FrancophonIA/ELRC3.0 huggingface dataset:
English: Adjuvant: Liquid paraffin
Maltese: KWALITAJIET IMMUNOLOĠIĊI
English: CONTROL TESTS ON THE FINISHED PRODUCT
Maltese: TESTIJIET TA' KONTROLL FUQ IL PRODOTT LEST
English: From 14 days to 6 weeks old: 0.25 or 0.5ml subcutaneously or intramuscularly 6 weeks and older: 0.5ml subcutaneously or intramuscularly Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination No information is available on vaccination in the presence of maternally derived antibodies.
Maltese: Jekk il-virus tal-influwenza avjarja li qed jiċċirkula fil-beraħ għandu l-komponent H u/jew N tiegħu differenti mill-H7N1, inkluż fil-vaċċin, ikun possibli li tagħraf tagħżel bejn tjur imlaqqma u dawk infettati billi tuża test dijagnostiku li jagħraf il-]aemagglutinin jew/u antikorpi Nuraminidejs.
English: Chickens and ducks
Maltese: Flieles u papri
English: Light liquid paraffin
Maltese: HUWA INDIKAT IL-PRODOTT Flieles u papri
English: Intervet International BV Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat 35 NL-5831 AN Boxmeer.
English: The level of efficacy for other species may differ from that observed in chickens.
Maltese: Illivell ta' effikaċja fi speċi oħra jista' jkun differenti minn dak osservat fil-flieles.
English: or S.C. injection of 0.25, 0.5 ml or 1 ml, depending on the age and species.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Titqiba fil-muskolu jew taħt il-ġilda ta' 0.25ml , 0.5ml jew 1.0ml skond l-eta'.
English: ROUTE(S) OF ADMINISTRATION I.M.
Maltese: U INGREDJENT(I)
English: From 2 to 6 weeks: 0.5 ml subcutaneously or intramuscularly.
Maltese: Papri li għandhom minn 2 -6 ġimghat: 0.5ml taħt il-ġilda jew fil-muskolu.
English: A revised supporting TSE compliance table should be provided with deletion of the words ‘or equivalent' after the source companies for the tryptose and NZ-Amines and ‘e.g.'
Maltese: Anke jekk ġew injettati ammonti żgħar, injezzjoni bi żball ta' dan il-prodott tista' tikkawża nefħa intensa, li tista' per eżempju tikkawża nekrożi iskimika u anke l-bżonn li jinqata' xi subgħa.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose no adverse reactions other than those described in section 4.6 have been observed.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti)jekk ikun hemm bżonn
English: 6.3 Shelf life
Maltese: II.F STABBILITA
English: Although it has not been investigated with this particular AI vaccine strain, studies performed with other strains show that protective levels of serum antibody titres would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.
Maltese: A1, studji mwettqa bi strejns oħra juru li anti-korpi fis-sirum hu mistenni li jippersistu għal tal-anqas 12 -il xahar wara amministrazzjoni ta' żewg dożi tal-vaċċin.
English: Liquid light paraffin
Maltese: KONTENUT BĦALA
English: • Marketing authorisation under exceptional circumstances The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.
Maltese: Is-CHMP, wara li kkunsidra l-applikazzjoni huwa tal-fehma li l-bilanċ bejn ir-riskju u l-benefiċċju huwa wieħed favorevoli biex jirrakkomanda l-għoti tal-awtorizzazzjoni għat-tqegħid fis-suq taħt kondizzjonijiet eċċezzjonali kif spjegat aktar fir-Rapport Pubbliku Ewropew ta' Valutazzjoni.
English: Conclusions presented by the European Medicines Agency on:
Maltese: Konklużjonijiet imressqa mill-Aġenzija Ewropea għall-Mediċini dwar:
English: Annex IV Conclusions on the granting of the marketing authorisation under exceptional circumstances presented by the European Medicines Agency
Maltese: Konklużjonijiet dwar l-għoti tal-awtorizzazzjoni għat-tqegħid fis-suq taħt ċirkustanzi eċċezzjonali ppreżentati mill-Aġenzija Ewropea għall-Mediċini
English: 25 June 2013
Maltese: 25 ta' Ġunju 2013
English: May 2013 CMDh meeting
Maltese: Laqgħa tas-CMDh ta' Mejju 2013
English: 25 July 2013
Maltese: 25 ta' Lulju 2013
English: Annex III
Maltese: Anness III Skeda għall-implimentazzjoni tal-ftehim
English: The full EPAR for Yellox can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Yellox bromfenac
Maltese: Yellox bromfenak
English: The active substance in Yellox, bromfenac, is a non-steroidal anti-inflammatory drug (NSAID).
Maltese: Is-sustanza attiva f'Yellox, il-bromfenak, hija mediċina antinfjammatorja nonsterojdali (NSAID).
English: This is a summary of the European public assessment report (EPAR) for Yellox.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Yellox.
English: The most common or most important side effects seen with Yellox are abnormal sensation in eye (0.5%), mild or moderate erosion of the cornea (the transparent layer in front of the eye) (0.4%), eye pruritus (itching) (0.4%), eye pain (0.3%) and eye redness (0.3%).
Maltese: L-effetti sekondarji l-aktar komuni jew l-aktar importanti li dehru b'Yellox huma sensazzjonijiet anormali fl-għajnejn (0.5%), erożjoni minn ħafifa sa moderata tal-kornea (is-saff trasparenti quddiem l-għajn) (0.4%), prurite tal-għajnejn (ħakk) (0.4%), uġigħ fl-għajnejn (0.3%) u ħmura fl-għajnejn (0.3%).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Yellox on 18 May 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Yellox fit-18 ta' Mejju 2011.
English: Other information about Yellox
Maltese: Informazzjoni oħra dwar Yellox
English: Yellox contains the active substance bromfenac.
Maltese: Yellox fih is-sustanza attiva bromfenak.
English: In the second study, the figures were: 63% (124 out of 198) for patients treated with Yellox and 40% (39 out of 98) for those treated with placebo.
Maltese: Fit-tieni studju, iċ-ċifri kienu: 63% (124 minn 198) għall-pazjenti kkurati b'Yellox u 40% (39 minn 98) għal dawk ikkurati bi plaċebo.
English: Why is Yellox approved?
Maltese: Għaliex ġie approvat Yellox?
English: Yellox was found to be more effective than placebo (a dummy treatment) at relieving inflammation in the eye following cataract surgery in two main studies involving a total of 527 patients undergoing cataract surgery.
Maltese: Yellox instab li kien aktar effettiv mill-plaċebo (kura finta) fit-taffija tal-infjammazzjoni fl-għajnejn wara l-operazzjoni tal-katarretti f'żewġ studji ewlenin li involvew total ta' 527 pazjent li saritilhom loperazzjoni tal-katarretti.
English: What are the risks associated with Yellox?
Maltese: X'inhuma r-riskji assoċjati ma' Yellox?
English: It must not be used in patients who get asthma attacks, urticaria (itchy rash) or acute rhinitis (stuffy and runny nose) from taking acetylsalicylic acid (aspirin) or other NSAIDs.
Maltese: Ma għandux jintuża f'pazjenti li jaqbduhom l-attakki tal-ażżma, l-urtikarja (raxx bil-ħakk) jew ir-rinite akuta (imnieħer imblukkat u jnixxi) meta jieħdu aċidu aċetilsaliċiliku (aspirina) jew NSAIDs oħra.
English: In one study, 66% of patients treated with Yellox (104 out of 158) had no signs of inflammation after two weeks compared with 48% of patients receiving placebo (35 out of 73).
Maltese: Fi studju wieħed, 66% tal-pazjenti kkurati b'Yellox (104 minn 158) ma kellhom l-ebda sinjal ta' infjammazzjoni wara ġimagħtejn meta mqabbla ma' 48% tal-pazjenti li rċevew plaċebo (35 minn 73).
English: Yellox is a medicine used in adults to treat inflammation in the eye that can occur after an operation to remove a cataract (clouding of the lens).
Maltese: Yellox huwa mediċina li tintuża fl-adulti fil-kura ta' infjammazzjoni fl-għajnejn li sseħħ wara operazzjoni biex titneħħa katarretta (il-lenti tiċċajpar).
English: It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Maltese: Din taħdem billi timblokka l-enzima msejħa ċiklooksiġenażi, li tipproduċi l-prostaglandini, sustanzi involuti fil-proċess ta' infjammazzjoni.
English: For the full list of all side effects reported with Yellox, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Yellox, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Yellox?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Yellox?
English: It is not intended to provide practical advice on how to use Yellox.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Yellox.
English: Melovem is a ‘generic'.
Maltese: Melovem huwa ‘ġeneriku'.
English: It is available as a solution for injection (5 mg/ml, 20 mg/ml and 30 mg/ml).
Maltese: Jiġi f'soluzzjoni għall-injezzjoni (5 mg/ml u 20 mg/ml u 30 mg/ml).
English: Melovem is a medicine that contains the active substance meloxicam.
Maltese: Melovem huwa mediċina li fiha s-sustanza attiva melossikam.
English: Melovem contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Maltese: Melovem fih il-melossikam li jappartjeni għal klassi ta' mediċini msejħin mediċini anti-infjammatorji mhux sterojdali (NSAIDs).
English: This means that Melovem is similar to a ‘reference veterinary medicine' containing the same active substance.
Maltese: Dan ifisser li Melovem huwa simili għal ‘mediċina veterinarja ta' referenza' li fiha l-istess sustanza attiva.
English: Why has Melovem been approved?
Maltese: Għaliex ġie approvat Melovem?
English: Other information about Melovem:
Maltese: Aktar tagħrif dwar Melovem:
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Maltese: Il-melossikam taġixxi billi timblokka enzima msejħa ċikloossiġenażi li hija involuta fil-produzzjoni tal-prostaglandina.
English: While the reference medicine, Metacam, is available as 5 mg/ml and 20 mg/ml solutions for injection, Melovem is also available as a 30 mg/ml solution for injection.
Maltese: Filwaqt li l-mediċina ta' referenza, Metacam, tiġi f'soluzzjonijiet ta' 5 mg/ml u 20 mg/ml għal injezzjoni, Melovem jiġi wkoll bħala soluzzjoni għal injezzjoni ta' 30 mg/ml.
English: As Melovem is considered to be bioequivalent to the reference medicine, its benefit is taken as being the same as that of the reference medicine.
Maltese: Peress li Melovem tqies bijoekwivalenti mal-mediċina ta' referenza, il-benefiċċju tiegħu jitqies bħala analogu għal dak tal-mediċina ta' referenza.
English: What is Melovem?
Maltese: X'inhu Melovem?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Melovem on 7 July 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Melovem fis-7 ta' Lulju 2009.
English: The 20 mg/ml and 30 mg/ml solutions for injection are also used in combination with antibiotic therapy to treat acute mastitis (inflammation of the udder).
Maltese: Is-soluzzjonijiet għal injezzjoni ta' 20 mg/ml u 30 mg/ml jintużaw ukoll flimkien ma' terapija antibijotika għat-trattament tal-mastite akuta (infjammazzjoni fil-glandola mammarja).
English: What is the risk associated with Melovem?
Maltese: X'riskji huma assoċjati ma' Melovem?
English: Melovem is used in cattle, together with appropriate antibiotic therapy, to reduce the signs of acute respiratory infections (infection of the lung and airways).
Maltese: Melovem jintuża fuq il-frat, flimkien ma' terapija antibijotika adatta, biex jitnaqqsu s-sintomi talinfezzjoni respiratorja akuta (infezzjoni fil-pulmun u fil-passaġġi tal-arja).
English: The 20 mg/ml and 30 mg/ml solution for injection can be used together with appropriate antibiotic therapy for the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia (bacteria present in blood) and toxaemia (a toxic state) (mastitismetritis-agalactia syndrome).
Maltese: Is-soluzzjoni għal injezzjoni tista' tintuża flimkien ma' terapija antibijotika adatta għat-trattament ta' mard wara t-tifrigħ (il-ħlas) bħassettiċemija (batterji fid-demm) u t-tossjemija tat-tifrigħ stat tossiku) (is-sindromu tal-mastite-metriteagalassija).
English: Melovem solution for injection (5 mg/ml, 20 mg/ml and 30 mg/ml) is used in pigs to reduce the symptoms of lameness (inability to walk normally) and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move).
Maltese: Is-soluzzjoni għal injezzjoni Melovem (5 mg/ml, 20 mg/ml u 30 mg/ml) tintuża fil-ħnieżer biex jitnaqqsu s-sintomi taz-zappip (disturb fil-mixi normali) u l-infjammazzjoni f'disturbi lokomotorji mhux infettivi tal-mixi (mard li jaffettwa l-abbiltà tal-mixi).
English: Melovem solution for injection (20 mg/ml) is used in horses to relieve colic (abdominal pain) and the inflammation and pain in musculo-skeletal disorders.
Maltese: Is-soluzzjoni għall-injezzjoni Melovem (20 mg/ml) tintuża fiż-żwiemel biex ittaffi l-uġigħ koliku (uġigħ addominali) u l-infjamazzjoni u l-uġigħ f'disturbi muskuloskeletriċi.
English: The 5 mg/ml solution for injection can be used for the relief of post-operative pain associated with minor soft tissue surgery such as castration (surgical removal of the testicles).
Maltese: Is-soluzzjoni għal injezzjoni ta' 5 mg/ml tista' tintuża għat-taffija tal-uġigħ postoperattiv assoċjat ma' kirurġija minuri tat-tessut artab bħall kastrazzjoni (it-tneħħija tat-testikoli b'intervent kirurġiku).
English: Therefore, the CVMP's view was that, as for Metacam, Melovem's benefits are greater than its risks for the approved indications and the Committee recommended that Melovem be given a marketing authorisation.
Maltese: Għalhekk il-fehma tas-CVMP kienet li, l-istess bħal Metacam, il-benefiċċji ta' Melovem huma akbar mir-riskji tiegħu għall-indikazzjonijiet approvati u l-Kumitat irrakkomanda li Melovem jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has Melovem been studied?
Maltese: Kif ġie studjat Melovem?
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Maltese: Peress li l-prostaglandini huma sustanzi li jiskattaw linfjamazzjoni, l-uġigħ u t-tagħriq (fluwidu fl-għamla ta' għaraq li joħroġ mill-vini matul l-infjamazzjoni) u d-deni, il-melossikam tnaqqas is-sinjali tal-mard.
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Melovem.
Maltese: Il-persuni ipersensittivi (allerġiċi) għall-NSAIDs għandhom jevitaw il-kuntatt ma' Melovem.
English: This summary was last updated in July 2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Lulju 2013.
English: It can be used in combination with oral rehydration therapy (medicines given by mouth to restore water levels in the body) for diarrhoea in calves of over one week of age and young, non-lactating cattle.
Maltese: Jintuża flimkien ma' terapija orali ta' reidratazzjoni (mediċini li jingħataw b'mod orali biex jistabbilizzaw il-livell tal-ilma fil-ġisem) kontra d-dijarrea f'għoġġiela ikbar minn ġimgħa jew fi frieħ ta' età żgħira li ma jkunux qed jiġu mreddgħa.
English: Relative risk reduction (95% CI)
Maltese: Tnaqqis fir-riskju relattiv (95% CI)
English: Hypromellose Titanium dioxide (E171) Macrogol 400
Maltese: Titanium dioxide (E171) Macrogol 400
English: Multiple dose 20 mg/day 6.2 ± 2.2 1.7 ± 1.8 28 ± 11 82 ± 37 4.1 ± 1.7
Maltese: Doża multipla 20 mg/jum 6.2 ± 2.2 1.7 ± 1.8 28 ± 11 82 ± 37 4.1 ± 1.7
English: EU/1/09/511/001 EU/1/09/511/002 EU/1/09/511/003 EU/1/09/511/004 EU/1/09/511/005
Maltese: EU/1/09/511/001 EU/1/09/511/002 EU/1/09/511/003 EU/1/09/511/004
English: Manufacturer: PfizerIrelandPharmaceuticals, Little Connell,Newbridge, County Kildare, Ireland.
Maltese: Pfizer Ireland Pharmaceuticals, Little Connell Newbridge, County Kildare, L-Irlanda.
English: d p-value=0.035
Maltese: d valur p=0.035
English: There is no evidence of endometrial proliferation.
Maltese: Ma hemmx evidenza ta' proliferazzjoni endometrijali.
English: c p-value=0.22
Maltese: c valur p=0.22
English: Total number of subjects n=1,724 n=1,741
Maltese: Għadd totali ta' individwi n=1,724 n=1,741
English: Bazedoxifene is highly bound (98% - 99%) to plasma proteins in vitro.
Maltese: Bazedoxifene jintrabat ħafna (98% - 99%) mal-proteini tal-plażma in vitro.
English: The active substance is bazedoxifene.
Maltese: Is-sustanza attiva hi bazedoxifene.
English: Mean ± SD pharmacokinetic parameters of bazedoxifene (n=23) Cmax (ng/ml)
Maltese: Medja ± SD mill-parametri farmakokinetiċi ta' bazedoxifene (n=23) Cmax (ng/ml)
English: Deep vein thrombosis*, thrombophlebitis superficial
Maltese: Trombożi profonda talvina*, tromboflebite superfiċjali
English: Number (%)
Maltese: Għadd (%)
English: Date of latest renewal: 17 April 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 17 ta' April 2009 Data tal-aħħar tiġdid: 17 ta' April 2014
English: Latvijā Pfizer Luxembourg SARL filiāle Latvijā
Maltese: Pfizer Luxembourg SARL filialas Lietuvoje
English: CONBRIZA contains lactose
Maltese: CONBRIZA fiha lactose
English: PVC/Aclar blister packs of 7, 28, 30, 84, and 90 film-coated tablets.
Maltese: Pakketti ta' folji tal-PVC/Aclar ta' 7, 28, 30, 84, u 90 pillola miksija b'rita.
English: CONBRIZA contains lactose.
Maltese: CONBRIZA fih lactose.
English: Each film-coated tablet contains 142.8 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 142.8 mg lactose (bħala monohydrate).
English: The mean LS and FN T-scores at baseline were -2.4 and -1.7, respectively.
Maltese: Il-punteġġi T tal-LS u FN medji fil-linja bażi kienu -2.4 u -1.7, rispettivament.
English: The other ingredients are lactose monohydrate (see section 2 “CONBRIZA contains lactose”), microcrystalline cellulose, pre-gelatinised starch (maize), sodium starch glycolate, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, ascorbic acid, hypromellose, titanium dioxide (E171) and macrogol 400.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate (ara sezzjoni 2 “CONBRIZA fih lactose”), microcrystalline cellulose, pre-gelatinised starch (qamħirrun), sodium starch glycolate, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, ascorbic acid, hypromellose, titanium dioxide (E171) u macrogol 400.
English: Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
Maltese: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Il-Belġju.
English: Lactose monohydrate Microcrystalline cellulose Pregelatinised starch (maize) Sodium starch glycolate Sodium lauryl sulfate
Maltese: Lactose monohydrate Microcrystalline cellulose Pre-gelatinised starch (maize) Sodium starch glycolate Sodium lauryl sulfate Colloidal anhydrous silica Magnesium stearate Ascorbic acid
English: Vision disorders/Ocular events
Maltese: Disturbi filvista/Episodji okulari
English: Cerebrovascular effects
Maltese: Effetti ċerebrovaskulari
English: 18 months.
Maltese: 20 mg.
English: The risk factors associated with VTE cases in clinical trials included: advanced age, obesity, immobilisation, surgery, major trauma and malignancy.
Maltese: Ilfatturi ta' riskju assoċjati ma' każijiet ta' VTE fil-provi kliniċi kienu jinkludu: età avvanzata, obeżità, immobilizzazzjoni, kirurġija, trawma maġġuri u malinnità.
English: Urine parameters were pathologically changed.
Maltese: Il-parametri tal-awrina kienu patoloġikament mibdula.
English: Median reductions from baseline over 25% for C-telopeptide and osteocalcin were observed with bazedoxifene therapy.
Maltese: Tnaqqis medjan mil-linja bażi 'il fuq minn 25% għal C-telopeptide u osteocalcin kien osservat għal terapija b'bazedoxifene.
English: In subjects with a fracture probability of 20% or greater (n = 618), the risk of non-vertebral fractures in bazedoxifene-treated subjects was decreased by 55% (95% CI: 18-76) compared to placebo-treated subjects.
Maltese: F'individwi bi probabilità ta' ksur ta' 20% jew aktar (n = 618), ir-riskju ta' ksur mhux vertebrali f'individwi trattati b'bazedoxifene tnaqqas b'55% (95% CI: 18-76) meta mqabbel ma' individwi trattati bi plaċebo.
English: Bazedoxifene has not been studied in women with triglyceride levels 300 mg/dl (3.4 mmol/litre).
Maltese: Bazedoxifene ma ġiex studjat f'nisa li l-livell ta' trigliċeridi hu ta' 300 mg/dl ( 3.4 mmol/litru).
English: Serious side effects - Stop taking CONBRIZA and see a doctor immediately
Maltese: Effetti sekondarji serji - Tiħux aktar CONBRIZA u ara tabib immedjatament
English: Retinal vein thrombosis*
Maltese: Trombożi fil-vina retinali*
English: Other medicines and CONBRIZA
Maltese: Mediċini oħra u CONBRIZA
English: Absolute risk reduction
Maltese: Tnaqqis fir-riskju assolut
English: Limited clinical data (n=5) are available in subjects with moderate renal impairment (CrCl  50 ml/min).
Maltese: Tagħrif kliniku limitat (n=5) hu disponibbli għal individwi b'indeboliment tal-kliewi moderat (CrCl  50 ml/min).
English: After 7 year study period the relative risk was 1.51 (see section 5.1).
Maltese: Wara 7 snin ta' perijodu ta' studju, ir-riskju relattiv kien ta' 1.51 (ara sezzjoni 5.1).
English: Bazedoxifene undergoes metabolism by uridine diphosphate glucuronosyltransferase (UGT) enzymes in the intestinal tract and liver (see section 5.2).
Maltese: Bazedoxifene jgħaddi minn metaboliżmu permezz tal-enzimi tal-uridine diphosphate glucuronosyltransferase (UGT) fil-passaġġ intestinali u fil-fwied (ara sezzjoni 5.2).
English: CONBRIZA is associated with an increased risk of venous thromboembolism (VTE).
Maltese: CONBRIZA huwa assoċjat ma żieda fir-riskju ta' tromboemboliżmu fil-vini (VTE).
English: Deutschland Pfizer Pharma PFE GmbH Tel: +49 (0) 800 8535555
Maltese: PFE GmbH Tel: +49 (0) 800 8535555
English: The absolute bioavailability of bazedoxifene is approximately 6%.
Maltese: Il-bijodisponibilità assoluta ta' bazedoxifene hi madwar 6%.
English: Bazedoxifene-5-glucuronide is the major circulating metabolite.
Maltese: Bazedoxifene-5-glucuronide huwa l-metabolit ewlieni fiċ-ċirkolazzjoni.
English: After 3 years the relative risk was 1.63 and after a 5 year study period the relative risk was 1.50; after 7 years the relative risk was 1.51 (see sections 4.8 and 5.1).
Maltese: Wara 3 snin, ir-riskju relattiv kien ta' 1.63 u wara 5 snin ta' studju irriskju relattiv kien ta' 1.50; wara 7 snin ir-riskju relattiv kien ta' 1.51 (ara sezzjonijiet 4.8 u 5.1).
English: Pharmacotherapeutic group: Selective estrogen receptor modulator, ATC code: G03XC02.
Maltese: Kategorija farmakoterapewtika: modulatur silettiv tar-riċettatur tal-estroġen; Kodiċi ATC:
English: Bazedoxifene caused corticomedullar nephrocalcinosis and enhanced spontaneous chronic progressive nephropathy (CPN) in male rats.
Maltese: Bazedoxifene kkaġuna nefrokalċinożi kortikomedullari u ħarrax in-nefropatija kronika progressiva spontanja (CPN) f'firien irġiel.
English: A total of 1,732 subjects continued into the second 2-year extension (bazedoxifene 20 mg: n=560, bazedoxifene 40/20 mg: n=582, and placebo: n=590).
Maltese: Total ta' 1,732 individwu komplew bit-tieni sentejn ta' estensjoni (bazedoxifene 20mg: n=560, bazedoxifene 40/20 mg: n=582, u plaċebo: n=590).
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffetwaw sa persuna 1 minn kull 100):
English: The median T-score ranged from -0.6 to -1.4, depending on the skeletal site.
Maltese: Il-punteġġ T medjan kien f'medda ta' bejn -0.6 sa -1.4, skont il-lok skeletriku.