FrancophonIA/ELRC3.0 huggingface dataset:
English: • Thiotepa (intensified regimen5 mg/kg twice a day), given as two intravenous infusions over 2
Danish: • Thiotepa (forstærket program 5 mg/kg to gange dagligt), der gives som 2 intravenøse infusioner i løbet af 2-4 timer på dag -2 før en stamcelleinfusion (dag 0).
English: • Treosulfan 10-14 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -6, -5, -4) before stem cell infusion (day 0).
Danish: • Treosulfan 10-14 g/m² legemsoverfladeareal (BSA) pr. dag som en 2-timers intravenøs infusion, der gives i 3 på hinanden følgende dage (dag -6, -5, -4) før en stamcelleinfusion (dag 0).
English: Rare Epistaxis, pneumonitis
Danish: Epistaksis, pneumonitis Ikke kendt
English: • Treosulfan 14 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -6, -5, -4) before stem cell infusion (day 0).
Danish: • Treosulfan 14 g/m² legemsoverfladeareal (BSA) pr. dag som en 2-timers intravenøs infusion, der gives i 3 på hinanden følgende dage (dag -6, -5, -4) før en stamcelleinfusion (dag 0).
English: Not known Cardiac arrest, myocardial infarction
Danish: Hjertestop, myokardieinfarkt
English: Acute kidney injury, renal failure
Danish: Almindelig Akut nyreskade, hæmaturi
English: NAME OF THE MEDICINAL PRODUCT Trecondi 1 g powder for solution for infusion Trecondi 5 g powder for solution for infusion
Danish: Trecondi 1 g pulver til infusionsvæske, opløsning Trecondi 5 g pulver til infusionsvæske, opløsning
English: Uncommon Acute kidney injury, haematuria
Danish: Ikke almindelig Akut nyreskade, hæmaturi
English: Reconstitute each vial of Trecondi containing 1 g treosulfan in 20 mL of pre-warmed (maximum 30 °C) sodium chloride 4.5 mg/mL (0.45%) solution by shaking.
Danish: Hvert hætteglas med Trecondi, der indeholder 1 g treosulfan, rekonstitueres i 20 ml forvarmet (maks.
English: Infections (bacterial, viral, fungal) Common
Danish: Infektioner (bakterielle, virale, mykotiske), sepsisa Ikke kendt
English: abdominal pain
Danish: Mave-tarm-kanalen
English: Rare Pain in extremities, bone pain
Danish: Smerter i ekstremiteter, knoglesmerter
English: • tiredness
Danish: • kløe
English: Mouth haemorrhage, abdominal distension, oesophageal or gastrointestinal pain, dry mouth
Danish: Ikke almindelig Blødning i munden, abdominal udspiling, øsofageale eller mavetarm-smerter, mundtørhed
English: Veno-occlusive liver disease, hepatotoxicity
Danish: Venookklusiv leversygdom, hepatotoksicitet Ikke kendt
English: l t o r
Danish: r l
English: Split influenza virus inactivated, containing antigen* equivalent to:
Danish: Split influenzavirus, inaktiveret, indeholdende antigen* svarende til:
English: EU/1/10/664/001 Pumarix
Danish: EU/1/10/664/001
English: 50 vials (suspension)
Danish: 50 hætteglas (suspension)
English: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Danish: AS03 adjuvans bestående af squalen (10,69 mg), DL-α-tocopherol (11,86 mg) og polysorbat 80 (4,86 mg)
English: A/Indonesia/05/2005 (H5N1) 3.75 micrograms** * propagated in eggs ** haemagglutinin
Danish: A/Indonesia/05/2005 (H5N1) 3,75 mikrogram** * opformeret i æg ** hæmagglutinin
English: After mixing, 1 dose (0.5 ml) contains:
Danish: Efter sammenblanding indeholder 1 dosis (0,5 ml):
English: Suspension and emulsion for emulsion for injection
Danish: Suspension og emulsion til injektionsvæske, emulsion
English: 2 x 25 vials (emulsion)
Danish: 2 x 25 hætteglas (emulsion)
English: Intramuscular use suspension (H5N1): vial (glass); emulsion (adjuvant): vial (glass)
Danish: Intramuskulær anvendelse suspension (H5N1): hætteglas (glas); emulsion (adjuvans): hætteglas (glas)
English: Packaging Content (concentration)
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage Indhold (Koncentration)
English: 15 May 2019
Danish: 15. maj 2019
English: The study shall be conducted in more than one Member State and the protocol shall be submitted to the PRAC within 3 months of the commission decision for this procedure.
Danish: Undersøgelsen skal gennemføres i mere end én medlemsstat, og protokollen skal indsendes til PRAC inden for 3 måneder efter Kommissionens beslutning vedrørende denne procedure.
English: 16 March 2019
Danish: 16. marts 2019
English: Adoption of CMDh position:
Danish: Vedtagelse af CMDh's indstilling:
English: The CMDh agrees with the scientific conclusions made by the PRAC.
Danish: CMDh tilslutter sig PRAC's videnskabelige konklusioner.
English: Transmission to National Competent Authorities of the translations of the annexes to the position:
Danish: Oversættelser af bilagene for indstillingen fremsendes til de nationale kompetente myndigheder:
English: Timetable for the implementation of the position
Danish: Tidsplan for implementering af denne indstilling
English: January 2019 CMDh meeting
Danish: CMDh's møde i januar 2019
English: Annex III Timetable for the implementation of this position
Danish: Bilag III Tidsplan for implementering af denne indstilling
English: The Marketing Authorisation Holders shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures and to monitor off-label use.
Danish: Indehaverne af markedsføringstilladelse skal gennemføre en undersøgelse af lægemiddelanvendelse for at vurdere virkningen af de risikominimerende foranstaltninger og overvåge off label-brug.
English: The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through)
Danish: Indehaverne af markedsføringstilladelse skal slette følgende betingelse(r) (ny tekst er understreget og skrevet med fed skrift, slettet tekst er gennemstreget):
English: The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied.
Danish: CMDh er nået frem til, at markedsføringstilladelsen/-tilladelserne for produkter omfattet af denne PASS-studierapport bør ændres.
English: Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder):
Danish: Indstillingen implementeres i medlemsstaterne (indehaveren af markedsføringstilladelsen indsender ansøgning om ændring):
English: The joint database drug utilisation final study report submitted by the MAHs, together with the joint PASS (physician survey) final study report submitted by the MAHs as a separate procedure (EMEA/H/N/PSR/J/0010), comply with their obligation to conduct a drug utilisation study to assess the effectiveness of the risk minimisation measures and to monitor the off-label use of the drug as imposed during the referral under Article 31 of Directive 2001/83/EC for domperidone containing products.
Danish: Med indsendelsen af den endelige rapport for den fælles databasebaserede undersøgelse af lægemiddelanvendelse, sammen med den fælles endelige PASS-rapport (lægevurdering), som blev indsendt som en separat procedure (EMEA/H/N/PSR/J/0010), har indehaverne af markedsføringstilladelse opfyldt deres forpligtelse til at gennemføre en undersøgelse af lægemiddelanvendelse for at vurdere virkningen af de risikominimerende tiltag og overvåge off labelbrugen af lægemidlet som pålagt under henvisningsproceduren i henhold til artikel 31 i direktiv 2001/83/EF for domperiodon-holdige lægemidler.
English: Therefore, in view of available data regarding the joint database drug utilisation final study report, together with the joint PASS (physician survey) final study report submitted as a separate procedure (EMEA/H/N/PSR/J/0010), the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Danish: I lyset af de tilgængelige data vedrørende den endelige rapport for den fælles databaserede undersøgelse af lægemiddelanvendelse, sammenholdt med den fælles endelige PASS-rapport (lægevurdering), som blev indsendt som en separat procedure (EMEA/H/N/PSR/J/0010), er PRAC derfor af den opfattelse, at der er behov for ændringer i betingelserne for markedsføringstilladelse.
English: Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Danish: Bilag I Videnskabelige konklusioner og begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne
English: Annex II Conditions to the Marketing Authorisation(s)
Danish: Bilag II Betingelser for markedsføringstilladelsen/-tilladelserne
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance domperidone and concerned by the PASS final report, the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner vedrørende studieresultaterne for lægemidler, der indeholder det aktive stof domperidon, og som er omfattet af den endelige PASS-studierapport, er CMDh af den opfattelse, at benefit/risk-forholdet for disse lægemidler forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance domperidone and concerned by the PASS final report, the scientific conclusions are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport vedrørende den endelige PASS-studierapport (pålagt ikke-interventionel sikkerhedsundersøgelse efter markedsføring) for lægemidler, der indeholder det aktive stof domperidon, og som er omfattet af den endelige PASS-studierapport, er CMDh nået frem til følgende videnskabelige konklusioner:
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance domperidone concerned by the noninterventional imposed PASS final report
Danish: Ændringer, der skal indføres i betingelserne for markedsføringstilladelsen/-tilladelserne for det lægemiddel/de lægemidler, der indeholder det aktive stof domperidon, og som er omfattet af den endelige PASS-studierapport (pålagt ikke-interventionel sikkerhedsundersøgelse efter markedsføring)
English: * CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
Danish: * CCID50 = Den mængde virus som inficerer 50% af de inokulerede cellekulturer.
English: EU Number Tradename Strength
Danish: EU-nummer Handelsnavn
English: ContentPackage size Withdrawal period
Danish: Indhold Pakningsstørrelse
English: Target species
Danish: Dyrearter, som lægemidlet er beregnet til:
English: Page 1 of 1
Danish: Side 1 af 1
English: 1.2 Application Form - Annex A
Danish: 1.2 Ansøgningsskema - Bilag A
English: Zonisamide
Danish: Zonisamid
English: Confidential
Danish: Fortroligt
English: Strength Pharmaceutical Form Route of Administration
Danish: Lægemiddelform Administration Emballage
English: EU Number Invented name
Danish: EU-nummer
English: ** based on historical comparison.
Danish: ** Baseret på historisk sammenligning.
English: Some patients have committed suicide.
Danish: Nogle patienter har begået selvmord.
English: - if you are over 65.
Danish: Hvis De er over 65 år.
English: - Tell your doctor:
Danish: - Fortæl det til Deres læge:
English: • feeling worried or depressed
Danish: • Føle sig bekymret eller nedtrykt
English: M=Excluded
Danish: M=Ekskluderede
English: The virus may then become harder to treat.
Danish: Virus kan derved blive vanskeligere at behandle.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Danish: Typisk er sådanne reaktioner observeret inden for de første få uger eller måneder efter initiering af CART.
English: HORMONAL CONTRACEPTIVES Oral:
Danish: HORMONKONTRACEPTIVA Oral:
English: *lower than recommended dose
Danish: *lavere end den anbefalede dosis
English: QTc Prolongation
Danish: QTc-forlængelse
English: Atripla must be taken every day.
Danish: Atripla skal tages hver dag.
English: Keep the bottle tightly closed.
Danish: Hold beholderen tæt tillukket.
English: A risk to the infants cannot be excluded.
Danish: En risiko for spædbørn kan ikke udelukkes.
English: Parameters Test Reference
Danish: Parametre Test Reference
English: • disturbances of coordination and balance
Danish: • Koordinations- og balanceproblemer
English: Also, tell your doctor if you are taking maraviroc.
Danish: Fortæl det også til Deres læge, hvis De tager maraviroc.
English: - if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
Danish: - hvis et familiemedlem (forældre, bedsteforældre, brødre eller søstre) pludseligt er afgået ved døden på grund af et hjerteproblem eller blev født med hjerteproblemer.
English: Transmission of HIV
Danish: Overførsel af hiv
English: • proteins in urine
Danish: • Proteiner i urinen
English: If this is unavoidable, your doctor will monitor your kidney function once a week.
Danish: Hvis dette er uundgåeligt, vil Deres læge kontrollere Deres nyrefunktion en gang om ugen.
English: *lower than recommended doses; similar findings are expected with recommended doses.
Danish: *lavere end de anbefalede doser; lignende fund forventes med de anbefalede doser.
English: PC: {number} SN: {number} NN: {number} [outer packaging only]
Danish: PC: {nummer} SN: {nummer} NN: {nummer}
English: This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time.
Danish: Dette er meget vigtigt, da mængden af virus kan begynde at stige, hvis medicinindtagelsen standses - selv i kort tid.
English: Confirmatory testing by a more specific method such as gas chromatography/mass spectrometry is recommended in such cases.
Danish: Bekræftende testning med en mere specifik metode, såsom gaskromatografi/massespektrometri anbefales i sådanne tilfælde.
English: • allergic reactions
Danish: • Allergiske reaktioner
English: A summary of resistance mutation development is shown in Table 3.
Danish: Et resumé over udviklingen af resistensmutation findes i tabel 3.
English: Based on the different elimination pathways, no interaction is expected.
Danish: På grund af forskellige eliminationsveje forventes ingen interaktion.
English: If you are over 65 years of age and are prescribed Atripla, your doctor will monitor you carefully.
Danish: Hvis De er over 65 år og har fået ordineret Atripla, vil Deres læge overvåge Dem nøje.
English: Keep the tablet bottle with you so that you can easily describe what you have taken.
Danish: Tag tabletbeholderen med, så De let kan vise, hvad De har taget.
English: Wait and take the next dose at the regular time.
Danish: Vent og tag den næste dosis på det normale tidspunkt.
English: - if you have severe liver disease.
Danish: - hvis De har alvorlig leversygdom.
English: - any signs of inflammation or infection.
Danish: Tegn på betændelse eller infektion.
English: Always notify your doctor immediately if you have these symptoms.
Danish: Kontakt altid straks Deres læge, hvis De får disse symptomer.
English: Tell your doctor immediately if you are pregnant or intend to become pregnant.
Danish: Kontakt straks Deres læge, hvis De er gravid eller planlægger at blive gravid.
English: Interaction studies with these agents have only been performed in adults.
Danish: Interaktionsstudier med disse lægemidler er kun udført hos voksne.
English: Similar results were found by other investigators, although the MPA plasma levels were more variable in the second study.
Danish: Andre investigatorer kom frem til lignende resultater, selvom plasmakoncentrationerne for MPA var mere variable i det andet studie.
English: Atripla contains three active substances that are used to treat human immunodeficiency virus (HIV) infection:
Danish: Atripla indeholder tre aktive stoffer, som anvendes til at behandle human immundefekt virus (hiv)infektion:
English: • increased appetite
Danish: • Øget appetit
English: Modified LOCF 190/203 (93.6%)
Danish: Modificeret LOCF 190/203 (93,6%)
English: The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1%.
Danish: Forekomsten af erythema multiforme eller Stevens-Johnsons syndrom var ca. 0,1%.
English: This medicine is not a cure for HIV infection.
Danish: Denne medicin helbreder ikke hiv-infektion.
English: Women should not get pregnant during treatment with Atripla and for 12 weeks thereafter.
Danish: Kvinder bør ikke blive gravide under behandling med Atripla og i 12 uger derefter.
English: This is equivalent to 1.2% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 1,2 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: Date of first authorisation: 13 December 2007 Date of latest renewal: 17 September 2012
Danish: Dato for seneste fornyelse: 17. september 2012
English: Concomitant use of posaconazole and Atripla should be avoided unless the benefit to the patient outweighs the risk.
Danish: Samtidig brug af posaconazol og Atripla bør undgås, med mindre fordelene for patienten overstiger risici.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på beholderen og kartonen efter (Exp).
English: One tablet taken each day by mouth.
Danish: 1 tablet om dagen taget gennem munden.
English: Studies conducted with other medicinal products
Danish: Studier udført med andre lægemidler
English: (mechanism of interaction unknown) Tenofovir:
Danish: (interaktionsmekanismen er ukendt) Tenofovir:
English: Difference between Atripla and original treatment regimen (95%CI)
Danish: Forskel mellem Atripla og originalt behandlingsregime (95% CI)
English: If bone abnormalities are suspected then appropriate consultation should be obtained.
Danish: Hvis der er mistanke om knogleabnormiteter, bør relevant konsultation foretages.
English: This decrease in atazanavir Cmin might negatively impact the efficacy of atazanavir.
Danish: Dette fald i atazanavirs Cmin kan have negativ indflydelse på virkningen af atazanavir.
English: 3 See section 4.8 Description of selected adverse reactions for more details.
Danish: 4.8 Beskrivelse af udvalgte bivirkninger for flere detaljer.
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Danish: For de børn, hvis mødre har taget NRTI'er i løbet af graviditeten, opvejede fordelen ved beskyttelse mod hiv risikoen ved bivirkningerne.
English: Atripla should be taken on an empty stomach (commonly defined as 1 hour before or 2 hours after a meal) preferably at bedtime.
Danish: Atripla bør tages på tom mave (sædvanligvis defineret som 1 time før eller 2 timer efter et måltid), helst ved sengetid.
English: once daily as “q.d.” and once every 8 hours as “q8h”).
Danish: „b.i.d.“, en gang dagligt som „q.d.“ og en gang hver 8. time som „q8t“).
English: Table 6: Summary of pharmacokinetic data from study GS-US-177-0105
Danish: Tabel 6: Oversigt over farmakokinetiske data fra studie GS-US-177-0105
English: It is believed that these symptoms are due to improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Danish: Det antages, at disse symptomer skyldes en forbedring i kroppens immunforsvar, som gør kroppen i stand til at bekæmpe infektioner, der kan have været til stede uden tydelige symptomer.
English: An alternative anticonvulsant should be considered.
Danish: Et alternativt krampestillende lægemiddel bør overvejes.
English: Close monitoring of immunosuppressant concentrations for at least two weeks (until stable concentrations are reached) is recommended when starting or stopping treatment with Atripla.
Danish: Tæt monitorering af immunsuppressivakoncentrationerne i mindst to uger (indtil stabile koncentrationer er nået) anbefales, når behandlingen med Atripla indledes eller seponeres.
English: The net effect of co-administration is not clear.
Danish: Nettovirkningen ved samtidig administration er ikke klar.
English: Possible serious side effects: tell your doctor immediately
Danish: Mulige alvorlige bivirkninger: Tal straks med lægen
English: Increases in bupropion dosage should be guided by clinical response, but the maximum recommended dose of bupropion should not be exceeded.
Danish: Øgning af bupropiondosis bør styres af klinisk respons, men den maksimalt anbefalede bupropiondosis bør ikke overskrides.
English: PVR (KM): Pure virologic response assessed using the Kaplan Meier (KM) method M: Missing
Danish: PVR (KM): Rent virologisk respons vurderet ved hjælp af Kaplan Meier (KM) metoden M: Mangler
English: Do not wait until your next dose is due.
Danish: Vent ikke til tidspunktet for Deres næste dosis.
English: - if you have or have had kidney disease, or if tests have shown problems with your kidneys.
Danish: Hvis De har eller har haft en nyresygdom, eller hvis prøver har vist, at der er problemer med Deres nyrer.
English: • liver failure, in some cases leading to death or liver transplant.
Danish: • Leversvigt, som i nogle tilfælde medfører død eller levertransplantation.
English: • changes in skin colour including darkening of the skin in patches often starting on hands and soles of feet
Danish: • Ændringer i hudfarve inklusive pletvis mørkfarvning af huden, ofte begyndende på hænder og fodsåler
English: Most cases occurred in patients who already had liver disease, but there have been a few reports in patients without any existing liver disease
Danish: De fleste tilfælde forekom hos patienter, der allerede havde en leversygdom, men der har været nogle få indberetninger fra patienter uden allerede eksisterende leversygdom.
English: Adverse reactions were generally consistent with those seen in previous studies of the individual components.
Danish: Bivirkningerne var generelt sammenlignelige med bivirkningerne fra tidligere studier af de individuelle komponenter.
English: Insufficient numbers of patients over 65 years of age have been studied.
Danish: Kun et utilstrækkeligt antal patienter over 65 år er blevet undersøgt.
English: Consider doubling the rifabutin dose in regimens where rifabutin is given 2 or 3 times a week in combination with Atripla.
Danish: Overvej at fordoble rifabutin-dosis i regimer, hvor rifabutin gives 2 eller 3 gange om ugen i kombination med Atripla.
English: The use of Atripla in children and adolescents has not been studied.
Danish: Brug af Atripla til børn og unge er ikke blevet undersøgt.
English: Alternatives to clarithromycin (e.g. azithromycin) may be considered.
Danish: Alternativer til clarithromycin (f.eks. azithromycin) kan overvejes.
English: Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or 225 were also observed, but at lower frequencies, and often only in combination with K103N.
Danish: Substitutioner på RT-positionerne 98, 100, 101, 108, 138, 188, 190 eller 225 var allerede observeret men i lavere frekvens og ofte i kombination med K103N.
English: Lopinavir concentrations: ↓ 30-40%
Danish: Lopinavirkoncentrationer: ↓ 30-40%
English: Contact your doctor or nearest emergency department for advice.
Danish: Kontakt lægen eller den nærmeste skadestue for at få råd.
English: If you have both HIV infection and hepatitis B, it is especially important not to stop your Atripla treatment without talking to your doctor first.
Danish: Hvis De både har hiv-infektion og hepatitis B, er det særlig vigtigt ikke at stoppe behandlingen med Atripla uden at tale med Deres læge først.
English: Alternative treatment regimens should be considered for patients with osteoporosis that are at a high risk for fractures.
Danish: Alternative behandlingsregimer bør overvejes til patienter med osteoporose med høj risiko for frakturer.
English: (UDP-G induction)
Danish: (UDP-G-induktion)
English: Pregnancy should be avoided in women receiving Atripla.
Danish: Graviditet bør undgås hos kvinder, der får Atripla.