natgillin/translations-raw huggingface dataset:
Patienter med særlige risikofaktorer for kardiovaskulære hændelser (f.eks. hypertension, hyperlipidæmi, diabetes mellitus, rygning) bør kun behandles med lumiracoxib efter nøje overvejelse (se pkt.
Patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with lumiracoxib after careful consideration (see section 5.1).
Ændringer i oral antikonception er derfor ikke nødvendigt ved samtidig administration af lumiracoxib.
Thus no alteration in oral contraceptive medication is necessary when lumiracoxib is co-administered.
Race: Lumiracoxibs farmakokinetik er ens hos patienter af asiatisk, negroid og kaukasisk afstamning.
Race: The pharmacokinetics of lumiracoxib are similar in Asians, Blacks and Caucasians.
Daglige doser af 400 mg lumiracoxib er, sammenlignet med daglige doser af 200 mg, forbundet med en relativ højere forekomst af lægemiddelrelaterede bivirkninger, specielt gastrointestinale, neurologiske og psykiatriske hændelser.
Compared to a daily dose of 200 mg, a daily dose of 400 mg of lumiracoxib is associated with a relatively higher frequency of drug-related adverse events, especially the gastrointestinal, neurological and psychiatric events.
Lumiracoxib er i kliniske forsøg evalueret med henblik på sikkerhed hos ca. 7.000 patienter, inkluderende ca. 4.000 patienter med osteoarthrose (OA) og 2.100 patienter med rheumatoid arthritis (RA) (ca. 1.100 patienter med OA eller RA blev behandlet i 6 måneder og 530 patienter med OA blev behandlet i 1 år).
In clinical trials, lumiracoxib was evaluated for safety in approximately 7,000 patients, including approximately 4,000 patients with OA and 2,100 patients with RA (approximately 1,100 patients with OA or RA were treated for 6 month, and 530 patients with OA were treated for 1 year).
Nyreinsufficiens: Dosisjustering er ikke nødvendig hos patienter med creatininclearance ≥50 ml/min.
Renal insufficiency: No dose adjustment is necessary for patients with creatinine clearance ≥50 ml/min.
Hos nogle patienter med kompromitteret nyrefunktion (f.eks. dehydrerede patienter eller ældre patinter med kompromiteret nyrefunktion), kan samtidig administration af en ACE-hæmmer eller angiotensin II antagonist og midler der hæmmer cyclooxygenase medføre yderligere forværring af nyrefunktionen, inklusiv muligt akut nyresvigt, som sædvanligvis er reversibelt.
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal functions), the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Selektiv hæmning af COX-2 med lumiracoxib giver anti-inflammatorisk og analgetisk effekt.
Selective inhibition of COX-2 by lumiracoxib provides anti-inflammatory and analgesic effects.
In vivo studier antyder, at lumiracoxib har lille potentiale for interaktioner med CYP2C9 substrater.
In vivo studies suggest that lumiracoxib has low potential for interactions with CYP2C9 substrates.
Den anbefalede dosis er 400 mg, én gang daglig.
The recommended dose is 400 mg once daily.
Følgende sjældne alvorlige bivirkninger er indberettet i forbindelse med brug af NSAID og kan ikke udelukkes for lumiracoxib: Nefrotoksicitet inklusiv interstitiel nefritis og nefrotisk syndrom og nyresvigt; hepatotoksicitet inklusiv leversvigt og gulsot; cutaneo-mucosale bivirkninger og svære hudreaktioner.
The following rare serious undesirable effects have been reported in association with the use of NSAIDs and cannot be ruled out for lumiracoxib: nephrotoxicity including interstitial nephritis and nephrotic syndrome and renal failure; hepatotoxicity including hepatic failure and jaundice; cutaneomucosal adverse effects and severe skin reactions.
Cardiovaskulær effect I TARGET (12 måneders studie) Det primære kardiovaskulære (KV) effektmål undersøgt var Antiplatelet Trialists' Collaboration (APTC) endpoint: Bekræftet eller sandsynligt myokardieinfarkt (klinisk eller ikke symptomgivende), slagtilfælde (iskæmisk eller haemoragisk) og KV-død.
Cardiovascular Effect in TARGET (12-month study) The primary cardiovascular (CV) endpoint studied was the Antiplatelet Trialists' Collaboration (APTC) endpoint: confirmed or probable myocardial infarction (clinical or silent), stroke (ischemic or haemorrhagic) and CV death.
På baggrund af in vitro studier, forventes interaktioner med plasma-proteinbinding ikke at have klinisk relevant effekt på lumiracoxib eller samtidigt administrerede lægemidler.
Based on in vitro studies, interactions involving plasma protein binding are not expected to have any clinically relevant effects on lumiracoxib or co-administered drugs.
Lumiracoxib elimineres primært via hepatisk metabolisme.
Lumiracoxib is eliminated predominantly via hepatic metabolism.
Dialyse har ingen effekt på optagelsen af lumiracoxib eller dets aktive metabolit.
Dialysis has no effect on the exposure of patients to lumiracoxib or its active metabolite.
I en rotte-inflammationsmodel påvistes, 1 time efter oral administration af
One hour after oral administration of
Til korttidsvirkende lindring af moderate til svære akutte smerter forbundet med: primær dysmenorré, dental kirurgi, ortopædisk kirurgi.
For the short-term relief of moderate to severe acute pain associated with: primary dysmenorrhea, dental surgery, orthopaedic surgery.
[C]-mærket lumiracoxib, radioakivitetsratio målt ved inflammationsstedet versus radioakivitetsratio målt i blod i forholdet 2:1 og 8:1 fire timer efter dosering.
[C]-labeled lumiracoxib in a rat model of inflammation, the ratio of radioactivity detected at the site of inflammation versus that detected in the blood was 2:1, and was 8:1 four hours post dose.
Hvis der under behandlingen sker en forværring inden for et af de ovennævnte organsystemer, skal passende forholdsregler tages og seponering af behandlingen med lumiracoxib bør overvejes.
If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of lumiracoxib therapy should be considered.
Lumiracoxib var ikke teratogent i reproduktionstoksicitetforsøg med rotter og kaniner ved doser svarende til systemisk optagelse 10,4 (rotter) og 38 (kaniner) gange større end det humane terapeutiske niveau efter en dosis på 200 mg.
Lumiracoxib was not teratogenic in reproduction toxicity studies conducted in rats and rabbits at doses representing systemic exposure 10.4 (rat) and 38 (rabbit) times greater than the human therapeutic level after a 200 mg dose.
Forsigtighed skal udvises når behandling med lumiracoxib initieres hos dehydrerede patienter.
Caution should be used when initiating treatment with lumiracoxib in patients with dehydration.
Nogle selektive COX-2 hæmmere er blevet sat i forbindelse med en øget risiko for hudreaktioner hos patienter med enhver form for lægemiddelallergi i anamnesen.
Some selective COX-2 inhibitors have been associated with an increased risk of skin reactions in patients with a history of any drug allergy.
Beslutningen om at ordinere en selektiv COX-2 hæmmer bør bero på en vurdering af den samlede risiko for den enkelte patient (se pkt.
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see section 4.3 and 4.4).
Sygdomme i blod- og lymfesystem Usædvanlig: Anæmi
Blood and lymphatic system disorders Uncommon: anaemia
Karsygdomme Usædvanlig: Venøs insufficiens, hypotension, cerebrovaskulære tilfælde*
Uncommon: venous insufficiency, hypotension, cerebrovascular accident*
efter vurderingen af oplysningerne om alvorlige hudreaktioner tyder ikke på, at der er nogen sammenhæng mellem lumiracoxib og de usædvanligt mange indberetninger om alvorlige hudreaktioner.
Further to the assessment of the data on serious skin reactions, lumiracoxib does not appear to be associated with an unusually large number of reports of serious skin reactions.
Forsigtighed skal udvises hos ældre osteoarthrosepatienter når dosis øges fra 100 mg til 200 mg daglig (se pkt.
Caution should be exercised in elderly osteoarthritis patients when increasing from a 100 mg to a 200 mg daily dose (see section 4.4 and 5.2).
Dosisjustering er derfor ikke nødvendig hos patienter med mild eller moderat leverinsufficiens.
Thus, no dose adjustment is necessary in patients with mild or moderate hepatic impairment.
Farmakodynamiske interaktioner
Pharmacodynamic Interactions
* Baseret på analyser af kontrollerede kliniske langtidsundersøgelser med placebo og lægemidler, er selektive COX-2 hæmmere blevet sat i forbindelse med en øget risiko for alvorlige arterielle thrombotiske hændelser, inklusive myokardieinfarkt og apopleksi.
* Based on analyses of long-term placebo and active controlled clinical trials, some selective COX-2 inhibitors have been associated with an increased risk of serious thrombotic arterial events, including myocardial infarction and stroke.
Psykiske lidelser Usædvanlig: Depression, søvnløshed, angst
Psychiatric disorders Uncommon: depression, insomnia, anxiety
Almindelige: Abdominalsmerter, obstipation, diarré, dyspepsi, kvalme, opkastning, flatulens Usædvanlig: Gastroduodenalt ulcus, gastroduodenitis, esophagitis, abdominal udspiling, stomatitis aphtae, mundtørhed, dysfagi, epigastrisk ubehag, ræben, gastroesophageal refluks, gingivitis, hyperaciditet, tandsmerter
Common: abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting, flatulence Uncommon: gastroduodenal ulcer, gastroduodenitis, oesophagitis, abdominal distension, aphthous stomatitis, dry mouth, dysphagia, epigastric discomfort, eructation, gastrooesophageal reflux disease, gingivitis, hyperacidity, toothache
Indehaveren af markedsføringstilladelsen udarbejder og udbreder en lægevejledning om behandlingsvalg til brug for læger, der ordinerer lumiracoxib.
To develop and disseminate a Physician Decision Treatment Guide for prescribers of lumiracoxib.
Farmakokinetiske interaktioner
Pharmacokinetic Interactions
Antallet af frafald grundet hændelser relateret til hypertension var heller ikke signifikant forskellig mellem lumiracoxib (37) og NSAID (52).
The number of discontinuations due to hypertension-related events was also not significantly different between lumiracoxib (37) and NSAIDs (52).
Orale antikoagulantia: I et interaktionsforsøg mellem lægemidler med raske frivillige i stabil warfarinbehandling, var administration af lumiracoxib 400 mg, én gang daglig i 5 dage, forbundet med ca. 15% stigning i protrombintid.
Oral anticoagulants: In a drug-drug interaction study in healthy subjects stabilised on warfarin therapy, the administration of lumiracoxib 400 mg once daily for five days was associated with an approximate 15% increase in prothrombin time.
Dosisjustering er derfor ikke nødvendig hos patienter med nyreinsufficiens.
Thus no dose adjustment is necessary in patients with renal impairment.
Lumiracoxib påvirker ikke blodtrykskontrollen hos hypertensive patienter og adskilte sig i kliniske forsøg ikke fra placebo med hensyn til nyopstået hypertension.
Lumiracoxib did not affect blood pressure control in hypertensive patients, nor did it differ from placebo regarding newly occurring hypertension in clinical trials.
Den oxidative metabolisme af lumiracoxib er hovedsagelig CYP2C9-medieret.
The oxidative metabolism of lumiracoxib is mainly CYP2C9 mediated.
Lumiracoxibs farmakokinetik er ikke undersøgt hos patienter med svær leverinsufficiens (Child-Pugh >9).
The pharmacokinetics of lumiracoxib have not been studied in patients with severe hepatic impairment (Child-Pugh >9).
COX-2 selektive hæmmere kan ikke erstatte acetylsalicylsyre som profylakse for kardiovaskulær thromboembolisk sygdom på grund af deres manglende antithrombotiske virkning.
COX-2 selective inhibitors are not a substitute for ASA for prophylaxis of cardiovascular thromboembolic diseases because of their lack of antiplatelet effect.
Der bør udvises forsigtighed ved behandling af patienter, der har den største risiko for at udvikle gastrointestinale komplikationer i forbindelse med NSAID: Ældre, som får andre NSAID eller acetylsalicylsyre samtidig, eller patienter, der tidligere har haft gastrointestinal sygdom som f.eks. ulcera og gastrointestinal blødning.
Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs: the elderly, patients using any other NSAID or ASA concomitantly, or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.
Baseret på disse studier synes lumiracoxib at have lille potentiale for interaktioner med stoffer der cleares af cytokrom P450, bortset fra CYP2C9, hvor der er risiko for nedsat clearance af samtidigt administrerede substrater af CYP2C9.
Based on these studies, lumiracoxib appears to have a low potential for interactions with compounds cleared by cytochrome P450 except for CYP2C9 where there is possibility of decreased clearance of concomitantly administered substrates of CYP2C9.
Effekt af lumiracoxib på andre lægemidlers farmakokinetik (FK) Warfarin: I et forsøg med warfarin, som anses for et CYP2C9-substrat der er følsomt over for lægemiddelinteraktioner, havde samtidig administration af lumiracoxib 400 mg ingen effekt på plasma-AUC, Cmax eller Tmax af R-warfarin eller S-warfarin.
The effect of lumiracoxib on the PK of other drugs Warfarin: In a study with warfarin, which is considered to be a CYP2C9 substrate sensitive to drug interactions, co-administration with lumiracoxib 400 mg had no effect on plasma AUC, Cmax or Tmax of R-warfarin or S-warfarin.
Der er på baggrund af såvel plasmaoptagelsen af lumiracoxib som farmakogenetiske analyser, ikke fundet tegn på, at lumiracoxiboptagelsen er øget hos patienter med CYP2C9-genotyper forbundet med nedsat metabolisk clearance.
On the basis of both plasma exposure to lumiracoxib and pharmacogenetic analysis, no evidence has been found to suggest that exposure to lumiracoxib is increased in subjects with genotypes of CYP2C9 associated with reduced metabolic clearance.
Lumiracoxib udskilles i mælken hos diegivende rotter.
Lumiracoxib is excreted in the milk of lactating rats.
Forskellen i antithrombocytaktivitet mellem COX-1-hæmmende NSAID og COX-2 selektive hæmmere kan være af klinisk betydning for patienter med risiko for udvikling af thrombotiske 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.
Sygdomme i lever og galdeveje Sjældne: Cholecystitis, cholelithiasis, hepatitis
Hepatobiliary disorders Rare: cholecystitis, cholelithiasis, hepatitis
{SÆRNAVN} 100 mg filmovertrukne tabletter {SÆRNAVN} 100 mg filmovertrukne tabletter {SÆRNAVN} 100 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT {INVENTED NAME} 100 mg film-coated tablets {INVENTED NAME} 200 mg film-coated tablets {INVENTED NAME} 400 mg film-coated tablets
Hvis der opstår tegn på leverinsufficiens eller vedvarende abnorm leverfunktionstest (ALAT eller ASAT >3 x ULN) skal behandling med lumiracoxib seponeres.
If signs of hepatic insufficiency occur, or if abnormal liver function tests (ALT or AST>3xULN) persist, lumiracoxib should be discontinued.
Selvom nyreinsufficiens ikke påvirker farmakokinetikken af lumiracoxib og dets aktive metabolit signifikant, er brug af lumiracoxib til patienter med moderat til svær nyreinsufficiens kontraindiceret på grund af risiko for yderligere forværring af nyrefunktionen på grund af cyclooxygenase-hæmningen (se pkt.
While renal insufficiency does not significantly influence the pharmacokinetics of lumiracoxib and its active metabolite, use of lumiracoxib in patients with moderate to severe renal insufficiency is contraindicated because of potential further deterioration of renal function due to cyclooxygenase inhibition (see section 4.3 and
Usædvanlig: Synkope, hypoæstesi, migræne, paræstesi, dysgeusi, vertigo, tinnitus
Uncommon: syncope, hypoaesthesia, migraine, paraesthesia, dysgeusia, vertigo, tinnitus
The Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) TARGET, et 12 måneders, dobbeltblindet, fase III studie inkluderende 18.325 osteoarthrose patienter randomiseret til lumiracoxib 400 mg én gang daglig (to til fire gange den anbefalede dosis), naproxen 500 mg to gange daglig eller ibuprofen 800 mg tre gange daglig.
TARGET, a 12-month, double-blind, phase III study included 18,325 OA patients randomized to lumiracoxib 400 mg once daily (two to four times the recommended OA dose), naproxen 500 mg twice daily or ibuprofen 800 mg three times daily.
Antithrombotisk behandling bør derfor ikke seponeres (se pkt.
Therefore antiplatelet therapies should not be discontinued (see section 4.5 and 5.1).
Leverinsufficiens: Dosisjustering er ikke nødvendig hos patienter med mild (Child-Pugh 5-6) til moderat (Child-Pugh 7-8) leverinsufficiens.
Hepatic impairment: No dose adjustment is necessary for patients with mild (Child-Pugh 5-6) to moderate (Child-Pugh 7-8) hepatic impairment.
Patienter med moderat til svært nedsat nyrefunktion (estimeret creatininclearance ≤ 50 ml/min).
Patients with moderate to severe renal dysfunction (estimated creatinine clearance <50 ml/min).
Methotrexat: Samtidig administration af lumiracoxib ved doser på 400 mg, én gang daglig, havde ingen klinisk signifikant effekt på plasmafarmakokinetikken, plasmaproteinbindingen eller urinudskillelsen af methotrexat og 7-hydroxy methotrexatmetabolitten.
Methotrexate: Co-administration of lumiracoxib at doses of 400 mg once daily had no clinically significant effects on the plasma pharmacokinetics, plasma protein binding or urinary excretion of methotrexate and of the 7-hydroxy methotrexate metabolite.
Kliniske undersøgelser tyder på, at gruppen af selektive COX-2 hæmmere kan være forbundet med en risiko for thrombotiske hændelser (specielt myokardieinfarkt (MI) og apopleksi), i forhold til placebo og nogle NSAID.
Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially myocardial infarction (MI)and stroke), relative to placebo and some NSAID's.
Der er set øvre gastrointestinale komplikationer [perforation, ulcera eller blødninger (PUB)], nogle med fatal udgang hos patienter behandlet med lumiracoxib.
Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in a fatal outcome, have occurred in patients treated with lumiracoxib.
Sjældne: Stigninger i blod-bilirubin, stigninger i blod-glukose.
Rare: blood bilirubin increased, blood glucose increased
Derfor bør lumiracoxib anvendes med forsigtighed hos patienter med hjertesvigt, dysfunktion af venstre ventrikel eller hypertension i anamnesen og hos patienter med allerede eksisterende ødem af anden årsag.
Therefore, lumiracoxib should be used with caution in patients with history of cardiac failure, left ventricular dysfunction or hypertension, and in patients with pre-existing oedema from any other reason.
Tredje trimester af graviditet samt amning (se pkt.
Third trimester of pregnancy and breast feeding (see section 4.6 and 5.3).
Det vides ikke om lumiracoxib udskilles i modermælk.
It is not known whether lumiracoxib is excreted in human milk.
Hypromellose; macrogol; talcum; jernoxid rød (E 172); jernoxid sort (E 172) og titandioxid (E 171).
Hypromellose, Macrogol, talc, iron oxide red (E172), iron oxide black (E172) and titanium dioxide (E171)
Pædiatriske patienter: Lumiracoxibs farmakokinetik er ikke undersøgt hos børn.
Paediatric patients: The pharmacokinetics of lumiracoxib in paediatric patients have not been studied.
Der er indberettet alvorlige hypersensitivitetsreaktioner (anafylakse, angioødem) hos patienter som fik lumiracoxib.
Serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving lumiracoxib.
Patienter med størst risiko for dette, er de med allerede eksisterende nedsat nyrefunktion, ukompenseret hjertesvigt eller cirrhose samt patienter i behandling med diuretika eller ACE-hæmmere.
Patients at greatest risk of this response are those with pre-existing renal dysfunction, uncompensated heart failure, or cirrhosis and those receiving diuretics or ACE inhibitors.
Lumiracoxib er i prækliniske forsøg vist hverken at være mutagent eller carcinogent.
In preclinical studies, lumiracoxib has been demonstrated to be neither mutagenic nor carcinogenic.
Det tilrådes dog, at initiere behandlingen med den lavest anbefalede dosis hos disse patienter (se pkt.
However, it is prudent to initiate treatment at the lower recommended dose in such patients (see section 4.3, 4.4 and 5.2).
Indehaveren af markedsføringstilladelsen gennemfører en databaseundersøgelse af anvendelsen af lumiracoxib og andre markedsførte NSAID's og COX-2-hæmmere.
To conduct a database study of drug utilisation of lumiracoxib and other marketed NSAIDs and COX-2 inhibitors.
Sjælden: Gastrointestinal blødning
Rare: gastrointestinal haemorrhage
Oral antikonception: Samtidig administration af lumiracoxib påvirkede ikke steady-state farmakokinetik eller effekt af ethinyløstradiol og levonorgestrel.
Oral contraceptives: Co-administration of lumiracoxib did not affect the steady state pharmacokinetics or the efficacy of ethinylestradiol and of levonorgestrel.
Gastrointestinal effekt i TARGET (12 måneders studie) Det primære effektmål var distributionen af tid versus hændelser af konkrete eller sandsynlige ulcuskomplikationer (POB) i den øvre mavetarmkanal.
Gastrointestinal Effect in TARGET (12-month study) The primary endpoint was time to event distribution of definite or probable upper gastrointestinal tract ulcer (UGIT) complications (POBs).
Antacida: (Aluminiumhydroxid/magnesiumhydroxid) havde ingen klinisk relevant effekt på lumiracoxibs farmakokinetik.
Antacids: (aluminium hydroxide/magnesium hydroxide) had no clinically relevant effect on the pharmacokinetics of lumiracoxib.
Antallet af frafald i TARGET grundet ødem var ikke signifikant forskelligt mellem lumiracoxib (43) og NSAID (55).
The number of discontinuations in TARGET due to oedema was not significantly different between lumiracoxib (43) and NSAIDs (55).
For det diastole blodtryk var den gennemsnitlige ændring fra basislinien -0,1 mmHg for lumiracoxib og +0,5 mmHg for NSAID (p<0,0001).
For diastolic blood pressure, mean change from baseline were0.1 mmHg for lumiracoxib and +0.5 mmHg for NSAIDs (p<0.0001).
Ca. 1.100 patienter blev behandlet med lumiracoxib i analgetiske kliniske forsøg (smerter efter tandoperation, primær dysmenorré og smerter efter ortopædisk operation).
Approximately 1,100 patients were treated with lumiracoxib in analgesia clinical studies (post-surgical dental pain, primary dysmenorrhea, and post-orthopedic surgery pain).
Almindelige: Svimmelhed, hovedpine
Common: dizziness, headache
Behandlingen med lumiracoxib bør seponeres ved den første forekomst af hududslæt, slimhindeaffektioner, eller andre tegn på overfølsomhed.
Lumiracoxib, should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
I langtidsundersøgelser er der ikke vist en signifikant forskel på GI-sikkerheden mellem selektive COX-2 hæmmere + acetylsalicylsyre versus NSAID + acetylsalicylsyre (se pkt.
A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section 5.1).
Kendt overfølsomhed over for lumiracoxib eller over for et eller flere af hjælpestofferne.
Known hypersensitivity to lumiracoxib or to any of the excipients.
Lindring af akut smerte grundet dental kirurgi: Den maksimale behandlingsvarighed i kliniske studier var 24 timer.
Relief of acute pain due to dental surgery: the maximum treatment duration in clinical studies was 24 hours.