FrancophonIA/ELRC3.0 huggingface dataset:
English: Celecoxib has been shown to reduce the number and size of adenomatous colorectal polyps.
Maltese: Intwera li celecoxib inaqqas in-numru u d-daqs ta' polipi adenomatużi kolorettali.
English: Celecoxib is a diaryl-substituted pyrazole, chemically similar to other non-arylamine sulfonamides (e.g. thiazides, furosemide) but differing from arylamine sulfonamides (e.g. sulfamethoxizole and
Maltese: Celecoxib huwa pyrazole sostitwit fil-parti diarili, huwa kimikament simili għal sulfonamidi oħra li m'għandhomx arylamine (eż. thiazides, furosemide) imma li huma differenti minn sulfonamidi li għandhom arylamine (eż. sulphamethoxizole u antibijotiċi sulfonamidi oħra).
English: Plasma protein binding is about 97% at therapeutic plasma concentrations and celecoxib is not preferentially bound to erythrocytes.
Maltese: Ittwaħħil mal-proteini tal-plasma hu madwar 97% f'konċentrazzjonijiet terapewtiċi fil-plasma u celecoxib ma jaqbadx b'mod preferenzjali ma' l-eritroċiti.
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: Huwa maħsub ukoll li COX-2 hija involuta fl-ovulazzjoni, impjantazzjoni u għeluq tad-ductus arteriosus, regolament tal-funzjoni renali u funzjonijiet tas-sistema nervuża ċentrali (bidu ta' deni, perċezzjoni ta' uġigħ u funzjoni konjittiva).
English: Cumulative rates for this composite endpoint over 3 years were 3.0% (20/671 subjects) and 2.5% (17/685 subjects), respectively, compared to 0.9% (6/679 subjects) for placebo.
Maltese: Ir-rati kumulattivi għal dan l-endpoint kompost fuq 3 snin kienu 3.0% (20/671 persuna) u 2.5% (17/685 persuna), rispettivament, meta mqabbel ma' 0.9% (6/679 persuna) għall-plaċebo.
English: During celecoxib treatment, the mean plasma concentrations of the CYP2D6 substrate dextromethorphan were increased by 136%.
Maltese: Waqt il-kura/trattament b'celecoxib, ilkonċentrazzjonijiet medji tas-substrat ta' CYP2D6 dextromethorphan fil-plasma żdiedu b'136%.
English: Onsenal can be taken with low dose acetylsalicylic acid (aspirin).
Maltese: Onsenal jista' jittieħed ma' doża baxxa ta' acetylsalicylic acid (aspirina).
English: In the APC trial, the relative risks compared to placebo for a composite endpoint (adjudicated) of cardiovascular death, myocardial infarction, or stroke were 3.4 (95% CI 1.4 - 8.5) with celecoxib 400 mg twice daily and 2.8 (95% CI 1.1 - 7.2) with celecoxib 200 mg twice daily.
Maltese: Fil-prova APC, ir-riskji relattivi meta mqabbla mal-plaċebo għal endpoint kompost (aġġudikat) ta' mewt kardjovaskulari, infart mijokardijaku, jew puplesija kienu 3.4 (95% CI 1.4 - 8.5) b'celecoxib 400 mg darbtejn kuljum u 2.8 (95% CI 1.1 - 7.2) b'celecoxib 200 mg darbtejn kuljum.
English: In a pharmacokinetic study of celecoxib 200 mg administered once daily in healthy volunteers, genotyped as either CYP2C9*1/*1, CYP2C9*1/*3, or CYP2C9*3/*3, the median Cmax and AUC 024 of celecoxib on day 7 were approximately 4-fold and 7-fold, respectively, in subjects genotyped as CYP2C9*3/*3 compared to other genotypes.
Maltese: Fi studju farmakokinetiku ta' celecoxib 200 mg mogħti darba kuljum lil voluntiera b'saħħithom, ġenotipati bħala CYP2C9*1/*1, CYP2C9*1/*3, jew CYP2C9*3/*3, il-Cmax u l-AUC 0-24 medjan ta' celecoxib f'jum 7 kienu bejn wieħed u ieħor 4 darbiet aktar u 7 darbiet aktar, rispettivament, f'individwi ġenotipati bħala CYP2C9*3/*3 meta mqabbel ma' ġenotipi oħra.
English: Pilot Study in Juvenile FAP Patients: A total of 18 children 10 to 14 years of age who had genotype or phenotype positive FAP were treated with celecoxib 4 mg/kg/day (4 patients, compared to 2 patients treated with placebo), celecoxib 8 mg/kg/day (4 patients, compared to 2 patients treated with placebo), or celecoxib 16 mg/kg/day (4 patients, compared to 2 patients treated with placebo).
Maltese: Studju Pilota fuq Pazjenti FAP Minorenni: Total ta' 18-il tifel/tifla ta' 10 sa 14-il sena li kellhom FAP pożittiv ta' ġenotip jew fenotip ingħataw kura b'celecoxib 4 mg/kg/kuljum (4 pazjenti, meta mqabbel ma' 2 pazjenti ttrattati bi plaċebo), celecoxib 8 mg/kg/kuljum (4 pazjenti, meta mqabbel ma' 2 pazjenti ttrattati bi plaċebo), jew celecoxib 16 mg/kg/kuljum (4 pazjenti, meta mqabbel ma' 2 pazjenti ttrattati bi plaċebo).
English: Examples of medicines which are metabolised by CYP2D6 are antidepressants (tricyclics and SSRIs), neuroleptics, anti-arrhythmics, etc.
Maltese: Eżempji ta' mediċini li huma metabolizzati b'CYP2D6 huma mediċini kontra d-depressjoni (triċikliċi u SSRIs), newrolettiċi, anti-arritmiċi.
English: Elevated levels of COX-2 are found in many pre-malignant lesions (such as adenomatous colorectal polyps) and epithelial cancers.
Maltese: Livelli għoljin ta' COX-2 jinstabu f'ħafna feriti pre-malinji (polipi adenomatużi kolorettali ) u kanċer epiteljali.
English: croscarmellose sodium, magnesium stearate and the colouring agent titanium dioxide E171.
Maltese: croscarmellose sodium, magnesium stearate u l-aġent tal-kulur titanium dioxide E171. - Il-linka ta' l-istampar fiha wkoll shellac, propylene glycol u iron oxide E172.
English: Myocardial infarction2
Maltese: Infart mijokardijaku 2 Arritmija
English: Cytochrome P450 CYP2C9 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity, such as those homozygous for the CYP2C9*3 polymorphism.
Maltese: L-attività taċċitokromu P450 CYP2C9 hija mnaqqsa f'individwi li għandhom polimorfiżmi ġenetiċi li jwasslu għal attività ridotta tal-enzimi, bħal dawk omozigoti għall-polimorfiżmu ta' CYP2C9*3.
English: The incidence of myocardial infarction (adjudicated) was 1.0% with (9/933 subjects) with celecoxib 400 mg once daily and 0.6% (4/628 subjects) with placebo.
Maltese: L-inċidenza tal-infart mijokardijaku (aġġudikata) kienet ta' 1.0% (9/933 persuna) b'celecoxib 400 mg darba kuljum u 0.6% (4/628 persuna) bi plaċebo.
English: Cumulative rates for this composite endpoint over 3 years were 2.3% (21/933 subjects) and 1.9% (12/628 subjects), respectively.
Maltese: Ir-rati kumulattivi għal dan l-endpoint kompost fuq 3 snin kienu 2.3% (21/933 persuna) u 1.9% (12/628 persuna), rispettivament.
English: Cardiovascular Safety - Long-Term Studies Involving Subjects With Sporadic Adenomatous Polyps: Two studies involving subjects with sporadic adenomatous polyps were conducted with celecoxib i.e., the APC trial (Adenoma Prevention with Celecoxib) and the PreSAP trial (Prevention of Spontaneous Adenomatous Polyps).
Maltese: Sigurtà Kardjovaskulari - Studji fuq Perjodu fit-Tul li Jinvolvu Persuni b'Polipi Adenomatużi Sporadiċi: Saru żewġ studji b'celecoxib li kienu jinvolvu persuni b'polipi adenomatużi sporadiċi, jiġifieri l-prova APC (Prevenzjoni tal-Adenomi b'Celecoxib) u l-prova PreSAP (Prevenzjoni talPolipi Adenomatużi Spontanji).
English: − Urinary infections
Maltese: apparat urinarju
English: Co-administration of NSAIDs and ciclosporin D derivatives or tacrolimus have been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus.
Maltese: Amministrazzjoni flimkien ta' NSAIDs u derivattivi taċ-ciclosporin D jew tacrolimus indikat żieda fleffett nefrotossiku ta' cyclosporin u tacrolimus.
English: A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical
Maltese: Ma ntwerietx differenza sinifikanti fis-sigurtà GI bejn inibituri COX-2 selettivi + acetylsalicylic acid vs.
English: The relative risk compared to placebo for a similar composite endpoint (CV death, MI, stroke) was 1.14 (95% CI 0.61 - 2.12) with celecoxib 200 mg twice daily.
Maltese: Ir-riskju relattiv ipparagunat mal-plaċebo għal endpoint simili kompost (mewt kardjovaskulari, infart mijokardijaku, puplesija) kien ta' 1.14 (95% CI 0.61 - 2.12) b'celecoxib 200 mg darbtejn kuljum.
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 kontra l-plejtlits bejn xi COX-1 li jinibixxu NSAIDs u inibituri selettivi COX2 tista' tkun ta' sinifikanza klinika f'pazjenti b'riskju ta' reazzjonijiet tromboemboliċi.
English: Celecoxib can be used with low dose acetylsalicylic acid, however it cannot be considered a substitute for acetylsalicylic acid for cardiovascular prophylaxis.
Maltese: Celecoxib jista' jintuża b'doża baxxa ta' acetlysalicyclic acid, iżda ma jistax jitqies bħala sostitut għal acetlysalicyclic acid għal profilassi kardjovaskolari.
English: Celecoxib exhibits dose- and time-independent pharmacokinetics in the therapeutic dose range.
Maltese: Celecoxib juri farmakokinetiċi indipendenti mid-doża u l-ħin fil-medda tad-doża terapewtika.
English: In FAP patients with moderate hepatic impairment (serum albumin of 25-35 g/l), the daily recommended dose of celecoxib should be reduced by 50%.
Maltese: F'pazjenti FAP b'indeboliment moderat talfwied (albumina fis-serum ta' 25-35 g /l), id-doża ta' kuljum rakkomandata ta' celecoxib għandha titnaqqas b'50%.
English: The greatest reduction was observed in patients treated with celecoxib 16 mg/kg/day, which corresponds to the recommended adult FAP dose of 800 mg daily.
Maltese: L-akbar tnaqqis kien osservat f'pazjenti ttrattati b'celecoxib 16 mg/kg/kuljum, li tikkorrispondi għad-doża rakkomandata ta' 800 mg kuljum għal FAP fl-adulti.
English: COX-2
Maltese: TAGĦRIF
English: Celecoxib is contraindicated in pregnancy and in women who can become pregnant unless using an effective method of contraception (see section 4.3).
Maltese: Celecoxib huwa kontra-indikat fit-tqala u f'nisa li jistgħu joħorġu tqal jekk ma jużawx metodu effettiv ta' kontraċezzjoni (ara sezzjoni 4.3).
English: - Neuroleptics (used to treat some mental disorders) - Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia) - Carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression) - Barbiturates ( used to treat epilepsy/seizures and some sleep disorders)
Maltese: - Newroleptiċi (użati għat-trattament ta' xi disturbi mentali) - Methotrexate (użat għall-kura tal-artrite rewmatika, il-psorjasi u l-lewkimja) - Carbamazepine (użat għall-kura tal-epilessija/aċċessjonijiet u xi forom ta' uġigħ jew depressjoni) - Barbiturati (użati għall-kura tal-epilessija/aċċessjonijiet u xi disturbi tal-irqad)
English: Single doses up to 1200 mg and multiple doses up to 1200 mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse events.
Maltese: Dożi waħdenin sa 1200 mg u dożi multipli sa 1200 mg darbtejn kuljum ingħataw lil persuni b'saħħithom għal disat ijiem mingħajr ebda episodji avversi klinikament sinifikanti.
English: Celecoxib metabolism is primarily mediated via cytochrome P450 CYP2C9.
Maltese: Il-metaboliżmu ta' celecoxib huwa medjat prinċipalment permezz taċ-ċitokromu P450 CYP2C9.
English: Data from a third long-term study, ADAPT (The Alzheimer's Disease Anti-inflammatory Prevention Trial), did not show a significantly increased cardiovascular risk with celecoxib 200mg BID compared to placebo.
Maltese: Informazzjoni mit-tielet studju fuq perjodu fit-tul, ADAPT (The Alzheimer's Disease Antiinflammatory Prevention Trial), ma wrietx żieda sinifikanti fir-riskju kardjovaskulari b'celecoxib 200mg BID meta mqabbel ma' plaċebo.
English: Celecoxib is a weak inhibitor of CYP2D6.
Maltese: Celecoxib huwa inibitur dgħajjef ta' CYP2D6.
English: Conventional embryo-foetal toxicity studies resulted in dose dependent occurrences of diaphragmatic hernia in rat foetuses and of cardiovascular malformations in rabbit foetuses at systemic exposures to free celecoxib approximately 3 times (rat) and 2 times (rabbit) higher than those achieved at the recommended daily human dose (800 mg).
Maltese: Studji konvenzjonali ta' tossiċità embriju-fetali rriżultaw f'okkorrenzi dipendenti fuq id-doża ta' ftuq dijaframmatiku fil-feti tal-firien u ta' malformazzjonijiet kardjovaskulari fil-feti tal-fniek f'esponimenti sistemiċi għal celecoxib liberu xi 3 darbiet (firien) u darbtejn (fniek) ogħla minn dawk miksuba bid-doża ta' kuljum rakkomandata għall-bniedem (800 mg).
English: Arrhythmia
Maltese: Anemija
English: COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effect.
Maltese: Inibituri selettivi COX-2 mhumiex sostituti għal acetylsalicylic acid għal profilassi ta' mard kardjovaskulari trombo-emboliku minħabba n-nuqqas ta' effett tagħhom kontra l-plejtlits.
English: The additional adverse reactions listed by system organ class and ranked by frequency in Table 2 were reported at incidence rates greater than placebo for subjects treated with celecoxib 400 mg to 800 mg daily in long-term polyp prevention trials of duration up to 3 years (the APC and PreSAP trials; see Section 5.1, Pharmacodynamic properties: Cardiovascular Safety - Long-Term Studies Involving Patients With Sporadic Adenomatous Polyps).
Maltese: Ir-reazzjonijiet avversi addizzjonali elenkati skont is-sistema tal-klassifika tal-organi u mpoġġija skont il-frekwenza f'Tabella 2 ġew irrappurtati b'rati ta' inċidenza akbar mill-plaċebo fil-każ tal-persuni ttrattati b'celecoxib 400 mg sa 800 mg kuljum fil-provi fuq perjodu fit-tul għall-prevenzjoni tal-polipi li damu sa 3 snin (il-provi APC u PreSAP; ara Sezzjoni 5
English: A more pronounced effect at 400 mg BID therefore
Maltese: Effett iżjed evidenti b'400 mg BID ma jistax jiġi eskluż.
English: Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib (see section 4.8).
Maltese: Reazzjonijiet ta' sensittività eċċessiva serji (anafilassi u anġjodema) ġew irrapportati f'pazjenti li kienu qegħdin jirċievu celecoxib (ara sezzjoni 4.8).
English: Additional reactions have been reported from actual use of the active ingredient of Onsenal (in post-marketing experience).
Maltese: Ġew irrappurtati reazzjonijiet addizzjonali mill-użu proprju tas-sustanza attiva ta' Onsenal (flesperjenza ta' wara t-tqegħid fis-suq).
English: Pfizer Luxembourg SARL Eesti filiaal Tel.: +372 6 405 328
Maltese: Pfizer Luxembourg SARL filiāle Latvijā Tel.: + 371 70 35 775
English: Onsenal is used to reduce the number of gastrointestinal polyps in patients with Familial Adenomatous Polyposis (FAP).
Maltese: Onsenal jintuża biex inaqqas l-ammont ta' polipi gastro-intestinali f'pazjenti b'Familial Adenomatous Polyposis (FAP).
English: Helicobacter infection, herpes zoster, erysipelas, wound infection, gingival infection, labrynthitis, bacterial infection Lipoma
Maltese: Infezzjoni tal-helicobacter, herpes zoster, irsipla, infezzjoni fil-ferita, infezzjoni fil-ħniek, labirintite
English: Blood and lymphatic system disorder / Cardio-vascular disorder Increased number of serious cardiovascular events, mainly myocardial infarction, has been found in a long-term placebo-controlled study in subjects with sporadic adenomatous polyps treated with celecoxib at doses of 200 mg BID and 400 mg BID compared to placebo (see section 5.1).
Maltese: Disturbi tad-demm u tas-sistema limfatika / Disturbi fil-qalb u vaskulari Fi studju ikkontrollat bi plaċebo fuq perjodu ta' żmien twil, kien hemm numru akbar ta' episodji kardjo-vaskulari serji, l-aktar minħabba infart mijokardijaku, f'suġġetti b'polipi adenomatuż sporadiku ittrattati b'celecoxib f'dożi ta' 200 mg BID u 400 mg BID meta mqabbla ma' plaċebo (ara sezzjoni 5.1).
English: Hepatic impairment: In patients with moderate hepatic impairment (serum albumin of 25-35 g/l), the daily recommended dose of celecoxib should be reduced by 50% (see sections 4.3 and 5.2).
Maltese: F'pazjenti bi ħsara moderata fil-fwied (serum albumina ta' 25-35 gramma / litru) id-doża rakkomandata ta' celecoxib għandha titnaqqas b'50% (ara sezzjonijiet 4.3 u 5.2).
English: Adverse reactions are listed by system organ class and ranked by frequency in Table 1, reflecting data from the following sources: - Adverse reactions reported in osteoarthritis patients and rheumatoid arthritis patients at incidence rates greater than 0.01% and greater than those reported for placebo during 12 placebo- and/or active-controlled clinical trials of duration up to 12 weeks at celecoxib daily doses from 100 mg up to 800 mg.
Maltese: - Reazzjonijiet avversi rrappurtati f'pazjenti bl-osteoartrite u f'pazjenti bl-artrite rewmatika b'rati ta' inċidenza akbar minn 0.01% u akbar minn dawk irrappurtati għall-plaċebo waqt 12-il prova klinika kkontrollati bil-plaċebo u/jew bis-sustanza attiva li damu għaddejjin sa 12-il ġimgħa b'dożi ta' celecoxib minn 100 mg sa 800 mg kuljum.
English: The MAH has previously committed to undertake a “Phase III placebo-controlled trial with celecoxib in genotype positive subjects with Familial Adenomatous Polyposis” (CHIP trial, Protocol A3191193) to generate further efficacy and safety data.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq kien preċedentement obbliga ruħu li jorganizza “Studju tal-Fażi III b'Celecoxib, kkontrollat bi Plaċebo, f'suġġetti b'ġenotip posittiv għal Poliposi Familjali Adenomatuża” (studjy CHIP, Protocol A3191193) sabiex jiġġenera iktar
English: Celecoxib is an oral, selective cyclooxygenase-2 (COX-2) inhibitor.
Maltese: Celecoxib huwa inibitur selettiv attiv ta' ċiklo-ossiġenażi-2 (COX-2) li jittieħed mill-ħalq.
English: Dysphonia
Maltese: Lipoma
English: Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see
Maltese: Onsenal huwa indikat għat-tnaqqis tal-polipi intestinali adenomatuż f'każijiet ta' polipi adenomatuż familjali (FAP) bħala aġġunt għal kirurġija u sorveljanza endoskopika fil-futur (ara sezzjoni 4.4).
English: Haemorrhoidal haemorrhage, frequent bowel movements, mouth ulceration, stomatitis
Maltese: Emorraġija mill-murliti, movimenti frekwenti talimsaren, ulċera tal-ħalq, stomatite
English: In healthy subjects, co-administration of celecoxib 200 mg twice daily with 450 mg twice daily of lithium resulted in a mean increase in Cmax of 16% and in AUC of 18% of lithium.
Maltese: F'suġġetti b'saħħithom, it-teħid ta' 200 mg celecoxib darbtejn kuljum flimkien ma' 450 mg darbtejn kuljum ta' litju rriżulta f'żieda medja fis- Cmax ta' 16% u fl-AUC ta' 18% ta' litju.
English: When dosed at 200 mg per day the corresponding values in patients with moderate hepatic impairment were 41% and 146% respectively.
Maltese: Meta ngħataw doża ta' 200 mg kuljum, il-valuri korrispondenti f'pazjenti b'indeboliment moderat tal-fwied kienu 41% u 146% rispettivament.
English: The capsules are white with ‘7767‘ and ‘200‘ marked in gold ink.
Maltese: Il-kapsuli huma bojod bin-numru ‘7767' u ‘200' immarkati b'linka kulur id-deheb.
English: - Adverse drug reactions from post-marketing surveillance as spontaneously reported during a period in which an estimated >70 million patients were treated with celecoxib (various doses, durations, and indications).
Maltese: - Reazzjonijiet avversi għall-mediċina mis-sorveljanza ta' wara t-tqegħid tal-prodott fis-suq kif irrappurtati b'mod spontanju matul perjodu li fih madwar >70 miljun pazjent ingħataw kura b'celecoxib (diversi dożi, tul ta' żmien, u indikazzjonijiet).
English: Concomitant use of 200 mg single dose of celecoxib and 200 mg once daily of fluconazole, a potent CYP2C9 inhibitor, resulted in a mean increase in celecoxib Cmax of 60% and in AUC of 130% (analogous studies have not been performed with amiodarone or other known CYP2C9 inhibitors).
Maltese: It-teħid flimkien ta' doża waħdanija ta' 200 mg ta' celecoxib u ta' doża waħdanija ta' 200 mg ta' fluconazole, inibitur qawwi ta' CYP2C9, jirriżulta f'żieda medja fis-Cmax ta' celecoxib ta' 60% u f'AUC ta' 130% (studji analogi ma ġewx imwettqa fuq amiodarone jew inibituri ta' CYP2C9 oħra magħrufa).
English: Onsenal is packed in blisters and supplied in boxes of 10 or 60 capsules.
Maltese: Onsenal huwa ppakkjat f'folji u fornut f'kaxxi ta' 10 jew 60 kapsula.
English: Diaphragmatic hernia was also seen in a peri-post natal toxicity study in rats, which included exposure during the organogenetic period.
Maltese: Ftuq dijaframmatiku kien osservat ukoll fi studji ta' tossiċità peri-post natali fil-firien, li kien jinkludi esponiment fil-perjodu organoġenetiku.
English: FAP patients carrying an ileorectal anastomosis or ileo pouch-anal anastomosis can develop anastomotic ulcerations.
Maltese: F'pazjenti FAP li jkollhomanastamożi ileorettali jew anastamożi ileo pouch-anali jistgħu jiżvillupaw ulċerazzjoni anastomotika.
English: NAME OF THE MEDICINAL PRODUCT Onsenal 400 mg hard capsules
Maltese: Onsenal 400 mg kapsuli iebsin
English: There is further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications) when celecoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Maltese: Hemm riskju akbar ta' effetti avversi gastro-intestinali (ulċerazzjoni gastro-intestinali jew kumplikazzjonijiet gastro-intestinali oħra) meta celocoxib jingħata flimkien ma' acetylsalicylic acid (anki f'dożi baxxi).
English: Patients with the CYP2C9*3 allele, and, in particular those with CYP2C9*3*3 homozygous genotype, may be exposed to celecoxib levels that are higher than those for which safety has been studied in clinical trials.
Maltese: Pazjenti bil-allele CYP2C9*3, partikolarment dawk bil-CYP2C9*3*3 ta' ġenotip omozigota, jistgħu jkunu esposti għal livelli ta' celecoxib li huma ogħla minn dawk li għalihom is-sigurtà ġiet studjata fil-provi kliniċi.
English: The maximum
Maltese: U KWANTITATTIVA
English: This medicine has been authorised under “exceptional circumstances”.
Maltese: Dan il-prodott mediċinali kien awtorizzat taħt ‘Ċirkustanzi ta' Eċċezzjoni'.
English: Excipients: Lactose Monohydrate 99.6 mg For a full list of excipients, see section 6.1.
Maltese: Lactose Monohydrate 99.6 mg.
English: In patients with rheumatoid arthritis celecoxib had no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (in rheumatologic doses).
Maltese: F'pazjenti bl-artrite rewmatika, celecoxib ma kellu ebda effett statistiku sinifikanti fuq ilfarmakokinetiċi (tneħħija mill-plażma jew renali) ta' methotrexate (f'dożi rewmatoloġiċi).
English: In the PreSAP trial, the relative risk compared to placebo for this same composite endpoint (adjudicated) was 1.2 (95% CI 0.6 - 2.4) with celecoxib 400 mg once daily compared to placebo.
Maltese: Fil-prova PreSAP, ir-riskju relattiv ipparagunat mal-plaċebo għal dan l-istess endpoint kompost (aġġudikat) kien ta' 1.2 (95% CI 0.6 - 2.4) b'celecoxib 400 mg darba kuljum meta mqabbel ma' plaċebo.
English: − Menstrual disturbances
Maltese: Disturbi fissistema nervuża
English: - Acetylsalcylic acid or other anti-inflammatory medicines - Cyclosporin and tacrolimus (used for immune system suppression e.g. after transplants) - Dextromethorphan (used as an antitussive in cough mixtures) - Diuretics (used to treat fluid retention) - Fluconazole (used to treat fungal infections)
Maltese: - Cyclosporin u tacrolimus (użati għat-trażżin tas-sistema immunitarja eż. wara trapjanti) - Dextromethorphan (użat bħala antitussiv f'mistura tas-sogħla) - Dijuretiċi (użati għall-kura taż-żamma ta' fluwidu) - Fluconazole (użat għall-kura ta' infezzjonijiet fungali) - Lithium (użat għall-kura tad-depressjoni) - Rifampicin (użat għall-kura ta' infezzjonijiet batteriċi) - Warfarin (użat biex jimpedixxi t-tagħqid tad-demm) jew antikoagulanti oħra - Mediċini oħra għall-kura tad-depressjoni, disturbi tal-irqad, il-pressjoni għolja tad-demm jew