FrancophonIA/ELRC3.0 huggingface dataset:
English: Component of a multipack, can't be sold separately.
Icelandic: Má ekki selja stakan.
English: • problems with the nose, throat and sinuses, breathing problems when sleeping
Icelandic: • nef-, háls-, og skútavandamál, öndunarerfiðleikar í svefni
English: • decreased levels of blood albumin
Icelandic: • minnkað magn albúmíns í blóði
English: • mouth problems, including dry or sore mouth, sensitive tongue, bleeding gums
Icelandic: munnvandamál, þ.m.t. þurrkur eða særindi í munni, viðkvæm tunga, blæðing í tannholdi
English: Revolade 25 mg film-coated tablets eltrombopag
Icelandic: Revolade 25 mg filmuhúðaðar töflur eltrombopag
English: • accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.
Icelandic: eru einnig með klínískum einkennum lifrarskaða eða merki um lifrarbilun
English: Hepatic impairment
Icelandic: Alvarlegt vanmyndunarblóðleysi
English: Don't breast-feed while you are taking Revolade.
Icelandic: Ekki hafa barn á brjósti samhliða töku Revolade.
English: EU/1/10/612/011 (28 film-coated tablets)
Icelandic: EU/1/10/612/011 (28 filmuhúðaðar töflur)
English: • abnormal colored urine
Icelandic: • óeðlilegur litur á þvagi
English: Revolade 25 mg film-coated tablets
Icelandic: Revolade 25 mg filmuhúðaðar töflur
English: EU/1/10/612/012 84 film-coated tablets (3 packs of 28)
Icelandic: EU/1/10/612/012 84 filmuhúðaðar töflur (3 pakkningar með 28)
English: CARTON OF 12.5 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Icelandic: ASKJA MEÐ 12,5 mg - 14, 28, 84 (3 PAKKNINGAR með 28) TÖFLUM
English: This risk is increased if eltrombopag treatment is discontinued in the presence of anticoagulants or anti-platelet agents.
Icelandic: Þessi hætta eykst ef meðferð með eltrombópagi er hætt á sama tíma og segavarnarlyf eða blóðflöguhemjandi lyf eru notuð.
English: What Revolade contains
Icelandic: Revolade inniheldur
English: • increased pH of urine
Icelandic: • aukið sýrustig (pH) í þvagi
English: Fatigue, pyrexia, chills
Icelandic: Mixtúruduft, dreifa
English: • eye problems including abnormal eye test, dry eye, eye pain and blurred vision
Icelandic: • augnvandamál, þ.m.t. óeðlileg augnpróf, þurr augu, augnverkur og þokusjón
English: Multipacks of 84 (3 packs of 28 film-coated tablets) - without blue box - 12.5 mg film-coated tablets
Icelandic: Fjölpakkning með 84 (3 pakkningar með 28 filmuhúðuðum töflum) án blue box- 12,5 mg filmuhúðaðar töflur
English: QTc interval prolongation has been reported in clinical studies of patients with ITP and thrombocytopenic patients with HCV.
Icelandic: Greint hefur verið frá lengingu QTc-bils í klínískum rannsóknum hjá sjúklingum með ITP og blóðflagnafæðarsjúklingum með lifrarbólgu C. Klínísk þýðing þessara tilvika með lengingu QTc er ekki þekkt.
English: The absolute oral bioavailability of eltrombopag after administration to humans has not been established.
Icelandic: Ekki hefur verið sýnt fram á heildaraðgengi eltrombópags eftir gjöf hjá mönnum.
English: Musculosketal and connective tissue disorders
Icelandic: Myndun beinmergsretíkúlíns og hætta á bandvefsaukningu í beinmerg
English: • 1 reusable mixing bottle with lid and cap (supplied in the kit)
Icelandic: 1 margnota blöndunarglas með loki og hettu (fylgir í settinu)
English: Based on urinary excretion and metabolites eliminated in faeces, the oral absorption of drug-related material following administration of a single 75 mg eltrombopag solution dose was estimated to be at least 52%.
Icelandic: Miðað við útskilnað í þvagi og umbrotsefni skilin út í hægðum, var frásog staks 75 mg skammts af eltrombópaglausn, áætlað a.m.k.
English: Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.
Icelandic: Hver filmuhúðuð tafla inniheldur eltrombópagólamín sem jafngildir 25 mg af eltrombópagi.
English: Platelet counts should be monitored every week prior to starting antiviral therapy.
Icelandic: Hafa skal vikulegt eftirlit með blóðflagnafjölda áður en veiruhamlandi meðferð er hafin.
English: Contact a doctor or pharmacist immediately.
Icelandic: - Látið lækninn eða lyfjafræðing vita um allar aukaverkanir.
English: • high temperature
Icelandic: • miklar tíðablæðingar
English: LABELLING AND PACKAGE LEAFLET
Icelandic: Eftirlit og aðlögun skammta
English: Patients with these characteristics should be closely monitored for signs and symptoms of hepatic decompensation.
Icelandic: Hafa skal nákvæmt eftirlit með einkennum starfstruflunar í lifur hjá sjúklingum með þessi einkenni.
English: Female paediatric ITP patients had approximately 25% higher plasma eltrombopag AUC(0-) values as compared to male patients.
Icelandic: Gildi AUC(0-τ) fyrir eltrombópag í plasma voru um það bil 25% hærri hjá stúlkum með ITP en drengjum.
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Icelandic: Samantekt á eiginleikum lyfs, kafla 4.2).
English: Myalgia
Icelandic: • mígreni
English: Nausea, diarrhoea
Icelandic: Ógleði, niðurgangur
English: Posology
Icelandic: sjónskerðing
English: • irritation and inflammation (swelling) of the sinuses
Icelandic: • erting og bólga (þroti) í skútum
English: Prior to initiation of eltrombopag, the peripheral blood smear should be examined closely to establish a baseline level of cellular morphologic abnormalities.
Icelandic: Skoða skal blóðstrok vandlega áður en meðferð með eltrombópagi er hafin, til að fá viðmið í útliti blóðfrumnanna.
English: Decrease the daily dose by 50 mg.
Icelandic: Minnka skal dagskammtinn um 50 mg.
English: No dosage adjustment is necessary for HCV patients of Asian ancestry or patients with mild hepatic impairment (see section 5.2).
Icelandic: Hafa skal náið eftirlit þegar eltrombópag er gefið ITP-sjúklingum og sjúklingum með alvarlegt vanmyndunarblóðleysi með skerta lifrarstarfsemi (sjá kafla 4.2).
English: • localised swelling filled with blood from a break in a blood vessel (haematoma)
Icelandic: • staðbundinn þroti fullur af blóði vegna rofinnar æðar (margúll)
English: • Empty all contents of each sachet into the mixing bottle
Icelandic: Tæmið allt innihaldið úr hverjum skammtapoka ofan í blöndunarglasið.
English: EU/1/10/612/007 (14 film-coated tablets)
Icelandic: EU/1/10/612/007 (14 filmuhúðaðar töflur)
English: In patients with low albumin levels (≤35 g/l) or MELD score ≥10 at baseline, there was a 3-fold greater risk of hepatic decompensation and an increase in the risk of a fatal adverse event compared to those with less advanced liver disease.
Icelandic: Hjá sjúklingum með lága albúmínþéttni (≤35 g/l) eða ≥10 á MELD-kvarða í upphafi var hættan á starfstruflun í lifur 3-falt meiri og aukin hætta á lífshættulegum aukaverkunum samanborið við þá sem voru ekki með eins alvarlegan lifrarsjúkdóm.
English: • mouth problems including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers
Icelandic: munnvandamál, þ.m.t. þurrkur eða særindi í munni, viðkvæm tunga, blæðing í tannholdi, sár í munni
English: The most common adverse reactions occurring in at least 10% of patients included headache, dizziness, cough, oropharyngeal pain, nausea, diarrhoea, abdominal pain, transaminases increased, arthralgia, pain in extremity, fatigue and pyrexia.
Icelandic: 10% sjúklinga voru höfuðverkur, sundl, hósti, verkur í munni og koki, ógleði, niðurgangur, kviðverkur, aukning á transamínösum, liðverkir, verkir í útlimum, þreyta og hiti.
English: EU/1/10/612/001 (14 film-coated tablets)
Icelandic: EU/1/10/612/001 (14 filmuhúðaðar töflur)
English: EU/1/10/612/004 (14 film-coated tablets)
Icelandic: EU/1/10/612/004 (14 filmuhúðaðar töflur)
English: While you are taking Revolade, you will be under the care of a doctor with specialist experience in treating your condition.
Icelandic: Læknir með sérfræðiþekkingu á meðferð sjúkdómsins hefur eftirlit með þér meðan á meðferð með Revolade stendur.
English: EU/1/10/612/008 (28 film-coated tablets)
Icelandic: EU/1/10/612/008 (28 filmuhúðaðar töflur)
English: • cough
Icelandic: • frunsa
English: In 2 controlled clinical studies in patients with HCV, ALT or AST 3 x ULN was reported in 34% and 38% of the eltrombopag and placebo groups, respectively.
Icelandic: C var greint frá ALAT eða ASAT 3 x eðlileg efri mörk hjá 34% í eltrombópaghópnum og 38% í lyfleysuhópnum.
English: Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag
Icelandic: Hver filmuhúðuð tafla inniheldur eltrombópagólamín sem jafngildir 75 mg af eltrombópagi.
English: Increased bone marrow reticulin
Icelandic: • aukið magn sumra próteina
English: To clean up
Icelandic: Þvoið tafarlaust
English: Renal effects were not observed in rats after 28 weeks or in dogs after 52 weeks at exposures 4 and 2 times the human clinical exposure in adult ITP patients and 3 and 2 times the human clinical exposure in paediatric ITP patients at 75 mg/day and 2 times and equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Icelandic: Áhrif á nýru komu ekki fram hjá rottum eftir 28 vikur við útsetningu sem var 4 sinnum hærri, eða hjá hundum eftir 52 vikur við útsetningu sem var 2 sinnum hærri en klínísk útsetning hjá fullorðnum sjúklingum með ITP og 3- og 2-föld klínísk útsetning hjá börnum með ITP við 75 mg/dag og 2 sinnum og jafngild klínískri útsetningu hjá sjúklingum með lifrarbólgu C, miðað við AUC.
English: EU/1/10/612/009 84 film-coated tablets (3 packs of 28)
Icelandic: EU/1/10/612/009 84 filmuhúðaðar töflur (3 pakkningar með 28)
English: Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag
Icelandic: Hver filmuhúðuð tafla inniheldur eltrombópagólamín sem jafngildir 50 mg af eltrombópagi.
English: In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.
Icelandic: Ef ofskömmtun verður gæti blóðflögum fjölgað óhóflega og valdið sega-/segareksvandamálum.
English: Eye examinations
Icelandic: Beinmergsrannsóknir
English: Multipacks of 84 (3 packs of 28 film-coated tablets) - without blue box -75 mg film-coated tablets
Icelandic: Fjölpakkning með 84 (3 pakkningar með 28 filmuhúðuðum töflum) án blue box- 75 mg filmuhúðaðar töflur
English: CARTON OF 75 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Icelandic: ASKJA MEÐ 75 mg - 14, 28, 84 (3 PAKKNINGAR með 28) TÖFLUM
English: • nose bleed
Icelandic: Algengar Blóðnasir
English: Treatment with eltrombopag in these patients should be initiated only by physicians experienced in the management of advanced HCV, and only when the risks of thrombocytopenia or withholding antiviral therapy necessitate intervention.
Icelandic: C skulu hefja meðferð hjá þessum sjúklingum og aðeins þegar hættan á blóðflagnafæð eða af því að hefja ekki veiruhamlandi meðferð veldur því að nauðsynlegt er að grípa til ráðstafana.
English: • muscle pain, muscle weakness
Icelandic: vöðvaverkir, vöðvakrampar, vöðvamáttleysi
English: Multipack containing 84 (3 packs of 28) film-coated tablets
Icelandic: 84 filmuhúðaðar töflur (3 pakkningar með 28)
English: • digestive system problems including being sick (vomiting), change in appetite (increased or decreased), stomach pain/discomfort, swollen stomach, passing wind, change in stool colour
Icelandic: • meltingarvandamál, þ.m.t. uppköst, breytingar á matarlyst (aukin eða minnkuð),
English: Patients should be closely monitored for signs and symptoms of TEE.
Icelandic: Hafa skal nákvæmt eftirlit með einkennum segarekstilvika hjá sjúklingum.
English: Give the medicine to the child. Do this straight away when you have mixed the dose.
Icelandic: Gerið þetta um leið og skammturinn hefur verið blandaður.
English: Disposal
Icelandic: yfirlið
English: Description of selected adverse reactions
Icelandic: tilfinning um aðskotahlut
English: The clinical relevance of the decrease in Cmin has not been established, increased clinical and laboratory monitoring for HCV suppression is recommended.
Icelandic: Ekki hefur verið sýnt fram á klíníska þýðingu lækkunar Cmin en mælt er með auknu klínísku eftirliti og eftirliti með rannsóknarniðurstöðum m.t.t. bælingar á lifrarbólguveiru C.
English: EU/1/10/612/005 (28 film-coated tablets)
Icelandic: EU/1/10/612/005 (28 filmuhúðaðar töflur)
English: Pyrexia, fatigue, influenza-like illness, asthenia, chills
Icelandic: Hiti, þreyta, inflúensulík veikindi, þróttleysi, kuldahrollur
English: EU/1/10/612/006 84 film-coated tablets (3 packs of 28)
Icelandic: EU/1/10/612/006 84 filmuhúðaðar töflur (3 pakkningar með 28)
English: Discontinuation
Icelandic: Aukaverkun
English: EU/1/10/612/002 (28 film-coated tablets)
Icelandic: EU/1/10/612/002 (28 filmuhúðaðar töflur)
English: Cough Common Oropharyngeal pain, rhinorrhoea♦ Uncommon Pulmonary embolism, pulmonary infarction, nasal discomfort, oropharyngeal blistering, sinus disorder, sleep apnoea syndrome
Icelandic: Hósti♦ Algengar Verkur í munni og koki, nefrennsli Sjaldgæfar Lungnasegarek, lungnadrep, óþægindi í nefi, blöðrumyndun í munnkoki, skútakvilli, kæfisvefn
English: No hepatic effects were observed after chronic dosing in rats (28 weeks) and in dogs (52 weeks) at 4 or 2 times the human clinical exposure in adult ITP patients and 3 or 2 times the human clinical exposure in paediatric ITP patients at 75 mg/day and 2 times or equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Icelandic: Engin áhrif á lifur komu fram við langvarandi meðhöndlun hjá rottum (28 vikur) við útsetningu sem var allt að 4 sinnum hærri, eða hundum (52 vikur) við útsetningu sem var allt að 2 sinnum hærri en klínísk útsetning hjá fullorðnum sjúklingum með ITP og 3- og 2-föld klínísk útsetning hjá börnum með ITP við 75 mg/dag og 2-falda eða jafngilda útsetningu hjá sjúklingum með lifrarbólgu C við 100 mg/dag, miðað við AUC.
English: Common Pyrexia*, chest pain, asthenia *Very common in paediatric ITP Uncommon Feeling hot, vessel puncture site haemorrhage, feeling jittery, inflammation of wound, malaise, sensation of foreign body
Icelandic: Algengar Hiti*, brjóstverkur, þróttleysi *Mjög algengar hjá börnum með ITP Sjaldgæfar Hitatilfinning, blæðing á stungustað í æð, taugaveiklun, bólga í sári, lasleiki, tilfinning um aðskotahlut
English: Risk of hepatotoxicity
Icelandic: blæðing úr tannholdi
English: CARTON OF 50 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Icelandic: ASKJA MEÐ 50 mg - 14, 28, 84 (3 PAKKNINGAR með 28) TÖFLUM
English: Dose adjustments are based upon the platelet count response.
Icelandic: Tvíblindar rannsóknir með samanburði við lyfleysu RAISE:
English: Revolade 12.5 mg film-coated tablets Tablet core
Icelandic: Revolade 12,5 mg filmuhúðaðar töflur Töflukjarni
English: EU/1/10/612/003 84 film-coated tablets (3 packs of 28)
Icelandic: EU/1/10/612/003 84 filmuhúðaðar töflur (3 pakkningar með 28)
English: N AUC(0-)
Icelandic: 45% til 283%) AUC(0-)
English: Common Vomiting, ascites, abdominal pain, abdominal pain upper, dyspepsia, dry mouth, constipation, abdominal distension, toothache, stomatitis, gastrooesophagal reflux disease, haemorrhoids, abdominal discomfort, varices oesophageal Uncomon Oesophageal varices haemorrhage, gastritis, aphthous stomatitis
Icelandic: Algengar Uppköst, skinuholsvökvi, kviðverkur, verkur ofarlega í kvið, meltingartruflanir, munnþurrkur, hægðatregða, þaninn kviður, tannverkur, munnbólga, bakflæðissjúkdómur í vélinda, gyllinæð, óþægindi í kvið, æðahnútar í vélinda
English: Diarrhoea, nausea, gingival bleeding, abdominal pain
Icelandic: Niðurgangur, ógleði, blæðing í tannholdi, kviðverkur
English: CARTON OF 25 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Icelandic: ASKJA MEÐ 25 mg - 14, 28, 84 (3 PAKKNINGAR með 28) TÖFLUM
English: Multipacks of 84 (3 packs of 28 film-coated tablets) - without blue box - 25 mg film-coated tablets
Icelandic: Fjölpakkning með 84 (3 pakkningar með 28 filmuhúðuðum töflum) án blue box- 25 mg filmuhúðaðar töflur
English: Multipacks of 84 (3 packs of 28 film-coated tablets) - without blue box - 50 mg film-coated tablets
Icelandic: Fjölpakkning með 84 (3 pakkningar með 28 filmuhúðuðum töflum) án blue box- 50 mg filmuhúðaðar töflur
English: hepatic function abnormal Uncommon Cholestasis, hepatic lesion, hepatitis, drug-induced liver injury
Icelandic: óeðlileg lifrarstarfsemi Sjaldgæfar Gallteppa, lifrarskemmd, lifrarbólga, lifrarskaði af völdum lyfja
English: Revolade 50 mg film-coated tablets eltrombopag
Icelandic: 50 mg filmuhúðaðar töflur eltrombopag
English: This decrease of exposure was attenuated when a single 25 mg dose of eltrombopag powder for oral suspension was administered 2 hours before a high-calcium meal (mean AUC0-∞ was decreased by 20% and mean Cmax by 14%).
Icelandic: fyrir kalsíumríka máltíð (meðaltals AUC0-∞ minnkaði um 20% og meðaltals Cmax um 14%).
English: • painful swollen joints caused by uric acid (gout)
Icelandic: sárir bólgnir liðir af völdum þvagsýru (þvagsýrugigt)
English: At poorly tolerated doses in rats and dogs (>10 or 7 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and>4 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC), decreased reticulocyte counts and regenerative bone marrow erythroid hyperplasia (rats only) were observed in short-term studies.
Icelandic: Við skammta sem þoldust illa hjá rottum og hundum (>10 eða 7 sinnum klíníska útsetningu hjá ITP-sjúklingum, fullorðnum eða börnum, við 75 mg/dag og >4 sinnum klíníska útsetningu hjá sjúklingum með lifrarbólgu
English: What Revolade looks like and contents of the pack Revolade 25 mg powder for oral suspension is available in kits containing 30 sachets; each sachet contains a reddish-brown to yellow powder.
Icelandic: Revolade 25 mg mixtúruduft, dreifa er fáanlegt í setti sem inniheldur 30 skammtapoka.
English: Uncommon Dry mouth, glossodynia, abdominal tenderness, faeces discoloured, food poisoning, frequent bowel movements, haematemesis, oral discomfort
Icelandic: Sjaldgæfar Munnþurrkur, tungusviði, eymsli í kvið, óeðlilegur hægðalitur, matareitrun, tíðar hægðir, blóðuppköst, óþægindi í munni
English: Once the platelet count is ≤100,000/µl, reinitiate therapy at a daily dose reduced by 25 mg*.
Icelandic: Þegar blóðflagnafjöldinn er ≤100.000/µl, skal meðferð hafin að nýju en skammturinn lækkaður um 25 mg*.
English: Once the platelet count is ≤100,000/µl, reinitiate therapy at a daily dose reduced by 25 mg. * For patients taking 25 mg eltrombopag once every other day, increase dose to 25 mg once daily.
Icelandic: Skammtaaðlögun eða svörun <50.000/µl eftir minnst 2 vikna meðferð Aukið dagskammtinn um 25 mg í að hámarki 75 mg/dag*.
English: Common Rash, dry skin, eczema, rash pruritic, erythema, hyperhidrosis, pruritus generalised, alopecia Uncommon Skin lesion, skin discolouration, skin hyperpigmentation, night sweats
Icelandic: Algengar Útbrot, hármissir, ofsvitnun, útbreiddur kláði, depilblæðingar Sjaldgæfar Ofsakláði, húðkvilli, kaldur sviti, roðaþot, svört húð, litabreytingar,
English: Common Paraesthesia, hypoaesthesia, somnolence, migraine Uncommon Tremor, balance disorder, dysaesthesia, hemiparesis, migraine with aura, neuropathy peripheral, peripheral sensory neuropathy, speech disorder, toxic neuropathy, vascular headache
Icelandic: Algengar Náladofi, snertiskynsminnkun, svefndrungi, mígreni Sjaldgæfar Skjálfti, jafnvægistruflanir, tilfinningatruflanir, helftarlömun, mígreni með fyrirboðaeinkennum, úttaugakvilli, útlægur skyntaugakvilli, taltruflanir, taugakvilli vegna eitrunar, æðahöfuðverkur
English: There is an increased risk for adverse events, including hepatic decompensation and thromboembolic events, in thrombocytopenic patients with advanced chronic liver disease treated with eltrombopag, either in preparation for invasive procedure or in HCV patients undergoing antiviral therapy (see sections 4.4 and 4.8).
Icelandic: Aukin hætta er á aukaverkunum, m.a. starfstruflun í lifur og segarekstilvikum hjá blóðflagnafæðarsjúklingum með langt genginn langvinnan lifrarsjúkdóm, sem fá meðferð með eltrombópagi, annaðhvort til að undirbúa aðgerð eða hjá sjúklingum með lifrarbólgu
English: Common Neutropenia, splenic infarction
Icelandic: Algengar Blóðsykurshækkun, óeðlilegt þyngdartap
English: Cytogenetic abnormalities
Icelandic: Algengar Asatíðir
English: Frequency Adverse reaction
Icelandic: fjölgun stafkjarnadaufkyrninga
English: Reproductive system and breast disorders
Icelandic: Próteasahemlar gegn lifrarbólgu
English: Common Dizziness, disturbance in attention, dysgeusia, hepatic encephalopathy, lethargy, memory impairment, paraesthesia
Icelandic: Algengar Sundl, einbeitingarvandamál, bragðskynstruflun, lifrarheilakvilli, svefnhöfgi, minnisskerðing, náladofi
English: Eltrombopag dosing requirements must be individualised based on the patient's platelet counts.
Icelandic: Skammta af eltrombópagi skal laga eftir þörfum og í samræmi við blóðflagnafjölda sjúklingsins.
English: Reporting of side effects
Icelandic: Framgangur mergmisþroskaheilkennis
English: constipation, swollen stomach, taste disturbances, inflammation of the stomach, piles
Icelandic: særindi í hálsi, nefrennsli, nefstífla og hnerri
English: Thrombocytopenia with HCV infection in adult patients
Icelandic: Áætluð gildi fyrir Cmax og AUC(0-τ) fyrir eltrombópag í plasma hjá sjúklingum með lifrarbólgu
English: At non-tolerated doses in pre-weaning rats, ocular opacities were observed.
Icelandic: Ógegnsær augasteinn kom fram við skammta sem ekki þoldust hjá rottum áður en þær voru vandar af spena.
English: Compared to healthy volunteers, patients with mild hepatic impairment had approximately 111% (95% CI: 45% to 283%) higher plasma eltrombopag AUC(0-) values and patients with moderate hepatic impairment had approximately 183% (95% CI: 90% to 459%) higher plasma eltrombopag AUC(0-) values.
Icelandic: -gildi fyrir eltrombópag í plasma og sjúklingar með miðlungi alvarlega skerðingu á lifrarstarfsemi voru með u.þ.b. 183% hærri (95% CI:
English: • flu-like illness
Icelandic: • lækkun blóðsykurs
English: Fertility
Icelandic: Hetta
English: ITP study population
Icelandic: stigs rannsóknir
English: Common side effects that may show up in the blood tests
Icelandic: Algengar aukaverkanir sem geta komið fram í blóðprófum:
English: • Push the cap firmly back on to the lid of the mixing bottle.
Icelandic: Þrýstið hettunni þétt aftur á lokið á blöndunarglasinu.
English: Marketing authorisation holder Novartis Europharm Limited Vista Building
Icelandic: Markaðsleyfishafi Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4
English: Revolade 25 mg powder for oral suspension eltrombopag
Icelandic: Revolade 25 mg mixtúruduft, dreifa eltrombopag
English: Common Dry eye, cataract, ocular icterus, vision blurred, visual impairment, vitreous floaters
Icelandic: Algengar Augnþurrkur, drer, gula í augum, þokusjón, sjónskerðing, augngrugg
English: Paediatric population
Icelandic: flensulík veikindi
English: Blood and lymphatic system disorders
Icelandic: Blóðflagnafæð tengd langvinnri lifrarbólgu
English: • feeling cold
Icelandic: • kuldahrollur
English: No dosage adjustment is necessary for HCV patients of East Asian ancestry or patients with mild hepatic impairment (see section 5.2).
Icelandic: Ekki er þörf á skammtaaðlögun hjá sjúklingum af austur-asískum uppruna með lifrarbólgu
English: • skin changes including excessive sweating, itching bumpy rash, red spots, changes in appearance of the skin
Icelandic: • húðbreytingar, þ.m.t. óhófleg svitamyndun, upphleypt útbrot með kláða, rauðir deplar,
English: Common Blood bilirubin increased, weight decreased, white blood cell count decreased, haemoglobin decreased, neutrophil count decreased, international normalised ratio increased, activated partial thromboplastin time prolonged, blood glucose increased, blood albumin decreased Uncommon Electrocardiogram QT prolonged Grouped term with preferred terms oliguria, renal failure and renal impairment
Icelandic: Algengar Hækkun bílírúbíns í blóði, þyngdartap, fækkun hvítra blóðfrumna, lækkun blóðrauða, fækkun daufkyrninga, hækkun INR, lenging APTT, hækkun blóðsykurs, lækkun blóðalbúmíns Sjaldgæfar Lenging QT á hjartalínuriti
English: • increased number of white blood cells (leukocytosis)
Icelandic: • fjölgun hvítra blóðfrumna (hvítfrumnafjölgun í blóði)
English: Common Menorrhagia
Icelandic: fjölgun merglinga
English: Revolade 75 mg film-coated tablets Tablet core
Icelandic: Revolade 75 mg filmuhúðaðar töflur Töflukjarni
English: • diarrhoea
Icelandic: • brjóstverkur