natgillin/translations-raw huggingface dataset:
Sandoz GmbH Biochemiestrasse 10 A- 6250 Kundl Østrig Hvis du vil have yderligere oplysninger om Omnitrope, skal du henvende dig til den lokale repræsentant:
Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria
10 A- 6250 Kundl Austria Tel. + 43 - (0) 5338 2000
10 A-6250 Kundl Austria Tel: + 43-(0)5338 2000
Veluwezoom 22 NL- 1327 AH Almere Tel. + 31 36 52 41 600
Veluwezoom 22 NL-1327 AH Almere Tel: + 31 36 52 41 600
11 D- 83607 Holzkirchen Tel. + 49 (0) 8024 902 40 00 E- Mail: info@ sandoz. de
11 D-83607 Holzkirchen Tel: + 49 (0)8024 902 40 00 E-Mail: info@sandoz. de
86 Eesti Österreich Sandoz d. d.
86 Eesti Österreich Sandoz d. d.
Eesti filiaal Pärnu mnt 105 EE - 11312 Talinn Tel: +372 665 2400
Eesti filiaal Pärnu mnt 105 EE - 11312 Tallinn Tel: +372 665 2400
10 A- 6250 Kundl Tel. + 43 - (0) 5338 2000
10 A-6250 Kundl Tel: + 43-(0)5338 2000
Domaniewska 50 C PL- 02 672 Warszawa Tel. + 48- 22 549 15 00
Domaniewska 50 C PL – 02 672 Warszawa Tel.: + 48-22 549 15 00
Verovškova 57 SI- 1526 Ljubljana Slovenia Tel: + 386 (0) 1 580 21 11
Verovš kova 57 SI-1526 Ljubljana Tel: + 386 (0)1 580 21 11
Boccioni, 1 I- 21040 Origgio (Va) Tel: + 39 2 96541
Boccioni, 1 I-21040 Origgio (Va) Tel: + 39 02 96541
Suomi/ Finland Sandoz Oy Ab / Marketing Rajatorpantie 41 B FIN- 01640 Vantaa Puh/ Tel: + 358 9 85 20 20 30
Suomi/ Finland Sandoz Oy Ab Rajatorpantie 41 B FIN-01640 Vantaa Puh/ Tel: + 358 9 85 20 20 30
87 Latvija Sandoz d. d.
87 Latvija Sandoz d. d.
United Kingdom Sandoz Limited 37, Woolmer Way Bordon, Hants GU35 9QE - UK Tel: + 44 1420 478 301
United Kingdom Sandoz Limited 37, Woolmer Way Bordon, Hants GU35 9QE – UK Tel: + 44 1420 478 301
Du kan finde yderligere information om Omnitrope på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
(small for gestational age (SGA)), som ikke har indhentet den forventede vækst ved 4 - års alderen eller senere
who failed to show catch-up growth by 4 years of age or later.
Hvis akut kritisk sygdom forekommer, skal din læge nøje overveje sikkerheden ved at fortsætte somatropinbehandlingen
If acute critical illness occurs, your doctor will have to carefully evaluate the safety of continuing somatropin treatment.
91 3.
3.
Omnitrope 6, 7 mg/ ml er beregnet til flergangsbrug.
Omnitrope 6.7 mg/ ml is intended for multiple use.
Det bør kun gives med Omnitrope Pen 10, en injektionsanordning som specifikt er udviklet til brug sammen med Omnitrope 6, 7 mg/ ml injektionsvæske, opløsning.
It should only be administered with the Omnitrope Pen 10, an injection device specifically developed for use with Omnitrope 6.7 mg/ ml solution for injection.
Hvor ofte skal du tage Omnitrope og hvor meget
How much and how often to use Omnitrope
Tilpasning af dosis kan med tiden være nødvendig afhængigt af din vægtforøgelse og respons på behandlingen.
91 Dose adjustments may be required over time, depending on your increase in body weight and response.
Hvordan du injicerer Omnitrope 6, 7 mg/ ml
How to inject Omnitrope 6.7 mg/ ml
Den følgende instruktion forklarer, hvordan du selv injicerer Omnitrope 6, 7 mg/ ml.
The following instructions explain how to inject Omnitrope 6.7 mg/ ml yourself.
92 Forberedelse Du skal bruge nedenstående, før du begynder:
Preparation Collect necessary items before you begin:
- En cylinderampul med Omnitrope 6, 7 mg/ ml injektionsvæske,
- a cartridge with Omnitrope 6.7 mg/ ml solution for injection.
- Omnitrope Pen 10, en injektionsanordning specielt udviklet til brug
- the Omnitrope Pen 10, an injection device specifically developed
Se instruktioner for brug, som leveres med Omnitrope Pen 10).
for use with Omnitrope 6.7 mg/ ml solution for injection (not supplied in the pack; see Instructions for Use provided with the Omnitrope Pen 10).
- Opløsningen skal være klar, når den tages ud af køleskabet.
Do
Hvis du holder op med at tage Omnitrope
If you stop using Omnitrope
93 Spørg lægen til råds, hvis du oplever nogen af symptomerne beskrevet i nedenstående.
93 General disorders and reactions at the injection site
94 Nervesystemet
94 Nervous system
Aktivt stof: somatroptin (6, 7 mg/ ml) i en cylinderampul.
The active substance of Omnitrope is somatropin (6.7 mg/ ml) in a cartridge.
En cylinderampul indeholder 10, 0 mg (svarende til 30 IU) somatropin i 1, 5 ml.
One cartridge contains 10.0 mg (corresponding to 30 IU) of somatropin in 1.5 ml.
Øvrige indholdsstoffer: dinatriumhydrogenphosphatheptahydrat natriumdihydrogenhosphatdihydrat
The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine
95 glycin poloxamer 188 phenol vand til injektionsvæske
95 poloxamer 188 phenol water for injections.
Omnitrope er en klar og farveløs opløsning.
Omnitrope is a clear and colourless solution.
96 Eesti Österreich Sandoz d. d.
96 Eesti Österreich Sandoz d. d.
Domaniewska 50 C PL – 02- 672 Warszawa Tel.: + 48- 22 549 15 00
Domaniewska 50 C PL – 02 672 Warszawa Tel.: + 48-22 549 15 00
97 Latvija Sandoz d. d.
97 Latvija Sandoz d. d.
Onsenal bruges til at reducere antallet af polypper hos patienter med familiær adenomatøs polypose (FAP).
Onsenal is used to reduce the number of polyps in patients with familial adenomatous polyposis (FAP).
FAP er en genetisk sygdom, der forårsager adenomatøse polypper i tarmen, dvs. udvækster på indersiden af tyktarmen eller endetarmen.
This is a genetic disease that causes ‘ adenomatous intestinal polyps’, growths that project from the lining of the large intestine or rectum.
Onsenal bruges som et supplement til kirurgi (til at fjerne polypperne) og endoskopisk kontrol, hvor lægen anvender et endoskop, som er et tyndt rør, til at se ind i tarmen og derved kontrollere, om polypperne udvikler sig.
Onsenal is used in addition to surgery (to remove the polyps) and endoscopic monitoring (to check if polyps are developing, using an endoscope, a thin tube that allows a doctor to look inside the gut).
Da der kun findes et lille antal patienter med FAP, anses sygdommen for at være sjælden, og Onsenal blev udpeget som lægemiddel til sjældne sygdomme den 20. november 2001.
Because the number of patients with FAP is low, the disease is considered ‘ rare’, and Onsenal was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 20 November 2001.
Den normale behandling af FAP- patienter skal fortsættes.
The usual medical care for FAP patients should be continued.
Patienter med moderat leversygdom skal have halv dosis Onsenal og anvendes med forsigtighed hos patienter, som har let eller moderat nyresygdom.
In patients with moderate liver disease, the dose of Onsenal should be halved, and it should be used with caution in patients with mild or moderate kidney problems.
Onsenal må ikke anvendes til patienter, som har svær lever - eller nyresygdom.
Onsenal must not be given to patients with severe liver or kidney problems.
Det bør anvendes med forsigtighed, om muligt med en lavere startdosis hos patienter, hvis krop er længere om at nedbryde Onsenal.
It should be used with caution, possibly with a lower starting dose, in patients whose bodies may break Onsenal down slowly.
Der bør udvises særlig forsigtighed, når lægemidlet bruges til ældre.
Special care should be taken when it is used in the elderly.
Det aktive stof i Onsenal, celecoxib, er et ” nonsteroidt antiinflammatorisk lægemiddel ” (NSAID), der hører til gruppen af lægemidler kaldet cyklooxygenase- 2 (COX- 2) - hæmmere.
The active substance in Onsenal, celecoxib, is a ‘ non-steroidal anti-inflammatory drug’ (NSAID) that belongs to the group ‘ cyclo-oxygenase-2 (COX-2) inhibitors’.
Det blokerer COX- 2 - enzymet og hæmmer derved produktionen af prostaglandiner, der medvirker i processer såsom betændelsesreaktioner og aktiviteten i glat muskulatur (muskler, der udfører automatisk arbejde som f. eks. åbning og lukning af blodkar).
COX-2 is found at high levels in adenomatous colorectal polyps.
Onsenal blev undersøgt i en hovedundersøgelse med 83 voksne FAP- patienter, hvor virkningen af to doser Onsenal blev sammenlignet med virkningen af placebo (en uvirksom behandling).
Onsenal has been studied in one main study involving 83 adults with FAP, in which the effectiveness of two doses of Onsenal was compared with that of placebo (a dummy treatment).
I undersøgelsen var tyktarmen intakt hos 25 patienter, men den øvrige del af patienterne havde fået fjernet tyktarmen helt eller delvist ved kirurgisk indgreb.
In the study, 25 patients had an intact colon (lower gut), but the remainder had had some or all of their colon removed through surgery.
Det primære mål for virkning var en reduktion i antallet af polypper i et afgrænset område af tyktarms - eller endetarmsvæggen efter seks måneders behandling.
The main measure of effectiveness was the reduction in the number of polyps in a defined area of the colon or rectum wall after six months of treatment.
Desuden så en undersøgelse nærmere på virkningerne af Onsenal hos 18 børn med FAP
An additional study looked at the effects of Onsenal in 18 children with FAP.
Hos voksne havde Onsenal reduceret det gennemsnitlige antal polypper med 28% efter seks måneder, mens antallet faldt med 5% hos patienter, der fik placebo.
In adults, Onsenal had reduced the average number of polyps by 28% after six months, while the number fell by 5% in the patients taking placebo.
Onsenal mindskede også antallet af polypper hos børn med FAP
Onsenal also reduced the number of polyps in children with FAP.
De mest almindelige bivirkninger ved behandlingen med Onsenal (som kunne observeres hos mere end 1 af 10 patienter) er forhøjet blodtryk og diarré.
The most common side effects with Onsenal (seen in more than 1 patient in 10) are hypertension (high blood pressure) and diarrhoea.
Patienter, der kan være overfølsomme over for celecoxib, et af indholdsstofferne eller sulfonamider (f. eks. antibiotika), bør ikke anvende Onsenal.
Onsenal should not be used in people who may be hypersensitive (allergic) to celecoxib, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Lægemidlet må ikke anvendes til patienter, som har aktive sår eller blødninger i mave eller tarm, eller til patienter, som har haft overfølsomhedslignende reaktioner, efter at de har taget aspirin eller et nonsteroidt antiinflammatorisk lægemiddel, herunder en anden COX- 2- hæmmer.
It must not be used in patients who have an active ulcer or bleeding in the stomach or gut, or in patients who have had allergic-type reactions after taking aspirin or an NSAID, including another COX-2 inhibitor.
Det må desuden ikke gives til patienter, der har svære lever - eller nyresygdomme, patienter med sygdomme, der forårsager betændelse i tarmen, eller patienter med visse problemer, der påvirker hjertet eller blodkarrene.
It must not be given to patients with severe liver or kidney disease, patients with a disease causing inflammation of the bowel, or patients with certain problems affecting the heart or blood vessels.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Onsenal opvejer risiciene i forbindelse med reduktion af antallet af adenomatøse tarmpolypper ved FAP, når Onsenal bruges som tillæg til kirurgisk indgreb og anden endoskopisk overvågning.
The Committee for Medicinal Products for Human Use (CHMP) decided that Onsenal’ s benefits are greater than its risks for the reduction of the number of adenomatous intestinal polyps in FAP as an adjunct to surgery and further endoscopic surveillance.
Udvalget bemærkede, at der i forbindelse med det lavere antal polypper efter behandling med Onsenal ikke er påvist nogen effekt på risikoen for udvikling af kræft i tarmen.
The Committee noted that no effect of the reduced number of polyps caused by Onsenal on the risk of developing cancer of the intestine had been shown.
Onsenal er blevet godkendt under ‘ særlige omstændigheder ’.
Onsenal has been authorised under ‘ Exceptional Circumstances’.
Hvert år gennemgår Det Europæiske Lægemiddelagentur (EMEA) alle nye oplysninger, der måtte være tilgængelige, og opdaterer om nødvendigt dette sammendrag.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Virksomheden, der fremstiller Onsenal, skal foretage en undersøgelse af patienter med FAP for at samle yderligere oplysninger om lægemidlets sikkerhed og virkning.
The company that makes Onsenal will carry out a study in patients with FAP, in order to collect more information on the medicine ’ s safety and effectiveness.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Onsenal den 17. oktober 2003.
The European Commission granted a marketing authorisation valid throughout the European Union for Onsenal on 17 October 2003.
Indehaveren af markedsføringstilladelse er Pfizer Limited.
The marketing authorisation holder is Pfizer Limited.
Markedsføringstilladelsen blev fornyet den 17. oktober 2008.
The marketing authorisation was renewed on 17 October 2008.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Onsenal som lægemiddel til sjældne sygdomme findes her.
The summary of opinion of the Committee for Orphan Medicinal Products for Onsenal is available here.
2/ 3 Dette sammendrag blev sidst ajourført i 02- 2009.
This summary was last updated in 02-2009.
EU/ 1/ 03/ 259/ 001
Route of administration
Onsenal
Packaging
Hårde kapsler
Package size
EU/ 1/ 03/ 259/ 002
EU/ 1/ 03/ 259/ 001 EU/ 1/ 03/ 259/ 002 EU/ 1/ 03/ 259/ 003 EU/ 1/ 03/ 259/ 004 EU/ 1/ 03/ 259/ 005 EU/ 1/ 03/ 259/ 006
Onsenal
Onsenal Onsenal Onsenal Onsenal Onsenal Onsenal
200 mg
200 mg 200 mg 200 mg 200 mg 400 mg 400 mg
Blisterpakning (PVC/ Aclar/ Alu) uigennemsigtig
Hard capsules Hard capsules Hard capsules Hard capsules Hard capsules Hard capsules
Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use
Blisterpakning (PVC/ Aclar/ Alu) klar
Blister (PVC/ Aclar/ Alu) clear Blister (PVC/ Aclar/ Alu) opaque Blister (PVC/ Aclar/ Alu) clear Blister (PVC/ Aclar/ Alu) opaque Blister (PVC/ Alu) Blister (PVC/ Alu)
Blisterpakning (PVC/ Aclar/ Alu) uigennemsigtig
10 capsules 10 capsules 60 capsules 60 capsules 10 capsules 60 capsules
Hjælpestoffer: lactosemonohydrat 49, 8 mg.
Excipients:
6. 1.
Lactose Monohydrate 49.8 mgFor a full list of excipients, see section 6.1.
4. 4).
Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4).
4. 4 og 5. 1).
The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)
Anbefalet oral dosis er 2 kapsler à 200 mg 2 gange dagligt i forbindelse med et måltid (se pkt.
The recommended oral dose is two 200 mg capsules twice per day, taken with food (see section 5.2).
Sædvanlig medicinsk behandling af FAP- patienter bør fortsættes under behandlingen med celecoxib.
Usual medical care for FAP patients should be continued while on celecoxib.
4. 3 og 5. 2).
In patients with moderate hepatic impairment (serum albumin of 25-35 g/ l), the daily recommended dose of celecoxib should be reduced by 50% (see sections 4.3 and 5.2).
4. 3, 4. 4 og 5. 2).
Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution (see sections 4.3, 4.4 and 5.2).
5. 1).
Experience with celecoxib in FAP patients below the age of 18 years is limited to a single pilot study in a very small population, in which patients were treated with celecoxib at doses up to 16 mg/ kg daily, which corresponds to the recommended adult FAP dose of 800 mg daily (see section 5.1).
Personer med nedsat CYP2C9- metabolisering:
CYP2C9 Poor Metabolizers:
Patienter med kendt eller formodet nedsat CYP2C9 - metabolisering baseret på genotyper eller tidligere anamnese/ erfaring med andre CYP2C9- substrater bør behandles med forsigtighed med celecoxib på grund af øget risiko for dosisafhængige bivirkninger.
Patients who are known or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/ experience with other CYP2C9 substrates should be administered celecoxib with caution, as the risk of dose-dependent adverse effects is increased.
5. 2).
Consider starting treatment at a reduced dose (see section 5.2).
Dosis til ældre FAP- patienter er ikke fastlagt.
The dose for elderly FAP patients has not been established.
5. 2).
Special care should be used in such patients (see section 5.2).
4. 6 og 5. 3). • Svær leverdysfunktion (serumalbumin < 25 g/ l eller Child- Pugh score > 10) (klasse C). • Patienter med nyreinsufficiens med estimeret kreatinclearance < 30 ml/ min. • Inflammatorisk tarmsygdom. • Kronisk venstresidig hjerteinsufficiens (NYHA II- IV). • Konstateret iskæmisk hjertesygdom, perifer arteriel sygdom og/ eller cerebrovaskulær sygdom.
2 • Hypersensitivity to the active substance or to any of the excipients (see section 6.1). • Known hypersensitivity to sulphonamides. • Active peptic ulceration or gastrointestinal (GI) bleeding. • Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or non steroidal anti-inflammatory drugs (NSAIDs) including COX-2 (cyclooxigenase-2) selective inhibitors. • In pregnancy and in women who can become pregnant unless using an effective method of contraception (see sections 4.5, 4.6 and 5.3) • Breast feeding (see sections 4.6 and 5.3) • Severe hepatic dysfunction (serum albumin< 25 g/l or Child-Pugh score > 10) (Class C). • Patients with renal insufficiency with estimated creatinine clearance < 30 ml/ min. • Inflammatory bowel disease. • Congestive heart failure (NYHA II-IV). • Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
Behandling med celecoxib hos FAP- patienter er blevet fulgt i op til 6 måneder og har ikke vist, at risikoen for gastrointestinal cancer, andre former for cancer eller behovet for kirurgi nedsættes.
Treatment with celecoxib in FAP has been studied for up to 6 months and has not been shown to reduce the risk of gastrointestinal or other form of cancer or the need for surgery.
Den sædvanlige behandling af FAP- patienter bør derfor ikke ændres på grund af den samtidige administration af celecoxib.
Therefore, the usual care of FAP patients should not be altered because of the concurrent administration of celecoxib.
Især bør hyppigheden af rutinemæssig endoskopisk kontrol ikke reduceres, og FAP- relateret kirurgi bør ikke udsættes.
In particular, the frequency of routine endoscopic surveillance should not be decreased and FAP-related surgery should not be delayed.
Gastrointestinale lidelser Der er set øvre gastrointestinale komplikationer [perforationer, ulcera og blødninger (PUBs)], nogle med fatal udgang, hos patienter behandlet med celecoxib.
Gastro-intestinal disorder Upper gastrointestinal complications [perforations, ulcers or bleeds (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with celecoxib.
Der bør udvises forsigtighed ved behandling af patienter, der har den største risiko for at udvikle gastrointestinale komplikationer i forbindelse med NSAID- præparater: ældre, patienter, som får andre NSAID- præparater eller acetylsalicylsyre samtidig, eller patienter, der tidligere har haft en gastrointestinal sygdom, 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.
Der ikke blevet fastslået nogen signifikant forskel i den gastrointestinale sikkerhed mellem selektive COX- 2- hæmmere + acetylsalicylsyre vs.
A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs.
Samtidig behandling med celecoxib og et ikke- acetylsalicylsyreholdigt NSAID bør undgås.
NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see 5.1). The concomitant use of celecoxib and a non-aspirin NSAID should be avoided.
FAP- patienter med en ileorektal anastomose eller ileorektal pouch analanastomose kan udvikle anastomotiske ulcerationer.
FAP patients carrying an ileorectal anastomosis or ileo pouch-anal anastomosis can develop anastomotic ulcerations.
5. 1).
Blood and lymphatic system disorder / Cardio-vascular disorder Increased number of serious cardiovascular events, mainly myocardial infarction, has been found in a long- term placebo-controlled study in subjects with sporadic adenomatous polyps treated with celecoxib at doses of 200 mg BID and 400 mg BID compared to placebo (see section 5.1).
4. 2, 4. 3, 4. 8 og 5. 1).
As the cardiovascular risks of celecoxib were increased with the 400 mg twice daily dose in the APC trial (section 5.1), the response of the FAP patient to celecoxib should be re-examined periodically in order to avoid unnecessary exposure in FAP patients for whom celecoxib is not effective (sections 4.2, 4.3, 4.8 and 5.1)
5. 1).
Patients with significant risk factors for cardiovascular events (e. g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with celecoxib after careful consideration (see section 5.1).
Selektive COX- 2- hæmmere kan ikke erstatte acetylsalicylsyre som profylakse ved kardiovaskulær tromboembolisk sygdom på grund af manglende effekt på blodpladefunktionen.
3 COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effect.
Derfor bør celecoxib anvendes med forsigtighed til patienter, der tidligere har haft hjertesvigt, venstre ventrikulær dysfunktion eller hypertension og hos patienter med kendt ødem af anden årsag, da prostaglandin- hæmning kan medføre en forværring af nyrefunktion og væskeretention.
Therefore, celecoxib 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, since prostaglandin inhibition may result in deterioration of renal function and fluid retention.
Forsigtighed bør også udvises hos patienter, som er i diuretika- behandling, eller som på anden måde har risiko for hypovolæmi.
Caution is also required in patients taking diuretic treatment or otherwise at risk of hypovolaemia.
Ældre har hyppigere nedsat nyre - og leverfunktion og især nedsat hjertefunktion, og patienterne bør derfor kontrolleres løbende.
Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically appropriate supervision should be maintained.
Nyre - og leverlidelser NSAID, herunder celecoxib, kan forårsage nyretoksicitet.
Renal and hepatic disorders NSAIDs, including celecoxib, may cause renal toxicity.
4. 2 og 5. 2).
Experience with celecoxib in patients with mild or moderate renal or hepatic impairment is limited, therefore such patients should be treated with caution (see sections 4.2 and 5.2).
Hudreaktioner I forbindelse med brugen af celecoxib er der meget sjældent indberettet alvorlige hudreaktioner, nogle fatale, inklusive dermatitis exfoliativa, Stevens- Johnsons syndrom, og toksisk epidermal nekrolyse (se pkt.
Skin Reactions Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of celecoxib (see section 4.8).
4. 8).
Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib (see section 4.8).
4. 3).
Patients with a history of sulphonamide allergy or any drug allergy may be at greater risk of serious skin reactions or hypersensitivity reactions (see section 4.3).
5. 2).
Other Patients known to be CYP2C9 poor metabolisers should be treated with caution (see section 5.2).