FrancophonIA/ELRC3.0 huggingface dataset:
English: As for NSAIDs, the risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients) when ACE inhibitors or angiotensin II receptor antagonists are combined with NSAIDs, including celecoxib.
Maltese: Fir-rigward ta' NSAIDs, ir-riskju ta' indeboliment tal-kliewi akut jista' jiżdied f'xi pazjenti b'funzjoni tal-kliewi kompromessa (eż. pazjenti deidrati jew pazjenti anzjani) meta inibituri ACE jew angiotensin II receptor antagonists jittieħdu f'kombinazzjoni ma' NSAIDs inkluż celecoxib.
English: Clear or opaque PVC/Aclar/Aluminium foil blisters.
Maltese: Folji ta' PVC opak/fojl ta' l-aluminju
English: Respiratory, thoracic,
Maltese: Artralġja, mijosite
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version dated 28 February 2005 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq jimpenja ruħu li jwettaq l-istudji u lattivitajiet addizzjonali ta' farmakoviġilanza dettaljati fil-Pjan ta' Farmakoviġilanza, kif miftiehem fil-verżjoni datata 28 ta' Frar 2005 tal-Pjan ta' Ġestjoni tar-Riskji (RMP) ppreżentat fil-Modulu 1.8.2. ta' l-Applikazzjoni għall-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornamenti suċċessivi miftiehma mill-CHMP.
English: Patients with severe hepatic impairment (serum albumin <25 g/l) have not been studied and celecoxib is contraindicated in this patient group.
Maltese: Pazjenti b'indeboliment tal-fwied serju ħafna (albumina fis-serum <25 gramma / litru) ma ġewx studjati u celecoxib huwa kontra-indikat f'dan il-grupp ta' pazjenti.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, b'defiċjenza Lapp lactase jew b'assorbiment ħażin ta' glucose-galactose m'għandhomx
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of celecoxib (see section 4.8).
Maltese: Reazzjonijiet qawwija fil-ġilda, uħud minnhom fatali, inkluż dermatite li tqaxxar il-ġilda, is-sindromu ta' Stevens-Johnson, kif ukoll meta l-ġilda tibda tmut u tinqala (‘epidermal necrolysis') ġew irrapportati fuq pazjenti li ħadu celecoxib (ara sezzjoni 4.8).
English: White, opaque capsules with two green bands marked 7767 and 400.
Maltese: Bajda, kapsuli opaki b'żewġ faxex ħodor immarkati b'7767 u 400
English: Onsenal belongs to a group of medicines called cyclo-oxygenase-2 (COX-2) inhibitors.
Maltese: Onsenal jappartjeni għal grupp ta' mediċini msejħa inibituri ta' cyclo-oxygenase-2 (COX-2) Cyclo-oxygenase-2 hija enzima li tiżdied f'siti ta' infjammazzjoni u f'ċelloli li jikbru b'mod mhux normali.
English: The majority of the interaction studies have been performed with celecoxib doses of 200 mg BID (i.e. those used for osteoarthritis/rheumatoid arthritis).
Maltese: Il-maġġoranza ta' l-istudji ta' interazzjoni saru b'dożi ta' celecoxib 200 mg BID (i.e. dawk użati għallartrite ta' l-għadam/artrite rewmatika).
English: Acute renal failure, interstitial nephritis, hyponatraemia Menstrual disorder
Maltese: Insuffiċjenza renali akuta, nefrite interstizjali, iponatrimija Disturb filmestrwazzjoni
English: • Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi (ara sezzjoni 6.1).
English: Pharyngitis, rhinitis, cough
Maltese: Parasteżija, ngħas Atassja, bidla fittogħma
English: Compared to subjects with normal hepatic function, patients with mild hepatic impairment had a mean increase in Cmax of 53% and in AUC of 26% of celecoxib.
Maltese: Meta mqabbla ma' suġġetti b'funzjoni normali tal-fwied, il-pazjenti b'indeboliment ħafif tal-fwied kellhom żieda medja fil-Cmax ta' 53% u fl-AUC ta' 26% ta' celecoxib.
English: - if you have had an allergic reaction to any of the ingredients of Onsenal - if you have had an allergic reaction to a group of medicines called “sulphfonamides”.
Maltese: - jekk kellek reazzjoni allerġika għal xi sustanza ta' Onsenal - jekk kellek reazzjoni allerġika għal grupp ta' mediċini msejħa “sulfonamidi”.
English: Onsenal 400 mg hard capsules celecoxib
Maltese: Onsenal 400 mg kapsuli Celecoxib
English: Onsenal 200 mg hard capsules celecoxib
Maltese: Onsenal 200 mg kapsuli Celecoxib
English: Consider starting treatment at a reduced dose (see section 5.2).
Maltese: Wieħed għandu jikkunsidra li jibda t-trattament b'doża mnaqqsa (ara sezzjoni 5.2).
English: In the event of suspected overdose, appropriate supportive medical care should be provided e.g. by eliminating the gastric contents, clinical supervision and, if necessary, the institution of symptomatic treatment.
Maltese: F'każ ta' suspett ta' doża eċċessiva, għandha tiġi provduta kura medika ta' appoġg xierqa eż. bit-tneħħija tal-kontenut gastriku, superviżjoni klinika u, jekk neċċessarju, istituzjoni ta' trattament simtomatiku.
English: Therefore, blood pressure should be monitored closely during the initiation of therapy with celecoxib and throughout the course of therapy.
Maltese: Għaldaqstant, il-pressjoni tad-demm għandha tiġi mmonitorjata mill-qrib waqt il-bidu tat-terapija b'celecoxib u matul it-terapija kollha.
English: Clinical aspects
Maltese: Aspetti Kliniċi
English: urticaria or other allergic-type reactions after taking acetylsalicylic acid or non steroidal anti inflammatory drugs (NSAIDs) including COX-2 (cyclooxigenase-2) selective inhibitors.
Maltese: Ulċerazzjoni peptika attiva jew fsada gastro-intestinali (GI) Pazjenti li kellhom l-ażżma, rinite akuta, polipi nażali, edema anġjonevrotika, urtikarja jew reazzjonijiet ta' tip allerġiku oħra wara t-teħid ta' aċidu aċetilsaliċiliku jew mediċini antiinfjammatorji non-sterojdali (NSAIDs) inklużi inibituri selettivi COX-2 (cyclooxygenase-2).
English: Headache, aggravated epilepsy, meningitis aseptic, ageusia , anosmia, fatal intracranial haemorrhage Conjunctivitis, ocular haemorrhage, retinal artery or vein occlusion
Maltese: Uġigħ ta' ras, epilessija aggravata, meninġite asettika, agewżja, anosmija, emorraġija ġolkranju fatali
English: Celecoxib, as with other medicinal products inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester.
Maltese: Celecoxib, bħal fil-każ ta' mediċini oħra li jinibixu s-sinteżi ta' prostaglandin, jista' jikkawża inerzja uterina u għeluq prematur tad-ductus arteriosus fl-aħħar tliet xhur tat-tqala.
English: Common side effects which may affect more than 1 person in 100, are listed below - Fluid build up with swollen ankles, legs and/or hands - Urinary infections - Sinusitis (sinus inflammation, sinus infection, blocked or painful sinuses), blocked or runny nose, sore throat, coughs, colds, flu-like symptoms - Dizziness, difficulty sleeping - stomach ache, diarrhoea, indigestion, wind - Rash, itching
Maltese: - Sinożite (infjammazzjoni tas-sinus, infezzjoni tas-sinus, sinus imblukkati jew juġgħu), imnieħer imblukkat jew iqattar, uġigħ fil-griżmejn, sogħla, irjiħat, sintomi bħall-influwenza - Sturdament, diffikultà biex torqod - Uġigħ fl-istonku, dijarea, indiġestjoni, gass - Raxx, ħakk - Ebusija fil-muskoli - Taħżin ta' allerġiji eżistenti
English: The capsules are white with ‘7767‘ and ‘400‘ marked in green ink.
Maltese: Il-kapsuli huma bojod bin-numru ‘7767' u ‘400' immarkati b'linka kulur id-deheb.
English: Abdominal
Maltese: Iperkalimja
English: Celecoxib inhibits tumour formation in preclinical models of colon cancer, which overexpress COX-2, whether induced by chemical (rat AOM model) or genetic (MIN mouse model) mutation.
Maltese: Celecoxib jinibixxi formazzjoni tat-tumur f'mudelli preklinikali ta' kanċer tal-kolon, li jespremu COX-2, kemm jekk hu indott b'mutazzjoni kimika (mudell AOM tal-firien) kif ukoll jekk indott b'mutazzjoni ġenetika (mudell MIN tal-ġurdien).
English: The study population included 58 patients with a prior subtotal or total colectomy and 25 patients with an intact colon.
Maltese: Il-popolazzjoni ta' l-istudju kienet tinkludi 58 pazjent b'kolektomija subtotali preċedenti jew totali u 25 pazjent b'kolon intatt.
English: Paediatric patients: Experience with celecoxib in FAP patients below the age of 18 years is limited to a single pilot study in a very small population, in which patients were treated with celecoxib at doses up to 16 mg/kg daily, which corresponds to the recommended adult FAP dose of 800 mg daily (see
Maltese: L-esperjenza b'celecoxib f'pazjenti FAP ta' inqas minn 18-il sena hija limitata għal studju pilota wieħed f'popolazzjoni żgħira ħafna, li fih il-pazjenti kienu kkurati b'celecoxib f'dożi sa 16 mg/kg kuljum, li tikkorrispondi mad-doża rakkomandata għall-adulti FAP ta' 800 mg kuljum (ara sezzjoni 5.1).
English: 6.3 Shelf life 3 years.
Maltese: 4.6 Tqala u Treddigħ
English: In final data (adjudicated) from the APC trial in patients treated with celecoxib 800 mg daily for up to 3 years, the excess rates over placebo were 11 events per 1000 patients for myocardial infarction (common); and 5 events per 1000 patients for stroke (uncommon; types of stroke not differentiated).
Maltese: Fid-dejta finali (aġġudikata) mill-prova APC f'pazjenti ttrattati b'celecoxib 800 mg kuljum sa perjodu ta' 3 snin, ir-rati ta' eċċess fuq il-plaċebo kienu 11-il episodju għal kull 1000 pazjent fil-każ tal-infart mijokardijaku (komuni); u 5 episodji għal kull 100 pazjent fil-każ tal-puplesija (mhux komuni; ma saritx differenza bejn it-tipi ta' puplesija).
English: In three separate single dose studies, involving a total of 5 subjects genotyped as CYP2C9*3/*3, single-dose AUC 0-24 increased by approximately 3-fold compared to normal metabolizers.
Maltese: Fi tliet studji separati b'doża waħda, li kienu jinvolvu total ta' 5 persuni ġenotipati bħala CYP2C9*3/*3, l-AUC 0-24 ta' doża waħda żdiedet b'madwar 3 darbiet meta pparagunat ma' metabolizzaturi normali.
English: COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Maltese: COX-2 ġiet identifikata f'tessuti madwar ulċeri gastriċi fil-bniedem iżda r-rilevanza tagħha fil-fejqan ta' l-ulċeri gastriċi għadu ma ġiex stabbilit.
English: Ataxia, taste alteration
Maltese: Nokturja prostata, infjammazzjoni
English: The dose of individually dose-titrated CYP2D6 substrates may need to be reduced when treatment with celecoxib is initiated or increased if treatment with celecoxib is terminated.
Maltese: Id-doża ta' substrati CYP2D6 titrati individwalment tista' teħtieġ li titnaqqas meta jinbeda trattament, jew inkella li tiżdied jekk it-trattament b'celecoxib jitwaqqaf.
English: Ear infection, fungal infection (fungal infections were primarily
Maltese: Infezzjoni fil-widnejn, infezzjoni fungali (linfezzjonijiet fungali kienu prinċipalment mhux sistemiċi)
English: Bronchospasm
Maltese: FARMAKOLOĠIKU
English: The long-term cardiovascular toxicity in children exposed to celecoxib has not been evaluated and it is unknown if the long-term risk may be similar to that seen in adults exposed to celecoxib or other COX-2 selective and non-selective NSAIDs (see section 4.4; cardiovascular effects.
Maltese: It-tossiċità kardjovaskulari fuq perjodu fit-tul fi tfal esposti għal celecoxib ma ġietx evalwata u mhux magħruf jekk ir-riskju fuq perjodu fit-tul jistax ikun simili għal dak li deher f'persuni adulti esposti għal celecoxib jew NSAIDs oħra COX-2 selettivi u mhux selettivi (ara sezzjoni 4.4; effetti
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 trials (see 5.1).The concomitant use of celecoxib and a non-aspirin NSAID should be avoided.
Maltese: NSAIDs + acetylsalicylic acid fi provi kliniċi fuq perjodu fit-tul (ara 5.1).
English: Deep vein thrombosis; hematoma
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: − Oedema (water retention that can cause swelling) − Enlarged or inflamed prostate, prostate specific antigen increased (lab test)
Maltese: Edema (żamma tal-ilma li tista' tikkawża nefħa) Tkabbir jew infjammazzjoni fil-prostata, antiġen speċifiku għall-prostata (test tal-laboratorju)
English: Patients who are known or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution (see Section 4.2).
Maltese: Pazjenti li huma magħrufin li mhumiex metabolizzaturi daqstant tajbin ta' CYP2C9 għandhom jiġu ttrattati b'kawtela (ara sezzjoni 5.2).
English: In a 28-day clinical study in patients with lisinopril-controlled Stage I and II hypertension, administration of celecoxib 200 mg BID resulted in no clinically significant increases, when compared to placebo treatment, in mean daily systolic or diastolic blood pressure as determined using 24-hour ambulatory blood pressure monitoring.
Maltese: Fi studju kliniku ta' 28 ġurnata fuq pazjenti bi pressjoni għolja ta' Stadju I u II ikkontrollata b'lisinopril, l-għoti ta' celecoxib 200 mg BID ma rriżulta f'ebda żidiet klinikament sinifikanti, meta mqabbel mat-trattament bil-plaċebo, fil-pressjoni sistolika jew dijastolika medja kuljum tad-demm kif stabbilita bl-użu ta' monitoraġġ ambulatorju tal-pressjoni tad-demm fuq 24 siegħa.
English: As the cardiovascular risks of celecoxib were increased with the 400 mg twice daily dose in the APC trial (section 5.1), the response of the FAP patient to celecoxib should be re-examined periodically in order to avoid unnecessary exposure in FAP patients for whom celecoxib is not effective (sections 4.2, 4.3, 4.8 and 5.1)
Maltese: Billi r-riskji kardjovaskulari ta' celecoxib żdiedu bid-doża ta' 400 mg darbtejn kuljum fil-prova APC (sezzjoni 5.1), ir-rispons tal-pazjent FAP għal celecoxib għandu jiġi eżaminat mill-ġdid b'mod perjodiku sabiex jiġi evitat l-esponiment bla bżonn f'pazjenti FAP li għalihom celecoxib ma jkunx effettiv (sezzjonijiet 4.2, 4.3, 4.8 u 5.1).
English: Studies in animals (rats and rabbits) have shown reproductive toxicity (see sections 4.3 and 5.3).
Maltese: Studji fuq il-bhejjem (firien u fniek) urew ħsara fuq is-sistema riproduttiva (ara sezzjoni 4.3 u 5.3).
English: In the APC trial, there was a dose-related increase in the composite endpoint of cardiovascular death, myocardial infarction, or stroke (adjudicated) with celecoxib compared to placebo over 3 years of treatment.
Maltese: Fil-prova APC, kien hemm żieda relatata mad-doża fl-endpoint kompost ta' mewt kardjovaskulari, infart mijokardijaku, jew puplesija (aġġudikati) b'celecoxib meta mqabbel ma' plaċebo fuq 3 snin ta' kura.
English: − Rash, itching
Maltese: Sturdament, ipertonija
English: There is no clinical experience of overdose in clinical trials.
Maltese: M'hemm l-ebda esperjenza klinika ta' doża eċċessiva fil-provi kliniċi.
English: Excipients: Lactose Monohydrate 49.8 mg For a full list of excipients, see section 6.1.
Maltese: Lactose Monohydrate 49.8 mg.
English: Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Maltese: Għalhekk, terapiji kontra l-plejtlits m'għandhomx jitwaqqfu (ara sezzjoni 5.1).
English: Vaginal haemorrhage, breast tenderness, dysmenorrhea, ovarian cyst, menopausal symptoms
Maltese: Emorraġija mill-vaġina, sensibilità fis-sider, mestrwazzjoni diffiċli jew li tweġġa', ċista fl-ovarju, sintomi tal-menopawsa
English: Hepatitis, hepatic failure jaundice
Maltese: Epatite, insuffiċjenza talfwied, suffejra
English: − Unstable angina (chest pain), troubles with heart valves, rhythm, or coronary arteries, or
Maltese: Anġina instabbli (uġigħ fis-sider), inkwiet bil-valvi tal-qalb, ir-ritmu, jew l-arterji koronarji, jew
English: Ganglion
Maltese: Oħrajn
English: Chest pain
Maltese: FEJN MA
English: White, opaque capsules with two gold bands marked 7767 and 200.
Maltese: Bajda, kapsuli opaki b'żewġ faxex tad-deheb immarkati b'7767 u 200
English: − Ulcers (bleeding) in the stomach, gullet or intestines; or rupture of the intestine (can cause stomach ache, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of the gullet (can cause difficulty in swallowing), inflammation of the pancreas (can lead to
Maltese: - Ulċeri (fsada) fl-istonku, fil-gerżuma jew fl-intestini; jew ftuq tal-intestini (jista' jikkawża wġigħ fl-istonku, deni, dardir, rimettar, imblokk intestinali), ippurgar skur jew iswed, infjammazzjoni tal-gerżuma (tista' tikkaġuna diffikultà biex tibla'), infjammazzjoni tal-frixa (tista' twassal għal uġigħ fl-istonku)
English: Effects of celecoxib on other medicinal products
Maltese: Effetti ta' celecoxib fuq mediċini oħra
English: Pregnancy and breast-feeding
Maltese: Disturbi filmetaboliżmu u n-nutrizzjoni
English: In individuals who are CYP2C9 poor metabolisers and demonstrate increased systemic exposure to celecoxib, concomitant treatment with CYP2C9 inhibitors (eg.
Maltese: F'individwi li mhumiex metabolizzaturi daqstant tajbin ta' CYP2C9 u juru esponiment sistemiku miżjud għal celecoxib, it-trattament simultanju b'inibituri ta' CYP2C9 (eż. fluconazole, amiodarone) jista' jirriżulta f'żidiet ulterjuri fl-esponiment għal celecoxib.
English: The pharmacokinetics of celecoxib has not been studied in patients with renal impairment but is unlikely to be markedly changed in these patients since it is mainly eliminated by hepatic metabolism.
Maltese: Il-farmakokinetika ta' celecoxib ma ġietx studjata f'pazjenti b'indeboliment tal-kliewi iżda mhux probabbli li jkun hemm tibdil markat f'dawn il-pazjent minħabba li jiġi eliminat primarjament bilmetaboliżmu tal-fwied.
English: In clinical studies where Onsenal was taken for up to 3 years to prevent spontaneous colon polyps, the following additional side effects have been observed (side effects marked with an asterisk were more common in these studies than in arthritis studies):
Maltese: Fi studji kliniċi fejn Onsenal ittieħed sa perjodu ta' 3 snin biex jiġu evitati polipi spontanji filmusrana l-ħoxra, ġew osservati l-effetti sekondarji addizzjonali li ġejjin (l-effetti sekondarji mmarkati b'asterisk kienu aktar komuni f'dawn l-istudji milli fl-istudji dwar l-artrite):
English: Bleeding events in association with increases in prothrombin time have been reported in arthritis patients (mainly elderly) receiving celecoxib concurrently with warfarin, some of them fatal (see section 4.4).
Maltese: Ġew irrapportati episodji ta' telf ta' demm assoċjati ma' żieda fil-prothrombin time f'pazjenti bl-artrite (l-iżjed fl-anzjani) li kienu qed jirċievu celecoxib flimkien mal-warfarina, xi uħud minnhom fatali (ara sezzjoni 4.4).
English: The clinical significance of this in vitro finding is unknown.
Maltese: Is-sinifikat kliniku ta' dan ir-riżultat in vitro mhuwiex magħruf.
English: Experimental evidence shows that the mechanism(s) of action by which celecoxib leads to tumour death may be related to induction of apoptosis and inhibition of angiogenesis.
Maltese: Evidenza sperimentali tindika li l-mekkaniżmu(i) ta' azzjoni li bih(om) celecoxib iwassal għall-mewta tat-tumur tista' tkun relatata ma' l-induzzjoni ta' apoptożi u inibizjoni ta' anġjoġenesi.
English: The inter-subject variability in the exposure of celecoxib is about 10-fold.
Maltese: Il-varjabilità bejn suġġett u ieħor fl-esponiment ta' celecoxib hija ta' xi 10 darbiet.
English: The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)
Maltese: L-effett tat-tnaqqis indott minn Onsenal ta' l-ammont ta' polipi fuq ir-riskju ta' kanċer intestinali għadu ma ntweriex (ara sezzjonijiet 4.4 and 5.1)
English: 2 In a pooled analysis of 20 placebo-controlled studies with duration greater than 2 weeks up to 1 year in patients with OA and RA, the excess rate of myocardial infarction in patients treated with celecoxib 200 or 400 mg daily over placebo was 0.7 events per 1000 patients (Rare) and there was no excess of strokes.
Maltese: F'analiżi miġbura ta' 20 studju kkontrollati bil-plaċebo li damu aktar minn ġimagħtejn sa sena f'pazjenti b'OA u RA, ir-rata żejda ta' infart mijokardijaku fil-pazjenti kkurati b'celecoxib 200 jew 400 mg kuljum fuq il-plaċebo kienet ta' 0.7 episodji għal kull 1000 pazjent (Rari) u ma kien hemm ebda eċċess ta' puplesiji.
English: Data from pooled analysis of controlled randomized trials also suggest that cardiovascular risk may be associated with the use of celecoxib compared to placebo, with evidence for differences in risk based
Maltese: Funzjoni kompromessa renali jew epatika u speċjalment id-disfunzjoni tal-qalb huma aktar probabbli fl-anzjani u għalhekk għandha
English: Arrhythmia tachycardia
Maltese: Reazzjonijiet tal-ġilda
English: NAME OF THE MEDICINAL PRODUCT Onsenal 200 mg hard capsules
Maltese: Onsenal 200mg kapsuli iebsin
English: Dyspnoea
Maltese: Ipoakusi
English: − Difficulty coordinating muscular movements
Maltese: Disturbi muskoluskeltrali u talconnective tissue
English: Such patients should be carefully monitored while receiving treatment with celecoxib.
Maltese: Jekk mara toħroġ tqila waqt it-trattament, celecoxib għandu jitwaqqaf.
English: SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE
Maltese: OBBLIGAZZJONIJIET SPEĊIFIĊI
English: Vascular disorders
Maltese: Disturbi fissistema immuni
English: The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq irid jassigura li s-sistema ta' farmakoviġilanza, kif deskritta fil-verżjoni 2.0 ippreżentata fil-Modulu 1.8.1. ta' lApplikazzjoni għall-Awtorizzazzjoni għat-Tqegħid fis-Suq, tkun fis-seħħ qabel u waqt li l
English: Decreased hearing
Maltese: Tqala u treddigħ
English: Polyps with the APC mutation overexpress COX-2 and left untreated, these polyps continue to form and enlarge in the colon or rectum resulting in essentially a 100% chance of developing colorectal cancer.
Maltese: Polipi li għandhom il-mutazzjoni APC jesprimu COX-2 iżżejjed u jekk jitħallew mhux trattati, dawn il-polipi jibqgħu jiffurmaw u jikbru filkolon u fir-rettum b'riżultat ta' 100% żvilupp ta' kanċer kolorettali.
English: − High levels of sodium or haemoglobin and low levels of hematocrit or testosterone in blood test
Maltese: Livelli għoljin ta' sodium jew emoglobina u livelli baxxi ta' ematokrit jew testosteron firriżultati ta' testijiet tad-demm
English: Caution should be exercised when combining celecoxib with warfarin and other oral anticoagulants (see section 4.5).
Maltese: Għandha tingħata attenzjoni spejali għal dawn il-pazjenti (ara sezzjoni 5.2).
English: Adults and adolescents
Maltese: Adulti u adolexxenti
English: MIU = million IU
Maltese: MIU = miljun IU
English: ≈ mg CBA
Maltese: IU ≈ mg CBA
English: ≈ mass of CMS (mg)*
Maltese: CMS (mg)*
English: ATC Code: J01XB01
Maltese: J01XB01
English: Potency
Maltese: Potenza
English: EUCAST Breakpoints
Maltese: Breakpoints ta' EUCAST
English: * Nominal potency of the drug substance = 12.500 IU/mg
Maltese: * Potenza nominali tas-sustanza mediċinali = 12.500
English: Stenotrophomonas maltophilia Achromobacter xylosoxidans (formerly Alcaligenes xylosoxidans)
Maltese: Stenotrophomonas maltophilia Achromobacter xylosoxidans (qabel kienet Alcaligenes xylosoxidans)
English: PK/PD relationship
Maltese: Relazzjoni PK/PD
English: No-HD days: 2.25 MIU/day (2.2-2.3 MIU/day).
Maltese: Jiem mingħajr HD: 2.25 MIU/jum (2.2-2.3 MIU/jum).
English: 3.5 MIU
Maltese: MIU 3.5 MIU
English: Section 4.3 Contraindications
Maltese: Sezzjoni 4.3 Kontraindikazzjonijiet
English: CMS conversion table
Maltese: Tabella ta' konverżjoni CMS