FrancophonIA/ELRC3.0 huggingface dataset:
English: Early signs of hypersensitivity are: flushing, rash, severe itching of the skin (with raised lumps), wheezing, difficulty in breathing with or without swelling of the face, lips, tongue and/or throat, difficulty in swallowing, fast heart beat, low blood pressure, fast decrease in blood pressure.
Danish: Tidlige symptomer på overfølsomhed er: anfaldsvis rødme af huden i ansigtet, udslæt, alvorlig hudkløe (med hævede områder), hvæsende vejrtrækning, vejrtrækningsbesvær med eller uden hævelse af ansigt, læber, tunge og/eller svælg, synkebesvær, hurtig hjerterytme (puls), lavt blodtryk, hurtigt blodtryksfald.
English: Symptoms may include erythema, rash, urticaria, pruritus, angioedema, tachycardia, hypotension or dyspnoea.
Danish: Symptomerne kan omfatte erytem, udslæt, urticaria, pruritus, angioødem, takykardi, hypotension eller dyspnø.
English: Females, patients with hypersensitivity to other drugs or with a history of allergy may be at a higher risk.
Danish: Kvinder, patienter med overfølsomhed over for andre lægemidler eller med allergi i anamnesen kan have en højere risiko.
English: Pharmacokinetic drug interaction studies with the CYP2D6 substrate dextromethorphan indicate that tolperisone co-administration may increase the blood levels of drugs which are metabolised dominantly by CYP2D6 such as thioridazine, tolterodine, venlafaxine, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine.
Danish: Farmakokinetiske interaktionsstudier med CYP2DC6-substratet dextromethorphan indikerer, at samtidig administration af tolperison kan øge plasmakoncentrationen af lægemidler, som hovedsageligt metaboliseres af CYP2D6, såsom thioridazin, tolterodin, venlafaxin, atomoxetin, desipramin, dextromethorphan, metoprolol, nebivolol og perphenazin.
English: During post marketing experience with medicinal products containing tolperisone (the active substance of {invented name}) the most frequently reported side effects were hypersensitivity reactions.
Danish: Fra erfaring efter markedsføring af lægemidler, der indeholder tolperison (det aktive stof i {produktnavn}), var de hyppigst indberettede bivirkninger overfølsomhedsreaktioner.
English: According to these data, the most frequently concerned system organ classes are skin and subcutaneous tissue disorders, general disorders, neurological disorders and gastrointestinal disorders.
Danish: Ifølge disse data er de hyppigst involverede systemorganklasser hud- og subkutant væv, almene symptomer, neurologiske forstyrrelser og mave-tarm-kanalen.
English: Tolperisone potentiates the effect of niflumic acid, therefore reduction of the dose of niflumic acid or other NSAID should be considered in case of co-administration.
Danish: Tolperison potenserer nifluminsyres virkning; ved samtidig administration bør nifluminsyredosis reduceres eller andre NSAID'ere overvejes.
English: Symptomatic treatment of post-stroke spasticity in adults.
Danish: Symptomatisk behandling af voksne med spasticitet efter apopleksi.
English: Tolperisone must not be re-administered after an episode of hypersensitivity to tolperisone.
Danish: Tolperison må ikke re-administreres efter et tilfælde med overfølsomhed over for tolperison.
English: 4.7 Effects on ability to drive and use machines [the wording below should be inserted]
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner [ordlyden nedenfor skal indsættes]
English: How to take Tolperisone film-coated tablet
Danish: Sådan skal du tage Tolperison
English: If you have a known allergy for lidocaine you have a higher risk to be allergic to tolperisone.
Danish: Du har højere risiko for at være allergisk over for tolperison, hvis du er allergisk over for lidocain.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion [ordlyden nedenfor skal indsættes]
English: Females, patients in older age, or treated with concomitant medications (mainly with NSAIDs) seem to be at a higher risk to experience hypersensitivity reactions.
Danish: Kvinder, ældre patienter og patienter, der samtidig fik andre lægemidler (hovedsageligt NSAID'ere), synes at have en højere risiko for at få overfølsomhedsreaktioner.
English: Hypersensitivity reactions ranged from mild skin reactions to severe systemic reactions including anaphylactic shock.
Danish: Overfølsomhedsreaktionerne varierede fra lette hudreaktioner til alvorlige systemiske reaktioner, herunder anafylaktisk shock.
English: Patients who experience dizziness, somnolence, disturbance in attention, epilepsy, blurred vision or muscular weakness while taking tolperisone should consult his/her doctor.
Danish: Patienter, der oplever svimmelhed, døsighed, nedsat opmærksomhed, epilepsi, sløret syn eller muskelsvaghed, mens de tager tolperison, bør informeres om at kontakte deres læge.
English: 4.2 Posology and method of administration [the wording below should be inserted]
Danish: 4.2 Dosering og administration [ordlyden nedenfor skal indsættes]
English: [the wording below should be deleted, as relevant]
Danish: [ordlyden nedenfor skal indsættes]
English: Hypersensitivity to the active substance tolperisone or to the chemically similar eperisone or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof tolperison, over for det kemisk lignende stof eperison eller et eller flere af hjælpestofferne anført i pkt.
English: Increase in tolperisone exposure is not expected after concomitant administration of CYP2D6 substrates and/or other drugs due to the diversity of the metabolic pathways of tolperisone.
Danish: Som følge af tolperisons mangfoldige metaboliske veje forventes der ikke øget eksponering for tolperison efter samtidig administration af CYP2D6-substrater og/eller andre lægemidler.
English: What {invented name} is and what it is used for Tolperisone is a medication that acts on the central nervous system.
Danish: Tolperison er et lægemiddel, der virker på centralnervesystemet.
English: It is for the treatment of the pathologically elevated skeletal muscle tone after a stroke in adults.
Danish: Det bruges til behandling af voksne med øget spænding i skeletmuskulaturen (muskelspasmer) efter slagtilfælde.
English: If you are allergic to the active substance (tolperisone hydrochloride) or to medicines containing eperisone or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal du vide, før du begynder at tage {produktnavn} Tag ikke {produktnavn} hvis du er allergisk over for det aktive stof (tolperisonhydrochlorid), over for lægemidler, der indeholder eperison, eller over for et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt
English: Paediatric population The safety and efficacy of tolperisone in children have not been established.
Danish: Pædiatrisk population Tolperisons sikkerhed og virkning hos børn er ikke klarlagt.
English: Therefore, individual titration with close monitoring of the patient's condition and renal function is recommended in patients with moderate renal impairment.
Danish: Derfor tilrådes individuel dosistitrering med nøje monitorering af patientens tilstand og leverfunktion hos patienter med moderat nedsat leverfunktion.
English: Your regular medical follow-up will include frequent monitoring of liver function and your condition during therapy with Tolperisone because a higher frequency of adverse events has been observed in this patient group.
Danish: De regelmæssige efterundersøgelser hos lægen vil omfatte hyppig overvågning af din leverfunktion og din almentilstand under behandling med tolperison, da bivirkninger er set hyppigere i denne patientgruppe.
English: Use in children and adolescents The safety and efficacy of Tolperisone in children have not been established.
Danish: Brug til børn og teenagere Tolperisons sikkerhed og virkning hos børn er ikke klarlagt.
English: During post marketing experience with tolperisone the most frequently reported adverse reactions were hypersensitivity reactions.
Danish: De hyppigst rapporterede bivirkninger fra erfaring med tolperison efter markedsføring var overfølsomhedsreaktioner.
English: Experience in patients with renal impairment is limited and a higher frequency of adverse events has been observed in this patient group.
Danish: Erfaring med patienter, der har nedsat nyrefunktion, er begrænset, og der er observeret hyppigere forekomst af bivirkninger hos denne patientgruppe.
English: Your regular medical follow-up will include frequent monitoring of kidney function and your condition during therapy with {invented name} because a higher frequency of adverse events has been observed in this patient group.
Danish: De regelmæssige efterundersøgelser hos lægen vil omfatte hyppig overvågning af din nyrefunktion og din almentilstand under behandling med {produktnavn}, da bivirkninger er set hyppigere i denne patientgruppe.
English: Children and adolescents The safety and efficacy of tolperisone in children have not been established.
Danish: Børn og teenagere Tolperisons sikkerhed og virkning hos børn er ikke klarlagt.
English: In case of a known hypersensitivity to lidocaine increased caution during the administration of tolperisone because of possible cross-reactions is warranted.
Danish: Der skal udvises større forsigtighed ved administration af tolperison til patienter med overfølsomhed over for lidocain, da der er risiko for krydsreaktioner.
English: Experience in patients with hepatic impairment is limited and a higher frequency of adverse events has been observed in this patient group.
Danish: Erfaring med patienter, der har nedsat leverfunktion, er begrænset, og der er observeret hyppigere forekomst af bivirkninger hos denne patientgruppe.
English: Hypersensitivity reactions ranged from mild skin reactions to severe systemic reactions (e.g. allergic shock).
Danish: Overfølsomhedsreaktionerne varierede fra lette hudreaktioner til alvorlige reaktioner, der omfattede hele kroppen (f.eks. allergisk shock).
English: Also, patients with drug allergy or allergic diseases or conditions (such as atopy: hay fever, asthma, atopic dermatitis with high serum
Danish: Derudover synes patienter med tidligere tilfælde af lægemiddelallergi eller allergiske tilstande (f.eks. medfødt overfølsomhed (atopi): høfeber, astma, atopisk dermatitis med højt IgE i blodet, nældefeber), eller som samtidigt lider af virusinfektioner, at have en højere risiko for allergiske reaktioner over for dette lægemiddel.
English: If you experience dizziness, somnolence, disturbance in attention, epilepsy, blurred vision or muscular weakness while taking {invented name} consult your doctor.
Danish: Du skal kontakte lægen, hvis du oplever svimmelhed, døsighed, nedsat opmærksomhed, epilepsi, sløret syn eller muskelsvaghed, mens du tager {produktnavn}.
English: Use of tolperisone is not recommended in patients with severe hepatic impairment.
Danish: Tolperison frarådes til patienter med alvorligt nedsat nyrefunktion.
English: Use of tolperisone is not recommended in patients with severe renal impairment.
Danish: Tolperison frarådes til patienter med alvorligt nedsat leverfunktion.
English: [the wording below should be deleted, as relevant] No hypersensitivity case with fatal outcome after tolperisone treatment has been registered.
Danish: Der er ikke registreret tilfælde af overfølsomhed med dødeligt forløb efter behandling med tolperison.
English: If you have ever had allergic reaction to tolperisone you must not use this medicine.
Danish: Du må ikke tage dette lægemiddel, hvis du på noget tidspunkt har haft en allergisk reaktion over for tolperison.
English: If you have severe kidney problems you should not take this medicine.
Danish: Du må ikke tage dette lægemiddel, hvis du har alvorlige nyreproblemer.
English: If you have severe liver problems you should not take this medicine.
Danish: Du må ikke tage dette lægemiddel, hvis du har alvorlige leverproblemer.
English: 5.2 Pharmacokinetic properties
Danish: 5.2 Farmakokinetiske egenskaber [ordlyden nedenfor skal indsættes]
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Danish: Bilag IV Videnskabelige konklusioner og begrundelse for ændringen af betingelserne for markedsføringstilladelserne
English: A trend was observed in the UPA group for increasing number of pregnancies with increasing weight or BMI.
Danish: I ulipristalacetatgrupperne var der tendens til tiltagende antal graviditeter med stigende vægt eller BMI.
English: Interval
Danish: Undervægtig
English: Therefore, even if data from some studies suggest a lower ability of LNG-containing emergency contraceptives to prevent pregnancies in women of higher weight/BMI, this is only one factor influencing the effect and it is difficult to define a certain cut-off for weight/BMI at which no effect is present.
Danish: Selv om data fra nogle undersøgelser tyder på lavere evne af levonorgestrelholdige postcoitale kontraceptiva til at forhindre graviditet hos kvinder med større vægt/BMI, er dette kun én faktor med indflydelse på virkningen, og det er vanskeligt at fastlægge et bestemt afskæringspunkt for vægt/BMI, hvor der ikke nogen virkning.
English: Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al.,
Danish: Tabel 1: Metaanalyse af tre WHO-undersøgelser (Von Hertzen et al., 1998 og 2002; Dada et al.,
English: All together, the current data are considered not robust enough to support the current recommendation of decreased efficacy in women with body weight above 75 kg and inefficacy in women with body weight above 80 kg as is currently included in the product information of one
Danish: Alt i alt anses de nuværende data for ikke for tilstrækkeligt solide til at støtte anbefalingen om nedsat virkning hos kvinder med legemsvægt over 75 kg og manglende virkning hos kvinder med legemsvægt over 80 kg, således som den angives i den nuværende produktinformation for det ene levonorgestrel-holdige postcoitale kontraceptivum (Norlevo).
English: Further, the data of the meta-analysis should be presented in section 5.1 of the SmPC.
Danish: Desuden bør dataene fra metaanalysen afspejles i produktresuméets afsnit 5.1.
English: Both meta-analyses excluded intake later than 72 hours after unprotected intercourse (i.e. offlabel use of LNG) and women who had further acts of unprotected intercourse.
Danish: Begge metaanalyser ekskluderede indtagelse senere end 72 timer efter ubeskyttet samleje (dvs. ikke godkendt anvendelse af levonorgestrel) samt kvinder, som havde yderligere ubeskyttede samlejer.
English: Ulipristal acetate (UPA)
Danish: Ulipristalacetat
English: The full EPAR for Viracept can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Viracept findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Viracept has also been studied in 37 children.
Danish: Viracept er endvidere blevet undersøgt hos 37 børn.
English: The dose for children aged three to 13 years depends on their body weight.
Danish: Den anbefalede dosis til børn i alderen tre til tretten år afhænger af deres legemsvægt.
English: Most of these patients had not taken protease inhibitors in the past.
Danish: De fleste af disse patienter havde ikke tidligere taget proteasehæmmere.
English: There were no differences between the two doses of Viracept.
Danish: Der var ingen forskel mellem de to doser af Viracept.
English: This is a summary of the European public assessment report (EPAR) for Viracept.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Viracept.
English: • medicines that are broken down in the same way as Viracept and are harmful at high levels in the blood.
Danish: • lægemidler, der nedbrydes på samme måde som Viracept, og som er skadelige ved et højt indhold i blodet.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Viracept.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om
English: Viracept does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Viracept kurerer ikke hiv-infektion eller aids, men det kan forsinke den beskadigelse af immunsystemet og den udvikling af infektioner og sygdomme, der er forbundet med aids.
English: It blocks an enzyme called protease that is involved in the reproduction of HIV.
Danish: Det blokerer et enzym kaldet protease, som medvirker ved formeringen af hiv.
English: • rifampicin (used to treat tuberculosis);
Danish: • rifampicin (anvendes til behandling af tuberkulose)
English: For patients unable to swallow the tablets, Viracept tablets may be dispersed in water or the oral powder may be used instead.
Danish: Til patienter, som ikke kan synke tabletter, kan Viracept-tabletterne opløses i vand, eller der kan anvendes oralt pulver i stedet.
English: The most common side effect with Viracept (seen in more than 1 patient in 10) is diarrhoea.
Danish: Den hyppigste bivirkning ved Viracept (som optræder hos flere end 1 ud af 10 patienter) er diarré.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Danish: Når enzymet blokeres, formerer viruset sig ikke normalt, så udbredelsen af infektionen bliver langsommere.
English: The study in children showed that the medicine produced similar levels of the active substance in the blood in children and adults, with similar side effects and effectiveness.
Danish: Undersøgelsen hos børn viste, at lægemidlet gav det samme indhold af det aktive stof i blodet hos børn og voksne, og at det gav de samme bivirkninger og havde den samme virkning.
English: For patients aged over 13 years, the recommended dose of Viracept is 1,250 mg twice a day or 750 mg three times a day, taken with food.
Danish: Den anbefalede dosis Viracept til patienter over tretten år er 1 250 mg to gange daglig eller 750 mg tre gange daglig og indtages sammen med et måltid.
English: In the second study, viral load had fallen by more than 99% in the patients taking the higher dose of Viracept, compared with 95% in those taking the comparator medicines.
Danish: I den anden undersøgelse var den virale belastning faldet med mere end 99 % hos de patienter, der tog den høje dosis Viracept, sammenlignet med 95 % hos de patienter, der tog sammenligningspræparaterne.
English: The main measures of effectiveness were the change in the levels of HIV in the blood (viral load) and the change in the number of CD4 T-cells in the blood (CD4 cell count).
Danish: Virkningen blev hovedsagelig målt på ændringen i hiv-indholdet i blodet (den virale belastning) og ændringen i antallet af CD4 T-celler i blodet (CD4-celletallet).
English: Doctors should consider using alternatives to medicines that speed up the breakdown of Viracept, such as phenobarbital and carbamazepine (used to treat epilepsy), in patients taking Viracept.
Danish: Læger bør overveje at anvende alternativer til lægemidler, der fremskynder nedbrydningen af Viracept, såsom phenobarbital og carbamazepin (anvendes til behandling af epilepsi), hos patienter, der tager Viracept.
English: Viracept brought about similar reductions in viral load whether it was taken twice or three times a day.
Danish: Viracept mindskede den virale belastning i samme grad, hvad enten det blev taget to eller tre gange om dagen.
English: Viracept, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Viracept tages i kombination med andre antiretrovirale lægemidler, nedsættes mængden af hiv i blodet og holdes på et lavt niveau.
English: Treatment with Viracept should be initiated by a doctor who has experience in the treatment of HIV infection.
Danish: Behandlingen med Viracept bør kun iværksættes af læger med erfaring i behandling af hiv-infektion.
English: The active substance in Viracept, nelfinavir, is a protease inhibitor.
Danish: Det aktive stof i Viracept, nelfinavir, er en proteasehæmmer.
English: CD4 cell counts increased by 150 and 95 cells/mm3, respectively.
Danish: CD4-celletallet steg med henholdsvis 150 og 95
English: Viracept is a medicine containing the active substance nelfinavir.
Danish: Viracept er et lægemiddel, som indeholder det aktive stof nelfinavir.
English: Viracept is an antiviral medicine.
Danish: Viracept er et antiretroviralt lægemiddel.
English: Viracept should not be used in patients who are taking any of the following medicines:
Danish: Viracept bør ikke anvendes til patienter, der får et eller flere af følgende lægemidler:
English: • omeprazole (used to reduce stomach acid levels);
Danish: • omeprazol (anvendes til at mindske mavesyreindholdet),
English: Caution is needed when Viracept is taken at the same time as other medicines.
Danish: Der skal udvises forsigtighed, når Viracept tages sammen med andre lægemidler.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Viracept on 22 January 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske
English: After 24 weeks, Viracept brought about greater reductions in viral load and increases in CD4 cell counts than the comparator medicines.
Danish: Efter 24 uger havde Viracept mindsket den virale belastning og øget CD4-celletallet mere end sammenligningspræparaterne.
English: CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Danish: T-celler er hvide blodlegemer, som er vigtige for, at kroppen kan bekæmpe infektioner, men som
English: For more information about treatment with Viracept, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Viracept, kan du læse indlægssedlen (også en del af denne EPAR) eller
English: For the full list of all side effects seen with Viracept, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Viracept fremgår af indlægssedlen.
English: In the second study, Viracept, in combination with zidovudine and lamivudine (other antiviral medicines) was compared with the combination of zidovudine and lamivudine in 297 treatment-naïve patients (who had not taken any antiviral medicines to treat HIV infection before).
Danish: I den anden undersøgelse blev Viracept i kombination med zidovudin og lamivudin (andre antiretrovirale lægemidler) sammenlignet med en kombination af zidovudin og lamivudin hos 297 behandlingsnaive patienter (patienter, der ikke tidligere havde taget antiretrovirale lægemidler til behandling af deres hiv-infektion).
English: Viracept has been studied in combination with other antiviral medicines in two main studies involving 605 patients aged 13 years or more, who were infected with HIV.
Danish: Viracept blev undersøgt i kombination med andre antiretrovirale lægemidler i to hovedundersøgelser, der omfattede 605 hiv-smittede patienter i alderen tretten år og derover.
English: Viracept must not be used in people who are hypersensitive (allergic) to nelfinavir or any of the other ingredients.
Danish: Viracept må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for nelfinavir eller andre af indholdsstofferne.
English: The CHMP decided that Viracept's benefits are greater than its risks in antiviral combination treatment of HIV-1 infected adults, adolescents and children of three years of age and older.
Danish: CHMP besluttede, at fordelene ved Viracept opvejer risiciene ved antiretroviral kombinationsbehandling af voksne, unge og børn i alderen tre år eller derover, der er smittet med HIV-1.