FrancophonIA/ELRC3.0 huggingface dataset:
English: After an initial decline of approximately -4.9 ml/min (using CockcroftGault equation) or -3.9 ml/min/1.73 m2 (using modification of diet in renal disease [MDRD] equation)
Danish: Efter en indledende reduktion på ca. -4,9 ml/min (ved anvendelse af Cockcroft-Gault-ligningen) eller -3,9 ml/min/1,73 m² (ved anvendelse af modification of diet in renal disease [MDRD]-ligningen) efter de første 4 ugers behandling var hastigheden af den årlige reduktion i nyrefunktionen efter baseline, der blev rapporteret hos patienter behandlet med tenofovirdisoproxil, -1,41 ml/min pr. år (ved anvendelse af Cockcroft-Gault-ligningen) og0,74 ml/min/1,73 m² pr. år (ved anvendelse af MDRD-ligningen).
English: Table 5: Efficacy parameters in compensated HBeAg negative patients at week 96, 144, 192, 240, 288 and 384 open-label treatment
Danish: Tabel 5: Virkningsparametre hos kompenserede HBeAg-negative patienter ved uge 96, 144, 192, 240, 288 og 384 open-label-behandling
English: Whole body mean (SD) change from baseline BMD Z-score a
Danish: Gennemsnitlig (SD) ændring i BMD Z-resultata for hele kroppen fra baseline n/a n/a
English: Twenty-five percent (14 of 56) of patients in the tenofovir disoproxil group and 24% (7 of 29) of patients in the placebo group achieved HBeAg seroconversion at Week 48.Response to treatment with tenofovir disoproxil was comparable in treatment-naïve and treatment-experienced subjects with 76% (38/50) of treatment-naïve and 80% (8/10) of treatment-experienced subjects achieving HBV DNA < 400 copies/mL (69 IU/ml) at Week 48.
Danish: Behandlingsresponset med tenofovirdisoproxil var sammenligneligt hos behandlingsnaive og behandlingserfarne forsøgspersoner, hvor 76% (38/50) behandlingsnaive og 80% (8/10) behandlingserfarne forsøgspersoner opnåede HBV-dna <400 kopier/ml (69 IE/ml) ved uge 48.
English: Frequency Tenofovir disoproxil Metabolism and nutrition disorders:
Danish: Metabolisme og ernæring:
English: Lumbar spine mean (SD) change from baseline BMD Z-score a
Danish: Gennemsnitl ig (SD) ændring i BMD Zresultata for columna lumbalis fra baseline n/a n/a
English: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, sofosbuvir/velpatasvir/voxila previr and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, sofosbuvir/velpatasvir/voxi la-previr og darunavir/ritonavir kan øge risikoen for bivirkninger relaterede til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: l Figures presented are cumulative percentages based upon a Kaplan Meier analysis excluding data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-tenofovir disoproxil).
Danish: l De viste tal er kumulative procenter baseret på en Kaplan Meier-analyse, som ekskluderer data indsamlet efter tillæg af emtricitabin til open-label tenofovirdisoproxil (KM-tenofovirdisoproxil).
English: EU/1/01/200/007
Danish: EU/1/01/200/006 EU/1/01/200/007
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Danish: Sikkerheden af tenofovirdisoproxil sammen med sofosbuvir/velpatasvir/voxilaprevir og en farmakokinetisk booster (f.eks. ritonavir eller cobicistat) er ikke klarlagt.
English: In the tenofovir disoproxil treatment arm, 7% of patients discontinued treatment due to an adverse event; 9% of patients experienced a confirmed increase in serum creatinine of ≥ 0.5 mg/dl or confirmed serum phosphate of < 2 mg/dl through week 48; there were no statistically significant differences between the combined tenofovir-containing arms and the entecavir arm. After 168 weeks, 16% (7/45) of the tenofovir disoproxil group, 4% (2/45) of the emtricitabine plus tenofovir disoproxil group, and 14% (3/22) of the entecavir group experienced tolerability failure.
Danish: I behandlingsarmen med tenofovirdisoproxil seponerede 7% af patienterne behandlingen på grund af en bivirkning, 9% af patienterne fik bekræftet forhøjelse i serumkreatinin på ≥ 0,5 mg/dl eller bekræftet serumphosphat på < 2 mg/dl til og med uge 48.
English: Serology (%) HBeAg loss/ seroconversion HBsAg loss/ seroconversion
Danish: Serologi (%) Tab af
English: • decreases in potassium in the blood
Danish: • fald i blodets kaliumniveau
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/001 30 film-coated tablets EU/1/01/200/002 90 (3 bottles of 30) film-coated tablets
Danish: EU/1/01/200/002 90 (3 tabletbeholdere med 30) filmovertrukne tabletter.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, ledipasvir/sofosbuvir og darunavir/ritonavir kan øge risikoen for bivirkninger relaterede til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: + Emtricitabine/Rilpivirine/Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
Danish: + Emtricitabin/rilpivirin/ tenofovirdisoproxil (200 mg/25 mg/245 mg q.d.)
English: + Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
Danish: + Emtricitabin/rilpivirin/tenofovirdisoproxil (200 mg/25 mg/245 mg q.d.)
English: Lumbar spine mean (SD) change from baseline BMD Z-scorea
Danish: Gennemsnitlig (SD) BMD Zresultata for columna lumbalis Gennemsnitlig (SD) ændring i BMD Z-resultata for columna lumbalis fra baseline n/a n/a
English: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, sofosbuvir/velpatasvir/voxilaprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Danish: Øget plasmakoncentration af tenofovir som følge af samtidig administration af tenofovirdisoproxil, sofosbuvir/velpatasvir/voxilaprevir og darunavir/ritonavir kan øge risikoen for bivirkninger relaterede til tenofovirdisoproxil, herunder nyrerelaterede bivirkninger.
English: n Figures presented are cumulative percentages based upon a Kaplan Meier analysis excluding data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-TDF).
Danish: n De viste tal er kumulative procenter baseret på en Kaplan Meier-analyse, som ekskluderer data indsamlet efter tillæg af emtricitabin til open-label tenofovirdisoproxil (KM-TDF).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate).
Danish: Hver filmovertrukket tablet indeholder 245 mg tenofovirdisoproxil (som fumarat).
English: EU/1/01/200/005
Danish: EU/1/01/200/004 EU/1/01/200/005
English: The following side effects are common (these can affect up to 10 in every 100 patients):
Danish: Følgende bivirkninger er almindelige (kan opstå hos op til 1 ud af 10 personer):
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/004 30 film-coated tablets EU/1/01/200/005 90 (3 bottles of 30) film-coated tablets
Danish: EU/1/01/200/005 90 (3 tabletbeholdere med 30) filmovertrukne tabletter.
English: Assessment of adverse reactions is based on one randomised study (Study GS-US-174-0115) in 106 adolescent patients (12 to < 18 years of age) with chronic hepatitis B receiving treatment with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks and another randomized study (study GS-US-174-0144) in 89 patients with chronic hepatitis B (2 to < 12 years of age) receiving treatment with tenofovir disoproxil (n = 60) or placebo (n = 29) for 48 weeks.
Danish: Vurderingen af bivirkninger er baseret på ét randomiseret studie (studie GS-US-174-0115) med 106 unge patienter (i alderen 12 til < 18 år) med kronisk hepatitis B, der blev behandlet med tenofovirdisoproxil 245 mg (n = 52) eller placebo (n = 54) i 72 uger og på et andet randomiseret studie (studie GS-US-174-0144) med 89 patienter med kronisk hepatitis B (i alderen 2 til < 12 år), der blev behandlet med tenofovirdisoproxil (n = 60) eller placebo (n = 29) i 48 uger.
English: + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.
Danish: + Emtricitabin/ tenofovirdisoproxil (200 mg/245 mg q.d.
English: Assessment of adverse reactions is based on a randomised study (study GS-US-174-0115) in 106 adolescent patients (12 to < 18 years of age) with chronic hepatitis B receiving treatment with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks and a randomised study (Study GS-US-174-0144) in 89 patients with chronic hepatitis B (2 to < 12 years of age) receiving treatment with tenofovir disoproxil (n = 60) or placebo (n = 29) for 48 weeks.
Danish: Vurderingen af bivirkninger er baseret på et randomiseret studie (studie GS-US-174-0115) med 106 unge patienter (i alderen 12 til < 18 år) med kronisk hepatitis B, der blev behandlet med tenofovirdisoproxil 245 mg (n = 52) eller placebo (n = 54) i 72 uger og et randomiseret studie (studie GS-US-174-0144) med 89 patienter med kronisk hepatitis B (i alderen 2 til < 12 år), der blev behandlet med tenofovirdisoproxil (n = 60) eller placebo (n = 29) i 48 uger.
English: + Emtricitabine/Rilpivirine/Tenofo vir disoproxil (200 mg/25 mg/245 mg q.d.)
Danish: + Emtricitabin/rilpivirin/tenofovirdi soproxil (200 mg/25 mg/245 mg q.d.)
English: Assessment of adverse reactions is based on a randomised study (study GS-US-174-0115) in 106 adolescent patients (12 to < 18 years of age) with chronic hepatitis B receiving treatment with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks and on a randomised study (study GS-US-174-0144) in 89 patients with chronic hepatitis B (2 to < 12 years of age) receiving treatment with tenofovir disoproxil (n = 60) or placebo (n = 29) for 48 weeks.
Danish: Vurderingen af bivirkninger er baseret på et randomiseret studie (studie GS-US-174-0115) med 106 unge patienter (i alderen 12 til < 18 år) med kronisk hepatitis B, der blev behandlet med tenofovirdisoproxil 245 mg (n = 52) eller placebo (n = 54) i 72 uger, og på et randomiseret studie (studie GS-US-174-0144) med 89 patienter med kronisk hepatitis B (i alderen 2 til < 12 år), der blev behandlet med tenofovirdisoproxil (n = 60) eller placebo (n = 29) i 48 uger.
English: Other populations
Danish: Andre populationer
English: The first marketing authorisation (MA) was granted in France on 03 April 1987.
Danish: Den første markedsføringstilladelse blev udstedt i Frankrig den 3. april 1987.
English: • the Committee considered the referral under Article 30 of Directive 2001/83/EC,
Danish: • udvalget behandlede indbringelsen i henhold til artikel 30 i direktiv 2001/83/EF,
English: These changes were mostly technical in nature and therefore not discussed in detail here.
Danish: Disse ændringer var hovedsagelig af teknisk art og omtales derfor ikke i detaljer her.
English: Section 1 - Name of the medicinal product and Section 2 - Qualitative and quantitative composition
Danish: Punkt 1 - Lægemidlets navn og Punkt 2 - Kvalitativ og kvantitativ sammensætning
English: This section was harmonised to reflect in a uniform way the following contraindications, of which not all were included across the EU, or different terminologies were used:
Danish: Dette punkt blev harmoniseret, så det på ensartet måde afspejler følgende kontraindikationer, hvoraf ikke alle var inkluderet i hele EU, eller der var forskelle i terminologi:
English: The treatment of UA and NSTEMI was not authorised in all Member States prior to the finalisation of this referral.
Danish: Behandling af UA og NSTEMI var ikke godkendt i alle medlemsstater før færdigbehandlingen af denne indbringelse.
English: The Product Information was split as follows according to the indications the individual products are approved for:
Danish: Produktinformationen blev opstillet på følgende måde efter de indikationer, de enkelte lægemidler er godkendt til:
English: Other sections such as “hyperkalaemia” were included as these were not uniformly worded across Member States.
Danish: Andre punkter såsom "hyperkaliæmi" blev omfattet, da ordlyden heraf ikke var ensartet i medlemsstaterne.
English: For STEMI, the higher dose on the first day as used in the study ExTRACT-TIMI 25 should be mentioned.
Danish: For STEMI bør nævnes den højere dosis på førstedagen, som er anvendt i ExTRACT-TIMI 25-undersøgelsen.
English: Sections 4.5 to 6 have been harmonised based on relevant available information or amended according to the latest QRD template.
Danish: Punkt 4.5 til 6 er harmoniseret på grundlag af de foreliggende oplysninger eller rettet efter den seneste QRD-skabelon.
English: The CHMP considered keeping the indication in line with the most common wording accepted in the countries.
Danish: CHMP overvejede at holde indikationen i overensstemmelse med den hyppigste ordlyd, der accepteres i landene.
English: • the product information proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: • den af markedsføringstilladelsesindehaverne foreslåede produktinformation er blevet vurderet på grundlag af den forelagte dokumentation og den videnskabelige drøftelse i udvalget,
English: Direct Healthcare Provider Communication (DHPC)
Danish: Direkte henvendelse til sundhedspersoner (DHPC)
English: • increased potential bleeding;
Danish: • øget blødningsrisiko
English: Furthermore, the indications were not the same depending on the strength of the product, which was addressed as part of the referral.
Danish: Indikationerne var desuden ikke de samme afhængigt af lægemidlets styrke, hvilket blev behandlet som led i indbringelsen.
English: On one hand, an expression and dosing in mg is consistent with the approvals in the majority of the EU and allows both identification and distinction between different presentations whilst favouring ease of prescribing, dosing, dispensing and administration.
Danish: På den ene side er doseringsangivelse i mg i overensstemmelse med godkendelserne i størstedelen af EU og gør det muligt både at identificere og skelne mellem forskellige pakninger, samtidig med at det letter ordinering, dosering, dispensering og administration.
English: Revisions were made to this section to add the risk of acute infectious endocarditis.
Danish: Dette punkt blev revideret med tilføjelse af risikoen for akut infektiøs endokarditis.
English: A consistent wording has been approved on platelet count monitoring to take into account current international guidelines, in order to avoid unnecessary monitoring in patients at low risk of HIT. Other changes were made to complement the information already present in other parts of the product information:
Danish: Der er godkendt en ensartet ordlyd om overvågning af trombocyttal for at tage de aktuelle internationale retningslinjer i betragtninger med henblik på undgåelse af unødig overvågning hos patienter med lav risiko for HIT. Andre af de foretagne ændringer supplerer oplysningerne i andre dele af produktinformationen:
English: Enoxaparin sodium is a low molecular weight heparin marketed under the trade names Lovenox and associated names.
Danish: Enoxaparinnatrium er et heparin med lav molekylvægt, der markedsføres under handelsnavnene Lovenox og relaterede navne.
English: Treatment of acute STEMI
Danish: Behandling af akut STEMI
English: Due to the divergent national decisions taken by Member States (MSs) concerning the authorisation of the above-mentioned product and its associated names, France notified the CHMP/European Medicines Agency of a referral under Article 30 of Directive 2001/83/EC for the above-mentioned product, in order to resolve divergences amongst the nationally authorised product information (PI) and thus to harmonise its divergent PIs across the EU.
Danish: På grund af de divergerende nationale afgørelser, der er truffet af medlemsstaterne ved godkendelsen af ovenstående lægemiddel og relaterede navne, foretog Frankrig en anmeldelse til CHMP/Det Europæiske Lægemiddelagentur af en indbringelse i henhold til artikel 30 i direktiv 2001/83/EF for ovennævnte lægemiddel for at få ophævet divergenserne mellem de nationalt godkendte produktinformationer og dermed harmonisere dem i EU.
English: No difference exists between countries in terms of enoxaparin dosage regimen (1 mg/kg every 12 hours by subcutaneous injection) in these indications.
Danish: Der er ingen forskelle mellem landene i dosisregimet for enoxaparin (1 mg/kg subkutant hver 12. time) til disse indikationer.
English: It is given as an injection subcutaneously or intravenously.
Danish: Det gives ved subkutan eller intravenøs injektion.
English: Lovenox and associated names is authorised in all EU member states (MSs) as well as in Iceland and Norway.
Danish: Lovenox og relaterede navne er godkendt i alle EU's medlemsstater og i Island og Norge.
English: Unstable angina and NSTEMI indications
Danish: Indikationerne ustabil angina og NSTEMI
English: • the Committee considered the divergences identified in the notification for Lovenox and associated names, as well as the remaining sections of the product information,
Danish: • udvalget behandlede de divergenser, der var konstateret i anmeldelsen vedrørende Lovenox og relaterede navne samt de øvrige punkter i produktinformationen,
English: The wording for the indication in this population therefore includes now disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism.
Danish: Ordlyden af indikationen hos denne population omfatter nu sygdom hos medicinske patienter med akut sygdom (såsom akut hjertesvigt, respirationsinsufficiens, svære infektioner eller reumatiske sygdomme) og nedsat mobilitet med øget risiko for venøs tromboembolisme.
English: This anticoagulant is used in the treatment and prophylaxis of thromboembolic disorders.
Danish: Dette antikoagulans anvendes til behandling og profylakse af tromboemboliske lidelser.
English: Taking into account the risk of medication errors and the clarification as regards indications and contraindications, the CHMP agreed the following key messages to be used in a direct healthcare professional communication (DHPC) to general practitioners, orthopaedics, internists, cardiologists, haematologists, surgeons, pharmacists, nurses (or other as per national health care system):
Danish: I betragtning af risikoen for medicineringsfejl og for at præcisere indikationer og kontraindikationer vedtog CHMP følgende hovedpunkter i en direkte henvendelse til sundhedspersoner (DHPC) til praktiserende læger, ortopædkirurger, internmedicinere, kardiologer, hæmatologer, kirurger, farmaceuter, sygeplejersker (eller andre, alt efter det nationale sundhedssystem):
English: The CHMP adopted a wording, which is in agreement with the clinical data and treatment guidelines (grade IIbB in ESC guidelines 2012, American Heart Association (AHA) guideline 2011).
Danish: CHMP vedtog en ordlyd, der er i overensstemmelse med de kliniske data og behandlingsretningslinjer (grad IIbB i ESC-retningslinjerne fra 2012, og 2011-retningslinjen fra American Heart Association (AHA)).
English: Patients in whom PCIs could be performed at any time for failed fibrinolysis or urgently in case of recurrent myocardial ischemia/infarction, but had to be deferred in other situations at least for 48 hours.
Danish: - patienter, hos hvem PCI kunne blive aktuelt når som helst ved svigtende fibrinolyse eller akut recidiverende myokardieiskæmi/myokardieinfarkt, men havde måttet udskydes i andre situationer i mindst 48 timer.
English: - Medically managed patients (not undergoing primarily invasive procedure such as percutaneous coronary intervention (PCI) or coronary bypass artery surgery (CABG);
Danish: - patienter, der behandledes medicinsk (uden at undergå en primært invasiv procedure, såsom perkutan koronarintervention (PCI) eller koronar bypass-operation (CABG))
English: In view of this indication, the CHMP noted the consensus document of the Joint ESC/American College of Cardiology Committee for the redefinition of myocardial infarction (MI), which led to the revision of the definition of acute coronary syndromes (ACS) to UA and NSTEMI.
Danish: I forbindelse med denne indikation noterede CHMP sig konsensusdokumentet fra Joint ESC/American College of Cardiology Committee med henblik på omdefinering af myokardieinfarkt (MI), hvorved definitionen af akutte koronarsyndromer blev revideret til UA og NSTEMI.
English: The harmonised indication is based on treatment guidelines (European Society of Cardiology (ESC), and ACCP), as well as clinical study and literature data presented by the MAH.
Danish: Den harmoniserede indikation er baseret på behandlingsretningslinjer (European Society of Cardiology (ESC), og ACCP) samt kliniske undersøgelser og litteraturdata forelagt af markedsføringstilladelsesindehaveren.
English: Lovenox and associated names solution for injection is currently approved in more than 140 countries worldwide including all the European Union (EU) member states as well as Norway and Iceland.
Danish: Lovenox og relaterede navne, injektionsvæske, opløsning, er aktuelt godkendt i over 140 lande verden over, herunder alle medlemsstater i Den Europæiske Union (EU) samt Norge og Island.
English: • use of multiple dose vials containing benzyl alcohol in newborns or premature neonates due to risk of gasping syndrome in this population.
Danish: • anvendelse af flerdosishætteglas indeholdende benzylalkohol hos nyfødte eller præmature nyfødte på grund af risikoen for gasping syndrom hos denne population
English: The principal pharmacological properties of enoxaparin include antifactor Xa and antifactor IIa (antithrombin) activity, which are dependent on its binding affinity for antithrombin.
Danish: Blandt enoxaparins vigtigste farmakologiske egenskaber er antifaktor Xa og antifaktor IIa (antitrombin)-aktiviteten, der beror på bindingsaffiniteten til antitrombin.
English: • gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities;
Danish: • gastrointestinalt ulcus, malign neoplasme med høj blødningsrisiko, nylig hjerne-, spinaleller øjenkirurgi, kendte esofagusvaricer eller mistanke herom, arteriovenøse misdannelser, vaskulære aneurismer og større intraspinale eller intracerebrale vaskulære abnormiteter
English: The section was harmonised to address variations in the exact wording in prophylaxis and treatment indications.
Danish: Dette punkt blev harmoniseret af hensyn til forskellene i den nøjagtige ordlyd af indikationerne til profylakse og behandling.
English: The CHMP referred also for this indication to the existing ACCP guidelines, and further preferred a wording more in line with the current recommendations for thromboprophylaxis in acutely ill medical patients in the literature.
Danish: Også for denne indikation henviste CHMP til de gældende ACCP-retningslinjer og foretrak en ordlyd, der stemmer bedre overens med de nuværende anbefalinger for tromboprofylakse hos akut syge medicinske patienter i litteraturen.
English: Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however some sections were left to be completed nationally.
Danish: De foretagne ændringer af produktresuméet blev konsekvent afspejlet i etiketteringen i relevant omfang, dog blev de fleste punkter overladt til national udarbejdelse.
English: Doses studied in the clinical studies vary from 0.5 mg/kg to 1.25 mg/kg.
Danish: De kliniske undersøgelser har omfattet doser mellem 0,5 mg/kg og 1,25 mg/kg.