FrancophonIA/ELRC3.0 huggingface dataset:
English: HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
Icelandic: HCV-arfgerð og veirumagn áður en meðferð hefst eru forspárþættir um horfur sem vitað er að hafa áhrif á svörunarhlutfall.
English: The reconstituted solution has a concentration of 100 micrograms in 0.5 ml.
Icelandic: Styrkur fullbúinnar lausnar er 100 míkróg í 0,5 ml.
English: HCV/HIV Co-infected patients
Icelandic: Sjúklingar sem eru samtímis með HCV-/HIV-sýkingu
English: Psoriasis, photosensitivity reaction, rash maculo-papular, dermatitis, erythematous rash, eczema, night sweats, hyperhidrosis, acne, furuncle, erythema, urticaria, abnormal hair texture, nail disorder
Icelandic: Psoriasis, ljósnæmisviðbrögð, dröfnuörðuútbrot, húðbólga, rauð útbrot, exem, nætursviti, ofsviti, þrymlabólur, graftarkýli, roðaþot, ofsakláði, óeðlileg áferð hárs, kvilli í nöglum
English: The reconstituted solution has a concentration of 100 micrograms/0.5 ml.
Icelandic: Styrkleiki fullbúinnar lausnar er 100 míkróg/0,5 ml.
English: - facial palsy (weakness and slumping on one side to the face), severe allergic reactions such as angioedema (an allergic skin disease characterized by patches of swelling involving the skin and its subcutaneous layers, the mucous membranes, and sometimes the internal organs), mania (excessive or unreasonable enthusiasm), pericardial effusion (a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself), Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord), change in colour of the tongue.
Icelandic: Þetta veldur alvarlegu blóðleysi sem m.a. getur lýst sér með óvenjulegri þreytu og orkuleysi - andlitslömun (slappleiki og sig í öðrum helmingi andlitsins), alvarleg ofnæmisviðbrögð eins og ofnæmisbjúgur (ofnæmissjúkdómur í húð sem einkennist af bólgu á afmörkuðum blettum í húð og undirhúð, slímhúð og stundum í innri líffærum), geðhæð (óhóflegur eða óeðlilegur ákafi), vökvi í kringum hjarta (vökvasöfnun á milli gollurshúss (sem er umhverfis hjartað) og hjartans), Vogt-Koyanagi-Harada-heilkenni (sjálfsnæmisbólgusjúkdómur sem hefur áhrif á augu, húð og himnur í eyrum, heila og mænu), litabreytingar á tungu - hugsanir um að ógna lífi annarra - bandvefsmyndun í lungum (örmyndun í lungum) - lungnaháþrýstingur - sjúkdómur með alvarlegri þrengingu í lungnaæðum sem leiðir til hækkunar á blóðþrýstingi í æðum sem flytja blóð frá hjarta til lungna.
English: The reconstituted solution has a concentration of 80 micrograms in 0.5 ml.
Icelandic: Styrkur fullbúinnar lausnar er 80 míkróg í 0,5 ml.
English: ViraferonPeg is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis C virus RNA (HCV-RNA), including patients with compensated cirrhosis and/or co-infected with clinically stable HIV (see section 4.4).
Icelandic: C-veiru RNA (HCV-RNA), þar með talið sjúklingar með skorpulifur án lifrarbilunar og/eða klínískt stöðuga HIV-sýkingu samtímis (sjá kafla 4.4).
English: Alopecia, dry skin
Icelandic: Sarklíki í húð
English: Chest pain, chest discomfort, injection site pain, malaise, face oedema, oedema peripheral, feeling abnormal, thirst
Icelandic: Brjóstverkur, óþægindi fyrir brjósti, verkur á stungustað, lasleiki, andlitsbjúgur, bjúgur í útlimum, óeðlileg líðan, þorsti
English: This medicine is used for the treatment of chronic hepatitis C, a viral infection of the liver.
Icelandic: Þetta lyf er notað við langvinnri lifrarbólgu
English: Abnormal behaviour, depressed mood, emotional disorder, fear, nightmare Nervous system disorders
Icelandic: Óeðlileg hegðun, geðdeyfð, tilfinningaröskun, ótti, martröð
English: The reconstituted solution has a concentration of 50 micrograms in 0.5 ml.
Icelandic: Styrkur fullbúinnar lausnar er 50 míkróg í 0,5 ml.
English: One vial of powder contains 80 micrograms of peginterferon alfa-2b and provides 80 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Icelandic: Eitt hettuglas af stungulyfsstofni inniheldur 80 míkróg af peginterferon alfa-2b sem gefur 80 míkróg/0,5 ml af peginterferon alfa-2b eftir blöndun samkvæmt ráðleggingum.
English: Amount of ViraferonPe g to administer (µg)
Icelandic: Magn ViraferonPe g sem gefa á (míkróg)
English: Predictability of sustained virological response - Naïve patients: Virological response by week 12 is defined as at least 2-log viral load decrease or undetectable levels of HCV-RNA.Virological response by week 4 is defined as at least 1-log viral load decrease or undetectable levels of HCV-RNA.
Icelandic: Veirufræðileg svörun í 12. viku er skilgreind sem að minnsta kosti 2 log minnkun á veirumagni eða ómælanlegt HCV-RNA.
English: ViraferonPeg 50 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 80 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 100 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 120 micrograms powder and solvent for solution for injection in pre-filled pen ViraferonPeg 150 micrograms powder and solvent for solution for injection in pre-filled pen
Icelandic: ViraferonPeg 50 míkróg stungulyfsstofn og leysir, lausn í áfylltum lyfjapenna ViraferonPeg 80 míkróg stungulyfsstofn og leysir, lausn í áfylltum lyfjapenna ViraferonPeg 100 míkróg stungulyfsstofn og leysir, lausn í áfylltum lyfjapenna ViraferonPeg 120 míkróg stungulyfsstofn og leysir, lausn í áfylltum lyfjapenna ViraferonPeg 150 míkróg stungulyfsstofn og leysir, lausn í áfylltum lyfjapenna
English: You can save the swab to clean the skin area where you will inject the dose.
Icelandic: Geymdu þurrkuna til að hreinsa húðina á væntanlegum stungustað.
English: General disorders and administration site conditions Very common:
Icelandic: Stoðkerfi og stoðvefur Mjög algengar:
English: ViraferonPeg 50 micrograms powder and solvent for solution for injection in pre-filled pen EU/1/00/132/031
Icelandic: ViraferonPeg 50 míkróg stungulyfsstofn og leysir, lausn í áfylltum lyfjapenna EU/1/00/132/031
English: Each pre-filled pen provides 150 micrograms/0.5 ml of solution when reconstituted as recommended.
Icelandic: Hver áfylltur penni inniheldur 150 míkróg/0,5 ml lausn þegar lyfið hefur verið leyst upp samkvæmt leiðbeiningum.
English: One vial of powder contains 120 micrograms of peginterferon alfa-2b and provides 120 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Icelandic: Eitt hettuglas af stungulyfsstofni inniheldur 120 míkróg af peginterferon alfa-2b sem gefur 120 míkróg/0,5 ml af peginterferon alfa-2b eftir blöndun samkvæmt ráðleggingum.
English: The reconstituted solution has a concentration of 50 micrograms/0.5 ml.
Icelandic: Styrkleiki fullbúinnar lausnar er 50 míkróg/0,5 ml.
English: ViraferonPeg should be administered as a once weekly subcutaneous injection.
Icelandic: Gefa skal ViraferonPeg einu sinni í viku með inndælingu undir húð.
English: Each pre-filled pen provides 120 micrograms/0.5 ml of solution when reconstituted as recommended.
Icelandic: Hver áfylltur penni inniheldur 120 míkróg/0,5 ml lausn þegar lyfið hefur verið leyst upp samkvæmt leiðbeiningum.
English: - Inject the solvent SLOWLY, aiming the stream of liquid at the glass wall of the vial.
Icelandic: - Sprautaðu leysinum HÆGT og beindu bununni að innanverðum hliðum hettuglassins.
English: Each vial provides 150 micrograms/0.5 ml of solution when reconstituted as recommended.
Icelandic: Hvert hettuglas inniheldur 150 míkróg/0,5 ml lausn þegar lyfið hefur verið leyst upp samkvæmt leiðbeiningum.
English: However, certain monkey species, e.g., Rhesus monkeys are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
Icelandic: Rhesus-apar móttækilegir fyrir lyfjahrifaörvun þegar þeir eru útsettir fyrir mannainterferonum af gerð I.
English: Retreatment duration greater than 48 weeks in non-responder patients with genotype 1 has not been studied with pegylated interferon alfa-2b and ribavirin combination therapy.
Icelandic: Endurtekin samsett meðferð með pegýleruðu interferoni alfa-2b og ríbavírini sem varir lengur en 48 vikur hjá sjúklingum með arfgerð 1, sem hafa ekki svarað meðferð, hefur ekki verið rannsökuð.
English: ViraferonPeg 1.5 micrograms/kg
Icelandic: P 1,5 ViraferonPeg 1,5 míkróg/kg
English: c: Patients with genotype 3 low viral load (< 600,000 IU/ml) were to receive 24 weeks of treatment while those with genotype 3 and high viral load (≥ 600,000 IU/ml) were to receive 48 weeks of treatment.
Icelandic: 24 vikna meðferð en þeir sem voru með arfgerð 3 og mikið veirumagn (≥ 600.000 a.e./ml) fengu
English: Rare side effects (may affect up to 1 in 1,000 people): - diabetic ketoacidosis (medical emergency due to build-up of ketone bodies in the blood as a result of out-of-control diabetes), - seizures (convulsions) and bipolar disorders (mood disorders characterized by alternating episodes of sadness and excitement), - eye problems including changes in vision, damage to the retina, obstruction of the retinal artery, inflammation of the optic nerve, swelling of the eye, - congestive heart failure, abnormal heart rhythm, pericarditis (inflammation of the lining of the heart), inflammation and degeneration of muscle tissue and peripheral nerves, kidney problems, - sarcoidosis (a disease characterized by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands).
Icelandic: - ketónblóðsýring af völdum sykursýki (neyðartilvik vegna uppsöfnunar ketóna í blóði vegna sykursýki sem ekki er undir stjórn) - flog (krampar), geðhvörf (lyndisröskun sem einkennist af sveiflum á milli dapurleika og æsings) - augnkvillar, m.a. breytingar á sjón, skaði á sjónhimnu, slagæðastífla í sjónhimnu, bólga í sjóntaug, bólga í auga - hjartabilun, óeðlilegur hjartsláttur, gollurshússbólga (bólga í himnu sem umlykur hjartað), bólga og hrörnun í vöðvum og úttaugum, nýrnakvilli - sarklíki (sjúkdómur sem einkennist af stöðugum hita, þyngdartapi, liðverkjum og liðbólgu sárum á húð og bólgnum eitlum).
English: EU/1/00/132/047 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/048 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/050 (12 pens, 12 injection needles and 24 cleansing swabs)
Icelandic: EU/1/00/132/047 (l lyfjapenni, 1 nál og 2 hreinsiþurrkur) EU/1/00/132/048 (4 lyfjapennar, 4 nálar og 8 hreinsiþurrkur) EU/1/00/132/050 (12 lyfjapennar, 12 nálar og 24 hreinsiþurrkur)
English: Minimum delivery for pen is 0.2 ml.
Icelandic: Lágmarksgjöf með penna er 0,2 ml. * Nota verður hettuglas.
English: Retinal exudates
Icelandic: Ríbavírinskammtur
English: - develop symptoms associated with a cold or other respiratory infection, such as fever, cough, or any difficulty in breathing.
Icelandic: Taka verður röntgenmynd af lungum hjá öllum sjúklingum sem fá hita, hósta, andnauð eða önnur einkenni frá öndunarvegi.
English: Each vial provides 120 micrograms/0.5 ml of solution when reconstituted as recommended.
Icelandic: Hvert hettuglas inniheldur 120 míkróg/0,5 ml lausn þegar lyfið hefur verið leyst upp samkvæmt leiðbeiningum.
English: 50 mcg/0.5 ml
Icelandic: 50 míkróg/0,5 ml
English: Baseline Viral Load
Icelandic: Bolur lyfjapennans
English: One vial of powder contains 150 micrograms of peginterferon alfa-2b and provides 150 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Icelandic: Eitt hettuglas af stungulyfsstofni inniheldur 150 míkróg af peginterferon alfa-2b sem gefur 150 míkróg/0,5 ml af peginterferon alfa-2b eftir blöndun samkvæmt ráðleggingum.
English: ViraferonPeg - ampoule of solvent
Icelandic: ViraferonPeg - lykja af leysi
English: Genotype 4
Icelandic: Tafla 7
English: Each pre-filled pen provides 80 micrograms/0.5 ml of solution when reconstituted as recommended.
Icelandic: Hver áfylltur penni inniheldur 80 míkróg/0,5 ml lausn þegar lyfið hefur verið leyst upp samkvæmt leiðbeiningum.
English: The active substance is a covalent conjugate of recombinant interferon alfa-2b* with monomethoxy polyethylene glycol.
Icelandic: Virka efnið er samgild samsetning raðbrigða interferon alfa-2b* og mónómetoxýpólýetýlenglýkóls.
English: ViraferonPeg 100 micrograms powder and solvent for solution for injection in pre-filled pen EU/1/00/132/039
Icelandic: ViraferonPeg 100 míkróg stungulyfsstofn og leysir, lausn í áfylltum lyfjapenna EU/1/00/132/039
English: Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface.
Icelandic: Frumuvirkni interferons er þannig að það binst sértækum himnuviðtökum á frumuyfirborðinu.
English: Dyspepsia, gingivitis
Icelandic: Taugakvilli, úttaugakvilli
English: ViraferonPeg 80 micrograms - vial of powder
Icelandic: ViraferonPeg 80 míkróg - hettuglas af stungulyfsstofni
English: EU/1/00/132/020 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/029 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Icelandic: EU/1/00/132/020 (6 hettuglös af stungulyfsstofni, 6 lykjur af leysi) EU/1/00/132/029 (12 hettuglös af stungulyfsstofni, 12 lykjur af leysi, 12 sprautur, 24 nálar og 12 hreinsiþurrkur)
English: EU/1/00/132/035 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/036 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/038 (12 pens, 12 injection needles and 24 cleansing swabs)
Icelandic: EU/1/00/132/035 (l lyfjapenni, 1 nál og 2 hreinsiþurrkur) EU/1/00/132/036 (4 lyfjapennar, 4 nálar og 8 hreinsiþurrkur) EU/1/00/132/038 (12 lyfjapennar, 12 nálar og 24 hreinsiþurrkur)
English: Platelets
Icelandic: Mælingar
English: Plasma HCV-RNA is measured with a research-based quantitative polymerase chain reaction assay by a central laboratory *Intent to treat population includes 7 patients for whom at least 12 weeks of prior therapy could not be confirmed.
Icelandic: HCV-RNA í plasma er mælt með kjarnsýrumögnunaraðferð (research-based quantitative polymerase chain reaction assay) á miðlægri rannsóknarstofu.
English: ViraferonPeg 150 micrograms - vial of powder
Icelandic: ViraferonPeg 150 míkróg - hettuglas af stungulyfsstofni
English: Each vial provides 80 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Icelandic: Hvert hettuglas gefur 80 míkróg/0,5 ml af peginterferon alfa-2b eftir blöndun samkvæmt ráðleggingum.
English: ViraferonPeg is available in different pack sizes: - 1 vial of powder for solution for injection and 1 ampoule of solvent for injection; - 1 vial of powder for solution for injection, 1 ampoule of solvent for injection, 1 injection syringe,
Icelandic: - 1 hettuglas af stungulyfsstofni og 1 lykja af leysi fyrir stungulyf; - 1 hettuglas af stungulyfsstofni, 1 lykja af leysi fyrir stungulyf, 1 sprauta, 2 nálar og
English: After administering the dose, the ViraferonPeg pre-filled pen and any unused solution contained in it is to be disposed of in accordance with local requirements.
Icelandic: Farga skal ViraferonPeg áfyllta pennanum og öllum lyfjaleifum og/eða úrgangi í samræmi við gildandi reglur eftir að skammtur hefur verið gefinn.
English: 2 injection needles and 1 cleansing swab; - 4 vials of powder for solution for injection and 4 ampoules of solvent for injection; - 4 vials of powder for solution for injection, 4 ampoules of solvent for injection, 4 injection syringes,
Icelandic: - 4 hettuglös af stungulyfsstofni og 4 lykjur af leysi til inndælingar; 4 sprautur, 8 sprautunálar og
English: The safety and efficacy of ViraferonPeg therapy has not been evaluated in patients with severe hepatic dysfunction, therefore ViraferonPeg must not be used for these patients.
Icelandic: Skert lifrarstarfsemi Lyfjahvörf ViraferonPeg hafa ekki verið metin hjá sjúklingum með alvarlega lifrarbilun.
English: EU/1/00/132/043 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/044 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/046 (12 pens, 12 injection needles and 24 cleansing swabs)
Icelandic: EU/1/00/132/043 (l lyfjapenni, 1 nál og 2 hreinsiþurrkur) EU/1/00/132/044 (4 lyfjapennar, 4 nálar og 8 hreinsiþurrkur) EU/1/00/132/046 (12 lyfjapennar, 12 nálar og 24 hreinsiþurrkur)
English: ViraferonPeg 120 micrograms powder and solvent for injection peginterferon alfa-2b
Icelandic: ViraferonPeg 120 míkróg stungulyfsstofn og leysir, lausn peginterferon alfa-2b
English: One vial of powder contains 100 micrograms of peginterferon alfa-2b and provides 100 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Icelandic: Eitt hettuglas af stungulyfsstofni inniheldur 100 míkróg af peginterferon alfa-2b sem gefur 100 míkróg/0,5 ml af peginterferon alfa-2b eftir blöndun samkvæmt ráðleggingum.
English: Reminder: Please read the “Other medicines” section of the Package Leaflet for ribavirin before using it in combination with this medicine.
Icelandic: „Notkun annarra lyfja“ í fylgiseðlinum með ríbavírini áður en það er notað með þessu lyfi.
English: Measuring the dose of ViraferonPeg from the reconstituted powder for injection Turn the vial and the syringe upside down in one hand.
Icelandic: Eftir að duftið í ViraferonPeg er uppleyst samkvæmt leiðbeiningum er nál sett á pennann og ávísaður skammtur gefinn undir húð.
English: ViraferonPeg 50 micrograms powder and solvent for solution for injection ViraferonPeg 80 micrograms powder and solvent for solution for injection ViraferonPeg 100 micrograms powder and solvent for solution for injection ViraferonPeg 120 micrograms powder and solvent for solution for injection ViraferonPeg 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b
Icelandic: ViraferonPeg 50 míkróg stungulyfsstofn og leysir, lausn ViraferonPeg 80 míkróg stungulyfsstofn og leysir, lausn ViraferonPeg 100 míkróg stungulyfsstofn og leysir, lausn ViraferonPeg 120 míkróg stungulyfsstofn og leysir, lausn ViraferonPeg 150 míkróg stungulyfsstofn og leysir, lausn peginterferon alfa-2b
English: One vial of powder contains 50 micrograms of peginterferon alfa-2b and provides 50 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Icelandic: Eitt hettuglas af stungulyfsstofni inniheldur 50 míkróg af peginterferon alfa-2b sem gefur 50 míkróg/0,5 ml af peginterferon alfa-2b eftir blöndun samkvæmt ráðleggingum.
English: Very common side effects (may affect more than 1 in 10 people): - feeling depressed, irritability, trouble falling asleep or staying asleep, feeling anxious or nervous, difficulty concentrating, mood swings, - headache, dizziness, tired feeling, shaking chills, fever, flu-like symptoms, virus infection, weakness, - difficult breathing, pharyngitis (sore throat), coughing, - stomach pain, vomiting, nausea, diarrhoea, loss of appetite, loss of weight, dry mouth, - hair loss, itching, dry skin, rash, irritation or redness (and rarely, skin damage) at the site of injection, - decreases in the number of red blood cells (that may cause fatigue, shortness of breath, dizziness), decrease in certain white blood cells (that makes you more susceptible to different infections),
Icelandic: þróttleysi - öndunarerfiðleikar, kokbólga (særindi í hálsi), hósti - kviðverkur, uppköst, ógleði, niðurgangur, lystarleysi, þyngdartap, munnþurrkur - hárlos, kláði, húðþurrkur, útbrot, erting eða roði (í mjög sjaldgæfum tilfellum húðskaði) á stungustað - fækkun rauðra blóðkorna (sem getur orsakað þreytu, mæði, sundl), fækkun ákveðinna hvítra blóðkorna (sem gerir þig næmari fyrir ýmsum sýkingum) - lið- og vöðvaverkir, vöðva- og beinverkir.
English: EU/1/00/132/039 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/040 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/042 (12 pens, 12 injection needles and 24 cleansing swabs)
Icelandic: EU/1/00/132/039 (l lyfjapenni, 1 nál og 2 hreinsiþurrkur) EU/1/00/132/040 (4 lyfjapennar, 4 nálar og 8 hreinsiþurrkur) EU/1/00/132/042 (12 lyfjapennar, 12 nálar og 24 hreinsiþurrkur)
English: Gently place the needle tip against the glass wall of the vial without touching the cleaned top of the vial with your hands.
Icelandic: á ViraferonPeg hettuglasinu og beindu henni varlega að hliðum þess án þess að snerta tappann með fingrunum.
English: Each vial provides 100 micrograms/0.5 ml of solution when reconstituted as recommended.
Icelandic: Hvert hettuglas inniheldur 100 míkróg/0,5 ml lausn þegar lyfið hefur verið leyst upp samkvæmt leiðbeiningum.
English: Sarcoidosis
Icelandic: Sarklíki
English: Each pre-filled pen provides 50 micrograms/0.5 ml of solution when reconstituted as recommended.
Icelandic: Hver áfylltur penni inniheldur 50 míkróg/0,5 ml lausn þegar lyfið hefur verið leyst upp samkvæmt leiðbeiningum.
English: ViraferonPeg 120 micrograms powder for injection peginterferon alfa-2b
Icelandic: ViraferonPeg 120 míkróg stungulyfsstofn peginterferon alfa-2b s.c.
English: - hepatitis B reactivation in HCV/HBV co-infected patients (recurrence of hepatitis B disease).
Icelandic: B hjá sjúklingum með samhliða sýkingu af HCV/HBV
English: ViraferonPeg 80 micrograms powder and solvent for injection peginterferon alfa-2b
Icelandic: ViraferonPeg 80 míkróg stungulyfsstofn og leysir, lausn peginterferon alfa-2b
English: Disposal of the injection materials
Icelandic: Upplýsingar fyrir notanda lyfsins
English: Pen label - ViraferonPeg 80 micrograms powder and solvent for solution for injection in prefilled pen
Icelandic: ViraferonPeg 80 míkróg stungulyfsstofn og leysir, lausn í áfylltum lyfjapenna
English: From pre-treatment to end of long-term followup among subjects treated for 24 or 48 weeks, height-for-age percentiles decreased 1.3 and 9.0 percentiles, respectively.
Icelandic: Frá því fyrir meðferð til loka langtímaeftirfylgni var 1,3 hundraðshlutamarkslækkun hæðar miðað við aldur hjá börnum sem fengu meðferð í 24 vikur og 9,0 hundraðshlutamarkslækkun hjá þeim sem fengu meðferð í 48 vikur.
English: Powder
Icelandic: Krampar
English: EU/1/00/132/010 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/027 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Icelandic: EU/1/00/132/010 (6 hettuglös af stungulyfsstofni, 6 lykjur af leysi) EU/1/00/132/027 (12 hettuglös af stungulyfsstofni, 12 lykjur af leysi, 12 sprautur, 24 nálar og 12 hreinsiþurrkur)
English: Anorexia, decreased appetite
Icelandic: Lystarleysi, minnkuð matarlyst
English: ViraferonPeg 150 micrograms powder for injection peginterferon alfa-2b
Icelandic: ViraferonPeg 150 míkróg stungulyfsstofn peginterferon alfa-2b s.c.
English: EU/1/00/132/015 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Icelandic: EU/1/00/132/015 (6 hettuglös af stungulyfsstofni, 6 lykjur af leysi) EU/1/00/132/028 (12 hettuglös af stungulyfsstofni, 12 lykjur af leysi, 12 sprautur, 24 nálar og 12 hreinsiþurrkur)
English: Early intervention for re-emergence or development of psychiatric disorders and substance use is recommended.
Icelandic: Mælt er með því að grípa fljótt til aðgerða ef geðraskanir koma fram eða ágerast eða ef vímuefnaneysla hefst á ný.
English: Each vial provides 120 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Icelandic: Hvert hettuglas gefur 120 míkróg/0,5 ml af peginterferon alfa-2b eftir blöndun samkvæmt ráðleggingum.
English: Diabetic ketoacidosis
Icelandic: Endurvirkjun lifrarbólgu
English: Pen label - ViraferonPeg 150 micrograms powder and solvent for solution for injection in prefilled pen
Icelandic: ViraferonPeg 150 míkróg stungulyfsstofn og leysir, lausn í áfylltum lyfjapenna
English: EU/1/00/132/025 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
Icelandic: EU/1/00/132/025 (6 hettuglös af stungulyfsstofni, 6 lykjur af leysi) EU/1/00/132/030 (12 hettuglös af stungulyfsstofni, 12 lykjur af leysi, 12 sprautur, 24 nálar og 12 hreinsiþurrkur)
English: 15 SEC
Icelandic: 15 sek.