FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint (fatal CHD plus non-fatal MI) was significantly reduced by atorvastatin in patients treated with amlodipine (HR 0.47 (0.32-0.69), p=0.00008), but not in those treated with atenolol (HR 0.83 (0.59-1.17), p=0.287).
Danish: Det primære endepunkt (letal koronar hjertesygdom samt ikke-letalt myokardieinfarkt) blev signifikant nedsat af atorvastatin hos patienter behandlet med amlodipin (hazard ratio (HR) 0,47 (0,32-0,69); p=0,00008), men ikke hos atenololbehandlede (HR 0,83 (0,59-1,17); p=0,287).
English: Heterozygous familial hypercholesterolaemia
Danish: Heterozygot familiær hyperkolesterolæmi
English: Gemfibrozil / fibric acid derivatives
Danish: Gemfibrozil/fibrater
English: Appropriate clinical monitoring is recommended after initiation or following dose adjustments of the inhibitor.
Danish: Passende klinisk monitorering anbefales efter initiering af behandling eller efter dosisjustering af en CYP3A4-hæmmer.
English: As with other statins, muscle related events, including rhabdomyolysis, have been reported in post-marketing experience with atorvastatin and fusidic acid given concurrently.
Danish: Som for andre statiner er der efter markedsføring set muskelrelaterede bivirkninger, herunder rabdomyolyse, ved samtidig behandling med atorvastatin og fusidinsyre.
English: Hepatobiliary disorders Uncommon: hepatitis.
Danish: Lever- og galdeveje Ikke almindelig: Hepatitis.
English: − Situations where an increase in plasma levels may occur, such as interactions (see section 4.5) and special populations including genetic subpopulations (see section 5.2)
Danish: 4.5) og hos særlige populationer, herunder genetiske subpopulationer (se pkt.
English: • nausea, constipation, wind, indigestion, diarrhoea
Danish: • kvalme, forstoppelse, luft i tarmen, fordøjelsesproblemer, diarré
English: At atorvastatin doses exceeding 20 mg, clinical monitoring of these patients is recommended.
Danish: Ved atorvastatindoser over 20 mg anbefales klinisk monitorering.
English: & Data given as x-fold change represent a simple ratio between co-administration and atorvastatin alone (i.e., 1
Danish: & Data udtrykt som x-gange ændring angiver et simpelt forhold mellem samtidigt administreret lægemiddel og atorvastatin alene (dvs. 1-gang = ingen ændring).
English: • urine tests that are positive for white blood cells
Danish: • hvide blodceller i urinprøver
English: ↑ 5.9 fold
Danish: ↑ 5,9 gange
English: • The risk of hemorrhagic stroke was increased in patients who entered the study with prior lacunar infarct (20/708 for atorvastatin versus 4/701 for placebo; HR 4.99; 95% CI, 1.71-14.61), but the risk of ischemic stroke was also decreased in these patients (79/708 for atorvastatin versus 102/701 for placebo; HR 0.76; 95% CI, 0.57-1.02).
Danish: • Risikoen for hæmoragisk apopleksi var øget hos patienter, som før forsøgets start havde haft lakunært infarkt (20/708 for atorvastatin versus 4/701 for placebo; HR 4,99; 95% CI: 1,71-14,61), men risikoen for koronar apopleksi faldt også hos disse patienter (79/708 for atorvastatin versus 102/701 for placebo; HR 0,76; 95% CI: 0,57-1,02).
English: Homozygous familial hypercholesterolaemia
Danish: Homozygot familiær hyperkolesterolæmi
English: LIPITOR and associated names (see Annex I) 10 mg film-coated tablets LIPITOR and associated names (see Annex I) 20 mg film-coated tablets LIPITOR and associated names (see Annex I) 40 mg film-coated tablets LIPITOR and associated names (see Annex I) 80 mg film-coated tablets
Danish: Zarator (se Bilag I) 10 mg filmovertrukne tabletter Zarator (se Bilag I) 20 mg filmovertrukne tabletter Zarator (se Bilag I) 40 mg filmovertrukne tabletter Zarator (se Bilag I) 80 mg filmovertrukne tabletter
English: Clarithromycin 500 mg BID, 9 days
Danish: Clarithromycin 500 mg x 2, 9 dage
English: In the atorvastatin group, LDL-C was reduced to a mean of 2.04 mmol/L ± 0.8 (78.9 mg/dl ± 30) from baseline 3.89 mmol/l ± 0.7 (150 mg/dl ± 28) and in the pravastatin group, LDL-C was reduced to a mean of 2.85 mmol/l ± 0.7 (110 mg/dl ± 26) from baseline 3.89 mmol/l ± 0.7 (150 mg/dl ± 26) (p<0.0001).
Danish: I atorvastatingruppen blev LDL-kolesterol reduceret til et gennemsnit på 2,04 mmol/l 0,8 (78,9 mg/dl 30) fra baseline 3,98 mmol/l 0,7 (150 mg/dl 28) og i pravastatingruppen til et gennemsnit på 2,85 mmol/l  0,7
English: The risk of muscle related side effects e.g rhabdomyolysis is known to increase when certain medicines are taken at the same time (see Section 2 “Taking other medicines”).
Danish: Risikoen for at få muskelrelaterede bivirkninger som rabdomyolyse øges, hvis De samtidigt bruger visse typer medicin (se pkt.
English: Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse reaction profile for {PRODUCT NAME}.
Danish: Zarators sikkerhedsprofil, baseret på data fra kliniske studier og omfattende erfaring efter markedsføring, fremgår af nedennævnte tabel.
English: Moderate CYP3A4 inhibitors (e.g. erythromycin, diltiazem, verapamil and fluconazole) may increase plasma concentrations of atorvastatin (see Table 1).. An increased risk of myopathy has been observed with the use of erythromycin in combination with statins.
Danish: Moderate CYP3A4-hæmmere (f.eks. erythromycin, diltiazem, verapamil og fluconazol) kan øge plasmakoncentrationen af atorvastatin (se tabel 1).
English: Check with your doctor or pharmacist before taking {PRODUCT NAME} − if you have severe respiratory failure.
Danish: Spørg Deres læge, før De tager Zarator, hvis De lider af alvorlige vejrtrækningsproblemer.
English: The risk of these events may be increased with the concomitant use of fibric acid derivatives and atorvastatin.
Danish: Risikoen for disse bivirkninger kan øges ved samtidig brug af fibrater og atorvastatin.
English: Pharmacotherapeutic group: Lipid modifying agents, HMG-CoA-reductase inhibitors, ATC code: C10AA05
Danish: Farmakoterapeutisk gruppe: Lipid-modificerende midler, HMG-CoA-reduktasehæmmere.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterpakning
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally]
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se Bilag I - Udfyldes nationalt]
English: Skeletal muscle effects
Danish: Påvirkning af skeletmuskulaturen
English: Other possible side effects with {PRODUCT NAME}:
Danish: Andre bivirkninger med Zarator:
English: Uncommon: urticaria, skin rash, pruritus, alopecia.
Danish: Ikke almindelig: Urticaria, hududslæt, kløe, alopeci.
English: {PRODUCT NAME} is contraindicated during pregnancy (see section 4.3).
Danish: Zarator er kontraindiceret under graviditet (se pkt.
English: • inflammation of the nasal passages, pain in the throat, nose bleed
Danish: • betændelse i næsen, halssmerter, næseblod
English: Very rare: anaphylaxis.
Danish: Meget sjælden: Leversvigt
English: The effect of atorvastatin on fatal and non-fatal coronary heart disease was assessed in a randomized, double-blind, placebo-controlled study, the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA).
Danish: I et randomiseret, dobbelt-blindt, placebokontrolleret studie, Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA) blev effekten af atorvastatin på letal og ikke-letal koronar hjertesygdom undersøgt.
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: Zarator er også indiceret til at nedsætte total-kolesterol og LDL-kolesterol hos patienter med homozygot familiær hyperkolesterolæmi som supplement til anden lipidsænkende behandling, f.eks. LDL-aferese, eller hvis anden behandling ikke er tilgængelig.
English: Creatine kinase measurement
Danish: Kreatinkinase (CK)-måling
English: Do not use {PRODUCT NAME} after the expiry date which is stated on the container and outer packaging after {EXP}.
Danish: Brug ikke Zarator efter den udløbsdato (anv.
English: At atorvastatin doses exceeding 40 mg, clinical monitoring of these patients is recommended.
Danish: Ved atorvastatindoser over 40 mg anbefales klinisk monitorering.
English: Erythromycin 500 mg QID, 7 days
Danish: Erythromycin 500 mg x 4, 7 dage
English: If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your {PRODUCT NAME} treatment to predict your risk of muscle related side effects.
Danish: Hvis De har haft nogle af ovenstående problemer, vil lægen tage en blodprøve før og muligvis under behandlingen med Zarator.
English: Hypercholesterolaemia
Danish: Hyperkolesterolæmi
English: Rifampin 600 mg OD, 5 days (doses separated)
Danish: Rifampicin 600 mg x 1, 5 dage (adskilt indgift)
English: The use of ezetimibe alone is associated with muscle related events, including rhabdomyolysis.
Danish: Monoterapi med ezetimibe er forbundet med muskelrelaterede bivirkninger, herunder rabdomyolyse.
English: • fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature
Danish: • kraftesløshed, utilpashed, svaghed, brystsmerter, hævede ankler (vand i kroppen), forhøjet temperatur
English: ↑ 2.5 fold
Danish: ↑ 2,5 gange
English: PHARMACEUTICAL FORM Film-coated tablet.
Danish: LÆGEMIDDELFORM Filmovertrukne tabletter [Udfyldes nationalt]
English: Very rare: affect less than 1 user in 10,000:
Danish: Meget sjældne (det sker hos færre end 1 ud af 10.000 patienter):
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) <[Udfyldes nationalt]>
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Zarator indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Gemfibrozil 600 mg BID, 7 days
Danish: Gemfibrozil 600 mg x 2, 7 dage
English: The response is maintained during chronic therapy.
Danish: Virkningen opretholdes under vedvarende behandling.
English: Use in the elderly
Danish: Kvinder i den fertile alder
English: In addition, in the case of potent CYP3A4 inhibitors, a lower starting dose of atorvastatin should be considered and appropriate clinical monitoring of these patients is recommended (see section 4.5).
Danish: Derudover bør det overvejes at nedsætte initialdosis af atorvastatin, hvis der behandles samtidig med en potent CYP3A4-hæmmer, og passende klinisk monitorering af disse patienter anbefales (se pkt.
English: The usual starting dose is 10 mg once a day.
Danish: Startdosis er sædvanligvis 10 mg 1 gang dagligt.
English: ↑ 2.3 fold
Danish: ↑ 2,3 gange
English: Fosamprenavir 1400 mg BID, 14 days
Danish: Fosamprenavir 1.400 mg x 2, 14 dage
English: • cholestasis (yellowing of the skin and whites of the eyes) • tendon injury
Danish: • ophobning af galde i leveren (kolestase; gulfarvning af huden og det hvide i øjnene)
English: 6.5 Nature and contents of container [To be completed nationally]
Danish: 6.5 Emballagetype og pakningsstørrelser [Udfyldes nationalt]
English: Nelfinavir 1250 mg BID, 14 days
Danish: Nelfinavir 1.250 mg x 2, 14 dage
English: Amlodipine 10 mg, single dose 80 mg, SD ↑ 18% No specific recommendation.
Danish: Amlodipin 10 mg enkeltdosis 80 mg enkeltdosis
English: Diltiazem 240 mg OD, 28 days 40 mg, SD ↑ 51% After initiation or following dose adjustments of diltiazem, appropriate clinical monitoring of these patients is recommended.
Danish: Digoxin 0,25 mg x 1, 20 dage ↑ 15% Patienter, der tager digoxin, skal monitoreres passende.
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 har en høj risiko for debut af en kardiovaskulær hændelse (se pkt.
English: Atherosclerosis
Danish: Atorvastatincalcium
English: ↑ 9.4 fold
Danish: ↑ 4,4 gange
English: The use of fibrates alone is occasionally associated with muscle related events, including rhabdomyolysis.
Danish: Monoterapi med fibrater kan i sjældne tilfælde være forbundet med muskelrelaterede bivirkninger, herunder rabdomyolyse.
English: When patients are receiving medicinal products that increase the plasma concentration of atorvastatin, a lower maximum dose of atorvastatin is recommended.
Danish: Der anbefales en lavere maksimaldosis af atorvastatin hos patienter, der får medicin, der øger atorvastatins plasmakoncentration.
English: CHD = coronary heart disease; MI = myocardial infarction.
Danish: Letal koronar hjertesygdom og ikke-letalt myokardieinfarkt
English: • joint pain, muscle pain and back pain
Danish: • ledsmerter, muskelsmerter og rygsmerter
English: 4.7 Effects on ability to drive and use machines {PRODUCT NAME} has negligible influence on the ability to drive and use machines.
Danish: Zarator har ubetydelig indflydelse på evnen til at føre bil eller betjene maskiner.
English: Effect of co-administered medicinal products on atorvastatin
Danish: Andre lægemidlers påvirkning af atorvastatin
English: Rare: myopathy, myositis, rhabdomyolysis, tendonopathy, sometimes complicated by rupture.
Danish: Sjælden: Myopati, myositis, rabdomyolyse, senelidelser heunder seneruptur.
English: & Data given as % change represent % difference relative to atorvastatin alone (i.e., 0% = no change)
Danish: & Data angivet som procentvis ændring angiver procentvis forskel i forhold til atorvastatin alene (dvs.
English: Musculoskeletal and connective tissue disorders Common: myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain.
Danish: Almindelig: Myalgi, artralgi, ekstremitetssmerter, muskelspasmer, hævede led, rygsmerter.
English: Itraconazole 200 mg OD, 4 days
Danish: Itraconazol 200 mg x 1, 4 dage 40 mg enkeltdosis
English: 40mg SD ↑ 35% Lower starting dose and clinical monitoring of these patients is recommended.
Danish: ↑ 35% Nedsat initialdosis samt klinisk monitorering anbefales.
English: Rare: affects 1 to 10 users in 10,000:
Danish: Sjældne (det sker hos mellem 1 og 10 ud af 10.000 patienter):
English: ↑ 8.7 fold
Danish: ↑ 8,7 gange
English: Safety in pregnant women has not been established.
Danish: Sikkerheden ved anvendelse af atorvastatin under graviditet er ikke fastslået.
English: Common side effects (affects 1 to 10 users in 100) include:
Danish: Almindelige (det sker hos mellem 1 og 10 ud af 100 patienter):
English: 80 mg OD for 15 days
Danish: 80 mg x 1 i 15 dage
English: General disorders and administration site conditions Uncommon: malaise, asthenia, chest pain, peripheral oedema, fatigue, pyrexia.
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke almindelig: Utilpashed, asteni, brystsmerter, perifært ødem, træthed, feber.
English: Fusidic acid
Danish: Fusidinsyre
English: Excipients: [To be completed nationally]
Danish: Fremstiller: [Udfyldes nationalt]
English: In this leaflet:
Danish: Zarator indeholder:
English: Rifampin 600 mg OD, 7 days (co-administered)
Danish: Rifampicin 600 mg x 1, 7 dage (samtidig indgift)
English: Fosamprenavir 700 mg BID/ Ritonavir 100 mg BID, 14 days
Danish: Fosamprenavir 700 mg x 2/ Ritonavir 100 mg x 2, 14 dage
English: 40mg SD ↑ 3% Lower starting dose and clinical monitoring of these patients is recommended.
Danish: ↑ 3% Nedsat initialdosis samt klinisk monitorering anbefales.
English: The usual starting dose of {PRODUCT NAME} is 10 mg once a day.
Danish: Den sædvanlige startdosis af Zarator er 10 mg 1 gang dagligt.
English: Fatal CHD plus non-fatal MI Total cardiovascular events and revascularization procedures Total coronary events
Danish: Totale kardiovaskulære hændelser og revaskulariserings-indgreb
English: Uncommon: hypoglycaemia, weight gain, anorexia
Danish: Ikke almindelig: Hypoglykæmi, vægtstigning, vægttab.
English: Taking {PRODUCT NAME} with food and drink See Section 3 for instructions on how to take {PRODUCT NAME}.
Danish: Brug af Zarator sammen med mad og drikke Se pkt.
English: 10 mg OD for 28 days
Danish: 10 mg x 1 i 28 dage
English: 40 mg OD for 22 days
Danish: 40 mg x 1 i 22 dage
English: 80 mg OD for 8 days
Danish: 80 mg x 1 i 8 dage
English: Lopinavir 400 mg BID/ Ritonavir 100 mg BID, 14 days
Danish: Lopinavir 400 mg x 2/ Ritonavir 100 mg x 2, 14 dage
English: • The risk of hemorrhagic stroke was increased in patients who entered the study with prior hemorrhagic stroke (7/45 for atorvastatin versus 2/48 for placebo; HR 4.06; 95% CI, 0.84-19.57), and the risk of ischemic stroke was similar between groups (3/45 for atorvastatin versus 2/48 for placebo; HR 1.64; 95% CI, 0.27-9.82).
Danish: • Risikoen for hæmoragisk apopleksi var øget hos patienter, som før forsøgets start havde haft hæmoragisk apopleksi (7/45 i atorvastatingruppen versus 2/48 i placebogruppen; HR 4,06; 95% CI: 0,84-19,57).
English: There are some medicines that may change the effect of {PRODUCT NAME} or their effect may be changed by {PRODUCT NAME}.
Danish: Anden medicin kan måske påvirke behandlingen med Zarator, eller Zarator kan påvirke behandlingen med anden medicin:
English: • hepatitis (liver inflammation)
Danish: • leverbetændelse
English: Darunavir 300 mg BID/ Ritonavir 100 mg BID, 9 days
Danish: Darunavir 300 mg x 2/ Ritonavir 100 mg x 2, 9 dage
English: − This medicine has been prescribed for you.
Danish: Lægen har ordineret Zarator til Dem personligt.
English: Uncommon: vomiting, abdominal pain upper and lower, eructation, pancreatitis.
Danish: Ikke almindelig: Opkastning, abdominalsmerter, ructus, pancreatitis.
English: − Medicines obtained without a prescription: St John's Wort
Danish: Medicin uden recept: perikon.
English: Clinical monitoring of these patients is recommended
Danish: Klinisk monitorering anbefales.
English: Therefore, a lower maximum dose of atorvastatin should be considered and appropriate clinical monitoring of the patient is recommended when concomitantly used with moderate CYP3A4 inhibitors.
Danish: Ved samtidig behandling med moderate CYP3A4-hæmmere bør en lavere maksimaldosis af atorvastatin derfor overvejes, og passende klinisk monitorering af patienten anbefales.
English: Fenofibrate 160 mg OD, 7 days
Danish: Fenofibrat 160 mg x 1, 7 dage 40 mg enkeltdosis
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 standard kolesterolsænkende diæt, inden der gives Zarator.
English: • gynecomastia (breast enlargement in men and women).
Danish: • brystforstørrelse hos mænd og kvinder
English: Grapefruit Juice, 240 mL OD * 40 mg, SD ↑ 37% Concomitant intake of large quantities of grapefruit juice and atorvastatin is not recommended.
Danish: ↑ 37% Samtidig indtagelse af store mængder grapefruitjuice og atorvastatin kan ikke anbefales.
English: Hepatic impairment {PRODUCT NAME} should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2).
Danish: Zarator skal anvendes med forsigtighed hos patienter med leverinsufficiens (se pkt.
English: • vomiting, belching, abdominal pain upper and lower, pancreatitis (inflammation of the pancreas leading to stomach pain)
Danish: • opkastning, bøvsen, mavesmerter, betændelse i bugspytkirtlen (viser sig ved voldsomme mavesmerter)
English: ↑ 3.3 fold
Danish: ↑ 3,3 gange
English: Paediatric use
Danish: Pædiatrisk population
English: In cases where co-administration of these medicinal products with atorvastatin cannot be avoided lower starting and maximum doses of atorvastatin should be considered and appropriate clinical monitoring of the patient is recommended (see Table 1).
Danish: I tilfælde, hvor samtidig behandling med disse lægemidler og atorvastatin ikke kan undgås, skal lavere initial- og maksimaldoser af atorvastatin overvejes.
English: 10 mg OD for 4 weeks
Danish: 10 mg x 1 i 4 uger
English: 80 mg OD for 10 days
Danish: 80 mg x 1 i 10 dage
English: If you have any further questions on the use of this medicine or wish to stop your treatment, ask your doctor or pharmacist.
Danish: Hvis De holder op med at tage Zarator Spørg lægen eller på apoteket, hvis der er noget, De er i tvivl om.
English: Metabolism and nutrition disorders Common: hyperglycaemia.
Danish: Almindelig: Hyperglykæmi.
English: 20 mg OD for 4 days
Danish: 20 mg x 1 i 4 dage
English: • rash, skin rash and itching, hives, hair loss
Danish: • udslæt , hudkløe, nældefeber, hårtab
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: ÆNDRINGER TIL DE RELEVANTE AFSNIT I PRODUKTRESUMÉET
English: Uncommon side effects (affects 1 to 10 users in 1000) include:
Danish: Ikke almindelige (det sker hos mellem 1 og 10 ud af 1.000 patienter):
English: Recurrent stroke
Danish: Leverpåvirkninger
English: Co-administered medicinal product
Danish: FARMACEUTISKE OPLYSNINGER
English: Very rare: hepatic failure.
Danish: Meget sjælden: Anafylaksi.
English: − if you regularly drink a large amount of alcohol
Danish: Hvis De har taget for mange Zarator
English: 40 mg OD for 4 days
Danish: 40 mg x 1 i 4 dage
English: 10 mg OD for 4 days
Danish: 10 mg x 1 i 4 dage
English: Women of childbearing potential
Danish: Patienter med nyreinsufficiens
English: Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate).
Danish: Hver tablet indeholder 40 mg atorvastatin (som atorvastatincalciumtrihydrat).
English: Cimetidine 300 mg QID, 2 weeks
Danish: Cimetidin 300 mg x 4, 2 uger 10 mg x 1 i 4 uger
English: Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate).
Danish: Hver tablet indeholder 10 mg atorvastatin (som atorvastatincalciumtrihydrat).
English: Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate).
Danish: Hver tablet indeholder 20 mg atorvastatin (som atorvastatincalciumtrihydrat).
English: ↑ 3.9 fold
Danish: ↑ 3,9 gange
English: If you take more {PRODUCT NAME} than you should If you accidently take too many {PRODUCT NAME} tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.
Danish: Kontakt lægen, skadestuen eller apoteket, hvis De har taget flere Zarator tabletter, end der står i her, eller flere end lægen har foreskrevet, og De føler Dem utilpas.
English: Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin calcium trihydrate).
Danish: Hver tablet indeholder 80 mg atorvastatin (som atorvastatincalciumtrihydrat).
English: Effect of atorvastatin on co-administered medicinal products
Danish: Atorvastatins virkning på andre lægemidler
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN <MM/ÅÅÅÅ> <[Udfyldes nationalt]>
English: 40 mg SD ↑ 30%
Danish: 40 mg enkeltdosis
English: What {PRODUCT NAME} is and what it is used for Before you take {PRODUCT NAME} How to take {PRODUCT NAME} Possible side effects
Danish: Det skal De vide, før De begynder at tage Zarator Sådan skal De tage Zarator Bivirkninger
English: • neck pain, muscle fatigue
Danish: • nakkesmerter, muskelsvaghed
English: Biotransformation
Danish: Metabolisme
English: The concurrent use of atorvastatin and fusidic acid is not recommended, therefore, temporary suspension of atorvastatin may be considered during fusidic acid therapy (see section 4.5).
Danish: Det bør derfor overvejes at seponere atorvastatin-behandling under behandling med fusidinsyre (se pkt.
English: Do not take {PRODUCT NAME} if you are able to become pregnant unless you use reliable contraceptive measures.
Danish: Hvis De er i den fødedygtige alder, skal De bruge sikker prævention, mens De tager Zarator.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name}
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN <[Udfyldes nationalt]> <[Se bilag I - Udfyldes nationalt]> [For referral procedures] {Navn og adresse} <{tlf}> <{fax}> <{email}>
English: Uncommon: neck pain, muscle fatigue.
Danish: Ikke almindelig: Nakkesmerter, muskelsvaghed.