minni en 20%).
English: If more than 6 hours have passed since Exviera is usually taken, the missed dose should NOT be taken and the patient should take the next dose per the usual dosing schedule.
Icelandic: eru liðnir frá þeim tíma sem Exviera er vanalega tekið skal EKKI taka skammtinn sem gleymdist og sjúklingur skal taka næsta skammt samkvæmt skammtaáætluninni.
English: While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Icelandic: Þótt ekki sé búist við breytingu á lyfjahvörfum warfarins er ráðlagt að hafa náið eftirlit með INR-gildum fyrir alla K-vítamínhemla.
English: Treatment with Exviera should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
Icelandic: Meðferð með Exviera skal hefja og vera undir eftirliti læknis sem hefur reynslu af meðferð sjúklinga með langvinna lifrarbólgu C.
English: The dose of ribavirin was individualized at the discretion of the investigator, with most patients receiving 600 to 800 mg 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: 5 mg single dose and other vitamin K antagonists
Icelandic: 5 mg stakur skammtur og aðrir K-vítamínhemlar
English: Co-administration of Exviera with other antivirals has not been studied and, therefore, cannot be recommended.
Icelandic: Gjöf Exviera samhliða öðrum veiruhamlandi lyfjum hefur ekki verið rannsökuð og því ekki hægt að ráðleggja hana.
English: 5 of 6 subjects with compensated cirrhosis in each arm achieved SVR12.
Icelandic: Fimm af 6 einstaklingum með væga skorpulifur í hvorum armi voru með SVR12.
English: ALT elevations were typically asymptomatic, generally occurred during the first 4 weeks of treatment (mean time 20 days, range 857 days) and most resolved with ongoing therapy.
Icelandic: Hækkað ALT er vanalega einkennalaust og kemur yfirleitt fram á fyrstu 4 vikum meðferðar (meðaltími 20 dagar, frá 8-57 dögum) og flest tilvikin ganga til baka við áframhaldandi meðferð.
English: There are very limited data from the use of Exviera in pregnant women.
Icelandic: Mjög takmarkaðar upplýsingar liggja fyrir um notkun Exviera á meðgöngu.
English: No (for any parameter listed above) *AFP= serum alpha fetoprotein
Icelandic: Nei (fyrir eitthverja breytuna hér aðofan) *AFP= alfa fetoprótein í sermi
English: ↑ norgestrel ↑ nor elgestromin e
Icelandic: ↑ norgestrel ↑ nor elgestromin
English: Exviera must not be administered as monotherapy.
Icelandic: Exviera má ekki gefa sem einlyfjameðferð.
English: Medicinal products that are strong CYP2C8 inhibitors may increase dasabuvir plasma concentrations and must not be co-administered with Exviera (see section 4.5).
Icelandic: Lyf sem eru öflugir CYP2C8 örvar geta aukið plasmaþéttni dasabuvirs og má ekki gefa samhliða Exviera (sjá kafla 4.5).
English: 7 of 7 subjects with genotype 1b infection and 51 of 56 subjects with genotype 1a infection achieved SVR12.
Icelandic: 7 af 7 einstaklingum með sýkingu af arfgerð 1b og 51 af 56 einstaklingum með sýkingu af arfgerð 1a voru með SVR12.
English: Exviera + ombitasvir/paritaprevir/ritonavir was administered as multiple doses in all the drug interaction studies except the drug interaction studies with carbamazepine, gemfibrozil, ketoconazole, and sulfamethoxazole/trimethoprim.
Icelandic: Exviera + ombitasvir/paritaprevir/ritonavir var gefið í fjölskömmtum í öllum rannsóknum á milliverkunum nema rannsóknum á milliverkunum við carbamazepin, gemfibrozil, ketoconazol og sulfamethoxazol/trimethoprim.
English: R155K D168A D168V
Icelandic: D168A D168V
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: Þrjátíu og þrír 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: Microcrystalline cellulose (E460(i)) Lactose monohydrate Copovidone
Icelandic: Örkristallaður sellulósi (E460(i)) Laktósaeinhýdrat Kopóvidón
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Icelandic: Sjúklingar með sjaldgæft arfgengt galaktósaóþol, Lapp laktasaskort, eða vanfrásog glúkósa-galaktósa skulu ekki nota lyfið.
English: Talk to your doctor or pharmacist before taking Exviera if you: -have liver disease other than hepatitis C; -have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Icelandic: Leitaðu ráða hjá lækninum eða lyfjafræðingi áður en Exviera er notað ef þú: - ert með lifrarsjúkdóm annan en lifrarbólgu C. - ert með, eða hefur verið með, lifrarbólgu B veirusýkingu, þar sem læknirinn kann að vilja fylgjast nánar með þér.
English: The safety of Exviera in children and adolescents aged < 18 years has not yet been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi Exviera hjá börnum og unglingum < 18 ára.
English: The recommended dose of dasabuvir is 250 mg (one tablet) twice daily (morning and evening).
Icelandic: Ráðlagður skammtur af dasabuviri er 250 mg (ein tafla) tvisvar sinnum á sólarhring (kvölds og morgna).
English: Exviera is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Icelandic: Exviera er veirueyðandi lyf sem notað er til meðferðar við langvinnri lifrarbólgu C (smitsjúkdómur sem hefur áhrif á lifur af völdum lifrarbólgu C veiru) hjá fullorðnum.
English: Exviera should be used in combination with other medicinal products for the treatment of HCV (see section 5.1).
Icelandic: Exviera skal nota samhliða öðrum lyfjum við meðferð á HCV (sjá kafla 5.1).
English: SVR12, n/N (%) [95% CI] Outcome for subjects not achieving SVR12 On-treatment virologic failurea Post-treatment relapse a
Icelandic: SVR12, n/N (%) [95% CI] Niðurstaða einstaklinga sem náðu ekki SVR12
English: THYROID HORMONES Levothyroxin e
Icelandic: SKJALDKIRTILSHORMÓN Levothyroxin
English: ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4) Haemoglobin <100-80 g/L (grade 2) <80-65 g/L (grade 3) <65 g/L (Grade 4) Total bilirubin >3-10 × ULN (grade 3) >10 × ULN (grade 4) *ULN: Upper Limit of Normal
Icelandic: Hemóglóbín (blóðrauði) <100-80 g/l (gráða 2) <80-65 g/l (gráða 3) <65 g/L (gráða 4) Heildar bílirúbín >3-10 × ULN
English: Rilpivirine was also administered with food in the evening and 4 hours after dinner with Exviera + ombitasvir/paritaprevir/ritonavir in the study.
Icelandic: Rilpivirin var einnig gefið með mat að kvöldi og 4 klst. eftir kvöldmat, ásamt Exviera + ombitasvir/paritaprevir/ritonavir í rannsókninni.
English: Coadministration with ethinylestradiol may lead to increased risk of ALT elevations (see sections 4.3 and 4.4).
Icelandic: Samhliðagjöf með etinýlestradíóli getur leitt til aukinnar hættu á hækkun ALT (sjá kafla 4.3 og 4.4).
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Exviera, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Icelandic: Exviera verður markaðsleyfishafinn að gera og senda inn niðurstöður framsýnnar öryggisrannsóknar með gögnum úr þýði (cohort) sem inniheldur vel skilgreindan hóp sjúklinga, á grunni samþykktrar rannsóknaráætlunar.
English: Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b)
Icelandic: Natríum kroscarmellósi Vatnsfrí kísilkvoða (E551) Magnesíum stearat (E470b)
English: No increase in incidence of ALT elevations was observed with other types of systemic estrogens commonly used for hormone replacement therapy (e.g., estradiol and conjugated estrogens).
Icelandic: Ekki kom fram aukin tíðni hækkaðs ALT með öðrum gerðum af altækum östrógenlyfjum sem algengt er að notuð séu í hormónauppbótarmeðferð (t.d. estradiol og samtengt östrogen).
English: In case a dose of Exviera is missed, the prescribed dose can be taken within 6 hours.
Icelandic: Ef skammtur af Exviera gleymist skal taka ávísaðan skammt innan 6 klst.
English: Exviera is not recommended for administration as monotherapy and must be used in combination with other medicinal products for the treatment of hepatitis C infection (see section 4.2 and 5.1).
Icelandic: Ekki er ráðlagt að gefa Exviera sem einlyfjameðferð og verður að nota lyfið samhliða öðrum lyfjum til meðferðar á lifrarbólgu C sýkingum (sjá kafla 4.2 og 5.1).
English: 34 subjects (29 with HCV genotype 1a infection and 5 with HCV genotype 1b infection) were enrolled who had not received treatment for HCV infection after transplantation and had a METAVIR fibrosis score of F2 or less.
Icelandic: 34 einstaklingar (29 með HCV sýkingu af arfgerð 1a og 5 með HCV sýkingu af arfgerð 1b) sem ekki höfðu fengið meðferð við HCV sýkingu eftir ígræðslu og sem höfðu METAVIR fíbrínskor
English: In the 7 genotype 1b infected subjects,treatment-emergent variants were observed in NS3 in 4 subjects, in NS5A in 2 subjects, and in both NS3 and NS5A in 1 subject.
Icelandic: Hjá 7 einstaklingum, sem sýktir voru af arfgerð 1b, sáust afbrigði af völdum meðferðarinnar í NS3 hjá 4 einstaklingum, í NS5A hjá 2 einstaklingum og í bæði NS3 og NS5A hjá 1 einstaklingi.
English: If a patient is already taking medicinal product(s) or initiating a medicinal product while receiving Exviera and ombitasvir/paritaprevir/ritonavir for which potential for drug interaction is expected, dose adjustment of the concomitant medicinal product(s) or appropriate clinical monitoring should be considered (Table 2).
Icelandic: Ef sjúklingur tekur eða er að hefja töku lyfs (lyfja), jafnframt því að fá Exviera og ombitasvir/paritaprevir/ritonavir, sem búast má við að valdi milliverkun, skal íhuga skammtaðlögun þeirra lyfja sem gefin eru samhliða eða viðeigandi eftirlit (tafla 2).
English: The safety summary is based on pooled data from phase 2 and 3 clinical trials in more than 2,600 subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin.
Icelandic: Samantekt um öryggi er byggð á gögnum úr klínískum 2. stigs og 3. stigs rannsóknum á yfir 2.600 sjúklingum sem fengu Exviera og ombitasvir/paritaprevir/ritonavir með eða án ribavirins.
English: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Exviera is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.
Icelandic: Gæta þarf ítrustu varúðar til að forðast að þungun eigi sér stað hjá kvenkyns sjúklingum og kvenkyns mökum karlkyns sjúklinga þegar Exviera er notað samhliða ribavirini, sjá kafla 4.6 og frekari upplýsingar í samantekt á eiginleikum ribavirins.
English: In vivo drug interaction studies evaluated the net effect of the combination treatment, including ritonavir.
Icelandic: Í in vivo rannsóknum á lyfjamilliverkunum var lagt mat á hreina verkun (net effect) samsettu meðferðarinnar, að ritonaviri meðtöldu.
English: As the incidence of such elevations was 26% among women taking a concomitant ethinylestradiol-containing medicine, such medicinal products are contraindicated with Exviera and ombitasvir/paritaprevir/ritonavir.
Icelandic: Þar sem tíðni slíkrar hækkunar var 26% hjá konum sem tóku samhliða lyf sem innihéldu etinýlestradíól má ekki nota slík lyf með Exviera og ombitasviri/paritapreviri/ritonaviri.
English: Subjects were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir or raltegravir, co-administered with a backbone of tenofovir plus emtricitabine or lamivudine.
Icelandic: Þátttakendur fylgdu stöðugri veiruhemlandi HIV-1-meðferðaráætlun (ART) sem fól í sér ritonavir-örvað atazanavir eða raltegravir með stuðningi tenofovirs auk emtricitabins eða lamivudins.
English: Examples of contraindicated CYP2C8 inhibitors are provided below.
Icelandic: Dæmi um CYP2C8 örva sem eru frábending eru gefin hér að neðan.
English: Y93H H58D, H58P, Y93N NS5B A553T S556G C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561H a. Observed in at least 2 subjects of the same subtype.
Icelandic: Y93H H58D, H58P, Y93N NS5B A553T S556G C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561H a. Sást hjá a.m.k. 2 einstaklingum úr sömu undirarfgerð.
English: ANTICANCER AGENTS Enzalutamid e
Icelandic: KRABBAMEINSLYF Enzalutamid