FrancophonIA/ELRC3.0 huggingface dataset:
English: Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Bayer Co-Codamol 8/500mg capsules capsule, hard Oral use
Maltese: Berkshire RG14 1JA, Ir-Renju Unit paracetamol + codeine Bayer Co-Codamol 8/500mg capsules kapsula, iebsa użu orali
English: Bene-Arzneimittel GmbH
Maltese: Il-Finlandja Bene-Arzneimittel GmbH
English: Combaren 50 mg/50 mg Filmtabletten film-coated tablet oral use
Maltese: Combaren 50 mg/50 mg Filmtabletten pillola miksija b'rita użu orali
English: 10 mg, 10 mg and 200 mg coated tablet
Maltese: 10 mg, 10 mg and 200 mg pillola miksija użu orali
English: Brentford TW8 9GS United Kingdom
Maltese: Brentford TW8 9GS Ir-Renju Unit
English: M & A Pharmachem Limited, Allenby Laboratories, Wigan Road, Westhoughton, Bolton, Lancashire BL5 2AL,
Maltese: Laboratories, Wigan Road, Westhoughton, Bolton, Lancashire BL5
English: U kabelovny 130 102 37 Praha 10Dolní Měcholupy Czech Republic
Maltese: 102 37 Praha 10Dolní Měcholupy Ir-Repubblika Ċeka
English: Galen Limited, Seogoe Industiral Estate, Craigavon BT 63 5 UA, United Kingdom
Maltese: Craigavon BT 63 5 UA
English: TALVOSILEN FORTE 30 mg + 500 mg capsule, hard oral use
Maltese: TALVOSILEN FORTE 30 mg + 500 mg kapsula, iebsa użu orali
English: Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom codeine phosphate
Maltese: Ir-Renju Unit Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, IrRenju Unit codeine phosphate
English: ALKALOID - INT d.o.o Šlandrova ulica 4, 1231 LjubljanaČrnuče, Slovenia paracetamol, propifenazonă , cafeină , fosfat de codeină sesquihidrat
Maltese: Črnuče, Is-Slovenja paracetamol, propifenazonă , cafeină , fosfat de codeină sesquihidrat
English: TW8
Maltese: PL 22
English: 400mg + 20mg suppository rectal use
Maltese: 400mg + 20mg suppożitorju użu minn ġorrektum
English: S.C. Farmacom S.A. Str. Zizinului Nr. 112, 2200 Braşov,
Maltese: Zizinului Nr. 112, 2200
English: 500mg + 8mg + 30mg capsule
Maltese: 500mg + 8mg + 30mg kapsula
English: paracetamol + codeine Tylex Tablets coated tablet
Maltese: Ir-Renju Unit paracetamol + codeine Tylex Tablets pillola miksija użu orali
English: 500mg + 20mg tablet
Maltese: 500mg + 20mg pillola
English: 500 mg and 15 mg tablet
Maltese: 500 mg and 15 mg pillola
English: SW1V 2SA United Kingdom ibuprofen +codeine
Maltese: Ir-Renju Unit ibuprofen +codeine
English: Hämeenlinna 13500 Finland paracetamol, codeine,
Maltese: Il-Finlandja paracetamol, codeine,
English: UCB Pharma Limited, 208 Bath Road, Slough, Berkshire SL1 3WE,
Maltese: Ir-Renju Unit UCB Pharma Limited, 208 Bath Road,
English: Belgium Bristol-Meyers Squibb Belgium sa
Maltese: Bristol-Meyers Squibb Belgium sa Chaussée de la Hulpe
English: SW1V 2SA United Kingdom paracetamol + codeine Solpadeine Max
Maltese: Renju Unit paracetamol + codeine Solpadeine Max
English: 400mg + 7.5mg + 50mg suppository rectal use
Maltese: 400mg + 7.5mg + 50mg suppożitorju użu minn ġorrektum
English: Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom paracetamol + doxylamine succinate + caffeine + codeine
Maltese: Ir-Renju Unit Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, IrRenju Unit paracetamol + doxylamine succinate + caffeine + codeine
English: 650 mg and 30 mg tablet
Maltese: 650 mg and 30 mg pillola
English: Germany codeinphosphathemihydrat paracetamol talvosilen 500 mg/30 mg 30 mg 500 mg suppository rectal use
Maltese: Il-Ġermanja codeinphosphathemihydrat paracetamol talvosilen 500 mg/30 mg 30 mg 500 mg suppożitorju użu minn ġorrektum
English: 300 mg and 30 mg tablet
Maltese: 300 mg and 30 mg pillola
English: ENNOGEN PHARMA LIMITED, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS United Kingdom
Maltese: Ir-Renju Unit ENNOGEN PHARMA LIMITED, Unit G4, Riverside
English: Czech Republic bene-Arzneimittel GmbH
Maltese: Ir-Repubblika Ċeka bene-Arzneimittel GmbH
English: Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom paracetamol + codeine Sandoz Co-Codamol Tablets 30/500mg
Maltese: Ir-Renju Unit Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Ir-Renju Unit paracetamol + codeine Sandoz Co-Codamol Tablets 30/500mg
English: BOEHRINGER INGELHEIM ITALIA S.P.A.
Maltese: BOEHRINGER INGELHEIM
English: Paracetamol/Kodein Evolan effervescent tablet
Maltese: Paracetamol/Kodein Evolan pillola li tfexfex
English: FANNIN (UK) LIMITED, 42-46 Booth Drive, Park Farm South, Wellingborough NN* 6GT
Maltese: Ir-Renju Unit FANNIN (UK) LIMITED, 42-46 Booth Drive,
English: 500mg + 60mg tablet
Maltese: 500mg + 60mg pillola
English: 500mg + 8mg + 6.25mg coated tablet
Maltese: 8mg + 520mg + 6.25mg pillola miksija
English: Vitabalans Oy Varastokatu 8, Hämeenlinna FI-13500 Finland codeine + paracetamol
Maltese: FI-13500 Il-Finlandja codeine + paracetamol
English: Ennogen Pharma Cocodamol effervescent tablet
Maltese: Ennogen Pharma Cocodamol pillola li tfexfex
English: 20144 Milano Italy paracetamol + codeine phosphate
Maltese: Milano L-Italja paracetamol + codeine phosphate
English: 400mg+50mg+20m g suppository rectal use
Maltese: 400mg+50mg+20 mg suppożitorju użu minn ġorrektum
English: 500mg + 8mg + 30mg capsule, hard Oral use
Maltese: 500mg + 8mg + 30mg kapsula, iebsa użu orali
English: NEOBRUFEN CON CODEÍNA 400 mg/ 30 mg comprimidos recubiertos con película
Maltese: CON CODEÍNA 400 mg/ 30 mg comprimidos recubiertos con película
English: Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom paracetamol + diphenhydramine hydrochloride + caffeine + codeine
Maltese: Ir-Renju Unit Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Ir-Renju Unit paracetamol + diphenhydramine hydrochloride + caffeine + codeine
English: WOCKHARDT UK LIMITED Ash Road North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom codeine phosphate+paracetamo l
Maltese: Industrial Estate, Wrexham LL13 9UF, Ir-Renju Unit codeine phosphate+paracetamo l
English: KG
Maltese: Str.
English: 125 mg + 7,5 mg effervescent granules
Maltese: 125 mg + 7,5 mg granijiet li jfexfxu
English: 15mg + 500mg capsule, hard Oral use
Maltese: 15mg + 500mg kapsula, iebsa użu orali
English: Czech Republic codeine + paracetamol
Maltese: Ir-Repubblika Ċeka codeine + paracetamol
English: 500 mg/ 8 mg/ 30 mg capsule, hard oral use
Maltese: 500 mg/ 8 mg/ 30 mg kapsula, iebsa użu orali
English: ZANZA
Maltese: Franza
English: 30 mg 250 mg 250 mg 50 mg
Maltese: 30 mg 250 mg 250 mg 50 mg oral use
English: 500 mg and 30 mg tablet
Maltese: 500 mg and 30 mg pillola
English: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom codeine phosphate
Maltese: Eastbourne, East Sussex BN22 9AG, Ir-Renju Unit codeine phosphate
English: 20 mg + 500 mg tablet
Maltese: 20 mg + 500 mg pillola
English: 500mg 8mg 30mg capsule, hard oral use
Maltese: 500mg 8mg 30mg kapsula iebsa użu orali
English: 500mg + 12.8mg + 30mg effervescent tablet
Maltese: 500mg + 12.8mg + 30mg pillola li tfexfex
English: 15mg + 500mg tablet
Maltese: 15mg + 500mg pillola
English: Citodon suppository rectal use
Maltese: Citodon suppożitorju użu minn ġorrektum
English: 500mg + 30mg tablet
Maltese: 500mg + 30mg pillola
English: 500 mg/8 mg/30 mg tablet
Maltese: 500 mg/8 mg/30 mg pillola
English: 500mg/8mg/30mg tablet
Maltese: 500mg/8mg/30mg pillola
English: Germany codeinphosphathemihydrat paracetamol talvosilen capsule
Maltese: Il-Ġermanja codeinphosphathemihydrat paracetamol talvosilen forte kapsula, iebsa użu orali
English: AUROBINDO PHARMA LIMITED Ares Block, Odyssey Business Park, West End Road, South Ruislip HA4 6QD,
Maltese: Park, West End Road, South Ruislip HA4
English: Paracetamol/Codeine CODOLIPRANE 500 mg/30 mg, comprimé effervescent sécable effervescent tablet
Maltese: Paracetamol/Codeine CODOLIPRANE 500 mg/30 mg, comprimé effervescent sécable pillola li tfexfex
English: Paracetamol/Codein 500 mg/30 mg bene suppository rectal use
Maltese: Paracetamol/Codein 500 mg/30 mg bene suppożitorju użu minn ġorrektum
English: RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED 103-105 Bath Road, Slough, Berkshire SL1 3UH, United Kingdom ibuprofen, fosfat de codeină hemihidrat
Maltese: Berkshire SL1 3UH, IrRenju Unit ibuprofen, fosfat de codeină hemihidrat
English: Herterichstrasse 1 D-81479 Munchen Germany
Maltese: D-81479 Munchen Il-Ġermanja
English: de Burgos, 91 28050 Madrid Spain
Maltese: LABORATORIES, S.A. Avda. de Burgos, 91 28050
English: 500mg 8mg 6.25mg film-coated tablet oral use
Maltese: 500mg + 8mg + 6.25mg pillola miksija użu orali
English: Sterwin Meds Cocodamol 8/500 effervescent tablets
Maltese: Sterwin Meds Cocodamol 8/500 effervescent tablets pillola għal soluzzjoni orali
English: Zakłady
Maltese: SUPPOSITORY
English: 30mg + 500mg capsule, hard oral use
Maltese: 30mg + 500mg kapsula, iebsa użu orali
English: 200mg +12.8mg film-coated tablet Oral use
Maltese: 200mg +12.8mg pillola miksija użu orali
English: 30mg + 500 mg capsule, hard oral use
Maltese: 30mg + 500 mg kapsula, iebsa użu orali
English: GlaxoSmithKline Export Ltd 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom
Maltese: Great West Road Brentford Middlesex TW8 9GS Ir-Renju Unit
English: 500 mg+8 mg+30 mg effervescent tablet
Maltese: 500 mg+8 mg+30 mg pillola li tfexfex
English: Sweden codeine phosphate hemihydrate/ paracetamol
Maltese: L-Isvezja codeine phosphate hemihydrate/ paracetamol
English: 400mg+50mg+10m g
Maltese: 400mg+50mg+10 mg
English: SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg effervescent tablet
Maltese: SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg pillola li tfexfex
English: Bene Arzneimittel GmbH
Maltese: L-Ungerija Bene Arzneimittel GmbH
English: Germany bene - Arzneimittel GmbH
Maltese: Il-Ġermanja bene - Arzneimittel GmbH
English: Nowy Dwór Mazowiecki
Maltese: Mazowiecki
English: Paralgin Minor suppository rectal use
Maltese: Paralgin Minor
English: 500 mg + 10 mg effervescent tablet
Maltese: 500 mg + 10 mg pillola li tfexfex
English: Migraleve Pink Tablets: Paracetamol, codeine phosphate, buclizine hydrochloride
Maltese: Paracetamol, codeine phosphate, buclizine hydrochloride
English: Pinex Forte effervescent tablet
Maltese: Pinex Forte pillola li tfexfex
English: 500mg/50mg/30mg effervescent tablet
Maltese: 500mg/50mg/30mg pillola li tfexfex
English: Germany codeinphosphathemihydrat paracetamol talvosilen forte suppository rectal use
Maltese: Il-Ġermanja codeinphosphathemihydrat paracetamol talvosilen oral use
English: Citodon effervescent tablet
Maltese: Citodon pillola li tfexfex
English: WOCKHARDT UK LIMITED Ash Road North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom
Maltese: Ir-Renju Unit WOCKHARDT UK LIMITED Ash Road North, Wrexhan
English: SW1V 2SA United Kingdom paracetamol + codeine + caffeine
Maltese: United Kingdom paracetamol + codeine + caffeine
English: Dafalgan codéine effervescent tablet
Maltese: Dafalgan codeine pillola li tfexfex
English: Paracetamol Codeine Phosphate Doxylamine succinate Caffeine
Maltese: Doxylamine succinate Caffeine
English: 500mg + 30mg + 8mg effervescent tablet
Maltese: 500mg + 30mg + 8mg pillola li tfexfex
English: Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Paracodol Tablets tablet for oral solution
Maltese: Berkshire RG14 1JA, Ir-Renju Unit paracetamol + codeine Paracodol Tablets pillola għal soluzzjoni orali
English: Paracetamol/Codeine COPRALGIR 400 mg/20 mg, comprimé sécable coated tablet
Maltese: Paracetamol/Codeine COPRALGIR 400 mg/20 mg, comprimé sécable pillola miksija użu orali
English: 500mg 8mg 30mg effervescent tablet
Maltese: 500mg 8mg 30mg pillola li tfexfex
English: Cupanol Co-codamol effervescent tablet
Maltese: Cupanol Co-codamol pillola li tfexfex
English: Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Paracodol Capsules capsule
Maltese: Berkshire RG14 1JA, Ir-Renju Unit paracetamol + codeine Paracodol Capsules kapsula
English: 500mg +8mg + 30mg tablet for oral solution
Maltese: 500mg +8mg + 30mg pillola għal soluzzjoni orali
English: 500mg + 8mg + 30mg effervescent tablet
Maltese: 500mg + 8mg + 30mg pillola li tfexfex
English: 9GS Brentford United Kingdom codeine + paracetamol + caffeine
Maltese: Ir-Renju Unit codeine + paracetamol + caffeine
English: Germany codeinphosphathemihydrat paracetamol talvosilen
Maltese: Il-Ġermanja codeinphosphathemihydrat paracetamol
English: Actavis UK Limited Whiddon Valley, Barnstaple, Devon, EX32 8NS United Kingdom
Maltese: Barnstaple, Devon, EX32 8NS
English: 8mg + 500mg + 30mg effervescent tablet
Maltese: 8mg + 500mg + 30mg pillola li tfexfex
English: Paracod Mylan dispersible tablet oral use
Maltese: Paracod Mylan pillola li tinxtered użu orali
English: 500 mg/8 mg/30 mg hard capsule
Maltese: 500 mg/8 mg/30 mg kapsula iebsa użu orali
English: 500 mg, 8 mg, 30 mg effervescent tablet
Maltese: 500mg, 8mg 30mg pillola li tfexfex
English: 500 mg/30 mg coated tablet
Maltese: 500 mg/30 mg pillola
English: 500 mg/8 mg/30 mg effervescent tablet
Maltese: 500 mg/8 mg/30 mg pillola li tfexfex
English: 500 mg and 30 mg film-coated tablet oral use
Maltese: 500 mg/30 mg pillola miksija użu orali
English: 500 mg, 10 mg and 30 mg film-coated tablet oral use
Maltese: 500 mg, 10 mg and 30 mg pillola miksija b'rita użu orali
English: 30 mg +500 mg tablet
Maltese: 30 mg +500 mg pillola
English: 30,6 mg + 500 mg film-coated tablet oral use
Maltese: 30,6 mg + 500 mg pillola miksija b'rita użu orali
English: 500 mg + 9,6 mg film-coated tablet oral use
Maltese: 500 mg + 9,6 mg pillola miksija b'rita użu orali
English: Belgium
Maltese: Berlin
English: 30mg + 500 mg tablet
Maltese: 30mg + 500 mg pillola
English: 15mg + 500mg effervescent tablet
Maltese: 15mg + 500mg pillola li tfexfex
English: 500mg/8mg/30mg effervescent tablet
Maltese: 500mg/8mg/30mg pillola li tfexfex
English: 1 cartridge and 1 pen
Maltese: 1 skartoċċ u 1 pen
English: 3 cartridges
Maltese: 3 skrataċ
English: 1 cartridge
Maltese: 1 skartoċċ
English: Strength Pharmaceutical Form
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: EU (MA) Number
Maltese: Numru tal-proċedura ta' l-EMA
English: EU (MA) Number
Maltese: Numru tal-UE Isem kummerċjali
English: - Summary of Product Characteristics (in full)
Maltese: - Sommarju tal-Karatteristiċi tal-Prodott (komplet)
English: Key elements to be included in the educational material:
Maltese: Elementi kruċjali li jridu jkunu inklużi fil-materjal edukattiv:
English: • Detailed information about the risk of haematological disorders (notably anaemia) associated with Victrelis, consisting of factual description of the haematological disorders in terms of frequency and time to onset and related clinical symptoms.
Maltese: • Tagħrif dettaljat dwar ir-riskju ta' disturbi ematoloġiċi (b'mod partikolari anemija) assoċjata ma' Victrelis, li jikkonsisti f'deskrizzjoni fattwali tad-disturbi ematoloġiċi mil-lat ta' frekwenza u żmien biex joħorġu u s-sintomi kliniċi relatati.
English: Prior to the launch in each Member State, the Marketing Authorisation Holder shall agree with the National Competent Authority the format and content of the Physician Educational Materials and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare information pack containing:
Maltese: Qabel jitqiegħed fis-suq f'kull Stat Membru, Sid l-Awtorizzazzjoni għat-Tqegħid fis-Suq irid jiftihem mal-Awtorità Kompetenti Nazzjonali il-format u kontenut tal-Materjali Edukattivi tat-Tabib u jrid iwettaq dan il-programm fuq bażi nazzjonali sabiex jaċċerta li, qabel ma jiktbu r-riċetti, it-tobba kollha jkollhom pakkett ta' tagħrif li jkun fih:
English: The member States must ensure that all conditions with regard to the safe and effective use of the medicinal product described below are implemented.
Maltese: KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TA' L-UŻU MINGĦAJR PERIKLU U EFFETTIV TAL-PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI
English: Date of latest renewal: 23 April 2018
Maltese: Data tal-aħħar tiġdid: 23 ta' April 2018
English: Age and gender
Maltese: Età u sess
English: >5% to ≤10% >10% to ≤15% >15% to ≤20% >20% to ≤25%
Maltese: >5% sa ≤10% >10% sa ≤15% >15% sa ≤20% >20% sa ≤25%
English: • total cholesterol
Maltese: • kolesterol totali
English: Store below 30°C.
Maltese: Aħżen f'temperatura taħt it-30°C.
English: EU/1/13/851/001 EU/1/13/851/002 EU/1/13/851/003 EU/1/13/851/004 EU/1/13/851/005 EU/1/13/851/006
Maltese: EU/1/13/851/001 EU/1/13/851/002 EU/1/13/851/003 EU/1/13/851/004
English: Lancaster Way, Wingates Industrial Estate, Westhoughton, Bolton, Lancashire, BL5 3XX United Kingdom
Maltese: Lancaster Way, Wingates Industrial Estate, Westhoughton, Bolton, Lancashire, BL5 3XX
English: Mean (SD)
Maltese: Medja (SD)
English: The absolute oral bioavailability of lomitapide is 7%.
Maltese: Il-bijodisponibilità orali assoluta ta' lomitapide hija ta' 7%.
English: o statins such as simvastatin.
Maltese: o statins bħal simvastatin.
English: Medicinal products
Maltese: Prodotti mediċinali
English: ≥3x and <5x Upper Limit of Normal (ULN)
Maltese: ≥3x u <5x l-Ogħla Limitu tan-Normal (ULN)
English: 48155 Münster Germany
Maltese: 48155 Münster Il-Ġermanja
English: * IU - international units, mg - milligrams
Maltese: * IU - unitajiet internazzjonali, mg - milligrammi
English: Week 78 (N=23)
Maltese: Ġimgħa 78 (N=23)
English: • The active substance is lomitapide.
Maltese: • Is-sustanza attiva hija lomitapide.
English: Lipoprotein (a) (Lp(a)) (nmol/L)
Maltese: Lipoproteina (a) (Lp(a)) (nmol/L)a
English: Gastrointestinal (GI) effects
Maltese: Effetti gastrointestinali (GI)
English: • antacids (e.g. ranitidine, cimetidine)
Maltese: • antaċidi (eż. ranitidine, cimetidine)
English: EU/1/13/851/001 - Lojuxta 5 mg hard capsules EU/1/13/851/002 - Lojuxta 10 mg hard capsules EU/1/13/851/003 - Lojuxta 20 mg hard capsules EU/1/13/851/004 - Lojuxta 30 mg hard capsules EU/1/13/851/005 - Lojuxta 40 mg hard capsules EU/1/13/851/006 - Lojuxta 60 mg hard capsules
Maltese: EU/1/13/851/001 - Lojuxta 5 mg kapsuli ibsin EU/1/13/851/002 - Lojuxta 10 mg kapsuli ibsin EU/1/13/851/003 - Lojuxta 20 mg kapsuli ibsin EU/1/13/851/004 - Lojuxta 30 mg kapsuli ibsin EU/1/13/851/005 - Lojuxta 40 mg kapsuli ibsin EU/1/13/851/006 - Lojuxta 60 mg kapsuli ibsin
English: CARTON AND BOTTLE (5 mg, 10 mg, 20 mg, 30 mg, 40 mg and 60 mg)
Maltese: KARTUNA U FLIXKUN (5 mg, 10 mg, 20 mg, 30 mg, 40 mg u 60 mg)
English: Omega-6 Linoleic acid
Maltese: Omega-6 Aċidu linolejku
English: LDL-C, direct (mg/dL)
Maltese: LDL-C, dirett (mg/dL)
English: • Pregnancy (see section 4.6).
Maltese: • Tqala (ara s-sezzjoni 4.6).
English: • combined oral contraceptives (e.g. ethinylestradiol, norgestimate)
Maltese: • kontraċettivi orali kkombinati (eż. ethinylestradiol, norgestimate)
English: Baseline Week 26/LOCF (N=29)
Maltese: Ġimgħa 26/LOCF (N=29)
English: Daily Amount Vitamin E
Maltese: Ammont Kuljum Vitamina E
English: Capsule content:
Maltese: Kontenut tal-kapsula:
English: • High sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), CK18 Fragment, NashTest (liver inflammation)
Maltese: • High sensitivity C-reactive protein (hs-CRP), rata ta' sedimentazzjoni tal-eritroċiti (ESR), CK-18 Fragment, NashTest (infjammazzjoni tal-fwied)
English: Apolipoprotein B (apo B) (mg/dL)
Maltese: Apolipoproteina B (apo B) (mg/dL)
English: Pregelatinised starch (maize) Sodium starch glycolate (Type A) Microcrystalline cellulose Lactose monohydrate Silica, colloidal anhydrous Magnesium stearate
Maltese: Pregelatinised starch (qamħirrum) Sodium starch glycolate (Tip A) Microcrystalline cellulose Lactose monohydrate Silica, colloidal anhydrous Magnesium stearate
English: *Recommendations based on an ULN of approximately 30-40 international units/L.
Maltese: *Rakkomandazzjonijiet ibbażati fuq ULN ta' madwar 30-40 unità internazzjonali/L.
English: Amryt Pharmaceuticals DAC Teл.
Maltese: Amryt Pharmaceuticals DAC
English: AUCs for R(+)-warfarin and S(-)-warfarin increased 25% and 30%, respectively.
Maltese: L-AUCs għal R(+)-warfarina u S(-)-warfarina żdiedu b'25% u 30%, rispettivament.
English: Frequency of the adverse reactions is defined as: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza tar-reazzjonijiet avversi hija definita bħala: komuni ħafna (1/10), komuni (1/100 sa <1/10), mhux komuni (1/1,000 sa <1/100), rari (1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Alopecia
Maltese: Alopeċja
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 July 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 31 ta' Lulju 2013
English: Number of Patients with Assessments >3 to ≤5 x ULN >5 to ≤10 x ULN >10 to ≤20 x ULN >20 x ULN
Maltese: Għadd ta' Pazjenti b'Valutazzjonijiet >3 sa ≤5 x ULN >5 sa ≤10 x ULN >10 sa ≤20 x ULN >20 x ULN
English: Table 5:
Maltese: Tabella 5:
English: Risk of supratherapeutic or subtherapeutic anticoagulation with coumarin based anticoagulants
Maltese: Riskju ta' antikoagulazzjoni supraterapewtika jew subterapewtika b'antikoagulanti abbażi ta' coumarin
English: • Enhanced Liver Fibrosis (ELF) panel, Fibrometer, AST/ALT ratio, Fib-4 score, Fibrotest (liver fibrosis)
Maltese: • Enhanced Liver Fibrosis (ELF) panel, Fibrometer, proporzjon tal-AST/ALT, punteġġ talFib-4, Fibrotest (fibrożi tal-fwied)
English: Entire trial weeks 0-78 N (%)
Maltese: Prova totali ġimgħat 0-78 N (%)
English: Lomitapide does not induce CYPs 1A2, 3A4, or 2B6, and does not inhibit CYPs 1A2, 2B6, 2C9, 2C19, 2D6, or 2E1.
Maltese: Lomitapide ma jinduċix is-CYPs 1A2, 3A4, jew 2B6, u ma jinibixxix is-CYPs 1A2, 2B6, 2C9, 2C19, 2D6, jew 2E1.
English: Cmax for R(+)-warfarin and S(-)-warfarin increased 14% and
Maltese: Is-Cmax għal R(+)-warfarina u S(-)-warfarin ażdiedu b'14% u 15%, rispettivament.
English: Concomitant use of HMG-CoA reductase inhibitors (‘statins')
Maltese: Użu konkomitanti ta' inibituri ta' HMG-CoA reductase (‘statins')
English: o St. John's Wort (for depression)
Maltese: John's Wort (għad-dipressjoni)
English: In patients with moderate hepatic impairment, lomitapide AUC and Cmax were 164% and 361% higher, respectively, compared with healthy volunteers.
Maltese: F'pazjenti b'indeboliment epatiku moderat, l-AUC u s-Cmax ta' lomitapide kienu 164% u 361% ogħla, rispettivament, meta mqabbla ma' voluntiera b'saħħithom.
English: Total Cholesterol (TC) (mg/dL)
Maltese: Kolesterol Totali (TC) (mg/dL)
English: Lomitapide can cause elevations in the liver enzymes alanine aminotransferase [ALT] and aspartate aminotransferase [AST] and hepatic steatosis (see section 5.1).
Maltese: Lomitapide jista' jikkawża żidiet fl-enzimi tal-fwied alanina aminotransferażi [ALT] u fl-aspartat aminotransferażi [AST], u stejatożi epatika (ara sezzjoni 5.1).
English: Table 7:
Maltese: Tabella 7:
English: Abdominal discomfort Dyspepsia
Maltese: Skonfort addominali Dispepsja
English: Grapefruit juice
Maltese: Meraq tal-grejpfrut
English: Oral contraceptives: When lomitapide 50 mg was administered to steady state along with an oestrogen-based oral contraceptive, no clinically meaningful or statistically significant impact on the pharmacokinetics of the components of the oral contraceptive (ethinyl estradiol and 17-deacetyl norgestimate, the metabolite of norgestimate) was observed.
Maltese: Kontraċettivi orali: Meta lomitapide 50 mg ingħata fi stat stabbli flimkien ma' kontraċettiv orali abbażi tal-estroġenu, ma kien osservat l-ebda impatt klinikament sinifikanti jew statistikament sinifikanti fuq il-farmakokinetika tal-komponenti tal-kontraċettiv orali (ethinyl estradiol u 17-deacetyl norgestimate, il-metabolit ta' norgestimate).
English: PHARMACEUTICAL FORM AND CONTENTS 28 hard capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 28 kapsula iebsa
English: Hard, capsule.
Maltese: Kapsula iebsa.
English: Rash erythematous Xanthoma
Maltese: Raxx eritematiku Xanthoma