natgillin/translations-raw huggingface dataset:
Dynastat anbefales ikke til behandling af børn eller unge.
Dynastat is not recommended for children or adolescents.
Det aktive stof i Dynastat, parecoxib, er et såkaldt prodrug for valdecoxib.
The active substance in Dynastat, parecoxib, is a ‘ prodrug ’ of valdecoxib.
Valdecoxib er et nonsteroidt antiinflammatorisk lægemiddel (NSAID), der hører til gruppen af lægemidler kaldet cyklooxygenase- 2 (COX- 2) - hæmmere.
Valdecoxib is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called ‘ cyclo-oxygenase-2 (COX-2) inhibitors’.
Det blokerer COX- 2- enzymet og hæmmer dermed produktionen af prostaglandiner, der medvirker i
It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process.
Reproduction is authorised provided the source is acknowledged. betændelsesprocessen.
Reproduction is authorised provided the source is acknowledged.
Dynastats evne til at behandle smerter efter operation er blevet undersøgt hos 2 582 voksne patienter, som havde fået foretaget forskellige kirurgiske indgreb, herunder tandoperationer, ortopædiske operationer (knogler) eller gynækologiske indgreb samt koronare (hjerte -) bypass- operationer.
The effectiveness of Dynastat in treating pain after an operation has been studied in 2,582 adults who had undergone a variety of surgical procedures including dental, orthopaedic (bone), gynaecological or coronary (heart) bypass surgery.
I nogle af undersøgelserne så man også den indvirkning, som det at give Dynastat mod smerter efter operation har på patientens forbrug af morfin som supplerende smertestillende middel efter operation.
Some of the studies also looked at the impact of giving Dynastat on the patient ’ s use of morphine for additional pain relief after surgery.
De mest almindelige bivirkninger ved Dynastat (som ses hos flere end 1 ud af 10 patienter) er blodmangel (for lavt antal røde blodlegemer), lavt kaliumindhold i blodet, uro, søvnbesvær, reduceret følesans, for højt eller lavt blodtryk, halsbetændelse, vejrtrækningsbesvær, betændelse efter tandudtrækning, fordøjelsesbesvær, luft i maven, kløe, rygsmerter, lille urinmængde ved urinering, hævelser (sædvanligvis i benene) og en stigning i kreatininindholdet i blodet (en markør for nyreproblemer).
The most common side effects with Dynastat (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), hypokalaemia (low blood potassium levels), agitation, insomnia (difficulty sleeping), hypoaesthesia (reduction in the sense of touch), high or low blood pressure, pharyngitis (sore throat), respiratory insufficiency (difficulty breathing), alveolar osteitis (inflammation after a tooth extraction), dyspepsia (indigestion), flatulence (wind), pruritus (itching), back pain, oliguria (low urine output), peripheral oedema (swelling, usually of the legs) and increase in blood creatinine levels (a marker of kidney problems).
Den fuldstændige liste over de indberettede bivirkninger ved Dynastat fremgår af indlægssedlen.
For the full list of all side effects reported with Dynastat, see the Package Leaflet.
Patienter, der kan være overfølsomme (allergiske) over for parecoxib eller andre af indholdsstofferne, bør ikke anvende Dynastat.
Dynastat should not be used in people who may be hypersensitive (allergic) to parecoxib or any of the other ingredients.
Dynastat må ikke anvendes til patienter, der:  tidligere har lidt af alvorlige overfølsomhedsreaktioner over for lægemidler, især hudreaktioner  har mavesår eller blødninger i maven eller tarmen  lider af overfølsomhedslignende reaktioner såsom astma, forkølelseslignende symptomer, polypper i næsen, hævelser i ansigtet eller nældefeber efter indtagelse af aspirin eller NSAID' er, herunder andre COX- 2- hæmmere  lider af svær leversygdom  lider af inflammatorisk tarmsygdom  lider af hjertesvigt (hjertets manglende evne til at pumpe blod nok rundt i kroppen), hjertesygdom, perifer arteriesygdom (blokering af arterierne i arme og ben) eller cerebrovaskulær sygdom (problemer, der berører blodkarene i armen).
Dynastat must not be used in patients with:  a history of serious allergic reactions to medicines, especially skin reactions;  stomach ulcers or bleeding in the stomach or gut;  allergic-type reactions such as asthma, cold-like symptoms, polyps in the nose, swelling of the face or hives after taking aspirin or NSAIDs, including other COX-2 inhibitors;  severe liver disease;  inflammatory bowel disease;  heart failure (an inability of the heart to pump enough blood around the body), heart disease, peripheral artery disease (obstruction of the arteries in the arms or legs), or cerebrovascular disease (problems affecting the blood vessels in the brain).
Dynastat må ikke gives til gravide kvinder i den sidste tredjedel af graviditeten eller til kvinder, der ammer.
Dynastat must not be given to women during the last three months of pregnancy or to breast-feeding women.
Det må ikke anvendes efter en koronar bypass- operation.
It must not be used after coronary bypass surgery.
Hvorfor blev Dynastat godkendt?
Why has Dynastat been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Dynastat opvejer risiciene ved kortvarig behandling af smerter efter operation.
The Committee for Medicinal Products for Human Use (CHMP) decided that Dynastat’ s benefits are greater than its risks for the short-term treatment of postoperative pain.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Dynastat.
The Committee recommended that Dynastat be given marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dynastat den 22. marts 2002.
The European Commission granted a marketing authorisation valid throughout the European Union for Dynastat on 22 March 2002.
Markedsføringstilladelsen blev forlænget den 22. marts 2007.
The marketing authorisation was renewed on 22 March 2007.
Den fuldstændige EPAR for Dynastat findes her.
The full EPAR for Dynastat is available here.
Dynastat 20 mg pulver til injektionsvæske, opløsning.
Dynastat 20 mg powder for solution for injection
20 mg hætteglas:
20 mg vial:
Hvert hætteglas indeholder 20 mg parecoxib (som 21, 18 mg parecoxibnatrium) til rekonstitution.
Each vial contains 20 mg parecoxib (present as 21.18 mg parecoxib sodium) for reconstitution.
Efter rekonstitution er den endelige parecoxibkoncentration 20 mg/ ml.
After reconstitution, the final concentration of parecoxib is 20 mg/ ml.
0, 22 mEq natrium pr. hætteglas.
When reconstituted in sodium chloride 9 mg/ ml (0.9%) solution, Dynastat contains approximately 0.22 mEq of sodium per vial.
Hvidt/ råhvidt pulver.
Powder for solution for injection White to off-white powder.
Til kortvarig behandling af postoperative smerter.
For the short-term treatment of postoperative pain.
4. 3 og 4. 4).
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).
Den anbefalede dosis er 40 mg indgivet intravenøst (i. v.) eller intramuskulært (i. m.) efterfulgt af 20 mg eller 40 mg hver 6. til 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.
Dosis må ikke overskride 80 mg/ dag. i. v. bolus injektion kan gives hurtigt og direkte i en vene eller i et eksisterende drop. i. m. injektion bør gives langsomt og dybt i musklen (se pkt.
The IV bolus injection may be given rapidly and directly into a vein or into an existing IV line.
6. 6 for instruktioner vedr. rekonstitution).
The IM injection should be given slowly and deeply into the muscle (see section 6.6 for instructions for reconstitution).
Samtidig brug af opioidanalgetika:
Concomitant Use with Opioid Analgesics:
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 needed basis (PRN).
Da den kardiovaskulære risiko ved brug af specifikke cyclooxygenase- 2 (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 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.
Udfældning kan opstå, når Dynastat blandes i opløsninger med andre lægemidler, og derfor må Dynastat ikke blandes med andre lægemidler, hverken under rekonstitution eller injektion.
Precipitation may occur when Dynastat is combined in solution with other medicinal products and therefore Dynastat must not be mixed with any other drug, either during reconstitution or injection.
Hos de patienter, hvor det samme i. v. drop skal anvendes til injektion af andre lægemidler, skal droppet skyldes grundigt med en opløsning af kendt forligelighed før og efter Dynastat injektion.
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.
Forligelige opløsninger til i. v. drop Efter rekonstitution med anbefalet solvens må Dynastat kun injiceres i. v. eller i. m., eller i i. v. drop med:
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
natriumchloridopløsning 0, 9 mg/ ml (0, 9%) glucose 50 g/ l (5%) infusionsvæske
2 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
Injektion i i. v. drop med Ringer- lactat med 50 g/ l (5%) glucose injektionsvæske, eller andre intravenøse væsker, som ikke er nævnt ovenfor, anbefales ikke, da der kan forekomme udfældning.
Injection into an IV line delivering glucose 50 g/ l (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed above, is not recommended as this may cause precipitation from solution.
Sædvanligvis er dosisjustering ikke nødvendig til ældre patienter (≥ 65 år).
No dosage adjustment is generally necessary in elderly patients (≥ 65 years).
5. 2).
However, for elderly patients weighing less than 50 kg, initiate treatment with half the usual recommended dose of Dynastat and reduce the maximum daily dose to 40 mg (see section 5.2).
Sædvanligvis er dosisjustering til patienter med let nedsat leverfunktion ikke nødvendig (Child- Pugh score 5- 6).
No dosage adjustment is generally necessary in patients with mild hepatic impairment (Child-Pugh score 5-6).
Behandlingen med Dynastat indledes med forsigtighed og med halv sædvanlig anbefalet dosis til patienter med moderat nedsat leverfunktion (Child- Pugh score 7- 9), og maksimal daglig dosis nedsættes til 40 mg.
Introduce Dynastat with caution and at half the usual recommended dose in patients with moderate hepatic impairment (Child-Pugh score 7-9) and reduce the maximum daily dose to 40 mg.
4. 3 og 5. 2).
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).
På grund af farmakokinetikken er dosisjustering ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion (kreatininclearance 30- 80 ml/ min).
On the basis of pharmacokinetics, no dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30-80 ml/ min.).
4. 4 og 5. 2).
In patients with severe renal impairment (creatinine clearance < 30 ml/ min.) or patients who may be predisposed to fluid retention parecoxib should be initiated at the lowest recommended dose and the patient ’ s kidney function closely monitored (see sections 4.4 and 5.2).
Derfor anbefales anvendelse ikke til disse patienter.
Therefore, its use is not recommended in these patients.
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).
Patienter, som tidligere har haft bronkospasme, akut rhinitis, nasale polypper, angioneurotisk ødem, urticaria eller anden type af allergisk reaktion efter at have taget acetylsalicylsyre eller NSAID - præparater herunder COX- 2 (cycclooxygenase- 2) hæmmere.
Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
4. 6 og 5. 3).
The third trimester of pregnancy and breast-feeding (see sections 4.6 and 5.3).
Svær leverdysfunktion (serum- albumin < 25 g/ l eller Child- Pugh score ≥ 10).
Severe hepatic dysfunction (serum albumin < 25 g/ l or Child-Pugh score ≥ 10).
Venstresidig hjerteinsufficiens (NYHA II- IV).
Congestive heart failure (NYHA II-IV).
4. 8 og 5. 1).
Treatment of post-operative pain following coronary artery bypass graft (CABG) surgery (see sections 4.8 and 5.1).
Konstateret iskæmisk hjertesygdom, perifer arteriel sygdom og/ eller cerebrovaskulær sygdom.
Established ischaemic heart disease, peripheral arterial disease and/ or cerebrovascular disease.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
3 4.4 Special warnings and precautions for use
4. 2).
Because of the possibility for increased adverse reactions at higher doses parecoxib, other COX-2 inhibitors and NSAIDs, patients treated with parecoxib should be reviewed following dose increase and, in the absence of an increase in efficacy, other therapeutic options should be considered (see section 4.2).
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.
5. 1).
Patients with significant risk factors for cardiovascular events (e. g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with parecoxib sodium after careful consideration (see section 5.1).
Der bør tages passende forholdsregler, og seponering af behandlingen med parecoxib bør overvejes, hvis der ses forværring af specifikke kliniske symptomer hos disse patienter (se pkt.
Appropriate measures should be taken and discontinuation of parecoxib therapy should be considered if there is clinical evidence of deterioration in the condition of specific clinical symptoms in these patients (see section 5.1).
Dynastat er ikke undersøgt ved kardiovaskulær revaskularisation udover koronar bypassopertion.
Dynastat has not been studied in cardiovascular revascularization procedures other than coronary artery bypass graft procedures.
Undersøgelser på andre former for operationer udover CABG omfatter kun patienter med ASA (American Society of Anaesthesiology) Physical Status klasse I- III.
Studies in other surgeries than CABG procedures included patients with ASA (American Society of Anaesthesiology) Physical Status Class I-III only.
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.
5. 1).
Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Der er set øvre gastrointestinale komplikationer (perforationer, ulcera eller blødninger (PUB)), nogle med fatal udgang hos patienter behandlet med parecoxib.
Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with parecoxib.
Der bør udvises forsigtighed ved behandling af patienter, der har den største risiko for at udvikle gastrointestinale komplikationer i forbindelse med NSAID- præparater: ældre, patienter, som får andre NSAID- præparater eller acetylsalicylsyre samtidig, eller patienter, der tidligere har haft en gastrointestinal sygdom, som f. eks. ulcera og gastrointestinal blødning.
Caution is advised in the treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.
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 is taken concomitantly with acetylsalicylic acid (even at low doses).
Der er lidt erfaring med andre typer kirurgi, f. eks. gastrointestinal eller urologisk kirurgi.
There is little experience in other types of surgery, for example gastrointestinal or urological surgery.
Alvorlige hudreaktioner, bl. a. erythema multiforme, dermatitis exfoliativa og Stevens- Johnson syndrom er blevet rapporteret efter markedsføringen hos patienter, der fik parecoxib.
Serious skin reactions, including erythema multiforme, exfoliative dermatitis and Stevens-Johnson syndrome have been reported through post-marketing surveillance in patients receiving parecoxib.
4. 8).
Additionally, serious skin reactions, some of them fatal, including 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).
Disse reaktioner optræder i de fleste tilfælde inden for den første måned af behandlingen.
Patients appear to be at highest risk for these reactions early in the course of therapy; the onset of the reaction occurring in the majority of cases within the first month of treatment.
Lægen bør tage passende forholdsregler med hensyn til kontrol for alvorlige hudreaktioner i forbindelse med behandlingen, f. eks. yderligere patientkontroller.
Appropriate measures should be taken by physicians to monitor for any serious skin reactions with therapy, e. g. additional patient consultations.
Behandlingen med parecoxib bør seponeres ved den første forekomst af hududslæt, slimhinde - affektioner, eller andre tegn på overfølsomhed.
Parecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Det er kendt, at alvorlige hudreaktioner ses med NSAID inklusive selektive COX- 2- hæmmere og anden medicin.
Serious skin reactions are known to occur with NSAIDs including COX-2 selective inhibitors as well as other medications.
Rapporteringshyppigheden af alvorlige hudreaktioner synes dog at være højere for valdecoxib (den aktive metabolit af parecoxib) sammenlignet med 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
4. 3).
Patients with a history of sulphonamide allergy may be at greater risk of skin reactions (see section 4.3).
4. 8).
Hypersensitivity reactions (anaphylaxis and angioedema) have been reported in post-marketing experience with valdecoxib and parecoxib (see section 4.8).
4. 3).
Some of these reactions have occurred in patients with a history of allergic-type reactions to sulphonamides (see section 4.3).
4. 8).
Acute renal failure has been reported through post-marketing surveillance in patients receiving parecoxib (see section 4.8).
4. 2) eller hypertension, eller til patienter med kompromitteret hjerte - eller leverfunktion eller andre tilstande, som disponerer for væskeretention.
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.
4. 2).
Dynastat should be used with caution in patients with moderate hepatic dysfunction (Child-Pugh score 7-9) (see section 4.2).
Hvis der under behandlingen sker en forværring inden for et af de ovennævnte organsystemer, skal passende forholdsregler tages, og seponering af behandlingen med parecoxibnatrium bør overvejes.
If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of parecoxib sodium therapy should be considered.
5. 1).
Dynastat may mask fever and other signs of inflammation (see section 5.1).
Der er i enkelte tilfælde beskrevet en forværring af bløddelsinfektioner i forbindelse med brug af NSAID- præparater og i ikke - kliniske 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).
4. 5).
Caution should be exercised when co-administering Dynastat with warfarin and other oral anticoagulants (see section 4.5).
4. 6 og 5. 1).
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 4.6 and 5.1).
Farmakodynamiske interaktioner Antikoagulationsbehandling bør monitoreres, især de første dage efter initiering af behandling med Dynastat hos patienter i behandling med warfarin eller andre antikoagulantia, da disse patienter har øget risiko for blødningskomplikationer.
Pharmacodynamic interactions Anticoagulant therapy should be monitored, particularly during the first few days after initiating Dynastat therapy in patients receiving warfarin or other anticoagulants, since these patients have an increased risk of bleeding complications.
4. 4).
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).
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.
Kliniske undersøgelser tyder på, at Dynastat kan gives sammen med lav- dosis acetylsalicylsyre (≤ 325 mg).
Clinical trials indicate that Dynastat can be given with low dose acetylsalicylic acid (≤ 325 mg).
5. 1).
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).
Samtidig administration af parecoxibnatrium og heparin påvirkede ikke heparins farmakodynamik (aktiveret partiel thromboplastintid) sammenlignet med heparin administreret alene.
Co-administration of parecoxib sodium and heparin did not affect the pharmacodynamics of heparin (activated partial thromboplastin time) compared to heparin alone.
NSAID- præparater kan reducere virkningen af diuretika og antihypertensiva.
5 NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
Som for NSAID - præparater kan risikoen for akut nyreinsufficiens være øget, når ACE- hæmmere eller diuretika gives samtidig med parecoxibnatrium.
As for NSAIDs, the risk of acute renal insufficiency may be increased when ACE inhibitors or diuretics are co- administered with parecoxib sodium.