FrancophonIA/ELRC3.0 huggingface dataset:
English: The following wording was agreed by the CHMP: ‘{PRODUCT NAME} is contraindicated in patients:
Danish: Følgende formulering er godkendt af CHMP: "{PRODUKTNAVN} er kontraindiceret til patienter:
English: Regarding the time of medication intake and meals, the information is taken from the MRP SmPC, where it is recommended that each daily dose is given all at once, and at any time of the day, with or without food.
Danish: Vedrørende tidspunkter for indtagelse af medicin og måltider tages oplysningerne fra det gensidigt anerkendte produktresumé, hvor det anbefales, at den daglige dosis gives på én gang og på et hvilket som helst tidspunkt af dagen med eller uden føde.
English: Section 4.5- Interaction with other medicinal products and other forms of interaction For pharmacokinetic interactions, introductory information has been retained in the text, whilst the interaction information as well as the corresponding clinical recommendation such as cut-off values for special dosage recommendations or other recommendations has been included.
Danish: Punkt 4.5 Interaktion med andre lægemidler og andre former for interaktion For farmakokinetiske interaktioner er indledende oplysninger bevaret i teksten, mens oplysningerne om interaktion samt den tilsvarende kliniske anbefaling, f.eks. afskæringsværdier for særlige dosisanbefalinger eller andre anbefalinger, er medtaget.
English: The MAH has submitted supporting data and arguments relating to these main areas, which have been assessed and considered acceptable by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen har indsendt underbyggende data og argumenter vedrørende disse hovedområder, som er vurderet og fundet acceptable af CHMP.
English: Lower starting doses of atorvastatin for potent CYP3A4 inhibitors and lower maximum doses of atorvastatin for both potent and moderate CYP3A4 inhibitors have been recommended as requested by the CHMP.
Danish: Lavere startdoser af atorvastatin for potente CYP3A4-hæmmere og lavere maksimumdoser af atorvastatin for både potente og moderate CYP3A4-hæmmere er anbefalet, sådan som CHMP har anmodet om.
English: The proposed SmPC changes were based on data from the Anglo-Scandinavian Cardiac Outcomes Trial - Lipid-Lowering Arm (ASCOT-LLA), and the Collaborative Atorvastatin Diabetes Study (CARDS).
Danish: De foreslåede ændringer i produktresuméet var baseret på data fra Anglo-Scandinavian Cardiac Outcomes Trial - Lipid-Lowering Arm (ASCOT-LLA) og Collaborative Atorvastatin Diabetes Study (CARDS).
English: Contraindications with regard to drug interactions were not included in this section as it is addressed in section 4.5.
Danish: Kontraindikationer med hensyn til lægemiddelinteraktioner er ikke medtaget i dette punkt, da de er behandlet i pkt.
English: For the hypercholesterolaemia indication, the MAH proposes removing the additional text around guidelines.
Danish: For hyperkolesterolæmiindikationen foreslår indehaveren af markedsføringstilladelsen at fjerne den ekstra tekst omkring retningslinjerne.
English: Experience in paediatrics is limited to a small number of patients (age 4 - 17 years) with severe dyslipidemias, such as homozygous familial hypercholesterolemia.
Danish: Erfaringen med børn og unge er begrænset til et lille antal patienter (i alderen 4-17 år) med svære dyslipidæmier som homozygot familiær hyperkolesterolæmi.
English: Section 4.4 - Special warnings and precautions for use The list of clinically relevant CYP3A4-inhibitors or transporter inhibitors has been made more general including inhibitors for which there is no interaction data available but where significant interaction could be assumed, since an increased risk can be expected for all potent CYP3A4 or OATP1B1 inhibitors.
Danish: Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen Listen over klinisk relevante CYP3A4-hæmmere eller transporterhæmmere er gjort mere generel og inkluderer inhibitorer, der ikke foreligger interaktionsdata for, men hvor signifikant interaktion må antages, da der kan forventes en øget risiko for alle potente CYP3A4- eller OATP1B1-hæmmere.
English: The MAH conducted a review of the pooled data from the 17 completed placebo-controlled clinical trials in the atorvastatin clinical trial database as of June 24, 2008, when the review was initiated.
Danish: Indehaveren af markedsføringstilladelsen har gennemgået de poolede data fra de 17 gennemførte placebokontrollerede kliniske undersøgelser i den kliniske atorvastatin-undersøgelsesdatabase pr. 24. juni 2008, hvor gennemgangen blev iværksat.
English: Hence, the MAH has not included this wording in the proposed harmonised SmPC.
Danish: Derfor har indehaveren af markedsføringstilladelsen ikke medtaget denne formulering i det foreslåede harmoniserede produktresumé.
English: The four cut-off ranges as proposed by the MAH take into account the dose proportional increase in AUC exposure over the 1080 mg atorvastatin dose range and the available strengths (10, 20, 40, and 80 mg) of atorvastatin tablets.
Danish: De fire afskæringsintervaller, som er foreslået af indehaveren af markedsføringstilladelsen, tager højde for den dosisproportionale stigning i AUCeksponering over atorvastatin-dosisintervallet på 10-80 mg og de tilgængelige styrker (10, 20, 40 og 80 mg) for atorvastatin-tabletter.
English: Information on paediatric studies has not been included in this procedure as the Art 29 paediatric referral has no bearing on this Art 30 harmonisation referral.
Danish: Oplysninger om undersøgelser med børn og unge er ikke omfattet af denne procedure, da den pædiatriske indbringelse ifølge artikel 29 ikke er relevant for denne artikel 30harmoniseringsindbringelse.
English: The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response.
Danish: Dosis bør individualiseres i henhold til basisniveau for LDL-C, mål for behandlingen og behandlingseffekt.
English: Variations to the drug product - atorvastatin calcium, small, round film-coated tablets - are comprehensively documented and the amendments proposed regarding the harmonisation are considered acceptable by the CHMP.
Danish: Ændringer i lægemidlet - atorvastatincalcium, små, runde, filmovertrukne tabletter - er grundigt dokumenteret, og de foreslåede ændringer vedrørende harmoniseringen anses som acceptable af CHMP.
English: As "insomnia" and "nightmares" have already been included in the SmPC and "memory loss" is found as "amnesia", additional terms were not considered to be necessary by the MAH, in order to fulfill the PhVWP Statin Class wording, and this proposal was accepted by the CHMP.
Danish: Da "søvnløshed" og "mareridt" allerede er medtaget i produktresuméet, og "hukommelsestab" findes som "amnesi", anså indehaveren af markedsføringstilladelsen ikke yderligere termer for nødvendige for at opfylde statinklasseformuleringen fra arbejdsgruppen vedrørende lægemiddelovervågning, og dette forslag blev accepteret af CHMP.
English: Use in the elderly
Danish: Ældre
English: Patients should be started with {PRODUCT NAME} 10 mg daily.
Danish: Patienter bør starte med {PRODUKTNAVN} 10 mg dagligt.
English: The adverse events in the database were all mapped to MedDRA dictionary terms.
Danish: Bivirkningerne i databasen blev alle knyttet til MedDRA-terminologi.
English: Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food.'
Danish: Dosis kan gives på et hvilket som helst tidspunkt af døgnet med eller uden føde."
English: The MAH's proposal regarding hypercholesterolaemia indications were mostly supported except for the proposal to include the wording that: ‘Lipitor also raises HDL-cholesterol and lowers the LDL/HDL and total cholesterol/HDL ratios'.
Danish: Indehaveren af markedsføringstilladelsens forslag vedrørende indikationer for hyperkolesterolæmi var for størstedelens vedkommende underbygget, bortset fra forslaget om at medtage følgende ordlyd: "Lipitor hæver også HDL-kolesterol og sænker LDL/HDL- og total kolesterol/HDL-forholdet".
English: The dose may be increased to 80 mg daily, according to the response and tolerability.
Danish: Dosis kan øges til 80 mg dagligt efter en måneds behandling alt efter respons og tolerabilitet.
English: There is no evidence to support a particular timeframe by which to discontinue atorvastatin treatment prior to conception.
Danish: Der er ingen dokumentation til støtte for et bestemt tidspunkt før undfangelse, hvor atorvastatin-behandling skal seponeres.
English: Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant may be combined with 40 mg atorvastatin once daily.
Danish: Derefter kan dosis enten øges til maksimalt 80 mg dagligt eller kombineres med en galdesyrebinder og 40 mg atorvastatin én gang dagligt.
English: The information that rare reports of congenital anomalies have been received following exposure to HMG-CoA reductase inhibitors has been included.
Danish: Oplysningen om, at der er modtaget sjældne indberetninger om medfødte misdannelser efter eksponering over for HMG-CoA-reduktasehæmmere, er medtaget.
English: - A review of the MAH's clinical trial data did not reveal a muscle safety concern in the renal impairment population and a review of the medical literature suggested that statins can be used safely in patients with chronic kidney disease (CKD).
Danish: - En gennemgang af indehaveren af markedsføringstilladelsens kliniske undersøgelsesdata viste ingen sikkerhedsproblemer for muskler hos patienter med nedsat nyrefunktion, og en gennemgang af litteraturen viste, at statiner er sikre til patienter med kronisk nyresygdom (CKD).
English: Summaries of the studies investigating the effect of atorvastatin on Atherosclerosis (REVERSAL study), Acute Coronary Syndrome (MIRACL trial), the Prevention of Cardiovascular Disease (ASCOT-LLA and CARDS trials), Recurrent Stroke (SPARCL study) were included.
Danish: Resuméer af de undersøgelser, hvor man undersøger effekten af atorvastatin på aterosklerose (REVERSAL-undersøgelsen), akut koronarsyndrom (MIRACL-undersøgelsen), forebyggelse af kardiovaskulær sygdom (ASCOT-LLA- og CARDS-undersøgelsen), tilbagevendende apopleksi (SPARCLundersøgelsen) er medtaget.
English: ‘Hypercholesterolaemia ‘{PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol (totalC), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Danish: "Hyperkolesterolæmi ”{PRODUKTNAVN} er indiceret som supplement til diæt med henblik på reduktion af forhøjet totalkolesterol (total-C), LDL-kolesterol (LDL-C), apolipoprotein B og forhøjede triglycerider hos patienter med primær hyperkolesterolæmi, herunder familiær hyperkolesterolæmi (heterozygot variant) eller kombineret (blandet) hyperlipidæmi (svarende til type IIa og IIb i Fredricksons klassifikation), når respons på diæt og andre ikke-farmakologiske foranstaltninger er utilstrækkelig.
English: Regarding special populations:
Danish: Særlige patientgrupper:
English: The dose of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily (see section 5.1).
Danish: Doseringen af atorvastatin til patienter med homozygot familiær hyperkolesterolæmi er 10-80 mg dagligt (se pkt.
English: {PRODUCT NAME} is contraindicated in patients with active liver disease (see section 4.3).
Danish: {PRODUKTNAVN} er kontraindiceret hos patienter med aktiv leversygdom (se pkt.
English: {PRODUCT NAME} is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.'
Danish: {PRODUKTNAVN} er også indiceret til at nedsætte total-C og LDL-C hos patienter med homozygot familiær hyperkolesterolæmi som supplement til anden lipidsænkende behandling (f.eks. LDL-aferese), eller hvis sådan behandling ikke er tilgængelig."
English: The MAH agreed to relocate the specified ADRs to their primary MedDRA SOC as requested by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen accepterede at flytte de angivne ADR'er til deres primære MedDRA-systemorganklasse, sådan som CHMP havde anmodet om.
English: The recommended starting dose in this population is 10 mg of atorvastatin per day.
Danish: Den anbefalede startdosis i denne patientgruppe er 10 mg atorvastatin dagligt.
English: Information regarding Concomitant treatment with other medications has been included in section 4.5.
Danish: Oplysninger vedrørende samtidig behandling med andre lægemidler er medtaget i pkt.
English: The remaining undesirable effects mentioned in the PhVWP Statin Class wording have also been included.
Danish: De resterende bivirkninger, som er nævnt i statinklasseformuleringen fra arbejdsgruppen vedrørende lægemiddelovervågning, er også medtaget.
English: In the primary prevention trials the dose was 10 mg/day.
Danish: I de primære forebyggelsesundersøgelser var dosis 10 mg dagligt.
English: Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients or if such treatments are unavailable.
Danish: 5.1) Atorvastatin bør anvendes som supplement til anden lipidsænkende behandling (f.eks. LDL-aferese) hos disse patienter, eller hvis sådan behandling ikke er tilgængelig.
English: The harmonized text is identical to the current approved MRP SPC.
Danish: Den harmoniserede tekst er identisk med det nuværende gensidigt anerkendte produktresumé.
English: Pharmacokinetic data in the paediatric population are not available.
Danish: Der foreligger ingen farmakokinetiske data for børn og unge.
English: The resulting harmonised SPC, labelling and package leaflet was agreed by the CHMP.
Danish: Det harmoniserede produktresumé, etikettering og indlægsseddel, som er resultatet heraf, er godkendt af CHMP.
English: The main areas of disharmony which were addressed by the MAH related to the indication, posology, special warnings and precaution for use, interaction with other medicinal products, pregnancy and lactation, undesirable effects, pharmacodynamic properties, pharmacokinetic properties and preclinical safety data.
Danish: De områder, der især er uenighed om, og som indehaveren af markedsføringstilladelsen har undersøgt, vedrørte indikation, dosering, særlige advarsler og forholdsregler, interaktion med andre lægemidler, fertilitet, graviditet og amning, bivirkninger, farmakokinetiske egenskaber og prækliniske sikkerhedsdata.
English: Information from the compassionateuse study in the homozygous familial hypercholesterolaemia patient population has also been included in this section.
Danish: Oplysninger fra undersøgelsen om anvendelse med særlig udleveringstilladelse hos patienter med homozygot familiær hyperkolesterolæmi er også medtaget i dette punkt.
English: The MAH has used the MRP text as the harmonised SmPC including the proposed harmonised wording for special populations such as the elderly, paediatrics, gender differences, patients with renal and hepatic insufficiency and SLOC1B1 polymorphism (and its effects on atorvastatin exposure) have been included.
Danish: Indehaveren af markedsføringstilladelsen har anvendt den gensidigt anerkendte tekst som det harmoniserede produktresumé, inklusive den foreslåede harmoniserede formulering for særlige patientgrupper som ældre, børn og unge, kønsforskelle, patienter med nedsat nyre- og leverfunktion samt SLOC1B1-polymorfisme (og dens indvirkning på atorvastatin-eksponering) er medtaget.
English: The patient should be placed on a standard cholesterol-lowering diet before receiving {PRODUCT NAME} and should continue on this diet during treatment with {PRODUCT NAME}.
Danish: Patienten bør sættes på en standardkolesterolsænkende diæt, inden der gives {PRODUKTNAVN}.
English: The MAH has provided satisfactory justification for the proposed atorvastatin dosing recommendations associated with the specific fold-increases of atorvastatin exposure during coadministration with the interacting drugs.
Danish: Indehaveren af markedsføringstilladelsen har fremlagt tilstrækkelig dokumentation for de foreslåede dosisanbefalinger for atorvastatin ved specifikke antal gange stigninger i atorvastatineksponering under samtidig administration med interagerende lægemidler.
English: ‘Renal impairment No adjustment of dose is required (see section 4.4).
Danish: "Nedsat nyrefunktion Dosisjustering er ikke påkrævet (se pkt.
English: Higher doses may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines……………… Method of administration {PRODUCT NAME} is for oral administration.
Danish: Højere dosis kan være nødvendig for at opnå LDL-kolesterolniveauer i henhold til gældende retningslinjer………………
English: The usual starting dose is 10 mg once a day.
Danish: Startdosis er sædvanligvis 10 mg én gang dagligt.
English: - during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures (see section 4.6).'
Danish: - under graviditet og amning og hos kvinder i den fertile alder, som ikke benytter sikker antikonception (se pkt.
English: For the indication relating to the prevention of cardiovascular disease, the dosing information is taken from the MRP SmPC.
Danish: For indikationen vedrørende forebyggelse af kardiovaskulær sygdom tages doseringsinformationen fra det gensidigt anerkendte produktresumé.
English: A contraindication in patients during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures was included.
Danish: Der blev inkluderet en kontraindikation for patienter under graviditet og amning og for fertile kvinder, som ikke benytter sikker antikonception.
English: As requested by the CHMP the reference to nefazodone as a concomitant treatment was removed.
Danish: Henvisningen til nefazodon som samtidig behandling er fjernet efter anmodning fra CHMP.
English: The MAH has used the MRP SmPC text as the proposed harmonised SmPC text as the overdose wording across the Member State SmPCs is essentially identical to the current MRP SmPC text.
Danish: Indehaveren af markedsføringstilladelsen har anvendt den gensidigt anerkendte produktresumétekst som den foreslåede harmoniserede produktresumétekst, da overdoseringsformuleringen i medlemsstaternes produktresuméer stort set er identisk med den nuværende gensidigt anerkendte produktresumétekst.
English: The information in Section 4.5 (text and table formats) has been rearranged such that drug interactions are now grouped under either “Effect of co-administered drugs on atorvastatin” or “Effect of atorvastatin on co-administered drugs.” As requested by the CHMP, the MAH has included mechanistic information and extrapolations.
Danish: 4.5 (tekst og tabelformater) er flyttet rundt, således at lægemiddelinteraktionerne nu er grupperet under enten “Samtidigt administrerede lægemidlers indvirkning på atorvastatin” eller “Atorvastatins virkning på samtidigt administrerede lægemidler”.
English: Section 4.2 - Posology and method of administration No differences are made in dosing recommendations for the treatment of hypercholesterolaemia related to the starting dose regimen and the dose titration in 4 week intervals.
Danish: Der skelnes ikke i doseringsanbefalingerne for behandling af hyperkolesterolæmi med hensyn til startdosisregime og dosistitrering i intervaller på 4 uger.
English: Clinical particulars
Danish: Kliniske oplysninger
English: Paediatric use Paediatric use should only be carried out by specialists.
Danish: Børn og unge Børn og unge bør kun behandles af specialister.
English: Hepatic impairment {PRODUCT NAME} should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2).
Danish: Nedsat leverfunktion {PRODUKTNAVN} bør anvendes med forsigtighed til patienter med nedsat leverfunktion (se pkt.
English: The CHMP agreed with the MAH's proposal.
Danish: CHMP godkendte indehaveren af markedsføringstilladelsens forslag.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Lipitor and associated names (see Annex I).
Danish: • produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den fremsendte dokumentation og udvalgets videnskabelige drøftelse,
English: Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.'
Danish: Forebyggelse af kardiovaskulære hændelser hos patienter, som vurderes at have en høj risiko for debut af en kardiovaskulær hændelse (se pkt.
English: The MAH considered it important that physicians be aware of the potential increased risk in this population and monitor these patients for skeletal muscle effects, and a cross-reference to section 4.4 has been added referring to precautionary information regarding patient history of renal impairment as a potential risk factor for development of rhabdomyolysis and recommending closer monitoring for muscle symptoms.
Danish: 4.4, hvor der henvises til forsigtighedsreglerne ved nedsat nyrefunktion i anamnesen som en potentiel risikofaktor for at udvikle rhabdomyolyse og anbefaling af tættere overvågning af muskelsymptomer.
English: - The information derived from a compassionate use study in the homozygous familial hypercholesterolemia patient population has been moved to section 5.1 as suggested by the CHMP.
Danish: - Oplysningerne fra en undersøgelse af anvendelse med særlig udleveringstilladelse hos patienter med homozygot familiær hyperkolesterolæmi er flyttet til pkt.
English: The MAH proposes the inclusion of the contraindication in patients during pregnancy, while breastfeeding and in women of childbearing potential not using appropriate contraceptive measures with a cross reference to section 4.3 of the SmPC.
Danish: Indehaveren af markedsføringstilladelsen foreslår, at kontraindikationen til patienter under graviditet og amning og til fertile kvinder, som ikke benytter sikker antikonception, medtages med krydshenvisning til pkt.
English: Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia The majority of patients are controlled with {PRODUCT NAME} 10 mg once a day.
Danish: Størstedelen af patienterne er velkontrollerede med {PRODUKTNAVN} 10 mg én gang dagligt.
English: - The MAH has followed the request by the CHMP to include a recommendation for caution for patients with hepatic impairment in section 4.2, with cross references to sections 4.4 and 5.2 of the harmonised SmPC.
Danish: - Indehaveren af markedsføringstilladelsen fulgte CHMP's anmodning om at medtage en forsigtighedsregel for patienter med nedsat leverfunktion i pkt.
English: • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) are provided with a prescriber kit containing the following: o Educational Health Care Professional's kit o Educational brochures for Patients o Patient cards o Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Danish: • Alle sundhedsfaglige personer, der har til hensigt at ordinere og/eller udlevere Opsumit, inden ordination (når det er hensigtsmæssigt og i overensstemmelse med den nationale kompetente myndighed), får udleveret et ordinationssæt der indeholder følgende: o Informations sæt til sundhedspersonale o Informations brochure til patienter o Patientkort o Produktresumé, indlægsseddel og etikettering.