FrancophonIA/ELRC3.0 huggingface dataset:
English: Metabolism: bexarotene metabolites in plasma include 6- and 7-hydroxy-bexarotene and 6- and 7-oxo-bexarotene.
Maltese: Il-metaboliti ta' bexarotene fil-plażma jinkludu 6- u 7-hydroxy-bexarotene u 6- u 7-oxo-bexarotene.
English: AL10 9SN
Maltese: 9SN
English: There are indications that bexarotene may induce CYP3A4.
Maltese: Hemm indikazzjonijiet li bexarotene jista' jirriżulta f'induzzjoni ta' CYP3A4.
English: The frequencies of adverse reactions are classified as very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000), and very rare (<1/10,000).
Maltese: Il-frekwenzi tar-reazzjonijiet avversi huma kklassifikati bħala komuni ħafna (>1/10), komuni (>1/100, <1/10), mhux komuni (>1/1,000, <1/100), rari (>1/10,000, <1/1,000), u rari ħafna (<1/10,000).
English: Excipient(s) with known effect: sorbitol
Maltese: Eċċipjent(i) b'effett magħruf: sorbitol
English: • erythromycin, clarithromycin and rifampicin (used against bacterial infections),
Maltese: • erythromycin, clarithromycin u rifampicin (jintużaw kontra l-infezzjonijiet batterjali),
English: Protein binding/distribution: bexarotene is highly bound (>99%) to plasma proteins.
Maltese: Twaħħil/distribuzzjoni tal-proteina: Bexarotene jeħel ħafna (>99%) mal-proteini tal-plażma.
English: Date of first authorisation: 29 March 2001.
Maltese: Data tal-ewwel awtorizzazzjoni: 29 ta' Marzu, 2001.
English: • ketoconazole and itraconazole (used against fungal infections),
Maltese: • ketoconazole u itraconazole (jintużaw kontra l-infezzjonijiet fungali),
English: • phenytoin and phenobarbital (used against seizures),
Maltese: • phenytoin u phenobarbital (jintużaw kontra l-puplesiji),
English: Proteins in urine, abnormal kidney function.
Maltese: Proteini fl-awrina, funzjoni anormali tal-kliewi.
English: Table 2 Adverse reactions reported in patients in clinical trials
Maltese: Tabella 2 Reazzjonijiet avversi rrappurtati fil-pazjenti fl-istudji kliniċi
English: • vitamin A supplements, protease inhibitors (used against viral infections),
Maltese: • supplimenti tal-vitamina A, inibituri tal-protease (jintużaw kontra infezzjonijiet virali),
English: Total daily dose (mg/day)
Maltese: Doża totali ta' kuljum (mg/kuljum)
English: Tél/Tel: +32 (0)800 158 58 (Belgique/Belgien)
Maltese: +32 (0)800 158 58 (Belgique/Belgien)
English: Name and address of the manufacturer responsible for batch release Eisai Manufacturing Limited
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Eisai Manufacturing Limited
English: Ongoing systemic infection.
Maltese: Infezzjoni sistemika li ghadha għaddejja.
English: Hyperlipaemia Hypercholesterolaemia
Maltese: Iperlipemija Iperkolesterolemija
English: A negative, sensitive, pregnancy test (e.g. serum beta-human chorionic gonadotropin, beta-HCG) should be obtained within one week prior to bexarotene therapy.
Maltese: Test tat-tqala negattiv, sensittiv, (eż. serum beta-human chorionic gonadotropin, beta-HCG) għandu jinkiseb fi żmien ġimgħa qabel ma tinbeda t-terapija b'bexarotene.
English: See leaflet for further information.
Maltese: Aqra l-fuljett għal aktar informazzjoni.
English: For example bexarotene may reduce the efficacy of oral contraceptives (see sections 4.4 and 4.6).
Maltese: Pereżempju, bexarotene jista' jnaqqas l-effikaċja talkontraċettivi orali (ara sezzjonijiet 4.4 u 4.6).
English: Single doses of 1500 mg/kg (9000 mg/m 2) and 720 mg/kg (14,400 mg/m 2) were tolerated without significant toxicity in rats and dogs, respectively.
Maltese: Dożi waħidhom ta' 1500 mg/kg (9000 mg/m2) u ta' 720 mg/kg (14,400 mg/m kienu ttollerati mingħajr tossiċità sinifikanti fil-firien u l-klieb, rispettivament.
English: Bexarotene has a different adverse reaction profile to other oral, non-retinoid X receptor (RXR)-selective retinoids.
Maltese: Bexarotene għandu profil differenti għar-reazzjonijiet avversi għal retinojdi selettivi nonretinoid X receptor (RXR)-orali oħrajn.
English: Skin reactions (Itching, redness, irritation, peeling).
Maltese: Reazzjonijiet tal-ġilda (Ħakk, ħmura, irritazzjoni, ġilda li titqaxxar).
English: Gastrointestinal disorder, liver failure, inflammation of the pancreas.
Maltese: Disturbi gastrointestinali, insuffiċjenza tal-fwied, infjammazzjoni tal-pankreas.
English: oC.
Maltese: A.
English: Body Surface Area (m
Maltese: Erja tas-superfiċje tal-ġisem (m
English: Off-white capsule, containing a liquid suspension and imprinted with “Targretin”.
Maltese: Kapsula bajda tagħti fil-griż, li fiha suspensjoni likwida u stampata bil-kliem“Targretin” fuqha.
English: Back pain, skin infection, fever, parasitic infection, abnormal laboratory test, disorder of mucous membrane, tumour.
Maltese: Uġigħ fid-dahar, infezzjoni tal-ġilda, deni, infezzjoni parassitika, test tal-laboratorju b'riżultat anormali, disturb tal-membrana mukuża, tumur.
English: Mental health problems
Maltese: Problemi tas-saħħa mentali
English: Single observations of the following were also reported: bone marrow depression, decreased prothrombin, decreased gonadotrophic luteinizing hormone, increased amylase, hyponatraemia, hypokalaemia, hyperuricaemia, hypocholesterolaemia, hypolipaemia, hypomagnesaemia, abnormal gait, stupor, circumoral paraesthesia, abnormal thinking, eye pain, hypovolaemia, subdural haematoma, congestive heart failure, palpitation, epistaxis, vascular anomaly, vascular disorder, pallor, pneumonia, respiratory disorder, lung disorder, pleural disorder, cholecystitis, liver damage, jaundice, cholestatic jaundice, melaena, vomiting, laryngismus, tenesmus, rhinitis, increased appetite, gingivitis, herpes zoster, psoriasis, furunculosis, contact dermatitis, seborrhoea, lichenoid dermatitis, arthritis, joint disorder, urinary retention, impaired urination, polyuria, nocturia, impotence, urine abnormality, breast enlargement, carcinoma, photosensitivity reaction, face oedema, malaise, viral infection, enlarged abdomen.
Maltese: Osservazzjonijiet waħidhom ta' dawn li ġejjin kienu rrappurtati wkoll: nuqqas fil-funzjoni talmudullun, tnaqqis fil-prothrombin, tnaqqis fl-ormon gonadotrofiku luteinizing, żieda fl-amylase, iponatremija, ipokalemija, iperurikemija, ipokolesterolemija, ipolipemija, ipomanjesemija, timxi b'mod anormali, sturdament, parestesija ċirkumorali, ħsibijiet anormali, uġigħ fl-għajnejn, ipovolemija, ematoma subdurali, insuffiċjenza konġestiva tal-qalb, palpitazzjoni, tinfaraġ, anomalija vaskulari, disturbi vaskulari, sfurija, pnewmonja, disturbi respiratorji, disturbi talpulmun, disturbi tal-plewra, koleċistite, ħsara fil-fwied, suffejra, suffejra kolestatika, melaena, rimettar, larinġiżmu, tenesmus, rinite, żieda fl-aptit, ġinġivite, herpes zoster, psorjasi, furunkolosi, dermatite tal-kuntatt, seborrea, dermatite lichenoid, artrite, disturbi tal-ġogi, żamma ta' l-awrina, indeboliment meta tagħmel l-awrina, tagħmel ammont eċċessiv ta' awrina, notturnja, impotenza, anormalità fl-awrina, tkabbir tas-sider, karċinoma, reazzjoni tas-sensittività għad-dawl, edema tal-wiċċ, telqa, infezzjoni virali, tkabbir fid-daqs taż-żaqq.
English: Of the total number of patients with CTCL in clinical studies, 61% were 60 years or older, while 30% were 70 years or older.
Maltese: Min-numru totali ta' pazjenti bis-CTCL fl-istudji kliniċi, 61% kienu ta' 60 sena jew aktar, filwaqt li 30% kienu ta' 70 sena jew aktar.
English: History of pancreatitis.
Maltese: Storja ta' pankreatite.
English: In 109 patients with CTCL treated at the recommended initial dose of 300 mg/m2/day, the most commonly reported adverse reactions to Targretin were hyperlipaemia ((primarily elevated triglycerides) 74%), hypothyroidism (29%), hypercholesterolaemia (28%), headache (27%), leucopenia (20%), pruritus (20%), asthenia (19%), rash (16%), exfoliative dermatitis (15%), and pain
Maltese: F'109-pazjent bis-CTCL li kienu kkurati fid-doża rakkomandata tal-bidu ta' 300-mg/m2/kuljum, l-aktar reazzjonijiet avversi għal Targretin li kienu rrappurtati b'mod komuni kienu iperlipemija ((primarjament livell għoli ta' triglycerides) 74%), ipotirojdiżmu (29%), iperkolesterolemija (28%), uġigħ ta' ras (27%), lewkopenja (20%), ħakk (20%), astenja (19%), raxx (16%), dermatite bil-qxur (15%), u uġigħ (12%).
English: Pancreatitis Hepatic Failure Gastrointestinal Disorder
Maltese: Insuffiċjenza Epatika Disturbi Gastrointestinali
English: Capsule shell: gelatin sorbitol special-glycerin blend (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol and water) titanium dioxide (E171) printing ink (SDA 35A alcohol (ethanol & ethyl acetate), propylene glycol (E1520), iron oxide black (E172), polyvinyl acetate phthalate, purified water, isopropyl alcohol, macrogol 400, ammonium hydroxide 28%)
Maltese: Il-qoxra tal-kapsula tikkonsisti minn gelatin, sorbitol special-glycerine blend (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol u ilma), titanium dioxide (E171) u linka ta' listampar (SDA 35A alcohol (ethanol u ethyl acetate), propylene glycol (E1520), iron oxide black (E172), polyvinyl acetate phthalate, purified water, isopropyl alcohol, macrogol 400, ammonium hydroxide 28%)
English: • gemfibrozil (used to reduce high levels of fats in the blood such as triglycerides and cholesterol),
Maltese: • gemfibrozil (jintuża biex inaqqas livelli għolja ta' xaħmijiet fid-demm, bħal triglycerides u kolesterol),
English: • insulin, agents enhancing insulin secretion, or insulin-sensitisers (used against diabetes mellitus).
Maltese: • insulina, sustanzi li jsaħħu s-sekrezzjoni tal-insulina, jew sensitizzaturi tal-insulina (użati kontra d- diabetes mellitus).
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX25
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi oħrajn, Kodiċi ATC:
English: Vitamin A supplementation
Maltese: Supplimentazzjoni ta' vitamina A
English: Caution is advised in case of combination with CYP3A4 substrates having a narrow therapeutic margin i.e. immunosuppressive agents (cyclosporine, tacrolimus, sirolimus) as well as CYP3A4-metabolised cytotoxics, i.e. cyclophosphamide, etoposide, finasteride, ifosfamide, tamoxifen, vinca-alcaloids.
Maltese: L-attenzjoni hi rakkomandata f'każ li jingħata ma' substrati ta' CYP3A4 li jkollhom marġni terapewtika dejqa, i.e. sustanzi immunosuppressivi (cyclosporine, tacrolimus, sirolimus) kif ukoll ċitotossi metabolati minn CYP3A4, i.e. cyclophosphamide, etoposide, finasteride, ifosfamide, tamoxifen, vinca-alcaloids.
English: • tamoxifen (used against some forms of cancer),
Maltese: • tamoxifen (jintuża kontra xi forom ta' kanċer),
English: Overactive thyroid.
Maltese: Tirojde attiva żżejjed.
English: Table 1 Recommended initial dose Initial dose level (300 mg/m2/day)
Maltese: Tabella 1 Doża tal-bidu rakkomandata Livell tad-doza tal-bidu (300 mg/m2/kuljum
English: Ecchymosis, petechia, abnormal white blood cells, thromboplastin decreased, abnormal erythrocytes, dehydration, increased gonadotrophic luteinizing hormone, weight loss, increased alkaline phosphatase, increased creatinine phosphokinase, lipase increased, hypercalcaemia, migraine, peripheral neuritis, paraesthesia, hypertonia, confusion, anxiety, emotional lability, somnolence, decreased libido, nervousness, night blindness, nystagmus, lacrimation disorder, tinnitus, taste perversion, chest pain, arrhythmia, peripheral vascular disorder, generalized oedema, haemoptysis, dyspnoea, increased cough, sinusitis, pharyngitis, dysphagia, mouth ulceration, oral moniliasis, stomatitis, dyspepsia, thirst, abnormal stools, eructation, vesicobullous rash, maculopapular rash, leg cramps, haematuria, flu syndrome, pelvic pain, and body odour.
Maltese: Ekkimożi, tbenġil, ċelluli bojod tad-demm anormali, tnaqqis fit-thromboplastin, eritroċiti anormali, deidrazzjoni, żieda fl-ormon gonadotrofiku luteinizing, telf ta' piż, żieda fl-alkaline phosphatase, żieda fil-krejatinina phosphokinase, żieda fil-lipase, iperkalċemija, emigranja, nevrite periferali, parestesija, ipertonija, konfużjoni, ansjetà, nuqqas ta' stabbilità emozzjonali, ngħas, tnaqqis fil-libido, nervożità, ma tibqax tara bil-lejl, nystagmus, disturbi fil-lakrimazzjoni, żanżin fil-widnejn, tibdil fit-togħma, uġigħ fis-sider, arritmija, disturbi vaskulari periferali, edema ġeneralizzata, emoptisi, qtugħ ta' nifs, żieda fis-sogħla, sinusite, farinġite, disfaġja, ulċerazzjoni tal-ħalq, moniliasi orali, stomatite, dispepsja, għatx, ippurgar anormali, titfewwaq,
English: The estimated renal clearance of bexarotene is less than 1 ml/minute.
Maltese: It-tneħħija stmata renali ta' bexarotene hi anqas minn 1 ml/minuta.
English: Targretin is indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) in adult patients refractory to at least one systemic treatment.
Maltese: Targretin huwa indikat għall-kura ta' manifestazzjonijiet fil-ġilda f'pazjenti adulti li qegħdin fi stadju avvanzat ta' cutaneous T-cell lymphoma (CTCL) li mhux qed jirrispondu għal mill-anqas kura sistemika waħda.
English: Bexarotene capsules were evaluated in clinical trials of 193 patients with CTCL of whom 93 had advanced stage disease refractory to prior systemic therapy.
Maltese: Il-kapsuli bexarotene kienu evalwati fi provi kliniċi fuq 193 pazjent li kellhom CTCL, li minnhom 93 kellhom il-marda li kienet fi stadju avvanzat u li kienet refrattarja għal terapija sistemika li saret qabel.
English: Psychiatric disorders
Maltese: Disturbi psikjatrici
English: Targretin contains sorbitol and butylated hydroxyanisole Targretin contains a small amount of sorbitol (a type of sugar).
Maltese: Targretin fih sorbitol u butylated hydroxyanisole Targretin fih ammont żgħir ta' sorbitol (tip ta' zokkor).
English: There are insufficient data to evaluate potential differences in the pharmacokinetics of bexarotene for other races.
Maltese: Hemm dejta insuffiċjenti biex jiġu evalwati differenzi potenzjali fil-farmakokinetika ta' bexarotene għal razez oħrajn.
English: The overall response rate according to this composite assessment was 31% (19/61) with a clinical complete response rate of 7% (4/61).
Maltese: Ir-rata totali tar-rispons skond din l-evalwazzjoni komposta kienet ta' 31% (19/61) flimkien ma' rata ta' rispons sħiħ kliniku ta' 7% (4/61).
English: Age: Based on the population pharmacokinetic analysis of data for 232 patients aged ≥ 65 years and 343 patients aged < 65 years, age has no statistically significant effect on bexarotene pharmacokinetics.
Maltese: Ibbażat fuq l-analiżi farmakokinetika tal-popolazzjoni ta' dejta għal 232 pazjent li kellhom ≥ 65 sena u 343 pazjent li kellhom < 65 sena, l-età ma kellha l-ebda effett statistikament sinifikanti fuq il-farmakokinetika ta' bexarotene.
English: The recommended dose is generally 4 to 10 capsules to be taken once daily.
Maltese: Id-doża rakkomandata hija ġeneralment hi minn 4 sa 10 kapsuli li jittieħdu darba kuljum.
English: Uncontrolled hypercholesterolaemia.
Maltese: Iperkolesterolemija mhux ikkontrollata.
English: Albuminuria Kidney Function Abnormal
Maltese: Albuminuria Funzjoni Anormali tal-Kliewi
English: Depression, depression aggravated, anxiety, and mood alterations have been reported in patients treated with systemic retinoids, including bexarotene.
Maltese: Depressjoni, depressjoni aggravata, ansjetà, u tibdil tal-burdata ġew irrappurtati f'pazjenti ttrattati b'retinojdi sistemiċi, li jinkludu bexarotene.
English: Chills, abdominal pain, allergic reaction, infection.
Maltese: Tertir ta' bard, uġigħ ta' żaqq, reazzjoni allerġika, infezzjoni.
English: In all evaluated patients, the estimated renal clearance of bexarotene was less than 1 ml/minute.
Maltese: Fil-pazjenti kollha li kienu evalwati, it-tneħħija renali ta' bexarotene kienet ta' inqas minn 1 ml/minuta.
English: Other medicines and Targretin
Maltese: Mediċini oħra u Targretin
English: Myasthaenia
Maltese: Mijastenja
English: Doses up to 1000 mg/m 2/day of bexarotene have been administered in clinical studies with no acute toxic effects.
Maltese: Dożi ta' bexarotene sa 1000 mg/m2/kuljum ingħataw fi studji kliniċi mingħajr l-ebda effetti tossiċi akuti.
English: Haemorrhage Hypertension Oedema Vasodilatation Varicose Vein
Maltese: Emorraġija Pressjoni tad-Demm Għolja Edema Vażodilatazzjoni Vini Varikużi
English: How to store Targretin
Maltese: Tieħux Targretin
English: Bexarotene is not genotoxic.
Maltese: Bexarotene mhuwiex ġenotossiku.
English: The active substance in Targretin, bexarotene, belongs to a group of medicines known as retinoids, which are related to vitamin A.
Maltese: Is-sustanza attiva f'Targretin, bexarotene, tappartjeni għall-grupp ta' mediċini magħrufin bħala retinojdi, li huma relatati ma' vitamina A.
English: In clinical trials, bexarotene was administered for up to 118 weeks to patients with CTCL.
Maltese: Fi provi kliniċi, bexarotene ingħata sa 118-il ġimgħa lill-pazjenti bis-CTCL.
English: Doses greater than 650 mg/m 2/day have not been evaluated in patients with CTCL.
Maltese: Dożi ta' aktar minn 650 mg/m2/kuljum ma kinux evalwati f'pazjenti bis-CTCL.
English: Changes in thyroid function tests have been observed in patients receiving bexarotene, most often noted as a reversible reduction in thyroid hormone (total thyroxine [total T4]) and thyroid-stimulating hormone (TSH) levels.
Maltese: Bidliet fit-testijiet tal-funzjoni tat-tirojde kienu osservati f'pazjenti li kienu qed jirċievu bexarotene, u fil-biċċa l-kbira tagħhom kienu osservati bħala tnaqqis riversibbli fil-livelli ta' lormon tat-tirojde (total ta' thyroxine ta' T4]) u fil-livelli ta' l-ormon li jistimula t-tirojde (thyroid-stimulating hormone - TSH).
English: Gastrointestinal disorders
Maltese: Mhux komuni gastrointestinali
English: At the recommended initial daily-dose level (300 mg/m2), single-dose and repeated daily-dose bexarotene pharmacokinetic parameters were similar.
Maltese: Fil-livell tad-doża rakkomandata tal-bidu ta' kuljum (300 mg/m2), il-parametri farmakokinetiċi ta' dożi waħidhom u ta' dożi ripetuti ta' kuljum ta' bexarotene kienu simili.
English: However, the exact mechanism of action of bexarotene in the treatment of cutaneous T-cell lymphoma (CTCL) is unknown.
Maltese: Madankollu, il-mekkaniżmu eżatt ta' l-azzjoni ta' bexarotene fil-kura ta' cutaneous T-cell lymphoma (CTCL) mhuwiex magħruf.
English: Thyroid disorder.
Maltese: Disturbi tat-tirojde.
English: Common (can occur in up to 1 in 10 patients treated):
Maltese: Komuni (jistgħu jseħħu f'sa 1 minn kull 10 pazjenti kkurati):
English: Bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the efficacy of oestroprogestive contraceptives.
Maltese: Bexarotene jista' potenzjalment jikkaġuna enzimi metaboliċi u għalhekk, teoretikament inaqqas l-effikaċja tal-kontraċettivi oestroprogestative.
English: Gender has no statistically significant effect on bexarotene pharmacokinetics.
Maltese: Is-sess tal-persuna ma kellu l-ebda effett statistikament sinifikanti fuq ilfarmakokinetika ta' bexarotene.
English: Magyarország Ewopharma Hungary Ltd. Tel: +36 1 200 46 50
Maltese: Ewopharma AG Sp. z o.o. Tel: +48 (22) 620 11 71
English: Elevated bilirubin in the blood, impaired kidney function, gout, decreased HDL cholesterol.
Maltese: Bilirubina għolja fid-demm, indeboliment tal-funzjoni tal-kliewi, gotta, tnaqqis fil-kolesterol
English: Muscle weakness.
Maltese: Mhux applikabbli.
English: Uncommon (can occur in up to 1 in 100 patients treated):
Maltese: Mhux komuni (jistgħu jseħħu f'sa 1 minn kull 100 pazjent ikkurat):
English: The capsules also contain the other ingredients macrogol, polysorbate, povidone and butylated hydroxyanisole.
Maltese: Il-kapsuli fihom ukoll is-sustanzi mhux attivi l-oħra macrogol, polysorbate, povidone u butylated hydroxyanisole.
English: Bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the efficacy of oestroprogestative contraceptives (see section 4.5).
Maltese: Bexarotene jista' potenzjalment jikkaġuna enzimi metaboliċi, u għalhekk, teoretikament, inaqqas l-effikaċja tal-kontraċettivi oestroprogestative (ara sezzjoni 4.5).
English: On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4, grapefruit juice may theoretically lead to an increase in plasma bexarotene concentrations.
Maltese: Fuq il-bażi tal-metaboliżmu li jossida ta' bexarotene minn ċitokrom P450 3A4, il-meraq talgrejpfrut teoretikament jista' jwassal għal żieda fil-konċentrazzjonijiet ta' bexarotene fil-plażma.
English: Each Targretin capsule contains 75 mg of the active substance bexarotene.
Maltese: Kull kapsula Targretin fiha 75 mg tas-sustanza attiva bexarotene.
English: Vomiting Diarrhoea Nausea Anorexia Liver Function Tests Abnormal Cheilitis Dry Mouth Constipation Flatulence
Maltese: Dijarea Nawseja Anoreksja Testijiet tal-Funzjoni tal-Kliewi b'Riżultat Anormali Cheilitis Ħalq Xott Stitikezza Gass
English: Leucopenia
Maltese: Lewkopenja
English: In vitro studies suggest glucuronidation as a metabolic pathway, and that cytochrome P450 3A4 is the major cytochrome P450 isozyme responsible for formation of the oxidative metabolites.
Maltese: In vitro, l-istudji jissuġġerixxu l-glukoronidazzjoni bħala l-passaġġ metaboliku, u li ċitokrom P450 3A4 hu ċ-ċitokrom maġġuri ta' l-isożima P450 responsabbli għall-formazzjoni tal-metaboliti li jossidaw.
English: Anaemia associated with bexarotene therapy has been reported in clinical studies.
Maltese: Anemija marbuta mat-terapija b'bexarotene kienet irrappurtata fl-istudji kliniċi.
English: With appropriate clinical monitoring, individual patients may benefit from doses above 300 mg/m 2/day.
Maltese: B'monitoraġġ kliniku adattat, il-pazjenti individwali jistgħu jibbenefikaw minn dożi ta' aktar minn 300 mg/m2/kuljum.
English: On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4), coadministration with other CYP3A4 substrates such as ketoconazole, itraconazole, protease inhibitors, clarithromycin and erythromycin may theoretically lead to an increase in plasma bexarotene concentrations.
Maltese: Fuq il-bażi talmetaboliżmu li jossida ta' bexarotene minn ċitokrom P450 3A4 (CYP3A4), l-għoti flimkien ma' sotto-strati oħrajn ta' CYP3A4, bħal ketoconazole, itraconazole, inibituri tal-protease, clarithromycin u erythromycin, jista' teoretikament iwassal għal żieda fil-konċentrazzjonijiet filplażma ta' bexarotene.
English: Agitation, difficulties with balance, depression, increased skin sensation on touching, abnormal nerve sensations, vertigo.
Maltese: Aġitazzjoni, diffikultajiet fil-bilanċ, dipressjoni, żieda fis-sensazzjoni fil-ġilda meta tmiss xi ħaġa, sensazzjonijiet anormali tan-nervaturi, sturdament.
English: Fasting triglycerides should be normal or normalised with appropriate intervention prior to bexarotene therapy.
Maltese: Il-livelli tat-triglycerides fl-istat sajjem għandhom ikunu normali jew normalizzati b'intervent adattat qabel ma tinbeda t-terapija b'bexarotene.
English: TARGRETIN 75 mg soft capsules Bexarotene
Maltese: TARGRETIN 75 mg kapsuli rotob Bexarotene
English: The safety and efficacy of bexarotene in children (aged below 18 years) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' bexarotene fit-tfal (ta' età taħt it-18-il sena) għadhom ma ġewx determinati s'issa.
English: The recommended initial dose is 300 mg/m 2/day.
Maltese: Id-doża rakkomandata tal-bidu hi ta' 300 mg/m2/kuljum.
English: Consideration should be given to a suspension or discontinuation of bexarotene if test results reach greater than three times the upper limit of normal values for SGOT/AST, SGPT/ALT, or bilirubin.
Maltese: Għandha tingħata konsiderazzjoni lis-sospensjoni jew it-twaqqif ta' bexarotene jekk ir-riżultati tat-test ikunu ta' aktar minn tliet darbiet tal-Limitu ta' Fuq tan-Normal għal SGOT/AST, SGPT/ALT, jew il-bilirubina.
English: Cataract Specified Amblyopia Visual Field Defect Corneal Lesion Abnormal Vision Blepharitis Conjunctivitis
Maltese: Katarretti Speċifikati Amblijopija Difett fil-Kamp Viżiv Leżjoni tal-Kornea Vista Anormali
English: Thyroid Disorder
Maltese: Disturbi tat-Tirojde
English: Targretin 75 mg soft capsules
Maltese: Targretin 75 mg kapsuli rotob