natgillin/translations-raw huggingface dataset:
− CHMP var enigt om, at der ikke var behov for begrænsninger for formuleringer til lokal anvendelse af piroxicam, og at benefit/risk-forholdet fortsat er gunstigt anbefalede CHMP følgelig opretholdelse af markedsføringstilladelserne for alle de i bilag I til udtalelsen omhandlede produkter og ændring af de pågældende afsnit af produktresuméet og indlægssedlen for systemiske formuleringer af piroxicam, således som disse fremgår af bilag III til udtalelsen i overensstemmelse med artikel 31, stk. 2, i direktiv 2001/83/EF, med senere ændringer.
As a consequence, the CHMP has recommended to maintain the Marketing Authorisations for all medicinal products referred to in Annex I of the Opinion and to amend the relevant sections of the Summary of Product Characteristics and Package Leaflet of systemic formulations of piroxicam, as set out in Annex III of the Opinion in accordance with Article 31(2) of Directive 2001/83/EC, as amended.
Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB Storbritannien
United Kingdom Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB United Kingdom
Ved gennemgangen fandtes de begrænsede epidemiologiske data og oplysninger om spontane bivirkningsindberetninger at pege på, at der er større risiko for gastrointestinale reaktioner og hudreaktioner (herunder livstruende bulløse reaktioner) end for andre ikke-selektive NSAID.
The review found that limited epidemiological data and spontaneous adverse drug reaction data provided a signal of increased risk of gastrointestinal and skin reactions (including life-threatening bullous reactions) relative to other nonselective NSAIDs.
ÆNDRINGER, DER SKAL INKLUDERES I RELEVANTE AFSNIT I PRODUKTRESUMEET FOR SYSTEMISKE LÆGEMIDDELFORMULERINGER, DER INDEHOLDER PIROXICAM
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR SYSTEMIC FORMULATIONS OF PIROXICAM CONTAINING MEDICINAL PRODUCTS
20 mg/sup Suppositorier
20 mg/sup Suppository
Kapsler, hårde
Capsule, hard
Som for andre NSAID-præparater skal brug af piroxicam sammen med acetylsalicylsyre eller samtidig brug med andre NSAID-præparater, herunder andre piroxicam-formuleringer undgås, da det ikke er tilstrækkeligt bevist, at kombinationsbehandling giver bedre resultat end piroxicam alene, og der er øget risiko for bivirkninger (se pkt.
“As with other NSAIDs, the use of piroxicam together with acetyl-salicylic acid or concomitant use with other NSAIDs, including other piroxicam formulations, must be avoided, since data are inadequate to show that such combinations produce greater improvement than that achieved with piroxicam alone; moreover, the potential for adverse reactions is enhanced (see section 4.4).
Peristeri 12134 Grækenland
Peristeri 12134 Greece
Alvorlige gastrointestinale komplikationer
Serious GI Complications
Patienter med signifikante risikofaktorer for alvorlige gastrointestinale bivirkninger bør kun behandles med piroxicam efter omhyggelig overvejelse (se pkt.
Patients with significant risk factors for serious GI events should be treated with piroxicam only after careful consideration (See sections 4.3 and below).
Via Felice Casati, 16 20124 Milano Italien
Via Felice Casati, 16 20124 Milano Italy
D-89070 Ulm Tyskland
D-89070 Ulm Germany
Merck Generiques 34, Rue Saint-Romain, 69359 Lyon Cedex 08 Frankrig
Merck Generiques 34, Rue Saint-Romain, 69359 Lyon Cedex 08 France
15, Boulevard Charles De Gaulle 92707 Colombes Cedex Frankrig
15, Boulevard Charles De Gaulle 92707 Colombes Cedex France
Nycomed Belgium S.A. 615, Chaussee De Gand B-1080 Bruxelles Belgien
Nycomed Belgium S.A. 615, Chaussee De Gand B-1080 Bruxelles Belgium
DEMO ABEE 21st Km National Road Athens-Lamia 14565 Grækenland
DEMO ABEE 21st Km National Road Athens-Lamia 14565 Greece
Lægen vil regelmæssigt kontrollere Dem, og vil fortælle Dem, hvor ofte De skal komme til kontrol, når De tager piroxicam.
Your doctor may need to give you check-ups and will tell you how often you need to be checked, due to your taking piroxicam.
Tablet
Tableta
• Patienter, der tidligere har haft alvorlige allergiske lægemiddelreaktioner af enhver type, især kutanreaktioner såsom erythema multiforme, Stevens-Johnsons syndrom, toksisk epidermal nekrolyse.
• History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
ÆNDRINGER, DER SKAL INKLUDERES I RELEVANTE AFSNIT I INDLÆGSSEDLEN FOR SYSTEMISKE LÆGEMIDDELFORMULERINGER, DER INDEHOLDER PIROXICAM
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLETFOR SYSTEMIC FORMULATIONS OF PIROXICAM CONTAINING MEDICINAL PRODUCTS
Merck Dura Gmbh Alsfelder Str. 19 D-64289 Darmstadt Tyskland
Merck Dura Gmbh Alsfelder Str. 19 D-64289 Darmstadt Germany
Sint Lenaartseweg 48/4 B-2320 Hoogstraten Belgien
Kela Laboratoria N.V. Sint Lenaartseweg 48/4 B-2320 Hoogstraten Belgium
Acharnai Attiki 13671 Grækenland
Acharnai Attiki 13671 Greece
− i produktresuméet og indlægssedlen er tilføjet nye kontraindikationer og skærpede advarsler, der begrænser eksponeringen af patienter med risikofaktorer for gastrointestinale reaktioner og hudreaktioner,
− new contraindications and strengthened warnings have been added to the Summary of Product characteristics and Package Leaflet in order to limit exposure of piroxicam to those patients without risk factors for gastrointestinal and skin reactions;
20144 Milano Italien
20144 Milano Italy
Hvis De er over 70 år, eller De tager anden medicin, såsom binyrebarkhormoner eller visse typer medicin mod depression, de såkaldte selektive serotoningenoptagshæmmere (SSRI) eller medicin, der forhindrer blodpropper, såsom acetylsalicylsyre, kan lægen give Dem [Særnavn] sammen med anden medicin for at beskytte maven og tarmene.
If you are over 70 years old, or you are taking other medicines like corticosteroids or certain drugs for depression called selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid to prevent blood clotting, your doctor may like to prescribe you together with [Invented name] a medicine for protecting your stomach and intestines.
Pallini Attiki 15351 Grækenland
Pallini Attiki 15351 Greece
3640 Ae Mijdrecht Holland
3640 Ae Mijdrecht The Netherlands
Da piroxicam har vist sig at være forbundet med stor risiko for gastrointestinale komplikationer, bør kombinationsbehandling med slimhindebeskyttende midler (f.eks. misoprostol eller protonpumpehæmmere) overvejes, især til ældre patienter.”
Given that piroxicam has been shown to be associated with an increased risk of gastrointestinal complications, the possible need for combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients.”
Disse nøgleelementer blev gjort offentligt tilgængelige på EMEA's website i september 2006 (ref.dok: EMEA/CHMP/381615/2006).
These key elements were published on the EMEA website (Doc ref: EMEA/CHMP/343456/2005).
Postoperative smerter
Post-operative pain
Patienter, der samtidig bruger orale kortikosteroider, selektive serotoningenoptagshæmmere (SSRI), eller trombocythæmmende midler som lave doser acetylsalicylsyre, har en øget risiko for gastrointestinale komplikationer (se nedenfor og pkt.
Patients taking concomitant oral corticosteroids, selective serotonin reuptake inhibitors (SSRIs) or anti-platelet agents such as low-dose acetylsalicylic acid are at increased risk of serious GI complications (see below and section 4.5).
Tillomed Laboratories Limited 3 Howard Road, Eaton Socon St. Neots, Cambs PE19 3ET Storbritannien
United Kingdom Tillomed Laboratories Limited 3 Howard Road, Eaton Socon St. Neots, Cambs PE19 3ET United Kingdom
Akut gigt
Acute Gout
Abz-Pharma Gmbh Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren Tyskland
Abz-Pharma Gmbh Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Estonien
Estonia
Kombinationsbehandling med gastroprotektive midler (f.eks. misoprostol eller syrepumpehæmmere) bør ligeledes overvejes for alle patienter, navnlig ældre.
Combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should also be carefully considered for all patients and in particular for the elderly.
Merck NM P.O.Box 23033 S-10435 Stockholm Sverige
Merck NM P.O.Box 23033 S-10435 Stockholm Sweden
5, Rue Charles Martigny, Bp 42, 94702 Maisons-Alfort Cedex Frankrig
5, Rue Charles Martigny, Bp 42, 94702 Maisons-Alfort Cedex
Gottlieb-Daimler-Strasse 19 891 50 Laichingen Tyskland
Gottlieb-Daimler-Strasse 19 891 50 Laichingen Germany
• hvis De tidligere har haft en alvorlig allergisk reaktion i forbindelse med brugen af piroxicam, andre NSAID og anden medicin, især alvorlige hudreaktioner (uanset sværhedsgrad), såsom eksfoliativ dermatitis (intens rødmen af huden med afskalning i skæl eller flager), dannelse af store og små blærer (Stevens-Johnsons syndrom, en tilstand med røde blærer, sårdannelse, blodig eller skorpet hud) og toksisk epidermal nekrolyse (en tilstand med blærer og afskalning af hudens øverste lag).
• If you previously had a serious allergic drug reaction to piroxicam, other NSAIDs and other medications, especially serious skin reactions (regardless of severity) such as exfoliative dermatitis (intense reddening of skin, with skin peeling off in scales or layers), vesiculo-bullous reactions (Stevens-Johnson syndrome, a condition with red blistered, eroded, bloody or crusted skin) and toxic epidermal necrolysis, (a disease with blistering and peeling of the top layer of skin).”
Den systemiske eksponering er væsentligt mindre ved lokal anvendelse end ved systemisk anvendelse af NSAID, hvorfor der forventes færre systemiske bivirkninger ved brug af formuleringer til lokal anvendelse.
The use of topical NSAIDs is accompanied by a markedly reduced systemic exposure compared to systemic dosing and therefore a lower rate of systemic adverse events is expected with use of topical formulations.
Piroxicam [Særnavn] bruges til at lindre visse symptomer, der er forårsaget af osteoarthritis (artrose, ledforandringer), reumatoid artritis (leddegigt) og ankyloserende spondylitis (gigt i ryghvirvlerne), såsom hævelse, stivhed og ledsmerter.
Piroxicam [Invented name] is used to relieve some symptoms caused by osteoarthritis (arthrosis, degenerative joint disease), rheumatoid arthritis and ankylosing spondylitis (rheumatism of the spine), such as swelling, stiffness and joint pain.
Str. Ziduri Intre Vii Nr.22 Sector 2, Bucurest Rumanien
S.C. Sintofarm S.A. Str. Ziduri Intre Vii Nr.22 Sector 2, Bucurest Romania
Hvis De glemmer at tage en dosis, skal De tage denne straks, De kommer i tanke om den, medmindre det er tid til næste dosis.
If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the correct time.
Ligesom for andre NSAID-præparater bør brugen af piroxicam i kombination med slimhindebeskyttende midler (f.eks. misoprostol eller protonpumpehæmmere) overvejes til disse risiko-patienter.
As with other NSAIDs, the use of piroxicam in combination with protective agents (e.g. misoprostol or proton pump inhibitors) must be considered for these atrisk patients.
Cephalon France 20, Rue Charles Martigny 94701 Maisons-Alfort Cedex Frankrig
Cephalon France 20, Rue Charles Martigny 94701 Maisons-Alfort Cedex France
Highfield, Cheadle Sk8 3gy Storbritannien
Highfield, Cheadle SK8 3GY
Laboratoires S.M.B S. S.A. Rue De La Pastorale 16/28 B-1080 Brussels Belgien
Laboratoires S.M.B S. S.A. Rue De La Pastorale 16/28 B-1080 Brussels Belgium
Industrieweg 23 Po Box 217, 3640 Ae Mijdrecht Holland
Po Box 217, 3640 Ae Mijdrecht The Netherlands
Smb Laboratories 26-28 Rue De La Pastorale B-1080 Bruxelles Belgien
Smb Laboratories 26-28 Rue De La Pastorale B-1080 Bruxelles Belgium
Samtidig brug af piroxicam med antikoagulantia bør undgås (se pkt.
Therefore, the use of piroxicam with concomitant anticoagulant such as warfarin should be avoided.
Sopharma Ad Iliensko Shose Str. 16 1220 Sofia Bulgarien
Sopharma Ad Iliensko Shose Str. 16 1220 Sofia Bulgaria
I produktresuméet og indlægssedlen er der tilføjet en række begrænsninger for brug, skærpede advarsler og kontraindikationer vedrørende den gastrointestinale sikkerhed og hudreaktioner.
A number of restrictions on use, strengthened warnings and contraindications have been added to the Summary Product Characteristics and Package Leaflet in relation to gastrointestinal and skin safety.
Både korttids-og langtidsbehandling med NSAID kan give en øget risiko for alvorlige gastrointestinale bivirkninger.
NSAID exposures of both short and long duration have an increased risk of serious GI event.
• Patienter med fortilfælde af gastrointestinale lidelser, der prædisponerer til blødningstilstande såsom colitis ulcerosa, Chrohns sygdom, gastrointestinal cancer eller diverculitis.
• Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers or diverticulitis.
Largo Boccioni, 1 21040 Origgio (Va) Italien
Sandoz S.P.A. Largo Boccioni, 1 21040 Origgio (Va) Italy
Comuna Bragadiru Jud.
Alexandriei 145a Comuna Bragadiru Jud.
4.2 Dosering og indgivelsesmåde
4.2 Posology and Method of administration
CHMP konkluderede den 21. juni 2007, at epidemiologiske undersøgelser peger på, at systemiske formuleringer af piroxicam er forbundet med en større risiko for alvorlig gastrointestinal toksicitet end andre NSAID og med en højere risiko for alvorlige hudreaktioner end andre NSAID, der ikke tilhører oxicam-gruppen.
The CHMP concluded on 21 June 2007 that epidemiological studies suggest that systemic formulations of piroxicam are associated with a higher risk of serious gastrointestinal toxicity, relative to other NSAIDs, and a higher risk of serious skin reactions (SCAR) than other non-oxicam NSAIDs.
Via Giacomo Chiesi 43100 Parma Italien
Via Giacomo Chiesi 43100 Parma Italy
Denne meddelelse skal informere de ordinerende sundhedspersoner om de risici for gastrointestinale reaktioner og hudreaktioner, der er forbundet med piroxicam, i overensstemmelse med den af
This communication should inform healthcare professionals of the risks of gastrointestinal and skin reactions associated with piroxicam and should be in line with the DHPC endorsed by the CHMP.
De skal især være opmærksom: - hvis De tager acetylsalicylsyre eller andre NSAID-præparater til lindring af smerter - hvis De tager binyrebarkhormoner, der er medicin til behandling af forskellige tilstande, såsom allergi og ubalance i hormonerne - hvis De tager blodfortyndende medicin for at hindre blodet i at størkne, såsom warfarin - hvis De tager visse typer medicin mod depression, de såkaldte selektive serotoningenoptagshæmmere
It's especially important to mention: - if you are taking aspirin or other non-steroidal anti-inflammatory drugs for pain relief - if you are taking corticosteroids, which are drugs given to treat a variety of conditions such as allergies and hormone imbalances - if you are taking anticoagulants such as warfarin to prevent blood clots - if you are taking certain drugs for depression called selective serotonin re-uptake inhibitors (SSRI) - if you are taking any drugs, such as acetylsalicylic acid to prevent platelet clumping
Kortikosteroider: Øget risiko for gastrointestinalt ulcus eller blødning (se pkt.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
17, Boulevards De La Plaine B-1050 Bruxelles Belgien
17, Boulevards De La Plaine B-1050 Bruxelles Belgium
1010 Vienna Østrig
1010 Vienna
Gastrointestinale virkninger, risiko for gastrointestinal ulceration, blødning og perforation.
“Gastrointestinal (GI) Effects, Risk of GI Ulceration, Bleeding, and Perforation.
500 mg/50 g Creme
500 mg/50 g Cream
Innotech International 7-9, Avenue François-Vincent Raspail Bp 32, 94111 Arcueil Cedex Frankrig
Innotech International 7-9, Avenue François-Vincent Raspail Bp 32, 94111 Arcueil Cedex France
Bruxicam 0,5% 0.50% Øjendråber, opløsning
Bruxicam 0,5% 0.50% Eye Drops, Solution Ocular
Ratiopharm Gmbh Graf-Arco Strasse 3 D-89070 Ulm Tyskland
Ratiopharm Gmbh Graf-Arco Strasse 3 D-89070 Ulm Germany
Boulevard De La Plaine 17 B-1050 Brussels Belgien
Boulevard De La Plaine 17 B-1050 Brussels Belgium
10mg/gm Creme
10mg/gm Cream
58-500 Jelenia Gora Polen
58-500 Jelenia Gora Poland
Trombocythæmmende midler og selektive serotoningenoptagshæmmere (SSRI): Øget risiko for gastrointestinal blødning (se pkt.
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).”
Trinity Chiesi Pharmaceuticals Ltd Cheadle Royal Business Park Highfield, Cheadle Sk8 3gy Storbritannien
Trinity Chiesi Pharmaceuticals Ltd Cheadle Royal Business Park Highfield, Cheadle Sk8 3gy United Kingdom
20 mg/3 mg Granulater til oral opløsning
20 mg/3 mg Granules for oral solution
CT-Arzneimittel Gmbh Lengeder Str. 42a D-13407 Berlin Tyskland
CT-Arzneimittel Gmbh Lengeder Str. 42a D-13407 Berlin Germany
Pfizer Aps Lautrupvang 8 Dk-2750 Ballerup Danmark
Pfizer Aps Lautrupvang 8 Dk-2750 Ballerup Denmark
Pfizer Aps Lautrupvang 8 Dk 2750 Ballerup Danmark
Pfizer Aps Lautrupvang 8 Dk 2750 Ballerup Denmark
11347, Post Box 23033 SE-10435 Stockholm Sverige
11347, Post Box 23033 SE-10435 Stockholm Sweden
Maximo Aguirre, 14 48940 Lamiaco-Lejona Spanien
Maximo Aguirre, 14 48940 Lamiaco-Lejona Spain
Deres læge vil kun udskrive piroxicam til Dem, hvis lindring af symptomerne ikke er tilfredsstillende efter brug af andre NSAID-præparater.
Your doctor will prescribe piroxicam to you only when you have had unsatisfactory relief of symptoms with other non-steroidal anti-inflammatory medicines (NSAIDs).”
0.5g/50g - 50g Creme
0.5g/50g - 50g Cream
Alpharma P.O. Box 158 Skøyen N-0212 Oslo Norge
Box 158 Skøyen N-0212 Oslo Norway
Keresztúri U. 30-38 1106 Budapest Ungarn
Keresztúri U. 30-38 1106 Budapest Hungary
De skal ikke tage dobbeltdosis som erstatning for den glemte tablet.
Do not double the dose.
Laboratorios faes Farma Sa maximo Aguirre, 14 48940 Lamiaco-Lejona Spanien
Laboratorios Faes Farma Sa Maximo Aguirre, 14 48940 Lamiaco-Lejona Spain
− piroxicam bør kun ordineres af læger med erfaring i diagnostisk vurdering og behandling af osteoartritis, reumatoid artritis og ankyloserende spondylitis,
− prescription of piroxicam should only be initiated by those physicians with experience in diagnostic evaluation and treatment of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis;
D- 85737 Ismaning Tyskland
D- 85737 Ismaning Germany
• hvis De har eller har haft fortilfælde af mave-tarm-lidelser (betændelse i maven eller tarmene), som kan føre til blødningstilstande, såsom blødende tyktarmbetændelse (colitis ulcerosa), kronisk betændelse i mave og tarm (Crohns sygdom), mave-tarmkræft eller diverticulitis (betændelse eller inficeret udposning i tyktarmen)
• If you have or have had a history of gastrointestinal disorders (inflammation of the stomach or intestines) that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers, diverticulitis (inflamed or infected pouches/pockets in the colon).
Ratiopharm Gmbh Graf-Arco-Str. 3 D-89079 Ulm Tyskland
Ratiopharm Gmbh Graf-Arco-Str. 3 D-89079 Ulm Germany
D-85737 Ismaning Tyskland
D-85737 Ismaning Germany
− Udvalget konkluderede på baggrund af de foreliggende oplysninger, at der er større risiko for gastrointestinale og alvorlige hudreaktioner i forbindelse med piroxicam end med de øvrige NSAID i gruppen.
− In view of the available data, the Committee concluded that there is an increased risk of gastrointestinal and serious skin reactions associated with systemic formulations of piroxicam when compared to other NSAIDs as a group.
PIROXICAMS [Særnavn] VIRKNING, OG HVAD DE SKAL BRUGE DET TIL Lægen vil vurdere fordelene ved denne medicin over for risikoen for at udvikle bivirkninger, før lægen ordinerer piroxicam.
“Before prescribing piroxicam, your doctor will assess the benefits this medicine may give you against your risk of developing side effects.
• Fortilfælde af gastrointestinal ulceration, blødning eller perforation.
• “History of gastro-intestinal ulceration, bleeding or perforation.
Gerakas 15344 Grækenland
Gerakas 15344 Greece
Bivirkningerne kan minimeres ved at bekæmpe symptomerne i så kort tid og med så lav dosis som muligt.
Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms.
10 mg/1 g Creme
10 mg/1 g Cream
• hvis De tager blodfortyndende medicin såsom warfarin
• If you are taking anticoagulants, such as warfarin, to prevent blood clots.
− fordelene ved piroxicam opvejer risiciene til symptomlindring ved osteoartritis, reumatoid artritis og ankyloserende spondylitis,
− the benefits of piroxicam outweigh the risks in the symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis;
Fortæl det altid til lægen, før De bruger denne medicin, hvis De har nogen medicinske problemer, eller nogen former for allergi, eller er i tvivl om, De kan bruge piroxicam.
If you have or had any medical problems or any allergies or if you are not sure as to whether you can use piroxicam tell your doctor before using this medicine.
3ddd Pharma N.N. Diestersteenweg 349 B-3510 Hasselt Belgien
Diestersteenweg 349 B-3510 Hasselt Belgium
D-25870 Norderfriedrichskoog Tyskland
D-25870 Norderfriedrichskoog Germany
Epidemiologiske studier tyder på, at brugen af piroxicam kan være forbundet med stor risiko for alvorlig gastrointestinal toksicitet i forhold til andre NSAID-præparater.
Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs.
Dorking Road Walton-0n-The-Hill Surrey KT20 7NS Storbritannien
Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Chiesi Farmaceutici Spa, Via Palermo, 26/A 43100 Parma Italien
Chiesi Farmaceutici Spa, Via Palermo, 26/A 43100 Parma Italy
Av. Berlin, 38-48 7ª Planta 08029 Barcelona Spanien
Chiesi España, S.A. Av. Berlin, 38-48 7ª Planta 08029 Barcelona Spain
Tad Pharma Gmbh Heinz-Lohmann-Str. 5 D-27472 Cuxhaven Tyskland
Tad Pharma Gmbh Heinz-Lohmann-Str. 5 D-27472 Cuxhaven Germany
Alvorlige hudreaktioner, som kan være fatale, er rapporteret meget sjældent i forbindelse med brugen af NSAID-præparater, omfatter bl.a. exfoliativ dermatitis, Stevens-Johnsons syndrom og toksisk epidermal nekrolyse (se pkt.
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 NSAIDs (see section 4.8).
Manx Healthcare Taylor Group House Wedgnock Lane Warwick CV34 5YA Storbritannien
United Kingdom Manx Healthcare Taylor Group House Wedgnock Lane
Ambachtenlaan B-3001 Heverlee Belgien
Docpharma N.V. Ambachtenlaan B-3001 Heverlee Belgium
Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS Storbritannien
Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Felcam20 mg/kap Kapsler, hårde
Felcam20 mg/cap Hard capsules
Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS
United Kingdom Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS
Suppositorer
Suppository
Zerospam20 mg/cap Kapsler, hårde
Zerospam20 mg/cap Hard capsules
Aliud Pharma Gmbh & Co.Kg Gottlieb-Daimler-Str. 19 D-89150 Laichingen Tyskland
Aliud Pharma Gmbh & Co.Kg Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Aliud Pharma Gmbh &Co. Kg. Gottlieb-Daimler Str. 19 89150 Laichingen Tyskland
Aliud Pharma Gmbh &Co. Kg. Gottlieb-Daimler Str. 19 89150 Laichingen Germany
Clonmel Healthcare Limited Waterford Road Clonmel, Co. Tipperary, Irland
United Kingdom Clonmel Healthcare Limited Waterford Road
Gentsesteenweg 615 B-1080 Brussels Belgien
Nycomed Belgium N.V. Gentsesteenweg 615 B-1080 Brussels Belgium
Er De i tvivl så spørg lægen eller på apoteket.
You should check with your doctor or pharmacist if you are not sure.