FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious skin reactions are known to occur with NSAIDs including COX-2 selective inhibitors as well as other medicinal products.
Danish: Det er kendt, at alvorlige hudreaktioner ses med NSAID inklusive selektive COX-2-hæmmere og andre lægemidler.
English: In reproduction toxicity tests, the incidence of post-implantation losses, resorptions and foetal body weight retardation occurred at doses not producing maternal toxicity in the rabbit studies.
Danish: I reproduktionstoksicitetstests forekom incidensen af post-implantationstab, resorptioner og nedsat fostervægt ved doser, som ikke forårsagede maternal toksicitet i kaninforsøg.
English: 2 ml solvent ampoule contains sodium chloride, hydrochloric acid, sodium hydroxide and water for injection.
Danish: 2 ml solvens ampul indeholder natriumchlorid, saltsyre, natriumhydroxid, vand til injektionsvæsker.
English: Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with parecoxib is initiated or the dose of parecoxib is changed (see section 4.4).
Danish: Patienter, som får orale antikoagulantia bør derfor kontrolleres nøje med hensyn til protrombintid INR, især i de første dage efter initiering af behandling med parecoxib, eller hvis dosis af parecoxib ændres (se pkt.
English: Modes of administration other than IV or IM (e.g. intra-articular, intrathecal) have not been studied and should not be used.
Danish: (f.eks. intra-artikulær, intratekal) er ikke undersøgt og bør derfor ikke anvendes.
English: However, the reported rate of serious skin events appears to be greater for valdecoxib (the active metabolite of parecoxib) as compared to other COX-2 selective inhibitors.
Danish: Rapporteringshyppigheden af alvorlige hudreaktioner synes dog at være højere for valdecoxib (den aktive metabolit af parecoxib) end for andre selektive COX-2-hæmmere.
English: This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free.
Danish: Dette lægemiddel indeholder mindre end 23 mg natrium pr. dosis, og er derfor praktisk taget natriumfrit.
English: Pre-specified events that occurred with the highest incidence in all three treatment groups involved the category of surgical wound complications, including deep surgical infections and sternal wound healing events.
Danish: Præ-definerede hændelser, der opstod med højeste hyppighed i alle 3 behandlingsgrupper omfatter kategorier af sårkomplikationer efter operation, inklusive dybe operationsinfektioner og sårhelingskomplikationer i sternum.
English: Acetylsalicyclic acid and other NSAIDs
Danish: Acetylsalicylsyre og andre NSAID-præparater
English: There is further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications), when parecoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Danish: Der er yderligere øget risiko for gastrointestinale bivirkninger (gastrointestinale ulcera eller andre gastrointestinale komplikationer), når parecoxib tages samtidig med acetylsalicylsyre (selv ved lave doser).
English: Dynastat has not been studied in cardiovascular revascularization procedures other than coronary artery bypass graft (CABG) procedures.
Danish: Dynastat er ikke undersøgt ved kardiovaskulær revaskularisation udover koronar bypassopertion (CABG).
English: Very common: may affect more than 1 in 10 people ▪ Nausea (feeling sick)
Danish: Meget almindelige bivirkninger: forekommer hos flere end 1 ud af 10 personer • Kvalme.
English: The most serious reactions occur uncommonly to rarely, and include cardiovascular events such as myocardial infarction and severe hypotension, as well as hypersensitivity events such as anaphylaxis, angioedema and severe skin reactions.
Danish: De mest alvorlige bivirkninger opstår som ikke almindelige til sjældne, og omfatter kardiovaskulære hændelser som f.eks. myokardieinfarkt og alvorlig hypotension, og overfølsomhedsreaktioner som f.eks. anafylaksi, angioødem og alvorlige hudreaktioner.
English: Serious skin reactions, including erythema multiforme, exfoliative dermatitis and Stevens-Johnson syndrome (some of them fatal) have been reported through post-marketing surveillance in patients receiving parecoxib.
Danish: Alvorlige hudreaktioner, bl.a. erythema multiforme, dermatitis exfoliativa og Stevens-Johnsons syndrom (nogle af dem fatale) er blevet rapporteret efter markedsføringen hos patienter, der fik parecoxib.
English: This medicine does not require any special storage conditions prior to reconstitution.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen før rekonstitution.
English: Intravenous or intramuscular use.
Danish: Til intravenøs eller intramuskulær anvendelse.
English: The usual dose to start with is 40 mg. You may be given another dose - either 20 mg or 40 mg - 6 to 12 hours after the first one.
Danish: Det er muligt, at De får endnu en dosis - enten 20 mg eller 40 mg - 6-12 timer efter den første dosis.
English: Dynastat had no effect on acetylsalicylic acid-mediated inhibition of platelet aggregation or bleeding times.
Danish: Dynastat havde ingen effekt på acetylsalicylsyre-medieret hæmning af trombocytaggregation eller blødningstid.
English: A hydroxylated metabolite of valdecoxib (via the CYP pathway) has been identified in human plasma that is active as a COX-2 inhibitor.
Danish: Der er blevet identificeret en hydroxyleret valdecoxibmetabolit i humant plasma (via CYP-vejen), som er aktiv som en COX-2-hæmmer.
English: Of the patients treated with placebo, 270 patients received placebo for up to 4 days, 43 patients for up to 5 days, while only 3 patients were treated for up to 6 days and 2 patients for 7 or more days.
Danish: Af de patienter, som blev behandlet med placebo, fik 270 patienter placebo i op til 4 dage, 43 patienter i op til 5 dage, mens kun 3 patienter blev behandlet i op til 6 dage og 2 patienter i 7 dage eller derover.
English: Dynastat may be coadministered with opioid analgesics.
Danish: Dynastat kan administreres sammen med opioidanalgetika.
English: Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Danish: Indehaver af markedsføringstilladelsen: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgien.
English: Reporting of overdose with parecoxib has been associated with adverse reactions which have also been described with recommended doses of parecoxib.
Danish: Ifølge rapporter er overdosering med parecoxib forbundet med bivirkninger, som også er set ved anbefalede doser af parecoxib.
English: Excipient with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per dose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis.
English: Parecoxib is rapidly hydrolysed to the active metabolite valdecoxib.
Danish: Parecoxib hydrolyseres hurtigt til den aktive metabolit valdecoxib.
English: Plasma exposure (AUC and Cmax) to valdecoxib was increased (62% and 19%, respectively) when coadministered with fluconazole (predominantly a CYP2C9 inhibitor), indicating that the dose of parecoxib should be reduced in those patients who are receiving fluconazole therapy.
Danish: Plasmaeksponering (AUC og Cmax) for valdecoxib blev øget (henholdsvis 62% og 19%), når det blev administreret sammen med fluconazol (hovedsagelig en CYP2C9-hæmmer), hvilket viser, at dosis af parecoxib bør reduceres hos de patienter, der er i fluconazolbehandling.
English: Medicines can sometimes interfere with each other.
Danish: Medicin kan somme tider påvirke virkningen af anden medicin.
English: Patients should be advised to immediately report any emergent skin condition to their physician.
Danish: Patienter skal opfordres til omgående at oplyse lægen om enhver form for pludseligt opstående hudreaktioner.
English: In isolated cases, an aggravation of soft tissue infections has been described in connection with the use of NSAIDs and in nonclinical studies with Dynastat (see section 5.3).
Danish: Der er i enkelte tilfælde beskrevet en forværring af bløddelsinfektioner i forbindelse med brug af NSAID-præparater og i ikkekliniske undersøgelser med Dynastat (se pkt.
English: Effect of parecoxib (or its active metabolite valdecoxib) on the pharmacokinetics of other medicinal products
Danish: Parecoxibs (eller dets aktive metabolit valdecoxibs) virkning på andre lægemidlers farmakokinetik
English: Caution should be exercised when coadministering Dynastat with warfarin and other oral anticoagulants (see section 4.5).
Danish: Der skal udvises forsigtighed, når Dynastat administreres samtidig med warfarin og andre orale antikoagulantia (se pkt.
English: No unchanged parecoxib is detected in urine and only trace amounts in the faeces.
Danish: Der findes intet uomdannet parecoxib i urinen og kun spor i fæces.
English: In a series of small, multiple dose studies in healthy young and elderly subjects, Dynastat 20 mg or 40 mg twice daily had no effect on platelet aggregation or bleeding compared to placebo.
Danish: I en række små undersøgelser med gentagne doser til raske unge og ældre forsøgspersoner, havde Dynastat 20 mg eller 40 mg 2 gange dagligt ingen effekt på trombocytaggregation eller blødning sammenlignet med placebo.
English: Reconstitution solvents This medicinal product must not be mixed with other medicinal products.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler.
English: Parecoxib should be discontinued at the first sign of hypersensitivity.
Danish: Behandlingen med parecoxib bør indstilles ved det første tegn på overfølsomhed.
English: Some of these reactions have occurred in patients with a history of allergic-type reactions to sulfonamides (see section 4.3).
Danish: Nogle af disse reaktioner forekommer hos patienter, der tidligere har haft allergiske reaktioner over for sulfonamider (se pkt.
English: Vascular disorders Hypertension, hypotension
Danish: Vasculære sygdomme Hypertension, hypotension
English: There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score 10), therefore its use is contraindicated in these patients (see sections 4.3 and 5.2).
Danish: Der er ingen klinisk erfaring med behandling af patienter med svært nedsat leverfunktion (Child-Pugh score  10), og det er derfor kontraindiceret til disse patienter (se pkt.
English: The occurrence of adverse events in patients receiving parecoxib for 4-7 days (median duration 4 days) was low after treatment Day 3 and similar to placebo.
Danish: Forekomsten af bivirkninger hos patienter, som fik parecoxib i 4-7 dage (median varighed på 4 dage), var lav efter behandlingsdag 3 og svarede til placebo.
English: Because renal elimination of valdecoxib is not important to its disposition, no changes in valdecoxib clearance were found even in patients with severe renal impairment or in patients undergoing dialysis (see section 4.2).
Danish: Da renal elimination af valdecoxib ikke er en betydende eliminationsvej, ses ingen ændringer i valdecoxibs clearance, selv hos patienter med svært nedsat nyrefunktion eller patienter i dialyse (se pkt.
English: Based on the mechanism of action, the use of NSAIDs, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.
Danish: Ud fra virkningsmekanismen kan anvendelse af NSAID-præparater forsinke eller forhindre ruptur af ovariefollikler, hvilket har været forbundet med reversibel infertilitet hos nogle kvinder.
English: For storage conditions of the reconstituted medicinal product see section 6.3.
Danish: Opbevaringsforhold for det rekonstituerede lægemiddel, se pkt.
English: Dynastat is preservative free.
Danish: Dynastat indeholder ikke konserveringsmidler.
English: The reconstituted product is isotonic.
Danish: Færdigtilberedt opløsning er isotonisk.
English: Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g. apixaban, dabigatran, and rivaroxaban) (see section 4.5).
Danish: Orale antikoagulantia inkluderer warfarin/coumarintypen og nye orale antikoagulantia (f.eks. apixaban, dabigatran og rivaroxaban) (se pkt.
English: In surgery studies in which parecoxib was administered pre-operatively, no evidence of pharmacodynamic interaction was observed in patients receiving parecoxib and the inhalation anaesthetic agents nitrous oxide and isoflurane (see section
Danish: I kirurgiske undersøgelser, hvor parecoxib blev administreret præ-operativt, ses ingen tegn på farmakodynamiske lægemiddelinteraktioner hos patienter, der fik parecoxib og inhalationsanæstesipræparaterne lattergas og isofluran (se pkt.
English: Dynastat is supplied as a sterile, single unit-of-use vial that is packaged with a 2 ml ampoule with a fill volume of 2 ml sodium chloride 9 mg/ml (0.9%) solution (see below for various pack sizes and configurations)
Danish: Dynastat leveres som et sterilt engangshætteglas i pakninger med 2 ml ampuller, der er fyldt med 2 ml natriumchloridinjektionsvæske 9 mg/ml (0,9%) (se de forskellige pakningsstørrelser og indhold nedenfor).
English: Cases of severe hypotension shortly following parecoxib administration have been reported in postmarketing experience with parecoxib.
Danish: Tilfælde af alvorlig hypotension kort efter indgivelse af parecoxib er blevet rapporteret efter markedsføringen af parecoxib.
English: Coadministration of NSAIDs and ciclosporin or tacrolimus has been suggested to increase the nephrotoxic effect of ciclosporin and tacrolimus because of NSAID effects on renal prostaglandins.
Danish: Det tyder på, at samtidig indgift af NSAID-præparater og ciclosporin eller tacrolimus kan øge den nefrotoksiske virkning af ciclosporin og tacrolimus på grund af NSAIDs påvirkning af renale prostaglandiner.
English: This interaction should be given consideration in patients receiving parecoxib concomitantly with ACE-inhibitors, angiotensin II antagonists, beta-blockers and diuretics.
Danish: Denne interaktion bør overvejes hos patienter, der behandles med parecoxib samtidig med ACE-hæmmere, angiotensin II-antagonister, betablokkere og diuretika.
English: The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions.
Danish: Forskellen i antitrombocytaktivitet mellem COX-1-hæmmende NSAID-præparater og COX-2 selektive hæmmere kan være af klinisk betydning for patienter med risiko for udvikling af tromboemboliske hændelser.
English: Appropriate measures should be taken by physicians to monitor for any serious skin reactions with therapy, e.g. additional patient consultations.
Danish: Lægen bør tage passende forholdsregler med hensyn til kontrol for alvorlige hudreaktioner i forbindelse med behandlingen, f.eks. yderligere patientkontroller.
English: Also contains disodium hydrogen phosphate, phosphoric acid and sodium hydroxide.
Danish: Indeholder også dinatriumhydrogenphosphat, phosphorsyre, natriumhydroxid.
English: Placebo/valdecoxib treatment was also associated with a higher incidence of CV thromboembolic events versus placebo treatment, but this difference did not reach statistical significance.
Danish: I gruppen behandlet med placebo/valdecoxib ses også en øget hyppighed af kardiovaskulære tromboemboliske hændelser sammenlignet med placebo, men forskellen er ikke statistisk signifikant.
English: For more information on storage see the package leaflet.
Danish: Yderligere information om opbevaring findes i indlægssedlen.
English: The exact magnitude of the risk associated with a single dose has not been determined, nor has the exact duration of therapy associated with increased risk.
Danish: Ligeledes er den nøjagtige behandlingsvarighed, som er forbundet med øget risiko, heller ikke fastlagt.
English: There was a significantly (p<0.05) greater incidence of cardiovascular/thromboembolic events (myocardial infarction, ischemia, cerebrovascular accident, deep vein thrombosis and pulmonary embolism) detected in the parecoxib/valdecoxib treatment group compared to the placebo/placebo treatment group for the IV dosing period (2.2% and 0.0% respectively) and over the entire study period (4.8% and 1.3% respectively).
Danish: Der ses en signifikant (p<0,05) større hyppighed af kardiovaskulære/tromboemboliske hændelser (myokardieinfarkt, iskæmi, cerebrovaskulær hændelse, dybe venetromboser og lungeemboli) i gruppen behandlet med parecoxib/valdecoxib end i den placebo/placebo-behandlede gruppe i perioden med i.v.behandling (henholdsvis 2,2% og 0,0%) og gennem hele behandlingsperioden (henholdsvis 4,8% og 1,3%).
English: They will dissolve the powder before giving you the injection, and will inject the solution into a vein or a muscle.
Danish: Lægen/sygeplejersken vil opløse pulveret, inden de giver Dem injektionen enten i en vene eller i en muskel.
English: Skin and subcutaneous tissue disorders Pruritus, hyperhidrosis
Danish: Hud og subkutane væv Pruritus, hyperhidrose
English: Within each frequency grouping, adverse reactions are listed using MedDRA terminology and presented in order of decreasing seriousness.
Danish: Inden for hver gruppe er bivirkningerne anført i henhold til MedDRA-terminologi og opstillet efter, hvor alvorlige de er.
English: Therefore, caution should be observed when administering Dynastat with medicinal products known to be substrates of CYP2C19 (e.g. phenytoin, diazepam, or imipramine).
Danish: Forsigtighed bør derfor udvises ved administration af Dynastat sammen med lægemidler, som er CYP2C19-substrater (f.eks. phenytoin, diazepam eller imipramin).
English: Dynastat should not be injected into an IV line delivering any other medicinal product.
Danish: Dynastat må ikke injiceres i et i.v.-drop, som anvendes til andre lægemidler.
English: Renal function should be monitored when parecoxib and any of these medicinal products are coadministered.
Danish: Nyrefunktionen bør monitoreres, når parecoxib og et af disse stoffer gives samtidig.
English: AUC and Cmax following twice daily administration is linear up to 50 mg IV and 20 mg IM.
Danish: AUC og Cmax er efter dosering 2 gange dagligt lineær op til 50 mg i.v.
English: A significantly (p=0.033) greater incidence of events in the cardiovascular/thromboembolic category was detected in the parecoxib/valdecoxib treatment group (2.0%) compared to the placebo/placebo treatment group (0.5%).
Danish: En signifikant (p=0,033) højere hyppighed af hændelser i den kardiovaskulære/tromboemboliske kategori ses i gruppen behandlet med parecoxib/valdecoxib (2,0%) end i gruppen behandlet med placebo/placebo (0,5%).
English: Dynastat must not be administered to women who breast-feed (see section 4.3).
Danish: Dynastat må ikke administreres til ammende kvinder (se pkt.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, and is therefore considered essentially ‘sodium- free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, og det vil sige, at det praktisk taget er "natriumfrit".
English: The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).
Danish: Beslutningen om at ordinere en selektiv cyklooxygenase-2 ( COX-2)-hæmmer bør bero på en vurdering af den samlede risiko for den enkelte patient (se pkt.
English: Therefore, caution should be observed when coadministering Dynastat and medicinal products that are predominantly metabolised by CYP2D6 and which have narrow therapeutic margins (e.g. flecainide, propafenone, metoprolol).
Danish: Forsigtighed bør derfor udvises, når Dynastat administreres sammen med lægemidler, som hovedsageligt metaboliseres via CYP2D6, og som har et smalt terapeutisk vindue (f.eks. flecainid, propafenon, metoprolol).
English: Caution is advised in the treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding, or patients using acetylsalicylic acid concomitantly.
Danish: Der bør udvises forsigtighed ved behandling af patienter, der har den største risiko for at udvikle gastrointestinale komplikationer i forbindelse med NSAID-præparater: ældre, eller patienter med gastrointestinal sygdom, såsom ulceration og gastrointestinal blødning i anamnesen, eller patienter, som samtidigt får acetylsalicylsyre.
English: Hypertension (aggravated), orthostatic hypotension Respiratory, thoracic and mediastinal disorders Respiratory insufficiency
Danish: Hypertension (forværret), ortostatisk hypotension Luftveje, thorax og mediastinum Respiratorisk insufficiens
English: Dynastat will be given to you by a doctor or nurse.
Danish: En læge eller en sygeplejerske vil give Dem Dynastat.
English: Inhibition of prostaglandins by NSAIDs, including COX-2 inhibitors, may diminish the effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin II antagonists, beta-blockers and diuretics.
Danish: Hæmning af prostaglandiner af NSAID, herunder COX-2-hæmmere, kan reducere virkningen af angiotensinkonverterende enzym (ACE)-hæmmere, angiotensin II-antagonister, betablokkere og diuretika.
English: Parecoxib is suspected to cause serious birth defects when administered during the last trimester of pregnancy because as with other medicinal products known to inhibit prostaglandin, it may cause premature closure of the ductus arteriosus or uterine inertia (see sections 4.3, 5.1 and 5.3).
Danish: Parecoxib mistænkes for at forårsage alvorlige medfødte misdannelser ved brug i sidste graviditetstrimester, idet det ligesom andre lægemidler, som hæmmer prostaglandin, kan medføre præmatur lukning af ductus arteriosus eller inertia uteri (se pkt.
English: Precipitation may occur when Dynastat is combined in solution with other medicinal products and therefore Dynastat must not be mixed with any other medicinal product, either during reconstitution or injection.
Danish: Udfældning kan opstå, når Dynastat blandes i opløsninger med andre lægemidler, og derfor må Dynastat ikke blandes med andre lægemidler, hverken under rekonstitution eller injektion.
English: Inflammatory bowel disease.
Danish: Inflammatorisk tarmsygdom.
English: Because of the possibility for increased adverse reactions at higher doses of parecoxib, other COX-2 inhibitors and NSAIDs, patients treated with parecoxib should be reviewed following dose increase and, in the absence of an increase in efficacy, other therapeutic options should be considered (see section 4.2).
Danish: Da der er mulighed for øgede bivirkninger ved højere doser af parecoxib, andre COX-2-hæmmere og NSAID-præparater, bør patienter, der behandles med parecoxib kontrolleres efter dosisøgning, og ved manglende effektøgning, bør andre terapeutiske muligheder overvejes (se pkt.
English: Therefore, parecoxib should be used with caution in patients with compromised cardiac function, preexisting oedema, or other conditions predisposing to, or worsened by, fluid retention including those taking diuretic treatment or otherwise at risk of hypovolemia.
Danish: Derfor bør parecoxib anvendes med forsigtighed til patienter, der har kompromitteret hjertefunktion, ødem i anamnesen, eller andre tilstande, som disponerer for eller forværres af væskeretention, herunder også patienter, der tager diuretika eller som på anden måde har risiko for udvikling af hypovolæmi.
English: There were no significant differences between active treatments and placebo for any of the other pre-specified event categories (renal dysfunction/failure, upper GI ulcer complications or surgical wound complications).
Danish: Der ses ingen signifikante forskelle mellem aktive behandlinger og placebo for de øvrige prædefinerede hændelseskategorier (nedsat nyrefunktion/nyresvigt, øvre gastrointestinale ulcuskomplikationer eller sårkomplikationer efter operation).
English: Dynastat should be used with caution in patients with moderate hepatic impairment (Child-Pugh score 7-9) (see section 4.2).
Danish: Dynastat bør anvendes med forsigtighed til patienter med moderat leverfunktionsnedsættelse (ChildPugh score 7-9) (se pkt.