FrancophonIA/ELRC3.0 huggingface dataset:
English: paracetamol + codeine Medocodene 30/500 Capsules
Norwegian Bokmål: Medocodene 30/500 Kapsels
English: Paracetamol Caffeine
Norwegian Bokmål: Paracetamol/ Koffein/
English: 30mg effervescent tablet
Norwegian Bokmål: 30mg brusetablettt
English: 500 mg and 15 mg tablet
Norwegian Bokmål: 500 mg og 15 mg
English: Codeine phosphate/ Paracetamol
Norwegian Bokmål: Kodeinfosfat/ Paracetamol
English: 650 mg and 30 mg tablet
Norwegian Bokmål: 650 mg og 30 mg
English: Acetylsalicylic acid/ Caffeine/
Norwegian Bokmål: Acetylsalisylsyre/ Kodein/
English: 500mg + 30mg effervescent granules
Norwegian Bokmål: 500mg + 30mg brusegranulat
English: Paracetamol/Codeine COPRALGIR 400 mg/20 mg, comprimé sécable coated tablet
Norwegian Bokmål: COPRALGIR 400 mg/20 mg, comprimé sécable
English: Citodon minor suppository rectal use
Norwegian Bokmål: Citodon minor
English: Codiene phosphate
Norwegian Bokmål: Kodeinfosfat
English: Codeine phosphate 60 mg tablets
Norwegian Bokmål: Kodeinfosfat 60 mg tabletts
English: 210mg+50mg+10m g
Norwegian Bokmål: 250mg+ 210mg+50mg+ 10mg
English: Codipar effervescent tablets 15mg/500mg
Norwegian Bokmål: Codipar brusetablettts 15mg/500mg
English: Aspirin/Codeine phosphate hemihydrate
Norwegian Bokmål: aspirin + Kodeinfosfat
English: Germany codeinphosphathemihydrat paracetamol talvosilen 500 mg/30 mg 30 mg 500 mg suppository rectal use
Norwegian Bokmål: Kodeinfosfathemidydrat/ Paracetamol talvosilen 500 mg/30 mg stikkpille rektal bruk
English: 400mg+50mg+10m g
Norwegian Bokmål: 400mg+50mg+ 10mg
English: SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg effervescent tablet
Norwegian Bokmål: SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg brusetablettt
English: 500 mg and 30 mg film-coated tablet oral use
Norwegian Bokmål: 500 mg/30 mg dispersible tablett oral bruk
English: GlaxoSmithKline Consumer Healthcare, GlaxoSmithKline Export Ltd. 980 Great West Road,
Norwegian Bokmål: GlaxoSmithKline Consumer Healthcare, GlaxoSmithKline Export Ltd. 980
English: Codeine phosphate tablets BP 15mg
Norwegian Bokmål: Kodeinfosfat tabletts BP 15mg
English: Paracetamol/Codeine PARACETAMOL CODEINE CRISTERS 500 mg/30 mg, comprimé effervescent sécable
Norwegian Bokmål: PARACETAMOL CODEINE CRISTERS 500 mg/30 mg, comprimé effervescent sécable
English: PARCOTEN TABLET
Norwegian Bokmål: Paracodol Tabletts
English: Belgium Sterop Laboratoires nv Avenue de Scheut 46
Norwegian Bokmål: Sterop Laboratoires nv
English: Codeine phosphate, hidroxicine dichlorhydrate and propifenazone
Norwegian Bokmål: Kodeinfosfat/ Hydroksyzinhydroklorid/ Propyfenazon
English: Paracetamol/Codeine PARACETAMOL CODEINE BIOGARAN 500 mg/30 mg, comprimé effervescent sécable
Norwegian Bokmål: PARACETAMOL CODEINE BIOGARAN 500 mg/30 mg, comprimé effervescent sécable
English: Film-coated tablet
Norwegian Bokmål: Kodipar tablettt, filmdrasjert
English: Sandoz Limted, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom codeine phosphate
Norwegian Bokmål: Storbritannia Sogoz Limted, Frimley Business Park, Frimley,
English: Codeine phosphate tablets BP 30mg
Norwegian Bokmål: Kodeinfosfat tabletts BP 30mg
English: 200mg + 12,8mg film-coated tablet oral use
Norwegian Bokmål: 200mg +12.8mg tablettt, filmdrasjert
English: Chaussée de la Hulpe
Norwegian Bokmål: Avenue de Scheut
English: 500 mg and 30 mg tablet
Norwegian Bokmål: 500 mg og 30 mg brusetablettt
English: Paracetamol/Codeine PARACETAMOL CODEINE MYLAN 500 mg/30 mg, comprimé effervescent sécable
Norwegian Bokmål: PARACETAMOL CODEINE MYLAN 500 mg/30 mg, comprimé effervescent sécable
English: WOCKHARDT UK LIMITED Ash Road North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom
Norwegian Bokmål: Storbritannia WOCKHARDT UK LIMITED Ash Road North, Wrexhan
English: 30mg + 500 mg capsule, hard oral use
Norwegian Bokmål: 30mg + 500 mg kapsel, hard
English: Codeine phosphate 60mg tablets
Norwegian Bokmål: Kodeinfosfat 60mg tabletts
English: Codeine Phosphate Tablets BP 60mg
Norwegian Bokmål: Kodeinfosfat tabletts BP 60mg
English: 30mg + 500mg tablet
Norwegian Bokmål: 30mg + 500mg tablett
English: Paracetamol/Codeine PARACETAMOL CODEINE EG 500 mg/30 mg, comprimé effervescent sécable
Norwegian Bokmål: PARACETAMOL CODEINE EG 500 mg/30 mg, comprimé effervescent sécable
English: Paracetamol/Codeine PARACETAMOL CODEINE ARROW 500 mg/30 mg, comprimé effervescent sécable
Norwegian Bokmål: PARACETAMOL CODEINE ARROW 500 mg/30 mg, comprimé effervescent sécable
English: Vitabalans Oy Varastokatu 8, Hämeenlinna FI-13500 Finland codeine + paracetamol
Norwegian Bokmål: Vitabalans Oy Varastokatu 8, Hämeenlinna FI13500 Finland
English: 200mg +12.8mg coated tablet
Norwegian Bokmål: 200mg +12.8mg tablett, drasjert
English: Braine-l'Alleud
Norwegian Bokmål: 1420 Braine-l'Alleud Belgia
English: Caffeine 30 mg film-coated tablet oral use
Norwegian Bokmål: Koffein 30 mg tablettt, filmdrasjert
English: 500mg + 30mg + 8mg effervescent tablet
Norwegian Bokmål: 500mg + 30mg + 8mg brusetablettt
English: Codeini phosphas hemihydricus + paracetamolum + pitofenoni hydrochloridum + fenpiverinii bromidum
Norwegian Bokmål: Kodeinfosfathemihydrat/ Paracetamol/ Pitofenonhydroklorid/ Fenpiverinbromid
English: Paracetamol/Codeine PARACETAMOL CODEINE ALMUS 500 mg/30 mg, comprimé effervescent sécable
Norwegian Bokmål: PARACETAMOL CODEINE ALMUS 500 mg/30 mg, comprimé effervescent sécable
English: Paracetamol/Codeine PARACETAMOL CODEINE TEVA 500 mg/30 mg, comprimé effervescent sécable
Norwegian Bokmål: PARACETAMOL CODEINE TEVA 500 mg/30 mg, comprimé effervescent sécable
English: Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom paracetamol + codeine Paracodol Capsules capsule
Norwegian Bokmål: Storbritannia Bayer plc, Bayer House, Strawberry Hill, Newbury,
English: Paracetamolum/Codeini phosphas hemihydricus
Norwegian Bokmål: Paracetamol/ Kodeinfosfatsesquihydrat
English: Propain Plus Tablets
Norwegian Bokmål: Nurofen Plus tablettt, filmdrasjert
English: 30mg + 500mg capsule, hard oral use
Norwegian Bokmål: 30mg + 500mg kapsel, hard
English: 500mg/8mg/30mg soluble tablets
Norwegian Bokmål: 500mg/8mg/30mg Oppløselig tabletts
English: 500 mg+8 mg+30 mg effervescent tablet
Norwegian Bokmål: 500 mg+8 mg+30 mg brusetablettt
English: 200 mg and 10 mg /1 ml oral solution oral use
Norwegian Bokmål: 200 mg og 10 mg /1 ml mikstur, oppløsning
English: Mercury Pharms Cocodamola effervescent tablets 30mg/500mg
Norwegian Bokmål: Mercury Pharms Cocodamola brusetablettts 30mg/500mg
English: 500mg +8mg + 30mg tablet for oral solution
Norwegian Bokmål: 500mg +8mg + 30mg tablett for mikstur, oppløsning
English: Ibuprofen and codeine phosphate hemihydrate
Norwegian Bokmål: Ibuprofen og codeine tabletts
English: Paracetamol/Codeine CO-CODAMOL
Norwegian Bokmål: Paracetamol/ Kodein
English: Paracetamol/ Codeine phosphate
Norwegian Bokmål: Paracetamol/ Kodeinfosfat
English: Romania acid acetilsalicilic, paracetamol , fosfat de codeină hemihidrat
Norwegian Bokmål: Acetylsalisylsyre/ Paracetamol/ Kodeinfosfathemihydrat
English: 8mg + 400mg
Norwegian Bokmål: 8mg + 400mg tablett
English: Paracetamol/ Codeine phosphate hemihydrate
Norwegian Bokmål: Paracetamol/ Kodeinfosfathemihydrat
English: Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
Norwegian Bokmål: Gottlieb-DaimlerStr.
English: Sterwin Meds Cocodamol 8/500 effervescent tablets
Norwegian Bokmål: Sterwin Meds Cocodamol 8/500 brusetablettts
English: Paracetamol 450 mg Codeine Phosphate Hemihydrate 10 mg Doxylamine succinate 5 mg
Norwegian Bokmål: Syndol Tablettt, filmdrasjerts Paracetamol 450 mg Kodeinfosfathemihydra t 10 mg
English: Codeine phosphate 30 mg tablets
Norwegian Bokmål: Kodeinfosfat 30 mg tabletts
English: 500mg + 12.8mg tablet
Norwegian Bokmål: 500mg + 8mg tablett
English: Ibuprofen Codeine phosphate
Norwegian Bokmål: Ibuprofen/ Kodeinfosfat
English: FRANCE 500 mg/30 mg, comprimé effervescent sécable
Norwegian Bokmål: CODOLIPRANE 500 mg/30 mg, comprimé effervescent sécable
English: Solpadol 500 mg/30 mg Effervescent Tablets effervescent tablet
Norwegian Bokmål: Solpadol 500 mg/30 mg Brusetablettts brusetablettt
English: Codeine phosphate hemihydrate
Norwegian Bokmål: Kodeinfosfathemihydrat
English: 500mg + 8mg + 30mg effervescent tablet
Norwegian Bokmål: 500mg + 8mg + 30mg brusetablettt
English: TW8
Norwegian Bokmål: 9NW
English: Germany Astellas Pharma GmbH Gearg-Brauchle-Ring
Norwegian Bokmål: Gearg-Brauchle-Ring
English: Codeine phosphate 30mg tablets
Norwegian Bokmål: Kodeinfosfat 30mg tabletts
English: 500mg + 30mg film-coated tablet oral use
Norwegian Bokmål: 500mg /30mg dispersible tablett oral bruk
English: Paracetamol and codeine phosphate
Norwegian Bokmål: Paracetamol og Codeine Caplets
English: 30 mg +500 mg tablet
Norwegian Bokmål: 30 mg +500 mg tablett
English: Paracetamol + codeine phosphate hemihydrate+ caffeine
Norwegian Bokmål: paracetamol + codein + koffein
English: 12489 Berlin
Norwegian Bokmål: 20144 Milano Italia
English: paracetamol + codeine M&A Pharmachem CoCodamol Tablets 60/500
Norwegian Bokmål: M&A Pharmachem CoCodamol Tabletts
English: Belgium Glaxosmithkline Consumer Healthcare sa
Norwegian Bokmål: GlaxoSmithKline Consumer Healthcare (Irland) Limited
English: 500 mg/30 mg coated tablet
Norwegian Bokmål: 500 mg/30 mg tablett
English: 30mg + 500 mg tablet
Norwegian Bokmål: 30mg + 500 mg tablett
English: 500mg/8mg/30mg effervescent tablet
Norwegian Bokmål: 500mg/8mg/30 mg brusetablettt
English: 8mg +500mg + 30mg effervescent tablet
Norwegian Bokmål: 8mg + 500mg + 30mg brusetablettt
English: 8mg + 500mg + 30mg effervescent tablet
Norwegian Bokmål: 8mg +500mg + 30mg brusetablettt
English: Winthrop Pharms Cocodamol 8/500 effervescent tablets effervescent tablet
Norwegian Bokmål: Winthrop Pharms Cocodamol 8/500 brusetablettts
English: 500 mg/8 mg/30 mg tablet
Norwegian Bokmål: 500 mg/8 mg/30 mg
English: Rua Carpeinteiros, 25 Polígono Industrial Ceao
Norwegian Bokmål: Street, Ergates Industrial
English: 400 mg and 30 mg film-coated tablet oral use
Norwegian Bokmål: 400 mg og 30 mg tablettt, filmdrasjert
English: 500mg/8mg/30mg tablet
Norwegian Bokmål: 500mg/8mg/30 mg
English: Paracetamol 500mg Codeine Phosphate Hemihydrate 8mg Caffeine 30mg
Norwegian Bokmål: Paracetamol 500mg Kodeinfosfathemihydra t 8mg
English: Reckitt Benkiser Healthcare (UK) Limited, Wellcroft House, Wellcroft Road, Slough, Berkshire SL1 4AQ,
Norwegian Bokmål: Limited, Wellcroft House, Wellcroft
English: 500 mg/8 mg/30 mg effervescent tablet
Norwegian Bokmål: 500 mg/8 mg/30 mg brusetablettt
English: Acetylsalicylic acid, Codeine phosphate hemihydrate and caffeine
Norwegian Bokmål: Acetylsalisylsyre/ Kodeinfosfathemihydrat/ Koffein
English: Sweden codeine phosphate hemihydrate/ paracetamol
Norwegian Bokmål: Kodeinfosfathemidydrat/ Acetylsalisylsyre/ Paracetamol
English: SOLPADEINE SOLUBLE TABLET
Norwegian Bokmål: SOLPADEINE OPPLØSELIG TABLETT
English: Paracetamol/Codeine ALGISEDAL, comprimé 400 mg/25 mg,
Norwegian Bokmål: ALGISEDAL, comprimé 400 mg/25 mg, tablett
English: LABORATORIES, S.A. Avda.
Norwegian Bokmål: LABORATORIES, S.A.
English: Codeine phosphate Paracetamol
Norwegian Bokmål: Kodeinfosfathemidydrat/ Paracetamol
English: CRESCENT PHARMA LTD, Polhampton Lane, Units 3&4, Quidhampton Business units, Overton, Hampshire, RG25 3ED, United Kingdom
Norwegian Bokmål: Overton, Hampshire, RG25 3ED,
English: 500 mg/30 mg effervescent tablet
Norwegian Bokmål: 500 mg/30 mg brusetablett
English: Romania paracetamol, cafeină anhidră, fosfat de codeină hemihidrat
Norwegian Bokmål: Paracetamol/ Koffein, vannfritt/ Kodeinfosfathemihydrat
English: 15mg + 500mg effervescent tablet
Norwegian Bokmål: 15mg + 500mg brusetablettt
English: 25 mg film-coated tablet oral use
Norwegian Bokmål: 25 mg tablettt, filmdrasjert
English: Paralgin Minor suppository rectal use
Norwegian Bokmål: Paralgin Minor
English: 500mg + 30mg effervescent tablet
Norwegian Bokmål: 500mg + 30mg brusetablettt
English: Paracetamol/Codeine PARACETAMOL CODEINE SANDOZ 500 mg/30 mg, comprimé effervescent sécable
Norwegian Bokmål: PARACETAMOL CODEINE SOGOZ 500 mg/30 mg, comprimé effervescent sécable
English: 92700 Colombes France
Norwegian Bokmål: 92500 RueilMalmaison Frankrike
English: Einsteinova 24
Norwegian Bokmål: Weihenstephaner Str. 28
English: Belgium Bristol-Meyers Squibb Belgium sa
Norwegian Bokmål: Bristol-Meyers Squibb Belgia sa Chaussée de la Hulpe 185
English: Tipperary, Ireland
Norwegian Bokmål: Tipperary
English: 182 12 Danderyd Sweden codeine phosphate hemihydrate/ paracetamol
Norwegian Bokmål: 182 12 Dogeryd Sverige
English: TALVOSILEN FORTE SUPPOSITORY
Norwegian Bokmål: TALVOSILEN FORTE STIKKPILLE
English: 1 cartridge and 1 pen
Norwegian Bokmål: 1 ampulle og 1 penn
English: 3 cartridges
Norwegian Bokmål: 3 ampuller
English: 1 cartridge
Norwegian Bokmål: 1 ampulle
English: EU (MA) Number
Norwegian Bokmål: MT (EU)-nummer Legemidlets navn Styrke Legemiddelform Administrasjonsmåte
English: EU (MA) Number
Norwegian Bokmål: MT (EU)-nummer Legemidlets navn
English: Strength Pharmaceutical form
Norwegian Bokmål: Styrke Legemiddelform Dyreart Administrasjonsvei(er)
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.
Norwegian Bokmål: • Detaljert informasjon om risiko for hematologiske sykdommer (spesielt anemi) som er assosiert med Victrelis, bl.a. en reell beskrivelse av de hematologiske sykdommene inkludert frekvens og latenstid og relaterte klinisk symptomer.
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.
Norwegian Bokmål: Medlemslandene skal sikre at alle betingelser når det gjelder sikker og effektiv bruk av legemidlet beskrevet under, blir implementert.
English: Key elements to be included in the educational material:
Norwegian Bokmål: Utdanningsmaterialet bør inneholde følgende nøkkelelementer:
English: - Summary of Product Characteristics (in full)
Norwegian Bokmål: • Preparatomtalen (den komplette)
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:
Norwegian Bokmål: Før lansering i hvert medlemsland, skal innehaver av markedsføringstillatelsen sammen med den nasjonale legemiddelmyndighet bli enige om formatet og innholdet i legens utdanningsmateriell.
English: • what dose to take and for how long.
Norwegian Bokmål: • hvilken dose du skal ta og hvor lenge.
English: Your doctor will tell you:
Norwegian Bokmål: Legen din vil fortelle deg:
English: The final study report shall be submitted by 31 December 2021.
Norwegian Bokmål: Den endelige studierapporten skal leveres innen 31 desember 2021.
English: The potential risk for humans is unknown.
Norwegian Bokmål: Den potensielle risikoen for mennesker er ikke kjent.
English: Do not change the dose yourself.
Norwegian Bokmål: Du må ikke endre dosen på egenhånd.
English: Date of latest renewal: 23 April 2018
Norwegian Bokmål: Dato for siste fornyelse: 23 april 2018
English: Just take your normal dose at the usual time the next day.
Norwegian Bokmål: Bare ta vanlig dose til vanlig tid neste dag.
English: Therefore, particular caution should be exercised in these patients.
Norwegian Bokmål: Det må derfor utvises spesiell forsiktighet hos disse pasientene.
English: Number of evaluable patients 22
Norwegian Bokmål: Antall evaluerbare pasienter 22
English: There are no reliable data on its use in pregnant women.
Norwegian Bokmål: Det finnes ikke pålitelige data på bruk hos gravide kvinner.
English: • At least one marker from each of the following categories:
Norwegian Bokmål: • Minst én markør fra hver av følgende kategorier:
English: o statins such as simvastatin.
Norwegian Bokmål: o statiner som simvastatin.
English: • when to increase or decrease your dose.
Norwegian Bokmål: • når du skal øke eller redusere dosen.
English: There is no specific treatment in the event of overdose.
Norwegian Bokmål: Det finnes ingen spesifikk behandling ved overdosering.
English: Genetic confirmation of HoFH should be obtained whenever possible.
Norwegian Bokmål: Genetisk bekreftelse av HoFH bør innhentes når det er mulig.
English: • Confirm elevation with a repeat measurement within one week.
Norwegian Bokmål: • Bekreft det forhøyede nivået ved å gjenta målingen innen 1 uke.
English: Grapefruit juice
Norwegian Bokmål: Grapefruktjuice
English: o Ginkgo (to improve memory)
Norwegian Bokmål: o ginkgo (for å bedre hukommelsen)
English: Any impact on efficacy is likely to be variable.
Norwegian Bokmål: En eventuell innvirkning på effekten vil sannsynligvis være variabel.
English: The objectives of the study are:
Norwegian Bokmål: Målene med studien er:
English: *Recommendations based on an ULN of approximately 30-40 international units/L.
Norwegian Bokmål: *Anbefalinger basert på ULN på omtrent 30-40 internasjonale enheter/liter.
English: Not known (frequency cannot be estimated from the available data)
Norwegian Bokmål: Ikke kjent (hyppighet kan ikke anslås ut ifra tilgjengelige data)
English: Age and gender
Norwegian Bokmål: Alder og kjønn
English: • Do not drink any type of grapefruit juice.
Norwegian Bokmål: • Drikk ikke noen type grapefruktjuice.
English: If you feel dizzy during treatment then do not drive or use machines until you feel better.
Norwegian Bokmål: Dersom du føler deg svimmel under behandlingen, skal du ikke kjøre eller bruke maskiner før du føler deg bedre.
English: Annual reports will be submitted at time of annual reassessment
Norwegian Bokmål: Det skal leveres inn årlige rapporter til årlig revurdering
English: Package leaflet: Information for the user
Norwegian Bokmål: Pakningsvedlegg: informasjon til brukeren
English: • tiredness, lack of energy or general weakness
Norwegian Bokmål: • tretthet, mangel på energi eller generell svakhet
English: Daily Amount Vitamin E
Norwegian Bokmål: Daglig mengde Vitamin E
English: Inform your doctor of any change in the medicines you are taking.
Norwegian Bokmål: Informer legen din om enhver endring i medisinene du tar.
English: • Advice to patients about:
Norwegian Bokmål: • Veiledning til pasienter om:
English: • Advice to patients about the risk of concomitant alcohol intake;
Norwegian Bokmål: • Veiledning til pasienter om risikoen ved samtidig inntak av alkohol;
English: • blood or protein in the urine
Norwegian Bokmål: • blod eller proteiner i urinen
English: These blood tests help your doctor adjust your dose.
Norwegian Bokmål: Disse blodprøvene hjelper legen din med å justere dosen din.
English: Keep the bottle tightly closed in order to protect from moisture.
Norwegian Bokmål: Oppbevar flasken godt lukket for å beskytte mot fuktighet.
English: The risk of liver damage is increased when this medicine is used at the same time as statins.
Norwegian Bokmål: Risikoen for leverskade øker når dette legemidlet brukes samtidig med statiner.
English: Your doctor may increase your dose slowly over time, up to a maximum of 60 mg each day.
Norwegian Bokmål: Legen din kan øke dosen din langsomt over tid, opp til maksimalt 60 mg daglig.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 July 2013
Norwegian Bokmål: DATO FOR FØRSTE MARKEDSFØRINGSTILLATELSE / SISTE FORNYELSE Dato for første markedsføringstillatelse: 31 juli 2013
English: Approximately 33% of the radioactivity was excreted in urine as metabolites.
Norwegian Bokmål: Omtrent 33 % av radioaktiviteten ble utskilt i urinen i form av metabolitten.
English: Doses higher than 60 mg suggest a trend toward nonlinearity and are not recommended.
Norwegian Bokmål: Doser høyere enn 60 mg viser en tendens til ikke-linearitet og er ikke anbefalt.
English: It should be taken on an empty stomach, at least 2 hours after the evening meal because the fat content of a recent meal may adversely impact gastrointestinal tolerability.
Norwegian Bokmål: Det bør tas på tom mage, minst 2 timer etter kveldsmat, siden fettinnholdet i et nylig inntatt måltid kan ha negativ innvirkning på gastrointestinal tolerabilitet.
English: These capsules may cause side effects which can also be symptoms of liver problems.
Norwegian Bokmål: Disse kapslene kan forårsake bivirkninger som også kan være symptomer på leverproblemer.
English: Do not use this medicine after the expiry date which is stated on the label or carton after “EXP”.
Norwegian Bokmål: Bruk ikke dette legemidlet etter utløpsdatoen som er angitt på etiketten eller esken etter " Utløpsdato".
English: It is important to avoid dehydration by drinking enough fluids (see section 4).
Norwegian Bokmål: Det er viktig å unngå dehydrering ved å drikke rikelig med væske (se avsnitt 4).
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).
Norwegian Bokmål: Hyppigheten av bivirkninger er definert som: svært vanlige (1/10), vanlige (1/100 til <1/10), mindre vanlige (1/1000 til <1/100), sjeldne (1/10 000 til <1/1000), svært sjeldne (<1/10 000), ikke kjent (kan ikke anslås ut ifra tilgjengelige data).
English: SPECIAL STORAGE CONDITIONS Store below 30°C.
Norwegian Bokmål: OPPBEVARINGSBETINGELSER Oppbevares ved høyst 30 °C.
English: >5% to ≤10% >10% to ≤15% >15% to ≤20% >20% to ≤25%
Norwegian Bokmål: > 5 % til ≤ 10 % > 10 % til ≤ 15 % > 15 % til ≤ 20 % > 20 % til ≤ 25 %
English: After the first year, do these tests at least every 3 months and before any increase in dose.
Norwegian Bokmål: Etter det første året skal disse testene utføres minst hver 3. måned og før enhver doseøkning.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measure:
Norwegian Bokmål: Ettersom dette er en godkjennelse gitt på særskilt grunnlag som følger Artikkel 14(8) av forordning (EF) 726/2004, skal innehaver av markedsføringstillatelsen utføre følgende tiltak innen de angitte tidsrammer:
English: If you stop taking this medicine your cholesterol may rise again.
Norwegian Bokmål: Dersom du slutter å ta dette legemidlet, kan kolesterolnivået øke igjen.
English: No studies have been conducted in children and adolescents under the age of 18.
Norwegian Bokmål: Det er ikke utført studier med barn og ungdom under 18 år.
English: Omega-6 Linoleic acid
Norwegian Bokmål: Omega-6 Linolensyre
English: The patient's “bad” cholesterol level is very high from a very early age.
Norwegian Bokmål: Pasientens nivå av det “dårlige” kolesterolet blir svært høyt fra ung alder.
English: Because of the possibility of interactions with other medicines, your doctor may change the time of day you take your medicines.
Norwegian Bokmål: På grunn av mulighetene for interaksjoner med andre medisiner kan legen din endre tidspunkt for når du skal ta medisinen din.
English: You should contact your doctor before you stop taking this medicine.
Norwegian Bokmål: Du bør kontakte legen din før du slutter å bruke dette legemidlet.
English: It is typically passed down by both father and mother, who also have high cholesterol passed down from their parents.
Norwegian Bokmål: Tilstanden kan arves fra både far og mor, som også har arvet et høyt kolesterolnivå fra sine foreldre.
English: Lojuxta can lower blood levels of:
Norwegian Bokmål: Lojuxta kan redusere blodnivået av:
English: The most common adverse reactions were gastrointestinal effects.
Norwegian Bokmål: De vanligste bivirkningene var gastrointestinale effekter.
English: Adverse clinical consequences of these reductions were not observed with lomitapide treatment of up to 78 weeks.
Norwegian Bokmål: Negative kliniske konsekvenser av disse reduserte nivåene ble ikke observert ved behandling med lomitapid i opptil 78 uker.
English: The following other side effects have also occurred:
Norwegian Bokmål: Følgende bivirkninger har også forekommet: