FrancophonIA/ELRC3.0 huggingface dataset:
English: It has no antibacterial effects.
Maltese: M'għandux effetti kontra l-batterja.
English: OS was similar.
Maltese: L-OS kienet simili.
English: Increased aspartate aminotransferase 27 (8.4)
Maltese: Żieda fl-aspartate aminotransferase 27 (8.4)
English: Parameter temsirolimus 175/75 mg n = 54
Maltese: Parametru temsirolimus 175/75 mg n = 54
English: Gender, weight, race, age
Maltese: Sess, piż, razza, età
English: Grade n (%)
Maltese: Grad n (%)
English: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium
Maltese: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Il-Belġju
English: CI = confidence interval; NA = not applicable.
Maltese: CI = intervall tal-kunfidenza; NA = mhux applikabbli.
English: PFIZER ΕΛΛΑΣ Α.Ε.
Maltese: PFIZER ΕΛΛΑΣ A.E.
English: Table 1: Adverse reactions from clinical trials in RCC (study 3066K1-304) and in MCL (study 3066K1-305)
Maltese: Tabella 1: Reazzjonijiet avversi minn provi kliniċi dwar RCC (studju 3066K1-304) u dwar MCL (studju 3066K1-305)
English: Twenty-four (24, 67%) were Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 1, and 12 (33%) were ECOG PS = 0.
Maltese: Erbgħa u għoxrin (24, 67%) kienu Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 1, u 12 (33%) kienu ECOG PS = 0.
English: Leukopenia ** Lymphopenia
Maltese: Lewkopenija ** Limfopenija
English: Investigator's choice (inv choice) n = 54
Maltese: Għażla talinvestigatur (għażla tal-inv) n = 54
English: Do not use Torisel:
Maltese: Tużax Torisel:
English: Interaction with medicinal products metabolised by CYP2D6 or CYP3A4/5
Maltese: Interazzjoni ma' prodotti mediċinali metabolizzati minn CYP2D6 jew CYP3A4/5
English: The active substance is temsirolimus.
Maltese: - Is-sustanza attiva hi temsirolimus.
English: Lung infection caused by Pneumocystis jiroveci (Pneumocystis jiroveci pneumonia).
Maltese: Infezzjoni tal-pulmun ikkawżata minn Pneumocystis jiroveci (Pneumocystis jiroveci pneumonia).
English: Sepsis* (including septic shock) Candidiasis (including oral and anal candidiasis) and fungal infection/fungal skin infections Urinary tract infection (including cystitis)
Maltese: Sepsis* (inkluż xokk settiku) Kandidjasi (inklużi kandidjasi orali u anali) u infezzjoni fungali/infezzjonijiet fungali fil-ġilda Infezzjoni fl-apparat urinarju (inkluża ċistite)
English: RCC clinical trial 1
Maltese: Prova klinika RCC 1
English: RCC clinical trial 2
Maltese: Prova klinika RCC 2
English: Via Franco Gorgone Zona Industriale 95100 Catania Italy
Maltese: Wyeth Lederle S.r.l. Via Franco Gorgone Zona Industriale 95100 Catania L-Italja
English: Pharmacokinetic data on temsirolimus and sirolimus are available in patients up to age 79 years.
Maltese: Informazzjoni farmakokinetika fuq temsirolmus u sirolimus hi disponibbli f'pazjenti sa l-età ta' 79 sena.
English: Opportunistic infections such as PCP should be considered in the differential diagnosis.
Maltese: Infezzjonijiet opportunistiċi bħal PCP għandhom jiġu kkunsidrati fid-dijanjosi differenzjali.
English: Torisel contains ethanol (alcohol)
Maltese: Torisel fih l-etanol (alkoħol)
English: Dose of temsirolimus
Maltese: Doża ta' temsirolimus
English: Hyperglycaemia/glucose intolerance/diabetes mellitus
Maltese: Ipergliċemija/intolleranza għal glucose/dijabete mellitus
English: MCL clinical trial
Maltese: Prova klinika MCL
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: In in vitro studies in human liver microsomes, temsirolimus inhibited CYP3A4/5, CYP2D6, CYP2C9 and CYP2C8 catalytic activity with Ki values of 3.1, 1.5, 14 and 27 μM, respectively.
Maltese: Fi studji in vitro fuq mikrosomi tal-fwied uman, temsirolimus inibixxa attività katalitika ta' CYP3A4/5, CYP2D6, CYP2C9 u CYP2C8 b'valuri Ki ta' 3.1, 1.5, 14 u 27 μM, rispettivament.
English: Summary of efficacy results in temsirolimus RCC clinical trial 1 Parameter temsirolimus n = 209
Maltese: Sommarju tar-riżultati ta' l-effikaċja fil-prova klinika RCC 1 ta' temsirolimus Parametru temsirolimus n = 209
English: Hypersensitivity/infusion reactions
Maltese: Sensittività eċċessiva/infużjoni
English: P-value
Maltese: valur p
English: Dermatitis Exfoliative rash Acne
Maltese: Dermatite Raxx esfoljattiv Akne
English: Date of the latest renewal: 13 July 2017
Maltese: Data tal-aħħar tiġdid: 13 ta' Lulju 2017
English: • Withdraw 1.8 ml of the supplied solvent.
Maltese: • Iġbed 1.8 ml tas-solvent fornut.
English: Interactions with medicinal products that are P-glycoprotein substrates
Maltese: Interazzjonijiet ma' prodotti mediċinali li jkunu substrati ta' glikoproteina P
English: Temsirolimus and sirolimus were demonstrated to be substrates for P-gp in vitro.
Maltese: Intwera li temsirolimus u sirolimus kienu sottostrati għal P-gp in vitro.
English: Very common Neutropenia Thrombocytopenia** Anaemia
Maltese: Komuni ħafna Newtropenija Tromboċitopenija** Anemija
English: Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin).
Maltese: Temsirolimus hu inibitur selettiv ta' mTOR (mira mammifera ta' rapamycin).
English: (CYPRUS BRANCH) Tηλ: +357 22 817690
Maltese: Tηλ: +357 22 817690
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2007
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Novembru 2007
English: Mean half-lives of temsirolimus and sirolimus were 17.7 hours and 73.3 hours, respectively.
Maltese: Il-medja tal-half-lives ta' temsirolimus u ta' sirolimus kienu 17.7 sigħat u 73.3 sigħat, rispettivament.
English: In an in vitro study, temsirolimus inhibited the transport of P-glycoprotein (P-gp) substrates with an IC50 value of 2 µM.
Maltese: Fi studju in vitro temsirolimus inibixxa t-trasport tas-substrati ta' glikoproteina P (P-gp) b'valur IC50 ta' 2 µM.
English: One vial of 2.2 ml solvent.
Maltese: Kunjett wieħed ta' 2.2 ml ta' solvent.
English: Teratogenic effects (omphalocele) were seen in rabbits (see section 5.3).
Maltese: Effetti teratoġeniċi (omphalocele) kienu osservati filfniek (ara sezzjoni 5.3).
English: For patients treated weekly with 25 mg temsirolimus OS was 13.8 months (95% CI: 9.0, 18.7 months); ORR was 5.6% (95% CI: 0.7, 18.7%).
Maltese: Għal pazjenti kkurati kull ġimgħa b'25 mg ta' temsirolimus, l-OS kien ta' 13.8 xhur (95% CI: 9.0, 18.7 xhur); l-ORR kienet 5.6% (95% CI: 0.7, 18.7%).
English: This medicine contains ethanol (alcohol), equivalent to 17.6 ml beer, 7.3 ml wine per 25 mg dose.
Maltese: Din il-mediċina fiha etanol (alkoħol), ekwivalenti għal 17.6 ml ta' birra, 7.3 ml ta' nbid f'kull doża ta' 25 mg.
English: Anhydrous ethanol all-rac-α-Tocopherol (E 307) Propylene glycol Citric acid (E 330)
Maltese: Anhydrous ethanol all-rac-ά-Tocopherol (E 307) Propylene glycol Citric acid (E 330)
English: Adverse events were generally similar to those observed in adults (see section 4.8).
Maltese: L-avvenimenti avversi kienu ġeneralment simili għal dawk osservati f'persuni adulti (ara sezzjoni 4.8).
English: Temsirolimus is not recommended for use in paediatric patients (see sections 4.2, 4.8 and 5.1).
Maltese: Temsirolimus mhuwiex rakkomandat għall-użu f'pazjenti pedjatriċi (ara sezzjonijiet 4.2, 4.8 u 5.1).
English: Torisel contains the active substance temsirolimus.
Maltese: Torisel fih is-sustanza attiva temsirolimus.
English: Aphthous stomatitis
Maltese: Stomatite aftuża
English: Sinusitis
Maltese: Sinusite
English: It is important that the recommendations in sections 4.2 and 6.6 be followed closely.
Maltese: Huwa importanti li r-rakkomandazzjonijiet f'sezzjonijiet 4.2 u 6.6 ikunu segwiti mill-qrib.
English: Grades 3 and 4 thrombocytopenia and/or neutropenia have been observed in the MCL clinical trial (see section 4.8).
Maltese: Tromboċitopenija u/jew newtropenija ta' Gradi 3 u 4 kienu osservati fil-prova klinika MCL (ara sezzjoni 4.8).
English: Starting dose 175 mg
Maltese: Doża tal-bidu 175 mg
English: For subjects with neuroblastoma, the objective response rate was 5.3% (95% CI: 0.1%, 26.0%).
Maltese: Għal persuni b'newroblastoma, ir-rata ta' rispons oġġettiv kienet ta' 5.3% (95% CI: 0.1%, 26.
English: Other medicines and Torisel
Maltese: Mediċini oħra u Torisel
English: The administration materials must consist of nonDEHP, non-PVC tubing with appropriate filter.
Maltese: Il-materjal ta' l-għoti għandu jikkonsisti minn non-DEHP, non-PVC tubing b'filtru adattat.
English: During in vitro temsirolimus metabolism studies, sirolimus, seco-temsirolimus and seco-sirolimus were observed; additional metabolic pathways were hydroxylation, reduction and demethylation.
Maltese: Waqt studji dwar il-metaboliżmu in vitro ta' temsirolimus, sirolimus, seco-temsirolimus u seco-sirolimus kienu osservati; passaġġi metaboliċi addizzjonali kienu hydroxylation, tnaqqis u demethylation.
English: Investigator's choice therapies included: gemcitabine (intravenous: 22 [41.5%]), fludarabine (intravenous: 12 [22.6%] or oral: 2 [3.8%]), chlorambucil (oral: 3 [5.7%]), cladribine (intravenous: 3 [5.7%]), etoposide (intravenous: 3 [5.7%]), cyclophosphamide (oral: 2 [3.8%]), thalidomide (oral: 2 [3.8%]), vinblastine (intravenous: 2 [3.8%]), alemtuzumab (intravenous: 1 [1.9%]), and lenalidomide (oral: 1 [1.9%]).
Maltese: It-terapiji tal-għażla talinvestigatur kienu jinkludu: gemcitabine (ġol-vini: 22 [41.5%]), fludarabine (ġol-vini: 12 [22.6%] jew orali: 2 [3.8%]), chlorambucil (orali: 3 [5.7%]), cladribine (ġol-vini:
English: Thrombocytopenia, neutropenia, and anaemia
Maltese: Tromboċitopenija, newtropenija u anemija
English: Table 2: Adverse reactions reported in post-marketing setting System Organ class
Maltese: Tabella 2: Reazzjonijiet avversi rrapportati fl-esperjenza ta' wara t-tqegħid fis-suq
English: Different end-filters can be used ranging in filter pore size from 0.2 microns up to 5 microns.
Maltese: End-filters differenti jistgħu jintużaw, li jvarjaw fid-daqs tal-pori tal-filtru minn 0.2 microns sa 5 microns.
English: Mantle cell lymphoma
Maltese: Limfoma taċ-ċelluli mantle
English: Objective response rateb % (95% CI)
Maltese: Rata ta' Rispons Oġġettiv % (95% CI)
English: Examples of live vaccines are: measles, mumps, rubella, oral polio, Bacillus CalmetteGuérin (BCG), yellow fever, varicella, and TY21a typhoid vaccines.
Maltese: Eżempji ta' tilqim ħaj huma: ħosba, gattone, ħosba Ġermaniża, polio orali, Bacillus Calmette-Guérin (BCG), yellow fever, ġidri r-riħ, u tilqim tat-tifojde TY21a.
English: The use of both an in-line and end-filter is not recommended (see sections 6.1 and 6.2).
Maltese: L-użu kemm ta' in-line kief ukoll ta' end-filter mhuwiex rakkomandat (ara sezzjonijiet 6.1 u 6.2).
English: The combination of temsirolimus 15 mg and IFN-α did not result in a significant increase in overall survival when compared to IFN-α alone at either the interim analysis (median 8.4 vs. 7.3 months, hazard ratio = 0.96, p = 0.6965) or final analysis (median 8.4 vs. 7.3 months, hazard ratio = 0.93, p = 0.4902).
Maltese: Il-kumbinazzjoni temsirolimus 15 mg u IFN-ma rriżultatx f'żieda sinifikanti fis-sopravivenza totali meta mqabbla ma' IFN-waħdu jew fl-analiżi interim (medjan ta' 8.4 kontra 7.3 xhur, proporzjon talperiklu = 0.96, p = 0.6965), jew l-analiżi finali (medjan ta' 8.4 kontra 7.3 xhur, proporzjon tal-periklu = 0.93 p = 0.4902).
English: Hyperlipaemia
Maltese: Iperlipidemija
English: Cases of anaemia have been reported in RCC and MCL (see section 4.8).
Maltese: Każijiet ta' anemija ġew irrappurtati f'RCC u MCL (ara sezzjoni 4.8).
English: The AUCsum of temsirolimus and sirolimus on day 8 in patients with mild and moderate hepatic impairment receiving 25 mg temsirolimus was similar to that observed in patients without hepatic impairment receiving 75 mg (mean AUCsum mild: approximately 9770 ng*h/ml, n=13; moderate: approximately 12380 ng*h/ml, n=6; normal approximately 10580 ng*h/ml, n=4).
Maltese: L-AUCsum ta' temsirolimus u sirolimus f'jum 8 f'pazjenti b'indeboliment tal-fwied ħafif u moderat li rċevew 25 mg temsirolimus kienet simili għal dik osservata f'pazjenti mingħajr indeboliment talfwied li rċevew 75 mg (medja ta' AUCsum ħafifa: madwar 9770 ng*h/ml, n=13; moderata: madwar 12380 ng*h/ml, n=6; normali madwar 10580 ng*h/ml, n=4).
English: In vitro, at high concentrations (10-20 M), temsirolimus can bind and inhibit mTOR in the absence of FKBP-12.
Maltese: In vitro, f'konċentrazzjonijiet għolja (10-20 M), temsirolimus jista' jwaħħal u jinibixxi mTOR fl-assenza ta' FKBP-12.
English: It is important that the recommendations in sections 4.2 and 6.6 in the SmPC be followed closely.
Maltese: Huwa importanti li r-rakkomandazzjonijiet f'sezzjonijiet 4.2 u 6.6 fil-SmPC ikunu segwiti mill-qrib.
English: Months (97.5% CI)
Maltese: Proporzjon talperiklu (97.5% CI)
English: Temsirolimus 175/75 (temsirolimus 175 mg weekly for 3 weeks followed by 75 mg weekly) led to an improvement in PFS compared with investigator's choice in patients with relapsed and/or refractory MCL that was statistically significant (hazard ratio = 0.44; p-value = 0.0009).
Maltese: Temsirolimus 175/75 (temsirolimus 175 mg fil-ġimgħa għal 3 ġimgħat segwit minn 75 mg fil-ġimgħa) wasslu għal titjib fil-PFS li kien statistikament sinifikanti meta mqabbel mal-għażla tal-investigatur f'pazjenti li rkadew u/jew li huma b'MCL refrattarja (proporzjon tal-periklu = 0.44; valur-p = 0.0009).
English: • Torisel is infused over a 30- to 60-minute period once a week.
Maltese: • Torisel jingħata bħala infużjoni fuq perijodu ta' minn 30 sa 60-minuta darba fil-ġimgħa.
English: In RCC clinical trial 1, 31% of patients treated with temsirolimus were 65 or older.
Maltese: Fil-prova klinika RCC 1, 31% tal-pazjenti kkurati b'temsirolimus kellhom 65 sena jew aktar.
English: Patients should be given intravenous diphenhydramine 25 mg to 50 mg (or similar antihistamine) approximately 30 minutes before the start of each dose of temsirolimus (see section 4.4).
Maltese: Il-pazjenti għandhom jingħataw diphenhydramine 25 mg sa 50 mg ġol-vini (jew antistamina simili) madwar 30 minuta qabel il-bidu ta' kull doża ta' temsirolimus (ara sezzjoni 4.4)
English: Very common Bacterial and viral infections (including infection, viral infection, cellulitis, herpes zoster, oral herpes, influenza, herpes simplex, herpes zoster ophthalmic, herpes virus infection, bacterial infection, bronchitis*, abscess, wound infection, post-operative wound infections) Pneumoniaa (including interstitial pneumonia)
Maltese: Komuni ħafna Infezzjonijiet batteriċi u virali (li jinkludu infezzjoni, infezzjoni virali, ċellulite, herpes zoster, herpes orali, influwenza, herpes simplex, herpes zoster fl-għajnejn, infezzjoni bil-virus tal-herpes, infezzjoni batterika, bronkite*, axxess, infezzjoni fil-feriti, infezzjonijiet fil-feriti wara loperazzjoni)
English: IC50 values for inhibition of CYP2B6 and CYP2E1 by temsirolimus were 48 and 100 μM, respectively.
Maltese: Valuri IC50 għal inibizzjoni ta' CYP2B6 u CYP2E1 minn temsirolimus kienu ta' 48 u 100 μM, rispettivament.
English: Summary of efficacy results in temsirolimus MCL clinical trial
Maltese: Sommarju tar-riżultati tal-effikaċja fil-prova klinika MCL dwar temsirolimus
English: • Inject the 1.8 ml of solvent into the vial of Torisel 30 mg concentrate.
Maltese: • Injetta l-1.8 ml tas-solvent ġol-kunjett tal-konċentrat Torisel 30 mg.
English: Agents inhibiting CYP3A metabolism
Maltese: Sustanzi li jikkaġunaw il-metaboliżmu CYP3A
English: An in-line polyethersulfone filter with a pore size of not greater than 5 microns is recommended for administration to avoid the possibility of particles bigger than 5 microns being infused.
Maltese: Filtru in-line tal-polyethersulfone b'daqs tal-pori ta' mhux aktar minn 5 mikrons hu rakkomandat għall-għoti biex tiġi evitata l-possibbiltà li partikuli ta' iktar minn 5 microns jiġu infużi.
English: It is important that the recommendations in section 4.2 be followed closely.
Maltese: Huwa importanti li r-rakkomandazzjonijiet f'sezzjoni 4.2 jkunu segwiti mill-qrib.
English: Pack size: 1 vial of concentrate and 1 vial of solvent
Maltese: Daqs tal-pakkett: 1 kunjett konċentrat u 1 kunjett ta' solvent.
English: Temsirolimus binds to an intracellular protein (FKBP-12), and the protein/temsirolimus complex binds and inhibits the activity of mTOR that controls cell division.
Maltese: Temsirolimus jeħel ma' proteina intraċellulari (FKBP-12), u l-kumpless proteina/temsirolimus jeħel u jinibixxi l-attività ta' mTOR li tikkontrolla d-diviżjoni taċ-ċelluli.
English: In the RCC clinical trial 1, hyperlipaemia was reported as an adverse event in 27% of patients.
Maltese: Fil-prova klinika RCC 1, l-iperlipemija kienet irrappurtata bħala avveniment avvers f'27% tal-pazjenti.
English: • Withdraw the required amount of concentrate-solvent mixture (containing temsirolimus 10 mg/ml) from the vial; i.e., 2.5 ml for a temsirolimus dose of 25 mg.
Maltese: • Iġbed l-ammont meħtieġ tat-taħlita ta' konċentrat-solvent (li jkun fiha 10 mg/ml ta' temsirolimus) mill-kunjett; i.e., 2.5 ml għal doża ta' temsirolimus ta' 25 mg.
English: In addition to regulating cell cycle proteins, mTOR can regulate translation of the hypoxia-inducible factors, HIF-1 and HIF-2 alpha.
Maltese: Minbarra li jirregola l-proteini taċ-ċiklu taċ-ċelluli, mTOR jista' jirregola l-bidla tal-fatturi hypoxiainducible, HIF-1 u HIF-2 alpha.
English: The solvent contains polysorbate 80 (E 433), macrogol 400 and anhydrous ethanol (see section “Torisel contains ethanol [alcohol]”).
Maltese: Is-solvent fih polysorbate 80 (E 433), macrogol 400, u anhydrous ethanol (ara s-sezzjoni “Torisel fih l-etanol [alkoħol]”).
English: Concomitant use of angiotensin-converting enzyme (ACE) inhibitors and/or calcium channel blockers
Maltese: L-użu fl-istess ħin ta' inibituri ta' enzima li tibdel angiotensin (angiotensin-converting enzyme - ACE) u/jew imblokkaturi tal-kanal tal-kalċju
English: The evaluations of PFS and ORR were based on blinded independent radiologic assessment of tumour response using the International Workshop Criteria.
Maltese: L-evalwazzjonijiet ta' PFS u ORR kienu bbażati fuq evalwazzjoni radjoloġika indipendenti blinded dwar ir-rispons tat-tumur bl-użu talInternational Workshop Criteria.
English: Stomatitis
Maltese: Stomatite
English: In 36 patients with MCL, including 4 poor metabolisers, the effect of CYP2D6 inhibition after administration of single doses of 175 mg and 75 mg temsirolimus was investigated.
Maltese: F'36 pazjent b'MCL, inkluż 4 metabolizzaturi batuti, ġie investigat l-effett tal-inibizzjoni ta' CYP2D6 wara l-għoti ta' dożi waħdanin ta' 175 mg u 75 mg temsirolimus.
English: Holda a Upon recovery to ANC 1.0 x 109/l (1000 cells/mm3) and platelets to 50 x 109/l
Maltese: 9/l (1000 ċelluli/mm 3) u plejtlits għal 50 x 10
English: b Disease assessment is based on radiographic review by independent radiologists and review of clinical data by independent oncologists.
Maltese: L-evalwazzjoni tal-marda hi bbażata fuq evalwazzjoni radjografika minn radjoloġisti indipendenti u evalwazzjoni tad-dejta klinika minn onkoloġisti indipendenti.
English: Frequencies are defined as follows: very common (1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Maltese: Il-frekwenzi huma definiti kif ġej: komuni ħafna (1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (1/10,000 sa <1/1,000), rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The incidence and severity of adverse events is dose-dependent.
Maltese: L-inċidenza u s-severità ta' avvenimenti avversi jiddependu mid-doża.
English: The combination of temsirolimus and sunitinib resulted in dose-limiting toxicity.
Maltese: Il-kombinazzjoni ta' temsirolimus u sunitinib irriżultat f'tossiċità li tillimita d-doża.
English: The adverse reactions reported by the highest percentage of patients were haematologic (anaemia, leukopenia, neutropenia, and thrombocytopenia), metabolic (hypercholesterolemia, hyperlipaemia, hyperglycaemia, increase of serum aspartate amino transferase (AST) and serum alanine aminotransferase (ALT) plasma levels), and digestive (mucositis, stomatitis, nausea, and vomiting).
Maltese: Ir-reazzjonijiet avversi rrappurtati skont l-ogħla perċentwali ta' pazjenti kienu ematoloġiċi (anemija, lewkopenija, newtropenija, u tromboċitopenija), metaboliċi (iperkolesterolemija, iperlipemija, ipergliċemija, żieda fil-livelli ta' serum aspartate amino transferase (AST) u serum alanine aminotransferase (ALT) fil-plażma), u diġestivi (mukożite, stomatite, nawsja, u rimettar).
English: Population PK analysis based on sparse sampling indicated no clinically significant interaction effect on AUC and Cmax of the CYP2D6 substrate desipramine.
Maltese: L-analiżi tal-popolazzjoni PK ibbażata fuq kampjun spars ma indikat ebda effett ta' interazzjoni klinikament sinifikanti fuq l-AUC u s-Cmax tas-substrat ta' CYP2D6 desipramine.
English: Torisel may increase the risk of problems with wound healing.
Maltese: Torisel jista' jżid ir-riskju ta' problemi bil-fejqan tal-feriti.
English: Continuing dosea 75 mg
Maltese: Doża li tkompli 75 mg
English: Renal impairment/renal failure
Maltese: Indeboliment renali/insuffiċjenza tal-kliewi
English: Contains: polysorbate 80 (E 433), macrogol 400, anhydrous ethanol.
Maltese: Il-prodott fih: polysorbate 80 (E 433), macrogol 400, anhydrous ethanol.
English: The effect of a 175 or 75 mg temsirolimus dose on CYP3A4/5 substrates has not been studied.
Maltese: L-effett ta' doża ta' 175 jew 75 mg ta' temsirolimus fuq substrati ta' CYP3A4/5 ma ġewx studjati.
English: In vivo, the effect of P-gp inhibition has not been investigated in a clinical drugdrug interaction study, however, recent preliminary data from a Phase 1 study of combined lenalidomide (dose of 25 mg) and temsirolimus (dose of 20 mg) seem to support the in vitro findings and suggest an increased risk of adverse events.
Maltese: In vivo, l-effett ta' inibizzjoni ta' P-gp ma kienx investigat fi studju kliniku ta' interazzjoni mediċina-mediċina, madankollu, dejta preliminari reċenti minn studju ta' Fażi 1 ta' lenalidomide (doża ta' 25 mg) u temsirolimus (doża ta' 20 mg) tidher li tappoġġa s-sejbiet in vitro u tissuġġerixxi riskju miżjud ta' avvenimenti avversi.
English: In the RCC clinical trial, a Phase 3 clinical trial for RCC, 26% of patients reported hyperglycaemia as an adverse event.
Maltese: Fil-prova klinika RCC, prova klinika ta' Fażi 3 għal RCC, 26% tal-pazjenti rrappurtaw l-iperġliċemija bħala avveniment avvers.
English: The solvent contains: polysorbate 80 (E 433), macrogol 400 and anhydrous ethanol.
Maltese: Is-solvent fih: polysorbate 80 (E 433), macrogol 400, anhydrous ethanol.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Torisel 30 mg sterile concentrate temsirolimus
Maltese: Torisel 30 mg konċentrat sterili temsirolimus
English: Hypersensitivity to temsirolimus, its metabolites (including sirolimus), polysorbate 80, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal temsirolimus, il-metaboliti tiegħu (li jinkludu sirolimus), polysorbate 80, jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: One hundred eleven (111) patients were randomly assigned in a 1:1:1 ratio to receive 25 mg, 75 mg, or 250 mg intravenous temsirolimus weekly.
Maltese: Mija u ħdax-il (111) pazjent kienu assenjati b'mod random fi proporzjon ta' 1:1:1 biex jirċievu 25 mg, 75 mg, jew 250 mg ta' temsirolimus ġol-vini darba fil-ġimgħa.
English: One vial of 1.2 ml concentrate.
Maltese: Kunjett wieħed ta' 1.2 ml ta' konċentrat.
English: Thrombophlebitis
Maltese: Tromboflebite