FrancophonIA/ELRC3.0 huggingface dataset:
English: - Severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation which may occur very rarely following treatment with antibiotics.
Danish: inklusive allergisk chok eller alvorlig sygdom i huden ledsaget af røde pletter og blærer - Alvorlig, vedvarende eller blodig diarré ledsaget af mavesmerter eller feber, som kan være tegn på alvorlig maveinfektion som kan opstå i meget sjældne tilfælde i forbindelse med antibiotikabehandling - Tegn eller symptomer på hepatitis (leverbetændelse)såsom gulfarvning af hud og øjne, mørk urin, kløe, tab af appetit eller mavesmerter.
English: POSSIBLE SIDE EFFECTS
Danish: HVILKE MULIGE BIVIRKNINGER LEVVIAX HAR
English: Hypromellose 6 cp Titanium dioxide E171 Yellow iron oxide E172 Red iron oxide E172
Danish: Titandioxid (E171)
English: Tablet core:
Danish: Nedsat nyrefunktion:
English: During post-marketing experience the following reactions have been reported (frequency unknown): -Immune system disorders: Angioneurotic oedema, anaphylactic reactions including anaphylactic shock -Cardiac disorders: QT/QTc interval prolongation -Gastrointestinal disorders: Pancreatitis, -Hepato-biliary disorders: Severe hepatitis and liver failure (see section 4.4) -Nervous system disorders: Cases of rapid onset of exacerbation of myasthenia gravis have been reported (see sections 4.3 and 4.4).
Danish: Fra erfaringen i markedsføringsperioden er følgende reaktioner blevet rapporteret (frekvens ukendt): - Forstyrrelser i immunsystemet: Angioneurotisk ødem, anafylaktiske reaktioner inklusive anafylaktisk shock.
English: Streptococcus pneumoniae * Viridans group streptococci Aerobic Gram- negative bacteria
Danish: Streptococcus pneumoniae *
English: Flush Palpitations
Danish: Blussen, palpitationer
English: -Paediatric patients
Danish: -Ældre forsøgspersoner
English: Pharmacotherapeutic group: macrolides, lincosamides and streptogramins, ATC Code: J01FA15.
Danish: Farmakoterapeutisk klassifikation: Macrolider, lincosamider og streptogramin, ATC-kode: J01FA15 Telithromycin er et semisyntetisk derivat af erythromycin A, og tilhører gruppen af ketolider, en ny gruppe af antibakterielle midler beslægtet med macrolider.
English: The major CYP450 enzyme involved in the metabolism of telithromycin is CYP3A4.
Danish: Telithromycin metaboliseres både af CYP450.
English: Eczema
Danish: Diarré
English: Please tell your doctor if you are taking or have recently taken any other medecines, including medicines obtained without a prescription, as some of them could have an interaction with Levviax.
Danish: Visse typer medicin kan påvirke effekten af Levviax og omvendt Hvis De tager eller for nylig har taget andre lægemidler, bør De oplyse Deres læge eller apotek herom, også hvis der er tale om ikke-receptpligtige lægemidler.
English: Italia sanofi-aventis S.p.A. Tel. +39 02 393 91
Danish: Tel. +39 02 393 91
English: - Signs and symptoms of hepatitis (liver disease) such as yellowing of skin and eyes, dark urine,
Danish: - Sygdomme i lever- og galdeveje:Alvorlig hepatitis og leversvigt (se pkt.
English: Muscle cramps
Danish: Chlamydia psittaci
English: Available as pack of 5 x 2 tablets.
Danish: Hvert blisterhul indeholder 2 tabletter.
English: Croscarmellose sodium Magnesium stearate
Danish: Croscarmellosenatrium
English: Other side effects which may commonly (1 to 10 out of 100 patients) occur with Levviax are:
Danish: Andre bivirkninger som kan forekomme med Levviax er:
English: Mode of action
Danish: Virkningsmekanisme
English: Telithromycin interferes with the ribosome translation at the 23S ribosomal RNA level, where it interacts with domain V and II.
Danish: hvor det interagerer med område V og II.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Levviax 400 mg film-coated tablets
Danish: Levviax 400 mg filmovertrukne tabletter Telithromycin
English: please tell your doctor or pharmacist.
Danish: De bør konsultere Deres læge eller apotek, hvis De er usikker.
English: Staphylococcus aureus methicillin susceptible (MSSA)*
Danish: Haemophilus parainfluenzae
English: cannot be estimated from the available data
Danish: kan ikke estimeres ud fra de tilgængelige data
English: You may be more likely to think like this:
Danish: Det er mere sandsynligt, at du tænker sådan,
English: • if you have, or have ever had one of the following conditions.
Danish: • hvis du har eller har haft en af følgende tilstande.
English: Therefore the following wording was recommended:
Danish: Derfor anbefales følgende formulering:
English: The general wording on absence of interactions should not be included.
Danish: Den generelle formulering om fraværet af interaktioner skal ikke medtages.
English: This FDA Guidance was superseded in 1998.
Danish: Denne FDA-vejledning blev erstattet i 1998.
English: This is most likely to occur within the first few weeks of treatment.
Danish: Dette vil mest sandsynligt ses inden for de første få uger af behandlingen.
English: Drink the mixture all at once.
Danish: Drik blanding på én gang.
English: The low number of post-marketing reports does not justify this either.
Danish: Det lave antal indberetninger efter markedsføringen retfærdiggør heller ikke dette.
English: Your doctor will decide when treatment can be stopped.
Danish: Lægen vil afgøre, hvornår behandlingen kan stoppes.
English: The warning at section 4.5 seems sufficient for its purpose.
Danish: Advarslen i afsnit 4.5 forekommer tilstrækkelig til formålet.
English: Fatal cases mostly concerned patients with an age above 65.
Danish: De fatale tilfælde omhandlede hovedsageligt patienter over 65 år.
English: The recommended dose is the same as that for adults.
Danish: Den anbefalede dosis er den samme som for voksne.
English: The following sections of the Product Information were addressed during this harmonisation procedure.
Danish: Følgende afsnit af produktinformationen blev behandlet under harmoniseringsproceduren.
English: Treatment with an adequate dose should result in a positive response within 2-4 weeks.
Danish: Behandling med den rette dosis bør resultere i positivt respons indenfor 2-4 uger.
English: The dose is usually the same for all ages.
Danish: Dosis er normalt den samme for alle aldersgrupper.
English: When can you expect to start feeling better
Danish: Hvornår kan du forvente en forbedring
English: If you stop too early, your depression might come back.
Danish: Hvis du stopper behandlingen for tidligt, kan din depression vende tilbage.
English: • if you are a young adult.
Danish: • hvis du er ung.
English: Take your next dose at the normal time.
Danish: Tag den næste dosis til normal tid.
English: The pump is now ready for use.
Danish: Pumpen er nu klar til brug.
English: • if you are an elderly person.
Danish: • hvis du er ældre.
English: The CHMP considered that the addition of “in adults” was not acceptable.
Danish: CHMP vurderede, at tilføjelsen af "hos voksne" ikke var acceptabel.
English: Conditions which need supervision
Danish: Tilstande der kræver overvågning
English: Steady state is reached after 3-4 days, after which there is no further accumulation.
Danish: Steady-state nås efter 3-4 dage, hvorefter der ikke sker yderligere akkumulation.
English: Increase in appetite1
Danish: Øget appetit1
English: You may need to press the nozzle more than once to get the dose your doctor has prescribed (see picture).
Danish: Det kan være du skal trykke mere end én gang for at få den dosis lægen har ordineret (se billedet).
English: If there is no response within a further 2-4 weeks, then treatment should be stopped.
Danish: Hvis der ikke er respons efter yderligere 2-4 uger, bør behandlingen afbrydes.
English: The CHMP considered that the proposed wording under bullet point a and b were acceptable.
Danish: CHMP vurderede, at den foreslåede formulering under punkt a og b var acceptabel.
English: Treatment of episodes of major depression.
Danish: Behandling af episoder med major depression.
English: Some side effects are more likely to occur than others.
Danish: Nogle bivirkninger forekommer hyppigere end andre.
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Danish: Det er en generel klinisk erfaring, at risikoen for selvmord kan øges i de tidlige stadier af bedring.
English: The possible side effects of Remeron are listed below and can be divided as:
Danish: De mulige bivirkninger af Remeron er nævnt nedenfor og kan opdeles i:
English: Your doctor will tell you how to decrease the dose gradually.
Danish: Lægen vil fortælle dig, hvordan du nedtrapper dosis gradvist.
English: You are advised not to drink any alcohol.
Danish: Det anbefales derfor, at du ikke drikker alkohol.
English: This risk persists until significant remission occurs.
Danish: Denne risiko vedvarer, indtil der forekommer tydelig bedring.
English: Accordingly hyponatraemia and SIADH are already described under 4.4 Special warnings.
Danish: Derfor er hyponatriæmi og SIADH allerede beskrevet under 4.4 Særlige advarsler.
English: 167 77 Athens, Greece
Danish: 167 77 Athens,
English: It is therefore proposed to keep this warning in the corresponding section, section 4.4.
Danish: Derfor foreslås det at beholde denne advarsel i det tilsvarende afsnit, afsnit 4.4.
English: Usually Remeron will start working after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better.
Danish: Normalt begynder Remeron at virke efter en til to uger, og efter 2 til 4 uger kan du mærke en forbedring.
English: It is therefore sometimes difficult to ascertain which symptoms are a result of the illness itself and which are a result of treatment with Remeron.
Danish: Det er undertiden vanskeligt at skelne, hvilke symptomer der er en følge af selve sygdommen, og hvilke der er en følge af behandling med Remeron.
English: • Hold a glass or cup under the nozzle (see picture).
Danish: • Hold et glas eller en kop under tuden (se billedet).
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Danish: Da bedring ikke nødvendigvis forekommer i løbet af de første uger eller mere af behandlingen, bør patienter monitoreres tæt, indtil en sådan bedring forekommer.
English: 2 years Shelf life after first opening of the bottle: 6 weeks
Danish: 2 år Efter åbning af flasken: 6 uger
English: Make sure these abilities are not affected before you drive or operate machinery.
Danish: Vær sikker på, at disse evner ikke er påvirkede, inden du færdes i trafikken eller arbejder med maskiner.
English: Somnolence1, 4 Sedation1, 4
Danish: Somnolens1, 4 Sedation1, 4
English: Activated charcoal or gastric lavage should also be considered.
Danish: Aktivt kul eller maveudskylning bør også overvejes.
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Danish: Hos patienter, som udvikler disse symptomer, kan øgning af dosis være skadelig.
English: In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response.
Danish: Hos ældre patienter bør en dosisøgning iværksættes under nøje overvågning med henblik på at fremkalde et tilfredsstillende og sikkert respons.
English: While rare, these symptoms most commonly appear after 4-6 weeks of treatment.
Danish: Symptomerne, der er sjældne, forekommer oftest efter 4-6 ugers behandling.
English: Like all medicines, Remeron can cause side effects, although not everybody gets these side effects.
Danish: Remeron kan som al anden medicin give bivirkninger, men ikke alle får disse bivirkninger.
English: Suicidal ideation6 Suicidal behaviour6
Danish: Selvmordstanker6 Selvmordsadfærd6
English: Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Danish: Patienter med depression bør behandles over en tilstrækkelig lang periode på mindst 6 måneder for at sikre symptomfrihed.
English: Finally, the cimetidine interaction study should be included in section 4.5.
Danish: Endelig skal undersøgelsen af interaktion med cimetidin medtages i afsnit 4.5.
English: Despite this, in special cases your doctor may prescribe Remeron for you because it may be in the best interest of you and your child.
Danish: Trods dette kan din læge i særlige tilfælde ordinere Remeron til dig, da det kan være for dit eget og dit barns bedste.
English: You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet.
Danish: Det kan være en hjælp at fortælle et familiemedlem eller en nær ven, at du er deprimeret, og bede vedkommende læse denne indlægsseddel.
English: The higher dose should be taken before you go to bed.
Danish: Den største dosis bør tages inden du går i seng.
English: Usually you will need to take Remeron until your symptoms of depression have disappeared for 4 to 6 months.
Danish: Normalt skal du tage Remeron indtil depressionssymptomerne har været forsvundet i 4 til 6 måneder.
English: With an insufficient response, the dose can be increased up to the maximum dose.
Danish: Ved insufficient respons kan dosis øges til maksimal dosering.
English: EXP Do not use the bottle more than 6 weeks after opening.
Danish: EXP Anvend ikke flasken mere end 6 uger efter åbningen.
English: Hence it is proposed not to include MAO-inhibitors as absolute contraindication in section 4.3.
Danish: Dermed foreslås det, at MAO-inhibitorer ikke medtages som absolut kontraindikation i afsnit 4.3.
English: Just skip it.
Danish: Spring den over.
English: Insulin and/or oral hypoglycaemic dosage may need to be adjusted and close monitoring is recommended.
Danish: Dosering af insulin og/eller orale hypoglykæmiske midler må muligvis justeres og tæt monitorering anbefales.
English: You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Danish: Du kan også bede vedkommende om at fortælle dig det, hvis han eller hun synes, at din depression bliver værre, eller hvis han eller hun er bekymret for ændringer i din adfærd.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF REMERON AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF REMERON OG TILKNYTTEDE NAVNE (SE BILAG I)
English: The usual starting dose is 15 or 30 mg every day.
Danish: Den almindelige begyndelsesdosis er 15 eller 30 mg daglig.
English: In reproductive toxicity studies in rats and rabbits no teratogenic effects were observed.
Danish: I reproduktive toksicitetsstudier på rotter og kaniner påvistes ingen teratogen effekt.
English: Even though they have been reported as withdrawal symptoms, it should be realized that these symptoms may be related to the underlying disease.
Danish: Selvom de er rapporteret som seponeringssymptomer, bør man være opmærksom på, at disse symptomer kan være relateret til en underliggende sygdom.
English: However, the CHMP did not consider this explanation acceptable and requested that the applicant/MAH should argue why these contraindications are not absolute.
Danish: Men CHMP vurderede ikke denne forklaring til at være acceptabel og anmodede om, at ansøgeren/indehaveren af markedsføringstilladelsen skal argumentere for, hvorfor disse kontraindikationer ikke er absolutte.
English: The nozzle has two positions - locked and open.
Danish: Tuden har to indstillingsmuligheder - åben og lukket.
English: The Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product (EMEA/CHMP/QWP/396951/2006) and the above mentioned guideline (CHMP/463/00) indicate which excipients and information should appear in the labelling.
Danish: Retningslinjen vedrørende hjælpestoffer i dokumentationen til en ansøgning om markedsføringstilladelse for et lægemiddel (EMEA/CHMP/QWP/396951/2006) samt ovennævnte retningslinje (CHMP/463/00) angiver, hvilke hjælpestoffer og oplysninger der skal fremgå af etiketteringen.
English: monitoring for signs of beginning serotonergic overstimulation maintained is warranted.
Danish: Overvågning af tegn på begyndende serotonerg overstimulation er påkrævet.
English: - When the depressive phase of bipolar disorder is being treated, it can transform into the manic phase.
Danish: - Når den depressive fase ved bipolar lidelse behandles, kan den ændre sig til manisk fase.
English: The plastic films contain: PVC (polyvinyl chloride), polyamide and polyester.
Danish: Plastikfilmen indeholder: PVC (polyvinyl chlorid), polyamid og polyester.
English: However, there is a possibility of more serious outcomes (including fatalities) at dosages much higher than the therapeutic dose, especially with mixed overdoses.
Danish: Alvorligere følger (inklusive dødsfald) er dog mulige ved doser, der er meget højere end den terapeutiske dosis, specielt i tilfælde af blandingsoverdosering.
English: Do not use the bottle more than 6 weeks after opening.
Danish: Anvend ikke flasken mere end 6 uger efter den er åbnet.
English: - low blood pressure.
Danish: - Lavt blodtryk.
English: The CHMP considered that the explanations provided appear scientifically sound and justified, noting that the aspartame content of the product is adequately addressed in the proposed form
Danish: CHMP vurderede, at de tilvejebragte forklaringer virkede fagligt forsvarlige og berettigede, og noterer, at aspartamindholdet i produktet imødekommes tilstrækkeligt i den foreslåede form.
English: Pour a little water into a glass or cup, and hold it under the nozzle.
Danish: Hæld lidt vand i et glas eller en kop og hold det under tuden.
English: These symptoms can be avoided by stopping gradually.
Danish: Disse symptomer kan undgås ved at nedtrappe dosis gradvist.
English: The nozzle can then be released and the pump is ready for the following dose.
Danish: Tuden kan derefter slippes og pumpe er klar til den følgende dosis.
English: The majority of withdrawal reactions are mild and self-limiting.
Danish: Størstedelen af disse symptomer er milde og selvbegrænsende.
English: If your doctor has prescribed Remeron for a patient under 18 and you want to discuss this, please go back to your doctor.
Danish: Hvis din læge har ordineret Remeron til en patient under 18 år, og du ønsker at drøfte dette, skal du henvende dig til lægen.
English: The CHMP considered this explanation to be acceptable and the issue was resolved.
Danish: CHMP vurderede denne forklaring til at være acceptabel, og spørgsmålet blev således afklaret.
English: If so, you must talk to your doctor as soon as you can before taking Remeron.
Danish: Hvis det er tilfældet, skal du kontakte lægen så hurtigt som muligt inden du indtager Remeron.
English: Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself.
Danish: Selvmordstanker og forværring af din depression Hvis du er deprimeret, kan du af og til tænke på at skade dig selv eller begå selvmord.
English: Pathological alterations of blood count
Danish: Patologiske ændringer i blodtællingen
English: Remeron can affect your concentration or alertness.
Danish: Remeron kan påvirke din koncentration og opmærksomhed.
English: Remeron oral solution contains 0.3 % v/v ethanol.
Danish: Remeron oral opløsning indeholder 0,3 % v/v ethanol.
English: Despite this, your doctor may prescribe Remeron for patients under 18 because he/she decides that this is in their best interests.
Danish: Trods dette kan din læge ordinere Remeron til patienter under 18 år, hvis han/hun beslutter, at det er i deres bedste interesse.
English: The oral solution should not be mixed with fluids other than water.
Danish: Oral opløsning må ikke blandes med anden væske end vand.
English: This medicinal product is authorised in the Member States of the EEA under the following names: [not applicable for art 30 referral]
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: [ikke relevant for art 30]
English: Do not take Remeron while you are pregnant.
Danish: Tag ikke Remeron, mens du er gravid.
English: Remeron is used to treat depressive illness.
Danish: Remeron anvendes til behandling af depression.
English: In case of combination it is advised that a doctor monitors your blood carefully.
Danish: Hvis denne kombination anvendes, tilrådes det, at lægen omhyggeligt kontrollerer dit blod.
English: Given the very low incidence of the most serious condition, i.e. agranulocytosis (independent from the question of causality or whether it surpasses the background incidence), this is not an absolute contraindication and should not be included in section 4.3
Danish: I betragtning af den lave hyppighed af den alvorligste tilstand, dvs. agranulocytose (uafhængigt af spørgsmålet om årsagen, eller om det overstiger baggrundshyppigheden), er dette ikke en absolut kontraindikation og skal ikke inkluderes i afsnit 4.3.
English: Aspartame may be/is considered contraindicated in infants, but mirtazapine is not to be used in this age category and, consequently, requires no further warning.
Danish: Aspartam (kan) betragtes som kontraindiceret til børn, men mirtazapin må ikke anvendes i denne aldersgruppe og kræver dermed ingen yderligere advarsel.
English: Remeron has minor or moderate influence on the ability to drive and use machines.
Danish: Remeron påvirker i mindre til moderat grad evnen til at føre bil og betjene maskiner.
English: Remeron may impair concentration and alertness (particularly in the initial phase of treatment).
Danish: Remeron kan svække koncentrationsevnen og årvågenheden (især i begyndelsen af behandlingen).
English: Depressed patients display a number of symptoms that are associated with the illness itself.
Danish: Deprimerede patienter har en række symptomer pga. selve sygdommen.
English: Extension phases of these trials have been excluded to maintain comparability to placebo treatment.
Danish: Forlængede faser i disse forsøg er udelukket for at bevare sammenligneligheden med placebo-behandlingen.
English: • if you have previously had thoughts about killing or harming yourself.
Danish: • hvis du tidligere har haft selvmordstanker eller tanker om at gøre skade på dig selv,
English: Mirtazapine has an elimination half-life of 20-40 hours and therefore Remeron is suitable for once daily administration.
Danish: Mirtazapin har en elimineringshalveringstid på 20-40 timer, og derfor er Remeron velegnet til indtagelse én gang daglig.
English: Your doctor may advise you to increase your dose after a few days to the amount that is best for you (between 15 and 45 mg per day).
Danish: Din læge kan råde dig til at forhøje din dosis (mellem 15 og 45 mg daglig) efter nogle få dage, for at du opnår den dosis, der er bedst for dig.
English: The frequencies of the adverse reactions from spontaneous reporting are based on the reporting rate of these events in the clinical trials.
Danish: Hyppigheden af bivirkningerne fra spontan rapportering er baseret på rapporteringsraten for disse hændelser i de kliniske forsøg.
English: 5 Upon treatment with antidepressants in general, anxiety and insomnia (which may be symptoms of depression) can develop or become aggravated.
Danish: 5 Ved behandling med antidepressiva generelt, kan angst og søvnløshed (der kan være symptomer på depression) udvikle sig eller blive forværret.
English: This leaflet was last revised/approved in.
Danish: Denne indlægsseddel blev senest revideret/godkendt i
English: If you are supposed to take your dose twice a day
Danish: Hvis du skal tage din dosis to gange daglig
English: MAO-inhibitors
Danish: MAO-inhibitorer
English: In very rare cases these can be signs of serotonin syndrome.
Danish: I meget sjældne tilfælde kan dette være tegn på serotonergt syndrom.
English: MAO-inhibitors are therefore relatively contra-indicated with Remeron.
Danish: MAOinhibitorer er derfor relativt kontraindiceret med Remeron.
English: Maistraatinportti 2 00240 Helsinki, Finland
Danish: Oy Organon Ab Maistraatinportti 2 00240 Helsinki, Finland