FrancophonIA/ELRC3.0 huggingface dataset:
English: After intravenous administration of palonosetron 0.25 mg once daily for 3 days in 12 healthy subjects, the mean (± SD) increase in plasma palonosetron concentration from Day 1 to Day 3 was 110 ± 45 %.
Danish: Efter intravenøs indgift af palonosetron 0,25 mg én gang dagligt i tre dage i 12 raske studiedeltagere var den gennemsnitlige stigning (± SD) i plasma-palonosetronkoncentration fra dag 1 til dag 3 110 ± 45 %.
English: NAME OF THE MEDICINAL PRODUCT Aloxi 250 micrograms solution for injection Palonosetron (as hydrochloride)
Danish: LÆGEMIDLETS NAVN Aloxi 250 mikrogram injektionsvæske, opløsning Palonosetron (som hydrochlorid)
English: No dosage adjustment is necessary in elderly patients.
Danish: Det er ikke nødvendigt med dosisjusteringer hos ældre patienter.
English: NAME OF THE MEDICINAL PRODUCT Aloxi 500 micrograms soft capsules Palonosetron
Danish: LÆGEMIDLETS NAVN Aloxi 500 mikrogram bløde kapsler Palonosetron
English: Each ml of solution contains 50 micrograms palonosetron.
Danish: Hver ml af opløsningen indeholder 50 mikrogram palonosetron.
English: Aloxi 500 micrograms soft capsules Palonosetron
Danish: Aloxi 500 mikrogram bløde kapsler Palonosetron
English: Aloxi is used in adults to help stop you feeling or being sick (nausea and vomiting) when having cancer treatments called chemotherapy.
Danish: Aloxi anvendes til voksne som en hjælp til at stoppe Deres kvalme eller opkastning, når De får kræftbehandlinger, som kaldes kemoterapi.
English: At all dose levels tested, palonosetron did not induce clinically relevant prolongation of the QTc interval.
Danish: Ved alle testede dosisniveauer fremkaldte palonosetron ikke klinisk relevant forlængelse af QTcintervallet.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT3) antagonists.
Danish: Farmakoterapeutisk klassifikation: Antiemetica og midler mod kvalme, Serotonin (5HT3)antagonister.
English: It is not recommended to take Aloxi in the days following chemotherapy unless you are going to have another chemotherapy cycle.
Danish: De bør ikke tage Aloxi i dagene efter kemoterapi, medmindre De skal have endnu et kemoterapiforløb.
English: Tell your doctor straight away if you notice any of the serious side effects listed above.
Danish: Fortæl det straks til lægen, hvis De bemærker en eller flere af de alvorlige bivirkninger anført overfor.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug
English: No dose adjustment is necessary for the elderly.
Danish: Dosisjustering hos ældre er ikke nødvendig.
English: What you need to know before you take Aloxi
Danish: Det skal De vide, før De begynder at tage Aloxi
English: Medicines for depression or anxiety Tell your doctor or pharmacist if you are taking any medicines for depression or anxiety, including:
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis De tager lægemidler mod depression eller angst, herunder:
English: Talk to your doctor or nurse before you are given Aloxi if:
Danish: Kontakt lægen eller sundhedspersonalet, før De får Aloxi, hvis:
English: Asthenia, pyrexia, fatigue, feeling hot, influenza like illness
Danish: Asteni, feber, træthed, varmefølelse, influenzalignende sygdom
English: Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart, Dublin 15 Ireland
Danish: Damastown, Mulhuddart, Dublin 15
English: Glycerol Titanium dioxide
Danish: Titandioxid
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2005
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Palonosetron does not inhibit or induce cytochrome P450 isoenzymes at clinically relevant concentrations.
Danish: Palonosetron hæmmer ikke og inducerer ikke CYPisoenzymer i klinisk relevante koncentrationer.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Danish: Bør ikke anvendes til patienter med arvelig fructoseintolerans.
English: It is not recommended you are given Aloxi in the days following chemotherapy unless you are going to have another chemotherapy cycle.
Danish: De bør ikke få Aloxi i dagene efter kemoterapi, medmindre De skal have endnu et kemoterapi-forløb.
English: 12 to <17 y µg/kg
Danish: <2 år til <6 år til <12 år til <17 år µg/kg
English: Gender does not affect the pharmacokinetics of palonosetron.
Danish: Køn påvirker ikke palonosetrons farmakokinetik.
English: • hiccups, passing wind (flatulence), dry mouth or indigestion
Danish: • Hikke, luftafgang, tør mund eller fordøjelsesbesvær
English: • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Danish: • forebyggelse af akut kvalme og opkastning i forbindelse med cancerkemoterapi med kraftig kvalmefremkaldende virkning og forebyggelse af kvalme og opkastning i forbindelse med cancerkemoterapi med moderat kvalmefremkaldende virkning.
English: p-valuec
Danish: p-værdic
English: Hypotension, hypertension, vein discolouration, vein distended
Danish: Hypotension, hypertension, misfarvning af vener, distenderede vener
English: What Aloxi is and what it is used for What you need to know before you take Aloxi How to take Aloxi
Danish: Virkning og anvendelse Det skal De vide, før De begynder at få Aloxi Sådan vil De få Aloxi
English: palonosetron (1 µg/kg, max 0.075 mg) versus i.v.
Danish: 0,075 mg) versus i.v.
English: Each capsule contains 500 micrograms palonosetron (as hydrochloride).
Danish: Hver kapsel indeholder 500 mikrogram palonosetron (som hydrochlorid).
English: A single-dose of 250 mcg, 500 mcg, or 750 mcg oral palonosetron capsules given one hour prior to moderately emetogenic chemotherapy was compared to a single-dose of 250 mcg intravenous Aloxi given 30 minutes prior to chemotherapy.
Danish: Oral indgivelse af palonosetron-kapsler i enkeltdoser a 250 mikrogram, 500 mikrogram eller 750 mikrogram én time før moderat kvalmefremkaldende kemoterapi blev sammenlignet med intravenøs behandling med 250 mikrogram Aloxi 30 minutter før kemoterapi.
English: The signs may include hives, skin rash, itching, difficulty breathing or swallowing, swollen mouth, face, lips, tongue or throat and sometimes a drop in blood pressure.
Danish: Tegnene kan bestå i hævelse af læber, ansigt, tunge eller svælg, vejrtrækningsbesvær eller kollaps, og De kan også bemærke et kløende, ujævnt udslæt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Aloxi 250 micrograms solution for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Aloxi 250 mikrogram injektionsvæske, opløsning Palonosetron
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid Aloxi nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Helsinn Birex Pharmaceuticals Limited.
Danish: Helsinn Birex Pharmaceuticals Limited Damastown
English: NAME OF THE MEDICINAL PRODUCT Aloxi 500 micrograms soft capsules
Danish: LÆGEMIDLETS NAVN Aloxi 500 mikrogram bløde kapsler.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 500 micrograms palonosetron.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 500 mikrogram palonosetron.
English: Serious side effects
Danish: Almindelige bivirkninger
English: Severe renal impairment reduces renal clearance, however total body clearance in these patients is similar to healthy subjects.
Danish: Den totale kropsclearance hos disse patienter er dog den samme som hos raske studiepersoner.
English: • The other ingredients are glycerol monocaprylocaproate (type I), polyglycerol oleate, glycerol,
Danish: • Øvrige indholdsstoffer: glycerolmonocaprylocaproat (type I), polyglycerololeat, glycerol, renset vand, butylhydroxyanisol, gelatine, sorbitol, titandioxid.
English: Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or think you might be.
Danish: Spørg Deres læge eller apotekspersonalet til råds, før De bruger dette lægemiddel, hvis De er gravid eller har mistanke om, at De er gravid.
English: Dyspepsia, abdominal pain, abdominal pain upper, dry mouth, flatulence
Danish: Dyspepsi, abdominalsmerter, øvre abdominalsmerter, mundtørhed, flatulens
English: Tell your doctor straight away if you notice any of the following serious side effects:
Danish: Alvorlige bivirkninger Fortæl det straks til lægen, hvis De bemærker en eller flere af de følgende alvorlige bivirkninger:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 micrograms palonosetron (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder 500 mikrogram palonosetron (som hydrochlorid).
English: Aloxi can be taken with or without food.
Danish: Aloxi kan tages sammen med et måltid eller mellem måltiderne.
English: Aloxi Intravenous 250 micrograms (n=162)
Danish: Intravenøs Aloxi 250 mikrogram (n=162)
English: • trouble sleeping
Danish: • Søvnbesvær
English: Aloxi 250 micrograms (n= 189)
Danish: Aloxi 250 mikrogram (n= 189)
English: • headache, feeling dizzy,
Danish: • Hovedpine, følelse af svimmelhed
English: Each vial of 5 ml of solution contains 250 micrograms of palonosetron.
Danish: Hvert hætteglas med 5 ml opløsning indeholder 250 mikrogram palonosetron.
English: Name and address of the manufacturer responsible for batch release
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Helsinn Birex Pharmaceuticals Ltd.
English: Ask your doctor or nurse for advice before being given this medicine if you are pregnant or think you might be.
Danish: Spørg Deres læge eller sundhedspersonalet til råds, før De får dette lægemiddel, hvis De er gravid eller har mistanke om, at De er gravid.
English: • constipation
Danish: • Stakåndethed
English: For Palonosetron no clinical data on exposed pregnancies are available.
Danish: Der foreligger ingen kliniske data fra anvendelse af Aloxi til gravide.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller på apoteket.
English: Single-dose i.v.
Danish: Farmakokinetiske enkeltdosisdata for i.v.
English: Uncommon ARs (≥1/1,000 to <1/100)
Danish: Ikke almindelige bivirkninger (≥1/1.000 til <1/100)
English: Common ARs (≥1/100 to<1/10)
Danish: Almindelige bivirkninger (≥1/100 til<1/10)
English: • the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Danish: • forebyggelse af kvalme og opkastning i forbindelse med cancerkemoterapi med moderat kvalmefremkaldende virkning.
English: No dose adjustment is necessary for patients with impaired renal function.
Danish: Dosisjustering er ikke nødvendig til patienter med nedsat leverfunktion.
English: Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride).
Danish: Hvert hætteglas med 5 ml opløsning indeholder 250 mikrogram palonosetron (som hydrochlorid).
English: What Aloxi contains
Danish: Aloxi indeholder:
English: • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,
Danish: • forebyggelse af akut kvalme og opkastning i forbindelse med cancerkemoterapi med kraftig kvalmefremkaldende virkning.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml opløsning indeholder 50 mikrogram palonosetron (som hydrochlorid).
English: NAME OF THE MEDICINAL PRODUCT Aloxi 250 micrograms solution for injection.
Danish: LÆGEMIDLETS NAVN Aloxi 250 mikrogram injektionsvæske, opløsning.
English: Table 2: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus dolasetron Aloxi 250 micrograms (n= 185)
Danish: Tabel 2: Procentdel af patientera, der responderer ud fra behandlingsgruppe og fase i studiet med moderat kvalmefremkaldende kemoterapia sammenlignet med dolasetron.
English: Aloxi 250 micrograms solution for injection Palonosetron
Danish: Aloxi 250 mikrogram injektionsvæske, opløsning
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml opløsning indeholder 50 mikrogram palonosetron (som hydrochlorid).
English: ≤1,500 mg/m2 and doxorubicin >25 mg/m2, palonosetron 250 micrograms and 750 micrograms were compared with ondansetron 32 mg (half-life 4 hours) or dolasetron 100 mg (half-life 7.3 hours) administered intravenously on Day 1, without dexamethasone.
Danish: Pyreksi, smerter på infusionsstedet, reaktion på infusionsstedet, smerter sammenlignet med ondansetron 32 mg (halveringstid 4 timer) eller dolasetron 100 mg (halveringstid 7,3 timer) indgivet intravenøst på dag 1 uden dexamethason.
English: In two randomised, double-blind studies with a total of 1,132 patients receiving moderately emetogenic chemotherapy that included cisplatin ≤50 mg/m2, carboplatin, cyclophosphamide
Danish: I to randomiserede dobbelt blinde studier med sammenlagt 1.132 patienter, der fik moderat kvalmefremkaldende kemoterapi omfattende cisplatin ≤ 50 mg/m2, carboplatin, cyclophosphamid ≤ 1.500 mg/m2 og doxorubicin > 25 mg/m2, blev palonosetron 250 mikrogram og 750 mikrogram
English: Ask your doctor or pharmacist for advice before using this medicine if you are breast-feeding.
Danish: Spørg Deres læge eller apotekspersonalet til råds, før De bruger dette lægemiddel, hvis De ammer.
English: • nosebleed
Danish: • Næseblod
English: • abnormal heart rate
Danish: • Unormal puls
English: • medicines called SSRIs (‘selective serotonin reuptake inhibitors') - such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
Danish: • lægemidler, der kaldes SSRI'er (”selektive serotoningenoptagshæmmere”), såsom fluoxetin,
English: How to take Aloxi
Danish: Sådan skal De tage Aloxi
English: How you are given Aloxi
Danish: Sådan vil De få Aloxi
English: • coughing or shortness of breath
Danish: • Hoste eller stakåndethed
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/306/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/04/306/002
English: Table 3: Percentage of patients a responding by treatment group and phase in the Highly Emetogenic Chemotherapy study versus ondansetron Aloxi 250 micrograms (n= 223)
Danish: Tabel 1: Andel af patientera, der responderer ud fra behandlingsgruppe og fase Oral Aloxi 500 mikrogram (n=160)
English: Tell your doctor or pharmacist if you are taking any medicines that affect your heart beat - this is because they could cause heart beat problems when taken with Aloxi.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis De tager lægemidler, der påvirker hjerteslaget.
English: Arthralgia
Danish: Artralgier
English: D. CONDITIONS OR RESTRICTIONSWITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: Pharmacokinetic information is provided in section 5.2.
Danish: Farmakokinetiske data fremgår af pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/306/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/04/306/001
English: 20 µg/kg (maximum 1.5 mg) or ondansetron (3 x 0.15 mg/kg , maximum total dose 32 mg) 30 minutes prior to the start of emetogenic chemotherapy during Cycle 1.
Danish: dosis i alt 32 mg) 30 minutter før start af emetogen kemoterapi i løbet af cyklus 1.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/306/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/04/306/003
English: What you need to know before you are given Aloxi
Danish: Det skal De vide, før De begynder at få Aloxi
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Danish: Kontakt lægen, før De tager dette lægemiddel, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: Ask your doctor or nurse for advice before being given this medicine if you are breast-feeding.
Danish: Spørg Deres læge eller sundhedspersonalet til råds, før De får dette lægemiddel, hvis De ammer.
English: Table 1: Percentage of patients a responding by treatment group and phase in the Moderately
Danish: Tabel 1: Procentdel af patientera, der responderer ud fra behandlingsgruppe og fase i studiet med moderat kvalmefremkaldende kemoterapi sammenlignet med ondansetron.
English: No dosage adjustment is necessary in patients with renal insufficiency.
Danish: Det er ikke nødvendigt med dosisreduktion hos patienter med nyreinsufficiens.
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, De vil vide.
English: • This medicine has been prescribed for you only.
Danish: • Lægen har ordineret Aloxi til Dem personligt.
English: Dermatitis allergic, pruritic rash
Danish: Allergisk dermatitis, kløende udslæt
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Danish: Kontakt lægen eller apotekspersonalet, før De tager dette lægemiddel, hvis De er i tvivl.
English: IV use
Danish: Intravenøs anvendelse
English: If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Aloxi - this is because these medicines could cause heart beat problems when taken with Aloxi.
Danish: Kontakt lægen eller apotekspersonalet, før De tager Aloxi, hvis noget af det ovenstående gælder for Dem (eller De er i tvivl).
English: Possible side effects
Danish: Ikke almindelige bivirkninger
English: NAME OF THE MARKETING AUTHORISATION HOLDER Helsinn
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: • If you have any further questions, ask your doctor or nurse.
Danish: • Spørg lægen eller sundhedspersonalet, hvis der er mere, De vil vide.
English: Delta
Danish: Administration
English: If you are allergic to peanut or soya, do not take this medicine.
Danish: De må ikke tage Aloxi, hvis De er overfølsom over for jordnødder eller soja.
English: If any of the above applies to you (or you are not sure), talk to your doctor or nurse before taking Aloxi - this is because these medicines could cause a heart beat problem when taken with Aloxi.
Danish: Kontakt lægen eller sundhedspersonalet, før De tager Aloxi, hvis noget af det ovenstående gælder for Dem (eller De er i tvivl).
English: For how long?
Danish: Hvor længe?
English: It has not been determined whether they respond differently than younger patients.
Danish: Det er ikke fastlagt, om de reagerer anderledes end yngre patienter.
English: What is multiple sclerosis?
Danish: Hvad er multipel sclerose?
English: When?
Danish: Hvornår?
English: 82.7% of these patients completed the study.
Danish: 82,7% af disse patienter gennemførte studiet.
English: • Procedures for proper handling and disposal should be observed.
Danish: • Procedurerne for korrekt håndtering og bortskaffelse skal overholdes.
English: It is also possible to develop a herpes infection for the first time.
Danish: Det er også muligt at udvikle en herpesinfektion for første gang.
English: The maximum daily dose is one infusion.
Danish: Den maksimale daglige dosis er én infusion.
English: Date of first authorisation: 12 September 2013 Date of latest renewal: 2 July 2018
Danish: Dato for første markedsføringstilladelse: 12. september 2013 Dato for seneste fornyelse: 2. juli 2018
English: 3 Estimated using a mixed model for repeated measures.
Danish: 3 Estimeret ved anvendelse af en blandet model for gentagne målinger.
English: However, these changes did not affect fertility and were therefore considered to be non-adverse.
Danish: Disse ændringer påvirkede dog ikke fertiliteten og blev derfor ikke betragtet som værende virkninger.
English: • Previously diagnosed cancer
Danish: • Tidligere diagnosticeret cancer
English: Classical biotransformation studies have not been conducted.
Danish: Der er ikke udført klassiske studier i biotransformation.
English: Percentage of Patients with CDW
Danish: Procentdel af patienter med CDW
English: Occasionally allergic reactions could occur.
Danish: I visse tilfælde kan allergiske reaktioner forekomme.
English: He/She will advise you what is right for you and your baby.
Danish: Lægen vil rådgive dig om, hvad der er bedst for dig og dit barn.
English: Therefore, it is important to tell your doctor about all medicines you are taking.
Danish: Derfor er det vigtigt, at du fortæller lægen om alle de lægemidler, du tager.
English: (to diagnose all important serious side effects listed above)
Danish: (for at diagnosticere alle de alvorlige bivirkninger, der er anført ovenfor)
English: These are conditions in which your immune system mistakenly attacks your body.
Danish: Det er tilstande, hvor dit immunsystem fejlagtigt angriber din krop.
English: This may be a serious medical condition that can be life threatening.
Danish: Dette kan være en alvorlig medicinsk tilstand, der kan være livstruende.
English: Do not freeze or shake.
Danish: Må ikke nedfryses eller rystes.
English: These results were obtained from a post hoc analysis and should be interpreted cautiously.
Danish: Resultaterne er indhentet fra en post-hoc analyse og bør tolkes med varsomhed.
English: There is 1 vial in each carton.
Danish: Der er 1 hætteglas i hver karton.
English: However, in some cases ITP developed years later.
Danish: I nogle tilfælde opstod ITP dog år senere.
English: Each infusion will take approximately 4 hours.
Danish: Hver infusion tager cirka 4 timer.
English: It is unlikely that your dose would be missed since it is administered by a health care professional.
Danish: Det er usandsynligt, at din dosis vil blive glemt, da den administreres af en sundhedsperson.
English: 88397 Biberach an der Riss GERMANY
Danish: 88397 Biberach an der Riss Tyskland
English: Your doctor will explain to you what tests you will need.
Danish: Lægen vil forklare dig, hvilke prøver du har behov for.
English: Testing is needed even if you are feeling well and your MS symptoms are under control.
Danish: Disse prøver er også nødvendige, selv om du føler dig rask, og dine MS-symptomer er under kontrol.
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C - 8°C.
Danish: Kemisk og fysisk stabilitet er påvist for 8 timer ved 2 °C - 8 °C.
English: Before treatment starts and every month after treatment
Danish: Før behandlingen starter og hver måned efter behandlingen
English: Patients with uncontrolled hypertension.
Danish: Patienter med ukontrolleret hypertension.
English: The benefits and risks of 5 or more treatment courses have not been established.
Danish: Fordele og risici ved 5 eller flere behandlingsforløb er ikke fastslået.
English: When the inflammation causes symptoms this is often called an “attack” or a “relapse”.
Danish: Når denne inflammation fremkalder symptomer, kaldes det ofte et "attak" eller et "tilbagefald".
English: You must NOT receive certain types of vaccines (live viral vaccines) if you have recently received LEMTRADA.
Danish: Du må IKKE få visse typer af vacciner (levende virusvacciner), hvis du har fået LEMTRADA for nylig.
English: If affected, stop these activities until you feel better.
Danish: Hvis dette skulle ske, skal du standse den pågældende aktivitet, indtil du får det bedre.
English: The majority of these may be due to cytokine release during infusion.
Danish: Størstedelen af disse kan skyldes frigivelse af cytokiner under infusionen.
English: The most important side effects are the autoimmune conditions described in section 2 which include:
Danish: De vigtigste bivirkninger er autoimmune tilstande, der beskrives under punkt 2, og som omfatter:
English: Educational Materials for Healthcare Providers are also available:
Danish: Der findes også oplysningsmaterialer til sundhedspersonale:
English: Until 4 years after your last LEMTRADA infusion
Danish: Indtil 4 år efter din sidste LEMTRADA-infusion
English: Two treatment courses may reduce MS activity for up to 6 years.
Danish: To behandlingsforløb kan reducere MSaktiviteten i op til 6 år.