natgillin/translations-raw huggingface dataset:
Exantem, pruritus, urticaria, alopecia, Meget sjældne:
Exanthema, pruritus, urticaria, alopecia Very rare:
Angioødem Isolerede tilfælde af allergiske reaktioner inkluderende pruritus, hududslag, angiaoødem, erythema exsuditavum multiforme, exfoliativ dermatit, Steven Johnson syndrom og Quinkes ødem er raporteret.
Angiooedema Isolated cases of allergic reactions including including pruritus, rash, angioedema and erythema exsudativum multiforme, exfoliative dermatitis and Stevens Johnson syndrome, Quincke oedema have been reported.
Almindelige:
Musculoskeletal, connective tissue and bone disorders Common:
Muskelkramper.
Muscle cramps Uncommon:
Rygsmerter, myalgi og arthralgi.
Back pain, myalgia and arthralgia
Ualmindelige:
Renal and urinary disorders Uncommon:
Øget vandladningsfrekvens.
Increased micturition frequency
Ualmindelig:
Reproductive system and breast disorders Uncommon:
Impotens.
Impotence.
Ualmindelige:
General disorders and administration site conditions Uncommon:
Farmakoterapeutisk klassifikation:
Dihydropyridine derivates, ATC-code:
C08C A01
C08C A01
Den aktive virkestof i Amlovita tabletter, amlodipin et dihydropyridin derivat, er et chiralt stof, sammensat af et racemat.
The active substance in Amlovita tablets, the dihydropyridine derivative amlodipine, is a chiral substance, composed of a racemate.
Amlodipin er en calciumantagonist, der hæmmer den transmembrale influx af calciumioner gennem de potentielt afhængige L- type kanaler ind i hjertet og den glatte muskulatur.
Amlodipine is a calcium antagonist that inhibits the transmembranal influx of Ca ions through the potential dependent L-type channels into the heart and smooth muscle.
Amlodipin modvirker hypertension ved en direkte afslappende virkning på arteriernes glatte muskulatur.
Amlodipine acts on hypertension through a direct relaxant effect on arterial smooth muscle.
Dyreforsøg har vist at amlodipin er relativt karselektiv med en signifikant mindre virkning på hjertemuskulaturen end på den glatte muskulatur i karrene.
Animal studies have demonstrated that amlodipine is relatively vessel-selective with significantly less effect on cardiac muscle than on vascular smooth muscle.
Amlodipin påvirker ikke AV - overledningen og har ingen negativ inotrop effekt.
Amlodipine does not impair AV conduction and does not have a negative inotropic effect.
Amlodipin reducerer nyrernes vaskulære modstand und forøger det renale plasmaflow.
Amlodipine reduces renal vascular resistance and increases renal plasma flow.
Amlodipin kan anvendes til patienter med bestående kompenseret hjerteinsufficiens.
Amlodipine can be given to patients with co-existing compensated heart failure.
Kontrollerede studier af de hæmodynamiske virkninger og arbejdskapaciteten hos patienter med hjerteinsufficiens klasse II- IV har vist, at amlodipin ikk medfører klinisk forværring med hensyn til arbejdskapacitet, uddrivningsfraktion fra venstre ventrikel og klinisk symptomatologi.
Controlled studies of haemodynamic effects and exercise tolerance in patients with heart failure class II-IV have demonstrated that amlodipine does not lead to clinical deterioration regarding exercise tolerance, left ventricular ejection fraction and clinical symptomatology.
Ingen metabolisk virkning, f. eks. på plasmalipider eller glucosemetabolisme blev iagttaget under behandling med amlodipin.
No metabolic effects, e. g. on plasma lipids or glucose metabolism, have been seen during treatment with amlodipine.
Antihypertensiv virkning:
Antihypertensive effect:
Den antihypertensive virkning af amlodipin opnås gennem den direkte afslappende virkning på arteriernes glatte muskulatur.
Amlodipine has an effect on hypertension by a directly relaxing effect on the smooth muscle in the arterial blood vessels.
EMEA/ CPMP/ 0539/ 04
Dosing once daily produces a decrease in blood pressure EMEA/ CPMP/ 0539/ 04
Da den farmakologiske virkning af amlodipin indtræder langsomt, fremkalder det ikke akut hypotension eller reflektorisk takykardi.
The antihypertensive effect follows the normal diurnal variations in blood pressure with very small changes over the 24-hour period.
Amlovita tabletter kan anvendes i kombination med betablokkere, saluretika, ACE- hæmmere eller som monoterapi.
Amlovita tablets can be used in combination with beta-blockers, saluretics, ACE inhibitors, or as monotherapy.
Amlovita tabletter kan anvendes i kombination med betablokkere, nitrater eller som monoterapi ved angina pectoris.
Amlovita tablets can be used in combination with beta-blockers, nitrates or as monotherapy in angina pectoris.
Et opfølgningsstudie (PRAISE 2) viste at amlodipin ikke påvirkede den totale eller kardiovaskulære mortalitet uden iskæmisk oprindelse hos hjerteinsufficienspatienter i klasse III- IV.
In a follow-up study (PRAISE 2) showed that amlodipine did not have an affect on the total or cardiovascular mortality of heart failure class III-IV patients without ischaemic origin.
I studiet blev amlodipinbehandlingen associeret med en øgning af lungeødem, selvom dette ikke kunne relateres til en øgning af symptomerne.
In this study treatment with amlodipine was associated with an increase in pulmonary oedema, although this could not be related to an increase in symptoms.
Absorption og fordeling Biotilgængeligheden er 64- 80%.
Absorption and distribution The bioavailability is 64-80%.
Biotilgængeligheden påvirkes ikke ved samtidig fødeindtagelse.
The bioavailability is not influenced by concomitant intake of food.
Amlodipin forventes ikke at være dialyserbar på grund af den høje plasmaproteinbinding.
Patients with renal impairment and elderly patients:
Toksikologiske studier på dyr viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentoksicitet, karcinogenicitet og studier med gentagen dosistoksicitet.
Toxicological animal studies reveal no special hazards for humans regarding safety pharmacology, genotoxicity, carcinogenicity and studies with repeated dosing.
Lactose monohydrate Povidon k 30 Povidon k 90 Mikrokrystallinsk cellulose Krospovidone Natriumstearylfumarat
6.1 List of excipients Lactose monohydrate Povidone k 30 Povidone k 90 Microcrystalline cellulose Crospovidone
6. 2 Uforligeligheder
6.2 Sodium stearyl fumarate. Incompatibilities Not applicable.
18 måneder
6.3 Shelf life 18 months
Må ikke opbevares over 30°C
6.4 Special precautions for storage Do not store above 30°C.
6. 5 Emballage (art og indhold)
6.5 Nature and contents of container 5 mg tablets:
Perivita AS Håndverksveien 2 1403 Langhus Norway
Perivita AS Håndverksveien 2 1403 Langhus Norge
EMEA/ CPMP/ 0539/ 04 8.
EMEA/ CPMP/ 0539/ 04 8.
19443 10 mg:
19443 10 mg:
19444
19444
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Indgivelsesvej
Route of adminitration
Merck Sharp and Dohme Chaussée de Waterloo 1135 B- 1180 Brussels Belgium
Merck Sharp and Dohme Chasussée de Waterloo 1135 B-1180 Brussels Belgium
Waanderweg 39 NL - 2031 BN Haarlem The Netherlands
Waanderweg 39 NL-2031 BN Haarlem The Netherlands
Waarderweg 39, NL- 2031 BN Haarlem, The Netherlands
Waarderweg 39 NL-2031 BN Haarlem The Netherlands
Waarderweg 39, NL- 2031 BN, Haarlem, Postbox 581 The Netherlands
Waarderweg 39 Postbox 581 NL 2031 BN Haarlem The Netherlands
Waarderweg 39 P. O Box 581
Waarderweg 39, P. O Box 581 NL-2031 BN Haarlem The Netherlands
Frankrig
2 France
Tatoiou Street, Nea Erythrea 14671 Greece
Tatoiou Street Nea Erythrea 14671 Greece
Merck Sharp & Dohme - Regulatory Affairs Iceland, Smedeland 8 DK- 2600 Glostrup Danmark
Merck Sharp & Dohme - Regulatory Affairs Iceland Smedeland 8 DK-2600 Glostrup Danmark
Styrke
Italy
Letland
3 Latvia
SIA Merck Sharp & Dohme Latvija, Skanstes 13 Riga, LV- 1013 Latvia
SIA Merck Sharp & Dohme Latvija Skanstes 13 Riga, LV-1013 Latvia
UAB, Merck Sharp & Dohme “, Lenktoji str.
UAB, ,Merck Sharp & Dohme“ Lenktoji str.
Merck Sharp & Dohme Chaussee de Waterloo 1135 B - 1180 Bruxelles Belgium
Merck Sharp & Dohme Chaussee de Waterloo 1135 B – 1180 Bruxelles Belgium
Merck, Sharp & Dohme Ltd Hertfordshire Road Hoddesdon Hertsfordshire EN11 9BU United Kingdom
Hertfordshire Road Hoddesdon Hertsfordshire EN11 9BU United Kindgdom
Waanderweg 39 NL- 2031 BN Haarlem Netherlands
Waanderweg 39 NL-2031 BN Haarlem The Netherlands
Styrke
Poland
Slovakiet
Portugal Slovakia
Merck Sharp & Dohme B. V. Waarderweg 39 P. O.
Waarderweg 39 P. O.
Merck Sharp & Dohme de España, S. A., Josefa Valcárcel, 38 28027 Madrid Spain
Josefa Valcárcel, 38 28027 Madrid Spain
Merck Sharpe & Dohme Limited, Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom
Merck Sharpe & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom
6 BILAG II
5 ANNEX II
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET OG INDLÆGSSEDLEN FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
7 FAGLIGE KONKLUSIONER
6 SCIENTIFIC CONCLUSIONS
Etoricoxib er en selektiv hæmmer af COX- 2 (cyclooxygenase 2), der er indiceret til symptomlindring ved osteoartrose (OA, 30- 60 mg én gang daglig), reumatoid artritis (RA, 90 mg én gang daglig) og smerter og tegn på inflammation i forbindelse med akut artritis urica (120 mg én gang daglig).
Etoricoxib is a selective inhibitor of COX-2 (cyclooxygenase 2) indicated in the symptomatic relief of osteoarthritis (OA, 30-60mg once daily (od)), rheumatoid arthritis (RA, 90mg od) and the pain and signs of inflammation associated with acute gouty arthritis (120mg od).
Etoricoxib var omfattet af tidligere indbringelser for CHMP om sikkerheden af selektive COX- 2 - hæmmere, som blev afsluttet i 2004 og 2005.
Etoricoxib was included in previous CHMP referrals on the safety of COX-2 selective inhibitors in which concluded in 2004 and 2005.
Begge indbringelsesprocedurer omhandlede sikkerheden af COX- 2- hæmmere, heriblandt etoricoxib, med særligt fokus på gastrointestinal (GI) og kardiovaskulær (CV) sikkerhed.
Both referral procedures pertained to the safety of the COX-2 inhibitor products, including etoricoxib, with a particular focus on gastrointestinal (GI) and cardiovascular (CV) safety.
Disse indbringelser resulterede i opdateringer af produktoplysningerne, så disse kom til at omfatte lægemiddelgruppeadvarsler om risikoen for kardiovaskulære tromboemboliske reaktioner, gastrointestinale reaktioner og alvorlige hudreaktioner i forbindelse med brug af selektive COX- 2- hæmmere.
These led to updates of the product information to include class warnings on the risk of CV thrombotic, GI and severe skin reactions with COX-2 selective inhibitors.
Ud over de lægemiddelgruppeadvarsler og kontraindikationer, der blev indført for alle selektive COX- 2- hæmmere, blev der specifikt for etoricoxib også tilføjet en kontraindikation for patienter med hypertension, hvis blodtryk ikke er behandlet tilstrækkeligt, fordi der er tegn på, at etoricoxib hyppigere medfører kardiorenale hændelser end andre selektive COX- 2- hæmmere.
In addition to class warnings and contraindications, introduced for all COX-2 selective inhibitors, a contraindication in patients with hypertension whose blood pressure is not adequately controlled was included specifically for etoricoxib because of evidence of higher rates of cardiorenal events than other COX-2 inhibitor products.
I marts 2006 indsendte indehaverne af markedsføringstilladelse for Arcoxia (etoricoxib) en ansøgning om udvidelse af den godkendte indikation, så denne kom til at omfatte behandling af ankyloserende spondylit (AS) ved en anbefalet daglig dosis på 90 mg.
In March 2006, the marketing authorisation holders (MAH) for Arcoxia (etoricoxib) submitted an application to extend the licensed indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
Under vurdering af proceduren blev der udtrykt betænkeligheder ved den langsigtede sikkerhed ved etoricoxib 90 mg til patienter med AS.
During the assessment of the procedure, concerns were raised over the long-term safety of etoricoxib 90mg in patients with AS.
Efter at der var udtrykt betænkeligheder ved en mulig øget kardiovaskulær (CV) risiko i forbindelse med brug af dosen på 90 mg etoricoxib, anså Frankrig, at der var behov for en revurdering af benefit/ risk- forholdet for Arcoxia.
Following concerns of a possible increased cardiovascular (CV) risk related to the use of the 90mg dose of etoricoxib, France considered that a review of the benefit/ risk profile of Arcoxia was needed.
CHMP konkluderede den 26. juni 2008, at dataene bekræfter den kendte relativt ugunstige renovaskulære sikkerhedsprofil for etoricoxib (hypertension, ødem og kongestiv hjerteinsufficiens), men med tilsvarende kardiovaskulær tromboembolisk risiko som diclofenac og med en lidt gunstigere øvre GI- sikkerhedsprofil end naproxen og diclofenac (men ingen nævneværdig fordel med hensyn til nedre GI- sikkerhed).
The CHMP concluded on 26 June 2008 that the data confirm the known relatively adverse renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure), but similar CV thrombotic risk as diclofenac and some degree of upper GI safety advantage over naproxen and diclofenac (though no particular lower GI safety advantage).
Der foreligger kun få direkte sammenlignelige sikkerhedsdata for bestemte NSAID' er ud over diclofenac og naproxen, og det er derfor vanskeligt at vurdere risiciene for etoricoxib sammenlignet med ibuprofen, ketoprofen eller andre mindre gængse NSAID' er.
There is little direct comparative safety data for individual NSAIDs other than diclofenac and naproxen and it is therefore difficult to determine risks for etoricoxib compared with ibuprofen, ketoprofen or other less-commonly used NSAIDs.
Dataene fra de kliniske undersøgelser viste klinisk betydningsfuld behandlingseffekt af 90 mg etoricoxib én gang daglig ved AS- indikationerne, men der foreligger dog data, som indikerer, at den lavere dosis muligvis også viser effekt.
Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for AS indications; however, some data are available to indicate that lower doses might also show effect.
8 På baggrund af gennemgangen af de tilgængelige data anser CHMP, at fordelene ved etoricoxib til behandling af ankyloserende spondylit er større end risiciene.
Based on the review of the available data, the CHMP considers that the benefits of etoricoxib outweigh the risks in the treatment of ankylosing spondylitis.
9 BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET OG INDLÆGSSEDLEN
7 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
12, i Kommissionens
- The Committee considered the referral made under Article 6(12) of Commission Regulation EC No
1084/ 2003, for Arcoxia og tilknyttede navne.
1084/ 2003, for Arcoxia and associated names.
- På grundlag af de tilgængelige data anser CHMP, at benefit/ risk- forholdet for Arcoxia
- In view of the available data, the CHMP considered that the benefit/ risk balance for Arcoxia
(etoricoxib) 90 mg til indikationen AS er gunstigt, men i forbindelse med den kardiorenale sikkerhed er produktresuméets og indlægssedlens afsnit om kontraindikationer og advarsler blevet revideret -
(etoricoxib) 90mg dose in AS indication is positive; however, revisions to the contraindications and warnings sections have been added to the summary of product characteristics and package leaflet in relation to cardiorenal safety.
anbefalede CHMP godkendelse af ændringen af markedsføringstilladelserne.
The CHMP recommended the granting of the variation of the Marketing Authorisations for which the summaries of product characteristics, labelling and package leaflets are set out in Annex III and under the conditions set out in Annex IV.
Produktresumé, etikettering og indlægsseddel fremgår af bilag III.
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
De særlige betingelser fremgår af bilag IV.
9 SUMMARY OF PRODUCT CHARACTERISTICS
10 BILAG III
10 1.
ARCOXIA (se Bilag I) 30 mg filmovertrukne tabletter ARCOXIA (se Bilag I) 60 mg filmovertrukne tabletter ARCOXIA (se Bilag I) 90 mg filmovertrukne tabletter ARCOXIA (se Bilag I) 120 mg filmovertrukne tabletter
< ARCOXIA (see Annex 1) > 30 mg film-coated tablets< ARCOXIA (see Annex 1) > 60 mg film-coated tablets< ARCOXIA (see Annex 1) > 90 mg film-coated tablets < ARCOXIA (see Annex 1) > 120 mg film-coated tablets [See Annex 1- To be completed nationally]
5, 6 mg lactose
30 mg: lactose 1.4 mg 60 mg: lactose 2.8 mg 90 mg: lactose 4.2 mg 120 mg: lactose 5.6 mg
30 mg tablet:
30 mg Tablets:
Blågrøn, æbleformet, bikonveks tablet med "101" præget på den ene side og "ACX 30" på den anden side.
Blue-green, apple-shaped biconvex tablets< debossed ‘101’ on one side and ‘ACX 30’ on the other side >.
60 mg tablet:
60 mg Tablets:
Mørkegrøn, æbleformet, bikonveks tablet med ” 200 ” præget på den ene side og ” ARCOXIA 60 ” på den anden side.
Dark green, apple-shaped, biconvex tablets< debossed ‘200’ on one side and ‘ARCOXIA 60’ on the other side >.
90 mg tablet:
90 mg Tablets:
Hvid, æbleformet, bikonveks tablet med ” 202 ” præget på den ene side og ” ARCOXIA 90 ” på den anden side.
White, apple-shaped, biconvex tablets< debossed ‘202’ on one side and ‘ARCOXIA 90’ on the other side >.
120 mg tablet:
120 mg Tablets:
Lysegrøn, æbleformet, bikonveks tablet med ” 204 ” præget på den ene side og ” ARCOXIA 120 ” på den anden side.
Pale-green, apple-shaped, biconvex tablets< debossed ‘204’ on one side and ‘ARCOXIA 120’ on the other side >.
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, 4.4).
ARCOXIA administreres oralt og kan tages med eller uden mad.
< ARCOXIA > is administered orally and may be taken with or without food.
Virkningen af lægemidlet kan indtræde hurtigere når ARCOXIA administreres uden mad.
The onset of the effect of the medicinal product may be faster when< ARCOXIA > is administered without food.
Da de kardiovaskulære risici ved anvendelse af etoricoxib kan øges med dosis og behandlingsvarighed, bør den kortest mulige behandlingstid og den laveste effektive daglige dosis
11 As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
4. 3, 4. 4, 4. 8 og 5. 1).
The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).
Osteoarthrose Anbefalet dosis er 30 mg én gang dagligt.
Osteoarthritis The recommended dose is 30 mg once daily.
Rheumatoid arthritis Anbefalet dosis er 90 mg én gang dagligt.
Rheumatoid arthritis The recommended dose is 90 mg once daily.
Akut arthritis urica Anbefalet dosis er 120 mg én gang dagligt.
Acute gouty arthritis The recommended dose is 120 mg once daily.
Ankylosis spondylitis Anbefalet dosis er 90 mg én gang dagligt.
Ankylosing spondylitis The recommended dose is 90 mg once daily.
Doser, der er højere end de anbefalede for hver indikation, har enten ikke vist yderligere effekt eller er ikke undersøgt.
Therefore:
Dosis ved akut arthritis urica bør ikke overstige 120 mg dagligt, og behandlingen bør begrænses til at vare i højst 8 dage.
The dose for OA should not exceed 60 mg daily The dose for RA and ankylosing spondylitis should not exceed 90 mg daily The dose for acute gout should not exceed 120 mg daily, limited to a maximum of 8 days treatment.
Justering af dosis er ikke nødvendig til ældre patienter.
Elderly No dosage adjustment is necessary for elderly patients.
4. 4).
As with other drugs, caution should be exercised in elderly patients (see section 4.4).
Hos patienter med mild leverdysfunktion (Child- Pugh score 5- 6) bør dosis på 60 mg én gang dagligt ikke overskrides uanset indikationen.
Hepatic insufficiency Regardless of indication, in patients with mild hepatic dysfunction (Child-Pugh score 5-6) a dose of 60 mg once daily should not be exceeded.
Hos patienter med moderat leverdysfunktion (Child- Pugh score 7- 9) bør dosis på 60 mg hver anden dag ikke overskrides uanset indikationen; administration af 30 mg én gang dagligt kan også overvejes.
In patients with moderate hepatic dysfunction (Child-Pugh score 7-9), regardless of indication, the dose of 60 mg every other day should not be exceeded; administration of 30 mg once daily can also be considered.
4. 3, 4. 4, og 5. 2).
There is no clinical experience in patients with severe hepatic dysfunction (Child-Pugh score ≥ 10); therefore, its use is contra-indicated in these patients (see sections 4.3, 4.4 and 5.2).
5. 2).
Renal insufficiency No dosage adjustment is necessary for patients with creatinine clearance ≥ 30 ml/ min (see section 5.2).
4. 3 og 4. 4).
The use of etoricoxib in patients with creatinine clearance < 30 ml/ min is contra-indicated (see sections 4.3 and 4.4).
4. 3).
Paediatric patients Etoricoxib is contra-indicated in children and adolescents under 16 years of age (see section 4.3).
6. 1). Aktivt peptisk ulcus eller gastrointestinal (GI) blødning.
Active peptic ulceration or active gastro-intestinal (GI) bleeding.
Patienter som tidligere har haft bronchospasmer, akut rhinitis, nasale polypper, angioneurotisk ødem, urticaria eller anden type allergisk reaktion efter at have taget acetylsalicylsyre eller NSAIDherunder COX- 2 (cyclooxygenase- 2) hæmmere.
12 Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
4. 6 og 5. 3).
Pregnancy and lactation (see sections 4.6 and 5.3).
Svær leverdysfunktion (serumalbumin < 25 g/ l eller Child Pugh score ≥ 10).
Severe hepatic dysfunction (serum albumin < 25 g/ l or Child-Pugh score ≥ 10).
14 Anslået creatininclearance < 30 ml/ min.
Estimated renal creatinine clearance < 30 ml/ min.
Patienter med hypertension, hvor blodtrykket er vedvarende forhøjet over 140/ 90mmHg og ikke er tilfredsstillende kontrolleret.
Patients with hypertension whose blood pressure is persistently elevated above 140/ 90mmHg and has not been adequately controlled.
Konstateret iskæmisk hjertesygdom, perifer arteriel sygdom og/ eller cerebrovaskulær sygdom.
Established ischaemic heart disease, peripheral arterial disease, and/ or cerebrovascular disease.
Gastrointestinal effekt Der er set øvre gastrointestinale komplikationer [perforation, ulcera eller blødninger (PUB)], nogle med fatal udgang hos patienter behandlet med etoricoxib.
Gastrointestinal effects Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with etoricoxib.
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 acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.
5. 1).
NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section 5.1).
Kardiovaskulær effekt Kliniske undersøgelser tyder på, at gruppen af selektive COX- 2 hæmmere kan være forbundet med risiko for thrombotiske hændelser (specielt myokardieinfarkt (MI) og apopleksi) i forhold til placebo og nogle NSAID.
Cardiovascular effects 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 NSAIDs.