natgillin/translations-raw huggingface dataset:
Der rådes til forsigtighed og klinisk overvågning ved samtidig administration.
Caution is warranted and clinical monitoring is recommended during co-administration.
Tybost 150 mg filmovertrukne tabletter
Tybost 150 mg film-coated tablets
Tybost 150 mg filmovertrukne tabletter cobicistat
Tybost 150 mg film-coated tablets cobicistat
Hjælpestof(fer), som behandleren skal være opmærksom på Hver tablet indeholder 59 mikrogram sunset yellow FCF aluminium lake (E110).
Each tablet contains 59 micrograms sunset yellow FCF aluminium lake (E110).
Samtidig administration af cobicistat med lægemidler, som hæmmer CYP3A kan nedsætte clearance af cobicistat, hvilket resulterer i øgede plasmakoncentrationer af cobicistat (se pkt.
Co-administration of cobicistat with medicinal products that inhibit CYP3A may decrease the clearance of cobicistat, resulting in increased cobicistat plasma concentrations (see section 4.5).
Samtidig administration af rilpivirin og cobicistat forventes at øge plasmakoncentrationen af rilpivirin.
Co-administration of rilpivirine and cobicistat is expected to increase the plasma concentration of rilpivirine.
Den anbefalede dosis for voksne er: • En tablet om dagen gennem munden sammen med mad.
• One tablet each day by mouth, with food.
Samtidig administration af cobicistat og carbamazepin er kontraindiceret (se pkt.
Co-administration of cobicistat with carbamazepine is contraindicated (see section 4.3).
• blod i urinen (hæmaturi)
• blood in the urine (haematuria)
Carbamazepin, en potent CYP3Ainduktor, reducerer plasmakoncentrationerne af cobicistat og af atazanavir eller darunavir, hvilket kan forårsage svigtende terapeutisk virkning og udvikling af resistens.
Carbamazepine, a potent CYP3A inducer, decreases cobicistat plasma concentrations and that of atazanavir or darunavir, which may result in loss of therapeutic effect and development of resistance.
Koncentrationer af disse sedativa/hypnotika kan øges ved samtidig administration af cobicistat.
Concentrations of these sedatives/hypnotics may be increased when co-administered with cobicistat.
alfuzosin, anvendes til at behandle en forstørret blærehalskirtel dabigatran, anvendes til at forebygge og behandle blodpropper amiodaron, quinidin, anvendes til at korrigere uregelmæssige hjerteslag carbamazepin, phenobarbital, phenytoin, anvendes til at forebygge krampeanfald rifampicin, anvendes til at forebygge og behandle tuberkulose og andre infektioner dihydroergotamin, ergometrin, ergotamin, anvendes til at behandle migræne hovedpine prikbladet perikum (Hypericum perforatum), et naturlægemiddel, der anvendes mod depression og angst lovastatin, simvastatin, anvendes til at sænke kolesterol i blodet pimozid, lurasidon, anvendes til at behandle unormale tanker og følelser sildenafil, anvendes til at behandle pulmonal arteriel hypertension - en lungesygdom, der gør det vanskeligt at trække vejret oralt administreret midazolam, triazolam, anvendes til at hjælpe dig med at sove og/eller lindre angst
alfuzosin, used to treat an enlarged prostate gland amiodarone, quinidine, used to correct irregular heartbeats dabigatran, used to prevent and treat blood clots carbamazepine, phenobarbital, phenytoin, used to prevent seizures rifampicin, used to prevent and treat tuberculosis and other infections dihydroergotamine, ergometrine, ergotamine, used to treat migraine headache
MIDLER MOD PODAGRA Colchicin
ANTI-GOUT Colchicine
Når clarithromycin administreres samtidig med darunavir/cobicistat, konsulteres darunavirs produktresumé for doseringsanbefalinger.
When clarithromycin is co-administered with darunavir/cobicistat, consult the darunavir Summary of Product Characteristics for dosing recommendations.
Samtidig administration af cobicistat med lægemidler, som er moderate til svage induktore af CYP3A kan føre til reducerede plasmakoncentrationer af cobicistat og derved til, at atazanavir og darunavir boostes, hvilket kan forårsage svigtende terapeutisk virkning og mulig udvikling af resistens.
Co-administration of cobicistat with medicinal products that are moderate to weak inducers of CYP3A may result in decreased plasma concentration of cobicistat and consequently that of atazanavir or darunavir being boosted, leading to loss of therapeutic effect and possible development of resistance.
Koncentrationer af voriconazol kan øges eller reduceres ved samtidig administration af cobicistat.
Concentrations of voriconazole may increase or decrease when co-administered with cobicistat.
Der rådes til forsigtighed og klinisk overvågning ved samtidig administration af disse antiarytmika og Tybost.
Caution is warranted and clinical monitoring is recommended upon co-administration of these antiarrhythmic medicinal products with Tybost.
Samtidig administration af cobicistat med lægemidler, som hæmmer CYP3A kan føre til øgede plasmakoncentrationer af cobicistat.
Co-administration of cobicistat with medicinal products that inhibit CYP3A may result in increased plasma concentration of cobicistat.
Plasmakoncentrationer af HMG Co-A reduktasehæmmere kan øges ved samtidig administration af cobicistat.
Plasma concentrations of HMG Co-A reductase inhibitors may be increased when co-administered with cobicistat.
Fås i pakninger, der indeholder 1 tabletbeholder med 30 filmovertrukne tabletter og 90 (3 tabletbeholdere med 30) filmovertrukne tabletter.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.
Derfor bør behandling med cobicistat og darunavir ikke påbegyndes under graviditet, og kvinder, der bliver gravide under behandling med cobicistat og darunavir, skal skiftes til et andet regime (se pkt.
Therefore, therapy with cobicistat and darunavir should not be initiated during pregnancy, and women who become pregnant during therapy with cobicistat and darunavir should be switched to an alternative regimen (see sections 4.2 and 4.6).
Plasmakoncentrationer af pitavastatin, fluvastatin eller pravastatin forventes at stige, når de administreres samtidig med atazanavir/cobicistat eller darunavir/cobicistat.
Plasma concentrations of, pitavastatin, fluvastatin or pravastatin are expected to increase when co-administered with atazanavir/cobicistat or darunavir/cobicistat.
Samtidig administration af cobicistat og lægemidler, som er potente induktorer af CYP3A (såsom prikbladet perikum (Hypericum perforatum), rifampicin, carbamazepin, phenobarbital og phenytoin) kan føre til reducerede plasmakoncentrationer af cobicistat og derved til, at atazanavir eller darunavir boostes, hvilket kan forårsage svigtende terapeutisk virkning og mulig udvikling af resistens (se pkt.
Co-administration of cobicistat with medicinal products that are strong inducers of CYP3A (such as St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital, phenytoin) may result in decreased plasma concentrations of cobicistat and consequently that of atazanavir or darunavir being boosted, leading to loss of therapeutic effect and possible development of resistance (see section 4.3).
-2,1 % (95 % CI = -8,7 %,
HIV-1 RNA < 50 copies/ml Treatment difference -2.2% (95% CI = -7.4%, 3.0%) -2.1% (95% CI = -8.7%, 4.5%)
myalgi
myalgia
Koncentrationer af warfarin kan påvirkes ved samtidig administration af cobicistat.
Concentrations of warfarin may be affected upon co-administration with cobicistat.
Behandling med cobicistat og darunavir bør ikke påbegyndes under graviditet, og kvinder, der bliver gravide under behandling med cobicistat og darunavir, skal skiftes til et andet regime (se pkt.
Therapy with cobicistat and darunavir should not be initiated during pregnancy, and women who become pregnant during therapy with cobicistat and darunavir should be switched to an alternative regimen (see sections 4.2 and 4.4).
• amlodipine, digoxin, diltiazem, disopyramid, felodipin, flecainid, systemisk lidocain, metoprolol, mexiletin, nicardipin, nifedipin, propafenon, timolol og verapamil, lægemidler,
• amlodipine, digoxin, diltiazem, disopyramide, felodipine, flecainide, lidocaine, metoprolol,
Konsultér maravirocs produktresumé for yderligere oplysninger.
For further details, consult the Summary of Product Characteristics for maraviroc.
Cmax: ↑ 41 % Cmin: ND
AUC: ↔ Cmax: ↑ 41% Cmin: ND
Samtidig administration af carbamazepin, en potent CYP3A-induktor, kan reducere plasmakoncentrationerne af cobicistat signifikant.
Co-administration of carbamazepine, a potent CYP3A inducer, may significantly decrease cobicistat plasma concentrations.
Samtidig administration af bosentan og cobicistat kan føre til nedsatte plasmakoncentrationer af cobicistat.
Co-administration of bosentan with cobicistat may lead to decreased cobicistat plasma concentrations.
Koncentrationer af calciumkanalblokkere kan øges ved samtidig administration af cobicistat.
Concentrations of calcium channel blockers may be increased when co-administered with cobicistat.
Der anbefales terapeutisk overvågning ved samtidig administration af Tybost.
Therapeutic monitoring is recommended upon co-administration with Tybost.
Samtidig administration af tenofovirdisoproxil og cobicistat forventes at øge tenofovirplasmakoncentrationen.
Co-administration of tenofovir disoproxil with cobicistat is expected to increase tenofovir plasma concentration.
Koncentrationerne af disse lægemidler kan øges, når de administreres samtidig med cobicistat.
Concentrations of these medicinal products may be increased when co-administered with cobicistat.
Koncentrationer af norgestimat kan påvirkes ved samtidig administration af cobicistat.
Concentrations of norgestimate may be affected on co-administration with cobicistat.
Koncentrationer af disse immunosuppressiva kan øges ved administration af cobicistat.
Concentrations of these immunosuppressants may be increased when co-administered with cobicistat.
Sunset yellow FCF aluminium lake (E110) Macrogol 3350 (E1521) Polyvinylalkohol (delvist hydrolyseret) (E1203) Talkum (E553B)
Sunset yellow FCF aluminium lake (E110) Macrogol 3350 (E1521)
Koncentrationer af clarithromycin kan øges ved samtidig administration med cobicistat.
Concentrations of clarithromycin may be increased upon co-administration with cobicistat.
Hvis De har taget for meget Tybost
If you take more Tybost than you should
ORALE ANTIKONCEPTIVA Drospirenon/Ethinylestradiol (3 mg/0,02 mg enkeltdosis)/ Darunavir (800 mg én gang dagligt)/Cobicistat (150 mg én gang dagligt)
ORAL CONTRACEPTIVES Drospirenone/Ethinyloestradiol (3 mg/0.02 mg single dose)/ Darunavir (800 mg once daily)/Cobicistat (150 mg once daily)
Non-nukleosid-revers transkriptase-hæmmere (NNRTI'er) Efavirenz (600 mg enkeltdosis)
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz (600 mg single dose) Co-administration of efavirenz and cobicistat is expected to decrease cobicistat plasma concentrations.
Samtidig administration af rifabutin, en potent CYP3Ainduktor, kan reducere plasmakoncentrationerne af cobicistat signifikant.
Co-administration of rifabutin, a potent CYP3A inducer, may significantly decrease cobicistat plasma concentrations.
f Plus baggrundsbehandlingsplan med emtricitabin 200 mg og tenofovirdisoproxilfumarat 300 mg i fastdosis-kombination
f Plus background regimen of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg fixed-dose combination
a Plus baggrundsbehandlingsplan med emtricitabin 200 mg og tenofovirdisoproxilfumarat 300 mg i fastdosis-kombination
a Plus background regimen of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg fixed-dose combination
Hvis drospirenon/ethinylestradiol administreres samtidig med atazanavir/cobicistat, anbefales klinisk monitorering på grund af risikoen for hyperkaliæmi.
If drospirenone/ethinyloestradiol is co-administered with atazanavir/cobicistat clinical monitoring is recommended due to the potential for hyperkalemia.
Samtidig administration af nevirapin og cobicistat forventes at reducere plasmakoncentrationerne af cobicistat.
Co-administration of nevirapine and cobicistat is expected to decrease cobicistat plasma concentrations.
Hvis drospirenon/ethinylestradiol administreres samtidig med atazanavir/cobicistat eller darunavir/cobicistat, anbefales klinisk monitorering på grund af risikoen for hyperkaliæmi.
If drospirenone/ethinyloestradiol is co-administered with atazanavir/cobicistat or darunavir/cobicistat clinical monitoring is recommended due to the potential for hyperkalemia.
Samtidig administration af etravirine og cobicistat forventes at reducere plasmakoncentrationerne af cobicistat.
Co-administration of etravirine and cobicistat is expected to decrease cobicistat plasma concentrations.
Hvis drospirenon/ethinylestradiol administreres samtidig med darunavir/cobicistat, anbefales klinisk monitorering på grund af risikoen for hyperkaliæmi.
If drospirenone/ethinyloestradiol is co-administered with darunavir/cobicistat clinical monitoring is recommended due to the potential for hyperkalemia.
ANTIKONVULSIVA Carbamazepin (200 mg to gange dagligt)/Elvitegravir (150 mg én gang dagligt)/Cobicistat (150 mg én gang dagligt)
ANTICONVULSANTS Carbamazepine (200 mg twice daily)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
Plasmakoncentrationerne af nevirapin kan øges, når de administreres samtidig med cobicistat.
Nevirapine plasma concentrations may be increased when co-administered with cobicistat.
Antimykobakterielle lægemidler Rifabutin (150 mg hver anden dag)/Elvitegravir (150 mg én gang dagligt)/Cobicistat (150 mg én gang dagligt)
Antimycobacterials Rifabutin (150 mg every other day)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
Plasmakoncentrationerne af digoxin kan øges ved samtidig administration af cobicistat.
Plasma concentrations of digoxin may be increased when co-administered with cobicistat.
Drospirenon/Ethinylestradiol (3 mg/0,02 mg enkeltdosis)/A tazanavir (300 mg én gang dagligt)/Cobicistat (150 mg én gang dagligt)
Drospirenone/Ethinyloestradiol (3 mg/0.02 mg single dose)/Atazanavir (300 mg once daily)/Cobicistat (150 mg once daily)
Indeholder sunset yellow FCF aluminium lake (E110).
Contains sunset yellow FCF aluminium lake (E110), see leaflet for further information.
Plasmakoncentrationerne af drospirenon øges efter administration af drospirenon/ethinylestradiol samtidig med atazanavir/cobicistat eller med darunavir/cobicistat.
Plasma concentrations of drospirenone are increased following administration of drospirenone/ethinyloestradiol with atazanavir/cobicistat or with darunavir/cobicistat.
Meget almindelig: gulsot Almindelig:
Eye disorders: Very common:
Dosisjustering af cobicistat er ikke nødvendigt hos patienter med nedsat eller alvorligt nedsat nyrefunktion.
No dose adjustment of cobicistat is required for patients with renal impairment, including those with severe renal impairment.
Plasmakoncentrationer af rosuvastatin øges ved samtidig administration med darunavir/cobicistat.
Plasma concentrations of rosuvastatin are increased when co-administered with darunavir/cobicistat.
Atorvastatin (10 mg enkeltdosis)/Darunavir (800 mg)/Cobicistat (150 mg én gang dagligt)
Atorvastatin (10 mg single dose)/Darunavir (800 mg)/Cobicistat (150 mg once daily)
Plasmakoncentrationer af colchicin kan øges ved samtidig administration af cobicistat.
Colchicine plasma concentrations may be increased when co-administered with cobicistat.
Atorvastatin (10 mg enkeltdosis)/Atazanavir (300 mg)/Cobicistat (150 mg én gang dagligt)
Atorvastatin (10 mg single dose)/Atazanavir (300 mg)/Cobicistat (150 mg once daily)
Plasmakoncentrationer af rosuvastatin øges ved samtidig administration med atazanavir/cobicistat.
Plasma concentrations of rosuvastatin are increased when co-administered with atazanavir/cobicistat.
Rosuvastatin (10 mg enkeltdosis)/Darunavir (800 mg én gang dagligt)/Cobicistat (150 mg én gang dagligt)
Rosuvastatin (10 mg single dose)/Darunavir (800 mg once daily)/Cobicistat (150 mg once daily)
Det skal De vide, før De begynder at tage Tybost Sådan skal De tage Tybost Bivirkninger
What Tybost is and what it is used for What you need to know before you take Tybost How to take Tybost
Meget almindelig: okulær icterus Mave-tarm-kanalen:
ocular icterus Gastrointestinal disorders: Very common:
Rosuvastatin (10 mg enkeltdosis)/Atazanavir (300 mg én gang dagligt)/Cobicistat (150 mg én gang dagligt)
Rosuvastatin (10 mg single dose)/Atazanavir (300 mg once daily)/Cobicistat (150 mg once daily)
Plasmakoncentrationer af trazodon kan øges ved samtidig administration af cobicistat.
Plasma concentrations of trazodone may be increased when co-administered with cobicistat.
Plasmakoncentrationerne af drospirenon øges efter administration af drospirenon/ethinylestradiol samtidig med atazanavir/cobicistat.
Plasma concentrations of drospirenone are increased following co-administration of drospirenone/ethinyloestradiol with atazanavir/cobicistat.
• kvalme
nausea
Knogler, led, muskler og bindevæv: Ikke almindelig:
Musculoskeletal and connective tissue disorders: Uncommon:
Plasmakoncentrationer af atorvastatin øges ved samtidig administration med atazanavir/cobicistat.
Plasma concentrations of atorvastatin are increased when co-administered with atazanavir/cobicistat.
Plasmakoncentrationer af atorvastatin øges ved samtidig administration med darunavir/cobicistat.
Plasma concentrations of atorvastatin are increased when co-administered with darunavir/cobicistat.
Koncentrationer af disse antiarytmika kan øges ved samtidig administration af cobicistat.
Concentrations of these antiarrhythmic medicinal products may be increased when co-administered with cobicistat.
4.3 og 4.5), da nedsatte plasmakoncentrationer af cobicistat kan resultere i plasmaniveauer, derer utilstrækkelige til at opnå adækvat øgede plasmakoncentration af atazanavir eller darunavir.
Co-administration of cobicistat with medicinal products that induce CYP3A is contraindicated or is not recommended (see sections 4.3 and 4.5) because decreased plasma concentrations of cobicistat could result in plasma levels that are insufficient to achieve adequate pharmacoenhancement of atazanavir or darunavir.
• dasatinib, nilotinib, vinblastin og vincristin, lægemidler, der anvendes til at behandle kræft
• dasatinib, nilotinib, vinblastine and vincristine, medicines used to treat cancer • corticosteroids including betamethasone, budesonide, fluticasone, mometasone,
Plasmakoncentrationerne af ethinylestradiol sænkes efter administration af drospirenon/ethinylestradiol samtidig med darunavir/cobicistat.
Plasma concentrations of ethinyloestradiol are decreased following co-administration of drospirenone/ethinyloestradiol with darunavir/cobicistat.
Når De snart ikke har mere af Tybost, skal De bede om mere fra lægen eller på apoteket.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Plasmakoncentrationerne af drospirenon øges efter administration af drospirenon/ethinyloestradiol samtidig med darunavir/cobicistat.
Plasma concentrations of drospirenone are increased following co-administration of drospirenone/ethinyloestradiol with darunavir/cobicistat.
• colchicin, et lægemiddel, der anvendes til behandling af podagra.
• colchicine, a medicine used to treat gout  Tell your doctor if you are taking any of these medicines.
Nervesystemet: Almindelig:
depression, sleep disorder Nervous system disorders: Common:
Meget almindelig: kvalme
• feeling sick (nausea)
• cobicistat
• ritonavir • cobicistat
Udseende og pakningsstørrelser
What Tybost looks like and contents of the pack
Koncentrationer af betablokkere kan øges ved samtidig administration af cobicistat.
Concentrations of beta-blockers may be increased when co-administered with cobicistat.
• ritonavir
• itchiness
Kontakt lægen, før De tager Tybost:
Talk to your doctor before taking Tybost: • If you are taking another protease inhibitor.
EU-nummer Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage Indhold (Koncentration) Pakningsstørrelse EU/1/02/225/001 Xigris
Invented name Strength Pharmaceutical Form Route of administration Packaging Content (concentration)
r l g
l t o r d
• Mycamine bør ikke anvendes under graviditet, med mindre det er strengt nødvendigt.
• Mycamine should not be used during pregnancy unless clearly necessary.
• Patienter skal nøje overvåges for leverskade og for forværring af nyrefunktionen.
• Patients should be carefully monitored for liver damage and for worsening of renal function.
BILAG 127a BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET SKAL IMPLEMENTERES AF MEDLEMSLANDENE
ANNEX 127a CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
• For at formindske risikoen for adaptiv regenerering og potentiel efterfølgende dannelse af levertumorer tilrådes tidlig seponering, hvis der ses signifikant og vedvarende forhøjelse af ALAT/ASAT.
• To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/AST is recommended.
• Patienter, der modtager sirolimus, nifedipin eller itraconazol i kombination med Mycamine skal overvåges for sirolimus-, nifedipin- eller itraconazoltoksicitet, og sirolimus-, nifedipineller itraconazoldoseringen skal om nødvendigt reduceres.
• Patients receiving sirolimus, nifedipine or itraconazole in combination with Mycamine should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary.
• Der skal udvises forsigtighed, hvis patienten: - har alvorligt forringet leverfunktion - har kronisk leversygdom, der udviser kendte præneoplastiske tilstande (fx. fremskreden leverfibrose, cirrose, viral hepatitis, neonatal leversygdom eller kongenitte enzymdefekter) - modtager samtidig behandling, der omfatter hepatotoksiske og/eller genotoksiske egenskaber - modtager samtidig behandling med amphotericin B-deoxycholat - har anamnestisk hæmolyse, hæmolytisk anæmi eller nedsat nyrefunktion.
• Caution must be demonstrated if the patient: - has severe liver function impairment - has chronic liver diseases known to represent preneoplastic conditions (e.g. advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects) - is receiving a concomitant therapy including hepatotoxic and/or genotoxic properties - is receiving concomitant therapy with amphotericin B desoxycholate - has history of haemolysis, haemolytic anaemia or renal impairment.
• Mycamine er kontraindiceret, hvis patienten har kendt hypersensitivitet over for micafungin, andre echinocandiner eller hjælpestofferne.
• Mycamine is contra-indicated if the patient has a history of hypersensitivity to micafungin, other echinocandins or excipients.
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET SKAL IMPLEMENTERES AF MEDLEMSLANDENE
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Medlemslandene skal sikre, at alle betingelser eller begrænsninger mht. sikker og effektiv anvendelse af nedenstående beskrevne lægemidler d.v.s. om udlevering og brug implementeres:
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below i.e. the details of a prescription checklist are implemented:
Undersøgelsen begyndte den 1. juni 2009, og resultaterne ventes at foreligge i 2013.
The study started on the 1st of June 2009 and results are expected to be available in 2013.
Disse oplysninger blev udsendt som en hurtig varsling, der udløste en procedure i henhold til artikel 107 i direktiv 2001/83/EF, som ændret.
This information was circulated in a rapid alert triggering a procedure under Article 107 of Directive 2001/83/EC, as amended.
Alle 10 330 patienter blev tilordnet til tre risikokategorier for langsigtet mortalitet på grundlag af deres kliniske tilstand.
All 10,330 patients were assigned to three risk categories for long-term mortality based on the clinical condition.