FrancophonIA/ELRC3.0 huggingface dataset:
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 għal osteoporożi, ikkontrollati bl-użu tal-plaċebo, il-każijiet tromboembolitiċi fil-vini, li jinkludu t-trombożi tal-vini profondi, l-emboliżmu pulmonari u t-trombożi tal-vina tar-retina, seħħew bi frekwenza ta' madwar 0.8 % jew 3.22 każijiet għal kull 1,000 sena tal-etajiet magħduda tal-pazjenti.
English: Very common: Vasodilation (hot flushes)
Maltese: Komuni ħafna: Vażodilatazzjoni (fwawar)
English: Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Maltese: Storja attiva jew fil-passat ta' każijiet tromboemboliċi fil-vini (VTE), li jinkludu t-trombożi profonda fil-vini, emoboliżmu pulmonari u trombożi fil-vina retinali.
English: The Cmax of digoxin increased by less than 5 %.
Maltese: Cmax ta' digoxin żdiedet b'inqas minn 5 %.
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 fl-istess żmien kienu jinkludu: paracetamol, mediċini kontra l-infjammazzjoni li mhumiex sterojdi (bħal acethylsalicylic acid, ibuprofen u naproxen), l-antibijotiċi orali, l-antagonisti
English: • Hot flushes (vasodilatation).
Maltese: • Fwawar (twessigħ tal-vażi tad-demm).
English: In accidental overdose in children younger than 2 years of age, the maximum reported dose has been 180 mg.
Maltese: F'doża eċċessiva aċċidentali fi tfal iżgħar minn sentejn, id-doża massima rapportata kienet ta' 180 kg.
English: Over the 4 years of the osteoporosis treatment trial (involving 7705 patients), raloxifene 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 it-trattament tal-osteoporożi (li kienet tinvolvi 7705 pazjenti), it-trattament b'raloxifene meta mqabbel mal-plaċebo naqqas ir-riskju 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,
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
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: Hekk ukoll, fl-istudju RUTH, raloxifene meta mqabbel ma' plaċebo, ma effettwax l-inċidenza ta' attakki ta' qalb, il-ħtieġa ta' dħul fi sptar minħabba sindromu koronarju akut, ta' attakk ta' puplesija, jew ta'mortalità globali li jinkludi l-imwiet kardjovaskulari kollu, (għaż-żieda fir-riskju ta' puplesija fatali ara sezzjoni 4.4).
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 RUTH, l-edema periferali seħħet f'14.1 % tal-pazjenti trattati b'raloxifene u 11.7 %
English: Clinical trials showed that a 60 mg daily dose of raloxifene significantly decreased total cholesterol (3 to 6 %), and LDL cholesterol (4 to 10 %).
Maltese: b) Effetti fuq il-metaboliżmu tal-lipidi u riskji kardjovaskulari Provi kliniċi wrew li doża ta' 60 mg kuljum ta' raloxifene naqqset b'mod sinifikanti il-kolesterol totali (b'3 sa 6 %) u l-kolesterol LDL (b'4 sa 10 %).
English: Limited clinical data suggest that in patients with a history of oral oestrogen-induced hypertriglyceridemia (> 5.6 mmol/l), raloxifene may be associated with a marked increase in serum triglycerides.
Maltese: Tagħrif kliniku limitat tissuġġerixxi li f'pazjenti bi storja medika ta' ipertrigliċeridimja (> 5.6 mmol/l), dovuti għall-estroġenu orali, raloxifene jista' jkun assoċjat ma' żieda qawwija fil-livelli tat-trigliċeridi fis-serum.
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 madwar 2.5 drabi ogħla mill-kontrolli u kienu jikkorrelaw mal-konċentrazzjonijiet tal-bilirubin.
English: In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion.
Maltese: Fl-adulti, sintomi ta' bugħawwieġ fir-riġlejn u sturdament ġew rapportati f'pazjenti li f'doża orali waħda ħadu iżjed minn 120 mg.
English: 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, li hu ekwivalenti għal 56 mg tal-bażi libera ta' raloxifene.
English: Date of first renewal: 06 February 2015
Maltese: Data tal-ewwel tiġdid: 06 ta' Frar 2015
English: During an average follow-up of 5.6 years, 59 (1.2%) raloxifene-treated women died due to a stroke compared to 39 (0.8%) placebo-treated women.
Maltese: Matul perjodu ta' segwitu medju ta' 5.6 snin, 59 (1.2%) min-nisa kkurati b'raloxifene mietu minħabba puplesija meta mqabbla ma' 39 (0.8%) mara kkurati bi plaċebo.
English: Severe renal impairment.
Maltese: Indeboliment sever tal-kliewi.
English: Raloxifene should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Maltese: Raloxifene m'għandux jintuża f'pazjenti b'indeboliment tal-fwied (ara sezzjoni 4.3 u 4.4).
English: 14 film-coated tablets 28 film-coated tablets 84 film-coated tablets
Maltese: Pillola miksija b'rita 14-il pillola miksija b'rita 28 pillola miksija b'rita 84 pillola miksija b'rita
English: In children, symptoms of accidental overdose included ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, and elevation in alkaline phosphatase.
Maltese: Fi tfal, is-sintomi ta' doża eċċessiva aċċidentali kienet tinkludi atassja, sturdament, remettar, raxx, dijarea, rogħda, u fwawar, u żieda f'alkaline phosphatase.
English: Flu syndrome was reported by 16.2 % of raloxifene treated patients and 14.0 % of placebo treated patients.
Maltese: Is-sindromu tal-influwenza kien irrapportat f'16.2 % f'dawk ittrattati b'raloxifene u 14.0 % ta'
English: Each film-coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene.
Maltese: Kull pillola miksija b'rita fiha 60 mg raloxifene hydrochloride, li hu ekwivalenti għal 56 mg ta' raloxifene.
English: Raloxifene Teva reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
Maltese: Raloxifene Teva jixbah lil ċerti effetti tajbin tal-estroġen wara l-menopawsa.
English: c) Effects on the endometrium and on the pelvic floor
Maltese: ċ) Effetti fuq l-endometriju u l-qiegħ tal-pelvi
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 Common: Peripheral oedema Investigations
Maltese: Komuni ħafna: sindromu tal-influwenza Komuni: Edema periferali
English: Patients with renal impairment:
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq:
English: The frequencies for postmarketing reports were calculated from placebo-controlled clinical trials (comprising a total of 15,234 patients, 7,601 on raloxifene 60 mg and 7,633 on placebo) in postmenopausal women with osteoporosis, or established coronary heart disease (CHD) or increased risk for CHD, without comparison to the frequencies of adverse events in the placebo assignment groups.
Maltese: (b'total ta' 15,234 pazjent, 7,601 li jieħdu raloxifene 60 mg u 7,633 li jieħdu plaċebo) f'nisa wara l menopawża bl-osteoporożi, jew mard koronarju stabbilit tal-qalb (CHD) jew riskju akbar għas-CHD,
English: The reproductive and developmental effects observed in animals are consistent with the known pharmacological profile of raloxifene.
Maltese: L-effetti riproduttivi u fuq l-iżvilupp, osservati fl-annimali, huma konsistenti mal-profil farmakoloġiku magħruf ta' raloxifene.
English: • Increased risk of blood clots in the legs (deep vein thrombosis).
Maltese: • Riskju ogħla ta' emboli tad-demm fir-riġlejn (trombożi profonda fir-riġlejn)
English: In rats retardation of foetal development, wavy ribs and kidney cavitation occurred (≥ 1 mg/kg).
Maltese: Fil-firien kien hemm ittardjar tal-iżvilupp tal-fetu, kustilji mgħawwġa u kavitajiet fil-kliewi (≥ 1 mg/kg).
English: In a study of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, overall mortality, including overall cardiovascular mortality, or stroke, compared to placebo.
Maltese: Fi studju fuq nisa wara l-menopawsa u li hu dokumentat li jbatu minn mard tal-qalb koronarju jew li qegħdin f'riskju ogħla għal problemi koronarji, raloxifene meta mqabbel ma' plaċebo, ma kellu ebda effett fuq l-inċidenza ta' infarti mijokardijaċi, sindromu koronarju akut li tiddaħħal l-isptar għalih, mortalità globali, li tinkludi l-mortalità minħabba problemi kardjovaskulari globali, jew puplesija.
English: There is no relevant use of Raloxifene in the paediatric population.
Maltese: M'hemm ebda użu rilevanti ta' Raloxifene fil-popolazzjoni pedjatrika.
English: • Flu syndrome.
Maltese: • Sindomu tal-influwenza.
English: Endometrial biopsies taken after six months therapy with raloxifene 60 mg daily demonstrated non-proliferative endometrium in all patients.
Maltese: Bijopsiji tal-endometriju meħudin wara terapija ta' 60 mg ta' raloxifene kuljum għal sitt xhur, urew endometriju mhux proliferattiv fil-pazjenti kollha.
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 nisa, raloxifene xekkel iċ-ċikli estroji fil-firien nisa waqt it-trattament, 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 taliżvilupp tal-wild.
English: • Mild breast symptoms such as pain, enlargement and tenderness
Maltese: • Sintomi ħfief tas-sider bħal uġigħ, tkabbir u sensittività
English: When determining the choice of raloxifene 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: Għal kull mara individwali wara l-menopawsa, meta wieħed jiġi biex jagħżel bejn raloxifene jew terapiji oħra, li jinkludu l-estroġeni, konsiderazzjoni xierqa għandha tingħata għas-sintomi tal-menopawsa, l-effetti fuq it-tessuti tal-utru u tas-sider, u r-riskji u s-siwi kardjovaskulari (ara sezzjoni 5.1).
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 f'100 persuna)
English: INFORMATION IN BRAILLE Raloxifene Teva 60 mg
Maltese: It-tul tal-kura f'dawn l-istudji jvarja minn 6 sa 60 xahar.
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' bażi libera ta' raloxifene.
English: Three trials included 1,764 postmenopausal women who were treated with raloxifene and calcium or calcium supplemented placebo.
Maltese: Saru tliet provi li kienu jinkludu 1,764 mara wara l-menopawża li ġew trattati b'raloxifene u kalċju, jew il-plaċebo flimkien ma' kalċju.
English: Film-coated tablet
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: In the RUTH study, venous thromboembolic events occurred at a frequency of approximately 2.0 % or 3.88 cases per 1000 patient-years in the raloxifene group and 1.4 % or 2.70 cases per 1000 patient-years in the placebo group.
Maltese: 3.88 każijiet kull 1000 sena ta' pazjent fil-grupp ta' raloxifene u 1.4 % jew 2.70 każijiet kull 1000 sena ta' pazjent fil-grupp tal-plaċebo.
English: • Gallstones.
Maltese: ′-diglucuronide.
English: In a study comparing raloxifene with oestrogen, bone from patients treated with either medicinal product was histologically normal, with no evidence of mineralisation defects, woven bone or marrow fibrosis.
Maltese: pazjenti trattati ma kull wieħed minn dawn il-prodotti mediċinali kien ħistoloġikament normali, mingħajr evidenza ta' difetti fil-mineraliżżazjoni, għadam minsuġ u fibrożi tal-mudullun.
English: Raloxifene is a potent antioestrogen in the rat uterus and prevented growth of oestrogen-dependent mammary tumours in rats and mice.
Maltese: Raloxifene huwa antiestroġenu qawwi fl-utru tal-far u impedixxa l-iżvilupp ta' tmuri mammarji dipendenti mill-estroġen fil-firien u l-ġrieden.
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 it-trattament b'raloxifene għal 4 snin, il-qarnit benin tal-endometriju kien irrapportat f'0.9 %
English: The table below gives the adverse reactions and frequencies observed in treatment and prevention studies involving over 13,000 postmenopausal women along with adverse reactions arising from postmarketing reports.
Maltese: It-tabella ta' hawn taħt turi r-reazzjonijiet avversi u l-frekwenzi osservati fl-istudji dwar il-kura u lprevenzjoni li involvew aktar minn 13,000 mara wara l-menopawża flimkien ma' reazzjonijiet avversi li rriżultaw minn rapporti ta' wara t-tqegħid fis-suq.
English: In addition, in a study with 2.5 x the recommended daily dose of raloxifene there was no evidence of endometrial proliferation and no increase in uterine volume.
Maltese: raloxifene kienet 2.5 drabi akbar minn dik rakkomandata li għandha tittieħed kuljum, ma kienx hemm evidenza ta' proliferazzjoni tal-endometriju,u anqas żieda fil-volum tal-utru.
English: Store in the original package to protect from moisture.
Maltese: Żommu fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: It is unlikely that Raloxifene Teva will cause vaginal bleeding.
Maltese: Mhux probabbli li Raloxifene Teva ser jikkawża emorraġija vaġinali.
English: Replacement therapies generally reverse the excessive resorption of bone.
Maltese: Terapiji ta' sostituzzjoni ġeneralment ireġġgħu lura t-tmermir eċċessiv tal-għadam.
English: When given during the preimplantation period, raloxifene delayed and disrupted embryo implantation resulting in prolonged gestation and reduced litter size but development of offspring to weaning was not affected.
Maltese: Fl-istudju RUTH, raloxifene ma affettwax l-inċidenza ta' puplesija, meta mqabbel mal-plaċebo.
English: Hepatic insufficiency - The pharmacokinetics of a single dose of raloxifene in patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) have been compared to that in healthy individuals.
Maltese: L-insuffiċjenza tal-fwied - Il-farmakokinetika ta' doża waħda ta' raloxifene f'pazjenti b'ċirrożi u b'indeboliment moderat tal-fwied (Klassi A Child-Pugh) kien imqabbel ma' dak ta' individwi b'saħħithom.
English: Gastrointestinal disorders Very common: Gastrointestinal symptoms a such as nausea, vomiting, abdominal pain, dyspepsia
Maltese: Komuni ħafna: Sintomi gastrointestinalia bħal dardir, rimettar, uġigħ fl-addome, dispepsja
English: Effects on prothrombin time may develop over several weeks if raloxifene treatment is started in patients who are already on coumarin anticoagulant therapy.
Maltese: jekk it-trattament b'raloxifene tinbeda f'pazjenti li diġa qegħdin fuq it-terapija antikoagulanti bil-coumarin.
English: The PSUR submission schedule for Raloxifene Teva should follow PSUR submission schedule for the reference medicinal product.
Maltese: L-iskeda tas-sottomissjonijiet tal-PSUR għandu jsegwi l-iskeda tas-sottomissjoni tal-PSUR għal prodott mediċinali ta' riferiment.
English: What Raloxifene Teva contains
Maltese: Jekk tinsa tieħu Raloxifene Teva
English: In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years.
Maltese: F' xi provi kliniċi, dożi ta' kuljum ta' 600 mg għal 8 ġimgħat u 120 mg, għal 3 snin, kienu ttollerati tajjeb.
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 fl-istess ħin jew ta' calcium carbonate inkella ta' aluminium u magnesium hydroxide li jinstabu fl-antaċidi, ma jaffetwax l-espożizzjoni sistemika ta' raloxifene.
English: Raloxifene 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'raloxifene għal 8 snin ma effettwatx b'mod sinifikanti r-riskju ta' każijiet kardjovaskulari f'pazjenti involuti fl-istudju dwar il-kura tal-osteoporożi.
English: Pliva Ljubljana d.o.o.
Maltese: H2, u l-benzodijażepini.
English: Raloxifene should not be used in patients with severe renal impairment (see section 4.3).
Maltese: Raloxifene għandu jintuża f'pazjenti li għandhom indeboliment sever tal-kliewi (ara sezzjoni 4.3).
English: Musculoskeletal and connective tissue disorders Common: Leg cramps
Maltese: Mhux komuni: Tromboċitopenjaa Disturbi fis-sistema nervuża
English: ATC code: G03XC01 Mechanism of action and Pharmacodynamic effect As a selective oestrogen receptor modulator (SERM), raloxifene has selective agonist or antagonist activities on tissues responsive to oestrogen.
Maltese: Mekkaniżmu ta' azzjoni u Effett farmakondinamiku Bħala modulatur silettiv għar-riċetturi tal-estroġen (SERM), raloxifene għandu attivitajiet silettivi agonistiċi jew antagonistiċi, fuq it-tessuti li jirrispondu għall-effett tal-estroġen.
English: In a 2-year carcinogenicity study in rats, an increase in ovarian tumors of granulosa/theca cell origin was observed in high-dose females (279 mg/kg/day).
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà tal-mediċina Fi studju li dam sejjer sentejn dwar il-karċinoġenitċità fil-firien, ġie osservat li kien hemm żieda fit-tumuri ovarjani ta' granulosa/teka f'nisa li ġew mogħtija dożi għoljin (279 mg/kg/kuljum).
English: As safety information regarding co-administration of raloxifene with systemic oestrogens, is limited, such use is not recommended.
Maltese: Peress li l-informazzjoni dwar is-sigurtà dwar l-għoti flimkien ta' raloxifene ma' estroġeni sistemiċi hi limitata, dan l-użu mhux irrakkomandat.
English: Slightly decreased (6-10 %) platelet counts have been reported during raloxifene treatment in placebo-controlled clinical trials of raloxifene in osteoporosis.
Maltese: Ġie rappurtat tnaqqis fl-għadd ta' plejtlets (6-10 %) waqt it-trattament b'raloxifene fi trattament kontrollat bi plaċebo fil-provi kliniċi ta'
English: Raloxifene treated women consistently had an endometrial thickness which was indistinguishable from placebo.
Maltese: Inċidenza simili ta' żidiet kienet innotata fost il-pazjenti fuq il-plaċebo.
English: • Skin around the vein is red and painful (superficial vein thrombophlebitis).
Maltese: • Il-ġilda madwar il-vina hi ħamra u bl-uġigħ (tromboflebite f'vina superfiċjali).
English: Tablet core:
Maltese: Kodiċi ATC:
English: Systemic exposure (AUC) of raloxifene in this group was approximately 400 times that in postmenopausal women administered a 60 mg dose.
Maltese: Espożizzjoni sistemika (AUC) ta' raloxifene f'dan il-grupp kienet ta' madwar 400 darba dak fin-nisa ta' wara l-menopawża li ngħataw doża ta' 60 mg.
English: Across all placebo-controlled trials, raloxifene was indistinguishable from placebo with regard to frequency and severity of breast symptoms (no swelling, tenderness and breast pain).
Maltese: Fil-firxa kollha tal-provi kliniċi, ikkontrollati bil-plaċebo, raloxifene ma setax jingħaraf mill-plaċebo rigward il-frekwenza u severità tas-sintomi fis-sider (ebda nefħa, tenerezza u uġigħ fis-sider).
English: Raloxifene 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: Ma kienx hemm effetti klinikament rilevanti bl-użu konkomittanti ta' dawn is-sustanzi fuq il-konċentrazzjonijiet ta' raloxifene fil-plażma.
English: Teva Santé
Maltese: Teva
English: The women were 2 to 8 years postmenopausal.
Maltese: 8 snin bil-menopawsa.
English: White to off-white, film coated, oval shaped tablets, embossed with the number “60” on one side and “N” on the other side of the tablet.
Maltese: Pilloli bojod għal ofwajt, miksija b'rita, f'għamla ovali, imnaqqxin bin-numru “60” fuq naħa waħda u
English: A similar increase in BMD was seen in the treatment population who received raloxifene for up to 7 years.
Maltese: Żieda simili fil-BMD dehret fil-grupp tal-kura li rċevew raloxifene għal perijodu ta' 7 snin.
English: MA (EU) number (Invented) name
Maltese: Numru MA (EU)
English: Pharmaceutical form
Maltese: 14-il pillola
English: Pack size
Maltese: Imballaġġ immedjat
English: Senshio (ospemifene)
Maltese: Senshio (ospemifen)
English: Further information on Senshio can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/senshio .
Maltese: Aktar informazzjoni dwar Senshio tinstab fis-sit web tal-Aġenzija: www.ema.europa.eu/medicines/human/EPAR/senshio.
English: Senshio is available as tablets (60 mg).
Maltese: Senshio jiġi bħala pilloli (60 mg).
English: Senshio received a marketing authorisation valid throughout the EU on 15 January 2015.
Maltese: Senshio ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fil-15 ta' Jannar 2015.
English: Senshio contains the active substance ospemifene.
Maltese: Senshio fih is-sustanza attiva ospemifen.
English: Other information about Senshio
Maltese: Informazzjoni oħra dwar Senshio
English: The most commonly reported side effects with Senshio (affecting up to 1 in 10 people) are vulvovaginal candidiasis and other mycotic (fungal) infections, hot flushes, headache, muscle spasms, vaginal bleeding, vaginal and genital discharge, and rash.
Maltese: L-effetti sekondarji l-aktar komuni rrappurtati b'Senshio (li jaffettwaw sa persuna 1 minn kull 10) huma kandidjażi vulvovaġinali u infezzjonijiet mjokotiċi (fungali) oħrajn, fwawar tas-sħana, uġigħ ta' ras, spażmi fil-muskoli, fsada vaġinali, tnixxija vaġinali u ġenitali, u raxx
English: Senshio improved symptoms of vulvovaginal atrophy in postmenopausal women.
Maltese: Senshio tejjeb is-sintomi tal-atrofija vulvovaġinali fin-nisa wara lmenopawża.
English: This can cause irritation and soreness and make sexual intercourse painful.The active substance in Senshio, ospemifene, is a selective oestrogen receptor modulator (SERM).
Maltese: Is-sustanza attiva f'Senshio, l-ospemifen, hija modulatur selettiv tar-riċettur tal-estroġenu (SERM).
English: Why is Senshio approved?
Maltese: Għaliex ġie approvat Senshio?