FrancophonIA/ELRC3.0 huggingface dataset:
English: If you notice any of these signs or symptoms, call your doctor right away to report them.
Icelandic: Hafið tafarlaust samband við lækni ef einhver þessara einkenna gera vart við sig og tilkynnið honum um þau.
English: While not observed in clinical trials, alveolar haemorrhage manifested as haemoptysis may occur with anti-GBM disease.
Icelandic: Þrátt fyrir að blæðingar í lungnablöðrum, sem koma fram sem blóðhósti, hafi ekki sést í klínískum rannsóknum geta þær komið fyrir með anti-GBM sjúkdómnum.
English: • Patients should be premedicated with corticosteroids immediately prior to LEMTRADA infusion for the first 3 days on any treatment course.
Icelandic: Gefa skal sjúklingum barkstera strax fyrir innrennsli með LEMTRADA fyrstu 3 dagana á hverju meðferðartímabili.
English: Throat tightness*, throat irritation
Icelandic: Herpingur í hálsi, erting í hálsi
English: Symptoms of acquired hemophilia A are described in section 4.
Icelandic: Einkennum nýrnasjúkdóms er lýst í kafla 4.
English: • Infusion reactions
Icelandic: Innrennslistengd viðbrögð
English: Neutrophils, monocytes, eosinophils, basophils, and natural killer cells are only transiently affected by LEMTRADA.
Icelandic: LEMTRADA hefur aðeins skammvinn áhrif á daufkyrninga, einkjörnunga, rauðkyrninga, blákyrninga og náttúrulegar drápsfrumur.
English: Study population
Icelandic: Rannsóknarskipan
English: Patients with clinical symtoms suggesting development of a serious adverse event temporarily associated with the infusion (myocardial ischemia, haemorrhagic stroke, cervico-cephalic arterial dissection or pulmonary alveolar haemorrhage) should be closely monitored until complete resolution of the symptoms.
Icelandic: Fylgjast skal náið með sjúklingum sem eru með klínísk einkenni sem benda til tímabundinnar alvarlegrar aukaverkunar sem tengist innrennslinu (blóðþurrð í hjarta, blæðingarslag, flysjun háls-höfuðslagæðar eða blæðingar í lungnablöðrum) þar til einkennin hafa gengið til baka til fulls.
English: irregular or abnormal heart beat, high blood pressure, impaired kidney function, white blood cells in urine
Icelandic: frávik sem hægt er að finna með rannsóknum: blóð eða prótín í þvagi, hægsláttur, óreglulegur eða óeðlilegur hjartsláttur, hár blóðþrýstingur, skert starfsemi nýrna, hvít blóðkorn í þvagi
English: Proteinuria, haematuria
Icelandic: Stoðkerfi og bandvefur
English: • Third or fourth course: 12 mg/day on 3 consecutive days (36 mg total dose) administered at least
Icelandic: 12 mg/ dag í 3 daga samfleytt (36 mg heildarskammtur) gefið a.m.k.
English: To allow for the full effect of the VZV vaccination to occur, treatment with LEMTRADA should be postponed for 6 weeks following vaccination.
Icelandic: Fresta ber meðferð með LEMTRADA í 6 vikur eftir bólusetningu við hlaupabóluveiru til að ná fram fullri virkni hennar.
English: In general, once a patient has had a herpes infection, they have an increased risk of developing another one.
Icelandic: Yfirleitt er meiri hætta á að önnur herpes-sýking þróist hjá sjúklingi sem hefur fengið hana áður.
English: • autoimmune over-active or under-active thyroid gland, thyroid antibodies or goitre (swelling of the thyroid gland in the neck)
Icelandic: sjálfnæmis of- eða vanvirkni skjaldkirtils, skjaldkirtilsmótefni eða skjaldkirtilsstækkun (bólga á skjaldkirtli í hálsinum)
English: Duration
Icelandic: Tímalengd
English: LEMTRADA may increase the risk of acute acalculous cholecystitis.
Icelandic: LEMTRADA getur aukið hættu á bráðri gallblöðrubólgu án gallsteina.
English: Common (may affect up to 1 in 10 people)
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum):
English: Carcinogenesis and mutagenesis
Icelandic: Stökkbreytandi áhrif og krabbameinsvaldandi áhrif
English: Complete blood counts with differential should be obtained prior to initiation of treatment and at monthly intervals thereafter until at least 48 months after the last infusion.
Icelandic: Gera skal heildarblóðkornatalningu með deilitalningu áður en meðferð hefst og á mánaðarfresti þar á eftir í að minnsta kosti 48 mánuði frá síðasta innrennsli.
English: It is recommended that the diluted product be administered immediately.
Icelandic: Mælt er með því að þynnta lyfið sé gefið strax.
English: Abdominal pain, vomiting, diarrhoea dyspepsia*, stomatitis
Icelandic: Kviðverkur, uppköst, niðurgangur, meltingartruflun*, munnbólga
English: IARs may occur in patients despite pretreatment.
Icelandic: Innrennslistengd viðbrögð geta komið fram þrátt fyrir lyfjaforgjöf.
English: o Immune Thrombocytopenic Purpura (ITP)
Icelandic: Sjálfvakinn blóðflagnafæðarpurpuri (ITP)
English: Skin papilloma
Icelandic: Skjaldkirtilstruflunum
English: Serious infections occurred in 2.7% of patients treated with LEMTRADA as compared to 1% of patients treated with IFNB-1a in controlled clinical trials in MS. Serious infections in the LEMTRADA group included: appendicitis, gastroenteritis, pneumonia, herpes zoster, and tooth infection.
Icelandic: Alvarlegar sýkingar komu fyrir hjá 2,7% sjúklinga í meðferð með LEMTRADA en hjá 1% sjúklinga í meðferð með IFNB-1a í klínískum samanburðarrannsóknum á MS.
English: • general discomfort, weakness, vomiting, diarrhoea, abdominal pain, gastric flu, hiccups
Icelandic: • almenn óþægindi, slappleiki, uppköst, niðurgangur, verkur í kviðarholi, magapest
English: Patients who were accidentally given too much LEMTRADA in one infusion have experienced serious reactions, such as headache, rash, low blood pressure or increased heart rate.
Icelandic: Ef gefinn er stærri skammtur af LEMTRADA en mælt er fyrir um Sjúklingar sem fyrir mistök fengu of stóran skammt af LEMTRADA í einu innrennsli fundu fyrir alvarlegum aukaverkunum eins og höfuðverk, útbrotum, lágum blóðþrýstingi eða hraðari hjartslætti.
English: Dyspnoea*, cough, epistaxis, hiccups, oropharyngeal pain, asthma
Icelandic: Mæði*, hósti, blóðnasir, hiksti, hálssærindi, astmi
English: • LEMTRADA Prescriber's Check-list
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: Patients in clinical trials in MS had serum samples collected 1, 3, and 12 months after each treatment course for determination of antialemtuzumab antibodies.Approximately 85% of patients receiving LEMTRADA tested positive for antialemtuzumab antibodies during the study, with ≥90% of these patients testing positive also for antibodies that inhibited alemtuzumab binding in vitro.
Icelandic: LEMTRADA reyndust jákvæð fyrir mótefnum gegn alemtuzumabi meðan á rannsókninni stóð og ≥90% þeirra reyndust einnig jákvæð fyrir mótefnum sem hamla bindingu alemtuzumabs in vitro.
English: Study design
Icelandic: Fræðsluáætlun
English: Autoimmune disease
Icelandic: Sjálfsnæmissjúkdómur
English: Listeriosis/listeri a meningitis, Epstein-Barr infection, herpes virus infection,1
Icelandic: Listeríusýking/ heilahimnubólga af völdum listeríu, endurvirkjun Epstein-Barr veiru (EBV)
English: • Obligation to conduct post-authorisation measures
Icelandic: Skylda til að grípa til ráðstafana eftir markaðssetningu
English: • swollen glands
Icelandic: Lifur og gall
English: • Infusion reactions that can happen at the time of the infusion or within 24 hours after the infusion:
Icelandic: Innrennslistengd viðbrögð sem geta komið fram við innrennsli eða innan 24 klst.
English: As with other immunomodulatory therapies, caution should be exercised in initiating LEMTRADA therapy in patients with pre-existing and/or an on-going malignancy.
Icelandic: Gæta skal varúðar þegar byrjað er á meðferð með LEMTRADA hjá sjúklingum sem hafa verið með og/eða eru með illkynja sjúkdóm, líkt og gert er í öðrum ónæmismótandi meðferðum.
English: LEMTRADA contains the active substance alemtuzumab, which is used to treat a form of multiple sclerosis (MS) in adults, called relapsing remitting multiple sclerosis (RRMS).
Icelandic: LEMTRADA inniheldur virka efnið alemtuzumab sem er notað til meðferðar á tegund af heila- og mænusiggi (MS) hjá fullorðnum, sem kallast heila- og mænusigg með hléum.
English: This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Icelandic: Einnig er hægt að tilkynna aukaverkanir beint samkvæmt fyrirkomulagi sem gildir í hverju landi fyrir sig, sjá Appendix V.
English: • acne, redness of the skin, excessive sweating, skin discoloration, skin lesion, dermatitis
Icelandic: • þrymlabólur, húðroði, óhófleg svitamyndun, mislitun húðar, húðskemmd, húðbólga
English: - Alterations in the number, proportions, and properties of some lymphocyte subsets post-treatment - Increased representation of regulatory T cell subsets - Increased representation of memory T- and B-lymphocytes - Transient effects on components of innate immunity (i.e., neutrophils, macrophages, NK cells)
Icelandic: T- og B-minnisfrumna - Skammvinnum áhrifum á þætti ósértæka ónæmiskerfisins (þ.e. daufkyrninga, gleypifrumur, náttúrulegar drápsfrumur (NK))
English: • If the patient shows clinical symptoms suggesting development of a serious adverse event associated with the infusion (myocardial ischemia, hemorrhagic stroke, cervico-cephalic arterial dissection or pulmonary alveolar haemorrhage
Icelandic: Ef sjúklingurinn fær klínísk einkenni sem benda til alvarlegrar aukaverkunar í tengslum við innrennslið (blóðþurrð í hjarta, blæðingarslag, flysjun háls-höfuðslagæða eða blæðingu í lungnablöðrum)
English: A fatal event of transfusion associated graft versus host disease has been reported in an alemtuzumab-treated oncology patient.
Icelandic: Tilkynnt hefur verið um banvænt tilvik af hýsilssótt í tengslum við blóðgjöf hjá krabbameinssjúklingi í meðferð með alemtuzumabi.
English: Signs and symptoms of ITP are described in section 4.
Icelandic: Einkennum áunninnar dreyrasýki A er lýst í kafla 4.
English: Pharmacotherapeutic group: Immunosuppressants, Selective immunosuppressants, ATC code: L04AA34
Icelandic: Ónæmisbælandi lyf. Sértæk ónæmisbælandi lyf, ATC-flokkur:
English: MS relapse, dizziness*, hypoaesthesia, paraesthesia, tremor, dysgeusia*, migraine*
Icelandic: Höfuðverkur* MS-kast, sundl*, skert snertiskyn, náladofi, skjálfti, bragðtruflun*, mígreni
English: Commonly, patients have developed a bleeding disorder caused by a low level of blood platelets, called immune thrombocytopenic purpura (ITP).
Icelandic: Sjálfvakinn blóðflagnafæðarpurpuri (ITP) Algengt er að sjúklingar hafi fengið blæðingarsjúkdóm af völdum lítils fjölda blóðflagna, sem kallast sjálfvakinn blóðflagnafæðarpurpuri.
English: Symptoms of acute acalculous cholecystitis include abdominal pain, abdominal tenderness, fever, nausea, and vomiting.
Icelandic: Einkenni bráðrar gallblöðrubólgu án gallsteina eru m.a. kviðverkur, eymsli í kvið, hiti, ógleði og uppköst.
English: A description of the risks associated with the use of LEMTRADA namely: Immune Thrombocytopenic Purpura (ITP) Nephropathies including anti-Glomerular Basement Membrane (anti-GBM) disease Thyroid disorders Serious infections Other secondary autoimmune or immune system diseases, including HLH, AIH, and acquired haemophilia A. Serious reactions temporally associated with LEMTRADA infusion, including myocardial ischaemia, haemorrhagic stroke, cervico-cephalic arterial dissection and pulmonary alveolar haemorrhage.
Icelandic: Ónæmismiðluðum viðbrögðum svo sem skjaldkirtilstruflunum, sjálfvöktum blóðflagnafæðarpurpura (ITP), nýrnakvillum, þ.m.t. sjúkdómi vegna mótefnisvaka í grunnhimnu gaukla (anti-GBM), sjálfsnæmislifrarbólgu (AIH), áunninni dreyrasýki A og HLH Alvarlegum sýkingum Alvarlegum viðbrögðum sem tímabundið tengjast innrennsli á LEMTRADA, þ.m.t. blóðþurrðarsjúkdómur í hjarta, blæðingarslag, flysjun háls-höfuðslagæða og blæðing í lungnablöðrum.
English: Patients with known coagulopathy, on anti-platelet or anti-coagulant therapy.
Icelandic: Sjúklingar með þekktan storkukvilla sem eru á blóðþynnandi meðferð eða segavarnarmeðferð.
English: 1 Co-primary endpoints: ARR & CDW.
Icelandic: ARR og CDW.
English: What you need to know before you are administered LEMTRADA Do not use LEMTRADA:
Icelandic: Áður en byrjað er að nota LEMTRADA
English: LEMTRADA 12 mg concentrate for solution for infusion
Icelandic: LEMTRADA 12 mg innrennslisþykkni, lausn.
English: Ear pain
Icelandic: % fengu
English: Cognitive, physical, and sexual development of pups exposed to alemtuzumab during lactation were not affected at doses up to 10 mg/kg/day alemtuzumab.
Icelandic: Skammtar allt að 10 mg/kg/dag af alemtuzumab hafði ekki áhrif á vitsmunalegan, líkamlegan þroska og kynþroska hjá ungum meðan á mjólkurgjöf stóð.
English: Controlled, randomised, rater and dose-blinded
Icelandic: Sýkingar af völdum sýkla og sníkjudýra
English: Other medicines and LEMTRADA
Icelandic: LYFJAFORM OG INNIHALD
English: Your doctor will explain to you how LEMTRADA will be given.
Icelandic: Látið lækninn vita ef þungun er fyrirhuguð.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Icelandic: EINKVÆMT AUÐKENNI - UPPLÝSINGAR SEM FÓLK GETUR LESIÐ PC: {númer}
English: • athlete's foot
Icelandic: • fótsveppir
English: The current evidence is insufficient to conclude on a causal relationship with Lemtrada.
Icelandic: Tilkynning aukaverkana sem grunur er um að tengist lyfinu
English: Myalgia, muscle weakness, arthralgia, back pain, pain in extremity, muscle spasms, neck pain, musculoskeletal pain
Icelandic: Sýkingar: magakveisa, bólga í gómum, naglsveppur, bólga í eitlum, bráð skútabólga, bakteríusýking í húð, lungnabólga, stórfrumuveirusýking
English: Flushing*
Icelandic: Gáttatif*
English: To help you better understand the duration of the effects of treatment and the length of required follow-up, please refer to the diagram below.
Icelandic: Skýringarmyndin hér á eftir veitir nánari upplýsingar um hversu lengi áhrifin af meðferðinni vara og hversu lengi er þörf á eftirfylgni.
English: Marketing Authorisation Holder
Icelandic: Gátlisti fyrir ávísun
English: Reporting of suspected adverse reactions
Icelandic: Tilkynnt hefur verið um endurvirkjun
English: Signs and symptoms of thyroid disorders are described in section 4.
Icelandic: Einkennum truflana á starfsemi skjaldkirtils er lýst í kafla 4.
English: Any spillage or waste material should be disposed of in accordance with local requirements.
Icelandic: Farga skal öllum leka eða úrgangi í samræmi við gildandi reglur.
English: infections, gastroenteritis, oral candidiasis, vulvovaginal candidiasis, influenza, ear infection, pneumonia, vaginal infection, tooth infection tonsillitis, acute sinusitis, cellulitis, pneumonitis, tuberculosis, cytomegalovirus infection virus (EBV) reactivation
Icelandic: Sýkingar: hósti, sýking í eyra, inflúensulík veikindi, berkjubólga, lungnabólga, þruska í munni eða leggöngum, ristill, áblástur, bólgnir eða stækkaðir eitlar, inflúensa, ristill, tannsýking
English: No data are available on the association of LEMTRADA with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) reactivation as patients with evidence of active or chronic infections were excluded from clinical trials.
Icelandic: C veiru (HCV) þar sem sjúklingar með vísbendingar um virkar eða langvinnar sýkingar voru útilokaðir frá klínískum rannsóknum.
English: How LEMTRADA will be administered
Icelandic: Hvernig LEMTRADA er gefið
English: Cervical dysplasia, amenorrhoea
Icelandic: Prótínmiga, blóðmiga
English: Your doctor can also prescribe a medicine for cold sores (see section 2: What you need to know before you are administered LEMTRADA - Infections).
Icelandic: Læknirinn getur einnig ávísað lyfi við áblæstri (sjá kafla 2:
English: There are certain signs and symptoms that you should look out for yourself.
Icelandic: Það eru tiltekin einkenni sem sjúklingi ber að fylgjast með.
English: Hypotension*, hypertension*
Icelandic: Blæðingarslag**, flysjun hálshöfuðslagæða**
English: A description of the sign and symptoms of autoimmune risks A description of the best course of action if sign and symptoms of those risks present themselves (e.g. How to reach your doctors) Recommendations for the planning of the monitoring schedule The patient alert card shall contain the following key messages: A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient has been treated with LEMTRADA That LEMTRADA treatment may increase the risk of: Immune mediated reactions such as thyroid disorders, Immune Thrombocytopenic Purpura (ITP).
Icelandic: Lýsingu á bestu aðgerðinni sem grípa ber til ef slík einkenni gera vart við sig (t.d. hvernig hægt sé að ná sambandi við lækna) Ráðleggingar varðandi skipulagningu eftirlitsáætlunar Öryggiskort sjúklings skal innihalda eftirfarandi lykilatriði:
English: • swelling of arms and/or legs
Icelandic: bólga í handleggjum og/eða fótleggjum
English: Skin and subcutaneous tissue disorders
Icelandic: Flysjun (dissection) háls-höfuðslagæða
English: Malignancy
Icelandic: LOTUNÚMER
English: Do not freeze or shake.
Icelandic: Má ekki hrista.
English: Autoimmune thyroiditis including thyroiditis subacute, goitre, anti-thyroid antibody positive
Icelandic: Sjálfsnæmissjúkdómur í skjaldkirtli, skjaldkirtilsstækkun, jákvæð mótefni gegn skjaldkirtli
English: During post-marketing use, additional cases of acute acalculous cholecystitis have been reported in LEMTRADA-treated patients.
Icelandic: Við notkun eftir markaðssetningu var greint frá viðbótartilvikum bráðrar gallblöðrubólgu án gallsteina hjá sjúklingum sem fengu LEMTRADA.
English: Prophylaxis with an oral anti-herpes agent should be initiated starting on the first day of LEMTRADA treatment and continuing for a minimum of 1 month following each course of treatment.
Icelandic: Hefja skal fyrirbyggjandi meðferð með lyfi gegn áblæstri frá fyrsta degi meðferðar með LEMTRADA og henni haldið áfram í a.m.k.
English: Constipation, gastrooesophageal reflux disease, gingival bleeding, dry mouth, dysphagia, gastrointestinal disorder, haematochezia
Icelandic: Hægðatregða, vélindisbakflæðissjúkdómur, tannholdsblæðingar, munnþurrkur, kyngingartregða, meltingartruflun, blóðhægðir
English: Nephropathies
Icelandic: United Kingdom Sanofi
English: Contraception
Icelandic: Lyfjaforgjöf
English: In addition, you will be monitored during the infusion and for 2 hours after the infusion has been completed.
Icelandic: Auk þess er vel fylgst með sjúklingnum meðan á innrennslinu stendur og í 2 klst.
English: • Autoimmune conditions
Icelandic: • óeðlilegt leggangastrok
English: NAME OF THE MEDICINAL PRODUCT
Icelandic: Rannsókn á eiturverkunum
English: Musculoskeletal stiffness, limb discomfort
Icelandic: Stífleiki í stoðkerfi, óþægindi í útlim
English: Serum concentrations were low or undetectable within approximately 30 days following each treatment course.
Icelandic: 30 daga eftir hvert meðferðartímabil var lítil eða ógreinanleg.
English: bacterial skin infection, pneumonitis, cytomegalovirus infection
Icelandic: Basedowsjúkdómur, skjaldvakaóhóf, skjaldvakabrestur
English: During your treatment course and for 4 months afterwards, you may have LEMTRADA in your body.
Icelandic: LEMTRADA getur verið til staðar í líkamanum meðan á meðferðartímabilinu stendur og í 4 mánuði eftir það.
English: If acute acalculous cholecystitis is suspected, evaluate and treat promptly.
Icelandic: Ef grunur er um bráða gallblöðrubólgu án gallsteina á að meta ástandið og meðhöndla tafarlaust.
English: Patients with severe active infection until complete resolution.
Icelandic: Sjúklingar með alvarlega virka sýkingu fram að því að hún er fullkomlega gengin til baka.
English: • stroke
Icelandic: vörtur
English: Annex IV
Icelandic: VIÐAUKI III
English: Summary of tests you will have for autoimmune conditions: Test
Icelandic: Samantekt á rannsóknum vegna sjálfsnæmissjúkdóma:
English: Suspected autoimmune cytopenias such as neutropenia, haemolytic anaemia and pancytopenia have been infrequently reported in clinical trials in MS.
Icelandic: Sjaldan hefur verið tilkynnt um grunaða frumufæð af völdum sjálfsnæmis, svo sem daufkyrningafæð, rauðalosblóðleysi og blóðfrumnafæð, í klínískum rannsóknum á MS.
English: If you have not completed the standard required vaccinations, your doctor will consider whether you should have them before your LEMTRADA treatment.
Icelandic: Læknirinn íhugar hvort sjúklingur, sem ekki hefur fengið þær hefðbundnu bólusetningar sem krafist er, skuli fá þær áður en meðferðin með
English: • Infections: airway infections such as colds and sinus infections, urinary tract infections, herpes infections
Icelandic: Sýkingar: sýkingar í öndunarvegi s.s. kvef og sýkingar í ennisholum, þvagfærasýkingar,
English: Serious and sometimes fatal viral, bacterial, protozoan, and fungal infections, including those due to reactivation of latent infections, have been reported in non-MS patients treated with alemtuzumab at higher and more frequent doses than used in MS. Progressive multifocal leukoencephalopathy (PML) has been reported in patients with B-CLL with or without treatment with alemtuzumab.
Icelandic: Hjá sjúklingum sem eru ekki með MS í meðferð með hærri og tíðari skömmtum af alemtuzumabi en notaðir eru við MS hafa komið fram alvarleg og stundum banvæn tilvik sýkinga af völdum veira, baktería, frumdýra og sveppa, þ.m.t. þær sem orsakast af endurvirkjunum á duldum sýkingum.
English: Contents of the pack and other information What LEMTRADA contains
Icelandic: Samskiptaupplýsingar þess sem ávísar LEMTRADA
English: Cardiac disorders
Icelandic: Hægtaktur*, hjartsláttarónot
English: VZV vaccination of antibody-negative patients should be considered prior to treatment initiation with LEMTRADA.
Icelandic: Áður en meðferð með LEMTRADA hefst skal íhuga bólusetningu við hlaupabóluveiru hjá sjúklingum sem mælast neikvæðir fyrir mótefni.
English: swelling of lymph nodes
Icelandic: HEITI LYFS
English: Premedication, general health, and pregnancy and contraception checks immediately before treatment Infusion instructions (before, during and after) to reduce risk for serious reactions temporally associated with the Lemtrada infusion Monitoring activities during treatment and for at least 48 months after last treatment A specific reference to the fact that the patient has been informed and understands the risks of serious autoimmune disorders, infections and malignancies, and the measures to minimize them The patient guide shall contain the following key messages: A description of the risks associated with the use of LEMTRADA namely: Immune Thrombocytopenic Purpura (ITP) Nephropathies, including anti-Glomerular Basement Membrane (anti-GBM) disease Thyroid disorders Serious infections Other secondary autoimmune or immune system diseases, including HLH, AIH, and acquired haemophilia A. Serious reactions temporally associated with LEMTRADA infusion, including myocardial ischemia, hemorrhagic stroke, cervico-cephalic arterial dissection and pulmonary alveolar haemorrhage .
Icelandic: Hjá sjúklingum sem eru ekki með MS í meðferð með hærri og tíðari skömmtum af alemtuzumabi en notaðir eru við MS hafa komið fram alvarleg og stundum banvæn tilvik af innrennslistengdum viðbrögðum, þ.m.t. berkjukrampi, súrefnisskortur, yfirlið, íferð í lungum, brátt andnauðarheilkenni, öndunarstopp, hjartadrep, takttruflanir, bráð hjartabilun og hjartastopp.
English: shingles, cold sore, swollen or enlarged glands, influenza, herpes zoster infection, tooth infection
Icelandic: Hörundsroði, flekkblæðing, skalli, ofsvitnun, þrymlabólur, húðskemmdir, húðbólga
English: Patients with active MS, defined as at least 2 relapses within the prior 2 years and 1 or more contrastenhancing lesions
Icelandic: Hjá undirhópi sjúklinga með heila- og mænusigg með hléum (RRMS) sem höfðu fengið kast tvisvar sinnum eða oftar undanfarið ár og með að minnsta kosti eina meinsemd á
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports (PSURSs)
Icelandic: Öryggisrannsókn án inngrips eftir markaðssetningu (PASS):
English: Very Common Common
Icelandic: Koma örsjaldan fyrir
English: 4.9 Overdose asthenia, influenza-like illness, malaise, infusion site pain
Icelandic: inflúensulík veikindi, slappleiki, verkur á innrennslisstað
English: What you need to know before you are administered LEMTRADA 3.
Icelandic: Áður en byrjað er að nota LEMTRADA 3. Hvernig LEMTRADA er gefið 4. Hugsanlegar aukaverkanir