FrancophonIA/ELRC3.0 huggingface dataset:
English: In the double blind, placebo controlled VIKING-4 study (ING116529), 30 HIV-1 infected, ART-experienced adults with primary genotypic resistance to INIs at Screening, were randomised to receive either dolutegravir 50 mg twice daily or placebo with the current failing regimen for 7 days followed by an open label phase with all subjects receiving dolutegravir.
Icelandic: Í tvíblindu VIKING-4-rannsókninni með samanburði við lyfleysu (ING116529) var 30 HIV-1smituðum fullorðnum, með reynslu af notkun retróveirulyfja og frumkomið arfgerðarónæmi fyrir INIlyfjum við skimun, slembiraðað á annaðhvort dolutegravír 50 mg tvisvar á dag eða lyfleysu, ásamt meðferðaráætluninni sem þeir voru að nota og sem var að bregðast, í 7 daga, fylgt eftir með opnum fasa þar sem allir einstaklingar fengu dolutegravír.
English: Tivicay 50 mg film-coated tablets are yellow, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘50' on the other side.
Icelandic: Tivicay 50 mg filmuhúðaðar töflur eru gular, kringlóttar, tvíkúptar töflur, merktar með kóðanum „SV 572“ á annarri hliðinni og „50“ á hinni.
English: In paediatric patients the weight-based once daily dose should be administered twice daily.
Icelandic: Gefa skal börnum skammt ætlaðan einu sinni á dag, byggðan á þyngd, tvisvar á dag.
English: Pharmacotherapeutic group: Antivirals for systemic use, other antivirals, ATC code: J05AX12
Icelandic: Veirusýkingalyf til altækrar notkunar, önnur veirulyf, ATC-flokkur:
English: Mean increase in CD4+ T cell (cells/mm3) ‡ Adjusted for baseline stratification factors.
Icelandic: Meðalfjölgun á CD4+ T-frumum (frumur/mm3)
English: Tablet coating
Icelandic: Samhliða sýking af lifrarbólgu
English: DTG 50 mg BID N=88* n Mean (SD) Plasma HIV-1 RNA log10 c/mL
Icelandic: HIV-1-RNA í plasma log10 eintök/ml
English: There is no evidence that common polymorphisms in drug metabolising enzymes alter dolutegravir pharmacokinetics to a clinically meaningful extent.
Icelandic: Engar vísbendingar eru um að algengur fjölbreytileiki tengdur lyfjaumbrotsensímum valdi breytingum á lyfjahvörfum dolutegravírs, sem hafa klíníska þýðingu.
English: facial oedema, eosinophilia, angioedema).
Icelandic: • sýrubindandi lyf, gegn meltingartruflunum og brjóstsviða.
English: Cohort I (12 to <18 years) (n=23)
Icelandic: TIVICAY ~1 mg/kg einu sinni á dag + kjörbakgrunnsmeðferð Hópur I (12 til < 18 ára) (n=23)
English: → If you think any of these apply to you, tell your doctor.
Icelandic:  Láttu lækninn vita ef þú heldur að þetta eigi við um þig.
English: At baseline, median patient age was 48 years, 23% were female, 29% non-white, and 20% had hepatitis B and/or C co-infection.
Icelandic: Í upphafi var miðgildi aldurs sjúklinga 48 ár, 23% voru konur, 29% voru ekki af hvíta kynþættinum og 20% voru einnig með lifrarbólgu B og/eða C. Miðgildi CD4+ var í upphafi 140 frumur/mm
English: EU/1/13/892/002
Icelandic: EU/1/13/892/001 EU/1/13/892/002
English: Elderly
Icelandic: magaverkur
English: Tivicay 25 mg film-coated tablets
Icelandic: Tivicay 25 mg filmuhúðaðar töflur
English: At baseline, median patient age was 49 years, 20% were female, 58% non-white, and 23% had hepatitis B and/or C co-infection.
Icelandic: Í upphafi var miðgildi aldurs sjúklinga 49 ár, 20% voru konur, 58% voru ekki af hvíta kynstofninum og 23% einnig með lifrarbólgu B og/eða C. Miðgildi CD4+ var í upphafi 160 frumur/mm
English: Dolutegravir ↔ Methadone ↔ AUC ↓ 2% Cmax ↔ 0% Cτ ↓ 1%
Icelandic: Dolutegravír  Metadon  AUC  2% Cmax  0% C  1%
English: Hepatic impairment
Icelandic: Ónæmisendurvirkjunarheilkenni
English: Baseline with ongoing RAL/EVG
Icelandic: IN-stökkbreytingarhópur í upphafi með áframhaldandi notkun RAL/EVG Frumkomin stökkbreyting
English: The 50 mg dose should be taken as a single 50 mg tablet.
Icelandic: Taka skal 50 mg skammt sem eina 50 mg töflu en ekki fimm 10 mg töflur.
English: Polymorphisms in drug metabolising enzymes
Icelandic: Lyf gegn mýkóbakteríum
English: Dolutegravir 50 mg Once Daily + 2 NRTI N=411
Icelandic: Dolutegravír 50 mg einu sinni á dag + BR N=354§
English: WOCBP who are taking dolutegravir should use effective contraception throughout treatment.
Icelandic: Konur á barneignaraldri sem nota Triumeq skulu nota örugga getnaðarvörn allan meðferðartímann.
English: Tivicay 50 mg film-coated tablets
Icelandic: Tivicay 50 mg filmuhúðaðar töflur
English: Median
Icelandic: Fjölvítamín
English: (induction of UGT1A1 and CYP3A enzymes)
Icelandic: Etravírín  (örvun UGT1A1 og CYP3A ensíma)
English: Each film-coated tablet contains dolutegravir sodium equivalent to 10 mg dolutegravir.
Icelandic: Hver filmuhúðuð tafla inniheldur dolutegravírnatríum sem jafngildir 10 mg af dolutegravíri.
English: EU/1/13/892/004
Icelandic: EU/1/13/892/003 EU/1/13/892/004
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with etravirine without boosted protease inhibitors.
Icelandic: Ráðlagður skammtur af dolutegravíri handa fullorðnum er 50 mg tvisvar á dag við gjöf samtímis etravíríni án örvaðra próteasahemla.
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers.
Icelandic: Ráðlagður skammtur af dolutegravíri handa fullorðnum er 50 mg tvisvar á dag við gjöf samhliða þessum ensímörvum.
English: If you take more Tivicay than you should
Icelandic: áður en þú tekur Tivicay eða fyrr en a.m.k.
English: Yellow, round, biconvex tablets approximately 9 mm in diameter debossed with ‘SV 572' on one side and ‘50' on the other side.
Icelandic: Gular, kringlóttar, tvíkúptar töflur u.þ.b. 9 mm í þvermál, merktar með „SV 572“ á annarri hliðinni og „50“ á hinni.
English: Darunavir/ritonavir
Icelandic: Darúnavír/rítónavír
English: The PK variability of dolutegravir is low to moderate.
Icelandic: Breytileiki í lyfjahvörfum dolutegravírs er lítill til miðlungs mikill.
English: 209b
Icelandic: 20. janúar 2014
English: Each film-coated tablet contains dolutegravir sodium equivalent to 25 mg dolutegravir.
Icelandic: Hver filmuhúðuð tafla inniheldur dolutegravírnatríum sem jafngildir 25 mg af dolutegravíri.
English: Musculoskeletal and connective tissue disorders
Icelandic: Fjölbreytileiki tengdur lyfjaumbrotsensímum
English: Tivicay 25 mg film-coated tablets are pale yellow, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘25' on the other side.
Icelandic: Tivicay 25 mg filmuhúðaðar töflur eru fölgular, kringlóttar, tvíkúptar töflur, merktar með „SV 572“ á annarri hliðinni og „25“ á hinni.
English: Marketing Authorisation Holder ViiV Healthcare BV Huis ter Heideweg 62
Icelandic: Markaðsleyfishafi ViiV Healthcare BV Huis ter Heideweg 62 3705 LZ Zeist Holland
English: White, round, biconvex tablets approximately 6 mm in diameter debossed with ‘SV 572' on one side and ‘10' on the other side.
Icelandic: Hvítar, kringlóttar, tvíkúptar töflur u.þ.b. 6 mm í þvermál, merktar með „SV 572“ á annarri hliðinni og „10“ á hinni.
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓72% (induction of UGT1A1 and CYP3A enzymes)
Icelandic: Dolutegravír  AUC  54% Cmax  43% Cτ 72% (örvun UGT1A1 og CYP3A ensíma)
English: 4.6 Fertility, pregnancy and lactation Women of childbearing potential
Icelandic: 4.6 Frjósemi, meðganga og brjóstagjöf
English: Dolutegravir ↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49% (induction of UGT1A1 and CYP3A enzymes)
Icelandic: Dolutegravír  AUC  35% Cmax  24% Cτ  49% (örvun UGT1A1 og CYP3A ensíma)
English: Atazanavir ↔ Ritonavir ↔ (inhibition of UGT1A1 and CYP3A enzymes)
Icelandic: Atazanavír  Rítónavír  (hindrun UGT1A1 og CYP3A ensíma)
English: Cmax ↑ 6% Cτ ↑ 17%
Icelandic: Dolutegravír  AUC  11% Cmax  6% Cτ  17%
English: Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir.
Icelandic: Hver filmuhúðuð tafla inniheldur dolutegravírnatríum sem jafngildir 50 mg af dolutegravíri.
English: HIV sub type
Icelandic: HIV-undirtegund
English: In a randomized, dose-ranging trial, HIV-1-infected subjects treated with dolutegravir monotherapy (ING111521) demonstrated rapid and dose-dependent antiviral activity, with mean decline in HIV-1 RNA of 2.5 log10 at day 11 for 50 mg dose.
Icelandic: Í slembaðri rannsókn með mismunandi skömmtum hjá HIV-1-smituðum einstaklingum með dolutegravíri einu saman (ING111521) kom fram hröð og skammtaháð veiruhamlandi verkun.
English: Alternative combinations that do not include St. John's wort should be used where possible in INI-resistant patients.
Icelandic: Nota skal aðrar samsetningar, sem ekki innihalda jóhannesarjurt, ef unnt er hjá INI-ónæmum sjúklingum.
English: In animal reproductive toxicity studies, no adverse development outcomes, including neural tube defects, were identified (see section 5.3).
Icelandic: Engin skaðleg áhrif á þroska, þ.m.t. gallar í taugapípu, komu fram í dýrarannsóknum á eiturverkun á æxlun (sjá kafla 5.3).
English: >200 c/ mm3 By HIV-1 subtype B
Icelandic: HIV-1 undirflokki B
English: Tivicay does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Icelandic: Það fækkar veirunum í líkamanum og heldur fjölda þeirra niðri.
English: • For the treatment of HIV that is resistant to other medicines similar to Tivicay, the usual dose of
Icelandic: Til meðferðar við HIV sem er ónæmt fyrir öðrum lyfjum svipuðum Tivicay er venjulegur skammtur af Tivicay 50 mg tafla tvisvar á dag.
English: In previously untreated patients receiving dolutegravir + lamivudine in the GEMINI studies through week 48 (n=716), no development of resistance to the integrase class, or to the NRTI class was seen.
Icelandic: Í GEMINI rannsóknunum hjá sjúklingum sem ekki höfðu fengið meðferð áður kom ekki fram nein þróun ónæmis gegn integrasaflokknum eða flokkum bakritahemlanna hjá sjúklingum sem fengu dolutegravír + lamivúdín á 48 vikum (n=716).
English: Table 6 Response in SAILING at 48 Weeks (Snapshot algorithm, <50 copies/mL) Dolutegravir 50 mg Once Daily + BR N=354§
Icelandic: Tafla 6 Svörun í SAILING eftir 48 vikur (örreiknirit, <50 eintök/ml)
English: Dolutegravir should not be used with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir in INIresistant patients (see further below in table).
Icelandic: Dolutegravír skal ekki nota með etravíríni nema samtímis atazanavíri/rítónavíri,
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Icelandic: Heiti og heimilisfang framleiðanda sem er ábyrgur fyrir lokasamþykkt viðkomandi lotu skal koma fram í prentuðum fylgiseðli
English: EU/1/13/892/006
Icelandic: EU/1/13/892/005 EU/1/13/892/006
English: If you take too many tablets of Tivicay, contact your doctor or pharmacist for advice.
Icelandic: Ef tekinn er stærri skammtur en mælt er fyrir um Leitið ráða hjá lækninum eða lyfjafræðingi ef teknar eru of margar töflur af Tivicay.
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with tipranavir/ritonavir.
Icelandic: Ráðlagður skammtur af dolutegravíri handa fullorðnum er 50 mg tvisvar á dag við gjöf samhliða típranavíri/rítónavíri.
English: Median Change from Baseline, cells/mm3
Icelandic: Miðgildi breytingar miðað við upphafsgildi, frumur/mm a b
English: RAL 400 mg Twice Daily + 2 NRTI N=411
Icelandic: RAL 400 mg tvisvar
English: Renal clearance of unchanged active substance is a minor pathway of elimination for dolutegravir.
Icelandic: Úthreinsun óbreytts virks efnis um nýru skiptir litlu máli fyrir brotthvarf dolutegravírs.
English: Teл.
Icelandic: Skv.
English: 1 Historical or phenotypic evidence of INI resistance only.
Icelandic: Eingöngu INI-ónæmi, skv. sögu eða staðfest með svipgerð.
English: Absorption
Icelandic: INstökkbreyting
English: Symptoms of infection and inflammation
Icelandic: LYFJAFORM OG INNIHALD
English: If you miss a dose, take it as soon as you remember.
Icelandic: Ef gleymist að taka skammt skal taka hann um leið og það uppgötvast, nema ef innan við 4 klst.
English: HIV-1 Antiviral Agents Non-nucleoside Reverse Transcriptase Inhibitors Etravirine without boosted protease inhibitors
Icelandic: Sjúklingar með HIV-1-sýkingu án þess að staðfest eða klínískur grunur sé um ónæmi gegn integrasaflokknum sé til staðar
English: ANNEX II
Icelandic: OSS>2
English: Background Regimen Genotypic Susceptibility Score* <2 Genotypic Susceptibility Score* =2 Use of DRV in background regimen No DRV use DRV use with primary PI mutations DRV use without primary PI mutations Gender Male Female Race White African-America/African Heritage/Other Age (years)
Icelandic: Bakgrunnsmeðferð Arfgerðarnæmiskvarði* <2 Arfgerðarnæmiskvarði * =2 Notkun DRV í bakgrunnsmeðferð Engin DRV notkun
English: Do not take an antacid during the 6 hours before you take Tivicay, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as Tivicay.
Icelandic: Önnur sýrulækkandi lyf, svo sem ranitidín og ómeprazól má taka á sama tíma og Tivicay.
English: Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (Complex binding to polyvalent ions)
Icelandic: Cmax  35% C24  32% (Mynda komplexa með fjölgildum jónum)
English: Pale yellow, round, biconvex tablets approximately 7 mm in diameter debossed with ‘SV 572' on one side and ‘25' on the other side.
Icelandic: Fölgular, kringlóttar, tvíkúptar töflur u.þ.b. 7 mm í þvermál, merktar með „SV 572“ á annarri hliðinni og „25“ á hinni.
English: Median baseline CD4+ was 160 cells/mm3, median duration of prior ART was 13 years, and 63% were CDC Class C. Subjects showed multiple class ART resistance at baseline: 80% had ≥2 NRTI, 73% ≥1 NNRTI, and 67% ≥2 PI major mutations; 83% had non-R5 virus.
Icelandic: 80% voru með ≥2 NRTI, 73% ≥1 NNRTI og 67% ≥2 PI meiriháttar stökkbreytingar; 83% voru með veiru sem ekki var R5.
English: Immune Reactivation Syndrome
Icelandic: Samhliða sýking af völdum lifrarbólgu
English: • joint pain
Icelandic: • húðútbrot
English: No primary IN mutation1
Icelandic: Engin veirusvörun HIV-1
English: Dolutegravir is present in cerebrospinal fluid (CSF).
Icelandic: Dolutegravír er til staðar í heila-mænuvökva.
English: Tivicay is one 50 mg tablet, twice a day.
Icelandic: Ráðlagður skammtur er 50 mg af dolutegravíri (ein tafla) til inntöku einu sinni á dag.
English: NAME OF THE MEDICINAL PRODUCT Tivicay 10 mg film-coated tablets dolutegravir
Icelandic: Tivicay 10 mg filmuhúðaðar töflur dolutegravir
English: NAME OF THE MEDICINAL PRODUCT Tivicay 25 mg film-coated tablets dolutegravir
Icelandic: Tivicay 25 mg filmuhúðaðar töflur dolutegravir
English: Renal impairment
Icelandic: Tivicay inniheldur
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 January 2014
Icelandic: DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS / ENDURNÝJUNAR MARKAÐSLEYFIS
English: Uncommon Arthralgia Uncommon Myalgia
Icelandic: Bakritahemlar sem ekki eru núkleósíð Etravírín án örvaðra próteasahemla
English: Description of selected adverse reactions
Icelandic: Ráðleggingar varðandi samhliða gjöf
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with St. John's wort.
Icelandic: Ráðlagður skammtur af dolutegravíri handa fullorðnum er 50 mg tvisvar á dag við gjöf samhliða jóhannesarjurt.
English: Immune reactivation syndrome
Icelandic: Lyf gegn hjartsláttartruflunum
English: At baseline, median patient age was 35 years, 16% were female, 32% nonwhite, 7% had hepatitis C co-infection and 4% were CDC Class C, these characteristics were similar between treatment groups.
Icelandic: Í upphafi var miðgildi aldurs sjúklinga 35 ár, 16% voru konur, 32% voru ekki af hvíta kynþættinum, 7% voru einnig með lifrarbólgu
English: NAME OF THE MEDICINAL PRODUCT Tivicay 50 mg film-coated tablets dolutegravir
Icelandic: Tivicay 50 mg filmuhúðaðar töflur dolutegravir
English: Patients with prior treatment failure that included an integrase inhibitor (and integrase class resistance) In the multicentre, open-label, single arm VIKING-3 study (ING112574), HIV-1 infected, ART-experienced adults with virological failure and current or historical evidence of raltegravir and/or elvitegravir resistance received Tivicay 50 mg twice daily with the current failing background regimen for 7 days but with optimised background ART from Day 8.
Icelandic: (ING112574) fengu HIV-1-smitaðir fullorðnir, með reynslu af notkun retróveirulyfja og meðferðarbrest og nýja eða eldri staðfestingu á ónæmi fyrir raltegravíri og/eða elvítegravíri, Tivicay 50 mg tvisvar
English: 6.6 Special precautions for disposal No special requirements for disposal.
Icelandic: Engin sérstök fyrirmæli um förgun.
English: Hypersensitivity reactions
Icelandic: Veirufræðileg bæling
English: blister (PVC/PVDC/alu) 50 x 1 tablets (unit dose)
Icelandic: Pakkningastærð þynna (PVC/PVDC/ál) 50 x 1 tafla (stakskammta)
English: This may be repeated up to six times.
Icelandic: Þetta þarf hugsanlega að endurtaka allt að sex sinnum.
English: • Wash your hands before you begin.
Icelandic: Þvoið hendurnar áður en byrjað er.
English: Do not point towards your face or anyone else's face.
Icelandic: Ekki beina henni í átt að andliti þínu eða annarra.
English: Tell your doctor as soon as possible.
Icelandic: Láttu lækninn tafarlaust vita.
English: Your doctor will tell you the dose you need.
Icelandic: Læknirinn segir þér hvaða skammt þú þarft.
English: 3F, No. 28, Keya West Road
Icelandic: 28, Keya West Road
English: After first use
Icelandic: Eftir fyrstu notkun
English: These elevations were mostly transient and occurred during the first treatment year.
Icelandic: Þessar hækkanir voru að mestu skammvinnar og komu fram á fyrsta ári meðferðar.
English: Tell your doctor if you are being treated with telbivudine.
Icelandic: Láttu lækninn vita ef þú færð meðferð með telbivudini.
English: Do not use the pen if it appears damaged.
Icelandic: Ekki nota pennann ef hann virðist hafa orðið fyrir skemmdum.
English: Years*
Icelandic: Ár*
English: (N=178) Leukopenia 34 (19.1) 27.2 3 (8.8)* 23 (67.6) 7 (20.6)
Icelandic: (N=178) Hvítkornafæð 34 (19,1) 27,2 3 (8,8)* 23 (67,6) 7 (20,6)
English: The safety and efficacy of Besremi in children and adolescents has not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun Besremi hjá börnum og unglingum.
English: Apply an adhesive plaster if needed.
Icelandic: Setjið plástur ef þarf.
English: Read them before you start using Besremi.
Icelandic: Lestu þær áður en þú byrjar að nota Besremi.
English: Insert the needle at a 90 degrees angle until the blue protective sleeve on the needle is no longer visible.
Icelandic: Stingið nálinni í með 90 gráðu horni þar til blái hlífðarhólkurinn á nálinni sést ekki lengur.
English: Do not stop using Besremi before you have talked to your doctor.
Icelandic: Ekki hætta að nota Besremi án þess að ræða við lækninn.
English: Treatment should be initiated under supervision of a physician experienced in the management of the disease.
Icelandic: Meðferðina á að hefja undir eftirliti læknis með reynslu af meðferð sjúkdómsins.
English: If TSH levels can be controlled within the normal range, the therapy can be continued.
Icelandic: Ef hægt er að halda TSH gildum innan eðlilegra marka má halda meðferðinni áfram.
English: You have to use a different injection site for each of the two pens.
Icelandic: Þú þarft mismunandi inndælingarstaði fyrir hvorn penna.
English: Your doctor will usually check your vision before starting your treatment.
Icelandic: Yfirleitt athugar læknirinn sjónina áður en meðferð hefst.
English: The pre-filled pen may be used up to two times within these 30 days.
Icelandic: Áfyllta pennann má nota allt að tvisvar sinnum innan þessara 30 daga.
English: After 36 months of treatment, the complete haematological response was 70.5%.
Icelandic: Eftir 36 mánaða meðferð var algjör blóðfræðileg svörun 70,5%.
English: AOP Orphan Pharmaceuticals AG Wilhelminenstrasse 91/II f 1160 Vienna
Icelandic: AOP Orphan Pharmaceuticals AG Wilhelminenstrasse 91/II f 1160
English: - if you have kidney problems.
Icelandic: - ef þú ert með nýrnavandamál.
English: Your doctor or pharmacist will show you how to use the pen.
Icelandic: Læknirinn eða lyfjafræðingur sýna þér hvernig á að nota pennann.
English: Do not give this medicine to children and adolescents because no information is available on the use of Besremi in this age group.
Icelandic: Ekki gefa lyfið börnum og unglingum þar sem engar upplýsingar liggja fyrir um notkun Besremi hjá þessum aldurshóp.
English: Your doctor will help you decide if you have to stop breast-feeding when you are using this medicine.
Icelandic: Læknirinn hjálpar þér með að ákveða hvort þú þurfir að hætta brjóstagjöf þegar lyfið er notað.
English: Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Icelandic: Sjúklingar ættu að bursta tennur vandlega tvisvar á dag og fara reglulega í tannskoðun.
English: You should brush your teeth thoroughly twice daily and have regular dental checks.
Icelandic: Þú skalt bursta tennur vandlega tvisvar á dag og fara reglulega í tannskoðun.
English: • Combination with telbivudine (see section 4.5)
Icelandic: Samhliða telbivudini (sjá kafla 4.5)
English: Your doctor or pharmacist will explain to you how to use the two pens.
Icelandic: Læknirinn eða lyfjafræðingur útskýra hvernig eiga að nota þessa tvo penna.
English: Almost 50% of patients showed a complete haematological response with an improvement in disease burden after 36 months of treatment.
Icelandic: Næstum 50% sjúklinga sýndu algjöra blóðfræðileg svörun og minnkaða sjúkdómsbyrði eftir 36 mánaða meðferð.
English: Since Besremi is a solution, it does not require resuspension before use.
Icelandic: Þar sem Besremi er lausn þarf ekki að endurdreifa því fyrir notkun.
English: Talk to your doctor before using Besremi: - if you have thyroid disease.
Icelandic: Leitið ráða hjá lækninum áður en Besremi er notað: - ef þú ert með skjaldkirtilssjúkdóm.
English: If your vision worsens, your doctor may decide to discontinue your treatment.
Icelandic: Ef sjónin versnar getur verið að læknirinn ákveði að stöðva meðferðina.
English: Get a new pen and start afresh.
Icelandic: Notaðu nýjan penna og byrjaðu upp á nýtt.
English: Your doctor will reduce your starting dose to 50 microgram if you have severe kidney problems.
Icelandic: Læknirinn minnkar upphafsskammtinn í 50 míkróg ef þú ert með veruleg nýrnavandamál.
English: Empty pens must never be reused and must be properly discarded.
Icelandic: Tóma penna má aldrei nota aftur og þeim á að farga á réttan hátt
English: Patient characteristics at screening in the PROUD-PV Study.
Icelandic: Eiginleikar sjúklinga við skimun í PROUD-PV rannsókninni.
English: To prevent passing on infectious diseases, you should never share Besremi pre-filled pen with anyone else, even when the needle is changed.
Icelandic: Til þess að koma í veg fyrir smitsjúkdóma á aldrei að deila Besremi áfylltum penna með öðrum jafnvel þótt skipt hafi verið um nál.
English: - if you have liver problems − you will have blood tests regularly to check how your liver is working if you are on a long-term Besremi therapy.
Icelandic: - ef þú ert með lifrarvandamál - blóðpróf verða tekin reglulega til þess að athuga lifrarstarfsemi ef þú ert á langtímameðferð með Besremi.
English: Haematocrit (%)* Platelets (109/L)* Leukocytes (109/L)*
Icelandic: Blóðkornaskil (%)* Blóðflögur (109/l)* Hvít blóðkorn (109/l)*
English: Always use a new needle for each injection.
Icelandic: Notið nýja nál fyrir hverja inndælingu.
English: Instead, get a new pen.
Icelandic: Notið nýjan penna í staðinn.
English: - if you have changes in your vision − you must tell your doctor and have an immediate eye examination.
Icelandic: - ef breytingar á sjón koma fram - þá þarftu að láta lækninn vita og fá tafarlausa augnskoðun.
English: Your doctor will decide if it is necessary to treat you with another medicine for an early reduction of your blood cell number to prevent blood clots and bleeding.
Icelandic: Læknirinn mun ákveða hvort nauðsynlegt sé að meðhöndla þig með öðru lyfi til þess að draga snemma úr fjölda blóðfrumna svo koma megi í veg fyrir blóðtappa og blæðingu.