FrancophonIA/ELRC3.0 huggingface dataset:
English: Xolair 150 mg powder and solvent for solution for injection
Danish: Xolair 150 mg pulver og solvens til injektionsvæske, opløsning
English: One syringe of 0.5 ml solution contains 75 mg omalizumab.
Danish: En fyldt injektionssprøjte på 0,5 ml opløsning indeholder 75 mg omalizumab.
English: Xolair 75 mg powder and solvent for solution for injection
Danish: Xolair 75 mg pulver og solvens til injektionsvæske, opløsning
English: Xolair 75 mg powder for solution for injection omalizumab
Danish: Xolair 75 mg pulver til injektionsvæske, opløsning omalizumab
English: One vial contains 150 mg omalizumab.
Danish: 1 hætteglas indeholder 150 mg omalizumab.
English: Common (may affect up to 1 in 10 people) - reactions at the injection site including pain, swelling, itching and redness - pain in the upper part of the tummy (in children) - headache (very common in children)
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 patienter) - reaktioner ved injektionsstedet, såsom smerte, hævelse, kløe og rødme.
English: 150 mg solution for injection in pre-filled syringe (10 x 1)
Danish: 150 mg injektionsvæske, opløsning i fyldt injektionssprøjte (10 x 1)
English: Xolair 150 mg powder and solvent for solution for injection omalizumab
Danish: Xolair 150 mg pulver og solvens til injektionsvæske, opløsning omalizumab
English: Xolair 75 mg powder and solvent for solution for injection omalizumab
Danish: Xolair 75 mg pulver og solvens til injektionsvæske, opløsning omalizumab
English: 150 mg solution for injection in pre-filled syringe (4 x 1)
Danish: 150 mg injektionsvæske, opløsning i fyldt injektionssprøjte (4 x 1)
English: 3 purple (150 mg)
Danish: 3 lilla (150 mg)
English: One syringe of 1 ml solution contains 150 mg omalizumab.
Danish: En fyldt injektionssprøjte på 1 ml opløsning indeholder 150 mg omalizumab.
English: Your Xolair 75 mg pre-filled syringe
Danish: Din Xolair 75 mg fyldte injektionssprøjte
English: Xolair 150 mg powder for solution for injection is supplied in a single-use vial.
Danish: Xolair 150 mg pulver til injektionsvæske, opløsning, leveres som et engangshætteglas.
English: 150 mg solution for injection in pre-filled syringe
Danish: 150 mg injektionsvæske, opløsning i fyldt injektionssprøjte
English: Xolair 75 mg powder for solution for injection is supplied in a single-use vial.
Danish: Xolair 75 mg pulver til injektionsvæske, opløsning, leveres som et engangshætteglas.
English: One vial contains 75 mg of omalizumab*.
Danish: Et hætteglas indeholder 75 mg omalizumab*.
English: Musculoskeletal and connective tissue disorders Rare
Danish: Knogler, led, muskler og bindevæv Sjælden
English: One vial contains 150 mg of omalizumab*.
Danish: Et hætteglas indeholder 150 mg omalizumab*.
English: 75 mg solution for injection in pre-filled syringe
Danish: 75 mg injektionsvæske, opløsning i fyldt injektionssprøjte
English: Your Xolair 150 mg pre-filled syringe
Danish: Din Xolair 150 mg fyldte injektionssprøjte
English: BLISTER OF PRE-FILLED SYRINGE
Danish: BLISTER TIL FYLDT INJEKTIONSSPRØJTE
English: Xolair 75 mg solution for injection in pre-filled syringe omalizumab
Danish: Xolair 75 mg injektionsvæske, opløsning i fyldt injektionssprøjte omalizumab
English: One vial contains 150 mg of omalizumab.
Danish: Et hætteglas indeholder 150 mg omalizumab.
English: Anaphylaxis
Danish: Serumsyge
English: One vial contains 75 mg of omalizumab.
Danish: Et hætteglas indeholder 75 mg omalizumab.
English: Xolair 150 mg solution for injection in pre-filled syringe omalizumab
Danish: Xolair 150 mg injektionsvæske, opløsning i fyldt injektionssprøjte omalizumab
English: If expired, return the entire pack to the pharmacy.
Danish: Aflevér hele pakningen til apoteket, hvis udløbsdatoen er overskredet.
English: Xolair 75 mg solution for injection in pre-filled syringe
Danish: Xolair 75 mg injektionsvæske, opløsning i fyldt injektionssprøjte
English: Keeping the vial inverted position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe.
Danish: Lad hætteglasset forblive vendt, og lad spidsen på kanylen nå bunden af opløsningen i hætteglasset, og træk opløsningen op i sprøjten.
English: The population pharmacokinetics of Xolair were analysed to evaluate the effects of demographic characteristics.
Danish: Alder, race/etnisk oprindelse, køn, body mass index Populationsfarmakokinetiske data for Xolair blev analyseret for at evaluere effekten af demografiske karakteristika.
English: Xolair 150 mg solution for injection in pre-filled syringe
Danish: Xolair 150 mg injektionsvæske, opløsning i fyldt injektionssprøjte
English: - if you are travelling to a region where infections caused by parasites are common - Xolair may weaken your resistance to such infections.
Danish: - hvis du rejser i et område, hvor parasitinfektioner er hyppige.
English: How to use the Xolair pre-filled syringe
Danish: Sådan bruger du Xolair fyldt injektionssprøjte
English: PRE-FILLED SYRINGE LABEL
Danish: ETIKET TIL FYLDT INJEKTIONSSPRØJTE
English: It's important that you do this.
Danish: Det er vigtigt, at du gør dette.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: {navn og adresse} <{tlf.}> <{fax}> <{e-mail}>
English: The reason is unclear.
Danish: Årsagen er uklar.
English: Never take only part of a tablet.
Danish: Tag aldrig kun en del af en tablet.
English: Elderly (above 65 years)
Danish: Ældre (over 65 år)
English: • if you are under 25 years old.
Danish: • hvis du er under 25 år.
English: The results are shown in Table 7.
Danish: Resultaterne fremgår af tabel 7.
English: Less than 10% is excreted unchanged in the urine.
Danish: Mindre end 10 % udskilles uændret i urinen.
English: Target Stabilisation Dose (Week 6)*
Danish: Målstabiliseringsdosis (uge 6)*
English: - The CHMP concluded that the data are supportive of the following indications:
Danish: konkluderede CHMP, at dataene understøtter følgende indikationer:
English: • when you first start treatment
Danish: • når du starter behandlingen
English: There are no data in children below 1 month of age.
Danish: Der findes ingen data om børn under 1 måned.
English: Patients should be monitored with respect to this.
Danish: Patienterne skal monitoreres med henblik på dette.
English: Dose reductions of up to 90% were required in some patients at the end of week 2.
Danish: Dosisreduktioner på op til 90 % var nødvendige hos nogle patienter i slutningen af uge 2.
English: An effect of this magnitude is not generally expected to be clinically relevant.
Danish: En effekt af denne størrelsesorden forventes generelt ikke at være klinisk relevant.
English: Symptoms of these reactions include:
Danish: Symptomer på disse reaktioner omfatter:
English: Watch out for important symptoms
Danish: Hold øje med vigtige symptomer
English: Other data sets have not confirmed this finding.
Danish: Andre datasæt har ikke bekræftet dette fund.
English: Development in children
Danish: Udvikling hos børn
English: Î Talk to your doctor, who will discuss suitable methods of contraception with you.
Danish: Î Tal med lægen, der vil drøfte egnede svangerskabsforebyggende metoder med dig.
English: Î Contact a doctor or pharmacist immediately.
Danish: Î Kontakt lægen eller apoteket omgående.
English: 37135 Verona Italy
Danish: 37135 Verona Italien
English: 82104 Bratislava Slovakia
Danish: 82104 Bratislava Slovakiet
English: These effects were observed at the expected clinical exposure.
Danish: Disse effekter blev observeret ved den forventede kliniske eksponering.
English: Î See a doctor as soon as possible or go to the nearest hospital for help.
Danish: Î skal du søge læge så hurtigt som muligt eller tage på det nærmeste hospital for at få hjælp.
English: 28760 Tres Cantos Madrid Spain
Danish: 28760 Tres Cantos Madrid Spanien
English: In addition Lamictal has been approved for use in bipolar patients in several EU member states except in the UK, Netherlands, France and Cyprus.
Danish: Desuden er Lamictal godkendt til behandling af patienter med bipolar lidelse i en række EU-medlemsstater bortset fra Det Forenede Kongerige, Nederlandene, Frankrig og Cypern.
English: • hallucinations (‘seeing' or ‘hearing' things that aren't really there)
Danish: • Hallucinationer (du ser eller hører ting, som ikke er der)
English: Inclusion criterion
Danish: Inklusionskriterium
English: • Drink all the liquid.
Danish: - Drik al væsken.
English: They smell of blackcurrant.
Danish: De lugter af solbær.
English: You may need to drink a little water at the same time to help the tablet dissolve in your mouth.
Danish: Det kan være nødvendigt at drikke lidt vand på samme tid for at opløse tabletten i munden.
English: 105 Reykjavik Iceland
Danish: 105 Reykjavik Island
English: Ljubljana Knezov stradon 90 1000 Ljubljana Slovenia
Danish: Ljubljana Knezov stradon 90 1000 Ljubljana Slovenien
English: The difference was not statistically significant: 26.3%, CI95% -2.6% <> 50.2%, p=0.07.
Danish: Forskellen var ikke statistisk signifikant: 26,3 %, CI 95 % -2,6 % <> 50,2 %, p = 0,07.
English: Stevens-Johnson Syndrome.
Danish: Stevens-Johnsons syndrom.
English: • rapid, uncontrollable eye movements (nystagmus)
Danish: • Hurtige, ukontrollerede øjenbevægelser (nystagmus)
English: However, there is an increased risk of birth defects in babies whose mothers took Lamictal during pregnancy.
Danish: Der er dog en øget risiko for fødselsdefekter hos spædbørn, hvis mødre har taget Lamictal under graviditeten.
English: • Always take the full dose that your doctor has prescribed.
Danish: • Tag altid hele den dosis, som lægen har ordineret.
English: Infants aged 2 to 26 months
Danish: Spædbørn i alderen 2 til 26 måneder
English: • your age
Danish: • Din alder
English: Approximately half of these cases have been reported as Stevens-Johnson syndrome (1 in 1000).
Danish: Ca. halvdelen af disse tilfælde er rapporteret som Stevens-Johnsons syndrom (1 ud af 1.000).
English: Time to maximum concentration is slightly delayed after food but the extent of absorption is unaffected.
Danish: Opnåelsen af den maksimal koncentration er let forsinket efter fødeindtagelse, men omfanget af absorptionen påvirkes ikke.
English: The greater the interval of time since the previous dose, the more consideration should be given to escalation to the maintenance dose.
Danish: Jo længere tid der er gået siden den foregående dosis, jo stærkere skal det overvejes at optrappe dosis til vedligeholdelsesdosis.
English: You can take it with or without food.
Danish: Lamictal kan tages sammen med eller uden mad.
English: The drug substance and the drug product have been appropriately described and generally satisfactory documentation has been provided.
Danish: Det aktive stof og lægemidlet er tilstrækkeligt beskrevet, og der er generelt fremlagt tilfredsstillende dokumentation.
English: Solna Sweden
Danish: Solna Sverige
English: Clinical efficacy and safety in children aged 1 to 24 months
Danish: Klinisk effekt og sikkerhed hos børn i alderen 1 til 24 måneder
English: Don't break, chew or crush them.
Danish: Du må ikke knække, tygge eller knuse dem.
English: In the event of overdosage, the patient should be admitted to hospital and given appropriate supportive therapy.
Danish: I tilfælde af overdosering skal patienten hospitalsindlægges og gives en passende understøttende behandling.
English: This text should be therefore moved to section 4.2, Posology and method of administration.
Danish: Denne tekst bør derfor flyttes til afsnit 4.2 om dosering og indgivelsesmåde.
English: The tablets may be slightly mottled.
Danish: Tabletterne kan være en anelse spættede.
English: Grunwaldzka 189, 60-322 Poznan, Poland.>
Danish: Grunwaldzka 189, 60-322 Poznan, Polen.
English: The age range will be modified considering that patients aged 12 years fall within the definition of adolescents.
Danish: Aldersintervallet vil blive justeret ud fra den betragtning, at patienter på 12 år hører under definitionen af unge.
English: Week 1 (beginning with addition)
Danish: Uge 1 (starter ved tilføjelsen)
English: If necessary, the dose should be adapted.
Danish: Dosis skal tilpasses, hvis det er nødvendigt.
English: Children and adolescents below 18 years
Danish: Børn og unge under 18 år
English: Extremadura, 3, Poligono Industrial Allenduero, 09400 Aranda de Duero (Burgos), Spain.>
Danish: Extremadura, 3, Poligono Industrial Allenduero, 09400 Aranda de Duero (Burgos), Spanien.
English: The impact of these changes on ovarian ovulatory activity is unknown.
Danish: Virkningen af disse forandringer på ovariets ovulatoriske aktivitet kendes ikke.
English: • if you have previously had thoughts about harming yourself or about suicide
Danish: • hvis du tidligere har haft tanker om at skade dig selv eller om selvmord
English: Children below 2 years
Danish: Børn under 2 år
English: In addition, dose-related undesirable effects should be monitored after birth.
Danish: Endvidere skal dosisrelaterede bivirkninger monitoreres efter fødslen.
English: Dose increases should not exceed this rate, unless the clinical response supports larger increases.
Danish: Dosisøgningerne må ikke overstige denne frekvens, medmindre den kliniske respons understøtter større øgninger.
English: Lamictal belongs to a group of medicines called anti-epileptics.
Danish: Lamictal tilhører en gruppe af lægemidler, der kaldes antiepileptika.
English: • whether you are taking Lamictal with other medicines
Danish: • Om du tager Lamictal sammen med andre lægemidler
English: However, based on interaction studies with other medicinal products, the following recommendations can be made:
Danish: Følgende anbefalinger, der er baseret på interaktionsforsøg med andre lægemidler, kan dog benyttes:
English: • a sore throat, or more infections (such as colds) than usual.
Danish: • Ondt i halsen eller flere infektioner (f.eks. forkølelser) end normalt.
English: MOM Park, Gesztenyes torony Hungary
Danish: MOM Park, Gesztenyes torony
English: Physiological changes during pregnancy may affect lamotrigine levels and/or therapeutic effect.
Danish: Fysiologiske forandringer under graviditeten kan påvirke niveauerne og/eller den terapeutiske effekt af lamotrigin.
English: • whether you have problems with your kidneys or liver.
Danish: • Om du har problemer med nyrerne eller leveren.
English: In addition, the assessment of quality issues has led to the harmonisation of the pharmaceutical forms (tablet and dispersible/chewable tablet) across the EU.
Danish: Desuden har vurderingen af kvalitetsspørgsmål ført til en harmonisering af lægemiddelformerne (tablet og dispergibel tablet/tyggetablet) i EU.
English: confusion, hallucinations, tics.
Danish: Konfusion, hallucinationer, tics.
English: • rifampicin, which is an antibiotic
Danish: • Rifampicin, der er et antibiotikum
English: Your doctor may also advise you to start or stop taking other medicines, depending on what condition you're being treated for and the way you respond to treatment.
Danish: Lægen kan også råde dig til at begynde eller holde op med at tage andre lægemidler, afhængigt af hvilken tilstand du behandles for, og hvordan du responderer på behandlingen.
English: • pain in your back or joints, or elsewhere.
Danish: • Smerter i ryg eller led eller andre steder.
English: The main areas of disharmony of the existing Summary of Product Characteristics concerned the Therapeutic Indications.
Danish: De væsentligste uoverensstemmelser i det eksisterende produktresumé vedrørte de terapeutiske indikationer.
English: If you have epilepsy, talk to your doctor about driving and using machines.
Danish: Hvis du har epilepsi, skal du tale med lægen om at føre motorkøretøj og betjene maskiner.
English: If you suddenly stop taking Lamictal, your epilepsy may come back or get worse.
Danish: Hvis du pludselig holder op med at tage Lamictal, kan epilepsien vende tilbage eller blive værre.
English: If you plan to start using a hormonal contraceptive:
Danish: Hvis du planlægger at begynde at bruge et hormonalt svangerskabsforebyggende middel:
English: The following convention has been utilised for the classification of undesirable effects:- Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000).
Danish: Følgende benævnelser er anvendt til klassificering af bivirkninger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000).
English: Then drink some more water to make sure you have swallowed all the medicine.
Danish: Drik herefter noget mere vand for at sikre, at du har sunket al medicinen.
English: You should not stop treatment for your epilepsy while you're pregnant.
Danish: Du må ikke ophøre med epilepsibehandlingen, mens du er gravid.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LAMICTAL AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LAMICTAL OG TILKNYTTEDE NAVNE (SE BILAG I)
English: Dose-related adverse events cannot be excluded.
Danish: Dosisrelaterede bivirkninger kan ikke udelukkes.
English: The symptoms listed above can develop into more serious problems, such as organ failure or a very severe skin condition, if they are not treated.
Danish: De ovennævnte symptomer kan udvikle sig til mere alvorlige problemer, f.eks. organsvigt eller en meget svær hudtilstand, hvis de ikke bliver behandlet.
English: It is not yet known how Lamictal works in the brain to have this effect.
Danish: Det vides endnu ikke, hvordan Lamictal udløser denne effekt i hjernen.
English: Therefore patients should be monitored for signs of suicidality during treatment with Lamictal.
Danish: Patienter bør derfor overvåges for tegn på suicidalitet under behandling med Lamictal.
English: It is likely that patients aged two to six years will require a maintenance dose at the higher end of the recommended range.
Danish: Børn i alderen 2-6 år vil sandsynligvis have behov for en vedligeholdelsesdosis i den øvre ende af det anbefalede interval.
English: Serum levels were measured at the end of week 2 of titration and the subsequent dose either reduced or not increased if the concentration exceeded 0.41 µg/mL, the expected concentration in adults at this time point.
Danish: Serumniveauet blev målt i slutningen af uge 2 med titrering, og den efterfølgende dosis blev enten reduceret eller blev ikke øget, hvis koncentrationen oversteg 0,41 µg/ml, hvilket er den forventede koncentration hos voksne på dette tidspunkt.
English: Lamotrigine may induce its own metabolism but the effect is modest and unlikely to have significant clinical consequences.
Danish: Lamotrigin kan inducere sin egen metabolisering, men effekten er beskeden og har sandsynligvis ingen signifikante kliniske konsekvenser.
English: Like all medicines, Lamictal can cause side effects, but not everyone gets them.
Danish: Lamictal kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Suicidality analysis
Danish: Selvmordsanalyser
English: However, both sections should be consulted when considering the overall safety profile of lamotrigine.
Danish: Begge afsnit skal dog gennemgås, når den samlede sikkerhedsprofil af lamotrigin bedømmes.
English: Your doctor will start you on a low dose, and gradually increase the dose over a few weeks until you reach a dose that works for you (called the effective dose).
Danish: I første omgang vil lægen ordinere en lav dosis og herefter gradvist øge denne dosis over nogle få uger, indtil du når en dosis, der passer til dig (også kaldet den effektive dosis).
English: - Quality aspects
Danish: - Kvalitetsaspekter
English: Therefore lamotrigine serum concentrations should be monitored before, during and after pregnancy, as well as shortly after birth.
Danish: Derfor skal serumkoncentrationen af lamotrigin monitoreres før, under og efter graviditeten samt lige efter fødslen.
English: It should be also underlined that lamotrigine is not indicated for acute treatment.
Danish: Det bør desuden understreges, at lamotrigin ikke er indiceret til akut behandling.
English: The excipients used in the formulations of the drug product and manufacturing processes are standard for the proposed pharmaceutical forms.
Danish: De hjælpestoffer, som anvendes ved formuleringen af lægemidlet og i fremstillingsprocessen, er standardtyper for de foreslåede lægemiddelformer.
English: Acute ingestion of doses in excess of 10 to 20 times the maximum therapeutic dose has been reported.
Danish: Der er rapporteret om akut indtagelse af doser på over 10 til 20 gange den maksimale terapeutiske dosis.
English: There are no data on the effect of lamotrigine on growth, sexual maturation and cognitive, emotional and behavioural developments in children.
Danish: Der findes ingen data på effekten af lamotrigin på børns vækst, modning og kognitiv, følelsesmæssig samt adfærdsmæssig udvikling.
English: If you chew the tablet:
Danish: Hvis du tygger tabletten:
English: The IC50 was approximately nine-times above the maximum therapeutic free concentration.
Danish: IC50-værdierne var ca. ni gange højere end den maksimale terapeutiske frie koncentration.
English: Lamictal tablets should be swallowed whole, and should not be chewed or crushed.
Danish: Lamictal-tabletterne skal synkes hele og må ikke tygges eller knuses.
English: Weeks 1 + 2 Weeks 3 + 4 Week 5
Danish: Uge 1 + 2 Uge 3 + 4 Uge 5
English: - The Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee
Danish: - de produktresuméer og den etikettering og indlægsseddel, der er foreslået af indehaverne af markedsføringstilladelsen, er vurderet på baggrund af den indsendte dokumentation og udvalgets videnskabelige drøftelse,
English: Lamictal can also affect the way hormonal contraceptives work, although it's unlikely to make them less effective.
Danish: Lamictal kan også påvirke den måde, som hormonale svangerskabsforebyggende midler virker på, selvom det ikke er sandsynligt, at de bliver mindre effektive.
English: These symptoms are more likely to happen during the first few months of treatment with Lamictal, especially if you start on too high a dose or if your dose is increased too quickly, or if you're taking Lamictal with another medicine called valproate.
Danish: Der er størst sandsynlighed for, at disse symptomer opstår i løbet af de første måneder af behandlingen med Lamictal, særligt hvis du får en for høj dosis til at starte med, hvis din dosis bliver øget for hurtigt, eller hvis du tager Lamictal sammen med et andet lægemiddel, der hedder valproat.
English: The CHMP concluded that conversion to monotherapy is not an indication but information on correct use of the product.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at overgangen til monoterapi ikke er en indikation, men blot information om korrekt anvendelse af lægemidlet.
English: The volume of distribution is 0.92 to 1.22 L/kg.
Danish: Fordelingsvolumenet er ca. 0,92-1,22 l/kg.
English: Important information about some of the ingredients of Lamictal Lamictal tablets contain small amounts of a sugar called lactose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Lamictal Lamictal-tabletterne indeholder små mængder af en sukkerart, der kaldes lactose.
English: But you should still talk to your doctor first, if you want to stop taking Lamictal.
Danish: Du skal dog stadig rådføre dig med lægen først, hvis du ønsker at holde op med at tage Lamictal.
English: If necessary, the dose should be adapted to maintain the lamotrigine serum concentration at the same level as before pregnancy, or adapted according to clinical response.
Danish: Hvis det er nødvendigt, skal dosis tilpasses, så serumkoncentrationen af lamotrigin holdes på det samme niveau som før graviditeten eller tilpasses i overensstemmelse med den kliniske respons.
English: Lamictal can cause dizziness and double vision.
Danish: Lamictal kan forårsage svimmelhed og dobbeltsyn.
English: Some patients may experience severe seizures, which may cause serious health problems.
Danish: Nogle patienter kan opleve svære epileptiske anfald, som kan give alvorlige helbredsproblemer.