FrancophonIA/ELRC3.0 huggingface dataset:
English: Chemical and physical in-use stability of the reconstituted solution, which should not be refrigerated or frozen, have been demonstrated for up to 24 hours at 25C.
Danish: Kemisk og fysisk stabilitet for færdigtilberedt opløsning, som ikke må opbevares i køleskab eller nedfryses, er vist i op til 24 timer ved 25C.
English: Diuresis or alkalisation of urine may not be useful due to high protein binding of valdecoxib.
Danish: Diurese eller alkalisering af urinen er muligvis ikke effektiv på grund af valdecoxibs høje proteinbinding.
English: In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including Dynastat should be considered.
Danish: Hos kvinder, som har vanskeligt ved at undfange, eller som gennemgår fertilitetsundersøgelser, skal seponering af NSAID-præparater, herunder Dynastat, overvejes.
English: Patients without a history of sulfonamide allergy may also be at risk for serious skin reactions.
Danish: Patienter, der ikke har kendt sulfonamidallergi, kan også have risiko for udvikling af alvorlige hudreaktioner.
English: Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Danish: Konstateret iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom.
English: Most trials were designed for dosing of parecoxib up to 3 days.
Danish: I de fleste undersøgelser var det hensigten, at parecoxib skulle doseres i op til 3 dage.
English: ▪ If you are breast-feeding, you must not receive Dynastat, as a small amount of Dynastat will be transferred to your breast milk.
Danish: • De må ikke få Dynastat, hvis De ammer, da små mængder Dynastat går over i mælken.
English: Dynastat is contraindicated in the third trimester of pregnancy (see section 4.3).
Danish: Dynastat er kontraindiceret i 3. graviditetstrimester (se pkt.
English: Chemical and physical in-use stability of the reconstituted solution have been demonstrated for up to 24 hours at 25C.
Danish: Kemisk og fysisk stabilitet for færdigtilberedt opløsning er vist i op til 24 timer ved 25C.
English: Dissolve the powder completely using a gentle swirling motion and inspect the reconstituted product before use.
Danish: Opløs pulveret fuldstændigt ved forsigtig svingning og undersøg det rekonstituerede produkt før brug.
English: The concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding.
Danish: Samtidig brug af NSAID og orale antikoagulantia øger risikoen for blødning.
English: However caution is advised when methotrexate is administered concurrently with NSAIDs, because NSAID administration may result in increased plasma levels of methotrexate.
Danish: Det tilrådes imidlertid at udvise forsigtighed, når methotrexat administreres samtidig med NSAID, da administration af NSAID kan medføre øget plasmaniveau af methotrexat.
English: Dynastat can lead to an increase in blood pressure or worsening of existing high blood pressure which may result in an increase in side-effects associated with heart conditions.
Danish: Dynastat kan give forhøjet blodtryk eller forværre eksisterende for højt blodtryk, som kan medføre flere bivirkninger forbundet med hjertesygdom.
English: Steady state plasma concentrations of valdecoxib were reached within 4 days with twice daily dosing.
Danish: Valdecoxibs steady state plasmakoncentrationer nås inden for 4 dage ved dosering 2 gange dagligt.
English: Cyclooxygenase is responsible for generation of prostaglandins.
Danish: Cyklooxygenase er ansvarlig for dannelsen af prostaglandiner.
English: Parecoxib is a prodrug of valdecoxib.
Danish: Parecoxib er et prodrug af valdecoxib.
English: Blood pressure should be monitored closely during the initiation of therapy with parecoxib and throughout the course of therapy.
Danish: Blodtrykket bør kontrolleres nøje ved opstart af behandling med parecoxib og under hele behandlingsforløbet.
English: Coadministration of valdecoxib and lithium produced significant decreases in lithium serum clearance (25%) and renal clearance (30%) with a 34% higher serum exposure compared to lithium alone.
Danish: Samtidig administration af valdecoxib og lithium medførte signifikante fald i lithiums serumclearance (25%) og renale clearance (30%) med en 34% højere serumeksponering sammenlignet med lithium alene.
English: Solvent ampoules 2 ml ampoule: colourless neutral glass, Type I.
Danish: Ampuller med solvens 2 ml ampuller: farveløst neutralt glas, type I.
English: Dynastat may mask fever and other signs of inflammation (see section 5.1).
Danish: Dynastat kan maskere feber og andre tegn på inflammation (se pkt.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren ansvarlige for batchfrigivelse
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology or repeated dose toxicity at 2-fold the maximum human exposure to parecoxib.
Danish: De ikke-kliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi eller toksicitet efter gentagne doser ved en eksponering for parecoxib, der er 2 gange den maksimale humane eksponering.
English: Adequate monitoring of methotrexate-related toxicity should be considered when coadministering parecoxib and methotrexate.
Danish: Passende monitorering af methotrexatrelateret toksicitet bør overvejes, når parecoxib og methotrexat kombineres.
English: COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function).
Danish: COX-2 er også involveret i ovulation, implantation og lukning af ductus arteriosus, regulering af nyrefunktionen og funktioner i centralnervesystemet (induktion af feber, smerteopfattelse og kognitive funktioner).
English: The concomitant use of parecoxib with other non- acetylsalicylic acid NSAIDs should be avoided.
Danish: Samtidig anvendelse af parecoxib og andre non-acetylsalicylsyre NSAID-præparater skal undgås.
English: Data from epidemiological studies suggest an increased risk of miscarriage after use of prostaglandin synthesis inhibitors in early pregnancy.
Danish: Data fra epidemiologiske forsøg tyder på en øget risiko for abort efter anvendelse af prostaglandinsyntesehæmmere tidligt i graviditeten.
English: The only other acceptable solvents for reconstitution are:
Danish: De eneste andre forligelige opløsninger til rekonstitution er:
English: COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Danish: Det er vist, at COX-2 er isoformen af det enzym, som induceres af proinflammatoriske stimuli, og som man mener, hovedsagelig har ansvaret for syntese af prostanoide mediatorer af smerte, inflammation og feber.
English: If Dynastat is used with strong pain killers (called opioid analgesics) such as morphine the dose of Dynastat will be the same as explained above.
Danish: Hvis Dynastat bruges sammen med stærk smertestillende medicin (såkaldte opioidanalgetika) som f.eks. morphin, vil De få samme dosis, som anført ovenfor.
English: Coadministration of parecoxib and heparin did not affect the pharmacodynamics of heparin (activated partial thromboplastin time) compared to heparin alone.
Danish: Samtidig administration af parecoxib og heparin påvirkede ikke heparins farmakodynamik (aktiveret partiel thromboplastintid) sammenlignet med heparin administreret alene.
English: Parecoxib is rapidly and almost completely converted to valdecoxib and propionic acid in vivo with a plasma half-life of approximately 22 minutes.
Danish: Parecoxib omdannes hurtigt og næsten fuldstændigt til valdecoxib og propionsyre in vivo med en plasmahalveringstid på ca. 22 minutter.
English: In patients with varying degrees of renal impairment administered 20 mg IV Dynastat, parecoxib was rapidly cleared from plasma.
Danish: Hos patienter med varierende grader af nyreinsufficiens, som fik 20 mg Dynastat i.v., blev parecoxib hurtigt fjernet fra plasma.
English: Valdecoxib, but not parecoxib, is extensively partitioned into erythrocytes.
Danish: Valdecoxib, men ikke parecoxib, fordeles i stor udstrækning til erytrocytterne.
English: Lithium serum concentration should be monitored closely when initiating or changing parecoxib therapy in patients receiving lithium.
Danish: Serumkoncentrationen af lithium bør monitoreres tæt, når behandling med parecoxib initieres eller ændres hos patienter, der behandles med lithium.
English: Anticoagulant therapy should be monitored, particularly during the first few days after initiating Dynastat therapy in patients receiving warfarin or other anticoagulants, since these patients have an increased risk of bleeding complications.
Danish: Antikoagulationsbehandling bør monitoreres, især de første dage efter initiering af behandling med Dynastat hos patienter i behandling med warfarin eller andre antikoagulantia, da disse patienter har øget risiko for blødningskomplikationer.
English: The solvent is contained in colourless neutral glass ampoules (2 ml).
Danish: Solvens findes i farveløse neutale glasampuller (2 ml).
English: The IM injection should be given slowly and deeply into the muscle.
Danish: injektion skal gives langsomt og dybt i musklen.
English: Appropriate measures should be taken and discontinuation of parecoxib therapy should be considered if there is clinical evidence of deterioration in the condition of specific clinical symptoms in these patients.
Danish: Der bør tages passende forholdsregler, og seponering af behandlingen med parecoxib bør overvejes, hvis der ses forværring af specifikke kliniske symptomer hos disse patienter.
English: Do not use this medicine after the expiry date which is stated on the carton and on the vial label after Exp.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og på hætteglassets etiket efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The first perceptible analgesic effect occurred in 7-13 minutes, with clinically meaningful analgesia demonstrated in 23-39 minutes and a peak effect within 2 hours following administration of single doses of 40 mg IV or IM Dynastat.
Danish: Den første mærkbare analgetiske virkning indtræder i løbet af 7-13 minutter med klinisk meningsfuld analgesi i løbet af 23-39 minutter og maksimal effekt inden for 2 timer efter administration af enkeltdoser på 40 mg Dynastat i.v.
English: The injection may be given rapidly and directly into a vein or into an existing intravenous line (a thin tube running into a vein), or it can be given slowly and deeply into a muscle.
Danish: Injektionen kan gives hurtigt og direkte i en vene eller i et eksisterende intravenøst drop (en tynd slange, der løber ind i en vene) eller det kan gives langsomt og dybt i en muskel.
English: Pregnant women on NSAIDs should be closely monitored for amniotic fluid volume.
Danish: Gravide kvinder som får NSAIDs bør derfor monitoreres tæt med hensyn til mængden af fostervand.
English: If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of parecoxib should be taken.
Danish: Hvis der er kliniske tegn på forværring af tilstanden hos disse patienter, skal der tages passende forholdsregler, herunder seponering af parecoxib.
English: Dynastat is available in packs containing 10 vials.
Danish: Dynastat leveres i pakninger med 10 hætteglas.
English: Do not use Dynastat if you have severe liver disease
Danish: De må ikke få Dynastat, hvis De har en svær leversygdom.
English: On the basis of pharmacokinetics, no dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30-80 ml/min.
Danish: På grund af farmakokinetikken er dosisjustering ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion (kreatininclearance 30-80 ml/min).
English: What you need to know before you use Dynastat
Danish: Det skal De vide, før De får Dynastat
English: Dynastat contains the active substance parecoxib.
Danish: Dynastat indeholder det aktive stof parecoxib.
English: Caution should be used when initiating treatment with Dynastat in patients with dehydration.
Danish: Der bør udvises forsigtighed ved start af behandling med Dynastat til patienter med dehydrering.
English: There are no data indicating less overall adverse events associated with the use of parecoxib compared to placebo when used in conjunction with opioids.
Danish: Der er ingen data, der indikerer, at der samlet er færre bivirkninger forbundet med brugen af paracoxib sammenlignet med placebo, når paracoxib anvendes sammen med opioider.
English: Valdecoxib is eliminated via hepatic metabolism with less than 5% unchanged valdecoxib recovered in the urine.
Danish: Valdecoxib udskilles via levermetabolisme, og mindre end 5% uomdannet valdecoxib genfindes i urinen.
English: • Use of Sterile Water for Injection for reconstitution is not recommended, as the resulting solution is not isotonic.
Danish: • Brug af vand til injektionsvæsker til rekonstitution anbefales ikke, da den opnåede opløsning ikke er isotonisk.
English: There is limited experience in other types of surgery, for example gastrointestinal or urological surgery (see section 5.1).
Danish: Der er begrænset erfaring med andre typer kirurgi, f.eks. gastrointestinal eller urologisk kirurgi (se pkt.
English: However, in the repeated dose toxicity studies in dogs and rats, the systemic exposures to valdecoxib (the active metabolite of parecoxib) were approximately 0.8-fold the systemic exposure in elderly human subjects at the maximum recommended therapeutic dose of 80 mg daily.
Danish: Toksicitetsforsøg efter gentagne doser på hunde og rotter viser imidlertid, at den systemiske eksponering for valdecoxib (den aktive metabolit af parecoxib) er ca. 0,8 gange den systemiske eksponering hos ældre forsøgspersoner ved den maksimalt anbefalede terapeutiske dosis på 80 mg dagligt.
English: White to off-white powder.
Danish: Dynastat er et hvidt/off-white pulver.
English: In addition, the following rare, serious adverse reactions have been reported in association with the use of NSAIDs and cannot be ruled out for Dynastat: bronchospasm and hepatitis.
Danish: Derudover er følgende sjældne alvorlige bivirkninger rapporteret i forbindelse med brug af NSAID-præparater og kan ikke udelukkes for Dynastat: bronkospasme og hepatitis.
English: Cerebrovascular disorder
Danish: Cerebrovaskulær forstyrrelse
English: The metabolism of valdecoxib may increase when coadministered with enzyme inducers such as rifampicin, phenytoin, carbamazepine or dexamethasone.
Danish: Valdecoxibs metabolisme kan øges, når det administreres sammen med enzyminduktorer, såsom rifampicin, phenytoin, carbamazepin eller dexamethason.
English: Reconstitution process
Danish: Rekonstitutionsproces
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller sygeplejersken, hvis De tager anden medicin, har gjort det for nylig eller påtænker at tage anden medicin.
English: Severe hepatic impairment (serum albumin <25 g/l or Child-Pugh score  10).
Danish: Svært nedsat leverfunktion (serum-albumin < 25 g/l eller Child-Pugh score  10).
English: However, due to the importance of microbiological infection risk for injectable products, the reconstituted solution should be used immediately unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: På grund af den mikrobiologiske infektionsrisiko ved injektionspræparater er det vigtigt, at rekonstitueret opløsning anvendes straks, medmindre rekonstitution er foretaget under kontrollerede og validerede aseptiske forhold.
English: There were no significant differences in the overall safety profile, including the four pre-specified event categories described above for the second CABG surgery study, for parecoxib/valdecoxib compared to placebo treatment in these post-surgical patients.
Danish: Der ses ingen signifikant forskel i den samlede sikkerhedsprofil, omfattende de 4 præ-definerede hændelseskategorier beskrevet ovenfor i den anden CABG-undersøgelse, ved parecoxib/valdecoxib sammenlignet med placebobehandling hos disse postoperative patienter.
English: However, inhibition of prostaglandin synthesis might adversely affect pregnancy.
Danish: Hæmning af prostaglandinsyntesen kan dog have negativ indvirkning på graviditet.
English: As with all NSAIDs, parecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events.
Danish: Som for alle NSAID kan parecoxib føre til debut af hypertension eller forværring af eksisterende hypertension, som begge kan være medvirkende årsager til øget hyppighed af kardiovaskulære hændelser.
English: Plasma clearance (CLp) for valdecoxib is about 6 l/hr.
Danish: Valdecoxibs plasmaclearance (CLp) er ca. 6 l/time.
English: Česká Republika Pfizer PFE, spol.
Danish: Česká Republika Pfizer PFE, spol sr.o.
English: NSAID use during the second or third trimester of pregnancy may cause foetal renal dysfunction which may result in reduction of amniotic fluid volume or oligohydramnios in severe cases.
Danish: Brug af NSAID i 2. og 3. trimester kan give renal dysfunktion hos fostret som kan resultere i en reduceret mængde fostervand eller i svære tilfælde oligohydramnios.
English: Reconstitution solvents Acceptable solvents for reconstitution of Dynastat are:
Danish: Anbefalet solvens til rekonstitution af Dynastat er:
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with parecoxib after careful consideration (see section 5.1).
Danish: Patienter med særlige risikofaktorer for kardiovaskulære hændelser (f.eks. hypertension, hyperlipidæmi, diabetes mellitus, rygning) bør kun behandles med parecoxib efter nøje overvejelse (se pkt.
English: Of the patients treated with parecoxib, 317 patients received parecoxib for up to 4 days, 32 patients for up to 5 days, while only 8 patients were treated for up to 6 days and 1 patient for 7 or more days.
Danish: Af de patienter, som blev behandlet med parecoxib, fik 317 patienter parecoxib i op til 4 dage, 32 patienter i op til 5 dage, mens kun 8 patienter blev behandlet i op til 6 dage og 1 patient i 7 dage eller derover.
English: COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Danish: COX-2 selektive hæmmere reducerer dannelsen af systemiske (og dermed muligvis endotel-deriveret) prostacyclin uden at påvirke tromboxan i blodpladerne.
English: Solvent for Dynastat 40 mg
Danish: Solvens til Dynastat 40 mg
English: Manufacturer: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
Danish: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgien.
English: Moderate hepatic impairment did not result in a reduced rate or extent of parecoxib conversion to valdecoxib.
Danish: Moderat nedsat leverfunktion resulterede ikke i reduceret hastighed eller omfang af omdannelse af parecoxib til valdecoxib.
English: Treatment with valdecoxib (40 mg twice daily for 7 days) produced a 3-fold increase in plasma concentrations of dextromethorphan (CYP2D6 substrate).
Danish: Behandling med valdecoxib (40 mg 2 gange dagligt i 7 dage) gav en 3 gange så stor stigning i plasmakoncentrationerne af dextromethorphan (CYP2D6-substrat).
English: In short-term studies (7 days), the incidence of endoscopically observed gastroduodenal ulcers or erosions in healthy young and elderly ( 65 years) subjects administered Dynastat (5-21%), although higher than placebo (5-12%), was statistically significantly lower than the incidence observed with NSAIDs (66-90%).
Danish: I korttids-endoskopiundersøgelser (7 dage) med raske unge og ældre (> 65 år) resulterede behandling med Dynastat i en forekomst af endoskopisk observerede gastroduodenale sår eller erosioner (5-21%), der selv om tallet er højere end for placebo (5-12%), er statistisk signifikant lavere end forekomsten observeret med NSAID-præparater (66-90%).
English: These decreases were not considered clinically important since Cmax of valdecoxib is comparable after IM and IV parecoxib administration.
Danish: Disse fald blev ikke betragtet som klinisk vigtige, idet valdecoxibs Cmax er sammenlignelig efter administration af parecoxib i.m.
English: Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Danish: Antitrombotisk behandling bør derfor ikke seponeres (se pkt.
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret i {måned ÅÅÅÅ}.
English: There is limited clinical experience with Dynastat treatment beyond three days.
Danish: Der er begrænset klinisk erfaring med Dynastatbehandling i mere end 3 dage.
English: The mean (SD) duration of treatment was 4.1 (0.4) days for parecoxib and 4.2 (0.5) days for placebo, the range was 4-7 days for parecoxib and 4-9 days for placebo.
Danish: Den gennemsnitlige (SD) behandlingsvarighed var 4,1 (0,4) dage for parecoxib og 4,2 (0,5) dage for placebo, og intervallet var på 4-7 dage for parecoxib og 4-9 dage for placebo.
English: Exposure of valdecoxib following single doses of Dynastat, as measured by both the area under the plasma concentration vs. time curve (AUC) and peak concentration (Cmax), is approximately linear in the range of clinical doses.
Danish: Eksponering for valdecoxib efter enkeltdoser af Dynastat målt ved både arealet under plasmakoncentrationskurven vs. tidskurven (AUC) og maksimal koncentration (Cmax), er omtrent lineær i området af kliniske doser.
English: Elimination of valdecoxib is by extensive hepatic metabolism involving multiple pathways, including cytochrome P 450 (CYP) 3A4 and CYP2C9 isoenzymes and glucuronidation (about 20%) of the sulfonamide moiety.
Danish: Elimination af valdecoxib sker ved udbredt levermetabolisme via flere veje inklusive cytokrom P450 (CYP) 3A4 og CYP2C9 isoenzymer og glucuronidering (ca. 20%) af sulfonamiddelen.
English: Use of water for injection is not recommended, as the resulting solution is not isotonic.
Danish: Brug af vand til injektionsvæsker anbefales ikke, da den færdige opløsning ikke vil være isotonisk.
English: Additionally, coadministration of valdecoxib had no clinically significant effect on the hepatic or intestinal CYP 3A4-mediated metabolism of orally administered midazolam.
Danish: Derudover har samtidig administration af valdecoxib ingen klinisk effekt på hepatisk eller intestinal CYP 3A4-medieret metabolisme af oralt administreret midazolam.
English: In two pharmacokinetic interaction studies in rheumatoid arthritis patients receiving a stable weekly methotrexate dose (5-20 mg/week, as a single oral or intramuscular dose), orally administered valdecoxib (10 mg twice daily or 40 mg twice daily) had little or no effect on the steady-state plasma concentrations of methotrexate.
Danish: I to farmakokinetiske interaktionsforsøg med patienter med reumatoid artritis, der fik en stabil ugentlig dosis methotrexat (5-20 mg ugentligt som en enkelt oral eller intramuskulær dosis), havde oralt administreret valdecoxib (10 mg to gange dagligt eller 40 mg 2 gange dagligt) ringe eller ingen virkning på steady-state-plasmakoncentrationenerne af methotrexat.
English: In humans, studies demonstrated that valdecoxib metabolism is predominantly mediated via CYP3A4 and 2C9 isozymes.
Danish: Undersøgelser på mennesker har vist, at metaboliseringen af valdecoxib hovedsagelig er medieret af CYP3A4 og 2C9 isoenzymer.
English: COX-2 inhibitors have been associated with increased risk of cardiovascular and thrombotic adverse events when taken long term.
Danish: COX-2-hæmmere har været forbundet med øget risiko for kardiovaskulære og trombotiske uønskede hændelser ved langtidsbehandling.