FrancophonIA/ELRC3.0 huggingface dataset:
English: 2.5 mL vials (Type I clear glass), closed with a stopper (butyl rubber) and seal (aluminium).
Danish: 2,5 ml hætteglas (farveløst glas, Type I) med prop af butylgummi og aluminiumkapsel.
English: Defibrotide is not removed by dialysis (see section 5.2).
Danish: Defibrotid fjernes ikke ved dialyse (se pkt.
English: No formal pharmacokinetic studies have been performed in hepatic impaired patients.
Danish: Der er ikke udført egentlige farmakokinetiske undersøgelser hos patienter med nedsat leverfunktion.
English: In vitro defibrotide demonstrates anti-inflammatory effects that attenuate the release and production of reactive oxygen species and inflammatory mediators such as interleukin 6, thromboxane A2, leukotriene B4 and tumour necrosis factor-α (TNF-α).
Danish: In vitro viser defibrotid antiinflammatoriske virkninger, som attenuerer frigivelsen og dannelsen af reaktive oxygenforbindelser og inflammatoriske mediatorer, såsom interleukin 6, tromboxan A2, leukotrien B4 og tumornekrosefaktor-α (TNF-α).
English: The most frequent adverse reactions observed during the treatment of hepatic VOD are haemorrhage (including but not limited to gastrointestinal haemorrhage, pulmonary haemorrhage and epistaxis) and hypotension.
Danish: De hyppigste bivirkninger, der er iagttaget under behandling af hepatisk VOD, er blødning (bl.a. gastrointestinal blødning, pulmonal blødning og epistaxis) samt hypotension.
English: The solution is clear light yellow to brown, free from particulate matter or turbidity.
Danish: Opløsningen er bleggul til brun og fri for partikler eller turbiditet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON
English: Tell your doctor if you are taking medicines to prevent blood clotting such as acetylsalicylic acid, heparins, warfarin, dabigatran, rivaroxaban or apixaban or if you are taking anti-inflammatory medicines (e.g., ibuprofen, naproxen, diclofenac and other non-steroidal anti-inflammatory medicines).
Danish: Brug af anden medicin sammen med Defitelio Sig det til lægen, hvis du får lægemidler til forebyggelse af blodpropper, såsom acetylsalicylsyre, hepariner, warfarin, dabigatran, rivaroxaban eller apixaban, eller hvis du får antiinflammatoriske lægemidler (f.eks. ibuprofen, naproxen, diclofenac eller andre ikke-steroide antiinflammatoriske lægemidler).
English: The total volume of infusion should be determined based on the individual patient's weight.
Danish: Det samlede infunderede volumen skal fastsættes i henhold til den enkelte patients vægt.
English: General disorders and administration site conditions Common
Danish: Almene symptomer og reaktioner på administrationsstedet
English: Administration of defibrotide to patients who have haemodynamic instability, defined as inability to maintain mean arterial pressure with single pressor support, is not recommended.
Danish: Det frarådes at administrere defibrotid hos patienter, som er hæmodynamisk ustabile, dvs. mangler evnen til at opretholde det arterielle middeltryk støttet af en enkelt pressorsubstans.
English: Defitelio pharmacokinetic parameters after intravenous infusion of 6.25 mg/kg to healthy subjects.
Danish: Tabel 3 Farmakokinetiske parametre for Defitelio efter intravenøs infusion af 6,25 mg/kg til raske forsøgspersoner.
English: In a mouse model of thromboembolism, recombinant t-PA potentiated the antithrombotic effect of defibrotide when given intravenously and thus co-administration may present an increased risk of haemorrhage and is contraindicated (see section 4.3).
Danish: I en musemodel for tromboemboli potenserede rekombinant t-PA den antitrombotiske virkning af defibrotid ved intravenøs indgift; samtidig administration kan således medføre øget blødningsrisiko og er kontraindiceret (se pkt.
English: Vials are intended for a single use and unused solution from a single dose must be discarded (see section 6.6)
Danish: Hætteglassene er til engangsbrug, og ikke-anvendt opløsning fra en enkeltdosis skal kasseres (se pkt.
English: Defibrotide has demonstrated antithrombotic and fibrinolytic effects in vitro and in vivo by: increasing systemic tissue factor pathway inhibitor (TFPI), tissue plasminogen activator (t-PA) and thrombomodulin (TM) expression; decreasing von Willebrand factor (vWF) and plasminogen activator inhibitor-1 (PAI-1) expression; and enhancing the enzymatic activity of plasmin to hydrolyse fibrin clots.
Danish: Defibrotid har vist antitrombotiske og fibrinolytiske virkninger in vitro og in vivo ved at: øge systemisk ekspression af inhibitor af vævsfaktoraktiveringsvejen (tissue factor pathway inhibitor, TFPI), vævsplasminogenaktivator (tissue plasminogen activator, t-PA) og trombomodulin (TM), reducere ekspressionen af von Willebrand-faktor (vWF) og plasminogenaktivator-inhibitor (plasminogen activator inhibitor-1, PAI-1) og øge den enzymatiske aktivitet af plasmin til hydrolyse af fibrinpropper.
English: Each 2.5 mL vial contains 200 mg defibrotide.
Danish: Hvert 2,5 ml hætteglas indeholder 200 mg defibrotid.
English: Compared to healthy controls, subjects with renal impairment demonstrated 1.6- and 1.4-fold increases in AUC and Cmax, respectively and a half-life of about twice that of healthy subjects.
Danish: Forsøgspersoner med nedsat nyrefunktion udviste stigninger i AUC og Cmax, der var henholdsvis 1,6 og 1,4 gange større end hos raske kontroller, samt en halveringstid, der var ca. to gange så lang som hos raske forsøgspersoner.
English: However, chemical and physical in-use stability has been demonstrated for 72 hours at 15-25°C for a concentration range of 4 mg/mL to 20 mg/mL in sodium chloride 9 mg/mL (0.9%) solution for infusion or 5% glucose solution for infusion at 15-25ºC for 72 hours.
Danish: I koncentrationsområdet fra 4 mg/ml til 20 mg/ml er der imidlertid påvist kemisk og fysisk stabilitet under brug i 72 timer ved 15-25 °C i natriumchlorid, infusionsvæske, opløsning, 9 mg/ml (0,9 %), og i 72 timer ved 15-25 °C i glukose, infusionsvæske, opløsning, 5 %.
English: 4.5 Interaction with other medicinal products and other forms of interaction Potential interactions with recombinant t-PA
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: There is currently no reported experience in patients on the concomitant treatment with Low Molecular Weight Heparins (LMWHs), warfarin or the concomitant treatment with direct thrombin inhibitors (e.g., dabigatran) or direct Factor Xa inhibitors (e.g., rivaroxaban and apixaban).
Danish: Der er hidtil ikke beskrevet kliniske erfaringer hos patienter ved samtidig behandling med lavmolekylære hepariner (LMWH), warfarin eller direkte trombinhæmmere (f.eks. dabigatran) eller direkte faktor Xa-hæmmere (f.eks. rivaroxaban og apixaban).
English: In vitro and in vivo studies have demonstrated that defibrotide inhibits leukocyte and platelet adhesion to endothelium by: suppressing P-selectin and vascular cell adhesion molecule-1 (VCAM)-1; interfering with lymphocyte function-associated antigen 1-intercell adhesion molecule (LFA-1-ICAM) mediated leukocyte transmigration; and increasing nitric oxide (NO), Prostaglandin I2 (PGI2) and Prostaglandin E2 (PGE2).
Danish: In vitro- og in vivo-studier har vist, at defibrotid hæmmer leukocyt- og trombocytadhæsion til endotel ved at: undertrykke P-selectin og vaskulært celleadhæsionsmolekyle-1 (VCAM)-1, interferere med lymfocytfunktionsassocieret antigen 1-intercellulært adhæsionsmolekyle (LFA-1-ICAM)-medieret leukocyttransmigration og øge nitrogenoxid (NO), prostaglandin I2 (PGI2) og prostaglandin E2 (PGE2).
English: Pharmaswiss Hellas A.E.
Danish: Ελλάδα, Κύπρος Pharmaswiss Hellas A.E.
English: • bleeding from the eye
Danish: • blødning fra øjnene
English: p= 0.0131
Danish: Komplet respons på dag p = 0,0131
English: The safety and efficacy of defibrotide in children aged less than 1 month has not yet been established.
Danish: Defibrotids sikkerhed og virkning hos børn i alderen under 1 måned er endnu ikke klarlagt.
English: Cerebral haemorrhage
Danish: Hæmorrhagia cerebri
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige (kan forekomme hos indtil 1 ud af 10 behandlede):
English: Each 2.5 mL vial contains 200 mg defibrotide and each mL solution contains 80 mg defibrotide.
Danish: Hvert 2,5 ml hætteglas indeholder 200 mg defibrotid, og hver ml opløsning indeholder 80 mg defibrotid.
English: The number of vials to be diluted should be determined based on the individual patient's weight (see section 4.2).
Danish: Antallet af hætteglas, der skal fortyndes, bestemmes på grundlag af patientens vægt (se pkt.
English: • bleeding at the site of injection
Danish: • blødning på injektionsstedet
English: Defitelio has been used in clinical trials in patients with hepatic impairment without dose adjustment with no major safety issues identified (see section 4.2).
Danish: Defitelio er uden dosisjustering blevet anvendt i kliniske undersøgelser hos patienter med nedsat leverfunktion, uden at der derved er konstateret større sikkerhedsproblemer (se pkt.
English: • bleeding in the lungs
Danish: • blødning i lungerne
English: The amount of defibrotide excreted in urine over 24 hrs was about 5% of the total dose administered in those with renal impairment versus about 12% in healthy subjects.
Danish: Hos patienter med nedsat nyrefunktion var den mængde defibrotid, der blev udskilt i urinen i løbet af 24 timer, ca. 5 % af den samlede indgivne dosis mod ca. 12 % hos raske forsøgspersoner.
English: Embryo-foetal developmental toxicology studies in pregnant rats and rabbits of defibrotide doses close to the recommended therapeutic human dose, revealed a high rate of haemorrhagic abortion (see section 5.3).
Danish: I toksikologiske undersøgelser af den embryoføtale udvikling hos drægtige rotter og kaniner med doser af defibrotid nær den anbefalede terapeutiske dosis til mennesker var der høj forekomst af hæmoragisk abort (se pkt.
English: What you need to know before you take Defitelio
Danish: Det skal du vide, før du begynder at tageDefitelio
English: However, patients would not be expected to drive or operate machinery due to the nature of the underlying disease.
Danish: Normalt forventes patienterne på grund af den underliggende sygdom dog ikke at føre motorkøretøj eller betjene maskiner.
English: In addition, although in the defibrotide studies in VOD there have been no reports of hypersensitivity, cases of hypersensitivity including anaphylaxis were reported from a previously marketed formulation of defibrotide, consequently hypersensitivity is included as an ADR.
Danish: Da der imidlertid med en tidligere markedsført formulering af defibrotid blev indberettet tilfælde af overfølsomhed, herunder anafylaksi, er overfølsomhed medtaget som en bivirkning.
English: Medicinal products that affect platelet aggregation (e.g. non-steroidal anti-inflammatory agents) should be administered with care, under close medical supervision, during Defitelio administration.
Danish: Ved administration af lægemidler, der påvirker trombocytaggregationen (f.eks. NSAID), bør forsigtighed udvises og patienten overvåges tæt under administrationen af Defitelio.
English: For adverse reactions reported in both studies, the highest frequency was used in the table below.
Danish: Den højeste frekvens er brugt i nedenstående tabel for bivirkninger rapporteret i begge studier.
English: • bleeding into the skin
Danish: • blødning i huden
English: Defitelio PK Parameters Mean ± SD
Danish: Farmakokinetiske parametre for Defitelio Gennemsnit ± SD
English: Also contains: sodium citrate dihydrate, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections
Danish: Øvrige indholdsstoffer: natriumcitrat (dihydrat), saltsyre og natriumhydroxid (til pH-justering), vand til injektionsvæsker
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Defitelio 80 mg/mL sterile concentrate defibrotide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Defitelio, 80 mg/ml, sterilt koncentrat defibrotid i.v.
English: Dose adjustment is not required for patients with renal impairment or who are on intermittent haemodialysis (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion, eller som er i intermitterende hæmodialyse (se pkt.
English: Defitelio is not recommended in children less than 1 month of age.
Danish: Det frarådes at anvende Defitelio til børn under 1 måned.
English: This means that because of the rarity of this disease and for ethical reasons it has been impossible perform a placebo-controlled clinical trials and to get complete information on this medicine.
Danish: Det betyder, at det af etiske grunde ikke har været muligt at udføre placebokontrollerede kliniske undersøgelser og opnå fuldstændig dokumentation for lægemidlet, fordi det anvendes til en sjælden sygdom.
English: The final concentration of Defitelio should be in the concentration range of 4 mg/mL - 20 mg/mL (see section 6.3).
Danish: Den endelige koncentration af Defitelio skal være mellem 4 mg/ml og 20 mg/ml (se pkt.
English: Non-defibrotide treated Defibrotide treated
Danish: Gruppe behandlet med defibrotid
English: If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Defitelio 80 mg/mL concentrate for solution for infusion defibrotide
Danish: Defitelio, 80 mg/ml, koncentrat til infusionsvæske, opløsning defibrotid
English: • bleeding from the mouth
Danish: • blødning fra munden
English: In a sub-study it was shown that haemodialysis did not remove defibrotide (see section 4.2)
Danish: Et delstudie har vist, at defibrotid ikke fjernes ved hæmodialyse (se pkt.
English: Marketing Authorisation Holder and Manufacturer Gentium Srl
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Gentium S.r.l.
English: Open Label Treatment IND (25mg/kg/day)
Danish: Ikke-blindet INDbehandlingsundersøgelse (25 mg/kg/dag)
English: Consideration should be given to discontinuation of Defitelio during use of such therapy.
Danish: Under sådan behandling bør det overvejes at seponere Defitelio.
English: This means that due to the rarity of the disease and for ethical reasons preventing to perform a placebo-controlled study, it has not been possible to obtain complete information on this medicinal product.
Danish: Det betyder, at det af etiske grunde ikke har været muligt at udføre en placebokontrolleret undersøgelse og opnå fuldstændig dokumentation for lægemidlet, fordi det anvendes til en sjælden sygdom.
English: For patients treated with Defitelio the following side effects were reported.
Danish: Nedenstående bivirkninger er indberettet for patienter, der har fået behandling med Defitelio.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller , der er ansvarlig for batchfrigivelse Gentium S.r.l.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Phone: +39 031 5373200 Fax: +39 031 5373241 info@gentium.it
Danish: 22079 Italien Telefon: +39 031 5373200 Fax: +39 031 5373241 info@gentium.it
English: • blood in the stool
Danish: • blod i afføringen
English: It can be diluted with 5% glucose solution for infusion or sodium chloride 9 mg/mL (0.9%) solution for infusion, to a suitable concentration to permit infusion over 2 hours.
Danish: Det kan fortyndes med glukose, infusionsvæske, opløsning, 5 % eller natriumchlorid, infusionsvæske, opløsning, 9 mg/ml (0,9 %) til en koncentration, der er passende til infusion over 2 timer.
English: Potential interactions with other medicinal products Defibrotide does not inhibit or induce CYP450s (see section 5.2).
Danish: Defitelio hverken hæmmer eller inducerer CYP450-enzymer (se pkt.
English: What Defitelio looks like and contents of the pack Defitelio is a clear light yellow to brown concentrate for solution for infusion, free from particulate matter or turbidity.
Danish: Defitelio er et bleggult til brunt koncentrat til infusionsvæske, opløsning, og er fri for partikler eller uklarhed.
English: In patients who have or develop clinically significant acute bleeding requiring blood transfusion, Defitelio is not recommended or should be discontinued.
Danish: Hos patienter med klinisk betydningsfuld, transfusionskrævende akut blødning frarådes brug af Defitelio, og igangværende behandling med Defitelio bør seponeres.
English: Temporary discontinuation of Defitelio is recommended in patients who undergo surgery or invasive procedures at significant risk of major bleeding.
Danish: For patienter, som får foretaget operative indgreb eller invasive procedurer med betydelig risiko for større blødninger, tilrådes midlertidig seponering af Defitelio.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 October 2013
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: However, tell your doctor or healthcare professional if you think that a dose has been forgotten.
Danish: Spørg lægen, sygeplejersken eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: Measure 2 In order to provide comparative data on efficacy, the MAH will submit
Danish: For at fremskaffe komparative data vedrørende effekten vil indehaveren af markedsføringstilladelsen indsende
English: How to store Defitelio
Danish: Sådan får du Defitelio
English: A volume of the sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 5% solution for infusion from the infusion bag should be withdrawn and discarded, equal to the total volume of Defitelio solution to be added.
Danish: Fra infusionsposen fjernes og kasseres et volumen af natriumchlorid, infusionsvæske, opløsning, 9 mg/ml (0,9 %), eller glukose, infusionsvæske, opløsning, 5 %, svarende til det samlede volumen Defitelio-opløsning, der skal tilsættes.
English: Haematemesis Mouth haemorrhage
Danish: Nyrer og urinveje
English: NAME OF THE MEDICINAL PRODUCT Defitelio 80 mg/mL concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Defitelio, 80 mg/ml, koncentrat til infusionsvæske, opløsning
English: A significantly higher proportion of patients in the Defitelio treated group achieved a complete response defined as total bilirubin less than 2 mg/dL and resolution of MOF (multiple organ failure); Day+100 complete response was 23.5% (24/102) with Defitelio versus 9.4% (3/32) in the historical control (p=0.013).
Danish: På dag +100 var der komplet respons hos 23,5 % (24/102) i Defitelio-gruppen mod 9,4 % (3/32) i den historiske kontrolgruppe (p=0,013).
English: One mL of concentrate contains 80 mg defibrotide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En ml koncentrat indeholder 80 mg defibrotid.
English: Dose-Finding (25mg/kg/day arm)
Danish: Dosisfastsættelsesundersøgelse (gruppe på 25 mg/kg/dag)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be expected to exceed 24 hours at 2-8°C.
Danish: Hvis lægemidlet ikke anvendes straks, er brugeren ansvarlig for opbevaringstid og -betingelser før brug.
English: After the infusion is complete, the intravenous line should be flushed with sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 5% solution for infusion.
Danish: Når infusionen er afsluttet, skal den intravenøse slange skylles med natriumchlorid, infusionsvæske, opløsning, 9 mg/ml (0,9 %), eller glukose, infusionsvæske, opløsning, 5 %.
English: Very Common (may affect more than 1 in 10 people )
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 behandlede): • lavt blodtryk
English: • bleeding from the infusion line
Danish: • blødning ved infusionsslangen
English: In 52 healthy volunteers, after a single 6.25 mg/kg dose of Defitelio given as a 2-hour infusion, the pharmacokinetic parameters were as follows:
Danish: Følgende farmakokinetiske parametre blev bestemt hos 52 raske forsøgspersoner ved infusion af en enkelt dosis af Defitelio på 6,25 mg/kg over to timer:
English: The combined volumes of Defitelio should be added to the sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 5% solution for infusion.
Danish: Det kombinerede volumen af Defitelio tilsættes opløsningen af natriumchlorid, infusionsvæske, opløsning, 9 mg/ml (0,9 %), eller glukose, infusionsvæske, opløsning, 5 %.
English: Potential interactions with antithrombotic fibrinolytic agents Defibrotide has a profibrinolytic effect (see section 5.1) and this may potentially enhance the activity of antithrombotic/fibrinolytic medicinal products.
Danish: 5.1) og kan således potentielt øge aktiviteten af antitrombotiske/fibrinolytiske lægemidler.
English: Historically Controlled Trial (25mg/kg/day) Defibrotide treated group
Danish: Undersøgelse med historisk kontrolgruppe (25 mg/kg/dag)
English: Concomitant systemic anticoagulant therapy (e.g. heparin, warfarin, direct thrombin inhibitors and direct factor Xa inhibitors) (see section 4.5), except for routine maintenance or reopening of central venous line, requires careful monitoring.
Danish: Der kræves nøje monitorering ved samtidig systemisk antikoagulationsbehandling (f.eks. heparin, warfarin, direkte trombinhæmmere og direkte faktor Xa-hæmmere) (se pkt.
English: Defitelio should be diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion or 5% glucose solution for infusion (see section 6.3 for concentration range and stability of the diluted solution) to a suitable concentration to permit 2 hours infusion time (see section 4.2).
Danish: 6.3 vedrørende koncentrationsområde og stabilitet af den fortyndede opløsning) til en koncentration, der er passende til en infusionstid på to timer (se pkt.
English: Defitelio is for single use only.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Defitelio er udelukkende til engangsbrug.
English: Sodium hydroxide (for pH adjustment)
Danish: Natriumcitrat, dihydrat Saltsyre (til pH-justering) Natriumhydroxid (til pH-justering) Vand til injektionsvæsker
English: Renal impairment
Danish: Cerebralt hæmatom
English: Conjunctival haemorrhage
Danish: Nedsat nyrefunktion
English: − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 − Concomitant use of thrombolytic therapy (e.g. t-PA) (see section 4.5).
Danish: − Samtidig trombolytisk behandling (f.eks. t-PA) (se pkt.
English: 19 May 2010
Danish: 19. maj 2010
English: The application was withdrawn after ‘day 181'.
Danish: Ansøgningen blev trukket tilbage efter dag 181.
English: The main measure of effectiveness was based on how patients rated their pain and disease activity after 13 weeks of treatment.
Danish: Det primære effektmål var baseret på, hvordan patienterne vurderede deres smerte og sygdomsaktivitet efter 13 ugers behandling.
English: The Committee had concerns about its effect on blood pressure and the potential risk of toxic effects in the liver.
Danish: Udvalget havde betænkeligheder med hensyn til dets virkning på blodtryk og den mulige risiko for toksiske virkninger i leveren.
English: What is Beprana?
Danish: Hvad er Beprana?
English: The effects of Beprana were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Beprana blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Two of the studies involved 1,929 patients with knee osteoarthritis while the third study involved 810 patients with hip osteoarthritis.
Danish: To af undersøgelserne omfattede 1.929 patienter med osteoarthritis i knæ, mens den tredje undersøgelse omfattede 810 patienter med osteoarthritis i hofter.
English: Naproxen is a non-steroidal anti-inflammatory drug (NSAID).
Danish: Naproxen er et non-steroidt, antiinflammatorisk lægemiddel (NSAID).