FrancophonIA/ELRC3.0 huggingface dataset:
English: In young subjects, Dynastat 40 mg twice daily had no clinically significant effect on acetylsalicylic acid-mediated inhibition of platelet function (see section 4.5).
Danish: Hos unge forsøgspersoner havde Dynastat 40 mg 2 gange dagligt ingen klinisk signifikant virkning på acetylsalicylsyremedieret hæmning af trombocytfunktionen (se pkt.
English: In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors or Angiotensin-II antagonists, may result in further deterioration of renal function, including possible acute renal failure.
Danish: Hos ældre patienter, der lider af væskemangel (inklusive patienter i diuretikabehandling), eller som har kompromitteret nyrefunktion, kan samtidig behandling med NSAID-præparater, herunder selektive COX-2-hæmmere, og ACE-hæmmere eller angiotensin-II-antagonister føre til yderligere forværring af nyrefunktionen, herunder muligt akut nyresvigt.
English: In those patients where the same IV line is to be used to inject another medicinal product, the line must be adequately flushed prior to and after Dynastat injection with a solution of known compatibility.
Danish: Hos de patienter, hvor det samme i.v.-drop skal anvendes til injektion af andre lægemidler, skal droppet skylles grundigt med en opløsning af kendt forligelighed før og efter Dynastat-injektion.
English: Administration other than IV or IM
Danish: Andre administrationsmåder end i.v.
English: History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme or patients with known hypersensitivity to sulfonamides (see sections 4.4 and 4.8).
Danish: Kendt tidligere alvorlig lægemiddelallergi af enhver type, især hudreaktioner som f.eks. StevensJohnsons syndrom, toksisk epidermal nekrolyse, erythema multiforme, eller patienter med kendt overfølsomhed over for sulfonamider (se pkt.
English: Asthenia, injection site pain, injection site reaction
Danish: Asteni, smerter ved injektionsstedet, reaktion på injektionsstedet
English: Parecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Danish: Behandlingen med parecoxib bør seponeres ved den første forekomst af hududslæt, slimhindeaffektioner, eller andre tegn på overfølsomhed.
English: Other medicines and Dynastat
Danish: Brug af anden medicin sammen med Dynastat
English: In healthy elderly subjects, the apparent oral clearance of valdecoxib was reduced, resulting in an approximately 40% higher plasma exposure of valdecoxib compared to healthy young subjects.
Danish: Hos raske, ældre forsøgspersoner blev valdecoxibs tilsyneladende orale clearance reduceret med en ca. 40 % højere plasmaeksponering for valdecoxib til følge, sammenlignet med raske, unge forsøgspersoner.
English: Patients with severe hepatic impairment have not been studied and therefore the use of Dynastat in patients with severe hepatic impairment is not recommended (see sections 4.2 and 4.3).
Danish: Patienter med svært nedsat leverfunktion er ikke undersøgt, og derfor anbefales brugen af Dynastat ikke til patienter med svært nedsat leverfunktion (se pkt.
English: Following IV or IM injection, parecoxib is rapidly converted to valdecoxib, the pharmacologically active substance, by enzymatic hydrolysis in the liver.
Danish: injektion omdannes parecoxib hurtigt til valdecoxib, den farmakologisk aktive substans, ved enzymatisk hydrolyse i leveren.
English: Hypersensitivity reactions including anaphylaxis and angioedema
Danish: Overfølsomhedsreaktioner omfattende anafylaksi og angioødem
English: In patients with moderate hepatic impairment (Child-Pugh score 7-9), treatment should be initiated with half the usual recommended dose of Dynastat and the maximum daily dose should be reduced to 40 mg since valdecoxib exposures were more than doubled (130%) in these patients.
Danish: Hos patienter med moderat nedsat leverfunktion (Child-Pugh score 7-9) bør behandling initieres med halv sædvanlig anbefalet dosis af Dynastat, og den maksimale daglige dosis bør reduceres til 40 mg, da valdecoxib eksponering var mere end fordoblet hos disse patienter (130%).
English: Infections and infestations Pharyngitis, alveolar osteitis (dry socket)
Danish: Infektioner og parasitære sygdomme Pharyngitis, ostitis alveolaris
English: If, during treatment, patients deteriorate in any of the organ system functions described below, appropriate measures should be taken and discontinuation of parecoxib therapy should be considered.
Danish: Hvis der under behandlingen sker en forværring inden for et af de organsystemer, som er nævnt nedenfor, skal passende forholdsregler tages, og seponering af behandlingen med parecoxibnatrium bør overvejes.
English: The solution should not be used if discolored or cloudy, or if particulate matter is observed.
Danish: Opløsningen må ikke anvendes, hvis den er misfarvet eller uklar, eller hvis den indeholder synlige partikler.
English: Upper gastrointestinal (GI) complications (perforations, ulcers or bleedings [PUBs]), some of them resulting in fatal outcome, have occurred in patients treated with parecoxib.
Danish: Der er set øvre gastrointestinale (GI) komplikationer (perforationer, ulcera eller blødninger (PUB)), nogle med dødelig udgang hos patienter behandlet med parecoxib.
English: Plasma exposure of omeprazole (CYP 2C19 substrate) 40 mg once daily was increased by 46% following administration of valdecoxib 40 mg twice daily for 7 days, while the plasma exposure to valdecoxib was unaffected.
Danish: Plasmaeksponeringen af omeprazol (CYP 2C19-substrat) 40 mg 1 gang dagligt blev øget med 46% efter administration af valdecoxib 40 mg 2 gange dagligt i 7 dage, mens plasmaeksponeringen af valdecoxib var upåvirket.
English: Exposure to valdecoxib was similar in terms of AUC and Cmax following IV and IM administration.
Danish: Eksponeringen for valdecoxib var sammenlignelig med hensyn til både AUC og Cmax efter i.v.
English: However, for elderly patients weighing less than 50 kg, treatment should be initiated with half the usual recommended dose of Dynastat and reduce the maximum daily dose to 40 mg (see section 5.2).
Danish: Behandling af ældre patienter, som vejer mindre end 50 kg, bør indledes med halv sædvanlig anbefalet dosis af Dynastat, og maksimal daglig dosis nedsættes til 40 mg (se pkt.
English: Parecoxib administered intravenously to lactating rats as a single dose showed concentrations of parecoxib, valdecoxib and a valdecoxib active metabolite in milk similar to that of maternal plasma.
Danish: En enkeltdosis parecoxib administreret intravenøst til diegivende rotter gav mælkekoncentrationer af parecoxib, valdecoxib og en aktiv valdecoxibmetabolit svarende til koncentrationer i maternel plasma.
English: Pancreatitis, oesophagitis, oedema mouth (perioral swelling)
Danish: Pancreatitis, øsofagitis, ødem i munden (periorale hævelser)
English: In animals, administration of prostaglandin synthesis inhibitors, including parecoxib, has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality (see sections 5.1 and 5.3).
Danish: Hos dyr er det vist, at administration af prostaglandinsyntesehæmmere, herunder parecoxib, resulterer i øget præ- og postimplantationstab og fosterdødelighed (se pkt.
English: No dosage adjustment is generally necessary in patients with mild hepatic impairment (Child-Pugh score 5-6).
Danish: Sædvanligvis er dosisjustering til patienter med let nedsat leverfunktion ikke nødvendig (Child-Pugh score 5-6).
English: Opioid analgesics can be used concurrently with parecoxib, dosing as described in the paragraph above.
Danish: Opioidanalgetika kan anvendes sammen med parecoxib i en dosis svarende til den, der er anført ovenfor.
English: Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or nonsteroidal antiinflammatory drugs (NSAIDs) including COX-2 inhibitors.
Danish: Patienter, som tidligere har haft bronkospasme, akut rhinitis, nasale polypper, angioødem, urticaria eller anden type af allergisk reaktion efter at have taget acetylsalicylsyre eller non-steroide antiinflammatoriske midler (NSAID-præparater), herunder COX-2-hæmmere.
English: It is one of a family of medicines called COX-2 inhibitors (this is short for cyclo-oxygenase-2 inhibitors).
Danish: Dynastat tilhører en lægemiddelgruppe, der kaldes COX-2-hæmmere (en forkortelse af cyklo-oxygenase-2-hæmmere).
English: Reconstitution solvents Reconstitute Dynastat 40 mg with 2 ml sodium chloride 9 mg/ml (0.9%) solution.
Danish: Solvens til rekonstitution Opløs 40 mg Dynastat med 2 ml natriumchloridinjektionsvæske 9 mg/ml (0,9%).
English: ibuprofen) or to COX-2 inhibitors.
Danish: (f.eks. ibuprofen) eller andre COX-2-hæmmere.
English: Effects of other medicinal products on the pharmacokinetics of parecoxib (or its active metabolite valdecoxib)
Danish: Andre lægemidlers virkning på parecoxibs (eller dets aktive metabolit valdecoxibs) farmakokinetik
English: Valdecoxib is not removed by haemodialysis.
Danish: Valdecoxib fjernes ikke ved hæmodialyse.
English: Three of the six cardiovascular thromboembolic events in the placebo/valdecoxib treatment group occurred during the placebo treatment period; these patients did not receive valdecoxib.
Danish: 3 af de 6 kardiovaskulære tromboemboliske hændelser i gruppen behandlet med placebo/valdecoxib ses i perioden, hvor der behandles med placebo.
English: Psychiatric disorders Agitation, insomnia Nervous system disorders Hypoaesthesia, dizziness
Danish: Psykiske forstyrrelser Agitation, insomni Nervesystemet Hypæstesi, svimmelhed
English: 5 + 5 pack: contains 5 powder vials and 5 solvent ampoules.
Danish: 5 + 5 pakning: indeholder 5 hætteglas med pulver og 5 ampuller med solvens.
English: Nine prespecified adverse event categories were evaluated (cardiovascular thromboembolic events, pericarditis, new onset or exacerbation of congestive heart failure, renal failure/dysfunction, upper GI ulcer complications, major non-GI bleeds, infections, non-infectious pulmonary complications, and death).
Danish: 9 præ-definerede uønskede hændelseskategorier blev undersøgt (kardiovaskulære tromboemboliske hændelser, hjertehindebetændelse, debut af eller forværring af kronisk hjerteinsufficiens, nedsat nyrefunktion/nyresvigt, øvre gastrointestinal kompliceret ulcus, større ikkegastrointestinale blødninger, infektioner, ikke-infektiøse pulmonale komplikationer og død).
English: Coadministration of valdecoxib with glibenclamide (CYP3A4 substrate) did not affect either the pharmacokinetics (exposure) or the pharmacodynamics (blood glucose and insulin levels) of glibenclamide.
Danish: Samtidig administration af valdecoxib og glibenclamid (CYP3A4-substrat) påvirkede hverken glibenclamids farmakokinetik (eksponering) eller farmakodynamik (blodsukker og insulinniveauer).
English: What Dynastat is and what it is used for What you need to know before you use Dynastat How to use Dynastat
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal De vide, før De får Dynastat Sådan gives Dynastat
English: 1 + 1 pack: contains 1 powder vial and 1 solvent ampoule.
Danish: 1 + 1 pakning: indeholder 1 hætteglas med pulver og 1 ampul med solvens.
English: How to store Dynastat
Danish: Sådan gives Dynastat
English: Dynastat should be introduced with caution and at half the usual recommended dose in patients with moderate hepatic impairment (Child-Pugh score 7-9) and the maximum daily dose should be reduced to 40 mg.
Danish: Behandlingen med Dynastat bør indledes med forsigtighed og med halv sædvanlig anbefalet dosis til patienter med moderat nedsat leverfunktion (Child-Pugh score 7-9), og maksimal daglig dosis bør nedsættes til 40 mg.
English: Injectable anaesthetics
Danish: Injicerbare anæstetika
English: The powder is contained in colourless glass vials (5 ml) with a stopper, sealed with a purple flip-off cap on the aluminium overseal.
Danish: Pulveret findes i farveløse hætteglas af glas (5 ml) med en prop, lukket med en lilla aftagelig plasthætte på en aluminiumskapsel.
English: Concomitant use with opioid analgesics
Danish: Samtidig brug af opioidanalgetika
English: There is limited clinical experience with Dynastat treatment beyond three days (see section 5.1).
Danish: Der er begrænset klinisk erfaring med Dynastatbehandling i mere end 3 dage (se pkt.
English: VIAL LABEL: 40 mg
Danish: HÆTTEGLAS ETIKET: 40 mg
English: In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of parecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see section 5.1).
Danish: I de indsendte kliniske undersøgelser ses, som for andre NSAIDpræparater, en øget risiko for gastrointestinal ulceration eller andre gastrointestinale komplikationer ved samtidig administration af lav-dosis acetylsalicylsyre end med brugen af parecoxib alene (se pkt.
English: The NSAIDs class is also associated with increased GI complications when coadministered with glucocorticoids, selective serotonin reuptake inhibitors, other antiplatelet drugs, other NSAIDs or patients ingesting alcohol.
Danish: Lægemidler, der hører under NSAID-præparater, associeres også med øgede gastrointestinale komplikationer ved samtidig administration med glukokortikoider, eller selektive serotonin-genoptagelseshæmmere, andre antitrombotiske lægemidler, andre NSAID-præparater eller hvis patienten, indtager alkohol.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Danish: Information om rekonstitution af dette lægemiddel inden administration findes i pkt.
English: Coadministration of IV parecoxib 40 mg with propofol (CYP2C9 substrate) or midazolam (CYP3A4 substrate) did not affect either the pharmacokinetics (metabolism and exposure) or the pharmacodynamics (EEG effects, psychomotor tests and waking from sedation) of IV propofol or IV midazolam.
Danish: og propofol (CYP2C9-substrat) eller midazolam (CYP3A4-substrat) påvirker hverken farmakokinetikken (metabolisme og eksponering) eller farmakodynamikken (EEG-påvirkninger, psykomotoriske tests og opvågning fra sedation) for propofol i.v.
English: This medicinal product does not require any special storage conditions prior to reconstitution.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen, før det bliver blandet.
English: The first CABG surgery study evaluated patients treated with IV parecoxib 40 mg bid for a minimum of 3 days, followed by treatment with valdecoxib 40 mg bid (parecoxib/valdecoxib group) (n=311) or placebo/placebo (n=151) in a 14-day, double-blind placebo-controlled study.
Danish: parecoxib 40 mg 2 gange dagligt i mindst 3 dage, efterfulgt af behandling med valdecoxib 40 mg 2 gange dagligt (parecoxib/valdecoxib gruppe) (n=311) eller placebo/placebo (n=151) i en 14 dages dobbeltblind, placebokontrolleret undersøgelse.
English: Type I colourless glass vials (5 ml) with a butyl rubber stopper, sealed with a purple polypropylene flip-off cap on the aluminium overseal.
Danish: Farveløst hætteglas (5 ml, type I glas) med en butylgummiprop, lukket med en lilla flip-offpolypropylenhætte på en aluminiumkapsel.
English: Additional studies in other surgical settings provided similar observations.
Danish: Der er set tilsvarende observationer i forsøg ved andre kirurgiske indgreb.
English: In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needed basis.
Danish: Parecoxib blev indgivet med et fastsat tidsinterval, mens opioiderne blev indgivet efter behov i alle de kliniske vurderinger.
English: 40 mg vial: Remove the purple flip-off cap to expose the central portion of the rubber stopper of the parecoxib 40 mg vial.
Danish: 40 mg hætteglas: Fjern den lilla flip-off-hætte for at afdække den centrale del af 40 mg parecoxib hætteglassets gummiprop.
English: 5 vials and 5 solvent ampoules
Danish: 5 hætteglas og 5 ampuller med solvens
English: Treatment of post-operative pain following coronary artery bypass graft (CABG) surgery (see sections 4.8 and 5.1).
Danish: Behandling af post-operative smerter efter koronar bypassoperation (CABG) (se pkt.
English: Patients with a history of sulfonamide allergy may be at greater risk of skin reactions (see section 4.3).
Danish: Patienter, der tidligere har haft allergi over for sulfonamider, kan have større risiko for at få hudreaktioner (se pkt.
English: In post-marketing experience, toxic epidermal necrolysis has been reported in association with the use of valdecoxib, and cannot be ruled out for parecoxib (see section 4.4).
Danish: Efter markedsføringen er toksisk epidermal nekrolyse rapporteret i forbindelse med brug af valdecoxib og kan ikke udelukkes for parecoxib: (se pkt.
English: The reduction in opioid use with Dynastat treatment on Days 2 and 3 was 7.2 mg and 2.8 mg (37% and 28% respectively).This reduction in opioid use was accompanied by significant reductions in patient-reported opioid symptom distress.
Danish: Reduktion i brugen af opioider i forbindelse med Dynastat-behandling var 7,2 mg på dag 2 og 2,8 mg på dag 3 (henholds vis 37 % og 28 %).
English: As the cardiovascular risk of COX-2 specific inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Danish: Da den kardiovaskulære risiko ved brug af specifikke COX-2-hæmmere kan øges med dosis og behandlingsvarighed, bør den kortest mulige behandlingsvarighed og den laveste effektive daglige dosis anvendes.
English: The efficacy of Dynastat was established in studies of dental, gynaecologic (hysterectomy), orthopaedic (knee and hip replacement), and coronary artery bypass graft surgical pain.
Danish: Dynastats effekt er fastslået i undersøgelser af smerter efter dentale, gynækologiske (hysterektomi), ortopædiske (knæ- og hofteudskiftning) og koronar bypassoperationer.
English: In the second CABG surgery study, four pre-specified event categories were evaluated (cardiovascular/thromboembolic; renal dysfunction/renal failure; upper GI ulcer/bleeding; surgical wound complication).
Danish: I den anden CABG-undersøgelse blev 4 præ-definerede hændelseskategorier undersøgt (kardiovaskulær/tromboembolisk hændelse, nedsat nyrefunktion/nyresvigt, øvre gastrointestinal ulcus/blødning, sårkomplikation efter operation).
English: Dynastat should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Før indgift skal Dynastat undersøges visuelt for partikler og misfarvning.
English: 3 + 3 pack: contains 3 powder vials and 3 solvent ampoules.
Danish: 3 + 3 pakning: indeholder 3 hætteglas med pulver og 3 ampuller med solvens.
English: Dynastat should be administered within 24 hours of reconstitution (see section 6.3), or discarded.
Danish: Dynastat skal indgives senest 24 timer efter rekonstitution (se pkt.
English: Dynastat has been studied in dental, orthopaedic, gynaecologic (principally hysterectomy) and coronary artery bypass graft surgery.
Danish: Dynastat er undersøgt ved tandkirurgi, ortopædkirurgi, gynækologisk kirurgi (især hysterektomi) og koronar bypassoperation.
English: When adjusted for body weight, steady state plasma exposure of valdecoxib was 16% higher in elderly females compared to elderly males (see section 4.2).
Danish: Valdecoxibs steady state plamaeksponering hos ældre kvinder justeret for legemsvægt var 16 %højere end hos ældre mænd (se pkt.
English: Valdecoxib is a selective COX-2 inhibitor within the clinical dose range.
Danish: Valdecoxib er inden for det kliniske dosisinterval en oral, selektiv COX-2-hæmmer.
English: Reactions might include wheezing (bronchospasm), badly blocked nose, itchy skin, rash or swelling of the face, lips or tongue, other allergic reactions or nasal polyps after taking these medicines - if you are more than 6 months pregnant - if you are breast-feeding - if you have severe liver disease - if you have inflammation of the intestines (ulcerative colitis or Crohn's disease) - if you have heart failure - if you are about to have heart surgery or surgery on your arteries (including any coronary artery procedure)
Danish: hudkløe, udslæt eller hævelser i ansigtet, læber eller tunge, andre allergiske reaktioner eller polypper i næsen - hvis De er mere end 6 måneder henne i graviditeten - hvis De ammer - hvis De har en alvorlig leverlidelse - hvis De har tarmbetændelse (ulcerøs colitis eller Crohns sygdom) - hvis De har hjertesvigt - hvis De i nær fremtid skal have foretaget en hjerteoperation eller en operation i en pulsåre
English: Withdraw with a sterile needle and syringe, 2 ml of an acceptable solvent and insert the needle through the central portion of the rubber stopper transferring the solvent into the parecoxib 40 mg vial.
Danish: Tag med en steril nål og sprøjte 2 ml forligelig solvens og stik nålen ind gennem gummiproppens centrale del og overfør solvens til 40 mg parecoxib hætteglasset.
English: • Ringer-Lactate solution for injection.
Danish: • Ringer-lactat-injektionsvæske
English: Remove the purple flip-off cap to expose the central portion of the rubber stopper of the 40 mg parecoxib vial.
Danish: Fjern den lilla flip-off kapsel for at afdække den centrale del af 40 mg parecoxib hætteglassets gummiprop.
English: Renal failure acute
Danish: • Akut nyresvigt
English: When reconstituted in sodium chloride 9 mg/ml (0.9%) solution, Dynastat contains approximately 0.44 mmol of sodium per vial.
Danish: Ved rekonstitution i natriumchloridinjektionsvæske 9 mg/ml (0,9%) indeholder Dynastat ca. 0,44 mmol natrium pr. hætteglas.
English: Circulatory collapse, congestive heart failure, tachycardia
Danish: Kredsløbskollaps, kronisk venstresidig hjerteinsufficiens, takykardi
English: Surgical wound complications (most involving the sternal wound) were observed at an increased rate with parecoxib/valdecoxib treatment.
Danish: Sårkomplikationer efter operation (hyppigst omfattende sternumsår) ses hyppigere i gruppen behandlet med parecoxib/valdecoxib.
English: Powder for solution for injection (powder for injection).
Danish: Pulver til injektionsvæske, opløsning (pulver til injektion).
English: Additionally, fatal reports of toxic epidermal necrolysis have been reported through postmarketing surveillance in patients receiving valdecoxib (the active metabolite of parecoxib) and cannot be ruled out for parecoxib (see section 4.8).
Danish: Desuden er der efter markedsføringen af valdecoxib rapporteret fatale tilfælde af toksisk epidermal nekrolyse hos patienter, der fik valdecoxib (den aktive metabolit af parecoxib), og dette kan ikke udelukkes ved brug af parecoxib (se-pkt.