FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the Phase 1 study, no dose adjustment of temsirolimus is recommended for RCC patients with baseline platelet counts 100 x 109/l and mild to moderate hepatic impairment (total bilirubin up to 3 times upper limit of normal [ULN] with any abnormality of AST, or as defined by Child-Pugh Class A or B).
Maltese: 9/l u indeboliment tal-fwied minn ħafif sa moderat (bilirubina totali sa 3 darbiet tal-limitu ta' fuq tan-normal [ULN] bi kwalunkwe anormalità ta' AST, jew kif definit minn Child-Pugh Klassi A jew B).
English: In a Phase 1/2 safety and exploratory efficacy study, 71 patients (59 patients, aged from 1 to 17 years, and 12 patients, aged from 18 to 21 years) received temsirolimus as a 60-minute intravenous infusion once weekly in three-week cycles.
Maltese: Fi studju ta' Fażi 1/2 dwar is-sigurtà u l-effikaċja esploratorja, 71 pazjent (59 pazjent, li kellhom minn sena sa 17-il sena, u 12-il pazjent, li kellhom minn 18 sa 21 sena) irċevew temsirolimus bħala infużjoni ġol-vini ta' 60 minuta darba fil-ġimgħa f'ċikli ta' tliet ġimgħat.
English: The temsirolimus 175 mg (3 successive weekly doses) followed by 25 mg weekly treatment arm did not result in a significant increase in PFS when compared with investigator's choice (median 3.4 vs. 1.9 months, hazard ratio = 0.65, CI = 0.39, 1.10, p = 0.0618).
Maltese: 1.9 xhur, proporzjon tal-periklu = 0.65, CI = 0.39, 1.10, p = 0.0618).
English: The other ingredients in the concentrate are anhydrous ethanol, all-rac-α-tocopherol (E 307), propylene glycol and citric acid (E 330).
Maltese: Is-sustanzi l-oħra fil-konċentrat huma anhydrous ethanol, all-rac-ά-tocopherol (E 307), propylene glycol, u anhydrous citric acid (E 330).
English: Therefore, substances that are potent inhibitors of CYP3A4 activity (e.g. nelfinavir, ritonavir, itraconazole, ketoconazole, voriconazole, nefazodone) increase sirolimus blood concentrations.
Maltese: (eż. nelfinavir, ritonavir, itraconazole, ketoconazole, voriconazole, nefazodone) iżidu lkonċentrazzjonijiet ta' sirolimus fid-demm.
English: Direct addition of Torisel 30 mg concentrate to aqueous solutions will result in precipitation of medicinal product.
Maltese: Iżżieda diretta ta' konċentrat Torisel 30 mg ma' soluzzjonijiet akweji ser tirriżulta fil-preċipitazzjoni tal-prodott mediċinali.
English: • Torisel, when diluted, contains polysorbate 80,and therefore appropriate administration materials must be used (see sections 6.1 and 6.2).
Maltese: • Meta dilwit, Torisel ikun fih polysorbate 80, u għalhekk għandu jintuża materjal talamministrazzjoni xieraq (ara sezzjonijiet 6.1 u 6.2).
English: The recommended dose of temsirolimus for advanced RCC is 25 mg administered by intravenous infusion over a 30- to 60-minute period once a week.
Maltese: Id-doża rakkomandata ta' temsirolimus għal RCC avvanzata hi ta' 25 mg li tingħata permezz ta' infużjoni fil-vini fuq perijodu ta' 30 sa 60 minuta darba fil-ġimgħa.
English: Antihistamines are given to help prevent an allergic reaction to Torisel, including some lifethreatening and rare fatal allergic reactions.
Maltese: L-antistamini jingħataw biex jgħinu fil-prevenzjoni ta' reazzjoni allerġika għal Torisel, inklużi xi reazzjonijiet ta' theddida għall-ħajja u reazzjonijiet allerġiċi fatali rari.
English: In patients younger than 65, median overall survival was 12 months (95% CI 9.9, 14.2) with a hazard ratio of 0.67 (95% CI 0.52, 0.87) compared with those treated with IFN-α.
Maltese: F'pazjenti li għandhom inqas minn 65 sena, il-medjan tas-sopravivenza totali kien ta' 12-il xahar (95% CI 9.9,14.2) bi proporzjon tal-periklu ta' 0.67 (95% CI 0.52,0.
English: Serious adverse reactions observed in clinical trials of temsirolimus for MCL, but not in clinical trials of temsirolimus for advanced RCC include: thrombocytopenia, and neutropenia (including febrile neutropenia).
Maltese: Ir-reazzjonijiet avversi serji li kienu osservati fil-provi kliniċi b'temsirolimus għal MCL, iżda mhux fil-provi kliniċi b'temsirolimus għal RCC avanzata jinkludu: tromboċitopenija, u newtropenija (inkluża newtropenija bid-deni).
English: In the 25 mg arm (n = 36), all patients had metastatic disease; 4 (11%) had no prior chemo- or immunotherapy; 17 (47%) had one prior treatment, and 15 (42%) had 2 or more prior treatments for RCC. Twenty-seven (27, 75%) had undergone a nephrectomy.
Maltese: Fil-parti ta' l-istudju fejn il-pazjenti kienu qed jingħataw 25 mg (n = 36), il-pazjenti kollha kellhom mard metastatiku; 4 (11%) qatt ma kienu ħadu kimoterapija jew immunoterapija qabel; 17 (47%) kellhom kura waħda fil-passat, u 15 (42%) kellhom 2 jew aktar kuri għal RCC.
English: The temsirolimus arm showed a 49% increase in median OS compared with the IFN-α arm. Temsirolimus also was associated with statistically significant advantages over IFN-α in the secondary endpoints of PFS, TTF, and clinical benefit rate.
Maltese: Il-parti ta' l-istudju ta' temsirolimus uriet żieda ta' 49% fil-medjan ta' OS meta mqabbel malparti ta' l-istudju ta' IFN-. temsirolimus kien assoċjat ukoll ma' vantaġġi statistikament sinifikanti fuq IFN- fir-riżultati aħħarin sekondarji ta' PFS, TTF, u r-rata tal-benefiċċju kliniku.
English: At the discretion of the physician, treatment may be resumed after the administration of an H1-receptor antagonist (diphenhydramine or similar antihistamine) and a H2-receptor antagonist (intravenous famotidine 20 mg or intravenous ranitidine 50 mg) approximately 30 minutes before restarting the temsirolimus infusion.
Maltese: Fid-diskrezzjoni tat-tabib, il-kura tista' titkompla wara l-għoti ta' antagonist ta' riċettur H1 (diphenhydramine jew antistamina simili) u antagonist ta' riċettur H2 (20 mg famotidine ġol-vini jew 50 mg ranitidine ġol-vini) madwar 30 minuta qabel ma tibda millġdid l-infużjoni b'temsirolimus.
English: Venous thromboembolism (including deep vein thrombosis, venous thrombosis)
Maltese: Tromboemboliżmu fil-vini (li jinkludi trombożi fil-vini fondi, trombożi filvini)
English: Torisel 30 mg concentrate and solvent for solution for infusion
Maltese: Torisel 30 mg konċentrat u solvent għal soluzzjoni għall-infużjoni
English: Malignancies
Maltese: Deidrazzjoni
English: Uncommon Intestinala/duodenal perforation
Maltese: Perforazzjoni intestinali a/duwodenali 2 ( 0.6)
English: Therefore, for patients with RCC, continuous administration beyond 5-7 days with agents that have CYP3A4/5 induction potential should be avoided.
Maltese: Għalhekk, għal pazjenti b'RCC, l-għoti kontinwu lilhemm minn 5-7 ijiem b'mediċini li għandhom potenzjal li jinduċu CYP3A4/5, għandu jkun evitat.
English: This incompatibility has to be considered during the preparation and administration of Torisel.
Maltese: Din l-inkompatibilità għandha tiġi kkunsidrata waqt il-preparazzjoni u l-għoti ta' Torisel.
English: Folliculitis
Maltese: Plejtlits
English: For mantle cell lymphoma, the recommended dose is 175 mg infused (as a drip) over a 30- to 60-minute period once weekly for 3 weeks followed by single weekly doses of 75 mg infused (as a drip) over a 30- to 60-minute period.
Maltese: Għal limfoma taċ-ċelluli mantle, id-doża rakkomanda hi ta' 175 mg mogħtija bħala infużjoni (biddripp) fuq perijodu ta' 30 sa 60 minuta darba fil-ġimgħa għal 3 ġimgħat, segwit minn dożi waħidhom ta' 75 mg darba fil-ġimgħa mogħti bħala infużjoni (bid-dripp) fuq perijodu ta' 30 sa 60 minuta.
English: No clinically significant effect is anticipated when temsirolimus is co-administered with agents that are metabolised by CYP2D6.
Maltese: L-ebda effett klinikament sinifikanti ma hu antiċipat meta temsirolimus ikun ko-amministrat ma' mediċini li huma metabolizzati minn CYP2D6.
English: Very common Hyperglycaemia Hypercholesterolaemia Hypertriglyceridaemia Decreased appetite Hypokalaemia
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Following administration of [14C] temsirolimus, excretion was predominantly via the faeces (78%), with renal elimination of active substance and metabolites accounting for 4.6% of the administered dose.
Maltese: C] temsirolimus, ittneħħija kienet il-biċċa l-kbira permezz ta' l-ippurgar (78%), b'eliminazzjoni renali tas-sustanza attiva u tal-metaboliti li jammontaw għal 4.6% tad-doża li tingħata.
English: An increased incidence of angioneurotic oedema (including delayed reactions occurring two months following initiation of therapy) has been observed in patients who received temsirolimus or other mTOR inhibitors in combination with an ACE inhibitor (e.g. ramipril) and/or a calcium channel blocker (e.g. amlodipine) (see sections 4.4 and 4.8).
Maltese: Ġiet osservata inċidenza ikbar ta' edema anġjonewrotika (li jinkludu reazzjonijiet li jseħħu wara ċertu żmien li jseħħu wara xahrejn wara l-bidu tat-terapija) f'pazjenti li rċivew temsirolimus jew inibituri oħra ta' mTOR flimkien ma' inibitur ta' ACE (eż. ramipril) u/jew imblokkatur tal-kanal tal-kalċju (eż. amlodipine) (ara sezzjonijiet 4.4 u 4.8).
English: The mean ±standard deviation (SD) dissociation constant (Kd) of binding was 5.1 ± 3.0 ng/ml, denoting the concentration at which 50% of binding sites in blood cells were occupied.
Maltese: Il-medja tad±devjazzjoni standard (SD) dissoċjazzjoni kostanti (Kd) tat-twaħħil kienet ta' 5.1 ± 3.0 ng/ml, li tindika l-konċentrazzjoni li fiha 50% tas-siti tat-twaħħil fiċ-ċelluli tad-demm, kienu okkupati.
English: Patients receiving the higher dose of 175 mg of Torisel for the initial treatment of mantle cell lymphoma may receive a dose of ethanol equivalent to up to 123 ml beer or 51 ml wine per dose.
Maltese: Pazjenti li jkunu qed jirċievu d-doża ogħla ta' 175 mg ta' Torisel għall-kura inizjali tallimfoma taċ-ċelluli mantle, jistgħu jirċievu doża ta' ethanol ekwivalenti għal 123 ml ta' birra jew 51 ml ta' nbid f'kull doża.
English: Subjects were randomly assigned in a 1:1:1 ratio to receive intravenous temsirolimus 175 mg (3 successive weekly doses) followed by 75 mg weekly (n = 54), intravenous temsirolimus 175 mg (3 successive weekly doses) followed by 25 mg weekly (n = 54), or the investigator's choice of single-agent treatment (as specified in the protocol; n = 54).
Maltese: Il-persuni ntgħażlu b'mod każwali fi proporzjon ta' 1:1:1 biex jirċievu temsirolimus ġol-vini 175 mg (3 dożi suċċessivi kull ġimgħa) segwiti minn 75 mg fil-ġimgħa (n = 54), temsirolimus ġol-vini 175 mg (3 dożi suċċessivi kull ġimgħa) segwiti minn 25 mg fil-ġimgħa (n=54), jew l-għażla talinvestigatur ta' kura b'mediċina waħda (kif speċifikat fil-protokoll; n = 54).
English: After further dilution of the concentrate-solvent mixture with sodium chloride 9 mg/ml (0.9%) solution for injection
Maltese: Wara dilwizzjoni addizzjonali tat-taħlita ta' konċentrat-solvent b'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni
English: General feeling of weakness, chills, swelling due to fluid retention, pain (including abdominal, back, chest and joint pain), feeling sick to the stomach (nausea and vomiting), diarrhoea, constipation , headache, fever, sores and inflammation in the mouth and/or the digestive tract, cough, pneumonia, nose bleed, rash, itching, dry skin, decreased appetite, shortness of breath, low levels of potassium in the blood (which may cause muscle weakness), low red blood cell count, decreased number of a type of white blood cells which is associated with an increased risk of infection, high blood sugar, high cholesterol, high triglycerides abscess, infections ( including eye infection, flu, viral infections, bronchitis), abnormal kidney function (including kidney failure), blood tests that show changes in the way the kidney is working, change in the sense of taste, difficulty falling asleep, low number of platelets which may cause bleeding and bruising.
Maltese: Sensazzjoni ġenerali ta' dgħjufija, tertir ta' bard, nefħa minħabba żamma ta' fluwidu, uġigħ (li jinkludi wġigħ fiż-żaqq, fid-dahar, fis-sider u fil-gogi), tħoss l-istonku mhux f'postu (nawsja u rimettar), dijarea, stitikezza, uġigħ ta' ras, deni, feriti u infjammazzjoni fil-ħalq u/jew fl-apparat diġestiv, sogħla, pnewmonja, ħruġ ta' demm mill-imnieħer, raxx, ħakk, ġilda xotta, tnaqqis fl-aptit, qtugħ ta' nifs, livelli baxxi ta' potassium fid-demm (li jista' jikkawża dgħjufija fil-muskoli), għadd baxx ta' ċelluli tad-demm ħomor, tnaqqis fin-numru ta' tip ta' ċelloli bojod tad-demm li huwa assoċjat ma' żieda fir-riskju ta' infezzjoni, livell għoli ta' zokkor fid-demm, livell għoli ta' kolesterol, livell għoli ta' trigliċeridi, axxess, infezzjonijiet (inklużi infezzjoni fl-għajnejn, influwenza, infezzjonijiet virali, bronkite), funzjoni anormali tal-kliewi (li tinkludi insuffiċjenza tal-kliewi), testijiet tad-demm li juru tibdil fil-mod kif tkun qiegħda taħdem il-kilwa, tibdil fis-sens tat-togħma, diffikultà biex torqod, għadd baxx ta' plejtlits li jista' jikkaġuna fsada u tbenġil.
English: In population pharmacokinetic-based data analysis, increased body weight (between 38.6 and 158.9 kg) was associated with a two-fold range of trough concentration of sirolimus in whole blood.
Maltese: F'analiżi tad-dejta bbażata fuq il-farmakokinetika tal-popolazzjoni, żieda fil-piż tal-ġisem (bejn 38.6 u 158.9 kg) kienet assoċjata ma' medda ta' darbtejn iżjed fil-konċentrazzjoni minima ta' sirolimus fiddemm sħiħ.
English: Wyeth Lederle S.r.l.
Maltese: Vivian Corporation Ltd.
English: Concomitant treatment with moderate CYP3A4 inhibitors (e.g. aprepitant, erythromycin, fluconazole, verapamil, grapefruit juice) should only be administered with caution in patients receiving 25 mg and should be avoided in patients receiving temsirolimus doses higher than 25 mg (see section 4.5).
Maltese: (eż. aprepitant, erythromycin, fluconazole, verapamil, meraq tal-grejpfrut) għandha tingħata biss bl-attenzjoni f'pazjenti li jkunu qed jirċievu 25 mg u għandha tiġi evitata f'pazjenti li jkunu qed jirċievu dożi ogħla minn 25 mg ta' temsirolimus (ara sezzjoni 4.5).
English: Following a single 25 mg intravenous dose of temsirolimus, temsirolimus mean ± SD systemic clearance from whole blood was 11.4 ± 2.4 l/h.
Maltese: Wara doża waħda ta' 25 mg ġol-vini ta' temsirolimus, il-medja  SD sistemika tat-tneħħija ta' temsirolimus mid-demm sħiħ kienet ta' 11.4  2.4 l/siegħa.
English: a Hazard ratio IFN-α n = 207 P-value (95% CI)
Maltese: IFN- n = 207
English: Model-predicted values for clearance from plasma, after applying a 175 mg dose for 3 weeks, and subsequently 75 mg for 3 weeks, indicate temsirolimus and sirolimus metabolite trough concentrations of approximately 1.2 ng/ml and 10.7 ng/ml, respectively.
Maltese: Valuri mbassra minn mudelli għat-tneħħija mill-plażma, wara li tingħata doża ta' 175 mg għal 3 ġimgħat, u sussegwentement 75 mg għal 3 ġimgħat, jindikaw konċentrazzjonijiet minimi ta' temsirolimus u sirolimus ta' madwar 1.2 ng/ml u 10.
English: Runny nose, gum redness and swelling, mouth pain (including sores inside the mouth), stomach bloating, sore throat, high blood pressure, pink eye including watery eye disorder, taste loss, redness and swelling of the follicles in the skin, allergic reactions, severe scaling of the skin, increased blood clotting (including thrombosis of the veins), low levels of calcium in the blood, low levels of phosphates in the blood, upper respiratory infections, inflammation of the lung, fluid in the chest cavity, infection in the blood, dehydration, agitation, depression, numbness and tingling of the skin, dizziness, sleepiness, bleeding (from the lips, mouth, stomach or intestines), inflammation of the lining of the stomach, trouble with swallowing, skin bleeding (bruising), small pin-point haemorrage, nail disorder, acne, yeast infection, fungal infection, urinary tract infections, cystitis, blood tests that show changes in the way the liver is working, high blood fats other than triglycerides, diabetes, muscle pain.
Maltese: Imnieħer inixxi, ħmura u nefħa fil-ħanek, uġigħ fil-ħalq (li jinkludi feriti fil-ħalq), stonku minfuħ, uġigħ fil-griżmejn, pressjoni għolja tad-demm, għajn roża li tinkludi disturb ta' għajnejn li jdemmgħu, telf fis-sens tat-togħma, ħmura u nefħa tal-follikuli fil-ġilda, reazzjonijiet allerġiċi, tqaxxir sever talġilda, żieda fit-tgħaqid tad-demm (li jinkludu trombożi tal-vini), livelli baxxi ta' kalċju fid-demm, livelli baxxi ta' fosfati fid-demm, infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju, infjammazzjoni tal-pulmun, fluwidu fil-kavità tas-sider, infezzjoni fid-demm, deidratazzjoni, aġitazzjoni, dipressjoni, tmewwit u tnemnim tal-ġilda, sturdament, ngħas, ħruġ ta' demm (mixxofftejn, mill-ħalq, mill-istonku jew l-imsaren), infjammazzjoni tal-kisja tal-istonku, problemi biex tibla', ħruġ ta' demm mill-ġilda (tbenġil), petekje, disturbi fid-dwiefer, akne, infezzjoni tal-ħmira, infezzjoni fungali, infezzjonijiet fl-apparat urinarju, ċistite, testijiet tad-demm li juru tibdil fil-mod kif ikun qed jaħdem il-fwied, livelli għoljin ta' xaħam fid-demm għajr trigliċeridi, dijabete, uġigħ filmuskoli.
English: Concentrate and solvent for solution for infusion (sterile concentrate).
Maltese: Konċentrat u solvent għal soluzzjoni għall-infużjoni (konċentrat sterili).
English: Following a single 25 mg intravenous dose in patients with cancer, sirolimus AUC was 2.7-fold that of temsirolimus AUC, due principally to the longer half-life of sirolimus.
Maltese: Wara doża waħda ta' 25 mg ġol-vini f'pazjenti bil-kanċer, l-AUC ta' sirolimus kienet ta' 2.7 darbiet ta' l-AUC ta' temsirolimus, minħabba prinċipalment il-half-life itwal ta' sirolimus.
English: Dizziness
Maltese: Uġigħ
English: Dose-limiting toxicities (Grade 3/4 erythematous maculopapular rash, gout/cellulitis requiring hospitalisation) were observed in 2 out of 3 patients treated in the first cohort of a Phase 1 study at doses of temsirolimus 15 mg intravenous per week and sunitinib 25 mg oral per day (Days 1-28 followed by a 2-week rest) (see section 4.5).
Maltese: Tossiċitajiet li jillimitaw id-doża (raxx makulopapulari eritematuż ta' Grad 3/4, gotta/ċellulite bil-ħtieġa li l-pazjent jiddaħħal l-isptar) kienu osservati fi tnejn minn tliet pazjenti li kienu kkurati fl-ewwel koorti ta' studju ta' Fażi 1, f'dożi ta' temsirolimus ta' 15 mg ġol-vini kull ġimgħa u sunitinib 25 mg orali kuljum (Jiem 1-28 segwiti minn intervall ta' ġimagħtejn) (ara sezzjoni 4.5).
English: Temsirolimus and sirolimus pharmacokinetics have been investigated in an open-label, dose-escalation study in 110 patients with advanced malignancies and either normal or impaired hepatic function.
Maltese: Il-farmakokinetiċi ta' temsirolimus u ta' sirolimus kienu investigati fi studju open label li fih id-doża tiżdied, li sar fuq 110 persuni li kellhom tumuri malinni fi stat avvanzat u jew funzjoni normali indebolita tal-fwied.
English: In the MCL clinical trial, there was no difference in efficacy in patients with respect to age, sex, race, geographic region, or baseline disease characteristics.
Maltese: Fil-prova klinika MCL, ma kien hemm l-ebda differenza fl-effikaċja f'pazjenti fir-rigward tal-età, sess, razza, reġjun ġeografiku, jew karatteristiċi tal-marda fil-linja bażi.
English: The potential risk for humans is unknown.
Maltese: Mhux magħruf ir-riskju potenzjali fuq in-nies.
English: Torisel 30 mg concentrate and solvent for solution for infusion temsirolimus
Maltese: Torisel 30 mg konċentrat u solvent għal soluzzjoni għall-infużjoni temsirolimus
English: For MCL, multiple vials will be required for each dose over 25 mg.
Maltese: Għal MCL, sejrin ikunu meħtieġa kunjetti multipli għal kull doża ta' iktar minn 25 mg.
English: The safety and efficacy of temsirolimus in the treatment of advanced RCC were studied in the following two randomised clinical trials:
Maltese: Is-sigurtà u l-effikaċja ta' temsirolimus fil-kura ta' RCC avvanzata kienu studjati fiż-żewġ provi kliniċi randomised li ġejjin:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: When mTOR activity is inhibited, its ability to phosphorylate, and thereby control the activity of protein translation factors (4E-BP1 and S6K, both downstream of mTOR in the P13 kinase/AKT pathway) that control cell division, is blocked.
Maltese: Meta l-attività ta' mTOR tkun inibita, il-ħila tiegħu li jagħmel phosphorylate, u b'hekk jikkontrolla l-attività tal-fatturi tal-bdil tal-proteina (4E-BP1 u S6K, it-tnejn li huma downstream ta' mTOR fil-passaġġ P13 kinase/AKT) li jikkontrollaw id-diviżjoni taċ-ċelluli, tkun imblukkata.
English: protease inhibitors used in the treatment of Human Immunodeficiency Virus (HIV) antibiotics (including rifampicin) or antifungal medicines (including itraconazole, ketoconazole and voriconazole) used to treat infections nefazodone or selective serotonin re-uptake inhibitors used to treat depression anti-epileptic medicines, including carbamazepine, phenytoin and phenobarbital rifabutin used to treat infection in people with HIV and other diseases herbal medicines or natural remedies containing St. John's wort (Hypericum perforatum) used to treat mild depression angiotensin converting enzyme (ACE) inhibitors (such as enalapril, ramipril, lisinopril) or a calcium channel blocker (such as amlodipine) used to treat high blood pressure or other cardiovascular problems amphiphilic medicines used to treat heart arrhythmias (such as amiodarone), or statins used to treat high cholesterol sunitinib used to treat cancer of the kidney medicines which are P-gp substrates (such as digoxin, vincristine, colchicine, dabigatran, lenalidomide, paclitaxel)
Maltese: John's wort (Hypericum perforatum) jintuża biex jikkura dipressjoni ħafifa - inibituri tal-enzima li tibdel angiotensin (ACE) (bħal enalapril, ramipril, lisinopril) jew imblokkatur tal-kanal tal-kalċju (bħal amlodipine) li jintużaw għall-kura ta' pressjoni tad-demm għolja jew problemi kardjovaskulari oħrajn - mediċini amfifiliċi li jintużaw għall-kura ta' arritmiji tal-qalb (bħal amiodarone), jew statins li jintużaw għall-kura ta' kolesterol għoli - sunitinib użat għall-kura tal-kanċer tal-kliewi - mediċini li huma substrati tal-P-gp (bħal digoxin, vincristine, colchicine, dabigatran, lenalidomide, paclitaxel)
English: In patients 65 or older, median overall survival was 8.6 months (95% CI 6.4, 11.5) with a hazard ratio of 1.15 (95% CI 0.78, 1.68) compared with those treated with IFN-α.
Maltese: 87) meta mqabbel ma' dawk ilpazjenti kkurati b'IFN-F'pazjenti li għandhom iktar minn 65 sena, il-medjan tas-sopravivenza totali kien ta' 8.6 xhur (95% CI 6.4,11.5) bi proporzjon tal-periklu ta' 1.15 (95% CI 0.78,1.68) meta mqabbel ma' dawk il-pazjenti kkurati b'IFN-a
English: RCC clinical trial 2 was a randomised, double-blind, multi-centre, outpatient trial to evaluate the efficacy, safety, and pharmacokinetics of three dose levels of temsirolimus when administered to previously treated patients with advanced RCC.
Maltese: Il-prova klinika RCC 2 kienet prova randomised, double-blind, multiċentriku, u outpatient biex jevalwa l-effikaċja, is-sigurtà, u l-farmakokinetiċi ta' tliet livelli ta' doża ta' temsirolimus meta jingħata lil pazjenti li kienu kkurati qabel, li kellhom RCC avvanzata.
English: Intracerebral bleeding
Maltese: Mard interstizjali tal-pulmun
English: For 7 patients with severe hepatic impairment (ODWG, group D) receiving the 10 mg dose of temsirolimus, the mean AUC of temsirolimus was ~1.7-fold higher compared to 7 patients with mild hepatic impairment (ODWG, group B).
Maltese: Għal 7 pazjenti b'indeboliment sever tal-fwied (ODWG, grupp D) li kienu qed jirċievu d-doża ta' 10 mg ta' temsirolimus, il-medja tal-AUC ta' temsirolimus kienet ~1.7-drabi ogħla meta mqabbla ma' 7 pazjenti li kellhom indeboliment ħafif tal-fwied (ODWG, grupp B).
English: In male rats, decreased fertility and partly reversible reductions in sperm counts were reported (see section 5.3).
Maltese: F'firien irġiel, tnaqqis fil-fertilità u tnaqqis parzjalment riversibbli fl-għadd tal-isperma, kienu rrappurtati (ara sezzjoni 5.3).