FrancophonIA/ELRC3.0 huggingface dataset:
English: As with other nicotinic acid medicinal products, elevations in fasting glucose (a median increase of approximately 4 mg/dL), and uric acid (mean change from baseline of +14.7 %), and reductions in platelet counts (a mean change from baseline of -14.0 %) were reported in controlled clinical studies with Pelzont (2,000 mg/40 mg) (see section 4.4).
Danish: Som med andre nicotinsyrepræparater er der i kontrollerede kliniske undersøgelser med Pelzont (2.000 mg/40 mg) rapporteret om stigninger i fasteglucose (en gennemsnitlig stigning på ca. 4 mg/dl), urinsyre (gennemsnitlig ændring i forhold til baseline på +14,7 %) samt fald i antal blodplader (en gennemsnitlilg ændring i forhold til baseline på -14,0 %) (se pkt.
English: Hepatic insufficiency Pelzont: Use in patients with hepatic insufficiency has not been studied.
Danish: Leverinsufficiens Pelzont: Anvendelse til patienter med leverinsufficiens er ikke undersøgt.
English: The no-observed-adverse-effect level (NOAEL) was at least 118 times the human exposure based on the AUC of the recommended daily human dose.
Danish: Niveauet af doseringer, hvor der ikke observeredes skadelige virkninger (NOAEL), var mindst 118 gange eksponeringen hos mennesker på basis af AUC for den anbefalede daglige dosis til mennesker.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains 1,000 mg of nicotinic acid and 20 mg of laropiprant.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet med modificeret udløsning indeholder 1.000 mg nicotinsyre og 20 mg laropiprant.
English: Studies in animals have shown foetal developmental toxicity at high doses of laropiprant (see section 5.3).
Danish: Dyreforsøg har vist føtal udviklingstoksicitet ved høje doser laropiprant (se pkt.
English: EU/1/08/460/001 14 modified-release tablets EU/1/08/460/002 28 modified-release tablets EU/1/08/460/003 56 modified-release tablets EU/1/08/460/004 84 modified-release tablets EU/1/08/460/005 98 modified-release tablets EU/1/08/460/006 168 modified-release tablets EU/1/08/460/007 196 modified-release tablets EU/1/08/460/008 49 x 1 modified-release tablets EU/1/08/460/012 196 (2 packs of 98) modified-release tablets
Danish: EU/1/08/460/001 14 tabletter med modificeret udløsning EU/1/08/460/002 28 tabletter med modificeret udløsning EU/1/08/460/003 56 tabletter med modificeret udløsning EU/1/08/460/004 84 tabletter med modificeret udløsning EU/1/08/460/005 98 tabletter med modificeret udløsning EU/1/08/460/006 168 tabletter med modificeret udløsning EU/1/08/460/007 196 tabletter med modificeret udløsning EU/1/08/460/008 49 x 1 tabletter med modificeret udløsning EU/1/08/460/012 196 (2 pakninger à 98) tabletter med modificeret udløsning
English: Acetylsalicylic acid: In a clinical study, concomitant administration of laropiprant with acetylsalicylic acid did not have an effect on collagen-induced platelet aggregation or on bleeding time compared to treatment with acetylsalicylic acid alone (see section 5.1).
Danish: Acetylsalicylsyre: Sammenlignet med acetylsalicylsyre alene havde samtidig administration af laropiprant og acetylsalicylsyre ingen indvirkning på kollagen-induceret blodpladeaggregation eller på blødningstiden i en klinisk undersøgelse (se pkt.
English: 14 modified-release tablets 28 modified-release tablets 56 modified-release tablets 168 modified-release tablets 32 x 1 modified-release tablets
Danish: 14 tabletter med modificeret udløsning 28 tabletter med modificeret udløsning 56 tabletter med modificeret udløsning 168 tabletter med modificeret udløsning 32 x 1 tabletter med modificeret udløsning
English: Rare: elevations in total bilirubin, amylase; reductions in phosphorus and platelet counts (see below)
Danish: Sjælden: stigninger i total-bilirubin, amylase, fald i phosphor og
English: Age had no clinically meaningful effect on the pharmacokinetics of laropiprant.
Danish: Alder har ingen klinisk relevant effekt på laropiprants farmakokinetik.
English: • To lower your chance of flushing, avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Pelzont.
Danish: • For at mindske risikoen for rødmen bør De undgå at drikke alkohol eller varme drikke og at spise krydret mad tæt på det tidspunkt, hvor De tager Pelzont.
English: • eye disorders called toxic amblyopia and cystoid macular oedema which may lead to blurred,
Danish: • Toksisk amblyopi og cystisk makulært ødem, der er øjensygdomme, som kan medføre sløret eller nedsat syn eller synstab
English: In an interim analysis of an ongoing clinical outcome study, an independent safety monitoring committee identified a higher than expected incidence of myopathy in Chinese patients taking Pelzont and simvastatin 40 mg.
Danish: I en interimanalyse af en igangværende outcome-undersøgelse identificerede en uafhængig sikkerhedsmonitoreringskomité en højere incidens af myopati end hos hos kinesiske patienter, der tog Pelzont og simvastatin 40 mg. Der bør derfor udvises forsigtighed, når kinesiske patienter behandles med Pelzont sammen med simvastatin eller ezetimibe/simvastatin (især ved simvastatindoser på 40 mg eller derover).
English: 196 modified-release tablets
Danish: 196 tabletter med modificeret udløsning
English: Use of Pelzont in patients with hepatic or renal insufficiency has not been studied.
Danish: Anvendelse af Pelzont er ikke undersøgt hos patienter med lever- eller nyreinsufficiens.
English: flushing, headache, pruritus (itching), nausea, dizziness, vomiting, diarrhoea, abdominal pain/discomfort, and back pain.
Danish: Rødmen, hovedpine, kløe, kvalme, svimmelhed, opkastning, diarré, mavesmerter/mavegener samt smerter i ryggen.
English: Gender had no clinically meaningful effect on the pharmacokinetics of laropiprant.
Danish: Køn har ingen klinisk relevant effekt på laropiprants farmakokinetik.
English: Those patients switching from 2,000 mg or more of prolonged-release nicotinic acid can initiate Pelzont at the 2,000 mg/40 mg dose.
Danish: Patienter, som skifter fra 2.000 mg eller mere af et nicotinsyredepotpræparat, kan starte behandling med Pelzont med en dosis på 2.000 mg/40 mg.
English: When driving vehicles or operating machines, it should be taken into account that dizziness has been reported (see section 4.8).
Danish: Svimmelhed er blevet rapporteret, hvilket der bør tages hensyn til, når man skal føre motorkøretøj eller betjene maskiner (se pkt.
English: • nicotinic acid, a lipid modifying medicine, and
Danish: • nicotinsyre, medicin som ændrer indholdet af fedtstoffer i blodet og
English: • you have an ulcer in your stomach.
Danish: • De har mavesår.
English: As no effect was observed in severe renal insufficiency, no effect is expected in patients with mild and moderate renal insufficiency; however, the effects of end-stage renal failure and dialysis on laropiprant pharmacokinetics cannot be inferred from this study.
Danish: Da der ikke sås effekt ved svær nyreinsufficiens, forventedes ingen effekt hos patienter med mild eller moderat nyreinsufficiens.
English: 168 modified-release tablets
Danish: 168 tabletter med modificeret udløsning
English: Each modified-release tablet contains 128.4 mg of lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet med modificeret udløsning indeholder 128,4 mg lactosemonohydrat.
English: Aluminium/Aluminium blister with push-through lidding in pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in perforated unit dose blister.
Danish: Aluminium/aluminium blister med push-through folie i pakningsstørrelser à 14, 28, 56, 168 tabletter med modificeret udløsning og 32 x 1 tabletter med modificeret udløsning.
English: Nicotinic acid was not teratogenic in rats and rabbits up to exposure levels approximately 253 and 104 times the human AUC of nicotinic acid at the recommended daily human dose, respectively.
Danish: Nicotinsyre var ikke teratogent hos rotter og kaniner ved eksponeringer, der var op til ca. henholdsvis 253 og 104 gange human AUC for nicotinsyre ved anbefalet daglig dosis til mennesker.
English: As with other nicotinic acid medicinal products, Pelzont (2,000 mg/40 mg) was associated with small increases in uric acid levels (see section 4.8).
Danish: Som med andre nicotinsyrepræparater er Pelzont (2.000 mg/40 mg) blevet forbundet med små stigninger i urinsyrekoncentrationen (se pkt.
English: Opaque PVC/Aclar blister with push-through aluminium lidding in pack sizes of 14, 28, 56, 84, 98, 168, 196 modified-release tablets, multi-packs containing 196 (2 packs of 98) modified-release tablets and 49 x 1 modified-release tablets in perforated unit dose blister.
Danish: Uigennemsigtig PVC/Aclar blister med push-through aluminiumfolie i pakningsstørrelser à 14, 28, 56, 84, 98, 168, 196 tabletter med modificeret udløsning, multipakninger med 196 (2 pakninger à 98) tabletter med modificeret udløsning og 49 x 1 tabletter med modificeret udløsning i perforeret enkeltdosisblister.
English: Degeneration in the stomach and hepatocyte vacuolation were observed in rats following 6 months of dosing at systemic exposure values at least 179 times the human exposure based on the AUC of the recommended daily human dose.
Danish: Der blev observeret nedbrydning i maven og levercellevakuolisering hos rotter efter 6 måneders dosering ved systemiske eksponeringsværdier på mindst 179 gange eksponeringen hos mennesker på basis af AUC for den anbefalede daglige dosis til mennesker.
English: • upset stomach or heartburn
Danish: • Maveproblemer eller halsbrand
English: Pack sizes of 14, 28, 56, 84, 98, 168, 196 modified-release tablets, multi-packs containing 196 (2 packs of 98) modified-release tablets and 49 x 1 modified-release tablets in a perforated unit dose blister.
Danish: Pakningsstørrelser à 14, 28, 56, 84, 98, 168, 196 tabletter med modificeret udløsning, multipakninger med 196 (2 pakninger à 98) tabletter med modificeret udløsning og 49 x 1 tabletter med modificeret udløsning i perforeret enkeltdosisblister.
English: Gender has no clinically meaningful effect on pharmacokinetics of nicotinic acid (prolonged-release formulation).
Danish: Køn har ingen klinisk relevant effekt på nicotinsyres (depotformulering) farmakokinetik.
English: Pelzont 1,000 mg/20 mg modified-release tablets nicotinic acid/laropiprant
Danish: Pelzont 1.000 mg/20 mg tabletter med modificeret udløsning Nicotinsyre/laropiprant
English: As with other nicotinic acid medicinal products, Pelzont (2,000 mg/40 mg) was associated with small reductions in platelet count (see section 4.8).
Danish: Som med andre nicotinsyrepræparater er Pelzont (2.000 mg/40 mg) blevet forbundet med små reduktioner i antallet af blodplader (se pkt.
English: In a multicentre, double-blind, 12-week factorial study, Pelzont 1,000 mg/20 mg co-administered with simvastatin, when compared with simvastatin alone or Pelzont 1,000 mg/20 mg alone, for 4 weeks, significantly lowered LDL-C (-44.2 %, -37.4 %, -8.2 % respectively), TG (-25.8 %, -15.7 %, -18.7 % respectively), TC (-27.9 %, -25.8 %, -4.9 % respectively) and significantly increased HDL-C (19.2 %, 4.2 %, 12.5 % respectively).
Danish: I en multicenter, dobbeltblindet 12-ugers faktoriel undersøgelse reducerede Pelzont 1.000 mg/20 mg og simvastatin signifikant LDL-C (henholdsvis -44,2 %, -37,4 % og -8,2 %), TG (henholdsvis -25,8 %, -15,7 % og -18,7 %), TC (henholdsvis -27,9 %, -25,8 % og -4,9 %), når det blev sammenlignet med simvastatin alene eller Pelzont 1.000 mg/20 alene i 4 uger.
English: Pelzont contains lactose.
Danish: Pelzont indeholder lactose.
English: Triglycerides are another fat in your blood.
Danish: Triglycerider er et andet fedtstof i blodet, der kan øge risikoen for hjerteproblemer.
English: • you have kidney problems.
Danish: • De har nyreproblemer.
English: • you currently have liver problems.
Danish: • De har leverproblemer.
English: Laropiprant: No dose adjustment is necessary based on race.
Danish: Laropiprant: Dosisjustering er ikke nødvendig på basis af race.
English: Laropiprant: No dose adjustment is necessary based on gender.
Danish: Laropiprant: Dosisjustering er ikke nødvendig på basis af køn.
English: No nicotinic acid-related adverse effects on fertility were observed in male and female rats up to exposure levels approximately 391 times the human AUC of nicotinic acid based on the AUC of the recommended daily human dose.
Danish: Der er ikke set nicotinsyrerelaterede bivirkninger hos han- og hunrotter ved eksponeringer, der var op til ca. 391 gange human AUC for nicotinsyre baseret på AUC ved den anbefalede daglige dosis til mennesker.
English: • rapid heart rate.
Danish: • Hurtig hjerterytme
English: No adverse effects on fertility were observed in male or female rats given laropiprant prior to mating and throughout mating, at systemic exposure levels at least 289 times the human exposure based on the AUC of the recommended daily human dose.
Danish: Der blev ikke observeret skadelige virkninger på fertiliteten hos han- eller hunrotter, der fik laropiprant før og under parring, ved systemiske eksponeringsniveauer, der var mindst 289 gange eksponeringen hos mennesker på basis af AUC for den anbefalede daglige dosis til mennesker.
English: • migraine
Danish: • Migræne
English: For patients switching from immediate-release nicotinic acid to Pelzont, therapy should be initiated at the 1,000 mg/20 mg dose and advanced to the 2,000 mg/40 mg maintenance dose after four weeks.
Danish: Patienter, der skifter fra nicotinsyre med umiddelbar udløsning til Pelzont, bør starte behandling med 1.000 mg/20 mg og overgå til en vedligeholdelsesdosis på 2.000 mg/40 mg efter fire uger.
English: Pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in a perforated unit dose blister.
Danish: Pakningsstørrelser à 14, 28, 56, 168 tabletter med modificeret udløsning og 32 x 1 tabletter med modificeret udløsning i perforeret enkeltdosisblister.
English: Uncommon: gout Rare: impaired glucose tolerance
Danish: Ikke almindelig: arthritis urica Sjælden: nedsat glucosetolerance
English: NAME OF THE MEDICINAL PRODUCT Pelzont 1,000 mg/20 mg modified-release tablets.
Danish: LÆGEMIDLETS NAVN Pelzont 1.000 mg/20 mg tabletter med modificeret udløsning.
English: Merck Sharp & Dohme Cyprus Limited Τηλ: 80000 673 (+357 22866700) cyprus_info@merck.com
Danish: Τηλ: 80000 673 (+357 22866700) cyprus_info@merck.com
English: 56 modified-release tablets
Danish: 56 tabletter med modificeret udløsning
English: Patients switching from less than 2,000 mg of prolonged-release nicotinic acid should initiate therapy at the starting dose of 1,000 mg/20 mg and advance to the 2,000 mg/40 mg maintenance dose after four weeks.
Danish: Patienter, der skifter fra < 2.000 mg af et nicotinsyredepotpræparat, bør starte behandling med en startdosis på 1.000 mg/20 mg og gå over til en vedligeholdelsesdosis på 2.000 mg/40 mg efter fire uger.
English: Nicotinic acid: No dose adjustment is necessary based on gender.
Danish: Nicotinsyre: Dosisjustering er ikke nødvendig på basis af køn.
English: Nicotinic acid: No dose adjustment is necessary based on race.
Danish: Nicotinsyre: Dosisjustering er ikke nødvendig på basis af race.
English: In a multicentre, double-blind, 24-week placebo-controlled study, patients taking Pelzont (2,000 mg/40 mg) with or without a statin, when compared to placebo, had significantly decreased LDL-C (-18.9 % vs. -0.5 %), TG (-21.7 % vs. 3.6 %), LDL-C:HDL-C (-28.9 % vs. 2.3 %), non-HDL-C (-19.0 % vs. 0.8 %), apo B (-16.4 % vs. 2.5 %), TC (-9.2 % vs. -0.6 %), Lp(a) (-17.6 % vs. 1.1 %), and TC:HDL-C (-21.2 % vs. 1.9 %) and also had significantly increased HDL-C (18.8 % vs. -1.2 %), and apo A-I (11.2 % vs. 4.3 %) as measured by percent change from baseline.
Danish: I en multicenter, dobbeltblindet, 24-ugers placebokontrolleret undersøgelse havde de patienter, der tager Pelzont (2.000 mg/40 mg) med eller uden statin, i sammenligning med placebo, signifikant nedsat LDL-C (-18,9 % versus -0,5 %), TG (-21,7 % versus 3,6 %), LDL-C:HDL-C (-28,9 % versus 2,3 %), non-HDL-C (-19,0 % versus 0,8 %) apo-B (-16,4 % versus 2,5 %), TC (-9,2 % versus
English: 14 modified-release tablets
Danish: 14 tabletter med modificeret udløsning
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each modified-release tablet contains 1,000 mg of nicotinic acid and 20 mg of laropiprant.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet med modificeret udløsning indeholder 1.000 mg nicotinsyre og 20 mg laropiprant.
English: • sleeplessness
Danish: • Svedtendens
English: • anxiety
Danish: • Stakåndethed
English: • swelling of the lips
Danish: • Hævede læber
English: 98 modified-release tablets
Danish: 98 tabletter med modificeret udløsning
English: 84 modified-release tablets
Danish: 84 tabletter med modificeret udløsning
English: Hepatic effects
Danish: Hæmatologisk påvirkning
English: What Pelzont contains
Danish: Pelzont indeholder:
English: Very common: flushing Uncommon: hypotension Rare: orthostatic hypotension
Danish: Ikke almindelig: hypotension
English: Common: abdominal pain; diarrhoea; dyspepsia; nausea; vomiting Rare: mouth oedema; eructation; peptic ulcer
Danish: Almindelig: abdominalsmerter, diarré, dyspepsi, kvalme, opkastning
English: • rash
Danish: • Kløe
English: Keep this medicine out of the sight and reach of children.
Danish: Opbevaring Opbevar dette lægemiddel utilgængeligt for børn.
English: Safety and effectiveness of Pelzont in paediatric patients under the age of 18 years have not been established.
Danish: Pelzont bør ikke anvendes til pædiatriske patienter under 18 år p.g.a. manglende dokumentation for sikkerhed og virkning.
English: Uncommon: chills; pain; peripheral oedema Rare: asthaenia; face oedema; generalised oedema
Danish: Ikke almindelig: kuldegysninger, smerter, perifere ødemer Sjælden: asteni, ansigtsødem, generaliseret ødem
English: Merck Sharp & Dohme Ltd.
Danish: Merck Sharp & Dohme Cyprus Limited.
English: • stomach ulcer
Danish: • Mavesmerter
English: PHARMACEUTICAL FORM AND CONTENTS 98 modified-release tablets.
Danish: 98 tabletter med modificeret udløsning.
English: • fainting
Danish: • Svimmelhed
English: Tel: +43 (0) 1 26 044 msd-medizin@merck.com
Danish: Merck Sharp & Dohme Ges.m.b.H Tel: +43 (0) 1 26 044 msd-medizin@merck.com
English: If you take more Pelzont than you should
Danish: Hvis De har taget for meget Pelzont
English: Posology
Danish: Hjælpestof
English: • headache
Danish: • Mavesår
English: • you have thyroid problems.
Danish: • De har problemer med skjoldbruskkirtlen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Actraphane on 7 October 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Actraphane den 7. oktober 2002.
English: The full EPAR for Actraphane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Actraphane findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Actraphane is given 30 minutes before a meal.
Danish: Actraphane indtages 30 minutter før et måltid.
English: This is a summary of the European public assessment report (EPAR) for Actraphane.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Actraphane.
English: A risk management plan has been developed to ensure that Actraphane is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Actraphane anvendes så sikkert som muligt.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Actraphane.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Actraphane.
English: For more information about treatment with Actraphane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Actraphane, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Other information about Actraphane
Danish: Andre oplysninger om Actraphane
English: What measures are being taken to ensure the safe and effective use of Actraphane?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Actraphane?
English: Actraphane was effective for both type 1 and type 2 diabetes.
Danish: Actraphane var effektiv ved såvel type 1- som type 2-diabetes.
English: The most common side effect with Actraphane (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Danish: Den hyppigste bivirkning ved Actraphane (som optræder hos flere end 1 ud af 10 patienter) er hypoglykæmi (lave blodsukkerniveauer).
English: By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Danish: Ved at holde blodsukkeret under kontrol mindskes diabetessymptomerne ogkomplikationerne.
English: The active substance in Actraphane, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin.
Danish: Det aktive stof i Actraphane, human insulin, produceres via en metode, der er kendt som "rekombinant teknologi": Insulinet fremstilles af gærceller, der har fået indsat et gen (DNA), som gør dem i stand til at producere insulin.
English: Actraphane has been studied in a total of 294 patients with type 1 diabetes, when the pancreas cannot produce insulin, and type 2 diabetes, when the body is unable to use insulin effectively.
Danish: Actraphane blev undersøgt i en undersøgelse med i alt 294 patienter, dels med type 1-diabetes, hvor bugspytkirtlen ikke kan producere insulin, dels med type 2-diabetes, hvor kroppen ikke er i stand til at udnytte insulin effektivt.
English: Actraphane contains insulin in two forms: a soluble form, which acts quickly (within 30 minutes of injection) and an isophane form, which is absorbed much more slowly during the day.
Danish: Actraphane indeholder insulin i to former: en opløselig form, som er hurtigvirkende (inden for 30 minutter efter injektion), og isofan form, som optages meget langsommere dagen igennem.
English: The CHMP decided that Actraphane's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Actraphane opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Actraphane.
English: Actraphane led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with other human insulin.
Danish: Actraphane medførte et fald i HbA1c-niveauet, hvilket tyder på, at blodsukkeret var blevet holdt under kontrol på et niveau svarende til det, der var observeret for andre typer human insulin.
English: What is the risk associated with Actraphane?
Danish: Hvilken risiko er der forbundet med Actraphane?
English: It is available as vials, cartridges (Penfill) or prefilled pens (InnoLet or FlexPen).
Danish: Det fås som hætteglas, cylinderampuller (Penfill) eller fyldte penne (InnoLet eller FlexPen).
English: Actraphane is used to treat diabetes.
Danish: Actraphane anvendes til behandling af diabetes (sukkersyge).
English: Actraphane is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Danish: Actraphane gives som injektion under huden i låret, bugvæggen (maveskindet), sædemuskelregionen (ballerne) eller deltamuskelregionen (skulderen).
English: The study compared Actraphane 30 to a similar mix, but made up using an insulin analogue (insulin aspart).
Danish: I undersøgelsen blev Actraphane 30 sammenlignet med en tilsvarende blanding, som er fremstillet ved hjælp af en insulin-analog (insulin aspart).