FrancophonIA/ELRC3.0 huggingface dataset:
English: Laropiprant is metabolised primarily via acyl glucuronidation, with a smaller component of oxidative metabolism, followed by excretion of the glucuronide into faeces (via bile) and urine.
Danish: Laropiprant metaboliseres primært via acylglucuronidering med en mindre komponent af oxidativ metabolisme efterfulgt af udskillelse af glucuronid i fæces (via galden) og urin.
English: If you are switching from a medicine with less than 2,000 mg of prolonged-nicotinic acid, you should start by taking one tablet of Pelzont a day.
Danish: Hvis De skifter fra et depotlægemiddel, der indeholder mindre end 2.000 mg nicotinsyre, skal De starte med at tage én Pelzont-tablet om dagen.
English: The first pathway results in the formation of nicotinamide adenine dinucleotide (NAD) and nicotinamide.
Danish: Den første metaboliseringsvej resulterer i dannelsen af nicotinamidadenindinukleotid (NAD) og nicotinamid.
English: approximately 68 % of the dose was recovered in faeces (primarily as parent compound, comprising unabsorbed active substance and/or hydrolysed glucuronic acid conjugate) and 22 % was recovered in urine (primarily as metabolites).
Danish: Efter peroral administration af 14C-laropiprant hos mennesker blev ca. 68 % af dosis genfundet i fæces (primært som stamprodukt indeholdende uabsorberet aktiv substans og/eller hydrolyseret glucuronidsyrekonjugat), og 22 % blev genfundet i urinen (primært som metabolitter).
English: Nicotinic acid was not carcinogenic in mice when administered for the duration of their life.
Danish: Nicontinsyre var ikke karcinogent hos mus ved livslang eksponering.
English: Laropiprant is eliminated primarily via acyl glucuronidation, followed by excretion of the glucuronide in faeces (via bile) and urine.
Danish: Laropiprant elimineres primært via acylglucuronidering efterfulgt af glucuronidudskillelse i fæces (via galden) og urin.
English: As with other nicotinic acid medicinal products, patients with a history of jaundice, hepato-biliary disorder or peptic ulcer should be observed closely (see sections 4.2 and 4.3).
Danish: Som med andre nicotinsyrepræparater bør patienter med icterus, hepatobiliær sygdom eller ulcus pepticum observeres nøje (se pkt.
English: LIST OF EXCIPIENTS Contains lactose monohydrate.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også lactosemonohydrat.
English: • Avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Pelzont.
Danish: • Undgå at drikke alkohol eller varme drikke og at spise krydret mad tæt på det tidspunkt, hvor De tager Pelzont.
English: Aluminium/Aluminium blister with push-through lidding containing 7 modified-release tablets.
Danish: Aluminium/aluminiumblister med push-through folie, der indeholder 7 tabletter med modificeret udløsning.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pelzont in all subsets of the paediatric population in homozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Pelzont hos alle undergrupper af den pædiatriske population ved homozygot familiær hyperkolesterolæmi.
English: Effects of nicotinic acid on other medicinal products Antihypertensive therapy: Nicotinic acid may potentiate the effects of ganglionic blocking agents and vasoactive medicinal products such as nitrates, calcium channel blockers, and adrenergic receptor blocking agents, resulting in postural hypotension.
Danish: Antihypertensiv behandling: Nicotinsyre kan forstærke virkningen af ganglieblokerende stoffer og vasoaktive lægemidler, såsom nitrater, calciumkanalblokkere og adrenerge receptorblokkere, som kan resultere i postural hypotension.
English: TP plays a role in platelet function; however, therapeutic doses of laropiprant had no clinically relevant effect on bleeding time and collagen-induced platelet aggregation (see section 4.5).
Danish: TP spiller en rolle i blodpladefunktionen; terapeutiske doser af laropiprant havde dog ingen klinisk relevant effekt på blødningstiden og den kollageninducerede blodpladeaggregation (se pkt.
English: Prolongation of collagen-induced platelet aggregation was observed in subjects taking multiple doses of 300 mg or greater (see section 5.1).
Danish: Forlænget kollageninduceret blodpladeaggregation sås hos forsøgspersoner, der fik multiple doser på 300 mg eller mere (se pkt.
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelige (kan berøre flere end 1 ud af 10 personer)
English: There are no adequate data from the use of high dose nicotinic acid in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af højdosis-nicotinsyre til gravide kvinder.
English: This will lower your chance of flushing (redness of the skin, feeling warm, itching, or tingling, particularly in your head, neck, chest and upper back).
Danish: Dette vil nedsætte risikoen for rødmen (rødme af huden, varmefølelse, kløe eller prikkende fornemmelse, især i hovedet, på halsen, brystet og den øverste del af ryggen).
English: Laropiprant was not carcinogenic in 2 year studies in mice and rats at the highest doses tested, which represents at least 218 to 289 times the human exposure based on the AUC of the recommended daily human dose.
Danish: Laropiprant var ikke karcinogent i 2-års undersøgelser på mus og rotter ved de højeste doser, der blev testet, hvilket repræsenterer mindst 218-289 gange eksponeringen hos mennesker på basis af AUC for den anbefalede daglige dosis til mennesker.
English: Not known: vesicular or vesiculobullous rash
Danish: Ikke kendt: vesikuløst eller vesikulobulløst udslæt
English: Uncommon: insomnia Rare: anxiety
Danish: Ikke almindelig: søvnløshed Sjælden: angst
English: Laropiprant: No dose adjustment is necessary in the elderly.
Danish: Laropiprant: Dosisjustering er ikke nødvendig hos ældre.
English: Following a 2,000 mg dose of nicotinic acid administered orally as two modified-release tablets of nicotinic acid/laropiprant with food, nicotinic acid was absorbed with a median time to peak plasma concentration (Tmax) of 4 hours, a mean area under the plasma concentration-time curve (AUC0-last) of approximately 58.0 μM·hr and a mean peak plasma concentration (Cmax) of approximately 20.2 μM.
Danish: Efter en dosis på 2.000 mg nicotinsyre , der blev administreret peroralt som to tabletter med modificeret udløsning af nicotinsyre/laropiprant sammen med mad, blev nicotinsyren absorberet med en mediantid til peak plasmakoncentration (Tmax) på 4 timer, gennemsnitligt areal under kurven for plasmakoncentrationen over tid (AUC0-last) på ca. 58,0 µM∙t samt gennemsnitlig peakplasmakoncentration (Cmax) på ca. 20,2 µM.
English: The mean absolute bioavailability of laropiprant is approximately 71 % following a 40 mg dose when administered as two modified-release tablets of nicotinic acid/laropiprant after an overnight fast.
Danish: Laropiprants gennemsnitlige absolutte biotilgængelighed er ca. 71 % efter en 40 mg dosis, når denne administreres som to tabletter med modificeret udløsning af nicotinsyre/laropiprant efter en nats faste.
English: Pelzont: Use in patients with renal insufficiency has not been studied.
Danish: Pelzont: Anvendelse til patienter med nyreinsufficiens er ikke undersøgt.
English: It should be used with caution in patients with renal insufficiency, because nicotinic acid and its metabolites are primarily excreted by the kidneys (see sections 4.3, 4.4 and 5.2).
Danish: Det bør anvendes med forsigtighed hos patienter med nyreinsufficiens, da nicotinsyre og dets metabolitter primært udskilles via nyrerne (se pkt.
English: Race had no clinically meaningful effect on the pharmacokinetics of laropiprant based on a composite analysis of pharmacokinetic data including subjects of White, Hispanic, Black, Asian, and Native American racial groups.
Danish: Race har ingen klinisk relevant effekt på laropiprants farmakokinetik på basis af en sammensat analyse af farmakokinetiske data, herunder hvide, latinamerikanere, negroide, asiater og indianere.
English: Similar treatment-related changes were observed in rabbit foetuses but in the presence of maternal toxicity at exposure levels approximately 629 times the human AUC of nicotinic acid at the recommended daily human dose.
Danish: Lignende behandlingsrelaterede forandringer blev set hos kaninfostre men med tilstedeværelse af maternel toksicitet ved eksponeringer, der var ca. 629 gange human AUC for nicotinsyre ved anbefalet daglig dosis til mennesker.
English: • you are allergic to nicotinic acid, to laropiprant, or to any of the other ingredients of this medicine (listed in section 6).
Danish: • De er allergisk over for nicotinsyre, laropiprant eller et af de øvrige indholdsstoffer i Pelzont
English: Like other lipid-lowering therapies, nicotinic acid medicinal products have been associated with abnormal liver function tests (see section 4.8).
Danish: Som andre lipidsænkende behandlinger er nicotinsyrepræparater blevet forbundet med unormale leverfunktionsprøver (se pkt.
English: However, nicotinic acid a component of Pelzont does pass into breast milk.
Danish: Nicotinsyre, der er en af bestanddelene i Pelzont, går dog over i modermælken.
English: Marked and persistent increases of serum transaminases have been reported infrequently (see section 4.4).
Danish: Der er sjældne rapporter om markante og vedvarende stigninger i serumtransaminaser (se pkt.
English: Reproduction toxicity studies showed slight treatment-related decreases in mean maternal weight gain and foetal body weight, slight increases in pup mortality, and increased incidence of supernumerary rib and incomplete ossification of the sternebra in the foetus were observed in rats at systemic exposure levels at least 513 times the human exposure based on the AUC of the recommended daily human dose.
Danish: Undersøgelser vedrørende reproduktionstoksicitet viste lette behandlingsrelaterede fald i den gennemsnitlige maternelle vægtforøgelse og i fosterets kropsvægt, lette stigninger i mortaliteten blandt ungerne, og der sås øget incidens af overtallige ribben og ufuldstændig forbening af sternebra hos fostret hos rotter ved systemiske eksponeringsniveauer på mindst 513 gange eksponeringen hos mennesker på basis af AUC for den anbefalede daglige dosis til mennesker.
English: The starting dose is one modified-release tablet (1,000 mg nicotinic acid/20 mg laropiprant) once a day.
Danish: Startdosis er én tablet med modificeret udløsning (1.000 mg nicotinsyre/20 mg laropiprant) én gang dagligt.
English: Skin and subcutaneous tissue disorders
Danish: Lever og galdeveje Hud og subkutane væv
English: Multi-pack containing 196 (2 packs of 98) modified-release tablets 49 x 1 modified-release tablets
Danish: Multipakning indeholdende 196 (2 pakningerà 98) tabletter med modificeret udløsning 49 x 1 tabletter med modificeret udløsning
English: Check with your doctor or pharmacist before and while taking your medicine if:
Danish: Kontakt lægen eller apoteket, før De tager medicinen, hvis:
English: No other effects were observed in dog studies with exposures at least 100 times the human exposure based on the AUC of the recommended daily human dose.
Danish: Der sås ikke andre virkninger i hundeundersøgelser med eksponeringer på mindst 100 gange eksponeringen hos mennesker på basis af AUC for den anbefalede daglige dosis til mennesker.
English: Each tablet contains 1000 mg nicotinic acid and 20 mg laropiprant.
Danish: Hver tablet indeholder 1.000 mg nicotinsyre og 20 mg laropiprant.
English: Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Pelzont be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant (see section 4.5).
Danish: Da samtidig administration af galdesyrebindende lægemidler kan reducere biotilgængeligheden af sure lægemidler, såsom nicotinsyre, bør Pelzont gives >1 time før eller >4 timer efter administration af et galdesyrebindende lægemiddel (se pkt.
English: Effects of laropiprant on other medicinal products
Danish: Laropiprants indvirkning på andre lægemidler
English: If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Pelzont.
Danish: Hvis De er i tvivl om noget af ovenstående passer på Dem, skal De tale med lægen eller apoteket, før De tager Pelzont.
English: Therefore, Pelzont should be used with caution in patients with or predisposed to gout.
Danish: Pelzont bør derfor anvendes med forsigtighed hos patienter, der har eller er disponeret for urinsyregigt.
English: A multicenter, randomized, double-blind, placebo-controlled 32-week study to assess the effects of withdrawal of laropiprant showed that dyslipidaemic patients in whom laropiprant was withdrawn after 20 weeks on Pelzont experienced significantly more flushing than patients who continued taking
Danish: Et randomiseret, dobbeltblindet, placebokontrolleret 32-ugers multicenterstudie til at vurdere virkningen af seponering af laropiprant viste, at patienter med dyslipidæmi, hvor laropiprant blev seponeret efter 20 uger på Pelzont, oplevede signifikant mere flushing end patienter, som fortsatte med at tage Pelzont i form af antal dage pr. uge med moderat eller mere udbredt flushing, p<0,01, figur 2.
English: • If you are switching from a medicine containing 2,000 mg or more of a prolonged-release nicotinic acid, your doctor can start you with two tablets of Pelzont a day.
Danish: • Hvis De skifter fra et depotlægemiddel, der indeholder 2.000 mg nicotinsyre eller mere, kan lægen sætte Deres behandling i gang med to Pelzont tabletter om dagen.
English: ●Pelzont (1000 mg/20 mg to 2000 mg/40 mg at week 5) ▲Nicotinic acid (prolonged-release 1000 mg to 2000 mg at week 5)
Danish: ● Pelzont (1.000 mg/20 mg til 2.000 mg/40 mg ved uge 5)
English: In patients continuing in the first study (24 weeks), the frequency of moderate or greater flushing in patients treated with Pelzont declined and approached that of patients receiving placebo (see Figure 1), whereas in patients treated with nicotinic acid (prolonged-release formulation) the flushing frequency remained constant (after Week 6).
Danish: Hos patienter, der fortsatte i den første undersøgelse (24 uger), aftog hyppigheden af moderat eller mere udbredt flushing hos patienter, der blev behandlet med Pelzont, og nærmede sig reaktionen hos de patienter, der fik placebo (se figur 1).
English: Modified-release tablet.
Danish: Tablet med modificeret udløsning.
English: In rats, foetotoxic effects (significantly decreased foetal body weights associated with a decrease in the number of ossified sacrocaudal vertebrae and an increased incidence of foetuses with sites of incomplete ossification) were noted in the absence of any signs of maternal toxicity at exposure levels approximately 959 times the human AUC of nicotinic acid at the recommended daily human dose.
Danish: Hos rotter sås føtotoksiske virkninger (signifikant nedsat fostervægt associeret med nedsat forbening af korsben og halehvirvler og en øget forekomst af fostre med stedvis ufuldstændig forbening af knogler) uden at der var tegn på maternel toksicitet ved eksponeringer, der var ca. 959 gange human AUC for nicotinsyre ved anbefalet daglig dosis til mennesker.
English: Studies in animals have shown foetal developmental toxicity at high doses of nicotinic acid (see section 5.3).
Danish: Dyreforsøg har påvist føtal udviklingstoksicitet ved høje doser af nicotinsyre (se pkt.
English: Following a 40 mg dose of laropiprant administered orally as two modified-release tablets of nicotinic acid/laropiprant with food, laropiprant is rapidly absorbed with a median Tmax of 1 hour, a mean AUC0-∞ of approximately 13 μM·hr, and a mean Cmax of approximately 1.6 μM.
Danish: Efter en 40 mg laropiprantdosis, der blev administreret peroralt som to tabletter med modificeret udløsning af nicotinsyre/laropiprant sammen med mad, absorberedes laropiprant hurtigt med en median Tmax på 1 time, gennemsnitlig AUC0-∞ på ca. 13 µM∙t og en gennemsnitlig Cmax på ca. 1,6 µM.
English: • you have arterial bleeding.
Danish: • De har pulsåreblødning.
English: Rare (may affect up to 1 in 1000 people)
Danish: Sjælden (kan berøre op til 1 ud af 1.000 personer)
English: Nicotinic acid: see section 4.4.
Danish: Nicotinsyre: Se pkt.
English: Common: erythema; pruritus; rash; urticaria Uncommon: dry skin; macular rash Rare: acanthosis nigricans; hyperpigmentation; sweating (night or cold sweat)
Danish: Almindelig: erytem, pruritus, udslæt, urticaria Ikke almindelig: tør hud, makuløst udslæt Sjælden: acanthosis nigricans, hyperpigmentering, svedtendens
English: The apparent terminal half-life (t1/2) following a 40 mg dose of laropiprant administered as two modified-release tablets of nicotinic acid/laropiprant with food was approximately 17 hours.
Danish: Den tilsyneladende terminale halveringstid (t½) efter en dosis på 40 mg laropiprant, som blev administreret som to tabletter med modificeret udløsning af nicotinsyre/laropiprant sammen med mad, var ca. 17 timer.
English: Laropiprant was not teratogenic in rats or in rabbits at systemic exposure levels at least 153 and 438 times the human exposure based on the AUC of the recommended daily human dose.
Danish: Laropiprant var ikke teratogent hos rotter eller kaniner ved systemiske eksponeringsniveauer, der var mindst 153 og 438 gange eksponeringen hos mennesker på basis af AUC for den anbefalede daglige dosis til mennesker.
English: Nicotinic acid Nicotinic acid is excreted in human breast milk.
Danish: Nicotinsyre Nicotinsyre udskilles i modermælk.
English: If Pelzont is missed for 7 or more consecutive days, therapy should be resumed at the 1,000 mg/20 mg dose for 1 week, before advancing to the maintenance dose of 2,000 mg/40 mg.
Danish: Hvis patienten har undladt at tage Pelzont i 7 eller flere på hinanden følgende dage, kan behandlingen genoptages med 1.000 mg/20 mg i en uge, før dosis øges til vedligeholdelsesdosis på 2.000 mg/40 mg.
English: • muscle pain or tenderness
Danish: • Muskelsmerter eller -ømhed
English: Figure 2 Percentage of Patients with Moderate or Greater Flushing Symptoms Across Weeks 1-32
Danish: mere udbredte flushing-symptomer hen over ugerne 1-32
English: Effects of other medicinal products on nicotinic acid Bile acid sequestrants: Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Pelzont be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant.
Danish: Galdesyrebindende lægemidler: Da samtidig administration af galdesyrebindende lægemidler kan reducere biotilgængeligheden af sure lægemidler, såsom nicotinsyre, anbefales det, at Pelzont administreres > 1 time før eller > 4 timer efter administration af et galdesyrebindende lægemiddel.
English: To reduce the possibility of flushing, drinking alcohol or hot drinks or eating spicy foods should be avoided at the time of ingestion of the medicinal product.
Danish: For at reducere risikoen for flushing bør det undgås at drikke alkohol eller varme drikke og at spise krydret mad samtidig med indtagelse af lægemidlet.
English: Other abnormal laboratory values reported were elevations in LDH, fasting glucose, uric acid, total bilirubin, and amylase, and reductions in phosphorus and platelet counts (see section 4.4).
Danish: Andre unormale, rapporterede laboratorieværdier var stigninger i LDH, fasteglucose, urinsyre, totalt bilirubin og amylase samt fald i fosfor og fald i antal blodplader (se pkt.
English: • You are breast-feeding or plan to breast-feed.
Danish: • De ammer eller planlægger at amme.
English: (ALT) or aspartate aminotransferase (AST) of ≥ 3 X ULN persist, reduction of dose or withdrawal of Pelzont is recommended.
Danish: Hvis en forhøjelse i alaninaminotransferase (ALAT) eller aspartataminotransferase (ASAT) af ≥ 3 x ULN (øvre normalgrænse) varer ved, bør Pelzont reduceres eller seponeres.
English: Therefore, patients switching from immediate-release nicotinic acid to Pelzont should be initiated at the 1,000 mg/20 mg dose.
Danish: Patienter, der skifter fra nicotinsyre med umiddelbar udløsning til Pelzont, bør derfor starte med 1.000 mg/20 mg.
English: Common: headache; paraesthesia Uncommon: dizziness Rare: migraine; syncope
Danish: Almindelig: hovedpine, paræstesi Ikke almindelig: svimmelhed Sjælden: migræne, synkope
English: • weakness
Danish: • Svaghed
English: • patches of darkened skin
Danish: • Mørke hudpletter
English: There are no data from the combined use of nicotinic acid and laropiprant in pregnant women.
Danish: Der er ingen data fra samtidig anvendelse af nicotinsyre og laropiprant til gravide kvinder.
English: Race has no clinically meaningful effect on the pharmacokinetics of nicotinic acid (prolonged-release formulation) based on pharmacokinetic data including subjects of Hispanic, White, Black, and Native American racial groups.
Danish: Race har ingen klinisk relevant effekt på nicotinsyres (depotformulering) farmakokinetik på basis af farmakokinetiske data, herunder latinamerikanere, hvide, negroide og indianere.
English: Increases in serum alanine aminotransferase (ALT) levels were observed in all dog studies, at systemic exposure levels at least 14 times the human exposure based on the AUC of the recommended daily human dose.
Danish: Stigninger i serumalaninaminotransferase (ALAT) sås i alle hundeundersøgelserne ved systemisk eksponering, der var mindst 14 gange eksponeringen hos mennesker på basis af AUC for den anbefalede daglige dosis til mennesker.
English: Retinopathy and/or corneal lesions were observed in dogs following 6 months of dosing at systemic exposure values at least 240 times the human exposure based on the AUC of the recommended daily human dose.
Danish: Retinopati og/eller cornealæsioner sås hos hunde efter 6 måneders dosering ved systemiske eksponeringsværdier på mindst 240 gange eksponeringen hos mennesker på basis af AUC for den anbefalede daglige dosis til mennesker.
English: How Pelzont Works
Danish: Sådan virker Pelzont
English: Pelzont contains lactose
Danish: Pelzont indeholder lactose
English: Pelzont (2000 mg/40 mg) co-administered with simvastatin when compared with simvastatin alone or Pelzont (2000 mg/40 mg) alone for 12 weeks, significantly lowered LDL-C (-47.9 %, -37.0 %, -17.0 % respectively), TG (-33.3 %, -14.7 %, -21.6 % respectively), apo B (-41.0 %, -28.8 %, -17.1 % respectively), and TC (-29.6 %, -24.9 %, -9.1 % respectively), as well as LDL-C:HDL-C (-57.1 %, -39.8 %, -31.2 % respectively), non-HDL-C (-45.8 %, -33.4 %, -18.1 % respectively), and TC:HDL-C (-43.0 %, -28.0 %, -24.9 % respectively), and significantly increased HDL-C (27.5 %, 6.0 %, 23.4 % respectively).
Danish: Sammenlignet med simvastatin alene eller Pelzont (2.000 mg/40 mg) alene i 12 uger sænkede Pelzont (2.000 mg/40 mg) sammen med simvastatin LDLC (henholdsvis -47,9 %, -37,0 %, -17,0 %), TG (henholdsvis -33,3 %, -14,7 %, -21,6 %), apo B (henholdsvis -41,0 %, -28,8 %, -17,1 %) og TC (henholdsvis -29,6 %, -24,9 %, 9,1 %) samt LDLC:HDL-C (henholdsvis -57,1 %, -39,8 %, -31,2 %), non-HDL-C (henholdsvis -45,8 %, -33,4 %, -18,1 %) og TC:HDL-C (henholdsvis -43,0 %, -28,0 %, -24,9 %) signifikant og øgede HDL-C signifikant (henholdsvis 27,5 %, 6,0 %, 23,4 %).
English: Nicotinic acid medicinal products have been associated with increases of fasting blood glucose levels (see section 4.8).
Danish: Nicotinsyrepræparater er blevet forbundet med øget koncentration af fasteblodsukkeret (se pkt.
English: Effect on glucose
Danish: Glucosepåvirkning
English: EU/1/08/460/009 14 modified-release tablets EU/1/08/460/010 28 modified-release tablets EU/1/08/460/011 56 modified-release tablets EU/1/08/460/013 168 modified-release tablets EU/1/08/460/014 32 x 1 modified-release tablets
Danish: EU/1/08/460/009 14 tabletter med modificeret udløsning EU/1/08/460/010 28 tabletter med modificeret udløsning EU/1/08/460/011 56 tabletter med modificeret udløsning EU/1/08/460/013 168 tabletter med modificeret udløsning EU/1/08/460/014 32 x 1 tabletter med modificeret udløsning
English: How to take Pelzont
Danish: Sådan skal De tage Pelzont