FrancophonIA/ELRC3.0 huggingface dataset:
English: Posterior reversible encephalopathy syndrome (PRES) also known as reversible posterior leukoencephalopathy syndrome (RPLS)
Maltese: Sindrome enċefalopatika posterjuri riversibbli (PRES) magħrufa wkoll bħala sindrome lewkoenċefalopatika posterjuri riversibbli (RPLS)
English: A statistically significant advantage was seen for vandetanib for the secondary endpoint of time to worsening of pain (derived as a composite endpoint using the worst pain score from BPI and patient reported opioid analgesic use) (vandetanib 49%, placebo 57%, HR 0.61, 97.5%CI 0.43-0.87, p< 0.006: 8 vs. 3 months).
Maltese: Vantaġġ ta' sinifikat statistiku deher għal vandetanib għal-fini sekondarja taż-żmien sabiex l-ugigħ imur għal-agħar (miksub bħala fini kompositu permezz tal-punteġġ tal-agħar uġigħ mill-BPI u l-użu ta' analġesiku opjojd irrappurtat mill-pazjent) (vandetanib 49%, placebo 57%, HR 0.61, 97.5%CI
English: Ocular events such as blurred vision are common in patients who received vandetanib for MTC.
Maltese: Episodji okulari bħal vista mċajpra huma komuni f'pazjenti li jirċievu vandetanib għal MTC..
English: Use in adults
Maltese: L-użu fl-adulti
English: Pharmacokinetics in paediatric population
Maltese: Il-farmakokinetika fil-popolazzjoni pedjatrika
English: Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
Maltese: Caprelsa hija indikata għall-kura ta' kanċer tat-tirojde medullari (MTC) sintomatiku u aggressiv, f'pazjenti fejn il-marda tkun metastatika jew tkun avvanzat lokalment u ma tistax tiġi operata.
English: A randomised, double-blind, placebo-controlled study (Study 58) was conducted to demonstrate safety and efficacy of vandetanib 300 mg versus placebo.
Maltese: Dejta klinika mill-kanċer tat-tirojde medullari (MTC) Studju randomized, double blind, kontrollat bi plaċebo (Studju 58) sar sabiex juri s-sigurtà u leffikaċja ta' vandetanib 300 mg kontra l-plaċebo.
English: There is no experience in paediatric patients with hereditary MTC below 9 years of age (see section 5.1).
Maltese: M'hemm ebda esperjenza f'pazjenti pedjatriċi taħt id-9 snin b'MTC ereditarja (ara sezzjoni 5.1).
English: Vandetanib also inhibited the growth of MTC xenograft tumours in vivo.
Maltese: Vandetanib ikkawża l-inibizzjoni wkoll ta' tumuri ta' ksenografts tal-MTC in vivo.
English: An ECG, and levels of serum potassium, calcium and magnesium and thyroid stimulating hormone (TSH) should be obtained at baseline, at 1, 3, 6 and 12 weeks after starting treatment and every 3 months for at least a year thereafter.
Maltese: Għandhom jinkisbu elettrokardjogramma, u l-livelli ta' potassium, calcium, magnesium u ormon li jistimula t-tirojde (TSH) fis-serum mal-linja bażi, ma' ġimgħa, 3, 6 ġimgħat u 12-il ġimgħa wara li tkun bdiet il-kura u perjodikament kull 3 xhur għal mill-anqas sena wara.
English: • Combinations not recommended: Methadone, haloperidol, amisulpride, chlorpromazine, sulpiride, zuclopenthixol, halofantrine, pentamidine and lumefantrine.
Maltese: Methadone, haloperidol, amisulpride, chlorpromazine, sulpiride,
English: Photosensitivity reaction, rash and other skin rections (including acne, dry skin, dermatitis, pruritus), nail disorders
Maltese: Reazzjoni ta' fotosensittività, raxx u reazzjonijiet oħra tal-ġilda (inkluż akne, ġilda xotta, dermatite, ħakk),
English: • CAPRELSA prolongs the QTc interval and can cause Torsades de pointes and sudden death
Maltese: • CAPRELSA jtawwal l-intervall QTc u jista' jikkawża Torsades de Pointes u mewt f'daqqa
English: Vandetanib is not a substrate of multidrug resistance protein 2 (MRP2), p-glycoprotein (P-gp) or breast cancer resistance protein (BCRP).
Maltese: Vandetanib mhuwiex sottostrat ta l-proteina 2 resistenti għal ħafna mediċini (MRP2),
English: How to take Caprelsa
Maltese: X'fih Caprelsa
English: • The need for an ECG, and serum levels of potassium, calcium and magnesium and thyroid stimulating hormone (TSH) and the times and situations when it should be performed;
Maltese: • Il-bżonn ta' ECG, u livelli ta' potassium, calcium u magnesium u ormon li jistimula t-tirojde fisserum (TSH) u żmienijiet u sitwazzjonijiet meta għandhom isiru;
English: Tablet core
Maltese: Fejqan indebolit
English: • Stones or calcium deposits in the urinary tract (nephrolithiasis).
Maltese: • Ġebel jew depożiti tal-kalċju fil-passaġġ tal-awrina (nefrolitijażi).
English: Caprelsa 300 mg tablets
Maltese: Caprelsa 300 mg pilloli vandetanib
English: • Tiredness.
Maltese: • Dijarea.
English: Pneumonia, sepsis, influenza, cystitis, sinusitis, laryngitis, folliculitis, furuncle, fungal infection, pyelonephritis
Maltese: follikulite, musmar, infezzjoni tal-fungu, pajilonefrite
English: They are seen in 8% of people taking Caprelsa for medullary thyroid cancer.
Maltese: Dawn jidhru fi 8% tan-nies li qed jieħdu Caprelsa għal kanċer tat tirojde medullari.
English: Proteinuria, nephrolithiasis
Maltese: deidratazzjoni, iponatremija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/749/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/749/002
English: Dosing at 100mg/m2/day of the indicated posology (function of BSA) in paediatrics delivers similar exposure to that achieved in adults at 300 mg daily.
Maltese: Dożaġġ b'100mg/m2/jum fil-pożoloġija indikata (il-funzjoni ta' BSA) fil-pedjatrija tforni espożizzjoni simili għal dak milħuq fl-adulti b'300 mg kuljum.
English: QTc prolongation and Torsades de pointes
Maltese: Titwil tal-QTc u Torsades de Pointes
English: A single dose pharmacokinetic study in volunteers indicated that exposure to vandetanib is enhanced (up to 1.5, 1.6 and 2-fold) in mild, moderate and severe renal impaired subjects respectively compared to subjects with normal renal function (see sections 4.2, 4.4 and 4.5).
Maltese: Studju farmakokinetiku b'doża waħda f'voluntiera indika li l-esponiment għal vandetanib għola ftit (sa' 1.5,1.6 u 2) f'individwi b'indeboliment renali ħafif ,moderat u sever rispettivament meta mqabbel ma' individwi b'funzjoni renali normali (ara sezzjoni 4.2, 4.4 u 4.5).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/749/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/749/001
English: • Upper respiratory tract infections.
Maltese: • Infezzjoni batterika tal-ġilda.
English: Adverse reactions associated with overdose may be prolonged due to the long half-life of vandetanib (see section 5.2).
Maltese: Ir-reazzjonijiet avversi assoċjati ma' doża eċċessiva jistgħu jiddewmu minħabba l-half-life twila ta' vandetanib (ara sezzjoni 5.2).
English: 100 every other day 100 daily 100 daily
Maltese: 100 kuljum 100 kuljum Skeda ta' 7 ijiem:
English: Renal impairment in adult patients with MTC
Maltese: Indeboliment tal-kliewi f'pazjenti adulti b'MTC
English: M918T mutation is the most frequent mutation observed in patients with sporadic MTC; however it cannot be ruled out that some patients tested RET negative for M918T mutation might be positive for mutation on other exons.
Maltese: Il-mutazzjoni M918T hija l-aktar mutazzjoni frekwenti li dehret f'pazjenti b'MTC sporadiku;
English: Caprelsa 100 mg tablets
Maltese: Caprelsa 100 mg pilloli vandetanib
English: Intent-to-treat (ITT) analysis includes patients who received open-label vandetanib before progression according to the central read.
Maltese: Analiżi Intent-to-treat (ITT) tinkludi pazjenti li rċievew vanetanib open-label qabel ma avvanzat skont il-qari ċentrali.
English: Actually 79 patients were identified by absence of an M918T mutation and no RET mutation identified at any of the other 6 exons tested but in 71 of such patients sequencing of the 6 exons was incomplete.
Maltese: 79 pazjent kienu identifikati bl-assenza ta' mutazzjoni M918T u l-ebda mutazzjoni RET ma kienet identifikata fis-6 eksons ittestjati iżda f'71 minn dawn il-pazjenti is-sekwenzar tas-6 eksons ma kienx komplet.
English: • Abnormal sensation of the skin.
Maltese: • Sensazzjoni anormali tal-ġilda.
English: 6.3 Shelf life
Maltese: 19.3 xhur
English: At 12 months, the proportion of patients alive and progression-free was 192 (83%) for patients randomised to vandetanib and 63 (63%) for patients randomised to placebo.
Maltese: Mat-12-il xahar, il-proporzjon tal-pazjenti ħajjin u mingħajr avvanz tal-marda kien 192 (83%) tal-pazjenti randomized fuq vandetanib u 63 (63%) għall-pazjenti randomized fuq plaċebo.
English: In healthy subjects, the exposure for midazolam (CYP3A4 substrate) was not affected when given together with a single dose of vandetanib at 800 mg.
Maltese: L-effett ta' vandetanib fuq prodotti mediċinali oħra F'individwi b'saħħithom, l-espożizzjoni għal midazolam (substrat ta' CYP3A4) ma ġietx affettwata meta ngħata ma' doża unika ta' 800 mg vandetanib.
English: Increased haemoglobin,serum amylase increased
Maltese: jiżdied l-amylase fis-serum
English: The secondary endpoints were evaluation of overall objective response rate (ORR), disease control rate (DCR) defined as, partial response (PR) or complete response (CR) or stable disease (SD) lasting at least 24 weeks, duration of response (DOR), time to worsening of pain based on Brief Pain Inventory (BPI) worst pain scale, and overall survival (OS).
Maltese: L-għanijiet sekondarji kienu evalwati fuq ir-rata ta' rispons oġġettiv globali (ORR), rata tal-kontroll tal-marda (DCR) definita bħala, rispons parzjali (PR) jew rispons komplet (CR) jew marda stabbli (SD) li ddum mill-anqas 24 ġimgħa, tul tar-rispons (DOR),
English: There is limited clinical data with vandetanib in patients with MTC aged over 75.
Maltese: Hemm dejta klinika limitata b'vandetanib f'pazjenti b'MTC li jkollhom 75 sena jew aktar.
English: • Decrease in thyroid function.
Maltese: • Tonqos il-funzjoni tat-tirojde.
English: • vitamin K antagonists and dabigatran often referred to as ‘blood thinners'
Maltese: • antagonisti tal-vitamina K sikwiet referuti bħala ‘li jraqqu d-demm'
English: Tlf: +45 45 16 70 00
Maltese: Danmark Sanofi A/S Tlf: +45 45 16 70 00
English: • Gastrointestinal bleeding.
Maltese: emorraġija gastrotintestinali
English: - the clinical study report of study D4200C00104, an observational study including a retrospective arm to evaluate the Benefit/Risk of vandetanib (Caprelsa) 300 mg in RET mutation negative and RET mutation positive patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic thyroid cancer (MTC).
Maltese: (CAPRELSA) 300 mg f'pazjenti b'mutazzjoni RET Negattiva u mutazzjoni RET pożittiva ta' kanċer tat-tirojde sintomatiku, aggressiv, sporadiku, inoperabbli, avvanzat lokalment/metastatiku (MTC),
English: • Boil.
Maltese: • Musmar.
English: In clinical studies, a small number of patients had surgery while receiving vandetanib and there were no reported wound healing complications.
Maltese: Fi studji kliniċi, numru żgħir ta' pazjenti kellhom operazzjoni waqt li kienu qed jirċievu vandetanib u ma kienx hemm komplikazzjonijiet fil-fejqan tal-feriti irrappurtati.
English: A post-hoc subgroup analysis of RET negative status based on absence of M918T mutation of the pivotal study 58 was performed.
Maltese: Saret analiżi wara li ntemm l-istudju tas-sottogrupp tal-istat RET negattiv ibbażat fuq l-assenza tal mutazzjoni M918T tal-istudju pivitali 58.
English: Pharmacotherapeutic Group: antineoplastic agent, protein kinase inhibitor, ATC Code: L01XE12
Maltese: Sustanzi antineoplastiċi, Kodiċi ATC:
English: In addition, vandetanib inhibits epidermal growth factor (EGF)-stimulated EGF receptor tyrosine kinase in tumour cells and endothelial cells.
Maltese: (EGF) fiċ-ċelluli tat-tumur u fiċ-ċelluli tal-endotilju.
English: • Fainting.
Maltese: • Sturdament.
English: For more severe skin reactions (such as Stevens-Johnson syndrome), referral of the patient to seek urgent medical advice is recommended.
Maltese: Għal reazzjonijiet aktar severi tal-ġilda (bħal sindrome ta' Stevens-Johnson),
English: The concomitant use of vandetanib with ondansetron is not recommended (see section 4.5)
Maltese: L-użu ta' vandetanib ma' ondansetron mhux rakkomandat (ara sezzjoni 4.5).
English: • cisapride (used to treat heart burn), pimozide (used to treat uncontrolled repeated movements of the body and verbal outbursts) and halofantrine and lumefantrine (used to treat malaria)
Maltese: • cisapride (jintuża sabiex jikkura ħruq ta' stonku), pimozide (jintuża sabiex jikkura movimenti repetuti mhux ikkontrollati tal-ġisem u outburst verbali) u halofantrine u lumefantrine (jintuża għall-kura tal-malarja)
English: - if you are taking any of the following medicines: arsenic, cisapride (used to treat heartburn), erythromycin intravenous and moxifloxacin (used to treat infection), toremifene (used to treat breast cancer), mizolastine (used to treat allergies), Class IA and III antiarrhythmics (used to control heart rhythm).
Maltese: • jekk qed tieħu kwalunkwe minn dawn il-mediċini: arsenic, cisapride (jintuża għall-ħruq ta' stonku), erythromycin minn ġol-vina u moxifloxacin (jintuża għall-kura ta' infezzjoni), toremifene (jintuża għall-kura tal-kanċer tas-sider), mizolastine (jintuża għall-kura ta' allerġiji), antiarritmijaċi tal-Klassi
English: • Pain.
Maltese: • Deni.
English: Vandetanib has shown no carcinogenic potential effect in a 6 month carcinogenicity study in rasH2 transgenic mice.
Maltese: Vandetarib ma wera ebda potenzjal karċinoġeniku fi studju ta' karċinoġeniċità li dam 6 xhur u li sar fi ġrieden rasH2 transġeniċi.
English: • A type of diarrhoea (colitis).
Maltese: • Tip ta' dijarea (kolite).
English: • An irritation of the eyes (conjunctivitis).
Maltese: • Irritazzjoni fl-għajnejn (konġuntivite).
English: Caprelsa 300 mg tablets Each film-coated tablet contains 300 mg of vandetanib.
Maltese: Caprelsa 300 mg pilloli Kull pillola miksija b'rita fiha 300 mg vandetanib.
English: • Hole in your bowel.
Maltese: • Infjammazzjoni tas-sinuses.
English: Norge sanofi-aventis Norge AS
Maltese: Ireland sanofi-aventis Ireland Ltd.
English: The administration of vandetanib with substances known to prolong the ECG QTc interval is contraindicated or not recommended (see section 4.3 and 4.5).
Maltese: L-għotja ta' vandetanib ma' mediċini magħrufin li jtawwlu l-intervall QTc tal-elettrokardjogramma hija kontra-indikata jew mhux rakkomandata (ara sezzjoni 4.3 u 4.5).
English: • Bacterial infection.
Maltese: • Infezzjoni tal-batteri.
English: • Before starting Caprelsa
Maltese: • Kif jintuża / jingħata CAPRELSA ;
English: The safety findings in this study are consistent with the safety profile of vandetanib in adult patients with MTC.
Maltese: Il-konklużjonijiet dwar is-sigurtà f'dan l-istudju huma konsistenti mal-profil ta' sigurtà ta' vandetanib f'pazjenti adulti b'MTC.
English: Posology in paediatric patients with MTC
Maltese: Pożoloġija f'pazjenti pedjatriċi b'MTC
English: However, RET status could not be tested in a large proportion of patients (mainly because of unavailable results for direct sequencing of DNA) and response rate was somewhat lower in the patients with unknown RET status compared with RET mutation positive status: 51.8% vs. 35.9 % respectively.
Maltese: Madankollu, l-istat RET ma setgħax jiġi testjat f'proporzjon kbir tal-popolazzjoni (l-aktar minħabba li ma kienx hemm riżultati għal sekwenzar dirett tad-DNA) u r-rata ta' rispons kienet xi ftit aktar baxxa fil-pazjenti bi stat ta'RET mhux magħruf meta mqabbel mal-istat ta' mutazzjoni RET pożittiv: 51.8% vs. 35.9% rispettivament.
English: MARKETING AUTHORISATION HOLDER Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Genzyme Europe B.V., Paasheuvelweg 25,1105
English: • Tremor.
Maltese: • Influwenza.
English: Asthenia, fatigue, pain, oedema
Maltese: Astenja, għeja, uġigħ, edema
English: Danmark Sanofi A/S
Maltese: T/A SANOFI
English: Calcium hydrogen phosphate dihydrate Microcrystalline cellulose Crospovidone (type A) Povidone (K 29-32) Magnesium stearate
Maltese: Povidone (K 29-32) Magnesium stearate
English: • ondansetron (used to treat nausea and vomiting)
Maltese: • ondansetron (jintużaw għall-kura tad-dardir u rimettar)
English: PFS
Maltese: Jew
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.>
English: As expected from its pharmacological actions, vandetanib has shown significant effects on all stages of female reproduction in rats (see section 5.3).
Maltese: Kif mistenni mill-azzjonijiet farmakoloġiċi tiegħu, vandetanib intwera li għandu effetti sinifikanti fuq l-istadji kollha tar riproduzzjoni femminili fil-firien (ara sezzjoni 5.3).
English: Caprelsa 100 mg tablets Each film-coated tablet contains 100 mg of vandetanib.
Maltese: Caprelsa 100 mg pilloli Kull pillola miksija b'rita fiha 100 mg vandetanib.
English: Results according to RET status (positive, unknown and RET M918T mutation negative definition) are presented in Table 4.
Maltese: Ir-riżultati skont l-istat RET (definizzjoni pożittiv, mhux magħruf u mutazzjoni RET negattiva) qed jiġu preżentati f'Tabella 4.
English: These may be signs of a change in the electrical activitiy of your heart.
Maltese: Dawn jistgħu jkunu sinjali ta' bidla fl attività elettrika ta' qalbek.
English: Tremor, lethargy, loss of consciousness, balance disorders, dysgeusia
Maltese: Tregħid, tħeddil, telf mis-sensi, disturbi tal
English: Vandetanib exposure in children between 5-8 years old with glioma-related indications was comparable to MTC patients aged 9-18 years.
Maltese: L-espożizzjoni ta' vandetanib fit-tfal b'etajiet minn 5-8 snin b'indikazzjonijiet relatati ma' glioma kienet komparabbli ma' pazjenti b'MTC b'etajiet minn 9-18-il sena.
English: Vandetanib is not recommended for use in patients with hepatic impairment (serum bilirubin greater than 1.5 times upper limit of normal), since there is limited data in patients with hepatic impairment, and safety and efficacy have not been established.
Maltese: Vandetanib mhux rakkomandat għall-użu f'pazjenti b'indeboliment tal-fwied (bilirubin fis-serum aktar minn 1.5 l-ogħla limitu tan-normali), peress li hemm dejta limitata f'pazjenti b'indeboliment tal fwied, u s-sigurtà u l-effiċja ma ġewx stabbiliti.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Genzyme Europe B.V.
Maltese: Genzyme Europe B.V.
English: • Difficulty swallowing.
Maltese: • Disturbi tad-dwiefer.
English: 116/231 81.6 months 0.99
Maltese: 81.6 xhur
English: Objective response rate (vandetanib arm)
Maltese: Rata ta' rispons eoġġettiva (fergħa vandetanib)
English: Vision blurred, corneal structural change (including corneal deposits and corneal opacity)
Maltese: (inklużi depożiti fil-korneja u opaċità tal korneja)
English: Hypertensive crisis, ischaemic cerebrovascular conditions
Maltese: Disturbi vaskulari Pressjoni għolja Kriżi ipertensiva, kundizzjonijiet iskemiċi ċerebrovaskulari
English: The median PFS for patients randomised to placebo was 19.3 months.
Maltese: Il-medjan PFS għall-pazjenti randomized fuq plaċebo kien 19.3 xhur.
English: • Gallstones (cholelithiasis).
Maltese: • Ġebel fil-marrara (kolelitijasi).
English: • Severe high blood pressure.
Maltese: • Pressjoni għolja ħafna.
English: Furthermore, the bradycardiac effect of digoxin may increase the risk of vandetanib QTc interval prolongation and Torsade de Pointes.
Maltese: Minbarra hekk il-possibilità ta' titwil tal-QTc u Torsade de pointes għandha titqies.
English: Vandetanib had no effect on fertility in male rats.
Maltese: Vandetanib ma kellux effett fuq il-fertilità tal-firien maskili.
English: Interstitial lung disease
Maltese: Mard interstizzju tal-pulmun
English: Vandetanib inhibits EGFR-dependent cell proliferation and cell survival in vitro.
Maltese: Vandetanib jinibixxi l-proliferazzjoni taċ-ċelluli u s-sopravivenza taċ-ċelluli in vitro.
English: • Swelling caused by excess fluid (oedema).
Maltese: • Telf ta' fluwidi tal-ġisem (deidratazzjoni).
English: Carcinogenicity
Maltese: MEDIĊINALI
English: • proton pump inhibitors (used to treat heartburn)
Maltese: • Proteina jew demm fl-awrina (jidher b'test tal-awrina).
English: Package leaflet: Information for the patient Caprelsa 100 mg film-coated tablets Caprelsa 300 mg film-coated tablets vandetanib
Maltese: Caprelsa 100 mg pilloli miksijin b'rita Caprelsa 300 mg pilloli miksijin b'rita vandetanib
English: Class
Maltese: Deskrizzjoni
English: • Contact details of the CAPRELSA prescriber.
Maltese: • Infjammazzjoni tal-bużżieqa tal-awrina.
English: The half-life of vandetanib (19 days) renders this prolongation in QTc interval particularly problematic (see section 4.8).
Maltese: (19-il jum) jgħamel dan it-titwil tal-intervall tal-QTc problematiku b'mod partikolari (ara sezzjoni 4.8).
English: If there is no appropriate alternative therapy, not recommended combinations with vandetanib may be made with additional ECG monitoring of the QTc interval, evaluation of electrolytes and further control at onset or worsening of diarrhoea.
Maltese: Jekk ma jkunx hemm terapija oħra xierqa, it-taħlita ta' mediċini mhux rakkomandati ma' vandetanib jista' jsir b'monitoraġġ tal-intervall QTc tal-elettrokardjogramma, evalwazzjoni tal-elettroliti u aktar kontroll meta tibda jew taggrava d-dijarea.
English: (For vandetanib monitoring, see section 4.2 Posology and Method of administration and section 4.4 Special warnings and precautions for use).
Maltese: (Għall-monitoraġġ ta' vandetanib, ara sezzjoni 4.2 Pożoloġija u Metodu ta' kif għandu jingħata u sezzjoni 4.4
English: PVC/ PVDC/Alu blisters, sealed with aluminium foil, each containing 30 film-coated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-PVC/PVDC/Alu, issiġillati b'folja ta' aluminium kull waħda jkun fiha 30 pillola miksija b'rita.
English: The tablet is to be dropped in water, without crushing, stirred until dispersed (approximately 10 minutes) and the resultant dispersion swallowed immediately.
Maltese: Il-pillola għandha titpoġġa fl-ilma, mingħajr ma tfarrakha, tħawwadha sakemm tinħall (madwar 10 minuti) u d-dispersjoni li tifforma tinxtorob mill-ewwel.
English: • cyclosporine and tacrolimus (used to treat transplant rejection), digoxin (used to treat irregular heart rate), and metformin (used to control your blood sugar)
Maltese: • cyclosporine u tacrolimus (jintużaw sabiex jikkuraw riġett tat-trapjant), digoxin (jintuża sabiex jikkura taħbit irregolari tal-qalb), u metformin (jintuża sabiex jikkontrolla z-zokkor fid demm)
English: As regards other P-gp substrates such as dabigatran, a clinical monitoring is recommended in case of combination with vandetanib.
Maltese: Fir-rigward ta' substrati oħra tal-P-gp bħal dabigatran, huwa rakkomandat monitoraġġ kliniku meta dawn jingħataw flimkien ma' vandetanib.
English: Disease control rate = response rate + stable disease at 24 weeks.
Maltese: Rata tal-kontroll tal-marda = rata ta' rispons + marda stabbli f'24 ġimgħa.
English: A patient was considered to have a RET mutation if either an M918T mutation by the ARMS assay, or a RET mutation in any exons sequenced was present in the tumour.
Maltese: Pazjent kien meqjus li għandu mutazzjoni RET jekk il mutazzjoni M918T permezz tal-essej ARMS fi kwalunkwe ekson kien preżenti fit-tumur.
English: PC:
Maltese: Frekwenza:
English: The appropriate interval between discontinuation of vandetanib and subsequent elective surgery required to avoid the risks of impaired wound healing has not been determined.
Maltese: Lintervall xieraq bejn it-twaqqif ta' vandetanib u operazzjoni elettiva li jkollha sseħħ wara meħtieġ biex jiġu evitati r-riskji ta' tixkil tal-fejqan tal-ferita ma ġiex stabbilit.
English: Each tablet contains 100 or 300 mg of vandetanib.
Maltese: Kull pillola fiha 300 mg vandetanib.
English: • 1, 3 and 6 weeks after starting Caprelsa
Maltese: 1, 3 u 6 ġimgħat wara li tibda tieħu Caprelsa 12-il ġimgħa wara li tibda tieħu Caprelsa
English: Do not store above 30°C.
Maltese: Taħżinx f'aktar minn 30°C