natgillin/translations-raw huggingface dataset:
20 Metabolisme og ernæring Almindelig: hypokalæmi
Pyschiatric disorders:
Følgende sjældne alvorlige uønskede hændelser er rapporteret i forbindelse med brugen af NSAID - præparater, og kan ikke udelukkes for Dynastat: bronkospasmer og hepatitis.
The following rare, serious adverse events have been reported in association with the use of NSAIDs and cannot be ruled out for Dynastat: bronchospasm and hepatitis.
Efter koronar bypassoperation har patienter, der får Dynastat en øget risiko for uønskede hændelser som f. eks. kardiovaskulære/ tromboemboliske hændelser, dybe sårinfektioner og sternale sårhelingskomplikationer.
21 Following coronary artery bypass graft surgery, patients administered Dynastat have a higher risk of adverse events, such as cardiovascular/ thromboembolic events, deep surgical infections and sternal wound healing complications.
Efter markedsføring er følgende alvorlige uønskede hændelser rapporteret i forbindelse med brug af parecoxib:
In post-marketing experience, the following reactions have been reported in association with the use of parecoxib:
I et placebo- kontrolleret forsøg (n=1050) med ortopædiske/ almen kirurgiske indgreb fik patienterne en initialdosis af Dynastat 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
2 gange dagligt i mindst 72 timer som tillæg til standardbehandling, herunder supplerende patientkontrollerede opioider.
22 a minimum of 72 hours in addition to receiving standard care including supplemental patient controlled opioids.
Denne reduktion i brugen af opioider var ledsaget af en signifikant reduktion i ubehag af opioidsymptomer rapporteret af patienterne.
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.
22 CABG post- operative sikkerhedsundersøgelser:
CABG post-operative Safety Studies:
Foruden rutineindberetninger af uønskede hændelser blev præ- definerede kategorier af hændelser, udvalgt af en uafhængig ekspertkomité, undersøgt i 2 placebo- kontrollerede sikkerhedsundersøgelser, hvor patienterne fik parecoxibnatrium i mindst 3 dage og derefter blev skiftet til oral valdecoxib i ialt 10- 14 dage.
In addition to routine adverse event reporting, pre-specified event categories, adjudicated by an independent expert committee, were examined in two placebo- controlled safety studies in which patients received parecoxib sodium for at least 3 days and then were transitioned to oral valdecoxib for a total duration of 10-14 days.
Alle patienter fik standard smertelindrings - behandling under forløbet.
All patients received standard of care analgesia during treatment.
Patienterne fik lav- dosis acetylsalicylsyre forud for randomisering og gennem begge de 2 CABG - undersøgelser.
Patients received low-dose acetylsalicylic acid prior to randomization and throughout the two CABG surgery studies.
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. 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. efterfulgt af oral placebo (n=525).
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
Trombocytundersøgelser:
23 followed by placebo PO (n=525).
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 trombocyt - aggregation eller blødning sammenlignet med placebo.
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 sodium/ valdecoxib compared to placebo treatment in these post-surgical patients.
Hos unge forsøgspersoner havde Dynastat 40
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.
Hos raske, ældre forsøgspersoner blev valdecoxibs tilsyneladende orale clearance reduceret med en ca.
In healthy elderly subjects, the apparent oral clearance of valdecoxib was reduced, resulting in an approximately 40% higher plasma exposure of valdecoxib
40% højere plasmaeksponering for valdecoxib til følge, sammenlignet med raske, unge forsøgspersoner.
24 compared to healthy young subjects.
24 Nedsat leverfunktion 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.
Solvens Natriumchlorid Saltsyre eller natriumhydroxid (til pH- justering) Vand til injektionsvæsker.
Solvent Sodium chloride Hydrochloric acid or sodium hydroxide (for pH adjustment) Water for injections.
Dynastat og opioider bør ikke administreres samtidig i den samme sprøjte.
25 Dynastat and opioids should not be administered together in the same syringe.
25 Injicér ikke Dynastat i et i. v. drop, som anvendes til andre lægemidler. i. v. droppet skal skylles grundigt med en kendt forligelig opløsning (se pkt.
Do not inject Dynastat into an IV line delivering any other drug.
Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen før rekonstitution
This medicinal product does not require special storing conditions prior to reconstitution.
6. 3.
For storage conditions of the reconstituted medicinal product see section 6.3.
Solvens ampuller 2 ml ampuller: farveløst neutralt glas, type I.
Solvent ampoules 2 ml ampoule: colourless neutral glass, Type I.
Dynastat leveres som et sterilt engangshætteglas i pakninger med 2 ml ampuller, der er fyldt med 1 ml natriumchloridopløsning 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 1 ml sodium chloride 9mg/ ml (0.9%) solution (see below for various pack sizes and configurations).
Pakningsstørrelser 1 x 1 pakning: indeholder 1 hætteglas med 20 mg parecoxib og 1 ampul med 1 ml natriumchloridopløsning 9 mg/ ml (0, 9%).
Pack sizes 1 x 1 pack: contains 1 vial with parecoxib 20 mg and 1 ampoule with 1 ml sodium chloride 9 mg/ ml (0.9%) solution.
3 x 3 pakning: indeholder 3 hætteglas med 20 mg parecoxib og 3 ampuller med 1 ml natriumchloridopløsning 9 mg/ ml (0, 9%).
3 x 3 pack: contains 3 vials of parecoxib 20 mg and 3 ampoule with 1 ml sodium chloride 9 mg/ ml (0.9%) solution.
5 x 5 pakning: indeholder 5 hætteglas med 20 mg parecoxib og 5 ampuller med 1 ml natriumchloridopløsning 9 mg/ ml (0, 9%).
5 x 5 pack: contains 5 vials of parecoxib 20 mg and 5 ampoule with 1 ml sodium chloride 9 mg/ ml (0.9%) solution.
6. 6 Regler for destruktion og anden håndtering
26 6.6 Special precautions for disposal and other handling
Solvens til rekonstitution Opløs 20 mg Dynastat med 1 ml natriumchloridopløsning 9 mg/ ml (0, 9%).
Reconstitution solvents Reconstitute Dynastat 20 mg with 1 ml sodium chloride 9 mg/ ml (0.9%) solution.
26 glucose 50 g/ l (5%) infusionsvæske natriumchlorid 4, 5 mg/ l (0, 45%) og glucose 50 g/ l (5%) injektionsvæske
The only other acceptable solvents for reconstitution are: glucose 50 g/ l (5%) solution for infusion sodium chloride 4.5 mg/ ml (0.45%) and glucose 50 g/ l (5%) solution for injection
6. 3), eller bortskaffes.
Dynastat should be administered within 24 hours of reconstitution (see section 6.3), or discarded
natriumchloridopløsning 0, 9 mg/ ml (0, 9%) glucose 50 g/ l (5%) infusionsvæske natriumchlorid 4, 5 mg/ l (0, 45%) og glucose 50 g/ l (5%) injektionsvæske Ringer- lactat injektionsvæske
sodium chloride 9 mg/ ml (0.9%) solution glucose 50 g/ l (5%) solution for infusion sodium chloride 4.5 mg/ ml (0.45%) and glucose 50 g/ l (5%) solution for injection Ringer-Lactate solution for injection
EU/ 1/ 02/ 209/ 02 EU/ 1/ 02/ 209/ 03 EU/ 1/ 02/ 209/ 04
EU/ 1/ 02/ 209/ 002-004
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
40 mg hætteglas:
40 mg vial:
Hvert hætteglas indeholder 40 mg parecoxib (som 42, 36 mg parecoxibnatrium) til rekonstitution.
Each vial contains 40 mg parecoxib (present as 42.36 mg parecoxib sodium) for reconstitution.
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.
natriumchloridopløsning 0, 9 mg/ ml (0, 9%) glucose 50 g/ l (5%) infusionsvæske
29 glucose 50 g/ l (5%) solution for infusion sodium chloride 4.5 mg/ ml (0.45%) and glucose 50 g/ l (5%) solution for injection Ringer-Lactate solution for injection
4. 4 og 4. 8).
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 sulphonamides (see sections 4.4 and 4.8).
4. 8 og 5. 1).
Treatment of post-operative pain following coronary artery bypass graft (CABG) surgery (see section 4.8 and 5.1).
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
30 4.4 Special warnings and precautions for use
Rapporteringshyppigheden af alvorlige hudreaktioner synes dog at være højere for valdecoxib (den aktive metabolit af parecoxib) sammenlignet med andre selektive COX- 2- hæmmere.
31 appears to be greater for valdecoxib (the active metabolite of parecoxib) as compared to other COX-2 selective inhibitors.
NSAID- præparater kan reducere virkningen af diuretika og antihypertensiva.
32 NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
32 Det tyder på, at samtidig indgift af NSAID- præparater og ciclosporin eller tacrolimus kan øge den nefrotoksiske virkning af ciclosporin og tacrolimus.
Co-administration of NSAIDs and cyclosporin or tacrolimus has been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus.
Samtidig administration af valdecoxib og glibenclamid (CYP3A4 substrat) påvirkede hverken glibenclamids farmakokinetik (eksponering) eller farmakodynamik (blodsukker og insulinniveauer).
33 Co-administration of valdecoxib with glibenclamide (CYP3A4 substrate) did not affect either the pharmacokinetics (exposure) or the pharmacodynamics (blood glucose and insulin levels) of glibenclamide.
33 Inhalationsanæstetika:
Inhalation anaesthetics:
4. 3, 5. 1 og 5. 3).
Parecoxib sodium is suspected to cause serious birth defects when administered during the last trimester of pregnancy because as with other medicinal products known to inhibit prostaglandin synthesis, it may cause premature closure of the ductus arteriosus oruterine inertia (see sections 4.3, 5.1 and 5.3).
Dynastat bør ikke anvendes i de to første graviditetstrimestre, medmindre det er klart nødvendigt, (dvs. de potentielle fordele for patienten opvejer den potentielle risiko for fostret).
Dynastat should not be used during the first two trimesters of pregnancy unless clearly necessary (i. e. the potential benefit to the patient outweighs the potential risk to the foetus).
Sepone - ringshyppigheden på grund af bivirkninger i disse undersøgelser var 5, 0% for patienter, der fik Dynastat og 4, 3% for patienter, der fik placebo.
34 discontinuation rate due to adverse events in these studies was 5.0% for patients receiving Dynastat and 4.3% for patients receiving placebo.
[Meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100, < 1/ 10), ikke almindelig (≥ 1/ 1000, < 1/ 100), sjælden (≥ 1/ 10. 000, < 1/ 1000), meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data)]
[Very Common (≥ 1/ 10), Common (≥ 1/ 100, < 1/ 10) Uncommon (≥ 1/ 1000, < 1/ 100) Rare (≥ 1/ 10,000, < 1/ 1000) Very rare (< 1/ 10,000), not known (cannot be estimated from the available data)]
34 Metabolisme og ernæring Almindelig: hypokalæmi
Metabolism and nutrition disorders Common: hypokalaemia
Undersøgelser Almindelig: serum- kreatininstigning Ikke almindelig: øget ALAT, øget ASAT, øget serum- carbamid
SGOT increased, SGPT increased, blood urea nitrogen increased
Følgende sjældne alvorlige uønskede hændelser er rapporteret i forbindelse med brugen af NSAID - præparater, og kan ikke udelukkes for Dynastat: bronkospasmer og hepatitis.
35 The following rare, serious adverse events have been reported in association with the use of NSAIDs and cannot be ruled out for Dynastat: bronchospasm and hepatitis.
Efter koronar bypassoperation har patienter, der får Dynastat en øget risiko for uønskede hændelser som f. eks. kardiovaskulære/ tromboemboliske hændelser, dybe sårinfektioner og sternale sårhelings - komplikationer.
Following coronary artery bypass graft surgery, patients administered Dynastat have a higher risk of adverse events, such as cardiovascular/ thromboembolic events, deep surgical infections and sternal wound healing complications.
Opioid- besparende effekt:
36 Opioid-sparing Effects:
2 gange dagligt i mindst 72 timer som tillæg til standardbehandling, herunder supplerende patientkontrollerede opioider.
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.
36 CABG post- operative sikkerhedsundersøgelser:
CABG post-operative Safety Studies:
Almen kirurgi:
37 General Surgery:
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. 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. efterfulgt af oral placebo (n=525).
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).
Der ses ingen signifikant forskel i den samlede sikkerhedsprofil, omfattende de 4 præ- definerede hændelseskategorier beskrevet ovenfor i den anden CABG- undersøgelse, ved parecoxibnatrium/ valdecoxib sammenlignet med placebobehandling hos disse post- operative 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 sodium/ valdecoxib compared to placebo treatment in these post-surgical patients.
38 Nedsat leverfunktion 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.
De ikke- kliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi eller toksicitet efter gentagne doserved en eksponering for parecoxib, der er 2 gange den maksimale humane eksponering.
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.
Brug af Ringer- lactat injektionsvæske eller Ringer- lactat med 50 g/ l (5%) glucose injektionsvæske til rekonstitution vil medføre udfældning af parecoxib, og det kan derfor ikke anbefales.
39 Use of Ringer-Lactate solution for injection or glucose 50 g/ l (5%) in Ringer Lactate solution for injection for reconstitution will cause the parecoxib to precipitate from solution and therefore is not recommended.
Injicér ikke Dynastat i et i. v. drop, som anvendes til andre lægemidler. i. v. droppet skal skylles grundigt med en kendt forligelig opløsning (se pkt.
Do not inject Dynastat into an IV line delivering any other drug.
39 6. 3 Opbevaringstid
6.3 Shelf life
Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen før rekonstitution.
This medicinal nproduct does not require special storing conditions prior to reconstitution.
Parecoxibnatrium hætteglas 40 mg hætteglas:
Parecoxib sodium vials 40 mg vials:
Type I farveløst hætteglas (5 ml) med en lamineret gummiprop, lukket med en lilla flip- off aluminiumkapsel.
Type I colourless glass vials (5 ml) with a laminated stopper, sealed with a purple flip- off cap on the aluminium overseal.
6. 6 Regler for destruktion og anden håndtering
6.6 Special precautions for disposal and other handling.
Rekonstitutionsproces Benyt aseptisk teknik til opløsning af frysetørret parecoxib (som parecoxibnatrium).
Reconstitution Process Use aseptic technique to reconstitute lyophilised parecoxib (as parecoxib sodium).
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.
Efter rekonstitution og før indgift skal Dynastat undersøges visuelt for partikler og misfarvning.
40 After reconstitution, Dynastat should be inspected visually for particulate matter and discoloration prior to administration.
40 glucose 50 g/ l (5%) infusionsvæske natriumchlorid 4, 5 mg/ l (0, 45%) og glucose 50 g/ l (5%) injektionsvæske Ringer- lactat injektionsvæske
sodium chloride 9 mg/ ml (0.9%) solution glucose 50 g/ l (5%) solution for infusion sodium chloride 4.5 mg/ ml (0.45%) and glucose 50 g/ l (5%) solution for injection Ringer-Lactate solution for injection
EU/ 1/ 02/ 209/ 05
EU/ 1/ 02/ 209/ 005
Parecoxib blev indgivet med et fastsat tidsinterval, mens opioiderne blev indgivet efter behov (p. n.) i alle de kliniske vurderinger.
In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needs basis (PRN).
42 natriumchloridopløsning 0, 9 mg/ ml (0, 9%) glucose 50 g/ l (5%) infusionsvæske natriumchlorid 4, 5 mg/ l (0, 45%) og glucose 50 g/ l (5%) injektionsvæske Ringer- lactat injektionsvæske
42 IV line solution compatibility After reconstitution with acceptable solvents, Dynastat may only be injected IV or IM, or into IV lines delivering: sodium chloride 9 mg/ ml (0.9%) solution glucose 50 g/ l (5%) solution for infusion sodium chloride 4.5 mg/ ml (0.45%) and glucose 50 g/ l (5%) solution for injection Ringer-Lactate solution for injection
Konstateret iskæmisk hjertesygdom, perifer arteriel sygdom og/ eller cerebrovaskulær sygdom.
43 Established ischaemic heart disease, peripheral arterial disease and/ or cerebrovascular disease.
Der er yderligere øget risiko for gastrointestinale bivirkninger (gastrointestinale ulcera eller andre gastrointestinale komplikationer), når parecoxibnatrium 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 sodium istaken concomitantly with acetylsalicylic acid (even at low doses).
Behandlingen med parecoxib bør seponeres ved den første forekomst af hududslæt, slimhinde - affektioner, eller andre tegn på overfølsomhed.
44 Parecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Samtidig administration af parecoxibnatrium og heparin påvirkede ikke heparins farmakodynamik (aktiveret partiel thromboplastintid) sammenlignet med heparin administreret alene.
45 Co-administration of parecoxib sodium and heparin did not affect the pharmacodynamics of heparin (activated partial thromboplastin time) compared to heparin alone.
45 Det tyder på, at samtidig indgift af NSAID- præparater og ciclosporin eller tacrolimus kan øge den nefrotoksiske virkning af ciclosporin og tacrolimus.
Co-administration of NSAIDs and cyclosporin or tacrolimus has been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus.
Samtidig administration af valdecoxib og glibenclamid (CYP3A4 substrat) påvirkede hverken glibenclamids farmakokinetik (eksponering) eller farmakodynamik (blodsukker og insulinniveauer).
46 Co-administration of valdecoxib with glibenclamide (CYP3A4 substrate) did not affect either the pharmacokinetics (exposure) or the pharmacodynamics (blood glucose and insulin levels) of glibenclamide.
46 Inhalationsanæstetika:
Inhalation anaesthetics:
Indenfor hver gruppe af bivirkninger med samme frekvens er bivirkningerne opstillet efter hvor alvorlige bivirkningerne er.
Within each frequency grouping, undesirable effect are presented in order of decreasing seriousness.
Sepone - ringshyppigheden på grund af bivirkninger i disse undersøgelser var 5, 0% for patienter, der fik Dynastat og 4, 3% for patienter, der fik placebo.
47 discontinuation rate due to adverse events in these studies was 5.0% for patients receiving Dynastat and 4.3% for patients receiving placebo.
47 Metabolisme og ernæring Almindelig: hypokalæmi
Metabolism and nutrition disorders Common: hypokalaemia
Følgende sjældne alvorlige uønskede hændelser er rapporteret i forbindelse med brugen af NSAID - præparater, og kan ikke udelukkes for Dynastat: bronkospasmer og hepatitis.
48 The following rare, serious adverse events have been reported in association with the use of NSAIDs and cannot be ruled out for Dynastat: bronchospasm and hepatitis.
Efter koronar bypassoperation har patienter, der får Dynastat en øget risiko for uønskede hændelser som f. eks. kardiovaskulære/ tromboemboliske hændelser, dybe sårinfektioner og sternale sårhelingskomplikationer.
Following coronary artery bypass graft surgery, patients administered Dynastat have a higher risk of adverse events, such as cardiovascular/ thromboembolic events, deep surgical infections and sternal wound healing complications.
Sjælden: akut nyresvigt, nedsat nyrefunktion, myokardieinfarkt, venstresidig hjerteinsufficiens, abdominalsmerter, kvalme, opkastning, dyspnø, takykardi og Stevens- Johnson syndrom,.
Rare: acute renal failure, renal failure, myocardial infarction, congestive heart failure, abdominal pain, nausea, vomiting, dyspnoea, tachycardia and Stevens-Johnson syndrome.
Opioid- besparende effekt:
49 Opioid-sparing Effects:
49 CABG post- operative sikkerhedsundersøgelser:
CABG post-operative Safety Studies:
Almen kirurgi:
50 General Surgery:
51 Nedsat leverfunktion 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.
52 Injicér ikke Dynastat i et i. v. drop, som anvendes til andre lægemidler. i. v. droppet skal skylles grundigt med en kendt forligelig opløsning (se pkt.
Do not inject Dynastat into an IV line delivering any other drug.
Dynastat leveres som et sterilt engangshætteglas i pakninger med 2 ml ampuller, der er fyldt med 2 ml natriumchloridopløsning 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)
Pakningsstørrelser 1 x 1 pakning: indeholder 1 hætteglas med 40 mg parecoxib og 1 ampul med 2 ml natriumchloridopløsning 9 mg/ ml (0, 9%).
Pack Sizes 1 x 1 pack: contains 1 vial with parecoxib 40 mg and 1 ampoule with 2 ml sodium chloride 9 mg/ ml (0.9%) solution.