FrancophonIA/ELRC3.0 huggingface dataset:
English: Lornoxicam was tested in 34 pain studies with 7,761 patients.
Slovenian: Lornoksikam je bil preizkušan v 34 raziskavah bolečin s 7761 bolniki.
English: SPC recommendations
Slovenian: Priporočila SPC
English: (No interaction between lornoxicam and ranitidine, or lornoxicam and antacids has been demonstrated).
Slovenian: (Ni dokazanih interakcij med lornoksikamom in ranitidinom ali med lornoksikamom in antacidi).
English: Interaction with other medicinal products and other forms of interaction - Section 4.5
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij - poglavje 4.5
English: Therapeutic indication - osteoarthritis (OA)
Slovenian: Terapevtska indikacija - osteoartritis (OA)
English: Preclinical safety data - Section 5.3 The divergences between the MS have been harmonised.
Slovenian: Predklinični podatki o varnosti - poglavje 5.3 Razhajanja med državami članicami so bila usklajena.
English: Listed below are undesirable effects which generally occurred in more than 0.05% of the 6.417 patients treated in clinical phase II, III and IV trials.
Slovenian: V nadaljevanju so našteti neželeni učinki, ki so se na splošno pojavili pri več kot 0,05 % od 6.417 bolnikov, ki so prejemali lornoksikam v kliničnih preskusih faze II, III in IV.
English: - the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: - Povzetek glavnih značilnosti zdravila, označevanje in Navodilo za uporabo, ki jih je predlagal imetnik dovoljenja za promet, so bili ocenjeni na podlagi posredovane dokumentacije in znanstvene razprave v okviru Odbora,
English: Incidence by dose was: 17.0% (8mg), 27.0% (12mg) and 22.7% (16mg).
Slovenian: Pogostost glede na odmerek: 17,0 % (8 mg), 27,0 % (12 mg) in 22,7 % (16 mg).
English: The absolute bioavailability of lornoxicam is 90-100 %.
Slovenian: Absolutna biološka razpoložljivost lornoksikama je 90-100 %.
English: Laboratorios Andromaco SA, Doctor Zamenhof 36, 29027 Madrid, Spain
Slovenian: Laboratorios Andromaco SA, Doctor Zamenhof 36, 29027 Madrid, Španija
English: Food may decrease the absorption with about 20% and increase Tmax.
Slovenian: Hrana lahko zmanjša absorpcijo zdravila za približno 20 % in podaljša Tmax.
English: Any risk is more likely with high doses and prolonged treatment.
Slovenian: Tveganje je verjetnejše pri uporabi višjih odmerkov in dolgotrajnem zdravljenju.
English: TOTPAR = total pain relief, SPID = sum of pain intensity differences, IMP = overall impression
Slovenian: TOTPAR = popolna ublažitev bolečine, SPID = vsota razlik v intenziteti bolečine, IMP = celokupni vtis
English: Of the total number of patients 57.8% (7,046/12,192) received lornoxicam (see Table below).
Slovenian: Od skupnega števila bolnikov jih je 57,8 % (7046 od 12.192) prejemalo lornoksikam (glejte spodnjo tabelo).
English: The usual emergency measures including gastric lavage should be considered.
Slovenian: Preučiti je treba možnost uporabe običajnih ukrepov v nujnih primerih, vključno z gastrično lavažo.
English: A total of 21% of the patients had at least one ADR.
Slovenian: Skupno 21 % bolnikov je imelo vsaj en neželen učinek.
English: Effects on ability to drive and use machines - Section 4.7
Slovenian: Vpliv na sposobnost vožnje in upravljanja s stroji - poglavje 4.7
English: Clinical monitoring at regular intervals is recommended.
Slovenian: Priporočeno je klinično spremljanje v rednih intervalih.
English: Lornoxicam is absorbed rapidly and almost completely from the gastrointestinal tract.
Slovenian: Lornoksikam se hitro in skoraj popolnoma absorbira iz gastrointestninalnega trakta.
English: Difficulties with data interpretation due to differences in the applied methodology such as dose regimens, study designs and durations of treatment, resulted in only 4 of these studies being considered applicable for a scientifically sound overall analysis of efficacy data - meta analysis.
Slovenian: Iz težav pri interpretaciji podatkov zaradi razlik v uporabljeni metodologiji, na primer v shemah odmerjanja, načrtovanju raziskav in trajanju zdravljenja, izhaja, da so samo 4 od teh raziskav uporabne za znanstveno trdno celokupno analizo podatkov o učinkovitosti - metaanalizo.
English: The third died from myocardial infarction.
Slovenian: Tretji je umrl zaradi miokardnega infarkta.
English: The frequency of death per patient year for lornoxicam was 0.007; the corresponding number for active comparator treatment was almost three times as high (0.020).
Slovenian: Frekvenca smrti na bolnik-leto je bila pri lornoksikamu 0,007; ustrezno število pri zdravljenju s primerjalno učinkovino je bilo skoraj trikrat večje (0,020).
English: The reason for exclusion of study CT32 is not clear (it was included in meta-analysis 2; single doses were applied post surgery).
Slovenian: Razlog za izključitev raziskave CT32 ni jasen (bila je vključena v 2. metaanalizi; enkratni odmerki so bili dajani postoperativno).
English: Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment.
Slovenian: Največja nevarnost za pojav teh reakcij je v zgodnji fazi zdravljenja, saj se v večini primerov reakcija pojavi v prvem mesecu zdravljenja.
English: Nycomed Danmark ApS, Langebjerg 1, 4000 Roskilde, Denmark
Slovenian: Nycomed Danmark ApS, Langebjerg 1, 4000 Roskilde, Danska
English: Based on these data it appears that a higher initial dose of lornoxicam - QR may be justified.
Slovenian: Iz teh podatkov izhaja, da utegne biti večji začetni odmerek lornoksikama - QR utemeljen.
English: The effect on TOTPAR and PPRA with 2 mg and 4 mg in study CT01 was not significantly different from placebo.
Slovenian: Učinek na TOTPAR in PPRA z 2 mg in 4 mg v raziskavi CT01 ni bil pomembno različen od placeba.
English: - Long term treatment (longer than 3 months): Regular laboratory assessments of haematology (haemoglobin), renal functions (creatinine) and liver enzymes are recommended.
Slovenian: - Dolgoročno zdravljenje (daljše od 3 mesecev): Priporočamo redne laboratorijske preiskave hematologije (hemoglobin), ledvične funkcije (kreatinin) in jetrnih encimov.
English: Nycomed UK Ltd., The Magdalen Centre Oxford Science Park, OX4 4GA Oxford, United Kingdom
Slovenian: Nycomed UK Ltd., The Magdalen Centre Oxford Science Park, OX4 4GA Oxford, Združeno kraljestvo
English: Due to the divergent national decisions taken by the Member States concerning the authorisation of the above-mentioned product, Nycomed Danmark ApS notified the EMEA of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised Product Information (SPCs, PLs and labellings) for the above-mentioned product and thus to harmonise the Product Information (SPCs, PLs and labellings) and Quality documentation across the EU
Slovenian: Zaradi razhajajočih se nacionalnih odločitev, ki so jih sprejele države članice glede odobritve zgoraj navedenega zdravila, je Nycomed Danmark ApS agencijo EMEA obvestil o uradnem napotitvenem postopku v skladu s členom 30 Direktive 2001/83/ES, kot je bila spremenjena, z namenom razrešitve razhajanj med nacionalno odobrenimi Informacijami o zdravilu (SPC, Navodili za uporabo in označevanji) za zgoraj navedeno zdravilo in z namenom usklajevanja Informacij o zdravilu (SPC, Navodila za uporabo in označevanj) ter dokumentacije o kakovosti v celotni EU.
English: In addition, to reaching an agreement on the main quality part of the SPC (shelf-life, storage conditions), the CHMP also took the opportunity to harmonise the Quality documentation concerning a number of minor issues related to the Drug Substance and Finished Product manufacturing and control.
Slovenian: Poleg doseganja sporazuma o glavnem delu SPC o kakovosti (rok uporabnosti, pogoji shranjevanja) je CHMP izkoristil priložnost tudi za usklajevanje dokumentacije o kakovosti v zvezi s številnimi manjšimi težavami glede izdelave in kontrole zdravilne učinkovine in končnega izdelka.
English: As for all NSAIDs, gastro-intestinal (GI) events were the most frequent (14%) followed by central nervous system (CNS), Peripheral nervous system (PNS), Psychiatric (Psych) (6%), Other (2%), Whole body (2%) and Skin (1%).
Slovenian: Pri vseh NSAID so bili najpogostejši gastrointestinalni dogodki (14 %), sledili so dogodki osrednjega živčnega sistema, perifernega živčnega sistema, psihiatrični dogodki (6 %), drugo (2 %), dogodki z učinkom na celotno telo (2 %) in kožo (1 %).
English: A comparison of significance levels in the original data and in meta-analysis 2 was not performed and is missing in the response.
Slovenian: Primerjava ravni pomembnosti izvirnih podatkov in 2. metaanalize ni bila izvedena, zato manjka v odzivu.
English: The osmolarity of the reconstituted solution is about 328 mosmol/kg and pH is about 8.7
Slovenian: Osmolarnost pripravljene raztopine je 328 mosmol/kg, pH je približno 8,7.
English: On the other hand the parameter IMP (general impression) analysed in meta-analysis 3 is a week efficacy parameter, which can only be considered as supportive to the TOTPAR analysis and the judgement on efficacy has to be based mainly on meta-analysis 1 and 2.
Slovenian: Na drugi strani pa je parameter IMP (splošni vtis), ki je bil analiziran v 3. metaanalizi, parameter tedenske učinkovitosti in ga lahko štejemo kot podporo analizi TOTPAR, ocena učinkovitosti pa mora temeljiti pretežno na 1. in 2. metaanalizi.
English: Nycomed Italy S.r.l., Via Carducci 125, Edificio A, 20099 Sesto San Giovanni, Italy
Slovenian: Nycomed Italy S.r.l., Via Carducci 125, Edificio A, 20099 Sesto San Giovanni, Italija
English: Each blister strip contains 10 film-coated tablets.
Slovenian: Vsak pretisni trak vsebuje 10 filmsko obloženih tablet.
English: In study CT02 there was no significant difference in TOTPAR between groups in the ITT population, but between placebo and active treatment in the PP-population.
Slovenian: V raziskavi CT02 ni bilo pomembne razlike pri popolni ublažitvi bolečine (TOTPAR) med skupinami v populaciji ITT, bila pa je med placebom in aktivnim zdravljenjem v populaciji PP.
English: Adults: The recommended dose is 8 mg i.v.
Slovenian: Odrasli: Priporočeni odmerek je 8 mg i.v.
English: The construction of a dose-dependence up to 16 mg depends on 2 studies.
Slovenian: Konstrukt odvisnosti od odmerka do 16 mg temelji na dveh raziskavah.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking the medicinal product
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred jemanjem zdravila posvetujte s svojim zdravnikom.
English: • Safety issues
Slovenian: Varnostni vidiki
English: Instruction for use and handling
Slovenian: Navodila za uporabo in ravnanje
English: The elimination half-life of 5-hydroxylornoxicam is about 9 hours after a parenteral single or twice daily dose.
Slovenian: Povprečna razpolovna doba eliminacije 5-hidroksilornoksikama je približno 9 ur po parenteralnem dajanju enkratnega ali dvakratnega dnevnega odmerka.
English: Therapeutic indication - pain
Slovenian: Terapevtska indikacija - bolečine
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF XEFO AND ASSOCIATED NAMES (see Annex I)
Slovenian: SPLOŠEN POVZETEK ZNANSTVENE OCENE ZDRAVILA XEFO IN Z NJIM POVEZANIH IMEN (glejte Dodatek I)
English: Nycomed Christians, Gentsesteenweg 615, 1080 Brussels, Belgium
Slovenian: Nycomed Christians, Gentsesteenweg 615, 1080 Brussels, Belgija
English: The recent PhVWP core information regarding cardiovascular safety of NSAIDs (January 2007) has also been taken into account.
Slovenian: Upoštevane so bile tudi nedavne osrednje informacije, ki jih je priskrbela delovna skupina PhVWP, v zvezi s kardiovaskularno varnostjo NSAID (januar 2007).
English: Nycomed SEFA, Jaama 55B, 63308 Pölva, Estonia
Slovenian: Nycomed SEFA, Jaama 55B, 63308 Pölva, Estonija
English: Undesirable effects - Section 4.8
Slovenian: Neželeni učinki - poglavje 4.8
English: The medicinal product is for single use only
Slovenian: Zdravilo je samo za enkratno uporabo.
English: Nycomed AB, Tegeluddsvägen 17-21, 102 53 Stockholm, Sweden
Slovenian: Nycomed AB, Tegeluddsvägen 17-21, 102 53 Stockholm, Švedska
English: A meta-analysis consisting of three parts was performed to assess the overall analgesic effect of lornoxicam.
Slovenian: Metaanaliza, sestavljena iz treh delov, je bila izvedena za oceno celokupnega analgetičnega učinka lornoksikama.
English: It is common practice when initiating acute pain treatment with NSAIDs to start treatment with a high first dose (e.g., double dose) in order to obtain a significant reduction of the pain from the beginning of the treatment.
Slovenian: Ob začetku zdravljenja akutnih bolečin z NSAID se zdravljenje običajno začne z visokim prvim odmerkom (npr. dvojnim odmerkom), da se bolečina od začetka zdravljenja bistveno zmanjša.
English: Reactions of liver and haematology have all been mild.
Slovenian: Vse reakcije jeter in hematologije so bile blage.
English: Due to differences in study designs and dosage regimens, only 4 of these studies (CT18, CT33, CT63, CT80) were selected for a retrospective comprehensive evaluation.
Slovenian: Zaradi razlik v načrtovanju raziskav in shemah odmerjanja so bile samo 4 od teh raziskav (CT18, CT33, CT63, CT80) izbrane za retrospektivno izčrpno ovrednotenje.
English: Whole body
Slovenian: Na celotno telo
English: The clinical development program for the effect of lornoxicam against pain consisted of 27 studies.
Slovenian: Klinični razvojni program v zvezi z učinkovitostjo lornoksikama proti bolečinam je obsegal 27 raziskav.
English: - Elderly patients above 65 years: Monitoring of renal and hepatic function is recommended.
Slovenian: - Starostniki, starejši od 65 let: Priporočamo spremljanje ledvične in jetrne funkcije.
English: 4.2 Posology and method of administration For all patients the appropriate dosing regimen should be based upon individual response to treatment.
Slovenian: 4.2 Odmerjanje in način uporabe Pri vseh bolnikih režim odmerjanja prilagodimo odzivu posameznika na zdravljenje.
English: A central effect on nociception which seems to be independent of anti-inflammatory effects has also been suggested.
Slovenian: Domnevajo, da ima tudi osrednji učinek nocicepcije, ki je neodvisen od protivnetnih učinkov.
English: There are no adequate data from the use of lornoxicam in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi lornoksikama pri nosečnicah.
English: Nycomed Hellas S.A., 196 Kifissias Avenue, 15231 Athens, Greece
Slovenian: Nycomed Hellas S.A., 196 Kifissias Avenue, 15231 Athens, Grčija
English: In addition, the use of the endpoint overall impression, which was used as a secondary endpoint in all studies in meta-analysis 3 can not convincingly support the MAH approach for a general indication for pain relief.
Slovenian: Poleg tega uporaba pokazatelja celokupnega vtisa, ki je bil uporabljen kot sekundarni pokazatelj v vseh raziskavah, vključenih v 3. metaanalizo, ne more prepričljivo podpreti pristopa imetnika dovoljenja za promet za splošno indikacijo za lajšanje bolečin.
English: At this time, there is no experience of overdose to permit definition of the consequence of an overdose, or to suggest specific managements.
Slovenian: Trenutno ni poročil o primerih prevelikega odmerjanja, kar onemogoča opredelitev posledic prevelikega odmerjanja ali priporočil o specifični obravnavi takšnega stanja.
English: Euro-Labor SA, Rua Alfredo da Silva no16, 2610-016 Amadora, Portugal
Slovenian: Euro-Labor SA, Rua Alfredo da Silva no16, 2610-016 Amadora, Portugalska
English: Lornoxicam has no effect on vital signs (e.g. body temperature, respiratory rate, heart rate, blood pressure, ECG, spirometry).
Slovenian: Lornoksikam ne vpliva na vitalne znake (npr. telesno temperaturo, hitrost dihanja, krvni tlak, EKG, spirometrijo).
English: Another three cases were caused by cardiovascular events and occurred in patients with rheumatological disorders participating in long-term studies.
Slovenian: Drugi trije smrtni primeri so nastali zaradi kardiovaskularnih dogodkov in sicer pri bolnikih z revmatološkimi motnjami, ki so sodelovali v dolgoročnih raziskavah.
English: Maximum plasma concentrations are achieved after approximately 30 minutes.
Slovenian: Najvišje plazemske koncentracije doseže po približno 30 minutah.
English: BATCH NUMBER
Slovenian: ŠTEVILKA SERIJE Batch
English: Treatment with lornoxicam should be discontinued if renal function deteriorates during treatment.
Slovenian: Zdravljenje z lornoksikamom morate prekiniti, če se med zdravljenjem delovanje ledvic poslabša.
English: The MAH has applied the PhVWP core information for NSAIDs in relation to gastrointestinal safety, skin reactions and cardiovascular safety (October 2005).
Slovenian: Imetnik dovoljenja za promet je uporabil osrednje informacije za NSAID, ki jih je priskrbela delovna skupina PhVWP, v zvezi z gastrointestinalno varnostjo, kožnimi reakcijami in kardiovaskularno varnostjo (oktober 2005).
English: For all the pharmaceutical forms and strengths of lornoxicam It was agreed that the following would be included: - Methotrexate: Increased serum concentration of methotrexate.
Slovenian: Za vse farmacevtske oblike in jakosti lornoksikama Dogovorjeno je bilo, da se vključi naslednje: - Metotreksat: Povečana koncentracija metotreksata v serumu.
English: Nycomed Austria GmbH, St. Peter Strasse 25, 4020 Linz, Austria
Slovenian: Nycomed Austria GmbH, St. Peter Strasse 25, 4020 Linz, Avstrija
English: Only 2/7 studies included a 16 mg dose and only 1/7 study included a 32 mg dose.
Slovenian: Samo 2 od 7 raziskav sta vključevali 16 mg odmerek in samo ena od 7 raziskav je vključevala 32 mg odmerek.
English: Concomitant intake of food may reduce the uptake of the medicinal product.
Slovenian: Sočasno uživanje hrane lahko zmanjša privzem zdravila.
English: Uncommon: Increase in liver function tests, SGPT (ALT) or SGOT (AST).
Slovenian: Občasni: zvišane ravni v preiskavah jetrne funkcije, SGPT (ALT) ali SGOT (AST).
English: After IM injection, maximum plasma concentrations are achieved after approximately 0.4 hours.
Slovenian: injiciranju doseže najvišje plazemske koncentracije po približno 0,4 ure.
English: Metabolic/Endocrine
Slovenian: Presnovni/endokrini
English: If visible signs of deterioration are seen in the medicinal product, the product must be disposed of in accordance with local requirements
Slovenian: Če ima zdravilo vidne znake kvarjenja, ga zavrzite v skladu z lokalnimi predpisi.
English: When tested in animal models, lornoxicam did not induce liver enzymes.
Slovenian: V poskusih na živalskih modelih lornoksikam ni induciral jetrnih encimov.
English: The analgesic properties of lornoxicam have been demonstrated successfully in several clinical trials during development of the drug.
Slovenian: Analgetične lastnosti lornoksikama so uspešno dokazali v več kliničnih preskušanjih v fazah razvoja zdravila.
English: The aim of the overall analysis (meta-analysis) was to compare the efficacy of different dosages of lornoxicam with comparator drugs or placebo, in a cohort of RA patients.
Slovenian: Cilj celokupne analize (metaanalize) je bila primerjava učinkovitosti različnih odmerkov lornoksikama s primerjalnimi zdravili ali placebom v skupini bolnikov z RA.
English: - Beta-adrenergic blockers: Decreased antihypertensive efficacy.
Slovenian: - Zaviralci beta-adrenergičnih receptorjev: Zmanjšana antihipertenzivna učinkovitost.
English: The absolute bioavailability (calculated on AUC) after IM administration is 97 %
Slovenian: Absolutna biološka razpoložljivost (izračunana na osnovi AUC) po i.m.
English: Lornoxicam is metabolised completely, and approximately 2/3 is eliminated via the liver and 1/3 via the kidneys as inactive substance.
Slovenian: Lornoksikam se popolnoma presnovi: približno 2/3 se ga izloči preko jeter, 1/3 pa preko ledvic v obliki neaktivne snovi.
English: Treatment of rheumatoid arthritis has been approved by 16/16 Member States (AT, BE, CZ, DE, DK, EE, ES, GR, HU, IT, LT, LV, PT, SE, UK).
Slovenian: Zdravljenje revmatoidnega artritisa je odobrilo 16 od 16 držav članic (AT, BE, CZ, DE, DK, EE, ES, GR, HU, IT, LT, LV, PT, SE, UK).
English: - Digoxin: Decreased renal clearance of digoxin.
Slovenian: - Digoksin: Zmanjšan ledvični očistek digoksina.
English: The classic rheumatology disorders were investigated in 26 studies with 3,621 patients: 12 studies in rheumatoid arthritis (RA), 8 studies in osteoarthritis (OA), 3 in both indications and 3 in other rheumatology indications (i.e. ankylosing spondylitis (AKS), non-arthritic rheumatism and acute gout).
Slovenian: Klasične revmatološke bolezni so preučevali v 26 raziskavah s 3621 bolniki: 12 raziskavah revmatoidnega artritisa (RA), 8 raziskavah osteoartritisa (OA), 3 v obeh indikacijah in 3 v drugih revmatoloških indikacijah (npr. ankilozni spondilitis (AKS), neartritični revmatizem in akutni urični artritis).
English: After oral administration about 50% is excreted in the faeces and 42% through the kidneys, mainly as 5-hydroxylornoxicam.
Slovenian: Pri peroralnem dajanju se približno 50 % odmerka izloči v blatu in 42 % preko ledvic, v glavnem kot 5-hidroksilornoksikam.
English: Nycomed Pharma GmbH, Edisonstrasse 16, 85716 Unterschleissheim, Germany
Slovenian: Nycomed Pharma GmbH, Edisonstrasse 16, 85716 Unterschleissheim, Nemčija
English: 4 of 7 studies investigated the efficacy in third molar surgery pain (and three of these studies were already included in meta-analysis
Slovenian: V 4 od 7 raziskav je bila preučevana učinkovitost glede bolečine pri operativni odstranitvi modrostnih zob (tri od teh raziskav so bile že vključene v 1. metaanalizo).
English: Treatment of osteoarthritis has been approved by 14/16 Member States (AT, BE, CZ, DE, DK, ES, GR, HU, LT, LV, PT, SE, UK).
Slovenian: Zdravljenje osteoartritisa je odobrilo 14 od 16 držav članic (AT, BE, CZ, DE, DK, ES, GR, HU, LT, LV, PT, SE, UK).
English: Powder: Yellow, solid substance
Slovenian: Prašek: rumena trdna snov
English: Lornoxicam is found in the plasma in unchanged form and as its hydroxylated metabolite.
Slovenian: Lornoksikam se nahaja v plazmi v nespremenjeni obliki ter kot hidroksiliran presnovek.
English: The duration of blinded treatment was 4 weeks for studies CT18 and CT80 and 12 weeks for CT33 and CT63.
Slovenian: Slepo zdravljenje je pri raziskavah CT18 in CT80 trajalo 4 tedne, pri raziskavah CT33 in CT63 pa 12 tednov.
English: Very rare: Hepatocellular damage.
Slovenian: Zelo redki: hepatocelične poškodbe.
English: Data from 103 clinical studies were included in the SDB including 57 double-blind studies, 4 singleblind studies and 50 open studies of which 8 were follow-up to randomised studies.
Slovenian: V zbirko podatkov o varnosti so bili vključeni podatki iz 103 kliničnih raziskav, vključno s 57 dvojno slepimi raziskavami, 4 enojno slepimi raziskavami in 50 odprtimi raziskavami, od katerih jih je bilo 8 nadaljevanje randomiziranih raziskav.
English: Thus meta-analysis 3 does not essentially contribute to the MAH's claim for an unrestricted use of lornoxicam in the treatment of pain.
Slovenian: Zato 3. metaanaliza ne prispeva bistveno k zahtevi imetnika dovoljenja za promet za neomejeno uporabo lornoksikama pri zdravljenju bolečin.
English: It increased by duration of treatment (0.3%, 0.5% and 1.9% for short-, medium- and long-term treatment, respectively) and was influenced by the vulnerability of patients with chronic diseases in long-term treatment: The majority of patients with SADR had RA or were elderly patients included in post-operative pain studies such as hip replacement.
Slovenian: Povečevala se je s trajanjem zdravljenja (0,3 % pri kratkoročnem zdravljenju, 0,5 % pri srednjeročnem zdravljenju in 1,9 % pri dolgoročnem zdravljenju); nanjo je vplivala občutljivost bolnikov s kroničnimi boleznimi pri dolgoročnem zdravljenju: Večina bolnikov z resnimi neželenimi učinki je imela RA oz. so bili starejši bolniki, ki so bili vključeni v postoperativne raziskave bolečin, npr. po zamenjavi kolka.