FrancophonIA/ELRC3.0 huggingface dataset:
English: Nicotinic acid lowers the levels of low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), very low density lipoprotein cholesterol (VLDL-C), apolipoprotein B (apo B, the major LDL protein), triglycerides (TG), and lipoprotein(a) (Lp(a), a modified LDL particle) and elevates the levels of high-density lipoprotein cholesterol (HDL-C) and apolipoprotein A-I (apo A-I, the major protein component of HDL).
Danish: Nicotinsyre sænker koncentrationen af low-density lipoprotein kolesterol (LDL-C), totalt kolesterol (TC), very low density lipoprotein kolesterol (VLDL-C), apolipoprotein-B (apo-B, det væsentlige LDL-protein) triglycerider (TG) og lipoprotein(a) (Lp(a), en modificeret LDL-partikel) og øger koncentrationen af high-density lipoprotein kolesterol (HDL-C) og apolipoprotein-A-I (apo-A-I, den væsentlige proteinkomponent i HDL).
English: Nicotinic acid: There is no pharmacokinetic data in the elderly (≥ 65 years).
Danish: Nicotinsyre: Farmakokinetiske data for ældre (≥ 65 år) er ikke tilgængelige.
English: Toxicologic findings in these co-administration studies were consistent with those seen with nicotinic acid and laropiprant administered individually.
Danish: Toksikologiske fund i disse undersøgelser af samtidig administration var i overensstemmelse med de fund, der blev gjort, når nicotinsyre og laropiprant blev administreret enkeltvis.
English: No studies in lactating animals have been conducted with Pelzont.
Danish: Der er ikke udført undersøgelser med Pelzont hos diegivende dyr.
English: Elevated plasma TG levels are frequently found in a triad with low HDL-C levels and small LDL particles, as well as in association with non-lipid metabolic risk factors for coronary heart disease (CHD).
Danish: Der er hyppigt fundet forhøjede TG-koncentrationer i plasma i en triade med lave HDL-C-koncentrationer og små LDLpartikler og også i forbindelse med non-lipide metaboliske risikofaktorer for koronar hjertesygdom.
English: Rare cases of myopathy/rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (≥ 1,000 mg/day) of nicotinic acid and HMG-CoA reductase inhibitors (statins) (see section 4.8).
Danish: Sjældne tilfælde af myopati/rhabdomyolyse er blevet forbundet med samtidig administration af lipidsænkende doser (≥ 1.000 mg/dag) af nicotinsyre og HMG-CoA-reduktasehæmmere (statiner) (se pkt.
English: In controlled clinical studies, the incidence of clinically important elevations in serum transaminases (ALT and/or AST ≥ 3 X ULN, consecutive) was 1.0 % for patients treated with Pelzont with or without a statin.
Danish: I kontrollerede kliniske undersøgelser var incidensen af klinisk relevante stigninger i serumtransaminaser (ALAT og/eller ASAT ≥ 3 x ULN (øvre normalgrænse) konsekutivt) 1,0 % for patienter, der blev behandlet med Pelzont med eller uden et statin.
English: LDL cholesterol, fatty substances called triglycerides and apo B (a part of LDL) in the blood;
Danish: kolesterol, fedtholdige stoffer (triglycerider) og apo-B (en del af LDL) i blodet.
English: The hepatocellular centrilobular hypertrophy was consistent with rodent specific enzyme induction.
Danish: Den hepatocellulære centrilobulære hypertrofi var i overensstemmelse med den specifikke enzyminduktion hos gnavere.
English: It does this by lowering the levels of total cholesterol,
Danish: Dette sker ved at sænke den totale mængde af kolesterol, LDL
English: Fertility Animal studies are insufficient with respect to impairment on fertility (see section 5.3).
Danish: Fertilitet Data fra dyreforsøg er utilstrækkelige med hensyn til indvirkning på fertiliteten (se pkt.
English: HMG-CoA reductase inhibitors: When simvastatin is combined with nicotinic acid, a modest increase in AUC and Cmax of simvastatin acid (the active form of simvastatin) was observed, which may be devoid of clinical relevance.
Danish: HMG-CoA reduktasehæmmere: Når simvastatin kombineredes med nicotinsyre, sås en beskeden stigning i simvastatinsyres (den aktive form af simvastatin) AUC og Cmax, som kan være uden klinisk relevans.
English: Nicotinic acid
Danish: Nicotinsyre
English: There is no difference in the oral bioavailability of nicotinic acid in men and women receiving Pelzont.
Danish: Der er ingen forskel i nicotinsyres perorale biotilgængelighed hos mænd og kvinder, der får Pelzont.
English: Common: elevations in ALT and/or AST (consecutive, ≥ 3 X ULN), fasting glucose (see below) Uncommon: elevations in CK (≥ 10 X ULN), LDH, uric acid (see
Danish: Almindelig: stigninger i ALAT og/eller ASAT (konsekutivt, ≥ 3 X ULN), fasteglucose (se nedenfor) Ikke almindelig: stigninger i kreatinkinase (≥ 10 X ULN), LDH,
English: Eye disorders: Cystoid macular oedema, toxic amblyopia.
Danish: Øjne: Cystisk makulært ødem, toksisk amblyopi.
English: • you have ever had liver disease, jaundice (a liver disorder causing yellowing of the skin and whites of the eyes), or hepatobiliary (liver and bile duct) disease.
Danish: • De tidligere har haft leversygdom, gulsot (leversygdom, der medfører gulfarvning af huden og det hvide i øjnene) eller sygdom i lever og galdegang (hepatobiliær sygdom).
English: Physicians should consider the nicotinic acid intake from vitamins and nutritional supplements when prescribing Pelzont.
Danish: Lægen bør overveje indtaget af nicotinsyre fra vitaminer og enæringstilskud, når Pelzont ordineres.
English: Nicotinic acid inhibits release of free fatty acids (FFA) from adipose tissue, which may contribute to the reduced plasma LDL-C, TC, VLDL-C, apo B, TG, and Lp(a), as well as elevated HDL-C, and apo A-I, all of which are associated with lower cardiovascular risk.
Danish: Nicotinsyre hæmmer frigørelsen af frie fedtsyrer (FFA) fra adipøst væv, som kan bidrage til reduceret plasma LDL-C, TC, VLDL-C, apo-B, TG og Lp(a) samt forhøjet HDL-C og apo-A-I, som alle er forbundet med lavere kardiovaskulær risiko.
English: Laropiprant suppresses PGD2 mediated flushing associated with administration of nicotinic acid.
Danish: Laropiprant hæmmer PGD2-medieret flushing, som er forbundet med administration af nicotinsyre.
English: It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated.
Danish: Pelzont kan anvendes som monoterapi hos patienter, hvor HMG-CoA-reduktasehæmmere anses for at være uhensigtsmæssige eller ikke tåles.
English: Pelzont contains a sugar called lactose.
Danish: Pelzont indeholder et sukkerstof, der kaldes lactose.
English: Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly to keep track of your cholesterol and discuss your goals with your doctor.
Danish: Gå til lægen regelmæssigt for at følge Deres kolesteroltal, og tal med lægen om målet for Dem.
English: Also tell your doctor if you are taking simvastatin (a statin) or a medicine containing simvastatin and are Chinese.
Danish: Fortæl det også til lægen, hvis De er kineser og tager simvastatin (et statin) eller medicin, der indeholder simvastatin.
English: Hypromellose (E464) Colloidal anhydrous silica (E551) Sodium stearyl fumarate Hydroxypropylcellulose (E463) Microcrystalline cellulose (E460) Croscarmellose sodium Lactose monohydrate Magnesium stearate
Danish: Hypromellose (E464) Silica, kolloid vandfri (E551) Natriumstearylfumarat Hydroxypropylcellulose (E463) Mikrokrystallinsk cellulose (E460) Croscarmellosenatrium Lactosemonohydrat Magnesiumstearat
English: Patients with combined mixed dyslipidaemia have high blood levels of ‘bad' LDL cholesterol and triglycerides (a type of fat), and low levels of ‘good' HDL cholesterol.
Danish: Patienter med kombineret dyslipidæmi har et højt indhold af det "dårlige" LDL-kolesterol og triglycerider (en slags fedt) i blodet og et lavt indhold af det "gode" HDL-kolesterol.
English: Uncommon: hypersensitivity reaction (see below) Rare: angio-oedema; type I hypersensitivity Not known: anaphylactic shock
Danish: Ikke almindelig: overfølsomhedsreaktion (se nedenfor) Sjælden: angioødem, type 1-overfølsomhed Ikke kendt: anafylaktisk shock
English: Caution should be used when Pelzont is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Danish: Forsigtighed bør udvises, når Pelzont administreres sammen med lægemidler, der overvejende metaboliseres af UGT2B4 eller UGT2B7, f.eks. zidovudin.
English: Additional adverse reactions reported with other nicotinic acid medical products Additional adverse reactions that have been reported with other nicotinic acid medicinal products (with or without a statin) in post-marketing use or in clinical trials include the following:
Danish: Øvrige bivirkninger, der er rapporteret sammen med andre nicotinsyrepræparater Yderligere bivirkninger, som er blevet rapporteret sammen med andre nicotinsyrepræparater (med eller uden statin) ved brug efter markedsføring eller i kliniske studier, omfatter følgende:
English: Laropiprant: Administration of laropiprant 40 mg in non-dialysed patients with severe renal insufficiency resulted in no clinically meaningful change in the AUC and Cmax of laropiprant, compared to healthy control subjects.
Danish: Laropiprant: Administration af laropiprant 40 mg til ikke-dialyserede patienter med svær nyreinsufficiens resulterede ikke i klinisk relevant forandring i laropiprants AUC og Cmax, når man sammenlignede med raske kontrolpersoner.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Pelzont in paediatric patients from 7-18 years old in heterozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Pelzont hos pædiatriske patienter i alderen 7-18 år med heterozygot familiær hyperkolesterolæmi (se pkt.
English: Very few medicinal products are known to be metabolised predominantly by UGT2B4 or UGT2B7.
Danish: Meget få lægemidler metaboliseres overvejende af UGT2B4 eller UGT2B7.
English: Further analysis showed Pelzont (2000 mg/40 mg) co-administered with simvastatin when compared with simvastatin alone significantly increased apo A-I (8.6 %, 2.3 % respectively) and significantly decreased Lp(a) (-19.8 %, 0.0 % respectively ).
Danish: Yderligere analyse viste, at Pelzont (2.000 mg/40 mg) administreret sammen med simvastatin i sammenligning med simvastatin alene øgede apo-A-I signifikant (henholdsvis 8,6 %, 2,3 %) og reducerede Lp(a) signifikant (henholdsvis -19,8 %, 0,0 %).
English: Age has no clinically meaningful effect on pharmacokinetics of nicotinic acid (prolonged-release formulation) based on a composite analysis of subjects ages 18-65 years.
Danish: Alder har ingen klinisk relevant effekt på nicotinsyres (depotformulering) farmakokinetik på basis af en sammensat analyse af personer i alderen 18-65 år.
English: However, cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have switched from immediate-release nicotinic acid to long-acting nicotinic acid at equivalent doses.
Danish: Der er dog set tilfælde af svær levertoksicitet, herunder fulminant levernekrose, hos patienter, som har skiftet fra nicotinsyre med umiddelbar udløsning til langtidsvirkende nicotinsyre-præparater i tilsvarende doser.
English: CYP3A4 Inhibitor: Clarithromycin (a potent inhibitor of CYP3A4 and P-gp) did not have a clinically meaningful effect on the pharmacokinetics of laropiprant.
Danish: CYP3A4-hæmmer: Clarithromycin (der er en potent hæmmer af CYP3A4 og P-gp) havde ingen klinisk relevant indvirkning på laropiprants farmakokinetik.
English: The oral bioavailability of nicotinic acid is not altered when it is taken with a high-fat meal.
Danish: Nicotinsyrens orale biotilgængelighed ændres ikke, når det tages sammen med et måltid med højt fedtindhold.
English: Laboratory abnormalities included increased amylase and lipase, decreased haematocrit and occult blood in the stool.
Danish: Unormale laboratorieværdier inkluderede forhøjet amylase og lipase, nedsat hæmatokrit og okkult blod i afføringen.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om Pelzont findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Because the risk of myopathy with statins is dose-related, the use of Pelzont with simvastatin 80 mg or ezetimibe/simvastatin 10/80 mg is not recommended in Chinese patients.
Danish: Da risikoen for myopati er dosisrelateret, bør Pelzont ikke gives sammen med simvastatin 80 mg eller ezetimibe/simvastatin 10 mg/80 mg til kinesiske patienter.
English: • dry skin
Danish: • Tør hud
English: LDL cholesterol is often called ‘bad' cholesterol because it can build up in the walls of your arteries and form plaque.
Danish: LDL-kolesterol kaldes ofte det "dårlige" kolesterol, fordi det kan ophobe sig i blodårerne og danne plak.
English: Pelzont is used in addition to diet
Danish: Pelzont bruges som tillæg til diæt for at:
English: It is not known if Pelzont will pass into your breast milk.
Danish: Det er ukendt, om Pelzont går over i modermælken.
English: Like other nicotinic acid medicinal products, Pelzont is contraindicated in patients with significant or unexplained hepatic dysfunction.
Danish: Som andre nicotinsyrepræparater er Pelzont kontraindiceret til patienter med signifikant eller uforklarlig leverinsufficiens.
English: • tingling or numbness of the hands or feet
Danish: • Prikkende fornemmelse eller følelsesløshed i hænder eller fødder
English: It is unknown whether laropiprant is excreted in human breast milk.
Danish: Det er ukendt, om laropiprant udskilles i modermælk.
English: Clopidogrel: In a clinical study, there was no meaningful effect of laropiprant on the inhibition of ADP-induced platelet aggregation by clopidogrel, but there was a modest increase in the inhibition of collagen-induced platelet aggregation by clopidogrel.
Danish: Clopidogrel: I en klinisk undersøgelse sås ingen relevant indvirkning af laropiprant på clopidogrels hæmning af ADP-induceret blodpladeaggregation, men der var en beskeden stigning i clopidogrels hæmning af kollagen-induceret blodpladeaggregation.
English: This is characterised by multiple symptoms that may include: angio-oedema, pruritus, erythema, paraesthesia, loss of consciousness, vomiting, urticaria, flushing, dyspnoea, nausea, incontinence of urine and stool, cold sweats, shivering, chills, increased blood pressure, lip swelling, burning sensation, drug eruption, arthralgia, leg swelling, and tachycardia.
Danish: Denne er karakteriseret ved multiple symptomer, som kan inkludere: Angioødem, pruritus, erythema, paræstesi, bevidsthedstab, opkastning, urticaria, flushing, dyspnø, kvalme, urin- og afføringsinkontinens, koldsved, rysten, kuldegysninger, forhøjet blodtryk, hævede læber, brændende fornemmelse, medicinudslæt, artralgi, hævede ben og takykardi.
English: In healthy subjects receiving Pelzont, pretreatment with acetylsalicylic acid 325 mg had no additional beneficial effects in reducing nicotinic acid-induced flushing symptoms compared to Pelzont alone (see section 4.8).
Danish: Hos raske forsøgspersoner, der fik Pelzont, havde forudgående behandling med acetylsalicylsyre 325 mg ingen yderligere gavnlig effekt på reduktionen af nicotinsyreinducerede flushing-symptomer sammenlignet med Pelzont alene (se pkt.
English: The most commonly reported adverse reactions from the subjects who received this higher dose were consistent with a high dose of nicotinic acid and included: flushing, headache, pruritus, nausea, dizziness, vomiting, diarrhoea, epigastric and abdominal pain/discomfort, and back pain.
Danish: De mest almindeligt rapporterede bivirkninger fra forsøgspersoner, der havde fået disse højere doser, svarede til en høj dosis af nicotinsyre og omfattede: Flushing, hovedpine, kløe, kvalme, svimmelhed, opkastning, diarré, epigastrisk og abdominal smerte/ubehag samt rygsmerter.
English: Hypophosphatemia
Danish: Hypofosfatæmi
English: Effect on skeletal muscle
Danish: Påvirkning af skeletmuskulaturen
English: Opaque PVC/Aclar blister with push-through aluminium lidding containing 14 modified-release tablets.
Danish: Uigennemsigtig PVC/Aclar blister med push-through aluminiumsfolie, der indeholder 14 tabletter med modificeret udløsning.
English: Patients receiving Pelzont, nicotinic acid (prolonged-released formulation), or placebo were also taking statins (29 % atorvastatin [5-80 mg], 54 % simvastatin [10-80 mg], 17 % other statins [2.5-180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)), of which 9 % were also taking ezetimibe [10 mg].
Danish: Patienter, der fik MK524A, nicotinsyre (depotformulering) eller placebo, tog også statiner (29 % atorvastatin [5-80 mg], 54 % simvastatin [10-80 mg], 17 % andre statiner [2,5-180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)), hvoraf 9 % også tog ezetimibe [10 mg].
English: • medicines used to lower cholesterol called ‘bile acid sequestrants', such as colestyramine.
Danish: • Medicin til at sænke kolesterol kaldet "galdesyrebindende lægemidler", f.eks. colestyramin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (for Alu/Alu blister)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (til Alu/Alublister)
English: Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3 % of the patients treated with Pelzont with or without a statin (see section 4.4).
Danish: Der sås klinisk relevante stigninger i kreatinkinase (≥ 10 x ULN) hos 0,3 % af de patienter, der blev behandlet med Pelzont med eller uden et statin (se pkt.
English: Symptoms included fainting, shortness of breath, wheezing or trouble breathing, swelling of the face, lips, tongue, itching or hives on the skin.
Danish: Symptomerne omfattede besvimelse, kortåndethed, hvæsende vejrtrækning eller besvær med at trække vejret, hævelse af ansigt, læber, tunge samt kløe eller udslæt på huden.
English: There is no change in the oral bioavailability of nicotinic acid with age.
Danish: Der er ingen ændring i nicotinsyres perorale biotilgængelighed med alderen.
English: However, the plasma concentration of a metabolite of midazolam, 1'-hydroxymidazolam, was increased approximately 2-fold with multiple doses of laropiprant.
Danish: Plasmakoncentrationen af en af midazolams metabolitter, l'-hydroxymidazolam, steg imidlertid ca. 2
English: Uncommon: palpitations Rare: atrial fibrillation and other cardiac arrhythmias; tachycardia
Danish: Ikke almindelig: palpitationer Sjælden: atrieflimren og andre hjertearytmier, takykardi
English: Pelzont should be used in patients in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate.
Danish: Pelzont bør anvendes sammen med HMG-CoA reduktasehæmmere (statiner), når den kolesterolsænkende effekt af monoterapi med HMG-CoA-reduktasehæmmere er utilstrækkelig.
English: • laropiprant, which reduces symptoms of flushing, a common side effect of nicotinic acid.
Danish: • laropiprant, som mindsker rødmen, der er en almindelig bivirkning ved nicotinsyre.
English: EU/1/08/460/001 EU/1/08/460/002 EU/1/08/460/003 EU/1/08/460/004 EU/1/08/460/005 EU/1/08/460/006 EU/1/08/460/007 EU/1/08/460/008 EU/1/08/460/009 EU/1/08/460/010
Danish: EU/1/08/460/001 EU/1/08/460/002 EU/1/08/460/003 EU/1/08/460/004 EU/1/08/460/005 EU/1/08/460/006 EU/1/08/460/007 EU/1/08/460/008 EU/1/08/460/009 EU/1/08/460/010 EU/1/08/460/011 EU/1/08/460/012 EU/1/08/460/013 EU/1/08/460/014
English: What Pelzont looks like and contents of the pack Each modified-release tablet is a capsule-shaped, white to off-white tablet, with “552” debossed on one side.
Danish: Hver tablet med modificeret udløsning er kapselformet, hvid til off-white, med "552" præget på den ene side.
English: As with other nicotinic acid medicinal products, Pelzont was associated with small decreases in phosphorus levels.
Danish: Som med andre nicotinsyrepræparater er Pelzont blevet forbundet med små fald i fosfor.
English: • See your doctor regularly to check your LDL (bad) and HDL (good) cholesterol levels and your triglyceride level.
Danish: • Gå regelmæssigt til lægen for at få kontrolleret Deres LDL (det "dårlige" kolesterol) og HDL
English: • The other ingredients are: hypromellose (E464), colloidal anhydrous silica (E551), sodium stearyl fumarate, hydroxypropylcellulose (E463), microcrystalline cellulose (E460), croscarmellose sodium, lactose monohydrate, and magnesium stearate.
Danish: • Øvrige indholdsstoffer: Hypromellose (E464), silica (kolloid vandfri) (E551), natriumstearylfumarat, hydroxypropylcellulose (E463), mikrokrystallinsk cellulose (E460), croscarmellosenatrium, lactosemonohydrat og magnesiumstearat.
English: This includes medicines obtained without a prescription, vitamins, and herbal supplements.
Danish: Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
English: In in vitro studies, laropiprant did not inhibit CYP1A2, CYP2B6, CYP2C19, CYP2D6, or CYP2E1-mediated reactions.
Danish: I in vitro-undersøgelser hæmmede laropiprant ikke CYP1A2, CYP2B6, CYP2C19, CYP2D6 eller CYP2E1-medierede reaktioner.
English: In in vitro studies, nicotinic acid and its metabolites did not inhibit CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4-mediated reactions or UGT1A1-mediated 3-glucuronidation of estradiol.
Danish: I in vitro-undersøgelser hæmmede nicotinsyre og dets metabolitter ikke CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 eller CYP3A4-medierede reaktioner eller estradiols UGT1A1medierede 3-glucuronidering.
English: • dizziness upon standing
Danish: • Svimmelhed, når man rejser sig op
English: - This medicine has been prescribed for you only.
Danish: • Lægen har ordineret dette lægemiddel til Dem personligt.
English: In the second pathway, glycine is conjugated with nicotinic acid to form nicotinuric acid (NUA).
Danish: Den anden metaboliseringsvej konjugerer glycin med nicotinsyre til dannelsen af nicotinurinsyre (NUA).
English: After four weeks, it is recommended that patients be advanced to the maintenance dose of 2,000 mg/40 mg taken as two modified-release tablets (1,000 mg/20 mg each) once daily.
Danish: Efter fire uger bør dosis øges til en vedligeholdelsesdosis på 2.000 mg/40 mg, der tages som to tabletter med modificeret udløsning (1.000 mg/20 mg hver) én gang dagligt.
English: Acetylsalicylic acid and clopidogrel: In a clinical study in dyslipidaemic patients receiving both acetylsalicylic acid (81 mg) and clopidogrel (75 mg), laropiprant induced transient (4 hours post-dose) inhibition of platelet function in vivo (as evaluated by bleeding time and platelet aggregation studies), but had little effect across the dosing interval.
Danish: Acetylsalicylsyre og clopidogrel: I en klinisk undersøgelse hos patienter med dyslipidæmi, der fik både acetylsalicylsyre (81 mg) og clopidogrel (75 mg), medførte laropirant forbigående (4 timer efter dosering) hæmning af trombocytfunktionen in vivo (vurderet på baggrund af blødningstid og trombocytaggregations-studier), men havde kun lille effekt i hele doseringsintervallet.
English: • flushing (which usually includes redness of the skin, feeling warm, itching, or tingling, particularly in the head, neck, chest and upper back).
Danish: • Rødmen (som normalt medfører rødme af huden, varmefølelse, kløe eller prikkende fornemmelse, især i hovedet, på halsen, brystet eller den øverste del af ryggen).
English: There are no data from the use of laropiprant in pregnant women.
Danish: Der foreligger ingen data for anvendelsen af laropiprant til gravide.
English: Other medicines and Pelzont
Danish: Brug af anden medicin sammen med Pelzont
English: Caution should be used when treating Chinese patients with Pelzont co-administered with simvastatin or ezetimibe/simvastatin (particularly simvastatin doses of 40 mg or higher).
Danish: Forsigtighed bør udvises ved behandling af kinesiske patienter med Pelzonti kombination med simvastatin eller ezetimibe/simvastatin (især ved simvastatin i doser på 40 mg eller derover).