FrancophonIA/ELRC3.0 huggingface dataset:
English: Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml * Pegasys 180 mcg & ribavirin 800 mg vs. Interferon alfa-2a 3 MIU & ribavirin 800 mg: Odds Ratio (95% CI) = 5.40 (3.42 to 8.54), P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0001 * Pegasys 180 mcg & ribavirin 800 mg vs. Pegasys 180 mcg:
Icelandic: Lítið veirumagn = ≤ 800.000 a.e./ml; Mikið veirumagn= > 800.000 a.e./ml * Pegasys 180 míkróg ogog ríbavírin 800 mg á móti Interferón alfa-2a 3 milljón a.e. ogog ríbavírin 800 mg:
English: Pegasys 180 mcg Ribavirin 1000/1200 mg 48 weeks
Icelandic: Pegasys 180 míkróg og ríbavírin 1000/1200 mg 48 vikur
English: ● a short needle for the subcutaneous injection
Icelandic: ● stutt nál til þess að sprauta undir húð
English: solution for injection
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF
English: Refer also to the package leaflets of any other medicines that are used in combination with Pegasys.
Icelandic: Lesið einnig fylgiseðla fyrir öll lyf sem notuð eru í samsetningu með Pegasys.
English: Pegasys 180 mcg Ribavirin 1000/1200 mg 24 weeks
Icelandic: Pegasys 180 míkróg og ríbavírin 1000/1200 mg 24 vikur
English: (5 days after your Friday dose).
Icelandic: dögum síðar en miðvikudagsskammturinn.
English: ● Remove the needle guard.
Icelandic: Fjarlægið nálarhlífina.
English: Pegasys dosing
Icelandic: Skammtur Pegasys
English: With your other hand hold the syringe as you would a pencil.
Icelandic: Haldið á sprautunni með hinni eins og um blýant væri að ræða.
English: Each syringe should be used by one person only and is for single use.
Icelandic: Hvert hettuglas skal einungis nota fyrir einn einstakling í eitt skipti.
English: ● shake
Icelandic: ● plástur
English: Do not use this medicine if you notice the vial or packaging is damaged, if the solution is cloudy or if it has floating particles or if the medicine is any colour besides colourless to light yellow.
Icelandic: Ekki skal nota lyfið ef þú tekur eftir að hettuglasið eða umbúðir eru skemmdar, ef lausnin er skýjuð, ef agnir eru í henni eða ef hún hefur annan lit en glæran til ljósgulan.
English: NAME OF THE MEDICINAL PRODUCT Pegasys 90 micrograms solution for injection in pre-filled syringe Pegasys 135 micrograms solution for injection in pre-filled syringe Pegasys 180 micrograms solution for injection in pre-filled syringe
Icelandic: Pegasys 90 míkrógrömm stungulyf, lausn í áfylltri sprautu Pegasys 135 míkrógrömm stungulyf, lausn í áfylltri sprautu Pegasys 180 míkrógrömm stungulyf, lausn í áfylltri sprautu
English: The risk of growth inhibition should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV co-infection), as well as prognostic factors of response (for HBVinfection mainly HBV genotype and ALT levels; for HCV-infection mainly HCV genotype and HCV-RNA levels) (see section 5.1).
Icelandic: Meta skal hættu á vaxtarhindrun á móti sjúkdómseinkennum barnsins, svo sem staðfestri versnun sjúkdóms (einkum bandvefsmyndun), aðra sjúkdóma sem geta haft neikvæð áhrif á versnun sjúkdóms (svo sem samtímis HIV sýking), sem og batahorfur við svörun af lyfinu (fyrir sýkingu af lifrarbólgu
English: In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.
Icelandic: Í meðferð samtímis ríbavírini skal taka tillit til texta fyrir lyf sem innihalda ríbavírin.
English: Pegasys 180 mcg Ribavirin 800 mg 24 weeks
Icelandic: Pegasys 180 míkróg og ríbavírin 800 mg 24 vikur
English: 1200 mg/day
Icelandic: 1.200 mg/ dag
English: Chronic hepatitis B in adult patients
Icelandic: Langvinn lifrarbólga B hjá fullorðnum
English: In a pharmacokinetic study of 24 HCV patients concomitantly receiving methadone maintenance therapy (median dose 95 mg; range 30 mg to 150 mg), treatment with Pegasys 180 micrograms sc once weekly for 4 weeks was associated with mean methadone levels that were 10% to 15% higher than at baseline.
Icelandic: 95 mg; á bilinu 30 mg til 150 mg) hækkuðu meðalmetadóngildi um 10% til 15% frá upphafsgildum hjá sjúklingum sem fengu meðferð með Pegasys, 180 míkrógrömm undir húð einu sinni í viku í 4 vikur.
English: Other published on-treatment biomarkers that are predictive of the final outcome of Pegasys treatment may be considered.
Icelandic: Meðan á meðferð stendur má íhuga að nota önnur lífmerki sem greint hefur verið frá í vísindaritum að hafi forspárgildi fyrir endanlegan árangur meðferðar með Pegasys.
English: Each pre-filled syringe of 0.5 ml solution contains 90, 135 or 180 micrograms peginterferon alfa-2a.
Icelandic: Hver áfylltur lyfjapenni með 0,5 ml lausn inniheldur 135 eða 180 míkrógrömm af peginterferóni alfa-2a.
English: Lamivudine 100 mg (N=179)
Icelandic: Pegasys 180 míkróg lamívúdín 100 mg (N=179)
English: In general, the safety profile observed in paediatric patients was similar to that seen in adults.
Icelandic: Öryggissnið hjá börnum var yfirleitt svipað og hjá fullorðnum.
English: Low viral load High viral load Genotype 4 (0/5)
Icelandic: Arfgerð 4 (0/5)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 135 µg PRE-FILLED SYRINGES (WITH BLUE BOX) - Multipack
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR - 12 x 135 µg ÁFYLLTAR SPRAUTUR (MEÐ BLUE BOX)
English: Regardless of the starting dose or degree of renal impairment, patients should be monitored and appropriate dose reductions of Pegasys during the course of therapy should be made in the event of adverse reactions.
Icelandic: Án tillits til upphafsskammtar eða stigs nýrnabilunar skal fylgjast með sjúklingum og viðeigandi lækkun á skömmtum
English: Table 18: Relapse of virological response after the end of treatment in genotype 2 or 3 patients with a rapid viral response
Icelandic: Versnun á veirufræðilegri svörun við meðferðarlok við arfgerð 2 eða 3 hjá einstaklingum með hraða veirufræðilega svörun
English: HCV RNA levels decline in a biphasic manner in responding patients with hepatitis C who have received treatment with 180 micrograms Pegasys.
Icelandic: Eftir meðferð með 180 míkrógrömmum af Pegasys falla HCV RNA gildi í tveimur þrepum hjá sjúklingum með lifrarbólgu C sem svara meðferð.
English: 800 mg/day
Icelandic: 800 mg/dag
English: Response rates at the end of follow-up for the two studies are presented in Table 12.
Icelandic: Tíðni svörunar úr rannsóknunum tveimur við lok eftirfylgninnar má sjá í töflu
English: Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24
Icelandic: Lítið veirumagn = ≤ 800.000 a.e./ml; Mikið veirumagn= > 800.000 a.e./ml RVR = hröð veirusvörun (HCV RNA ógreinanlegt) í 4. viku og HCV RNA ógreinanlegt í 24. viku
English: 400 mg/day
Icelandic: 400 mg/dag
English: Sarcoidosis, thyroiditis
Icelandic: Lungnabólga, húðsýking
English: ● a vial of Pegasys solution for injection Not included in the pack:
Icelandic: Pegasys meðferð var tengd óeðlilegum rannsóknarstofugildum:
English: Hepatic impairment
Icelandic: Taugakerfi höfuðverkur
English: 1 vial
Icelandic: Arfgerð 1
English: Retinal haemorrhage
Icelandic: Meltingarfæratruflanir
English: Pegasys 90 micrograms solution for injection in pre-filled syringe EU/1/02/221/017
Icelandic: Pegasys 90 míkrógrömm stungulyf, lausn í áfylltri sprautu EU/1/02/221/017
English: Other medicines and Pegasys
Icelandic: Notkun annarra lyfja samhliða Pegasys
English: Wheezing Interstitial pneumonitis including fatal outcome, pulmonary embolism
Icelandic: Millivefsbjúgbólga lungna að meðtalinni banvænni, lungnablóðrek
English: Pegasys 135 micrograms solution for injection in pre-filled syringe 4 years
Icelandic: Pegasys 135 míkrógrömm stungulyf, lausn í áfylltri sprautu
English: 200 mg/day
Icelandic: 200 mg/ dag
English: Activation button
Icelandic: Lungnaháþrýstingur
English: Immune system disorders: Idiopathic (or thrombotic) thrombocytopenic purpura (increased bruising, bleeding, decreased platelets, anaemia and extreme weakness) Eye disorders: Loss of vision
Icelandic: Sjálfvakinn (eða segamyndunar) blóðflagnafæðarpurpuri (aukning á marblettum, blæðing, fækkun blóðflagna, blóðleysi og mikið þróttleysi) Augu: Sjóntap
English: All treatment arms had 24 week treatment-free follow-up.
Icelandic: Fylgst var með öllum hópunum í 24 vikur eftir meðferð.
English: Vomiting, dyspepsia, dysphagia, mouth ulceration, gingival bleeding, glossitis, stomatitis, flatulence, dry mouth
Icelandic: Uppköst, meltingartruflanir, kyngingartregða, tannholdsblæðingar, sár í munni, tungubólga, munnbólga, uppþemba munnþurrkur
English: 1 pre-filled syringe + 1 injection needle 180 micrograms/0.5 ml
Icelandic: 1 áfyllt sprauta + 1 nál til innspýtingar 180 míkrógrömm/0,5 ml
English: Transient rashes do not necessitate interruption of treatment.
Icelandic: Ekki er nauðsynlegt að stöðva meðferð ef skammvinn útbrot myndast.
English: Anaphylaxis, systemic lupus erythematosu s rheumatoid arthritis
Icelandic: Samsett meðferð með ríbavírini við langvinnri lifrarbólgu
English: Pegasys 180 micrograms solution for injection Peginterferon alfa-2a
Icelandic: Pegasys 180 míkrógrömm stungulyf, lausn Peginterferón alfa-2a
English: Liver and renal graft rejections have been reported with Pegasys, alone or in combination with ribavirin.
Icelandic: Tilkynnt hefur verið um höfnun lifrar- eða nýrnaígræðslu við meðferð með Pegasys einu sér eða í samsettri meðferð með ríbavírini.
English: Syncope, migraine, memory impairment, weakness, hypoaesthesia hyperaesthesi a, paraesthesia, tremor, taste disturbance, nightmares, somnolence
Icelandic: Yfirlið, mígreni, minnisskerðing, magnleysi, snertiskynsminnkun, snertiskynsaukning, náladofi, skjálfti, truflanir á bragðskyni, martraðir, svefndrungi
English: Myositis
Icelandic: Miðlungs
English: Neoplasms benign and malignant
Icelandic: Æxli, góðkynja og illkynja
English: 1 x 200 mg tablets A.M. 1 x 200 mg tablets P.M.
Icelandic: 1 x 200 mg tafla að morgni 1 x 200 mg tafla að kvöldi
English: Ribavirin 1000/1200 mg 48 Weeks (N = 469) SVR in Pts with VR at Wk 12 b
Icelandic: Pegasys 360/180 eða 180 míkróg og ríbavírin 1000/1200 mg 48 vikur (N = 469) SVR hjá sjúklingum með VR í 12.viku b
English: When Pegasys is used in combination with ribavirin, both male and female patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur, as ribavirin can be very damaging to an unborn baby:
Icelandic: Gæta verður sérstakrar varúðar til þess að koma í veg fyrir þungun hjá kvenkyns sjúklingum eða rekkjunautum karlkyns sjúklinga meðan á meðferð með Pegasys ásamt ríbavírini stendur, þar sem ríbavírin getur verið ófæddu barni mjög skaðlegt:
English: After intravenous administration, the terminal half-life of peginterferon alfa2a in healthy subjects is approximately 60 to 80 hours compared to values of 3-4 hours for standard interferon.
Icelandic: Eftir gjöf í æð hjá heilbrigðum einstaklingum er lokahelmingunartími peginterferóns alfa-2a um 60 til 80 klst.
English: Pegasys 135 micrograms solution for injection in pre-filled syringe EU/1/02/221/005
Icelandic: Pegasys 135 míkrógrömm stungulyf, lausn í áfylltri sprautu EU/1/02/221/005
English: 600 mg/day
Icelandic: 600 mg/dag
English: Predictability of response and non-response with Pegasys and ribavirin dual therapy - treatmentexperienced patients
Icelandic: Líkindi á svörun og engri svörun í samsettri meðferð með Pegasys ásamt ríbavírini - sjúklingar sem hafa fengið meðferð áður
English: The recommended dose of Pegasys in combination with ribavirin is 180 mcg once weekly by subcutaneous administration.
Icelandic: Ráðlagður skammtur af Pegasys ásamt ríbavírini er 180 míkróg einu sinni í viku með gjöf undir húð.
English: ● if you are being treated with telbivudine, a medicine for hepatitis B infection (see “Other medicines and Pegasys”).
Icelandic: B veiru (sjá „Notkun annarra lyfja samhliða Pegasys“).
English: Breathing disorders: Shortness of breath with activity, nose bleeds, nose and throat inflammation, infections of the nose and sinuses (air-filled spaces found in the bones of the head and face), runny nose, sore throat
Icelandic: Áreynslumæði, blóðnasir, bólga í nefi og hálsi, sýking í nefi og skútum (loftfyllt rými í beinum í höfði og andliti), nefrennsli, hálsbólga
English: Early intervention for re-emergence or development of psychiatric disorders and substance use is recommended.
Icelandic: Mælt er með snemmtækri íhlutun ef einkenni koma fram á ný eða ef geðræn vandamál og vímuefnaneysla þróast.
English: 1 level reduction (mcg)
Icelandic: C Upphafsskammtur (míkrógrömm)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 180 mcg/0.5 ml
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 180 µg/0,5 ml
English: Ascites
Icelandic: Innkirtlar
English: ● a cleansing swab
Icelandic: ● bómullarhnoðri til hreinsunar
English: Rhabdomyoly sis
Icelandic: B. FYLGISEÐILL
English: ● Clean the rubber top of the vial with a cleansing swab.
Icelandic: Hreinsið gúmmílok hettuglassins með bómullarhnoðra til hreinsunar.
English: Operating characteristics of these biomarkers are presented in Table 11.
Icelandic: Starfræn einkenni (operating characteristics) þessara lífmerkja eru sýnd í töflu
English: *These adverse reactions were common (≥1/100 to < 1/10) in CHB patients treated with Pegasys monotherapy § Class label for interferon products, see below Pulmonary arterial hypertension.
Icelandic: *Þessar aukaverkanir voru algengar (≥1/100 til <1/10) hjá sjúklingum með langvinna lifrarbólgu
English: Each vial of 1.0 ml solution contains 180 micrograms peginterferon alfa-2a.
Icelandic: Í hverju hettuglasi með 1 ml af lausn eru 180 míkrógrömm af peginterferóni alfa-2a*.
English: Pegasys 135 micrograms solution for injection in pre-filled pen Pegasys 180 micrograms solution for injection in pre-filled pen
Icelandic: Pegasys 135 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna Pegasys 180 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna
English: Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml RVR = rapid viral response (HCV RNA undetectable) at week 4
Icelandic: Lítið veirumagn = ≤ 800.000 a.e./ml; Mikið veirumagn = > 800.000 a.e./ml RVR = hröð veirufræðileg svörun (HCV RNA ógreinanlegt) í 4. viku
English: HBeAg Seroconversion HBV DNA < 20,000 IU/mL* HBV DNA < 2,000 IU/mL ALT Normalization HBsAg Seroconversion Loss of HBsAg
Icelandic: B veiru DNA <2.000 a.e./ml ALT komið í eðlilegt horf HBsAg mótefnavending HBsAg ekki lengur greinanlegt
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 135 mcg/0.5 ml
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 135 µg/0,5 ml
English: Ribavirin 800 mg 48 weeks
Icelandic: 800 mg, 48 vikur:
English: Very common side effects with the combination of Pegasys and ribavirin (may affect more than 1 in 10 people) are:
Icelandic: Mjög algengar aukaverkanir við samsetningu af Pegasys og ríbavírini (sem geta komið fram hjá meira en 1 af hverjum 10 sjúklingum) eru:
English: The recommended duration of therapy is 48 weeks in patients with CHB. Before initiating therapy for CHB, persistently elevated serum ALT levels should have been documented.
Icelandic: Viðvarandi hækkað gildi ALT í sermi ætti að hafa verið skráð áður en meðferð við langvinnri lifrarbólgu B er hafin.
English: Hearing loss
Icelandic: Við lok
English: Ear pain
Icelandic: Alls fengu
English: Ribavirin 1000/1200 mg 72 Weeks (N = 473) SVR in Pts with VR at Wk 12 b
Icelandic: Pegasys 360/180 eða 180 míkróg og ríbavírin 1000/1200 mg 72 vikur (N = 473) SVR hjá sjúklingum með VR í 12.viku b
English: Peripheral neuropathy
Icelandic: NPV Næmi
English: Multipack: 12 (2 packs of 6) pre-filled syringes + 12 injection needles 135 micrograms/0.5 ml
Icelandic: LYFJAFORM OG INNIHALD Stungulyf, lausn‘ 12 áfylltir lyfjapennar 135 míkrógrömm/0,5 ml
English: Substance overdose
Icelandic: Meðferðarlengd
English: Metabolism and nutrition disorders
Icelandic: Efnaskipti og næring lystarleysi
English: Study NV15495
Icelandic: Rannsókn NV15495 Rannsókn NV15942
English: Each pen should be used by one person only and is for single use.
Icelandic: Hverja áfyllta sprautu skal einungis nota fyrir einn einstakling í eitt skipti.
English: ● Remove the needle guard from the syringe needle (5).
Icelandic: Takið nálarhlífina af nálinni á sprautunni (5).
English: Overall, the safety profile for Pegasys in combination with ribavirin in prior non-responder patients was similar to that in naïve patients.
Icelandic: Í heildina var öryggi Pegasys ásamt ríbavírini hjá sjúklingum sem ekki höfðu áður svarað meðferð álíka mikið og hjá sjúklingum sem ekki höfðu fengið meðferð áður.
English: 8) Dispose of pre-filled pen
Icelandic: 8) Fargið notaða lyfjapennanum
English: Pegasys 135 micrograms solution for injection in pre-filled pen Each pre-filled pen of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a*.
Icelandic: Pegasys 135 míkrógrömm stungulyf, lausn í áfylltri sprautu Í hverri áfylltri sprautu með 0,5 ml af lausn eru 135 míkrógrömm af peginterferóni alfa-2a*.
English: The use of Pegasys and ribavirin combination therapy in CHC patients who failed prior treatment has not been adequately studied in patients who discontinued prior therapy for haematological adverse reactions.
Icelandic: C sem ekki hafa svarað fyrri meðferðum hefur ekki verið rannsökuð nægilega hjá sjúklingum sem hættu fyrri meðferð vegna aukaverkana í blóði.
English: Psychiatric and nervous system disorders: Thoughts of suicide, hallucinations (severe problems with personality and deterioration in normal social functioning), peripheral neuropathy (disorder of the nerves affecting the extremities)
Icelandic: Sjálfsvíg, geðrofssjúkdómar (alvarleg persónuleika vandamál og versnun í félagslegri færni), dá (djúpt, langvinnt meðvitundarleysi), krampar, andlitslömun (slappir andlitsvöðvar)
English: Heart and blood vessel disorders: Heart attack, heart failure, heart pain, rapid heart rhythm, rhythm disorders or inflammation of the lining of the heart and cardiac muscle, bleeding in the brain and inflammation in the vessels
Icelandic: Hjartaáfall, hjartabilun, hjartverkur, hraður hjartsláttur, takttruflanir eða bólga í pokanum sem umlykur hjartað (gollurshússbólga) og hjartavöðva, heilablæðing og æðabólga
English: Odds Ratio (95% CI) = 0.53 (0.33 to 0.85), P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0084
Icelandic: 3% til 16% p-gildi (lagskipt Cochran-Mantel-Haenszel próf) = 0,003
English: Pegasys 180 micrograms solution for injection in pre-filled syringe EU/1/02/221/007
Icelandic: Pegasys 180 míkrógrömm stungulyf, lausn í áfylltri sprautu EU/1/02/221/007
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 90 mcg/0.5 ml
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 90 µg/0,5 ml
English: Specific recommendations for management of treatment-emergent anaemia in adults are as follows: ribavirin should be reduced to 600 milligrams/day (200 milligrams in the morning and 400 milligrams in the evening) if either of the following apply: (1) a patient without significant cardiovascular disease experiences a fall in haemoglobin to < 10 g/dl and ≥ 8.5 g/dl, or (2) a patient with stable cardiovascular disease experiences a fall in haemoglobin by ≥ 2 g/dl during any 4 weeks of treatment.
Icelandic: (1) Sjúklingur án marktæks hjarta- og æðasjúkdóms með lækkun á hemóglóbíni í <10 g/dl og ≥8,5 g/dl, eða (2) sjúklingur með stöðugan hjarta- og æðasjúkdóm verður fyrir lækkun á hemóglóbíni um ≥2 g/dl á 4 vikna tímabili.
English: Withhold Pegasys
Icelandic: Pegasys
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 180 µg PRE-FILLED PENS
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR - 12 x 180 µg ÁFYLLTAR
English: Pegasys is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels.
Icelandic: B sem er jákvæð fyrir HBeAg hjá börnum og unglingum 3 ára og eldri sem eru ekki með skorpulifur og með vísbendingar um veirueftirmyndun og viðvarandi hækkað gildi ALT í sermi.
English: For HIV-HCV patients receiving Pegasys and ribavirin combination therapy other undesirable effects have been reported in ≥ 1% to ≤ 2% of patients: hyperlactacidaemia/lactic acidosis, influenza, pneumonia,
Icelandic: Tilkynnt hefur verið um aðrar aukaverkanir hjá ≥ 1% til ≤ 2% HIV-HCV sjúklingum sem fengu samsetta meðferð með Pegasys og ríbavírini:
English: Virological response was defined as undetectable HCV RNA as measured by the COBAS AMPLICOR HCV Test, version 2.0 (limit of detection 100 copies/ml equivalent to 50 International Units/ml) and sustained response as one negative sample approximately 6 months after end of therapy.
Icelandic: (mörk greiningar 100 eintök/ml sem samsvarar 50 alþjóðlegum einingum/ml) og viðvarandi svörun sem eitt neikvætt sýni um 6 mánuðum eftir að meðferð lýkur.
English: Table 20: Sustained virological response in HALT-C by previous treatment regimen in nonresponder population
Icelandic: Viðvarandi veirufræðileg svörun í HALT-C við fyrri meðferð hjá sjúklingum sem ekki höfðu svarað meðferð Fyrri meðferð
English: Psoriasis, urticaria, eczema, rash, sweating increased, skin disorder, photosensitivi ty reaction, night sweats
Icelandic: Psóríasis, ofsakláði, exem, útbrot, aukin svitamyndun, húðkvillar, ljósnæmisviðbrögð, nætursviti
English: Table 14: Sustained virological response based on genotype and pre-treatment viral load after Pegasys combination therapy with ribavirin in CHC patients
Icelandic: Viðvarandi veirufræðileg svörun byggð á arfgerð og veirumagni fyrir meðferð, eftir samsetta meðferð Pegasys og ríbavírins hjá sjúklingum með langvinna lifrarbólgu
English: NOTE: Do not yet attempt to press the activation button.
Icelandic: Reynið ekki að þrýsta á virkjunarhnappinn.
English: HBeAg positive
Icelandic: Ofskömmtun lyfs
English: Table 10: Adverse reactions reported among paediatric patients infected with HCV and assigned to Pegasys plus ribavirin in study NV17424
Icelandic: Pegasys ásamt ríbavíríni í rannsókn NV17424
English: Keep the pre-filled syringe in the outer carton in order to protect from light
Icelandic: Geymið áfylltu sprautuna í ytri öskju til varnar gegn ljósi
English: Liver and renal graft rejection, VogtKoyanagiHarada disease
Icelandic: Áverkar og eitranir og fylgikvillar vegna lyfjagjafar
English: The negative predictive value for sustained response in patients treated with Pegasys in monotherapy was 98%.
Icelandic: Neikvætt forspárgildi viðvarandi svörunar hjá sjúklingum sem fengu Pegasys einlyfja meðferð var
English: Educational problem
Icelandic: Geðræn vandamál
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 135 µg PRE-FILLED PENS
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR - 4 x 135 µg ÁFYLLTAR SPRAUTUR
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/008
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/008
English: Pegasys 135 micrograms solution for injection in pre-filled pen EU/1/02/221/011
Icelandic: Pegasys 135 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna EU/1/02/221/011
English: Pegasys use is restricted to children and adolescents with chronic hepatitis C aged 5 years and above or children and adolescents with chronic hepatitis B aged 3 years and above.
Icelandic: Notkun Pegasys er inskorðuð við börn og unglinga 5 ára og eldri með langvinna lifrarbólgu C og börn og unglinga 3 ára og eldri með langvinna lifrarbólgu B. Ekki má gefa börnum yngri en 3 ára Pegasys þar sem lyfið inniheldur benzýl alkóhól og getur valdið eiturverkunum og ofnæmisviðbrögðum hjá börnum á þessum aldri.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/016
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/016