natgillin/translations-raw huggingface dataset:
4. 5).
Caution should be exercised when combining celecoxib with warfarin and other oral anticoagulants (see section 4.5).
4 Onsenal 200 mg kapsler indeholder lactose (49, 8 mg).
Onsenal 200 mg capsules contain lactose (49.8 mg).
Onsenal bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Farmakodynamiske interaktioner Størstedelen af interaktionsforsøgene er blevet udført med celecoxibdoser på 200 mg 2 gange dagligt (dvs. de doser, der anvendes ved osteoarthritis/ reumatoid artrit).
4 The majority of the interaction studies have been performed with celecoxib doses of 200 mg BID (i. e. those used for osteoarthritis/ rheumatoid arthritis).
4. 4).
Bleeding events in association with increases in prothrombin time have been reported in arthritis patients (mainly elderly) receiving celecoxib concurrently with warfarin, some of them fatal (see section 4.4).
Som for NSAID kan risikoen for akut nyreinsufficiens, som sædvanligvis er reversibel, muligvis være øget hos nogle patienter med kompromitteret nyrefunktion (f. eks. dehydrerede patienter eller ældre patienter), hvis ACE- hæmmere eller angiotensin II- receptorantagonister kombineres med NSAID, inklusive celecoxib.
As for NSAIDs, the risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e. g. dehydrated patients or elderly patients) when ACE inhibitors or angiotensin II receptor antagonists are combined with NSAIDs, including celecoxib.
I et klinisk forsøg af 28 dages varighed med patienter med lisinoprilkontrolleret stadie I og II hypertension førte administration af celecoxib 200 mg 2 gange dagligt ikke til klinisk signifikante stigninger i det gennemsnitlige daglige systoliske eller diastoliske blodtryk beregnet ud fra 24- timers ambulant blodtryksmåling sammenlignet med placebo.
In a 28-day clinical study in patients with lisinopril-controlled Stage I and II hypertension, administration of celecoxib 200 mg BID resulted in no clinically significant increases, when compared to placebo treatment, in mean daily systolic or diastolic blood pressure as determined using 24-hour ambulatory blood pressure monitoring.
Denne forskel er statistisk signifikant.
Among patients treated with celecoxib 200 mg BID, 48% were considered unresponsive to lisinopril at the final clinic visit (defined as either cuff diastolic blood pressure > 90 mmHg or cuff diastolic blood pressure increased > 10% compared to baseline), compared to 27% of patients treated with placebo; this difference was statistically significant.
Samtidig behandling med NSAID og ciclosporin D- derivater eller tacrolimus synes at kunne øge den nyretoksiske effekt af ciclosporin og tacrolimus.
Co-administration of NSAIDs and ciclosporin D derivatives or tacrolimus have been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus.
5. 1).
As with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of celecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see section 5.1).
Virkningen af celecoxib på andre lægemidler Celecoxib er en svag hæmmer af CYP2D6.
Effects of celecoxib on other medicinal products Celecoxib is a weak inhibitor of CYP2D6.
Under behandling med celecoxib steg den gennemsnitlige plasmakoncentration af CYP2D6- substratet dextromethorphan med 136%.
During celecoxib treatment, the mean plasma concentrations of the CYP2D6 substrate dextromethorphan were increased by 136%.
Eksempler på lægemidler, som metaboliseres af CYP2D6, er antidepressiva (tricykliske og SSRI- præparater), neuroleptika, antiarrytmika osv.
Examples of medicines which are metabolised by CYP2D6 are antidepressants (tricyclics and SSRIs), neuroleptics, anti-arrhythmics, etc.
Doseringen af individuelt dosistitrerede CYP2D6- substrater bør måske nedsættes, når samtidig behandling med celecoxib initieres, eller øges, hvis behandling med celecoxib afsluttes.
The dose of individually dose-titrated CYP2D6 substrates may need to be reduced when treatment with celecoxib is initiated or increased if treatment with celecoxib is terminated.
5 In vitro- forsøg har vist mulighed for, at celecoxib kan hæmme CYP2C19- katalyseret metabolisme.
In vitro studies have shown some potential for celecoxib to inhibit CYP2C19 catalysed metabolism.
Den kliniske betydning af disse in vitro- fund er ikke kendt.
The clinical significance of this in vitro finding is unknown.
I et interaktionsforsøg havde celecoxib ikke havde nogen klinisk relevant virkning på farmakokinetikken af orale kontraceptiva (1 mg norethisteron/ 35 µg ethinylestradiol).
In an interaction study, celecoxib had no clinically relevant effects on the pharmacokinetics of oral contraceptives (1 mg norethistherone / 35 microg ethinylestradiol).
Celecoxib påvirker ikke i klinisk relevant grad farmakokinetikken af tolbutamid (CYP2C9- substrat), eller glibenclamid.
Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate), or glibenclamide to a clinically relevant extent.
Hos patienter med reumatoid artrit havde celecoxib ingen signifikant virkning på farmakokinetikken (plasma - eller renal clearance) af methotrexat (i reumatologiske doser).
5 In patients with rheumatoid arthritis celecoxib had no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (in rheumatologic doses).
Virkninger af andre lægemidler på celecoxib Hos personer, som har nedsat CYP2C9- metabolisering, og som viser øget systemisk eksponering for celecoxib, kan samtidig behandling med CYP2C9- hæmmere føre til yderligere stigning i eksponering for celecoxib.
In individuals who are CYP2C9 poor metabolisers and demonstrate increased systemic exposure to celecoxib, concomitant treatment with CYP2C9 inhibitors could result in further increases in celecoxib exposure.
4. 2 og 5. 2).
Such combinations should be avoided in known CYP2C9 poor metabolisers (see sections 4.2 and 5.2).
Samtidig brug af 200 mg celecoxib taget som én enkeltdosis og 200 mg fluconazol, en potent CYP2C9- hæmmer, én gang dagligt resulterede i en gennemsnitlig stigning i celecoxibs Cmax på 60% og i AUC på 130%.
Concomitant use of 200 mg single dose of celecoxib and 200 mg once daily of fluconazole, a potent CYP2C9 inhibitor, resulted in a mean increase in celecoxib Cmax of 60% and in AUC of 130%.
Plasmakoncentrationen af celecoxib kan reduceres ved samtidig brug af CYP2C9- induktorer som rifampicin, carbamazepin og barbiturater.
Concomitant use of inducers of CYP2C9 such as rifampicin, carbamazepine and barbiturates may reduce plasma concentrations of celecoxib.
Der foreligger ikke kliniske data om eksponering for celecoxib under graviditet.
For celecoxib no clinical data on exposed pregnancies are available..
4. 3 og 5. 3).
Studies in animals (rats and rabbits) have shown reproductive toxicity (see sections 4.3 and 5.3).
4. 3).
Celecoxib is contraindicated in pregnancy and in women who can become pregnant unless using an effective method of contraception (see section 4.3).
- Bivirkninger rapporteret med hyppigheder større end 0, 01% og større end for placebo hos
- Adverse reactions reported in osteoarthritis patients and rheumatoid arthritis patients at incidence rates
Bivirkningerne er rapporteret fra 12 placebo - og/ eller aktivt- kontrollerede kliniske forsøg i varigheder op til 12 uger ved indgivelse af celecoxibdoser på 100 mg og op til 800 mg dagligt.
greater than 0.01% and greater than those reported for placebo during 12 placebo- and/ or active- controlled clinical trials of duration up to 12 weeks at celecoxib daily doses from 100 mg up to 800 mg.
2. 300 patienter behandlet i 1 år eller mere.
In additional studies using non-selective NSAID comparators, approximately 7400 arthritis patients have been treated with celecoxib at daily doses up to 800 mg, including approximately 2300 patients treated for 1 year or longer.
- Bivirkninger fra overvågning efter markedsføring er rapporteret som spontane rapporter over en
- Adverse drug reactions from post-marketing surveillance as spontaneously reported during a period in
periode, hvor det anslås, at > 70 millioner patienter er blevet behandlet med celecoxib (variable doser, varigheder og indikationer).
which an estimated > 70 million patients were treated with celecoxib (various doses, durations, and
TABEL 1.
6 indications).
Organklasse
TABLE 1
Frekvens ikke
Frequency Not
≥1/ 100 til < 1/ 10
(≥ 1/ 100 to < 1/ 10)
almindelig
(≥ 1/ 1000 to < 1/ 100)
≥1/ 10. 000 til
(≥ 1/ 10,000 to
kendt
Known
< 1/ 1000
< 1/ 1000)
(kan ikke
(Post-marketing experience)1
estimeres ud fra
Infections and infestations
pancytopeni
Pancytopenia
Psykiske forstyrrelser
Psychiatric
konfusion
Confusion
hallucinationer
Hallucinations
7 Metabolisme og ernæring
Metabolism and nutrition
svimmelhed, hypertoni
Dizziness, hypertonia
ataksi, smags - forandringer
Ataxia, taste alteration
hovedpine, forværret epilepsi, aseptisk meningitis, tab af smagssans, anosmi, fatal intrakraniel blødning
Headache, aggravated epilepsy, meningitis aseptic, ageusia, anosmia, fatal intracranial haemorrhage
sløret syn
Blurred vision
conjunctivitis, øjenblødning, okklusion af nethindearterie eller nethindevene
Conjunctivitis, ocular haemorrhage, retinal artery or vein occlusion
myokardieinfarkt2
Myocardial infarction2
arytmi
Arrhythmia
hypertension, forværret hypertension
Hypertension, hypertension aggravate d
flushing, vaskulitis
Flushing, vasculitis
Luftveje, thorax og mediastinum
Respiratory, thoracic, and mediastinal
bronkospasme
Bronchospasm
abdominalsmerter, diarré, dyspepsi, flatulens
Abdominal pain, diarrhoea,
obstipation, opstød, gastrit, stomatit, opkastning, forværring af gastrointestinal inflammation
Constipation, eructation, gastritis,
sår i tolvfingertarmen, mavesæk, spiserør, tyndtarmen og tyktarmen; dysfagi, intestinal perforation, esophagitis, melaena, pankreatit
Duodenal, gastric, oesophageal,
kvalme, akut pankreatit, gastro - intestinal blødning, colitis/ forværret colitis
Nausea, acute pancreatitis,
Lever og galdeveje
dyspepsia, flatulence
abnorm leverfunktion, forhøjet ASAT og ALAT
stomatitis, vomiting, aggravation of gastrointestinal inflammation
forhøjede leverenzymer
Hepatobiliary
hepatitis, leversvigt, icterus
Abnormal hepatic function, increased
Hud og subkutane væv
Elevation of hepatic Hepatitis, enzymes hepatic failure
udslæt, pruritus
SGOT and SGPT
urticaria
jaundice
alopeci, foto - sensitivitet
Skin and subcutaneous
ekkymose, bulløs erruption, exfoliativ dermatitis, erythema multiforme, Stevens- Johnsons syndrom, toksisk epidermal nekrolyse, angioødem
Rash, pruritus
2
Urticaria
Der ses ingen overrepræsentation af slagtilfælde.
Alopecia, Ecchymosis, photosensitivity bullous eruption, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema
8 Knogler, led, muskler og bindevæv
Musculoskeletal and connective
kramper i benene
Leg cramps
forhøjet kreatinin, forhøjet serumcarbami d
Increased creatinine, BUN increased
Det reproduktive system og mammae Almene symptomer og reaktioner på adminitrationsstede t
Reproductive and breast General
influenzalignende symptomer, perifere ødemer/ væskere - tention
Flu-like symptoms, peripheral oedema/ fluid retention
menstruations - forstyrrelser
Menstrual disorder
I tabel 2 anføres de øvrige bivirkninger, som er set med hyppigheder højere end placebo hos patienter behandlet med 400- 800 mg dagligt i langtidsforsøg på op til 3 år ved forebyggelse af polypper (APC - og PreSAP- forsøgene; se pkt.
Adverse drug reactions spontaneously reported to the safety surveillance database over a period in which an estimated > 70 million patients were treated with celecoxib (various doses, durations, and indications).
5. 1, Farmakodynamiske egenskaber:
As a result, the frequencies of these adverse drug reactions cannot be reliably determined.
Kardiovaskulær sikkerhed – langtidsforsøg hos patienter med sporadisk adenomatøs polypose).
2 In a pooled analysis of 20 placebo-controlled studies with duration greater than 2 weeks up to 1 year in patients with OA and RA, the excess rate of myocardial infarction in patients treated with celecoxib 200 or 400 mg daily over placebo was 0.7 events per 1000 patients (Rare) and there was no excess of strokes.
TABEL 2
Cardiovascular Safety – Long-Term Studies Involving Patients With Sporadic Adenomatous Polyps).
Organklasse
TABLE 2
(≥1/ 100 til < 1/ 10)
(≥ 1/ 100 to < 1/ 10)
(≥1/ 1000 til < 1/ 100)
(≥ 1/ 1000 to < 1/ 100)
Infektioner og parasitære sygdomme Tumorer Psykiske forstyrrelser
Infections and infestations
øreinfektion, svampe - infektion (svampeinfek - tionerne var primært ikke- systemiske)
Ear infection, fungal infection (fungal infections were primarily nonsystemic)
helicobacterinfektion, herpes zoster, erysipelas, sårinfektion, gingival infektion, labrynthitis, bakteriel infektion lipom søvnforstyrrelser
Helicobacter infection, herpes zoster, erysipelas, wound infection, gingival infection, labrynthitis, bacterial infection
Nervesystemet Øjne
Neoplasms Psychiatric Nervous system Eye
cerebralt infarkt mouches volantes, konjunktival blødning
Lipoma Sleep disorder Cerebral infarction Vitreous floaters; conjunctival hemorrhage
unstabil angina, aortaklapregur - gitation, aterosklerose af koronararterier, sinusbradykardi, ventrikulær hypertrofi
Angina unstable, aortic valve incompetence, coronary artery atherosclerosis, sinus bradycardia, ventricular hypertropy
hypertension *
Hypertension *
dysfoni
Dysphonia
Mave - tarmkanalen
Gastrointestinal
diarré *
Diarrhoea*
kvalme, gastroøsofageal reflukssygdom, divertikel, opkastning *, dysfagi, colon irritabile - syndrom
Nausea, gastroesophageal reflux disease, diverticulum, vomiting, * dysphagia, irritable bowel syndrome
Knogler, led, muskler og
Musculoskeletal nd connective
muskelkramper
Muscle spasms
ganglion
Ganglion
nykturi
Nocturia
Det reproduktive system og mammae
Reproductive and breast
benign prostatahyperplasi, prostatitis, øget prostata - specifikt antigen
Benign prostatic hyperplasia, prostatitis, prostatic specific antigen increased
Almene symptom - er og reaktioner på adminitrations - stedet
General and administrative site
vægtøgning
Weight increased
Traumer, forgift - ninger og behand - lingskomplikationer
Injury, poisoning, procedural
fodfraktur, frakturer i underekstre- miteterne, epikondylit, seneruptuk, fraktur
Foot fracture, lower limb fracture, epicondylitis, tendon rupture, fracture
* Hypertension, opkastning og diarré er indkluderet i Tabel 2, fordi de er hyppigere rapporteret i disse forsøg, som forløb over 3 år, end bivirkninger i Tabel 1, som omfatter bivirkninger fra forsøg af 12 ugers varighed.
* Hypertension, vomiting and diarrhoea are included in Table 2 because they were reported more frequently in these studies, which were of 3-year duration, compared to Table 1, which includes adverse reactions from studies of 12-week duration.
1000 patienter (almindelig), og der ses en overrepræsentation af slagtilfælde på 5 hændelser pr.
In final data (adjudicated) from the APC trial in patients treated with celecoxib 800 mg daily for up to 3 years, the excess rates over placebo were 11 events per 1000 patients for myocardial infarction (common); and 5 events per 1000 patients for stroke (uncommon; types of stroke not differentiated).
Ved mistanke om overdosering skal relevant medicinsk behandling iværksættes f. eks. ventrikeltømning, klinisk overvågning, og om nødvendigt iværksættes symptomatisk behandling.
In the event of suspected overdose, appropriate supportive medical care should be provided e. g. by eliminating the gastric contents, clinical supervision and, if necessary, the institution of symptomatic treatment.
Antineoplastisk middel, ATC kode:
Antineoplastic, ATC code:
L01XX33.
L01XX33
Celecoxib er en diarylsubstitueret pyrazol og kemisk ligner det andre non- arylaminsulfonamider (f. eks. thiazider, furosemid), men det adskiller sig fra arylaminsulfonamider (f. eks. sulfamethoxizol og andre sulfonamid- antibiotika).
Celecoxib is a diaryl-substituted pyrazole, chemically similar to other non-arylamine sulfonamides (e. g. thiazides, furosemide) but differing from arylamine sulfonamides (e. g. sulfamethoxizole and other sulfonamide antibiotics).
Celecoxib er en oral selektiv cyclooxygenase- 2- hæmmer (COX- 2).
9 Celecoxib is an oral, selective cyclooxygenase-2 (COX-2) inhibitor.
Der er ikke observeret nogen statistisk signifikant hæmning af COX- 1 (vurderet som ex vivo hæmning af tromboxan B2 [TxB2] dannelse) hos raske frivillige personer ved den terapeutiske dosis til FAP på 400 mg 2 gange dagligt.
No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2 [TxB2] formation) was observed in healthy volunteers at the FAP therapeutic dose of 400 mg BID.
Der er identificeret 2 iso- former, COX - 1 og COX- 2.
Two isoforms, COX-1 and COX-2, have been identified.
Der er set forhøjede COX- 2- niveauer i mange præmaligne læsioner
COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation and fever.
10 (såsom adenomatøse colorektale polypper) og epitelcancer.
Elevated levels of COX-2 are found in many pre-malignant lesions (such as adenomatous colorectal polyps) and epithelial cancers.
Familiær adenomatøs polypose (FAP) er en genetisk sygdom, som skyldes en autosomal dominant genetisk forandring af et tumorsuppressorgen, adenomatosis polyposis coli- gen (APC- gen).
Familial Adenomatous Polyposis (FAP) is a genetic disease resulting from an autosomal dominant genetic alteration of a tumor suppressor gene, the adenomatous polyposis coli (APC) gene.
Polypper med APC- mutationen udtrykker COX- 2 i større grad, og hvis de ikke behandles, vil disse polypper fortsat blive dannet og vokse i colon eller rektum, hvilket vil medføre en risiko på næsten 100% for udvikling af colorektalcancer.
Polyps with the APC mutation overexpress COX-2 and left untreated, these polyps continue to form and enlarge in the colon or rectum resulting in essentially a 100% chance of developing colorectal cancer.
COX- 2 er også involveret i ovulation, implantation og lukning af ductus arteriosus, regulering af nyrefunktion og funktioner i centralnervesystemet (feber, smerteopfattelse og kognitive funktioner).
COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function).
COX- 2 er påvist i væv omkring mavesår hos mennesker, men dets relevans i forbindelse med sårheling er ikke kendt.
COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Forskellen i antitrombocytaktivitet mellem nogle COX- 1- hæmmende NSAID- præparater og selektive COX- 2- hæmmere kan være af klinisk betydning for patienter med risiko for 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.
COX- 2- hæmmere mindsker dannelsen af systemisk (og derfor muligvis endotelial) prostacyclin uden at påvirke trombycytternes tromboxan.
COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Der er observeret en dosisafhængig effekt på TxB2- dannelse ved høje doser af celecoxib.
A dose-dependent effect on TxB2 formation has been observed after high doses of celecoxib.
Eksperimentelle data viser, at den/ de virkningsmekanisme( r) for celecoxib, som medfører tumordød, kan relateres til induktion af apoptose og hæmning af angiogenese.
Experimental evidence shows that the mechanism(s) of action by which celecoxib leads to tumour death may be related to induction of apoptosis and inhibition of angiogenesis.
Hæmning af COX- 2 kan have konsekvenser for tumorlevedygtighed, som ikke er relateret til inflammation.
Inhibition of COX-2 may have consequences on tumour viability that are unrelated to inflammation.
Celecoxib hæmmer tumordannelsen i prækliniske coloncancer- modeller, som udtrykker COX- 2 i større grad, hvad enten det er induceret ved kemisk mutation (rotte AOM- model) eller genetisk mutation (MIN musemodel).
Celecoxib inhibits tumour formation in preclinical models of colon cancer, which overexpress COX-2, whether induced by chemical (rat AOM model) or genetic (MIN mouse model) mutation.
En randomiseret dobbelt- blind placebokontrolleret undersøgelse blev udført med 83 FAP- patienter.
A randomized double-blind placebo controlled study was conducted in 83 patients with FAP.
13 patienter havde den svækkede FAP- fænotype.
Thirteen patients had the attenuated FAP phenotype.
Der blev set en betydende reduktion af det adenomatøse område i duodenum sammenlignet med placebo (14, 5% for celecoxib 400 mg 2 gange dagligt versus 1, 4% for placebo), hvilket dog ikke er statistisk signifikant.
A meaningful reduction in duodenal adenoma area was also observed compared with placebo (14.5% celecoxib 400 mg BID versus 1.4% placebo), which however was not statistically significant.
Pilotforsøg hos børn med FAP:
Pilot Study in Juvenile FAP Patients:
I alt 18 børn i alderen 10- 14 år med positiv FAP- geno - eller FAB - fænotype blev behandlet med celecoxib 4 mg/ kg dagligt (4 patienter sammenlignet med 2 behandlet med placebo), celecoxib 8 mg/ kg dagligt (4 patienter sammenlignet med 2 patienter behandlet med placebo) eller celecoxib 16 mg/ kg dagligt (4 patienter sammenlignet med 2 patienter behandlet med placebo).
A total of 18 children 10 to 14 years of age who had genotype or phenotype positive FAP were treated with celecoxib 4 mg/ kg/ day (4 patients, compared to 2 patients treated with placebo), celecoxib 8 mg/ kg/ day (4 patients, compared to 2 patients treated with placebo), or celecoxib 16 mg/ kg/ day (4 patients, compared to 2 patients treated with placebo).
Det største reduktion blev set i gruppen af patienter behandlet med 16 mg/ mg dagligt, som svarer til den anbefalded FAP- voksendosis på 800 mg dagligt.
The greatest reduction was observed in patients treated with celecoxib 16 mg/ kg/ day, which corresponds to the recommended adult FAP dose of 800 mg daily.
Sikkerhedsdata er blevet gennemgået i detaljer af en data- sikkerheds- monitorerings- komité, som konkluderede, at celecoxib 16 mg/ kg dagligt er en sikker dosis, som kan anbefales ved fremtidige forsøg hos børn med FAP.
Safety data were reviewed in detail by a Data Safety Monitoring Committee, which concluded that celecoxib 16 mg/ kg/ day was a safe dose to recommend for further studies in juvenile FAP patients.
4. 4; kardiovaskulære lidelser).
The long-term cardiovascular toxicity in children exposed to celecoxib has not been evaluated and it is unknown if the long-term risk may be similar to that seen in adults exposed to celecoxib or other COX-2 selective and non-selective NSAIDs (see section 4.4; cardiovascular effects.).
Kardiovaskulær sikkerhed – langtidsforsøg med patienter med sporadisk adenomatøs polypose:
10 Cardiovascular Safety – Long-Term Studies Involving Subjects With Sporadic Adenomatous Polyps:
APC- forsøget (Adenoma Prevention with Celecoxib) og PreSAP- forsøget (Prevention of Spontaneous Adenomatous Polyps).
Two studies involving subjects with sporadic adenomatous polyps were conducted with celecoxib i. e., the APC trial (Adenoma Prevention with Celecoxib) and the PreSAP trial (Prevention of Spontaneous Adenomatous Polyps).