FrancophonIA/ELRC3.0 huggingface dataset:
English: On 25 August 2017 Septodont on behalf of all marketing authorisation holders (MAHs) presented to the European Medicines Agency a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the national summary of product characteristics (SmPC), labelling, package leaflet and quality Module 3 of the medicinal products Scandonest and associated names (see Annex I of CHMP opinion).
Maltese: Fil-25 ta' Awwissu 2017, Septodont, f'isem id-detenturi kollha tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs), ippreżentat lill-Aġenzija Ewropea għall-Mediċini referenza skont l-Artikolu 30 tadDirettiva 2001/83/KE, sabiex jiġu armonizzati s-sommarju tal-karatteristiċi tal-prodott (SmPC) nazzjonali, it-tikkettar, il-fuljett ta' tagħrif u l-Modulu 3 tal-kwalità tal-prodotti mediċinali Scandonest u ismijiet assoċjati (ara Anness I tal-opinjoni tas-CHMP).
English: Mepivacaine was first approved in 1960 by the US Food and Drug Administration.
Maltese: Mepivacaine ġie approvat għall-ewwel darba fl-1960 mill-Amministrazzjoni għall-Ikel u għall-Mediċini tal-Istati Uniti.
English: The finished product is presented as a solution for injection containing 30 mg/ml of mepivacaine hydrochloride as active substance.
Maltese: Il-prodott finali huwa ppreżentat bħala soluzzjoni għall-injezzjoni li fiha 30 mg/ml ta' kloridat ta' mepivacaine bħala sustanza attiva.
English: Section 4.2 - Posology and methods of administration Posology
Maltese: Sezzjoni 4.2 - Pożoloġija u metodi ta' kif għandu jingħata
English: The revised therapeutic indications in section 4.1 of the SmPC are:
Maltese: L-indikazzjonijiet terapewtiċi reveduti f'sezzjoni 4.1 tal-SmPC huma:
English: This information should be reflected in the SmPC section 4.2 with a cross reference to section 4.5 (Interactions with other medicinal products).
Maltese: Din l-informazzjoni għandha tiġi riflessa fis-sezzjoni 4.2 tal-SmPC b'kontroreferenza għal sezzjoni 4.5 (Interazzjonijiet ma' prodotti mediċinali oħra).
English: This may lead to hypotension and circulatory collapse.
Maltese: Dan jista' jwassal għal ipotensjoni u kollass ċirkolatorju.
English: A harmonised version of section 4.8 of adverse events has been agreed by the CHMP after assessing data from global pharmacovigilance database and literature and in line with data assessed in previous periodic update assessment reports (PSURs).
Maltese: Sar qbil mis-CHMP dwar verżjoni armonizzata tas-sezzjoni 4.8 tal-avvenimenti avversi wara valutazzjoni tad-data minn bażi ta' data ta' farmakoviġilanza globali u letteratura u f'konfomità maddata vvalutata f'rapporti perjodiċi preċedenti ta' aġġornament dwar is-sigurtà (PSURs).
English: A harmonised description of the symptoms and the management of overdose has been agreed in accordance with the EMA SmPC guideline (2009).
Maltese: Sar qbil dwar deskrizzjoni armonizzata tas-sintomi u l-immaniġġjar ta' doża eċċessiva skont il-linja gwida tal-SmPC tal-EMA (2009).
English: The CHMP deemed the submitted evidence adequate to support the indication in adults and in children from 4 years of age (ca. 20 kg body weight).
Maltese: Is-CHMP qies l-evidenza ppreżentata bħala adegwata sabiex tappoġġja lindikazzjoni fl-adulti u fit-tfal mill-età ta' 4 snin (ca. 20 kg piż tal-ġisem).
English: The MAH proposed harmonised dosing recommendations based on the doses studied in clinical trials and supported by pharmacodynamic and pharmacokinetic data and in line with international, European and national guidelines.
Maltese: L-MAH ippropona rakkomandazzjonijiet armonizzati għad-dożaġġ abbażi tad-dożi studjati fi provi kliniċi u appoġġjati minn data farmakodinamika u farmakokinetika u f'konformità mal-linji gwida internazzjonali, Ewropej u nazzjonali.
English: The CHMP noted that there is literature evidence that mepivacaine provides vasoconstrictive features compared with anaesthetics from other pharmaceutical groups, however this cannot consist an indication itself.
Maltese: IsCHMP innota li hemm evidenza tal-letteratura li mepivacaine jipprovdi karatteristiċi vażokostrittivi meta mqabbel ma' anestetiċi minn gruppi farmaċewtiċi oħra, madankolllu dan ma jistax jikkonsisti f'indikazzjoni fiha nnifisha.
English: As a result of the review of mepivacaine during a worksharing procedure in accordance to Article 45 of Regulation No 1901/2006, in 2010, the use of mepivacaine is contraindicated in children below 4 years of age (and less than 20kg of body weight).
Maltese: Bħala riżultat tar-rieżami ta' mepivacaine waqt proċedura ta' kondiviżjoni ta' xogħol skont l-Artikolu 45 tar-Regolament Nru 1901/2006, fl-2010, l-użu ta' mepivacaine huwa kontraindikat fit-tfal taħt l-età ta' 4 snin (u inqas minn 20kg ta' piż tal-ġisem).
English: • In addition, the Committee reviewed the documentation submitted by the MAH in support of the proposed harmonised Quality documentation (Module 3);
Maltese: • Barra minn hekk, il-Kumitat irrieżamina d-dokumentazzjoni ppreżentata mill-MAH bħala appoġġ għad-Dokumentazzjoni dwar il-kwalità armonizzata proposta (Modulu 3);
English: Other warnings not related with the above categories were harmonised, such as for patients with coagulation disorder and coadministration of antiplatelet/anticoagulant medicines.
Maltese: Twissijiet oħra mhux relatati mal-kategoriji ta' hawn fuq ġew armonizzati, bħal għal pazjenti b'disturb tal-koagulazzjoni u lgħoti flimkien ta' mediċini kontra l-pjastrini/antikoagulanti.
English: Therefore, the CHMP recommended that the statement regarding mepivacaine's use when vasoconstrictor is contraindicated should be moved from section 4.1 to 5.1 (pharmacodynamic properties) of the SmPC.
Maltese: Għalhekk, is-CHMP irrakkomanda li d-dikjarazzjoni dwar l-użu ta' mepivacaine meta l-vażokostrittur jiġi kontraindikat għandha timxi minn sezzjoni 4.1 għal 5.1 (proprjetajiet farmakodinamiċi) tal-SmPC.
English: Mepivacaine is an intermediate-acting local anaesthetic, which inhibits the conduction of nerve impulses by decreasing sodium (Na+) flow during propagation of the nerve action potential.
Maltese: Mepivacaine huwa anestetiku lokali li jaġixxi b'mod intermedju, li jinibixxi l-konduzzjoni ta' impulsi tannervituri billi jnaqqas il-fluss tas-sodju (Na+) waqt il-propagazzjoni tal-potenzjal tal-azzjoni tannervituri.
English: {(Invented) name and associated names, strength pharmaceutical form} is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental surgery in adults, adolescents and children above 4 years of age (c.a.
Maltese: {Isem (ivvintat) u ismijiet assoċjati, qawwa għamla farmaċewtika} huwa anestetiku lokali indikat għall-anesteżija lokali u lokoreġjonali f'kirurġija dentali fl-adulti, fl-adolexxenti u fit-tfal ta' età ta' ‘l fuq minn 4 snin (c.a. 20 kg piż tal-ġisem).
English: • The Committee reviewed the data submitted by the MAH in support of the proposed harmonisation of the Product Information, including based on the documentation submitted and the scientific discussion within the Committee;
Maltese: • Il-Kumitat irrieżamina d-data ppreżentata mill-MAH li tappoġġja l-armonizzazzjoni proposta talInformazzjoni dwar il-Prodott, inkluż abbażi tad-dokumentazzjoni ppreżentata u d-diskussjoni xjentifika fi ħdan il-Kumitat;
English: Mepivacaine is largely metabolised in the liver by microsomal enzymes and the principal route of excretion is via the kidney.
Maltese: Mepivacaine jiġi mmetabolizzat fil-biċċa l-kbira fil-fwied mill-enzimi mikrożomali u r-rotta prinċipali ta' eliminazzjoni hija permezz tal-kliewi.
English: The CHMP agreed on a common wording, on fertility, pregnancy and lactation (section 4.6) with data supported from pre-clinical studies.
Maltese: Is-CHMP qabel dwar formulazzjoni ta' kliem komuni, dwar fertilità, tqala u treddigħ (sezzjoni 4.6) b'data appoġġjata minn studji prekliniċi.
English: The wording for the method of use was harmonised to the standard terms “infiltration and perineural use” taking in consideration the requirements from the EDQM (European Directorate for the Quality of Medicines & HealthCare).
Maltese: Il-formulazzjoni tal-kliem għall-metodu tal-użu ġiet armonizzata għat-termini standard "infiltrazzjoni u użu perinewrali" filwaqt li ġew ikkunsidrati r-rekwiżiti mill-EDQM (Direttorat Ewropew għall-Kwalità talMediċini u tal-Kura tas-Saħħa).
English: • The Committee considered the identified divergences for Scandonest and associated names, for the indications, posology, contraindications, special warnings and precaution for use, as well as the remaining sections of the SmPC, labelling and package leaflet;
Maltese: • Il-Kumitat ikkunsidra d-diverġenzi identifikati għal Scandonest u ismijiet assoċjati, għallindikazzjonijiet, il-pożoloġija, il-kontraindikazzjonijiet, it-twissijiet speċjali u l-prekawzjoni għall-użu, kif ukoll is-sezzjonijiet li jifdal tal-SmPC, it-tikkettar u l-fuljett ta' tagħrif;
English: Although in dental practices, local anaesthetics administrated in therapeutic dosages do not interact with standard antiepileptic drugs, the situation for patients with uncontrolled epilepsy may be different.
Maltese: Għalkemm fi prattiki dentali, l-anestetiċi lokali mogħtija f'dożaġġi terapewtiċi ma jinteraġixxux ma' mediċini antiepilettiċi standard, is-sitwazzjoni għal pazjenti b'epilessija mhux ikkontrollata tista' tkun differenti.
English: This recommendation is also supported by the inconsistency of recognition and professional rights of chiropodist profession across EU.
Maltese: Din ir-rakkomandazzjoni hija wkoll appoġġjata min-nuqqas ta' konsistenza ta' rikonoxximent u drittijiet professjonali tal-professjoni talkiropodista fl-UE kollha.
English: Pharmacokinetic changes are also observed with aging.
Maltese: - Pazjent epilettiku mhux ikkontrollat tajjeb.
English: Overall summary of the scientific evaluation by the CHMP
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika mis-CHMP
English: Information for medical staff on how to avoid a blood vessel penetration during injection as well as instructions to avoid injections to inflamed or infected tissues are maintained in the SmPC.
Maltese: Barra minn hekk, ġiet inkluża informazzjoni dwar l-immaniġġjar ta' tossiċità relatata mad-doża u emerġenzi akuti oħra.
English: Therefore, the CHMP concluded in the inclusion of the contraindications summarised below: - Hypersensitivity to the active substance (or any local anaesthetics agent of the amide type) or to any of the excipients listed in section 6.1, - Children below 4 years of age (ca. 20 kg body weight), - Severe disorders of atrioventicular conduction not compensated by pace maker, - Poorly controlled epileptic patient.
Maltese: - Sensittività eċċessiva għas-sustanza attiva (jew għal kwalunkwe aġent ta' anestetiku lokali tattip amide) jew għal kwalunkwe eċċipjent elenkat fis-sezzjoni 6.1,
English: Other Sections
Maltese: Sezzjonijiet oħra
English: 20 kg of body weight).
Maltese: - Tfal taħt l-età ta' 4 snin (ca. 20 kg ta' piż tal-ġisem),
English: In the presence of high blood levels, local anaesthetics cross the blood-brain barrier.
Maltese: Madankollu, ġew armonizzati ssezzjonijiet kollha tal-PI.
English: Polysorbate 80
Maltese: Polysorbejt 80
English: Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer Olanda
English: ATC vet code: QI09AB08.
Maltese: Kodici ATĊ veterinarja QI09AB08.
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fil-friġġ (2 °C - 8 °C).
English: Sodium chloride Potassium chloride Disodium hydrogen phosphate Potassium dihydrogenphosphate Simethicone
Maltese: Disodium hydrogen Phosphate Potassju Dihydrogen Phosphate Simetichone
English: dl-α-tocopheryl acetate
Maltese: dl-α-tocopherol acetate
English: EU/2/12/141/004 EU/2/12/141/005 EU/2/12/141/006 EU/2/12/141/007 EU/2/12/141/008 EU/2/12/141/009
Maltese: EU/2/12/141/005 EU/2/12/141/006 EU/2/12/141/007 EU/2/12/141/008 EU/2/12/141/009
English: E.coli: fimbrial adhesins, LT toxoid C. perfringens toxoid
Maltese: ATTIVA E.coli: fimbrial adhesins, LT toksojd C.perfringend toksojd
English: 100, 200 and 250 ml
Maltese: 100, 200 u 250ml
English: - LT toxoid
Maltese: - LT toksojd
English: Walton Manor, Walton, Milton Keynes
Maltese: Walton Manor, Walton, Milton Keynes Buckinghamshire, MK7 7AJ, UK
English: Clostridium perfringens component: - Type C (strain 578) beta toxoid
Maltese: - Type C (strain 578) beta toksojd
English: 100 ml (50 doses) 200 ml (100 doses) 250 ml (125 doses)
Maltese: 100 ml (50 doża) 200 ml (100 doża) 250 ml (125 doża)
English: 20 ml (10 doses) 50 ml (25 doses) 100 ml (50 doses) 200 ml (100 doses) 250 ml (125 doses)
Maltese: 20 ml (10 dożi) 50 ml (25 doża) 100 ml (50 doża) 200 ml (100 doża) 250 ml (125 doża)
English: Date of first authorisation: 14/06/2012 Date of last renewal: 29/03/2017
Maltese: Data tal-aħħar tiġdid: 29-03-2017
English: Adjuvant:
Maltese: Tqala:
English: Porcilis ColiClos suspension for injection
Maltese: Porcilis ColiClos suspensjoni għall-injezzjoni
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated bacterial vaccine.
Maltese: Immunoloġiku ghall-ħnieżer, vaċċin batteriku inattivat.
English: 150 mg For the full list of excipients, see section 6.1
Maltese: 150 mg Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: CONTRAINDICATIONS
Maltese: MANIFATTURI
English: Detailed information on this veterinary 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 veterinarju tinstab fuq il-websajt ta' lAġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Immunological properties of the product: To stimulate active immunity in order to provide passive immunity to the progeny against enterotoxicosis caused by E. coli expressing fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99), F6 (987P) and against (necrotic) enteritis caused by C. perfringens type C.
Maltese: Biex jistimula immunita` attiva sabiex jipprovdi immunita` passiva talqżieqeż kontra enterotoxicosis ikkawżata minn E.coli, li jesprimu l- adhesins F4ab(K88ab), F4ac (K88ac), F5 (K99) jew F6 (987P) u kontra enterite` (nekrotika) ikkawżata minn C. perfringens type C.
English: 20 ml (10 doses) 50 ml (25 doses)
Maltese: 50 ml (25 doża)
English: The active substances being a principle of biological origin intended to produce passive immunity are not within the scope of Regulation (EC) No 470/2009.
Maltese: Peress illi s-sustanza attiva hija ta'oriġini bijoloġika u intenzjonata biex tipproduċi immunita attiva , ma taqax taħt ir-Regoalment tal-Kunsill (KE) Nru 470/2009.
English: Disposal: read the package leaflet.
Maltese: Mhux id-daqs tal-pakketti kollha jistgħu qegħdin fis-suq.
English: ≥20 IU2
Maltese: ≥ 7.8 log2 Ab tajter1
English: Marketing authorisation holder:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: Reduced activity and lack of appetite on the day of vaccination commonly occurred and/or a sometimes painful and hard swelling up to 10 cm diameter for up to 25 days were very commonly observed at the site of injection.
Maltese: Tnaqqis fl-ikel u fl-attivita fil-ġurnata tal-vaċċinazzjoni kienu komuni u/jew xi drabi nefħa li tuġgħa u iebsa b'dijametru sa 10cm li tistgħa ddumu sa 25 ġurnata ġiet komunamnet osservata ħafna fil-post tal-injezzjoni.
English: Cardboard box with a PET vial of 20, 50, 100, 200 or 250 ml.
Maltese: Kaxxa tal-kartun b'kunjett PET ta' 20, 50, 100, 200 or 250 ml.
English: adhe.
Maltese: IEĦOR
English: Packsizes:
Maltese: PAKKETT
English: C. perfringens type C toxoid
Maltese: C. perfringens:
English: For animal treatment only.To be supplied only on veterinary prescription.
Maltese: Tħallatx ma l-ebda prodott mediċinali veterinarju ieħor.
English: Escherichia coli components: - F4ab fimbrial adhesin
Maltese: Komponenti Escherichia coli:
English: Cardboard box with type I glass vial of 20 ml, 50 ml, 100 ml or 250 ml.
Maltese: Kaxxa tal-kartun kunjett tal-ħġieġ tip I ta' 20ml, 50ml, 100ml jew 250ml.
English: Pigs (sows and gilts)
Maltese: INDIKAZZJONI (JIET)
English: LT toxoid
Maltese: Tiffriżax
English: Porcilis ColiClos suspension for injection for pigs
Maltese: Porcilis ColiClos suspensjoni għall-injezzjoni għall-ħnieżer
English: Cardboard box with a vial of 20, 50, 100, 200 or 250 ml
Maltese: Kaxxa tal-kartuna b'kunjett ta' 20, 50, 100, 200 jew 250ml
English: Vaccination results in an antibody response with neutralizing activity against LT toxin.
Maltese: Il-vaċċinazzjoni tirriżulta f'rispons fl-antikorpi b'effett newtralizzanti kontra l-attivita ta' tossini LT.
English: Vaccination scheme:
Maltese: Skema ta' vaċċinazzjoni:
English: An increase in body temperature up to 2°C was very commonly observed on the day of vaccination.
Maltese: Żieda fit-temperatura tal-ġisem sa 2o C kienet komunament osservata fil-jum il-vaċċinazzjoni.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu fil-muskolu
English: Cardboard box with a glass vial of 20, 50, 100 or 250 ml.
Maltese: Kaxxa tal-kartun b'kunjett tal-ħġieġ ta' 20, 50, 100 or 250 ml.
English: Per dose of 2 ml: E. coli: F4ab fimb.
Maltese: 2 sa 4 ġimgħat qabel id-data mistennija tat-tifrigħ.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES
Maltese: TAS-SUSTANZI BIOLOĠIĊI ATTIVI
English: Pig pictogram
Maltese: PARIR SABIEX
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: Is-sustanzi mhuz attivi msemijja f' sezzjoni 6.1 tal- KPQ huma sustanzi permessi liema tabella 1 talanness għar Regolment tal-Kunsill (KE) Nru 37/2010 tindika li m'hemmx bżonn MRLs jew huma kunsidrati li ma jaqgħux fl-iskop tar-regolament (EC) No 470/2009 meta jintuza bħal f'dan il-prodott mediċinali veterinarju.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Maltese: VETERINARJU
English: Intramuscular use.
Maltese: Injezzjoni fil-muskolu.
English: County Kildare Ireland
Maltese: County Kildare L-Irlanda
English: EU/1/14/960/001 28 tablets
Maltese: EU/1/14/960/001 28 pillola
English: Pfizer Ireland Pharmaceuticals, Little Connell, Newbridge, County Kildare, Ireland.
Maltese: Pfizer Ireland Pharmaceuticals, Little Connell, Newbridge, County Kildare, L-Irlanda.
English: (see sections 4.6 and 5.3).
Maltese: (ara sezzjoni 4.4).
English: AUCss (nghr/mL)
Maltese: AUCss (ngsiegħa/mL)
English: Mean ± SD Steady-State Pharmacokinetic Parameters (n=24) Cmax (ng/mL)
Maltese: Medja ± SD tal-Parametri Farmakokinetiċi fi Stat Fiss (n=24) Cmax (ng/mL)
English: Erythema multiforme; erythema nodosum
Maltese: Eritema multiforme; eritema nodosum
English: Coronary artery disease (CAD)
Maltese: Mard tal-arterji koronarji (CAD)
English: 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: Medical history and regular check-ups
Maltese: Storja medika u visti regolari
English: CE/BZA has not been studied in women with baseline triglyceride levels >300 mg/dL (>3.4 mmol/L).
Maltese: CE/BZA ma ġiex studjat f'nisa b'livelli ta' trigliċeridi tal-linja bażi > 300 mg/dL (> 3.4 mmol/L).
English: • Medicines for tuberculosis (such as rifampicin, rifabutin);
Maltese: • Mediċini għat-tuberkolożi (bħal rifampicin, rifabutin);
English: Polydextrose (E1200) (contains glycerol and glucose) Maltitol liquid
Maltese: Polydextrose (E1200) (fih gliċerol u glukożju) Maltitol liquid
English: DUAVIVE (CE/BZA) has not been studied in the treatment of premature menopause.
Maltese: DUAVIVE (CE/BZA) ma ġiex studjat fit-trattament tal-menopawża prematura.
English: The other ingredients are: lactose monohydrate, sucrose, sucrose monopalmitate, polydextrose (E1200, containing glucose and sorbitol) and maltitol liquid (see section 2), microcrystalline cellulose, powdered cellulose, hydroxypropylcellulose, hydroxyethylcellulose, magnesium stearate, ascorbic acid, hypromellose (E464), povidone (E1201), poloxamer 188, calcium phosphate, titanium dioxide (E171), macrogol (400), red iron oxide (E172), black iron oxide (E172) and propylene glycol (E1520).
Maltese: Is-sustanzi l-oħra huma: lactose monohydrate, sucrose, sucrose monopalmitate, polydextrose (E1200, li fih glukożju u sorbitol) u maltitol likwidu (ara sezzjoni 2), microcrystalline cellulose, powdered cellulose, hydroxypropylcellulose, hydroxyethylcellulose, magnesium stearate, ascorbic acid, hypromellose (E464), povidone (E1201), poloxamer 188, calcium phosphate, titanium dioxide (E171), macrogol (400), red iron oxide (E172), black iron oxide (E172) u propylene glycol (E1520).
English: The active ingredients of CE are primarily the sulphate esters of estrone, equilin sulphates and 17α/β- estradiol.
Maltese: Is-sustanzi attivi ta' CE huma primarjament l-esteri tas-sulfat ta' estrone, sulfati tal-equilin u 17α/β- estradiol.
English: Vulvovaginal candidiasis
Maltese: Kandidjażi vulvovaġinali
English: In vitro and in vivo studies have shown that oestrogens are partially metabolised by cytochrome P450 enzymes, including CYP3A4.
Maltese: Studji in vitro u in vivo wrew li l-estroġeni huma parzjalment metabolizzati minn enzimi taċcytochrome P450, inkluż CYP3A4.
English: • Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine);
Maltese: • Mediċini għall-epilessija (bħal phenobarbital, phenytoin u carbamazepine);
English: Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1 antitrypsin, ceruloplasmin).
Maltese: Proteini oħra tal-plażma jistgħu jiżdiedu (angiotensinogen/renin substrate, alpha-1 antitrypsin, ceruloplasmin).
English: Deep vein thrombosis, thrombophlebitis superficial
Maltese: Trombożi profonda filvini, tromboflebite superfiċjali
English: Bazedoxifene Baseline-adjusted total estrone
Maltese: Bazedoxifene Estrone totali aġġustat għal-linja bażi
English: Urticaria, rash, pruritus
Maltese: Urtikarja, raxx, prurite
English: Tmax (hr)
Maltese: Tmax (siegħa)
English: • if you have systemic lupus erythematosus (SLE).
Maltese: • jekk għandek lupus erythematosus sistemika (SLE).
English: • seizures (epilepsy)
Maltese: • aċċessjonijiet (epilessija)
English: Limited clinical data (n=5) for bazedoxifene monotherapy are available in subjects with moderate renal impairment (creatinine clearance 50 ml/min).
Maltese: Dejta klinika limitata (n=5) għal monoterapija bil-bazedoxifene hija disponibbli f'individwi b'indebolimenti moderat tal-kliewi (eliminazjoni ta' kreatinina ta'  50 ml/min).
English: Blood triglycerides increased, alanine aminotransferase increased; aspartate aminotransferase increased
Maltese: Żieda fittrigliċeridi taddemm, żieda flalanine aminotransferase; żieda fl-aspartate aminotransferase
English: SERMs (including bazedoxifene) and oestrogens individually increase the risk of VTE (see section 4.8).
Maltese: SERMs (inkluż bazedoxifene) u l-estroġeni jżidu b'mod individwali r-riskju ta' VTE (ara sezzjoni 4.8).
English: Exacerbation of chorea
Maltese: Aggravament talkorea
English: Risk ratio & 95% CI
Maltese: Proporzjon ta' riskju u 95 % CI
English: A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56).
Maltese: Meta-analiżi minn 52 studju epidemijoloġiku rrapportat żieda fir-riskju tal-kanċer tal-ovarji fin-nisa li bħalissa qegħdin jużaw l-HRT meta mqabbla ma' nisa li qatt ma għamlu użu mill-HRT (RR 1.43, 95% CI 1.31-1.56)
English: • Herbal remedies containing St John's Wort (Hypericum perforatum)
Maltese: John's Wort (Hypericum perforatum)
English: Venous thromboembolic events (including, pulmonary embolism, retinal vein thrombosis, deep vein thrombosis and thrombophlebitis)
Maltese: Avvenimenti tromboemboliċi filvini (inkluż emboliżmu pulmonari, trombożi fil-vini tar-retina, trombożi profonda fil-vini u tromboflebite)
English: The experience treating women older than 65 years is limited.
Maltese: L-esperjenza fit-trattament ta' nisa li għandhom aktar minn 65 sena hija limitata.