FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 19: Week 12 virological response (VR) and sustained virological response (SVR) in patients with virological response at week 12 after treatment with Pegasys and ribavirin combination therapy in nonresponders to peginterferon alfa-2b plus ribavirin Study MV17150 Pegasys 360/180 or 180 mcg
Icelandic: Veirufræðileg svörun (VR) í 12. viku og viðvarandi veirufræðileg svörun (SVR) hjá sjúklingum með veirufræðilega svörun í 12. viku eftir samsetta meðferð með Pegasys og ríbavírini hjá þeim sem ekki hafa sýnt svörun við peginterferón alfa-2b ásamt ríbavírini.
English: Table 9 summarises the undesirable effects reported with Pegasys monotherapy in CHB or CHC adult patients and with Pegasys in combination with ribavirin in CHC patients.
Icelandic: Í töflu 9 er yfirlit yfir aukaverkanir sem tilkynnt var um við Pegasys einlyfja meðferð hjá fullorðnum sjúklingum með langvinna lifrarbólgu
English: Excipient
Icelandic: Lystarleysi
English: Pegasys 180 micrograms solution for injection in pre-filled syringe Each syringe of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a*.
Icelandic: Pegasys 180 míkrógrömm stungulyf, lausn í áfylltri sprautu Í hverri áfylltri sprautu með 0,5 ml af lausn eru 180 míkrógrömm af peginterferóni alfa-2a*.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 135 µg PRE-FILLED PENS
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR - 12 x 135 µg ÁFYLLTIR LYFJAPENNAR
English: Heart and blood vessel disorders: Rapid heart rate, pulsation of the heart beats, swelling in the extremities, flushing
Icelandic: Hraður hjartsláttur, hjartsláttarónot, þroti í útlimum, roði Öndunarfæri:
English: Comprehensive instructions for the preparation and administration of Pegasys in pre-filled pen are given in the package leaflet.
Icelandic: Ítarlegar leiðbeiningar um undirbúning og gjöf Pegasys í áfylltum lyfjapenna er að finna í fylgiseðlinum.
English: * Similar to end point of HBV DNA < 10
Icelandic: B veiru (HBV) DNA < 10
English: What you need to know before you use Pegasys
Icelandic: Áður en byrjað er að nota Pegasys
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 90 µg PRE-FILLED SYRINGE
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR - 1 x 90 µg ÁFYLLT SPRAUTA
English: The reversibility of growth inhibition is uncertain.
Icelandic: Óvíst er hvort vaxtarskerðingin er afturkræf.
English: Multipack: 12 (2 packs of 6) pre-filled syringes + 12 injection needles 180 micrograms/0.5 ml
Icelandic: LYFJAFORM OG INNIHALD Stunguloyf, lausn 12 áfylltir lyfjapennar 180 míkrógrömm/0,5 ml
English: Results from pharmacokinetic substudies of pivotal phase III trials demonstrated no pharmacokinetic interaction of lamivudine on Pegasys in HBV patients or between Pegasys and ribavirin in HCV patients.
Icelandic: stigs rannsóknum sýndu engar lyfjahvarfa milliverkanir lamívúdíns við Pegasys hjá sjúklingum með lifrarbólgu
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 135 µg PRE-FILLED PEN
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR - 1 x 135 µg ÁFYLLT SPRAUTA
English: Dose-proportional increases in exposure of Pegasys are seen in healthy subjects and in patients with chronic hepatitis B or C after once-weekly dosing.
Icelandic: Aukning útsetningar fyrir Pegasys í réttu hlutfalli við skammt sést hjá heilbrigðum einstaklingum og hjá sjúklingum með langvinna lifrarbólgu
English: NAME OF THE MEDICINAL PRODUCT Pegasys 135 micrograms solution for injection in pre-filled pen Peginterferon alfa-2a
Icelandic: Pegasys 135 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna Peginterferón alfa-2a
English: Increases in ALT levels above baseline (BL) have been observed in patients treated with Pegasys, including patients with a virological response.
Icelandic: Sveiflur í frávikum á lifrarprófum eru algengar hjá sjúklingum með langvarandi lifrarbólgu C. Aukning á ALT gildum yfir grunnlínu (baseline, BL) sést hjá sjúklingum á meðferð með Pegasys, þar með töldum sjúklingum með veirufræðilega svörun.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/006
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/006
English: Table 9: Undesirable effects reported with Pegasys monotherapy for CHB or CHC or in combination with ribavirin for CHC patients in clinical trials and post marketing Body system Very common
Icelandic: B eða C eða ásamt ríbavírini hjá sjúklingum með langvinna lifrarbólgu C í klínískum rannsóknum og eftir markaðssetningu
English: 4 pre-filled syringes + 4 injection needles 135 micrograms/0.5 ml
Icelandic: 4 áfylltir lyfjapennar 135 míkrógrömm/0,5 ml
English: HBeAg seroconversion rates
Icelandic: Tíðni HBeAg mótefnavendingar
English: Ribavirin mg
Icelandic: B veiru <
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pegasys 90 micrograms solution for injection in pre-filled syringe Each syringe of 0.5 ml solution contains 90 micrograms peginterferon alfa-2a*.
Icelandic: Pegasys 90 míkrógrömm stungulyf, lausn í áfylltri sprautu Í hverri áfylltri sprautu með 0,5 ml af lausn eru 90 míkrógrömm af peginterferóni alfa-2a*.
English: Fever/infections
Icelandic: Sótthiti/sýkingar
English: Back pain, arthritis, muscle weakness, bone pain, neck pain, musculoskelet al pain, muscle cramps
Icelandic: Bakverkir, liðbólga, vöðvaslappleiki, beinverkir, verkur í hálsi, stoðkerfisverkir, sinadráttur
English: Pegasys is administered subcutaneously in the abdomen or thigh.
Icelandic: Pegasys er gefið undir húð (s.c.) í kvið eða læri.
English: Pegasys 90 micrograms solution for injection in pre-filled syringe 3 years.
Icelandic: Pegasys 90 míkrógrömm stungulyf, lausn í áfylltri sprautu
English: For patients <75 kg and ≥75 kg, 1000 mg daily and 1200 mg daily of ribavirin, respectively, and regardless of genotype, should be administered.
Icelandic: <75 kg 1000 mg af ríbavírini og sjúklingum ≥75 kg 1200 mg, óháð arfgerð.
English: You will find the expiration date on the box as well as on the label of the pre-filled pen itself.
Icelandic: Fyrningardagsetning er prentuð á öskjuna og límmiðann á áfyllta lyfjapennanum.
English: Pegasys 180 micrograms solution for injection in pre-filled pen EU/1/02/221/014
Icelandic: Pegasys 180 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna EU/1/02/221/014
English: Dyspnoea, cough
Icelandic: Lifur og gall
English: HBV-DNA was measured by the COBAS AMPLICOR HBV MONITOR Assay (limit of detection 200 copies/ml).
Icelandic: 21. Veirufræðileg svörun var skilgreind sem ómælanlegt HCV RNA mælt með COBAS AMPLICORTM HCV prófi, útgáfu 2.0
English: Pegasys plus ribavirin
Icelandic: Pegasys ásamt ríbavírini
English: ● if you develop symptoms of Vogt-Koyanagi-Harada syndrome; combination of complaints of neck stiffness, headache, loss of colour in skin or hair, eye disorders (such as blurred vision), and/or hearing abnormality (such as ringing in the ears).
Icelandic: Vogt-Koyanagi-Harada sjúkdómur - mjög sjaldgæfur sjúkdómur sem einkennist af sjónleysi, heyrnarleysi og litarmyndun í húð; höfnun lifrar- eða nýrnaígræðslu Geðræn vandamál og vandamál frá taugakerfi:
English: Musculoskeletal pain
Icelandic: Vöðvabólga
English: Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml * Pegasys 180 mcg & ribavirin 1000/1200 mg, 48 w vs. Pegasys 180 mcg & ribavirin 800 mg, 48 w: Odds Ratio (95% CI) = 1.52 (1.07 to 2.17) P-value (stratified Cochran-Mantel-Haenszel test) = 0.020 * Pegasys 180 mcg & ribavirin 1000/1200 mg, 48 w vs. Pegasys 180 mcg & ribavirin 1000/1200 mg, 24 w: Odds Ratio (95% CI) = 2.12 (1.30 to 3.46) P-value (stratified Cochran-Mantel-Haenszel test) = 0.002.
Icelandic: Lítið veirumagn = ≤ 800.000 a.e./ml; Mikið veirumagn= > 800.000 a.e./ml * Pegasys 180 míkróg og og ríbavírin 1000/1200 mg, 48 vikur á móti Pegasys 180 míkróg ogog ríbavírin
English: In these patients, tolerability to combination therapy and additional prognostic factors such as degree of fibrosis should be taken into account when deciding on treatment duration.
Icelandic: Þegar meðferðarlengd fyrir þessa sjúklinga er ákveðin skal taka mið af þoli gagnvart samsettri meðferð og viðbótar þáttum sem gefa vísbendingu um bata, eins og stig bandvefsmyndunar.
English: In paediatric patients, ribavirin treatment-associated toxicities, such as treatment-emergent anaemia, will be managed by reduction of the full dose.
Icelandic: Bregðast skal við eituráhrifum sem tengjast ríbavírini hjá börnum, svo sem meðferðartengdu blóðleysi, með því að draga úr fullum skammti.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a.
Icelandic: VIRK(T) EFNI Hver áfylltur lyfjapenni með 0,5 ml lausn inniheldur 135 míkrógrömm af peginterferóni alfa-2a.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 90 micrograms peginterferon alfa-2a.
Icelandic: VIRK(T) EFNI Hver áfyllt sprauta með 0,5 ml lausn inniheldur 90 míkrógrömm af peginterferóni alfa-2a.
English: ● Select the injection site in the abdomen or thigh (except your navel or waistline).
Icelandic: Veljið stungustað á kvið eða læri (ekki nafla eða mitti).
English: Hepatic neoplasm
Icelandic: Húðsjúkdómar
English: Table 16: Relapse of virological response at the end of treatment for rapid virological response population
Icelandic: Versnun á veirufræðilegri svörun við meðferðarlok hjá einstaklingum með hraða veirufræðilega svörun
English: Rare side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 1000 people) are:
Icelandic: Mjög sjaldgæfar aukaverkanir við samsetningu af Pegasys og ríbavírini (sem geta komið fram hjá allt að 1 af hverjum 1000 sjúklingum) eru:
English: 3 x 200 mg tablets A.M. 3 x 200 mg tablets P.M.
Icelandic: 3 x 200 mg töflur að kvöldi
English: Patients who have detectable virus at week 12 should stop therapy.
Icelandic: Stöðva skal meðferð hjá sjúklingum sem hafa greinanlega veiru í 12. viku.
English: Pegasys 180 micrograms solution for injection in pre-filled syringe 4 years
Icelandic: Pegasys 180 míkrógrömm stungulyf, lausn í áfylltri sprautu
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 180 µg PRE-FILLED SYRINGES
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR - 4 x 180 µg aÁFYLLTAR SPRAUTUR
English: In patients with compensated cirrhosis (e.g., Child-Pugh A), Pegasys has been shown to be effective and safe.
Icelandic: Sýnt hefur verið fram á virkni og öryggi Pegasys hjá sjúklingum með væga skorpulifur (t.d. ChildPugh A).
English: Uncommon side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 100 people) are:
Icelandic: Sjaldgæfar aukaverkanir við samsetningu af Pegasys og ríbavírini (sem geta komið fram hjá allt að 1 af hverjum 100 sjúklingum) eru:
English: A patient-level meta-analysis of 9 Pegasys clinical studies (n=1,423) in CHB HBeAg positive and HBeAg-negative patients demonstrated that HBsAg and HBV DNA levels at Week 12 of treatment, are predictive of final treatment outcome at Week 24 post-treatment in certain genotypes.
Icelandic: B sem er jákvæð eða neikvæð fyrir HBeAg sýndi fram á að gildi HBsAg (yfirborðsmótefnavaka lifrarbólgu B veiru) og HBV DNA í 12. viku meðferðar hafa forspárgildi fyrir endanlegan árangur meðferðar, metinn 24 vikum eftir lok meðferðar, hjá tilteknum arfgerðum.
English: Weekly dose (mcg)
Icelandic: Vikuskammtur (míkrógrömm)
English: Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml *Pegasys 180 mcg & ribavirin 1000/1200 mg, 48 w vs. Pegasys 180 mcg & ribavirin 800 mg, 48 w: Odds Ratio (95% CI) = 1.52 (1.07 to 2.17), P-value (stratified Cochran-Mantel-Haenszel test) = 0.020 *Pegasys 180 mcg & ribavirin 1000/1200 mg, 48 w vs. Pegasys 180 mcg & ribavirin 1000/1200 mg, 24 w: Odds Ratio (95% CI) = 2.12 (1.30 to 3.46), P-value (stratified Cochran-Mantel-Haenszel test) = 0.002.
Icelandic: Haenszel próf) = 0,020 * Pegasys 180 míkróg ogog ríbavírin 1000/1200 mg, 48 vikur á móti Pegasys 180 míkróg ogog ríbavírin 1000/1200 mg, 24 vikur:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/005
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/005
English: INSTRUCTIONS ON USE
Icelandic: Förgun innspýtingaráhalda
English: ● if you have been withdrawn from previous therapy for Hepatitis C because of anaemia or low blood count.
Icelandic: Ef hætt hefur verið við fyrri meðferð hjá þér við langvinnri lifrarbólgu
English: Consideration for early treatment discontinuation should be evaluated in the context of a particular clinical situation.
Icelandic: Ef íhugað er að hætta meðferð fyrr en áætlað var á að meta það út frá klínískum aðstæðum hverju sinni.
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.2 and 5.1.
Icelandic: Sjá kafla 4.2 og 5.1 fyrir sértæka virkni eftir arfgerð lifrarbólguveiru C (HCV).
English: b Patients who achieved viral suppression at week 12 but were missing HCV RNA results at the end of follow-up were considered to be non-responders.
Icelandic: 12. viku en vantaði HCV RNA niðurstöður þegar eftirfylgni lauk voru metnir sem sjúklingar sem ekki svöruðu meðferð.
English: * Subgroup of patients with genotype D had a higher proportion with baseline ALT < 1.5x ULN (13/31) compared to other genotype groups ** Patients switched to Pegasys treatment post-principal observation period and before Week 24 follow-up were counted as non-responders.
Icelandic: D var hærra hlutfall með upphafsgildih ALT < 1,5 x ULN (13/31) en hjá sjúklingum sem sýktir voru með veiru af öðrum arfgerðum (16/70).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a.
Icelandic: VIRK(T) EFNI Hver áfylltur lyfjapenni með 0,5 ml lausn inniheldur 180 míkrógrömm af peginterferóni alfa-2a.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 135 µg PRE-FILLED SYRINGES
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR - 4 x 135 µg ÁFYLLTIR LYFJAPENNAR
English: Flushing Hypertension Cerebral haemorrhage, vasculitis
Icelandic: Hraður hjartsláttur, útlægur bjúgur, hjartsláttarónot
English: Bronchitis, upper respiratory infection, oral candidiasis, herpes simplex, fungal, viral and bacterial infections
Icelandic: Berkjubólga, sýking í efri hluta öndunarvegar, sveppasýking í munni, áblástur sveppa-, veiru- og bakteríusýkingar
English: 2 x 200 mg tablets A.M. 2 x 200 mg tablets P.M.
Icelandic: 2 x 200 mg töflur að kvöldi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 180 µg PRE-FILLED SYRINGE
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR - 1 x 180 µg ÁFYLLT SPRAUTA
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 1 ml solution contains 180 micrograms peginterferon alfa-2a.
Icelandic: VIRK(T) EFNI Hvert hettuglas með 1 ml lausn inniheldur 180 míkrógrömm af peginterferóni alfa-2a.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/012
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/012
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/004
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/004
English: Abdominal pain upper, stomatitis, nausea, aphthous stomatitis, oral disorder
Icelandic: Meltingarfæri: Niðurgangur, ógleði, kviðverkir
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/011
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/011
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/015
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/015
English: Summary of the safety profile
Icelandic: Líkindahlutfall öryggismörk)
English: 1 pre-filled syringe + 1 injection needle 135 micrograms/0.5 ml
Icelandic: 1 áfylltur lyfjapenni 135 míkrógrömm/0,5 ml
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/009
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/009
English: The duration of treatment with Pegasys in combination with ribavirin in paediatric patients with CHC depends on viral genotype.
Icelandic: Lengd meðferðar með Pegasys ásamt ríbavírini hjá börnum með langvinna lifrarbólgu
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 180 µg PRE-FILLED PENS
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR - 4 x 180 µg HETTUGLÖS
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/013
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/013
English: LVL = ≤ 800,000 IU/ml; HVL = > 800,000 IU/ml (a) It is presently not clear whether a higher dose of ribavirin (e.g.1000/1200 mg/day based on body weight) results in higher SVR rates than does the 800 mg/day, when treatment is shortened to 16 weeks.
Icelandic: Sem stendur er ekki ljóst hvort stærri skammtar af ríbavírini (t.d. 1000/1200 mg/dag miðað við líkamsþyngd) leiði til hærra hlutfalls af viðvarandi veirufræðilegri svörun en skammtur sem nemur 800 mg/dag, þegar meðferð er stytt í 16 vikur.
English: Paediatric population
Icelandic: - Fjölpakkning
English: Keep the vial in the outer carton in order to protect from light
Icelandic: Geymið hettuglasið í ytri öskju til varnar gegn ljósi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/014
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/014
English: 1) Visually check the pre-filled pen 2) Allow the pre-filled pen to adjust to room temperature 3) Clean your hands
Icelandic: Skoðið áfyllta lyfjapennann Látið áfyllta lyfjapennann ná herbergishita Þvoið hendur
English: Pegasys is used to treat chronic hepatitis B or chronic hepatitis C in adults.
Icelandic: Pegasys er notað til meðferðar á langvinnri lifrarbólgu
English: The “Instructions for the User”, provided in the carton, must be followed carefully by the patient.
Icelandic: Sjúklingur skal fylgja nákvæmlega leiðbeiningum fyrir notkun sem fylgja í pakkanum.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/017
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/017
English: After the injection: Wipe the injection site with the alcohol pad, if necessary.
Icelandic: Strjúkið af stungustaðnum með klút vættum í alkóhóli ef nauðsynlegt er.
English: 10% and 8% of patients receiving Pegasys monotherapy and combination therapy, respectively.
Icelandic: sjúklinga sem fengu Pegasys einlyfjameðferð og hjá 8% sem fengu samsetta meðferð.
English: Hepatic failure, cholangitis, fatty liver
Icelandic: Lifrarbilun, gallrásabólga, fitulifur
English: When Pegasys is used alone in hepatitis B or C patients, some of these effects are less likely to occur
Icelandic: Þegar Pegasys er notað eitt sér hjá sjúklingum með lifrarbólgu
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/007
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/010
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/010
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 135 µg PRE-FILLED SYRINGE
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR - 1 x 135 µg ÁFYLLTUR LYFJAPENNI
English: Some children and adolescents treated with Pegasys for chronic hepatitis B for 48 weeks did not grow or gain weight as much as expected for their age.
Icelandic: B í 48 vikur var líkamsvöxtur og þyngdaraukning minni en búast mátti við miðað við aldur.
English: Table 22: Serological, virological and biochemical responses in paediatric patients with chronic hepatitis B
Icelandic: B veiru eða milli Pegasys og ríbavírins hjá sjúklingum með lifrarbólgu C veiru.
English: (N=88) 48 weeks
Icelandic: (N=88) vikur
English: Breathing disorders: Interstitial pneumonia (inflammation of the lungs including fatal outcome), blood clots in the lung
Icelandic: Millivefslungnabólga (sem getur verið banvæn), blóðtappar í lungum Meltingarfæri:
English: Pegasys treatment was associated with abnormal laboratory values: ALT increase, bilirubin increase, electrolyte disturbance (hypokalaemia, hypocalcaemia, hypophosphataemia), hyperglycaemia, hypoglycaemia and elevated triglycerides (see section 4.4.).
Icelandic: ALT hækkun, hækkun á bílirúbíni, truflunum á saltajafnvægi (lækkun kalíums í blóði, lækkun kalsíums í blóði, lækkun fosfats í blóði), blóðsykurshækkun, blóðsykurslækkun og hækkun þríglýseríða (sjá kafla 4.4).
English: A puncture-proof container with lid for safe disposal of used pens
Icelandic: SÉRSTAKAR VARÚÐARRÁÐSTAFANIR VIÐ FÖRGUN LYFJALEIFA
English: 4) Choose and prepare an injection site 5) Remove cap
Icelandic: Veljið stungustað og undirbúið hann Fjarlægið hettuna
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 June 2002
Icelandic: 20. júní 2002 Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/003
Icelandic: MARKAÐSLEYFISNÚMER EU/1/02/221/003
English: Very rare side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 10,000 people) are:
Icelandic: Aukaverkanir sem koma örsjaldan fyrir við samsetningu af Pegasys og ríbavírini (sem geta komið fram hjá allt að 1 af hverjum 10.000 sjúklingum) eru:
English: Ribavirin dose
Icelandic: Skammtur ríbavírins
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 180 µg VIAL
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR - 1 x 180 µg HETTUGLAS
English: Undesirable effects reported in clinical studies are grouped according to frequency as follows: very common (≥ 1/10), common
Icelandic: B eða C og við samsetta meðferð með Pegasys og ríbarvírini hjá sjúklingum með langvinna lifrarbólgu C. Tilkynntar aukaverkanir úr klínískum rannsóknum eru teknar saman samkvæmt eftirfarandi tíðni: mjög algengar (≥ 1/10), algengar (≥1/100 til < 1/10), sjaldgæfar
English: Dizziness, disturbance in attention, migraine
Icelandic: Bólga og þroti í sjóntaug, bólga í sjónhimnu, sár í hornhimnu
English: Common side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 10 people) are:
Icelandic: Algengar aukaverkanir við samsetningu af Pegasys og ríbavírini (sem geta komið fram hjá allt að 1 af hverjum 10 sjúklingum) eru:
English: Impotence
Icelandic: Frásog
English: Optic neuropathy, papilloedema, retinal vascular disorder, retinopathy, corneal ulcer
Icelandic: LYFJAFORM OG INNIHALD Stungulyf, lausn
English: Mania, bipolar disorders, homicidal ideation
Icelandic: Geðhæð, geðhvarfasjúkdómur, manndrápshugsanir
English: Duration
Icelandic: Forspárgildi
English: 3 MIU
Icelandic: 4 hettuglös
English: Combination therapy with ribavirin in chronic hepatitis C In the case of combination therapy with Pegasys and ribavirin, please follow the dosing regimen recommended by your doctor.
Icelandic: C Í þeim tilvikum þegar Pegasys er gefið samtímis ríbavírini, vinsamlega farið eftir þeirri skammtaáætlun sem ráðlögð er af lækninum.
English: In CHB, unlike CHC, disease exacerbations during therapy are not uncommon and are characterised by transient and potentially significant increases in serum ALT.
Icelandic: C er ekki óalgengt að sjúkdómurinn versni meðan á meðferð stendur hjá sjúklingum með langvinna lifrarbólgu B og einkennist þetta af skammvinnum og mögulega marktækum hækkunum á ALT í sermi. Í klínískum rannsóknum
English: 4 pre-filled syringes + 4 injection needles 180 micrograms/0.5 ml
Icelandic: 4 áfylltir lyfjapennar 180 míkrógrömm/0,5 ml
English: Chest pain, influenza like illness, malaise, lethargy, hot flushes, thirst
Icelandic: Verkur fyrir brjósti, inflúensulík veikindi, slappleiki, svefnhöfgi, hitakóf, þorsti
English: 1 x 200 mg tablets A.M.
Icelandic: 1 x 200 mg tafla að morgni
English: Genotype 4 with RVR*
Icelandic: Arfgerð 4 RVR
English: Myocardial infarction, congestive heart failure, cardiomyopat hy, angina, arrhythmia, atrial fibrillation, pericarditis, supraventricu lar tachycardia
Icelandic: Hjartadrep, hjartabilun, hjartavöðvakvilli, hjartaöng, hjartsláttartruflanir, gáttaflökt, gollurshússbólga, ofanslegilshraðsláttur
English: 6) Place the pre-filled pen on the injection site
Icelandic: Komið áfyllta lyfjapennanum fyrir á stungustaðnum
English: Ribavirin 1000/1200 mg
Icelandic: Pegasys 180 míkróg og ríbavírin 1000/1200 mg
English: Alcohol pad
Icelandic: Blóðflagnafjöldi
English: Pancytopenia Aplastic anaemia
Icelandic: Svörun DNA lifrarbólgu
English: Cerebral ischaemia
Icelandic: ● ílát fyrir úrgangsefni