FrancophonIA/ELRC3.0 huggingface dataset:
English: SJS or TEN occurred within one month of the medicinal combination and fatal outcomes have resulted.
Maltese: SJS jew TEN seħħew fi żmien xahar mill-kombinazzjoni mediċinali u kkawżaw riżultati fatali.
English: Evaluation of the potential for phototoxicity in the embryonic murine fibroblast cell line BALB/c 3T3 was inconclusive for idelalisib due to cytotoxicity in the in vitro assay.
Maltese: 3T3 ma kinitx konklussiva għal idelalisib minħabba ċitotossiċità fl-assaġġ in vitro.
English: Luxembourg/Luxemburg
Maltese: BALB/c
English: DOR was a secondary endpoint and was defined as the time from the first documented response (CR, PR, or MR) to the first documentation of disease progression or death from any cause.
Maltese: Id-DOR kien punt finali sekondarju u kien definit bħala ż-żmien mill-ewwel rispons dokumentat (CR, PR, jew MR) għallewwel dokumentazzjoni tal-progressjoni tal-marda jew mewt minn kwalunkwe kawża.
English: Treatment with Zydelig must be withheld in the event of Grade 3 or 4 rash.
Maltese: It-trattament b'Zydelig għandu jitwaqqaf fil-każ ta' raxx ta' Grad 3 jew 4.
English: Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and UGT1A4.
Maltese: Idelalisib huwa metabolizzat primarjament permezz ta' aldehyde oxidase, u fuq livell inqas permezz ta' CYP3A u UGT1A4.
English: The film-coated tablets are pink, oval-shaped tablets, debossed on one side with “GSI” and “150” on the other side.
Maltese: Il-pilloli miksija b'rita huma roża, b'forma ovali, imnaqqxin b'“GSI” fuq naħa waħda u “150” fuq innaħa l-oħra.
English: • rifampicin, a medicine used to prevent and treat tuberculosis and other infections • St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety
Maltese: • rifampicin, mediċina li tintuża għall-prevenzjoni u t-trattament tat-tuberkulosi u infezzjonijiet oħra
English: • who have received at least one prior therapy (see section 4.4), or
Maltese: • li jkunu rċevew għallinqas terapija preċedenti waħda (ara sezzjoni 4.4), jew
English: Alfuzosin
Maltese: Anzjani
English: It is currently unknown whether idelalisib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method as a second form of contraception.
Maltese: Bħalissa mhux magħruf jekk idelalisib jistax inaqqas l-effettività ta' kontraċettivi ormonali, u għalhekk nisa li jkunu jużaw kontraċettivi ormonali għandhom iżidu metodu barriera bħala t-tieni forma ta' kontraċezzjoni.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with idelalisib in one or more subsets of the paediatric population in the treatment of mature B-cell neoplasms (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'idelalisib f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fit-trattament ta' neoplażmi maturi taċ-ċellula B (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Film-coating
Maltese: GLUKOKORTIKOJDI
English: Serious and fatal infections have occurred in patients taking Zydelig.
Maltese: Infezzjonijiet serji u fatali seħħew f'pazjenti li kienu qed jieħdu Zydelig.
English: ↑ serum concentrations
Maltese: Magnesium stearate
English: Zydelig may be prescribed in combination with other medicines for the treatment of CLL.
Maltese: Zydelig jista' jingħata f'kombinazzjoni ma' mediċini oħrajn għat-trattament ta' CLL.
English: Interrupt Zydelig dosing.
Maltese: Jekk tieħu Zydelig aktar milli suppost
English: 28 tablets (7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg)
Maltese: pillola miksija b'rita folja (PVC/PVDC/Alu) 28 pillola (7 x 5 mg + 7 x 10 mg + 7 x
English: --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
Maltese: - Eimeria acervulina, strein 003 - 332 - 450 ooċisti sporulati - Eimeria brunetti, strein 034 - 213 - 288 ooċisti sporulati - Eimeria maxima, strein 013 - 196 - 265 ooċisti sporulati - Eimeria necatrix, strein 033 - 340 - 460 ooċisti sporulati - Eimeria tenella, strein 004 - 276 - 374 ooċisti sporulati
English: EU (MA) Number
Maltese: Anness A
English: • Conclusions
Maltese: • Konklużjonijiet
English: Route of administration TOTPAR SPID IMP 1.
Maltese: TOTPAR SPID IMP 1.
English: Metabolic/Endocrine
Maltese: Metaboliku/Endokrinali
English: Opaque PVC/Aluminium.
Maltese: PVC opak/Aluminju.
English: Laboratorios Andromaco SA, Doctor Zamenhof 36, 29027 Madrid, Spain
Maltese: Laboratorios Andromaco SA, Doctor Zamenhof 36, 29027 Madrid, Spanja
English: IM/oral
Maltese: IM/orali
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: {Isem u indirizz} <{tel}> <{faks}> <{e-mail}>
English: 2610-016 Amadora, Portugal
Maltese: 2610-016 Amadora, Il-Portugall
English: Nycomed Italy S.r.l., Via Carducci 125, Edificio A, 20099 Sesto San Giovanni, Italy
Maltese: Nycomed Italy S.r.l., Via Carducci 125, Edificio A, 20099 Sesto San Giovanni, L-Italja
English: Respiratory
Maltese: Respiratorju
English: Nycomed SEFA, Jaama 55B, 63308 Pölva, Estonia
Maltese: Nycomed SEFA, Jaama 55B, 63308 Pölva, L-Estonja
English: Powder: Mannitol, Trometamol, Disodium edetate
Maltese: Mannitol, Trometamol, Disodium edetate
English: Croscarmellose sodium Magnesium stearate Film:
Maltese: Croscarmellose sodium Magnesium stearate Rita:
English: Euro-Labor SA, Rua Alfredo da Silva no16, 2610-016 Amadora, Portugal
Maltese: Euro-Labor SA, Rua Alfredo da Silva no16, 2610-016 Amadora, Il-Portugall
English: Incidence by dose was: 17.0% (8mg), 27.0% (12mg) and 22.7% (16mg).
Maltese: L-inċidenza skond id-doża kienet: 17.0% (8mg), 27.0% (12mg) u 22.7% (16mg).
English: Nycomed Pharma GmbH, Edisonstrasse 16, 85716 Unterschleissheim, Germany
Maltese: Nycomed Pharma GmbH, Edisonstrasse 16, 85716 Unterschleissheim, Il-Ġermanja
English: Nycomed Hellas S.A., 196 Kifissias Avenue, 15231 Athens, Greece
Maltese: Nycomed Hellas S.A., 196 Kifissias Avenue, 15231 Athens, Il-Greċja
English: 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).
Maltese: Mhux komuni (≥1/1000, <1/100); rari (≥1/10,000, <1/1,000);
English: 1 set contains:
Maltese: Sett 1 jinkludi:
English: Nycomed AB, Tegeluddsvägen 17-21, 102 53 Stockholm, Sweden
Maltese: Nycomed AB, Tegeluddsvägen 17-21, 102 53 Stockholm, L-Iżvezja
English: Nycomed UK Ltd., The Magdalen Centre Oxford Science Park, OX4 4GA Oxford, United Kingdom
Maltese: Nycomed UK Ltd., The Magdalen Centre Oxford Science Park, OX4 4GA Oxford, Ir-Renju Unit
English: Therapeutic indication - osteoarthritis (OA)
Maltese: Indikazzjoni terapewtika - osteoartrite (OA)
English: In elderly patients above age 65, the clearance is reduced with 30-40%.
Maltese: F'pazjenti anzjani 'l fuq minn 65 sena, l-eliminazzjoni hija mnaqqsa bi 30-40%.
English: Cellulose, microcrystalline Sodium hydrogen carbonate Calcium hydrogen phosphate, anhydrous Low substituted hydroxypropylcellulose Hydroxypropylcellulose Calcium stearate
Maltese: Cellulose, microcrystalline Sodium hydrogen carbonate Calcium hydrogen phosphate, anhydrous Low substituted hydroxypropylcellulose
English: Meta-analysis 3:
Maltese: Meta-analiżi 3:
English: TOTPAR = total pain relief, SPID = sum of pain intensity differences, IMP = overall impression
Maltese: TOTPAR = serħan totali mill-uġigħ, SPID = total tad-differenzi fl-intensità ta' l-uġigħ, IMP = impressjoni globali
English: Of the total number of patients 57.8% (7,046/12,192) received lornoxicam (see Table below).
Maltese: Min-numru total ta' pazjenti, 57.8% (7,046/12,192) ingħataw lornoxicam (ara t-Tabella hawn taħt).
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).
Maltese: It-trattament ta' artrite b'rewmatiżmu ġie approvat minn 16/16-il Stat Membru (AT, BE, CZ, DE, DK, EE, ES, GR, HU, IT, LT, LV, PT, SE, UK).
English: The absolute bioavailability of lornoxicam is 90-100 %.
Maltese: Ilbijodisponibbilta' assoluta ta' lornoxicam hija 90-100 %.
English: Lornoxicam has shown compatibility with 0.9% NaCl, 5% dextrose (glucose) and Ringer's solution.
Maltese: Lornoxicam wera kompatibbiltà ma' 0.9% NaCl, 5% dekstrows (glukows) u soluzzjoni ta' Ringer.
English: Pack sizes: 1, 5, 6, 10 sets.
Maltese: Settijiet ta' 1, 5, 6, 10.
English: Propylene glycol
Maltese: Propylene glycol Hypromellose
English: Powder: Yellow, solid substance
Maltese: Sustanza safra, solida
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).
Maltese: It-trattament ta' osteoartrite ġie approvat minn 14/16-il Stat Membru (AT, BE, CZ, DE, DK, ES, GR, HU, LT, LV, PT, SE, UK).
English: Nycomed Danmark ApS, Langebjerg 1, 4000 Roskilde, Denmark
Maltese: Nycomed Danmark ApS, Langebjerg 1, 4000
English: Rare: Dermatitis, purpura.
Maltese: Dermatite, pupura.
English: Rare: Confusion, nervousness, agitation.
Maltese: Konfużjoni, nervożiżmu, aġitazzjoni.
English: Nycomed Christians, Gentsesteenweg 615, 1080 Brussels, Belgium
Maltese: Nycomed Christians, Gentsesteenweg 615, 1080
English: Meta-analysis 1
Maltese: Meta-analiżi 1
English: The absolute bioavailability (calculated on AUC) after IM administration is 97 %
Maltese: Il-bijodisponibbiltà assoluta (ikkalkulata bħala AUC) wara amministrazzjoni IM hija 97 %.
English: CYP2C9 is involved in this biotransformation of lornoxicam.
Maltese: CYP2C9 huwa involut f'din il-bijotrasformazzjoni ta' lornoxicam.
English: Treatment of osteoarthritis has not been approved by 2/16 Member States (EE, IT).
Maltese: It-trattament ta' l-osteoartrite ma ġiex approvat minn 2/16-il Stat Membru (EE, IT).
English: Compatibilities
Maltese: Kompatibilitajiet
English: Contraindications - Section 4.3
Maltese: Kontra-indikazzjonijiet -Sezzjoni 4.3
English: Immune system disorders Rare: Hypersensitivity.
Maltese: Disturbi fis-sistema immuni Rari: Sensittività eċċessiva.
English: 28802 Alcalá de Henares, Madrid, Spain
Maltese: M-300, Km 30,500. 28802 Alcalá de Henares, Madrid, Spanja
English: Low 8mg 12mg 16mg High Total Low 8mg 12mg 16mg High TotalTotal
Maltese: Total Baxx 8mg 12mg 16mg Għoli TotalTotal
English: Adverse events
Maltese: Episodji avversi
English: The absorption of lornoxicam (calculated on AUC) can be reduced up to 20 %.
Maltese: L-assorbiment ta' lornoxicam (ikkalkolat fuq AUC) jista' jitnaqqas sa 20 %.
English: - Beta-adrenergic blockers: Decreased antihypertensive efficacy.
Maltese: - Imblokkaturi beta-adrenerġiċi:
English: The second meta-analysis included seven studies (CT01, CT02, CT03, CT14, CT32, CT78 and CT85) with orally applied lornoxicam including a total of 1581 patients.
Maltese: It-tieni meta-analiżi inkludiet seba' studji (CT01, CT02, CT03, CT14, CT32, CT78 u CT85) b'lornoxicam applikat oralment li flimkien kienu jinkludu 1581 pazjent.
English: The overall serious ADR (SADR) incidence for lornoxicam was 0.6%.
Maltese: L-inċidenza ta' ADR (SADR) serji globali għal lornoxicam kienet ta' 0.6%.
English: Uncommon: Flushing, oedema.
Maltese: Mhux komuni: Fwawar, edema.
English: Exposed # of patients % of patients with ADR 14 14 24 Gastro-intestinal
Maltese: # ta' pazjenti esposti % ta' pazjenti bl-ADR 14 14 24
English: - Other NSAIDs: Increased risk of gastrointestinal bleeding.
Maltese: - NSAIDs oħrajn: Żjieda fir-riskju ta' fsada gastrointestinali.
English: Lornoxicam was tested in 34 pain studies with 7,761 patients.
Maltese: Lornoxicam ġie ttestjat f'34 studju fuq l-uġigħ b'7,761 pazjent.
English: Data from table 2.13 in Clinical Safety Report, dated 21 December 2001
Maltese: Data mit-tabella 2.13 fir-Rapport dwar is-Sigurtà Klinika, datat il-21 ta' Diċmebru 2001
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%).
Maltese: Fir-rigward ta' l-NSAIDs kollha, episodji gastro-intestinali (GI) kienu l-aktar frekwenti (14%) segwiti b'sistema nervuża ċentrali (CNS), Sistema nervuża periferali (PNS), Psikjattriċi (Psych) (6%), Oħrajn (2%), il-Ġisem sħiħ (2%) u l-Ġilda (15).
English: Only 2/7 studies included a 16 mg dose and only 1/7 study included a 32 mg dose.
Maltese: 2/7 studji biss inkludew doża ta' 16 mg u 1/7 studji biss inkluda doża ta' 32 mg.
English: Trometamol Disodium edetate
Maltese: Disodium edetate
English: Posology - Section 4.2
Maltese: Pożoloġija - Sezzjoni 4.2
English: - Known inducers and inhibitors of CYP2C9 isoenzymes: Lornoxicam (as other NSAIDs depending on the cytochrome P450 2C9 (CYP2C9 isoenzyme)) has interactions with known inducers and inhibitors of CYP2C9 isoenzymes (see section 5.2 Biotransformation).
Maltese: - Indutturi u inibituri magħrufin ta' isoenzimi CYP2C9: Lornoxicam (bħal NSAIDs oħrajn li jiddependu fuq iċ-ċitokroma P450 2C9 (isoenzim CYP2C9)) għandu interazzjonijiet ma' indutturi u inibituri magħrufin ta' isoenzimi CYP2C9 (ara sezzjoni 5.2 Bijotrasformazzjoni).
English: Film:
Maltese: Folja:
English: - Methotrexate: Increased serum concentration of methotrexate.
Maltese: Konċentrazzjoni miżjuda ta' methotrexate fis-serum.
English: LABELLING
Maltese: Indication
English: Study reference no.
Maltese: Reference source not found..
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).
Maltese: Id-disturbi rewmatoloġiċi klassiċi kienu investigati f'26 studju bi 3,621 pazjent: 12-il studju fuq l-artrite b'rewmatiżmu (RA), 8 studji fuq l-osteoartrite (OA), 3 fiż-żewġ indikazzjonijiet u 3 f'indikazzjonijiet rewmatoloġiċi oħrajn (jiġifieri ankylosing spondylitis (AKS), rewmatiżmu mhux bl-artrite u gotta akuta).
English: Study CTX 87 was excluded since single doses of 4-20 mg LNX were administered i.m.
Maltese: L-Istudju CTX 87 ġie eskluż peress li dożi singoli ta' 4-20 mg LNX ġew amministrati i.m.
English: Very rare: Oedema and bullous reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis
Maltese: Rari ħafna: Edema u reazzjonijiet bullużi, sindromu ta' Stevens-Johnson, nekroliżi epidermali tossika
English: The osmolarity of the reconstituted solution is about 328 mosmol/kg and pH is about 8.7
Maltese: L-osmolarità tas-soluzzjoni rikostitwita hija madwar 328 mosmol/kg u l-pH huwa madwar 8.7.
English: Pharmacokinetic properties - Section 5.2
Maltese: Tagħrif farmakokinetiku - Sezzjoni 5.2
English: The mean elimination half-life is 3-4 hours.
Maltese: Il-half-life medja ta' l-eliminazzjoni hija 3-4 sigħat.
English: Study CT85 used only a single oral dose of 8 mg LNX p.o.
Maltese: L-istudju CT85 uża biss doża orali singola ta' 8 mg LNX p.o.
English: Simultaneous intake of lornoxicam with meals reduces Cmax by approximately 30 % and Tmax increases from 1.5 to 2.3 hours.
Maltese: Teħid simultanju ta' lornoxicam ma' l-ikel inaqqas Cmax b'bejn wieħed u ieħor 30 % u Tmax jiżdied minn 1.5 sa 2.3 sigħat.
English: Tablet container:
Maltese: Kontenitur tal-pilloli:
English: (No interaction between lornoxicam and ranitidine, or lornoxicam and antacids has been demonstrated).
Maltese: (Ma ġiet murija l-ebda interazzjoni bejn lornoxicam u ranitidina, jew lornoxicam u antaċidi).
English: Studies included in meta-analyses Parameters used
Maltese: Studji inklużi fil-meta-analżi Parametri wżati
English: Indication lornoxicam dose
Maltese: Indikazzjoni ta' doża lornoxicom
English: Ear and labyrinth disorders Uncommon: Vertigo, tinnitus.
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Mhux komuni: Vertigo, tinnite.
English: Table
Maltese: Tabella
English: After oral administration about 50% is excreted in the faeces and 42% through the kidneys, mainly as 5-hydroxylornoxicam.
Maltese: Wara amministrazzjoni orali madwar 50% joħroġ ma' l-ippurgar u 42% permezz tal-kliewi, l-aktar bħala 5hydroxylornoxicam.
English: Overall discussion on the meta-analyses
Maltese: Diskussjoni globali dwar il-meta-analiżi
English: During combined treatment renal function should be monitored.
Maltese: Waqt trattament kombinat il-funzjoni tal-kliewi għandha tkun immonitorata.
English: Incidence of ADRs reported for lornoxicam by SOC, Indication and Dose
Maltese: Tabella Inċidenza ta' ADRs rapportati għal lornoxicam mill-SOC, Indikazzjoni u Doża
English: Uncommon: Rash, pruritus, hyperhidrosis, rash erythematous, urticaria, alopecia.
Maltese: Mhux komuni: Raxx, ħakk tal-ġilda, iperidrożi, raxx eritematiku, urtikarja, alopeċja.
English: When given as IV injection, the time of injection should be at least 15 seconds, and for IM injection, at least 5 seconds.
Maltese: Meta mogħti bħala injezzjoni IV, il-ħin ta' l-injezzjoni għandu jkun ta' l-inqas 15-il sekonda, u għal injezzjoni IM, ta' l-inqas 5 sekondi.
English: Pharmacotherapeutic group: antiinflammatory and antirheumatic products, non-steroids, oxicams ATC code: M01 AC05
Maltese: Prodotti anti-infjammatorji u antirewmatiċi, mhux-sterojdi, oxicams Kodiċi ATC:
English: Excipients: Lactose 90 mg For a full list of excipients, see section 6.1.
Maltese: Lactose 94 mg Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Lornoxicam 8mg bid is at least as effective as diclofenac 50mg tid and naproxen 500mg bid.
Maltese: Lornoxicam 8mg bid huwa effettiv mill-inqas daqs diclofenac 50mg tid u naproxen 500mg bid.
English: The duration of blinded treatment was 4 weeks for studies CT18 and CT80 and 12 weeks for CT33 and CT63.
Maltese: CT18 u CT80 u 12-il ġimgħa għal CT33 u CT63.
English: Lornoxicam is metabolised completely, and approximately 2/3 is eliminated via the liver and 1/3 via the kidneys as inactive substance.
Maltese: Lornoxicam huwa metabilzzat għal kollox, u bejn wieħed u ieħor 2/3 jiġi eliminat permezz tal-fwied u 1/3 permezz tal-kliewi bħala sustanza inattiva.
English: The absolute bioavailability of Xefo Rapid film-coated tablets is 90-100 % which is equivalent to Xefo film-coated tablet.
Maltese: Il-bijodisponibbiltа' assoluta ta' Xefo Rapid pilloli miksijin b'rita hija 90-100 % li hija ekwivalenti għal Xefo pilloli miksijin b'rita.
English: 4 mg
Maltese: 4 mg/ml
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.
Maltese: Dejta minn 103 studju kliniku ġiet inkluża fl-SPD inkluż 57 studju double-blind, 4 studji single-blind u 50 studju miftuħ li minnhom 8 kienu follow-up għal studji meħudin b'mod każwali.
English: Rare: Melaena, haematemesis, stomatitis, oesophagitis, gastrooesophageal reflux, dysphagia, aphthous stomatitis, glossitis, perforated peptic ulcer.
Maltese: Melina, ħematemeżiżi, stomatite tal-afta, osofaġite, refluss gastroosofagali, disfaġja, stomatite ta' l-afta, glossite, ulċera peptika perforata.
English: The most commonly observed adverse events of NSAIDs are gastrointestinal in nature.
Maltese: L-aktar episodji avversi komuni osservati ta' NSAIDs huma oriġinarjament gastrointestinali.
English: Rare: Asthenia.
Maltese: Rari ħafna:
English: Lornoxicam, 4 mg & 8mg, film-coated tablets
Maltese: Lornoxicam, 4 & 8 mg, pilloli miksijin b'rita
English: The safety database (SDB) included all lornoxicam studies under the control of Nycomed Pharma (studies performed by third parties were excluded) comprised a total of 12,570 patients of who 7,427 received lornoxicam.
Maltese: Database ta' sigurtà, numru ta' pazjenti u espożizzjoni Id-database ta' sigurtà (SDB) inkludiet l-istudji ta' lornoxicam kollha taħt il-kontroll ta' Nycomed Pharma (studji mwettqin minn terzi ġew esklużi) magħmula minn total ta' 12,570 pazjent li minnhom 7,427 irċevew Lornoxicam.
English: Uncommon: Increase in liver function tests, SGPT (ALT) or SGOT (AST).
Maltese: Mhux komuni: Żjieda fit-testijiet tal-funzjoni tal-fwied SGPT (ALT) jew SGOT (AST).
English: The plasma protein binding of lornoxicam is 99 % and not concentration dependent.
Maltese: Ir-rabta tal-proteina tal-plażma ma' lornoxicam hija 99% u mhux dipendenti fuq il-konċentrazzjoni.
English: Pharmacodynamic properties - Section 5.1
Maltese: Tagħrif farmakodinamiku - Sezzjoni 5.1
English: Lornoxicam is available as film coated tablets 4 mg and 8 mg, rapid release film-coated tablets 8 mg, and as powder and solvent for solution for injection 4 mg/ml for intramuscular and intravenous injection.
Maltese: Lornoxicam huwa disponibbli bħala pilloli miksijin b'rita 4 mg u 8 mg, pilloli miksijin b'rita ta' 8 mg għal rilaxx rapidu, u bħala trab u solvent għal soluzzjoni għal injezzjoni ta' 4 mg/ml għal injezzjoni ġol-muskoli u ġol-vina.
English: There are insufficient data to exclude such a risk for lornoxicam.
Maltese: M'hemmx biżżejjed informazzjoni biex jiġi eskluż tali riskju għal lornoxicam.
English: Therapeutic indication - pain
Maltese: Indikazzjoni terapewtika - uġigħ
English: Shelf life after reconstitution: 24 hours at 21°C (±2 °C)
Maltese: Kemm idum tajjeb wara r-rikostituzzjoni: 24 siegħa f'temperatura ta' 21°C (±2 °C)
English: The pack sizes are 1, 5, 6 and 10 sets.
Maltese: Id-daqsijiet tal-pakkett huma settijiet ta' 1, 5, 6 u 10.
English: The meta-analysis included only 3 studies on third molar surgery (CT01, CT14, CT78) with orally applied lornoxicam.
Maltese: Il-meta-analiżi inkludiet biss 3 studji dwar l-operazzjoni fuq it-tielet sinna fuq wara tal-ħalq (CT01, CT14, CT78) b'Lornoxicam applikat oralment.
English: Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.
Maltese: Edema, pressjoni għolja, u arrest kardijaku, ġew rapportati f'assoċjazzjoni mat-trattament NSAID.
English: The mean elimination half-life of the parent compound is 3 to 4 hours.
Maltese: Il-half-life medja ta' l-eliminazzjoni tal-kompost ewlieni tvarja bejn 3 u 4 sigħat.
English: Particular care should be taken if you are receiving any of the following substances: - Cimetidine - Anticoagulantia as heparin, phenprocoumon - Corticosteroids - Methotrexate - Lithium - Immunosuppressive agents as ciclosporine, tacrolimus - Heart medicine as digoxin, ACE-inhibitors, beta-adrenergic blockers - Diuretics - Quinolone antibiotics - Anti-platelet agents - NSAIDs as ibuprofen, acetylsalicylic acids - SSRI - Sulphonylureas - Inducer and inhibitors of CYP2C9-isoenzymes
Maltese: Għandha tingħata attenzjoni partikulari jekk qed tieħu xi waħda minn dawn is-sustanzi: - Cimetidine - Antikoagulanti bħal ħeparina, phenprocoumon - Kortikosterojdi - Methotrexate - Litju - Aġenti immunosoppressivi bħal ċiklosporina, takrolimus - Mediċina tal-qalb bħal dijossina, inibituri ACE, imblokkaturi beta-adrenerġiċi - Dijuretiċi - Antibijotiċi quinolone - Aġenti anti-plejtlits - NSAIDs bħal ibuprofen, acetylsalicylic acids - SSRI - Sulphonylureas - Mediċini indutturi u inibituri ta' isoenzimi ta' CYP2C9
English: - Sulphonylureas: Increased risk of hypoglycaemia.
Maltese: - Sulphonylureas: Riskju ogħla ta' ipogliċemija .
English: Lornoxicam at dosages 4mg tid and 8mg bid is effective in the symptomatic treatment of RA.
Maltese: Lornoxicam f'dożi ta' 4 mg tid u ta' 8mg bid huwa effettiv fit-trattament tas-sintomi ta' l-RA.
English: Serious adverse event/deaths/other significant events
Maltese: Episodju avvers serju/imwiet/avvenimenti sinifikanti oħrajn
English: Gastrointestinal disorders can for example be treated with a prostaglandin analogue or ranitidine.
Maltese: Id-disturbi gastrointestinali jistgħu per eżempju jkunu trattati b'analogi tal-prostaglandin jew ranitidin.
English: The MAH has applied the PhVWP core information for NSAIDs in relation to gastrointestinal safety, skin reactions and cardiovascular safety (October 2005).
Maltese: Il-MAH applika l-informazzjoni prinċipali tal-PhVWP għall-NSAIDs fir-rigward tas-sigurtà gastrointestinali, reazzjonijiet tal-ġilda u sigurtà karjovaskulari (Ottubru 2005).