FrancophonIA/ELRC3.0 huggingface dataset:
English: This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1 % for Evista and 1.9 % for placebo; and in the treatment population occurred at an incidence of 7.1 % for Evista and 6.1 % for placebo.
Maltese: Din kienet l-edema periferali li okkorriet fil-grupp ta' prevenzjoni b'inċidenza ta' 3.1% għal Evista u 1.8% għall-plaċebo; u fil-grupp ta' trattament l-inċidenza kienet ta' 7.1% għall-Evista u 6.1% għall-plaċebo.
English: Ink:
Maltese: Linka:
English: As a selective oestrogen receptor modulator (SERM), raloxifene has selective agonist or antagonist activities on tissues responsive to oestrogen.
Maltese: Bħala modulatur selettiv għar-riċetturi ta' l-estroġenu (SERM), raloxifene għandu attivitajiet selettivi agonistiċi jew antagonistiċi, fuq it-tessuti li jirrispondu għall-effett ta' l-estroġenu.
English: Similarly, in the RUTH study, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, stroke or overall mortality, including overall cardiovascular mortality, compared to placebo (for the increase in risk of fatal stroke see section 4.4).
Maltese: L-istess fl-istudju kliniku RUTH, raloxifene meta mqabbel ma' plaċebo, ma effettwax l-inċidenza ta' attakki ta' qalb, ta' bżonn li wieħed jidħol l-isptar minħabba sindromu koronarju akut, ta' attakk ta' puplesija, jew ta'mortalità in ġenerali inkluż l-imwiet kardjovaskulari kollu, (għaż-żieda fir-riskju ta' puplesija fatali ara sezzjoni
English: Endometrial biopsies taken after six months therapy with Evista 60 mg daily demonstrated nonproliferative endometrium in all patients.
Maltese: Bijopsiji ta' l-endometriju meħudin wara terapija ta' 60 mg ta' Evista kuljum għal sitt xhur, urew endometriju mhux proliferattiv fil-pazjenti kollha.
English: See leaflet for further information
Maltese: Ara l-fuljett għal aktar informazzjoni.
English: Evista reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
Maltese: Evista tnaqqas irriskju ta' ksur tal-vertebri fin-nisa bl-osteoporożi wara l-menopawsa.
English: Evista therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
Maltese: It-terapija b'Evista għal 8 snin ma effetwatx b'mod sinifikanti r-riskju ta' avvenimenti kardjovaskulari f'pazjenti involuti fl-istudju dwar il-kura ta' l-osteoporożi.
English: When determining the choice of Evista or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Maltese: Meta wieħed jagħżel bejn Evista u terapiji oħra, inkluż l-estroġenu, għal mara li qiegħda filmenopawsa, fuq bażi individwali jridu jitqiesu s-sintomi tal-menopawsa, l-effetti fuq it-tessuti ta' lutru u s-sider, ir-riskji u l-benefiċji kardjovaskulari (ara sezzjoni 5.1).
English: How to store Evista
Maltese: Kif taħdem Evista
English: At doses of 0.1 to 10 mg/kg/day in female rats, raloxifene disrupted estrous cycles of female rats during treatment, but did not delay fertile matings after treatment termination and only marginally reduced litter size, increased gestation length, and altered the timing of events in neonatal development.
Maltese: F'dożi ta' 0.1 sa 10 mg/kg/jum fil-firien ta' sess femminil, Raloxifene fixkel iċ-ċiklu estrous fil-firien ta' sess femminil waqt il-kura, iżda ma ttardjax it-tgħammir fertili wara li twaqqaf il-kura, u naqqas bi ftit biss id-daqs tal-boton, żied it-tul ta' żmien tat-tqala, u biddel iż-żmien fl-avvenimenti ta' l-iżvilupp tal-wild.
English: You should have this investigated by your doctor.
Maltese: Gruppi speċjali ta' pazjenti
English: This increase was generally a 2 % increase in BMD compared to placebo.
Maltese: Din iż-żieda kienet ġeneralment waħda ta' 2 % fil-BMD, komparata mal-plaċebo.
English: Magyarország Goodwill Pharma Kft. Tel: +36 62 443 571
Maltese: Tel: +36 62 443 571
English: What Evista looks like and contents of the pack Evista are white, oval, film coated tablets which are marked with the number 4165.
Maltese: Evista huma pilloli bojod, ovali, miksija b'rita u li għandhom in-numru 4165 stampat fuqhom.
English: Concurrent administration of either calcium carbonate or aluminium and magnesium-hydroxide containing antacids do not affect the systemic exposure of raloxifene.
Maltese: It-teħid konkomittanti ta' calcium carbonate jew ta' aluminium u magnesium hydroxide li jinstabu filmediċini kontra l-aċidu ta' l-istonku, ma jaffetwax l-espożizzjoni sistemika ta' raloxifene.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi Sankyo Europe GmbH
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Pharmacotherapeutic group: Selective Oestrogen Receptor Modulator, ATC code: G03XC01.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Raloxifene is a potent antioestrogen in the rat uterus and prevented growth of oestrogen-dependent mammary tumours in rats and mice.
Maltese: Evista u l-estroġenu jeffetwaw bl-istess mod ir-rimodellar ta' l-għadam u lmetaboliżmu tal-calcium.
English: • Medicinal product subject to medical prescription
Maltese: TAL-PRODOTT MEDIĊINALI
English: Slightly decreased (6-10 %) platelet counts have been reported during raloxifene treatment in placebocontrolled clinical trials of raloxifene in osteoporosis.
Maltese: Ġie rrappurtat li l-għadd tal-plejtlits naqas ftit (6-10%) waqt il-kura b'raloxifene fi studji kliniċi kkontrollati bi plaċebo ta' raloxifene fl-osteoporożi
English: EXPIRY DATE EXP {MM/YYYY}
Maltese: DATA TA' REVIŻJONI TAT-TEST JJ xahar SSSS
English: NAME OF THE MEDICINAL PRODUCT Evista 60 mg film coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Evista 60 mg pilloli miksija b'rita
English: These observations support the conclusion that raloxifene has no intrinsic oestrogen agonist activity in breast tissue.
Maltese: Evista tista' biss tikkuralek jew tipprevenilek l-osteoporożi jekk tkompli tieħu lpilloli.
English: This usually lasts 4-5 days.
Maltese: Din normalment idum 4-5 ijiem.
English: * Post hoc analysis
Maltese: * Analiżi post hoc
English: Sodium starch glycolate (Type A) Magnesium stearate
Maltese: Sodium starch glycolate (Tip A) Magnesium stearate
English: CI= confidence interval
Maltese: CI = confidence interval a.
English: Tablet coating Hypromellose Titanium dioxide (E171) Macrogol (400) Polysorbate 80
Maltese: Kisja tal-pillola Hypromellose Titanium dioxide (E171) Macrogol (400) Polysorbate 80
English: 17.2 mos (13.9, 19.2)
Maltese: 17.2 xhur (13.9, 19.2)
English: Immune system disorders Rare
Maltese: Disturbi fis-sistema immuni Rari
English: EU/1/07/440/004 70 tablets EU/1/07/440/005 140 tablets EU/1/07/440/006 84 tablets EU/1/07/440/007 105 tablets
Maltese: EU/1/07/440/004 70 pillola EU/1/07/440/005 140 pillola EU/1/07/440/006 84 pillola EU/1/07/440/007 105 pillola
English: Overall 58 % of these symptomatic patients recovered.
Maltese: Globalment 58 % ta' l-pazjenti li kellhom sintomi rpiljaw.
English: ITT population N
Maltese: Popolazzjoni ITT N
English: - The active substance in Tyverb is lapatinib.
Maltese: - Is-sustanza attiva f'Tyverb hi lapatinib.
English: Microcrystalline cellulose Povidone (K30)
Maltese: Qalba tal-pillola Microcrystalline cellulose Povidone (K30)
English: 8.9 mos (6.7, 11.8)
Maltese: 8.9 xhur (6.7, 11.8)
English: - The other ingredients are: microcrystalline cellulose, povidone (K30), sodium starch glycolate (Type A), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol (400), polysorbate 80, iron oxide yellow (E172), and iron oxide red (E172).
Maltese: - Is-sustanzi l-oħra huma: microcrystalline cellulose, povidone (K30), sodium starch glycolate (Type A), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol (400), polysorbate 80, iron oxide yellow (E172), u iron oxide red (E172).
English: HER2 overexpression = IHC 3+ and/or FISH positive; HER2 negative = IHC 0, 1+ or 2+ and/or FISH negative
Maltese: Espressjoni żejda ta' HER2 = IHC 3+ u/jew pożittiv għal FISH; negattiv għal HER2 = IHC 0, 1+ jew 2+ u/jew negattiv għal FISH
English: Deaths (%)
Maltese: Mwiet (%)
English: Lapatinib alone (N=148 )
Maltese: Lapatinib waħdu (N = 148 )
English: Lapatinib inhibits CYP3A (Ki 0.6 to 2.3 µg/ml) and CYP2C8 (0.3 µg/ml) in vitro at clinically relevant concentrations.
Maltese: Lapatinib jimpedixxi CYP3A (Ki 0.6 sa 2.3 µg/ml) u CYP2C8 (0.3 µg/ml) in vitro f'konċentrazzjonijiet klinikament rilevanti.
English: The Phase III study (EGF30008) was randomised, double-blind, and placebo controlled.
Maltese: III (EGF30008) kien randomised, double-blind, u kkontrollat bil-plaċebo.
English: The effect on human fertility is unknown.
Maltese: L-effett fuq il-fertilità umana mhux magħruf.
English: • severe allergic reactions (see the beginning of section 4)
Maltese: • reazzjonijiet allerġiċi severi (ara l-bidu ta' sezzjoni 4)
English: Kaplan-Meier estimates
Maltese: Stimi ta' Kaplan-Meier Tabella 5
English: Investigator-assessed PFS
Maltese: PFS stmata mill-investigatur
English: EU/1/07/440/001 70 tablets EU/1/07/440/003 84 tablets
Maltese: EU/1/07/440/001 70 pillola EU/1/07/440/003 84 pillola
English: 15.4 wks (8.4, 16.9)
Maltese: 15.4 ġimgħat (8.4, 16.9)
English: HER2 receptor status was retrospectively determined by central laboratory testing.
Maltese: L-istat tar-riċettur HER2 kien determinat b'mod retrospettiv permezz ta' testijiet f'laboratorju ċentrali.
English: Letrozole 2.5 mg /day + placebo
Maltese: Letrozole 2.5 mg /jum + placebo
English: Pulmonary arterial hypertension**.
Maltese: Pressjoni għolja arterjali pulmonari**.
English: Inhibitors (ketoconazole, itraconazole, quinidine, verapamil, cyclosporine, and erythromycin) and inducers (rifampicin and St John's Wort) of these proteins may alter the exposure and/or distribution of lapatinib (see section 5.2).
Maltese: Impedituri (ketoconazole, itraconazole, quinidine, verapamil, cyclosporine, u erythromycin) u indutturi (rifampicin u St John's Wort) ta' dawn il-proteini jistgħu jibdlu l-esponiment u/jew id-distribuzzjoni ta' lapatinib (ara sezzjoni 5.2).
English: Don't take any more tablets.
Maltese: Tieħux aktar pilloli.
English: Lapatinib is highly bound (greater than 99%) to albumin and alpha-1 acid glycoprotein.
Maltese: Lapatinib jeħel ħafna (aktar minn 99 %) ma' l-albumina u mal-glikoproteina alpha-1 acid.
English: Lapatinib inhibits the transport proteins BCRP and OATP1B1 in vitro.
Maltese: Lapatinib jimpedixxi l-proteini ta' trasport BCRP u OATP1B1 in vitro.
English: It cannot be excluded that lapatinib will affect the pharmacokinetics of substrates of BCRP (e.g. topotecan) and OATP1B1 (e.g. rosuvastatin) (see section 5.2).
Maltese: Ma jistax jiġi eskluż li lapatinib jaffettwa l-farmakokinetika tas-sustrati ta' BCRP (e.ż. topotecan) u OATP1B1 (e.ż. rosuvastatin) (ara sezzjoni 5.2).
English: Effects of other medicinal products on lapatinib
Maltese: Effetti ta' prodotti mediċinali oħra fuq lapatinib
English: The following convention has been utilised for the classification of frequency: 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) and very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-konvenzjoni li ġejja ġiet utilizzata għall-klassifikazzjoni tal-frekwenza: komuni ħafna ( 1/10), komuni ( 1/100 sa < 1/10), mhux komuni ( 1/1,000 to < 1/100), rari ( 1/10,000 to < 1/1,000), u rari ħafna (< 1/10,000), mhux magħrufa (ma tistax tiġi kkalkulata mid-data disponibbli).
English: 8.2 wks (7.4, 9.3)
Maltese: 8.2 ġimgħat (7.4, 9.3)
English: Lapatinib produced a maximum mean concentration of 3920 (3450-4460) ng/ml (geometric mean/95% CI), exceeding the geometric mean Cmax.ss and 95% CI values observed following the approved dosing regimens.
Maltese: Lapatinib ipproduċa konċentrazzjoni medja massima ta' 3920 (3450-4460) ng/ml (medja ġeometrika/CI ta' 95%), li taqbeż il-medja ġeometrika tas-Cmax u l-valuri tas-CI ta' 95% osservati wara r-reġimi ta' dożaġġi approvati.
English: Lapatinib plus trastuzumab (N=148)
Maltese: Lapatinib flimkien ma' trastuzumab (N = 148)
English: Systemic exposure (AUC) to lapatinib after a single oral 100 mg dose increased approximately 56% and 85% in patients with moderate and severe hepatic impairment, respectively.
Maltese: L-esponiment sistemiku (AUC) għal lapatinib wara doża orali waħda ta' 100 mg żdied bejn wieħed u ieħor 56 % u 85 % f'pazjenti b'indeboliment epatiku moderat u serju, rispettivament.
English: In vitro studies indicate that lapatinib is a substrate for the transporters BCRP (ABCG1) and p-glycoprotein (ABCB1).
Maltese: Studji in vitro jindikaw li lapatinib huwa sustrat għat-trasportaturi BCRP (ABCG1) u l-glikoproteina p (ABCB1).
English: Marketing Authorisation Holder Novartis Europharm Limited Vista Building
Maltese: Detentur tal-Aworizzazzjoni għat-Tqegħid fis-Suq Novartis Europharm Limited Vista Building
English: Tyverb 1500 mg / day + Letrozole 2.5 mg /day N=111
Maltese: Tyverb 1500 mg / jum + Letrozole 2.5 mg /jum N = 111
English: • cisapride - a medicine used to treat certain digestive system problems
Maltese: • cisapride - mediċina użata biex tikkura ċerti problemi fis-sistema diġestiva
English: Nail disorders including paronychia.
Maltese: Disturbi fid-dwiefer inkluż paronikkja.
English: Pulmonary toxicity may be severe and lead to respiratory failure.
Maltese: Tossiċità pulmonari tista' tkun severa u twassal għallinsuffiċjenza respiratorja.
English: Response rate, % (95% CI)
Maltese: Rata ta' rispons, % (95 % CI)
English: Median (95% CI) Stratified Hazard ratio b
Maltese: Medjan (95 % CI) Proporzjon ta' periklu stratifikat b
English: • phenytoin, carbamazepine - medicines used to treat seizures
Maltese: • phenytoin, carbamazepine - mediċini użati biex jikkuraw aċċessjonijiet
English: Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.
Maltese: Kull pillola miksija b'rita fiha lapatinib ditosylate monohydrate, ekwivalenti għal 250 mg lapatinib.
English: Hypersensitivity reactions including anaphylaxis (see section 4.3) Metabolism and nutrition disorders Very common Anorexia
Maltese: Reazzjonijiet ta' sensittività eċċessiva inkluż anafilassi (ara sezzjoni 4.3) Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna
English: Novartis Pharma B.V. Tel: +31 26 37 82 555
Maltese: Nederland Novartis Pharma B.V. Tel: +31 26 37 82 555
English: Carriage of the HLA risk alleles is common (15 to 25%) in Caucasian, Asian, African and Hispanic populations but lower (1%) in Japanese populations.
Maltese: Il-ġarr tal-alleles HLA ta' riskju huwa komuni (15 sa 25 %) fil-popolazzjonijiet Kawkasiċi, Asjatiċi, Afrikani u Hispanic iżda anqas komuni (1 %) fil-popolazzjoni Ġappuniża.
English: The solubility of lapatinib is pH-dependent.
Maltese: Is-solubilità ta' lapatinib hija dipendenti mill-pH.
English: Serious cutaneous reactions, including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)** Musculoskeletal and connective tissue disorders Very common Pain in extremity*
Maltese: Reazzjonijiet serji tal-ġilda, inklużi sindrome ta' Stevens Johnson (SJSStevens Johnson syndrome) u nekrolisi tossika tal-epidermide (TEN - toxic epidermal necrolysis)
English: Proactive management of diarrhoea with anti-diarrhoeal medicinal product is important.
Maltese: Immaniġġar proattiv tad-dijarea bi prodotti mediċinali kontra d-dijarea huwa importanti.
English: The effect of lapatinib on the QT-interval was evaluated in a single-blind, placebo-controlled, single sequence (placebo and active treatment) crossover study in patients with advanced solid tumours (EGF114271) (n=58).
Maltese: L-effett ta' lapatinib fuq l-intervall QT kien evalwat fi studju crossover, single-blind, ikkontrollat bilplaċebo, b'sekwenza waħda (plaċebo u trattament attiv) f'pazjenti b'tumuri solidi avanzati (EGF114271) (n=58).
English: • Risk management Plan (RMP)
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP)
English: Table 2 Overall survival data from Study EGF100151 (Tyverb / capecitabine)
Maltese: Tabella 2 Dejta ta' sopravivenza globali mill-Istudju EGF100151 (Tyverb / capecitabine)
English: HER2 (ErbB2) overexpressing tumours are defined by IHC3+, or IHC2+ with gene amplification or gene amplification alone.
Maltese: Tumuri li jesprimu HER2 (ErbB2) żejjed huma definiti b'IHC3+, jew IHC2+ b'amplifikazzjoni talġene jew b'amplifikazzjoni tal-ġene biss.
English: Tyverb 250 mg tablets lapatinib
Maltese: Tyverb 250 mg pilloli lapatinib
English: Daily dosing of 1250 mg produces steady state geometric mean (coefficient of variation) Cmax values of 2.43 (76%) µg/ml and AUC values of 36.2 (79%) µg*hr/ml.
Maltese: Dożaġġ kuljum ta' 1250 mg jipproduċi valuri tal-medja ġeometrika (ko-effiċjent ta' varjazzjoni) Cmax fl-istat fiss ta' 2.43 (76 %) µg/ml u valuri AUC ta' 36.2 (79 %) µg*siegħa/ml.
English: • topotecan, paclitaxel, irinotecan, docetaxel - medicines used to treat certain types of cancer
Maltese: • topotecan, paclitaxel, irinotecan, docetaxel - mediċini użati biex jikkuraw ċerti tipi ta' kanċer
English: Table 1 Time to progression data from Study EGF100151 (Tyverb / capecitabine)
Maltese: Tabella 1 Dejta taż-żmien sal-progressjoni mill-Istudju EGF100151 (Tyverb / capecitabine)
English: Each pack of Tyverb contains 70 film-coated tablets in foil blisters (polyamide / aluminium / polyvinyl chloride / aluminium) of 10 tablets each.
Maltese: Kull pakkett ta' Tyverb fih 70 pillola miksija b'rita f'folji tal-fojl (polyamide / aluminium / polyvinyl chloride / aluminium) ta' 10 pilloli l-waħda.
English: Date of first authorisation: 10 June 2008 Date of latest renewal: 17 February 2015
Maltese: Data tal-aħħar tiġdid: 17 Frar 2015
English: Grapefruit juice should be avoided during treatment with Tyverb (see section 4.5).
Maltese: Meraq tal-grejpfrut għandu jiġi evitat waqt kura b'Tyverb (ara sezzjoni 4.5).
English: • nefazodone - a medicine used to treat depression
Maltese: • nefazodone - mediċina użata biex tikkura depressjoni
English: The ΔΔQTcF exceeded the 5 ms threshold and the upper bound 90% CIs exceeded the 10 ms threshold at multiple time points.
Maltese: Id-ΔΔQTcF qabeż il-limitu ta' 5 ms u CIs ta' 90% massimi qabżu l-limitu ta' 10 ms f'diversi punti ta' żmien.
English: The risk of lapatinib-induced hepatotoxicity was associated with carriage of the HLA alleles DQA1*02:01 and DRB1*07:01 (see section 4.4).
Maltese: Ir-riskju ta' tossiċità fil-fwied ikkawżat minn lapatinib kien marbut mal-ġarr tal-alleles DQA1*02:01 u DRB1*07:01 ta' HLA (ara sezzjoni 4.4).
English: To care for sensitive skin:
Maltese: Għall-kura ta' ġilda sensittiva:
English: In rabbits, lapatinib was associated with maternal toxicity at 60 and 120 mg/kg/day (8% and 23% of the expected human clinical exposure, respectively) and abortions at 120 mg/kg/day.
Maltese: Fil-fniek, lapatinib kien assoċjat ma' tossiċità ta l-omm f'doża ta' 60 u 120 mg/kg/kuljum (8 % u 23 % ta' l-esponiment kliniku uman mistenni, rispettivament) u aborti f'doża ta' 120 mg/kg/kuljum.
English: Table 7 Overall survival (OS) results from study EGF30008 (in the HER2-positive population only)
Maltese: Tabella 7 Sopravivenza totali (OS) riżultati minn EGF30008 studju (fil-popolazzjoni HER2 pożittiv biss)
English: Median (95%
Maltese: HR (95 %
English: • pimozide - a medicine used to treat certain mental health problems
Maltese: • pimozide - mediċina użata biex tikkura ċertu problemi ta' saħħa mentali
English: Hyperbilirubinaemia, hepatotoxicity (see section 4.4).
Maltese: Iperbilirubinimja, tossiċità tal-fwied (ara sezzjoni 4.4).
English: • rosuvastatin - a medicine used to treat high cholesterol
Maltese: • rosuvastatin - mediċina użata biex tikkura livelli għolja ta' kolesterol
English: Tyverb / aromatase inhibitor combination posology Each pack of Tyverb contains 84 film-coated tablets in foil blisters (polyamide / aluminium / polyvinyl chloride / aluminium) of 12 tablets each.
Maltese: Pożoloġja tat-taħlita Tyverb / inibitur ta' aromatase Kull pakkett ta' Tyverb fih 84 pillola miksija b'rita f'folji tal-fojl (polyamide / aluminium / polyvinyl chloride / aluminium) ta' 12-il pillola l-waħda.
English: The median age was 51 years and 13% were 65 years or older.
Maltese: L-età medjana kienet 51 sena u 13 % kellhom 65 sena jew aktar.
English: Hazard ratio a
Maltese: Odds ratio
English: Bottles Tyverb is also available in plastic bottles containing 70, 84, 105 or 140 tablets.
Maltese: Fliexken Tyverb jiġi wkoll fi fliexken tal-plastik li fihom 70, 84, 105 jew 140 pillola.
English: Lapatinib has been associated with reports of pulmonary toxicity including interstitial lung disease and pneumonitis (see section 4.8).
Maltese: Lapatinib ġie assoċjat ma' rapporti ta' tossiċità pulmonari inkluż mard ta' l-interstizju tal-pulmun u pulmonite (ara sezzjoni 4.8).
English: • verapamil - a medicine used to treat high blood pressure or heart problems (angina)
Maltese: • verapamil - mediċina użata biex tikkura pressjoni għolja jew problemi tal-qalb (anġina)
English: Symptomatic LVEF decreases were observed in approximately 0.3% of patients who received lapatinib.
Maltese: Tnaqqis sintomatiku fl-LVEF kien osservat f'bejn wieħed u ieħor 0.3 % tal-pazjenti li rċevew lapatinib.
English: In addition, 150 [50%] of patients were hormone receptor negative.
Maltese: Barra minn hekk, 150 [50 %] mill-pazjenti kienu negattivi għar-riċettur tal-ormoni.
English: Co-administration of Tyverb with known inducers of CYP3A4 (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or Hypericum perforatum [St John's Wort]) should be avoided.
Maltese: (e.ż. rifampicin, rifabutin, carbamazepine, phenytoin or Hypericum perforatum [St John's Wort]) għandha tiġi evitata.
English: Table 6 Progression free survival data from Study EGF30008 (Tyverb / letrozole)
Maltese: Tabella 6 Dejta ta' sopravivenza mingħajr progressjoni mill-Istudju EGF30008 (Tyverb / letrozole)
English: • cyclosporine - a medicine used to suppress the immune system for example after organ transplantations
Maltese: • cyclosporine - mediċina użata biex trażżan is-sistema immuni per eżempju wara trapjanti ta'
English: • ritonavir, saquinavir - medicines used to treat HIV
Maltese: • ritonavir, saquinavir - mediċini użati biex jikkuraw l-HIV
English: a. Estimate of the treatment hazard ratio, where <1 indicates a lower risk with letrozole 2.5 mg + lapatinib 1500 mg compared with letrozole 2.5 mg + placebo.
Maltese: Stima tal-proporzjon ta' periklu tat-trattament, fejn < 1 jindika riskju aktar baxx ma' letrozole 2.5 mg + lapatinib 1500 mg meta mqabbla ma' letrozole 2.5 mg + plaċebo.
English: Lapatinib is a substrate for the transport proteins Pgp and BCRP.
Maltese: Lapatinib huwa sustrat għal proteini ta' trasport Pgp u BCRP.
English: The pharmacokinetics of lapatinib were examined in patients with moderate (n = 8) or severe (n = 4) hepatic impairment (Child-Pugh scores of 7-9, or greater than 9, respectively) and in 8 healthy control patients.
Maltese: Il-farmakokinetika ta' lapatinib kienet eżaminata f'pazjenti b'indeboliment epatiku moderat (n = 8) jew serju (n = 4) (Punti Child-Pugh minn 7-9, jew aktar minn 9, rispettivament) u fi 8 pazjenti b'saħħithom bħala kontroll.
English: Lapatinib inhibits CYP3A4 in vitro at clinically relevant concentrations.
Maltese: Lapatinib jimpedixxi CYP3A4 in vitro f'konċentrazzjonijiet klinikament rilevanti.
English: Multipacks contain 140 (2 packs of 70) film-coated tablets.
Maltese: Pakkett multiplu: 140 (2 pakketti ta' 70) pillola miksija b'rita.
English: Pre-treatment with a proton pump inhibitor (esomeprazole) decreased lapatinib exposure by an average of 27% (range: 6% to 49%).
Maltese: Kura minn qabel b'inibitur tal-pompa tal-proton (esomeprazole) naqqset l-esponiment għal lapatinib b'medja ta' 27 % (firxa: 6 % sa 49 %).
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE07
Maltese: Mediċini kontra l-kanċer, mediċini oħra kontra l-kanċer, impedituri tal-proteina kinase, Kodiċi ATC: