FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies with infliximab have not been performed in patients with liver or renal disease.
Icelandic: Engar rannsóknir hafa farið fram á infliximab hjá sjúklingum með lifrar- eða nýrnasjúkdóma.
English: You will find detailed “Instructions for Use” at the end of this leaflet.
Icelandic: Nánari upplýsingar er að finna í “Notendaleiðbeiningar“ aftast í þessum fylgiseðli.
English: Specific studies of infliximab in elderly patients have not been conducted.
Icelandic: Sértækar rannsóknir á infliximab hjá öldruðum hafa ekki farið fram.
English: Upon removal from refrigerated storage, Remsima must not be returned to refrigerated storage.
Icelandic: Eftir að Remsima hefur verið tekið úr kæli má ekki setja það aftur í kæli.
English: • The abdomen except for the 5 cm around the belly button (navel).
Icelandic: Kvið nema 5 cm kringum naflann.
English: • Low blood counts, including a severely decreased number of white blood cells
Icelandic: Lág blóðgildi, þ.á m. veruleg fækkun hvítra blóðkorna.
English: Mucosal healing at Week 8a
Icelandic: Slímhúðargræðsla í 8. vikua
English: Reconstitute and dilute before use.
Icelandic: Til notkunar í bláæð Blandið og þynnið fyrir notkun.
English: b. Remove the syringe from the carton stored in your refrigerator by holding the middle of the syringe body.
Icelandic: Taktu sprautuna úr öskjunni sem geymd er í kælinum með því að halda um miðjan bol sprautunnar.
English: Note: After you remove the pen from the injection site, the needle will be automatically covered (see Figure I).
Icelandic: Þegar lyfjapennanum er lyft af stungustaðnum hylur hlífin nálina sjálfvirkt (sjá mynd I).
English: An association between development of antibodies to infliximab and reduced duration of response has also been observed with intravenously administered infliximab.
Icelandic: Einnig hafa sést tengsl á milli myndunar mótefna gegn infliximabi og styttingar tímans sem svörun varði þegar infliximab var gefið í bláæð.
English: The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4).
Icelandic: Alvarlegustu aukaverkanirnar sem tengdust notkun TNF-hemla sem greint var frá hjá infliximab voru m.a. endurvirkjun HBV, hjartabilun, alvarlegar sýkingar (m.a. sýklasótt, tækifærissýkingar og berklar), sermissótt (síðkomin ofnæmisviðbrögð), áhrif á blóð, rauðir úlfar/heilkenni sem líkist rauðum úlfum, afmýlandi sjúkdómar, lifrar- og gallsjúkdómar, eitilæxli, T-frumu eitilæxli í lifur og milta, hvítblæði, bjálkakrabbamein, sortuæxli, illkynja sjúkdómar hjá börnum, sarklíki/viðbrögð sem líkjast sarklíki, ígerð í görnum eða ígerð við endaþarm (Crohns sjúkdómur) og alvarleg innrennslisviðbrögð (sjá kafla 4.4).
English: Remove the syringe from the injection site (see Figure G).
Icelandic: Fjarlægðu nálina úr stungustaðnum (sjá mynd G).
English: • The other ingredients are sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate and disodium phosphate dihydrate.
Icelandic: Önnur innihaldsefni eru súkrósi pólýsorbat 80, natríumdíhýdrógenfosfat mónóhýdrat og dínatríumfosfat díhýdrat.
English: Subcutaneous administration of Remsima is not recommended for paediatric use and no data are available on the use of Remsima administered subcutaneously in the paediatric population.
Icelandic: Gjöf Remsima undir húð er ekki ráðlögð hjá börnum og engin gögn ligga fyrir um notkun Remsima undir húð hjá börnum.
English: EU/1/13/853/012 1 pre-filled pen EU/1/13/853/013 2 pre-filled pens EU/1/13/853/014 4 pre-filled pens
Icelandic: EU/1/13/853/012 1 áfylltur lyfjapenni EU/1/13/853/013 2 áfylltir lyfjapennar EU/1/13/853/014 4 áfylltir lyfjapennar
English: Solution for injection (injection).
Icelandic: Stofn fyrir innrennslisþykkni, lausn (þykknisstofn).
English: a. Clean the injection site with an alcohol swab.
Icelandic: Hreinsaðu stungustaðinn með alkóhólvættum klút.
English: Signs of a local injection site reaction can include redness, pain, itching, swelling, hardness, bleeding, bruising, cold sensation, irritation, tingling sensation, ulcer, hives, rash and scab on the skin of the injection site.
Icelandic: Merki um staðbundin viðbrögð á stungustað geta meðal annars verið roði, verkur, kláði, bólga, hersli, blæðing, mar, kuldatilfinning, erting, náladofi, sár, ofsakláði, útbrot og hrúður á húð á stungustað.
English: PGA of cleared (0) or minimal (1)
Icelandic: ≥ 50% framfarir PGA metið sem horfið (0) eða lágmarks (1)
English: The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of juvenile rheumatoid arthritis have not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun infliximab hjá börnum og unglingum yngri en 18 ára við ábendingunni sóra.
English: Each pack contains 1 pre-filled syringe with automatic needle guard with 2 alcohol pads, 2 pre-filled syringes with automatic needle guard with 2 alcohol pads or 4 pre-filled syringes with automatic needle guard with 4 alcohol pads.
Icelandic: Hver pakkning inniheldur 1 áfyllta sprautu með sjálvirkri nálarhlíf með 2 alkóhólvættum grisjum, 2 áfylltar sprautur með sjálvirkri nálarhlíf með 2 alkóhólvættum grisjum eða 4 áfylltar sprautur með sjálvirkri nálarhlíf með 4 alkóhólvættum grisjum.
English: Do not use if the solution is cloudy, discoloured or contains visible particulate matter.
Icelandic: Ekki má nota lyfið er lausnin er skýjuð, mislit eða inniheldur sýnilegar agnir.
English: • Other skin problems such as erythema multiforme, blisters and peeling skin, or boils (furunculosis)
Icelandic: Önnur húðvandamál eins og regnbogaroðasótt, blöðrur og húðflögnum eða graftarkýli (kýlasótt)
English: • 4 prefilled syringes (1 mL sterile solution) with 4 alcohol pads.
Icelandic: 4 áfylltir lyfjapennar (1 ml smitsæfð lausn) með 4 alkóhólvættum grisjum.
English: Table 6
Icelandic: Vika 6
English: Remsima 100 mg powder for concentrate for solution for infusion infliximab
Icelandic: Remsima 100 mg stofn fyrir innrennslisþykkni, lausn infliximab
English: Once you remove the cap, do not recap the syringe.
Icelandic: Þegar búið er að fjarlægja lokið má ekki setja lokið aftur á lyfjapennann.
English: The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, sarcoidosis/sarcoid-like reaction, and serious infusion reactions (see section 4.4).
Icelandic: Alvarlegustu aukaverkanirnar sem tengdust notkun TNF-hemla sem greint var frá hjá infliximab voru m.a. endurvirkjun HBV, hjartabilun, alvarlegar sýkingar (m.a. sýklasótt, tækifærissýkingar og berklar), sermissótt (síðkomin ofnæmisviðbrögð), áhrif á blóð, rauðir úlfar/heilkenni sem líkist rauðum úlfum, afmýlandi sjúkdómar, lifrar- og gallsjúkdómar, eitilæxli, T-frumu eitilæxli í lifur og milta, hvítblæði, bjálkakrabbamein, sortuæxli, sarklíki/viðbrögð sem líkjast sarklíki og alvarleg innrennslisviðbrögð (sjá kafla 4.4).
English: In psoriatic arthritis, short term treatment with infliximab reduced the number of T-cells and blood vessels in the synovium and psoriatic skin.
Icelandic: Skammtímameðferð með infliximab við sóraliðagigt dró úr fjölda T-frumna og blóðæðum í liðvökva og húð sóra sjúklinga.
English: 2 Number of patients evaluated for ALT. 3 Median follow-up is based on patients treated.
Icelandic: 3 Miðgildi eftirfylgni byggt á meðhöndluðum sjúklingum.
English: 3.4 (1.3)b a Two-sided 95% CI for difference in the mean change from baseline for DAS28 (CRP) at Week 22 was well above the pre-defined non-inferiority margin of -0.6 b Remsima IV was switched to Remsima SC at Week 30
Icelandic: 3,4 (1,3)b a Tvíhliða 95% CI fyrir mun á meðalbreytingu frá upphafsgildi fyrir DAS28 (CRP) í viku
English: • Do not reuse the syringe.
Icelandic: Ekki má nota sprautuna aftur.
English: Other medicines and Remsima
Icelandic: Notkun annarra lyfja samhliða Remsima
English: Do not touch the needle.
Icelandic: Ekki má snerta nálina.
English: Week 10 Week 24
Icelandic: 10. vika 24. vika
English: 10 mg/kg q 8 wks
Icelandic: 10 mg/k g q 8 vikur
English: Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Remsima.
Icelandic: Segðu lækninum strax frá því ef þú færð einkenni taugasjúkdóms meðan á meðferð með Remsima stendur.
English: Packs of:
Icelandic: Pakkningar:
English: • Do not use the pen if it has been dropped or is visibly damaged.
Icelandic: Ekki nota lyfjapennann ef hann hefur dottið eða ef á honum eru sýnilegar skemmdir
English: Remsima is a clear to opalescent, colourless to pale brown solution which is supplied as a single use pre-filled syringe.
Icelandic: Remsima er tær til ópallýsandi, litlaus til ljósbrún laus sem fáanleg er í einnota áfylltri sprautu.
English: Remsima contains sorbitol
Icelandic: Remsima inniheldur sorbítól
English: Choose an injection site (see Figure C).
Icelandic: 5. Veldu stungustað (sjá mynd C).
English: Remsima 120 mg solution for injection in pre-filled syringe with automatic needle guard Remsima 120 mg solution for injection in single-use pre-filled syringe with automatic needle guard.
Icelandic: Remsima 120 mg stungulyf, lausn í áfylltri sprautu með sjálfvirkri nálarhlíf Remsima 120 mg stungulyf, lausn í einnota áfylltri sprautu með sjálfvirkri nálarhlíf.
English: During treatment with Remsima
Icelandic: Meðan á meðferð með Remsima stendur
English: The dose and the number of Remsima vials have to be calculated.
Icelandic: Reikna þarf út skammtinn og fjölda Remsima hettuglasa.
English: c. With a quick and “dart-like” motion, insert the needle completely into the fold of the skin at a 45-degree angle.
Icelandic: Stingdu nálinni alveg í húðfellinguna með snöggri hreyfingu við 45 gráðu horn.
English: Endophthalmitis
Icelandic: Lifrarsjúkdómar
English: Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥10% and Psoriasis Area and Severity Index [PASI] score ≥12).
Icelandic: ≥ 10% og sórasvæðis og alvarleikastuðuls [PASI] skor ≥ 12).
English: Gather the supplies for the injection.
Icelandic: 1. Taktu saman búnaðinn fyrir inndælinguna.
English: Keep the pre-filled syringe in its package in order to protect from light.
Icelandic: Geymið áfyllt sprautuna í ytri umbúðum til varnar gegn ljósi.
English: Local injection site reactions
Icelandic: Viðbrögð tengd innrennsli
English: b all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs c p <0.001, for each infliximab treatment group vs. control d greater values indicate more joint damage.
Icelandic: c p < 0,001, fyrir hvern infliximabhóp á móti samanburðarhóp d hærri tölur gefa til kynna meiri liðskemmdir e HAQ Health Assessment Questionnaire; hærri tala gefur til kynna minni vanhæfni
English: Remsima 120 mg solution for injection in pre-filled pen Remsima 120 mg solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe.
Icelandic: Remsima 120 mg stungulyf, lausn í áfylltum lyfjapenna Remsima 120 mg stungulyf, lausn í áfylltum lyfjapenna til notkunar fyrir sjúklinga sem inniheldur áfyllta sprautu.
English: • Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating.
Icelandic: Einkenni sýkingar (þ.m.t. berklar) svo sem hiti, þreytutilfinning, hósti sem getur verið þrálátur, mæði, flensulík einkenni, þyngdartap, nætursviti, niðurgangur, sár, uppsafnaður gröftur í meltingarvegi eða í kringum endaþarm (ígerð),tannsjúkdómar eða sviðatilfinning við þvaglát.
English: Type 1 glass vial with a (butyl) rubber stopper and an aluminium seal with a flip-off button.
Icelandic: Tegund I hettuglas úr gleri með (bútýl) gúmmítappa og álinnsigli sem rífa má af.
English: Tell your doctor if you are using, have recently used or might use any other medicines, including any other medicines to treat rheumatoid arthritis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Icelandic: Látið lækninn vita um öll önnur lyf sem eru notuð, hafa nýlega verið notuð eða kynnu að verða notuð, þ.m.t.
English: Doing so may result in a needle stick injury.
Icelandic: Það gæti valdið stungumeiðslum.
English: In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with infliximab intravenous administration (see section 4.4).
Icelandic: Eftir markaðssetningu lyfsins hafa komið fram tilfelli af bráðaofnæmislíkum viðbrögðum, þar með töldum barkakýlis-/kokbjúg og alvarlegum berkjukrampa og flogakasti sem tengist gjöf infliximabs í bláæð (sjá kafla 4.4).
English: Common: may affect up to 1 in 10 people
Icelandic: Algengar:kunna að koma fyrir hjá allt að 1 af hverjum 10 einstaklingum
English: Remsima 100 mg powder for concentrate for solution for infusion
Icelandic: Remsima 100 mg stofn fyrir innrennslisþykkni, lausn.
English: Do not rub the injection site.
Icelandic: Ekki má nudda stungustaðinn.
English: Remsima contains sodium
Icelandic: Remsima inniheldur natríum
English: One vial contains 100 mg of infliximab.
Icelandic: Eitt hettuglas inniheldur 100 mg af infliximab.
English: Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis
Icelandic: Sýking í neðri öndunarvegi (t.d. berkjubólga, lungnabólga), mæði, blóðnasir
English: Table 2 Proportion of patients with increased ALT activity in clinical studies
Icelandic: Hlutfall sjúklinga með aukna ALT virkni í klínískum rannsóknum Sjúkdómur Fjöldi sjúklinga3
English: Give the injection (see Figure F).
Icelandic: Sprautaðu lyfinu (sjá mynd F).
English: Remsima 120 mg solution for injection in pre-filled syringe infliximab
Icelandic: Remsima 120 mg stungulyf, lausn í áfylltri sprautu infliximab
English: • Treatment with TNF blockers such as Remsima may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
Icelandic: Meðferð með TNF-hemlum eins og Remsima getur valdið endurvirkjun lifrarbólgu
English: • Most of these reactions are mild to moderate and resolve on their own within a day.
Icelandic: Flestar þessar aukaverkanir eru vægar til miðlungs alvarlegar og ganga til baka af sjálfu sér innan sólarhrings.
English: In this situation, infliximab should be re-initiated as a single dose followed by the maintenance dose recommendations described above.
Icelandic: Í þeim tilvikum er ráðlagt að byrja með stakan skammt af Remsima sem fylgt er eftir með ráðlögðum viðhaldsskammti eins og lýst er hér að ofan.
English: * p-values represent each infliximab treatment group vs. AZA monotherapy.
Icelandic: (p < 0,001)* * P-gildi er hver infliximab meðferðar hópur fyrir sig borinn saman við AZA einlyfjameðferð.
English: At
Icelandic: Nál
English: b Based on patients with PASI >2.5 at baseline for IMPACT, and patients with >3% BSA psoriasis skin involvement at baseline in IMPACT 2.
Icelandic: Byggt á sjúklingum með PASI ≥ 2,5 sem upphafsgildi fyrir IMPACT og sjúklingum með ≥ 3%
English: Remove the cap (see Figure D).
Icelandic: 8. Fjarlægðu lokið (sjá mynd D).
English: Rheumatoid arthritis1 1 Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Icelandic: Lyfleysusjúklingar fengu metotrexat en infliximabsjúklingar fengu bæði infliximab og metotrexat.
English: Use of live vaccines can result in clinical infections, including disseminated infections.
Icelandic: Notkun lifandi bóluefna getur leitt til klínískra sýniga, þ.m.t. útbreiðslu sýkinga.
English: The concurrent administration of live vaccines with infliximab is not recommended.
Icelandic: Gjöf lifandi bóluefna samhliða infliximabi er ekki ráðlegt.
English: Keratitis, periorbital oedema, hordeolum
Icelandic: Sóri, húðvandamál t.d. exem og hárlos
English: • 4 prefilled syringes with automatic needle guard (1 mL sterile solution) with 4 alcohol pads.
Icelandic: 4 áfylltar sprautur með sjálfvirkri nálarhlíf (1 ml smitsæfð lausn) með 4 alkóhólvættum grisjum.
English: In this situation, do not return to refrigerated storage again.
Icelandic: Ef svo er máttu ekki nota lyfjapennann aftur.
English: • Signs of a local injection site reaction such as redness, pain, itching, swelling, hardness, bleeding, bruising, cold sensation, irritation, tingling sensation, ulcer, hives, rash and scab.
Icelandic: Merki um staðbundin viðbrögð á stungustað svo sem roði, verkur, kláði, bólga, hersli, blæðing, mar, kuldatilfinning, erting, náladofi, sár, ofsakláði, útbrot og hrúður.
English: All systemic injection reactions were mild to moderate.
Icelandic: Öll altæk viðbrögð við inndælingu voru væg til miðlungs alvarleg.
English: Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis The safety and efficacy of infliximab 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 verið sýnt fram á öryggi og verkun infliximab hjá börnum og unglingum yngri en 18 ára við ábendingunni liðagigt hjá börnum, sóraliðagigt og hryggikt.
English: Moderately to severely active Crohn's disease
Icelandic: Viðhaldsmeðferð við virkum fistilmyndandi Crohns sjúkdómi
English: Localised injection site reactions predominantly of mild to moderate in nature included the following reactions limited to injection site: erythema, pain, pruritus, swelling, induration, haematoma, oedema, bruising, coldness, irritation, paraesthesia, ulcer, urticaria, haemorrhage, rash and scab were reported to be associated with infliximab subcutaneous treatment.
Icelandic: Staðbundin viðbrögð á stungustað, að mestu væg til miðlungs alvarleg, sem greint var frá í tengslum við meðferð með infliximab undir húð voru eftirfarandi: roði, verkur, kláði, bólga, hersli, margúll, bjúgur, mar, kuldi, erting, náladofi, sár, ofsakláði, blæðing, útbrot og hrúður.
English: EXP, if not refrigerated ___________________
Icelandic: Fyrnist, ef lyfið er ekki geymt í kæli ___________________
English: Package leaflet: Information for the user Remsima 120 mg solution for injection in pre-filled syringe infliximab
Icelandic: Upplýsingar fyrir notanda lyfsins Remsima 120 mg stungulyf, lausn í áfylltri sprautu infliximab
English: • 1 prefilled syringe (1 mL sterile solution) with 2 alcohol pads.
Icelandic: 1 áfylltur lyfjapenni (1 ml smitsæfð lausn) með 2 alkóhólvættum grisjum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PRE-FILLED PEN
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI ASKJA FYRIR ÁFYLLTAN LYFJAPENNA
English: Elderly
Icelandic: Ediksýra
English: The efficacy of subcutaneous infliximab in rheumatoid arthritis patients was assessed in a randomised, parallel-group pivotal Phase I/III study consisting of two parts: Part 1 to determine the optimal dose of subcutaneous infliximab and Part 2 to demonstrate non-inferiority in terms of efficacy of subcutaneous infliximab compared to intravenous infliximab treatment.
Icelandic: Verkun infliximab undir húð hjá sjúklingum með iktsýki var metin í slembaðri, I./III. stigs lykilrannsókn á samhliða hópum sem samanstóð af tveimur hlutum:
English: Tell your doctor straight away if you get signs of infection during treatment with Remsima.
Icelandic: Segðu lækninum samstundis frá því ef þú færð einkenni sýkingar meðan á meðferð með Remsima stendur.
English: Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Icelandic: Altæk viðbrögð við inndælingu, þ. á m. ofnæmislost, og síðkomin ofnæmisviðbrögð hafa tengst gjöf infliximabs (sjá kafla 4.8).
English: The safety and efficacy of infliximab 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 infliximab hjá börnum yngri en 6 ára með sáraristilbólgu.
English: Placebo → Infliximab
Icelandic: Allir infliximab b
English: One vial contains 100 mg of infliximab*.
Icelandic: Eitt Remsima hettuglas inniheldur 100 mg af infliximabi*.
English: • Sharps disposal container* *Items not included in the carton.
Icelandic: Ílát fyrir oddhvassa hluti* *Fylgir ekki með í öskjunni.
English: During Remsima treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Icelandic: Meðan á meðferð með Remsima stendur, ætti að vanda sérstaklega skömmtun annarra lyfja sem notuð eru samtímis t.d. barkstera og ónæmisbælandi lyfja.
English: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation
Icelandic: Maga- og þarmablæðingar, niðurgangur, meltingartruflanir, bakflæði, hægðatregða
English: • 2 prefilled syringes (1 mL sterile solution) with 2 alcohol pads.
Icelandic: 2 áfylltir lyfjapennar (1 ml smitsæfð lausn) með 2 alkóhólvættum grisjum.
English: Date of Remsima therapy initiation:
Icelandic: Dagsetning þegar Remsima meðferð hófst:
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 Remsima over
Icelandic: Lyfið er gefið með innrennsli (dreypi) (á 2 klukkustundum) í bláæð, venjulega í handlegginn.
English: Date of first authorisation: 10 September 2013 Date of latest renewal: 21 June 2018
Icelandic: 21 júní 2018
English: Package leaflet: Information for the user Remsima 100 mg powder for concentrate for solution for infusion infliximab
Icelandic: Upplýsingar fyrir notanda lyfsins Remsima 100 mg stofn fyrir innrennslisþykkni, lausn infliximab
English: Invasive fungal infections
Icelandic: Aukaverkanir tengdar iinndælingu
English: Prepare for the injection 1.
Icelandic: Undirbúningur fyrir inndælingu
English: • Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus.
Icelandic: Sumir sjúklingar sem fá Remsima hafa fengið einkenni sjúkdóms í ónæmiskerfi sem kallast rauðir úlfar.
English: • made of a heavy-duty plastic;
Icelandic: • úr þykku plasti,
English: 5 mg/kg (at week 24)
Icelandic: Infliximab 5 mg/kg (í 24. viku)
English: • Remsima 120 mg solution for injection is administered by injection under the skin (subcutaneous use) only.
Icelandic: Remsima 120 mg stungulyf, lausn er aðeins gefið með inndælingu undir húð.
English: CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
Icelandic: 4.2 Skammtar og lyfjagjöf
English: c. Gently press a cotton ball or gauze over the injection site and apply an adhesive bandage, if necessary.
Icelandic: Lyftu lyfjapennanum af stungustaðnum (sjá mynd H). c. Þrýstu varlega bómullarhnoðra eða grisju yfir stungustaðinn og settu plástur á hann, ef þarf.
English: Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥220 ≤400) in a randomised, double-blinded, placebo-controlled, dose-response study.
Icelandic: Upphafsmeðferð við miðlungs virkum eða mjög virkum Crohns sjúkdómi Verkun meðferðar með stökum skammti af infliximabi var metin hjá 108 sjúklingum með virkan