FrancophonIA/ELRC3.0 huggingface dataset:
English: Cats: After administration of 40 micrograms dexmedetomidine/kg bw intramuscularly concurrently with 5 mg ketamine/kg bw to cats, the maximum concentration of dexmedetomidine increased twofold but there was no effect on T max.
Maltese: Wara amministrazzjoni ta' 40 mikrogrammi dexmedetomidine /kg piż fil-muskolu flimkien ma' 5 mg ketamina /kg piż fil-qtates, l-ogħla konċentrazzjoni ta' dexmedetomidine żdiedet b'darbtejn imma ma kienx hemm effett fuq Tmax.
English: 6.5 Nature and composition of immediate packaging Cardboard box with 1 glass (Type I) vial of 10ml with a chlorobutyl or bromobutyl rubber stopper and aluminium cap.
Maltese: In-natura u l-għamla ta' l-ewwel ippakkjar Kaxxa tal-kartun b'fjala waħda tal-ħġieġ (Tip I) ta' 10 ml b'tapp tal-klorobutil jew tal-bromobutil u għatu tal-aluminjum.
English: 6.5 Nature and composition of immediate packaging Cardboard box with 1 glass (Type I) vial of 20 ml (with filling volume of 15 ml) with a bromobutyl rubber stopper and aluminium cap.
Maltese: Kaxxa tal-kartun b'fjala waħda tal-ħġieġ (Tip I) ta' 20 ml (b'volum mimli ta' 15 ml) b'tapp talklorobutil jew tal-bromobutil u għatu tal-aluminjum.
English: Dexmedetomidine 300 mcg/m2 intramuscularly
Maltese: Dexmedetomidine 300 mcg/m2 fil-muskolu
English: METHOD AND ROUTE(S) OF ADMINISTRATION Dogs: intravenous or intramuscular use Cats: intramuscular use
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Klieb: injezzjoni fil-vina jew fil-muskolu Qtates: injezzjoni fil-muskolu Aqra l-fuljett ta' tagħrif qabel tuża.
English: In a clinical study, dexmedetomidine contributed to postoperative analgesia for 0.5 - 4 hours.
Maltese: Fi studju kliniku dexmedetomidine wassal għal serħan mill-uġiġħ għal 0.5 - 4 siegħat.
English: Cats: The maximum plasma concentration is reached about 0.24 h after intramuscular administration.
Maltese: L-ogħla konċentrazzjoni fil-plażma tintlaħaq madwar 0.24 ta' siegħa wara amministrazzjoni filmuskolu.
English: The specific α2-adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans only experimentally to antagonize dexmedetomidine-induced effects.
Maltese: adrenoceptor speċifiku, atipamezole, li huwa approvat għall-użu f'annimali żgħar, intuża fin-nies biexjantagonizza l-effetti ta' dexmedetomidine, b'mod sperimentali biss.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 ml, 10 x 10 ml
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 10 ml, 10 x 10 ml
English: Nervous, aggressive or excited animals should be given the possibility to calm down before initiation of treatment.
Maltese: Annimali nervużi, aggressivi jew eċċitati għandhom jingħataw il-possibilita li jikkalmaw qabel jinbeda ttrattament.
English: ROUTE(S) OF ADMINISTRATION Dogs: intravenous or intramuscular use Cats: intramuscular use
Maltese: MOD TA' AMMINISTRAZZJONI Klieb: injezzjoni fil-vina jew fil-muskolu Qtates: injezzjoni fil-muskolu
English: The dosage for cats is 40 micrograms dexmedetomidine hydrochloride/ kg bw equal to a dose volume 0.08 ml Dexdomitor/ kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Maltese: Id-doża għall-qtates hija ta' 40 mikrogrammi dexmedetomidine hydrochloride /kg piż li huma daqs volum ta' doża ta' 0.08 ml Dexdomitor /kg piż meta jintuża għal proċeduri u eżaminazzjonijiet minn barra, li jikkawżaw ftit uġiġħ jew uġiġħ moderat fejn ikun hemm bżonn li trażżan, traqqad u sserraħ mill-uġiġħ.
English: Within 15 minutes dogs and cats are normally awake and standing.
Maltese: Normalment il-klieb u l-qtates ikunu mqajma u fuq saqajhom fi żmien 15-il minuta.
English: One ml contains 0.5 mg dexmedetomidine hydrochloride equivalent to 0.42 mg dexmedetomidine.
Maltese: 0.5 mg dexmedetomidine hydrochloride ekwivalenti għal 0.
English: By virtue of its α2-adrenergic activity, dexmedetomidine causes a decrease in heart rate and body temperature.
Maltese: Meta intuża b'dan il-mod, ġew irrapportati każi ta' remettar, temperatura baxxa u nervożiżmu.
English: Brady- and tachyarrhythmias have been reported and include profound sinus bradycardia, 1st and 2nd degree AV block and sinus arrest.
Maltese: Taħbit tal-qalb bil-mod jew mgħaġġel ġew irrapportati u jinkludu sinus bradycardia fil-fond, AV block ta' l-ewwel u ta' t-tieni grad u waqfien tas-sinus.
English: The dosage for cats is 40 micrograms dexmedetomidine hydrochloride/ kg bw equal to a dose volume 0.4 ml Dexdomitor/ kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Maltese: Id-doża għall-qtates hija ta' 40 mikrogrammi dexmedetomidine hydrochloride /kg piż li huma daqs volum ta' doża ta' 0.4 ml Dexdomitor /kg piż meta jintuża għal proċeduri u eżaminazzjonijiet minn barra, li jikkawżaw ftit uġiġħ jew uġiġħ moderat fejn ikun hemm bżonn li trażżan, traqqad u sserraħ mill-uġiġħ.
English: Dexmedetomidine also induces a number of other α2adrenoceptor mediated effects, which include piloerection, depression of motor and secretory functions of the gastrointestinal tract, diuresis and hyperglycaemia.
Maltese: Dawn jinkludu twaqqif tal-pil, tnaqqis fil-moviment u tnixxijiet tas-sistema gastro-intestinali, żieda fil-produzzjoni ta' l-urina u żieda fil-livell ta' zokkor fiddemm.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/02/033/003
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/02/033/003
English: Blood pressure will increase initially and then return to normal or below normal.
Maltese: Il-pressjoni tad-demm titla' fil-bidu, u wara tinżel għan-normal jew taħt in-normal.
English: ANNEX 127A CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Maltese: ANNESS 127A KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU MINGĦAJR PERIKLU U EFFETTIV TAL-PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure).
Maltese: • Kawtela fl-użu fl-anzjani fid-dawl tar-riskji relatati ma' l-età (b'mod partikolari l-kanċer talbużżieqa, ksur u insuffiċjenza tal-qalb).
English: The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone.
Maltese: Kundizzjonijiet jew restrizzjonijiet fir-rigward tal-użu mingħajr periklu u effettiv tal-prodott mediċinali li jridu jiġu implimentati mill-istati membri.
English: Date of latest renewal: 8 August 2008
Maltese: Data ta' l-aħħar tiġdid: 8 ta' Awwissu 2008
English: INFORMATION IN BRAILLE Evista
Maltese: INFORMAZZJONI BIL-BRAILLE Evista
English: D-81379 Munich Germany
Maltese: D-81379 Munich Il-Ġermanja
English: After 3 years therapy Evista decreased fibrinogen (6.71 %).
Maltese: Wara 3 snin ta' terapija Evista naqqset il-fibrinoġen (6.71%).
English: Do not take Evista:
Maltese: Tiħux Evista:
English: Uncommon: Thrombocytopenia a
Maltese: Mhux komuni:Tromboċitopenja a
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 August 1998
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 5 Awwissu 1998
English: Evista contains the active substance raloxifene hydrochloride.
Maltese: Evista fiha is-sustanza attiva raloxifene hydrochloride.
English: Evista (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
Maltese: Evista (n=317) kienet imqabbla ma' terapija kontinwa (n=110) ta' sostituzzjoni bl-ormoni (HRT) jew dik ċiklika (n=205) f'xi ftit provi kliniċi.
English: Evista contains lactose.
Maltese: Evista fih lactose.
English: Marketing Authorisation Holder Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, D-81379 Munich, Germany.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, D-81379 Munich, Il-Ġermanja
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).
Maltese: Ġiet użata s-sistema li ġejja bħala klassifikazzjoni tar-reazzjonijiet avversi: komuni ħafna (≥ 1/10), komuni (≥ 1/100, <1/10), mhux komuni (>1/1,000, <1/100), rari (>1/10,000, <1/1,000), rari ħafna
English: The hazard ratio for all VTE events in the RUTH study was HR = 1.44 (1.06 - 1.95).
Maltese: Irriskju ta' komplikazzjonijiet għal każijiet kollha ta' VTE fl-istudju RUTH kien ta' HR= 1.44, (1.061.95).
English: What Evista contains - The active substance is raloxifene hydrochloride.
Maltese: X'fiha Evista - Is-sustanza attiva hi raloxifene hydrochloride.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/073/001 14 film coated tablets EU/1/98/073/002 28 film coated tablets EU/1/98/073/003 84 film coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/98/073/001 14-il pillola miksija b'rita EU/1/98/073/002 28 pillola miksija b'rita EU/1/98/073/003 84 pillola miksija b'rita
English: Evista reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47
Maltese: Evista naqqset l-inċidenza ta' ksur kliniku tal-vertebri b'35% meta mqabbla ma' plaċebo (HR 0.65, CL 0.47 0.89).
English: In the 4th year alone, Evista reduced the new vertebral fracture risk by 39 % (RR 0.61, CI 0.43, 0.88).
Maltese: Fir-raba' sena biss, Evista naqqset ir-riskju ta' ksur ġdid tal-vertebri b'39% (RR 0.61, CI 0.43, 0.88).
English: Clinical trials showed that a 60 mg daily dose of Evista significantly decreased total cholesterol (3 to 6 %), and LDL cholesterol (4 to 10 %).
Maltese: Provi kliniċi wrew li t-teħid ta' doża ta' Evista f'doża ta' 60 mg kuljum ta' naqqset b'mod sinifikanti il-kolesterol totali (b'3 sa 6%) u l-kolesterol LDL (b'4 sa 10%).
English: Another adverse reaction observed was leg cramps (5.5 % for Evista, 1.9 % for placebo in the prevention population and 9.2 % for Evista, 6.0 % for placebo in the treatment population).
Maltese: Reazzjoni avversa oħra kienu l-bugħawwiġijiet fir-riġlejn (5.5% għal Evista, 1.9% għall-plaċebo filgrupp tal-prevenzjoni u 9.2% għal Evista, 6.0% għall-plaċebo fil-grupp tal-kura).
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, Evista 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 nisa wara l-menopawsa ta' età medja ta' 66 sena li għandhom l-osteoporożi jew l-osteoporożi bi ksur eżistenti, il-kura b'Evista għal 3 snin naqqset linċidenza ta' ksur tal-vertebri b'47% (RR 0.53, CI 0.35 0.79; p < 0.001) u 31% (RR 0.69, CI 0.56, 0.86; p < 0.001), rispettivament.
English: Evista 60 mg film coated tablets raloxifene hydrochloride
Maltese: EVISTA 60 mg pilloli miksija b'rita raloxifene hydrochloride
English: Evista lowers total cholesterol and LDL ("bad") cholesterol.
Maltese: Evista tbaxxilek il-livell totali tal-kolesterol u tal- kolesterol LDL (dak li hu ‘ħażin').
English: Evista 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: Il-kura b'Evista għal 4 snin tnaqqas 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 the RUTH study, peripheral oedema occurred in 14.1 % of the raloxifene-treated patients and 11.7 % of the placebo-treated patients, which was statistically significant.
Maltese: Fl-istudju kliniku RUTH, l-edema periferali okkorriet f'14.1% ta' pazjenti kkurati b'raloxifene u fi 11.7% ta' pazjenti kkurati bi plaċebo u dan kien statistikament sinifikanti.
English: Frequently co-administered medicinal products included: paracetamol, non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid, ibuprofen, and naproxen), oral antibiotics, H1 antagonists, H2 antagonists, and benzodiazepines.
Maltese: Prodotti mediċinali li jingħataw spiss inkludew paracetamol, is-sustanzi kontra l-infjammazzjoni li mhumiex sterojdi (bħal acethylsalicylic acid, ibuprofen u naproxen), l-antibijotiċi orali, l-antagonisti
English: Evista should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Maltese: Evista m'għandhiex tintuża f'indeboliment epatiku (ara sezzjonijiet 4.3 u 4.4).
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 li sar fuq grupp ta' nies, tnaqqis ta' 47% fit-tneħħija tal-krejatinina, meta jitqies il-piż tal-ġisem mingħajr it-tessut xaħmi, irriżulta f'17% tnaqqis fit-tneħħija ta' raloxifene u 15% tnaqqis fittneħħija tal-konjugi ta' raloxifene.
English: Flu syndrome was reported by 16.2 % of Evista treated patients and 14.0 % of placebo treated patients.
Maltese: Is-sindromu ta' l-influwenza kien irrapportat f'16.2% f'dawk ittrattati bl-Evista u 14% ta' dawk ilpazjenti ittrattati bil-plaċebo.
English: Other medicines and Evista
Maltese: Mediċini oħra u Evista
English: Across all placebo-controlled clinical trials of raloxifene in osteoporosis, venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis occurred at a frequency of approximately 0.8 % or 3.22 cases per 1,000 patient years.
Maltese: Tul il-provi kliniċi kollha ta' raloxifene fl-osteoporożi, ikkontrollati bl-użu tal-plaċebo, l-avvenimenti tromboembolitiċi fil-vini, inklużi t-trombożi tal-vini fondi, l-emboliżmu pulmonari u t-trombożi talvina tar-retina, okkorrew bi frekwenza ta' madwar 0.8% jew 3.22 każijiet għal kull 1,000 sena ta' letajiet magħduda tal-pazjenti.
English: iv) Histomorphometry (bone quality).
Maltese: iv) Ħistomorfometrija (il-kwalità ta' l-għadam).
English: Nearly 3,000 transvaginal ultrasound (TVUs) examinations were evaluated from 831 women in all dose groups.
Maltese: Kważi 3,000 eżami transvaġinali li saru bl-ultrasawnd (TVU) fuq 831 pazjenta, kienu evalwati fil-gruppi kollha ta' dożaġġi differenti.
English: Very common: Vasodilation (hot flushes)
Maltese: Komuni ħafna : Vażodilatazzjoni (fwawar)
English: Reproductive system and breast disorders Common: Mild breast symptoms a such as pain, enlargement and tenderness General disorders and administration site conditions Very common: Flu syndrome
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Komuni: Sintomi ħfief fis-sidera bħal uġigħ, tkabbir u sensibilità Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna : Sindromu ta' l-influwenza Komuni : Edema periferali
English: Over the 4 years of the osteoporosis treatment trial (involving 7,705 patients), Evista treatment compared to placebo reduced the risk of total breast cancer by 62 % (RR 0.38; CI 0.21, 0.69), the risk of invasive breast cancer by 71 % (RR 0.29, CI 0.13, 0.58) and the risk of invasive oestrogen receptor (ER) positive breast cancer by 79 % (RR 0.21, CI 0.07, 0.50).
Maltese: Tul l-4 snin tal-prova rigward il-kura ta' l-osteoporożi (li nvolviet 7705 pazjenti), il-kura b'Evista meta mqabbla mal-plaċebo naqqset ir-riskju totali ta' kanċer tas-sider b'62%, (RR 0.38, CI 0.21, 0.69) u r-riskju ta' kanċer mifrux tas-sider li jinfirex b'71% (RR 0.29, CI 0.13, 0.58) u r-riskju ta' kanċer tas-sider li jinfirex li hu pożittiv għar-riċettur ta' l-estroġenu (ER) b'79% (RR 0.21, CI 0.07, 0.50).
English: A relative risk of 1.60 (CI 0.95, 2.71) was observed in Evista treated patients compared to placebo.
Maltese: Riskju relattiv ta' 1.60 (CI 0.95, 2.71) kien osservat fil-pazjenti ittrattati bl-Evista meta mqabbla ma' dawk fuq il-plaċebo.
English: Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed.
Maltese: Illivelli tal-bilirubin fis-serum, gamma-glutamyl transferase, alkaline phosphatase, ALT u AST għandhom ikunu immoniterjati mill-qrib waqt il-kura jekk jinstabu livelli għoljin.
English: In the prevention population discontinuations of therapy due to any adverse reaction occurred in 10.7 % of 581 Evista treated patients and 11.1 % of 584 placebo-treated patients.
Maltese: F'pazjenti fejn Evista intużat għall-prevenzjoni, kien hemm bżonn li titwaqqaf it-terapija minħabba xi reazzjoni avversa f'10.7% ta' 581 pazjenta fuq Evista u 11.1% ta' 584 pazjenta fuq il-plaċebo.
English: Compared with placebo-treated patients the occurrence of vasodilatation (hot flushes) was modestly increased in Evista patients (clinical trials for the prevention of osteoporosis, 2 to 8 years postmenopausal, 24.3 % Evista and 18.2 % placebo; clinical trials for the treatment of osteoporosis, mean age 66, 10.6 % for Evista and 7.1 % placebo).
Maltese: Meta mqabbel mal-plaċebo, l-okkorrenza tal-vażodilatazzjoni (il-fwawar) kienet moderatament aktar komuni fil-pazjenti fuq Evista (il-provi kliniċi għal-prevenzjoni ta' l-osteoporożi; minn 2 sa 8 snin wara l-menopawsa, 24.3% bl-Evista u 18.2% bil-plaċebo, il-provi kliniċi għall-kura ta' l-osteoporożi, età medja ta' 66, 10.
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 fil-vini, inkluża t-trombożi tal-vini fondi,l-emboliżmu pulmonari, it-trombożi tal-vina tar-retina, it-tromboflebite tal-vini superfiċjali,
English: Evista belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs).
Maltese: Evista tagħmel parti minn grupp ta' mediċini mhux ormonali msejħa Modulaturi Selettivi għarRiċetturi ta' l-Estroġenu (SERMs).
English: Plasma raloxifene concentrations were approximately 2.5-fold higher than in controls and correlated with bilirubin concentrations.
Maltese: Il-konċentrazzjonijiet ta' raloxifene fil-plażma kienu bejn wieħed u ieħor 2.5 drabi ogħla mill-kontrolli u kienu jikkorrelaw mal-konċentrazzjonijiet tal-bilirubin.
English: Three trials included 1,764 postmenopausal women who were treated with Evista and calcium or calcium supplemented placebo.
Maltese: Tliet provi inkludew 1,764 mara wara l-menopawża li kienu ikkurati b'Evista u calcium, jew il-plaċebo flimkien ma' calcium.
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 ma' l-ormoni, inklużi lglubulini li jaqbdu ma' l-ormoni sesswali sterojdi (SHBG), il-globulina li taqbad ma' l-ormon thyroxine (TBG) u l-globulina li taqbad mal-kortikosterojdi (CBG), b'żidiet korrispondenti filkonċentrazzjonijiet totali ta' l-ormoni.
English: Superficial vein thrombophlebitis occurred in a frequency of 1 % in the raloxifene group and 0.6 % in the placebo group.
Maltese: It-tromboflebite tal-vini superfiċjali okkorriet bi frekwenza ta' 1% fil-grupp ta' raloxifene u ta' 0.6% fil-grupp ta' plaċebo.
English: How to take Evista
Maltese: MANIFATTUR RESPONSABBLI
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.
Maltese: Kull pillola miksija b'rita fiha 60 mg raloxifene hydrochloride, ekwivalenti għal 56 mg ta' raloxifene bażi libera.
English: In the prevention trials, the percentage of subjects experiencing an increase or decrease in BMD during raloxifene therapy was: for the spine 37 % decreased and 63 % increased; and for the total hip 29 % decreased and 71 % increased.
Maltese: Fil-provi tal-prevenzjoni, il-perċentaġġ ta' individwi li kellhom żieda jew tnaqqis fil-BMD waqt it-terapija b'raloxifene kienu: fil-każ ta' l-ispina 37% tnaqqis u 63% żieda; u għall-għadam sħiħ tal-ġenbejn 29% tnaqqis u 71% żieda.
English: NAME OF THE MEDICINAL PRODUCT EVISTA 60 mg film coated tablets raloxifene hydrochloride
Maltese: Informazzjoni għall-utent Evista 60 mg pilloli miksija b'rita raloxifene hydrochloride
English: Evista tablets are packed either in PVC/PE/PCTFE blisters or in high density polyethylene bottles.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Il-pilloli ta' Evista jiġu fil-folji ta' PVC/PE/PCTFE jew fil-fliexken tal-polyethylene ta' densità għolja.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, ta' difett fil-Lapp lactase jew ta' nuqqas fl-assorbiment ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: The clinically most important adverse reactions reported in postmenopausal women treated with Evista were venous thromboembolic events (see section 4.4), which occurred in less than 1% of treated patients.
Maltese: Mil-lat kliniku, l-aktar reazzjonijiet avversi importanti li ġew irrapportati fin-nisa wara l-menopawża kkurati b'Evista kienu avvenimenti tromboemboliċi tal-vini (ara sezzjoni 4.4), li seħħew f'inqas minn 1 % tal-pazjenti kkurati.
English: Charles de Giorgio Ltd. Tel: +356 25600 500
Maltese: Tel: +356 25600 500
English: In clinical trials, Evista did not stimulate the postmenopausal uterine endometrium.
Maltese: Fi provi kliniċi, Evista ma stimulatx l-endometriju ta' l-utru fil-perijodu ta' wara l-menopawsa.
English: In the treatment population discontinuations of therapy due to any clinical adverse event occurred in 12.8 % of 2,557 Evista treated patients and 11.1 % of 2,576 placebo treated patients.
Maltese: F'dawk il-pazjenti li kienu qegħdin jieħdu Evista bħala kura, kien hemm bżonn li titwaqqaf it-terapija minħabba kwalunkwe avveniment kliniku avvers, f'12.8% ta' 2,557 pazjenta li kienu ittrattati b'Evista u 11.1% ta' 2,576 pazjenta ittrattati bil-plaċebo.
English: In postmenopausal women who received raloxifene treatment for 4 years, benign endometrial polyps were reported in 0.9 % compared to 0.3 % in women who received placebo treatment.
Maltese: Fin-nisa wara l-menopawsa li ngħataw kura b'raloxifene għal 4 snin, il-qarnit beninju ta' l-endometriju kien irrapportat f'0.9% meta mqabbel ma' 0.3% fin-nisa li rċevew trattament bil-plaċebo.
English: In the RUTH study, venous thromboembolic events occurred at a frequency of approximately 2.0 % or 3.88 cases per 1,000 patient-years in the raloxifene group and 1.4 % or 2.70 cases per 1,000 patient-years in the placebo group.
Maltese: Fl-istudju kliniku RUTH, l-avvenimenti tromboembolitiċi fil-vini okkorrew bi frekwenza ta' madwar 2.0% jew 3.88 każijiet għal kull 1,000 sena ta' l-etajiet magħduda tal-pazjenti fil-grupp ta' raloxifene u 1.4% jew 2.70 każijiet għal kull 1000 sena ta' l-etajiet magħduda tal-pazjenti fil-grupp ta' plaċebo.
English: Musculoskeletal and connective tissue disorders Common: Leg cramps
Maltese: Disturbi muskolu-skeletali u tat-tessuti konnettivi Komuni: Bugħawwiġijiet tar-riġlejn
English: Common: Headache, including migraine a
Maltese: Komuni: Uġigħ ta' ras, inkluż l-emikranjaa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/073/004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/98/073/004
English: 84 film coated tablets
Maltese: 84 pillola miksija b'rita
English: Evista was associated with reduced bone resorption and a mean positive shift in calcium balance of 60 mg per day, due primarily to decreased urinary calcium losses.
Maltese: Evista kienet assoċjata ma' tnaqqis fit-tmermir ta' l-għadam u ċaqlieq medju u pożittiv fil-bilanċ tal-calcium ta' 60 mg kuljum, dovut primarjament għat-tnaqqis fit-telf ta' calcium fl-awrina.
English: Also includes lactose
Maltese: Evista fiha l-lactose
English: Bottles contain 100 tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 100 pillola miksija b'rita.