FrancophonIA/ELRC3.0 huggingface dataset:
English: Nine prespecified adverse event categories were evaluated (cardiovascular thromboembolic events, pericarditis, new onset or exacerbation of congestive heart failure, renal failure/dysfunction, upper GI ulcer complications, major non-GI bleeds, infections, non-infectious pulmonary complications, and death).
Maltese: Disa' kategorija ta' episodji avversi speċifikati minn qabel ġew evalwati (episodji tromboemboliċi, perikardite, bidu jew taħrix ta' insufiċjenza tal-qalb konġestiva, indeboliment renali/funzjoni renali ħażina, kumplikazzjonijiet ta' ulċeri GI fil-parti ta' fuq, fsada mhux GI maġġuri, infezzjonijiet, kumplikazzjonijiet pulmonari mhux infettużi, u mewt).
English: The IV line must be adequately flushed prior to and after Dynastat injection with a solution of known compatibility (see section 6.6).
Maltese: Il-linja IV għandha tiġi mlaħalħa adegwatament qabel u wara injezzjoni ta' Dynastat b'soluzzjoni li huwa mgħruf li hija kompatibbli (ara sezzjoni 6.6).
English: Injection into an IV line delivering glucose 50 mg/ml (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed in section 6.6, is not recommended as this may cause precipitation from solution.
Maltese: Injezzjoni fit-tubu IV li jwassal il-glukosju 50 mg/ml (5%) f'soluzzjoni Ringer-Lactate għallinjezzjoni, jew fluwidi IV oħra mhux imsemmija fis-sezzjoni 6.6, mhijiex rakkomondata għax din tista tikkawża preċipitazzjoni fis-soluzzjoni.
English: Phosphoric acid and/or sodium hydroxide (for pH adjustment).
Maltese: Phosphoric acid u/jew sodium hydroxide (għal aġġustament tal-pH).
English: Plasma exposure of omeprazole (CYP 2C19 substrate) 40 mg once daily was increased by 46% following administration of valdecoxib 40 mg twice daily for 7 days, while the plasma exposure to valdecoxib was unaffected.
Maltese: L-esponiment tal-plażma ta' omeprazole (sustrat ta' CYP2C19) 40 mg darba kuljum, ġie miżjud b'46 % wara l-amministrazzjoni ta' valdecoxib 40 mg darbtejn kuljum għal 7 ijiem, filwaqt li l-esponiment tal-plażma għal-valdecoxib ma ġiex affettwat.
English: For storage conditions of the reconstituted medicinal product see section 6.3.
Maltese: Għal kundizzjonijiet ta' ħażna tal-prodott mediċinali rikostitwit ara sezzjoni 6.3.
English: Parecoxib is rapidly hydrolysed to the active metabolite valdecoxib.
Maltese: Parecoxib huwa idrolożżat malajr għal metabolu attiv valdecoxib.
English: In the second CABG surgery study, four pre-specified event categories were evaluated (cardiovascular/thromboembolic; renal dysfunction/renal failure; upper GI ulcer/bleeding; surgical wound complication).
Maltese: Fit-tieni studju fuq kirurġija CABG, erba' kategoriji ta' episodji speċifikati minn qabel ġew evalwati (kardjovaskulari/tromboemboliċi; indeboliment renali/funzjoni renali ħażina; ulċeri GI fil-parti ta' fuq/fsada, kumplikazzjonijiet ta' feriti kirurġiċi).
English: Treatment with valdecoxib (40 mg twice daily for 7 days) produced a 3-fold increase in plasma concentrations of dextromethorphan (CYP2D6 substrate).
Maltese: Il-kura b'valdecoxib (40 mg darbtejn kuljum għal 7 tijiem) ikkawżat żieda ta' tlett darbiet aktar filkonċentrazzjonijiet fil-plażma ta' dextrometorphan (sustrat ta' CYP2DS).
English: The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).
Maltese: Id-deċiżjoni li jiġi preskritt inibitur selettiv ta' cyclooxygenase-2 (COX-2) għandha tkun ibbażata fuq valutazzjoni tar-riskji ġenerali tal-pazjent individwali (ara sezzjonijiet 4.3 u 4.4).
English: General disorders and administration site conditions Oedema peripheral
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jittieħed Edema periferali
English: Dynastat has been studied in dental, orthopaedic, gynaecologic (principally hysterectomy) and coronary artery bypass graft surgery.
Maltese: Dynastat ġie studjat f'kirurġija dentali, ortopedika, ġinekoloġika (l-aktar fl-isterektomija) u filkirurġija bypass graft tal-arterja koronarja.
English: Use aseptic technique to reconstitute lyophilised parecoxib (as parecoxib sodium).
Maltese: • Is-sustanza attiva hija parecoxib (bħala parecoxib sodium).
English: In addition to routine adverse event reporting, pre-specified event categories, adjudicated by an independent expert committee, were examined in two placebo-controlled safety studies in which patients received parecoxib for at least 3 days and then were transitioned to oral valdecoxib for a total duration of 10-14 days.
Maltese: Barra mir-rapportar ta' episodji avversi ta' rutina, kategoriji ta' episodji speċifikati minn qabel, meqjusin minn kumitat espert indipendenti, ġew eżaminati f'żewġ studji tas-sigurtà kkontrollati bi plaċebo li fihom, il-pazjenti rċevew parecoxib għal mill-inqas 3 ijiem u mbagħad inqelbu għal valdecoxib orali għal perjodu totali ta' 10-14-il ġurnata.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Parecoxib is rapidly and almost completely converted to valdecoxib and propionic acid in vivo with a plasma half-life of approximately 22 minutes.
Maltese: Parecoxib huwa mibdul b'mod mgħaġġel u kważi għal kollox f'valdecoxib u propionic acid in vivo, b'half life fil-plażma ta' madwar 22 min.
English: Adverse Drug Reaction Frequency Very Common
Maltese: Il-frekwenza tar-Reazzjonijiet Avversi
English: Also contains disodium hydrogen phosphate, phosphoric acid and sodium hydroxide.
Maltese: Ingredjenti oħra huma dibasic sodium phosphate heptahydrate, phosphoric acid u sodium hydroxide.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għall-istruzzjonijiet għarrikostituzzjoni tal-prodott mediċinali qabel ma' jingħata, ara sezzjoni 6.6.
English: In a placebo-controlled, orthopedic and general surgery study (n =1050), patients received Dynastat at an initial parenteral dose of 40 mg IV followed by 20 mg twice daily for a minimum of 72 hours in addition to receiving standard care including supplemental patient controlled opioids.
Maltese: Fi studju ta' kirurġija ortopedika u ġenerali kkontrollat bi plaċebo (n=1050), pazjenti inizjalment irċevew Dynastat b'doża parenterali ta' 40mg IV, segwita minn doża ta' 20mg darbtejn kuljum għal 72 siegħa mill-inqas, mat-terapija standard li tinkludi teħid ta' opioids skond il-bżonn tal-pazjent.
English: Chemical and physical in-use stability of the reconstituted solution have been demonstrated for up to 24 hours at 25C.
Maltese: Stabilità kimika u fiżika waqt l-użu ta' soluzzjoni rikostitwita ġew murija sa 24 siegħa f'temperatura ta' 25˚C.
English: Therefore, caution should be observed when administering Dynastat with medicinal products known to be substrates of CYP2C19 (e.g. phenytoin, diazepam, or imipramine).
Maltese: Għalhekk wieħed għandu juża kawtela meta jagħti Dynastat ma' prodotti mediċinali magħrufa bħala sustrati ta' CYP2C19 ( ez. phenytoin, diazepam jew imipramina).
English: Inhalation anaesthetics
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Gastrointestinal disorders Nausea Abdominal pain, vomiting, constipation, dyspepsia, flatulence
Maltese: Żieda fil-creatine phosphokinase fiddemm, żieda fil-lactate dehydrogenase fiddemm, żieda f' SGOT, żieda f'SGPT, żieda f'BUN
English: There is limited experience in other types of surgery, for example gastrointestinal or urological surgery (see section 5.1).
Maltese: Hemm esperjenza limitata f'tipi ta' kirurġiji oħra, bħal per eżempju dawk gastro-intestinali u uroloġiċi (ara sezzjoni 5.1).
English: Valdecoxib is eliminated via hepatic metabolism with less than 5% unchanged valdecoxib recovered in the urine.
Maltese: Valdecoxib huwa imneħħi permezz ta' metaboliżmu epatiku b'inqas minn 5% ta' valdecoxib mhux mibdul jiġi rkuprat mill-urina.
English: In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors or Angiotensin-II antagonists, may result in further deterioration of renal function, including possible acute renal failure.
Maltese: F'pazjenti li huma anzjani, b'volum baxx (inkluż dawk li qegħdin jieħdu terapija dijuretika), jew għandhom funzjoni renali kompromessa, ko-amministrazzjoni ta' NSAIDs, inkluż inibituri selettivi ta' COX-2, fl-istess ħin ma' inibituri tal-ACE jew antagonisti ta' Angiotensin-II, tista' tirriżulta f'aktar deterjorazzjoni tal-funzjoni tal-kliewi, li jinkludi possibbilta ta' insuffiċjenza akuta renali.
English: Dynastat may mask fever and other signs of inflammation (see section 5.1).
Maltese: Dynastat jista' jgħatti deni u sinjali oħra ta' infjammazjoni (ara sezzjoni 5.1).
English: Effect of parecoxib (or its active metabolite valdecoxib) on the pharmacokinetics of other medicinal products
Maltese: Effett ta' parecoxib (jew valdecoxib metabolu attiv tiegħu) fuq il-farmakokinetiċi ta' prodotti mediċinali ohra.
English: The efficacy of Dynastat was established in studies of dental, gynaecologic (hysterectomy), orthopaedic (knee and hip replacement), and coronary artery bypass graft surgical pain.
Maltese: L-effikaċja ta' Dynastat giet stabbilita fi studji dentali, ġinekoloġiċi (isterektomija), ortopediċi (trapjant ta' l-irkoppa u tal-ġenbejn (hip)) u uġigħ talcoronary artery bypass graft .
English: There is further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications), when parecoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Maltese: Hemm żieda fir-riskju ta' effetti avversi gastro-intestinali (ulċerazzjoni gastrointestinali jew kumplikazzjonijiet gastrointestinali oħra), meta parecoxib jittieħed flimkien ma' acetylsalicylic acid (anke f'dożi żgħar).
English: VIAL LABEL: 40 mg
Maltese: Fjali ta' 40 mg
English: Dyspnoea
Maltese: Tromboċitopenja
English: Administration of IV parecoxib 40 mg had no significant effect on the pharmacokinetics of either IV fentanyl or IV alfentanil (CYP3A4 substrates).
Maltese: L-amministrazzjoni ta' 40 mg IV parecoxib ma kellha l-ebda effett sinifikanti fuq il-farmakokinetiċi ta' L-IV fentanyl jew IV alfentanil (sustrati ta'CYP3A4).
English: • sodium chloride 9 mg/ml (0.9%) solution for injection/infusion;
Maltese: • soluzzjoni għall-injezzjoni/infużjoni ta' sodium chloride 9 mg/ml (0.9%);
English: Of the patients treated with placebo, 270 patients received placebo for up to 4 days, 43 patients for up to 5 days, while only 3 patients were treated for up to 6 days and 2 patients for 7 or more days.
Maltese: Mill-pazjenti kkurati bi plaċebo, 270 pazjent irċevew plaċebo sa 4 ijiem, 43 pazjent sa 5 ijiem, filwaqt li 3 pazjenti biss ġew ikkurati sa 6 ijiem u 2 pazjenti għal 7 ijiem jew aktar.
English: There were no significant differences in the overall safety profile, including the four pre-specified event categories described above for the second CABG surgery study, for parecoxib/valdecoxib compared to placebo treatment in these post-surgical patients.
Maltese: Ma kien hemm ebda differenzi sinifikanti fil-profil ta' sigurtà totali, inkluż lerba' kategoriji ta' avvenimenti speċifikati qabel deskritti fuq għat-tieni studju tal-kirurġija CABG, għal parecoxib/valdecoxib meta mqabbel ma' trattament bi plaċebo f'dawn il-pazjenti wara kirurġija.
English: Data from 3 randomised placebo-controlled trials, where the protocols allowed treatment of parecoxib for >3 days was pooled and analysed.
Maltese: Inġabret u ġiet analizzata dejta minn 3 provi randomizzati kkontrollati bi plaċebo, fejn il-protokolli ppermettew kura ta' parecoxib għal >3 ijiem.
English: Concomitant use with opioid analgesics
Maltese: Użu flimkien ma' analġeżiċi opioid
English: COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Maltese: COX-2 hija l-iżoforma ta' l-enżima li tiġi ndotta minn stimulazzjonijiet pro-infjammatorji u li ġiet akkreditata bħala primarjament responsabbli għas-sintesi ta' medjaturi prostanojdi ta' l-uġigħ, infjammazzjoni u deni.
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with parecoxib after careful consideration (see section 5.1).
Maltese: Pazjenti b'fatturi ta' riskju sinifikanti għal episodji kardjovaskulari (eż. pressjoni għolja, hyperlipidimia, dijabete mellitus, tipjip) għandhom jiġu ttrattati biss b' parecoxib wara li tkun tqieset b'attenzjoni (ara sezzjoni 5.1).
English: Dynastat is preservative free.
Maltese: Dynastat ma fihx priservattivi.
English: However, in the repeated dose toxicity studies in dogs and rats, the systemic exposures to valdecoxib (the active metabolite of parecoxib) were approximately 0.8-fold the systemic exposure in elderly human subjects at the maximum recommended therapeutic dose of 80 mg daily.
Maltese: l-esponimenti sistematiċi għal valdecoxib (il-metabolu attiv ta' parecoxib) kienu bejn wieħed u ieħor 0.8 aktar mill-esponiment sistematiku f'persuni anzjani b'doża terapewtikamassima rakkomandata ta' 80 mg kuljum.
English: Injectable anaesthetics
Maltese: Disturbi gastro-intestinali
English: Following single IV and IM doses of parecoxib 20 mg, Cmax of valdecoxib is achieved in approximately 30 minutes and approximately 1 hour, respectively.
Maltese: IV u IM ta' 20 mg parecoxib, is-Cmax ta' valdecoxib huwa milħuq f'madwar 30 min u siegħa rispettivament.
English: COX-2 inhibitors have been associated with increased risk of cardiovascular and thrombotic adverse events when taken long term.
Maltese: Inibituri ta' COX-2 ġew assoċjati ma' riskju akbar ta' episodji avversi kardjovaskulari u trombotiċi meta meħudin fuq perjodu ta' żmien twil.
English: Surgical wound complications (most involving the sternal wound) were observed at an increased rate with parecoxib/valdecoxib treatment.
Maltese: Kumplikazzjonijiet f'feriti kirurġiċi (ħafna minnhom jinvolvu feriti sternali) ġew osservati b'rata ogħla bi trattament ta' parecoxib/valdecoxib.
English: Dynastat is not recommended in the first 6 months of pregnancy and you must not receive Dynastat in the last three months of pregnancy.
Maltese: Dynastat jaġixxi billi jnaqqas lammont ta' dawn il-prostaglandins.
English: In patients with varying degrees of renal impairment administered 20 mg IV Dynastat, parecoxib was rapidly cleared from plasma.
Maltese: F'pazjenti bi gradi differenti ta' indeboliment renali li ġie amministrat lilhom 20 mg IV Dynastat, parecoxib ġie mneħħi malajr mill-plażma.
English: Musculoskeletal and connective tissue disorders Back pain Arthralgia Renal and urinary disorders Oliguria
Maltese: Disturbi tal-kliewi u tas-sistema urinarja Oligurja
English: Dynastat 40 mg powder and solvent for solution for injection parecoxib
Maltese: Dynastat 40 mg trab u solvent għal soluzzjoni għal injezzjoni parecoxib
English: SOLVENT AMPOULE LABEL : 2 ml
Maltese: Is-solvent jinżamm f'ampulli tal-ħġieġ bla kulur (2 ml).
English: PFIZER ΕΛΛΑΣ Α.Ε.
Maltese: PFIZER ΕΛΛΑΣ Α.Ε. (Cyprus Branch)
English: Use of Ringer-Lactate solution for injection or glucose 50 mg/ml (5%) in Ringer Lactate solution for injection for reconstitution will cause the parecoxib to precipitate from solution and therefore is not recommended.
Maltese: L-użu ta' soluzzjoni Ringer-Lactate għall-injezzjoni jew glukosju 50 mg/ml (5%) f'soluzzjoni Ringer-Lactate għall-injezzjoni għar-rikostituzzjoni, iġġiegħel lil parecoxib jippreċipita u għalhekk mhuwiex rakkomandat.
English: Hydrochloric acid or sodium hydroxide (for pH adjustment) Water for injection.
Maltese: Hydrochloric acid jew sodium hydroxide (għal aġġustament tal-pH).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: Valdecoxib, but not parecoxib, is extensively partitioned into erythrocytes.
Maltese: Valdecoxib iżda mhux parecoxib, jiġi mqassam ħafna fl-eritroċiti..
English: Dynastat is contraindicated in the third trimester of pregnancy (see section 4.3).
Maltese: Dynastat huwa kontraindikat matul t-tielet trimestru tat-tqala (ara sezzjoni 4.3).
English: Therefore, caution should be observed when coadministering Dynastat and medicinal products that are predominantly metabolised by CYP2D6 and which have narrow therapeutic margins (e.g. flecainide, propafenone, metoprolol).
Maltese: Għalhekk wieħed għandu juża kawtela meta jkun qed jagħti flimkien Dynastat u prodotti mediċinali li huma primarjament metaboliżżati bis-CYP2DS u li għandhom effetti terapewtiċi marġinali dojoq (eż. flecainide, propafenon, metoprolol).
English: When reconstituted in sodium chloride 9 mg/ml (0.9%) solution, Dynastat contains approximately 0.44 mEq of sodium per vial.
Maltese: Meta rikostitwit f'soluzzjoni 9 mg/ml (0.9%) ta' sodium chloride, Dynastat fih madwar 0.44 mEq ta' sodium kull fjala.
English: Powder vial: Each vial contains 40 mg parecoxib (as 42.36 mg parecoxib sodium).
Maltese: Kull fjala fiha 40 mg parecoxib (bħala parecoxib sodium).
English: In addition, the following rare, serious adverse reactions have been reported in association with the use of NSAIDs and cannot be ruled out for Dynastat: bronchospasm and hepatitis.
Maltese: Barra minn hekk, ir-reazzjonijiet avversi rari u serji li ġejjin ġew irrapportati ma' l-użu ta' NSAIDs u ma jistgħux jiġu eliminati għal Dynastat: spażmu fil-bronki u epatite.
English: The first perceptible analgesic effect occurred in 7-13 minutes, with clinically meaningful analgesia demonstrated in 23-39 minutes and a peak effect within 2 hours following administration of single doses of 40 mg IV or IM Dynastat.
Maltese: L-ewwel effett analġeżiku li jidher, seħħ f'minn 7 sa 13-il minuta, b'analġeżja klinikament valida murija minn 23 sa 39 minuta u bl-ogħla effett fi żmien sagħtejn wara lamministrazzjoni ta' dożi waħda ta' 40 mg IV jew IM Dynastat.
English: Each 2 ml of reconstituted powder contains 40 mg of parecoxib.
Maltese: Għalhekk, kull 2 ml tas-soluzzjoni rikostitwita fiha 40 mg ta' parecoxib.
English: • Use of Ringer-Lactate solution for injection or glucose 50 mg/ml (5%) in Ringer-Lactate solution for injection for reconstitution will cause the parecoxib to precipitate from solution and therefore is not recommended.
Maltese: • Użu tas-soluzzjoni għall-injezzjoni Ringer-Lactate jew glukosju 50mg/ml (5%) fis-soluzzjoni għall-injezzjoni Ringer-Lactate għar-rikostituzzjoni minħabba li jikkawża preċipitazzjoni talparecoxib minn mas-soluzzjoni u għalhekk mhux rakkomandat.
English: In short-term studies (7 days), the incidence of endoscopically observed gastroduodenal ulcers or erosions in healthy young and elderly ( 65 years) subjects administered Dynastat (5-21%), although higher than placebo (5-12%), was statistically significantly lower than the incidence observed with NSAIDs (66-90%).
Maltese: Fi studji li ma ħadux fit-tul (7 ijiem), il-frekwenza ta' ulceri gastroduwodenali u erożjonijiet, li setgħu jidhru b'endoskopju f'persuni b'saħħithom kemm żgħar kif ukoll anzjani (≥65 sena) li ingħataw Dynastat ( 5-21%), għalkemm ogħla mill-plaċebo, kienet statistikament ferm inqas mill-frekwenza innutata bin-NSAIDs (66 sa 90%).
English: Following IV or IM injection, parecoxib is rapidly converted to valdecoxib, the pharmacologically active substance, by enzymatic hydrolysis in the liver.
Maltese: Wara injezzjoni IV jew IM, parecoxib huwa malajr mibdul għal valdecoxib, is-sustanza farmakoloġikament attiva, b'idroliżi enżimatika fil-fwied.
English: • sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) solution for injection/infusion
Maltese: • soluzzjoni għall-injezzjoni/infużjoni ta' sodium chloride 4.5 mg/ml (0.45%) u glukosju 50
English: Parecoxib administered intravenously to lactating rats as a single dose showed concentrations of parecoxib, valdecoxib and a valdecoxib active metabolite in milk similar to that of maternal plasma.
Maltese: Parecoxib amministrat b'doża waħda fil-vina ta' firien li kienu qed ireddgħu, irriżulta f'konċentrazzjoni ta' parecoxib, valdecoxib u metabolu attiv ta' valdecoxib fil-ħalib simili għal dak tal-plażma ta' l-omm.
English: Parecoxib should be discontinued at the first sign of hypersensitivity.
Maltese: Parecoxib għandu jitwaqqaf ma' l-ewwel sinjal ta' sensittività eċċessiva.
English: • glucose 50 mg/ml (5%) solution for infusion
Maltese: 50 mg/ml (5%) jew
English: ▪ Acetylsalicylic acid (aspirin) or other anti-inflammatory medicines ▪ Fluconazole - used for fungal infections ▪ ACE inhibitors, Angiotensin-II inhibitors, beta blockers and diuretics - used for high blood pressure and heart conditions ▪ Ciclosporin or Tacrolimus - used after transplants ▪ Warfarin - or other warfarin like medicines used to prevent blood clots including newer medicines like apixaban, dabigatran, and rivaroxaban
Maltese: • Inibituri tal-ACE, inibituri tal-Angiotensin II, imblokkaturi beta u dijuretiċi - użati għal pressjoni għolja u mard tal-qalb
English: Coadministration of NSAIDs and ciclosporin or tacrolimus has been suggested to increase the nephrotoxic effect of ciclosporin and tacrolimus because of NSAID effects on renal prostaglandins.
Maltese: L-amministrazzjoni flimkien ta' NSAIDs u ciclosporin jew tacrolimus ġiet issuġgerita sabiex iżżid l-effett nekrotossiku ta' l-istess ciclosporin u tacrolimus minħabba l-effetti ta' NSAID fuq ilprostaglandini tal-kliewi.
English: Additionally, fatal reports of toxic epidermal necrolysis have been reported through postmarketing surveillance in patients receiving valdecoxib (the active metabolite of parecoxib) and cannot be ruled out for parecoxib (see section 4.8).
Maltese: Fl-esperjenza li nkisbet wara li Dynastat tpoġġa fis-suq, każijiet ta' nekroliżi tossika epidermali ġew irrapportati u kienu assoċjati mal-użu ta' valdecoxib, u ma jistgħux jiġu eliminati għal parecoxib (ara sezzjoni 4.4).
English: Dynastat 40 mg powder for injection Parecoxib
Maltese: Dynastat 40 mg trab għall-injezzjoni
English: Gastroduodenal ulceration, gastrooesophageal reflux disease, dry mouth, gastrointestinal sounds abnormal
Maltese: Tużax Dynastat jekk fil-preżent għandek ulċera gastrika jew intestinali jew fsada gastrointestinali
English: CABG post-operative safety studies
Maltese: Studji tas-sigurtà wara operazzjoni tat-tip CABG
English: Intravenous or intramuscular use
Maltese: Studji Gastro-intestinali
English: The third trimester of pregnancy and breast-feeding (see sections 4.6 and 5.3).
Maltese: It-tielet trimestru tat-tqala u treddigħ mis-sider (ara sezzjoni 4.6 u 5.3).
English: In surgery studies in which parecoxib was administered pre-operatively, no evidence of pharmacodynamic interaction was observed in patients receiving parecoxib and the inhalation anaesthetic agents nitrous oxide and isoflurane (see section
Maltese: Fi studji kirurġiċi fejn parecoxib ġie amministrat qabel operazzjoni, ma ġie nnutat l-ebda sinjal ta' interazzjoni farmakodinamika f'pazjenti li kienu qed jingħataw parecoxib u l-aġenti nitrous oxide u isoflurane, li huma anestetiċi li jittieħdu man-nifs (ara sezzjoni 5.1).
English: Dynastat should be used with caution in patients with moderate hepatic impairment (Child-Pugh score 7-9) (see section 4.2).
Maltese: Dynastat għandu jiġi użat b'kawtela f'pazjenti b'indeboliment moderat tal-fwied (skala Child-Pugh 79) (ara sezzjoni.