natgillin/translations-raw huggingface dataset:
• Brug af vand til injektionsvæsker til rekonstitution anbefales ikke, da den opnåede opløsning ikke er isotonisk.
• Use of Sterile Water for Injection for reconstitution is not recommended, as the resulting solution is not isotonic.
Der er begrænset erfaring med andre typer kirurgi, f.eks. gastrointestinal eller urologisk kirurgi (se pkt.
There is limited experience in other types of surgery, for example gastrointestinal or urological surgery (see section 5.1).
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.
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.
Dynastat er et hvidt/off-white pulver.
White to off-white powder.
Derudover er følgende sjældne alvorlige bivirkninger rapporteret i forbindelse med brug af NSAID-præparater og kan ikke udelukkes for Dynastat: bronkospasme og hepatitis.
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.
Cerebrovaskulær forstyrrelse
Cerebrovascular disorder
Valdecoxibs metabolisme kan øges, når det administreres sammen med enzyminduktorer, såsom rifampicin, phenytoin, carbamazepin eller dexamethason.
The metabolism of valdecoxib may increase when coadministered with enzyme inducers such as rifampicin, phenytoin, carbamazepine or dexamethasone.
Rekonstitutionsproces
Reconstitution process
Fortæl altid lægen eller sygeplejersken, hvis De tager anden medicin, har gjort det for nylig eller påtænker at tage anden medicin.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Svært nedsat leverfunktion (serum-albumin < 25 g/l eller Child-Pugh score  10).
Severe hepatic impairment (serum albumin <25 g/l or Child-Pugh score  10).
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.
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.
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.
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.
Hæmning af prostaglandinsyntesen kan dog have negativ indvirkning på graviditet.
However, inhibition of prostaglandin synthesis might adversely affect pregnancy.
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.
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.
Valdecoxibs plasmaclearance (CLp) er ca. 6 l/time.
Plasma clearance (CLp) for valdecoxib is about 6 l/hr.
Česká Republika Pfizer PFE, spol sr.o.
Česká Republika Pfizer PFE, spol.
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.
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.
Anbefalet solvens til rekonstitution af Dynastat er:
Reconstitution solvents Acceptable solvents for reconstitution of Dynastat are:
Patienter med særlige risikofaktorer for kardiovaskulære hændelser (f.eks. hypertension, hyperlipidæmi, diabetes mellitus, rygning) bør kun behandles med parecoxib efter nøje overvejelse (se pkt.
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).
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.
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.
COX-2 selektive hæmmere reducerer dannelsen af systemiske (og dermed muligvis endotel-deriveret) prostacyclin uden at påvirke tromboxan i blodpladerne.
COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Solvens til Dynastat 40 mg
Solvent for Dynastat 40 mg
Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgien.
Manufacturer: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
Moderat nedsat leverfunktion resulterede ikke i reduceret hastighed eller omfang af omdannelse af parecoxib til valdecoxib.
Moderate hepatic impairment did not result in a reduced rate or extent of parecoxib conversion to valdecoxib.
Behandling med valdecoxib (40 mg 2 gange dagligt i 7 dage) gav en 3 gange så stor stigning i plasmakoncentrationerne af dextromethorphan (CYP2D6-substrat).
Treatment with valdecoxib (40 mg twice daily for 7 days) produced a 3-fold increase in plasma concentrations of dextromethorphan (CYP2D6 substrate).
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%).
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%).
Disse fald blev ikke betragtet som klinisk vigtige, idet valdecoxibs Cmax er sammenlignelig efter administration af parecoxib i.m.
These decreases were not considered clinically important since Cmax of valdecoxib is comparable after IM and IV parecoxib administration.
Antitrombotisk behandling bør derfor ikke seponeres (se pkt.
Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Denne indlægsseddel blev senest ændret i {måned ÅÅÅÅ}.
This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Der er begrænset klinisk erfaring med Dynastatbehandling i mere end 3 dage.
There is limited clinical experience with Dynastat treatment beyond three days.
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.
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.
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.
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.
Elimination af valdecoxib sker ved udbredt levermetabolisme via flere veje inklusive cytokrom P450 (CYP) 3A4 og CYP2C9 isoenzymer og glucuronidering (ca. 20%) af sulfonamiddelen.
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.
Brug af vand til injektionsvæsker anbefales ikke, da den færdige opløsning ikke vil være isotonisk.
Use of water for injection is not recommended, as the resulting solution is not isotonic.
Derudover har samtidig administration af valdecoxib ingen klinisk effekt på hepatisk eller intestinal CYP 3A4-medieret metabolisme af oralt administreret midazolam.
Additionally, coadministration of valdecoxib had no clinically significant effect on the hepatic or intestinal CYP 3A4-mediated metabolism of orally administered midazolam.
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.
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.
Undersøgelser på mennesker har vist, at metaboliseringen af valdecoxib hovedsagelig er medieret af CYP3A4 og 2C9 isoenzymer.
In humans, studies demonstrated that valdecoxib metabolism is predominantly mediated via CYP3A4 and 2C9 isozymes.
COX-2-hæmmere har været forbundet med øget risiko for kardiovaskulære og trombotiske uønskede hændelser ved langtidsbehandling.
COX-2 inhibitors have been associated with increased risk of cardiovascular and thrombotic adverse events when taken long term.
Det er kendt, at alvorlige hudreaktioner ses med NSAID inklusive selektive COX-2-hæmmere og andre lægemidler.
Serious skin reactions are known to occur with NSAIDs including COX-2 selective inhibitors as well as other medicinal products.
I reproduktionstoksicitetstests forekom incidensen af post-implantationstab, resorptioner og nedsat fostervægt ved doser, som ikke forårsagede maternal toksicitet i kaninforsøg.
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.
2 ml solvens ampul indeholder natriumchlorid, saltsyre, natriumhydroxid, vand til injektionsvæsker.
2 ml solvent ampoule contains sodium chloride, hydrochloric acid, sodium hydroxide and water for injection.
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.
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).
(f.eks. intra-artikulær, intratekal) er ikke undersøgt og bør derfor ikke anvendes.
Modes of administration other than IV or IM (e.g. intra-articular, intrathecal) have not been studied and should not be used.
Rapporteringshyppigheden af alvorlige hudreaktioner synes dog at være højere for valdecoxib (den aktive metabolit af parecoxib) end for andre selektive COX-2-hæmmere.
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.
Dette lægemiddel indeholder mindre end 23 mg natrium pr. dosis, og er derfor praktisk taget natriumfrit.
This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free.
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.
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.
Acetylsalicylsyre og andre NSAID-præparater
Acetylsalicyclic acid and other NSAIDs
Der er yderligere øget risiko for gastrointestinale bivirkninger (gastrointestinale ulcera eller andre gastrointestinale komplikationer), når parecoxib tages samtidig med acetylsalicylsyre (selv ved lave doser).
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).
Dynastat er ikke undersøgt ved kardiovaskulær revaskularisation udover koronar bypassopertion (CABG).
Dynastat has not been studied in cardiovascular revascularization procedures other than coronary artery bypass graft (CABG) procedures.
Meget almindelige bivirkninger: forekommer hos flere end 1 ud af 10 personer • Kvalme.
Very common: may affect more than 1 in 10 people ▪ Nausea (feeling sick)
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.
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.
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.
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.
Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen før rekonstitution.
This medicine does not require any special storage conditions prior to reconstitution.
Til intravenøs eller intramuskulær anvendelse.
Intravenous or intramuscular use.
Det er muligt, at De får endnu en dosis - enten 20 mg eller 40 mg - 6-12 timer efter den første dosis.
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.
Dynastat havde ingen effekt på acetylsalicylsyre-medieret hæmning af trombocytaggregation eller blødningstid.
Dynastat had no effect on acetylsalicylic acid-mediated inhibition of platelet aggregation or bleeding times.
Der er blevet identificeret en hydroxyleret valdecoxibmetabolit i humant plasma (via CYP-vejen), som er aktiv som en COX-2-hæmmer.
A hydroxylated metabolite of valdecoxib (via the CYP pathway) has been identified in human plasma that is active as a COX-2 inhibitor.
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.
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.
Dynastat kan administreres sammen med opioidanalgetika.
Dynastat may be coadministered with opioid analgesics.
Indehaver af markedsføringstilladelsen: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgien.
Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Ifølge rapporter er overdosering med parecoxib forbundet med bivirkninger, som også er set ved anbefalede doser af parecoxib.
Reporting of overdose with parecoxib has been associated with adverse reactions which have also been described with recommended doses of parecoxib.
Hjælpestof, som behandleren skal være opmærksom på: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis.
Excipient with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per dose.
Parecoxib hydrolyseres hurtigt til den aktive metabolit valdecoxib.
Parecoxib is rapidly hydrolysed to the active metabolite valdecoxib.
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.
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.
Medicin kan somme tider påvirke virkningen af anden medicin.
Medicines can sometimes interfere with each other.
Patienter skal opfordres til omgående at oplyse lægen om enhver form for pludseligt opstående hudreaktioner.
Patients should be advised to immediately report any emergent skin condition to their physician.
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.
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).
Parecoxibs (eller dets aktive metabolit valdecoxibs) virkning på andre lægemidlers farmakokinetik
Effect of parecoxib (or its active metabolite valdecoxib) on the pharmacokinetics of other medicinal products
Der skal udvises forsigtighed, når Dynastat administreres samtidig med warfarin og andre orale antikoagulantia (se pkt.
Caution should be exercised when coadministering Dynastat with warfarin and other oral anticoagulants (see section 4.5).
Der findes intet uomdannet parecoxib i urinen og kun spor i fæces.
No unchanged parecoxib is detected in urine and only trace amounts in the faeces.
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.
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.
Dette lægemiddel må ikke blandes med andre lægemidler.
Reconstitution solvents This medicinal product must not be mixed with other medicinal products.
Behandlingen med parecoxib bør indstilles ved det første tegn på overfølsomhed.
Parecoxib should be discontinued at the first sign of hypersensitivity.
Nogle af disse reaktioner forekommer hos patienter, der tidligere har haft allergiske reaktioner over for sulfonamider (se pkt.
Some of these reactions have occurred in patients with a history of allergic-type reactions to sulfonamides (see section 4.3).
Vasculære sygdomme Hypertension, hypotension
Vascular disorders Hypertension, hypotension
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.
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).
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.
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.
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.
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).
Ud fra virkningsmekanismen kan anvendelse af NSAID-præparater forsinke eller forhindre ruptur af ovariefollikler, hvilket har været forbundet med reversibel infertilitet hos nogle kvinder.
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.
Opbevaringsforhold for det rekonstituerede lægemiddel, se pkt.
For storage conditions of the reconstituted medicinal product see section 6.3.
Dynastat indeholder ikke konserveringsmidler.
Dynastat is preservative free.
Færdigtilberedt opløsning er isotonisk.
The reconstituted product is isotonic.
Orale antikoagulantia inkluderer warfarin/coumarintypen og nye orale antikoagulantia (f.eks. apixaban, dabigatran og rivaroxaban) (se pkt.
Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g. apixaban, dabigatran, and rivaroxaban) (see section 4.5).
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.
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
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).
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)
Tilfælde af alvorlig hypotension kort efter indgivelse af parecoxib er blevet rapporteret efter markedsføringen af parecoxib.
Cases of severe hypotension shortly following parecoxib administration have been reported in postmarketing experience with parecoxib.
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.
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.
Denne interaktion bør overvejes hos patienter, der behandles med parecoxib samtidig med ACE-hæmmere, angiotensin II-antagonister, betablokkere og diuretika.
This interaction should be given consideration in patients receiving parecoxib concomitantly with ACE-inhibitors, angiotensin II antagonists, beta-blockers and diuretics.
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.
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.