natgillin/translations-raw huggingface dataset:
Piroxicam Dispersible Tablets 20mg
Piroxicam Tableta za
Tablet for oral solution
Tableta za peroralno
Waymade Plc Sovereign House
Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR Velika Britanija
Piroxicam 0.5% Gel
0. 5% Gel
0.5% w/ w
0. 5% w/ w Gel
Miles Gray Road Basildon, Essex SS14 3FR United Kingdom United Kingdom
Velika Britanija
Neolab Limited 57 High Street Odiham, Hampshire RG29 1LF United Kingdom
Neolab Limited 57 High Street Odiham, Hampshire RG29 1LF Velika Britanija
Piroxicam 0.5%
0. 5% Gel
Dr Reddy's Laboratories (Uk) Limited 6 Riverview Road Beverley, E Yorks HU17 0LD United Kingdom
Dr Reddy' s Laboratories (Uk) Limited 6 Riverview Road Beverley, E Yorks HU17 0LD Velika Britanija
Trinity-Chiesi Pharmaceuticals Limited Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY United Kingdom
Trinity- Chiesi Pharmaceuticals Limited Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY Velika Britanija
Brexidol 20mg Tablets
Brexidol Tablets
Brexidol 20 Mg
20 Mg
Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY United Kingdom
Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY Velika Britanija
Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB United Kingdom
Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB Velika Britanija
Neots, Cambs PE19 3ET United Kingdom
Neots, Cambs PE19 3ET Velika Britanija
Neots, Cambs PE19 3ET United Kingdom United Kingdom
Velika Britanija
Manx Healthcare Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom
Manx Healthcare Taylor Group House Wedgnock Lane Warwick CV34 5YA Velika Britanija
Teva Pharma Bv Industrieweg 23 Po Box 217 3640 Ae Mijdrecht The Netherlands
Teva Pharma Bv Industrieweg 23 Po Box 217 3640 Ae Mijdrecht Nozozemska
Flamatrol Capsules
Flamatrol 10mg Kapsulas
Teva Pharma Bv Industrieweg 23 Po Box 217 3640 Ae Mijdrecht The Netherlands
Teva Pharma Bv Industrieweg 23 Po Box 217 3640 Ae Mijdrecht Nizozemska
Flamatrol Capsules
Flamatrol 20mg Kapsulas
Pfizer Consumer Healthcare Walton Oaks Dorking Road Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Pfizer Consumer Healthcare Walton Oaks Dorking Road Walton- 0n- The- Hill Surrey KT20 7NS Velika Britanija
Piroxicam Bp 10mg
Piroxicam Kapsulas Bp 10mg
94 Member State
94 Member State
Overton, Hampshire RG25 3ED United Kingdom United Kingdom
Overton, Hampshire RG25 3ED Velika Britanija Velika Britanija
Strides Arcolab International Limited 201 Jersey Road Isleworth, Middx TW7 4QJ United Kingdom
Strides Arcolab International Limited 201 Jersey Road Isleworth, Middx TW7 4QJ Velika Britanija
Piroxicam Capsules
Piroxicam Kapsulas
95 ANNEX II
95 DODATEK II
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)
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, VSEBUJOČIH PIROKSIKAM (glejte Dodatek I)
Further to a request from the European Commission the CHMP reviewed safety data on non-selective NSAIDs.
Na podlagi zahteve Evropske komisije je CHMP preučil podatke o varnosti neselektivnih NSAID- ov.
This review, which concluded in October 2005, did not reveal any new safety concerns for the class of NSAIDs as a whole.
Ta pregled, ki je bil zaključen oktobra 2005, ni razkril novih pomislekov glede varnosti razreda NSAID- ov kot celote.
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.
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.
These key elements were published on the EMEA website (Doc ref:
Ti ključni elementi so bili objavljeni na spletni strani EMEA (ref. št. dok.:
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.
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.
Pregled je pokazal, da omejeni epidemiološki podatki in podatki iz spontanih poročil o neželenih učinkih zdravila nakazujejo na povečano tveganje gastrointestinalnih in kožnih reakcij (vključno s smrtno nevarnimi buloznimi reakcijami), povezanih z drugimi neselektivnimi NSAID- i.
The CHMP considered that the assessment raised concerns on the benefit/ risk balance of piroxicam and informed the European Commission accordingly.
CHMP je menil, da je ocena vzbudila pomisleke glede razmerja med koristmi in tveganji za piroksikam, ter je skladno s tem obvestil Evropsko komisijo.
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:
„ 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. dok.:
The European Commission considered it to be in the interest of public health to perform a new benefit/ risk assessment of piroxicam.
Evropska komisija je ocenila, da je izvedba ponovnega vrednotenja razmerja med koristmi in tveganji za piroksikam v interesu javnega zdravja.
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.
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.
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.
Therefore the Committee has made a number of recommendations as outlined below.
Iz tega razloga je Odbor oblikoval več priporočil, ki so navedena v nadaljevanju.
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.
− 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.
− 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; − koristi piroksikama pri simptomatskem lajšanju osteoartritisa, revmatoidnega artritisa ali ankilozirajočega spondilitisa so večje od z njim povezanih tveganj; − v primeru indikacije za NSAID piroksikam ni več terapija prve izbire; − piroksikam smejo uvesti samo zdravniki, ki imajo izkušnje z diagnostičnim ocenjevanjem in zdravljenjem osteoartritisa, revmatoidnega artritisa ali ankilozirajočega spondilitisa; − 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; − 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.
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.
Pri vseh bolnikih, še zlasti pa pri starejših, je treba temeljito pretehtati tudi kombinirano zdravljenje z učinkovinami za zaščito prebavnega trakta (npr. z mizoprostolom ali zaviralci protonske črpalke).
Ref.
726/ 2004, izdane oktobra 2006 in objavljene na spletni strani EMEA (ref. št. dok.
EMEA/ 413136/ 2006) remain valid for piroxicam containing medicinal products.
EMEA/ 413136/ 2006) ostanejo v veljavi za zdravila, ki vsebujejo piroksikam.
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.
− The CHMP considered the referral made under article 31of Directive 2001/ 83/ EC, as amended, for medicinal products containing piroxicam.
− CHMP je obravnaval napotitev v skladu s členom 31 Direktive 2001/ 83/ ES, kot je bila spremenjena, za zdravila, ki vsebujejo piroksikam.
− 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.
− Ob upoštevanju razpoložljivih podatkov je Odbor zaključil, da v primerjavi z drugimi NSAID - i kot skupino obstaja pri sistemskih formulacijah piroksikama povečano tveganje za gastrointestinalne in resne kožne reakcije.
− 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.
− 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.
− 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.
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.
AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
DOPOLNILA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
These sections of the Summary of Product Characteristics are the ones that were annexed to the Commission Decision on this Article 31 referral.
Ta razdelek Povzetka glavnih značilnosti zdravila je bil priložen k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu s členom 31.
These sections of the Package Leaflet are the ones that were Annexed to the Commission Decision on this Article 31 referral.
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.
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.
Zaradi tega je možno, da ta zapis ne predstavlja trenutno veljavnega besedila.
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) .”
DOPOLNILA, KI JIH JE TREBA DODATI USTREZNIM POGLAVJEM POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA PRI ZDRAVILIH ZA SISTEMSKO ZDRAVLJENJE, KI VSEBUJEJO PIROKSIKAM
The following indications must be deleted from this section:
4. 1 Terapevtske indikacije
Acute Gout Primary dysmenorrhea Post-operative pain Dental treatment and in the course of infections Relief of fever and pain associated with acute upper respiratory tract inflammation.
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.
Acute musculoskeletal disorders (e. g bursitis, tendonitis) Acute post-traumatic disorders.
Piroksikam zaradi svojega varnostnega profila (glejte poglavja 4. 2, 4. 3 in 4. 4) ni zdravilo prve izbire, kadar je indiciran nesteroidni antirevmatik.
Radiculalgia
Iz besedila tega odstavka je treba izbrisati naslednje indikacije: akutna faza protina primarna dismenoreja pooperativna bolečina stomatološki posegi in med okužbami zmanjšanje vročine in bolečine pri akutnem vnetju zgornjih dihalnih poti akutna mišično- skeletna obolenja (na primer burzitis, tendinitis) akutne motnje po poškodbah radikulalgija
4.2 Posology and Method of administration
4. 2 Odmerjanje in način uporabe
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:
“ 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.
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 .”
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). ''
Posology relating to the following indications are to be deleted from this section in line with Section 4.1:
Iz tega poglavja je treba v skladu z besedilom v poglavju 4. 1 izbrisati navodila o odmerjanju za naslednje indikacije:
Acute muscoloskeletal disorders(e. g bursitis, tendonitis) Acute post-traumatic disorders.
akutna faza protina primarna dismenoreja pooperativna bolečina stomatološki posegi in med okužbami zmanjšanje vročine in bolečine pri akutnem vnetju zgornjih dihalnih poti akutna mišično- skeletna obolenja (na primer burzitis, tendinitis) akutne motnje po poškodbah radikulalgija
4.4 Special Warnings and Special Precautions for Use
4. 3 Kontraindikacije... [] …
… []… “ Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms.
''Neželene učinke lahko zmanjšamo na minimum, tako da uporabimo najmanjši učinkoviti odmerek in ga dajemo najkrajši možni čas, potreben za odpravo simptomov.
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 .” … []…
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. ''
… []… “ Gastrointestinal (GI) Effects, Risk of GI Ulceration, Bleeding, and Perforation.
''Učinki na prebavila, tveganje razjede v prebavilih, krvavitve in predrtja.
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).
(see section 4.2).
Skrbno moramo presoditi o morebitni potrebi po kombiniranem zdravljenju z zdravili z zaščitnim delovanjem na želodec (na primer mizoprostolom ali zaviralci protonske črpalke) (glejte poglavje 4. 2).
Serious GI Complications Identification of at-risk subjects The risk for developing serious GI complications increases with age.
Resni zapleti v prebavilih Odkrivanje bolnikov s povečanim tveganjem Tveganje razvoja resnih zapletov v prebavilih se s starostjo veča.
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).
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).
As with other NSAIDs, the use of piroxicam in combination with protective agents (e. g. misoprostol or proton pump inhibitors) must be considered for these at- risk patients.
Pri teh bolnikih s povečanim tveganjem moramo enako kot pri zdravljenju z drugimi nesteroidnimi antirevmatiki presoditi o uporabi piroksikama v kombinaciji z zdravili z zaščitnim delovanjem (na primer mizoprostolom ali zaviralci protonske črpalke).
Patients and physicians should remain alerted for signs and symptoms of GI ulceration and/ or bleeding during piroxicam treatment.
Bolniki in zdravniki morajo biti med zdravljenjem s piroksikamom pozorni na pojav znakov ali simptomov razjede ali krvavitve v prebavilih.
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. ''
… []… “ Skin reactions 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).
''Kožne reakcije 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).
Piroxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity .” … []…
Zdravljenje s piroksikamom je treba ukiniti takoj, ko se pojavijo kožni izpuščaj, spremembe na sluznicah ali katerikoli drugi znak preobčutljivosti. ''
4.5 Interaction with other Medicinal Products and other forms of Interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
… []… “ 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).
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 Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Raziskave pri ljudeh so pokazale, da se pri sočasni uporabi piroksikama in acetilsalicilne kisline koncentracija piroksikama v plazmi zmanjša na približno 80% običajne vrednosti.
Anti-coagulants:
Kortikosteroidi: povečano tveganje razjed ali krvavitev v prebavilih (glejte poglavje 4. 4).
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.
Therefore, the use of piroxicam with concomitant anticoagulant such as warfarin should be avoided.
... [] … DOPOLNILA, KI JIH JE TREBA DODATI USTREZNIM POGLAVJEM V NAVODILU ZA UPORABO PRI ZDRAVILIH ZA SISTEMSKO UPORABO, KI VSEBUJEJO PIROKSIKAM
(see section 4.3).
KAJ JE PIROKSIKAM (izmišljeno ime) IN ZA KAJ GA UPORABLJAMO
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4) .” … []… AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLETFOR SYSTEMIC FORMULATIONS OF PIROXICAM CONTAINING MEDICINAL PRODUCTS
... [] …