natgillin/translations-raw huggingface dataset:
Posology relating to the indications as outlined in section 4.1 should read as follows:
Besedilo o odmerjanju, ki se nanaša na indikacije, naštete v poglavju 4.1, se mora glasiti:
− 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.
− nadaljnji ukrepi za zmanjšanje tveganja vključujejo omejitev odmerka piroksikama na 20 mg dnevno in priporočila, naj zdravljenje bolnikov traja najkrajši možni čas, potreben za lajšanje simptomov, s preverjanjem najpozneje v 14 dneh.
Your doctor will give you a regular check-up to make sure you are taking the optimal dose of piroxicam.
Zdravnik vas bo redno pregledoval, da bi zagotovil, da jemljete optimalni odmerek piroksikama.
Maramures Romania
Maramures Romunija
“Skin reactions
''Kožne reakcije
Tallinna Farmaatsiatehase As 33 Tondi Street Ee - 11316, Tallinn Estonia
Tallinna Farmaatsiatehase As 33 Tondi Street Ee - 11316, Tallinn Estonija
Carretera De Barcelona 2 46132 Almacera Spain
Carretera De Barcelona 2 46132 Almacera Španija
25125 Brescia Italy
25125 Brescia Italija
You should not take this medicine if you are older than 80 years.
Če ste starejši od 80 let, tega zdravila ne smete jemati.
The risk for developing serious GI complications increases with age.
Tveganje razvoja resnih zapletov v prebavilih se s starostjo veča.
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.
Iz tega razloga je Evropska komisija poslala obvestilo, ki ga je EMEA prejela 2. avgusta 2006, v skladu s katerim je bil 21. septembra 2006 sprožen napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES, kot je bila spremenjena.
2300 Ak Leiden The Netherlands
2300 Ak Leiden Nizozemska
00-895 Warszawa Poland
00-895 Warszawa Poljska
Kraanlei 27-29 B-900 Gent Belgium
Kraanlei 27-29 B-900 Gent Belgija
WHAT IS PIROXICAM [Invented name] AND WHAT IT IS USED FOR
KAJ JE PIROKSIKAM (izmišljeno ime) IN ZA KAJ GA UPORABLJAMO
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.
Piroksikam zaradi svojega varnostnega profila (glejte poglavja 4.2, 4.3 in 4.4) ni zdravilo prve izbire, kadar je indiciran nesteroidni antirevmatik.
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).”
Odločitev o zdravljenju s piroksikamom mora temeljiti na oceni splošnega tveganja pri posameznem bolniku (glejte poglavji 4.3 in 4.4).''
De Europa, 20 B 28108 Alcobendas Madrid Spain
De Europa, 20 B 28108 Alcobendas Madrid Španija
Human studies have shown that concomitant use of piroxicam and acetyl-salicylic acid reduces the plasma piroxicam concentration to about 80% of the usual value
Raziskave pri ljudeh so pokazale, da se pri sočasni uporabi piroksikama in acetilsalicilne kisline koncentracija piroksikama v plazmi zmanjša na približno 80 % običajne vrednosti.
4.4 Special Warnings and Special Precautions for Use
4.4 Posebna opozorila in previdnostni ukrepi
3508 Limassol Cyprus
3508 Limassol Ciper
Via Aurelia, 58 00165 Roma Italy
Via Aurelia, 58 00165 Roma Italija
− 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;
− piroksikam se zaradi dolgega razpolovnega časa 50 ur in varnostnega profila ne sme uporabljati za zdravljenje akutnih stanj, saj so na voljo enako učinkovita, a varnejša zdravila;
Biomedica-Chemica G. Lyra 25, Kato Kifissia Greece
Biomedica-Chemica G. Lyra 25, Kato Kifissia Grčija
If you have any further questions on the use of this product, ask your doctor.”
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom.
V.Emanuele, 73 88074 Crotone (Kr) Italy
V.Emanuele, 73 88074 Crotone (Kr) Italija
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.
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.
20041 Agrate Brianza (Mi) Italy
20041 Agrate Brianza (Mi) Italija
Karib House 63-65 Imperial Way Cr9 4qy Croydon, Surrey United Kingdom
Karib House 63-65 Imperial Way Cr9 4qy Croydon, Surrey Velika Britanija
However a need to further evaluate the benefit/risk balance of some non-selective NSAIDs including piroxicam was identified.
Ugotovljena pa je bila tudi potreba po nadaljnji presoji razmerja med koristmi in tveganji za nekatere neselektivne NSAID-e, vključno s piroksikamom.
Areta 31620 Huarte Pamplona Spain
Areta 31620 Huarte Pamplona Španija
89143 Blaubeuren Germany
89143 Blaubeuren Nemčija
Beverley, E Yorks HU17 0LD
Beverley, E Yorks HU17 0LD Velika Britanija
16147 Genova Italy
16147 Genova Italija
Make sure you have told your doctor about any other medicines that you are taking, including those that you have bought without a prescription.”
Zdravnika obvestite o vseh drugih zdravilih, ki jih jemljete, tudi če ste jih kupili brez recept..''
B-2610 Wilrijk Belgium
B-2610 Wilrijk Belgija
• If you are taking anticoagulants, such as warfarin, to prevent blood clots.
• če jemljete antikoagulanse, na primer varfarin, za preprečevanje nastajanja krvnih strdkov;
48 81379, München
48 81379, München Nemčija
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.
Če imate ali ste imeli kakršnekoli zdravstvene težave ali alergije ali ne veste, če lahko jemljete piroksikam, se posvetujte z zdravnikom.
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.
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.
If you feel that the medicine is not very effective, always talk to your doctor.
Če menite, da je zdravilo premalo učinkovito, se posvetujte z zdravnikom.
Pharmapartner Nv Kolonel Begaultlaan 16 B-3012 Leuven Belgium
Pharmapartner Nv Kolonel Begaultlaan 16 B-3012 Leuven Belgija
If you forget to use piroxicam:
Če ste pozabili vzeti piroksikam:
Str. Stirbei Voda Nr. 53-55 Sector 1, Bucuresti Romania
Str. Stirbei Voda Nr. 53-55 Sector 1, Bucuresti Romunija
Via Orazio, 20/22 80122 Napoli Italy
Via Orazio, 20/22 80122 Napoli Italija
The maximum recommended daily dose is 20 mg.
Največji priporočeni dnevni odmerek je 20 mg.
4823 Ae Breda The Netherlands
4823 Ae Breda Nizozemska
Brusselsesteenweg 288 B-3090 Overijse Belgium
Brusselsesteenweg 288 B-3090 Overijse Belgija
Via Tranquillo Cremona 10 20092 Cinisello Balsamo (Mi) Italy
Via Tranquillo Cremona 10 20092 Cinisello Balsamo (Mi) Italija
- If any of these applies to you tell your doctor immediately.”
- Če jemljete katerokoli od naštetih zdravil, nemudoma obvestite svojega zdravnika.''
N-1324 Lysaker
N-1324 Lysaker Norveška
1504 Lefkosia Cyprus
1504 Lefkosia Ciper
1070-325 Lisboa
1070-325 Lisboa Portugalska
Sandoz B.V Veluwezoon 22 1327 Ah Almere The Netherlands
Sandoz B.V Veluwezoon 22 1327 Ah Almere Nizozemska
2800 Bd Gouda The Netherlands
2800 Bd Gouda Nizozemska
4870 Ag Etten Leur The Netherlands
4870 Ag Etten Leur Nizozemska
Avenue Jules Bordet 168 B-1140 Brussels Belgium
Avenue Jules Bordet 168 B-1140 Brussels Belgija
Under no circumstances should you change the dose without first speaking to your doctor.
Odmerka brez posveta z zdravnikom nikakor ne smete spremeniti.
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.
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.
Av. D. João Ii Lote 1.02.2.1 D - 2º 1990-090 Lisboa Portugal
Av. D. João Ii Lote 1.02.2.1 D - 2º 1990-090 Lisboa Portugalska
Via Mario Lalli, 8 56127 Pisa Italy
Via Mario Lalli, 8 56127 Pisa Italija
Epifarma S.R.L Via S.Rocco, 6 85033 Episcopia Pz Italy
Epifarma S.R.L Via S.Rocco, 6 85033 Episcopia Pz Italija
1500 Gb Zaandam The Netherlands
1500 Gb Zaandam Nizozemska
S.C. Labormed-Pharma S.A. Splaiul Independentei Nr. 319e Sector 6, Bucuresti Romania
S.C. Labormed-Pharma S.A. Splaiul Independentei Nr. 319e Sector 6, Bucuresti Romunija
Hampshire Gu35 9qe United Kingdom
Hampshire Gu35 9qe Velika Britanija
S.C. Terapia S.A. Str. Fabricii Nr.124 Cluj-Napoca Jud.
Str. Fabricii Nr.124 Cluj-Napoca Jud.
“Before prescribing piroxicam, your doctor will assess the benefits this medicine may give you against your risk of developing side effects.
''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.
Faran Abee Achaias & Troizinias New Kifissia 14564 Greece
Faran Abee Achaias & Troizinias New Kifissia 14564 Grčija
Hexal A/S Kanalholmen 8-12 Dk-2650 Hvidovre Denmark
Hexal A/S Kanalholmen 8-12 Dk-2650 Hvidovre Danska
Cipla (Uk) Limited 53a High Street Esher Surrey Kt10 9qr United Kingdom
Cipla (Uk) Limited 53a High Street Esher Surrey Kt10 9qr Velika Britanija
Ratiopharm Belgium S.A. Rue Saint-Lambert 141 B-1200 Bruxelle Belgium
Ratiopharm Belgium S.A. Rue Saint-Lambert 141 B-1200 Bruxelle Belgija
11, Avenue Dubonnet 92400 Courbevoie France
11, Avenue Dubonnet 92400 Courbevoie Francija
Telecom Ardens - Medialaan 40 B-1800 Vilvoorde Belgium
Telecom Ardens - Medialaan 40 B-1800 Vilvoorde Belgija
B-Ul Timisoara Nr.50 Sector 6, Bucuresti Romania
B-Ul Timisoara Nr.50 Sector 6, Bucuresti Romunija
C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Denmark
C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Danska
08007 Barcelona Spain
08007 Barcelona Španija
“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.
''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.
Thurzó U. 5/C 1133 Budapest Hungary
Thurzó U. 5/C 1133 Budapest Madžarska
Parnithos Avenue 189 Acharnai Attiki 13671 Greece
Parnithos Avenue 189 Acharnai Attiki 13671 Grčija
Diestersteenweg 349 B-3510 Hasselt Belgium
Diestersteenweg 349 B-3510 Hasselt Belgija
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.
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.
Expanpharm International 6, rue de la Rochefoucauld 16000 Angouleme France
Expanpharm International 6, rue de la Rochefoucauld 16000 Angouleme Francija
Ivax Pharmaceuticals 34, Avenue Franklin Roosevelt 92150 Suresnes France
Ivax Pharmaceuticals 34, Avenue Franklin Roosevelt 92150 Suresnes Francija
18, Rue Du Docteur Ragnaud 16000 Angoulême France
18, Rue Du Docteur Ragnaud 16000 Angoulême Francija
Isleworth, Middx TW7 4QJ
Isleworth, Middx TW7 4QJ Velika Britanija
Norma Hellas Ae Menandrou 54 Athens 10431 Greece
Norma Hellas Ae Menandrou 54 Athens 10431 Grčija
Alpharma A/S Harbitzalleen 3 158 Skoyen 0212 Oslo Norway
Alpharma A/S Harbitzalleen 3 158 Skoyen 0212 Oslo Norveška
1, Cours Du Triangle, 92936 Paris La Défense Cedex France
1, Cours Du Triangle, 92936 Paris La Défense Cedex Francija
179, Bureaux De La Colline 92213 Saint-Cloud Cedex France
179, Bureaux De La Colline 92213 Saint-Cloud Cedex Francija
Wincentego Pola 21 58-500 Jelenia Gora Poland
Wincentego Pola 21 58-500 Jelenia Gora Poljska
Pierre Fabre Medicament 45, Place Abel Gance 92654 Boulogne Cedex France
Pierre Fabre Medicament 45, Place Abel Gance 92654 Boulogne Cedex Francija
Biogal-Teva Pharma Rákóczi U. 70-72 1074 Budapest Hungary
Biogal-Teva Pharma Rákóczi U. 70-72 1074 Budapest Madžarska
D-76139 Karlsruhe Germany
D-76139 Karlsruhe Nemčija
D-22761 Hamburg Germany
D-22761 Hamburg Nemčija
Leuvensestraat 28 Bus 2 B-1800 Vilvoorde Belgium
Leuvensestraat 28 Bus 2 B-1800 Vilvoorde Belgija
Anti-coagulants: NSAIDs, including piroxicam, may enhance the effects of anti-coagulants, such as warfarin.
Antikoagulansi: nesteroidni antirevmatiki, tudi piroksikam, lahko povečajo učinke antikoagulansov, kot je varfarin.
Patients with significant risk factors for serious GI events should be treated with piroxicam only after careful consideration (See sections 4.3 and below).
Bolnike z večjimi dejavniki tveganja za resne zaplete v prebavilih smemo zdraviti s piroksikamom le po skrbnem premisleku (glejte poglavje 4.3 in nadaljevanje).
Po Box 217, 3640 Ae Mijdrecht The Netherlands
Po Box 217, 3640 Ae Mijdrecht Nizozemska
New Psychiko 15451 Greece
New Psychiko 15451 Grčija
Quartiere Varignano, 12 - 13 - 14 55049 Viareggio (Lu) Italy
Quartiere Varignano, 12 - 13 - 14 55049 Viareggio (Lu) Italija
Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No.7, Hardicker Street M19 2rb Manchester United Kingdom
Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No.7, Trdaicker Street M19 2rb Manchester Velika Britanija
49, Avenue Georges Pompidou 92300 Levallois-Perret France
49, Avenue Georges Pompidou 92300 Levallois-Perret Francija
18038 Villa Sayonara - Sanremo (Im) Italy
18038 Villa Sayonara - Sanremo (Im) Italija
Odiham, Hampshire RG29 1LF United Kingdom
Odiham, Hampshire RG29 1LF Velika Britanija
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.
Morda vam bo moral predpisati kontrolne preglede in vam bo povedal, kako pogosto jih boste morali imeti med jemanjem piroksikama.
− The CHMP concluded that the benefit/risk balance of systemic formulations of piroxicam containing medicinal products in the agreed restricted indications is favourable.
− CHMP je sklenil, da je razmerje med koristmi in tveganji za zdravila, ki vsebujejo sistemske formulacije piroksikama, pri odobrenih omejenih indikacijah ugodno.
Gounari 25 & Areos Kamatero Attiki 13451 Greece
Gounari 25 & Areos Kamatero Attiki 13451 Grčija
Laboratoire Pharmy II 26 rue des Gaudines 78100 Saint-Germain-Laye France
Laboratoire Pharmy II 26 rue des Gaudines 78100 Saint-Germain-Laye Francija
Pfizer Hellas Ae 243 Mesogion Ave, 15451 N. Psychiko Greece
Pfizer Hellas Ae 243 Mesogion Ave, 15451 N. Psychiko Grčija
Barbera Del Valles 08210 Barcelona Spain
Barbera Del Valles 08210 Barcelona
38 Princes Court 88 Brompton Road Knightsbridge, SW3 1ES London United Kingdom
38 Princes Court 88 Brompton Road Knightsbridge, SW3 1ES London Velika Britanija
− 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 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.
Patients should be asked to report any new or unusual abdominal symptom during treatment.
Bolnike je treba poučiti, da morajo zdravnika med zdravljenjem obvestiti o vseh novih ali neobičajnih trebušnih simptomih.
Identification of at-risk subjects
Odkrivanje bolnikov s povečanim tveganjem
If a gastrointestinal complication is suspected during treatment, piroxicam should be discontinued immediately and additional clinical evaluation and treatment should be considered.”
Če zdravnik med zdravljenjem posumi na zaplet v prebavilih, mora piroksikam nemudoma ukiniti in ponovno presoditi o dodatni klinični oceni in zdravljenju.''
72028 Torre Santa Susanna (Br) Italy
72028 Torre Santa Susanna (Br) Italija
“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).
''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).
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.
Našteti resni neželeni dogodki se lahko pri bolnikih, ki se zdravijo z nesteroidnimi antirevmatiki pojavijo ob kateremkoli času, z opozorilnimi simptomi ali brez njih.
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.
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.
“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.
''Zdravljenje s piroksikamom smejo uvesti le zdravniki, ki imajo izkušnje z diagnostično oceno in zdravljenjem bolnikov z vnetnimi ali degenerativnimi revmatičnimi boleznimi.
Athens-Lamia 14565 Greece
Athens-Lamia 14565 Grčija
Doc Generici Srl Via Manuzio, 7 20124 Milano Italy
Doc Generici Srl Via Manuzio, 7 20124 Milano Italija
Your doctor will prescribe piroxicam to you only when you have had unsatisfactory relief of symptoms with other non-steroidal anti-inflammatory medicines (NSAIDs).”
Zdravnik vam bo piroksikam predpisal le, če vam simptomov niso dovolj ublažili drugi nesteroidni antirevmatiki.''
Overton, Hampshire RG25 3ED United Kingdom
Overton, Hampshire RG25 3ED Velika Britanija
Strada Statale 156 Km 50 04010 Borgo San Michele (Lt) Italy
Strada Statale 156 Km 50 04010 Borgo San Michele (Lt) Italija
Metamorfosi Attiki 14452 Greece
Metamorfosi Attiki 14452 Grčija
D-42781 Haan Germany
D-42781 Haan Nemčija
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.
Piroksikam morate nemudoma prenehati jemati in obvestiti zdravnika, če boste opazili kakršnokoli alergijsko reakcijo, na primer kožni izpuščaj, otekanje obraza, piskanje ali oteženo dihanje.
Se-102 53 Stockholm Sweden
Se-102 53 Stockholm Švedska
43100 Parma Italy
43100 Parma Italija
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.
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.
D-82256 Fürstenfeldbruck Germany
D-82256 Fürstenfeldbruck Nemčija
Via Di Scandicci, 37 50143 Firenze Italy
Via Di Scandicci, 37 50143 Firenze Italija
Luoizalaan 149 Bus 4 B-1050 Brussels Belgium
Luoizalaan 149 Bus 4 B-1050 Brussels Belgija
− The CHMP agreed that no restrictions were required with regards to topical formulations of piroxicam and the benefit/risk balance remains favourable.
− CHMP je sklenil, da omejitve pri topičnih formulacijah piroksikama niso potrebne, razmerje med koristmi in tveganji pa ostaja ugodno.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Kortikosteroidi: povečano tveganje razjed ali krvavitev v prebavilih (glejte poglavje 4.4).
The maximum daily dose is 20 milligrams of piroxicam as one single daily dose.
Največji dnevni odmerek je 20 miligramov piroksikama v enem odmerku na dan.
Do not increase the dose
Odmerka ne povečujte.
Serious GI Complications
Resni zapleti v prebavilih
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).
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.
− 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;
− 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;
United Kingdom Pharmvit Limited Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ United Kingdom
Pharmvit Limited Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ Velika Britanija
Hexal Pharma Gmbh Carlbergergasse 44 1235 Wien Austria
Hexal Pharma Gmbh Carlbergergasse 44 1235 Wien Avstrija
Laboratorios Salvat S.A.Gallo, 30-36 08950 Barcelona Spain
Laboratorios Salvat S.A.Gallo, 30-36 08950 Barcelona Španija
Laboratorios Robert, S.A. Gran Via Carlos Iii 94 08028 Barcelona Spain
Laboratorios Robert, S.A. Gran Via Carlos Iii 94 08028 Barcelona Španija
D- 76437 Rastatt Germany
D- 76437 Rastatt Nemčija
Topgen Esv E.Demunterlaan 1/8 B-1090 Brussels Belgium
Topgen Esv E.Demunterlaan 1/8 B-1090 Brussels Belgija
The CHMP reviewed the data submitted by Marketing Authorisation Holders from clinical trials, epidemiological studies, and spontaneous reporting of adverse drug reactions.
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.
20092 Cinisello Balsamo (Mi)
20092 Cinisello Balsamo (Mi) Italija