FrancophonIA/ELRC3.0 huggingface dataset:
English: The long-term efficacy of atorvastatin therapy in childhood to reduce morbidity and mortality in adulthood has not been established.
Danish: Langtidsvirkninger af atorvastatinbehandling hos børn og unge til reduktion af morbiditet og mortalitet i voksenalderen er ikke undersøgt.
English: The study lasted 3 years: LDL-cholesterol was lowered by 36%.
Danish: LDL-cholesterol blev sænket med 36 %.
English: The mean percent decreases in lipid parameters were similar for both cohorts, regardless of whether subjects remained at their initial dose or doubled their initial dose.
Danish: Det gennemsnitlige procentvise fald i lipidparametre var ens for begge kohorter, uanset om forsøgspersonerne fik uændret initialdosis eller fik fordoblet initialdosis.
English: Body weight was the only significant covariate in atorvastatin population PK model.
Danish: Legemsvægt var den eneste signifikante covariant i den farmakokinetiske model for atorvastatinpopulationen.
English: [To be completed nationally] {Name and Address} <{tel}> <{fax}> <{e-mail}>
Danish: <[Udfyldes nationalt]> {Navn og adresse} <{tlf}> <{fax}> <{email}>
English: Cohort A included 15 children, 6 to 12 years of age and at Tanner Stage 1.
Danish: Kohorte A omfattede 15 børn i alderen 6-12 år i Tanner-stadie 1.
English: Paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia and patients should be re-evaluated on a regular basis to assess progress.
Danish: Børn og unge bør kun behandles af specialister inden for pædiatrisk hyperlipidæmi, og patienterne bør regelmæssigt revurderes for at vurdere virkningen af behandlingen.
English: • Restart the cycle of PSUR submission for Sortis and associated names as follows: o Six-monthly PSURs until two full years of experience with the paediatric indication in the EU has been gained o Yearly PSURs for the following two years o Thereafter submission at 3-yearly intervals The PSURs should focus on the use in the paediatric population.
Danish: • Indsendelse af PSUR genstartes for Zarator (og tilhørende navne) som følger: o Halvårlige PSUR, indtil der er opnået to års erfaring med den pædiatriske indikation i EU o Årlige PSUR i de efterfølgende 2 år o Derefter PSUR hvert 3. år Disse PSUR bør fokusere på brug hos den pædiatriske population.
English: Common: Alanine aminotransferase increased, blood creatine phosphokinase increased Based on the data available, frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Danish: Almindelig: Forhøjet alaninaminotransferase, forhøjet serum-kreatinfosfokinase Ud fra de tilgængelige data forventes frekvens, type og alvorlighed af bivirkningerne hos børn og unge at være de samme som hos voksne.
English: s r.o., Stroupežnického 17, 150 00 Prague 5,
Danish: s r.o., Stroupežnického 17, 150 00 Prague 5, Czech Republic
English: EXPIRY DATE EXP:
Danish: UDLØBSDATO EXP
English: Hypercholesterolaemia:
Danish: Hyperkolesterolæmi:
English: Your doctor will adapt the dosage at intervals of 4 weeks or more.
Danish: Lægen vil vurdere, om dosis skal justeres efter 4 uger.
English: ANNEX II AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BILAG II ÆNDRINGER TIL PRODUKTRESUMÉ, MÆRKNING OG INDLÆGSSEDDEL
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E)OG INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: A compassionate use study in patients with severe hypercholesterolaemia (including homozygous hypercholesterolaemia) included 46 paediatric patients treated with atorvastatin titrated according to response (some subjects received 80 mg atorvastatin per day).
Danish: Et særligt klinisk program (”compassionate use”) med patienter med svær hyperkolesterolæmi (inklusive homozygot hyperkolesterolæmi) omfattede 46 pædiatriske patienter behandlet med atorvastatin titreret til respons (nogle patienter fik 80 mg atorvastatin dagligt).
English: The Risk Management Plan should include the ongoing study A2581173 (3-year study of the safety and follow-up study of efficacy of atorvastatin treatment of children and adolescents aged 6 years to less than 18 years with heterozygous familial hypercholesterolaemia).
Danish: RMP skal desuden inkludere det igangværende kliniske forsøg A2581173 (3-year study of the safety and follow-up study of efficacy of atorvastatin treatment of children and adolescents aged 6 years to less than 18 years with heterozygous familial hypercholesterolaemia).
English: Important information about some of the ingredients of {PRODUCT NAME} If youhave been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Zarator Kontakt lægen, før De tager denne medicin, hvis lægen har fortalt dem, at De ikke tåler visse sukkerarter.
English: Cohort B included 24 children, 10 to 17 years of age and at Tanner Stage 2.
Danish: Kohorte B omfattede 24 børn i alderen 10-17 år i Tanner-stadie ≥ 2.
English: There is limited experience in children between 6-10 years of age (see section 5.1).
Danish: Der er begrænset erfaring med behandling af børn i alderen 6-10 år (se pkt.
English: The blisters consist of a forming foil made of polyamide/aluminium foil/polyvinyl chloride and a backing made of aluminium foil/vinyl/acryl heat-seal coating.
Danish: Blisteren består af en folie af polyamid/aluminiumsfolie/polyvinylchlorid samt en alluminiumsfolie/vinyl/acryl varmeforseglet bagside.
English: Experience in pediatrics is limited to a small number of patients (age 4 - 17 years) with severe dyslipidemias, such as homozygous familial hypercholesterolemia.
Danish: Erfaring med brug hos børn er begrænset til et lille antal patienter (4-17 år) med svær dyslipidæmi som f.eks. homozygot familiær hyperkolesterolæmi.
English: {PRODUCT NAME} tablets can be chewed or swallowed whole with a drink of water, and can be taken at any time of day, with or without food.
Danish: Zarator tyggetabletter kan tygges eller synkes hele med et glas vand og kan tages på alle tider af døgnet, med eller uden mad.
English: Each {PRODUCT NAME} 5 mg chewable tablet contains 0.625 mg aspartame.
Danish: 1 Zarator 5 mg tyggetablet indeholder 0,625 mg aspartam.
English: {PRODUCT NAME} tablets can be chewed or should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food.
Danish: Zarator tyggetabletter skal kan tygges eller synkes hele med et glas vand og kan tages på et hvilket som helst tidspunkt af døgnet med eller uden mad.
English: This medicine is available as 5 mg, 10 mg, 20 mg and 40 mg chewable tablets and 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets.
Danish: Zarator findes som tyggetabletter på 5 mg, 10 mg, 20 mg og 40 mg, samt som filmovertrukne tabletter på 10 mg, 20 mg, 40 mg og 80 mg.
English: At Week 8, on average, the percent change from baseline in LDL-C and TC was approximately 40% and 30%, respectively, over the range of exposures.
Danish: Ved uge 8 var den gennemsnitlige procentvise ændring fra baseline i LDL-cholesterol og total-cholesterol hhv. ca. 40 % og 30 % over hele gruppen.
English: The mean achieved LDL-C value was 3.38 mmol/l (range: 1.81-6.26 mmol/l) in the atorvastatin group compared to 5.91 mmol/l (range: 3.93-9.96 mmol/l) in the placebo group during the 26week double-blind phase.
Danish: Gennemsnitlig LDL-cholesterol på 3,38 mmol/l (1,81-6,26 mmol/l) i atorvastatingruppen sammenlignet med 5,91 mmol/l (3,93-9,96 mmol/l) i placebogruppen blev nået i løbet af de første 26 uger (dobbelt-blindede fase).
English: {PRODUCT NAME} tablets also contain the inactive ingredients: calcium carbonate, microcrystalline cellulose, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, amylum pregelificatum, mannitol, aspartame, sucralose, grape flavour and magnesium stearate.
Danish: Øvrige indholdsstoffer: calciumcarbonat, mikrokrystallinsk cellulose, croscarmellosenatrium, polysorbat 80, hydroxypropylcellulose, pregelatineret stivelse, mannitol, aspartam, sucralose, vindruesmag samt magnesiumstearat.
English: White to off-white, round chewable tablets with pink to purple specks, debossed "5" on one side and “Pfizer” on the other measuring 5.6 mm in diameter.
Danish: Hvide til råhvide, runde tyggetabletter med lyserøde til violette prikker, præget med ”5” på den ene side og ”Pfizer” på den anden side.
English: The dosage of atorvastatin (once daily) was 10 mg for the first 4 weeks and up-titrated to 20 mg if the LDL-C level was >3.36 mmol/l.
Danish: Atorvastatin-dosis var 10 mg 1 gang dagligt i de første 4 uger og blev derefter titreret til 20 mg, hvis LDL-cholesterol var > 3,36 mmol/l.
English: May be harmful for people with phenylketonuria.
Danish: Kan være skadelig for patienter med fenylketonuri (PKU, Føllings sygdom).
English: Developmental safety in the paediatric population has not been established (see section 4.8).
Danish: Pædiatrisk brug Udviklingsmæssig sikkerhed i den pædiatriske population er ikke blevet undersøgt (se pkt.
English: Heterozygous Familial Hypercholesterolaemia in Paediatric Patients aged 6-17 years old
Danish: Heterozygot familiær hyperkolesterolæmi hos pædiatriske patienter i alderen 6-17 år
English: PHARMACEUTICAL FORM AND CONTENTS 30 chewable tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 30 tyggetabletter
English: Apparent oral clearance of atorvastatin in paediatric subjects appeared similar to adults when scaled allometrically by body weight.
Danish: Den tilsyneladende clearance efter oral administration var sammenlignelig med voksnes efter korrektion for legemsvægt ved allometrisk skalering.
English: Heterozygous Familial Hypercholesterolaemia in Paediatric Patients aged 10-17 years old
Danish: Heterozygot familiær hyperkolesterolæmi hos pædiatriske patienter i alderen 10-17 år
English: 4.5 Interaction with other medicinal products and other forms of interaction {To be completed nationally}.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister
English: {PRODUCT NAME} chewable tablet contains aspartame which is a source of phenylalanine.
Danish: Zarator tyggetabletter indeholder aspartam, en phenylalaninkilde.
English: An 8-week, open-label study to evaluate pharmacokinetics, pharmacodynamics, and safety and tolerability of atorvastatin was conducted in children and adolescents with genetically confirmed heterozygous familial hypercholesterolemia and baseline LDL-C 4 mmol/L.
Danish: Et 8-ugers, open-label klinisk forsøg til evaluering af farmakokinetik, farmakodynamik samt sikkerhed og tolerabilitet af atorvastatin blev udført med børn og unge med genetisk bekræftet heterozygot familiær hyperkolesterolæmi og baseline LDL-cholesterol ≥ 4 mmol/l.
English: The usual starting dose of {PRODUCT NAME} is 10 mg once a day in adults and children aged 10 years or older.
Danish: Den sædvanlige startdosis af Zarator er 10 mg 1 gang dagligt til voksne og børn over 10 år.
English: If you have any further questions, ask your doctor or pharmacist.
Danish: - Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
English: • Submit a Risk Management Plan (or its update) for Sortis and associated names at National level, taking into account the new paediatric data and the CHMP recommendations.
Danish: • Indsendelse af et risikostyringsprogram (RMP) (eller opdatering heraf) for Zarator (og tilhørende navne) på nationalt niveau.
English: In a double-blind, placebo controlled study followed by an open-label phase, 187 boys and postmenarchal girls 10-17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolaemia (FH) or severe hypercholesterolaemia were randomised to atorvastatin (n=140) or placebo (n=47) for 26 weeks and then all received atorvastatin for 26 weeks.
Danish: I et dobbelt-blindet, placebokontrolleret klinisk forsøg efterfulgt af en periode med open-label blev 187 drenge og piger (der havde fået første menstruation) i alderen 10-17 år (gennemsnit 14,1 år) med heterozygot familiær hyperkolesterolæmi eller svær hyperkolesterolæmi randomiseret til enten atorvastatin (n=140) eller placebo (n=47) i 26 uger, hvorefter alle fik atorvastatin i 26 uger.
English: The active substance of {PRODUCT NAME} is atorvastatin.
Danish: Aktivt stof: atorvastatin.
English: The clinical safety database includes safety data for 249 paediatric patients who received atorvastatin, among which 7 patients were < 6 years old, 14 patients were in the age range of 6 to 9, and 228 patients were in the age range of 10 to 17.
Danish: Heriblandt var 7 patienter < 6 år, 14 patienter var mellem 6 og 9 år og 228 patienter var mellem 10 og 17 år.
English: Pediatric use should only be carried out by specialists.
Danish: Børn og unge Børn bør kun behandles af specialister.
English: 4.9 Overdose {To be completed nationally}.
Danish: 4.9 Overdosering [Udfyldes nationalt]
English: Each tablet contains 5 mg of atorvastatin as atorvastatin calcium trihydrate.
Danish: 1 tablet indeholder 5 mg atorvastatin som atorvastatincalciumtrihydrat.
English: Hypercholesterolaemia {PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients adults, adolescents and children aged 10 years or older 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: Zarator er indiceret som supplement til diæt ved forhøjet total-cholesterol, LDL-cholesterol, apolipoprotein B og forhøjede triglycerider hos patienter voksne, unge samt børn over 10 år med primær hyperkolesterolæmi inklusive familiær hyperkolesterolæmi (heterozygot variant) eller kombineret hyperlipidæmi (svarende til type IIa og IIb i Fredericksons klassifikation), hvor diæt og andre ikke farmakologiske foranstaltninger er utilstrækkelige.
English: In an openlabel, 8-week study, Tanner Stage 1 (N=15) and Tanner Stage 2 (N=24) paediatric patients (ages 6-17 years) with heterozygous familial hypercholesterolemia and baseline LDL-C 4 mmol/L were treated with 5 or 10 mg of chewable or 10 or 20 mg of filmcoated atorvastatin tablets once daily, respectively.
Danish: I et 8-ugers, open-label klinisk forsøg, blev børn i alderen 6-17 år og i Tanner-stadie 1 (n=15) eller Tanner-stadie ≥ 2 (n=24) med heterozygot familiær hyperkolesterolæmi og baseline LDL-cholesterol ≥ 4 mmol/l behandlet med hhv. 5 mg eller 10 mg tyggetabletter eller 10 mg eller 20 mg filmovertrukne tabletter 1 gang dagligt.
English: {PRODUCT NAME} are available in blister packs containing 30 chewable tablets.
Danish: Zarator findes i en blisterpakning, der indeholder 30 tyggetabletter.
English: The European Medicines Agency has waived the obligation to submit the results of studies with atorvastatin in children aged 0 to less than 6 years in the treatment of heterozygous hypercholesterolaemia and in children aged 0 to less than 18 years in the treatment of homozygous familial hypercholesterolaemia, combined (mixed) hypercholesterolaemia, primary hypercholesterolaemia and in the prevention of cardiovascular events (see section 4.2 for information on paediatric use).
Danish: Det europæiske Lægemiddelagentur (EMA) har dispenseret fra kravet om fremlæggelse af resultaterne fra studier med atorvastatin hos børn i alderen 0-6 år til behandling af heterozygot hyperkolesterolæmi og hos børn i alderen 0-18 år til behandling af af homozygot familiær hyperkolesterolæmi, kombineret hyperkolesterolæmi, primær hyperkolesterolæmi og til forebyggelse af kardiovaskulære hændelser (se pkt.
English: 6.2 Incompatibilities {To be completed nationally}.
Danish: 6.2 Uforligeligheder [Udfyldes nationalt]
English: Atorvastatin significantly decreased plasma levels of totalC, LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase.
Danish: Atorvastatin sænkede signifikant total-cholesterol, LDL-cholesterol, triglycerider og apolipoprotein B i de første 26 uger
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE LABELLING
Danish: ÆNDRINGER TIL DE RELEVANTE DELE AF MÆRKNINGSTEKSTEN
English: Prevention of cardiovascular events in adult 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 har en høj risiko for debut af en kardiovaskulær hændelse (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 5 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 tyggetablet indeholder 5 mg atorvastatin (som atorvastatincalciumtrihydrat).
English: The above mentioned interactions for adults and the warnings in section 4.4 should be taken into account for the paediatric population.
Danish: Ved behandling af børn og unge skal der tages højde for de oven for nævnte interaktioner for voksne og for advarslerne i pkt.
English: There is currently limited experience with respect to longterm safety in the paediatric population.
Danish: Der er begrænset erfaring med sikkerhed ved langtidsbehandling hos børn og unge.
English: {PRODUCT NAME} is also indicated to reduce total-C and LDL-C in patients adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Danish: Zarator er også indiceret til at nedsætte total-cholesterol og LDL-cholesterol hos patientervoksne med homozygot familiær hyperkolesterolæmi som supplement til anden lipidsænkende behandling, f.eks. LDL-aferese, eller hvis anden behandling ikke er tilgængelig.
English: 6.4 Special precautions for storage {To be completed nationally}.
Danish: 6.4 Særlige opbevaringsforhold [Udfyldes nationalt]
English: The maximum dose of {PRODUCT NAME}is 80 mg once daily for adults and 20 mg once daily for children.
Danish: VoksneDe må højst tage 80 mg Zarator 1 gang dagligt og børn må højst tage 20 mg 1 gang dagligt.
English: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day.
Danish: Anbefalet startdosis til patienter over 10 år er 10 mg dagligt, der kan optitreres til 20 mg dagligt.
English: An additional paediatric study of atorvastatin versus colestipol in patients with hypercholesterolaemia aged 10-18 years demonstrated that atorvastatin (N=25) caused a significant reduction in LDL-C at week 26 (p<0.05) compared with colestipol (N=31).
Danish: Dette forsøg viste, at atorvastatin (n=25) gav en singnifikant reduktion af LDL-cholesterol ved uge 26 (p<0,05) sammenlignet med colestipol (n=31).
English: Do not use {PRODUCT NAME} after the expiry date {EXP:} which is stated on the blister container and outer packaging.
Danish: Brug ikke Zarator efter den udløbsdato (anv.
English: OTHER SPECIAL WARNING(S), IF NECESSARY [To be completed nationally].
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER [Udfyldes nationalt]
English: Hydroxypropyl cellulose
Danish: Magnesiumstearat Hydroxypropylcellulose Pregelatineret stivelse
English: What {PRODUCT NAME} looks like and contents of the pack {PRODUCT NAME} 5 mg chewable tablets are white to off-white with pink to purple specks with a round shape.
Danish: Zarator 5 mg tyggetabletter er runde og hvide til råhvide med lyserøde til violette prikker.
English: NAME OF THE MEDICINAL PRODUCT {PRODUCT NAME} 5 mg chewable tablets Atorvastatin
Danish: LÆGEMIDLETS NAVN Zarator 5 mg tyggetabletter Atorvastatin
English: INFORMATION IN BRAILLE {PRODUCT NAME} 5 mg chewable tablets
Danish: INFORMATION I BRAILLE-SKRIFT Zarator 5 mg tyggetabletter
English: 4.7 Effects on ability to drive and use machines {To be completed nationally}.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 5 mg atorvastatin (as calcium salt trihydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 tyggetablet indeholder 5 mg atorvastatin (som atorvastatincalciumtrihydrat)
English: NAME OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally] {Name}
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN <[Udfyldes nationalt]> {Navn}
English: Microcrystalline cellulose
Danish: Calciumcarbonat Mikrokrystallinsk cellulose Croscarmellosenatrium Polysorbat 80
English: Mean values for LDL-C, TC, VLDL-C, and Apo B decreased by Week 2 among all subjects.
Danish: Gennemsnitsværdier for LDL-cholesterol, total-cholesterol, VLDL-cholesterol og apolipoprotein B faldt ved uge 2 hos alle forsøgspersoner.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Danish: ÆNDRINGER TIL DE RELEVANTE AFSNIT I PRODUKTRESUMÉET
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev sidst revideret <måned> <år>
English: Before you take {PRODUCT NAME} 3.
Danish: Det skal De vide, før De begynder at tage Zarator 3.
English: Consistent decreases in LDL-C and TC were observed over the range of atorvastatin and o-hydroxyatorvastatin exposures.
Danish: Tilsvarende hermed sås fald i LDL-cholesterol og total-cholesterol i forhold til atorvastatinog o-hydroxyatorvastatin-niveauer.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: 6.6 Special precautions for disposal {To be completed nationally}.
Danish: 6.6 Regler for destruktion [Udfyldes nationalt]
English: What {PRODUCT NAME} is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET
Danish: ÆNDRINGER TIL DE RELEVANTE DELE AF INDLÆGSSEDLEN
English: How to take {PRODUCT NAME} 4.
Danish: Sådan skal De tage Zarator 4.
English: The initial dose of atorvastatin was 5 mg daily of a chewable tablet in Cohort A and 10 mg daily of a tablet formulation in Cohort B. The atorvastatin dose was permitted to be doubled if a subject had not attained target LDL-C of <3.35 mmol/L at Week 4 and if atorvastatin was well tolerated.
Danish: Atorvastatindosis kunne fordobles, hvis patienten ikke havde nået target-LDL-cholesterol på < 3,35 mmol/l i uge 4, og hvis atorvastatin var veltolereret.
English: {To be completed nationally}.
Danish: -[Udfyldes nationalt]
English: This medicine has been prescribed for you.
Danish: - Lægen har ordineret Zarator til Dem personligt.
English: MARKETING AUTHORISATION HOLDER [To be completed nationally] [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: <[Se bilag I - Udfyldes nationalt]> [For referral procedures]
English: Blister packs containing 30 chewable tablets.
Danish: 6.5 Emballagetype og pakningsstørrelser Blisterpakning med 30 tyggetabletter.
English: POSSIBLE SIDE EFFECTS {To be completed nationally}.
Danish: BIVIRKNINGER [Udfyldes nationalt]
English: Paediatric: Pharmacokinetic data in the paediatric population are not available.
Danish: Særlige patientgrupper: -[Udfyldes nationalt] - Børn: Der findes ikke farmakokinetiske data hos børn.
English: Calcium carbonate
Danish: Hyperkolesterolæmi
English: 4.4 Special warnings and precautions for use {To be completed nationally}.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Warnings and precautions
Danish: Advarsler og forforsigtighedsregler