FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Renvela?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Renvela?
English: The European Medicines Agency therefore concluded that Renvela's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Renvela opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: An overview of Renvela and why it is authorised in the EU
Danish: En oversigt over Renvela, og hvorfor det er godkendt i EU
English: For more information about using Renvela, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Renvela, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Renvela (sevelamer carbonate) EMA/357790/2019
Danish: Renvela (sevelamercarbonat) EMA/357790/2019
English: Renvela is available as tablets (800 mg) and as powder (0.8 g, 1.6 g and 2.4 g) in a sachet to be taken 3 times a day with meals.
Danish: Renvela findes som tabletter (800 mg) og som pulver i et brev (0,8 g, 1,6 g og 2,4 g), som tages tre gange om dagen sammen med et måltid.
English: Why is Renvela authorised in the EU?
Danish: Hvorfor er Renvela godkendt i EU?
English: Side effects reported with Renvela are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Renvela vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The most common side effects with Renvela (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, upper abdominal (belly) pain and constipation.
Danish: De hyppigste bivirkninger ved Renvela (som kan forekomme hos mere end 1 ud af 10 personer) er kvalme, opkastning, smerter i den øvre del af maven og forstoppelse.
English: Renvela must not be taken on an empty stomach and patients should keep to their prescribed diets.
Danish: Renvela må ikke tages på tom mave, og patienterne bør overholde den ordinerede kostplan.
English: The dose to take depends on the patient's level of blood phosphate and, in case of children, their height and weight.
Danish: Dosen afhænger af patientens fosfatindhold i blodet og for børns vedkommende af deres højde og vægt.
English: Renvela (sevelamer carbonate)
Danish: Renvela (sevelamercarbonat)
English: Renvela should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Danish: Renvela bør anvendes sammen med andre behandlinger, såsom tilskud af calcium og D-vitamin, for at forebygge knoglesygdom.
English: When taken with meals, it attaches in the gut to phosphate from food, thereby preventing the phosphate from being absorbed into the body and helping reduce phosphate levels in the blood.
Danish: Når det tages med et måltid, binder det sig i tarmen til fosfat fra maden og forhindrer dermed fosfatet i at blive optaget i kroppen, hvilket reducerer fosfatindholdet i blodet.
English: In a third main study in 49 adults who were not on dialysis, Renvela reduced phosphate levels from 2.0 mmol/l to 1.6 mmol/l.
Danish: I et tredje hovedstudie med deltagelse af 49 voksne, som ikke var i dialyse, reducerede Renvela fosfatindholdet fra 2,0 mmol/l til 1,6 mmol/l.
English: What are the risks associated with Renvela?
Danish: Hvilke risici er der forbundet med Renvela?
English: What is Renvela and what is it used for?
Danish: Hvad er Renvela, og hvad anvendes det til?
English: In two main studies in 110 adults with kidney disease who were on dialysis, Renvela brought phosphate levels down to around 1.5-1.6 mmol/l (which is within or close to the normal range) and was as effective as another authorised medicine Renagel.
Danish: I to hovedstudier med deltagelse af 110 voksne med nyresygdom, som var i dialyse, nedsatte Renvela fosfatindholdet til ca. 1,5-1,6 mmol/l (hvilket er inden for eller tæt på normalintervallet), og det var lige så effektivt som et andet godkendt lægemiddel, Renagel.
English: The active substance in Renvela, sevelamer carbonate, is a phosphate binder.
Danish: Det aktive stof i Renvela, sevelamercarbonat, er en fosfatbinder.
English: Renvela must not be used in people with low blood phosphate levels or with bowel obstruction (a blockage in the gut).
Danish: Renvela må ikke anvendes af personer med lavt fosfatindhold i blodet eller med tarmobstruktion (en blokering af tarmen).
English: Renvela is a medicine used to control hyperphosphataemia (high blood phosphate levels) in:
Danish: Renvela er et lægemiddel, der anvendes til at regulere hyperfosfatæmi (højt fosfatindhold i blodet) hos:
English: Studies show that Renvela is effective at reducing levels of blood phosphate in patients with hyperphosphataemia, and its side effects are considered manageable.
Danish: Studier har vist, at Renvela er effektivt til at reducere fosfatindholdet i blodet hos patienter med hyperfosfatæmi, og bivirkningerne anses for håndterbare.
English: Finally, a main study also showed that Renvela was effective at lowering phosphate levels in 100 children: children who took Renvela had a greater reduction in phosphorous (0.87 mg/dl) than those taking placebo (a dummy treatment) who had a rise in phosphorous of 0.04 mg/dl.
Danish: Hos børn, der tog Renvela, sås en større reduktion af fosfor (0,87 mg/dl) end hos børn, der tog placebo (en uvirksom behandling), hvor der sås en stigning i fosfor på 0,04 mg/dl.
English: How is Renvela used?
Danish: Hvordan anvendes Renvela?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Renvela have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Renvela.
English: What benefits of Renvela have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Renvela?
English: How does Renvela work?
Danish: Hvordan virker Renvela?
English: For the full list of side effects with Renvela, see the package leaflet.
Danish: Den fuldstændige liste over alle indberettede bivirkninger ved Renvela fremgår af indlægssedlen.
English: Renvela has been shown in studies to be effective at lowering levels of blood phosphate in patients with hyperphosphataemia.
Danish: Det er i studier påvist, at Renvela er effektivt til at nedsætte fosfatindholdet i blodet hos patienter med hyperfosfatæmi.
English: Have you recently become ill?
Danish: - Har du været syg for nylig?
English: Paediatric population Humalog can be used in adolescents and children (see section 5.1).
Danish: Pædiatrisk population Humalog kan anvendes til unge og børn (se punkt 5.1).
English: The target audience and the modalities for distribution all of these materials are to be agreed at Member State level.
Danish: Målgruppen og måden, disse materialer skal distribueres på, skal aftales i hvert medlemsland.
English: Do not use the pen to administer Humalog by a different way.
Danish: Brug derfor ikke pennen til at administere Humalog på en anden måde.
English: Systemic allergy, which is rare but potentially more serious, is a generalised allergy to insulin.
Danish: Systemisk allergi, som er sjælden, men potentielt mere alvorlig, er en generaliseret overfølsomhed overfor insulin.
English: You should only inject it into a muscle if your doctor has told you to.
Danish: Du bør kun injicere Humalog i en muskel, hvis din læge har sagt dette.
English: • If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before.
Danish: • Hvis du ændrer insulintype (f.eks. fra human eller animalsk insulin til et Humalog produkt), skal du måske tage mere eller mindre insulin end før.
English: Check each time you inject yourself.
Danish: Kontrollér det hver gang du skal injicere dig selv.
English: (mean at baseline = 8.5%)
Danish: ved baseline = 8.5%)
English: Humalog is suitable for use in adults and children.
Danish: Humalog kan bruges af voksne og børn.
English: • Humalog is now available in 2 strengths
Danish: • Humalog er nu tilgængelig i 2 styrker.
English: (mean at baseline = 8.7%)
Danish: ved baseline = 8.7%)
English: * produced in E.coli by recombinant DNA technology.
Danish: *produceret i E. coli ved rekombinant DNA-teknologi.
English: • Your doctor will tell you if you have to mix Humalog with one of the human insulins.
Danish: • Din læge vil fortælle dig, hvis du skal blande Humalog med en af de humane insuliner.
English: In one clinical study there was a small (0.38 mmol/l) increase in blood glucose levels at night (3a.m.
Danish: I et klinisk forsøg sås en svag (0,38 mmol(l) stigning i blodglucoseniveauet om natten (klokken 3).
English: 100 units/ml
Danish: 100 enheder/ml
English: You should never mix Humalog with insulins produced by other manufacturers or animal insulins.
Danish: Du bør aldrig blande Humalog med insulinpræparater fremstillet af andre producenter eller med animalsk insulin.
English: Humalog with alcohol
Danish: Humalog sammen med alkohol
English: Humalog KwikPen is available in two strengths.
Danish: Humalog KwikPen er tilgængelig i to styrker.
English: 1 from baseline to end of Humalog Mix25 treatment 2 in patients randomised to Humalog Mix25 during the first crossover period
Danish: 1 fra baseline til afslutning af Humalog Mix25 behandling 2 hos patienter randomiseret til Humalog Mix25 under den første crossover periode
English: • Do not freeze Humalog.
Danish: • Du må ikke nedfryse Humalog.
English: Humalog is also indicated for the initial stabilisation of diabetes mellitus.
Danish: Humalog er også indiceret til initial stabilisering af diabetes mellitus.
English: Inject Humalog as your physician or nurse has taught you.
Danish: Injicer Humalog som din læge eller diabetessygeplejerske har lært dig.
English: If the therapeutic regimen requires the injection of basal insulin and Humalog at the same time, the two can be mixed in the syringe.
Danish: Hvis doseringsregimet foreskriver injektion af basal insulin og Humalog på samme tid, kan disse blandes i en sprøjte.
English: Pen colour:
Danish: Pennens farve:
English: The MAH shall ensure that healthcare professionals are informed that all patients who have been prescribed Humalog should be trained on the correct use of the pre-filled pen before prescribing or dispensing Humalog.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at sundhedspersonalet er informeret om, at alle patienter, som får udskrevet Humalog, skal trænes i korrekt brug af den fyldte pen, før udskrivning eller udlevering af Humalog.
English: The DHPC and patient communication are aimed at increasing awareness about the fact that Humalog is now available in two strengths and describing key differences in the design of the packages and the pre-filled pen devices to minimise the risk of medication errors and mix up between the two different strengths of Humalog.
Danish: Den direkte sikkerhedsinformation og patientinformationen er beregnet til at øge opmærksomheden omkring, at Humalog/Liprolog nu er tilgængelig i to styrker samt beskrive hovedforskellene i designet af pakningerne og den fyldte pen for at minimere risikoen for fejlmedicinering og forveksling mellem de to forskellige styrker af Humalog.
English: • specific medicines to treat high blood pressure, kidney damage due to diabetes, and some heart problems (angiotensin II receptor blockers).
Danish: • specifikke lægemidler til behandling af forhøjet blodtryk, nyreskade forårsaget af sukkersyge samt visse hjerteproblemer(angiotensin II-receptorblokkere).
English: If repeated or severe low blood glucose levels occur consider the need to reduce or stop an insulin infusion.
Danish: Hvis der forekommer gentagne eller svært nedsatte blodglucosekoncentrationer, bør nødvendigheden af at reducere eller stoppe en insulininfusion overvejes.
English: Do not share your Pen with other people, even if the needle has been changed.
Danish: Del ikke din pen med andre, selvom du har skiftet nål.
English: No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors e.g. a patient`s level of diet and exercise.
Danish: Der er ikke anført nogen specifik hyppighed for hypoglykæmi eftersom, hypoglykæmi er et resultat af både insulindosis og andre faktorer så som patientens diæt og motionsniveau.
English: - If you usually need more than 30 units, ask your healthcare professional if a different
Danish: - Hvis du normalt behøver mere end 30 enheder, spørg sundhedspersonalet om en anden Humalog KwikPen vil være bedre for dig.
English: - Do you have trouble with your kidneys or liver?
Danish: - Har du symptomer fra dine nyrer eller lever?
English: Please make sure that Humalog or Lilly cartridges are mentioned in the leaflet accompanying your pen.
Danish: Vær sikker på, at Humalog eller Lilly cylinderampuller er nævnt i den brugsanvisning, der følger med din pen.
English: Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer to a meal (within zero to 15 minutes of the meal) when compared to soluble insulin (30 to 45 minutes before).
Danish: Insulin lispro har en hurtigt indsættende virkning (efter ca. 15 minutter), hvorfor insulin lispro kan gives tættere på et måltid (indenfor 0-15 minutter) sammenlignet med opløselig insulin (30-45 minutter før).
English: Changes in strength, brand (manufacturer), type (regular/soluble, NPH/isophane, etc.), species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage.
Danish: Ændringer i styrke, varemærke (fremstiller), type (regular/opløselig, NPH/isophan etc.), art (animalsk, human, human insulin-analog) og/eller fremstillingsmetode (rekombinant DNA versus insulin af animalsk oprindelse) kan resultere i et behov for ændring af dosis.
English: The label is white with an orange colour bar and there is an orange to yellow, burgundy colour band.
Danish: Etiketten er hvid med en orange stribe og et orange-gult og bourgogne farvet bånd.
English: One KwikPen contains multiple doses of insulin.
Danish: Én Kwikpen indeholder flere doser af insulin.
English: Date of first authorisation: 30th April 1996 Date of last renewal: 30th April 2006
Danish: Dato for første markedsføringstilladelse: 30. april 1996 Dato for seneste fornyelse : 30. april 2006
English: • It is normal to see a small amount of insulin left in the Pen that you cannot inject.
Danish: • Det er normalt, at pennen har en lille mængde insulin tilbage, som du ikke kan indsprøjte.
English: Pharmacotherapeutic group : Drugs used in diabetes, insulins and analogues for injection, fast-acting, ATC code: A10AB04
Danish: Farmakoterapeutisk klassifikation: Antidiabetica, insuliner og analoger til injektion, hurtigtvirkende, ATC-kode: A10AB04
English: Dose Knob Blue, with raised ridges on end and side
Danish: Doseringsknap Blå, med hævede riller på ende og side
English: This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Danish: Dette er af særlig betydning hos patienter, som har nedsat eller mistet evnen til at mærke advarselstegn på hypoglykæmi, eller har hyppige tilfælde af hypoglykæmi.
English: Step 2: (For HUMALOG suspensions cloudy insulins only)
Danish: Trin 2: (Gælder kun for HUMALOG uklar insulin suspension)
English: For subcutaneous injection of Humalog using a continuous infusion pump, you may fill the pump reservoir from a Humalog 100 units/ml vial.
Danish: Til subkutan injektion af Humalog ved hjælp af en kontinuerlig infusionspumpe kan du fylde pumpereservoiret fra et Humalog 100 enheder/ml hætteglas.
English: Humalog in cartridges is only suitable for subcutaneous injections from a Lilly reusable pen or compatible pump systems for continuous subcutaneous insulin infusion (CSII).
Danish: Humalog i cylinderampuller er kun beregnet til subkutane injektioner med en Lilly injektionspen eller kompatible pumpesystemer til kontinuerlig subkutan insulininfusion (CSII).
English: Gently roll the Pen 10 times.
Danish: Rul forsigtigt pennen 10 gange.
English: Now inject air into the Humalog vial in the same manner, but do not withdraw the needle.
Danish: Sprøjt nu luft ind i Humalog-hætteglasset på samme måde som tidligere omtalt, men træk ikke nålen ud bagefter.
English: Pens in use should be stored below 30°C and should not be refrigerated.
Danish: Penne i brug bør opbevares ved temperaturer under 30°C og bør ikke nedkøles.
English: Do this until a drop of Humalog comes out of the needle.
Danish: Gør dette indtil en dråbe Humalog kommer ud af nålen.
English: The KwikPen and Junior KwikPen are only suitable for subcutaneous injections.
Danish: KwikPen og Junior Kwikpen er kun beregnet til subkutane injektioner.
English: • flushed face fruity smell on the breath
Danish: • blussende ansigt frugtagtig ånde
English: If you stop using Humalog.
Danish: Hvis du holder op med at tage Humalog
English: How to recognize your Humalog Junior KwikPen: • Pen colour:
Danish: Sådan genkender du din Humalog Junior KwikPen: • Pennens farve:
English: For fast-acting insulins, any patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the whole day, particularly nocturnal/fasting glucose control.
Danish: Patienter, som anvender hurtigt virkende insulin samtidigt med middellangt virkende insulin, skal optimere dosis af begge typer insulin for at opnå glucosekontrol over hele døgnet, specielt natlig og fastende glucosekontrol.
English: OTHER SPECIAL WARNINGS, IF NECESSARY Resuspend carefully.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Opblandes forsigtigt.
English: 10 ml Vial: Pack of 1.
Danish: 10 ml hætteglas: Pakning a 1.
English: Use of injection sites should be rotated so that the same site is not used more than approximately once a month.
Danish: Indstiksstedet bør skiftes fra gang til gang, således at det samme sted ikke benyttes mere end ca. 1 gang pr. måned.
English: This rapid onset of activity allows a Humalog injection (or, in the case of administration by continuous subcutaneous infusion, a Humalog bolus) to be given very close to mealtime.
Danish: På grund af den hurtige effekt kan en Humalog injektion (eller i tilfælde af administration ved kontinuerlig subkutan infusion, en Humalog bolusinjektion) gives lige før eller efter et måltid.
English: • Additional risk minimisation measures (Humalog 200 units/ml)
Danish: Yderligere risikominimeringsforanstaltninger (Humalog 200 enheder/ml)
English: Humalog 200 units/ml KwikPen is also indicated for the initial stabilisation of diabetes mellitus.
Danish: Humalog 200 enheder/ml KwikPen er også indiceret til initial stabilisering af diabetes mellitus.
English: Check the appearance of the insulin.
Danish: Trin 3: Kontroller insulinets udseende.
English: Humalog 100 units/ml Junior KwikPen is suitable for patients who may benefit from finer insulin dose adjustments.
Danish: Humalog 100 enheder/ml Junior KwikPen er velegnet til patienter, som har gavn af finjusteringer af insulindosis.
English: Administration of Humalog Mix50 to children below 12 years of age should be considered only in case of an expected benefit when compared to soluble insulin.
Danish: Administration af Humalog Mix50 til børn under 12 år bør kun overvejes i tilfælde af en forventet gavnlig effekt af produktet sammenlignet med opløselig insulin.
English: - HUMALOG suspensions - cloudy insulins - should look white after mixing.
Danish: - HUMALOG suspension - uklar insulin - skal være mælkehvidt efter blanding.
English: • Inject Humalog under the skin (subcutaneously).
Danish: • Injicer Humalog under huden (subkutant).
English: For example if you do need to inject a mixture, draw the Humalog into the syringe before the long acting insulin.
Danish: Hvis du skal injicere en blanding, skal Humalog trækkes op i sprøjten før det længerevirkende insulin.
English: You should not normally mix Humalog with one of the mixtures of human insulins.
Danish: Du bør almindeligvis ikke blande Humalog med blandinger af human insulin.
English: Administration of Humalog Mix25 to children below 12 years of age should be considered only in case of an expected benefit when compared to soluble insulin.
Danish: Administration af Humalog Mix25 til børn under 12 år bør kun overvejes i tilfælde af en forventet gavnlig effekt af produktet sammenlignet med opløselig insulin.
English: This should be kept in mind, if treatment with the combination of pioglitazone and Humalog is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og Humalog overvejes.
English: Use of Humalog in an insulin infusion pump
Danish: Brug af Humalog i en insulininfusionspumpe
English: Local allergy in patients is common.
Danish: Lokale allergiske reaktioner er almindelig forekommende.
English: Using Humalog in an infusion pump
Danish: Brug af Humalog i en infusionspumpe
English: Humalog KwikPen is available in two strengths, 100 units/ml and 200 units/ml.
Danish: Humalog KwikPen fås i to styrker, 100 enheder/ml og 200 enheder/ml.
English: PLEASE READ THESE INSTRUCTIONS BEFORE USE Read the Instructions for Use before you start taking Humalog Junior KwikPen and each time you get another Humalog Junior KwikPen.
Danish: LÆS VENLIGST DENNE BRUGSANVISNING INDEN BRUG Læs brugsanvisningen før du begynder at tage Humalog Junior KwikPen og hver gang du får en ny Humalog Junior KwikPen, da brugsanvisningen kan være opdateret med ny information.
English: Humalog BASAL has an activity profile that is very similar to that of a basal insulin (NPH) over a period of approximately 15 hours.
Danish: Virkningsprofilen af Humalog BASAL svarer til virkningsprofilen af basal insulin (isophan) over en tidsperiode på ca. 15 timer.
English: Pack of 1
Danish: Pakning med 1
English: - The whole unit numbers are printed on the dial.
Danish: - Hele enheder er trykt på doseringsskiven.
English: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between the two different strengths of Humalog KwikPen as well as other insulin products.
Danish: Patienter skal instrueres i altid at kontrollere insulinetiketten før hver injektion for at undgå forveksling af de to forskellige styrker af Humalog KwikPen såvel som andre insuliner.
English: If necessary, Humalog may also be administered intravenously, for example: for the control of blood glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods.
Danish: Dette kan f.eks. være for at kontrollere blodglucoseniveauet under en ketoacidose, i forbindelse med akut sygdom eller under/efter en operation.
English: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between the two different strengths of Humalog as well as other insulin products.
Danish: Patienter skal instrueres i altid at kontrollere insulinetiketten før hver injektion for at undgå forveksling af de to forskellige styrker af Humalog såvel som andre insuliner.
English: Other forms of Humalog 100 unit /ml are available if this is necessary.
Danish: Humalog 100 enheder/ml er tilgængelig i andre former, hvis det er nødvendigt.
English: Insulin lispro takes effect rapidly and has a shorter duration of activity (2 to 5 hours) when compared to soluble insulin.
Danish: Insulin lispro virker hurtigere og har en kortere virkningsvarighed (2-5 timer) sammenlignet med opløselig insulin.
English: Humalog should not be used if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.
Danish: Humalog må ikke anvendes, hvis det virker uklart, tyktflydende, er let farvet, eller hvis der ses faste partikler i væsken.