FrancophonIA/ELRC3.0 huggingface dataset:
English: Rarely, anaphylactic reactions have been reported with pancreatic enzyme products with different formulations of the same active ingredient (pancreas powder).
Danish: Der er rapporteret sjældne tilfælde af anafylaktiske reaktioner med pancreasenzym-præparater i forskellige formuleringer af det samme aktive stof (pancreas-pulver).
English: Adverse reactions associated with pancreas powder obtained from clinical studies, post-marketing surveillance and some additional class effects are tabulated below.
Danish: De bivirkninger ved pancreas-pulver, der er observeret i kliniske studier og efter markedsføringen, samt nogle yderligere klasseeffekter, er opstillet i tabellen nedenfor.
English: Each patient's CFA-72h during placebo treatment was used as their no-treatment CFA-72h value.
Danish: Den enkelte patients CFA-72t-værdi fra placebobehandling blev anvendt som vedkommendes ikke-behandlingsværdi for CFA-72t.
English: For each snack, half of the prescribed Enzepi dose for a full meal should be given.
Danish: Ved hvert mellemmåltid skal patienten indtage halvdelen af den ordinerede Enzepi-dosis for et hovedmåltid.
English: All patients consumed a high-fat diet (greater than or equal to 100 grams of fat per day) during the treatment period.
Danish: Alle patienter fik en kost med højt fedtindhold (100 g fedt eller mere om dagen) i behandlingsperioden.
English: The most common adverse reactions reported with Enzepi were gastrointestinal complaints [abdominal pain (16%); flatulence (12%); abdominal distention (7%); diarrhoea and vomiting (6%); constipation (5%); nausea (3%)], and headache occurring in approximately 6% of patients.
Danish: De hyppigste bivirkninger, der er rapporteret for Enzepi, er relateret til mave-tarm-kanalen [abdominalsmerter (16 %), flatulens (12 %), abdominal distension (7 %), diarré og opkastning (6%), obstipation (5 %), kvalme (3 %)] og hovedpine, der ses hos ca. 6 % af patienterne.
English: For paediatric patients below 1 year of age, Enzepi must be administered immediately prior to each feed.
Danish: Til børn under 1 år skal Enzepi administreres umiddelbart inden hver amning.
English: If you stop taking Enzepi
Danish: Hvis du holder op med at tage Enzepi
English: If you forget to take Enzepi
Danish: Hvis du har glemt at tage Enzepi
English: Then, enzymes catalyze the hydrolysis of fats to monoglycerides, glycerol, and free fatty acids, protein into peptides and amino acids, and starch into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.
Danish: Enzymerne katalyserer derefter hydrolysen af fedtstoffer til monoglycerider, glycerol og frie fedtsyrer, af protein til peptider og aminosyrer og af stivelse til dekstriner og kortkædede sukkerarter såsom maltose og maltotriose i duodenum og den proksimale tyndtarm, idet de fungerer ligesom fordøjelsesenzymer, der er fysiologisk udskilt af pancreas.
English: Enzepi is for use by adults, adolescents, children and infants with ‘exocrine pancreatic insufficiency', a condition that makes the body less able to break down and digest food.
Danish: Enzepi bruges til voksne, unge, børn og spædbørn med såkaldt eksokrin pancreasinsufficiens, der er en sygdom, som gør, at kroppen har svært ved at nedbryde og fordøje maden.
English: Your doctor will adjust your dose which will depend on: the severity of your illness, how much fat is in your stools, your diet, your weight.
Danish: Dosis afhænger af: sværhedsgraden af din sygdom hvor meget fedt, der er i din afføring din kost din vægt.
English: After a 4-14 days screening period on their usual PEP, patients received Enzepi at individually titrated doses ranging between 2,300 and 10,000 lipase units per kg body weight per day, with a mean of approximately 5,000 lipase units per kg body weight per day (not to exceed 2,500 lipase units per kilogram per meal) for 14 days.
Danish: Efter en screeningsperiode på 414 dage på deres sædvanlige PEP fik patienterne individuelt titrerede doser mellem 2.300 og 10.000 lipase-enheder pr. kg legemsvægt pr. dag med et gennemsnit på ca. 5.000 lipase-enheder pr. kg legemsvægt pr. dag (dosis oversteg ikke 2.500 lipase-enheder pr. kg legemsvægt pr. måltid) i 14 dage.
English: If you still have fatty stools (smelly, loose, oily, pale stools) or other stomach or gut problems (gastrointestinal symptoms), talk to your doctor as your dose may need to be adjusted again.
Danish: Hvis du stadig har fedtholdig afføring (afføring, der lugter, eller løs, olieagtig, bleg afføring) eller andre problemer med maven eller tarmene, skal du tale med din læge, da det kan være nødvendigt at tilpasse din dosis igen.
English: Difference in LS means (95% confidence limits)
Danish: Forskel i gennemsnit, beregnet ved mindste kvadraters metode (95 %-KI)
English: The dosage of Enzepi should be individualised based on clinical symptoms, the degree of steatorrhoea present, the fat content of the diet, or actual body weight.
Danish: Enzepi-dosis skal tilpasses den enkelte patient på grundlag af kliniske symptomer, graden af aktuel steatoré, fedtindholdet i kosten og den aktuelle legemsvægt.
English: If you have cystic fibrosis and you are taking pancreatic enzymes exceeding10,000 lipase units per kilogram body weight per day and have unusual abdominal symptoms (such as severe stomach pain, trouble passing stools, nausea or vomiting) or changes in abdominal symptoms, tell your doctor straightaway.
Danish: Hvis du har cystisk fibrose og tager pancreasenzymer i doser over 10.000 lipase-enheder pr. kg legemsvægt pr. dag, og du har usædvanlige mavesymptomer (såsom alvorlige mavesmerter, problemer med afføringen, kvalme eller opkastning) eller ændringer i mavesymptomer, skal du straks kontakte din læge.
English: Crushing, chewing, or mixing capsule contents with food or fluid with a pH greater than 5 or storing the food mixture (see below), can lead to a disruption of the protective gastro-resistant coating.
Danish: Hvis kapslerne knuses eller tygges, eller hvis kapselindholdet blandes med mad eller væske med en pH over 5, eller hvis blandingen med mad gemmes (se nedenfor), kan det medføre, at det beskyttende syreresistente overtræk ødelægges.
English: The primary efficacy endpoint was the coefficient of fat absorption over 72 hours (CFA-72h) which was calculated at the end of each treatment period, from the stools collected during the last 3 days of each treatment period.
Danish: Det primære effektmål var fedtabsorptionskoefficienten over 72 timer (CFA-72t), der blev beregnet i slutningen af hver behandlingsperiode på basis af afføringsprøver indsamlet i løbet af de sidste tre dage i perioden.
English: The supportive EUR-1008-M, conducted in the US, was a randomized, double-blind, placebo-controlled, crossover study of 34 patients, ages 7 to 23 years, with EPI due to CF.
Danish: Det understøttende studie EUR-1008-M, der blev gennemført i USA, er et randomiseret, dobbeltblindt, placebokontrolleret cross-over-studie med 34 patienter i alderen 7-23 år med eksokrin pancreasinsufficiens forårsaget af cystisk fibrose.
English: In clinical trials, most of them were mild to moderate in severity.
Danish: De fleste af disse bivirkninger var lette til moderate i sværhedsgrad i de kliniske studier.
English: The short-term efficacy and safety of Enzepi were assessed in clinical studies in paediatric patients, ages 1 to 17 years, with EPI due to CF.
Danish: Den kortsigtede virkning af og sikkerhed ved Enzepi blev bedømt i kliniske studier hos pædiatriske patienter i alderen 1 til 17 år med eksokrin pancreasinsufficiens forårsaget af cystisk fibrose.
English: Then, starting on the second day, the dose of assigned treatment could be changed (titrated up and/or titrated down) to stabilize the symptoms of EPI.
Danish: På dag 2 kunne dosen af det tildelte studielægemiddel så ændres (titreres op eller ned) for at stabilisere symptomerne på eksokrin pancreasinsufficiens.
English: The most relevant class effects of the pancreatic enzyme products include fibrosing colonopathy, hyperuricaemia/ hyperuricosuria and anaphylactic reactions.
Danish: De mest relevante klasseeffekter ved pancreasenzym-præparater inkluderer fibroserende colonopati, hyperurikæmi/hyperurikosuri og anafylaktiske reaktioner.
English: Marketing Authorisation Holder Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate Coolock
Danish: Indehaver af markedsføringstilladelsen Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate Coolock
English: This can result in early release of the enzymes in the oral cavity, irritation of the mucous membranes and may lead to loss of enzyme activity.
Danish: Det kan resultere i for tidlig frigivelse af enzymerne i mundhulen, irritation af slimhinderne og tab af enzymaktivitet.
English: Blood glucose decreased Blood glucose increased Weight decreased Weight increased
Danish: Lavt blodglucose Forhøjet blodglucose Vægttab
English: If you or your child have trouble swallowing Enzepi capsules, open carefully the capsules and sprinkle the contents (granules) on a small amount of acidic food such as fruit puree (apple/ pear), yoghurt, or juice (orange/pineapple/apple).
Danish: Hvis du eller dit barn har problemer med at synke Enzepi-kapslerne, kan du forsigtigt åbne dem og blande indholdet (granulatet) med en lille smule syreholdig mad, f.eks. frugtmos (æble eller pære), yoghurt eller juice (appelsin, ananas eller æble).
English: Enzepi should always be taken with a meal or snack.
Danish: Enzepi skal altid tages sammen med et hovedmåltid eller et mellemmåltid.
English: Enzepi belongs to the family of pancreatic enzyme products and contains a defined amount of lipase, amylase and protease that have been extracted from porcine pancreas and purified using a process designed to inactivate viruses.
Danish: Enzepi tilhører gruppen af pancreasenzym-præparater og har et defineret indhold af lipase, amylase og protease, udvundet af svinepancreas og renset ved en proces, der er designet til at inaktivere vira.
English: Nevertheless, undersirable effects on the breastfed newborn/infant are not anticipated since systemic exposure in breast-feeding women to the pancreatic enzymes present in Enzepi is not expected.
Danish: Ikke desto mindre forventes der ingen bivirkninger hos det ammede barn, da den diegivende kvinde ikke forventes at blive systemisk eksponeret for pancreasenzymerne i Enzepi.
English: Immediately give them milk, formula or breast-milk to drink to ensure the granules are completely swallowed and none remain in your child's mouth.
Danish: Giv straks derefter barnet noget mælk, modermælkserstatning eller modermælk for at sikre, at al granulatet synkes, og at intet er tilbage i munden.
English: not less than 7,800 units*
Danish: mindst 7.800 enheder*
English: Your total daily dose should not exceed 2,500 lipase units per kg of body weight per meal (or 10,000 lipase units per kg of body weight per day).
Danish: Din samlede daglige dosis må ikke overstige 2.500 lipase-enheder pr. kg legemsvægt pr. måltid (eller 10.000 lipase-enheder pr. kg legemsvægt pr. dag).
English: Children (over 4 years of age), adolescents and adults (including elderly) The recommended starting dose for children over 4 years of age, adolescents (12 to 18 years) and adults is 500 lipase units per kg of body weight per meal.
Danish: Børn (over 4 år), unge og voksne (herunder ældre) Den anbefalede startdosis for børn over 4 år, unge (12-18 år) og voksne er 500 lipase-enheder/kg legemsvægt ved hvert måltid.
English: Mean CFA-72h was 88% with Enzepi treatment compared to 63% with placebo treatment.
Danish: Den gennemsnitlige CFA-72t var 88 % ved Enzepi-behandling og 63 % ved placebo.
English: For infants below 1 year of age the recommended starting dose is 5,000 lipase units per meal (generally 120 ml of milk) (see section Method of administration).
Danish: Til spædbørn under 1 år er den anbefalede startdosis 5.000 lipase-enheder pr. måltid (typisk 120 ml mælk) (se afsnittet "Administration").
English: The maximum recommended total dose is 2,500 lipase units/kg of body weight per meal (or 10,000 lipase units/kg of body weight per day), or 4,000 lipase units/g fat ingested per day.
Danish: Den højeste anbefalede samlede dosis er 2.500 lipase-enheder/kg legemsvægt pr. måltid (eller 10.000 lipase-enheder/kg legemsvægt pr. dag) eller 4.000 lipase-enheder/g fedt indtaget pr. dag.
English: The primary efficacy endpoint was the mean difference in the coefficient of fat absorption (CFA-72h) between Enzepi and placebo treatment.
Danish: Det primære effektmål var middelforskellen i fedtabsorptionskoefficient (CFA-72t) mellem Enzepi og placebo.
English: Pancreatic enzyme replacement treatment in exocrine pancreatic insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer).
Danish: Pancreasenzym-substitutionsterapi ved eksokrin pancreasinsufficiens forårsaget af cystisk fibrose eller andre tilstande (f.eks. kronisk pancreatitis, efter pankreatektomi, pancreascancer).
English: What you need to know before you take Enzepi
Danish: Det skal du vide, før du begynder at tage Enzepi
English: Median (minimum - maximum)
Danish: Statistik opsummering Gennemsnit (SD) Median (minimum-maksimal)
English: Study PR-005
Danish: Studie PR-005
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains: lipase:
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder: lipase:
English: Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations.
Danish: Der er rapporteret om strikturer i ileum-caecum og tyktarm (fibroserende colonopati) hos patienter med cystisk fibrose, der fik høje doser af pancreatinpræparater.
English: Infants (below 1 year of age)
Danish: Spædbørn (under 1 år)
English: Administration should be followed by breast-milk or formula to ensure complete ingestion.
Danish: Administrationen skal følges op af amning eller modermælkserstatning for at sikre, at alt indholdet i kapslen indtages.
English: The mean difference in CFA-72h was 26 percentage points greater with Enzepi treatment with a 95% Confidence Interval of (19, 32) and p<0.001.
Danish: Den gennemsnitlige forskel i CFA-72t var 26 procentpoint højere med Enzepi-behandling (95 %-KI: 19; 32; p < 0,001).
English: Study PR-011
Danish: Studie PR-011
English: - The other ingredients are: o Capsule content: croscarmellose sodium, hydrogenated castor oil, colloidal anhydrous silica, cellulose microcrystalline, magnesium stearate, hypromellose phthalate, talc, triethyl citrate.
Danish: Øvrige indholdsstoffer: o Kapselindhold: croscarmellosenatrium, hydrogeneret ricinusolie, vandfri kolloid silica, mikrokrystallinsk cellulose, magnesiumstearat, hypromellosephthalat, talcum, triethylcitrat.
English: For patients who are unable to swallow capsules whole, the capsules may be carefully opened and the contents mixed (without crushing) with small amounts of acidic soft food of pH 5 or less (e.g., fruit puree [apple/ pear], yoghurt, juice [orange/pineapple/apple]).
Danish: Patienter, der ikke kan synke kapslerne hele, kan åbne kapslerne forsigtigt og blande indholdet (uden at knuse det) med små mængder sure, bløde madvarer med en pH på 5 eller derunder (f.eks. frugtmos (æble eller pære), yoghurt, juice (appelsin, ananas, æble)).
English: Capsule content (gastro-resistant granules) Croscarmellose sodium Hydrogenated castor oil Colloidal anhydrous silica Microcrystalline cellulose Magnesium stearate
Danish: Kapselindhold (enterogranulat) Croscarmellosenatrium Hydrogeneret ricinusolie Vandfri kolloid silica Mikrokrystallinsk cellulose Magnesiumstearat Hypromellosephthalat Talcum
English: Caution must be exercised when prescribing Enzepi to patients with a history of gout, renal impairment, or hyperuricaemia.
Danish: Der skal udvises forsigtighed ved ordinering af Enzepi til patienter med tidligere urinsyregigt, nyresvigt eller hyperurikæmi.
English: Higher doses should be used with caution if warranted (see sections 4.4 and 4.9) and only if they are documented to be effective by 3day faecal fat measurements that indicate a significantly improved coefficient of fat absorption.
Danish: 4.4 og 4.9) og kun, hvis det ved fæces-fedtmålinger over 3 dage, der viser en væsentligt forbedret fedtabsorptionskoefficient, kan dokumenteres, at de er effektive.
English: Pancreatic enzyme medicinal products do not cause pharmacokinetic and pharmacodynamic interactions based on their pharmacology, as they are not absorbed from the gastrointestinal tract.
Danish: Baseret på deres farmakologi forårsager pancreasenzymer ingen farmakokinetiske eller farmakodynamiske interaktioner, da de ikke absorberes fra mave-tarm-kanalen.
English: Table 1 Analysis of coefficient of fat absorption over 72 hours (CFA72h) - completers population (study : PR005)
Danish: Tabel 1 Analyse af fedtabsorptionskoefficienten over 72 timer (CFA-72t) - Patienter, der
English: Consideration should be given to blood glucose monitoring in patients at risk of abnormal blood glucose levels as glycaemic control may be affected by administration of pancreatic enzyme replacement therapy (see section 4.8).
Danish: Det bør overvejes at monitorere blodglucose hos patienter med risiko for unormale blodglucoseniveauer, da den glykæmiske kontrol kan blive påvirket af substitutionsbehandling med pancreasenzymer (se pkt.
English: Enzepi should be taken during meals or snacks, with a drink of water or juice.
Danish: Enzepi skal tages til et hovedmåltid eller mellemmåltid sammen med et glas vand eller juice.
English: Study PR-018
Danish: Studie PR-018
English: Do not sprinkle the capsule contents directly into the formula or breast-milk.
Danish: Bland ikke kapsel-indholdet direkte i modermælkserstatning eller modermælk.
English: Thus, Enzepi demonstrated both non-inferiority and equivalence to the comparator in fat absorption control (measured as CFA-72h) in adolescents and adults with CF-associated EPI.
Danish: Enzepi viste både non-inferioritet og ækvivalens i forhold til komparatoren med hensyn til kontrolleret absorption af fedt (målt som CFA-72t) hos unge og voksne med eksokrin pancreasinsufficiens relateret til cystisk fibrose.
English: However as pancreatic enzymes are not absorbed from the gastrointestinal tract, no systemic toxicity is expected following oral administration of pancreas powder.
Danish: Der er ikke gennemført prækliniske undersøgelser af Enzepi, men da pancreasenzymer ikke optages fra mave-tarm-kanalen, forventes der ingen systemisk toksicitet efter oral administration af pancreaspulver.
English: The CFA-72h was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured.
Danish: CFA-72t blev bestemt på grundlag af en 72 timers afføringsindsamling i de 2 behandlinger, hvor både fedtudskillelse og fedtindtagelse blev målt.
English: Repeated high doses of pancreatic enzyme replacement medicines can also cause scarring or thickening of the bowel wall that can lead to blockage of the intestines, a condition called fibrosing colonopathy.
Danish: Gentagne høje doser af lægemidler til erstatning af pancreas-enzymer kan også forårsage ardannelse eller fortykkelse af tarmvæggen, hvilket kan medføre blokering af tarmene (fibroserende colonopati).
English: It is not known if Enzepi passes into your breast-milk.
Danish: Det vides ikke, om Enzepi udskilles i mælken hos mennesker.
English: Do not mix the Enzepi granules with water, milk, breast-milk, formula feeds, flavoured milk or hot food.
Danish: Bland ikke Enzepi-granulatet med vand, mælk, modermælk, modermælkserstatning, aromatiseret mælk eller varm mad.
English: Make sure the medicine and food mixture is swallowed completely and that no granules are left in your or your child's mouth.
Danish: Vær sikker på, at al medicinen og madblandingen synkes, og at der ikke er noget granulat tilbage i munden.
English: Common (may affect up to 1 in 10 people): abdominal discomfort or bloating flatulence/passing wind diarrhoea headache.
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter): ubehag i maven eller oppustethed luft i maven diarré hovedpine.
English: not less than 650 units*
Danish: mindst 650 enheder*
English: Enzepi capsules or its contents should not be crushed or chewed as they can cause irritation inside your mouth.
Danish: Enzepi-kapsler og deres indhold må ikke knuses eller tygges, da dette kan medføre irritation af slimhinden i munden.
English: o Printing ink: shellac, propylene glycol, indigotine (E132).
Danish: o Prægeblæk: shellac, propylenglycol, indigotin (E132).
English: Other medicines and Enzepi Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: If you sprinkle the Enzepi granules on food, swallow the mixture or give it to your child straight after you have mixed it, followed by a drink of water or juice.
Danish: Hvis du blander Enzepi-granulatet med mad, skal du sørge for, at blandingen synkes lige efter, når du har tilberedt den, og derefter skal du drikke (eller give dit barn) et glas vand eller juice.
English: Study PR-011 was an open-label crossover study in 15 patients, ages 1 to 11 months, with EPI due to CF.
Danish: Studie PR-011 er et åbent cross-over-studie med 15 patienter i alderen 1-11 måneder med eksokrin pancreasinsufficiens forårsaget af cystisk fibrose.
English: High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricaemia, and should be used with caution in patients with a history of gout, renal impairment or hyperuricaemia (see section 4.4).
Danish: Høje doser af pancreasenzymer er blevet forbundet med hyperurikosuri og hyperurikæmi og bør anvendes med forsigtighed hos patienter med tidligere urinsyregigt, nedsat nyrefunktion eller hyperurikæmi (se pkt.
English: o Capsule shell :
Danish: o Kapselskal:
English: How much Enzepi to take
Danish: Så meget Enzepi skal du tage
English: EUR 1009-M was an open-label, single arm study in 19 patients, ages 1 to 6 years, with EPI due to CF.
Danish: EUR 1009-M er et åbent studie med en enkelt arm hos 19 patienter i alderen 1-6 år, som alle havde eksokrin pancreasinsufficiens forårsaget af cystisk fibrose.
English: In patients at risk of abnormal blood glucose levels glycaemic control may be affected by administration of pancreatic enzyme replacement therapy (see section 4.4).
Danish: Hos patienter med risiko for unormale blodglucoseniveauer kan den glykæmiske kontrol blive påvirket af substitutionsbehandling med pancreasenzymer (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1113/001-016
Danish: EU/1/16/1113/001-016
English: The recommended starting dose for infants below 1 year of age is 5,000 lipase units per 120 ml of formula milk or breast-milk.
Danish: Den anbefalede startdosis til spædbørn under 1 år er 5.000 lipase-enheder pr. 120 ml modermælkserstatning eller modermælk.
English: If you have severe stomach pain, trouble passing stools (constipation), nausea or vomiting, tell your doctor straightaway.
Danish: Hvis du får alvorlige mavesmerter, problemer med at komme af med afføringen (forstoppelse), kvalme eller opkastning, skal du fortælle det til lægen med det samme.
English: Pack size: one bottle of 20, 50, 100 or 200 gastro-resistant hard capsules.
Danish: Pakningsstørrelser: beholder med 20, 50, 100 eller 200 hårde enterokapsler.
English: Care should be taken to ensure that Enzepi is not retained in the mouth.
Danish: Det skal sikres, at der ikke er noget Enzepi tilbage i munden.
English: Do not mix with water, milk, breast-milk, formula, flavoured milk or hot food.
Danish: Kapselindholdet må ikke blandes med vand, mælk, modermælk, modermælkserstatning, aromatiseret mælk eller varm mad.
English: Abdominal discomfort
Danish: Abdominalt ubehag