FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Posledično je CHMP priporočil ohranitev dovoljenj za promet za vsa zdravila iz Dodatka I k Mnenju ter spremembo ustreznih poglavij Povzetka glavnih značilnosti zdravila in Navodil za uporabo za sistemske formulacije piroksikama, kot je določeno v Dodatku III k Mnenju v skladu s členom 31(2) Direktive 2001/83/ES, kot je bila spremenjena.
English: 20041 Agrate Brianza (Mi) Italy
Slovenian: 20041 Agrate Brianza (Mi) Italija
English: Karib House 63-65 Imperial Way Cr9 4qy Croydon, Surrey United Kingdom
Slovenian: Karib House 63-65 Imperial Way Cr9 4qy Croydon, Surrey Velika Britanija
English: However a need to further evaluate the benefit/risk balance of some non-selective NSAIDs including piroxicam was identified.
Slovenian: Ugotovljena pa je bila tudi potreba po nadaljnji presoji razmerja med koristmi in tveganji za nekatere neselektivne NSAID-e, vključno s piroksikamom.
English: Areta 31620 Huarte Pamplona Spain
Slovenian: Areta 31620 Huarte Pamplona Španija
English: 89143 Blaubeuren Germany
Slovenian: 89143 Blaubeuren Nemčija
English: Beverley, E Yorks HU17 0LD
Slovenian: Beverley, E Yorks HU17 0LD Velika Britanija
English: 16147 Genova Italy
Slovenian: 16147 Genova Italija
English: Make sure you have told your doctor about any other medicines that you are taking, including those that you have bought without a prescription.”
Slovenian: Zdravnika obvestite o vseh drugih zdravilih, ki jih jemljete, tudi če ste jih kupili brez recept..''
English: B-2610 Wilrijk Belgium
Slovenian: B-2610 Wilrijk Belgija
English: • If you are taking anticoagulants, such as warfarin, to prevent blood clots.
Slovenian: • če jemljete antikoagulanse, na primer varfarin, za preprečevanje nastajanja krvnih strdkov;
English: 48 81379, München
Slovenian: 48 81379, München Nemčija
English: 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.
Slovenian: Če imate ali ste imeli kakršnekoli zdravstvene težave ali alergije ali ne veste, če lahko jemljete piroksikam, se posvetujte z zdravnikom.
English: 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.
Slovenian: Uporabo topičnih NSAID-ov spremlja izrazito manjša sistemska izpostavljenost v primerjavi s sistemskim odmerjanjem, zato se pri uporabi topičnih formulacij pričakuje nižja stopnja sistemskih neželenih učinkov.
English: If you feel that the medicine is not very effective, always talk to your doctor.
Slovenian: Če menite, da je zdravilo premalo učinkovito, se posvetujte z zdravnikom.
English: Pharmapartner Nv Kolonel Begaultlaan 16 B-3012 Leuven Belgium
Slovenian: Pharmapartner Nv Kolonel Begaultlaan 16 B-3012 Leuven Belgija
English: If you forget to use piroxicam:
Slovenian: Če ste pozabili vzeti piroksikam:
English: Str. Stirbei Voda Nr. 53-55 Sector 1, Bucuresti Romania
Slovenian: Str. Stirbei Voda Nr. 53-55 Sector 1, Bucuresti Romunija
English: Via Orazio, 20/22 80122 Napoli Italy
Slovenian: Via Orazio, 20/22 80122 Napoli Italija
English: The maximum recommended daily dose is 20 mg.
Slovenian: Največji priporočeni dnevni odmerek je 20 mg.
English: 4823 Ae Breda The Netherlands
Slovenian: 4823 Ae Breda Nizozemska
English: Brusselsesteenweg 288 B-3090 Overijse Belgium
Slovenian: Brusselsesteenweg 288 B-3090 Overijse Belgija
English: Via Tranquillo Cremona 10 20092 Cinisello Balsamo (Mi) Italy
Slovenian: Via Tranquillo Cremona 10 20092 Cinisello Balsamo (Mi) Italija
English: United Kingdom Crescent Pharma Limited Units 3&4, Quidhampton Business Units Polhampton Lane
Slovenian: Crescent Pharma Limited Units 3&4, Quidhampton Business Units Polhampton Lane
English: - If any of these applies to you tell your doctor immediately.”
Slovenian: - Če jemljete katerokoli od naštetih zdravil, nemudoma obvestite svojega zdravnika.''
English: N-1324 Lysaker
Slovenian: N-1324 Lysaker Norveška
English: 1504 Lefkosia Cyprus
Slovenian: 1504 Lefkosia Ciper
English: 1070-325 Lisboa
Slovenian: 1070-325 Lisboa Portugalska
English: Sandoz B.V Veluwezoon 22 1327 Ah Almere The Netherlands
Slovenian: Sandoz B.V Veluwezoon 22 1327 Ah Almere Nizozemska
English: 2800 Bd Gouda The Netherlands
Slovenian: 2800 Bd Gouda Nizozemska
English: 4870 Ag Etten Leur The Netherlands
Slovenian: 4870 Ag Etten Leur Nizozemska
English: Avenue Jules Bordet 168 B-1140 Brussels Belgium
Slovenian: Avenue Jules Bordet 168 B-1140 Brussels Belgija
English: Under no circumstances should you change the dose without first speaking to your doctor.
Slovenian: Odmerka brez posveta z zdravnikom nikakor ne smete spremeniti.
English: 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.
Slovenian: Iz pregleda sledi, da majhnega povečanja absolutnega tveganja za pojav trombotičnih zapletov zaradi neselektivnih NSAID-ov ni mogoče izključiti, vendar pa skupno razmerje med tveganji in koristmi ostaja pozitivno.
English: Av. D. João Ii Lote 1.02.2.1 D - 2º 1990-090 Lisboa Portugal
Slovenian: Av. D. João Ii Lote 1.02.2.1 D - 2º 1990-090 Lisboa Portugalska
English: Via Mario Lalli, 8 56127 Pisa Italy
Slovenian: Via Mario Lalli, 8 56127 Pisa Italija
English: Epifarma S.R.L Via S.Rocco, 6 85033 Episcopia Pz Italy
Slovenian: Epifarma S.R.L Via S.Rocco, 6 85033 Episcopia Pz Italija
English: 1500 Gb Zaandam The Netherlands
Slovenian: 1500 Gb Zaandam Nizozemska
English: S.C. Labormed-Pharma S.A. Splaiul Independentei Nr. 319e Sector 6, Bucuresti Romania
Slovenian: S.C. Labormed-Pharma S.A. Splaiul Independentei Nr. 319e Sector 6, Bucuresti Romunija
English: Hampshire Gu35 9qe United Kingdom
Slovenian: Hampshire Gu35 9qe Velika Britanija
English: S.C. Terapia S.A. Str. Fabricii Nr.124 Cluj-Napoca Jud.
Slovenian: Str. Fabricii Nr.124 Cluj-Napoca Jud.
English: United Kingdom Pfizer Consumer Healthcare Walton Oaks
Slovenian: Pfizer Consumer Healthcare Walton Oaks
English: “Before prescribing piroxicam, your doctor will assess the benefits this medicine may give you against your risk of developing side effects.
Slovenian: ''Preden vam bo zdravnik predpisal piroksikam, bo ocenil koristi, ki bi jih lahko imeli od zdravljenja s tem zdravilom, glede na vaše individualno tveganje za razvoj neželenih učinkov.
English: Faran Abee Achaias & Troizinias New Kifissia 14564 Greece
Slovenian: Faran Abee Achaias & Troizinias New Kifissia 14564 Grčija
English: Hexal A/S Kanalholmen 8-12 Dk-2650 Hvidovre Denmark
Slovenian: Hexal A/S Kanalholmen 8-12 Dk-2650 Hvidovre Danska
English: Cipla (Uk) Limited 53a High Street Esher Surrey Kt10 9qr United Kingdom
Slovenian: Cipla (Uk) Limited 53a High Street Esher Surrey Kt10 9qr Velika Britanija
English: Ratiopharm Belgium S.A. Rue Saint-Lambert 141 B-1200 Bruxelle Belgium
Slovenian: Ratiopharm Belgium S.A. Rue Saint-Lambert 141 B-1200 Bruxelle Belgija
English: 11, Avenue Dubonnet 92400 Courbevoie France
Slovenian: 11, Avenue Dubonnet 92400 Courbevoie Francija
English: Telecom Ardens - Medialaan 40 B-1800 Vilvoorde Belgium
Slovenian: Telecom Ardens - Medialaan 40 B-1800 Vilvoorde Belgija
English: B-Ul Timisoara Nr.50 Sector 6, Bucuresti Romania
Slovenian: B-Ul Timisoara Nr.50 Sector 6, Bucuresti Romunija
English: C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Denmark
Slovenian: C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Danska
English: 08007 Barcelona Spain
Slovenian: 08007 Barcelona Španija
English: Arena Group S.A. Str. Stefan Mihaileanu Nr.31 Etaj 1, Ap. 1
Slovenian: Str. Stefan Mihaileanu Nr.31 Etaj 1, Ap. 1
English: “Take special care with [Invented name] and always tell your doctor before using [Invented name]: like all non-steroidal-anti-inflammatory drugs, [Invented name] can cause serious reactions in the stomach and intestines, such as pain, bleeding, ulceration, and perforation.
Slovenian: ''Bodite posebno pozorni s/z [izmišljeno ime] in se vedno posvetujte z zdravnikom, preden vzamete [izmišljeno ime]: Kot vsi nesteroidni antirevmatiki lahko tudi [izmišljeno ime] povzroči resne zaplete v želodcu in črevesu, na primer bolečino, krvavitev, razjedo in predrtje.
English: Thurzó U. 5/C 1133 Budapest Hungary
Slovenian: Thurzó U. 5/C 1133 Budapest Madžarska
English: Parnithos Avenue 189 Acharnai Attiki 13671 Greece
Slovenian: Parnithos Avenue 189 Acharnai Attiki 13671 Grčija
English: Diestersteenweg 349 B-3510 Hasselt Belgium
Slovenian: Diestersteenweg 349 B-3510 Hasselt Belgija
English: 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.
Slovenian: To sporočilo mora zdravstvene delavce seznaniti s tveganji za gastrointestinalne in kožne reakcije zaradi piroksikama ter mora biti v skladu z neposrednim sporočilom za zdravstveno osebje, ki ga je odobril CHMP.
English: Expanpharm International 6, rue de la Rochefoucauld 16000 Angouleme France
Slovenian: Expanpharm International 6, rue de la Rochefoucauld 16000 Angouleme Francija
English: Ivax Pharmaceuticals 34, Avenue Franklin Roosevelt 92150 Suresnes France
Slovenian: Ivax Pharmaceuticals 34, Avenue Franklin Roosevelt 92150 Suresnes Francija
English: 18, Rue Du Docteur Ragnaud 16000 Angoulême France
Slovenian: 18, Rue Du Docteur Ragnaud 16000 Angoulême Francija
English: Isleworth, Middx TW7 4QJ
Slovenian: Isleworth, Middx TW7 4QJ Velika Britanija
English: Norma Hellas Ae Menandrou 54 Athens 10431 Greece
Slovenian: Norma Hellas Ae Menandrou 54 Athens 10431 Grčija
English: Alpharma A/S Harbitzalleen 3 158 Skoyen 0212 Oslo Norway
Slovenian: Alpharma A/S Harbitzalleen 3 158 Skoyen 0212 Oslo Norveška
English: 1, Cours Du Triangle, 92936 Paris La Défense Cedex France
Slovenian: 1, Cours Du Triangle, 92936 Paris La Défense Cedex Francija
English: 179, Bureaux De La Colline 92213 Saint-Cloud Cedex France
Slovenian: 179, Bureaux De La Colline 92213 Saint-Cloud Cedex Francija
English: Wincentego Pola 21 58-500 Jelenia Gora Poland
Slovenian: Wincentego Pola 21 58-500 Jelenia Gora Poljska
English: Pierre Fabre Medicament 45, Place Abel Gance 92654 Boulogne Cedex France
Slovenian: Pierre Fabre Medicament 45, Place Abel Gance 92654 Boulogne Cedex Francija
English: Biogal-Teva Pharma Rákóczi U. 70-72 1074 Budapest Hungary
Slovenian: Biogal-Teva Pharma Rákóczi U. 70-72 1074 Budapest Madžarska
English: D-76139 Karlsruhe Germany
Slovenian: D-76139 Karlsruhe Nemčija
English: D-22761 Hamburg Germany
Slovenian: D-22761 Hamburg Nemčija
English: Leuvensestraat 28 Bus 2 B-1800 Vilvoorde Belgium
Slovenian: Leuvensestraat 28 Bus 2 B-1800 Vilvoorde Belgija
English: Anti-coagulants: NSAIDs, including piroxicam, may enhance the effects of anti-coagulants, such as warfarin.
Slovenian: Antikoagulansi: nesteroidni antirevmatiki, tudi piroksikam, lahko povečajo učinke antikoagulansov, kot je varfarin.
English: United Kingdom Generics Uk Limited Albany Gate, Darkes Lane, Potters Bar Herts EN6 1AG
Slovenian: Generics Uk Limited Albany Gate, Darkes Lane, Potters Bar Herts EN6 1AG
English: Patients with significant risk factors for serious GI events should be treated with piroxicam only after careful consideration (See sections 4.3 and below).
Slovenian: Bolnike z večjimi dejavniki tveganja za resne zaplete v prebavilih smemo zdraviti s piroksikamom le po skrbnem premisleku (glejte poglavje 4.3 in nadaljevanje).
English: Po Box 217, 3640 Ae Mijdrecht The Netherlands
Slovenian: Po Box 217, 3640 Ae Mijdrecht Nizozemska
English: New Psychiko 15451 Greece
Slovenian: New Psychiko 15451 Grčija
English: Quartiere Varignano, 12 - 13 - 14 55049 Viareggio (Lu) Italy
Slovenian: Quartiere Varignano, 12 - 13 - 14 55049 Viareggio (Lu) Italija
English: Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No.7, Hardicker Street M19 2rb Manchester United Kingdom
Slovenian: Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No.7, Trdaicker Street M19 2rb Manchester Velika Britanija
English: 49, Avenue Georges Pompidou 92300 Levallois-Perret France
Slovenian: 49, Avenue Georges Pompidou 92300 Levallois-Perret Francija
English: 18038 Villa Sayonara - Sanremo (Im) Italy
Slovenian: 18038 Villa Sayonara - Sanremo (Im) Italija
English: Odiham, Hampshire RG29 1LF United Kingdom
Slovenian: Odiham, Hampshire RG29 1LF Velika Britanija
English: 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.
Slovenian: Morda vam bo moral predpisati kontrolne preglede in vam bo povedal, kako pogosto jih boste morali imeti med jemanjem piroksikama.
English: − The CHMP concluded that the benefit/risk balance of systemic formulations of piroxicam containing medicinal products in the agreed restricted indications is favourable.
Slovenian: − CHMP je sklenil, da je razmerje med koristmi in tveganji za zdravila, ki vsebujejo sistemske formulacije piroksikama, pri odobrenih omejenih indikacijah ugodno.
English: Gounari 25 & Areos Kamatero Attiki 13451 Greece
Slovenian: Gounari 25 & Areos Kamatero Attiki 13451 Grčija
English: Laboratoire Pharmy II 26 rue des Gaudines 78100 Saint-Germain-Laye France
Slovenian: Laboratoire Pharmy II 26 rue des Gaudines 78100 Saint-Germain-Laye Francija
English: Pfizer Hellas Ae 243 Mesogion Ave, 15451 N. Psychiko Greece
Slovenian: Pfizer Hellas Ae 243 Mesogion Ave, 15451 N. Psychiko Grčija
English: Barbera Del Valles 08210 Barcelona Spain
Slovenian: Barbera Del Valles 08210 Barcelona
English: 38 Princes Court 88 Brompton Road Knightsbridge, SW3 1ES London United Kingdom
Slovenian: 38 Princes Court 88 Brompton Road Knightsbridge, SW3 1ES London Velika Britanija
English: − 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.
Slovenian: − CHMP je menil, da je razmerje med koristmi in tveganji za sistemske formulacije piroksikama pri simptomatskem lajšanju osteoartritisa, revmatoidnega artritisa ali ankilozitajočega spondilitisa pozitivno; v nasprotju s tem pa je CHMP ocenil, da je razmerje med koristmi in tveganji za piroksikam pri zdravljenju akutnih stanj negativno in da je treba te indikacije razveljaviti.
English: Patients should be asked to report any new or unusual abdominal symptom during treatment.
Slovenian: Bolnike je treba poučiti, da morajo zdravnika med zdravljenjem obvestiti o vseh novih ali neobičajnih trebušnih simptomih.
English: Identification of at-risk subjects
Slovenian: Odkrivanje bolnikov s povečanim tveganjem
English: If a gastrointestinal complication is suspected during treatment, piroxicam should be discontinued immediately and additional clinical evaluation and treatment should be considered.”
Slovenian: Če zdravnik med zdravljenjem posumi na zaplet v prebavilih, mora piroksikam nemudoma ukiniti in ponovno presoditi o dodatni klinični oceni in zdravljenju.''
English: 72028 Torre Santa Susanna (Br) Italy
Slovenian: 72028 Torre Santa Susanna (Br) Italija
English: “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).
Slovenian: ''Tako kot velja za druge nesteroidne antirevmatike, se moramo tudi pri piroksikamu izogibati hkratne uporabe z acetilsalicilno kislino ali sočasnega zdravljenja z drugimi nesteroidnimi antirevmatiki, tudi drugimi oblikami piroksikama, ker ni na voljo dovolj podatkov, ki bi kazali, da je izboljšanje pri takšnih kombinacijah večje kot pri zdravljenju s samim piroksikamom; poleg tega se poveča nevarnost neželenih učinkov (glejte poglavje 4.4).
English: These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.
Slovenian: Našteti resni neželeni dogodki se lahko pri bolnikih, ki se zdravijo z nesteroidnimi antirevmatiki pojavijo ob kateremkoli času, z opozorilnimi simptomi ali brez njih.
English: 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.
Slovenian: Če ste stari več kot 70 let ali jemljete tudi druga zdravila, na primer kortikosteroide ali zdravila proti depresiji iz skupine selektivnih zaviralcev ponovnega privzema serotonina (SSRI), ali acetilsalicilno kislino za preprečitev nastajanja krvnih strdkov, vam lahko zdravnik hkrati s/z [izmišljeno ime] predpiše zdravilo z zaščitnim učinkom na želodec ali črevo.
English: “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.
Slovenian: ''Zdravljenje s piroksikamom smejo uvesti le zdravniki, ki imajo izkušnje z diagnostično oceno in zdravljenjem bolnikov z vnetnimi ali degenerativnimi revmatičnimi boleznimi.
English: Athens-Lamia 14565 Greece
Slovenian: Athens-Lamia 14565 Grčija
English: Doc Generici Srl Via Manuzio, 7 20124 Milano Italy
Slovenian: Doc Generici Srl Via Manuzio, 7 20124 Milano Italija
English: Your doctor will prescribe piroxicam to you only when you have had unsatisfactory relief of symptoms with other non-steroidal anti-inflammatory medicines (NSAIDs).”
Slovenian: Zdravnik vam bo piroksikam predpisal le, če vam simptomov niso dovolj ublažili drugi nesteroidni antirevmatiki.''
English: Overton, Hampshire RG25 3ED United Kingdom
Slovenian: Overton, Hampshire RG25 3ED Velika Britanija
English: Strada Statale 156 Km 50 04010 Borgo San Michele (Lt) Italy
Slovenian: Strada Statale 156 Km 50 04010 Borgo San Michele (Lt) Italija
English: Metamorfosi Attiki 14452 Greece
Slovenian: Metamorfosi Attiki 14452 Grčija
English: D-42781 Haan Germany
Slovenian: D-42781 Haan Nemčija
English: You should immediately stop taking piroxicam and tell your doctor if you have any allergic reaction such as a skin rash, swelling of the face, wheezing or difficulty breathing.
Slovenian: Piroksikam morate nemudoma prenehati jemati in obvestiti zdravnika, če boste opazili kakršnokoli alergijsko reakcijo, na primer kožni izpuščaj, otekanje obraza, piskanje ali oteženo dihanje.
English: Se-102 53 Stockholm Sweden
Slovenian: Se-102 53 Stockholm Švedska
English: United Kingdom Sandoz Limited Unit 37, Woolmer Way Bordon
Slovenian: Sandoz Limited Unit 37, Woolmer Way Bordon
English: 43100 Parma Italy
Slovenian: 43100 Parma Italija
English: If you are over 70 years old, your doctor may wish to minimise treatment duration and to see you more often while you are taking piroxicam.
Slovenian: Če ste stari več kot 70 let, se lahko zdravnik odloči za čim krajše zdravljenje in pogostejše kontrolne preglede v obdobju, ko boste jemali piroksikam.
English: D-82256 Fürstenfeldbruck Germany
Slovenian: D-82256 Fürstenfeldbruck Nemčija
English: Via Di Scandicci, 37 50143 Firenze Italy
Slovenian: Via Di Scandicci, 37 50143 Firenze Italija
English: Luoizalaan 149 Bus 4 B-1050 Brussels Belgium
Slovenian: Luoizalaan 149 Bus 4 B-1050 Brussels Belgija
English: − The CHMP agreed that no restrictions were required with regards to topical formulations of piroxicam and the benefit/risk balance remains favourable.
Slovenian: − CHMP je sklenil, da omejitve pri topičnih formulacijah piroksikama niso potrebne, razmerje med koristmi in tveganji pa ostaja ugodno.
English: Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Slovenian: Kortikosteroidi: povečano tveganje razjed ali krvavitev v prebavilih (glejte poglavje 4.4).
English: The maximum daily dose is 20 milligrams of piroxicam as one single daily dose.
Slovenian: Največji dnevni odmerek je 20 miligramov piroksikama v enem odmerku na dan.
English: Do not increase the dose
Slovenian: Odmerka ne povečujte.
English: Serious GI Complications
Slovenian: Resni zapleti v prebavilih
English: 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: EMEA/CHMP/381615/2006).
Slovenian: CHMP je oblikoval tudi priporočila za spremembe, t.i. „ključne elemente“, ki bi naj bile vključene v informacije o zdravilu za piroksikam, kakor tudi za nekatere druge neselektivne NSAID-e, ki so bili objavljeni na spletni strani EMEA septembra 2006 (ref. št.
English: − 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;
Slovenian: − v Povzetek glavnih značilnosti zdravila in Navodilo za uporabo so bile dodane nove kontraindikacije in dodatna opozorila, da bi tako omejili izpostavljenost piroksikamu na bolnike, pri katerih se ne pojavljajo dejavniki tveganja za gastrointestinalne in kožne reakcije;
English: United Kingdom Pharmvit Limited Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ United Kingdom
Slovenian: Pharmvit Limited Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ Velika Britanija
English: Hexal Pharma Gmbh Carlbergergasse 44 1235 Wien Austria
Slovenian: Hexal Pharma Gmbh Carlbergergasse 44 1235 Wien Avstrija
English: Laboratorios Salvat S.A.Gallo, 30-36 08950 Barcelona Spain
Slovenian: Laboratorios Salvat S.A.Gallo, 30-36 08950 Barcelona Španija
English: Laboratorios Robert, S.A. Gran Via Carlos Iii 94 08028 Barcelona Spain
Slovenian: Laboratorios Robert, S.A. Gran Via Carlos Iii 94 08028 Barcelona Španija
English: D- 76437 Rastatt Germany
Slovenian: D- 76437 Rastatt Nemčija
English: Topgen Esv E.Demunterlaan 1/8 B-1090 Brussels Belgium
Slovenian: Topgen Esv E.Demunterlaan 1/8 B-1090 Brussels Belgija
English: The CHMP reviewed the data submitted by Marketing Authorisation Holders from clinical trials, epidemiological studies, and spontaneous reporting of adverse drug reactions.
Slovenian: CHMP je pregledal podatke iz kliničnih preskušanj, epidemioloških študij in spontanih poročil o neželenih učinkih zdravila, ki so jih predložili imetniki dovoljenja za promet z zdravilom.
English: 20092 Cinisello Balsamo (Mi)
Slovenian: 20092 Cinisello Balsamo (Mi) Italija
English: United Kingdom Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB United Kingdom
Slovenian: Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB Velika Britanija
English: Via Felice Casati, 16 20124 Milano Italy
Slovenian: Via Felice Casati, 16 20124 Milano Italija
English: D- 06796 Brehna Germany
Slovenian: D- 06796 Brehna
English: 4.2 Posology and Method of administration
Slovenian: 4.2 Odmerjanje in način uporabe
English: Neo Irakleio 14122 Greece
Slovenian: Neo Irakleio 14122 Grčija
English: Acharnai Attiki 13671 Greece
Slovenian: Acharnai Attiki 13671 Grčija
English: 15, Boulevard Charles De Gaulle 92707 Colombes Cedex France
Slovenian: 15, Boulevard Charles De Gaulle 92707 Colombes Cedex Francija
English: Merck Generiques 34, Rue Saint-Romain, 69359 Lyon Cedex 08 France
Slovenian: Merck Generiques 34, Rue Saint-Romain, 69359 Lyon Cedex 08 Francija