FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu
English: Do not take more than 15,000 International Units of vitamin A supplements per day during treatment.
Maltese: Tiħux aktar minn 15,000 Unitajiet Internazzjonali ta' supplimenti ta' vitamina A kuljum matul il-kura.
English: Every attempt should be made to maintain triglyceride levels below 4.52 mmol/l in order to reduce the risk of clinical sequelae.
Maltese: 4.52 mmol/l biex jitnaqqas ir-riskju ta' kundizzjonijiet jew mard kliniku b'konsegwenza ta' dan.
English: Changes in hair, herpes simplex, nail disorder, pustular rash, serous drainage, skin discoloration.
Maltese: Tibdil fix-xagħar, herpes simplex, disturbi fid-dwiefer, raxx bil-ponot, ħruġ ta' likwidu qisu serum, tibdil fil-kulur tal-ġilda.
English: Liver Function Test (LFT) abnormalities
Maltese: Bidliet fit-test tal-funzjoni tat-tirojde
English: Elevation of blood fats (triglycerides and cholesterol).
Maltese: Żieda fix-xaħmijiet fid-demm (triglycerides u kolesterol).
English: Method of administration
Maltese: A MANIFATTUR RESPONSABBLI
English: Ewopharma AG Sp. z o.o.
Maltese: Magyarország Ewopharma Hungary Ltd.
English: Allergic Reaction Infection Chills Abdominal Pain Hormone Level Altered
Maltese: Reazzjoni Allerġika Infezzjoni Tertir ta' Bard Uġigħ ta' Żaqq Livelli Mibdula ta' l-Ormoni
English: - if you have ever had any mental health problems including depression, aggressive tendencies or mood changes.
Maltese: - Jekk qatt kellek xi problemi tas-saħħa mentali li jinkludu depressjoni, tendenzi aggressivi jew tibdil fil-burdata.
English: Targretin is available as soft capsules for oral use in a white plastic bottle containing 100 capsules.
Maltese: Targretin hu disponibbli bħala kapsuli rotob biex jittieħdu mill-ħalq, fi flixkun tal-plastik abjad li fih 100 kapsula.
English: Bexarotene may potentially enhance the action of insulin, agents enhancing insulin secretion (e.g. sulfonylureas), or insulin-sensitisers (e.g. thiazolidinediones), resulting in hypoglycaemia (see section
Maltese: Bexarotene jista' potenzjalment isaħħaħ l-azzjoni tal-insulina, ta' sustanzi li jsaħħu s-sekrezzjoni tal-insulina (eż. sulfonylureas), jew ta' sensitizzaturi tal-insulina (eż. thiazolidinediones), li jirriżultaw f'ipogliċemija (ara sezzjoni 4.4).
English: One capsule contains 75 mg of bexarotene.
Maltese: Kull kapsula fiha 75 mg ta' bexarotene.
English: Clinical pharmacokinetic data indicate that urinary elimination of bexarotene and its metabolites is a minor excretory pathway for bexarotene.
Maltese: Informazzjoni klinika farmakokinetika tindika li t-tneħħija ta' bexarotene fl-awrina u tal-metaboliti tiegħu, hi passaġġ sekondarju tat-tneħħija għal bexarotene.
English: Bexarotene is a synthetic compound that exerts its biological action through selective binding and activation of the three RXRs: , , and .
Maltese: Bexarotene hu kompost sintetiku li jeżercita l-azzjoni bijoloġika tiegħu permezz ta' twaħħil selettiv u l-attivazzjoni tal-tliet RXRs: , , u .
English: Marketing Authorisation Holder Eisai GmbH
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Among the 61 patients treated at an initial dose of 300 mg/m2/day, the overall response rate, according to a global assessment by the physician, was 51% (31/61) with a clinical complete response rate of 3%.
Maltese: Fost il-61 pazjent li kienu kkurati b'doża tal-bidu ta' 300 mg/m2/kuljum, ir-rata tar-rispons totali, skond evalwazzjoni globali mit-tabib, kienet ta' 51% (31/61) b'rata ta' rispons sħiħ kliniku ta' 3%.
English: Renal excretion is not a significant elimination pathway for bexarotene.
Maltese: It-tneħħija renali mhijiex passaġġ sinifikanti ta' l-eliminazzjoni għal bexarotene.
English: Serous Drainage Herpes Simplex Pustular Rash Skin Discoloration Hair Disorder Nail Disorder
Maltese: Ħruġ ta' Likwidu Qisu Serum Herpes Simplex Raxx bil-Ponot Tibdil fil-Kulur tal-Ġilda Disturbi fix-Xagħar Disturbi fid-Dwiefer
English: Paediatric population Targretin is not recommended in children (aged below 18 years).
Maltese: Popolazzjoni pedjatrika Targretin mhuwiex rakkomandat fit-tfal (taħt l-età ta' 18-il sena)
English: Fasting blood lipid determinations (triglycerides and cholesterol) should be performed before bexarotene therapy is initiated and at weekly intervals until the lipid response to bexarotene is established, which usually occurs within two to four weeks, and then at intervals no less than monthly thereafter.
Maltese: Id-determinazzjonijiet tal-lipidi fid-demm (triglycerides u kolesterol) fl-istat sajjem għandhom jitwettqu qabel ma tinbeda t-terapija b'bexarotene, u f'intervalli ta' kull ġimgħa sakemm irrispons tal-lipidi għal bexarotene ikun stabbilit, li normalment iseħħ fi żmien minn ġimagħtejn sa erba' ġimgħat, u mbagħad f'intervalli ta' mhux inqas minn darba f'xahar wara dak il-perjodu.
English: Race: Based on the population pharmacokinetic analysis of data for 540 Caucasian and 44 Black patients, bexarotene pharmacokinetics are similar in Blacks and Caucasians.
Maltese: 44 pazjent Iswed, il-farmakokinetika ta' bexarotene hi simili fis-Suwed u fil-Kawkasi.
English: Thus, if treatment with bexarotene is intended in a woman of childbearing potential, a reliable, non-hormonal form of contraception is also required, because bexarotene belongs to a therapeutic class for which the human malformative risk is high.
Maltese: Għaldaqstant, jekk il-kura b'bexarotene hi intenzjonata għal mara li jista' jkollha t-tfal, metodu kontraċettiv affidabbli u mhux ormonali hu rakkomandat ukoll, minħabba li bexarotene jappartjeni għal klassi terapewtika li għaliha, irriskju ta' malformazzjonijiet umani hu għoli.
English: Blood Dyscrasia Purpura Coagulation Disorder Coagulation Time Increased Anaemia Thrombocytopenia Thrombocythemia Eosinophilia Leukocytosis Lymphocytosis
Maltese: Żidiet tal-kolesterol fis-serum għandhom ikunu mmaniġġjati skond il-prattika medika kurrenti.
English: Furthermore, co-administration with CYP3A4 inducers such as rifampicin, phenytoin, dexamethasone or phenobarbital may theoretically cause a reduction in plasma bexarotene concentrations.
Maltese: Flimkien ma' dan, l-għoti flimkien ma' inducers ta' CYP3A4 bħal rifampicin, phenytoin, dexamethasone jew phenobarbital, jista' teoretikament jikkawża tnaqqis fil-konċentrazzjonijiet fil-plażma ta' bexarotene.
English: Deafness
Maltese: Treddigħ
English: Leucopenia associated with bexarotene therapy has been reported in clinical studies.
Maltese: Lewkopenja marbuta mat-terapija b'bexarotene kienet irrappurtata fl-istudji kliniċi.
English: • dexamethasone (used for inflammatory conditions),
Maltese: • dexamethasone (jintuża għal kundizzjonijiet infjammatorji),
English: Responses were also determined by a composite score of five clinical signs (surface area, erythema, plaque elevation, scaling and hypo/hyperpigmentation) which also considered all extracutaneous CTCL manifestations.
Maltese: Ir-risponsi kienu stabbiliti wkoll minn punteġġ kompost ta' ħames sinjali kliniċi (superfiċje tal-wiċċ, eritema, elevazzjoni tal-plakka, qoxra u ipo/iperpigmentazzjoni) li kkunsidraw ukoll il-manifestazzjonijiet kollha tas-CTCL 'il barra mill-ġilda.
English: Exfoliative Dermatitis Pruritus Rash
Maltese: Farmokinetika f'Popolazzjonijiet Speċjali
English: Joint aches, bone pain, muscle aches.
Maltese: Uġigħ fil-ġogi, uġigħ fl-għadam, uġigħ fil-muskoli.
English: Additional adverse reactions observed when used outside of the recommended dose and indication (i.e. used in CTCL at an initial dose >300mg/m2/day or in non-CTCL cancer indications):
Maltese: Reazzjonijiet avversi addizzjonali osservati meta l-mediċina tintuża 'il barra mid-doża rakkomandata u l-indikazzjoni (i.e. tintuża fis-CTCL f'doża tal-bidu ta' >300mg/m2/kuljum jew f'indikazzjonijiet ta' kanċer li mhux tas-CTCL):
English: However, among a total of 810 patients, including those without malignancy, treated with bexarotene, there were three serious adverse reactions with fatal outcome (acute pancreatitis, subdural haematoma and liver failure).
Maltese: Madankollu, fost total ta' 810 pazjenti, li jinkludi dawk mingħajr malinn, li kienu kkurati b'bexarotene, kien hemm tliet reazzjonijiet avversi serji b'riżultat fatali (pankreatite akuta, ematoma subdurali u insuffiċjenza tal-fwied).
English: Hyperthyroidism
Maltese: Tfal u adolexxenti
English: Following repeat once daily dose administration at dose levels  230 mg/m2, Cmax and AUC in some patients were less than respective single dose values.
Maltese: Wara l-għoti ta' dożi ripetuti darba kuljum f'livelli tad-doża ta'  230 mg/m2, is-Cmax u l-AUC f'xi pazjenti kienu anqas mill-valuri rispettivi għal doża waħda.
English: The majority of adverse reactions were noted at a higher incidence at doses greater than 300 mg/m2/day.
Maltese: Il-maġġoranza tar-reazzjonijiet avversi kienu osservati f'inċidenza ogħla f'dożi akbar minn 300 mg/m2/kuljum.
English: The following Targretin-related adverse reactions were reported during clinical studies in patients with CTCL (N=109) treated at the recommended initial dose of 300 mg/m2/day.
Maltese: Dawn ir-reazzjonijiet avversi li ġejjin, marbuta ma' Tagretin, kienu rrappurtati matul studji kliniċi f'pazjenti bis-CTCL (N=109) li kienu kkurati fid-doża rakkomandata tal-bidu ta' 300-mg/m2/kuljum.
English: Body Weight and Gender: Based on the population pharmacokinetics analysis of data for 614 patients with a weight range of 26 to 145 kg, the bexarotene apparent clearance increases with increasing body weight.
Maltese: Piż tal-Ġisem u Sess: Ibbażat fuq l-analiżi farmakokinetika tal-popolazzjoni ta' dejta għal 614-il pazjent b'medda ta' piż ta' 26 sa 145 kg, it-tneħħija apparenti ta' bexarotene tiżdied ma' żieda fil-piż tal-ġisem.
English: Nausea, diarrhoea, dry mouth, dry lips, loss of appetite, constipation, excess gas, abnormal liver function tests, vomiting.
Maltese: Nawseja, dijarea, ħalq xott, xufftejn xotti, telf ta' aptit, stitikezza, gass eċċessiv, testijiet talfunzjoni tal-fwied b'riżultat anormali, rimettar.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju talKaratteristiċi tal-Prodott, sezzjoni 4.2).
English: The mechanism of this interaction is unknown.
Maltese: Il-mekkaniżmu ta' din l-interazzjoni mhuwiex magħruf.
English: High-density polyethylene bottles with child-resistant closures containing 100 capsules.
Maltese: Fliexken tal-polyethylene b'densità għolja b'għatjien reżistenti għat-tfal, li fihom 100 kapsula.
English: Fertility studies have not been conducted; however, in sexually immature male dogs, reversible aspermatogenesis (28-day study) and testicular degeneration (91-day study) were seen.
Maltese: Ma sarux studji dwar il-fertilità; madankollu, fi klieb irġiel li kienu sesswalment immaturi, kienu osservati laspermatoġenesi riversibbli (fi studju li dam 28 jum) u deġenerazzjoni (fi studju li dam 91 jum).
English: Clinical results
Maltese: Riżultati kliniċi
English: Targretin capsules are used by patients with advanced stage cutaneous T-cell lymphoma (CTCL) whose disease has not responded to other therapies.
Maltese: Il-kapsuli Targretin jintużaw minn pazjenti li għandhom limfoma taċ-ċelluli T fil-ġilda (cutaneous T-cell lymphoma - CTCL)) fi stadju avvanzat, u li l-marda tagħhom ma tkunx irrispondiet għal terapiji oħrajn.
English: The safety of bexarotene has been examined in clinical studies of 193 patients with CTCL who received bexarotene for up to 118 weeks and in 420 non-CTCL cancer patients in other studies.
Maltese: Is-sigurtà ta' bexarotene kien eżaminata fi studji kliniċi fuq 193-pazjent li kellhom CTCL li rċivew bexarotene sa 118-il ġimgħa, u f'420 pazjent li ma kellhomx kanċer tas-CTCL fi studji oħrajn.
English: Therefore, repeated administration of bexarotene may result in an auto-induction of its own metabolism and, particularly at dose levels greater than 300 mg/m2/day, may increase the rate of metabolism and reduce plasma concentrations of other substances metabolised by cytochrome P450 3A4, such as tamoxifen.
Maltese: Għalhekk, l-għoti ripetut ta' bexarotene jista' jirriżulta f'awto-induzzjoni tal-metaboliżmu tiegħu stess u, partikularment, f'livelli tad-doża li jkunu ta' aktar minn 300 mg/m2/kuljum, jista' jżid ir-rata talmetaboliżmu u jnaqqas il-konċentrazzjonijiet fil-plażma ta' sustanzi oħrajn li jkunu metabolat minn ċitokrom P450 3A4, bħal tamoxifen.
English: Skin Ulcer Alopecia Skin Hypertrophy Skin Nodule Acne Sweating Dry Skin Skin Disorder
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V.
English: Targretin capsules should be used with caution in patients with a known hypersensitivity to retinoids.
Maltese: Il-kapsuli targretin għandhom jintużaw bl-attenzjoni f'pazjenti li hu magħruf li għandhom sensittività eċċessiva għar-retinojdi.
English: Bone Pain Arthralgia
Maltese: Disturbi flgħajnejn
English: Elevation of liver enzymes, impaired kidney function, low protein in blood, weight gain.
Maltese: Żieda fl-enzimi tal-fwied, indeboliment tal-funzjoni tal-kliewi, livell baxx ta' proteina fid-demm, żieda fil-piż.
English: 200 (2 x 100) tablets (multipack)
Maltese: (2 x 100) pillola (pakkett multiplu)
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA (UE) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Strength Pharmaceutical Form
Maltese: 10 pilloli
English: Alopecia, photosensitivity
Maltese: Alopeċja, fotosensittività
English: • Pfizer Manufacturing Deutschland GmbH, Heinrich-Mack-Strasse 35, 89257 Illertissen, Germany
Maltese: • Pfizer Manufacturing Deutschland GmbH, Heinrich-Mack-Strasse 35, 89257 Illertissen, IlĠermanja
English: Dermatitis allergic
Maltese: Dermatite allerġika
English: Pharmacokinetic interactions
Maltese: Interazzjonijiet Farmakokinetiċi
English: − The other ingredients are gelatin, lactose monohydrate, sodium lauryl sulphate, povidone K30,
Maltese: - Is-sustanzi l-oħra huma gelatin, lactose monohydrate, sodium lauryl sulphate, povidone K30,
English: Cyclooxygenase is responsible for generation of prostaglandins.
Maltese: Cyclooxygenase huwa responsabbli għall-ġenerazzjoni ta' prostaglandini.
English: Packs of 10 or 60 capsules.
Maltese: Pakketti ta' 10 jew 60 kapsula
English: The maximum recommended daily dose is 800 mg.
Maltese: Id-doża massima rakkomandata tal-ġurnata hi 800 mg.
English: Leucopenia, thrombocytopenia
Maltese: Lewkopenija, tromboċitopenija
English: In an interaction study, celecoxib had no clinically relevant effects on the pharmacokinetics of oral contraceptives (1 mg norethistherone /35 microg ethinylestradiol).
Maltese: Fi studju tal-interazzjonijiet, celecoxib ma kellux effetti kliniċi rilevanti fuq il-farmakokinetiċi talkontraċettivi orali (1 mg norethistherone /35 microg ethinylestradiol).
English: Pharmacological activity resides in the parent substance.
Maltese: L-attività farmakoloġika tinsab fis-sustanza oriġinali.
English: Onsenal 400 mg capsules contain lactose (99.6 mg).
Maltese: Onsenal 400 mg kapsuli fih lactose (99.6 mg).
English: Hypertension, hypertension aggravated
Maltese: Allerġija aggravata
English: Ελλάδα
Maltese: Qtugħ ta' nifs
English: Flushing, vasculitis, pulmonary embolism
Maltese: Fwawar, vaskulite, emboliżmu pulmonari Bronkospażmu
English: Uncommon (≥1/1000 to <1/100)
Maltese: Mhux komuni (≥1/1000 sa <1/100)
English: Onsenal 200 mg capsules contain lactose (49.8 mg).
Maltese: Onsenal 200 mg kapsuli fih lactose (49.8 mg).
English: Celecoxib is mainly eliminated by metabolism.
Maltese: Celecoxib huwa eliminat primarjament bil-metaboliżmu.
English: • Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score >10) (Class C).
Maltese: .3) Disfunzjoni severa fil-fwied (serum albumina <25 gramma / litru jew punteġġ Child-Pugh >10)
English: Elimination half-life is 8-12 hours.
Maltese: Il-half-life ta' l-eliminazzjoni hija 8-11-il siegħa.
English: Angina unstable, aortic valve incompetence, coronary artery atherosclerosis, sinus bradycardia, ventricular hypertropy
Maltese: Anġina instabbli, inkompetenza tal-valv aortiku, aterosklerożi tal-arterja koronarja, sinus bradycardia, ipertrofija ventrikulari
English: It is estimated that the frequency of the homozygous *3/*3 genotype is 0.3-1.0% among different ethnic groups.
Maltese: Huwa stmat li l-frekwenza tal-ġenotip omozigota *3/*3 huwa 0.3-1.0% fost gruppi etniċi differenti.
English: Pharmacotherapeutic group: Antineoplastic, ATC code: L01XX33
Maltese: Kategorija farmakoterapewtika: Antineoplastics, Kodiċi ATC:
English: No clinically significant differences were found in pharmacokinetic parameters of celecoxib between African-Americans and Caucasians.
Maltese: Ma nstabu l-ebda differenzi klinikament sinifikanti fil-parametri farmakokinetiċi ta' celecoxib bejn persuni Afro-Amerikani u Kawkasi.
English: Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate), or glibenclamide
Maltese: Celecoxib ma jaffettwax il-farmakokinetiċi ta' tolbutamide (substrat ta' CYP2C9), jew glibenclamide
English: Three metabolites, inactive as COX-1 or COX-2 inhibitors, have been identified in human plasma i.e., a primary alcohol, the corresponding carboxylic acid and its glucuronide conjugate.
Maltese: Tliet metaboliti, inattivi bħall-inibituri COX-1 jew COX-2, ġew identifikati fil-plażma umana, jiġifieri alkoħol primarju, carboxylic acid korrispondenti u l-konjugat glucuronide tiegħu.
English: Two isoforms, COX-1 and COX-2, have been identified.
Maltese: Ġew identifikati żewġ iżoforom, COX-1 U COX-2.
English: • Known hypersensitivity to sulphonamides.
Maltese: Sensittività eċċessiva għas-sulfonamidi.
English: The mean reduction in the number of colorectal polyps following six months of treatment was 28% (SD + 24%) for celecoxib 400 mg BID which was statistically superior to placebo (mean 5%, SD +16%).
Maltese: Ittnaqqis medju fin-numru ta' polipi kolorettali wara sitt xhur kura kien ta' 28% (SD + 24%) għal celecoxib 400 mg BID li kien statistikament superjuri għal plaċebo (medja ta' 5%, SD +16%).
English: Effects of other medicinal products on celecoxib
Maltese: Effetti ta' prodotti mediċinali oħra fuq celecoxib
English: Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs.
Maltese: Provi kliniċi b'celecoxib urew effetti renali simili għal dawk osservati b'NSAIDs komparaturi.
English: Onsenal contains lactose (a type of sugar).
Maltese: Onsenal fih il-lactose (tip ta' zokkor).
English: NSAIDs, including celecoxib, may cause renal toxicity.
Maltese: In-NSAIDs, fosthom celecoxib, jistgħu jikkawżaw effett tossiku renali.
English: Ramsgate Road
Maltese: Pfizer Limited Ramsgate Road Sandwich
English: Nausea, acute pancreatitis, gastrointestinal haemorrhage, colitis/colitis aggravated
Maltese: Dardir, pankreatite akuta, emorraġija gastrointestinali, kolite/kolite aggravata
English: Outer carton - 200 mg hard capsules (clear, opaque blister)
Maltese: Kartuna ta' barra - 200 mg kapsuli iebsin (folja ċara, opaka)
English: Among patients treated with celecoxib 200 mg BID, 48% were considered unresponsive to lisinopril at the final clinic visit (defined as either cuff diastolic blood pressure >90 mmHg or cuff diastolic blood pressure increased >10% compared to baseline), compared to 27% of patients treated with placebo; this difference was statistically significant.
Maltese: Fost il-pazjenti ttrattati b'celecoxib 200 mg BID, 48% tqiesu li ma rrispondewx għal lisinopril fl-aħħar żjara klinika (definita bħala cuff diastolic blood pressure >90 mmHg jew żieda fil-cuff diastolic blood pressure >10% pparagunata mal-linja bażi), meta mqabbel ma' 27% tal-pazjenti ttrattati bi plaċebo; din iddifferenza kienet statistikament sinifikanti.
English: Cerebral infarction
Maltese: Infart ċerebrali;
English: Outer carton - 400 mg hard capsules
Maltese: Kartuna ta' barra - 400 mg kapsuli iebsin
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilMediċini (EMA) http://www.ema.europa.eu/.
English: Ecchymosis, bullous eruption, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema Arthralgia, myositis
Maltese: Ekkimożi, imsiemer, dermatite esfoljattiva, eritema multiformi, sindrome ta' Stevens-Johnson, nekroliżi epidermika tossika, anġjoedema
English: A meaningful reduction in duodenal adenoma area was also observed compared with placebo (14.5% celecoxib 400 mg BID versus 1.4% placebo), which however was not statistically significant.
Maltese: Ġie osservat tnaqqis sinifikanti fl-erja ta' l-adenoma dwodenali meta mqabbel ma' plaċebo (14.5% celecoxib 400 mg BID kontra 1.4% plaċebo), li madankollu ma kienx statistikament sinifikanti.
English: Such combinations should be avoided in known CYP2C9 poor metabolisers (see sections 4.2 and 5.2).
Maltese: Tali kombinazzjonijiet għandhom jiġu evitati f'metabolizzaturi magħrufa mhux daqstant tajbin ta' CYP2C9 (ara sezzjonijiet 4.2 u 5.2).
English: Examples of medicinal products which are metabolised by CYP2C19 are diazepam, citalopram and imipramine.
Maltese: Eżempji ta' prodotti mediċinali li huma metabolizzati minn CYP2C19 huma diazepam, citalopram u imipramine.
English: The incidence of myocardial infarction was 1.1% (8/717 patients) with celecoxib 200 mg twice daily and 1.2% (13/1070 patients) with placebo.
Maltese: L-inċidenza ta' infart mijokardijaku kienet ta' 1.1% (8/717 pazjent) b'celecoxib 200 mg darbtejn kuljum u 1.2% (13/1070 pazjent) bi plaċebo.
English: No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2 [TxB2] formation) was observed in healthy volunteers at the FAP therapeutic dose of 400 mg BID.
Maltese: L-ebda inibizzjoni statistikament sinifikanti ta' COX-1 (stmata bħala inibizzjoni ex vivo ta' formazzjoni ta' thromboxane B2) ma ġiet osservata f‘volontiera b'saħħithom fid-doża terapewtika għal FAP ta' 400
English: The potential risk for humans is unknown.
Maltese: Ir-riskju li jista jkun hemm fuq in-nies, mhux magħruf.
English: Concomitant use of inducers of CYP2C9 such as rifampicin, carbamazepine and barbiturates may reduce plasma concentrations of celecoxib.
Maltese: It-teħid flimkien ta' indutturi ta' CYP2C9 bħal rifampicin, carbamaepine u barbiturates jista' jnaqqas il-konċentrazzjonijiet fil-plasma ta' celecoxib.
English: Familial Adenomatous Polyposis (FAP) is a genetic disease resulting from an autosomal dominant genetic alteration of a tumor suppressor gene, the adenomatous polyposis coli (APC) gene.
Maltese: Polipożi Familjali Adenomatuża (FAP) hija marda ġenetika li tirriżulta minn alterazzjoni ġenetika dominanti autosomal ta' ġene li jrażżan it-tumuri, il-ġene Koli Adenomatuż Polipożi (APC).
English: • Breast feeding (see sections 4.6 and 5.3)
Maltese: Treddigħ (ara sezzjonijiet 4.6 u 5
English: Vitreous floaters; conjunctival hemorrhage Hypoacusis
Maltese: Vitreous floaters; emorraġija mill-konġuntiva
English: Duodenal, gastric, oesophageal, intestinal, and colonic ulceration; dysphagia, intestinal perforation; oesophagitis, melaena; pancreatitis
Maltese: Ulċerazzjoni duwodenali, gastrika, esofagali, intestinali u tal-musrana l-ħoxna; disfaġja, perforazzjoni intestinali, esofaġite, melena, pankreatite
English: In vitro studies have shown some potential for celecoxib to inhibit CYP2C19 catalysed metabolism.
Maltese: Studji in vitro urew xi potenzjal għal celecoxib li jinibixxi metaboliżmu kkatalizzat minn CYP2C19.
English: COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Maltese: Inibituri ta' COX-2 inaqqsu l-formazzjoni ta' prostacyclin sistemiku (u allura possibilment endoteljali) mingħajr ma jaffetwaw it-thromboxane tal-plejtlits.