natgillin/translations-raw huggingface dataset:
Box 205, N- 1372 Asker 0010 Oslo Norge
Box 205, N-1372 Asker 0010 Oslo Norway
Oralt pulver i pose
Oral powder in sachet
Box 158 Skøyen N- 0212 Oslo Norge
Box 158 Skøyen N-0212 Oslo Norway
Merck NM P. O. Box 23033 S- 10435 Stockholm Sverige
Merck NM P. O. Box 23033 S-10435 Stockholm Sweden
Pfizer Europe MA EEIG Sandwich Kent Ct13 9nj Storbritannien
Pfizer Europe MA EEIG Sandwich Kent Ct13 9nj United Kingdom
189 60- 322, Poznań Polen
189
Polen
60-322, Poznań Poland Poland
189 60- 322, Poznań Polen
189 60-322, Poznań Poland
Pola 21 58- 500, Jelenia Góra Polen
Pola 21 58-500, Jelenia Góra Poland
Kereszturi Ut 30- 38 H- 1106, Budapest Ungarn
Kereszturi Ut 30-38 H-1106, Budapest Hungary
Kereszturi Ut 30- 38 H- 1106, Budapest Ungarn
Kereszturi Ut 30-38
Polen
H-1106, Budapest Hungary Poland
Biala 3 00- 895 Warszawa Polen
Biala 3 00-895 Warszawa Poland
Boehringer Ingelheim International Gmbh Binger Str 173 55216, Ingelheim Am Rhein Tyskland
Boehringer Ingelheim International Gmbh Binger Str 173 55216, Ingelheim Am Rhein Germany
João Ii Lote 1. 02. 2. 1 D - 2º 1990- 090 Lisboa Portugal
João Ii Lote 1.02.2.1 D - 2º 1990-090 Lisboa Portugal
80 Medlemsstat
80 Member State
1990- 090 Lisboa Portugal Portugal
Portugal
Empreendimento Lagoas Park Edifício 10 2740- 271 Porto Salvo Portugal
Empreendimento Lagoas Park Edifício 10 2740-271 Porto Salvo Portugal
Menarini Portugal - Farmacêutica, S. A.
Menarini Portugal - Farmacêutica, S. A.
Manuel I - Piso 2 Rua Dos Malhões Nº 1 2770- 071 Paço De Arcos Portugal
Manuel I - Piso 2 Rua Dos Malhões Nº 1 2770-071 Paço De Arcos Portugal
Manuel I - Piso 2 Rua Dos Malhões Nº 1 2770- 071 Paço De Arcos Portugal
Manuel I - Piso 2
Rua General Ferreira Martins, 8 - 7º Miraflores 1495- 137 Algés Portugal
Rua General Ferreira Martins, 8 - 7º Miraflores 1495-137 Algés Portugal
Intramuskulær anvendelse
Via intramuscular
Estrada Nacional 117- 2 Edifícios Azevedos - Alfragide 2724- 503 Amadora Portugal
Estrada Nacional 117-2 Edifícios Azevedos - Alfragide 2724-503 Amadora Portugal
Rua Quinta Do Pinheiro - Edifício Tejo - 6º Piso 2790- 143
Rua Quinta Do Pinheiro - Edifício Tejo - 6º Piso 2790-143 Carnaxide Portugal
82 Medlemsstat
82 Member State
Ratiopharm - Comércio E Indústria De Produtos Farmacêuticos, Lda.
Farmacêuticos, Lda.
Rua Quinta Do Pinheiro - Edifício Tejo - 6º Piso 2790- 143 Carnaxide Portugal
Rua Quinta Do Pinheiro - Edifício Tejo - 6º Piso 2790-143 Carnaxide Portugal
Rua Manuel Ribeiro De Pavia, 1 - 1º Venda Nova 2700- 547 Amadora Portugal
Rua Manuel Ribeiro De Pavia, 1 - 1º Venda Nova 2700-547 Amadora Portugal
José Malhoa - Edifício Malhoa Plaza Nº 2, Piso- Escritório 2. 2 1070- 325 Lisboa Portugal
José Malhoa - Edifício Malhoa Plaza Nº 2, Piso-Escritório 2.2 1070-325 Lisboa Portugal
83 Medlemsstat
83 Member State
Portugal
Portugal Portugal
Rua Manuel Ribeiro De Pavia, 1 - 1º - Venda Nova 2700- 547 Amadora Portugal
Rua Manuel Ribeiro De Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal
Rua Do Padrão, 98 3000- 312 Coimbra Portugal
Rua Do Padrão, 98 3000-312 Coimbra Portugal
Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790- 221 Carnaxide Portugal
Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal
Via Isonzo 6 16147 Genova Italien
Via Isonzo 6 16147 Genova Italy
Øjendråber, opløsning
Eye Drops, Solution
Okulær anvendelse
Ocular
Egis Pharmaceuticals Plc Kereszturi Ut 30- 38 H- 1106 Budapest Ungarn
Egis Pharmaceuticals Plc Kereszturi Ut 30-38 H-1106 Budapest Hungary
Injektionsvæske, opløsning
Solution For Injection
Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT 13 9 NJ
Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT 13 9 NJ United Kingdom
84 Medlemsstat
84 Member State
Boehringer Ingelheim Pharma Gmbh & Co. Kg, Binger Strasse 173 D- 55216 Ingelheim Am Rhein Tyskland
D-55216 Ingelheim Am Rhein Germany Romania
Chiesi Farmaceutici Spa, Via Palermo, 26/ A 43100 Parma Italien
Chiesi Farmaceutici Spa, Via Palermo, 26/ A 43100 Parma Italy
Pulver til oral anvendelse
Powder For Oral Solution
53- 55 Sector 1, Bucuresti Rumanien
53-55 Sector 1, Bucuresti Romania
Kutan anvendelse
Cutaneous
Valea Lupului Nr. 1 Iasi Rumanien
Valea Lupului Nr.1 Iasi Romania
Lokal anvendelse
Local
Alexandriei 145a
Alexandriei 145a Comuna Bragadiru Jud.
85 Medlemsstat
85 Member State
Ilfov Rumanien Rumanien
Romania
Ziduri Intre Vii Nr. 22 Sector 2, Bucurest Rumanien
Ziduri Intre Vii Nr.22 Sector 2, Bucurest Romania
Cluj Rumanien
Cluj Romania
B- Ul Timisoara Nr. 50 Sector 6, Bucuresti Rumanien
B-Ul Timisoara Nr.50 Sector 6, Bucuresti Romania
Victor Babes Nr. 50 Baia Mare, Jud Maramures Rumanien
Victor Babes Nr.50 Baia Mare, Jud Maramures Romania
1 Sector 2, Bucuresti Rumanien
1
Rumanien
Sector 2, Bucuresti Romania Romania
319e Sector 6, Bucuresti Rumanien
319e Sector 6, Bucuresti Romania
35 Iasi, Jud Iasi Rumanien
35 Iasi, Jud Iasi Romania
Kutan
Cutaneous
38 Princes Court
38 Princes Court 88 Brompton Road Knightsbridge, SW3 1ES London
88 Brompton Road
United Kingdom
87 Medlemsstat
87 Member State
Knightsbridge, SW3 1ES London Storbritannien Rumanien
38 Princes Court 88 Brompton Road Knightsbridge, SW3 1ES London United Kingdom Romania
Storbritannien Nycomed Ab Box 27264 Se- 102 53 Stockholm Sverige
United Kingdom Nycomed Ab Box 27264 Se-102 53 Stockholm Sweden
Creme Tabletter
Cream Tablet
Kutan Oral anvendelse
Cutaneous Oral use
Nycomed Ab Box 27264 Se- 102 53 Stockholm Sverige
Nycomed Ab Box 27264 Se-102 53 Stockholm Sweden
Pulver til oral anvendelse
Powder for oral solution
Merck Nm Ab Box 23033 Se- 104 35 Stockholm Sverige
Merck Nm Ab Box 23033 Se-104 35 Stockholm Sweden
Granulater
Granulát
Via Palermo 26/ A 43100 Parma Italien
Via Palermo 26/ A 43100 Parma
Tabletter
Tableta
Slovakiet
Italy Slovakia
Creme
Dermálny krém
Lokal anvendelse
topical use
Kapsler
Kapsula
Injektionsvæske, opløsning
Injekč ný roztok
Parenteral anvendelse
parenteral use
Telčská 114000 Praha 4 Tjekkiet
Telč ská 114000 Praha 4 Czech Republic
Krka, Tovarna Zdravil, D. D., Šmarješka Cesta 6 Si- 8501 Novo Mesto Slovenien
Krka, Tovarna Zdravil, D. D., Š marješ ka Cesta 6 Si-8501 Novo Mesto Slovenia
89 Medlemsstat
89 Member State
Slovenien
Slovenia Slovenia
Pfizer Limited Walton Oaks, Dorking Road Walton- 0n- The- Hill Surrey KT20 7NS Storbritannien
Pfizer Limited
Dispergible tabletter
Tablet for oral solution
Pfizer Limited Walton Oaks, Dorking Road Walton- 0n- The- Hill Surrey KT20 7NS
Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
90 Medlemsstat
90 Member State
Pfizer Limited Walton Oaks, Dorking Road Walton- 0n- The- Hill Surrey KT20 7NS Storbritannien
Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Feldene Intramuscular Injection 20mg/ Ml
Injection 20mg/ Ml
Smeltetabletter
Tablet for oral solution
Actavis Uk Limited Whiddon Vally Barnstaple Devon Ex32 8ns Storbritannien
Actavis Uk Limited Whiddon Vally Barnstaple Devon Ex32 8ns United Kingdom
Sandoz Limited Unit 37, Woolmer Way Bordon
Sandoz Limited Unit 37, Woolmer Way Bordon Hampshire Gu35 9qe United Kingdom
91 Medlemsstat
91 Member State
Sandoz Limited Unit 37, Woolmer Way Bordon Hampshire Gu35 9qe Storbritannien
Unit 37, Woolmer Way Bordon Hampshire Gu35 9qe United Kingdom
Piroxicam Capsules
Capsules
Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ Storbritannien
Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ United Kingdom
Pharmvit Limited Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ Storbritannien
Pharmvit Limited Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ United Kingdom
Generics Uk Limited Albany Gate, Darkes Lane, Potters Bar Herts EN6 1AG Storbritannien
Generics Uk Limited Albany Gate, Darkes Lane, Potters Bar Herts EN6 1AG United Kingdom
92 Medlemsstat
92 Member State
Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR Storbritannien
Miles Gray Road Basildon, Essex SS14 3FR United Kingdom United Kingdom
Neolab Limited 57 High Street Odiham, Hampshire RG29 1LF Storbritannien
Neolab Limited 57 High Street Odiham, Hampshire RG29 1LF United Kingdom
Piroxicam 0. 5%
Piroxicam 0.5%
Dr Reddy' s Laboratories (Uk) Limited 6 Riverview Road Beverley, E Yorks HU17 0LD Storbritannien
Dr Reddy's Laboratories (Uk) Limited 6 Riverview Road Beverley, E Yorks HU17 0LD United Kingdom
Trinity- Chiesi Pharmaceuticals Limited Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY Storbritannien
Trinity-Chiesi Pharmaceuticals Limited Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY United Kingdom
Brexidol 20 Mg
Brexidol 20 Mg
Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY Storbritannien
Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY United Kingdom
Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB Storbritannien
Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB United Kingdom
Tillomed Laboratories Limited 3 Howard Road, Eaton Socon
Tillomed Laboratories Limited 3 Howard Road, Eaton Socon St.
93 Medlemsstat
93 Member State
Tillomed Laboratories Limited 3 Howard Road, Eaton Socon St.
3 Howard Road, Eaton Socon St.
Neots, Cambs PE19 3ET Storbritannien
Neots, Cambs PE19 3ET United Kingdom United Kingdom
Manx Healthcare Taylor Group House Wedgnock Lane Warwick CV34 5YA Storbritannien
Manx Healthcare Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom
Teva Pharma Bv Industrieweg 23 Po Box 217 3640 Ae Mijdrecht Holland
Teva Pharma Bv Industrieweg 23 Po Box 217 3640 Ae Mijdrecht The Netherlands
Pfizer Consumer Healthcare Walton Oaks Dorking Road Walton- 0n- The- Hill Surrey KT20 7NS Storbritannien
Pfizer Consumer Healthcare Walton Oaks Dorking Road Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Crescent Pharma Limited Units 3 & 4, Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED Storbritannien
Crescent Pharma Limited Units 3 & 4, Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom
94 Medlemsstat
94 Member State
Crescent Pharma Limited Units 3 & 4, Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED Storbritannien
Overton, Hampshire RG25 3ED United Kingdom United Kingdom
Strides Arcolab International Limited 201 Jersey Road Isleworth, Middx TW7 4QJ Storbritannien
Strides Arcolab International Limited 201 Jersey Road Isleworth, Middx TW7 4QJ United Kingdom
95 BILAG II
95 ANNEX II
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER OG INDLÆGSSEDLER FREMLAGT AF EMEA SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE PIROXICAM (se bilag I)
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PIROXICAM CONTAINING MEDICINAL PRODUCTS (see Annex I)
Piroxicam er et non- steroidt antiinflammatorisk lægemiddel (NSAID), der virker antiinflammatorisk, analgetisk og antipyretisk.
Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties.
På foranledning af Europa- Kommissionen gennemgik CHMP de foreliggende oplysninger om sikkerheden af ikke- selektive NSAID.
Further to a request from the European Commission the CHMP reviewed safety data on non-selective NSAIDs.
For ikke - selektive NSAID vedtog udvalget imidlertid under gennemgangen en række anbefalinger om ændringer af produktoplysningerne, såkaldte "nøgleelementer", som i produktoplysningerne afspejler en fælles holdning om velkendte sikkerhedsproblemer.
However the Committee adopted recommendations for changes to the product information, or so called “ key elements” during this review which reflect a common position on well known safety issues in the product information of the non-selective NSAIDs.
Disse nøgleelementer blev gjort offentligt tilgængelige på EMEA' s website (ref. dok.:
These key elements were published on the EMEA website (Doc ref:
For visse ikke- selektive NSAID, herunder piroxicam, blev der imidlertid fundet at være behov for en nærmere vurdering af risk/ benefit- forholdet.
However a need to further evaluate the benefit/ risk balance of some non-selective NSAIDs including piroxicam was identified.
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 non- selective NSAIDs.
CHMP fandt, at vurderingen gav anledning til betænkeligheder vedrørende risk/ benefit- forholdet for piroxicam og underrettede Europa- Kommissionen herom.
The CHMP considered that the assessment raised concerns on the benefit/ risk balance of piroxicam and informed the European Commission accordingly.
Disse nøgleelementer blev gjort offentligt tilgængelige på EMEA' s website i september 2006 (ref. dok:
The CHMP also made recommendations for changes, or so called “ key elements”, to be included in the product information of piroxicam, as well as for some other non-selective NSAIDs which were published on the EMEA website in September 2006 (Doc ref:
Europa- Kommissionen fandt, at der af hensyn til folkesundheden burde foretages en revurdering af risk/ benefit- forholdet for piroxicam.
The European Commission considered it to be in the interest of public health to perform a new benefit/ risk assessment of piroxicam.
Europa- Kommissionen fremsendte derfor fremsendte derfor en meddelelse, der blev modtaget af EMEA den 2. august 2006, og den 21. september 2006 blev der indledt en indbringelse i henhold til artikel 31 i direktiv 2001/ 83/ EF, med senere ændringer.
Therefore, the European Commission sent a notification that was received by the EMEA on 2 August 2006 and a referral under Article 31 of Directive 2001/ 83/ EC, as amended was started on 21 September 2006.
Europa - Kommissionen anmodede CHMP om at fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende piroxicam burde opretholdes, ændres, suspenderes eller tilbagekaldes.
The European Commission requested the CHMP to give its opinion on whether the marketing authorisations for medicinal products containing piroxicam should be maintained, varied, suspended or revoked.
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.
− piroxicam bør ikke anvendes til akut behandling på grund af den lange halveringstid på 50 timer og sikkerhedsprofilen, da der findes andre lige så effektive midler, som er sikrere, − fordelene ved piroxicam opvejer risiciene til symptomlindring ved osteoartritis, reumatoid artritis og ankyloserende spondylitis, − piroxicam er ikke længere førstevalgspræparat, hvor et NSAID er indiceret, − piroxicam bør kun ordineres af læger med erfaring i diagnostisk vurdering og behandling af osteoartritis, reumatoid artritis og ankyloserende spondylitis, − i produktresuméet og indlægssedlen er tilføjet nye kontraindikationer og skærpede advarsler, der begrænser eksponeringen af patienter med risikofaktorer for gastrointestinale reaktioner og hudreaktioner, − andre foranstaltninger til risikominimering er begrænsning af dosis af piroxicam til 20 mg dagligt samt anbefalinger om at behandle patienterne i den kortest mulige tid til opnåelse af symptomlindring, med revurdering inden for 14 dage.
− piroxicam should not be used for treatment of any acute condition due to the long half life of 50 hours and the safety profile, since equally effective and safer therapies are available; − the benefits of piroxicam outweigh the risks in the symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; − piroxicam is no longer a first line option should an NSAID be indicated; − prescription of piroxicam should only be initiated by those physicians with experience in diagnostic evaluation and treatment of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; − 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; − further risk minimisation measures include limitation of the dose of piroxicam to 20 mg per day, and recommendations to treat patients for the shortest time possible to relieve symptoms with review within 14 days.
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.
726/ 2004, der blev fremsat i oktober 2006 og gjort offentligt tilgængelige på EMEA' s website (ref. dok.
The CHMP agreed that the recommendations of article 5(3) of regulation (EC) no 726/ 2004 issued in October 2006 and published on the EMEA website (Doc.
EMEA/ 413136/ 2006), fortsat skal være gældende for lægemidler indeholdende piroxicam.
EMEA/ 413136/ 2006) remain valid for piroxicam containing medicinal products.
Konklusionen på gennemgangen var, at det ikke kan udelukkes, at der i forbindelse med ikke- selektive NSAID er let forhøjet absolut risiko for trombotiske hændelser, skønt det overordnede risk/ benefit - forhold fortsat er positivt.
The review concluded that a small increase in the absolute risk for thrombotic events associated with non-selective NSAIDs cannot be excluded although the overall risk benefit/ balance remains positive.
− CHMP behandlede indbringelsen i medfør af artikel 31 i direktiv 2001/ 83/ EF, med senere ændringer, for lægemidler indeholdende piroxicam.
− The CHMP considered the referral made under article 31of Directive 2001/ 83/ EC, as amended, for medicinal products containing piroxicam.
− CHMP fandt, at benefit/ risk- forholdet for systemiske formuleringer af piroxicam er positivt til symptomlindring ved osteoartritis, reumatoid artritis og ankyloserende spondylitis; CHMP fandt imidlertid, at risk/ benefit- forholdet for piroxicam til behandling af akutte tilstande er negativt, og at disse indikationer bør slettes.
− The CHMP considered that the benefit/ risk balance for systemic formulations of piroxicam is positive in the treatment of symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; however the CHMP considered that the benefit/ risk balance of piroxicam in the treatment of acute conditions is negative and that these indications should be revoked.
− CHMP konkluderede, at benefit/ risk- forholdet for systemiske formuleringer af lægemidler indeholdende piroxicam til de vedtagne begrænsede indikationer er gunstigt.
− The CHMP concluded that the benefit/ risk balance of systemic formulations of piroxicam containing medicinal products in the agreed restricted indications is favourable.
− 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 -
− The CHMP agreed that no restrictions were required with regards to topical formulations of piroxicam and the benefit/ risk balance remains favourable.
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.
ÆNDRINGER TIL PRODUKTRESUMÉ OG INDLÆGSSEDDEL
AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Dette afsnit af SPCet, er det afsnit, der var bilag til Europa- Kommissionens beslutning vedrørende denne artikel 31 arbitreringssag.
These sections of the Summary of Product Characteristics are the ones that were annexed to the Commission Decision on this Article 31 referral.
Dette er det afsnit af indlægssedlen, er det afsnit, der var bilag til Europa- Kommissionens beslutning vedrørende denne artikel 31 arbitreringssag.
These sections of the Package Leaflet are the ones that were Annexed to the Commission Decision on this Article 31 referral.
Indikationer, der vedrører osteoarthritis, reumatoid arthritis og ankyloserende spondylitis, skal angives på følgende måde:
Indications regarding osteoarthritis, rheumatoid arthritis and ankylosing spondylitis should read as follows: “ Piroxicam is indicated for symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis.
Hvis et NSAID- præparat er indiceret, er piroxicam ikke førstevalgspræparat pga. dets sikkerhedsprofil (se pkt.
Due to its safety profile (see sections 4.2, 4.3 and 4.4), piroxicam is not a first line option should an NSAID be indicated.
4. 3 og 4. 4) ”.
The decision to prescribe piroxicam should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4) .”
Følgende indikationer skal slettes fra dette afsnit: akut gigt primær dysmenoré postoperative smerter efter dentalbehandling og i infektionsforløb lindring af feber og smerter i forbindelse med akut øvre luftvejsinfektion akutte muskuloskeletale lidelserakutte posttraumatiske lidelser radiculalgia
Radiculalgia
4. 2 Dosering og indgivelsesmåde
4.2 Posology and Method of administration
4. 1, skal angives på følgende måde:
Posology relating to the indications as outlined in section 4.1 should read as follows:
” Piroxicam bør ordineres af en læge med erfaring i diagnostisk evaluering og behandling af patienter med inflammatorisk eller degenerative reumatiske sygdommme.
“ The prescription of piroxicam should be initiated by physicians with experience in the diagnostic evaluation and treatment of patients with inflammatory or degenerative rheumatic diseases.
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 .”
Dosering, der er relateret til følgende indikationer, skal slettes fra dette afsnit, så det er i overensstemmelse med 4. 1.
Posology relating to the following indications are to be deleted from this section in line with Section 4.1:
Akut gigt Primær dysmenoré Postoperative smerter Dentalbehandling og i infektionsforløb Lindring af feber og smerter i forbindelse med akut øvre luftvejsinfektion Akutte muskuloskeletale lidelser (f. eks. bursitis, tendonitis) Akutte post- traumatiske lidelser Radiculalgia
Acute muscoloskeletal disorders(e. g bursitis, tendonitis) Acute post-traumatic disorders.