FrancophonIA/ELRC3.0 huggingface dataset:
English: An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: The granules may be administered with a small amount of appropriate acidic food or directly into the mouth.
Danish: Granulatet kan administreres sammen med en lille mængde passende syreholdig mad eller direkte i munden.
English: The risk and benefit of this medicinal product should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency.
Danish: Risikoen og fordelen ved dette lægemiddel bør overvejes i forhold til behovet for at give tilstrækkelig ernæringsstøtte til en gravid kvinde med eksokrin pancreasinsufficiens.
English: There was no wash-out period.
Danish: Der var ingen udvaskningsperiode.
English: 6.6 Special precautions for disposal and other handling Use in paediatric population
Danish: 6.6 Regler for bortskaffelse og anden håndtering Brug i den pædiatrisk population
English: Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially `sodium-free´.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er i det væsentlige natriumfrit.
English: If you are diabetic, you should speak with your doctor, if you notice any changes in your blood glucose levels.
Danish: Hvis du har diabetes (sukkersyge), skal du tale med lægen, hvis du bemærker ændringer i dit blodsukkerniveau.
English: Anaphylactic shock is a severe, potentially life-threatening allergic reaction that can develop rapidly.
Danish: Anafylaktisk shock er en alvorlig, eventuelt livstruende allergisk reaktion, der kan udvikle sig hurtigt.
English: For both treatment periods, patients received a dose as close as possible to their stabilized existing pancreatic enzyme product dose on the first day.
Danish: For begge behandlingsperioder gælder det, at patienterne fik en dosis, der var så tæt som muligt på den stabiliserede dosis af deres eksisterende pancreasenzympræparat på dag 1.
English: enzymes, Enzyme preparations, ATC code: A09AA02
Danish: enzymer; enzympræparater; ATC-kode: A09AA02
English: Depending on what strength of Enzepi you take, your doctor will tell you how many capsules you need to take with each meal or snack.
Danish: Afhængigt af, hvilken styrke Enzepi du får, vil din læge fortælle dig, hvor mange kapsler du skal tage sammen med hvert hovedmåltid og mellemmåltid.
English: Study PR-018 was a 12-month open-label extension of Study PR-011.
Danish: Studie PR-018 er en åben 12-måneders forlængelse af studie PR-011.
English: MedDRA System Organ Classification and are ranked under headings of frequency, using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: De præsenteres i henhold til MedDRA's systemorganklassificering og opstilles i henhold til hyppighed: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The mixture must not be stored.
Danish: Blandingen må ikke gemmes.
English: Many patients will need to take pancreatic enzyme replacement medicines for the rest of their life.
Danish: Mange patienter har behov for at tage medicin med pancreas-enzymer resten af deres liv.
English: No specific adverse reactions were identified in the elderly population.
Danish: Der sås ingen særskilte bivirkninger hos den ældre population.
English: Dyspnoea*
Danish: Dyspnø*
English: If you take more Enzepi than you should If you take more Enzepi than you should drink plenty of water and talk to your doctor as soon as possible.
Danish: Hvis du har taget for meget Enzepi Hvis du har for meget Enzepi, skal du drikke masser af vand og kontakte din læge snarest muligt.
English: Cases of blood glucose fluctuations have been reported with Enzepi, most of them non-serious and recovered after diabetic treatment adjustment.
Danish: Der er rapporteret tilfælde af blodglucose-fluktuationer med Enzepi, men de fleste var ikke-alvorlige og ophørte efter justering af diabetesbehandlingen.
English: If an allergic reaction occurs, stop your treatment and talk to your doctor.
Danish: Hvis du får en allergisk reaktion, skal du stoppe behandlingen og kontakte din læge.
English: Fibrosing colonopathy
Danish: Fibroserende colonopati
English: Pharmacotherapeutic group: Digestives, incl.
Danish: Farmakoterapeutisk klassifikation: Digestiva, incl.
English: Overall, an improvement was observed from baseline to study completion for growth indices including weight-for-age, length-for-age, and weight-for-length percentiles.
Danish: Generelt sås der en forbedring fra baseline til studiets afslutning med hensyn til vækstindeks, herunder vægt/alder-, længde/alder- og vægt/længde-percentilerne.
English: If you are breast-feeding or plan to breast-feed, or if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du ammer eller planlægger at amme, eller hvis du er gravid eller har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: The capsule should be carefully opened to empty the content (granules).
Danish: Kapslen skal åbnes forsigtigt for at tømme den for indhold (granulat).
English: Enzyme doses expressed as lipase units/kg of body weight per meal must be reduced in older patients because they tend to ingest less fat per kilogram of body weight.
Danish: Enzymdosis, udtrykt som lipase-enheder/kg legemsvægt pr. måltid, skal reduceres hos ældre patienter, da de har tendens til at indtage mindre fedt pr. kg legemsvægt.
English: Pack size of 20, 50, 100, and 200 capsules.
Danish: Pakningsstørrelser på 20, 50, 100 og 200 kapsler.
English: Do not take Enzepi - if you are allergic to the active subtance or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Enzepi - hvis du er allergisk over for det aktive pulver eller et af de øvrige indholdsstoffer i Enzepi (angivet i punkt 6).
English: Study EUR-1008-M
Danish: Studie EUR-1008-M
English: Patients were administered Enzepi at the same dose they were taking at the end of Study PR-011.
Danish: Patienterne fik Enzepi i samme dosis som ved afslutning af studie PR-011.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Adequate caloric intake during pregnancy is important for normal maternal weight gain and foetal growth.
Danish: En tilstrækkelig stor kalorieindtagelse under graviditet er vigtigt af hensyn til moderens vægtforøgelse og fostrets udvikling.
English: Reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes.
Danish: Reduceret vægtforøgelse hos moderen og fejlernæring kan være forbundet med et negativt udfald af graviditeten.
English: Ask your doctor about other foods you can sprinkle Enzepi granules on.
Danish: Spørg din læge, hvilke andre madvarer du kan blande Enzepi-granulatet med.
English: Inadequate hydration may predispose to/or aggravate constipation.
Danish: Utilstrækkelig hydrering kan disponere for eller forværre obstipation.
English: Enzepi can only be sprinkled on certain food (see section 3).
Danish: Enzepi må kun blandes med bestemte fødevarer (se pkt.
English: Pancreas powder
Danish: Pancreas-pulver
English: Therapy should be initiated at the lowest recommended dose and gradually increased under medical supervision with careful monitoring of the patient's response and symptoms.
Danish: Behandlingen bør initieres ved den lavest anbefalede dosis og tilpasses gradvist under omhyggelig overvågning af patientens respons og symptomer og supervision af en læge.
English: Your child should take all the food mixture and should then drink enough liquid straight after to wash down all the medicine.
Danish: Dit barn skal indtage hele blandingen og umiddelbart efter have nok at drikke, så al medicinen skylles ned.
English: Cystic fibrosis patients
Danish: Patienter med cystisk fibrose
English: Capsules should be swallowed whole and not chewed or crushed.
Danish: Kapslerne bør synkes hele og må ikke tygges eller knuses.
English: The difference in means was -1.25 (95% CI, -3.62 to 1.12), with p=0.2972.
Danish: Forskellen i middelværdier var -1,25 (95 %-KI: -3,62; 1,12; p = 0,2972).
English: As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000 lipase units/kg/day.
Danish: Som forsigtighedsregel bør usædvanlige eller ændrede abdominalsymptomer undersøges af en læge for at udelukke fibroserende colonopati, især hvis patienten får mere end 10.000 lipase-enheder/kg/dag.
English: If this occurs, call for urgent medical attention straightaway.
Danish: Hvis dette sker, har du brug for akut lægehjælp.
English: If this reaction occurs, patients should be advised to discontinue treatment immediately and seek urgent medical assistance.
Danish: Patienterne skal informeres om at stoppe behandlingen med det samme og straks søge lægehjælp.
English: Overall, caregivers were satisfied with using apple sauce as a dosing method compared with apple juice.
Danish: Generelt var omsorgspersonerne tilfredse med at bruge æblemos ved doseringen, idet de foretrak æblemos frem for æblejuice.
English: Anaphylactic reaction** Drug hypersensitivity/ Hypersensitivity
Danish: Anafylaktisk reaktion** Lægemiddeloverfølsomhed/ overfølsomhed
English: Very common (may affect more than 1 in 10 people): stomach pain.
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter): mavesmerter.
English: Fertility No human data on the effect of Enzepi on fertility are available.
Danish: Fertilitet Der foreligger ingen humane data om Enzepis indvirkning på fertiliteten.
English: The primary efficacy endpoint was the percentage of “responders”, defined as those patients without steatorrhoea (<30% faecal fat content) and without signs and symptoms of malabsorption after one and two weeks of treatment with Enzepi.
Danish: Det primære effektmål var procentdelen af responderende patienter defineret som patienter uden steatoré (< 30 % fæcesfedt) og uden tegn eller symptomer på malabsorption efter en og to ugers behandling med Enzepi.
English: A dose adjustment may be necessary.
Danish: Det kan være nødvendigt at justere dosen.
English: Clinical studies of Enzepi did not include sufficient numbers of subjects aged 65 and over to determine whether they respond different from younger subjects.
Danish: Kliniske studier med Enzepi omfatter ikke et tilstrækkeligt antal forsøgspersoner i alderen 65 år og derover til at klarlægge, om ældre responderer anderledes end yngre personer.
English: If required, carefully open the capsule and administer the contents (granules) to the patient as described in section 4.2.
Danish: Om nødvendigt kan kapslen åbnes forsigtigt og indholdet (granulatet) administreres til patienten som beskrevet i pkt.
English: Adare Pharmaceuticals Srl Via Martin Luther King 13 20060 Pessano Con Bornago ITALY
Danish: Adare Pharmaceuticals Srl Via Martin Luther King 13 20060 Pessano Con Bornago ITALIEN
English: You and your doctor should decide if you will take Enzepi or breast-feed.
Danish: Sammen med din læge skal du beslutte, om du vil tage Enzepi eller amme.
English: Although, no preclinical investigations were carried out with Enzepi there is no evidence for any absorption of this medicinal product.
Danish: Der er ikke udført prækliniske undersøgelser af Enzepi, men der foreligger ingen dokumentation for, at dette lægemiddel absorberes.
English: Supportive measures including stopping pancreatic enzyme therapy and ensuring adequate rehydration are recommended.
Danish: Det anbefales at iværksætte understøttende foranstaltninger, herunder afbrydelse af behandlingen med pancreasenzymer og sikring af tilstrækkelig hydrering.
English: The mean faecal fat content was similar at baseline (24.8%), after stabilization (27.0%) and after the second week of open-label treatment
Danish: Det gennemsnitlige indhold af fedt i fæces var det samme ved baseline (24,8 %), efter stabilisering (27,0 %) og efter den anden uge af åben behandling (27,3 %).
English: Fibrosing colonopathy** Lip swelling and swollen tongue*
Danish: Fibroserende colonopati** Hævede læber og tunge* Stomatitis
English: In clinical trials, 110 children with CF (cystic fibrosis) aged 1 month and older received Enzepi at a dose that ensured stabilization of symptoms.
Danish: I kliniske studier har 110 børn med cystisk fibrose i alderen 1 måned og derover fået Enzepi i en dosering, der sikrede stabilisering af symptomerne.
English: The number of responders (patients with less than 30% faecal fat content and without signs and symptoms of malabsorption) at baseline was 10/19 (52.6%), 13/19 (68.4%) after 1 week of treatment (stabilization) and 11/19 (57.9%) after the second week of open-label treatment with Enzepi.
Danish: Antallet af responderende patienter (patienter med mindre end 30 % fedt i fæces og uden tegn eller symptomer på malabsorption) var 10/19 (52,6 %) ved baseline, 13/19 (68,4 %) efter en uges behandling (stabilisering) og 11/19 (57,9 %) efter to ugers åben behandling med Enzepi.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not chew the capsules.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Kapslerne må ikke tygges.
English: The safety and efficacy in the paediatric patients in this study was similar to the adult patients.
Danish: Sikkerheden og virkningen hos pædiatriske patienter i dette studie var sammenlignelig med sikkerheden og virkningen hos voksne.
English: EUR-1008-M was conducted in 34 patients with EPI due to CF, 26 of whom were children, including 8 children aged 7 to 11 years, and 18 adolescents aged 12 to 17 years.
Danish: EUR-1008-M blev udført hos 34 patienter med eksokrin pancreasinsufficiens forårsaget af cystisk fibrose, hvoraf 26 var børn, herunder 8 børn i alderen 7-11 år og 18 unge i alderen 12-17 år.
English: Subjects achieved a mean CFA-72h of 84.08 with Enzepi and of 85.33 with comparator.
Danish: Forsøgspersonerne opnåede en gennemsnitlig CFA-72t på 84,08 med Enzepi og 85,33 med komparator.
English: The dose of Enzepi was adjusted during the 12month study as the patient's grew and gained weight.
Danish: Enzepi-dosen blev justeret i løbet af 12-måneders studiet, efterhånden som patienterne voksede og tog på i vægt.
English: Carefully open the capsule and empty the granules on a small amount of acidic food (see above).
Danish: Åbn forsigtigt kapslen og hæld granulatet på en lille smule sur mad (se ovenfor).
English: Patients were randomized to receive Enzepi or matching placebo for 6 to 7 days of treatment, followed by cross-over to the alternate treatment for an additional 6 to 7 days.
Danish: Patienterne blev randomiseret til at få Enzepi eller matchende placebo i 6-7 behandlingsdage efterfulgt af overkrydsning til den anden behandling i yderligere 6-7 dage.
English: Not known (frequency cannot be estimated from the available data): abnormal/discoloured faeces (stools) or frequent bowel movements shortness of breath indigestion swelling, pain, soreness or irritation in the mouth tiredness or general feeling of being unwell (malaise) changes (increase or decrease) in blood glucose levels changes (increase or decrease) in body weight decreased appetite high uric acid level in the urine (hyperuricosuria) high uric acid level in the blood (hyperuricemia).
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data): unormal, misfarvet eller hyppig afføring åndenød fordøjelsesbesvær hævelse, smerter, ømhed eller irritation i munden træthed eller generel følelse af utilpashed ændringer i blodsukkerniveauet (stigning eller fald) ændringer i legemsvægt (stigning eller fald) appetitløshed højt urinsyreniveau i urinen (hyperurikosuri) højt urinsyreniveau i blodet (hyperurikæmi)
English: Steatorrhoea was assessed from the faecal fat content measured by spot faecal fat testing on Days 11 and 18 compared with baseline (under usual PEPs).
Danish: Steatoré blev vurderet ud fra fedtindholdet i fæces ved test af en fæcesstikprøve på dag 11 og 18 sammenlignet med baseline (ved behandling med det sædvanlige PEP).
English: The contents of the capsule should not be mixed directly into formula or breast-milk as this may diminish efficacy.
Danish: Indholdet i kapslen bør ikke blandes direkte med modermælkserstatning eller modermælk, da dette kan nedsætte virkningen.
English: Potential for hyperuricaemia
Danish: Potentiel hyperurikæmi
English: Patients were transitioned to Enzepi from their usual PEP (pancreatic enzyme product) treatment.
Danish: Patienter blev overført til Enzepi fra behandling med deres sædvanlige PEP (pancreasenzympræparat).
English: The pancreatic enzymes in Enzepi are gastro-resistant to minimise destruction or inactivation in gastric acid.
Danish: Pancreasenzymerne i Enzepi er syreresistente for at minimere ødelæggelse eller inaktivering i mavesyren.
English: Hyperuricaemia/ hyperuricosuria** Decreased appetite
Danish: Hyperurikæmi/hyperurikosuri** Appetitløshed
English: Enzepi is a pancreatic enzyme replacement medicine for people whose bodies do not make enough of enzymes to digest food.
Danish: Enzepi er et lægemiddel til erstatning af pancreas (bugspytkirtel)-enzymer hos personer, hvis krop ikke producerer tilstrækkeligt med enzymer til at fordøje maden.
English: Manufacturer Adare Pharmaceuticals Srl Via Martin Luther King, 13 20060, Pessano Con Bornago Milan
Danish: Adare Pharmaceuticals Srl Via Martin Luther King, 13, 20060, Pessano Con Bornago Milano
English: Gastro-resistant granules are thoroughly mixed with chyme when the capsule dissolves in the stomach, without inactivating the acid-sensitive enzymes.
Danish: Enterogranulatet bliver grundigt blandet med chymus, når kapslen opløses i mavesækken, uden at de syrefølsomme enzymer inaktiveres.
English: As a risk to newborns/infants cannot be excluded, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Enzepi therapy taking into account the benefit of breast-feeding for the child and the benefit of continued Enzepi therapy for the breastfeeding woman.
Danish: Da det ikke kan udelukkes, at der er en risiko for nyfødte børn/spædbørn, skal det besluttes, om amning eller behandling med Enzepi skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen ved fortsat Enzepi-behandling.
English: The safety profile of Enzepi in the paediatric population was similar to that observed in adults.
Danish: Sikkerhedsprofilen for Enzepi hos den pædiatriske population svarer til sikkerhedsprofilen hos voksne.
English: If you notice any of the following seek urgent medical attention straightaway: itching, hives or rash swollen eyes, lips, hands or feet feeling lightheaded or faint trouble breathing or swallowing dizziness, collapse or unconsciousness.
Danish: Hvis du oplever noget af følgende, skal du straks søge akut lægehjælp: kløe, nældefeber eller udslæt hævede øjne, læber, hænder eller fødder følelse af svimmelhed, eller at du skal besvime vejrtræknings- eller synkebesvær svimmelhed, kollaps eller bevidstløshed
English: Model-based statistics (Enzepi minus Creon) LS mean (standard error)
Danish: Modelbaseret statistik (Enzepi minus Creon) Gennemsnit beregnet ved mindste kvadraters metode (standardfejl)
English: It was a randomized, double-blind, active controlled, two-treatment, crossover study, comparing Enzepi to standard pancreatic enzyme treatment during 2 treatments periods.
Danish: Det er et randomiseret, dobbeltblindt, aktivt kontrolleret cross-over-studie med to behandlinger, der sammenlignede Enzepi med standardbehandling med pancreasenzymer gennem to behandlingsperioder.
English: During the study, patients were instructed to consume 100 g (± 15 g) of fat per day and to maintain a consistent dietary fat intake for meals and snacks.
Danish: Patienterne blev instrueret i at indtage 100 g (± 15 g) fedt pr. dag og fastholde en konsistent fedtindtagelse ved hovedmåltider og mellemmåltider.
English: Model-based statistics are from a mixed effects linear model using CFA-72h as the response variable, fixed effect factors for treatment, period and treatment sequence, and subject within treatment sequence as a random effect.
Danish: Den modelbaserede statistik er beregnet på en lineær blandet effektmodel, der anvender CFA-72t som responsvariabel, behandling, periode og behandlingssekvens som fast effekt-faktorer, og forsøgsperson inden for behandlingssekvens som tilfældig effekt.
English: Care should be taken to ensure that no medicinal product is retained in the mouth.
Danish: Det skal sikres, at der ikke er noget lægemiddel tilbage i munden.
English: Porcine derived pancreatic enzyme products contain purines that may increase blood uric acid levels.
Danish: Præparater med pancreasenzymer af porcin oprindelse kan indeholde puriner, der kan øge urinsyreniveauet i blodet.
English: Enzepi has no influence on the ability to drive and use machines.
Danish: Enzepi påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: *Symptoms of allergic reactions.
Danish: *Symptomer på allergiske reaktioner **Klasseeffekter
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og beholderen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The Enzepi soft food mixture should be swallowed immediately without chewing and followed with water or juice to ensure complete ingestion.
Danish: Den bløde madblanding med Enzepi skal synkes med det samme uden at blive tygget, og den skal skylles ned med et glas vand eller juice for at sikre, at hele madblandingen indtages.
English: Patients were randomized to receive Enzepi from an opened capsule mixed and administered with apple juice (in a syringe nurser) or apple sauce (using a spoon) for 10 days of treatment, followed by a cross-over to the alternate mode of administration for an additional 10 days.
Danish: Patienterne blev randomiseret til at få Enzepi fra en åbnet kapsel, hvor indholdet blev blandet og administreret med æblejuice (i en sprøjte) eller æblemos (med en ske) i 10 dage efterfulgt af overkrydsning til den anden administrationsmetode i yderligere 10 dage.
English: Do not store Enzepi that has been sprinkled on food.
Danish: Du må ikke opbevare Enzepi, der er blandet med mad.
English: It is important to ensure adequate hydration of patients at all times whilst dosing Enzepi.
Danish: Det er vigtigt hele tiden at sikre, at patienterne er velhydrerede under behandling med Enzepi.