FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, statistically and clinically significant improvements in quality of life and height, as well as a significant reduction in corticosteroid use, were observed versus baseline.
Icelandic: Auk þess komu fram tölfræðilega og klínískt marktækt bætt lífsgæði og aukin hæð, sem og marktækt minni notkun barkstera miðað við það sem sást við upphaf rannsóknarinnar.
English: Percentage of subjects with mucosal healing Mucosal healing at week 8
Icelandic: Hundraðshluti sjúklinga með slímhúðargræðslu Slímhúðargræðsla eftir 8 vikur
English: All patients received an induction regimen of 5 mg/kg infliximab at weeks 0, 2, and 6.
Icelandic: Allir sjúklingar fengu byrjunarmeðferð með 5 mg/kg af infliximabi í viku 0, 2 og 6.
English: Results from week 54 are shown in Table 4.
Icelandic: 54 eru sýndar í töflu
English: It is recommended that therapeutic infectious agents not be given concurrently with Remicade (see section 4.4).
Icelandic: Ekki skal gefa sýkingavalda sem ætlaðir eru til meðferðar samhliða Remicade (sjá kafla 4.4).
English: Immune system disorder
Icelandic: Sýkingar vegna veiklaðs ónæmiskerfis
English: • Signs of low blood counts such as persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Icelandic: Einkenni lágra blóðgilda eins og þrálátur hiti, blæðing, marblettir, litlir rauðir eða purpurarauðir blettir undir húð eða fölvi.
English: 3 mg/kg q 8 wks
Icelandic: 3 mg/kg q 8 vikur
English: Date of Remicade therapy initiation:
Icelandic: Dagsetning þegar Remicade meðferð hófst:
English: Symptoms included, but were not limited to, dyspnea, urticaria, facial oedema, and hypotension.
Icelandic: Einkennin voru m.a., þó ekki eingöngu, andnauð, ofsakláði, andlitsbjúgur og lágþrýstingur.
English: All infliximab
Icelandic: Allir infliximab
English: Nervous system disease
Icelandic: Klínískt sjúkdómshlé
English: Renal and/or hepatic impairment
Icelandic: Nýrna- og/eða lifrarskerðing
English: Some of the cases have resulted in a fatal outcome.
Icelandic: Sum tilfellin hafa leitt til dauða.
English: Maintenance therapy with infliximab every 8 weeks significantly reduced disease-related hospitalisations and surgeries compared with placebo.
Icelandic: 8. hverja viku dró marktækt úr sjúkdómstengdum sjúkrahúsinnlögnum og skurðaðgerðum í samanburði við lyfleysu.
English: Patients did not receive any concomitant immunosuppressant therapy.
Icelandic: Engin ónæmisbælandi meðferð var gefin samhliða.
English: IV
Icelandic: n
English: Rare: Apathy.
Icelandic: Sinnuleysi (apathy)
English: • Serious lung problems (such as interstitial lung disease)
Icelandic: Alvarlegir lungnasjúkdómar (t.d. millivefslungnasjúkdómur)
English: • Bleeding in the stomach or intestines, diarrhoea, indigestion, heartburn, constipation
Icelandic: Blæðingar í maga eða þörmum, niðurgangur, meltingartruflanir, brjóstsviði, hægðatregða
English: Rare: Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis).
Icelandic: Millivefslungnabólga, (þ.m.t. mjög ágengur sjúkdómur, bandvefsmyndun í lungum og lungnabólga)
English: Low blood counts
Icelandic: Áhrif á blóð
English: The safety and efficacy of Remicade in children and adolescents younger than 18 years for the indication of psoriasis have not been established.
Icelandic: Ekki hefur enn verið sýnt fram á öryggi og verkun Remicade hjá börnum og unglingum yngri en 18 ára við ábendingunni sóra.
English: Signs include a fever, feeling tired, (persistent) cough, shortness of breath, weight loss, night sweats, diarrhea, wounds, dental problems, burning when urinating or ‘flu-like' signs.
Icelandic: Einkennin geta verið hiti, þreyta, (þrálátur) hósti, mæði, þyngdartap, nætursviti, niðurgangur, sár, tannkvillar, sviðatilfinning við þvaglát eða flensulík einkenni.
English: Infections were reported more frequently for subjects who received q8 week as opposed to q12 week infusions (73.6% and 38.0%, respectively), while serious infections were reported for 3 subjects in the q8 week and 4 subjects in the q12 week maintenance treatment group.
Icelandic: Oftar var greint frá sýkingum hjá þeim sem fengu innrennsli á 8 vikna fresti (73,6%) en þeim sem fengu innrennsli á 12 vikna fresti (38%), en greint var frá alvarlegum sýkingum hjá
English: This evaluation should include colonoscopy and biopsies per local recommendations.
Icelandic: Þetta mat á að taka til ristilspeglunar og vefsýnatöku í samræmi við gildandi leiðbeiningar.
English: Remicade should be administered
Icelandic: Remicade er gefið
English: Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Remicade.
Icelandic: Segðu lækninum samstundis frá því ef þú færð ný einkenni eða versnun einkenna hjartabilunar meðan á meðferð með Remicade stendur.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Icelandic: Ekki má blanda þessu lyfi saman við önnur lyf þar sem rannsóknir á ósamrýmanleika hafa ekki verið gerðar.
English: If adequate response is achieved, patients should be continued on the selected dose or dose frequency.
Icelandic: Náist fullnægjandi svörun á sjúklingurinn að halda áfram á sömu skömmtum eða skammtatíðni.
English: A patient who requires surgery while on Remicade should be closely monitored for infections, and appropriate actions should be taken.
Icelandic: Fylgjast verður náið með sjúklingi sem þarf á skurðaðgerð að halda, með tilliti til sýkinga og grípa skal til viðeigandi aðgerða.
English: Ulcerative colitis (6 to 17 years)
Icelandic: Sáraristilbólga (6 til 17 ára)
English: Patients treated with Remicade should be given the package leaflet and the patient reminder card.
Icelandic: Afhenda skal sjúklingum sem eru í meðferð með Remicade, fylgiseðil og áminningarkort sjúklings.
English: Antinuclear antibodies (ANA)/Anti-double-stranded DNA (dsDNA) antibodies Approximately half of infliximab-treated patients in clinical studies who were ANA negative at baseline developed a positive ANA during the study compared with approximately one fifth of placebo-treated patients.
Icelandic: Um það bil helmingur sjúklinga, sem meðhöndlaðir voru með infliximabi í klínískum rannsóknum og voru ANA neikvæðir í byrjun mynduðu jákvætt ANA meðan á rannsókninni stóð samanborið við um það bil einn fimmta sjúklinga sem fengu lyfleysu.
English: • Psoriasis.
Icelandic: B veiru.
English: Cases of malignancies, including lymphoma, have also been reported in the post-marketing setting (see section 4.4).
Icelandic: Eftir markaðssetningu hefur einnig verið greint frá tilfellum illkynja sjúkdóma, þ.á m. eitilæxli (sjá kafla 4.4).
English: • The medicine will be given as an infusion (drip) (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor may decide to give your dose of Remicade over 1 hour.
Icelandic: Lyfið er gefið með innrennsli (dreypi) (á 2 klukkustundum) í bláæð, venjulega í handlegginn.
English: Sustained remission (in remission at both week 8 and week 30)
Icelandic: Varanleg svörun (klínísk svörun bæði eftir 8 og
English: Patients received either 3 or 5 mg/kg infliximab or placebo infusions at weeks 0, 2 and 6.
Icelandic: 3 eða 5 mg/kg af infliximab eða lyfleysu innrennsli í viku 0, 2 og 6.
English: Patients assessed by the investigator to be in clinical response at week 10 were randomised and received 5 mg/kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen.
Icelandic: 10 samkvæmt rannsóknaraðilanum voru valdir með slembivali og fengu 5 mg/kg af infliximabi sem viðhaldsmeðferð annaðhvort á 8 eða 12 vikna fresti.
English: Beginning at week 22, patients who initially responded to treatment and subsequently lost their response were eligible to cross over to active re-treatment every 8 weeks at a dose of infliximab 5 mg/kg higher than the dose to which they were originally randomised.
Icelandic: Sjúklingar sem svöruðu meðferð í upphafi og svörun féll síðan niður voru hæfir til að skipta yfir í virka endurmeðferð 8. hverja viku með byrjun í viku
English: • Circulation problems such as low or high blood pressure
Icelandic: Blóðrásarkvillar, t.d. lágur eða hár blóðþrýstingur
English: 4 vials 100 mg
Icelandic: 4 hettuglös 100 mg
English: Radiographs of hands and feet were collected at baseline, weeks 24 and 54.
Icelandic: Breytingar á röntgenmyndum voru metnar í IMPACT 2. Röntgenmynd af höndum og fótum við upphaf rannsóknar, í viku 24 og 54 var safnað saman.
English: • Pain in the joints, muscles or back
Icelandic: Liðverkir, vöðvaverkir eða bakverkir
English: • Inflamed liver caused by a problem with the immune system (autoimmune hepatitis)
Icelandic: Bólga í lifur af völdum ónæmiskerfis (sjálfsnæmislifrarbólga)
English: Immunogenicity Antibodies to infliximab were detected in 3 (2.9%) paediatric patients.
Icelandic: Mótefnamyndun 3 börn (2,9%) mynduðu mótefni gegn infliximabi.
English: Fistulising Crohn's disease
Icelandic: Fistilmyndandi Crohns sjúkdómur
English: 3 mg/kg given as an intravenous infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Icelandic: 3 mg/kg gefið sem innrennsli í bláæð fylgt eftir með 3 mg/kg viðbótar innrennslisskammti, 2 og 6 vikum eftir fyrsta innrennslið, síðan 8. hverja viku þar á eftir.
English: Common: Conjunctivitis.
Icelandic: Samanburðarhópur =
English: The median AUCss in paediatric patients aged 2 years to less than 6 years was predicted to be approximately 40% lower than that in adults, although the number of patients supporting this estimate is limited.
Icelandic: 40% lægra en hjá fullorðnum, enda þótt áætlað sé út frá takmörkuðum fjölda sjúklinga.
English: For intravenous use after reconstitution and dilution.
Icelandic: Til notkunar í bláæð eftir að lyfið hefur verið leyst upp og þynnt
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.
Icelandic: Íhuga skal vandlega hvort halda eigi áfram meðferð hjá sjúklingum sem sýna engan árangur af meðferð eftir að skömmtum hefur verið breytt.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including infliximab, who are chronic carriers of this virus.
Icelandic: B hefur komið fyrir hjá sjúklingum sem eru langvinnir berar veirunnar og nota TNF-hemla, þ.m.t. infliximab.
English: No major age- or weight-related differences in clearance or volume of distribution were observed in rheumatoid arthritis patients.
Icelandic: Enginn meiriháttar mismunur sem tengdist aldri eða líkamsþyngd kom fram á úthreinsun eða dreifingarrúmmáli lyfsins hjá sjúklingum með iktsýki.
English: • Lung or chest infections such as bronchitis or pneumonia
Icelandic: Sýkingar í lungum eða brjósti t.d. berkjubólga eða lungnabólga
English: ACR 20 response* 5(10%) 34 (65%) 48 (62%) 16 (16%) 54 (54%) 53 (53%) ACR 50 response* 0(0%) 24 (46%) 35 (45%) 4 (4%) 41(41%) 33 (33%) ACR 70 response* 0(0%) 15 (29%) 27 (35%) 2 (2%) 27 (27%) 20 (20%) PASI response
Icelandic: ACR 20 svörun* 5(10%) ACR 50 svörun* 0(0%) ACR 70 svörun* 0(0%) PASI svörun (% sjúklinga)
English: Adult psoriasis
Icelandic: Sóraliðagigt hjá fullorðnum
English: Infections
Icelandic: Sjúkdómur
English: • You may get infections more easily when you are being treated with Remicade.
Icelandic: Þú ert í meiri hættu á að fá sýkingar meðan á meðferð með Remicade stendur.
English: Heart failure
Icelandic: Hjartaáfall
English: The safety and efficacy of Remicade have not been studied in children with ulcerative colitis below the age of 6 years.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun Remicade hjá börnum yngri en 6 ára með sáraristilbólgu.
English: • A statement that the brand name and batch number should be recorded
Icelandic: Yfirlýsing um að skrá eigi vörumerkið og lotunúmerið.
English: PHARMACEUTICAL PARTICULARS
Icelandic: Sértækar rannsóknir
English: At week 24, all placebo-treated patients crossed over to infliximab induction.
Icelandic: 24 var skipt yfir í infliximab meðferð hjá öllum sjúklingunum í lyfleysuhópnum.
English: Common: Chest pain, fatigue, fever, injection site reaction, chills, oedema.
Icelandic: Innrennslistengd viðbrögð, verkur Algengar: Brjóstverkur, þreyta, hiti, viðbrögð á stungustað, kuldahrollur, bjúgur
English: Each vial contains 100 mg of infliximab.
Icelandic: Hvert hettuglas inniheldur 100 mg af infliximab.
English: Rare: Endophthalmitis.
Icelandic: Dofi eða náladofi.
English: • Narrowed airway in the lungs, causing difficulty breathing
Icelandic: Þrenging í loftvegum lungna sem veldur
English: If a patient does not respond after 2 doses, no additional treatment with infliximab should be given.
Icelandic: Ef sjúklingur sýnir ekki svörun eftir 2 skammta, á ekki að gefa áframhaldandi meðferð með infliximabi.
English: Common: Hepatic function abnormal, transaminases increased.
Icelandic: Óeðlileg lifrarstarfsemi, hækkun lifrartransamínasa
English: • Temporary loss of sight during or within 2 hours of infusion
Icelandic: Tímabundið sjóntap sem kemur fram meðan á innrennslisgjöf stendur eða innan 2 klukkustunda eftir innrennslisgjöf
English: • Blood problems such as anaemia or low white blood cell count
Icelandic: Blóðsjúkdómar, t.d. blóðleysi eða of fá hvít blóðkorn
English: Each Remicade vial contains 100 mg infliximab.
Icelandic: Hvert Remicade hettuglas inniheldur 100 mg af infliximabi.
English: 2 vials 100 mg
Icelandic: 2 hettuglös 100 mg
English: • A type of blood cancer (lymphoma)
Icelandic: Krabbamein í blóði (eitilæxli)
English: Current administrations:
Icelandic: Núverandi lyfjagjöf:
English: 3 vials 100 mg
Icelandic: 3 hettuglös 100 mg
English: Invasive fungal infections
Icelandic: Ofnæmiseinkenni í öndunarfærum
English: After reconstitution each ml contains 10 mg of infliximab.
Icelandic: Eftir blöndun inniheldur hver ml 10 mg af infliximabi.
English: The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1100 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Icelandic: 1.100 þungunum með útsetningu fyrstu þrjá mánuðina, benda ekki til aukinnar tíðni vanskapana hjá nýburum.
English: • You have heart failure that is moderate or severe.
Icelandic: Ef þú ert með í meðallagi alvarlega eða alvarlega hjartabilun.
English: If you have active psoriatic arthritis you will first be given other medicines.
Icelandic: Ef þú ert með virka sóraliðagigt, munt þú fyrst fá önnur lyf.
English: The most common adverse event was worsening of ulcerative colitis, the incidence of which was higher in patients on the q12 week vs. the q8 week dosing regimen.
Icelandic: Algengasta aukaverkunin var versnun sáraristilbólgu, en tíðni hennar var hærri hjá sjúklingum sem fengu meðferð á 12 vikna fresti en hjá þeim sem fengu meðferð á 8 vikna fresti.
English: Common: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
Icelandic: Nýtilkomin eða versnandi tilvik sóra m.a. sóri með graftarbólum (aðallega í lófum og á iljum), ofsakláði, útbrot, kláði, ofsviti, þurr húð, húðbólga vegna sveppasýkingar, exem, hárlos
English: What is in this leaflet:
Icelandic: Fyrir blöndun:
English: Test
Icelandic: Próf:
English: Patients should be advised of and avoid exposure to potential risk factors for infection as appropriate.
Icelandic: Upplýsa á sjúklinga um mögulega áhættuþætti sýkinga og þeir ættu að forðast þá eins og við á.
English: • You should receive recommended vaccinations before starting Remicade treatment.
Icelandic: Þú átt að fá ráðlagðar bólusetningar áður en meðferð með Remicade er hafin.
English: During clinical studies of Remicade across all approved indications the incidence of lymphoma in Remicade-treated patients was higher than expected in the general population, but the occurrence of lymphoma was rare.
Icelandic: Remicade meðferð hærri en vænta má hjá almennu þýði, en tilvik eitilæxla voru mjög sjaldgæf.
English: Common: may affect up to 1 in 10 people
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum)
English: Ankylosing spondylitis is an inflammatory disease of the spine.
Icelandic: Hryggikt er bólgusjúkdómur í hryggnum.
English: Table 5 Effects on response and remission rate, data from ACCENT I (week-2 responders) ACCENT I (week-2 responders) % of Patients
Icelandic: ACCENT I (Sjúklingar sem sýndu svörun eftir 2 vikur) % Sjúklinga
English: In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Remicade (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Icelandic: Hjá vandlega völdum fullorðnum sjúklingum sem hafa þolað að minnsta kosti 3 fyrstu 2-klst.
English: If you have ankylosing spondylitis you will first be given other medicines.
Icelandic: Ef þú ert með hryggikt, munt þú fyrst fá önnur lyf.
English: AZA was given at a dose of 2.5 mg/kg daily.
Icelandic: Gefinn var 2,5 mg/kg skammtur af AZA á sólarhring.
English: • Inflamed lining of the lung, causing sharp chest pains that feel worse with breathing (pleurisy)
Icelandic: Bólga í himnu innan í lungum sem veldur stingandi verkjum sem versna við öndun
English: Subjects randomised
Icelandic: Ífarandi sveppasýkingar
English: Paediatric ulcerative colitis
Icelandic: Hryggikt Sóraliðagigt Skellusóri
English: • Slow down the damage in your joints
Icelandic: Hægja á skemmdum í liðum.
English: Tell your doctor straight away if you get symptoms of low blood counts during treatment with Remicade.
Icelandic: Segðu lækninum samstundis frá ef þú færð einkenni lágra blóðgilda meðan á meðferð með Remicade stendur.
English: Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Remicade.
Icelandic: Segðu lækninum strax frá því ef þú færð einkenni taugasjúkdóms meðan á meðferð með Remicade stendur.
English: • These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria, or other organisms in the environment and sepsis that may be life-threatening.
Icelandic: sveppa, baktería, eða annara lífvera í umhverfinu og blóðsýking sem getur verið lífshættuleg.
English: • Eye problems, including red eyes and infections
Icelandic: Augnkvillar þ.á m. roði í augum og sýkingar
English: Control
Icelandic: Yfirlið
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind, pivotal clinical studies: ATTRACT and ASPIRE.
Icelandic: Verkun infliximabs var metin í tveimur fjölsetra, slembiúrtaks, tvíblindum klínískum grundvallarrannsóknum:
English: There have been reports of active tuberculosis in patients receiving Remicade.
Icelandic: Greint hefur verið frá virkum berklum hjá sjúklingum sem fengu Remicade.
English: Common: Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis.
Icelandic: Sýking í neðri öndunarvegi (t.d. berkjubólga, lungnabólga), mæði, blóðnasir
English: Psychiatric disorders
Icelandic: Taugasjúkdómar
English: • Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur (see
Icelandic: Innrennsli af 5 mg/kg ef einkenni sjúkdómsins taka sig upp og síðan 5 mg/kg
English: 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks.
Icelandic: 5 mg/kg gefið sem innrennsli í bláæð og fylgt eftir með viðbótar 5 mg/kg innrennslisskammti 2 og 6 vikum eftir fyrsta innrennsli, síðan 6. til 8. hverja viku.
English: Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥ 220 ≤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Icelandic: Infliximab með eða án AZA var metið í tvíblindri, slembiraðaðri virkri samanburðarrannsókn (SONIC) hjá 508 fullorðnum sjúklingum með miðlungs virkan eða mjög virkan Crohns sjúkdóm (CDAI ≥ 220 ≤ 450) sem höfðu ekki fengið líffræðilega virk ónæmisbælandi lyf áður og miðgildi tímans sem þeir höfðu haft sjúkdóminn var 2,3 ár. Í upphafi fengu 27,4% sjúklinga almenna barkstera, 14,2% sjúklinga fengu búdesóníð og 54,3% sjúklinga fengu 5-ASA lyf.
English: Do not use if opaque particles, discolouration, or other foreign particles are present.
Icelandic: Ekki má nota lyfið ef til staðar eru ógegnsæjar agnir, mislitun eða aðrar framandi agnir.
English: INSTRUCTIONS ON USE
Icelandic: Ráðlagt er að nota blandaða
English: Median (Interquartile range)
Icelandic: Miðgildi eftirfylgni (vikur)
English: Heijde-modified Sharp score) Change from baseline (Mean ± SD
Icelandic: Heildarstig d (van der Heijde útgáfa Sharp kvarða) Breyting frá upphafsgildum
English: Uncommon: Amnesia, agitation, confusion, somnolence, nervousness.
Icelandic: Minnisleysi, æsingur, ringlun, svefnhöfgi, taugaveiklun Mjög sjaldgæfar:
English: Tell your doctor straight away if you get signs of infection during treatment with Remicade.
Icelandic: Segðu lækninum samstundis frá því ef þú færð einkenni sýkingar meðan á meðferð með Remicade stendur.
English: There have been reports of pancytopenia, leucopenia, neutropenia, and thrombocytopenia in patients receiving TNF-blockers, including Remicade.
Icelandic: Greint hefur verið frá blóðfrumufæð, hvítfrumufæð, daufkyrningafæð og blóðflagnafæð hjá sjúklingum sem fengu TNF-hemla, þ.m.t. Remicade.
English: Available data suggest an increased risk for delayed hypersensitivity with increasing Remicade-free interval.
Icelandic: Fyrirliggjandi upplýsingar benda til þess að hætta á síðkomnu ofnæmi aukist eftir því sem Remicade meðferðarhlé er lengra.
English: • Low platelet count, too many white blood cells
Icelandic: Fækkun blóðflagna, offjölgun hvítra blóðkorna
English: It is recommended that live vaccines not be given concurrently with Remicade.
Icelandic: Mælt er gegn því að lifandi bóluefni séu gefin samtímis Remicade.
English: Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis The safety and efficacy of Remicade in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Icelandic: Ekki hefur enn verið sýnt fram á öryggi og verkun Remicade hjá börnum og unglingum yngri en 18 ára við ábendingunni liðagigt hjá börnum, sóraliðagigt og hryggikt.
English: Paediatric ulcerative colitis patients
Icelandic: Viðbótarupplýsingar um sérstaka sjúklingahópa
English: Clinical response at week 8 was similar between those with or without concomitant immunomodulator use at baseline.
Icelandic: Klínísk svörun eftir 8 vikur var svipuð hjá þeim sem fengu samhliða meðferð með ónæmismótandi lyfjum í upphafi og þeim sem fengu ekki samhliða meðferð með ónæmismótandi lyfjum í upphafi.
English: In this situation, do not return to refrigerated storage again.
Icelandic: Eftir þetta má ekki setja lyfið aftur í kæli.
English: CARTON
Icelandic: Sýkingar
English: Remicade 100 mg powder for concentrate infliximab
Icelandic: Remicade 100 mg þykknisstofn infliximab i.v.
English: • Cervical cancer
Icelandic: Lifrarbólga
English: Some cases of active tuberculosis have been reported in patients treated with Remicade during and after treatment for latent tuberculosis.
Icelandic: Greint hefur verið frá nokkrum tilvikum virkra berkla hjá sjúklingum á meðferð með Remicade meðan á meðferð við duldum berklum stóð og eftir að henni lauk.
English: During Remicade treatment, other concomitant therapies, e.g., corticosteroids and immunosuppressants should be optimised.
Icelandic: Meðan á meðferð með Remicade stendur, ætti að vanda sérstaklega skömmtun annarra lyfja sem notuð eru samtímis t.d. barkstera og ónæmisbælandi lyfja.
English: Ankylosing spondylitis (Bechterew's disease)
Icelandic: Lungnavandamál (t.d. bjúgur)
English: • Infection due to a live vaccine because of a weakened immune system.
Icelandic: Sýking vegna lifandi bóluefnis (af völdum veiklaðs ónæmiskerfis).