FrancophonIA/ELRC3.0 huggingface dataset:
English: If you notice any side effects even those not already listed in this leaflet, or you think that the medicine has not worked, please inform your veterinary surgeon.
Icelandic: Gerið dýralækni viðvart ef vart verður einhverra aukaverkana, jafnvel aukaverkana sem ekki eru tilgreindar í fylgiseðlinum eða ef svo virðist sem lyfið hafi ekki tilætluð áhrif.
English: MANUFACTURER'S BATCH NUMBER Batch {number}
Icelandic: 17. LOTUNÚMER FRAMLEIÐANDA Lot{númer}
English: Topical application of diesters results in high therapeutic index: high local activity with reduced systemic secondary effects.
Icelandic: Við staðbundna notkun díestera næst hár lækningalegur stuðull: mikil staðbundin virkni með óverulegum almennum áhrifum.
English: MARKETING AUTHORISATION NUMBER(S) PET bottle of 76ml: EU/2/06/069/001
Icelandic: MARKAÐSLEYFISNÚMER Askja með PET glasi með 76 ml: EU/2/06/069/001
English: In the absence of specific information, the use in animal suffering from Cushing's syndrome shall be based on the risk-benefit assessment.
Icelandic: Ef ekki liggja fyrir sérstakar upplýsingar skal fara fram mat á áhættu og ávinningi áður en meðferð er hafin á dýri með Cushing sjúkdóms.
English: STATEMENT OF ACTIVE SUBSTANCES Hydrocortisone aceponate 0.584 mg/ml
Icelandic: Hýdrókortisónaceponat 0,584 mg/ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box with a bottle of 31 ml
Icelandic: YTRI UMBÚÐUM Pappaaskja með 31 ml glasi
English: 1ère avenue 2065 m LID 06516 Carros Frakkland
Icelandic: Avenue - 2065 m - LID 06516 Carros, Frakkland
English: In the case of concurrent microbial disease or parasitic infestation, the dog should receive appropriate treatment for such condition.
Icelandic: Ef hundurinn er einnig með sýkingu af völdum örvera eða sníkjudýra skal meðhöndla hann á viðeigandi hátt.
English: In case of conditions requiring an extended treatment, the responsible veterinarian should subject the use of the product to the risk-benefit assessment by the responsible veterinarian.
Icelandic: Ef lengri meðferð reynist vera nauðsynleg, á dýralæknirinn að gera ávinnings-/áhættumat vegna notkunar dýralyfsins.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box with a bottle of 76 ml
Icelandic: YTRI UMBÚÐUM Pappaaskja með 76 ml glasi
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Hydrocortisone aceponate 0.584 mg/ml.
Icelandic: VIRK(T) INNIHALDSEFNI Hýdrókortisónaceponat 0,584 mg/ml
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Icelandic: Heiti og heimilisfang framleiðenda sem eru ábyrgir fyrir lokasamþykkt VIRBAC
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 76 ml
Icelandic: INNRI UMBÚÐUM Glas með 76 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs Hydrocortisone aceponate
Icelandic: CORTAVANCE 0,584 mg/ml húðúði fyrir hunda hýdrókortisónaceponat
English: MARKETING AUTHORISATION HOLDER VIRBAC
Icelandic: MARKAÐSLEYFISHAFI VIRBAC
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release VIRBAC
Icelandic: FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT B. FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN C. UPPLÝSINGAR
English: NAME OF THE VETERINARY MEDICINAL PRODUCT CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs
Icelandic: FYLGISEÐILL CORTAVANCE 0,584 mg/ml húðúði fyrir hunda.
English: Use only accordingly to the risk-benefit assessment by the responsible veterinarian.
Icelandic: Notið eingöngu eftir samanburð dýralæknis á áhættu og ávinningi.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).>
Icelandic: - Koma örsjaldan fyrir (koma fyrir hjá færri en 1 af hverjum 10.000 dýrum sem fá meðferð, þ.m.t. einstök tilvik).
English: Carton box with a HDPE bottle of 76ml: EU/2/06/069/004
Icelandic: Askja með HDPE glasi með 76 ml: EU/2/06/069/004 17. LOTUNÚMER FRAMLEIÐANDA Lot{númer}
English: PACKAGE LEAFLET CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs
Icelandic: CORTAVANCE 0,584 mg/ml húðúði fyrir hunda.
English: MARKETING AUTHORISATION NUMBER(S) Carton with a PET bottle of 31ml: EU/2/06/069/002
Icelandic: MARKAÐSLEYFISNÚMER Askja með PET glasi með 31 ml: EU/2/06/069/002 Askja með HDPE glasi með 31 ml: EU/2/06/069/003 17. LOTUNÚMER FRAMLEIÐANDA Lot{númer}
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 31 ml
Icelandic: INNRI UMBÚÐUM Glas með 31 ml
English: ROUTE(S) OF ADMINISTRATION Cutaneous use.
Icelandic: VIRK(T) INNIHALDSEFNI
English: Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Icelandic: Geymsluþol dýralyfsins í söluumbúðum :
English: DK: Danmark
Icelandic: Danmark
English: Return to chronic phase (RTC)
Icelandic: Aftur í stöðugan fasa (RTC)
English: % of patients (CI95%)
Icelandic: % sjúklinga (CI95%)
English: Tell your doctor if you are using medicines that prevent the formation of blood clots.
Icelandic: Segðu lækninum frá því ef þú er að nota lyf sem hindra myndun blóðtappa.
English: - if you are taking the medicine levothyroxine because your thyroid has been removed.
Icelandic: - ef þú ert að nota lyfið levotyroxin vegna þess að skjaldkirtillinn hefur verið fjarlægður.
English: In all clinical studies 38-40% of patients were ≥ 60 years of age and 10-12% of patients were ≥ 70 years of age.
Icelandic: Í öllum klínískum rannsóknum voru 38-40% sjúklinga ≥ 60 ára og 10-12% sjúklinga voru ≥ 70 ára.
English: A limited number of patients were enrolled in phase I studies (n=10).
Icelandic: Takmarkaður fjöldi sjúklinga var skráður í I stigs rannsóknir (n=10).
English: Merckle GmbH Graf-Arco-Str. 3, 89079 Ulm Germany
Icelandic: Merckle GmbH Graf-Arco-Str. 3, 89079 Ulm Þýskaland
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni og þynnunum á eftir EXP.
English: In addition, children have been treated in two phase I studies and one phase II study.
Icelandic: Að auki hafa börn verið meðhöndluð í tveimur I. stigs rannsóknum og einni II. stigs rannsókn.
English: Leukaemia is a cancer of white blood cells.
Icelandic: Hvítblæði er krabbamein hvítra blóðkorna.
English: PVC/PE/PVdC/PE/PVC//Al blisters OPA/Al/PVC//Al blisters
Icelandic: PVC/PE/PVdC/PE/PVC//álþynnur OPA/ál/PVC//álþynnur
English: Date of latest renewal: 18 September 2017
Icelandic: 18. september 2017.
English: Bilirubin elevation was below 3%.
Icelandic: Hækkun bilirubins kom fram hjá innan við 3% sjúklinga.
English: Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Icelandic: Ara-C: cytosin arabinosid; CP: cyclofosfamid; DEX: dexamethason; MTX: metotrexat; 6-MP: 6-mercaptopurin; VM26: Teniposid; VCR: vincristin; IDA: idarubicin; i.v.: í bláæð.
English: • Once the tablet has dissolved, drink everything in the glass straight away.
Icelandic: Þegar taflan er uppleyst skaltu drekka allan vökvann úr glasinu strax.
English: The expiry date refers to the last day of the month.
Icelandic: á við síðasta dag mánaðarins sem þar kemur fram.
English: Chronic phase, Interferon failure
Icelandic: Stöðugur fasi, interferon árangurslaust
English: There were 59% males and 41% females; 89.9% caucasian and 4.7% black patients.
Icelandic: Karlar voru 59% og konur 41%; 89,9% voru af hvíta kynstofninum og 4,7% voru þeldökkir sjúklingar.
English: 532 adult patients were treated at a starting dose of 400 mg.
Icelandic: 532 fullorðnir sjúklingar voru meðhöndlaðir með 400 mg upphafsskammti.
English: Importantly, 27.7% of patients also achieved a major cytogenetic response, which was complete in 20.4% (confirmed 16%) of patients.
Icelandic: Mikilvægt var að 27,7% sjúklinganna náðu líka meiriháttar litningasvörun, sem var fullkomin hjá 20,4% (staðfest 16%) þeirra.
English: Your doctor will discuss with you the possible risks of taking Imatinib Teva during pregnancy.
Icelandic: Læknirinn mun ræða við þig um hugsanlega áhættu við notkun Imatinib Teva á meðgöngu.
English: 31-546, Krakow Poland
Icelandic: 31-546 Krakow
English: In this study 65% of the patients achieved a major cytogenetic response that was complete in 53% (confirmed 43%) of patients (Table 3).
Icelandic: Í þessari rannsókn náðu 65% sjúklinga meiriháttar litningasvörun sem var fullkomin hjá 53% (staðfest 43%) sjúklinga (tafla 3).
English: Some children and adolescents taking Imatinib Teva may have slower than normal growth.
Icelandic: Verið getur að sum börn og unglingar sem taka Imatinib Teva stækki hægar en eðlilegt er.
English: The median duration of second-line treatment with imatinib was 64 months.
Icelandic: Miðgildi meðferðarlengdar, þegar um aðra (second-line) meðferð með imatinib var að ræða, var 64 mánuðir.
English: The duration of imatinib therapy can vary with the treatment programme selected, but generally longer exposures to imatinib have yielded better results.
Icelandic: Lengd meðferðar með imatinib getur verið breytileg eftir meðferðaráætluninni sem valin er, en almennt gildir að lengri notkun imatinibs hefur skilað betri árangri.
English: If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Imatinib Teva should not be resumed.
Icelandic: Ef gildi mótefnis gegn ADAMTS13 er hækkað í tengslum við litla virkni ADAMTS13 skal ekki hefja meðferð með Imatinib Teva að nýju.
English: In this study, 31% of patients achieved a haematological response (36% in previously untreated patients and 22% in previously treated patients).
Icelandic: Í þessari rannsókn náðu 31% sjúklinga blóðsvörun (36% sjúklinga sem höfðu ekki verið meðhöndlaðir áður og 22% sjúklinga sem höfðu áður fengið meðferð).
English: Imatinib administration to patients without the genetic translocation generally results in no improvement.
Icelandic: Notkun imatinib handa sjúklingum sem ekki eru með yfirfærslu í erfðaefni (genetic translocation) skilar yfirleitt ekki ávinningi.
English: Severe elevation of transaminases (<5%) or bilirubin (<1%) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Icelandic: Alvarleg hækkun transaminasa (< 5%) eða bilirubins (< 1%) kom fyrir hjá sjúklingum með CML og venjulega tókst að bregðast við henni með því að minnka skammt eða rjúfa meðferð (miðgildi tímalengdar þessara lota var u.þ.b. ein vika).
English: The annual rate of progression to accelerated phase or blast crisis decreased with time on therapy and was less than 1% annually in the fourth and fifth years.
Icelandic: Árlegt hlutfall versnunar í hröðunarfasa eða bráðafasa minnkaði eftir því sem meðferðin var lengri og var innan við 1% á ári á fjórða og fimmta árinu.
English: 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: The primary efficacy endpoint of the study is progression-free survival.
Icelandic: Fyrsti endapunktur verkunar í rannsókninni er lifun án versnunar.
English: At 84 months the estimated overall survival is 86.4% (83, 90) vs. 83.3% (80, 87) in the randomised imatinib and the IFN+Ara-C groups, respectively (p=0.073, log-rank test).
Icelandic: Eftir 84 mánuði er áætluð heildarlifun 86,4% (83, 90) samanborið við 83,3% (80, 87) í slembuðu imatinib og IFN+Ara-C hópunum, tilgreint í sömu röð (p=0,073, log-rank próf).
English: There is no experience in children with CML below 2 years of age and with Ph+ALL below 1 year of age (see section 5.1).
Icelandic: Engin reynsla er af notkun lyfsins handa börnum yngri en 2 ára sem eru með CML og yngri en 1 árs sem eru með Ph+ ALL (sjá kafla 5.1).
English: Median age was 51 years (range 18-70 years), with 21.9% of patients ≥ 60 years of age.
Icelandic: Miðgildi aldurs var 51 ár (á bilinu 18-70 ára) og voru 21,9% sjúklinga ≥ 60 ára.
English: C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza Spain
Icelandic: C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza Spánn
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John's Wort).
Icelandic: Látið lækninn eða lyfjafræðing vita um öll önnur lyf sem eru notuð, hafa nýlega verið notuð eða kynnu að verða notuð, þar með talið lyf sem fengin eru án lyfseðils (svo sem paracetamol) og einnig náttúrulyf (svo sem jóhannesarjurt [jónsmessurunni, St. John's wort]).
English: • Stir with a spoon until the tablets have completely dissolved.
Icelandic: Hrærið í með skeið þar til töflurnar eru alveg uppleystar.
English: If this applies to you, tell your doctor without taking Imatinib Teva.
Icelandic: Ef þetta á við um þig skaltu láta lækninn vita án þess að nota Imatinib Teva.
English: Mean absolute bioavailability for imatinib is 98%.
Icelandic: Nýting (absolute bioavailability) imatinimbs er að meðaltali 98%.
English: These events can usually be managed with either a reduction of the dose or an interruption of treatment with imatinib, but can in rare cases lead to permanent discontinuation of treatment.
Icelandic: Yfirleitt má ráða við þessar aukaverkanir með því annaðhvort að draga úr skammti eða rjúfa meðferð með imatinib, en í einstöku tilvikum getur þurft að hætta meðferð alveg.
English: In contrast, there were 165 (29.8%) events in the IFN+Ara-C arm, of which 130 occurred during first-line treatment with IFN+Ara-C.
Icelandic: Á hinn bóginn voru 165 (29,8%) tilvik í hópnum sem fékk IFN+Ara-C, þar af 130 tilvik sem komu fyrir í fyrstu (first-line) meðferð með IFN+Ara-C.
English: Major response at 24 months (%)
Icelandic: Meiriháttar svörun eftir 24 mánuði (%)
English: In adults the dose should be reduced from 400 mg to 300 mg or from 600 mg to 400 mg or from 800 mg to 600 mg, and in children from 340 to 260 mg/m2/day.
Icelandic: Hjá fullorðnum ætti að minnka skammtana úr 400 mg í 300 mg eða úr 600 mg í 400 mg, eða úr 800 mg í 600 mg og hjá börnum úr 340 í 260 mg/m²/sólarhring.
English: The increase is approximately 1.5 to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Icelandic: Aukningin er um það bil 1,5 til 2föld, sem jafngildir 1,5-faldri hækkun AGP í plasma, en imatinib er mikið bundið AGP.
English: The content of the capsule is white to light yellow granulated powder.
Icelandic: Innihald hylkisins er hvítt til ljósgult kyrnt duft.
English: All patients received imatinib and consolidation chemotherapy (see Table 4) after induction and the levels of bcr-abl transcripts were identical in the two arms at 8 weeks.
Icelandic: Allir sjúklingarnir fengu imatinib og upprætingarmeðferð með krabbameinslyfjum (consolidation chemotherapy) (sjá töflu 3) eftir aðalmeðferð (induction) og bcr-abl umritun var sambærileg hjá báðum hópunum eftir 8 vikur.
English: A confirmed haematological response was achieved in 71.5% of patients (Table 3).
Icelandic: Staðfest blóðsvörun náðist hjá 71,5% sjúklinga (tafla 3).
English: Major response at 12 months (%)
Icelandic: Meiriháttar svörun eftir 12 mánuði (%)
English: Insomnia
Icelandic: Svefnleysi.
English: After 42 months of follow-up, 11 patients experienced a confirmed loss (within 4 weeks) of their cytogenetic response.
Icelandic: 42 mánaða eftirfylgni sýndi staðfest tap (innan 4 vikna) á litningasvörun hjá 11 sjúklingum.
English: Patients had received a median of 14 months of prior IFN therapy at doses ≥ 25 x 106 IU/week and were all in late chronic phase, with a median time from diagnosis of 32 months.
Icelandic: Miðgildi meðferðar sem sjúklingar höfðu fengið fyrir IFN meðferð var 14 mánuðir, þar sem gefnir voru skammtar ≥ 25 x 106 a.e./viku og voru allir seint í stöðugum fasa, með 32 mánaða miðgildi tíma frá sjúkdómsgreiningu.
English: Imatinib Teva is also a treatment for children and adolescents with CML.
Icelandic: Teva er einnig ætlað til meðferðar hjá börnum og unglingum með CML.
English: - If you are being treated for DFSP:
Icelandic: - Ef þú ert í meðferð við DFSP:
English: • Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Icelandic: • fullorðnum sjúklingum með mergrangvaxtarsjúkdóma/mergfrumnafjölgunarsjúkdóma (myelodysplastic/myeloproliferative diseases [MDS/MPD]) í tengslum við PDGFR (platelet derived growth factor receptor) endurröðun erfðavísa.
English: The length of the capsule is from 23.0 mm to 23.6 mm and the width is 8.53 mm.
Icelandic: Lengd hylkisins er frá 23,0 mm til 23,6 mm og breidd þess er 8,53 mm.
English: Total bilirubin: > 3-10 ULN
Icelandic: > 3-10 ULN AST:
English: Study 0109 40.5-month data Accelerated phase (n=235)
Icelandic: Rannsókn 0109 Upplýsingar eftir 40,5 mánuði Hröðunarfasi (n=235)
English: Imatinib Teva is a medicine containing an active substance called imatinib.
Icelandic: Teva er lyf sem inniheldur virkt efni sem kallast imatinib.
English: This clinical effect was associated with a higher reduction in bcr-abl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p=0.02).
Icelandic: Þessi klínísku áhrif tengdust meiri minnkun bcr-abl umritunar hjá sjúklingum sem fengu imatinib en þeim sem fengu krabbameinslyfjameðferð, eftir 2 vikna meðferð (p= 0,02).
English: A complete haematological response was achieved in 95% of patients.
Icelandic: Heildarblóðsvörun náðist hjá 95% sjúklinga.
English: Table 5 Chemotherapy regimen used in combination with imatinib in study I2301
Icelandic: Tafla 5 Krabbameinslyfjameðferð samhliða imatinibi í rannsókn I2301
English: Molecular response**
Icelandic: Sameindasvörun**
English: The tablet is debossed with “IT” and “1” at each side of the score line.
Icelandic: Taflan er greypt með „IT“ og „1“ sitt hvorumegin við deiliskoruna.
English: In clinical trials, there was an increased incidence of these events in the elderly and those with a prior history of cardiac disease.
Icelandic: Í klínískum rannsóknum kom fram aukin tíðni þessara atvika hjá öldruðum og hjá þeim sem höfðu sögu um hjartasjúkdóma.
English: In the imatinib arm, patients were treated with 400 mg daily.
Icelandic: Í imatinib hópnum fengu sjúklingar 400 mg daglega.
English: A total of 71 (12.8%) and 85 (15.4%) patients died in the imatinib and IFN+Ara-C groups, respectively.
Icelandic: Alls dó 71 sjúklingur (12,8%) í hópnum sem fékk imatinib og 85 sjúklingar (15,4%) í hópnum sem fékk IFN+Ara-C.
English: The tablet is debossed with “IT” and “4” at each side of the score line.
Icelandic: Taflan er greypt með „IT“ og „4“ sitt hvorumegin við deiliskoruna.
English: When needed, discontinuation of Imatinib Teva treatment may be considered.
Icelandic: Þegar þörf er á má íhuga að stöðva meðferð með Imatinib Teva.
English: For patients with reduction in Bcr-Abl transcripts of at least 3 logarithms at 12 months, the probability of remaining free from progression to accelerated phase/blast crisis was 99% at 84 months.
Icelandic: Hjá sjúklingum með fækkun Bcr-Abl afrita um að minnsta kosti 3 logaritma eftir 12 mánuði voru líkur á að ekki hefði komið fram versnun í hröðunarfasa/bráðafasa 99% eftir 84 mánuði.
English: VCR 2 mg i.v., days 6, 13, 20;
Icelandic: VCR 2 mg i.v., daga 6, 13, 20;
English: While you are taking Imatinib Teva your doctor will regularly check whether the medicine is working.
Icelandic: Teva mun læknirinn fylgjast reglulega með því hvort lyfið virkar.
English: This will help protect you from stomach problems when taking Imatinib Teva.
Icelandic: Það hjálpar til við að vernda þig gegn magavandamálum þegar þú notar Imatinib Teva.
English: Vindesine 3 mg/m2 i.v., day 1;
Icelandic: Vindesine 3 mg/m2 i.v., dag 1;
English: Teva Pharma Belgium N.V./S.A./AG
Icelandic: Teva Pharma Belgium N.V./S.A./AG Tél/Tel:
English: A major response (0-35%) combines both complete and partial responses.
Icelandic: Meiriháttar svörun (0-35%) sameinar bæði fulla svörun og svörun að hluta.
English: Daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
Icelandic: Daunorubicin 45 mg/m2 i.v., daga 6-7, 13-14
English: For adult patients with relapsed or refractory Ph+ALL imatinib monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs.
Icelandic: Um fullorðna sjúklinga með endurkomið eða þrálátt Ph+ ALL gildir að meðferð með imatinib einu sér, í skammtinum 600 mg/sólarhring, er örugg og virk og nota má lyfið þar til sjúkdómurinn tekur að versna.
English: In this retrospective analysis, the superiority of imatinib over IFN+Ara-C in overall survival was demonstrated (p<0.001); within 42 months, 47 (8.5%) imatinib patients and 63 (19.4%) IFN+Ara-C patients had died.
Icelandic: Í þessari afturskyggnu rannsókn var sýnt fram á yfirburði imatinib samanborið við IFN+Ara-C hvað varðar heildarlifun (p< 0,001); innan 42 mánaða voru 47 (8,5%) sjúklingar sem fengu imatinib og 63 (19,4%) sjúklingar sem fengu
English: Active substances that may increase imatinib plasma concentrations
Icelandic: Virk efni sem geta aukið plasmaþéttni imatinibs
English: The estimated rate of progression-free survival at 84 months was 81.2% in the imatinib arm and 60.6% in the control arm (p<0.001).
Icelandic: Áætlað hlutfall lifunar án versnunar eftir 84 mánuði var 81,2% í imatinib hópnum og 60,6% í samanburðarhópnum (p< 0,001).
English: Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of imatinib resulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Icelandic: Formeðferð með endurteknum skömmtum af rifampicini, 600 mg, fylgt eftir með einum 400 mg skammti af imatinib leiddi til minnkunar Cmax og AUC(0-∞) um að minnsta kosti 54% og 74% fyrir samsvarandi gildi án meðferðar með rifampicin.
English: Whereas an estimated 96% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/blast crisis at 84 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 84 months (p<0.001 overall, p=0.25 between CCyR and PCyR).
Icelandic: Áætlað var að 96% (93%) sjúklinga með CCyR (PCyR) eftir 12 mánuði væru án versnunar í hröðunarfasa/bráðafasa eftir 84 mánuði, en einungis 81% sjúklinga án MCyR eftir 12 mánuði voru án versnunar í langt gengið CML eftir 84 mánuði (p< 0,001 fyrir heildina, p=0,25 milli CCyR og PCyR).
English: Table 3 Response in adult CML study
Icelandic: Tafla 3 Svörun í CML rannsókn hjá fullorðnum
English: The effect of imatinib on the outcome of bone marrow transplantation has not been determined.
Icelandic: Áhrif imatinib á niðurstöðu beinmergsskipta hafa ekki verið staðfest.
English: Similar findings were found based on a 18months landmark analysis.
Icelandic: Svipaðar niðurstöður komu fram á grundvelli 18 mánaða áfangagreiningar.
English: When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11% decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in AUC (7.4%) compared to fasting conditions.
Icelandic: Þegar imatinib var gefið með fituríkri máltíð dró aðeins óverulega úr frásogi (11% minnkun á Cmax og lenging á tmax um 1,5 klst.) með smávægilegri minnkun á AUC (7,4%), samanborið við fastandi aðstæður.
English: Studies on patients receiving imatinib and its effect on fertility and gametogenesis have not been performed.
Icelandic: Rannsóknir á sjúklingum sem fá meðferð með imatinib og áhrifum þess á frjósemi þeirra og kynfrumumyndun hafa ekki verið gerðar.