FrancophonIA/ELRC3.0 huggingface dataset:
English: 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
Slovenian: Posebej pomembno je, da poveste: - če jemljete aspirin ali katere druge nesteroidne antirevmatike za lajšanje bolečine; - če jemljete kortikosteroid; to so zdravila za zdravljenje različnih bolezni, na primer alergij in hormonskih motenj; - če jemljete antikoagulanse, na primer varfarin, za preprečevanje nastajanja krvnih strdkov; - če jemljete zdravila proti depresiji iz skupine selektivnih zaviralcev ponovnega privzema serotonina (SSRI); - če jemljete katerakoli zdravila za preprečevanje zlepljanja trombocitov;
English: 58-500 Jelenia Gora Poland
Slovenian: 58-500 Jelenia Gora Poljska
English: 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.
Slovenian: Vendar pa je Odbor med tem pregledom sprejel priporočila za spremembe informacij o zdravilu oziroma tako imenovanih „ključnih elementov“, ki odražajo skupno stališče o dobro znanih varnostnih vidikih v informacijah o zdravilu za neselektivne NSAID-e. Ti ključni elementi so bili objavljeni na spletni strani EMEA (ref. št.
English: • History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Slovenian: • anamneza o kakršnihkoli resnih alergijskih reakcijah na zdravila, zlasti o kožnih reakcijah, kot so multiformni eritem, Stevens-Johnsonov sindrom in toksična epidermalna nekroliza,
English: DEMO ABEE 21st Km National Road Athens-Lamia 14565 Greece
Slovenian: DEMO ABEE 21st Km National Road Athens-Lamia 14565 Grčija
English: Peristeri 12134 Greece
Slovenian: Peristeri 12134 Grčija
English: 04010 Borgo San Michele (Lt) Italy
Slovenian: 04010 Borgo San Michele (Lt) Italija
English: Pallini Attiki 15351 Greece
Slovenian: Pallini Attiki 15351 Grčija
English: United Kingdom Tillomed Laboratories Limited 3 Howard Road, Eaton Socon St. Neots, Cambs PE19 3ET United Kingdom
Slovenian: Tillomed Laboratories Limited 3 Howard Road, Eaton Socon St. Neots, Cambs PE19 3ET Velika Britanija
English: Nycomed Belgium S.A. 615, Chaussee De Gand B-1080 Bruxelles Belgium
Slovenian: Nycomed Belgium S.A. 615, Chaussee De Gand B-1080 Bruxelles Belgija
English: United Kingdom Pfizer Limited Walton Oaks, Dorking Road
Slovenian: Pfizer Limited Walton Oaks, Dorking Road
English: United Kingdom Sandoz Limited
Slovenian: Sandoz Limited
English: • 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).”
Slovenian: • če ste v preteklosti imeli resno alergijsko reakcijo na piroksikam, kateri drugi nesteroidni antirevmatik ali druga zdravila, zlasti resne kožne reakcije (ne glede na to, kako hude so bile), na primer eksfoliativni dermatitis (izrazito kožno rdečico, pri kateri se koža lušči v obliki lusk ali plasti), vezikulo-bulozne reakcije (Stevens-Johnsonov sindrom, obolenje z rdečo, mehurjasto, razjedeno, krvavo ali krastavo kožo) in toksično epidermalno nekrolizo (bolezen, pri kateri nastajajo na koži mehurji in se lušči njen vrhnji sloj).''
English: Merck Dura Gmbh Alsfelder Str. 19 D-64289 Darmstadt Germany
Slovenian: Merck Dura Gmbh Alsfelder Str. 19 D-64289 Darmstadt Nemčija
English: Kela Laboratoria N.V. Sint Lenaartseweg 48/4 B-2320 Hoogstraten Belgium
Slovenian: Sint Lenaartseweg 48/4 B-2320 Hoogstraten Belgija
English: Piroxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.”
Slovenian: Zdravljenje s piroksikamom je treba ukiniti takoj, ko se pojavijo kožni izpuščaj, spremembe na sluznicah ali katerikoli drugi znak preobčutljivosti.''
English: Farmaceutici Caber S.P.A. Viale Citta' D'europa, 681 00100 Roma
Slovenian: Viale Citta' D'europa, 681 00100 Roma
English: D-89070 Ulm Germany
Slovenian: D-89070 Ulm Nemčija
English: Innotech International 7-9, Avenue François-Vincent Raspail Bp 32, 94111 Arcueil Cedex France
Slovenian: Innotech International 7-9, Avenue François-Vincent Raspail Bp 32, 94111 Arcueil Cedex Francija
English: Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).”
Slovenian: Protitrombocitna zdravila in selektivni zaviralci ponovnega privzema serotonina (SSRI): povečano tveganje krvavitve v prebavilih (glejte poglavje 4.4).''
English: 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.
Slovenian: Piroksikam [izmišljeno ime] je zdravilo za lajšanje nekaterih simptomov osteoartritisa (artroze, degenerativne sklepne bolezni), revmatoidnega artritisa in ankilozirajočega spondilitisa (revmatičnega obolenja hrbtenice), na primer otekanja, togosti in bolečine v sklepih.
English: Dermal use
Slovenian: Dermalna uporaba
English: Medochemie Ltd Pobox 51409, 3505 Lemesos, Cyprus
Slovenian: Medochemie Ltd Pobox 51409, 3505 Lemesos, Ciper
English: Las Matas 28290 Madrid Spain
Slovenian: 28290 Madrid Španija
English: 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.”
Slovenian: Ker se je pokazalo, da je piroksikam povezan s povečanim tveganjem zapletov v prebavilih, je treba zlasti pri starejših bolnikih skrbno presoditi o potrebi po kombiniranem zdravljenju z zdravili z zaščitnim delovanjem na želodec (na primer z mizoprostolom ali zaviralcem protonske črpalke).''
English: NSAIDs, including piroxicam, can cause serious gastrointestinal events including bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal.
Slovenian: Nesteroidni antirevmatiki, tudi piroksikam, lahko povzročijo resne zaplete v prebavilih, tudi krvavitev, razjedo in predrtje želodca, tankega črevesa ali debelega črevesa, ki so lahko usodni.
English: • If you are taking other NSAIDs, including COX-2 selective NSAIDs and acetyl-salicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Slovenian: • če jemljete druge nesteroidne antirevmatike, vključno s takšnimi, ki delujejo selektivno na ciklooksigenazo 2 in acetilsalicilno kislino, učinkovino, ki jo vsebujejo številna zdravila za lajšanje bolečine in proti vročini;
English: 5, Rue Charles Martigny, Bp 42, 94702 Maisons-Alfort Cedex
Slovenian: 5, Rue Charles Martigny, Bp 42, 94702 Maisons-Alfort Cedex Francija
English: Feldene 20 (20mg Capsules)
Slovenian: Feldene 20 (20mg Kapsulas)
English: Pro.Med.Cs Praha A.S. Telčská 1
Slovenian: Pro.Med.Cs Praha A.S.
English: Abz-Pharma Gmbh Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Slovenian: Abz-Pharma Gmbh Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren Nemčija
English: Gottlieb-Daimler-Strasse 19 891 50 Laichingen Germany
Slovenian: Gottlieb-Daimler-Strasse 19 891 50 Laichingen Nemčija
English: S.C. Sintofarm S.A. Str. Ziduri Intre Vii Nr.22 Sector 2, Bucurest Romania
Slovenian: Str. Ziduri Intre Vii Nr.22 Sector 2, Bucurest Romunija
English: “Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms.
Slovenian: '' Neželene učinke lahko zmanjšamo na minimum, tako da uporabimo najmanjši učinkoviti odmerek in ga dajemo najkrajši možni čas, potreben za odpravo simptomov.
English: Se-104 35 Stockholm Sweden
Slovenian: Se-104 35 Stockholm Švedska
English: The clinical benefit and tolerability should be re-evaluated periodically and treatment should be immediately discontinued at the first appearance of cutaneous reactions or relevant gastrointestinal events.”
Slovenian: Klinično korist in prenašanje je treba preverjati v rednih časovnih razmikih in zdravljenje nemudoma ukiniti, če se pojavijo kožne reakcije ali večji zapleti v prebavilih.''
English: These sections of the Package Leaflet are the ones that were Annexed to the Commission Decision on this Article 31 referral .
Slovenian: Ta razdelek Navodil za uporabo je bil priložen k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu s členom 31.
English: Box 205, N-1372 Asker 0010 Oslo
Slovenian: Nycomed Pharma As P.O. Box 205, N-1372 Asker 0010 Oslo
English: 20144 Milano Italy
Slovenian: 20144 Milano Italija
English: 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.
Slovenian: Besedilo odstavka o indikacijah, ki se nanaša na osteoartritis, revmatoidni artritis in ankilozirajoči spondilitis, se mora glasiti: ''Piroksikam je indiciran za zmanjšanje simptomov osteoartritisa, revmatoidnega artritisa ali ankilozirajočega spondilitisa.
English: Sopharma Ad Iliensko Shose Str. 16 1220 Sofia Bulgaria
Slovenian: Sopharma Ad Iliensko Shose Str. 16 1220 Sofia Bolgarija
English: Cephalon France 20, Rue Charles Martigny 94701 Maisons-Alfort Cedex France
Slovenian: Cephalon France 20, Rue Charles Martigny 94701 Maisons-Alfort Cedex Francija
English: Laboratoires S.M.B S. S.A. Rue De La Pastorale 16/28 B-1080 Brussels Belgium
Slovenian: Laboratoires S.M.B S. S.A. Rue De La Pastorale 16/28 B-1080 Brussels Belgija
English: Tableta
Slovenian: Tablet
English: You should immediately stop taking piroxicam and tell your doctor if you have stomach pain, or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements, or vomiting blood.
Slovenian: Piroksikam morate nemudoma prenehati jemati in se posvetovati z zdravnikom, če se bodo pojavili želodčna bolečina ali znaki krvavitve v želodcu ali črevesu, kot so na primer črno blato ali kri v blatu, ali če boste bruhali kri.
English: Smb Laboratories 26-28 Rue De La Pastorale B-1080 Bruxelles Belgium
Slovenian: Smb Laboratories 26-28 Rue De La Pastorale B-1080 Bruxelles Belgija
English: - A Direct Healthcare Professional Communication (DHPC) must be sent to all Health Care Professionals who prescribe piroxicam according to national practice.
Slovenian: - Vsem zdravstvenim delavcem, ki predpisujejo piroksikam v skladu z nacionalno prakso, mora biti poslano neposredno sporočilo za zdravstveno osebje (Direct Healthcare Professional
English: Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms.
Slovenian: Neželene učinke lahko zmanjšamo na minimum, tako da uporabimo najmanjši učinkoviti odmerek in ga dajemo najkrajši možni čas, potreben za odpravo simptomov.
English: • Hypersensitivity to the active substance, previous skin reaction (regardless of severity) to piroxicam, other NSAIDs and other medications.”
Slovenian: • preobčutljivost za zdravilno učinkovino, kožna reakcija (ne glede na resnost) po jemanju piroksikama,drugega nesteroidnega antirevmatika ali drugih zdravil v preteklosti.''
English: D-25870 Norderfriedrichskoog
Slovenian: D-25870 Norderfriedrichskoog Nemčija
English: − prescription of piroxicam should only be initiated by those physicians with experience in diagnostic evaluation and treatment of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis;
Slovenian: − piroksikam smejo uvesti samo zdravniki, ki imajo izkušnje z diagnostičnim ocenjevanjem in zdravljenjem osteoartritisa, revmatoidnega artritisa ali ankilozirajočega spondilitisa;
English: 11347, Post Box 23033 SE-10435 Stockholm Sweden
Slovenian: 11347, Post Box 23033 SE-10435 Stockholm Švedska
English: “Tell your doctor about any other medicines you are taking or took recently (in the last week) - even medicines you bought yourself without a prescription.
Slovenian: Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Abc Farmaceutici S.P.A. Corso Vittorio Emanuele Ii, 72 10121 Torino
Slovenian: Corso Vittorio Emanuele Ii, 72 10121 Torino
English: The European Commission considered it to be in the interest of public health to perform a new benefit/risk assessment of piroxicam.
Slovenian: Evropska komisija je ocenila, da je izvedba ponovnega vrednotenja razmerja med koristmi in tveganji za piroksikam v interesu javnega zdravja.
English: 17, Boulevards De La Plaine B-1050 Bruxelles Belgium
Slovenian: 17, Boulevards De La Plaine B-1050 Bruxelles Belgija
English: Evidence from observational studies suggests that piroxicam may be associated with a higher risk of serious skin reactions than other non-oxicam NSAIDs.
Slovenian: Podatki opazovalnih raziskav kažejo, da bi bil lahko piroksikam povezan z večjim tveganjem resnih kožnih reakcij kot drugi neoksikamski nesteroidni antirevmatiki.
English: 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.
Slovenian: CHMP je dne 21. junija 2007 odločil, da epidemiološke študije nakazujejo, da so sistemske formulacije piroksikama povezane z večjim tveganjem za resno gastrointestinalno toksičnost kot drugi NSAID-i in večjim tveganjem za resne kožne reakcije kot drugi neoksikamski NSAID-i. Iz tega razloga je Odbor oblikoval več priporočil, ki so navedena v nadaljevanju.
English: Kent Ct13 9nj United Kingdom
Slovenian: Kent Ct13 9nj
English: Bruxicam 0,5% 0.50% Eye Drops, Solution Ocular
Slovenian: Bruxicam 0,5% 0.50% Kapljice za oko, raztopina
English: 500 mg/50 g Cream
Slovenian: 500 mg/50 g Krema
English: Viale G. Richard, 7 20143 Milano Italy
Slovenian: Viale G. Rictrda, 7 20143 Milano Italija
English: Boulevard De La Plaine 17 B-1050 Brussels Belgium
Slovenian: Boulevard De La Plaine 17 B-1050 Brussels Belgija
English: • Concomitant use with other NSAIDs, including COX-2 selective NSAIDs and acetyl-salicylic acid at analgesic doses.
Slovenian: • sočasna uporaba z drugimi nesteroidnimi antirevmatiki, tudi nesteroidnimi antirevmatiki s selektivnim delovanjem na ciklooksigenazo 2 in acetilsalicilno kislino v analgetičnih odmerkih,
English: Ratiopharm Gmbh Graf-Arco Strasse 3 D-89070 Ulm Germany
Slovenian: Ratiopharm Gmbh Graf-Arco Strasse 3 D-89070 Ulm Nemčija
English: Patients and physicians should remain alerted for signs and symptoms of GI ulceration and/or bleeding during piroxicam treatment.
Slovenian: Bolniki in zdravniki morajo biti med zdravljenjem s piroksikamom pozorni na pojav znakov ali simptomov razjede ali krvavitve v prebavilih.
English: − piroxicam is no longer a first line option should an NSAID be indicated;
Slovenian: − v primeru indikacije za NSAID piroksikam ni več terapija prve izbire;
English: Therefore, the use of piroxicam with concomitant anticoagulant such as warfarin should be avoided.
Slovenian: Zato se je treba izogibati uporabi piroksikama ob sočasnem dajanju antikoagulansa, na primer varfarina (glejte poglavje 4.3).
English: Your doctor may prescribe piroxicam with another medicine to protect your stomach and intestine for potential side effects.
Slovenian: Zdravnik vam lahko hkrati s piroksikamom predpiše drugo zdravilo, ki bo preprečilo možne neželene učinke na želodec ali črevo.
English: • 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).
Slovenian: • če imate ali ste imeli anamnezo o boleznih prebavil (želodčno ali črevesno vnetje), ki povečajo nevarnost krvavitve, kot so na primer ulcerozni kolitis, Crohnova bolezen, rak prebavil, divertikulitis (vnetje ali okužba žepastih mešičkov v kolonu);
English: Pfizer Aps Lautrupvang 8 Dk-2750 Ballerup Denmark
Slovenian: Pfizer Aps Lautrupvang 8 Dk-2750 Ballerup Danska
English: − 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.
Slovenian: − Ob upoštevanju razpoložljivih podatkov je Odbor zaključil, da v primerjavi z drugimi NSAIDi kot skupino obstaja pri sistemskih formulacijah piroksikama povečano tveganje za gastrointestinalne in resne kožne reakcije.
English: Trinity Chiesi Pharmaceuticals Ltd Cheadle Royal Business Park Highfield, Cheadle Sk8 3gy United Kingdom
Slovenian: Trinity Chiesi Pharmaceuticals Ltd Cheadle Royal Business Park Highfield, Cheadle Sk8 3gy Veliak Britanija
English: Pfizer Aps Lautrupvang 8 Dk 2750 Ballerup Denmark
Slovenian: Pfizer Aps Lautrupvang 8 Dk 2750 Ballerup Danska
English: Rua Dos Malhões Nº 1 2770-071 Paço De Arcos Portugal
Slovenian: 2770-071 Paço De Arcos Portugalska
English: Edificio Euromadrid
Slovenian: Edificio Euromadrid Las Matas
English: • Patients with active peptic ulcer, inflammatory gastrointestinal disorder or gastrointestinal bleeding.
Slovenian: • bolniki z aktivno peptično razjedo, vnetno boleznijo prebavil ali krvavitvijo v prebavilih,
English: Str. Victor Babes Nr.50 Baia Mare, Jud Maramures Romania
Slovenian: Baia Mare, Jud Maramures Romunija
English: 75014 Paris France
Slovenian: 75012 Paris Francija
English: Tad Pharma Gmbh Heinz-Lohmann-Str. 5 D-27472 Cuxhaven
Slovenian: Tad Pharma Gmbh Heinz-Lohmann-Str. 5 D-27472 Cuxhaven Nemčija
English: CT-Arzneimittel Gmbh Lengeder Str. 42a D-13407 Berlin Germany
Slovenian: CT-Arzneimittel Gmbh Lengeder Str. 42a D-13407 Berlin Nemčija
English: Ct-Arzneimittel Gmbh Lengeder Str. 42a D-13407 Berlin Germany
Slovenian: Ct-Arzneimittel Gmbh Lengeder Str. 42a D-13407 Berlin Nemčija
English: Cream
Slovenian: Krema
English: “Always use piroxicam exactly as your doctor has told you.
Slovenian: ''Pri jemanju piroksikama natančno upoštevajte zdravnikova navodila.
English: Box 158 Skøyen N-0212 Oslo Norway
Slovenian: Alpharma P.O. Box 158 Skøyen N-0212 Oslo Norveška
English: 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.
Slovenian: V Povzetek glavnih značilnosti zdravila in Navodilo za uporabo je bilo dodanih več omejitev uporabe, dodatnih opozoril in kontraindikacij v zvezi z varnostjo za prebavni trakt in kožo.
English: 10mg/gm Cream
Slovenian: 10mg/gm Krema
English: DO NOT TAKE PIROXICAM:
Slovenian: NE JEMLJITE PIROKSIKAMA:
English: Slovakofarma As Nitrianská 100 92027 Hlomovec Hungary
Slovenian: 92027 Hlomovec Madžarska
English: Ratiopharm Gmbh Graf-Arco-Str. 3 D-89079 Ulm Germany
Slovenian: Ratiopharm Gmbh Graf-Arco-Str. 3 D-89079 Ulm Nemčija
English: 0.5g/50g - 50g Cream
Slovenian: 0.5g/50g - 50g Krema
English: 3640 Ae Mijdrecht The Netherlands
Slovenian: 3640 Ae Mijdrecht Nizozemska
English: These key elements were published on the EMEA website (Doc ref: EMEA/CHMP/343456/2005).
Slovenian: : EMEA/CHMP/343456/2005).
English: NSAID exposures of both short and long duration have an increased risk of serious GI event.
Slovenian: Kratkotrajna in dolgotrajna izpostavljenost nesteroidnim antirevmatikom poveča tveganje resnega zapleta v prebavilih.
English: Sandoz S.P.A. Largo Boccioni, 1 21040 Origgio (Va) Italy
Slovenian: Largo Boccioni, 1 21040 Origgio (Va) Italija
English: Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Slovenian: Walton-0n-The-Hill Surrey KT20 7NS Velika Britanija
English: Laboratorios Faes Farma Sa Maximo Aguirre, 14 48940 Lamiaco-Lejona Spain
Slovenian: Laboratorios Faes Farma Sa Maximo Aguirre, 14 48940 Lamiaco-Lejona Španija
English: 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).
Slovenian: V povezavi z uporabo nesteroidnih antirevmatikov so zelo redko poročali o resnih kožnih reakcijah, tudi eksfoliativnem dermatitisu, Stevens-Johnsonovem sindromu in toksični epidermalni nekrolizi, ki so bili v nekaterih primerih usodni (glejte poglavje 4.8).
English: HOW TO TAKE PIROXICAM
Slovenian: KAKO JEMATI PIROKSIKAM
English: 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).
Slovenian: Tveganje resnih zapletov v prebavilih je povečano pri bolnikih, ki sočasno jemljejo peroralne kortikosteroide, selektivne zaviralce ponovnega privzema serotonina (SSRI) ali protitrombocitna zdravila, na primer majhne odmerke acetilsalicilne kisline (glejte nadaljevanje in poglavje 4.5).
English: Via Giacomo Chiesi 43100 Parma Italy
Slovenian: Via Giacomo Chiesi 43100 Parma Italija
English: The following indications must be deleted from this section:
Slovenian: Iz tega poglavja je treba v skladu z besedilom v poglavju 4.1 izbrisati navodila o odmerjanju za naslednje indikacije:
English: Merckle Gmbh Ludwig-Merckle-Strasse 3 P.O.
Slovenian: Merckle Gmbh Ludwig-Merckle-Strasse 3 P.O. Box 1161
English: H-1106, Budapest Hungary
Slovenian: H-1106, Budapest Madžarska
English: • “If you previously had a stomach or intestinal ulcer, bleeding or perforation.
Slovenian: • če ste imeli v preteklosti želodčno ali črevesno razjedo, krvavitev ali predrtje;
English: 10 mg/1 g Cream
Slovenian: 10 mg/1 g Krema
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR SYSTEMIC FORMULATIONS OF PIROXICAM CONTAINING MEDICINAL PRODUCTS
Slovenian: DOPOLNILA, KI JIH JE TREBA DODATI USTREZNIM POGLAVJEM POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA PRI ZDRAVILIH ZA SISTEMSKO ZDRAVLJENJE, KI VSEBUJEJO PIROKSIKAM
English: • If you currently have stomach or intestinal ulcer, bleeding or perforation.
Slovenian: • če imate želodčno ali črevesno razjedo, krvavitev ali predrtje;
English: Feldene Capsules 10 Mg
Slovenian: Feldene Kapsulas 10 Mg
English: “Gastrointestinal (GI) Effects, Risk of GI Ulceration, Bleeding, and Perforation.
Slovenian: ''Učinki na prebavila, tveganje razjede v prebavilih, krvavitve in predrtja.
English: United Kingdom Manx Healthcare Taylor Group House Wedgnock Lane
Slovenian: Manx Healthcare Taylor Group House Wedgnock Lane Warwick CV34 5YA Velika Britanija
English: Chiesi Farmaceutici Spa, Via Palermo, 26/A 43100 Parma Italy
Slovenian: Chiesi Farmaceutici Spa, Via Palermo, 26/A 43100 Parma Italija
English: Felcam20 mg/cap Hard capsules
Slovenian: Felcam20 mg/cap Kapsula, trda
English: • Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers or diverticulitis.
Slovenian: • anamneza o boleznih prebavil, ki povečajo nevarnost krvavitev, kot so ulcerozni kolitis, Crohnova bolezen, rak v prebavilih ali divertikulitis,
English: Chiesi España, S.A. Av. Berlin, 38-48 7ª Planta 08029 Barcelona Spain
Slovenian: Av. Berlin, 38-48 7ª Planta 08029 Barcelona Španija
English: Kapsula
Slovenian: Kapsulas uporaba