FrancophonIA/ELRC3.0 huggingface dataset:
English: A QT clinical study with a 5-arm parallel design (placebo, moxifloxacin 400 mg, toremifene 20 mg, 80 mg, and 300 mg) has been performed in 250 male patients to characterize the effects of toremifene on the QTc interval duration.
Maltese: Twettaq studju kliniku tal-QT b'disinn parallel ta' 5 gruppi (plaċebo, moxifloxacin 400 mg, toremifene 20 mg, 80 mg, u 300 mg) fuq 250 pazjent irġiel biex jiġu kkaratterizzati l-effetti ta' toremifene fuq it-tul tal-intervall QTc.
English: Toremifene is extensively metabolised.
Maltese: Toremifene huwa metabolizzat b'mod estensiv.
English: hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide and ibutilide - medicines used to treat mental and behavioral disorders (neuroleptics); such as phenothiazines,
Maltese: hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide u ibutilide - mediċini użati għall-kura ta' disturbi mentali u ta' mġiba (newroleptiċi); bħal phenothiazines,
English: One tablet contains 28.5 mg of lactose.
Maltese: Pillola waħda fiha 28.5 mg ta' lactose.
English: Common (≥ 1/100 to <1/10)
Maltese: Komuni (≥ 1/100 sa < 1/10)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 tablet contains: 60 mg toremifene (as citrate)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Pillola 1 fiha 60 mg toremifene (bħala citrate)
English: Vascular disorders hot flushes thromboembolic events
Maltese: Disturbi vaskulari fwawar talmenopa wsa avvenimenti tromboemb oliċi
English: Fareston increases the QT interval in a dose-related manner (see also section 4.4).
Maltese: Fareston iżid l-intervall QT b'mod relatat mad-doża (ara wkoll sezzjoni 4.4).
English: Therefore co-administration of Fareston with any of the following medicinal products is contraindicated (see also section 4.3): antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) or antiarrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), certain antimicrobials agents (moxifloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), others (cisapride, vincamine IV, bepridil, diphemanil).
Maltese: Għalhekk, l-għoti ta' Fareston ma' xi wieħed millprodotti mediċinali li ġejjin huwa kontraindikat (ara wkoll sezzjoni 4.3): - antiarritmiċi ta' klassi IA (eż. quinidine, hydroquinidine, disopyramide) jew - antiarritmiċi ta' klassi III (eż. amiodarone, sotalol, dofetilide, ibutilide), - newroleptiċi (eż. phenothiazines, pimozide, sertindole, haloperidol, sultopride), - ċerti sustanzi kontra l-mikrobi (moxifloxacin, erythromycin IV, pentamidine, sustanzi kontra l malarja speċjalment halofantrine), - ċerti antistaminiċi (terfenadine, astemizole, mizolastine), - oħrajn (cisapride, vincamine IV, bepridil, diphemanil).
English: The half-life of the first (distribution) phase is 4 (range 2 - 12) hours, and of the second (elimination) phase 5 (range 210) days.
Maltese: Il-half life talewwel (distribuzzjoni) fażi hi ta' 4 sigħat (firxa 2 - 12) u tat-tieni (eliminazzjoni) fażi ħamest ijiem (firxa 2 - 10).
English: Thrombocytopenia, anaemia and leukopenia
Maltese: Tromboċitopenija, anemija u lewkopenija
English: The mean concentration of toremifene at steady-state is 0.9 (range 0.6 - 1.3) µg/ml at the recommended dose of 60 mg per day.
Maltese: Il-konċentrazzjoni medja ta' toremifene fi stat fiss hi ta' 0.9 (firxa 0.6 - 1.3) µg/ml fid-doża rrakkomandata ta' 60 mg kuljum.
English: Toremifene obeys linear serum kinetics at oral daily doses between 11 and 680 mg.
Maltese: Toremifene jimxi ma' kinetika lineari tas-serum f'dożi mill-ħalq ta' bejn 11 u 680 mg kuljum.
English: Thromboembolic events include deep venous thrombosis, thrombophlebitis and pulmonary embolism (see also section 4.4).
Maltese: Avvenimenti tromboemboliċi jinkludu trombożi fil-vini, tromboflebite, u emboliżmu fil-pulmun (ara wkoll sezzjoni 4.4).
English: Fareston contains lactose
Maltese: Fareston fih lactose
English: Enzyme complex, known to be responsible for the metabolism of toremifene in humans, is cytochrome P450-dependent hepatic mixed function oxidase.
Maltese: Il-kumpless ta' enzimi, magħruf li hu responsabbli għall-metaboliżmu ta' toremifene fil-bniedem, hu ċ-ċitokromju P450-dependant hepatic mixed function oxidase.
English: Fareston tablets contain lactose (28.5 mg/tablet).
Maltese: Il-pilloli Fareston fihom lactose (28.5 mg/pillola).
English: Pharmacokinetics of toremifene were investigated in an open study with four parallel groups of ten subjects: normal subjects, patients with impaired (mean AST 57 U/L - mean ALT 76 U/L - mean gamma GT 329 U/L) or activated liver function (mean AST 25 U/L - mean ALT 30 U/L - mean gamma GT 91 U/L - patients treated with antiepileptics) and patients with impaired renal function (creatinine: 176 µmol/L).
Maltese: Il-farmakokinetika ta' toremifene ġiet investigata fi studju miftuħ f'erba' gruppi paralleli ta' għaxar persuni: persuni normali, pazjenti b'indeboliment fil-funzjoni tal-fwied (AST medja 57 U/L - ALT medja 76 U/L - gamma GT medja 329 U/L) jew b'funzjoni tal-fwied attivata (AST medja 25
English: The main metabolic pathway, N-demethylation, is mediated mainly by CYP3A.
Maltese: Il-passaġġ metaboliku prinċipali, N-demethylation, hu kkontrollat prinċipalment minn CYP3A.
English: Ear and labyrinth disorders vertigo
Maltese: Disturbi filwidnejn u fissistema labirintika vertigo
English: Pharmacotherapeutic group: Anti-estrogens, ATC code: L02BA02
Maltese: Anti-estroġeni, Kodiċi ATC:
English: FI-02200 Espoo Finland
Maltese: Espoo Il-Finlandja
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT · Risk Management Plan (RMP)
Maltese: Pjan tal-ġestjoni tar-riskju (RMP)
English: endometrial cancer
Maltese: kanċer endometrijali
English: Examples of such drugs are antifungal imidazoles (ketoconazole); other antifungal agents (itraconazole, voriconazole, posaconazole); protease inhibitors (ritonavir, nelfinavir), macrolides (clarithromycin, erythromycin, telithromycine).
Maltese: Eżempji ta' mediċini bħal dawn huma imidazoles kontra l-moffa (ketoconazole); u sustanzi oħra kontra l-moffa (itraconazole, voriconazole, posaconazole); inibituri ta' protease (ritonavir, nelfinavir), macrolides (clarithromycin, erythromycin, telithromycine).
English: This might lead to an increased risk of ventricular arrhythmias, including Torsade de pointes.
Maltese: Dan jista' jwassal għal riskju akbar ta' arritmiji ventrikolari, fosthom Torsade de pointes.
English: pimozide, sertindole, haloperidol and sultopride - medicines used to treat infections (antimicrobials); such as moxifloxacin, erythromycin (infusion)
Maltese: pimozide, sertindole, haloperidol u sultopride - mediċini użati għall-kura ta' infezzjonijiet (sustanzi kontra l-mikrobi); bħal moxifloxacin,
English: BATCH NUMBER Batch:
Maltese: NUMRU TAL-LOTT Numru tal-lott:
English: What Fareston contains - The active substance is toremifene; each tablet contains 60 mg (as citrate).
Maltese: X'fih Fareston - Is-sustanza attiva hi toremifene; kull pillola fiha 60 mg (bħala citrate).
English: Eye disorders transient corneal opacity
Maltese: Disturbi flgħajnejn opaċità temporanja talkornea
English: Vertigo, headache and dizziness were observed in healthy volunteer studies at daily dose of 680 mg.
Maltese: Vertigo, uġigħ ta' ras u sturdament kienu osservati fi studji fuq voluntiera f'saħħithom b'doża ta' 680 mg kuljum.
English: Theoretically the metabolism of toremifene is inhibited by drugs known to inhibit the CYP3A enzyme system which is reported to be responsible for its main metabolic pathways.
Maltese: Teoretikament il-metaboliżmu ta' toremifene jitwaqqaf minn mediċini magħrufa li jinibixxu s-sistema tal-enzima CYP3A li huwa rrappurtat li hi responsabbli għall-metaboliżmu prinċipali tiegħu.
English: PHARMACEUTICAL FORM Tablet.
Maltese: Pillola.
English: How to store Fareston
Maltese: Mediċini oħra u Fareston
English: Fareston contains lactose (28.5 mg per tablet).
Maltese: Fareston fih lactose (28.5 mg f'kull pillola).
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 għall-galactose, defiċjenza ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Joensuunkatu 7
Maltese: Orionintie 1
English: It is also to be noted that the Cmax observed in the monkeys (1800 ng/ml) is two-fold compared to the mean Cmax observed in humans at a daily dose of 60 mg.
Maltese: Għandu jiġi nnutat ukoll li Cmax osservata fix-xadini (1800 ng/ml) hija d-doppju meta mqabbla ma' Cmax medja osservata fil-bnedmin b'doża ta' 60 mg kuljum.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 February 1996
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 14 ta' Frar 1996
English: In vivo, high plasma concentrations in monkeys caused a 24% prolongation in QTc, which is in line with QTc findings in humans.
Maltese: In vivo, konċentrazzjonijiet għoljin fil-plażma fix-xadini kkawżaw titwil ta' 24% fil-QTc, li huwa konsistenti ma' sejbiet dwar QTc fil-bnedmin.
English: The following information regarding QT-prolongation is of special importance (for contraindications see section 4.3).
Maltese: L-informazzjoni segwenti dwar titwil tal-QT hija ta' importanza speċjali (għallkontraindikazzjonijiet ara sezzjoni 4.3).
English: Reproductive system and uterine bleeding endometrial hypertrophy endometrial polyps endometrial hyperplasia,
Maltese: Disturbi fissistema riproduttiva u fis-sider fsada millutru lewkorreja ipertrofija endometrija li polipi endometrija li iperplasija endometrijali
English: About 10% of the administered dose is eliminated via urine as metabolites.
Maltese: Madwar 10% tad-doża li tingħata tiġi eliminata bħala metaboliti fl-awrina.
English: Common Uncommon Rare
Maltese: Komuni ħafna
English: Do not take Fareston together with the following medicines as there is an increased risk that your heartbeat may be altered (see section 2 Do not take Fareston): - medicines used to treat abnormal heart rhythm (antiarrhythmics); such as quinidine,
Maltese: Tiħux Fareston flimkien mal-mediċini li ġejjin peress li hemm żieda fir-riskju li r-rata ta' taħbit ta' qalbek tista' tinbidel (ara sezzjoni 2 Tiħux Fareston): - mediċini użati għall-kura ta' ritmu tal-qalb mhux normali (antiarritmiċi); bħal quinidine,
English: In human serum the main metabolite is N-demethyltoremifene with mean half-life of 11 (range 4 - 20) days.
Maltese: Fis-serum tal-bniedem, il-metabolita prinċipali hu Ndemethyltoremifene b'half life medja ta' 11-il jum (firxa 4 - 20).
English: Non clinical in vitro and in vivo studies have evidenced the potential of toremifene and its metabolite to prolong cardiac repolarisation and this can be attributed to the blockade of hERG channels.
Maltese: Studji in vitro u in vivo li mhumiex kliniċi taw evidenza tal-potenzjal ta' toremifene u l-metabolit tiegħu biex itawlu r-ripolarizzazzjoni tal-qalb u dan jista' jiġi attribwit għall-imblokk tal-kanali hERG.
English: There is a risk of increased endometrial changes including hyperplasia, polyps and cancer.
Maltese: Hemm riskju ta' żieda fit-tibdil endometrijali fosthom iperplasja, polipi u kanċer.
English: pentamidine and antimalarials (particularly halofantrine) - certain medicines to treat allergies; such as terfenadine, astemizole and mizolastine - others; cisapride, intravenous vincamine, bepridil, diphemanil.
Maltese: erythromycin (infużjoni), pentamidine u sustanzi kontra l-malarja (b'mod partikolari halofantrine) - ċertu mediċini għall-kura tal-allerġiji; bħal terfenadine, astemizole u mizolastine) - oħrajn; cisapride, vincamine fil-vini, bepridil, diphemanil.
English: There is no specific antidote and the treatment is symptomatic.
Maltese: M'hemm l-ebda antidotu speċifiku u l-kura hija sintomatika.
English: Metabolism and nutrition disorders loss of appetite
Maltese: Disturbi filmetaboliżmu u n-nutrizzjoni telf tal-aptit
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/004/001 30 tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/004/001 30 pillola
English: The recommended dose is 60 mg daily.
Maltese: Id-doża rakkomandata hi ta' 60 mg kuljum.
English: Pediatric population There is no relevant use of Fareston in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' Fareston fil-popolazzjoni pedjatrika.
English: Anemia, leukopenia and thrombocytopenia have been reported.
Maltese: Kienu rrappurtati anemija, lewkopenija u tromboċitopenija.
English: The acute toxicity of toremifene is low with LD-50 in rats and mice of more than 2000 mg/kg.
Maltese: It-tossiċità akuta ta' toremifene hi baxxa b'LD 50 fil-firien u fil-ġrieden ta' iżjed minn 2000 mg/kg.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 60 mg toremifene (as citrate).
Maltese: Kull pillola fiha 60 mg ta' toremifene (bħala citrate).
English: The most frequent adverse reactions are hot flushes, sweating, uterine bleeding, leukorrhea, fatigue, nausea, rash, itching, dizziness and depression.
Maltese: Ir-reazzjonijiet avversi l-iżjed frekwenti huma fwawar ta' sħana, għaraq, tnixxija ta' demm mill-utru, lewkorreja, għeja, dardir, raxx, ħakk, sturdament u depressjoni.
English: Neoplasms beningn, malignant and unspecified (including cysts and polyps)
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Il-ħtiġijiet għas-sottomissjoni ta' rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u f'kull aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Cases of liver injury, including elevation of liver enzymes (> 10 times upper limit of normal), hepatitis and jaundice have been reported with toremifene.
Maltese: B'toremifene kienu rrappurtati każijiet ta' ħsara fil-fwied, inkluż elevazzjoni tal-enzimi tal-fwied (> 10 darbiet l-ogħla limitu tan-normal), epatite u suffejra.
English: The results of this study show a clear positive effect of toremifene in the 80 mg group with mean prolongations of 21 - 26 ms.
Maltese: Ir-riżultati ta' dan l-istudju juru effett pożittiv ċar ta' toremifene fil-grupp ta' 80 mg b'titwil medju ta' 21 - 26 ms.
English: In post-menopausal breast cancer patients, toremifene treatment is associated with modest reductions in both total serum cholesterol and low density lipoprotein (LDL).
Maltese: F'pazjenti li għaddew mill-menopawsa li għandhom kanċer tas-sider, il-kura b'toremifene hi assoċjata ma' tnaqqis ħafif kemm tal-kolesterol totali fis-serum kif ukoll tal-lipoproteina ta' densità baxxa (LDLlow density lipoprotein).
English: No information is available concerning polymorphic metabolism.
Maltese: M'hemmx tagħrif dwar metaboliżmu polimorfiku.
English: Patients with additional risk of endometrial cancer, e.g. patients suffering from hypertension or diabetes, having high BMI (> 30) or history of hormone replacement therapy should be closely monitored (see also section 4.8).
Maltese: Pazjenti b'riskju miżjud ta' kanċer fl-endometriju, per eżempju pazjenti li jbatu minn pressjoni għolja jew dijabete, li għandhom BMI għoli (> 30) jew li ħadu terapija ta' sostituzzjoni tal-ormon għandhom jiġu mmonitorjati mill-qrib (ara wkoll sezzjoni 4.8).
English: Rare side effects (may affect up to 1 in 1,000 people) - a feeling of spinning (vertigo) - growth on the lining of the womb (endometrial polyps) - increase in liver enzymes (increase of liver transaminases).
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000) - tħoss kollox idur bik (vertigo) - tkabbir fil-kisja tal-utru (polipi endometrijali) - żieda fl-enzimi tal-fwied (żieda fit-transaminases tal-fwied).
English: Patients with a history of severe thromboembolic disease should generally not be treated with toremifene (see also section 4.8).
Maltese: Pazjenti li għandhom storja ta' mard tromoboemboliku gravi ġeneralment m'għandhomx jiġu kkurati b'toremifene (ara wkoll sezzjoni 4.8).
English: Enzyme inducers, like phenobarbital, phenytoin and carbamazepine, may increase the rate of toremifene metabolism thus lowering the steady-state concentration in serum.
Maltese: Indutturi tal-enzimi bħal phenobarbital, phenytoin u carbamazepine jistgħu jżidu r-rata ta' metaboliżmu ta' toremifene u għalhekk ibaxxu l-konċentrazzjoni fi stat fiss fis-serum.
English: Frequency not known (cannot be estimated from the available data) - low number of white blood cells, which are important in fighting infection (leukopenia) - low number of red blood cells (anaemia) - low number of platelets (thrombocytopenia)
Maltese: (lewkopenija) - Numru baxx ta' ċelluli ħomor tad-demm (anemija) - Numru baxx ta' plejtlits (tromboċitopenija) - infjammazzjoni tal-fwied (epatite).
English: MARKETING AUTHORISATION NUMBERS EU/1/96/004/001
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/004/001
English: Common side effects (may affect up to 1 in 10 people ) - fatigue, dizziness, depression - nausea (feeling sick), vomiting - rash, itching, oedema (swelling) - uterine bleeding, white discharge.
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) - għeja, sturdament , depressjoni - dardir (tħossok se tirremetti), rimettar - raxx, ħakk, edima (nefħa) - tnixxija ta' demm mill-utru, tnixxija bajda.
English: As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTc-prolonging medications.
Maltese: Peress li n-nisa għandhom tendenza li jkollhom intervall QTc itwal fil-linja bażi meta mqabbla mal-irġiel, huma jistgħu jkunu aktar sensittivi għal medikazzjonijiet li jtawlu l-QTc.
English: White, round, flat, bevelled edge tablet with TO 60 on one side.
Maltese: Pillola bajda, tonda, ċatta, bit-tarf imżerżaq u bil-kitba TO 60 fuq naħa waħda.
English: The elimination of toremifene and its metabolites was significantly increased in patients with activated liver function and decreased in patients with impaired liver function.
Maltese: L-eliminazzjoni ta' toremifene u tal-metaboliti tiegħu żdied b'mod sinifikanti f'pazjenti b'funzjoni tal-fwied attivata u naqset f'pazjenti b'indeboliment fil-funzjoni talfwied.
English: Psychiatric disorders depression insomnia
Maltese: Disturbi psikjatriċi depressjoni nuqqas ta' rqad
English: posaconazole - medicines used to treat bacterial infections (antibiotics) such as erythromycin, clarithromycin and telithromycin - medicines used to treat viral infection such as ritonavir and nelfinavir.
Maltese: clarithromycin u telithromycin - mediċini użati għall-kura ta' infezzjonijiet ikkawżati minn virusis bħal ritonavir u nelfinavir.
English: - if you experience an abnormal heart rhythm whilst taking Fareston.
Maltese: - jekk ikollok ritmu tal-qalb mhux normali waqt li qed tieħu Fareston.
English: First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.
Maltese: Kura preferita ormonali f'pazjenti li għaddew mill-menopawsa b'kanċer metastatiku tas-sider dipendenti fuq l-ormoni.
English: Drugs which decrease renal calcium excretion, e.g. thiazide diuretics, may increase the risk of hypercalcaemia.
Maltese: Mediċini li jnaqqsu l-eliminazzjoni tal-calcium mill-kliewi, per eżempju dijuretiċi thiazide jistgħu jżidu r-riskju ta' iperkalċimija.
English: Very rare side effects (may affect up to 1 in 10,000 people) - changes in the lining of the uterus (endometrium), cancer of the lining of the womb (endometrial cancer) - hair loss (alopecia) - cloudiness of the eye surface (transient corneal opacity) - yellowing of the skin or whites of the eyes (jaundice).
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000) - bidliet fil-kisja tal-utru (endometriju), kanċer tal-kisja tal-utru (kanċer endometrijali) - telf ta' xagħar (alopeċja) - superfiċje tal-għajn imċajpra (opaċità temporanja tal-kornea) - sfurija tal-ġilda jew tal-abjad tal-għajnejn (suffejra).
English: Fareston causes certain abnormal changes in the electrical recording of the heart (electrocardiogram or ECG).
Maltese: Fareston jikkawża ċerti bidliet mhux normali fl-irrekordjar elettriku tal-qalb (elettrokardjogramm jew ECG). Ara sezzjoni 2 Twissijiet u prekawzjonijiet.
English: Uncommon side effects (may affect up to 1 in 100 people) - headache, sleep disorders - weight increase, constipation, loss of appetite - thickening of the lining of the womb (endometrial hypertrophy) - blood clot for example in the lung (thromboembolic events) - shortness of breath.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100) - uġigħ ta' ras, disturbi fl-irqad - żieda fil-piż, stitikezza, telf ta' aptit - tħaxxin tal-kisja tal-utru (ipertrofija endometrijali) - embolu tad-demm per eżempju fil-pulmun (avvenimenti tromboemboliċi) - qtugħ ta' nifs.
English: Toremifene should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5).
Maltese: Toremifene m'għandux jintuża fl-istess waqt ma' mediċini oħra li jtawlu l-intervall QT (ara wkoll sezzjoni 4.5).
English: The basal disposition parameters (CL and V) could not be estimated due to the lack of intravenous study.
Maltese: Il-parametri tad-dispożizzjoni tal-bażi (CL u V) ma setgħux jiġu stmati minħabba nnuqqas ta' studju fil-vini.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Orion Corporation
Maltese: FIS-SUQ Orion Corporation
English: In the acute and chronic toxicity studies most of the findings are related to the hormonal effects of toremifene.
Maltese: Dak li nstab fl-istudji ta' tossiċità akuta u kronika huwa marbut mal-effetti ormonali ta' toremifene.
English: Hepatic impairment Toremifene should be used cautiously in patients with liver impairment (see section 5.2).
Maltese: Indeboliment tal-fwied Toremifene għandu jintuża b'attenzjoni f'pazjenti b'indeboliment tal-fwied (ara sezzjoni 5.2).
English: An additive effect on QT interval prolongation between Fareston and the following drugs and other medicinal products that may prolong the QTc interval cannot be excluded.
Maltese: Ma jistax jiġi eskluż effett addittiv fuq it-titwil tal-intervall QT bejn Fareston u l-mediċini segwenti u prodotti mediċinali oħra li jistgħu jtawlu l-intervall QTc.
English: You should have gynaecological examinations before you start treatment with Fareston and at least once a year following the start of treatment with Fareston.
Maltese: Id-doża ta' wħud minn dawn il-mediċini jista' jkun li jkollha tinbidel waqt li tkun qed tieħu Fareston.
English: In repeated toxicity studies the cause of death in rats is gastric dilatation.
Maltese: Fi studji ta' tossiċità ripetuta, il-kawza tal-mewt tal-firien hi d-dilatazzjoni gastrika.
English: It is available as tablets (200 mg).
Maltese: Jiġi bħala pilloli (200 mg).
English: The full EPAR for Entacapone Teva can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Entacapone Teva jinsab fis-sit web tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Entacapone Teva entacapone
Maltese: Entacapone Teva entakapon
English: Entacapone Teva is a ‘generic medicine'.
Maltese: Entacapone Teva huwa ‘mediċina ġenerika'.
English: This is a summary of the European public assessment report (EPAR) for Entacapone Teva.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Entacapone Teva.