FrancophonIA/ELRC3.0 huggingface dataset:
English: Ventavis 10 microgram/ml
Icelandic: Ventavis 10 míkrógrömm/ml
English: Ventavis contains ethanol
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: • Ventavis 20 microgram/ml:
Icelandic: Ventavis 20 míkrógrömm/ml:
English: At initiation of Ventavis treatment the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser.
Icelandic: Við upphaf meðferðar með Ventavis ætti fyrsti skammtur til innöndunar að vera 2,5 míkrógrömm af iloprosti eins og hann kemur úr munnstykki eimgjafans.
English: Each ampoule with 2 ml contains 20 microgram iloprost.
Icelandic: Hver lykja með 2 ml inniheldur 20 míkrógrömm iloprost.
English: The total clearance of iloprost is about 20 ml/kg/min, which indicates extrahepatic contribution to the metabolism of iloprost.
Icelandic: Heildarbrotthvarf iloprost er um það bil 20 ml/kg/mín, sem bendir til að umbrot iloprost fari einnig fram annars staðar en í lifur.
English: If this dose is well tolerated, dosing should be increased to 5 microgram iloprost and maintained at that dose.
Icelandic: Ef sá skammtur þolist vel ætti að auka skammta í 5 míkrógrömm af iloprosti og halda sig við þá skammtastærð.
English: Ventavis 20 microgram/ml
Icelandic: Ventavis 20 míkrógrömm/ml
English: For each inhalation session you should use a new ampoule of Ventavis.
Icelandic: Nota á nýja lykju af Ventavis fyrir hverja innöndunarlotu.
English: For each inhalation session with the I-Neb AAD, the content of one 1-ml ampoule of Ventavis 20 microgram/ml, showing two coloured rings (-yellow-red), will be transferred into the appropriate nebuliser medication chamber with golden coloured latch together with the golden colour disc immediately before use.
Icelandic: Í hverri innöndunarlotu með I-Neb AAD er innihald einnar lykju með 1 ml af Ventavis 20 míkrógrömm/ml, sem merkt er tveimur lituðum hringjum (-gult-rautt), flutt yfir í lyfjahólf eimgjafans með gylltu lokunni og gyllta disknum rétt fyrir notkun.
English: • Ventavis 10 microgram/ml:
Icelandic: Ventavis 10 míkrógrömm/ml:
English: Multipack: 168 (4 x 42) ampoules with 1 ml co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Icelandic: Fjölpakkning: 168 (4 x 42) lykjur með 1 ml pakkað með Breelib meðferðarsetti (inniheldur 1 munnstykki og 1 lyfjahólf).
English: For each medication chamber there is a corresponding colour coded control disc:
Icelandic: Stjórndiskur merktur samsvarandi lit er fyrir hendi fyrir hvort lyfjahólf:
English: Each ampoule with 1 ml contains 10 microgram iloprost.
Icelandic: Hver lykja með 1 ml inniheldur 10 míkrógrömm iloprost.
English: − Severe coronary heart disease or unstable angina.
Icelandic: Alvarlegur kransæðasjúkdómur eða hvikul hjartaöng
English: Ampoule coloured ring
Icelandic: Lykja litaður hringur
English: Dyspnoea Pharyngolaryngeal pain
Icelandic: Verkur í kjálka/kjálkastjarfi
English: Each ampoule with 1 ml solution contains 10 microgram iloprost.
Icelandic: Hver lykja með 1 ml af lausn inniheldur 10 míkrógrömm iloprost.
English: Fertility
Icelandic: Berlimed
English: Ventavis 10 microgram/ml nebuliser solution Ventavis 20 microgram/ml nebuliser solution
Icelandic: Ventavis 10 míkrógrömm/ml lausn fyrir eimgjafa Ventavis 20 míkrógrömm/ml lausn fyrir eimgjafa
English: • 30 ampoules
Icelandic: 30 lykjur
English: • if your pulmonary hypertension is due to a blocked or narrowed vein (venous occlusive disease).
Icelandic: ef lungnaháþrýstingur þinn stafar af stíflaðri eða þröngri bláæð.
English: Package leaflet: Information for the user Ventavis 20 microgram/ml nebuliser solution
Icelandic: Upplýsingar fyrir notanda lyfsins Ventavis 20 míkrógrömm/ml lausn fyrir eimgjafa
English: Management
Icelandic: Stjórndiskur
English: Diarrhoea Vomiting Mouth and tongue irritation including pain
Icelandic: erting í munni og tungu, þ.m.t. verkur
English: Ventavis 10 microgram/ml nebuliser solution (1 ml ampoule)
Icelandic: Ventavis 10 míkrógrömm/ml lausn fyrir eimgjafa (1 ml lykja)
English: • breathing difficulties (dyspnoea)
Icelandic: • hraður hjartsláttur (hraðtaktur)
English: In general, when starting Ventavis treatment the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece.
Icelandic: Almennt ætti fyrsti skammtur til innöndunar við upphaf meðferðar með Ventavis að vera 2,5 míkrógrömm af iloprosti eins og hann kemur úr munnstykkinu.
English: If your doctor decides to further increase the dose up to 5 microgram, again dosing intervals of 3 - 4 hours should be chosen initially and shortened depending on how you tolerate the treatment.
Icelandic: Ákveði læknirinn að auka skammtinn enn frekar upp í 5 míkrógrömm, skal hverfa aftur til 3 - 4 klst.
English: • if you have a heart problem, such as poor blood flow to the heart muscles (severe coronary heart disease or unstable angina).
Icelandic: o lélegt blóðflæði til hjartans (alvarlegir kransæðasjúkdómar eða hvikul hjartaöng).
English: Each ampoule with 2 ml solution contains 20 microgram iloprost.
Icelandic: Hver lykja með 2 ml af lausn inniheldur 20 míkrógrömm iloprost.
English: Each ampoule with 1 ml contains 20 microgram iloprost.
Icelandic: Hver lykja með 1 ml inniheldur 20 míkrógrömm iloprost.
English: What is in this leaflet
Icelandic: § sjá kaflann
English: Ventavis therapy should only be initiated by a physician experienced in treatment of pulmonary hypertension.
Icelandic: Einungis læknir með reynslu af meðferð lungnaháþrýstings skal hefja meðferð með Ventavis.
English: Each ampoule with 1 ml solution contains 20 microgram iloprost.
Icelandic: Hver lykja með 1 ml af lausn inniheldur 20 míkrógrömm iloprost.
English: Dosage
Icelandic: MedDRA
English: Ventavis 20 mcg/ml
Icelandic: Ventavis 20 míkróg/ml
English: Ventavis should only be initiated and monitored by a physician experienced in the treatment of pulmonary hypertension.
Icelandic: Einungis læknir með reynslu af meðferð lungnaháþrýstings skal hefja og hafa eftirlit með notkun Ventavis.
English: • 3 ml ampoules, colourless, glass type I, containing 2 ml nebuliser solution, ring coded with two coloured rings (white - pink).
Icelandic: I, sem innihalda 2 ml af lausn fyrir eimgjafa, hringmerktar með tveimur lituðum hringjum (hvítt - bleikt).
English: Room ventilation
Icelandic: YTRI UMBÚÐUM
English: Multipack containing 168 (4x42) ampoules with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Icelandic: Fjölpakkning með 168 (4x42) lykjum með Breelib meðferðarsetti (inniheldur 1 munnstykki og 1 lyfjahólf).
English: Package leaflet: Information for the user Ventavis 10 microgram/ml nebuliser solution
Icelandic: Upplýsingar fyrir notanda lyfsins Ventavis 10 míkrógrömm/ml lausn fyrir eimgjafa
English: For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis 10 microgram/ml, with two coloured rings (white - yellow), is transferred into the medication chamber immediately before use.
Icelandic: Í hverri innöndunarlotu með I-Neb AAD er innihald einnar 1 ml lykju af Ventavis 10 míkrógrömm/ml, sem merkt er tveimur lituðum hringjum (hvítt - gult), flutt yfir í lyfjahólf eimgjafans rétt fyrir notkun.
English: • Stimulation of endogenous fibrinolytic potential
Icelandic: Hugsanleg eituráhrif á erfðaefni, æxlamyndandi virkni
English: • I-Neb nebuliser
Icelandic: I-Neb eimgjafi
English: Bayer Austria Ges.
Icelandic: Bayer Austria Ges. m. b. H. Tel:
English: Musculoskeletal and connective tissue disorders
Icelandic: Útvíkkun slagæðlinga og bláæðlinga
English: For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis 20 microgram/ml with two coloured rings (yellow - red), is transferred into the medication chamber immediately before use.
Icelandic: Í hverri innöndunarlotu með I-Neb AAD er innihald einnar 1 ml lykju af Ventavis 20 míkrógrömm/ml, sem merkt er tveimur lituðum hringjum (gult - rautt), flutt yfir í lyfjahólf eimgjafans rétt fyrir notkun.
English: For each inhalation session with the Venta-Neb, the content of one 2 ml ampoule of Ventavis 10 microgram/ml with two coloured rings (white - pink) is transferred into the nebuliser medication chamber immediately before use.
Icelandic: Í hverri innöndunarlotu með Venta-Neb er innihald einnar 2 ml lykju af Ventavis 10 míkrógrömm/ml sem merkt er tveimur lituðum hringjum (hvítt - bleikt), flutt yfir í lyfjahólf eimgjafans rétt fyrir notkun.
English: No studies to investigate the metabolism of iloprost were performed following inhalation of Ventavis.
Icelandic: á efnaskiptum iloprosts hafa verið gerðar eftir innöndun Ventavis.
English: − Decompensated cardiac failure if not under close medical supervision.
Icelandic: Alvarleg hjartabilun án nákvæms lækniseftirlits
English: Multipack: 168 (4 x 42) ampoules with 1 ml.
Icelandic: 168 (4 x 42) lykjur með 1 ml.
English: • pain in jaw/spasm of the jaw muscles (trismus)
Icelandic: • verkur í kjálka/krampar í kjálkavöðvum (erfiðleikar við að opna munninn)
English: Dose of iloprost at Estimated inhalation time mouthpiece
Icelandic: Örvun á innrænni hæfni til fíbrínsundrunar
English: Ventavis 10 microgram/ml nebuliser solution Clear, colourless solution.
Icelandic: Ventavis 10 míkrógrömm/ml lausn fyrir eimgjafa Tær, litlaus lausn.
English: Description of selected adverse reactions
Icelandic: Lýsing tiltekinna aukaverkana
English: Contents of the pack and other information
Icelandic: 5 Hvernig geyma á Ventavis Pakkningar og aðrar upplýsingar
English: • 1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (white - yellow).
Icelandic: I, sem innihalda 1 ml af lausn fyrir eimgjafa, hringmerktar með tveimur lituðum hringjum (hvítt - gult).
English: What Ventavis looks like and content of the pack:
Icelandic: Lýsing á útliti Ventavis og pakkningastærðir
English: Ventavis 20 microgram/ml nebuliser solution
Icelandic: Ventavis 20 míkrógrömm/ml Breelib
English: Before physical exertion it might be useful to inhale.
Icelandic: Gagnlegt gæti verið að anda lyfinu að sér fyrir líkamlega áreynslu.
English: Ventavis 10 mcg/ml
Icelandic: Ventavis 10 míkróg/ml
English: For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis, with two coloured rings (white - yellow) is transferred into the medication chamber immediately before use.
Icelandic: Í hverri innöndunarlotu með I-Neb AAD er innihald einnar 1 ml lykju af Ventavis sem merkt er tveimur lituðum hringjum (hvítt- gult), flutt yfir í lyfjahólf eimgjafans rétt fyrir notkun.
English: The primary efficacy endpoint defined for this study, was a combined response criterion consisting of improvement in exercise capacity (6-minute walk test) at 12 weeks by at least 10% versus baseline, and improvement by at least one NYHA class at 12 weeks versus baseline, and no deterioration of pulmonary hypertension or death at any time before 12 weeks.
Icelandic: einn NYHA flokk við 12. viku miðað við grunnlínu og engin versnun á lungnaháþrýstingi eða andlát einhvern tímann innan 12 vikna.
English: • 1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (yellow - red).
Icelandic: I, sem innihalda 1 ml af lausn fyrir eimgjafa, hringmerktar með tveimur lituðum hringjum (gult - rautt).
English: Device
Icelandic: Búnaður
English: For each inhalation session, the content of one ampoule containing 2 ml of Ventavis 10 microgram/ml nebuliser solution and marked with two coloured rings (white - pink) is transferred into the nebuliser medication chamber immediately before use.
Icelandic: Í hverri innöndunarlotu er innihald einnar lykju með 2 ml af Ventavis 10 míkrógrömm/ml eimgjafalausn, sem merkt er tveimur lituðum hringjum (hvítt-bleikt), flutt yfir í lyfjahólf eimgjafans rétt fyrir notkun.
English: Inhalation use.
Icelandic: Lyfseðillskylt lyf.
English: • Low blood pressure (hypotension)
Icelandic: • blóðflagnafæð (fækkun blóðflagna í blóði)
English: • reduction in the number of blood platelets (thrombocytopenia)
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: 5 mcg purple purple
Icelandic: Bayer plc
English: Multipack: 90 (3 x 30) ampoules with 2 ml.
Icelandic: 90 (3 x 30) lykjur með 2 ml. 100 lykjur með 2 ml.
English: Medication chamber latch
Icelandic: 3. Læknirinn aðlagar stillinguna
English: There is no need for dose adaptation in patients with a creatinine clearance >30 ml/min (as determined from serum creatinine using the Cockroft and Gault formula).
Icelandic: (miðað við kreatínín í sermi samkvæmt Cockroft og Gault formúlunni).
English: LIST OF EXCIPIENTS
Icelandic: Lausn fyrir eimgjafa
English: Ventavis 10 microgram/ml nebuliser solution Iloprost
Icelandic: Ventavis 10 míkrógrömm/ml Breelib
English: • pain when swallowing (pharyngolaryngeal irritation)
Icelandic: • verkur við kyngingu (erting í koki og barkakýli)
English: ANNEX II
Icelandic: P2 Forstilling 2:
English: No disturbance of post-natal development and reproductive performance was seen in animals exposed during lactation.
Icelandic: Engin röskun sást á þroska eftir fæðingu eða æxlunargetu hjá afkvæmum sem komust í snertingu við lyfið í móðurmjólk.
English: Take your next dose at the scheduled time.
Icelandic: Taktu næsta skammt á áætluðum tíma.
English: Nevertheless, their impact remains limited (31%).
Icelandic: Þrátt fyrir það eru áhrif þeirra takmörkuð (31%).
English: Placebo (N=997)
Icelandic: Lyfleysa (N=997)
English: AUBAGIO should not be used in children and adolescents under 18 years of age.
Icelandic: AUBAGIO má ekki gefa börnum og unglingum yngri en 18 ára.
English: This stops nerves from working properly.
Icelandic: Þetta kemur í veg fyrir að taugarnar geti starfað eðlilega.
English: Common Uncommon Rare Very rare
Icelandic: Sjaldgæfar Mjög sjaldg æfar
English: Effect of teriflunomide on warfarin
Icelandic: Áhrif teriflúnómíðs á warfarín
English: AUBAGIO may be taken with or without food.
Icelandic: AUBAGIO má taka með eða án matar.
English: In such cases, patients should refrain from driving and using machines.
Icelandic: Í slíkum tilfellum ættu sjúklingar ekki að aka eða nota vélar.
English: AUBAGIO is taken every day as a single daily dose at any time of the day.
Icelandic: AUBAGIO er tekið á hverjum degi í stökum skammti, hvenær sem er dagsins.
English: The tablets should be swallowed whole with some water.
Icelandic: Töflurnar á að gleypa í heilu lagi með nægilegu vatni.
English: Information to educate the patient:
Icelandic: Upplýsingar til að fræða sjúklinginn og:
English: If they become pregnant:
Icelandic: Ef konur verða þungaðar:
English: Alternatively, activated charcoal may also be used (the 11 days do not need to be consecutive unless there is a need to lower teriflunomide plasma concentration rapidly).
Icelandic: Annars má einnig nota lyfjakol (dagarnir 11 þurfa ekki að vera samfelldir nema þörf sé á hraðri lækkun plasmaþéttni teriflúnómíðs).
English: - you have high blood pressure (hypertension) whether it is controlled with medicines or not.
Icelandic: 4. - þú ert með háan blóðþrýsting (háþrýsting) hvort sem hann er meðhöndlaður með lyfjum eða ekki.
English: This loss of myelin is called demyelination.
Icelandic: Þessi skemmd á mýelíni kallast afmýling.
English: Teriflunomide 14 mg (N=1002)
Icelandic: Teriflúnómíð 14 mg (N=1002)
English: Efficacy in patients with high disease activity:
Icelandic: Verkun hjá sjúklingum með mikla sjúkdómsvirkni:
English: Before you take AUBAGIO, your doctor will make sure you have enough white blood cells and platelets in your blood.
Icelandic: Áður en þú notar AUBAGIO mun læknirinn ganga úr skugga um að þú hafir nægilegt magn hvítra blóðkorna og blóðflagna í blóðinu.
English: The time can be reduced to a few weeks by taking certain medicines which speed up removal of AUBAGIO from your body.
Icelandic: Hægt er að stytta þennan tíma í nokkrar vikur með því að taka ákveðin lyf sem hraða brotthvarfi AUBAGIO úr líkamanum.
English: These elevations occurred mostly within the first 6 months of treatment.
Icelandic: Þessi hækkun kom einkum fram innan fyrstu 6 mánaða meðferðar.
English: Patients with severe hepatic impairment (Child-Pugh class C).
Icelandic: Alvarlega skert lifrarstarfsemi (Child-Pugh flokkur C).
English: AUBAGIO can cause an increase in blood pressure.
Icelandic: AUBAGIO getur valdið hækkun blóðþrýstings.
English: If you are affected, do not drive or use machines.
Icelandic: Finnir þú fyrir slíku skaltu hvorki aka né nota vélar.
English: • Affects blood cell counts and the immune system 2.
Icelandic: Hefur áhrif á fjölda blóðfrumna og á ónæmiskerfið 2.
English: Effect of teriflunomide on CYP1A2 substrate: caffeine
Icelandic: Áhrif teriflúnómíðs á CYP1A2 hvarfefni: koffín
English: AUBAGIO should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy.
Icelandic: AUBAGIO skal nota með varúð hjá sjúklingum 65 ára og eldri, þar sem ekki eru fyrirliggjandi nægjanlegar upplýsingar um öryggi og verkun.
English: - you are due to have a specific blood test (calcium level).
Icelandic: - þú átt að fara í blóðprufu (kalsíumgildi mæld).
English: België/Belgique/Belgien
Icelandic: België/Belgique/Belgien Sanofi Belgium
English: The safety and efficacy of teriflunomide in children aged from 10 to less than 18 years has not yet been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun teriflúnómíðs hjá börnum á aldrinum 10 til yngri en 18 ára.
English: AUBAGIO has no or negligible influence on the ability to drive and use machines.
Icelandic: AUBAGIO hefur engin eða óveruleg áhrif á hæfni til aksturs og notkunar véla.
English: The mean number of relapses within the year before study inclusion was 1.4.
Icelandic: Meðalfjöldi kasta innan árs fyrir inntöku í rannsóknina var 1,4.
English: Do not use this medicine after the expiry date which is stated on the carton, protective sleeve, and wallet after “EXP”.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni, hlífðarhulstrinu og veskinu á eftir EXP.
English: Women of childbearing potential must not take this medicine without using reliable contraceptive measures.
Icelandic: Konur á barneignaraldri mega ekki taka þetta lyf án þess að nota örugga getnaðarvörn.
English: • balance problems.
Icelandic: • jafnvægistruflanir.
English: The recovery time varied between months and years.
Icelandic: Breytilegt var hversu langan tíma það tók, allt frá mánuðum til ára.
English: This limits the inflammation that leads to nerve damage in MS.
Icelandic: Þetta takmarkar bólgu sem leiðir til taugaskemmda í MS.
English: You may experience side effects similar to those described in section 4 below.
Icelandic: Þú gætir fundið fyrir aukaverkunum líkt og þeim sem lýst er í kafla 4 hér að aftan.
English: Therefore, teriflunomide plasma concentrations should be measured before a woman begins to attempt to become pregnant.
Icelandic: Því skal mæla plasmaþéttni teriflúnómíðs áður en kona byrjar að reyna að verða þunguð.
English: ILD may be fatal.
Icelandic: Millivefslungnasjúkdómur getur verið banvænn.
English: These elevations in transaminase occurred mostly within the first 6 months of treatment and were reversible after treatment cessation.
Icelandic: Þessar hækkanir á transamínasa kom einkum fram innan fyrstu 6 mánuða meðferðar og gengu til baka eftir að meðferð lauk.
English: This can cause physical disabilities that may interfere with your daily activities.
Icelandic: Þetta getur valdið líkamlegri fötlun sem getur haft áhrif á athafnir daglegs lífs.
English: • Do this until the levels of AUBAGIO in your blood are low enough - your doctor will check this.
Icelandic: Gerðu það þar til magn AUBAGIO í blóðinu er nægilega lágt - læknirinn mun ganga úr skugga um það.
English: Although human data are lacking, no effect on male and female fertility is anticipated.
Icelandic: Þó að upplýsingar um menn skorti er ekki búist við áhrifum á frjósemi karla eða kvenna.
English: Serious opportunistic infections occurred in 0.2% of each group.
Icelandic: Alvarlegar tækifærissýkingar komu fyrir hjá 0,2% í hvorum hópi fyrir sig.
English: This is because the effects of the medicine in this age group are not known.
Icelandic: Ástæðan er að verkun lyfsins á þennan aldurshóp eru ekki þekkt.
English: TOWER-study
Icelandic: TOWER-rannsókn
English: To encourage the patients to read the PIL thoroughly 4.
Icelandic: Hvetja sjúklinga til þess að lesa fylgiseðilinn gaumgæfilega 4.
English: Also contains: lactose.
Icelandic: Inniheldur einnig: laktósa.
English: These symptoms vary from patient to patient but usually involve:
Icelandic: Þessi einkenni eru breytileg á milli sjúklinga en fela venjulega í sér:
English: Teriflunomide is extensively bound to plasma protein (>99%), probably albumin and is mainly distributed in plasma.
Icelandic: Teriflúnómíð er að miklu leyti bundið plasmapróteinum (>99%), líklegast albúmíní og dreifist aðallega í plasma.
English: No evidence of carcinogenicity was observed in rats and mice.
Icelandic: Engin merki um krabbameinsvaldandi áhrif komu fram í rottum eða músum.
English: If you suspect that you are pregnant while taking AUBAGIO or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Icelandic: Ef þig grunar að þú sért þunguð á meðan þú tekur AUBAGIO eða í tvö ár eftir að meðferð er hætt, skalt þú strax hafa samband við lækninn til þess að láta gera þungunarpróf.
English: EU/1/13/838/001 14 tablets EU/1/13/838/002 28 tablets EU/1/13/838/003 84 tablets EU/1/13/838/004 98 tablets EU/1/13/838/005 10x1 tablet
Icelandic: EU/1/13/838/001 14 töflur EU/1/13/838/002 28 töflur EU/1/13/838/003 84 töflur EU/1/13/838/004 98 töflur EU/1/13/838/005 10x1 tafla
English: Before treatment
Icelandic: Áður en meðferð hefst
English: Therefore, caution is required when switching patients from natalizumab to AUBAGIO.
Icelandic: Því skal gæta varúðar þegar sjúklingar skipta úr natalízúmabi yfir í AUBAGIO.
English: - you take leflunomide with AUBAGIO.
Icelandic: - þú tekur leflúnómíð samhliða AUBAGIO.
English: For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, monitoring must be performed weekly.
Icelandic: Við hækkun á ALT (SGPT) sem er á bilinu 2- og 3-föld eðlileg efri mörk verður að hafa vikulegt eftirlit.
English: • Blood pressure o Check periodically
Icelandic: Blóðþrýstingi o Athuga reglulega
English: Repeated doses of teriflunomide had no effect on the pharmacokinetics of S-warfarin, indicating that teriflunomide is not an inhibitor or an inducer of CYP2C9.
Icelandic: Endurteknir skammtar teriflúnómíðs höfðu engin áhrif á lyfjahvörf S-warfaríns, sem bendir til þess að teriflúnómíð hvorki hamli né virkji CYP2C9.
English: Over 21 days, 60.1% of the administered dose is excreted via feces (37.5%) and urine (22.6%).
Icelandic: Á 21 dags tímabili skiljast 60,1% skammtsins út með hægðum (37,5) og þvagi (22,6%).
English: Following discontinuation of teriflunomide and the administration of cholestyramine 8 g three times a day, the plasma concentration of teriflunomide is reduced 52% at the end of day 1, 91% at the end of day 3, 99.2% at the end of day 7, and 99.9% at the completion of day 11.
Icelandic: Eftir að meðferð með teriflúnómíði var hætt og 8 g af kólestýramíni voru gefin þrisvar sinnum á sólarhring, hafði plasmaþéttni teriflúnómíðs lækkað um 52% í lok 1. dags, 91% í lok 3. dags 3, 99,2% í lok 7. dags og 99,9% í lok 11. dags.
English: The risk of failure (confirmed relapse or permanent treatment discontinuation whichever came first) was the primary endpoint.
Icelandic: Hætta á meðferðarbresti (staðfest kast eða varanleg stöðvun meðferðar, hvort heldur varð á undan) var aðalendapunktur.
English: Excipient with known effect: each tablet contains 72 mg of lactose (as monohydrate).
Icelandic: Hjálparefni með þekkta verkun: hver tafla inniheldur 72 mg af laktósa (sem einhýdrat).
English: AUBAGIO might make you feel dizzy which may impair your ability to concentrate and react.
Icelandic: AUBAGIO kann að valda sundli sem getur dregið úr hæfni þinni til að einbeita þér og bregðast við.
English: - you are switching to or from AUBAGIO.
Icelandic: - þú skiptir í eða úr AUBAGIO.
English: Each wallet is placed in a protective sleeve.
Icelandic: Hvert vasi er í hlífðarhulstri