FrancophonIA/ELRC3.0 huggingface dataset:
English: Lornoxicam has no effect on vital signs (e.g. body temperature, respiratory rate, heart rate, blood pressure, ECG, spirometry).
Maltese: Lornoxicam m'għandu l-ebda effett fuq sinjali vitali (eż. temperatura tal-ġisem, rata respiratorja, pressjoni tad-demm, ECG, spirometrija).
English: 0.9% sodium chloride solution 5% dextrose (glucose) solutions
Maltese: Xefo 4 mg/ml soluzzjoni għall-injezzjoni hi kompatibbli ma': soluzzjoni Ringer soluzzjoni ta' 0.9% sodium chloride soluzzjonijiet ta' 5% dekstrows (glukows)
English: - Anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4).
Maltese: - Aġenti anti-plejtlits: Żjieda fir-riskju ta' fsada gastrointestinali (ara sezzjoni 4.4).
English: Water for injection, 2 ml: Clear glass ampoule
Maltese: Ilma għall-injezzjoni, 2 ml: Ampolla ċara tal-ħġieġ
English: Lornoxicam 4mg tid or 8mg bid is at least as effective as diclofenac 50mg tid and naproxen 500mg bid.
Maltese: Lornoxicam 4mg tid jew 8mg bid huwa effettiv minn ta' l-inqas daqs 50mg tid u naproxen 500mg bid.
English: Rheumatology
Maltese: Rewmatoloġija
English: Maximum plasma concentrations are achieved after approximately 30 minutes.
Maltese: Ilkonċentrazzjonijiet massimi fil-plażma jintlaħqu wara bejn wieħed u ieħor 30 minuta.
English: Reconstituted solution: One ml contains 4 mg lornoxicam
Maltese: Soluzzjoni rikostitwita: 1ml fih 4 mg ta' lornoxicam
English: The Table below shows the percentages of patients with ADRs in order of incidence by system organ classification (SOC, WHO), lornoxicam dose and indication.
Maltese: It-Tabella ta' hawn taħt turi l-perċentwali ta' pazjenti b'ADRs fl-ordni ta' l-inċidenza bilklassifikazzjoni ta' organu tas-sistema (SOC, WHO), id-doża lornoxicam u indikazzjoni.
English: A comparison of significance levels in the original data and in meta-analysis 2 was not performed and is missing in the response.
Maltese: Ma sarx tqabbil tal-livelli ta' sinifikanza fid-dejta oriġinali u f'meta-analiżi 2 dan huwa nieqes firrispons.
English: Lornoxicam Rapid, 8 mg, film coated tablets
Maltese: Lornoxicam Rapid, 8 mg, pilloli miksijin b'rita
English: Pack sizes: 6, 10, 20, 30, 50, 100, 250 film-coated tablets
Maltese: Daqsijiet tal-pakkett: 6, 10, 20, 30, 50, 100, 250 pilloli miksijin b'rita
English: The use of lornoxicam with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.
Maltese: L-użu ta' lornoxicam b'NSAIDs konkomittanti inkluż l-inibituri selettivi cyclooxygenase-2 għandu jiġi evitat.
English: Two studies on third molar surgery were excluded from meta-analysis 1.
Maltese: Żewġ studji dwar l-operazzjoni fuq it-tielet darsa ġew esklużi mill-meta-analiżi 1.
English: Studies not investigating the recommended doses of either 4 mg tid or 8 mg bid were excluded from the analysis.
Maltese: Studji li ma jinvestigawx id-dożi rakkomandati jew ta' 4 mg tid jew ta' 8 mg bid ġew esklużi mill-analiżi.
English: Lornoxicam (Xefo and its associated names) is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class approved and marketed for treatment of moderate to severe pain.
Maltese: Lornoxicam (Xefo u ismijiet assoċjati tiegħu) huwa droga kontra n-nefħiet mhux sterojdjali (NSAID) tal-klassi oxicam approvat u kummerċjalizzat għat-trattament ta' uġigħ moderat għal gravi.
English: The construction of a dose-dependence up to 16 mg depends on 2 studies.
Maltese: Il-kostruzzjoni ta' dipendenza fuq id-doża sa mhux aktar minn 16 mg tiddependi fuq 2 studji.
English: The chemical and physical in-use stability has been demonstrated for 24 hours at 21 °C (±2°C).
Maltese: Stabbiltà kimika u fiżika waqt l-użu ġiet ippruvata għal 24 siegħa f'21°C (±2°C).
English: The hydroxylated metabolite exhibits no pharmacological activity.
Maltese: Ilmetabolit idrossillizzat ma juri l-ebda attività farmakoloġika.
English: One vial contains 8 mg lornoxicam.
Maltese: U KWANTITATTIVA Kunjett wieħed fih 8 mg lornoxicam.
English: Nycomed Austria GmbH, St. Peter Strasse 25, 4020 Linz, Austria
Maltese: Peter Strasse 25, 4020 Linz, L-Awstrija
English: No differences were observed regarding the SPID parameter.
Maltese: Ma ġew osservati ebda differenzi fir-rigward tal-parametru SPID.
English: The MAH considered study CT80, comparing 4 mg bid and 8 mg bid to placebo, and study CT63, comparing 4 mg tid to 8 mg bid, and to 50mg diclofenac tid, as pivotal.
Maltese: Il-MAH ikkunsidra l-istudju CT80, li jqabbel 4 mg bid u 8 mg bid ma' plaċebo, u l-istudju CT63, li jqabbel 4 mg tid ma' 8 g bid, u ma' 50 mg diclofenac tid, bħala fundamentali.
English: Lornoxicam, 8 mg, Powder and solvent for solution for injection Recommended dose: 8 mg intravenous or intramuscular.
Maltese: Lornoxicam, 8 mg, Trab u solvent għal soluzzjoni għal injezzjoni Doża rakkomandata: 8 mg ġol-vini jew ġol-muskoli.
English: 6.1 List of excipients Core:
Maltese: 6.1 Lista ta' sustanzi mhux attivi
English: 6 film-coated tablets 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 100 film-coated tablets 250 film-coated tablets
Maltese: 6 pilloli miksijn b'rita 10 pilloli miksijn b'rita 20 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 100 pillola miksija b'rita 250 pillola miksija b'rita
English: Pregnancy and lactation - Section 4.6
Maltese: Tqala u Treddigħ - Sezzjoni 4.6
English: Lornoxicam caused renal toxicity and gastrointestinal ulceration single- and repeat-dose toxicity studies in several species.
Maltese: Lornoxicam ikkawża ħsara fil-kliewi u studji dwar it-tossiċità b'doża singola u ripetuta wrew ulċerazzjoni gastrointestinali f'diversi speċijiet.
English: - Keep this leaflet.
Maltese: Kien hemm inqas osservazzjonijiet ta' gastrite.
English: In rat, lornoxicam impaired fertility (effects on ovulation and implantation), and affected the pregnancy and delivery.
Maltese: Fil-firien, Lornoxicam fixkel il-fertilità (effetti fuq l-ovulazzjoni u l-impjantazzjoni), u affettwa t-tqala u l-ħlas.
English: Lornoxicam 8 mg powder for injection is intended for intravenous (IV) as well as intramuscular (IM) administration.
Maltese: Lornoxicam 8 mg trab għall-injezzjoni huwa intenzjonat għal amministrazzjoni ġol-vini (IV) kif ukoll għal ġol-muskoli (IM).
English: - Elderly patients above 65 years: Monitoring of renal and hepatic function is recommended.
Maltese: - Pazjenti anzjani 'l fuq minn 65 sena: Huwa rakkomandat monitoraġġ tal-funzjoni tal-kliewi u talfwied.
English: - Patients with blood coagulation disorders: Careful clinical monitoring and laboratory assessment is recommended (e.g. APTT).
Maltese: Huma rakkomandati monitoraġġ kliniku u valutazzjoni f'laboratorju attenta (eż. APTT).
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8).
Maltese: Kien hemm rapporti rari ħafna ta' reazzjoni tal-ġilda serji, xi wħud minnhom fatali, inkluża dermatite eksfoljattiva, is-sindromu ta' Stevens-Johnson, u nekrolożi epidermali tossika f'rabta ma' l-użu ta' NSAIDs (ara sezzjoni 4.8).
English: HOW TO STORE XEFO RAPID
Maltese: KIF TAĦŻEN XEFO RAPID
English: For several drugs causing interaction and which possibly increase the risk of toxicity in combination with NSAIDs/lornoxicam, the recommendation regarding drug monitoring (for methotrexate, lithium and cyclosporine) has been included in the SPC.
Maltese: Għal diversi mediċini li jikkaġunaw interazzjoni u li possibbilment iżidu r-riskju ta' tossiċità flimkien ma' NSAIDs/lornoixicam, ir-rakkomandazzjonijiet fir-rigward tal-monitoraġġ tal-mediċina (għal methotrexate, lithium u cyclosporine) ġew inklużi fl-SPC.
English: The divergences between the MS in the wording of the description of the pharmacokinetic properties have been harmonised.
Maltese: Id-diverġenzi bejn MS fil-formulazzjoni tad-deskrizzjoni tat-tagħrif farmakokinetiku ġew armonizzati.
English: Pain 8-16 mg lornoxicam daily divided into 2 or 3 doses.
Maltese: 8-16 mg lornoxicam kuljum maqsumin f'2 jew 3 dożi.
English: Powder for injection, 8 mg: Amber glass (class I) vial (4R/8R) with rubber stopper, sealed with aluminium snap-off closure.
Maltese: Trab għall-injezzjoni, 8 mg: Kunjett (4R/8R) tal-ħġieġ ambra (klassi I) b'tapp tal-lastiku, issiġillat b'għatu li jitqaċċat ta' l-aluminju
English: Lornoxicam is extensively metabolised in the liver, primarily to the inactive 5-hydroxylornoxicam by hydroxylation.
Maltese: Lornoxicam huwa ferm immetabolizzat fil-fwied, primarjament għal 5-hydroxylornoxicam inattiv bl-idrossilazzjoni.
English: - Long term treatment (longer than 3 months): Regular laboratory assessments of haematology (haemoglobin), renal functions (creatinine) and liver enzymes are recommended.
Maltese: Huma rakkomandati valutazzjonijiet f'laboratorju regolari ta' l-ematoloġija (emoglobina), funzjonijiet tal-kliewi (kreatinina) u enzimi tal-fwied.
English: Osteoarthritis and Rheumatoid arthritis
Maltese: Osteoartrite u Artrite b'rewmatiżmu
English: An initial dose of 16 mg lornoxicam administered i.m., followed by a subsequent dose of 8 mg has shown to be effective and safe in patients with pain after surgery (study CT89).
Maltese: Doża inizjali ta' 16 mg lornoixicam amministrat i.m., segwit b'doża sussegwenti ta' 8 mg uriet li hija effettiva u sikura f'pazjenti b'uġigħ wara l-kirurġija (studju CT89).
English: Lornoxicam is absorbed rapidly and almost completely from the gastrointestinal tract.
Maltese: Lornoxicam huwa assorbit malajr u kważi għal kollox mill-passaġġ gastrointestinali.
English: - One film-coated tablet contains 8 mg lornoxicam - The other ingredients are: Core: Cellulose, microcrystalline, Sodium hydrogen carbonate, Calcium hydrogen phosphate, anhydrous, Low substituted hydroxypropylcellulose, Hydroxypropylcellulose, Calcium stearate Film: Titanium dioxide (E171), Talc, Propylen glycol, Hypromellose.
Maltese: X'fih Xefo Rapid - Is-sustanza attiva hi lornoxicam - Pillola miksija b'rita fiha 8 mg ta' lornoxicam - Is-sustanzi l-oħra huma: Qalba: Cellulose, microcrystalline, Sodium hydrogen carbonate, Calcium hydrogen phosphate, anhydrous, Low substituted hydroxypropylcellulose, Hydroxypropylcellulose, Calcium stearate Rita:
English: The effect on TOTPAR and PPRA with 2 mg and 4 mg in study CT01 was not significantly different from placebo.
Maltese: L-effett fuq TOTPAR u PPRA b'2 mg u 4 mg fl-istudju CT01 ma kienx sinifikament differenti millplaċebo.
English: The elimination half-life of 5-hydroxylornoxicam is about 9 hours after a parenteral single or twice daily dose.
Maltese: Il-half-life ta' l-eliminazzjoni ta' 5-hydroxylornoxicam hija madwar 9 sigħat wara doża parenterali singola jew doppja ta' kuljum.
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
Maltese: Minħabba deċiżjonijiet nazzjonali differenti meħuda mill-Istati Membri fir-rigward ta' lawtorizzazzjoni tal-prodott imsemmi hawn fuq, Nycomed Danmark ApS innotifika lill-EMEA dwar referenza uffiċjali taħt l-Artikolu 30 tad-Direttiva 2001/83/KE kif emendata sabiex jiġu riżolti ddifferenzi fit-Tagħrif dwar il-Prodott (SPCs, PLs u tikketta) awtorizzati nazzjonalment għall-prodott imsemmi hawn fuq u b'hekk jiġi armonizzat it-Tagħrif dwar il-Prodott (SPCs, PLs u tikketta) u ddokumentazzjoni tal-Kwalità madwar l-UE
English: Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) have been reported following administration of NSAIDs.
Maltese: Dardir, rimettar, dijarea, gass, stitikezza, dispepsja, uġigħ addominali, melina, ħematemeżi, stomatite ulċerattiva, taħrix tal-kolite u l-marda ta' Crohn (ara sezzjoni 4.4) kienu rappurtati wara laministrazzjoni ta' NSAIDs.
English: Renal function must therefore be monitored closely in patients receiving combination therapy.
Maltese: Il-funzjoni tal-fwied għandha għalhekk tkun immonitorjata mill-qrib f'pazjenti li qed jirċievu terapija kombinatorja.
English: Meta-analysis 2
Maltese: Meta-analiżi
English: The usual emergency measures including gastric lavage should be considered.
Maltese: Għandu jitqiesu l-miżuri normali ta' emerġenza inkluż il-ħasil gastriku.
English: Number of Patients by Indication and Treatment
Maltese: Numru ta' Pazjenti b'Indikazzjoni u Trattament
English: For patients with mild to moderate renal impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses (see section 4.4).
Maltese: Għal pazjenti b'indeboliment epatiku moderat, id-doża massima ta' kuljum rakkomandata hija 12 mg maqsuma f'2 jew 3 dożi (ara sezzjoni 4.4).
English: The clinical development program for the effect of lornoxicam against pain consisted of 27 studies.
Maltese: Il-programm ta' żvilupp kliniku għall-effett ta' lornoxicam kontra l-uġigħ kien magħmul minn 27 studju.
English: Rare: Hepatic function abnormal.
Maltese: Funzjoni tal-fwied anormali.
English: Hepatocellular damage, ecchymosis, oedema and bullous reactions, Stevens-Johnson syndrome, Toxic epidermal necrolysis.
Maltese: Ħsara fiċ-ċelloli tal-kliewi, ekimożi, edema u reazzjonijiet bullużi, sindrome ta' Stevens-Johnson, nekroliże tossika ta' l-epiderme.
English: PHARMACEUTICAL FORM AND CONTENTS 250 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 250 pillola miksijin b'rita
English: Respiratory, thoracic and mediastinal disorders Uncommon: Rhinitis.
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni: Rinite.
English: Rare: Dyspnoea, cough, bronchospasm.
Maltese: Dispneja, sogħla, spażmi tal-bronki
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.
Maltese: (CT18, CT33, CT63, CT80) intagħżlu għal evalwazzjoni komprensiva retrospettiva.
English: Clinical monitoring at regular intervals is recommended.
Maltese: Huwa rakkomandat monitoraġġ kliniku f'intervalli regolari.
English: Maintenance dose should not exceed 16 mg lornoxicam daily.
Maltese: Id-doża ta' kuljum m'għandhiex taqbeż 16 mg lornoxicam.
English: Maximum recommended daily dose is 16 mg.
Maltese: Id-doża massima rakkomandata ta' kuljum hija 16 mg.
English: For IM injection a sufficiently long needle for a deep intramuscular injection.
Maltese: Għal injezzjoni IM labra twila biżżejjed għal injezzjoni profonda ġol-muskoli.
English: - Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Maltese: - Kortikosterojdi: Żjieda fir-riskju ta' ulċerazzjoni jew fsada gastrointestinali (ara sezzjoni 4.4). - Antibijotiċi quinolone:
English: - Hepatic impairment (e.g. liver cirrhosis): Clinical monitoring and laboratory assessments at regular intervals should be considered in patients with hepatic impairment as accumulation of lornoxicam (increase in AUC) may occur after treatment with daily doses of 12-16 mg. Apart from that, hepatic impairment does not seem to affect pharmacokinetic parameters of lornoxicam as compared to healthy subjects.
Maltese: - Indeboliment epatiku (eż. ċirrożi tal-fwied): Monitoraġġ kliniku u valutazzjonijiet f'laboratorju f'intervalli regolari għandhom ikunu kkunsidrati f'pazjenti b'indeboliment epatiku minħabba li tista' sseħħ akkumulazzjoni ta' lornoxicam (żjieda f'AUC) wara t-trattament b'dożi ta' kuljum ta' 12-16-il mg.
English: Xefo Rapid is distributed in pack sizes of 6, 10, 20, 30, 50, 100 and 250 film-coated tablets.
Maltese: Xefo Rapid huwa ddistribwit f'pakketti li fihom 6, 10, 20, 30, 50, 100 u 250 pillola miksija b'rita.
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 100 film-coated tablets
Maltese: 10 pilloli miksijn b'rita 20 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 100 pillola miksija b'rita
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).
Maltese: Il-frekwenza ta' mwiet għal kull sena pazjent għal lornoxicam kien 0.0007; in-numru korrispondenti għal trattament ta' l-aġent komparattiv attiv kien kważi tliet darbiet ogħla (0.020).
English: 6.1 List of excipients Powder:
Maltese: 6.1 Lista ta' sustanzi mhux attivi Qalba:
English: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.3).
Maltese: L-anzjani għandhom frekwenza miżjuda ta' reazzjonijiet mhux mixtieqa għal NSAIDs speċjalment fsada gastrointestinali u perforazzjoni li tista' tkun fatali (ara sezzjoni 4.3).
English: LIST OF EXCIPIENTS Lactose monohydrate For other excipients, see package leaflet
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Lactose monohydrate
English: Food may decrease the absorption with about 20% and increase Tmax.
Maltese: L-ikel jista' jnaqqas l-assorbiment b'madwar 20% u jżid Tmax.
English: Undesirable effects - Section 4.8
Maltese: Effetti mhux mixtieqa - Sezzjoni 4.8
English: - Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4).
Maltese: - Inibituri selettivi ta' assorbiment ta' serotonin (SSRIs): Żjieda fir-riskju ta' fsada gastrointestinali
English: A total of 21% of the patients had at least one ADR.
Maltese: Total ta' 21% tal-pazjenti kellhom mill-inqas ADR waħda.
English: Rare: Bone pain, muscle spasms, myalgia.
Maltese: Uġigħ fl-għadam, spażmi, mijalġija.
English: injection.
Maltese: - Indikazzjoni
English: Psychiatric disorders Uncommon: Insomnia, depression.
Maltese: Mhux komuni: Insomnja, dipressjoni.
English: Metabolism and nutritional disorders Uncommon: Anorexia, weight changes.
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni: Anoressija, bidliet fil-piż.
English: In the literature, incidences of SADRs for NSAIDs vary between 0.3% and 4.7% indicating that the risk of developing SADRs with lornoxicam is similar to that of other NSAIDs.
Maltese: Fil-letteratura, l-inċidenzi ta' SADRs għal NSAIDs ivarjaw bejn 0.3% u 4.7%.
English: Concomitant treatment with NSAIDs and heparin in the context of a spinal or epidural anaesthesia increases the risk of spinal/epidural haematoma (see section 4.5).
Maltese: Trattament fl-istess ħin b'NSAIDs u bl-eparina fil-kuntest ta' anestesija spinali jew epidurali jżid irriskju ta' ematoma spinali/epidurali (ara sezzjoni 4.5).
English: More than 12,000 patients were included in the 103 studies of which 43 were classified as phase I with 810 patients.
Maltese: Aktar minn 12,000 pazjent ġew inklużi fil-103 studji li minnhom 43 ġew ikklassifikati bħala fażi I bi 810 pazjenti.
English: Initial recommended dose is 12 mg lornoxicam daily divided into 2 or 3 doses.
Maltese: Id-doża rakkomandata inizjali hija 12 mg lornoxicam kuljum maqsuma f'2 jew 3 dożi.
English: Prostaglandin synthesis inhibitors administered during the third trimester of pregnancy may expose the foetus to cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary hypertension) and renal dysfunction which may lead to renal failure and hence a reduced quantity of amniotic fluid.
Maltese: L-inibituri tas-sintesi tal-prostaglandin amministrati waqt it-tielet trimestru tat-tqala jistgħu jesponu lill-fetu għal tossiċità kardjopulmonari (għeluq prematur tad-ductus arteriosus u pressjoni għolja pulmonari eċċessiva) u ħsara fil-kliewi li jistgħu jwasslu għal waqfien fil-funzjoni tal-kliewi u għalhekk għal kwantità mnaqqsa tal-fluwidu amnijotiku.
English: WHAT XEFO RAPID IS AND WHAT IT IS USED FOR Xefo Rapid is a non-steroidal anti-inflammatory drug and antirheumatic drug (NSAID) of the oxicam class.
Maltese: Xefo Rapid hi mediċina li ma fihiex sterojds kontra l-infjammazzjoni u kontra r-rewmatiżmu (NSAID) tal-kategorija oxicam.
English: Similarly an initially oral dose of 16 mg lornoxicam given in study LD-030-IN was followed by 8 mg as a second dose on day one and found to be effective and safe in patients with acute low back pain.
Maltese: B'mod simili, doża orali inizjali ta' 16 mg lornoxicam mogħti fl-istudju LD-030-IN kienet segwita bi 8 mg bħala t-tieni doża fl-ewwel ġurnata u nstab li kienet effettiva u sikura f'pazjenti b'uġigħ akut fil-parti t'isfel taddahar.
English: Infections and infestations Rare: Pharyngitis.
Maltese: Infezzjonijiet u infestazzjonijiet Rari: Farinġite.
English: Adults: The usual dose is 8-16 mg divided Into 2 or 3 doses.
Maltese: Id-doża normali hija 8-16 mg maqsuma f'2 jew 3 dożi.
English: A meta-analysis consisting of three parts was performed to assess the overall analgesic effect of lornoxicam.
Maltese: Meta-analiżi li tikkonsisti fi tliet partijiet twettqet biex tivvaluta l-effett analġessiku globali ta' lornoxicam.
English: Adults: The usual dose is 8-16 mg divided in doses of 8 mg twice daily.
Maltese: Id-doża normali hija 8-16 mg maqsuma f'dożi ta' 8 mg darbtejn kuljum.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 8 mg lornoxicam.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed fih 8 mg lornoxicam.
English: Pack sizes: 250 and 500 film-coated tablets.
Maltese: Daqs tal-pakkett (Pakkett ta' l-isptar): 250 u 500 pillola miksijin b'rita.
English: Included in analysis
Maltese: Inkluż fl-analiżi
English: Pack sizes: 10, 20, 30, 50 and 100 film-coated tablets.
Maltese: Daqs tal-pakkett: 10, 20, 30, 50 u 100 pillola miksijin b'rita.
English: Xefo Rapid may interfere with other medicines.
Maltese: Xefo Rapid jista' jfixkel xi mediċini oħra.
English: No data are available on simultaneous intake of Xefo Rapid film-coated tablets with meals, but based on data for Xefo film-coated tablets a reduction of Cmax, an increase in Tmax, and a reduction in the absorption (AUC) of lornoxicam may be expected.
Maltese: M'hemm ebda tagħrif disponibbli dwar it-teħid simultanju ta' Xefo Rapid pilloli miksijin b'rita ma' likel, iżda fuq il-bażi tad-data għal Xefo pilloli miksijin b'rita, tnaqqis ta' Cmax, żjieda f'Tmax , u tnaqqis fl-assorbiment (AUC) ta' lornoxicam jistgħu jkunu mistennija.
English: Lornoxicam “Nycomed” 4 mg Film-coated tablet
Maltese: Lornoxicam “Nycomed”
English: Xefo should not be used concomitantly with other NSAIDs such as acetylsalicylic acid, ibuprofen and COX-2 inhibitors.
Maltese: Xefo m'għandux jintuża fl-istess ħin ma' NSAIDs oħra bħal acetylsalicylic acid, ibuprofen u inibituri COX-2.
English: OUTER CARTON FOR TABLET CONTAINER AND LABEL OF TABLET CONTAINER
Maltese: KARTUNA TA' BARRA GĦALL-KONTENITUR TAL-PILLOLI
English: TOTPAR in the meta-analysis was significantly different from placebo at 4 mg LNX p.o. and doses >4 mg LNX p.o., however it should be noted that in 2/7 studies (CT01, CT03) the effect of 4 mg LNX on total pain relief was not significantly different from the placebo group.
Maltese: TOTPAR fil-meta-analiżi kien ferm differenti mill-plaċebo b'4 mg LNX p.o. u dożi >4 mg LNX p.o., madankollu għandu jiġi nnotat li fi 2/7 studji (CT01, CT03) l-effett ta' 4 mg LNX fuq is-serħan milluġigħ totali ma kinitx ferm differenti fit-TOTPAR bejn gruppi fil-popolazzjoni ITT, bejn il-plaċebo u t-trattament attiv fil-popolazzjoni-PP.
English: Musculoskeletal and connective tissue disorders Uncommon: Arthralgia.
Maltese: Disturbi muskolu-skeltrali, tal-connective tissue u ta' l-għadam Mhux komuni: Artralġija.
English: Solvent for solution for injection Water for injections i.v.
Maltese: Solvent għal soluzzjoni għall-injezzjoni Ilma għall-injezzjonijiet i.v. i.m.