natgillin/translations-raw huggingface dataset:
The median age was 71 years (range: 47 to 92) with 78.2% of subjects over 65 years; 65.5% were male, and 90.0% were white; 64.1% had a Rai stage of III or IV, and 55.9% had Binet Stage C. Most subjects had adverse cytogenetic prognostic factors: 43.2% had a 17p chromosomal deletion and/or tumour protein 53 (TP53) mutation, and 83.6% had unmutated genes for the immunoglobulin heavy chain variable region (IGHV). 
Mediana starost je bila 71 let (razpon: 47 do 92), pri čemer je bilo 78,2 % oseb starih več kot 65 let; 65,5 % je bilo moških in 90,0 % jih je bilo belcev; 64,1 % je imelo stadij III ali IV po Raiju, 55,9 % pa jih je imelo stadij C po Binetu.
PFS Median (months) (95% CI) Hazard ratio (95% CI) P-value ORR* n (%) (95% CI) Odds ratio (95% CI) P-value LNR** n/N (%) (95% CI) Odds ratio (95% CI) P-value OS Median (months) (95% CI) 
PFS Mediani čas (v mesecih) (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ) vrednost p ORR* n (%) (95-odstotni IZ) Razmerje verjetnosti (95-odstotni IZ) vrednost p LNR** n/N (%) (95-odstotni IZ) 153/164 (93,3 %) (88,3; 96,6) Razmerje verjetnosti (95-odstotni IZ) vrednost p OS Mediani čas (v mesecih) (95-odstotni IZ)
Zydelig 150 mg film-coated tablets 
IME ZDRAVILA Zydelig 150 mg filmsko obložene tablete
Zydelig 100 mg film-coated tablets 
IME ZDRAVILA Zydelig 100 mg filmsko obložene tablete
Contents of the pack and other information What Zydelig contains 
Shranjevanje zdravila Zydelig Vsebina pakiranja in dodatne informacije
* ORR defined as the proportion of subjects who achieved a complete response (CR) or partial response (PR) and maintained their response for at least 8 weeks. 
Analize PFS, celokupne stopnje odziva (ORR-overall response rate) in stopnje odziva bezgavk (LNR-lymph node response rate) so temeljile na oceni neodvisnega odbora za pregled (IRC-independent review committee) * Vrednost ORR je opredeljena kot delež oseb, ki so dosegle celoviti odziv (CR-complete response) ali delni odziv (PR-partial response) in pri katerih se je odziv ohranil vsaj 8 tednov.
CI: confidence interval; R: rituximab; n: number of responding subjects; N: number of subjects per group; NR: not reached. 
Razmerje tveganja (95-odstotni IZ) vrednost p IZ: interval zaupanja; R: rituksimab; n: število odzivnih oseb; N: število oseb na skupino; ND: ni doseženo.
Tablet core 
OZNAKA NA ŠKATLI
Zydelig 150 mg 
PODATKI V BRAILLOVI PISAVI Zydelig 150 mg
Package leaflet: Information for the patient Zydelig 150 mg film-coated tablets idelalisib 
Navodilo za uporabo Zydelig 150 mg filmsko obložene tablete idelalizib
* ORR defined as the proportion of subjects who achieved a complete response (CR) or partial response (PR) based on the 2013 National Comprehensive Cancer Network (NCCN) response criteria and Cheson (2012). 
Analize PFS, celokupne stopnje odziva (ORR-overall response rate) in stopnje odziva bezgavk (LNR-lymph node response rate) so temeljile na oceni neodvisnega odbora za pregled (IRC-independent review committee) * Vrednost ORR je opredeljena kot delež oseb, ki so dosegle celoviti odziv (CR-complete response) ali delni odziv (PR-partial response) na podlagi kriterijev odziva po NCCN (National Comprehensive Cancer Network)
↑ serum concentrations Clinical monitoring is recommended. 
↑ koncentracij v serumu Priporoča se klinično spremljanje.
Package leaflet: Information for the patient Zydelig 100 mg film-coated tablets idelalisib 
Navodilo za uporabo Zydelig 100 mg filmsko obložene tablete idelalizib
Respiratory, thoracic and mediastinal disorders Pneumonitis 
Bolezni dihal, prsnega koša in mediastinalnega prostora pnevmonitis pogosti pogosti organizirajoča pljučnica občasni občasni
ANTIDEPRESSANTS 
ANTIARITMIKI
PFS median (months) (95% CI) Hazard ratio (95% CI) ORR (95% CI) 
PFS mediani čas (v mesecih) (95-odstotni IZ) 16,4 (13,4; 17,8) Razmerje tveganja (95-odstotni IZ) ORR (95-odstotni IZ)
Other medicines and Zydelig 
Kaj vsebuje zdravilo Zydelig
Caution should be exercised, including consideration of dose reduction, when co-administering tadalafil with idelalisib. 
Pri sočasnem dajanju tadalafila z idelalizibom je potrebna previdnost, vključno z razmislekom o zmanjšanju odmerka.
PHARMACEUTICAL FORM AND CONTENTS 
FARMAKOLOŠKE LASTNOSTI
Idelalisib should not be co-administered with colchicine to patients with renal or hepatic impairment. 
Bolnikom z ledvično ali jetrno okvaro se idelaliziba ne sme dati sočasno s kolhicinom.
28 tablets (7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg) 
28 tablet (7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg)
EU/1/13/836/023 Memantine ratiopharm 5 mg; 10 mg; 
EU/1/13/836/023 Memantin ratiopharm 5 mg; 10 mg;
--1 - Eimeria acervulina, strain 003 - 332-450 sporulated oocysts - Eimeria brunetti, strain 034 - 213-288 sporulated oocysts - Eimeria maxima, strain 013 - 196-265 sporulated oocysts - Eimeria necatrix, strain 033 - 340-460 sporulated oocysts - Eimeria tenella, strain 004 - 276-374 sporulated oocysts 
- Eimeria acervulina, sev 003 - 332 - 450 sporuliranih oocist - Eimeria brunetti, sev 034 - 213 - 288 sporuliranih oocist - Eimeria maxima, sev 013 - 196 - 265 sporuliranih oocist - Eimeria necatrix, sev 033 - 340 - 460 sporuliranih oocist - Eimeria tenella, sev 004 - 276 - 374 sporuliranih oocist
EU (MA) Number 
EU (MA) številka
It was agreed that the following statement would be included: 
Dogovorjeno je bilo, da se vključi naslednja izjava:
Very rare (less than 1 in 10.000 patients treated) 
Zelo redki (pri manj kot 1 od 10.000 zdravljenih bolnikov)
{Name and address} <{tel}> <{fax}> <{e-mail}> 
{Ime in naslov} <{tel}> <{faks}> <{e-pošta}>
Data from table 2.13 in Clinical Safety Report, dated 21 December 2001 
Podatki iz tabele 2.13 poročila o klinični varnosti z dne 21. decembra 2001
From a microbiological point of view, the product should be used immediately. 
Z mikrobiološkega stališča pa je treba zdravilo porabiti nemudoma.
Overall discussion on OA 
Splošna razprava o OA
These patients should commence treatment on the lowest dose available. 
Ti bolniki morajo začeti zdravljenje z najmanjšim razpoložljivim odmerkom.
No differences were observed regarding the SPID parameter. 
V zvezi s parametrom SPID ni bilo opaženih razlik.
No first-pass effect has been observed. 
Učinka prvega prehoda niso opazili.
In case of premature termination, data of last observation were chosen. 
V primeru prezgodnjega zaključka so bili izbrani nazadnje zabeleženi podatki.
Increased toxicity may result. 
Lahko pride do povečane toksičnosti.
Overall discussion on RA With respect to RA, the following can be summarised: 
Splošna razprava o RA Z ozirom na RA je mogoče povzeti naslednje:
Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1000, <1/100); rare (≥1/10.000, <1/1.000); Very rare (<1/10.000). 
Zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000).
Do not exceed the recommended dose of duration of treatment. 
Ne prekoračite priporočenega odmerka ali trajanja zdravljenja.
Statistical analysis was therefore limited to a 4 week treatment phase which, based on international guidelines, is appropriate to assess therapeutic efficacy of NSAIDs in OA. 
Statistična analiza je bila zato omejena na 4-tedensko fazo zdravljenja, ki je glede na mednarodne smernice ustrezna za oceno terapevtske učinkovitosti NSAID pri OA.
Reactions relating to other System organs (SOCs) occurred in less than 1% of the patients. 
Reakcije, povezane z drugimi organskimi sistemi (OS), so se pojavile pri manj kot 1 % bolnikov.
The tablets should be taken before meals. 
Tablete morate vzeti pred obrokom.
In elderly patients above age 65, the clearance is reduced with 30-40%. 
Pri starostnikih nad 65 let je očistek manjši za 30-40 %.
Serious adverse event/deaths/other significant events 
Resni neželeni učinki/smrti/drugi pomembni učinki
Number of Patients by Indication and Treatment 
Število bolnikov glede na indikacijo in zdravljenje
This finding was supported by drug monitoring data from one year studies. 
Ti rezultati se ujemajo s podatki o spremljanju zdravila v obdobju enega leta.
Opaque PVC/Aluminium. 
Neprozoren PVC/aluminij.
2610-016 Amadora, Portugal 
2610-016 Amadora, Portugalska
For this reason a new metaanalysis 3 with the p.o. data alone will not add much to the discussion. 
Zato nova 3. metaanaliza samo s p.o. podatki ne bo veliko prispevala k razpravi.
Included in analysis 
Vključenost v analizo
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 
6.2 Inkompatibilnosti Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
Treatment of osteoarthritis has not been approved by 2/16 Member States (EE, IT). 
Zdravljenja osteoartritisa nista odobrili 2 od 16 držav članic (EE, IT).
These symptoms have generally occurred in less than 10% of patients in available studies. 
V razpoložljivih raziskavah so se ti simptomi na splošno pojavili pri manj kot 10 % bolnikov.
Additional information on special populations 
Dodatni podatki o posebnih populacijah
Overall the Applicant has responded to the questions raised during the procedure in a satisfactory way, although minor deficits exist in the MAH's efficacy and safety database mainly related to small shortterm clinical studies conducted 15-20 years ago. 
V splošnem je vlagatelj na vprašanja, ki so se pojavila med postopkom, odgovoril zadovoljivo, čeprav obstajajo manjše pomanjkljivosti v zbirki podatkov o učinkovitosti in varnosti imetnika dovoljenja za promet, ki so v glavnem povezane z manj obsežnimi kratkotrajnimi kliničnimi raziskavami, izvedenimi pred 15-20 leti.
Studies included in meta-analyses Parameters used 
Raziskave, vključene v metaanalizo Uporabljeni parametri
The MAH's response is considered acceptable and no further data are requested. 
Odgovor imetnika dovoljenja za promet je sprejemljiv, zato nadaljnji podatki niso zahtevani.
Lornoxicam was tested in 34 pain studies with 7,761 patients. 
Lornoksikam je bil preizkušan v 34 raziskavah bolečin s 7761 bolniki.
SPC recommendations 
Priporočila SPC
(No interaction between lornoxicam and ranitidine, or lornoxicam and antacids has been demonstrated). 
(Ni dokazanih interakcij med lornoksikamom in ranitidinom ali med lornoksikamom in antacidi).
Interaction with other medicinal products and other forms of interaction - Section 4.5 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij - poglavje 4.5
Therapeutic indication - osteoarthritis (OA) 
Terapevtska indikacija - osteoartritis (OA)
Preclinical safety data - Section 5.3 The divergences between the MS have been harmonised. 
Predklinični podatki o varnosti - poglavje 5.3 Razhajanja med državami članicami so bila usklajena.
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. 
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.
- 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, 
- 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,
Incidence by dose was: 17.0% (8mg), 27.0% (12mg) and 22.7% (16mg). 
Pogostost glede na odmerek: 17,0 % (8 mg), 27,0 % (12 mg) in 22,7 % (16 mg).
The absolute bioavailability of lornoxicam is 90-100 %. 
Absolutna biološka razpoložljivost lornoksikama je 90-100 %.
Laboratorios Andromaco SA, Doctor Zamenhof 36, 29027 Madrid, Spain 
Laboratorios Andromaco SA, Doctor Zamenhof 36, 29027 Madrid, Španija
Food may decrease the absorption with about 20% and increase Tmax. 
Hrana lahko zmanjša absorpcijo zdravila za približno 20 % in podaljša Tmax.
Any risk is more likely with high doses and prolonged treatment. 
Tveganje je verjetnejše pri uporabi višjih odmerkov in dolgotrajnem zdravljenju.
TOTPAR = total pain relief, SPID = sum of pain intensity differences, IMP = overall impression 
TOTPAR = popolna ublažitev bolečine, SPID = vsota razlik v intenziteti bolečine, IMP = celokupni vtis
Of the total number of patients 57.8% (7,046/12,192) received lornoxicam (see Table below). 
Od skupnega števila bolnikov jih je 57,8 % (7046 od 12.192) prejemalo lornoksikam (glejte spodnjo tabelo).
The usual emergency measures including gastric lavage should be considered. 
Preučiti je treba možnost uporabe običajnih ukrepov v nujnih primerih, vključno z gastrično lavažo.
A total of 21% of the patients had at least one ADR. 
Skupno 21 % bolnikov je imelo vsaj en neželen učinek.
Effects on ability to drive and use machines - Section 4.7 
Vpliv na sposobnost vožnje in upravljanja s stroji - poglavje 4.7
Clinical monitoring at regular intervals is recommended. 
Priporočeno je klinično spremljanje v rednih intervalih.
Lornoxicam is absorbed rapidly and almost completely from the gastrointestinal tract. 
Lornoksikam se hitro in skoraj popolnoma absorbira iz gastrointestninalnega trakta.
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. 
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.
The third died from myocardial infarction. 
Tretji je umrl zaradi miokardnega infarkta.
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). 
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).
The reason for exclusion of study CT32 is not clear (it was included in meta-analysis 2; single doses were applied post surgery). 
Razlog za izključitev raziskave CT32 ni jasen (bila je vključena v 2. metaanalizi; enkratni odmerki so bili dajani postoperativno).
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. 
Največja nevarnost za pojav teh reakcij je v zgodnji fazi zdravljenja, saj se v večini primerov reakcija pojavi v prvem mesecu zdravljenja.
Nycomed Danmark ApS, Langebjerg 1, 4000 Roskilde, Denmark 
Nycomed Danmark ApS, Langebjerg 1, 4000 Roskilde, Danska
Based on these data it appears that a higher initial dose of lornoxicam - QR may be justified. 
Iz teh podatkov izhaja, da utegne biti večji začetni odmerek lornoksikama - QR utemeljen.
The effect on TOTPAR and PPRA with 2 mg and 4 mg in study CT01 was not significantly different from placebo. 
Učinek na TOTPAR in PPRA z 2 mg in 4 mg v raziskavi CT01 ni bil pomembno različen od placeba.
- Long term treatment (longer than 3 months): Regular laboratory assessments of haematology (haemoglobin), renal functions (creatinine) and liver enzymes are recommended. 
- Dolgoročno zdravljenje (daljše od 3 mesecev): Priporočamo redne laboratorijske preiskave hematologije (hemoglobin), ledvične funkcije (kreatinin) in jetrnih encimov.
Nycomed UK Ltd., The Magdalen Centre Oxford Science Park, OX4 4GA Oxford, United Kingdom 
Nycomed UK Ltd., The Magdalen Centre Oxford Science Park, OX4 4GA Oxford, Združeno kraljestvo
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 
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.
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. 
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.
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%). 
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 %).
A comparison of significance levels in the original data and in meta-analysis 2 was not performed and is missing in the response. 
Primerjava ravni pomembnosti izvirnih podatkov in 2. metaanalize ni bila izvedena, zato manjka v odzivu.
The osmolarity of the reconstituted solution is about 328 mosmol/kg and pH is about 8.7 
Osmolarnost pripravljene raztopine je 328 mosmol/kg, pH je približno 8,7.
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. 
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.
Nycomed Italy S.r.l., Via Carducci 125, Edificio A, 20099 Sesto San Giovanni, Italy 
Nycomed Italy S.r.l., Via Carducci 125, Edificio A, 20099 Sesto San Giovanni, Italija
Each blister strip contains 10 film-coated tablets. 
Vsak pretisni trak vsebuje 10 filmsko obloženih tablet.
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. 
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.
Adults: The recommended dose is 8 mg i.v. 
Odrasli: Priporočeni odmerek je 8 mg i.v.
The construction of a dose-dependence up to 16 mg depends on 2 studies. 
Konstrukt odvisnosti od odmerka do 16 mg temelji na dveh raziskavah.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking the medicinal product 
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred jemanjem zdravila posvetujte s svojim zdravnikom.
• Safety issues 
Varnostni vidiki
Instruction for use and handling 
Navodila za uporabo in ravnanje
The elimination half-life of 5-hydroxylornoxicam is about 9 hours after a parenteral single or twice daily dose. 
Povprečna razpolovna doba eliminacije 5-hidroksilornoksikama je približno 9 ur po parenteralnem dajanju enkratnega ali dvakratnega dnevnega odmerka.
Therapeutic indication - pain 
Terapevtska indikacija - bolečine
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF XEFO AND ASSOCIATED NAMES (see Annex I) 
SPLOŠEN POVZETEK ZNANSTVENE OCENE ZDRAVILA XEFO IN Z NJIM POVEZANIH IMEN (glejte Dodatek I)
Nycomed Christians, Gentsesteenweg 615, 1080 Brussels, Belgium 
Nycomed Christians, Gentsesteenweg 615, 1080 Brussels, Belgija
The recent PhVWP core information regarding cardiovascular safety of NSAIDs (January 2007) has also been taken into account. 
Upoštevane so bile tudi nedavne osrednje informacije, ki jih je priskrbela delovna skupina PhVWP, v zvezi s kardiovaskularno varnostjo NSAID (januar 2007).
Nycomed SEFA, Jaama 55B, 63308 Pölva, Estonia 
Nycomed SEFA, Jaama 55B, 63308 Pölva, Estonija
Undesirable effects - Section 4.8 
Neželeni učinki - poglavje 4.8
The medicinal product is for single use only 
Zdravilo je samo za enkratno uporabo.
Nycomed AB, Tegeluddsvägen 17-21, 102 53 Stockholm, Sweden 
Nycomed AB, Tegeluddsvägen 17-21, 102 53 Stockholm, Švedska
A meta-analysis consisting of three parts was performed to assess the overall analgesic effect of lornoxicam. 
Metaanaliza, sestavljena iz treh delov, je bila izvedena za oceno celokupnega analgetičnega učinka lornoksikama.
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. 
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.
Reactions of liver and haematology have all been mild. 
Vse reakcije jeter in hematologije so bile blage.
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. 
Zaradi razlik v načrtovanju raziskav in shemah odmerjanja so bile samo 4 od teh raziskav (CT18, CT33, CT63, CT80) izbrane za retrospektivno izčrpno ovrednotenje.
Whole body 
Na celotno telo
The clinical development program for the effect of lornoxicam against pain consisted of 27 studies. 
Klinični razvojni program v zvezi z učinkovitostjo lornoksikama proti bolečinam je obsegal 27 raziskav.
- Elderly patients above 65 years: Monitoring of renal and hepatic function is recommended. 
- Starostniki, starejši od 65 let: Priporočamo spremljanje ledvične in jetrne funkcije.
4.2 Posology and method of administration For all patients the appropriate dosing regimen should be based upon individual response to treatment. 
4.2 Odmerjanje in način uporabe Pri vseh bolnikih režim odmerjanja prilagodimo odzivu posameznika na zdravljenje.
A central effect on nociception which seems to be independent of anti-inflammatory effects has also been suggested. 
Domnevajo, da ima tudi osrednji učinek nocicepcije, ki je neodvisen od protivnetnih učinkov.
There are no adequate data from the use of lornoxicam in pregnant women. 
Ni zadostnih podatkov o uporabi lornoksikama pri nosečnicah.
Nycomed Hellas S.A., 196 Kifissias Avenue, 15231 Athens, Greece 
Nycomed Hellas S.A., 196 Kifissias Avenue, 15231 Athens, Grčija
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. 
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.
At this time, there is no experience of overdose to permit definition of the consequence of an overdose, or to suggest specific managements. 
Trenutno ni poročil o primerih prevelikega odmerjanja, kar onemogoča opredelitev posledic prevelikega odmerjanja ali priporočil o specifični obravnavi takšnega stanja.