FrancophonIA/ELRC3.0 huggingface dataset:
English: BeneFIX is used for the treatment and prevention of bleeding in adults and children with haemophilia B (an inherited bleeding disorder).
Maltese: BeneFIX jintuża għall-kura u l-prevenzjoni ta' fsada f'adulti u fi tfal b'emofilja B (disturb ta' fsada ereditarju).
English: BeneFIX is given by a slow injection into a vein, usually at up to 4 ml per minute and should not be mixed with other infusion solutions or given using a kit other than the one supplied with the medicine.
Maltese: BeneFIX jingħata b'injezzjoni bil-mod fil-vina, normalment sa 4 ml fil-minuta u ma għandux jitħallat ma' soluzzjonijiet ta' infużjoni oħra jew jingħata b'apparat ieħor minflok dak mogħti mal-mediċina.
English: Why has BeneFIX been approved?
Maltese: Għaliex ġie approvat BeneFIX?
English: A risk management plan has been developed to ensure that BeneFIX is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li BeneFIX jintuża bl-aktar mod sigur possibbli.
English: Patients with haemophilia B may also develop neutralising antibodies (inhibitors) to factor IX.
Maltese: Pazjenti bl-emofilja B jistgħu jiżviluppaw ukoll antikorpi li jinnewtralizzaw (inibituri) għall-fattur IX.
English: How has BeneFIX been studied?
Maltese: Kif ġie studjat BeneFIX?
English: The active substance in BeneFIX, nonacog alfa, is a blood coagulation factor protein (a substance that helps the blood to clot).
Maltese: Is-sustanza attiva f'BeneFIX, in-nonakog alfa, hija proteina tal-fattur tal-koagulazzjoni tad-demm (sustanza li tgħin id-demm jagħqad).
English: The studies assessed the number of bleeding episodes that occurred and rated BeneFIX's effectiveness using a scale from ‘no response' to ‘excellent'.
Maltese: L-istudji vvalutaw in-numru ta' episodji ta' fsada li ġraw u kejlu l-effikaċja ta' BeneFIX permezz ta' skala li tvarja minn “l-ebda rispons” sa “eċċellenti”.
English: What is the risk associated with BeneFIX?
Maltese: X'inhu r-riskju assoċjat ma' BeneFIX?
English: The dose and the frequency of injection depend on whether BeneFIX is used to treat or prevent bleeding, or to reduce bleeding during surgery, and on the patient's condition.
Maltese: Iddoża u l-frekwenza tal-injezzjoni jiddependu minn jekk BeneFIX jintużax għall-kura jew għallprevenzjoni tal-fsada, jew biex inaqqas il-fsada matul intervent kirurġiku, u mill-kundizzjoni talpazjent.
English: For the full list of all side effects reported with BeneFIX, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji rrapportati b'BeneFIX, ara l-fuljett ta' tagħrif.
English: What is BeneFIX?
Maltese: Kif jaħdem BeneFIX?
English: The CHMP decided that BeneFIX's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' BeneFIX huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How is BeneFIX used?
Maltese: X'inhu BeneFIX?
English: Patients with haemophilia B lack a protein called factor IX, which is involved in blood clotting.
Maltese: Il-pazjenti b'emofilja B għandhom nuqqas ta' proteina msejħa fattur IX, li hija involuta fit-tagħqid tad-demm.
English: What measures are being taken to ensure the safe and effective use of BeneFIX?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' BeneFIX?
English: Hypersensitivity (allergic) reactions have been seen in patients treated with products containing factor IX and may sometimes be severe.
Maltese: Reazzjonijiet ta' ipersensittività (allerġiċi) dehru f'pazjenti kkurati bi prodotti li fihom il-fattur IX u xi drabi jistgħu jkunu severi.
English: BeneFIX must not be used in people who are hypersensitive (allergic) to recombinant coagulation factor IX, to any of the other ingredients, or to hamster proteins.
Maltese: BeneFIX ma għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għall-fattur IX ta' koagulazzjoni rikombinanti, għal xi waħda mis-sustanzi l-oħra, jew għall-proteini tal-ħemster.
English: 90 (3 x 30) tablets (multipack)
Maltese: 90 (3 pakketti ta' 30) pillola (Pakkett multiplu)
English: (Invented) name Strength Pharmaceutical Form
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: 16 December 2016 EMA/848709/2016 EMEA/H/C/II/0037
Maltese: EMA/848709/2016 EMEA/H/C/II/0037
English: What is Inovelon?
Maltese: X'inhu Inovelon?
English: Inovelon was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 20 October 2004 for Lennox-Gastaut syndrome.
Maltese: Inovelon kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fl-20 ta' Ottubru 2004 għas-sindrome ta' Lennox-Gastaut.
English: Inovelon contains the active substance rufinamide and has been authorised since January 2007.
Maltese: Inovelon fih is-sustanza attiva rufinamide u ilha awtorizzata minn Jannar 2007.
English: This reduces the likelihood of a seizure occurring.
Maltese: Dan inaqqas il-probabbiltà ta' puplesija.
English: Its signs and symptoms include multiple types of seizures (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.
Maltese: Is-sinjali u s-sintomi tagħha jinkludu diversi tipi ta' puplesija (aċċessjonijiet), attività elettrika abnormali fil-moħħ, diżabilità relatata mat-tagħlim u problemi flimġiba.
English: What was Inovelon expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Inovelon?
English: Inovelon is used for treating Lennox-Gastaut syndrome, a rare type of epilepsy that usually affects children but can continue into adulthood.
Maltese: Inovelon jintuża għall-kura tas-sindrome ta' Lennox-Gastaut, tip rari ta' epilessija li ġeneralment taffettwa lit-tfal iżda li jista' jkompli meta jikbru u jsiru adulti.
English: The active substance in Inovelon, rufinamide acts by attaching to special channels on the surface of brain cells (sodium channels), which control their electrical activity.
Maltese: Is-sustanza attiva f'Inovelon, rufinamide taġixxi billi teħel ma' kanali speċjali fuq il-wiċċ taċ-ċelloli talmoħħ (kanali tas-sodju), li jikkontrollaw l-attività elettrika tagħhom.
English: The study investigated the safety of Inovelon and also its impact on the child's behavioural and emotional development assessed by the patient's parent or guardian on a standardised scoring system.
Maltese: L-istudju investiga s-sigurtà ta' Inovelon kif ukoll l-impatt tiegħu fuq l-iżvilupp fl-imġiba u dak emozzjonali tat-tfal kif ivvalutat mill-ġenitur jew mill-kustodju tal-pazjent fuq sistema ta' klassifika standardizzata.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded the review of an application to extend the use of the epilepsy medicine Inovelon to children aged 1 to 4 years.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda r-reviżjoni ta' applikazzjoni biex jiġi estiż l-użu tal-mediċina tal-epilessija Inovelon għal tfal ta' bejn is-sena u l-erba' snin.
English: While the study showed that the safety of Inovelon in patients aged 1 to less than 4 years was consistent with the known safety profile in older children, the CHMP concluded that the study was too small to make conclusions on the medicine's effectiveness.
Maltese: Filwaqt li l-istudju wera li s-sigurtà ta' Inovelon fuq pazjenti ta' bejn is-sena u l-erba' snin kienet konsistenti mal-profil ta' sigurtà magħruf fi tfal akbar fl-età, is-CHMP ikkonkluda li l-istudju kien żgħir wisq biex isiru konklużjonijiet dwar l-effikaċja tal-mediċina.
English: There are no consequences of the outcome of this application on patients currently in or who may be joining clinical trials with Inovelon.
Maltese: Ma hemm l-ebda konsegwenza tal-eżitu ta' din l-applikazzjoni fuq pazjenti li bħalissa huma involuti jew ser ikunu involuti fi provi kliniċi b'Inovelon.
English: Lennox-Gastaut syndrome is one of the most severe forms of epilepsy in children.
Maltese: Is-sindrome ta' Lennox-Gastaut syndrome huwa wieħed mill-aktar forom severi ta' epilessija fit-tfal.
English: The CHMP therefore concluded that based on the currently available data, Inovelon could not be approved for patients with Lennox-Gastaut syndrome aged less than 4 years.
Maltese: Is-CHMP għalhekk ikkonkluda li abbażi tad-data attwalment disponibbli, Inovelon ma setax jiġi approvat għal pazjenti bis-sindrome ta' Lennox-Gastaut ta' inqas minn erba' snin.
English: The company presented data from a study in which 37 children aged between 1 and 4 years with Lennox-Gastaut syndrome received either Inovelon or another epilepsy medicine in addition to their existing treatment.
Maltese: Il-kumpanija ppreżentat data minn studju li fih 37 tifel u tifla bejn is-sena u l-erba' snin bis-sindrome ta' Lennox-Gastaut irċevew jew Inovelon jew mediċina oħra tal-epilessija flimkien mal-kura eżistenti tagħhom.
English: More information about Inovelon is available on EMA's website.
Maltese: Aktar tagħrif dwar Inovelon huwa disponibbli fuq is-sit elettroniku tal-EMA.
English: However, the Committee considered that the data could be important for healthcare professionals and recommended their inclusion in Inovelon's product information.
Maltese: Madanakollu, il-Kumitat qies li d-data tista' tkun importanti għall-professjonisti fil-qasam talkura tas-saħħa u rrakkomanda l-inklużjoni tagħha fl-informazzjoni dwar il-prodott ta' Inovelon.
English: There are no consequences on the use of Inovelon in patients with Lennox-Gastaut syndrome aged 4 years and over.
Maltese: Ma hemm l-ebda konsegwenza fuq l-użu ta' Inovelon fuq pazjenti bis-sindrome ta' Lennox-Gastaut ta' aktar minn 4 snin.
English: NE (NE, NE)
Maltese: (NE, NE)
English: Magnesium stearate
Maltese: Talc Magnesium stearate
English: • Premature puberty (precocious puberty)
Maltese: • Pubertà prematura (pubertà prekoċi)
English: Roche Polska Sp.z o.o.
Maltese: Polska Roche Polska Sp.z o.o.
English: Educational material
Maltese: Materjal edukattiv
English: • The active substance is vismodegib.
Maltese: • Is-sustanza attiva hija vismodegib.
English: • carbamazepine, phenytoin - used for epilepsy,
Maltese: • carbamazepine, phenytoin - użati għall-epilessija,
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included>
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D <barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: Roche farmacevtska družba d.o.o.
Maltese: Slovenija Roche farmacevtska družba d.o.o.
English: Each hard capsule contains 71.5 mg lactose monohydrate per capsule.
Maltese: Kull kapsula iebsa fiha 71.5 mg lactose monohydrate f'kull kapsula.
English: • Capsule contents: microcrystalline cellulose, lactose monohydrate, sodium lauril sulfate, povidone (K29/32), sodium starch glycolate (Type A), talc and magnesium stearate.
Maltese: Kontenut tal-kapsula: microcrystalline cellulose, lactose monohydrate, sodium lauril sulfate, povidone (K29/32), sodium starch glycolate (Tip A), talc u magnesium stearate.
English: Precocious puberty****
Maltese: Pubertà prekoċi****
English: mBCC (n = 33)
Maltese: (n = 33)
English: laBCC** (n = 63)
Maltese: (n = 63)
English: The single dose mean (CV %) absolute bioavailability of Erivedge is 31.8 (14.5) %.
Maltese: Ilbijodisponibilità assoluta medja (CV %) ta' doża waħda ta' Erivedge hija ta' 31.8 (14.5) %.
English: (see section 5.2)
Maltese: (ara sezzjoni 4.6).
English: • moderate: 1.5 x ULN < TB < 3 x ULN, AST any
Maltese: • moderat: 1.5 x ULN < TB < 3 x ULN, kull AST
English: Sodium lauril sulfate Povidone (K29/32) Sodium starch glycolate (Type A) Talc
Maltese: Povidone (K29/32) Sodium starch glycolate (Tip A)
English: Roche a/s
Maltese: Danmark Roche a/s
English: • surgical sterilisation.
Maltese: • sterilizzazzjoni permezz ta' kirurġija.
English: A WCBP must understand that:
Maltese: WCBP trid tifhem li:
English: • Coadministration of St John's wort (Hypericum perforatum) (see section 4.5).
Maltese: • Għoti fl-istess waqt ta' St John's wort (Hypericum perforatum) (ara sezzjoni 4.5).
English: **54 % of laBCC patients had no histopathologic evidence of BCC at 24 weeks.
Maltese: **54 % tal-pazjenti b'laBCC ma kellhomx evidenza istopatoloġika ta' BCC wara 24 ġimgħa.
English: • Capsule shell: iron oxide red (E172), iron oxide black (E172), titanium dioxide, gelatine,
Maltese: Qoxra tal-kapsula: iron oxide aħmar (E172), iron oxide iswed (E172), titanium dioxide, ġelatina,
English: Contraceptive steroids
Maltese: Sterojdi kontraċettivi
English: Erivedge contains lactose and sodium
Maltese: Erivedge fih lactose u sodium
English: PHARMACEUTICAL FORM AND CONTENTS 28 capsules
Maltese: 28 kapsula
English: The size of the capsule is ‘Size 1' (dimensions 19.0 x 6.6 mm).
Maltese: Id-daqs tal-kapsula huwa ‘Daqs 1' (dimensjonijiet 19.0
English: Excipients Erivedge capsules contain lactose monohydrate.
Maltese: Kapsuli Erivedge fihom lactose monohydrate.
English: The most common adverse drug reactions (ADR) occurring in ≥ 30 % of patients, were muscle spasms (74.6 %), alopecia (65.9%), dysgeusia (58.7%), weight decreased (50.0%), fatigue (47.1%), nausea (34.8 %) and diarrhea (33.3%).
Maltese: L-aktar reazzjonijiet avversi tal-mediċina (ADR - adverse drug reactions) komuni li jseħħu f'≥ 30% tal-pazjenti, kienu spażmi fil-muskoli (74.6%), alopeċja (65.9%), disġewżja (58.7%), tnaqqis fil-piż (50.0%), għeja (47.1%), tqalligħ (34.8%), u dijarea (33.3%).
English: It cannot be excluded that vismodegib may increase the exposure to substrates of OATP1B1, e.g. bosentan, ezetimibe, glibenclamide, repaglinide, valsartan and statins.
Maltese: Ma jistax jiġi eskluż li vismodegib jista' jżid lesponiment għal sottostrati ta' OATP1B1, eż. bosentan, ezetimibe, glibenclamide, repaglinide,
English: Rare ( ≥ 1/10,000 to < 1/1,000)
Maltese: Rari (≥ 1/10,000 sa < 1/1,000)
English: • The national part of the DHPC
Maltese: • Il-parti nazzjonali tad-DHPC
English: Erivedge is a highly permeable compound with low aqueous solubility (BCS Class 2).
Maltese: Erivedge huwa kompost permeabbli ħafna b'solubilità baxxa fl-ilma (BCS Klassi 2).
English: • Hormonal depot injection,
Maltese: • Injezzjoni depot ta' ormoni,
English: • mild:total bilirubin (TB) ≤ upper limit of normal (ULN), aspartate aminotransferase
Maltese: • ħafif: bilirubina totali (TB - total bilirubin) ≤ limitu ta' fuq tan-normal (ULN - upper limit of normal), aspartate aminotransferase (AST) > ULN jew ULN < TB ≤ 1.5 x ULN, kull AST
English: Roche S.p.A.
Maltese: Italia Roche S.p.A.
English: • ezetimibe and statins , such as atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin used for high cholesterol,
Maltese: • ezetimibe u statins, bħal atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin - użati għall-kolesterol għoli,
English: The safety of Erivedge has been evaluated in clinical trials with 138 patients treated for advanced basal cell carcinoma (aBCC), which includes both metastatic BCC (mBCC) and locally advanced BCC (laBCC).
Maltese: Is-sigurtà ta' Erivedge ġiet evalwata fi provi kliniċi b'138 pazjent ittrattati għall-karċinoma avanzata taċ-ċelluli bażi (aBCC - advanced basal cell carcinoma), li tinkludi kemm BCC metastatika (mBCCmetastatic BCC) kif ukoll BCC avanzata lokalment (laBCC - locally advanced BCC).
English: Investigator-Assessed mBCC (n = 33)
Maltese: Evalwat mill-Investigatur mBCC
English: IRF-Assessed
Maltese: Evalwat minn IRF
English: In vitro, CYP2C8 was the most sensitive CYP isoform for vismodegib inhibition.
Maltese: In vitro, CYP2C8 kien l-aktar isoforma ta' CYP sensittiva għall-inibizzjoni ta' vismodegib.
English: • symptomatic metastatic basal cell carcinoma
Maltese: • karċinoma metastatika sintomatika taċ-ċelluli bażi
English: • The need for adequate contraception and definition of adequate contraception
Maltese: • Il-ħtieġa ta' kontraċezzjoni adegwata u d-definizzjoni ta' kontraċezzjoni adegwata
English: • an intra-uterine device (“the coil” or IUD)
Maltese: • apparat ġewwa l-utru (“il-kojl” jew IUD - intra-uterine device)
English: Nervous system disorder
Maltese: Disturbi fis-sistema nervuża
English: • She must be able to comply with effective contraceptive measures,
Maltese: • Għandha tkun konformi ma' miżuri ta' kontraċezzjoni effettiva,
English: Figure 1 SHH4476g Metastatic BCC Cohort
Maltese: Figura 1 Koorti ta' BCC Metastatika f'SHH4476g
English: In vivo interaction data is not available.
Maltese: Mhix disponibbli data in vivo dwar interazzjoni.
English: • use 2 methods of contraception, one highly effective method and one barrier method (please see the examples below)
Maltese: • uża 2 metodi ta' kontraċezzjoni, metodu wieħed effettiv ħafna u metodu wieħed ta' barriera
English: The pivotal trial, ERIVANCE BCC (SHH4476g), was an international, single-arm, multi-centre, 2-cohort study.
Maltese: Il-prova pivitali ERIVANCE BCC (SHH4476g) kienet studju internazzjonali, bi grupp wieħed, b'aktar minn ċentru wieħed, b'żewġ koorti.
English: Common ( ≥ 1/100 to < 1/10)
Maltese: Komuni (≥ 1/100 sa < 1/10)
English: Figure 2 SHH4476g Locally Advanced BCC Cohort
Maltese: 2 Koorti ta' BCC Avanzata Lokalment f'SHH4476g
English: No dose adjustment is required in patients ≥ 65years of age (see section 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'età ta' ≥ 65 sena (ara sezzjoni 5.2).
English: • hair loss (alopecia),
Maltese: • telf ta' xagħar (alopeċja),
English: 95 % CI for overall response
Maltese: CI ta' 95 % għal rispons globali Rispons Komplut
English: ADRs are presented in table 1 below by system organ class (SOC) and absolute frequency.
Maltese: L-ADRs huma ppreżentati fit-tabella 1 hawn taħt skont il-klassi tas-sistemi u tal-organi (SOC - system organ class) u l-frekwenza assoluta.
English: Cutaneous squamous cell carcinoma (cuSCC)
Maltese: “karċinoma taċ-ċellula skwamuża tal-ġilda” (SCC - cutaneous squamous cell carcinoma).
English: Vismodegib and associated metabolic products are eliminated primarily by the hepatic route.
Maltese: Vismodegib u prodotti metaboliċi assoċjati jiġu eliminati primarjament permezz tar-rotta epatika.
English: • Women who are pregnant or breast-feeding (see sections 4.4 and 4.6).
Maltese: • Nisa li huma tqal jew li qed ireddgħu (ara sezzjonijiet 4.4 u 4.6).
English: In the mBCC cohort, tumour response was assessed according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0.
Maltese: Fil-koorti ta' mBCC, rispons tat-tumur kien evalwat skont il-Kriterji tal-Valutazzjoni tar-Rispons f'Tumuri Solidi (RECIST - Response Evaluation Criteria in Solid Tumours) verżjoni 1.0.
English: In vitro, vismodegib is an inhibitor of OATP1B1.
Maltese: In vitro, vismodegib huwa inibitur ta' OATP1B1.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Capsule contents
Maltese: 6.1 Lista ta' eċċipjenti
English: Clinically significant PK interactions between vismodegib and CYP450 substrates are not expected.
Maltese: Mhumiex mistennija interazzjonijiet PK klinikament sinifikanti bejn vismodegib u sottostrati ta' CYP450.
English: Erivedge has been administered at doses 3.6 times higher than the recommended 150 mg daily dose.
Maltese: Erivedge ngħata f'dożi 3.6 darbiet ogħla mid-doża rakkomandata ta' 150 mg kuljum.
English: Epiphyses premature fusion****
Maltese: Fużjoni prematura tal epifisi****
English: Median OS, (months) (95 % CI)
Maltese: Rispons (xhur) (CI ta' 95 %)
English: The median age of the efficacy evaluable population was 62 years (46 % were at least 65 years old), 61 % male and 100 % White.
Maltese: L-età medjana tal-popolazzjoni li setgħet tiġi evalwata għall-effikaċja kienet ta' 62 sena (46% kellhom mill-inqas 65 sena), 61% kienu rġiel u 100% kienu ta' razza bajda.
English: • severe: 3 x ULN < TB < 10 x ULN, AST any
Maltese: • sever: 3 x ULN < TB < 10 x ULN, kull AST (ara sezzjoni 5.2)
English: Carcinogenic potential was identified in rats only and was limited to benign hair follicle tumors, including pilomatricomas and keratoacanthomas respectively at ≥ 0.1-fold and ≥0.6-fold of the steady-state AUC(0-24h) of the recommended human dose.
Maltese: Ġie identifikat potenzjal karċinoġeniku fil-firien biss u kien limitat għal tumuri beninni tal-follikolu tax-xagħar, inklużi pilomatrikomi u keratoakantomi rispettivament f'≥ 0.1 darbiet u ≥ 0.6 darbiet l-AUC(0-24 siegħa) fi stat fiss tad-doża rakkomandata fil-bniedem.
English: Erivedge 150 mg hard capsules vismodegib
Maltese: Erivedge 150 mg kapsuli ibsin vismodegib
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/848/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/848/001
English: Pregnancy tests should have a minimum sensitivity of 25 mIU/mL as per local availability.
Maltese: Testijiet tat-tqala għandu jkollhom sensittività minima ta' 25 mIU/mL skont id-disponibbiltà lokali.
English: For the mBCC cohort, 97 % of patients had prior therapy including surgery (97 %), radiotherapy (58 %), and systemic therapies (30 %).
Maltese: Għall-koorti ta' mBCC, 97% talpazjenti ħadu terapija preċedenti inkluż kirurġija (97%), radjuterapija (58%), u terapiji sistemiċi (30%).
English: Of patients who had a confirmed response (partial or complete), the median Duration of Response was 23.0 months (95% CI: 20.4, 26.7) in the laBCC cohort and 13.9 months (95% CI: 9.2, NE) in the mBCC cohort.
Maltese: Mill-pazjenti li kellhom rispons ikkonfermat (parzjali jew komplut), it-Tul medjan tar-Rispons kien ta' 23.0 xahar (CI ta' 95%: 20.4, 26.7) fil-koorti ta' laBCC u 13.9 xhur (CI ta' 95%: 9.2, NE) fil-koorti ta' mBCC.
English: Roche Norge AS Tlf: +47 - 22 78 90 00
Maltese: Tlf: +47 - 22 78 90 00
English: • Tubal sterilisation,
Maltese: • Sterilizzazzjoni tat-tubi,
English: Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Acute Generalised Exanthematous Pustulosis (AGEP)******
Maltese: sindrome ta' Stevens-Johnson/Nekroliżi epidermali tossika (SJS - Stevens-Johnson syndrome/TEN - Toxic epidermal necrolysis), 2 każijiet ta' Reazzjoni għall-mediċina b'eosinofilja u sintomi sistemiċi (DRESS - Drug reaction with eosinophilia and systemic symptoms) u każ wieħed ta'
English: Since the number of subjects who were not Caucasian comprised only < 3% of the total population (6 Black, 219 Caucasian), race was not evaluated as a covariate in the population pharmacokinetic analysis.
Maltese: Peress li l-għadd ta' individwi li ma kinux Kawkasi kien biss < 3% tal-popolazzjoni totali (6 Suwed, 219 Kawkasi), ir-razza ma kinitx evalwata bħala kovarjabbli fl-analiżi farmakokinetika tal-popolazzjoni.
English: Musculoskeletal pain Blood creatine phosphokinase increased***
Maltese: Żieda ta' creatine phosphokinase fiddemm***
English: • Printing ink: shellac glaze and iron oxide black (E172).
Maltese: Linka għall-istampar: shellac glaze u iron oxide iswed (E172).
English: Partial response was achieved in 32.1% patients in the mBCC cohort and 35.1% in the laBCC cohort.
Maltese: Rispons parzjali nkiseb fi 32.1% talpazjenti fil-koorti ta' mBCC u f'35.1% fil-koorti ta' laBCC.
English: Uncommon ( ≥ 1/1,000 to < 1/100)
Maltese: Mhux komuni (≥ 1/1,000 sa < 1/100)
English: Hypogeusia
Maltese: Ipoġewżja
English: Table 2 SHH4476g Erivedge Efficacy Results (IRF 21 months and Investigator assessed
Maltese: Tabella 2 Riżulati tal-Effikaċja ta' Erivedge SHH4476g (segwitu ta' 21 xahar evalwat minn IRF u ta' 39 xahar evalwat mill-Investigatur wara li ddaħħal l-aħħar pazjent): pazjenti li l-effikaċja tagħhom setgħet tiġi evalwata*
English: A post-approval, open-label, non-comparative, multicenter, phase II clinical trial (MO25616) was conducted in 1232 patients with advanced BCC, of whom 1215 patients were evaluable for efficacy and safety with laBCC (n = 1119) or mBCC (n = 96).
Maltese: II wara l-approvazzjoni, open-label, mhux komparattiva, b'aktar minn ċentru wieħed (MO25616) fuq 1232 pazjent b'BCC avanzata, li minnhom 1215-il pazjent b'laBCC (n = 1119) jew mBCC (n = 96) setgħu jiġu evalwati għall-effikaċja u s-sigurtà.
English: CYP2C9 appears to contribute in part to vismodegib metabolism in vivo.
Maltese: CYP2C9 jidher li jikkontribwixxi parzjalment għall metaboliżmu ta' vismodegib in vivo.
English: Vismodegib binds to both human serum albumin and alpha-1-acid glycoprotein (AAG).
Maltese: alpha-1-acid glycoprotein) fis-serum uman.