FrancophonIA/ELRC3.0 huggingface dataset:
English: What Revolade looks like and contents of the pack Revolade 12.5 mg film-coated tablets are round, biconvex, white, debossed with ‘GS MZ1' and ‘12.5' on one side.
Danish: Revolade 12,5 mg filmovertrukne tabletter er runde, bikonvekse, hvide og præget ”GS MZ1” og ”12,5” på den ene side.
English: • eye problems including blurred vision, cloudy lens in the eye (cataract), spots or deposits in eye
Danish: • øjenproblemer herunder sløret syn, uklar linse i øjet (grå stær), prikker eller udfældninger i øjet
English: Eltrombopag was not carcinogenic in mice at doses up to 75 mg/kg/day or in rats at doses up to 40 mg/kg/day (exposures up to 4 or 2 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Danish: Eltrombopag var ikke karcinogent i mus ved doser på op til 75 mg/kg/dag eller hos rotter ved doser på op til 40 mg/kg/dag (op til 4 eller 2 gange den humane kliniske eksponering hos voksne eller pædiatriske ITP-patienter ved doser på 75 mg/dag og 2 gange den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC).
English: Eltrombopag did not affect male fertility in rats at doses up to 40 mg/kg/day, the highest dose tested (3 times the human clinical exposure in ITP patients at 75 mg/day and 2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Danish: Eltrombopag påvirkede ikke fertiliteten hos hanrotter i doser på op til 40 mg/kg/dag - den højeste testede dosis (3 gange den humane kliniske eksponering hos ITP-patienter ved doser på 75 mg/dag og 2 gange den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC).
English: Certain people may have a higher risk of blood clots, and medicines like Revolade could make this problem worse.
Danish: Lægemidler som Revolade kan forværre dette problem.
English: • feeling sick (nausea), diarrhoea
Danish: • kvalme, diarré
English: hepatic function abnormal Uncommon Cholestasis, hepatic lesion, hepatitis, drug-induced liver injury
Danish: Kolestasis, hepatisk læsion, hepatitis, lægemiddelinduceret leverskade
English: Revolade 12.5 mg film-coated tablets eltrombopag
Danish: Revolade 12,5 mg filmovertrukne tabletter eltrombopag
English: Once the platelet count is ≤100,000/µl, reinitiate therapy at a daily dose reduced by 50 mg.
Danish: Når trombocyttallet er ≤ 100.000 pr. µl, genstartes behandlingen med en daglig dosis, der er nedsat med 50 mg.
English: The longest RBC transfusion-free period for non-responders was 29 days (median).
Danish: Den længste periode uden transfusion af erytrocytter for ikkerespondenter var 29 dage (median).
English: Eltrombopag was not mutagenic or clastogenic in a bacterial mutation assay or in two in vivo assays in rats (micronucleus and unscheduled DNA synthesis, 10 times or 8 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 7 times the human clinical exposure in HCV patients at 100 mg/day, based on Cmax).
Danish: Eltrombopag var ikke mutagent eller klastogent i en bakteriel mutationsanalyse eller i to in vivo-analyser med rotter (mikronukleus og uplanlagt DNA-syntese, 10 gange eller 8 gange den humane kliniske eksponering hos voksne eller pædiatriske ITP-patienter ved doser på 75 mg/dag og 7 gange den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på Cmax).
English: Common Ear pain, vertigo
Danish: Almindelig Øresmerter, svimmelhed (vertigo)
English: Revolade 75 mg film-coated tablets EU/1/10/612/007
Danish: Revolade 75 mg filmovertrukne tabletter EU/1/10/612/007
English: Cough, oropharyngeal pain, rhinorrhoea
Danish: Hoste, orofaryngeale smerter, rinorré
English: • decreased haemaglobin level
Danish: • nedsat hæmoglobinniveau
English: Female paediatric ITP patients had approximately 25% higher plasma eltrombopag AUC(0-) values as compared to male patients.
Danish: Pædiatriske ITPpatienter af hunkøn havde ca. 25 % højere AUC(0-)-værdier for eltrombopag i plasma sammenlignet med patienter af hankøn.
English: If you take more Revolade than you should
Danish: Hvis du har taget for meget Revolade
English: Cataracts have not been observed in adult dogs after 52 weeks of dosing at 2 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Danish: Der er ikke observeret katarakt hos voksne hunde efter 52 ugers administration ved 2 gange den humane kliniske eksponering hos voksne eller pædriatriske ITP-patienter ved doser på 75 mg/dag, og ved eksponeringer, der er ækvivalente med den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC.
English: • yellowing of the skin or the whites of the eyes (jaundice)
Danish: • din hud eller det hvide i dine øjne bliver gult (gulsot)
English: pigmentation disorder, skin discolouration, skin exfoliation
Danish: Hudlæsion, misfarvning af huden, hyperpigmentering af huden, nattesved
English: Revolade 12.5 mg film-coated tablets
Danish: Revolade 12,5 mg filmovertrukne tabletter
English: White, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS NX3' and ‘25' on one side.
Danish: Hvid, rund, bikonveks, filmovertrukket tablet (ca, 10,3 mm i diameter), der er præget ”GS NX3” og ”25” på den ene side.
English: Uncommon Sunburn
Danish: • unormal urinfarve
English: Eltrombopag did not affect female fertility, early embryonic development or embryofoetal development in rats at doses up to 20 mg/kg/day (2 times the human clinical exposure in adult or adolescent (12-17 years old) ITP patients at 75 mg/day and equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Danish: Eltrombopag påvirkede ikke fertilitet hos hunnerne, tidlig fosterudvikling eller fosterudvikling hos rotter ved doser på op til 20 mg/kg/dag (2 gange den humane kliniske eksponering hos voksne eller unge (12-17 år) ITP-patienter ved doser på 75 mg/dag og ækvivalent med den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC).
English: In patients with low albumin levels (≤35 g/l) or with a 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.
Danish: Hos patienter med lavt albumin-niveau (≤ 35 g/l) eller med MELD-score ≥ 10 ved baseline var der 3 gange større risiko for hepatisk dekompensation og en øget risiko for at få en dødelig bivirkning sammenlignet med de patienter, med mindre fremskreden sygdom.
English: Checks for digestive bleeding
Danish: Blodprøver for at måle trombocyttal
English: Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag.
Danish: Hver filmovertrukken tablet indeholder eltrombopagolamin svarende til 12,5 mg eltrombopag.
English: Common Dry eye, vision blurred, eye pain, visual acuity reduced Uncommon Lenticular opacities, astigmatism, cataract cortical, lacrimation increased, retinal haemorrhage, retinal pigment epitheliopathy, visual impairment, visual acuity tests abnormal, blepharitis, keratoconjunctivitis sicca Ear and labyrinth disorders Common Ear pain, vertigo Cardiac disorders
Danish: Lentikulær uklarhed, bygningsfejl, kortikal katarakt, øget tåresekretion, retinal blødning, retinal pigment epiteliopati, forringet syn, unormale tests for skarpsyn, blefaritis, keratokonjunktivitis sicca
English: Common Oral mucosal blistering, oral pain, vomiting, abdominal discomfort, constipation, abdominal distension, dysphagia, faeces discoloured, swollen tongue, gastrointestinal motility disorder, flatulence
Danish: Almindelig Blærer i mundens slimhinde, smerter i munden, opkastning, ubehag i abdomen, obstipation, abdominal distension, dysfagi, misfarvet afføring, opsvulmet tunge, forstyrrelse af den gastrointestinale motilitet, flatulens
English: Data presented as geometric mean (95% CI).
Danish: Data vist som geometrisk middelværdi (95 % konfidensinterval).
English: To give a dose to a child
Danish: Sådan gives en dosis til barnet 8.
English: Chronic hepatitis C (HCV) associated thrombocytopenia
Danish: Trombocytopeni i forbindelse med kronisk hepatitis C (HCV)
English: Wash any exposed area immediately with soap and water.
Danish: Vask straks med vand og sæbe, hvis et område kommer i kontakt med lægemidlet.
English: In patients with low albumin levels (≤ 35 g/l) or with a 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.
Danish: Hos patienter med lavt albumin-niveau (≤ 35 g/l) eller med en MELD-score ≥ 10 ved baseline var der 3 gange øget risiko for dekompenseret leversygdom og en øget risiko for en dødelig bivirkning sammenlignet med patienter, med mindre fremskreden sygdom.
English: There were no effects of note on red cell mass or reticulocyte counts after dosing for up to 28 weeks in rats, 52 weeks in dogs and 2 years in mice or rats at maximally tolerated doses which were 2 to 4 times human clinical exposure in adult or paediatric ITP patients at 75 mg/day and ≤2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Danish: Der var ingen påvirkning af betydning på den røde cellemasse eller retikulocyttallet efter administration i op til 28 uger hos rotter, 52 uger hos hunde og 2 år hos mus eller rotter ved maksimalt tålte doser, som var 2-4 gange den humane kliniske eksponering hos voksne eller pædiatriske ITP-patienter ved doser på 75 mg/dag og ≤ 2 gange den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC.
English: Brown, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS UFU' and ‘50' on one side.
Danish: Brun, rund, bikonveks, filmovertrukket tablet (ca, 10,3 mm i diameter), der er præget ”GS UFU” og ”50” på den ene side.
English: TPO is the main cytokine involved in regulation of megakaryopoiesis and platelet production, and is the endogenous ligand for the TPO-R. Eltrombopag interacts with the transmembrane domain of the human TPO-R and initiates signalling cascades similar but not identical to that of endogenous thrombopoietin (TPO), inducing proliferation and differentiation from bone marrow progenitor cells.
Danish: TPO, der er den endogene ligand for TPO-R, er det vigtigste cytokin, der indgår i reguleringen af megakaryopoiesen og produktionen af trombocytter.
English: For more advice about suitable foods and drinks, talk to your doctor.
Danish: Spørg eventuelt lægen til råds om, hvad du må spise og drikke.
English: Revolade 12.5 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag.
Danish: Revolade 12,5 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder eltrombopagolamin svarende til 12,5 mg eltrombopag.
English: Revolade 75 mg film-coated tablets eltrombopag
Danish: Revolade 75 mg filmovertrukne tabletter eltrombopag
English: • sore throat, runny nose, nasal congestion and sneezing
Danish: • øm i halsen, løbende næse, tilstoppet næse og nysen
English: Revolade 50 mg film-coated tablets EU/1/10/612/004
Danish: Revolade 50 mg filmovertrukne tabletter EU/1/10/612/004
English: Common Anaemia, eosinophilia, leukocytosis, thrombocytopenia, haemoglobin decreased, white blood cell count decreased Uncommon Anisocytosis, haemolytic anaemia, myelocytosis, band neutrophil count increased, myelocyte present, platelet count increased, haemoglobin increased
Danish: Anisocytose, hæmolytisk anæmi, myelocytose, forhøjet båndneutrofiltal, tilstedeværelse af myelocytter, forhøjet trombocyttal, forhøjet hæmoglobin
English: Adults and children (6 to 17 years) - the usual starting dose for ITP is two 25 mg sachets of Revolade a day.
Danish: Voksne og børn (6 til 17 år): den sædvanlige startdosis af Revolade for patienter med ITP er to 25 mg breve med Revolade daglig.
English: 12.5 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag.
Danish: 12,5 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder eltrombopagolamin svarende til 12,5 mg eltrombopag.
English: Revolade 75 mg film-coated tablets
Danish: Revolade 75 mg filmovertrukne tabletter
English: What Revolade is and what it is used for What you need to know before you take Revolade How to take Revolade
Danish: Det skal du vide, før du begynder at tage Revolade Sådan skal du tage Revolade Bivirkninger
English: Once the platelet count is ≤100,000/µl, reinitiate therapy at a daily dose reduced by 25 mg*.
Danish: Når trombocyttallet er ≤ 100.000 pr. µl, genopstartes behandlingen med en daglig dosis, der er nedsat med 25 mg*.
English: Revolade 50 mg film-coated tablets eltrombopag
Danish: Revolade 50 mg filmovertrukne tabletter eltrombopag
English: >100,000/µl to ≤150,000/µl
Danish: > 150.000 pr. µl til ≤ 250.000 pr. µl
English: Cough♦ Common Oropharyngeal pain, rhinorrhoea Uncommon Pulmonary embolism, pulmonary infarction, nasal discomfort, oropharyngeal blistering, sinus disorder, sleep apnoea syndrome
Danish: Pulmonal emboli, pulmonalt infarkt, nasalt ubehag, orofaryngeale blærer, sinusforstyrrelse, søvnapnø
English: • muscle pain
Danish: • muskelspasmer
English: • muscle pain, muscle weakness
Danish: • muskelsmerter, muskelsvaghed
English: Revolade 25 mg film-coated tablets EU/1/10/612/001
Danish: Revolade 25 mg filmovertrukne tabletter EU/1/10/612/001
English: There were no bone changes observed in mice or rats after lifetime exposure (2 years) at 4 times or 2 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Danish: Der var ingen knogleændringer hos mus eller rotter efter livslang eksponering (2 år) ved 4 eller 2 gange den humane kliniske eksponering hos voksne eller pædiatriske ITP-patienter ved doser på 75 mg/dag og 2 gange den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC.
English: Revolade 25 mg film-coated tablets eltrombopag
Danish: Revolade 25 mg filmovertrukne tabletter eltrombopag
English: EU/1/10/612/011 (28 film-coated tablets)
Danish: EU/1/10/612/011 (28 filmovertrukne tabletter)
English: †, hyperbilirubinaemia, hepatic function abnormal Uncommon Cholestasis, hepatic lesion, hepatitis, drug-induced liver injury
Danish: †, hyperbilirubinæmi, unormal hepatisk funktion
English: Each sachet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.
Danish: Hvert brev indeholder eltrombopagolamin svarende til 25 mg eltrombopag.
English: Common Rash, dry skin, eczema, rash pruritic, erythema, hyperhidrosis, pruritus generalised, alopecia Uncommon Skin lesion, skin discolouration, skin hyperpigmentation, night sweats
Danish: Almindelig Udslæt, tør hud, eksem, kløende udslæt, erytem, hyperhidrose, generaliseret kløe, alopeci
English: Revolade 25 mg film-coated tablets
Danish: Revolade 25 mg filmovertrukne tabletter
English: EU/1/10/612/010 (14 film-coated tablets)
Danish: EU/1/10/612/010 (14 filmovertrukne tabletter)
English: Revolade 50 mg film-coated tablets
Danish: Revolade 50 mg filmovertrukne tabletter
English: • decreased levels of potassium
Danish: • nedsatte niveauer af kalium
English: For patients taking 25 mg once daily, the dose should be increased to 50 mg daily before increasing the dose amount by 50 mg. A dose of 150 mg daily must not be exceeded.
Danish: Hos patienter, der tager 25 mg én gang daglig, bør dosen øges til 50 mg om dagen, inden dosen øges i trin på 50 mg. Overskrid ikke en maksimal daglig dosis på 150 mg. Klinisk hæmatologi og levertal skal monitoreres regelmæssigt igennem hele behandlingen med eltrombopag, og eltrombopagdosis skal justeres på basis af trombocyttallet som vist i tabel 3.
English: Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.
Danish: Hver filmovertrukken tablet indeholder eltrombopagolamin svarende til 25 mg eltrombopag.
English: RAISE: 197 ITP patients were randomised 2:1, eltrombopag (n=135) to placebo (n=62), and randomisation was stratified based upon splenectomy status, use of ITP medicinal products at baseline and baseline platelet count.
Danish: RAISE: 197 ITP-patienter blev randomiseret i forholdet 2:1, eltrombopag (n = 135) mod placebo (n = 62).
English: • blood clot
Danish: • blodprop
English: • Pull cap off the lid of the mixing bottle
Danish: • Træk hætten af blandeflasken.
English: • sunburn
Danish: • tandpine
English: Revolade 75 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag.
Danish: Revolade 75 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder eltrombopagolamin svarende til 75 mg eltrombopag.
English: 75 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag.
Danish: 75 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder eltrombopagolamin svarende til 75 mg eltrombopag.
English: EU/1/10/612/012 84 film-coated tablets (3 packs of 28)
Danish: EU/1/10/612/012 84 filmovertrukne tabletter (3 pakninger med 28)
English: Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag
Danish: Hver filmovertrukken tablet indeholder eltrombopagolamin svarende til 75 mg eltrombopag.
English: Children (1 to 5 years) - the usual starting dose for ITP is one 25 mg sachet of Revolade a day.
Danish: Børn (1 til 5 år) - den sædvanlige startdosis for ITP er ét 25 mg brev Revolade daglig.
English: Revolade 50 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag.
Danish: Revolade 50 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder eltrombopagolamin svarende til 50 mg eltrombopag.
English: Multipacks of 84 (3 packs of 28 film-coated tablets) - without blue box - 12.5 mg film-coated tablets
Danish: Multipakning med 84 (3 pakninger med 28 filmovertrukne tabletter) - uden blue box - 12,5 mg filmovertrukne tabletter
English: CARTON OF 12.5 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Danish: ÆSKE MED 12,5 mg - 14, 28, 84 (3 PAKNINGER MED 28) TABLETTER
English: 50 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag.
Danish: 50 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder eltrombopagolamin svarende til 50 mg eltrombopag.
English: • increased blood urea
Danish: • forhøjet urinstof i blodet
English: • skin discolouration
Danish: • tandkødsinflammation
English: • digestive wind/gas
Danish: • luft i maven
English: Revolade 12.5 mg film-coated tablets Tablet core
Danish: Revolade 12,5 mg filmovertrukne tabletter Tabletkerne
English: Revolade 25 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.
Danish: Revolade 25 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder eltrombopagolamin svarende til 25 mg eltrombopag.
English: • skin changes including excessive sweating, itching bumpy rash, red spots, changes in appearance of the skin
Danish: • hudforandringer herunder overdreven svedtendens, kløende og knoppet udslæt, røde prikker,
English: Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag
Danish: Hver filmovertrukken tablet indeholder eltrombopagolamin svarende til 50 mg eltrombopag.
English: 25 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.
Danish: 25 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder eltrombopagolamin svarende til 25 mg eltrombopag.
English: Common Lymphopenia Uncommon Haemolytic anaemia
Danish: Almindelig Lymfopeni Ikke almindelig
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.
Danish: Der sås ingen renal påvirkning hos rotter efter 28 uger, eller hos hunde efter 52 uger, ved eksponeringer, der var hhv. 4 og 2 gange så store som den humane kliniske eksponering hos voksne ITP-patienter og 3 og 2 gange den humane kliniske eksponering hos pædiatriske ITP-patienter ved doser på 75 mg/dag, og ved eksponeringer, der er ækvivalente med den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC.
English: Common Myalgia, muscle spasm, musculoskeletal pain, bone pain, back pain Uncommon Muscular weakness Renal and urinary disorders Common Proteinuria, blood creatinine increased, thrombotic microangiopathy with renal failure Uncommon Renal failure, leukocyturia, lupus nephritis, nocturia, blood urea increased, urine protein/creatinine ratio increased
Danish: Nyresvigt, leukocyturi, lupus nefritis, nykturi, forhøjet urinstof i blodet, forhøjet protein/kreatinin-ratio i urinen
English: • Push the cap firmly back on to the lid of the mixing bottle.
Danish: • Tryk hætten fast på blandeflaskens låg igen.
English: • itchy, runny or blocked nose
Danish: • kløende, løbende eller tilstoppet næse
English: A very high blood platelet count may increase the risk of blood clotting.
Danish: Nogle patienter kan have en større risiko for at udvikle blodpropper.
English: EU/1/10/612/007 (14 film-coated tablets)
Danish: EU/1/10/612/007 (14 filmovertrukne tabletter)
English: EU/1/10/612/004 (14 film-coated tablets)
Danish: EU/1/10/612/004 (14 filmovertrukne tabletter)
English: EU/1/10/612/009 84 film-coated tablets (3 packs of 28)
Danish: EU/1/10/612/009 84 filmovertrukne tabletter (3 pakninger med 28)
English: Carton of 25 mg powder for oral suspension
Danish: ÆSKE MED 25 mg pulver til oral suspension
English: EU/1/10/612/001 (14 film-coated tablets)
Danish: EU/1/10/612/001 (14 filmovertrukne tabletter)
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.
Danish: Der blev ikke observeret leverpåvirkning efter kronisk administration hos rotter (28 uger) og hos hunde (52 uger) ved eksponeringer, der var 4 og 2 gange den humane kliniske eksponering hos voksne ITP-patienter og 3 eller 2 gange den humane kliniske eksponering hos pædiatriske ITP-patienter ved doser på 75 mg/dag, og ved eksponeringer, der er 2 gange eller ækvivalente med den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC.
English: Uncommon Injection site pruritus, injection site rash, chest discomfort
Danish: Kløe ved injektionsstedet, udslæt på injektionsstedet, ubehag i brystkassen
English: EU/1/10/612/008 (28 film-coated tablets)
Danish: EU/1/10/612/008 (28 filmovertrukne tabletter)
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 and 3 or 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.
Danish: Der blev ikke observeret leverpåvirkning efter kronisk administration hos rotter (28 uger) og hos hunde (52 uger) ved eksponeringer, der var 4 og 2 gange den humane kliniske eksponering hos voksne ITP-patienter og 3 eller 2 gange den humane kliniske eksponering hos pædiatriske ITP-patienter ved doser på 75 mg/dag, og ved eksponeringer, der er 2 gange og ækvivalente med den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC.
English: Multipacks of 84 (3 packs of 28 film-coated tablets) - without blue box -75 mg film-coated tablets
Danish: Multipakning med 84 (3 pakninger med 28 filmovertrukne tabletter) - uden blue box -75 mg filmovertrukne tabletter