FrancophonIA/ELRC3.0 huggingface dataset:
English: For the dose-relationship up to 32 mg only a single study (CT78) included the 16 mg and 32 mg dose, which reduces the relevance of the dose-relationship, i.g.
Maltese: Għar-relazzjoni tad-doża sa 32 mg, studju singolu biss (CT78) inkluda d-dożi ta' 16 mg u 32 mg, u dan inaqqas ir-relevanza tar-relazzjoni tad-doża, i.g. ir-relazzjoni rispons-doża 'l fuq minn 8 mg LNX p.o. hija bbażata fuq studju wieħed.
English: Lornoxicam is a non steroidal anti-inflammatory drug with analgesic properties and belongs to the class of oxicams.
Maltese: Lornoxicam huwa mediċina sterojdali anti-infjammatorja b'karatteristiċi analġesiċi u jappartejni għall-kategorija ta' oxicams.
English: M-300, Km 30,500.
Maltese: Taħżinx f'temperatura ‘l fuq minn 30C°.
English: Reactions relating to other System organs (SOCs) occurred in less than 1% of the patients.
Maltese: Reazzjonijiet relatati ma' organi oħrajn tas-Sistema (SOCs) irriżultaw f'inqas minn 1% tal-pazjenti.
English: Nervous system disorders Common: Mild and transient headache, dizziness.
Maltese: Disturbi fis-sistema nervuża Komuni: Uġigħ ta' ras ħafif u temporanju, sturdament.
English: - Cyclosporine: Increased serum concentration of cyclosporine.
Maltese: Żieda fil-konċentrazzjoni ta' serum taċ-ċiklosporine.
English: Lornoxicam, 4 & 8 mg, film-coated tablets 8-16 mg lornoxicam daily divided into 2 or 3 doses.
Maltese: Lornoxicam, 4 mg & 8mg, pilloli miksijin b'rita - Serħan għal terminu qasir ta' uġigħ mhux qawwi għal moderat
English: Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Maltese: Prova klinika u data epidemoloġika jissuġġerixxu li l-użu ta' xi NSAIDs (partikolarment f'dożi għolja u fi trattament għal terminu twil) jistgħu jkunu assoċjati ma' riskju miżjud ta' avvenimenti trombotiċi arterjali (per eżempju infart mijokardjali jew puplesija) (ara sezzjoni 4.4).
English: 4.3 Contraindications - Hypersensitivity to lornoxicam or any of the excipients - Thrombocytopenia - Hypersensitivity (symptoms like asthma, rhinitis, angioedema or urticaria) to other NSAIDs including acetylsalicylic acid - Severe heart failure - Gastro-intestinal bleeding, cerebrovascular bleeding or other bleeding disorders - History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy - Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - Severe hepatic impairment - Severe renal impairment (Serum creatinine > 700 µmol/l) - The third trimester of pregnancy (see section 4.6)
Maltese: 4.3 Kontra-indikazzjonijiet - Sensittività eċċessiva għal lornoxicam jew għal xi sustanzi mhux attivi - Tromboċitopenija - Ipersensitività eċċessiva (sintomi bħal ażma, rinite, anġjoedema jew urtikarja) għal NSAIDs oħrajn inkluż acetylsalicylic acid - Insuffiċjenza kardijaka severa - Fsada gastrointestinali, fsada ċerebrovaskulari u disturbi oħrajn ta' fsada - Storja ta' fsada jew perforazzjoni gastrointestinali, marbuta ma' terapija NSAIDs preċedenti - Ulċera peptika/emorraġija rikorrenti attiva jew storja tagħha (żewġ episodji jew iktar ta' ulċerazzjoni jew fsada ippruvati) - Ħsara epatika severa - Ħsara renali severa (krejatinina fis-serum > 700 µmol/l) - It-tielet trimestru ta' tqala (ara sezzjoni 4.6)
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza tal-galaktows, bid-defiċjenza Lapp lactase jew b'assorbiment ħażin ta' glukows-galaktows ma għandhomx jieħdu din il-mediċina.
English: For all the pharmaceutical forms and strengths of lornoxicam It was agreed that the following additional undesirable effects: weight changes, ecchymosis, prolonged bleeding time, bronchospasm, rhinitis, perforated peptic ulcer, pupura, increase in blood urea nitrogen and creatinine levels.
Maltese: Għall-forom farmaċewtiċi kollha u l-vantaġġi ta' lornoxicam Ġie maqbul li l-effetti mhux mixtieqa addizzjonali li ġejjin: bidliet fil-piż, ecchymosis, perijodu ta' fsada mtawwal, spażmi fil-bronki, rinite, ulċerazzjoni ta' l-istonku perforata, pupura, żieda finnitroġenu fl-urea u fil-livelli ta' kreatina.
English: 8-16 mg lornoxicam given in doses of 8 mg. An initial dose of 16 mg followed by 8 mg 12 hours later can be given on the first treatment day.
Maltese: 8-16 mg lornoxicam mogħti f'dożi ta' 8 mg.
English: Very rare (less than 1 in 10.000 patients treated)
Maltese: Rari ħafna (f'anqas minn 1 minn kull 10,000 pazjent ikkurat)
English: Xefo Rapid should not be used concomitantly with other NSAIDs such as acetylsalicylic acid, ibuprofen and COX-2 inhibitors.
Maltese: Xefo Rapid m'għandux jintuża fl-istess ħin ma' NSAIDs oħra bħal acetylsalicylic acid, ibuprofen u inibituri COX-2.
English: Therefore, the use of lornoxicam is contraindicated during the third trimester of pregnancy (see section 4.3).
Maltese: Għalhekk, l-użu ta' lornoxicam huwa kontroindikat waqt it-tielet tliet trimestru tat-tqala (ara sezzjoni 4.3).
English: Intravenous use Intramuscular use
Maltese: Gastro-intestinali
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.
Maltese: Elenkati hawn isfel hawn l-effetti mhux mixtieqa li ġeneralment seħħew f'aktar minn 0.05% tas-6,417il pazjent ittrattati fi provi kliniċi ta' fażi
English: In addition the following wording has been included as agreed by the PhVWP in October 2005 and January 2007:
Maltese: Il-formulazzjoni li ġejja ġiet inkluża kif maqbul mill-PhVWP f'Ottubru 2005 u f'Jannar 2007:
English: Xefo is distributed in pack sizes of 10, 20, 30, 50, 100, 250 and 500 film-coated tablets.
Maltese: Xefo huwa ddistribwit f'pakketti li fihom 10, 20, 30, 50, 100, 250 u 500 pillola miksija b'rita.
English: Uncommon: Constipation, flatulence, eructation, dry mouth, gastritis, gastric ulcer, abdominal pain upper, duodenal ulcer, mouth ulceration.
Maltese: Mhux komuni: Stitikezza, gass, tifwiq, ħalq xott, gastrite, ulċera fl-istonku, uġigħ fil-parti ta' fuq ta' laddome, ulċera duwodenali, ulċeri fil-ħalq.
English: Xefo Rapid tablets must be swallowed with sufficient fluid.
Maltese: Il-pilloli ta' Xefo Rapid għandhom jinbelgħu ma' fluwidu suffiċjenti.
English: The following information is intended for medical or healthcare professionals only Xefo 8 mg powder and solvent for solution for injection: - The active substance is lornoxicam One vial with powder contains 8 mg lornoxicam Reconstituted solution: One ml contains 4 mg lornoxicam - The other ingredients are mannitol, trometamol, disodium edetate.
Maltese: - Is-sustanza attiva hi lornoxicam - Kunjett wieħed fih 8 mg trab lornoxicam - Soluzzjoni rikostitwita: ml wieħed fih 4 mg ta' lornoxicam - Is-sustanzi l-oħra huma mannitol, trometamol, disodium edetate.
English: Unless compatibility is proven, Xefo 4 mg/ml solution for injection should always be administered separately.
Maltese: Sakemm ma jkun hemmx provi ta' kompatibilità, doża ta' Xefo 4 mg/ml soluzzjoni għall-injezzjoni għandha dejjem tingħata waħidha.
English: Due to a local gastrointestinal irritation and a systemic ulcerogenic effect related to the inhibition of prostaglandin (PG)-synthesis, gastrointestinal sequela are common side effects after treatment with lornoxicam as seen with other NSAIDs.
Maltese: Minħabba irritazzjoni gastrointestinali lokali u effett ulċeroġeniku sistematiku marbut ma' linibizzjoni tas-sintesi tal-prostaglandin (PG), effetti gastrointestinali huma effetti sekondarji komuni wara trattament b'Lornoxicam kif jidher ma' NSAIDs oħrajn.
English: Musculoskeletal and connective tissue disorders Uncommon: Arthralgia
Maltese: Disturbi muskolu-skeltrali, tal-connective tissue u ta' l-għadam Mhux komuni: Artralġija
English: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 8 mg lornoxicam
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Pillola waħda miksija b'rita fiha 8 mg lornoxicam
English: The maximum recommended doses is 16 mg daily.
Maltese: Id-dożi massimi rakkomandati huma 16 mg kuljum.
English: Solvent: One ampoule contains 2 ml water for injection
Maltese: Ampolla waħda fiha 2 ml ilma għall-injezzjoni
English: The divergences between the MS in the wording of the description of the pharmacodynamic properties have been harmonised.
Maltese: Id-diverġenzi bejn MS fil-formulazzjoni tad-deskrizzjoni ta' tagħrif farmakodinamiku ġew armonizzati.
English: Solvent: Water for injection
Maltese: Infezzjonijiet u infestazzjonijiet
English: Xefo Rapid and associated names (see Annex I) 8 mg film-coated tablets [see Annex I - to be completed nationally]
Maltese: Xefo Rapid u ismijiet assoċjati (Ara Anness I) 8 mg pilloli miksijin b'rita [Ara Anness I - biex timtela mill-pajjiż partikolari]
English: Do not use Xefo Rapid after the expiry date which is stated on the carton.
Maltese: Tużax Xefo Rapid wara d-data ta' skadenza li tidher fuq il-kartuna.
English: Common (less than 1 in 10, but more than 1 in 100 patients treated) Mild and transient headache, dizziness, nausea, abdominal pain, dyspepsia, diarrhoea, vomiting.
Maltese: Komuni (inqas minn 1 f'10, imma aktar minn 1 f'100 pazjent ikkurat) Uġigħ ta' ras mhux qawwi u temporanju, sturdament, dardir, uġigħ addominali, dispepsja, dijarea, rimettar.
English: Xefo 4 mg/ml solution for injection is intended for intramuscular (i.m.)
Maltese: X'fih Xefo 4 mg/ml soluzzjoni għall-injezzjoni Il-kunjett:
English: Lornoxicam should be administered with precaution as gastrointestinal adverse effects are less well tolerated in this group (see section 4.4).
Maltese: Lornoxicam għandu jingħata b'kawtela għaliex effetti avversi gastrointestinali huma inqas ittollerati tajjeb f'dan il-grupp (ara sezzjoni 4.4).
English: Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (see section 4.5).
Maltese: Għandha tingħata attenzjoni f'pazjenti li fl-istess ħin ikunu qed jirċievu medikazzjonijiet li jistgħu jżidu r-riskju ta' ulċerazzjoni jew fsada, bħal kortikosterojdi orali, antikoagulanti bħal warfarina, inibituri selettivi ta' assorbiment ta' serotonin jew aġenti anti-plejtlits bħal acetylsalicylic acid (ara sezzjoni 4.5).
English: White to yellowish oblong film-coated tablet with imprint “L08”
Maltese: Pillola miksija b'rita bajda għal safranija b'“L08” stampata fuqha
English: Rare: Somnolence, paraesthesia, dysgeusia, tremor, migraine.
Maltese: Ngħas, parasteżija, disgewsja, rogħda, emigranja.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 4 mg lornoxicam
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Pillola waħda miksija b'rita fiha 4 mg lornoxicam
English: The reason for exclusion of study CT32 is not clear (it was included in meta-analysis 2; single doses were applied post surgery).
Maltese: Ir-raġuni għall-esklużjoni ta' l-istudju CT32 ma kinitx ċara (huwa kien inkluż fil-meta-analiżi 2; dożi singoli ġew applikati wara l-kirurġija).
English: Therapeutic indication - rheumatic pain (RA)
Maltese: Pillola miksija b'rita
English: (The pharmacokinetic profile of a single dose of 8 mg lornoxicam i.m.
Maltese: (Il-profil farmakokinetiku ta' doża singola ta' lornoxicam ta' 8 mg i.m. huwa komparabbli ma' dak ta' doża orali ta' 8 mg ta' lornoxicam - QR).
English: Amber glass, class III (hydrolytic) with aluminium screw cap closures.
Maltese: Ħġieġ kulur l-ambra, klassi III (idrolitiku) b'għatu ta' l-aluminju li ddawwru biex tagħlqu.
English: Concomitant treatment of NSAIDs and tacrolimus may increase the risk of nephrotoxicity owing to reduced synthesis of prostacyclin in the kidney.
Maltese: Trattament konkomittanti ta' NSAIDs u takrolimus jista' jżid ir-riskju ta' nefrotossiċità minħabba sintesi mnaqqsa ta' prostaċiklin fil-kliewi.
English: The posology agreed for acute pain is:
Maltese: Effett imnaqqas ta' trattament bi phenprocoumon - Ħeparina:
English: In this leaflet:
Maltese: Konġuntivite Rari:
English: White to yellowish oblong film-coated tablet with imprint “L04”
Maltese: Pillola rettangolari miksija b'rita bajda għal safranija b'“L04” stampata fuqha
English: - One vial with powder contains 8 mg lornoxicam - Reconstituted solution: One ml contains 4 mg lornoxicam - The other ingredients are mannitol, trometamol, disodium edetate.
Maltese: Soluzzjoni rikostitwita: ml wieħed fih 4 mg ta' lornoxicam - Is-sustanzi l-oħra huma mannitol, trometamol, disodium edetate.
English: Lornoxicam i.v.
Maltese: X'INHU LORNOXICAM
English: - One film-coated tablet contains 4 mg lornoxicam - The other ingredients are: Core: Lactose monohydrate, Cellulose, microcrystalline, Povidone, Croscarmellose sodium, Magnesium stearate Film: Macrogol, Titanium dioxide (E171), Talc, Hypromellose
Maltese: Qalba: Lactose monohydrate, Cellulose, microcrystalline, Povidone, Croscarmellose sodium, Magnesium stearate Rita:
English: Medicines such as Xefo may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
Maltese: Mediċini bħal Xefo jistgħu jkunu assoċjati ma' riskju żgħir akbar ta' attakk tal-qalb (“infart mijokardijaku”) jew puplesija.
English: 4 of 7 studies investigated the efficacy in third molar surgery pain (and three of these studies were already included in meta-analysis
Maltese: 4 minn 7 studji investigaw leffikaċja ta' l-uġigħ ta' operazzjoni tat-tielet darsa (u tlieta minn dawn l-istudji diġà kienu inklużi filmeta-analiżi 1).
English: Lornoxicam is found in the plasma in unchanged form and as its hydroxylated metabolite.
Maltese: Lornoxicam jinsab fil-plażma f'forma mhux mibdula u bħala l-metabolit idrossilizzat tiegħu.
English: Uncommon (less than 1 in 100, but more than 1 in 1000 patients treated) Anorexia, insomnia, depression, conjunctivitis, vertigo, tinnitus, palpitations, tachycardia, flushing, constipation, flatulence, eructation, dry mouth, gastritis, gastric ulcer, abdominal pain upper, duodenal ulcer, mouth ulceration, increase in liver function tests, SGPT (ALT) or SGOT (AST), rash, pruritus, hyperhidrosis, rash erythematous, urticaria, alopecia, arthralgia, rheumatoid arthritis, osteoarthritis, malaise, face oedema, weight changes, oedema, rhinitis.
Maltese: Mhux komuni (inqas minn 1 f'100, imma aktar minn 1 f'1000 pazjent ikkurat) Anoressja, nuqqas ta' rqad, dipressjoni, konġuntivite, vertiġini, żanżin tal-widnejn, palpitazzjonijiet, takikardija, fwawar, stitikezza, gass, tifwiq, ħalq xott, gastrite, ulċera fl-istonku, uġigħ fl-addome filparti ta' fuq, ulċera duwodenali, ulċera fil-ħalq, żjieda fit-testijet tal-funzjoni tal-fwied, SGPT (ALT) jew SGOT (AST), raxx, ħakk tal-ġilda, idrożi eċċessiva, raxx eritematiku, urtikarja, alopeċja, artralġja, artrite tar-rewmatiżmu, osteoartrite, telqa tal-ġisem, edema fil-wiċċ, tibdil fil-piż, edema, rinite.
English: Severe urinary, CNS and skin reactions have not been reported.
Maltese: Reazzjonijiet severi relatati ma' lawrina, is-CNS u l-ġilda ma ġewx irrapportati.
English: Rare (less than 1 in 1000, but more than 1 in 10.000 patents treated) Pharyngitis, anaemia, thrombocytopenia, leucopoenia, hypersensitivity, confusion, nervousness, agitation, somnolence, paraesthesia, dysgeusia, tremor, migraine, visual disturbances, hypertension, hot flush, haemorrhage, haematoma, dyspnoea, cough, melaena, haematemesis, stomatitis, oesophagitis, gastrooesophageal reflux, dysphagia, aphthous stomatitis, glossitis, hepatic function abnormal, dermatitis, bone pain, muscle spasms, myalgia, nocturia, micturition disorders, asthenia, prolonged bleeding time, pupura, bronchospasm, increase in blood urea nitrogen and creatinine levels, perforated peptic ulcer
Maltese: Mhux komuni (inqas minn 1 f'1000, imma aktar minn 1 f'10,000 pazjent ikkurat) Farinġite, anemija, tromboċitopenja, lewkopenja, sensittività eċċessiva, konfużjoni, nervożiżmu, aġitazzjoni, ngħas, parasteżija, disgewsja, rogħda, emigranja, disturbi fil-vista, pressjoni għolja, fawra, emorraġija, ematoma, dispneja, sogħla, melina, ħematemeżi, stomatite tal-afta, esofagite, rifluss gastroosofogali, disfaġja, stomatite tal-afta, glossite, funzjoni anormali tal-fwied, dermatite, uġigħ flgħadam, spażmi, mijalġja, nokturja, disturbi marbuta mal-bżonn ta' tneħħija ta' l-awrina, astenja, ħin imtawwal ta' fsad, pupura, spażmi tal-bronki, żjieda fil-livelli ta' nitroġenu ta' l-urea u ta' krejatina fid-demm, ulċera peptika perforata
English: The third meta-analysis on the overall impression of the 12 placebo-controlled double blind lornoxicam efficacy studies included 1 study with parenteral (i.m.)
Maltese: It-tielet meta-analiżi dwar l-impressjoni globali tat-12-il studju dwar l-effikaċja ta' lornoxicam double blind ikkontrollati bi plaċebo inkludew studju wieħed b'applikazzjoni (i.m.) parenterali ta' LNX (CT87) u 2 studji b'aktar minn doża waħda i.v.
English: Due to a local gastrointestinal irritation and a systemic ulcerogenic effect related to the inhibition of prostaglandin (PG)-synthesis, gastrointestinal sequela are common undisirable effects after treatment with lornoxicam as seen with other NSAIDs.
Maltese: Minħabba irritazzjoni gastrointestinali lokali u effett ulċeroġeniku sistematiku marbut ma' l-inibizzjoni tas-sintesi tal-prostaglandin (PG), effetti gastrointestinali huma effetti mhux mixtieqa komuni wara trattament b'Lornoxicam kif jidher ma' NSAIDs oħrajn.
English: Pregnancy
Maltese: IPREŻENTATI
English: With respect to OA, the following can be summarised: Lornoxicam 8mg bid (16 mg) is more efficacious than placebo.
Maltese: Diskussjoni globali dwar l-OA Fir-rigward ta' l-OA, dan li ġej jista' jingħata f'sommarju: Lornoxicam 8mg bid (16 mg) huwa aktar effikaċi minn plaċebo.
English: WHAT XEFO IS AND WHAT IT IS USED FOR Xefo is a non-steroidal anti-inflammatory drug and antirheumatic drug (NSAID) of the oxicam class.
Maltese: Xefo hi mediċina li ma fihiex sterojds kontra l-infjammazzjoni u kontra r-rewmatiżmu (NSAID) talkategorija oxicam.
English: - Diuretics: Decreased diuretic and antihypertensive effect of loop diuretics and thiazide diuretics.
Maltese: - Dijuretiċi: Effett dijuretiku u kontra l-pressjoni għolja mnaqqas ta' dijuretiċi tat-tip loop u dijuretiċi tat-tip thiazide.
English: After IM injection, maximum plasma concentrations are achieved after approximately 0.4 hours.
Maltese: Wara injezzjoni IM, jintlaħqu l-konċentrazzjonijiet massimi ta' plażma wara bejn wieħed u ieħor 0.4 sigħat.
English: Lornoxicam, 8 mg, Powder and solvent for solution for injection Short-term relief of acute mild to moderate pain
Maltese: Lornoxicam, 8 mg, Trab jew solvent għal soluzzjoni għall-injezzjoni Serħan għal terminu qasir ta' uġigħ mhux qawwi akut għal moderat
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 8 mg lornoxicam.
Maltese: U KWANTITATTIVA Pillola waħda miksija b'rita fiha 8 mg ta' lornoxicam.
English: The recent PhVWP core information regarding cardiovascular safety of NSAIDs (January 2007) has also been taken into account.
Maltese: L-informazzjoni prinċipali PhVWP reċenti fir-rigward ta' sigurtà kardjovaskulari ta' l-NSAIDs (Jannar 2007) ġiet ikkunsidrata ukoll
English: 4.1 Therapeutic indications - Short-term relief of acute mild to moderate pain - Symptomatic relief of pain and inflammation in osteoarthritis - Symptomatic relief of pain and inflammation in rheumatoid arthritis
Maltese: 4.1 Indikazzjonijiet terapewtiċi - Ħelsien għal ftit ħin minn uġigħ akut ħafif għal moderat - Trattament simptomatiku ta' serħan mill-uġigħ u infjammazzjoni f'artrite ta' l-għadam.
English: Recommended dose: 8 mg intravenous or intramuscular.
Maltese: Doża rakkomandata: 8 mg għal ġol-vini jew għal ġol-muskoli.
English: The accumulation of lornoxicam in patients with chronic liver disease at higher doses (12 mg/d or 16 mg/d) as observed instudy CT13 has been described in the SPC: There is no significant change in the kinetic profile of lornoxicam in patients with renal or hepatic failure, except for accumulation in patients with chronic liver disease after 7 days of treatment with daily doses of 12 and 16 mg.
Maltese: M'hemm ebda bidla sinifikanti fil-profil kinetiku ta' lornoxicam f'pazjenti b'indeboliment renali jew epatiku, ħlief għall-akkumulazzjoni f'pazjenti b'mard kroniku tal-fwied wara 7 jiem trattament b'dożi ta' 12 u 16 mg kuljum.
English: - Short-term relief of acute mild to moderate pain
Maltese: Serħan għal ftit ħin minn uġigħ akut ħafif għal moderat
English: or i.v.
Maltese: Phase I
English: Approximately 20% of patients treated with lornoxicam can be expected to experience adverse reactions.
Maltese: Bejn wieħed u ieħor, 20% tal-pazjenti ttrattati b'Lornoxicam jistgħu jkun mistennija li jesperjenzaw reazzjonijiet avversi.
English: 500 film-coated tablets
Maltese: 500 pillola miksijin b'rita
English: PHARMACEUTICAL FORM Film-coated tablet
Maltese: U T-TIKKETTA TALKONTENITUR TAL-PILLOLI
English: What Xefo looks like and contents of the pack Xefo 8 mg film-coated tablet is a white to yellowish oblong film-coated tablet with imprint “L08”.
Maltese: Xefo 8 mg pillola miksija b'rita huwa pillola miksija b'rita li tvarja minn bajda għal safranija rettangolari b'"L08" stampata fuqha.
English: What Xefo contains - The active substance is lornoxicam.
Maltese: - Is-sustanza attiva hija lornoxicam
English: Solvent: Clear solution
Maltese: Solvent:
English: What Xefo looks like and contents of the pack Xefo 4 mg film-coated tablet is a white to yellowish oblong film-coated tablet with imprint “L04”.
Maltese: Barra dan il-formulazzjoni li ġejja ġiet inkluża kif maqbul mill-PhVWp f'Ottubru 2005 u Jannar 2007:
English: Batch
Maltese: Fwied
English: A clear reduction in pain intensity vs. placebo was only obtained at ≥8 mg LNX p.o. (8
Maltese: Tnaqqis ċar fl-intensità ta' l-uġigħ meta mqabbel mal-plaċebo inkiseb biss b'≥8 mg LNX p.o. (doża ta' 8 mg fl-istudju CT01).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 4 mg lornoxicam Excipients: Lactose 94 mg
Maltese: U KWANTITATTIVA Pillola waħda miksija b'rita fiha 4 mg ta' lornoxicam
English: Eye disorders Uncommon: Conjuctivitis Rare: Visual disturbances.
Maltese: Mhux komuni: Artralġija Rari:
English: Xefo and associated names (see Annex I) 8 mg film-coated tablets [see Annex I - To be completed nationally]
Maltese: Xefo u ismijiet assoċjati (Ara Anness I) 8 mg pilloli miksijn b'rita [Ara Anness I - biex timtela mill-pajjiż partikolari]
English: Elderly
Maltese: Ġilda
English: Overall discussion on RA With respect to RA, the following can be summarised:
Maltese: Diskussjoni globali dwar l-RA Fir-rigward ta' l-RA, dan li ġej jista' jingħata f'sommarju:
English: Caution should be advised in patients receiving concomitant medicinal products which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (see section
Maltese: Għandha tingħata attenzjoni f'pazjenti li fl-istess ħin ikunu qed jirċievu prodotti mediċinali li jistgħu jżidu r-riskju ta' ulċerazzjoni jew fsada, bħal kortikosterojdi orali, antikoagulanti bħal warfarina, inibituri selettivi ta' assorbiment ta' serotonin jew aġenti anti-plejtlits bħal acetylsalicylic acid (ara sezzjoni 4.5).
English: It was agreed that the following statement would be included:
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folja:
English: Lornoxicam Rapid, 8 mg, film coated tablets Short-term relief of acute mild to moderate pain
Maltese: Lornoxicam Rapid, 8 mg, pilloli miksijin b'rita Serħan għal terminu qasir minn uġigħ mhux qawwi akut għal moderat
English: Xefo Rapid is not recommended for use in children and adolescents below age 18 due to lack of data
Maltese: Xefo Rapid mhuwiex rakkomandat għal użu fuq tfal u adoloxxenti taħt l-età ta' 18-il sena minħabba nuqqas ta' tagħrif
English: Lornoxicam “Nycomed” 8 mg Film-coated tablet
Maltese: Kunjett wieħed fih 8 mg trab lornoxicam