FrancophonIA/ELRC3.0 huggingface dataset:
English: If co-administration cannot be avoided, simultaneous coadministration of atorvastatin with rifampin is recommended, with clinical monitoring.
Danish: Hvis samtidig behandling ikke kan undgås, anbefales samtidig indgift af atorvastatin og rifampicin samt klinisk monitorering.
English: In the primary prevention trials the dose was 10 mg/day.
Danish: I de primære forebyggelsesstudier var dosis 10 mg dagligt.
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-kolesterol, mål for behandlingen og behandlingseffekt.
English: All patients had at least 3 of the pre-defined cardiovascular risk factors: male gender, age ≥55 years, smoking, diabetes, history of CHD in a first-degree relative, TC:HDL-C >6, peripheral vascular disease, left ventricular hypertrophy, prior cerebrovascular event, specific ECG abnormality, proteinuria/albuminuria.
Danish: Alle patienter havde mindst 3 af de foruddefinerede kardiovaskulære risikofaktorer: mand, alder 55 år, ryger, diabetes, koronar hjertesygdom hos 1. grads slægtning, total-kolesterol:HDL-kolesterol >6, perifer vaskulær sygdom, venstre ventrikelhypertrofi, tidligere cerebrovaskulær hændelse, specifikke ekg-forandringer, proteinuri/albuminuri.
English: The risk of these events may therefore be increased with concomitant use of ezetimibe and atorvastatin.
Danish: Risikoen for disse bivirkninger kan øges ved samtidig brug af ezetimibe og atorvastatin.
English: Co-administered medicinal product and dosing regimen
Danish: Samtidigt administreret lægemiddel og dosisregime Dosisregime
English: − If you have any further questions, ask your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller på apoteket.
English: Hepatic insufficiency: Plasma concentrations of atorvastatin and its active metabolites are markedly increased (approx. 16-fold in Cmax and approx. 11-fold in AUC) in patients with chronic alcoholic liver disease (Child-Pugh B).
Danish: Leverinsufficiens: Plasmakoncentrationerne af atorvastatin og dets aktive metabolitter er markant forhøjede (Cmax ca. 16 gange og AUC ca. 11 gange) hos patienter med kronisk alkoholisk leversygdom (Child-Pugh B).
English: Atorvastatin and dosing regimen Medicinal product/Dose (mg)
Danish: Atorvastatindosisregime Lægemiddel/Dosisregime (mg) Ændring i AUC&
English: Gender: Concentrations of atorvastatin and its active metabolites in women differ from those in men (Women: approx. 20% higher for Cmax and approx. 10% lower for AUC).
Danish: Køn: Koncentrationen af atorvastatin og dets aktive metabolitter hos kvinder afviger (Cmax ca. 20 % højere og AUC ca. 10 % lavere) fra koncentrationerne hos mænd.
English: Uncommon: vision blurred.
Danish: Ikke almindelig: Uskarpt syn.
English: Atorvastatin iiss effective in reducing LDL-C in patients with homozygous familial hypercholesterolaemia, a population that has not usually responded to lipid-lowering medicinal products.
Danish: Atorvastatin reducerer effektivt LDL-kolesterol hos patienter med homozygot familiær hyperkolesterolæmi, en patientgruppe, som sædvanligvis ikke har responderet på lipidsænkende behandling.
English: ↓ 35%^ No specific recommendation.
Danish: ↑ 18% Ingen særlig rekommandation.
English: Patients were 60% male, 21-92 years of age (average age 63 years), and had an average baseline LDL of 133 mg/dL (3.4 mmol/L).
Danish: 60% af patienterne var mænd, aldersintervaller 21-92 år (gennemsnitsalder 63 år) og LDL-kolesterol 3,4 mmol/l (133 mg/dl) ved baseline.
English: {PRODUCT NAME} is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed.
Danish: Zarator bruges til at sænke koncentrationen af fedtstoffer (lipider) som kolesterol og triglycerider i blodet, når fedtfattig diæt og livsstilsændringer ikke er tilstrækkeligt.
English: In animal studies atorvastatin had no effect on male or female fertility (see section 5.3).
Danish: I dyreforsøg havde atorvastatin ingen indvirkning på fertiliteten hos hverken hanner eller hunner (se pkt.
English: All cause mortality was 10.9% (77/708) for atorvastatin versus 9.1% (64/701) for placebo in the subgroup of patients with prior lacunar infarct.
Danish: Død uanset årsag totalt var 10,9 % (77/708) for atorvastatin versus 9,1 % (64/701) for placebo i subgruppen af patienter, der tidligere havde haft lakunært infarkt.
English: Clinical Recommendation
Danish: Klinisk rekommandation
English: No adjustment of dose is required (see section 4.4).
Danish: Dosisjustering ikke er nødvendig (se pkt.
English: In a post-hoc analysis of stroke subtypes in patients without coronary heart disease (CHD) who had a recent stroke or transient ischemic attack (TIA) there was a higher incidence of hemorrhagic stroke in patients initiated on atorvastatin 80 mg compared to placebo.
Danish: I en post-hoc analyse af apopleksi-subgrupper hos patienter uden koronar hjertesygdom (CHD), som for nylig havde apopleksi eller transitorisk cerebral iskæmi (TCI), var der en større incidens af hæmoragisk apopleksi hos patienter, der fik atorvastatin 80 mg, sammenlignet med placebo.
English: In a multicenter 8 week open-label compassionate-use study with an optional extension phase of variable length, 335 patients were enrolled, 89 of which were identified as homozygous familial hypercholesterolaemia patients.
Danish: I et multicenter 8-ugers open-label compassionate-use klinisk forsøg med valgfri forlængelsesfase af variable længde blev 335 patienter indrulleret.
English: − If muscular symptoms are severe and cause daily discomfort, even if the CK levels are elevated to ≤ 5 x ULN, treatment discontinuation should be considered.
Danish: Hvis muskelsymptomerne er svære og foranlediger dagligt ubehag, bør seponering af behandlingen overvejes, selvom CK-værdien er forhøjet til 5 gange den øvre referenceværdi.
English: Specific treatment is not available for {PRODUCT NAME} overdose.
Danish: Der findes ingen specifik behandling af overdosering med Zarator.
English: Rare: cholestasis.
Danish: Sjælden: Kolestase.
English: In cases where coadministration with atorvastatin is necessary, do not exceed 10 mg atorvastatin daily.
Danish: Hvis samtidig behandling med atorvastatin er nødvendig, må atorvastatindosis ikke overskride 10 mg/dag.
English: Do not use any tools or machines if your ability to use them is affected by this medicine.
Danish: Men kør ikke bil eller motorcykel og lad være med at cykle, hvis medicinen påvirker Dem, og lad være med at arbejde med værktøj eller maskiner, hvis Deres evne til at bruge disse er påvirket.
English: Whilst on treatment
Danish: Under behandlingen
English: Atorvastatin is metabolized by cytochrome P450 3A4 (CYP3A4) and is a substrate to transport proteins e.g. the hepatic uptake transporter OATP1B1.
Danish: Atorvastatin metaboliseres via cytokrom P450 3A4 (CYP3A4) og er substrat for transportproteiner, f.eks. OATP1B1, der findes i leveren.
English: Always take {PRODUCT NAME} exactly as your doctor has told you.
Danish: Brug altid Zarator nøjagtigt efter lægens anvisning.
English: • ringing in the ears and/or head
Danish: • ringen for ørene
English: Table 1: Effect of co-administered medicinal products on the pharmacokinetics of atorvastatin Atorvastatin
Danish: Tabel 1: Effekt af samtidigt administrerede lægemidler på atorvastatins farmakokinetik Atorvastatin
English: The effect of atorvastatin on fatal and non-fatal cardiovascular disease was also assessed in a randomized, double-blind, multicenter, placebo-controlled trial, the Collaborative Atorvastatin Diabetes Study (CARDS) in patients with type 2 diabetes, 40-75 years of age, without prior history of cardiovascular disease, and with LDL-C ≤4.14 mmol/l (160 mg/dl) and TG ≤6.78 mmol/l (600 mg/dl).
Danish: I et randomiseret, dobbelt-blindt, multicenter, placebokontrolleret studie, Collaborative Atorvastatin Diabetes Study (CARDS) blev effekten af atorvastatin på letal og ikke-letal kardiovaskulær sygdom også vurderet hos patienter med type 2-diabetes i alderen 40-75 år, uden kardiovaskulær sygdom i anamnesen og med LDLkolesterol 4,14 mmol/l (160 mg/dl) og triglycerid 6,78 mmol/l (600 mg/dl).
English: {PRODUCT NAME} is contraindicated in patients with active liver disease (see section 4.3).
Danish: Zarator er kontraindiceret hos patienter med aktiv leversygdom (se pkt.
English: {PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), 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: Zarator er indiceret som supplement til diæt ved forhøjet total-kolesterol, LDL-kolesterol, apolipoprotein B og forhøjede triglycerider hos patienter med primær hyperkolesterolæmi inklusive familiær hyperkolesterolæmi (heterozygot variant) eller kombineret hyperlipidæmi (svarende til type IIa og IIb i Fredricksons klassifikation), hvor diæt og andre ikke farmakologiske foranstaltninger er utilstrækkelige.
English: In cases where coadministration with atorvastatin is necessary, lower maintenance doses of atorvastatin are recommended.
Danish: Hvis samtidig behandling med atorvastatin er nødvendig, anbefales en lavere vedligeholdelsesdosis af atorvastatin.
English: − If such symptoms occur whilst a patient is receiving treatment with atorvastatin, their CK levels should be measured.
Danish: Hvis sådanne symptomer opstår under behandling med atorvastatin, skal CK-værdien måles.
English: Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see section 4.8).
Danish: Meget sjældne tilfælde af interstitiel lungesygdom er blevet rapporteret ved brug af nogle statiner, særligt ved langtidsbrug (se pkt.
English: Co-administration of {PRODUCT NAME} with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol.
Danish: Samtidig anvendelse af Zarator og et oralt kontraceptivum medførte forhøjede plasmakoncentrationer af norethisteron og ethinylestradiol.
English: Clinically important (> 3 times upper normal limit) elevations in serum transaminases occurred in 0.8% patients on {PRODUCT NAME}.
Danish: Klinisk relevante (>3 gange den øvre referenceværdi) forhøjelser i serumtransaminaser er set hos 0,8 % af de patienter, som behandles med Zarator.
English: 100 vs. 154 389 vs. 483
Danish: 389 vs. 483
English: The median percent change, from baseline, in total atheroma volume (the primary study criteria) was0.4% (p=0.98) in the atorvastatin group and +2.7% (p=0.001) in the pravastatin group (n=249).
Danish: Den mediane ændring i total ateromavolumen (det primære studiekriterie) i procent fra baseline var -0,4 % (p=0,98) i atorvastatingruppen og +2,7 % (p=0,001) i pravastatingruppen (n=249).
English: In rats, plasma concentrations of atorvastatin are similar to those in milk.
Danish: Hos rotter svarer koncentrationerne i plasma til koncentrationerne i mælk.
English: In rats, there is evidence of placental transfer.
Danish: Hos rotter er der tegn på, at atorvastatin krydser placenta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton
English: HOSPITAL PACK LABEL
Danish: Label på hospitalspakning
English: All cause mortality was 9.1% (216/2365) for atorvastatin versus 8.9% (211/2366) for placebo.
Danish: Død uanset årsag var 9,1 (216/2.365) i atorvastatingruppen vs. 8,9% (211/2.366) i placebogruppen.
English: 1Based on difference in crude events rates occurring over a median follow-up of 3.9 years.
Danish: 21 vs. 39 1 På baggrund af forskelle i de samlede hændelseshyppigheder opstået over en middelopfølgningsperiode på 3,9 år.
English: Atorvastatin is contraindicated during breastfeeding (see section
Danish: Atorvastatin er kontraindiceret under amning (se pkt.
English: Atorvastatin has been shown to reduce concentrations of total-C (30% - 46%), LDL-C (41% - 61%), apolipoprotein B (34% - 50%), and triglycerides (14% - 33%) while producing variable increases in HDLC and apolipoprotein A1 in a dose response study.
Danish: I et dosis-respons-studie reducerede atorvastatin koncentrationen af total-kolesterol (30-46 %), LDLkolesterol (41-61 %), apolipoprotein B (34-50 %) og triglycerider (14-33 %) og forårsagede variable stigninger i HDL-kolesterol og apolipoprotein A1.
English: In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk (see section 5.3).
Danish: Hos rotter svarer koncentrationerne af atorvastatin og dets aktive metabolitter i plasma til koncentrationerne i mælken (se pkt.
English: Tipranavir 500 mg BID/ Ritonavir 200 mg BID, 8 days (days 14 to 21)
Danish: Tipranavir 500 mg x 2/ Ritonavir 200 mg x 2, 8 dage (dag 14 til 21)
English: In cases where co-administration of these medicinal products with atorvastatin is necessary, the benefit and the risk of concurrent treatment should be carefully considered.
Danish: Hvis samtidig anvendelse af denne type medicin er nødvendig, skal fordele og risici ved samtidig behandling nøje overvejes.
English: Both amiodarone and verapamil are known to inhibit CYP3A4 activity and co-administration with atorvastatin may result in increased exposure to atorvastatin.
Danish: Det er kendt, at både amiodaron og verapamil hæmmer CYP3A4, og samtidig indgift af atorvastatin kan resultere i forhøjede koncentrationer af atorvastatin.
English: Concomitant administration of atorvastatin with inducers of cytochrome P450 3A (e.g. efavirenz, rifampin, St. John's Wort) can lead to variable reductions in plasma concentrations of atorvastatin.
Danish: Samtidig anvendelse af atorvastatin og cytokrom P450 3A-induktorer (f.eks. efavirenz, rifampicin, perikon) kan medføre variable reduktioner i atorvastatins plasmakoncentration.
English: • an allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
Danish: • allergisk reaktion med hvæsende vejrtrækning, trykken for brystet eller brystsmerter, hævelse af øjenlåg, ansigt, læber, mund, tunge eller hals, vejrtrækningsbesvær, kollaps.
English: In a clinical study in patients receiving chronic warfarin therapy, coadministration of atorvastatin 80 mg daily with warfarin caused a small decrease of about 1.7 seconds in prothrombin time during the first 4 days of dosing which returned to normal within 15 days of atorvastatin treatment.
Danish: I et klinisk studie med patienter i kronisk warfarinbehandling forårsagede samtidig behandling med 80 mg atorvastatin dagligt en lille stigning på omkring 1,7 sekunder i protrombintid i løbet af de første 4 dage af behandlingen.
English: Atorvastatin 80 mg reduced the risk of the primary endpoint of fatal or non-fatal stroke by 15% (HR 0.85; 95% CI, 0.72-1.00; p=0.05 or 0.84; 95% CI, 0.71-0.99; p=0.03 after adjustment for baseline factors) compared to placebo.
Danish: Atorvastatin 80 mg reducerede risikoen for det primære endepunkt (letal eller ikke-letal apopleksi) med 15 % (HR 0,85; 95 % CI: 0,72-1,00; p=0,05 eller HR 0,84; 95% CI: 0,71-0,99; p=0,03 efter justering for baseline-faktorer) sammenlignet med placebo.
English: − Atorvastatin must be discontinued if clinically significant elevation of CK levels (> 10 x ULN) occur, or if rhabdomyolysis is diagnosed or suspected.
Danish: Atorvastatin skal seponeres ved klinisk signifikant stigning i CK-værdien (>10 gange den øvre referenceværdi), hvis der er mistanke om rabdomyolyse, eller hvis rabdomyolyse diagnosticeres.
English: In the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study, the effect of atorvastatin 80 mg daily or placebo on stroke was evaluated in 4731 patients who had a stroke or transient ischemic attack (TIA) within the preceding 6 months and no history of coronary heart disease (CHD).
Danish: I studiet Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) blev effekten af atorvastatin 80 mg dagligt eller placebo på apopleksi evalueret hos 4.731 patienter med apopleksi eller transitorisk cerebral iskæmi (TCI) inden for de forudgående 6 måneder og uden koronar hjertesygdom (CHD) i anamnesen.
English: Ear and labyrinth disorders Uncommon: tinnitus Very rare: hearing loss.
Danish: Ikke almindelig: Tinnitus Meget sjælden: Høretab.
English: − if you are hypersensitive (allergic) to {PRODUCT NAME} or to any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine - see Section 6 for details.
Danish: Tag ikke Zarator hvis De er overfølsom (allergisk) over for Zarator eller tilsvarende medicin, der anvendes til at sænke koncentrationen af fedtstoffer i blodet, eller et af de øvrige indholdsstoffer - se pkt.
English: Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis.
Danish: Behandling af gravide med atorvastatin kan nedsætte koncentrationen af mevalonat (et forstadium i kolesterolbiosyntesen) hos fostret.
English: Common: constipation, flatulence, dyspepsia, nausea, diarrhoea.
Danish: Almindelig: Obstipation, flatulens, dyspepsi, kvalme, diarré.
English: All cause mortality was 15.6% (7/45) for atorvastatin versus 10.4% (5/48) in the subgroup of patients with prior hemorrhagic stroke.
Danish: Død uanset årsag var 15,6 % (7/45) for atorvastatin versus 10,4 % (5/48) for placebo i subgruppen af patienter, der tidligere havde haft hæmoragisk apopleksi.
English: In a post-hoc analysis, atorvastatin 80 mg reduced the incidence of ischemic stroke (218/2365, 9.2% vs. 274/2366, 11.6%, p=0.01) and increased the incidence of hemorrhagic stroke (55/2365, 2.3% vs. 33/2366, 1.4%, p=0.02) compared to placebo.
Danish: I en post-hoc analyse reducerede atorvastatin 80 mg incidensen af koronar apopleksi (218/2.365, 9,2% vs. 274/2.366, 11,6%: p=0,01) og øgede incidensen af hæmoragisk apopleksi (55/2.365, 2,3% vs. 33/2.366, 1,4%; p=0,02) sammenlignet med placebo.
English: Respiratory, thoracic and mediastinal disorders: Common: pharyngolaryngeal pain, epistaxis.
Danish: Luftveje, thorax og mediastinum Almindelig: Faryngolaryngeale smerter epistaxis
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: Indehaver af markedsføringstilladelsen og fremstiller
English: Summary of product characteristics, labelling and package leaflet
Danish: Produktresumé, etikettering og indlægsseddel
English: The effect of inhibition of hepatic uptake transporters on atorvastatin concentrations in hepatocytes is unknown.
Danish: Det er ukendt, hvordan hæmning af transportproteiner i leveren påvirker atorvastatinkoncentrationen i hepatocytter.
English: Immune system disorders Common: allergic reactions.
Danish: Almindelig: Allergiske reaktioner.
English: Atorvastatin also significantly reduced mean TC by 34.1% (pravastatin: -18.4%, p<0.0001), mean TG levels by 20% (pravastatin: -6.8%, p<0.0009), and mean apolipoprotein B by 39.1% (pravastatin: -22.0%, p<0.0001).
Danish: Atorvastatin reducerede også signifikant det gennemsnitlige total-kolesterol (TC) med 34,1 % (pravastatin: -18,4 %; p<0,0001), de gennemsnitlige triglycerid (TG)-niveauer med 20 % (pravastatin: -6,8 %; p<0,0009), og det gennemsnitlige apolipoprotein B med 39,1 % (pravastatin: -22,0 %; p<0,0001).
English: Uncommon: dizziness, paraesthesia, hypoesthesia, dysgeusia, amnesia.
Danish: Ikke almindelig: Svimmelhed, paræstesi, hypæstesi, dysgeusi, amnesi.
English: Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicinal products that may increase the plasma concentration of atorvastatin such as potent inhibitors of CYP3A4 or transport proteins (e.g. ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc).
Danish: Risikoen for rabdomyolyse er øget, hvis atorvastatin gives samtidig med visse lægemidler, som kan øge atorvastatins plasmakoncentration, såsom potente CYP3A4-hæmmere eller transportproteiner (f.eks. ciclosporin, telithromycin, clarithromycin, delavirdin, stiripentol, ketoconazol, voriconazol, itraconazol, posaconazol og HIV-proteasehæmmere, herunder ritonavir, lopinavir, atazanavir, indinavir og darunavir mv.).
English: The safety of {PRODUCT NAME} during pregnancy and breast-feeding has not yet been proven.
Danish: Sikkerheden af Zarator under graviditet og amning er ikke undersøgt.
English: Reproductive system and breast disorders Very rare: gynecomastia.
Danish: Det reproduktive system og mammae Meget sjælden: Gynækomasti.
English: If concomitant administration cannot be avoided, the lowest dose of atorvastatin to achieve the therapeutic objective should be used and the patients should be appropriately monitored (see section
Danish: Hvis samtidig behandling ikke kan undgås, skal den lavest mulig atorvastatindosis anvendes, og patienten bør monitoreres passende (se pkt.
English: Co-administration of potent CYP3A4 inhibitors (e.g. ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.) should be avoided if possible.
Danish: Samtidig behandling med potente CYP3A4-hæmmere (f.eks. ciclosporin, telithromycin, clarithromycin, delavirdin, stiripentol, ketoconazol, voriconazol, itraconazol, posaconazol samt HIV-proteasehæmmere, herunder ritonavir, lopinavir, atanazavir, indinavir og darunavir m.fl.) bør så vidt muligt undgås.
English: The risk might also be increased at concomitant administration of atorvastatin with other medicinal products that have a potential to induce myopathy, such as fibric acid derivates and ezetimibe (see section 4.4).
Danish: Denne risiko er også være øget ved samtidig behandling med atorvastatin og andre lægemidler, der kan forårsage myopati, f.eks. fibrater og ezetimibe (se pkt.
English: Table 2: Effect of atorvastatin on the pharmacokinetics of co-administered medicinal products
Danish: Tabel 2: Atorvastatins virkning på farmakokinetikken af samtidigt administrerede lægemidler Samtidigt administreret lægemiddel
English: • dizziness, numbness or tingling in the fingers and toes, reductions of sensation to pain or touch,
Danish: • svimmelhed, følelsesløshed eller snurren i fingre og tæer, nedsat smertefølelse eller berøringsfølelse, smagsforstyrrelser, hukommelsestab
English: Atorvastatin is eliminated primarily in bile following hepatic and/or extrahepatic metabolism.
Danish: Atorvastatin udskilles primært i galden efter metabolisering i eller uden for leveren.
English: If you experience any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.
Danish: Stop med at tage tabletterne og kontakt straks læge eller skadestue.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev sidst revideret [måned år].
English: Patients should be started with {PRODUCT NAME} 10 mg daily.
Danish: Patienter bør starte med 10 mg Zarator dagligt.
English: − Serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes genitals and fever.
Danish: Alvorlig afskalning og hævelse af huden, blærer på huden, især omkring mund og øjne samt på kønsdele ledsaget af feber.
English: Should an increase in transaminases of greater than 3 times the upper limit of normal (ULN) persist, reduction of dose or withdrawal of {PRODUCT NAME} is recommended (see section 4.8).
Danish: Ved vedvarende transaminasestigning til mere end 3 gange den øvre referenceværdi anbefales dosisreduktion eller seponering af Zarator (se pkt.