FrancophonIA/ELRC3.0 huggingface dataset:
English: Braftovi is not recommended while breast-feeding.
Maltese: Fertilità Braftovi jista' jikkawża tnaqqis fl-għadd tal-isperma fl-irġiel.
English: Figure 2
Maltese: • Grad 2
English: Headache*
Maltese: Prurite*
English: Agents that are CYP3A4 substrates should be co-administered with caution.
Maltese: L-aġenti li huma substrati ta' CYP3A4 għandhom jiġu koamministrati b'attenzjoni.
English: VTE was reported when encorafenib is used in combination with binimetinib (see section 4.8 of binimetinib SmPC).
Maltese: RPED ġie rrapportat ukoll f'pazjenti ttrattati b'encorafenib flimkien ma' binimetinib (ara sezzjoni 4.8).
English: Similar results were observed per Investigator assessment.
Maltese: Riżultati simili kienu osservati għal kull valutazzjoni tal-investigaturi.
English: Encorafenib in combination with binimetinib in patients who have progressed on a BRAF inhibitor There are limited data for the use of the combination of encorafenib with binimetinib in patients who have progressed on a prior BRAF inhibitor given for the treatment of unresectable or metastatic melanoma with BRAF V600 mutation.
Maltese: Età Fuq il-bażi ta' analiżi tal-farmakokinetika tal-popolazzjoni, instab li l-età kienet kovarjat sinifikanti fuq il-volum ta' distribuzzjoni ta' encorafenib, iżda b'varjabbiltà għolja.
English: Survival at 12 months (95% CI)
Maltese: Sopravivenza wara 12-il xahar (95% CI)
English: Blood creatinine should be monitored as clinically indicated and creatinine elevation managed with dose modification or discontinuation (see Table 3 in section 4.2).
Maltese: Il-kreatinina fid-demm għandha tiġi ssorveljata kif jiġi indikat klinikament u l-elevazzjoni tal-kreatinina tiġi ġestita b'modifika jew b'waqfien fid-doża (ara t-Tabella 3 fis-sezzjoni 4.2).
English: Across pooled combination studies of encorafenib and binimetinib at the recommended doses and a single-agent encorafenib study, results suggest that encorafenib has the potential to result in small increases in QTc interval (see section 5.1).
Maltese: Pazjenti b'indeboliment epatiku ħafif sa sever jista' jkollhom esponiment akbar għal encorafenib (ara sezzjoni 5.2).
English: This observation was similar to that described in humans as central serous-like chorioretinopathy or central serous retinopathy.
Maltese: Din l-osservazzjoni kienet simili għal dik deskritta fil-bniedem bħala korjoretinopatija simili għal dik seruża ċentrali jew retinopatija seruża ċentrali.
English: Muscle problems: Braftovi, when taken with binimetinib, can cause breakdown of muscles (rhabdomyolysis) which can lead to kidney damage and can be fatal; signs and symptoms can include: - muscle pain, cramps, stiffness or spasm - dark urine
Maltese: Problemi fil-muskoli: Braftovi, meta jittieħed ma' binimetinib, jista' jikkawża tkissir tal-muskoli (rabdomijoliżi) li jista' jwassal għal ħsara fil-kliewi u jista' jkun fatali; is-sinjali u s-sintomi jistgħu jinkludu:
English: Colitis k
Maltese: Titwil tal-QT
English: Encorafenib undergoes minimal renal elimination.
Maltese: Encorafenib għandu jintuża b'attenzjoni f'pazjenti b'indeboliment renali sever.
English: Prior treatment with BRAF/ MEK inhibitors was not allowed.
Maltese: Trattament minn qabel b'inibituri tal-BRAF/ MEK ma kienx permess.
English: It is recommended that left ventricular ejection fraction (LVEF) is assessed by echocardiogram or multi-gated acquisition (MUGA) scan before initiation of encorafenib and binimetinib, one month after initiation, and then at approximately 3-month intervals or more frequently as clinically indicated, while on treatment.
Maltese: Huwa rrakkomandat li l-frazzjoni ta' tfigħ 'il barra ventrikolari tax-xellug (left ventricular ejection fraction, LVEF) tiġi vvalutata b'ekokardjogramma jew b'multi-gated acquisition (MUGA) scan qabel ma jinbdew encorafenib u binimetinib, xahar wara l-bidu, u mbagħad f'intervalli ta' madwar 3 xhur jew aktar spiss kif jiġi indikat klinikament, matul it-trattament.
English: Other skin cancers: Treatment with Braftovi may result in a different type of skin cancer such as cutaneous squamous cell carcinoma.
Maltese: It-trattament bi Braftovi jista' jirriżulta f'tip differenti ta' kanċer tal-ġilda bħal karċinoma kutanja taċ-ċelloli tat-tip skwamuż.
English: Encorafenib was phototoxic in an in vitro 3T3 Neutral Red Uptake Test. Encorafenib was not a sensitiser in the in vivo mouse sensitization assay.
Maltese: L-effett ta' encorafenib fuq is-substrati ta' CYP L-esperimenti in vitro jindikaw li encorafenib hu inibitur riversibbli relattivament potenti ta' UGT1A1,
English: For patients in the Phase III study (CMEK162B2301) who developed cuSCC, the median time to onset of the first event of cuSCC (all grades) was 2.3 months (range 0.3 to 12.0 months).
Maltese: Għall-pazjenti kollha fl-istudju tal-Fażi III (CMEK162B2301) li żviluppaw cuSCC, iż-żmien medjan sal-bidu tal-ewwel avveniment ta' cuSCC (il-gradi kollha) kien ta' 2.3 xhur (medda ta' 0.3 xhur sa 12.0-il xahar).
English: PFS as assessed by investigators (investigator assessment) was a supportive analysis.
Maltese: PFS kif ivvalutata mill-investigaturi (valutazzjoni tal-investigaturi) kienet analiżi ta' appoġġ.
English: COMBO 450
Maltese: N = 192 (Combo 450)
English: Teva Gyógyszergyár Zrt.,
Maltese: Teva Gyógyszergyár Zrt., Tel.:
English: Pregelatinized starch (maize) Magnesium stearate Povidone (K30)
Maltese: Pregelatinized starch (qamħirrun) Magnesium stearate Povidone (K30)
English: TEVA Pharmaceutical Works Private Limited Company Pallagi ùt 13, 4042 Debrecen Hungary
Maltese: TEVA Pharmaceutical Works Private Limited Company Pallagi ùt 13, 4042 Debrecen L-Ungerija
English: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Germany
Maltese: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren
English: - The active substance is raloxifene hydrochloride.
Maltese: - Is-sustanza attiva hi raloxifene hydrochloride.
English: United Kingdom Teva UK Limited Tel: +44 1977628500
Maltese: Teva UK Limited Tel: +44 1977628500
English: Colloidal anhydrous silica Microcrystalline cellulose, silicified
Maltese: Colloidal anhydrous silica Microcrystalline cellulose, siliċifikat
English: Raloxifene is strongly bound to plasma proteins (98-99 %).
Maltese: Raloxifene jintrabat sew mal-proteini tal-plażma (98-99 %).
English: After 3 years therapy raloxifene decreased fibrinogen (6.71 %).
Maltese: Wara 3 snin ta' terapija raloxifene naqqset il-fibrinogen (6.71 %).
English: There is no evidence of endometrial proliferation.
Maltese: M'hemmx evidenza ta' proliferazjoni tal-endometriju.
English: a) Skeletal Effects
Maltese: a) Effetti skeletriċi
English: Pack sizes of 14, 28 and 84 tablets.
Maltese: Daqsijiet tal-pakkettta' 14, 28 u 84 pillola.
English: Swensweg 5, 2031 GA, Haarlem The Netherlands
Maltese: Swensweg 5, 2031 GA, Haarlem L-Olanda
English: Deutschland Teva GmbH Tel: +49 73140208
Maltese: Teva GmbH Tel: +49 73140208
English: Teva UK Ltd, Brampton Road Hampden Park, Eastbourne East Sussex, BN22 9AG UK
Maltese: Teva UK Ltd, Brampton Road Hampden Park, Eastbourne East Sussex, BN22 9AG Ir-Renju Unit
English: Tél: +(33) 1 55 91 7800
Maltese: Teva Santé Tél: +(33) 1 55 91 7800
English: iii) Calcium kinetics.
Maltese: iii) Kinetiċi tal-kalċju.
English: Polydextrose (E1200) Titanium dioxide (E171) Hypromellose (E464) Macrogol 4000
Maltese: Polydextrose FCC (E1200) Titanium dioxide (E171) Hypromellose 2910 15cP (E464) Macrogol 4000
English: Slovenská republika Teva Pharmaceuticals Slovakia s.r.o.
Maltese: Teva Pharmaceuticals Slovakia s.r.o.
English: Tablet core: pregelatinized starch (maize), magnesium stearate, povidone (K30), colloidal anhydrous silica and microcrystalline cellulose, silicified.
Maltese: Il-qalba tal-pillola: pregelatinized starch (qamħirrun), magnesium stearate, povidone (K30), colloidal anhydrous silica u silicified microcrystalline cellulose, siliċifikat.
English: Tablet coating: polydextrose (E1200), titanium dioxide (E171), hypromellose (E464) and macrogol 4000.
Maltese: Il-kisi tal-pillola: polydextrose (E1200), titanium dioxide (E171), hypromellose (E464) u macrogol 4000.
English: Absolute bioavailability of raloxifene is 2 %.
Maltese: Il-bijodisponibbiltà assoluta ta' raloxifene hija ta' 2 %.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/627/001-003
Maltese: EU/1/10/627/001-003
English: Česká republika Teva Pharmaceuticals CR, s.r.o.
Maltese: Teva Pharmaceuticals CR, s.r.o.
English: for the spine 37 % decreased and 63 % increased; and for the total hip 29 % decreased and 71 % increased.
Maltese: 37 % tnaqqis u 63 % żieda; u għall-għadam sħiħ tal-ġenbejn 29 % tnaqqis u 71 % żieda.
English: Raloxifene undergoes extensive first pass metabolism to the glucuronide conjugates: raloxifene-4'-glucuronide, raloxifene-6-glucuronide, and raloxifene-6, 4′-diglucuronide .
Maltese: glucuronide: raloxifene-4'-glucuronide, raloxifene-6-glucuronide, u raloxifene-6, 4
English: 6.5 Nature and contents of container Transparent PVC/PVdC - Aluminium blisters.
Maltese: PVC/PVdC trasparenti/opaki - Folji tal-aluminju.
English: The hazard ratio for all VTE events in the RUTH study was HR = 1.44, (1.06-1.95).
Maltese: kienu HR = 1.44, (1.06 - 1.95).
English: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A.
Maltese: Teva Pharma Belgium N.V./S.
English: The following convention has been used for the classification of the adverse reactions: 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), not known (cannot be estimated from the available data).
Maltese: 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), mhux magħruf (ma jistax jiġi stmat mit-tagħrif disponibbli)
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
Maltese: Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG Ir-Renju Unit
English: Uncommon: Fatal strokes
Maltese: Mhux komuni: Puplesiji fatali
English: th year alone, raloxifene reduced the new vertebral fracture risk by 39 % (RR 0.61, CI 0.43, 0.88).
Maltese: Fir-raba' sena biss, raloxifene naqqset ir-riskju ta' ksur ġdid tal-vertebri b'39 % (RR 0.61, CI 0.43, 0.88).
English: In vitro, raloxifene did not interact with the binding of warfarin, phenytoin, or tamoxifen.
Maltese: Raloxifene in vitro ma wriex interazzjoni mal-irbit ta' warfarina, phenytoin jew tamoxifen.
English: Raloxifene Teva lowers total cholesterol and LDL ("bad") cholesterol.
Maltese: Raloxifene Teva jbaxxi l-kolesterol totali u l-kolesterol LDL (“ħażin”).
English: In a 21-month carcinogenicity study in mice, there was an increased incidence of testicular interstitial cell tumours and prostatic adenomas and adenocarcinomas in males given 41 or 210 mg/kg, and prostatic leiomyoblastoma in males given 210 mg/kg.
Maltese: Fi studju ta' 21 xahar dwar il-karċinoġeniċita fil ġrieden, kien hemm inċidenza ogħla f'tumuri ta' ċelluli testikulari interstizzjali u adenomi prostatiċi u adenokarċinomi f'irġiel li ngħataw 41 jew 210 mg/kg, u leijomijoblastoma prostatika fl-irġien li ngħataw 210 mg/kg.
English: In the treatment population discontinuations of therapy due to any clinical adverse event occurred in 12.8 % of 2,557 raloxifene treated patients and 11.1 % of 2,576 placebo treated patients.
Maltese: Fil-populazzjoni li kienet qed tiġi trattata, il-waqfien tat-terapija minħabba każijiet kliniċi avversi seħħet fi 12.8 % minn fost 2,557 pazjent trattat b'raloxifene u 11.1 % minn fost 2,576 pazjent trattat bi plaċebo.
English: iv) Histomorphometry (bone quality).
Maltese: iv) Ħistomorfometrija (il-kwalità tal-għadam).
English: Raloxifene (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
Maltese: Raloxifene (n = 317) kienet imqabbla ma' terapija kontinwa (n = 110) ta' sostituzzjoni bl-ormoni
English: Approximately 60 % of an oral dose is absorbed.
Maltese: Madwar 60 % ta' doża orali tiġi assorbita.
English: Raloxifene treatment for 4 years reduced the incidence of vertebral fractures by 46 % (RR 0.54, CI 0.38, 0.75) and 32 % (RR 0.68, CI 0.56, 0.83) in patients with osteoporosis or osteoporosis with an existing fracture respectively.
Maltese: It-trattament b'raloxifene għal 4 snin naqqas l-inċidenza ta' ksur tal-vertebri b'46 % (RR 0.54, CI 0.38, 0.75) u 32 % (RR 0.68, CI 0.56, 0.83) f'pazjenti bl-osteoporożi jew l-osteoporożi bi ksur eżistenti, rispettivament.
English: In a population pharmacokinetic study, a 47 % decrease in lean body mass adjusted creatinine clearance resulted in a 17 % decrease in raloxifene clearance and a 15 % decrease in the clearance of raloxifene conjugates.
Maltese: Fi studju farmakokinetiku tal-popolazzjoni, tnaqqis ta' 47 % fit-tneħħija tal-kreatinina, meta jitqies il-piż tal ġisem mingħajr it-tessut xaħmi irriżulta f'17 % tnaqqis fit-tneħħija ta' raloxifene u 15 % tnaqqis fit tneħħija tal-konjugi ta' raloxifene.
English: Raloxifene Teva 60 mg film-coated tablets raloxifene hydrochloride
Maltese: Raloxifene Teva 60 mg pilloli miksija b'rita raloxifene hydrochloride
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 April 2010
Maltese: Data tal-ewwel awtorizzazzjoni: 29 t'April 2010
English: EU/1/10/627/003 84 film coated tablets
Maltese: EU/1/10/627/001 14-il pillola miksija b'rita EU/1/10/627/002 28 pillola miksija b'rita EU/1/10/627/003 84 pillola miksija b'rita
English: Compared with placebo-treated patients the occurrence of vasodilatation (hot flushes) was modestly increased in raloxifene patients (clinical trials for the prevention of osteoporosis, 2 to 8 years postmenopausal, 24.3 % raloxifene and 18.2 % placebo; clinical trials for the treatment of osteoporosis, mean age 66, 10.6 % for raloxifene and 7.1 % placebo).
Maltese: Deskrizzjoni tar-reazzjonijiet avversi magħżula Meta mqabbel ma' pazjenti trattati bi plaċebo, każijiet ta' vażodilazzjoni (fwawar) kienu moderatament aktar komuni fil-pazjenti fuq raloxifene (provi kliniċi għal prevenzjoni ta' osteoporożi, minn 2 sa 8 snin wara l-menopawża, 24.3 % b'raloxifene u 18.2 % bi plaċebo; provi kliniċi għat trattament ta' osteoporożi, età medja 66, 10.6 % għal raloxifene u 7.1 % għal plaċebo).
English: Cholecystectomy rates for raloxifene (2.3 %) were not statistically significantly different from placebo (2.0 %).
Maltese: Rati ta' koleċistektomija għal raloxifene (2.3 %) ma wrewx differenzi li kienu statistikament sinifikanti minn dawk tal-plaċebo (2.0 %).
English: Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed.
Maltese: gamma-glutamyl transferase, alkaline phosphatase, ALT u AST għandhom ikunu immonitorjati mill-qrib waqt it-trattament jekk jinstabu livelli għoljin.
English: Uncommon: Venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, superficial vein thrombophlebitis, Arterial thromboembolic reactions a
Maltese: Mhux komuni: Avvenimenti tromboemboliċi venużi, li jinkludu trombożi profonda tal-vini, emboliżmu pulmonari, trombożi tal-vina retinali, tromboflebite tal-vina superfiċjali,
English: Raloxifene comprises less than 1 % of the combined concentrations of raloxifene and the glucuronide metabolites.
Maltese: Raloxifene jikkonsisti minn inqas minn 1 % tal-konċentrazzjonijiet ikkombinati ta' raloxifene u l-metaboliti ta' glucuronide.
English: b. Tabulated summary of adverse reactions
Maltese: Sommarju tabulat tar-reazzjonijiet avversi
English: ii) Bone Mineral Density (BMD): The efficacy of raloxifene once daily in postmenopausal women aged up to 60 years and with or without a uterus was established over a two-year treatment period.
Maltese: ii) Id-Densità Minerali tal-Għadam (Bone Mineral Density (BMD): L-effikaċja ta' raloxifene darba kuljum fin-nisa wara l-menopawsa ta' età sa 60 sena, kemm f'dawk li għandhom u dawk li m'għandhomx utru, kienet stabilita fuq perijodu ta' kura ta' sentejn.
English: In the prevention population discontinuations of therapy due to any adverse reaction occurred in 10.7 % of 581 raloxifene treated patients and 11.1 % of 584 placebo-treated patients.
Maltese: Fil-popolazzjoni ta' prevenzjoni, it-terapija kellha titwaqqaf f'10.7 % minn fost 581 pazjent trattati b'raloxifene u 11.1 % minn fost 584 pazjent li ngħata l-plaċebo minħabba reazzjonijiet avversi.
English: Raloxifene reduced the incidence of clinical vertebral fractures by 35 % compared with placebo (HR 0.65, CI 0.47 0.89).
Maltese: Raloxifene naqqset l-inċidenza ta' ksur kliniku tal-vertebri b'35 % meta mqabbla ma' plaċebo (HR 0.65, CL 0.47
English: Raloxifene levels are maintained by enterohepatic recycling, giving a plasma half-life of 27.7 hours.
Maltese: Il-livelli ta' raloxifene jinżamm permezz tar reċiklar enteroepatiku, li jirriżulta f'half-life fil-plażma ta' 27.7 sigħat.
English: Pharmaco-therapeutic group: Selective oestrogen receptor modulator.
Maltese: Grupp farmako-terapewtiku: modulatur silettiv għar-riċetturi tal-estroġenu (SERM).
English: Raloxifene modestly increases hormone-binding globulin concentrations, including sex steroid binding globulins (SHBG), thyroxine binding globulin (TBG), and corticosteroid binding globulin (CBG), with corresponding increases in total hormone concentrations.
Maltese: Raloxifene jżid moderatament il-konċentrazzjonijiet tal-globulini li jaqbdu mal-ormoni, inklużi l-globulini li jaqbdu mal-ormoni sterojdi sesswali (SHBG), il-globulina li taqbad mal-ormon thyroxine (TBG) u l-globulina li taqbad mal-kortikosterojdi (CBG), b'żidiet korrispondenti fil-konċentrazzjonijiet totali tal-ormoni.
English: • Increased risk of blood clots in the lungs (pulmonary embolism).
Maltese: • Riskju ogħla ta' emboli tad-demm fil-pulmun (emboliżmu pulmonari)
English: - If you have severe kidney problems.
Maltese: - Jekk għandek problemi severi tal-kliewi.
English: The relative risk of venous thromboembolic events observed during raloxifene treatment was 1.60 (CI 0.95, 2.71) when compared to placebo, and was 1.0 (CI 0.3, 6.2) when compared to oestrogen or hormonal replacement therapy.
Maltese: Ir-riskju relattiv ta' każijiet tromboembolici fil-vini osservati waqt il-kura b'raloxifene kien 1.60 (CI 0.95, 2.71) meta mqabbel ma' dak tal-plaċebo u kien 1.0 (CI 0.3, 6.2) meta mqabbel mat-terapija bl-estroġenu jew mat-terapija ta' sostituzzjoni tal-ormoni.
English: After 3 years of treatment, at least a 5 mm increase in endometrial thickness, assessed with transvaginal ultrasound, was observed in 1.9 % of the 211 women treated with raloxifene 60 mg/day compared to 1.8 % of the 219 women who received placebo.
Maltese: Wara 3 snin ta' kura, mhux inqas minn 5 mm żieda fil-ħxuna tal-endometriju, kif assessjat bl-ultrasawnd transvaġinali, kien osservat f'1.9 % ta' 211-il mara, ittrattat b'60 mg raloxifene kuljum meta mqabbla ma' 1.8 % ta' 219-il mara li rċevew il-plaċebo.
English: Raloxifene Teva 60 mg is available in pack sizes of 14, 28 and 84 film-coated tablets.
Maltese: Raloxifene Teva 60 mg jiġu f'pakketti ta' 14, 28 u 84 pillola miksija b'rita.
English: A relative risk of 1.60 (CI 0.95, 2.71) was observed in raloxifene treated patients compared to placebo.
Maltese: Riskju relattiv ta' 1.60 (CI 0.95, 2.71) kien osservat fil-pazjenti ttrattati b'raloxifene meta mqabbla ma' dawk fuq il-plaċebo.
English: Renal insufficiency - Less than 6 % of the total dose is eliminated in urine.
Maltese: L-insuffiċjenza tal-kliewi - Inqas minn 6 % tad-doża totali tiġi eliminata fl-awrina.
English: Superficial vein thrombophlebitis occurred in a frequency of 1 % in the raloxifene group and 0.6 % in the placebo group.
Maltese: Tromboflebite ta' vina superfiċjali seħħet fi frekwenza ta' 1 % fil grupp ta' raloxifene u 0.6 % fil-grupp ta' plaċebo.
English: If you stop taking Raloxifene Teva
Maltese: Tieħux Raloxifene Teva
English: In a study of 7,705 postmenopausal women with a mean age of 66 years and with osteoporosis or osteoporosis with an existing fracture, raloxifene treatment for 3 years reduced the incidence of vertebral fractures by 47 % (RR 0.53, CI 0.35, 0.79; p < 0.001) and 31 % (RR 0.69, CI 0.56, 0.86; p < 0.001) respectively.
Maltese: Fi studju fuq 7,705 mara wara l-menopawsa ta' età medja ta' 66 sena li għandhom l-osteoporożi jew l-osteoporożi bi ksur eżistenti, it-trattament b'raloxifene għal 3 snin naqqas l-inċidenza ta' ksur tal-vertebri b'47 % (RR 0.53, CI 0.35 0.79; p < 0.001) u 31 % (RR 0.69,
English: This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1 % for raloxifene and 1.9 % for placebo; and in the treatment population occurred at an incidence of 7.1 % for raloxifene and 6.1 % for placebo.
Maltese: Din kienet edema periferali, li seħħet fil-popolazzjoni ta' prevenzjoni b'inċidenza ta' 3.1 % għal raloxifene u 1.9 % għal placebo; u fil-grupp ta' trattament l inċidenza kienet ta' 7.1 % għal raloxifene u 6.1 % għal plaċebo.
English: The incidence of stroke mortality was 2.2 per 1,000 women per year for raloxifene versus 1.5 per 1,000 women per year for placebo (see section 4.4).
Maltese: Linċidenza ta' mortalità minħabba puplesija kienet ta' 2.2 għal kull 1,000 mara fis-sena għal raloxifene meta mqabbel ma' 1.5 għal kull 1,000 mara fis-sena għal plaċebo (ara sezzjoni 4.4).
English: Raloxifene Teva belongs to a group of non-hormonal medicines called selective oestrogen receptor modulators (SERMs).
Maltese: Raloxifene jappartjeni għal grupp ta' mediċini mhux ormonali li jissejħu modulaturi selettivi għarriċetturi tal-estroġen (selective oestrogen receptor modulators (SERMs)).
English: One further change was seen which was not statistically significant (p > 0.05), but which did show a significant dose trend.
Maltese: Kien hemm bidla oħra li kienet innotata, li ma kinitx statistikament sinifikanti (p > 0.05), iżda li wriet xejra sinifikanti relatata mad-doża.
English: In rabbits, abortion and a low rate of ventricular septal defects (≥ 0.1 mg/kg) and hydrocephaly (≥ 10 mg/kg) were seen.
Maltese: Fil-fniek, l-abort u rata baxxa ta' difetti fis-septum li jifred ilventrikoli tal-qalb (≥ 0.1 mg/kg), u l-idroċefalija (≥ 10 mg/kg) kienu innotati.
English: In the RUTH study, leg cramps were observed in 12.1 % of raloxifene-treated patients and 8.3 % of placebo-treated patients.
Maltese: Fl-istudju RUTH, il-bugħawwieġ fir-riġlejn kien osservat f'12.1 % ta' pazjenti trattati b'raloxifene u 8.3 % ta' pazjenti trattati bi plaċebo.
English: Another adverse reaction observed was leg cramps (5.5 % for raloxifene, 1.9 % for placebo in the prevention population and 9.2 % for raloxifene, 6.0 % for placebo in the treatment population).
Maltese: 1.9 % għal plaċebo fil-popolazzjoni ta' prevenzjoni u 9.2 % għal raloxifene, 6.0 % għal plaċebo fil-popolazzjoni fil-grupp tat-trattament).
English: In female mice, an increased incidence of ovarian tumours in animals given 9 to 242 mg/kg (0.3 to 32 times the AUC in humans) included benign and malignant tumours of granulosa/theca cell origin and benign tumours of epithelial cell origin.
Maltese: 9 sa 242 mg/kg (0.3 sa 32 darba l-AUC fil-bniedem) kienu jinkludu tumuri beninni u malinni ta'
English: • Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
Maltese: • Sintomi gastrointestinali bħal dardir, rimettar, uġigħ addominali u taqlib fl- istonku
English: • Swelling of hands, feet and legs (peripheral oedema).
Maltese: • Nefħa fl-idejn, is-saqajn u r-riġlejn (edema periferali).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu/.