FrancophonIA/ELRC3.0 huggingface dataset:
English: Early intervention for re-emergence or development of psychiatric disorders and substance use is recommended.
Icelandic: Mælt er með því að grípa snemma til aðgerða ef geðraskanir koma fram eða ágerast eða ef vímuefnaneysla hefst á ný.
English: IntronA must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e.g., chronic obstructive pulmonary disease) or diabetes mellitus prone to ketoacidosis.
Icelandic: Gæta skal varúðar við gjöf lyfsins hjá heilsutæpum sjúklingum, t. d. hjá þeim sem þjást af lungnasjúkdómum (þ.e.a.s. langvinnum teppusjúkdómi) eða sykursýki með tilhneigingu til sýringar.
English: Respiratory, thoracic and mediastinal disorders
Icelandic: Geðræn vandamál og truflanir í miðtaugakerfi
English: Injury and poisoning Common:
Icelandic: Áverkar og eitranir Algengar:
English: Retinal haemorrhages
Icelandic: Vessandi sjónulos
English: - One mL of solution contains 10 million IU of interferon alfa-2b
Icelandic: - Einn ml af lausn inniheldur 10 milljón a.e. af interferon alfa-2b
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Icelandic: Meðganga, brjóstagjöf og frjósemi Við meðgöngu, brjóstagjöf, grun um þungun eða ef þungun er fyrirhuguð skal leita ráða hjá lækninum eða lyfjafræðingi áður en lyfið er notað.
English: Do not use if discolouration or particulate matter is present.
Icelandic: Notið ekki lausina ef hún er mislit eða inniheldur einhverjar agnir.
English: Serum levels were below the detection limit 16 and 24 hours, respectively, post-injection.
Icelandic: Sermisþéttnivar undir greinanlegum mörkum eftir annars vegar 16 klst. og hins vegar 24 klst.
English: 2.5 mL of solution (corresponding to 25 MIU) is contained in a multidose vial (type I glass) with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
Icelandic: 2,5 ml af lausn (samsvarandi 25 milljónum a.e.) er í fjölskammtahettuglasi (gler, tegund 1) með tappa (halóbútýlgúmmí) í smelluinnsigli (ál) með hettu (pólýprópýlen).
English: 1 mL of solution (corresponding to 10 MIU) is contained in a single dose vial (type I glass) with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
Icelandic: 1 ml af lausn (samsvarandi 10 milljónum a.e.) er í stakskammtahettuglasi (gler, tegund 1) með tappa (halóbútýlgúmmí) í smelluinnsigli (ál) með hettu (pólýprópýlen).
English: All patients were followed for an additional 6 months after the end of treatment for the determination of sustained virologic response.
Icelandic: Meirihluti sjúklinganna í þessum klínísku rannsóknum var meðhöndlaður í eitt ár. Öllum sjúklingunum var fylgt eftir í 6 mánuði til viðbótar eftir lok meðferðarinnar til að meta viðvarandi veirusvörun.
English: Malignant melanoma
Icelandic: Lungnasjúkdómar
English: Respiratory, thoracic and mediastinal disorders Common:
Icelandic: Öndunarfæri, brjósthol og miðmæti Mjög algengar:
English: HAART therapy (see ribavirin SPC).
Icelandic: C veiru (HCVRNA) (sjá kafla 4.4).
English: One mL of solution contains 6 million IU of interferon alfa-2b.
Icelandic: Einn ml af lausn inniheldur 6 milljónir a.e. af interferon alfa-2b.
English: 25 million IU/2.5 mL solution for injection or infusion 1 multiple dose vial
Icelandic: 25 milljónir a.e./2,5 ml stungu- eða innrennslislyf, lausn 1 fjölskammta hettuglas
English: Volume to be withdrawn according to the dose:
Icelandic: Það rúmmál sem draga skal upp miðað við skammt:
English: Malignant melanoma, induction therapy: 20 million IU/m 2, intravenously, given daily for 5 days a week for a 4 week period.
Icelandic: 20 milljónir a.e./m 2 gefið í æð daglega, 5 daga vikunnar í 4 vikur.
English: In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.
Icelandic: Ef um samsetta meðferð með ríbavírini er að ræða skal athuga sérstaklega upplýsingar um lyf sem innihalda ríbavírin.
English: Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence
Icelandic: Ofhreyfni, skjálfti, raddtruflun, náladofi, skert snertiskyn, ofskynnæmi, skert einbeiting, svefnhöfgi
English: One vial of solution for injection or infusion contains 10 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 1 mL of solution.
Icelandic: Eitt hettuglas af stungu- eða innrennslislyfi, lausn, inniheldur 10 milljónir a.e. af raðbrigða interferon alfa-2b, framleitt með rDNA-erfðatækni í E.coli með samrunaerfðatækni í 1 ml af lausn.
English: At the discretion of the physician, the patient may self-administer the dose for maintenance dose regimens administered subcutaneously.
Icelandic: öðru lyfi er nauðsynlegt að sjúklingur lesi fylgiseðil lyfsins sem nota á samhliða.
English: Chronic myelogenous leukaemia
Icelandic: Samhliða krabbameinslyfjameðferð
English: EU/1/99/127/026 12 multiple dose vials
Icelandic: EU/1/99/127/026 12 fjölskammtahettuglös
English: The mean serum interferon concentrations following subcutaneous and intramuscular injections were comparable.
Icelandic: Meðalsermisþéttni interferons eftir inndælingu undir húð og í vöðva var sambærilegur.
English: Solution for injection or infusion.
Icelandic: Stungu- eða innrennslislyf, lausn.
English: - Chronic hepatitis with decompensated cirrhosis of the liver.
Icelandic: - Langvinn lifrarbólga með skorpulifur.
English: Laboratory Tests
Icelandic: LYFJAFRÆÐILEGAR
English: HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
Icelandic: HCVarfgerð og veirumagn við upphaf meðferðar eru þeir þættir sem vitað er að hafa áhrif á hlutfall svörunarinnar.
English: HOW TO SELF INJECT INTRONA Syringe with an attached needle
Icelandic: Með því að gefa ríbavírin með IntronA allt að tífaldaðist verkun IntronA gegn langvinnri lifrarbólgu
English: One vial of solution for injection or infusion contains 25 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 2.5 mL of solution.
Icelandic: Eitt hettuglas af stungu- eða innrennslislyfi, lausn, inniheldur 25 milljónir a.e. af raðbrigða interferon alfa-2b, framleitt með rDNA-erfðatækni í E.coli með samrunaerfðatækni í 2,5 ml af lausn.
English: More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
Icelandic: Skert meðvitund og dá, þar með talin tilvik heilakvilla, hafa komið fyrir, einkum hjá eldri sjúklingum sem voru á meðferð með stórum skömmtum.
English: 10 million IU/mL solution for injection or infusion 1 single dose vial
Icelandic: 10 milljónir a.e./ml stungu- eða innrennslislyf, lausn 1 stakskammtahettuglas
English: IntronA contains less than 1 mmol sodium (23 mg) per 2.5 mL, i.e., essentially "sodium-free".
Icelandic: IntronA inniheldur minna en 1 mmól (23 mg) af natríum í 2,5 ml, þ.e.a.s. er nær natríumfrítt.
English: Relapse patients (adults)
Icelandic: Sjúklingar (fullorðnir) sem fengið hafa bakslag
English: 0.5 mL of solution (corresponding to 5 MIU) is contained in a single dose vial (type I glass) with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
Icelandic: 0,5 ml af lausn (samsvarandi 5 milljónum a.e.) er í stakskammtahettuglasi (gler, tegund 1) með tappa (halóbútýlgúmmí) í smelluinnsigli (ál) með hettu (pólýprópýlen).
English: EU/1/99/127/023 1 multiple dose vial
Icelandic: EU/1/99/127/023 1 fjölskammtahettuglas
English: Select the injection site.
Icelandic: Veljið stungustað.
English: IntronA 18 million IU/3 mL solution for injection or infusion Interferon alfa-2b
Icelandic: IntronA 18 milljónir a.e./3 ml stungu- eða innrennslislyf, lausn interferon alfa-2b
English: Clinical experience indicates that a haematological and cytogenetic major/minor response is obtainable in the majority of patients treated.
Icelandic: Klínísk reynsla sýnir að meirihluti meðhöndlaðra sjúklinga nær meiri/minni blóð- og frumusvörun.
English: In patients treated for malignant melanoma, liver function and white blood cell (WBC) count and differential must be monitored weekly during the induction phase of therapy and monthly during the maintenance phase of therapy.
Icelandic: Fylgjast verður vikulega með lifrarstarfsemi og hvítum blóðkornum ásamt deilitalningu á meðan sjúklingar eru í meðferð við illkynja sortuæxli, en mánaðarlega þegar sjúklingar eru í viðhaldsmeðferð.
English: Genotype 1  2 million copies/mL Genotype 1 > 2 million copies/mL
Icelandic: Arfgerð 1 > 2 milljónir eintaka/ml
English: Vertigo, tinnitus Hearing loss, hearing disorder
Icelandic: Svimi, eyrnasuð Heyrnarleysi, truflanir á heyrn
English: Fungal infection, bacterial infection, pulmonary infection, otitis media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis
Icelandic: Sveppasýking, bakteríusýking, lungnasýking, miðeyrnabólga, tannígerð, herpes simplex, þvagfærasýking, leggangaþroti, maga- og garnabólga
English: IntronA (3 MIU TIW) + ribavirin
Icelandic: IntronA (3 milljónir a.e. þrisvar í viku) + ríbavírin
English: Arthralgia, myalgia, musculoskeletal pain
Icelandic: Rákvöðvalýsa, vöðvaþroti, sinadráttur, bakverkur
English: One vial of solution for injection or infusion contains 3 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 0.5 mL of solution.
Icelandic: Eitt hettuglas af stungu- eða innrennslislyfi, lausn, inniheldur 3 milljónir a.e. af raðbrigða interferon alfa-2b, framleitt með rDNA-erfðatækni í E.coli með samrunaerfðatækni í 0,5 ml af lausn.
English: IntronA contains less than 1 mmol sodium (23 mg) per 0.5 mL, i.e., essentially "sodium-free".
Icelandic: IntronA inniheldur minna en 1 mmól (23 mg) af natríum í 0,5 ml, þ.e.a.s. er nær natríumfrítt.
English: 12 multiple dose vials, 72 injection syringes of 1 mL, 72 injection needles and 144 cleansing swabs 12 multiple dose vial, 72 injection syringes with attached needle and needle protection device of 1 mL and 144 cleansing swabs
Icelandic: 12 fjölskammtahettuglös, 72 x 1 ml sprautur, 72 sprautunálar og 144 hreinsiþurrkur 12 fjölskammtahettuglös, 72 x 1 ml sprautur með áfastri nál og nálarvörn og 144 hreinsiþurrkur
English: If thyroid abnormalities are detected, the patient's thyroid status should be evaluated and treated as clinically appropriate.
Icelandic: Við óeðlilega starfsemi skjaldkirtils skal meta ástand hans og hefja viðeigandi klíníska meðferð.
English: 0.5 mL of solution (corresponding to 3 MIU) is contained in a single dose vial (type I glass) with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
Icelandic: 0,5 ml af lausn (samsvarandi 3 milljónum a.e.) er í stakskammtahettuglasi (gler, tegund 1) með tappa (halóbútýlgúmmí) í smelluinnsigli (ál) með hettu (pólýprópýlen).
English: Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking IntronA in combination with ribavirin.
Icelandic: Kvenkyns sjúklingar eða konur karlkyns sjúklinga, sem eru á samsettri meðferð með IntronA og ríbavírini, verða að gæta þess mjög vel að verða ekki þungaðar.
English: Multiple myeloma: 3 million IU/m 2, 3 times a week (every other day) injected subcutaneously (under the skin).
Icelandic: Mergæxli: 3 milljónir a.e./m 2, þrisvar í viku (annan hvern dag) undir húð.
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: c: sjúklingar með arfgerð 3 og lítið veirumagn (< 600.000 a.e./ml) fengu
English: IntronA is administered subcutaneously at a dose of 3 million IU three times a week (every other day) to adult patients, whether administered as monotherapy or in combination with ribavirin.
Icelandic: Hjá fullorðnum er gefinn 3 milljónir a.e.skammtur af IntronA þrisvar í viku undir húð (annan hvern dag), hvort sem lyfið er gefið eitt sér eða með ríbavírini.
English: Depression, insomnia, anxiety, emotional lability*, agitation, nervousness
Icelandic: Þunglyndi, svefnleysi, kvíði, tilfinningalegur óstöðugleiki*, uppnám, taugaóstyrkur Ringlun, svefntruflanir, minnkuð kynhvöt Sjálfsvígshugmyndir
English: Collect necessary items before you begin: - a vial of IntronA solution for injection; - a syringe (for example 2 mL); - a needle for the subcutaneous injection (for example 0.4 x 13 mm [27 gauge 0.5 inch]); - a cleansing swab.
Icelandic: Hafið allt sem til þarf við höndina áður en byrjað er: - hettuglas með IntronA stungulyfi; - 2 ml sprautu; - nál til inndælingar undir húð (t.d. 0,4 x 13 mm [27 gauge 0,5 tomma]); - hreinsiþurrku.
English: One mL of solution contains 10 million IU of interferon alfa-2b.
Icelandic: Einn ml af lausn inniheldur 10 milljónir a.e. af interferoni alfa-2b.
English: Carcinoid tumour Treatment of carcinoid tumours with lymph node or liver metastases and with "carcinoid syndrome".
Icelandic: Silfurfrumuæxli (carcinoid tumour) Meðhöndlun á silfurfrumuæxlum með meinvörpum í eitlum eða lifur og heilkenni silfurfrumuæxlis.
English: EU/1/99/127/027 1 multiple dose vial
Icelandic: EU/1/99/127/027 1 fjölskammtahettuglas
English: One vial of solution for injection or infusion contains 5 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 0.5 mL of solution.
Icelandic: Eitt hettuglas af stungu- eða innrennslislyfi, lausn, inniheldur 5 milljónir a.e. af raðbrigða interferon alfa-2b, framleitt með rDNA-erfðatækni í E.coli með samrunaerfðatækni í 0,5 ml af lausn.
English: Relapse patients
Icelandic: Heilsutæpir sjúklingar
English: 5 million IU/0.5 mL solution for injection or infusion 1 single dose vial
Icelandic: 5 milljónir a.e./0,5 ml stungu- eða innrennslislyf, lausn 1 stakskammtahettuglas
English: Photosensitivity reaction, maculopapular rash, eczema, acne, skin disorder, nail disorder, skin discolouration, pruritus, dry skin, erythema, bruise, sweating increased
Icelandic: Aukið ljósnæmi, dröfnuörðuútbrot, exem, þrymlabólur, húðkvilli, naglakvilli, mislitun húðar, kláði, þurr húð, roðaþot, mar, aukin svitamyndun
English: Table 1 Adverse reactions reported during clinical trials or following the marketing use of IntronA alone or in combination with ribavirin
Icelandic: Aukaverkanir eftir notkun IntronA eins og sér eða í samsettri meðferð með ríbavírini sem greint var frá í klínískum rannsóknum eða eftir markaðssetningu
English: Possible side effects listed below are grouped by frequency of occurrence: Very common (affects more than 1 user in 10) Common
Icelandic: Hugsanlegar aukaverkanir sem nefndar eru hér fyrir neðan eru flokkaðar eftir tíðni:
English: Sarcoidosis, exacerbation of sarcoidosis Systemic lupus erythematosus, vasculitis, rheumatoid arthritis (new or aggravated), Vogt-Koyanagi-Harada syndrome, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Icelandic: Sarklíki, versnun sarklíkis Rauðir úlfar, æðabólga, iktsýki (nýtilkomin eða versnandi), VogtKoyanagi-Harada-heilkenni, bráð ofnæmisviðbrögð m.a. ofsakláði, ofnæmisbjúgur, berkjuþrengingar, alvarlegt bráðaofnæmi
English: §, flu-like symptoms
Icelandic: § (cotton-wool spots)
English: - One mL of solution contains 6 million IU of interferon alfa-2b.
Icelandic: - Einn ml af lausn inniheldur 6 milljón a.e. af interferon alfa-2b
English: See ribavirin SPC for ribavirin-related undesirable effects if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Icelandic: Sjá samantekt á eiginleikum ríbavírins varðandi aukaverkanir sem tengjast ríbavírini ef gefa á sjúklingum með langvinna lifrarbólgu
English: Very rarely: Not known:
Icelandic: Aukaverkanir sem mjög sjaldan er tilkynnt um:
English: What is in this leaflet
Icelandic: Aukaverkanir á augu
English: Pack of 2 vials, 12 injection syringes with attached needle of 1 mL and 24 cleansing swabs Pack of 12 vials
Icelandic: - Pakkning með 2 hettuglösum, 12 x 1 ml sprautum með áfastri nál og 24 hreinsiþurrkum
English: IntronA contains less than 1 mmol sodium (23 mg) per 3 mL, i.e., essentially "sodium-free".
Icelandic: IntronA inniheldur minna en 1 mmól (23 mg) af natríum í 3 ml, þ.e.a.s. er nær natríumfrítt.
English: IntronA 10 MIU
Icelandic: IntronA 10 milljónir a.e.
English: Pack of 1 vial, 6 injection syringes with attached needle of 1 mL and 12 cleansing swabs Pack of 2 vials
Icelandic: - Pakkning með 1 hettuglasi, 6 x 1 ml sprautum með áfastri nál og 12 hreinsiþurrkum
English: 3 million IU/0.5 mL solution for injection or infusion 1 single dose vial
Icelandic: 3 milljónir a.e./0,5 ml stungu- eða innrennslislyf, lausn 1 stakskammtahettuglas
English: IntronA 10 million IU/mL solution for injection or infusion Interferon alfa-2b
Icelandic: IntronA 10 milljónir a.e./ml stungu- eða innrennslislyf, lausn Interferon alfa-2b
English: IntronA 10 million IU/mL solution for injection or infusion interferon alfa-2b
Icelandic: IntronA 10 milljónir a.e./ml stungu- eða innrennslislyf, lausn interferon alfa-2b
English: EU/1/99/127/025 2 multiple dose vials
Icelandic: EU/1/99/127/025 2 fjölskammtahettuglös
English: EU/1/99/127/044 12 multiple dose vials, 72 injection syringes of 1 mL, 72 injection needles and 144 cleansing swabs
Icelandic: EU/1/99/127/053 12 fjölskammtahettuglös, 72 x 1 ml sprautur með áfastri nál og 144 hreinsiþurrkur
English: Hypertriglyceridemia
Icelandic: Natríumklóríð
English: Dilute prior to intravenous use.
Icelandic: Blöndun IntronA til innrennslis:
English: 1 single dose vial, 1 injection syringe of 2 mL, 1 injection needle and 1 cleansing swab 6 single dose vials, 6 injection syringes of 2 mL, 6 injection needles and 6 cleansing swabs 12 single dose vials, 12 injection syringes of 2 mL, 12 injection needles and 12 cleansing swabs
Icelandic: 1 stakskammtahettuglas, 1 x 2 ml sprauta, 1 sprautunál og ein hreinsiþurrka 6 stakskammtahettuglös, 6 x 2 ml sprautur, 6 sprautunálar og 6 hreinsiþurrkur 12 stakskammtahettuglös, 12 x 2 ml sprautur, 12 sprautunálar og 12 hreinsiþurrkur
English: - Autoimmune hepatitis; or history of autoimmune disease; immunosuppressed transplant recipients.
Icelandic: - Sjálfsnæmislifrarbólga eða saga um annan sjálfsnæmissjúkdóm.
English: Epistaxis, respiratory disorder, nasal congestion, rhinorrhea, cough nonproductive Pulmonary infiltrates
Icelandic: Blóðnasir, öndunarfæratruflanir, nefstífla, nefrennsli, hósti án uppgangs Lungnaíferð
English: With one hand, pinch a fold of loose skin.
Icelandic: Takið um húðfellingu með annarri hendinni.
English: Carcinoid tumour: 5 million IU, 3 times a week (every other day) injected subcutaneously (under the skin).
Icelandic: Viðbótarmeðferð við krabbameinslyfjameðferð: 5 milljónir a.e. þrisvar í viku (annan hvern dag) undir húð.
English: Included are hairy cell leukaemia, chronic myelogenous leukaemia, multiple myeloma, follicular lymphoma, carcinoid tumour, and malignant melanoma.
Icelandic: Þessir sjúkdómar geta m.a. verið hárfrumuhvítblæði, langvinnt kyrningahvítblæði, mergæxli, hnútótt eitilfrumukrabbamein, silfurfrumuæxli og illkynja sortuæxli.
English: 2 multiple dose vials, 12 injection syringes of 1 mL, 12 injection needles and 24 cleansing swabs 2 multiple dose vials, 12 injection syringes with attached needle and needle protection device of 1 mL and 24 cleansing swabs
Icelandic: 2 fjölskammtahettuglös, 12 x 1 ml sprautur, 12 sprautunálar og 24 hreinsiþurrkur 2 fjölskammtahettuglös, 12 x 1 ml sprautur með áfastri nál og nálarvörn og 24 hreinsiþurrkur 12 fjölskammtahettuglös
English: Do not massage the injection site.
Icelandic: Nuddið ekki stungustaðinn.
English: Therefore, the combination of IntronA with telbivudine is contraindicated.
Icelandic: Því má ekki nota IntronA í samsettri meðferð með telbivúdíni.
English: Dizziness, headache, concentration impaired, mouth dry Tremor, paresthesia, hypoesthesia, migraine, flushing, somnolence, taste perversion
Icelandic: Skjálfti, náladofi, skert snertiskyn, mígreni, húðroði, svefnhöfgi, breytt bragðskyn Úttaugakvilli
English: IntronA alone or in combination with ribavirin has been studied in 4 randomised Phase III clinical trials in 2,552 interferon-naïve patients with chronic hepatitis C. The trials compared the efficacy of IntronA used alone or in combination with ribavirin.
Icelandic: Í sjaldgæfum tilvikum hefur starfsemi skjaldkirtils raskast, annaðhvort of- eða vanstarfsemi, hjá fullorðnum sjúklingum í IntronA-meðferð við langvinnri lifrarbólgu C. Í klínískum rannsóknum, þar sem IntronA var gefið, kom í ljós óeðlileg starfsemi skjaldkirtils hjá 2,8% sjúklinga.
English: IntronA contains less than 1 mmol sodium (23 mg) per 1 mL, i.e., essentially "sodium-free".
Icelandic: IntronA inniheldur minna en 1 mmól (23 mg) af natríum í 1 ml, þ.e.a.s. er nær natríumfrítt.
English: Based on the results of clinical trials, in which data are available for 6 months of treatment, it is recommended that patients be treated with IntronA in combination with ribavirin for 6 months.
Icelandic: Mælt er með að sjúklingar séu meðhöndlaðir með IntronA og ríbavírini í 6 mánuði og byggist það á niðurstöðum klínískra rannsókna, en gögn úr þeim liggja fyrir eftir 6 mánaða meðferð.
English: EU/1/99/127/011 1 single dose vial
Icelandic: EU/1/99/127/011 1 stakskammtahettuglas
English: 1 single dose vial, 1 injection syringe of 1 mL, 1 injection needle and 1 cleansing swab 6 single dose vials, 6 injection syringes of 1 mL, 6 injection needles and 6 cleansing swabs 12 single dose vials, 12 injection syringes of 1 mL, 12 injection needles and 12 cleansing swabs
Icelandic: 1 stakskammtahettuglas, 1 x 1 ml sprauta, 1 sprautunál og ein hreinsiþurrka 6 stakskammtahettuglöss, 6 x 1 ml sprautur, 6 sprautunálar og 6 hreinsiþurrkur 12 stakskammtahettuglös, 12 x 1 ml sprautur, 12 sprautunálar og 12 hreinsiþurrkur
English: §, malaise, irritability Chest pain, asthenia, oedema, injection site pain
Icelandic: §, lasleiki, erting Brjóstverkur, slen, bjúgur, verkur á stungustað
English: Not known
Icelandic: Ástæðan er ekki þekkt.
English: IntronA 25 million IU/2.5 mL solution for injection or infusion interferon alfa-2b
Icelandic: IntronA 25 milljón a.e./2,5 ml stungu- eða innrennslislyf, lausn interferon alfa-2b
English: Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of DNA of hepatitis B virus (HBV-DNA) and hepatitis B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis.
Icelandic: Meðhöndlun fullorðinna sjúklinga sem eru með langvinna lifrarbólgu B, sem hafa merki um lifrarbólgu B veirufjölgun (jákvæðir fyrir DNA lifrarbólgu
English: Any thyroid abnormality detected at that time must be treated with conventional therapy.
Icelandic: Meðhöndla skal alla óeðlilega starfsemi skjaldkirtils, sem kemur í ljós, með hefðbundinni meðferð.
English: Musculoskeletal and connective tissue disorders Very common:
Icelandic: Sýkingar af völdum sýkla og sníkjudýra Mjög algengar:
English: HOW TO SELF INJECT INTRONA Syringe with an attached needle and a needle protection device
Icelandic: Sprauta með áfastri nál og nálarvörn
English: The vial and injection materials intended for single use must be discarded.
Icelandic: Farga verður einnota hettuglasi og öllum einnota búnaði sem notaður hefur verið til inndælingar.
English: CLINICAL PARTICULARS
Icelandic: c: einstaklingar
English: §, retinopathies (including macular oedema), retinal artery or vein obstruction
Icelandic: B veiru (HBV-DNA) og mótefnisvaka lifrarbólgu
English: Viral infection, pharyngitis
Icelandic: Höfuðverkur, sundl
English: What IntronA contains
Icelandic: IntronA inniheldur
English: Remove the cap from the vial.
Icelandic: Takið sprautuna úr umbúðunum.