FrancophonIA/ELRC3.0 huggingface dataset:
English: Myocardial infarction, bradycardia
Maltese: Infart mijokardijaku, bradikardja
English: Ecchymosis, rash, urticaria
Maltese: Ekkimożi, raxx, urtikarja
English: Uncommon (1/1000 to <1/100)
Maltese: Mhux komuni (1/1000 sa <1/100)
English: Fluid retention, oedema, renal
Maltese: Ritenzjoni ta' fluwidu, edema, renali
English: ibuprofen) or to COX-2 inhibitors.
Maltese: ibuprofen) jew inibituri COX-2.
English: Parecoxib is a prodrug of valdecoxib.
Maltese: Parecoxib huwa prodrug ta' valdecoxib.
English: Dynastat may be coadministered with opioid analgesics.
Maltese: Dynastat jista jiġi amministrat ma' analġeżiċi opioid.
English: Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g. apixaban, dabigatran, and rivaroxaban) (see section 4.5).
Maltese: Antikoagulanti orali jinkludu warfarin/antikoagulanti tat-tip coumarin u antikoagulanti orali ġodda (eż. apixaban, dabigatran, u rivaroxaban) (ara sezzjoni 4.5).
English: Treatment of post-operative pain following coronary artery bypass graft (CABG) surgery (see sections 4.8 and 5.1).
Maltese: Trattament ta' uġigħ ta' wara operazzjoni wara kirurġija li tinvolvi coronary artery bypass graft (CABG) (ara s-sezzjonijiet 4.8 u 5.1).
English: Dynastat contains the active substance parecoxib.
Maltese: Dynastat fih is-sustanza attiva parecoxib.
English: Solvent for Dynastat 40 mg
Maltese: Solvent għal Dynastat 40 mg
English: IV line solution compatibility
Maltese: Kompatibilita' tas-soluzzjoni ma linja IV
English: Two isoforms, COX-1 and COX-2, have been identified.
Maltese: Żewġ iżoformi, COX1 u COX-2, ġew identifikati.
English: Clinical trials indicate that Dynastat can be given with low dose acetylsalicylic acid ( 325 mg).
Maltese: Provi kliniċi juru li Dynastat jista' jiġi amministrat ma' doża baxxa ta' acetylsalicylic acid (≤ 325 mg).
English: The following adverse reactions were reported for patients who received parecoxib (N=5,402) in 28 placebo-controlled clinical trials.
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrapurtati f'pazjenti li qed jirċievu parecoxib (N=5,402) fi 28 prova klinika kkontrollati bil-plaċebo.
English: 5 vials and 5 solvent ampoules
Maltese: 5 fjali u 5 ampulli bis-solvent
English: Pharmacodynamic interactions
Maltese: Interazzjonijiet Farmakodinamiċi
English: Pfizer Luxembourg SARL, organizačná zložka Tel: +421-2-3355 5500
Maltese: Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: +421-2-3355 5500
English: A hydroxylated metabolite of valdecoxib (via the CYP pathway) has been identified in human plasma that is active as a COX-2 inhibitor.
Maltese: Metabolu hydroxylated ta' valdecoxib (permezz tal-pathway CYP) ġiet identifikata fi plażma umana li hija attiva bħala inibitur ta' COX-2.
English: 5 + 5 pack: contains 5 powder vials and 5 solvent ampoules.
Maltese: Pakkett 5 + 5: li fih 5 fjali bit-trab u 5 ampulli bis-solvent.
English: Sodium chloride 9 mg/ml (0.9%) solution
Maltese: Sodium chloride 9 mg/ml (0.9%) soluzzjoni.
English: Severe hepatic impairment (serum albumin <25 g/l or Child-Pugh score  10).
Maltese: Indeboliment serju ħafna tal-fwied (albumina fis-serum <25 g/l jew punteġġ Child-Pugh  10).
English: It is one of a family of medicines called COX-2 inhibitors (this is short for cyclo-oxygenase-2 inhibitors).
Maltese: Huwa wieħed minn familja ta' mediċini li jissejħu inibituri COX-2 (titlu fil-qosor għal cyclo-oxygenase-2 inhibitors).
English: 3 vials and 3 solvent ampoules
Maltese: 3 fjali u 3 ampulli bis-solvent
English: Congestive heart failure (NYHA II-IV).
Maltese: Insuffiċjenza tal-qalb konġestiva (NYHA III-IV)
English: Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Maltese: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Il-Belġju
English: Coadministration of valdecoxib and lithium produced significant decreases in lithium serum clearance (25%) and renal clearance (30%) with a 34% higher serum exposure compared to lithium alone.
Maltese: L-amministrazzjoni ta' valdecoxib u lithium irriżulta fi tnaqqis sinifikanti fil-clearance mis-serum ta' lithium (25%) u clearance renali (30%) b'esponiment ogħla b'34% fis-serum meta mqabbel ma' lithium waħdu.
English: In the pooled analysis of 676 patients, 318 received placebo and 358 received parecoxib.
Maltese: Fl-analiżi miġbura ta' 676 pazjent, 318 irċevew plaċebo u 358 irċevew parecoxib.
English: Elimination of valdecoxib is by extensive hepatic metabolism involving multiple pathways, including cytochrome P 450 (CYP) 3A4 and CYP2C9 isoenzymes and glucuronidation (about 20%) of the sulfonamide moiety.
Maltese: L-eliminazzjoni ta' valdecoxib issir permezz ta' metaboliżmu epatiku estensiv li tinvolvi diversi triqat, inkluż iċ-ċitokromju P 450 (CYP) 3A4 u iżoenżimi CYP2C9 u glukuronidazzjoni (madwar 20%) ta' nofs il-biċċa (moiety) li fiha s-sulfonamide.
English: COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Maltese: Impedituri selettivi COX-2 inaqqsu l-formazzjoni ta' prostasiklin sistematiku (u allurapossibilment ta' l-endotilju) mingħajr ma jaffettwa l-plejtlet thromboxane.
English: 1 + 1 pack: contains 1 powder vial and 1 solvent ampoule.
Maltese: Pakkett 1 + 1: li fih fjala 1 bit-trab u ampulla 1 bis-solvent.
English: The volume of distribution of valdecoxib after its IV administration is approximately 55 litres.
Maltese: Il-volum ta' distribuzzjoni ta' valdecoxib wara li jiġi amministrat IV huwa bejn wieħed u ieħor ta' 55 litru.
English: It's especially important to mention:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Placebo/valdecoxib treatment was also associated with a higher incidence of CV thromboembolic events versus placebo treatment, but this difference did not reach statistical significance.
Maltese: Trattament plaċebo/valdecoxib ġie assoċjat ukoll ma' inċidenza ogħla ta' episodji tromboemboliċi CV kontra trattament bi plaċebo, iżda din id-differenza ma laħqitx sinifikanza statistika.
English: COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function).
Maltese: COX-2 hi nvoluta wkoll fl-ovulazzjoni, impjantazzjoni u fl-għeluq tad-ductus arteriosus, fir-regolazzjoni tal-funzjoni renali, u fil-funzjonijiet tas-sistema nervuża ċentrali (ħruġ ta' deni, perċezzjoni ta' l-uġigħ u l-funzjoni konjittiva).
English: • Ringer-Lactate solution for injection.
Maltese: • soluzzjoni Ringer-lactate għall-injezzjoni.
English: Effects of other medicinal products on the pharmacokinetics of parecoxib (or its active metabolite valdecoxib)
Maltese: Effetti ta' prodotti mediċinali oħra fuq il-farmakokinetika ta' parecoxib (jew valdecoxib metabolu attiv tiegħu)
English: 3 + 3 pack: contains 3 powder vials and 3 solvent ampoules.
Maltese: Pakkett 3 + 3: li fih 3 fjali bit-trab u 3 ampulli bis-solvent.
English: Coadministration of IV parecoxib 40 mg with propofol (CYP2C9 substrate) or midazolam (CYP3A4 substrate) did not affect either the pharmacokinetics (metabolism and exposure) or the pharmacodynamics (EEG effects, psychomotor tests and waking from sedation) of IV propofol or IV midazolam.
Maltese: L-amministrazzjoni flimkien ta' 40 mg IV parecoxib u propofol (sustrat ta' CYP2C9) jew midazolam (sustrat ta' CYP3A4) ma effettwax la l-farmakokinetiċi (metaboliżmu u esponiment) u l-anqas ilfarmakodinamiċi (effetti EEG, testijiet psikomuturi u qawmien mis-sedazzjoni) ta' l-IV propofol u IV midażolam.
English: There was a significantly (p<0.05) greater incidence of cardiovascular/thromboembolic events (myocardial infarction, ischemia, cerebrovascular accident, deep vein thrombosis and pulmonary embolism) detected in the parecoxib/valdecoxib treatment group compared to the placebo/placebo treatment group for the IV dosing period (2.2% and 0.0% respectively) and over the entire study period (4.8% and 1.3% respectively).
Maltese: Kien hemm inċidenza ferm ikbar (p<0.05) ta' episodji kardjovaskulari/tromboemboliċi (infart mikokardjali, iskemja, inċident ċerebrovaskulari, trombożi profonda fil-vini u emboliżmu pulmonary) mikxufin fil-grupp ta' trattament parecoxib/valdecoxib meta mqabbla mal-grupp ta' trattament plaċebo/plaċebo għall-perjodu ta' dożaġġ IV (2.2% u 0.0% rispettivament) u fuq il-perjodu kollu ta' l-istudju (4.8% u 1.3% rispettivament).
English: The mean (SD) duration of treatment was 4.1 (0.4) days for parecoxib and 4.2 (0.5) days for placebo, the range was 4-7 days for parecoxib and 4-9 days for placebo.
Maltese: Ittul ta' kura medjana (SD) kien 4.1 (0.4) jiem għal parecoxib u 4.2 (0.5) jiem għal plaċebo, il-medda kienet 4-7 ijiem għal parecoxib u 4-9 ijiem għal plaċebo.
English: 1 vial and 1 solvent ampoule
Maltese: Fjala 1 u ampulla 1 bis-solvent
English: AUC and Cmax following twice daily administration is linear up to 50 mg IV and 20 mg IM.
Maltese: AUC u Cmax wara dożi darbtejn kuljum huma linjari sa 50 mg IV u 20 mg IM.
English: The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions.
Maltese: Id-differenza fl-attività ta' kontra l-plejtlets ta' bejn xi NSAIDs li jimpedixxu COX-1 u mpedituri selettivi COX-2 tista' tkun ta' sinifikat kliniku f'pazjenti li għandhom riskju ta' reazzjonijiet trombo embolitiċi.
English: Renal failure acute
Maltese: Insuffiċjenza akuta renali
English: About 70% of the dose is excreted in the urine as inactive metabolites.
Maltese: Madwar 70% tad-doża hija imneħħija fl-urina bħala metaboli inattivi.
English: Patients were randomized within 24-hours post-CABG surgery to: parecoxib initial dose of 40 mg IV, then 20 mg IV Q12H for a minimum of 3 days followed by valdecoxib PO (20 mg Q12H) (n=544) for the remainder of a 10 day treatment period; placebo IV followed by valdecoxib PO (n=544); or placebo IV followed by placebo PO (n=548).
Maltese: Il-pazjenti tqassmu b'mod każwali fi żmien 24 siegħa wara kirurġija CABG għal: doża inizjali ta' 40 mg parecoxib IV, imbagħad 20 mg IV Q12H għal millinqas 3 ijiem segwit bi valdecoxib PO (20 mg Q12H) (n=544) għall-bqija tal-perjodu ta' trattament ta' 10 ijiem; plaċebo IV segwit bi valdecoxib PO (n=544); jew plaċebo IV segwit bi plaċebo PO (n=548).
English: A significantly (p=0.033) greater incidence of events in the cardiovascular/thromboembolic category was detected in the parecoxib/valdecoxib treatment group (2.0%) compared to the placebo/placebo treatment group (0.5%).
Maltese: Inkixfu ferm iktar inċidenzi (p=0.033) ta' episodji fil-kategorija kardjovaskulari/tromboemboliċi filgrupp ta' trattament parecoxib/valdecoxib treatment group (2.0%) meta mqabbel mal-grupp ta' trattament plaċebo/plaċebo (0.5%).
English: The first CABG surgery study evaluated patients treated with IV parecoxib 40 mg bid for a minimum of 3 days, followed by treatment with valdecoxib 40 mg bid (parecoxib/valdecoxib group) (n=311) or placebo/placebo (n=151) in a 14-day, double-blind placebo-controlled study.
Maltese: L-ewwel studju fuq kirurġija CABG evalwa pazjenti kkurati bi parecoxib 40 mg bid IV għal mill-inqas 3 ijiem, segwit bi trattament b'valdecoxib 40 mg bid (grupp parecoxib/valdecoxib) (n=311) jew plaċebo/plaċebo (n=151) fi studju kkontrollat bi plaċebo double-blind ta' 14-il jum.
English: The reduction in opioid use with Dynastat treatment on Days 2 and 3 was 7.2 mg and 2.8 mg (37% and 28% respectively).This reduction in opioid use was accompanied by significant reductions in patient-reported opioid symptom distress.
Maltese: Kien hemm tnaqqis ta' 7.2mg u 2.8mg (37% u 28% rispettivament) fl-użu ta' opioids mat-trattament b'Dynastat fit-2 u 3 jum tat-terapija.
English: Active peptic ulceration or gastrointestinal (GI) bleeding.
Maltese: Ulċera attiva fis-sistema diġestiva jew fsada gastro-intestinali (GI)
English: Following coronary artery bypass graft surgery, patients administered Dynastat have a higher risk of adverse reactions such as: cardiovascular/thromboembolic events (including myocardial infarction, stroke/TIA, pulmonary embolus, and deep vein thrombosis; see sections 4.3 and 5.1), deep surgical infections, and sternal wound healing complications.
Maltese: Wara kirurġija bypass graft tal-arterja koronarja, pazjenti li jkun ġie amministrat lilhom Dynastat, jkollhom riskju ogħla ta' effetti avversi: avvenimenti kardjovaskulari/tromboemboliċi (li jinkludu infart mijokardiku, puplesija/TIA, embolu fil-pulmun, u trombożi fil-vini tal-fond; ara sezzjonijiet 4.3 u 5.1), infezzjonijiet kirurġiċi fil-fond u kumplikazzjoni fil-fejqan ta' ferita sternali.
English: Other medicines and Dynastat
Maltese: Mediċini oħra u Dynastat
English: Metabolism and nutrition disorders Hypokalaemia Hyperglycaemia, anorexia
Maltese: Disturbi tal-metaboliżmu u nutrizzjoni Ipokalemija Livelli għoljin ta' zokkor fid-demm, anoressija
English: Dynastat has not been studied in cardiovascular revascularization procedures other than coronary artery bypass graft (CABG) procedures.
Maltese: Dynastat ma ġiex studjat fi proċeduri ta' rivaskularizzazzjoni kardjovaskulari għajr proċeduri ta' coronary artery bypass graft (CABG).
English: Studies in types of surgery other than CABG procedures included patients with American Society of Anaesthesiology (ASA) Physical Status Class I-III only.
Maltese: Studji f'tipi ta' kirurġija oħra għajr proċeduri CABG inkludew pazjenti bi Status Fiżiku tas-Soċjetà Amerikana ta' Anestesjoloġija (ASA) ta' Klassi
English: 2 ml solvent ampoule contains sodium chloride, hydrochloric acid, sodium hydroxide and water for injection.
Maltese: Ampulla solvent ta' 2 mlfiha sodium chloride, hydrochloric acid, sodium hydrochloride u ilma għallinjezzjoni.
English: After reconstitution with 2 ml of solvent, the concentration of parecoxib is 20 mg/ml.
Maltese: Meta tkun rikostitwita b' 2 ml solvent, il-konċentrazzjoni ta' parecoxib hija 20 mg/ml.
English: In a large (N=1050) major orthopedic/general surgery trial, patients received an initial dose of parecoxib 40 mg IV, then 20 mg IV Q12H for a minimum of 3 days followed by valdecoxib PO (20 mg Q12H) (n=525) for the remainder of a 10 day treatment period, or placebo IV followed by placebo PO (n=525).
Maltese: Fi prova ta' kirurġija ortopedika/ġenerali maġġuri kbira (N=1050), pazjenti irċevew doża inizjali ta' parecoxib 40 mg IV, imbagħad 20 mg IV Q12H għal minimu ta' 3 ijiem u wara ngħataw valdecoxib PO (20 mg Q12H) (n=525) għall-bqija ta' perjodu ta' trattament ta' 10 ijiem, jew plaċebo IV segwit bi plaċebo PO (n=525).
English: History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme or patients with known hypersensitivity to sulfonamides (see sections 4.4 and 4.8).
Maltese: Passat ta' reazzjoni allerġika serja ta' kwalunkwe tip għall-mediċina, b'mod speċjali reazzjonijiet fuq il-ġilda bħas-sindrome Stevens-Johnson, nekroliżi epidermali tossika, eritema multiforme jew pazjenti b'sensittività eċċessiva għal sulfonamides (ara sezzjonijiet 4.4 u 4.8).
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, Coxibs, ATC code: M01AH04
Maltese: Prodotti kontra l-infjammazjoni u kontra ir-rewmatiżmu, Coxibs, Kodiċi ATC:
English: Additional studies in other surgical settings provided similar observations.
Maltese: Studji oħra fl-ambjent kirurġiku wrew osservazzjonijiet simili.
English: Each vial contains 40 mg parecoxib, as 42.36 mg parecoxib sodium.
Maltese: Kull fjala fiha 40 mg parecoxib, bħala 42.36 mg parecoxib sodium.
English: Abnormal sternal serous wound drainage, wound infection Blood and lymphatic system disorders Anaemia postoperative
Maltese: Tnixxija anormali u serja ta' materja minn ferita sternali, infezzjoni tal-ferita Disturbi tad-demm u tas-sistema limfatika Anemija ta' wara operazzjoni
English: Reconstitution solvents Reconstitute Dynastat 40 mg with 2 ml sodium chloride 9 mg/ml (0.9%) solution.
Maltese: Irrikostitwixxi Dynastat 40 mg bi 2 ml soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) billi tuża teknika asettika.
English: Tell your doctor or nurse immediately.
Maltese: Kellem lit-tabib/a jew infirmier/a tiegħek immedjatament.
English: Dosing.
Maltese: methotrexate.
English: The metabolism of valdecoxib may increase when coadministered with enzyme inducers such as rifampicin, phenytoin, carbamazepine or dexamethasone.
Maltese: Il-metaboliżmu ta' valdecoxib jista' jiżdied meta dan ikun amministrat flimkien ma' prodotti li jinduċu l-enżimi bħal rifampicin, phenytoin, carbamazepine jew dexamethasone.
English: General surgery
Maltese: Kirurġija ġenerali
English: Parecoxib sodium vials
Maltese: Fjali ta' parecoxib sodium
English: Disodium hydrogen phosphate Phosphoric acid and/or sodium hydroxide (for pH adjustment).
Maltese: Disodium hydrogen phosphate Phosphoric acid u/jew sodium hydroxide (għal aġġustament tal-pH).
English: Plasma clearance (CLp) for valdecoxib is about 6 l/hr.
Maltese: Il-clearance mill-plażma (CLp) għal valdecoxib hi ta' madwar 61/hr.
English: Dynastat contains
Maltese: Tużax Dynastat:
English: Serious skin reactions, including erythema multiforme, exfoliative dermatitis and Stevens-Johnson syndrome (some of them fatal) have been reported through post-marketing surveillance in patients receiving parecoxib.
Maltese: Reazzjonijiet serji fil-ġilda, inkluż eritema multiforme, dermatite bi tqaxxir fil-ġilda u s-sindrome Stevens-Johnson (xi wħud minnhom fatali), ġew irrapportati permezz ta' sorveljanza wara t-tqegħid fis-suq f'pazjenti li kienu qegħdin jirċievu parecoxib.
English: Coadministration of valdecoxib with glibenclamide (CYP3A4 substrate) did not affect either the pharmacokinetics (exposure) or the pharmacodynamics (blood glucose and insulin levels) of glibenclamide.
Maltese: L-amministrazzjoni ta' valdecoxib flimkien ma' glibenclamide (sustrat ta' CYP3A4) ma affettwatx la l-farmakokinetiċi (esponiment) u lanqas il-farmakodinamiċi (livelli ta' glukosju fid-demm u ta' linsulina) ta' glibenclamide.
English: Dynastat is available in packs containing 10 vials.
Maltese: Dynastat jinstab f'pakketti ta' 10 fjali.
English: Plasma exposure (AUC and Cmax) to valdecoxib was increased (62% and 19%, respectively) when coadministered with fluconazole (predominantly a CYP2C9 inhibitor), indicating that the dose of parecoxib should be reduced in those patients who are receiving fluconazole therapy.
Maltese: L-esponiment tal-plażma (AUC u Cmax) għal valdecoxib żdied (62% u 19% rispettivament) meta ġiet amministrata flimkien ma' fluconazole (primerjament impeditur ta' CYP2C9).
English: Pre-specified events that occurred with the highest incidence in all three treatment groups involved the category of surgical wound complications, including deep surgical infections and sternal wound healing events.
Maltese: Episodji speċifikati minn qabel li seħħew ma' l-ogħla inċidenza fit-tliet gruppi ta' trattament involvew il-kategorija ta' kumplikazzjonijiet ta' feriti kirurġiċi, inkluż infezzjonijiet kirurġiċi fondi u episodji ta' fejqan ta' feriti sternali.
English: Psychiatric disorders Agitation, insomnia Nervous system disorders Hypoaesthesia, dizziness
Maltese: Disturbi psikjatriċi Aġitazzjoni, nuqqas ta' rqad Disturbi tas-sistema nervuża Ipoesteżja, sturdament
English: Plasma exposure (AUC and Cmax) to valdecoxib was increased (38% and 24%, respectively) when coadministered with ketoconazole (CYP3A4 inhibitor), however, a dosage adjustment should not generally be necessary for patients receiving ketoconazole.
Maltese: L-esponiment tal-plażma (AUC u Cmax) għal valdecoxib żdied (38% u 24% rispettivament) meta ġie amministrat flimkien ma' ketoconazole (impeditur CYPA4).
English: Pancreatitis, oesophagitis, oedema mouth (perioral swelling)
Maltese: Pankreatite, esofaġite, edema fil-ħalq ( nefħa maddawra talħalq)
English: Excipient with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per dose.
Maltese: Eċċipjent bl-effett magħruf Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) f'kull doża.
English: Use aseptic technique to reconstitute lyophilised parecoxib (as parecoxib).
Maltese: Uża teknika asettika biex tirrikostitwixxi parecoxib lajofilizzat (bħala parecoxib).
English: Parecoxib has been used in a range of major and minor surgeries.
Maltese: Parecoxib intuża f'firxa ta' kirurġiji maġġuri u minuri.
English: Solvent ampoules 2 ml ampoule: colourless neutral glass, Type I.
Maltese: Ampulla bis-solvent Ampulla ta' 2-ml: ampulla tal-ħġieġ bla kulur Tip Numru 1.
English: Dynastat has been administered to 335 elderly patients (65-96 years of age) in pharmacokinetic and therapeutic trials.
Maltese: Fi provi farmakokinetiċi u terapewtiċi Dynastat ġie amministrat lil 335 pazjent anzjan(65 sa 96 sena).
English: COX-2 inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effects.
Maltese: Inibituri ta' COX-2 mhumiex sostituti għal acetylsalicylic acid għal profilassi ta' mard kardjovaskulari trombo-emboliku minħabba n-nuqqas ta' effetti kontra il-plejtlits, li għandhom .
English: Hypersensitivity reactions (anaphylaxis and angioedema) have been reported in post-marketing experience with valdecoxib and parecoxib (see section 4.8).
Maltese: Ġew rapportati reazzjonijiet ta' sensittività eċċessiva (anafilassi u anġjoedema) b'valdecoxib u parecoxib fiż-żmien wara li l-prodott ħareġ fis-suq (ara sezzjoni 4.8).
English: Infections and infestations Pharyngitis, alveolar osteitis (dry socket)
Maltese: Infezzjonijiet u imfestazzjonijiet Farinġite, ostejite alvejolari
English: Circulatory collapse, congestive heart failure, tachycardia
Maltese: Kollass ċirkulari, insuffiċjenza konġestiva tal-qalb, takikardja
English: Of the patients treated with parecoxib, 317 patients received parecoxib for up to 4 days, 32 patients for up to 5 days, while only 8 patients were treated for up to 6 days and 1 patient for 7 or more days.
Maltese: Millpazjenti kkurati b'parecoxib, 317-il pazjent irċevew parecoxib sa 4 ijiem, 32 pazjent sa 5 ijiem, filwaqt li 8 pazjenti biss ġew ikkurati sa 6 ijiem u pazjent 1 għal 7 ijiem jew aktar.
English: Inhibition of prostaglandins by NSAIDs, including COX-2 inhibitors, may diminish the effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin II antagonists, beta-blockers and diuretics.
Maltese: L-inibizzjoni ta' prostaglandini minn NSAIDs, li jinkludu inibituri ta' COX-2, tista' tnaqqas l-effett ta' inibituri tal-enzima li tibdel angiotensin (ACE ), antagonisti ta' angiotensin II, imblokkaturi beta u dijuretiċi.
English: Dynastat is supplied as a sterile, single unit-of-use vial that is packaged with a 2 ml ampoule with a fill volume of 2 ml sodium chloride 9 mg/ml (0.9%) solution (see below for various pack sizes and configurations)
Maltese: Dynastat jista' jinstab fi vjali sterili għall-użu individwali ppakjati ma' ampulla ta' 2-ml li tista' iżżid magħha 1ml ta' soluzzjoni ta' sodium chloride 9mg/ml (0.9%) (ara hawn taħt għal daqsijiet u forom ta' pakketti varji).
English: Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or nonsteroidal antiinflammatory drugs (NSAIDs) including COX-2 inhibitors.
Maltese: Pazjenti li sofrew spażmu fil-bronki, rinite akuta, polipi nażali, edema anġjonewrotika, urtikarja u reazzjonijiet ta' natura allerġika (oħrajn), wara li jkun ġie amministrat lilhom acetylsalicylic acid jew mediċini anti-infjammatorji mhux sterojdali (NSAIDs) li jinkludu impedituri selettivi COX-2.
English: On the basis of pharmacokinetics, no dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30-80 ml/min.
Maltese: Fuq bażi farmakokinetika, ma hemm bżonn ta' l-ebda aġġjustament fid-doża, f'pazjenti li għandhom indeboliment renali ħafif għal moderat (clearance ta' Creatinine ta' 30 sa 80 ml/min).