natgillin/translations-raw huggingface dataset:
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 %). 
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.
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. 
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.
Dynastats effekt er fastslået i undersøgelser af smerter efter dentale, gynækologiske (hysterektomi), ortopædiske (knæ- og hofteudskiftning) og koronar bypassoperationer. 
The efficacy of Dynastat was established in studies of dental, gynaecologic (hysterectomy), orthopaedic (knee and hip replacement), and coronary artery bypass graft surgical pain.
I den anden CABG-undersøgelse blev 4 præ-definerede hændelseskategorier undersøgt (kardiovaskulær/tromboembolisk hændelse, nedsat nyrefunktion/nyresvigt, øvre gastrointestinal ulcus/blødning, sårkomplikation efter operation). 
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).
Før indgift skal Dynastat undersøges visuelt for partikler og misfarvning. 
Dynastat should be inspected visually for particulate matter and discoloration prior to administration.
3 + 3 pakning: indeholder 3 hætteglas med pulver og 3 ampuller med solvens. 
3 + 3 pack: contains 3 powder vials and 3 solvent ampoules.
Dynastat skal indgives senest 24 timer efter rekonstitution (se pkt. 
Dynastat should be administered within 24 hours of reconstitution (see section 6.3), or discarded.
Dynastat er undersøgt ved tandkirurgi, ortopædkirurgi, gynækologisk kirurgi (især hysterektomi) og koronar bypassoperation. 
Dynastat has been studied in dental, orthopaedic, gynaecologic (principally hysterectomy) and coronary artery bypass graft surgery.
Valdecoxibs steady state plamaeksponering hos ældre kvinder justeret for legemsvægt var 16 %højere end hos ældre mænd (se pkt. 
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).
Valdecoxib er inden for det kliniske dosisinterval en oral, selektiv COX-2-hæmmer. 
Valdecoxib is a selective COX-2 inhibitor within the clinical dose range.
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 
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)
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. 
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.
• Ringer-lactat-injektionsvæske 
• Ringer-Lactate solution for injection.
Fjern den lilla flip-off kapsel for at afdække den centrale del af 40 mg parecoxib hætteglassets gummiprop. 
Remove the purple flip-off cap to expose the central portion of the rubber stopper of the 40 mg parecoxib vial.
• Akut nyresvigt 
Renal failure acute
Ved rekonstitution i natriumchloridinjektionsvæske 9 mg/ml (0,9%) indeholder Dynastat ca. 0,44 mmol natrium pr. hætteglas. 
When reconstituted in sodium chloride 9 mg/ml (0.9%) solution, Dynastat contains approximately 0.44 mmol of sodium per vial.
Kredsløbskollaps, kronisk venstresidig hjerteinsufficiens, takykardi 
Circulatory collapse, congestive heart failure, tachycardia
Sårkomplikationer efter operation (hyppigst omfattende sternumsår) ses hyppigere i gruppen behandlet med parecoxib/valdecoxib. 
Surgical wound complications (most involving the sternal wound) were observed at an increased rate with parecoxib/valdecoxib treatment.
Pulver til injektionsvæske, opløsning (pulver til injektion). 
Powder for solution for injection (powder for injection).
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. 
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).
Stop med at tage Dynastat og fortæl straks Deres læge: - hvis De får udslæt eller sårdannelse på et vilkårligt sted på kroppen (f.eks. hud, mund, øjne, ansigt, læber eller tunge) eller ethvert andet tegn på overfølsomhedsreaktioner såsom hududslæt, hævelse i ansigtet, læber eller tunge, som giver hvæsende vejrtrækning, åndedrætsbesvær eller synkebesvær - dette opstår sjældent - hvis De får blæredannelse eller afskalning af huden - dette opstår sjældent - hudreaktioner kan optræde når som helst, men optræder hyppigst i løbet af den første måned af behandlingen. 
Stop taking Dynastat and tell your doctor immediately: - if you develop a rash or ulceration in any part of your body (e.g. skin, mouth, eyes, face, lips or tongue), or develop any other signs of an allergic reaction such as skin rash, swelling of the face, lips or tongue which may cause wheezing, difficulty breathing, or swallowing - this occurs rarely - if you have blistering or peeling of the skin - this occurs rarely - the onset of skin reactions can occur at any time but most often occur in the first month of treatment; the reported rate of these events appears to be greater for valdecoxib, a medicine related to parecoxib, as compared to other COX-2 inhibitors - if you have jaundice (your skin or the whites of your eyes appear yellow) - if you have any signs of bleeding in the stomach or intestine, such as passing a black or blood-stained bowel movement or vomiting blood
Kirurgiske patienter bør holdes under omhyggelig observation for tegn på sårinfektion ved behandling med Dynastat. 
Caution should be exercised with respect to monitoring the incision for signs of infection in surgical patients receiving Dynastat.
Efter rekonstitution med natriumchloridinjektionsvæske 9 mg/ml (0,9%) indeholder Dynastat ca. 0,44 mEq natrium pr. hætteglas. 
When reconstituted in sodium chloride 9 mg/ml (0.9%) solution, Dynastat contains approximately 0.44 mEq of sodium per vial.
Dinatriumhydrogenphosphat 
Disodium hydrogen phosphate
På grund af deres manglende virkning på trombocytfunktionen kan COX-2-hæmmere ikke erstatte acetylsalicylsyre som profylakse mod kardiovaskulære tromboemboliske sygdomme. 
COX-2 inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effects.
Natriumchloridinjektionsvæske 9 mg/ml (0,9%) 
Sodium chloride 9 mg/ml (0.9%) solution
Som for andre lægemidler, der hæmmer prostaglandinsyntesen, er der set væskeretention og ødemer hos patienter, som har fået parecoxib. 
As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in some patients taking parecoxib.
Da den kardiovaskulære risiko ved brug af selektive cyklooxygenase-2 (COX-2)-hæmmere kan øges med dosis og behandlingsvarighed, skal den kortest mulige behandlingsvarighed og den laveste effektive daglige dosis anvendes. 
As the cardiovascular risk of cyclooxygenase-2 (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.
3 hætteglas og 3 ampuller med solvens 
3 vials and 3 solvent ampoules
Administration af en enkelt dosis parecoxib til ammende kvinder efter kejsersnit medførte overførsel af relativt små mængder parecoxib og dets aktive metabolit valdecoxib til mælken. 
Administration of a single dose of parecoxib to lactating women following caesarean section resulted in the transfer of a relatively small amount of parecoxib and its active metabolite valdecoxib into human milk, and this resulted in a low relative dose for the infant (approximately 1% of the weight-adjusted maternal dose).
Phosphorsyre og/eller natriumhydroxid (til pH-justering). 
Phosphoric acid and/or sodium hydroxide (for pH adjustment).
Efter koronar bypassoperation har patienter, der får Dynastat en øget risiko for uønskede hændelser som f.eks. kardiovaskulære/tromboemboliske hændelser (herunder myokardieinfarkt, slagtilfælde/transitorisk iskæmisk attak(TIA), lungeembolus og dyb venetrombose; se pkt. 
Following coronary artery bypass graft surgery, patients administered Dynastat have a higher risk of adverse reactions such as: cardiovascular/thromboembolic events (including myocardial infarction, stroke/TIA, pulmonary embolus, and deep vein thrombosis; see sections 4.3 and 5.1), deep surgical infections, and sternal wound healing complications.
Lad vær med at arbejde med værktøj eller maskiner, før De føler Dem normal igen. 
If the injection makes you feel dizzy or tired, do not drive or use machines until you feel better again.
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne (anført i pkt. 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Plasmaeksponering (AUC og Cmax) for valdecoxib blev øget (henholdsvis 38% og 24%), når det blev administreret sammen med ketoconazol (CYP3A4-hæmmer). 
Plasma exposure (AUC and Cmax) to valdecoxib was increased (38% and 24%, respectively) when coadministered with ketoconazole (CYP3A4 inhibitor), however, a dosage adjustment should not generally be necessary for patients receiving ketoconazole.
1 hætteglas og 1 ampul med solvens 
1 vial and 1 solvent ampoule
opnås valdecoxibs Cmax efter henholdsvis ca. 30 minutter og ca. 1 time. 
Following single IV and IM doses of parecoxib 20 mg, Cmax of valdecoxib is achieved in approximately 30 minutes and approximately 1 hour, respectively.
Efter rekonstitution er parecoxibkoncentrationen 20 mg/ml. 
After reconstitution, the concentration of parecoxib is 20 mg/ml.
• hvis De er allergisk over for parecoxib eller et af de øvrige indholdsstoffer (angivet i afsnit 6) 
Do not take Dynastat: - if you are allergic to parecoxib or any of the other ingredients of this medicine (listed in section
• Brug af Ringer-lactat-injektionsvæske eller glucose 50 mg/ml (5%) i Ringer-lactat-injektionsvæske til rekonstitution vil få parecoxib til at udfælde fra opløsningen, og det kan derfor ikke anbefales. 
• Use of Ringer-Lactate solution for injection or glucose 50 mg/ml (5%) in Ringer-Lactate solution for injection for reconstitution will cause the parecoxib to precipitate from solution and therefore is not recommended.
Gastroduodenal ulceration, gastroøsofageal refluks, mundtørhed, abnorme mave-tarmlyde 
Gastroduodenal ulceration, gastrooesophageal reflux disease, dry mouth, gastrointestinal sounds abnormal
bolus-injektion kan gives hurtigt og direkte i en vene eller i en eksisterende i.v.-adgang. 
The IV bolus injection may be given rapidly and directly into a vein or into an existing IV line.
Væskeretention, ødem, nyrer 
Fluid retention, oedema, renal
Brug af Dynastat, og andre lægemidler, som er kendt for at hæmme cyklooxygenase-/prostaglandinsyntesen, anbefales ikke til kvinder, som ønsker at blive gravide (se pkt. 
The use of Dynastat, as with any medicinal product known to inhibit cyclooxygenase/prostaglandin synthesis, is not recommended in women attempting to conceive (see sections 4.3, 5.1 and 5.3).
Hver 2 ml rekonstitueret pulver indeholder 40 mg parecoxib. 
Each 2 ml of reconstituted powder contains 40 mg of parecoxib.
Mave-tarm-kanalet kvalme Abdominalsmerter, opkastning, obstipation, dyspepsi, flatulens 
Gastrointestinal disorders Nausea Abdominal pain, vomiting, constipation, dyspepsia, flatulence
Den rekonstituerede injektionsvæske må ikke anvendes, hvis den er misfarvet eller uklar eller indeholder synlige partikler. 
The reconstituted solution must not be used if discoloured or cloudy or if particulate matter is observed.
Benyt aseptisk teknik til opløsning af frysetørret parecoxib (som parecoxib). 
Use aseptic technique to reconstitute lyophilised parecoxib (as parecoxib).
Efter rekonstitution med 2 ml solvens er koncentrationen af parecoxib 20 mg/ml. 
After reconstitution with 2 ml of solvent, the concentration of parecoxib is 20 mg/ml.
Efter i.v. 
s r.o.
Det anbefales ikke at injicere i et i.v.-drop til glucose 50 mg/ml (5%) i Ringer-lactat-injektionsvæske, eller andre i.v.-opløsninger, som ikke er nævnt i dette afsnit, da dette kan føre til udfældning fra opløsningen. 
It is not recommended to inject into an IV line delivering glucose 50 mg/ml (5%) in RingerLactate solution for injection, or other IV fluids not listed in this section, as this may cause precipitation from solution.
Administration ved intramuskulær (i.m.) 
Administration is by intramuscular (IM) or intravenous (IV) injection.
3. graviditetstrimester og amning (se pkt. 
The third trimester of pregnancy and breast-feeding (see sections 4.6 and 5.3).
De må ikke få Dynastat, hvis De tidligere har haft mavesår, sår på tarmen eller blødning fra maven eller tarmen. 
Do not use Dynastat if you currently have a gastric or intestinal ulcer or gastrointestinal bleeding
Benyt aseptisk teknik til opløsning af frysetørret parecoxib (som parecoxibnatrium). 
Use aseptic technique to reconstitute lyophilised parecoxib (as parecoxib sodium).
Da prostaglandinsyntesehæmning kan medføre forringelse af nyrefunktion og væskeretention, bør der udvises forsigtighed ved administration af Dynastat til patienter med nedsat nyrefunktion (se pkt. 
Since prostaglandin synthesis inhibition may result in deterioration of renal function and fluid retention, caution should be observed when administering Dynastat in patients with impaired renal function (see section 4.2) or hypertension, or in patients with compromised cardiac or hepatic function or other conditions predisposing to fluid retention.
Brug af Ringer-lactat-injektionsvæske eller Ringer-lactat med 50 mg/ml (5%) glucoseinjektionsvæske til rekonstitution vil medføre udfældning af parecoxib, og det kan derfor ikke anbefales. 
Use of Ringer-Lactate solution for injection or glucose 50 mg/ml (5%) in Ringer Lactate solution for injection for reconstitution will cause the parecoxib to precipitate from solution and therefore is not recommended.
Hjerte-kar 
Cardiovascular
Knogler, led, muskler og bindevæv Rygsmerter Artralgi Nyrer og urinveje Oliguri 
Musculoskeletal and connective tissue disorders Back pain Arthralgia Renal and urinary disorders Oliguria
Saltsyre eller natriumhydroxid (kan være tilsat for pH-justering) Vand til injektionsvæsker 
Hydrochloric acid or sodium hydroxide (for pH adjustment) Water for injection.
administration er ca. 55 liter. 
The volume of distribution of valdecoxib after its IV administration is approximately 55 litres.
• glucose 50 mg/ml (5%) infusionsvæske 
• glucose 50 mg/ml (5%) solution for infusion
transitorisk iskæmisk attack) eller tilstopning af blodårerne til hjertet eller hjernen, eller har fået foretaget en ballonudvidelse eller en by-passoperation - hvis De har haft problemer med blodomløbet (perifer arteriel sygdom). 
- if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages - if you have or have had problems with your blood circulation (peripheral arterial disease)
Akut nyresvigt hos patienter i behandling med parecoxib er rapporteret ved post-marketing overvågning (se pkt. 
Acute renal failure has been reported through post-marketing surveillance in patients receiving parecoxib (see section 4.8).
Hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) eller patienter, der er disponerede for væskeretention, bør behandling initieres med den laveste anbefalede dosis (20 mg), og patienternes nyrefunktion bør monitoreres nøje (se pkt. 
or patients who may be predisposed to fluid retention, parecoxib should be initiated at the lowest recommended dose (20 mg) and the patient's kidney function should be closely monitored (see sections 4.4 and 5.2).
”sulfonamider” (f.eks. visse antibiotika, der bruges til at behandle infektioner med) - hvis De for tiden har mavesår, sår på tarmen eller blødning fra maven eller tarmen - hvis De har haft en allergisk reaktion mod acetylsalicylsyre eller andre NSAID-præparater 
- if you have had a serious allergic reaction (especially a serious skin reaction) to any medicines - if you have had an allergic reaction to a group of medicines called “sulfonamides” (e.g. some antibiotics used to treat infections) - if you currently have a gastric or intestinal ulcer or bleeding in the stomach or gut - if you have had an allergic reaction to acetylsalicylic acid (aspirin) or to other NSAIDs (e.g.
• Udslæt eller sårdannelse på et vilkårligt sted på kroppen (f.eks. hud, mund, øjne, ansigt, læber eller tunge) eller ethvert andet tegn på overfølsomhedsreaktioner såsom hududslæt, hævelse i ansigtet, læber og tunge, hvæsende vejrtrækning, åndedrætsbesvær eller problemer med at synke. 
Rare: may affect up to 1 in 1,000 people ▪ Rash or ulceration in any part of your body (e.g. skin, mouth, eyes, face, lips or tongue), or any other signs of allergic reactions such as skin rash, swelling of the face, lips and tongue,
Fortæl straks Deres læge eller sygeplejerske, hvis noget af ovenstående gælder for Dem, idet De i givet fald ikke vil få injektionen. 
If any of these applies to you, you will not be given the injection.
Efter markedsføringen af valdecoxib og parecoxib er der rapporteret overfølsomhedsreaktioner (anafylaksi og angioødem) (se pkt. 
Hypersensitivity reactions (anaphylaxis and angioedema) have been reported in post-marketing experience with valdecoxib and parecoxib (see section 4.8).
bolus-dosering, hvilket skyldes langsommere ekstravaskulær absorption efter i.m. 
Average Cmax of parecoxib after IM dosing was lower compared to bolus IV dosing, which is attributed to slower extravascular absorption after IM administration.
YDRE EMBALLAGE: 40 mg pulver og solvens til injektionsvæske, opløsning 
OUTER CARTON: 40 mg powder and solvent for solution for injection
Hætteglas med pulver: Hvert hætteglas indeholder 40 mg parecoxib (som 42,36 mg parecoxibnatrium). 
Powder vial: Each vial contains 40 mg parecoxib (as 42.36 mg parecoxib sodium).
• hvis De tidligere har haft mavesår, hul på tarmen eller blødning fra maven eller tarmen 
▪ If you have previously had an ulcer, bleeding or perforation of the gastrointestinal tract.
Hvert hætteglas indeholder 40 mg parecoxib (som 42,36 mg parecoxibnatrium). 
Each vial contains 40 mg parecoxib (as 42.36 mg parecoxib sodium).
Hvert hætteglas indeholder 40 mg parecoxib, som 42,36 mg parecoxibnatrium. 
Each vial contains 40 mg parecoxib, as 42.36 mg parecoxib sodium.
opioider signifikant reduceret, når opioider blev anvendt sammen med paracoxib. 
In clinical trials, the daily requirement for PRN opioids was significantly reduced when coadministered with parecoxib.
hver 12. time i mindst 3 dage, og derefter oral valdecoxib (20 mg hver 12. time) (n=544) i resten af den 10 dages behandlingsperiode; placebo i.v. 
Patients were randomized within 24-hours post-CABG surgery to: parecoxib initial dose of 40 mg IV, then 20 mg IV Q12H for a minimum of 3 days followed by valdecoxib PO (20 mg Q12H) (n=544) for the remainder of a 10 day treatment period; placebo IV followed by valdecoxib PO (n=544); or placebo IV followed by placebo PO (n=548).
• Forværring af forhøjet blodtryk 
Blood creatinine increased
I.v.-drop med Ringer-lactat med 50 mg/ml (5%) glucoseinjektionsvæske eller andre intravenøse væsker, som ikke er nævnt ovenfor, anbefales ikke, da der kan forekomme udfældning. 
Injection into an IV line delivering glucose 50 mg/ml (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed above, is not recommended as this may cause precipitation from solution.
I.v.-droppet skal skylles grundigt med en kendt forligelig opløsning (se pkt. 
The IV line must be adequately flushed prior to and after Dynastat injection with a solution of known compatibility (see section 6.6).
I en stor undersøgelse (n=1050) ved større ortopædiske/almen kirurgiske indgreb fik patienterne en initialdosis af parecoxib på 40 mg i.v., efterfulgt af 20 mg i.v. 
In a placebo-controlled, orthopedic and general surgery study (n =1050), patients received Dynastat at an initial parenteral dose of 40 mg IV followed by 20 mg twice daily for a minimum of 72 hours in addition to receiving standard care including supplemental patient controlled opioids.
Blod og lymfesystem Anæmi postoperativt 
Abnormal sternal serous wound drainage, wound infection Blood and lymphatic system disorders Anaemia postoperative
efterfulgt af 20 mg eller 40 mg hver 6.-12. time efter behov. 
The recommended dose is 40 mg administered intravenously (IV) or intramuscularly (IM), followed every 6 to 12 hours by 20 mg or 40 mg as required, not to exceed 80 mg/day.
Blodudtrædning, kløe, urticaria 
Ecchymosis, rash, urticaria
Efter rekonstitution med anbefalet solvens må Dynastat kun injiceres i.v. 
After reconstitution with acceptable solvents, Dynastat may only be injected IV or IM, or into IV lines delivering:
hver 12. time i mindst 3 dage, og derefter oral valdecoxib (20 mg hver 12. time) (n=525) i resten af den 10 dages behandlingsperiode, eller placebo i.v. 
In a large (N=1050) major orthopedic/general surgery trial, patients received an initial dose of parecoxib 40 mg IV, then 20 mg IV Q12H for a minimum of 3 days followed by valdecoxib PO (20 mg Q12H) (n=525) for the remainder of a 10 day treatment period, or placebo IV followed by placebo PO (n=525).
Dynastat 40 mg pulver og solvens til injektionsvæske, opløsning parecoxib 
Dynastat 40 mg powder and solvent for solution for injection Parecoxib
Omfanget af den analgetiske virkning af en 40 mg dosis er sammenlignelig med ketorolac 60 mg i.m. 
The magnitude of analgesic effect of the 40 mg dose was comparable with that of ketorolac 60 mg IM or ketorolac 30 mg IV. After a single dose, the duration of analgesia was dose and clinical pain model dependent, and ranged from 6 to greater than 12 hours.
administration var eksponering af parecoxib ens, udtrykt i AUC. 
Exposure to parecoxib was similar after IV or IM administration in terms of AUC.