natgillin/translations-raw huggingface dataset:
Det er vigtigt at udvise forsigtighed når etoricoxib administreres samtidig med andre lægemidler, der metaboliseres primært af humane sulfotransferaser (f. eks. oral salbutamol og minoxidil).
While knowledge about effects of multiple sulfotransferases is presently limited and the clinical consequences for many drugs are still being examined, it may be prudent to exercise care when administering etoricoxib concurrently with other drugs primarily metabolised by human sulfotransferases (e. g., oral salbutamol and minoxidil).
Etoricoxib effekt på lægemidler der metaboliseres via CYP- isoenzymer:
Effect of etoricoxib on drugs metabolised by CYP isoenzymes
Baseret på in vitro - undersøgelser, forventes etoricoxib ikke at hæmme cytokrom P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 eller 3A4.
Based on in vitro studies, etoricoxib is not expected to inhibit cytochromes P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4.
I en undersøgelse med raske frivillige, ændrede daglig administration af etoricoxib 120 mg ikke hepatisk CYP3A4- aktivitet, vurderet ved erythromycin- pustetest.
In a study in healthy subjects, daily administration of etoricoxib 120 mg did not alter hepatic CYP3A4 activity as assessed by the erythromycin breath test.
Andre lægemidlers effekt på etoricoxibs farmakokinetik:
Effects of other drugs on the pharmacokinetics of etoricoxib
In vitro undersøgelser indikerer at CYP2D6, CYP2C9, CYP1A2 og CYP2C19 også kan katalysere den primære metaboliseringsvej, men deres kvantitative roller in vivo er ikke undersøgt.
In vitro studies indicate that CYP2D6, CYP2C9, CYP1A2 and CYP2C19 also can catalyse the main metabolic pathway, but their quantitative roles have not been studied in vivo.
Ketoconazol, en potent hæmmer af CYP3A4, i doser på 400 mg én gang daglig i 11 dage til raske frivillige, påvirkede ikke etoricoxib 60 mg engangsdosis plasma- farmakokinetik i klinisk relevant grad (43% stigning af AUC).
Ketoconazole, a potent inhibitor of CYP3A4, dosed at 400 mg once a day for 11 days to healthy volunteers, did not have any clinically important effect on the single-dose pharmacokinetics of 60 mg etoricoxib (43% increase in AUC).
Samtidig administration af etoricoxib og rifampicin, en potent CYP- enzyminduktor, medførte et fald på 65% i plasmakoncentrationen af etoricoxib.
Co-administration of etoricoxib with rifampicin, a potent inducer of CYP enzymes, produced a 65% decrease in etoricoxib plasma concentrations.
Selvom denne information kan indikere en dosisøgning, er etoricoxibdoser højere end de, der er anført for de respektive indikationer, ikke undersøgt i kombination med rifampicin, og kan derfor ikke anbefales (se afsnit 4. 2).
While this information may suggest an increase in dose, doses of etoricoxib greater than those listed for each indication have not been studied in combination with rifampicin and are therefore not recommended (see section 4.2).
4. 6 Graviditet og amning Graviditet Etoricoxib kan, ligesom andre COX- 2 hæmmende lægemidler, ikke anbefales til kvinder, der forsøger at blive gravide.
The use of etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive.
Dyreundersøgelser har vist reproduktionstoksicitet (se afsnit 5. 3).
Studies in animals have shown reproductive toxicity (see section 5.3).
Etorixocib er kontraindiceret til gravide (se afsnit 4. 3).
Etoricoxib is contraindicated in pregnancy (see section 4.3).
Hvis graviditet forekommer under behandling bør < SÆRNAVN > seponeres.
If a woman becomes pregnant during treatment, etoricoxib should be discontinued.
Amning Det vides ikke om etoricoxib udskilles i modermælk.
It is not known whether etoricoxib is excreted in human milk.
Kvinder der tager etoricoxib bør ikke amme (se afsnit 4. 3 og 5. 3).
(See sections 4.3 and 5.3.)
Patienter der oplever svimmelhed, vertigo eller søvnighed, når de anvender < SÆRNAVN >, bør ikke køre bil eller betjene maskiner.
However, patients who experience dizziness, vertigo or somnolence while taking etoricoxib should refrain from driving or operating machinery.
600 patienter med OA eller RA blev behandlet i 1 år eller mere).
In clinical trials, etoricoxib was evaluated for safety in approximately 4800 individuals, including approximately 3400 patients with OA, RA or chronic low back pain (approximately 600 patients with OA or RA were treated for one year or longer).
[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) inklusiv enkeltstående rapporter]
34 [Very Common (> 1/ 10) Common (> 1/ 100 ,< 1/10) Uncommon (> 1/1000 ,< 1/100) Rare (> 1/10,000, < 1/1,000) Very rare (< 1/10,000) including isolated cases]
Infektioner og infestationer Ikke- almindelig:
Infections and infestations:
Lidelser i immunsystemet Meget sjælden:
Immune system disorder:
Overfølsomhedsreaktioner omfattende angioødem, anafylaktiske/ anafylaktoide reaktioner.
Very rare: hypersensitivity reactions, including angioedema, anaphylactic/ anaphylactoid reactions.
Ikke- almindelig:
Metabolism and nutrition disorders:
Ikke- almindelig:
Psychiatric disorders:
Meget sjælden:
Uncommon: anxiety, depression, mental acuity decreased.
Svimmelhed, hovedpine.
Nervous system disorder:
Ikke- almindelig:
Common: dizziness, headache.
Ikke- almindelig:
Eye disorders:
Sløret syn.
Uncommon: blurred vision.
Ikke- almindelig:
Ear and labyrinth disorders:
Ikke- almindelig:
Cardiac disorders:
Venstresidig hjerteinsufficiens, uspecifikke EKG- forandringer, myokardieinfarkt∗.
Uncommon: congestive heart failure, non-specific ECG changes, myocardial infarction ∗.
Ikke- almindelig:
Common: hypertension.
Rødmen, cerebrovaskulære tilfælde∗.
Uncommon: flushing, cerebrovascular accident ∗.
Ikke- almindelig:
Respiratory, thoracic and mediastinal disorders:
Meget sjælden:
Uncommon: cough, dyspnoea, epistaxis.
Gastrointestinale forstyrrelser (f. eks. mavesmerter, flatulens, halsbrand), diarré, dyspepsi, epigastriske gener, kvalme.
Common: gastrointestinal disorders (e. g., abdominal pain, flatulence, heartburn), diarrhea, dyspepsia, epigastric discomfort, nausea.
Abdominal udspilning, syrerefluks, ændringer i tarmmotilitetsmønstret, obstipation, tør mund, gastroduodenal ulcera, colon irritabile, esophagitis, orale ulcera, opkastning.
Uncommon: abdominal distention, acid reflux, bowel movement pattern change, constipation, dry mouth, gastroduodenal ulcer, irritable bowel syndrome, oesophagitis, oral ulcer, vomiting.
Meget sjælden:
* Based on analyses of long-term placebo and active controlled clinical trials, selective COX-2 inhibitors have been associated with an increased risk of serious thrombotic arterial events, including myocardial infarction and stroke.
Peptisk ulcera inklusiv gastrointestinal perforation og blødning (hovedsagelig hos ældre).
The absolute risk increase for such events is unlikely to exceed 1% per year based on existing data (uncommon).
Lever - og galdevejslidelser:
35 Very rare: peptic ulcers including gastrointestinal perforation and bleeding (mainly in the elderly).
Meget sjælden:
Hepatobiliary disorders:
Ikke- almindelig:
Skin and subcutaneous tissue disorders:
Ekkymoser, ansigtsødem, pruritus, udslæt.
Uncommon: ecchymosis, facial oedema, pruritus, rash.
Urticaria, Steven- Johnsons syndrom, toksisk epidermisk nekrolyse..
Very rare: urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Ikke- almindelig:
Musculoskeletal, connective tissue and bone disorders:
Ikke- almindelig:
Renal and urinary disorders:
Proteinuri.
Uncommon: proteinuria.
Nyreinsufficiens, inklusiv nyresvigt, som almindeligvis er reversibel ved seponering af behandling (se afsnit 4. 4).
Very rare: renal insufficiency, including renal failure, usually reversible upon discontinuation of treatment (see section 4.4).
Brystsmerter.
Uncommon: chest pain.
Øget ALAT/ ASAT.
ALT increased, AST increased.
Nefrotoksicitet inkluderende interstitiel nefritis og nefrotisk syndrom; hepatotoksicitet inkluderende leversvigt, icterus og pancreatitis.
The following serious undesirable effects have been reported in association with the use of NSAIDs and cannot be ruled out for etoricoxib: nephrotoxicity including interstitial nephritis and nephrotic syndrome; hepatotoxicity including hepatic failure, jaundice and pancreatitis.
I tilfælde af overdosering bør der tages sædvanlige forholdsregler, for eksempel fjernelse af ikke absorberet materiale fra gastrointestinalkanalen samt instituering af understøttende behandling, hvis dette er påkrævet.
In the event of overdose, it is reasonable to employ the usual supportive measures, e. g., remove unabsorbed material from the GI tract, employ clinical monitoring, and institute supportive therapy, if required.
Antiinflammatoriske og antirheumatiske lægemidler, non- steriod, coxiber.
Anti-inflammatory and antirheumatic products, non-steroids, coxibs
ATC- kode:
36 ATC Code:
M01 AH05
MO1 AH05
Etoricoxib er indenfor det kliniske dosisområde en oral aktiv selektiv cyclo- oxygenase- 2 (COX- 2) hæmmer.
Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor within the clinical dose range.
I alle kliniske, farmakologiske undersøgelser forårsagede < SÆRNAVN >, i doser op til 150 mg daglig, dosisafhængig hæmning af COX- 2 uden hæmning af COX- 1.
Across clinical pharmacology studies ,< INVENTED NAME > produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily.
COX- 2 er isoformen af det enzym, som induceres af proinflammatoriske stimuli, og som man mener hovedsagelig har ansvaret for syntesen af prostanoide mediatorer for smerte, inflammation og feber.
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.
3100 patienter blev behandlet med etoricoxib ≥ 60 mg daglig i 12 uger eller længere.
Approximately 3100 patients were treated with etoricoxib ≥ 60 mg daily for 12 weeks or longer.
Der var ingen mærkbar forskel i incidensen af alvorlige thrombotiske kardiovaskulære hændelser hos patienter der fik etoricoxib ≥ 60 mg, placebo eller non- naproxen NSAID.
There was no discernible difference in the rate of serious thrombotic cardiovascular events between patients receiving etoricoxib ≥ 60 mg, placebo, or non-naproxen NSAIDs.
Forskellen i antitrombocytaktivitet mellem COX- 1 hæmmende NSAID og COX- 2 selektive hæmmere kan være af klinisk betydning for patienter med risiko for udvikling af thromboemboliske 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 events.
COX- 2 selektive hæmmere reducerer dannelsen af systemiske (og dermed muligvis endotel- deriveret) prostacyclin uden at påvirke thromboxan i blodpladerne.
COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
7100 osteoarthrosepatienter sammenlignede den gastrointestinale tolerabilitet af etoricoxib 90 mg (1, 5 gange den anbefalede OA dosis) med diclofenac 150 mg.
A study of approximately 7100 osteoarthritis patients compared the gastrointestinal tolerability of etoricoxib 90 mg (1.5 times the recommended OA dose) with diclofenac 150 mg.
Gastrointestinal tolerabilitet og sikkerhedsresultater:
Gastrointestinal tolerability and safety results:
Etoricoxib var forbundet med en statistisk signifikant lavere forekomst af patienttilbagetrækninger på grund af et prædefineret, sammensat effektmål for kliniske gastrointestinale hændelser og laboratoriemæssige hændelser relateret til leverfunktionstest sammenlignet med diclofenac.
Etoricoxib was associated with a statistically significantly lower incidence of patient withdrawals due to a predefined composite endpoint of clinical gastrointestinal adverse events and laboratory adverse events related to elevated liver function tests compared to diclofenac.
Forekomsten af kliniske gastrointestinale hændelser, som førte til tilbagetrækninger, var statistisk signifikant lavere for etoricoxib versus diclofenac (respektivt 7, 1% versus 9, 1%).
The incidence of clinical gastrointestinal events leading to withdrawal was statistically significantly lower for etoricoxib versus diclofenac (7.1% versus 9.1%, respectively).
100 patientår).
The rates for confirmed upper gastrointestinal perforations, ulcerations and bleeds were the same for etoricoxib and diclofenac (1.11 events per 100 patient years.)
Kardiovaskulære data:
Cardiovascular data:
Forekomsten af alvorlige thrombotiske hændelser var for etoricoxib 1, 25 hændelse pr.
The event rates for serious thrombotic events were:
100 patientår for diclofenac (relativ risiko 1, 07; 95% konfidensinterval:
Etoricoxib 1.25 events per 100 patient years versus 1.15 events per 100 patient years for diclofenac (relative risk 1.07; 95% CI:
0, 65%, 1, 74%).
0.65%, 1.74%).
100 patientår for henholdsvis etoricoxib og diclofenac.
The rates of myocardial infarction were 0.68 versus 0.42 events per 100 patient years on etoricoxib and diclofenac respectively.
100 patientår henholdsvis for etoricoxib og diclofenac.
The rates of ischemic stroke were 0.14 versus 0.23 per 100 patient years on etoricoxib versus diclofenac respectively.
Kardiorenale hændelser:
Cardiorenal events:
Statistisk signifikant flere patienter, som blev behandlet med etoricoxib, i forhold til diclofenac, oplevede bivirkninger forbundet med hypertension (11, 7% versus 5, 9%) og
Statistically significantly more patients treated with etoricoxib than diclofenac experienced adverse effects associated with hypertension (11.7% versus 5.9%) and oedema (7.5% versus
32 ødemer (7, 5% versus 5, 9%).
37 5.9%).
Der sås en højere forekomst af behandlingsophør på grund af hypertension (2, 3% versus 0, 7%), og dette var statistisk signifikant.
A higher rate of discontinuation due to hypertension was seen (2.3% versus 0.7%) and this was statistically significant.
Forekomsten af behandlingsophør på grund af ødemer var 0, 9% for etoricoxib versus 0, 7% for diclofenac.
The incidence of patient discontinuations due to oedema was 0.9% for etoricoxib versus 0.7% for diclofenac.
Forekomsten af venstresidig hjerteinsufficiens var 0, 4% for etoricoxib versus 0, 2% for diclofenac.
The incidence of congestive heart failure was 0.4% for etoricoxib versus 0.2% for diclofenac.
Hepatiske hændelser:
Hepatic adverse events:
Etoricoxib var forbundet med en statistisk signifikant lavere forekomst af behandlingsophør på grund af store stigninger i leverfunktionstests end diclofenac (0, 3% versus 5, 2%).
Etoricoxib was associated with a statistically significantly lower rate of withdrawals than diclofenac (0.3% versus 5.2%), due largely to elevations in liver function tests.
Den gavnlige effekt blev observeret så tidligt som på anden behandlingsdag og blev opretholdt i op til 52 uger. Hos patienter med rheumatoid arthritis (RA), gav etoricoxib 90 mg én gang daglig signifikant forbedring af smerte, inflammation og mobilitet.
In patients with rheumatoid arthritis (RA), etoricoxib 90 mg once daily provided significant improvements in pain, inflammation, and mobility.
Den gavnlige effekt blev opretholdt over behandlingsperioden på 12 uger.
These beneficial effects were maintained over the 12- week treatment periods.
I 2, 12- ugers, dobbeltblinde endoskopiundersøgelser, var den kummulative incidens af gastroduodenal ulceration signifikant lavere hos patienter behandlet med etoricoxib 120 mg én gang daglig, end hos patienter behandlet med enten naproxen 500 mg 2 gange daglig eller ibuprofen 800 mg 3 gange daglig.
In two 12-week double-blind endoscopy studies, the cumulative incidence of gastroduodenal ulceration was significantly lower in patients treated with etoricoxib 120 mg once daily than in patients treated with either naproxen 500 mg twice daily or ibuprofen 800 mg three times daily.
4000 patienter med OA, RA eller kroniske lændesmerter:
A prespecified, combined analysis of eight clinical trials of approximately 4000 patients with OA, RA, or chronic low back pain assessed the incidence rate for the following endpoints:
1) seponering på grund af øvre GI symptomer; 2) seponering på grund af enhver GI hændelse; 3) ny anvendelse af gastroprotektive midler og 4) ny anvendelse af ethvert GI middel.
1) discontinuation for upper GI symptoms; 2) discontinuation for any GI adverse experiences; 3) new use of gastroprotective medications; and 4) new use of any GI medications.
50% for disse effektmål hos patienter behandlet med etoricoxib (60, 90 eller 120 mg daglig) sammenlignet med patienter behandlet med naproxen 500 mg 2 gange daglig eller diklofenak 50 mg 3 gange daglig.
There was an approximate 50% risk reduction for these endpoints in patients treated with etoricoxib (60, 90 or 120 mg daily) as compared to patients treated with naproxen 500 mg twice daily or diclofenac 50 mg three times daily.
En randomiseret, dobbeltblind, placebokontrolleret undersøgelse med parallelle grupper vurderede effekten af 15 dages behandling med etoricoxib (90 mg), celecoxib (200 mg to gange daglig), naproxen (500 mg to gange daglig) og placebo på natriumudskillelsen i urin, blodtryk, og andre nyrefunktionsparametre hos patienter mellem 60 og 85 år, som var på en natriumdiæt på 200 mEq/ dag.
A randomized, double-blind, placebo-controlled, parallel-group study evaluated the effects of 15 days of treatment of etoricoxib (90 mg), celecoxib (200 mg bid), naproxen (500 mg bid) and placebo on urinary sodium excretion, blood pressure, and other renal function parameters in subjects 60 to 85 years of age on a 200-mEq/ day sodium diet.
Etoricoxib, celecoxib og naproxen havde en lignende virkning på natriumudskillelsen i urinen i løbet af de to ugers behandling.
Etoricoxib, celecoxib, and naproxen had similar effects on urinary sodium excretion over the 2 weeks of treatment.
Absorption Oralt administreret etoricoxib absorberes godt.
Absorption
Den orale biotilgængelighed er ca.
38 Orally administered etoricoxib is well absorbed.
Absorptionen påvirkedes, resulterende i et 36% fald i Cmax og en øgning i
The rate of absorption was affected, resulting in a 36% decrease in Cmax and an increase in Tmax by 2 hours.
Elimination Efter intravenøs administration af enkeltdosis på 25 mg radioaktivmærket etoricoxib til raske frivillige, blev 70% af radioaktiviteten genfundet i urinen og 20% i fæces, hovedsageligt i form af metabolitter.
Elimination Following administration of a single 25-mg radiolabeled intravenous dose of etoricoxib to healthy subjects, 70% of radioactivity was recovered in urine and 20% in faeces, mostly as metabolites.
Ældre patienter Farmakokinetikken hos ældre patienter (65 år og derover) svarer til den hos yngre patienter.
Pharmacokinetics in the elderly (65 years of age and older) are similar to those in the young.
Køn Etoricoxibs farmakokinetik er sammenlignelig hos mænd og kvinder.
The pharmacokinetics of etoricoxib are similar between men and women.
Patienter med moderat leverdysfunktion (Child- Pugh score 7- 9), der fik etoricoxib 60 mg hver anden dag havde samme middel- AUC som raske frivillige, der fik etoricoxib 60 mg én gang daglig.
Patients with moderate hepatic dysfunction (Child-Pugh score 7-9) administered etoricoxib 60 mg every other day had similar mean AUC to the healthy subjects given
Der findes ingen kliniske eller farmakokinetiske data fra patienter med svær leverdysfunktion (Child- Pugh score ≥10) (se afsnit 4. 2 og 4. 3).
(See sections 4.2 and 4.3.)
Nyreinsufficiens Farmakokinetikken i forbindelse med enkeltdosis etoricoxib 120 mg hos patienter med moderat til svær nyreinsufficiens og patienter med nyresygdom i terminalt stadie i hæmodialyse, var ikke signifikant forskellig fra den hos raske frivillige.
The pharmacokinetics of a single dose of etoricoxib 120 mg in patients with moderate to severe renal insufficiency and patients with end-stage renal disease on hemodialysis were not significantly different from those in healthy subjects.
Hæmodialysen bidrog i negligiabel grad til eliminiation (dialyseclearance ca.
Hemodialysis contributed negligibly to elimination (dialysis clearance approximately 50 ml/ min).
50 ml/ min) (se afsnit 4. 3 og 4. 4).
(See sections 4.3 and 4.4.)
Børn Etoricoxibs farmakokinetik hos børn (< 12 år) er ikke undersøgt.
The pharmacokinetics of etoricoxib in paediatric patients (< 12 years old) have not been studied.
I en farmakokinetisk undersøgelse (n = 16) udført med unge (i aldersgruppen 12- 17 år), svarede
In a pharmacokinetic study (n=16) conducted in adolescents (aged 12 to 17) the pharmacokinetics in adolescents weighing 40 to 60 kg given etoricoxib 60 mg once daily and adolescents > 60 kg given etoricoxib 90 mg once daily were similar to the pharmacokinetics in adults given etoricoxib 90 mg once daily.
34 farmakokinetikken hos unge med en vægt på 40- 60 kg, der fik etoricoxib 60 mg én gang daglig, og unge med en vægt > 60 kg, der fik etoricoxib 90 mg én gang daglig til farmakokinetikken hos voksne, der fik etoricoxib 90 mg, én gang daglig.
Safety and effectiveness of etoricoxib in paediatric patients have not been established.
Sikkerhed og effekt af etoricoxib hos børn er ikke undersøgt (se afsnit 4. 2, Børn).
(See section 4.2 ‘ Paediatric use’.)
1, 5 gange den daglige humandosis [90 mg] baseret på systemisk optagelse).
Etoricoxib was not teratogenic in reproductive toxicity studies conducted in rats at 15 mg/ kg/ day (this represents approximately 1.5 times the daily human dose [90 mg] based on systemic exposure).
En non- dosis relateret lav incidens af kardiovaskulære misdannelser observeredes hos kaniner behandlet med etoricoxib.
A non-dose-related low incidence of cardiovascular malformations was observed in etoricoxib-treated rabbits.
Hos rotter og kaniner sås ingen embryo/ føtal påvirkning ved systemisk optagelse der svarer til, eller er lavere, end den daglige humandosis [90 mg].
In rats and rabbits, no embryo/ foetal effects were seen at systemic exposures equal to or less than those at the daily human dose [90 mg].
Der var imidlertid et fald i embryo/ føtal overlevelse ved doser højere eller svarende til 1, 5 gange den daglige humandosis (se afsnit 4. 3 og 4. 6).
(See sections 4.3 and 4.6.)
Calciumhydrogenfosfat (vandfri), croscarmellosenatrium, magnesiumstearat, mikrokrystallinsk cellulose.
Calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
Tabletovertræk:
40 Tablet coating:
Carnaubavoks, hypromellose, lactosemonohydrat, titandioxid (E171), glyceroltriacetat.
Carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate.
Beholder:
Bottles:
Opbevares i original emballage tæt tillukket.
Keep the container tightly closed.
35 Blisterpakning:
Blisters:
Aluminum/ aluminiumblister i pakninger indeholdende 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 eller 100 tabletter.
Aluminum/ aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets.
Aluminum/ aluminiumblister (enkeltdoser) i pakninger med 50 eller 100 tabletter.
Aluminum/ aluminium blisters (unit doses) in packs of 50 or 100 tablets.
Hvid, rund, HDPE- beholder med hvid polypropylenlukning, indeholdende 30 eller 90 tabletter.
White, round, HDPE bottles with a white, polypropylene closure containing 30 or 90 tablets.
Måned dag, år
Month Day, Year
36 BILAG IV
42 ANNEX IV
37 Registreringsindehaverens opfølgende foranstaltninger
43 Follow-up measures of the Marketing Authorisation Holder
Beskrivelse Indehaveren af markedsføringstilladelsen forpligter sig til at underrette CHMP om resultatet af MEDAL - og EDGE II- undersøgelserne af kardiovaskulær og gastrointestinal sikkerhed, så snart disse er afsluttet, og foretage eventuelle nødvendige opdateringer.
The MAH commits to inform the CHMP of the outcome of the MEDAL and EDGE II studies on cardiovascular and GI safety upon completion and will provide necessary updates as applicable.
Indehaveren af markedsføringstilladelsen overvåger fortsat patienteksponeringen for etoricoxib i GPRD og evaluerer mulige resultater fra observationsundersøgelsen (- erne).
To continue to monitor patient exposure to etoricoxib in GPRD and evaluate potential contribution of observational study(-ies).