FrancophonIA/ELRC3.0 huggingface dataset:
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Danish: Prækliniske data viser ingen særlig risiko for mennesker baseret på koventionelle studier af farmakologisk sikkerhed, gentagen dosis-toxicitet, genotoxicitet, karcinogen potentiale og reproduktionstoxicitet.
English: Monotard is human insulin to treat diabetes.
Danish: Monotard er humant insulin til diabetesbehandling.
English: Monotard vials that are being used or about to be used are not to be kept in the fridge.
Danish: Monotard hætteglas, som er taget i brug, eller som snart skal tages i brug, skal ikke opbevares i køleskab.
English: Monotard may be used alone or mixed with fast-acting insulin.
Danish: Monotard kan bruges alene eller blandes med hurtigtvirkende insulin.
English: Octreotide/ laneotide may both decrease and increase insulin requirement.
Danish: Octreotid/lanreotid kan både reducere og forøge insulinbehovet.
English: • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
Danish: Svær hypoglykæmi, hvor patienten er blevet bevidstløs, kan behandles med glukagon (0,5 - 1 mg) indgivet intramuskulært eller subkutant af en instrueret person eller med glukose indgivet intravenøst af en medicinsk uddannet person.
English: The following substances may reduce insulin requirement:
Danish: Følgende lægemidler kan forøge behovet for insulin:
English: If it isn't in perfect condition when you get the vial, return the vial to your supplier ► If it hasn't been stored correctly or been frozen (see 6 How to store Monotard) ► If it's not uniformly white and cloudy when it's mixed.
Danish: Hvis den er løs eller mangler, når De køber hætteglasset, skal De returnere hætteglasset til apoteket ► Hvis det ikke har været opbevaret korrekt eller har været nedfrosset (se 6 Hvordan De opbevarer Monotard) ► Hvis væsken ikke fremstår ensartet hvid og uklar efter opblanding.
English: Look out for the signs of allergy in 5 Possible side effects.
Danish: Se en beskrivelse af symptomer på allergi i 5 Hvilke mulige bivirkninger Monotard har.
English: Monotard should be protected from excessive heat and sunlight.
Danish: Monotard bør ikke udsættes for varme og direkte sollys.
English: The suspension consists of a mixture of amorphous and crystalline particles (ratio 3:7).
Danish: Suspensionen indeholder en blanding af amorfe og krystallinske partikler (forhold 3:7).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Monotard is a zinc suspension consisting of a mixture of amorphous and crystalline particles (ratio 3:7).
Danish: Monotard er en zinksuspension, der indeholder en blanding af amorfe og krystallinske partikler (forhold 3:7).
English: Monotard is often given in combination with fast-acting insulins.
Danish: Monotard gives ofte i kombination med hurtigtvirkende insulintyper.
English: • Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Danish: Mild hypoglykæmi kan behandles med oral indtagelse af glukose eller sukkerholdige produkter.
English: Glass vial (type 1) closed with a bromobutyl/polyisoprene rubber stopper and a protective tamperproof plastic cap.
Danish: Hætteglas (type 1) lukket med en gummiskive af brombutyl/polyisopren og en beskyttelsesplastikhætte som sikrer mod utilsigtet åbning.
English: Monotard is an insulin zinc suspension.
Danish: Monotard er en zinkinsulinsuspension.
English: Monotard is a cloudy, white, aqueous suspension.
Danish: Monotard er en uklar, hvid, vandig suspension.
English: During use: do not refrigerate.
Danish: Efter ibrugtagning: Må ikke opbevares i køleskab.
English: The suspension for injection comes as a white, cloudy aqueous suspension in packs of 1 or 5 vials of 10 ml (not all packs may be marketed).
Danish: Injektionsvæske, suspension, leveres som en ensartet hvid og uklar suspension i pakninger med 1 eller 5 hætteglas a 10 ml (ikke alle pakningsstørrelser er nødvendigvis markedsført).
English: See 4 What to do in an emergency for more about hypos ► If you have ever had an allergic reaction to this insulin product or any of the ingredients (see box, below left).
Danish: Se 4 Forholdsregler i nødsituationer - for yderligere oplysninger om hypoglykæmi (lavt blodsukker) ► Hvis De er allergisk over for dette insulinpræparat eller et af de øvrige indholdsstoffer (se boks nederst til venstre).
English: 6 How to store Monotard
Danish: 6 Hvordan De opbevarer Monotard
English: You can carry them with you and keep them at room temperature (below 25°C) for up to 6 weeks.
Danish: Kan medbringes og opbevares ved stuetemperatur (ikke over 25° C) i op til 6 uger.
English: Monotard is usually administered subcutaneously in the thigh.
Danish: Monotard administreres normalt subkutant i låret.
English: Monotard is a long-acting insulin.
Danish: Monotard er et langtidsvirkende insulin.
English: When mixing Actrapid with Monotard immediate injection is necessary to avoid blunting of the fast acting effect of Actrapid.
Danish: Når Actrapid blandes med Monotard, skal injektionen udføres straks for at undgå nedsættelse af Actrapids hurtige virkning.
English: Inject the air into the Monotard vial, then pull out the needle
Danish: Injicér luften i hætteglasset med Monotard, og træk nålen ud
English: Make sure there's no air left in the syringe, and check the dose
Danish: Kontrollér, at der ikke er luft i sprøjten, og kontrollér dosis.
English: Prevent this by choosing different injection sites each time within the same area.
Danish: For at undgå dette bør De vælge nyt injektionssted inden for samme område til hver injektion.
English: Before using Monotard ► Make sure it is the right type of insulin ► Disinfect the rubber membrane with surgical spirit.
Danish: Før De anvender Monotard ► Kontrollér, at det er den rigtige insulin type ► Afsprit gummimembranen.
English: Other medicines and Monotard
Danish: Monotard og andre lægemidler
English: 2 Before you use Monotard
Danish: 2 Hvad De skal gøre, før De begynder at tage Monotard
English: A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
Danish: Hvis en justering er nødvendig ved skift til Monotard, kan det vise sig ved første dosis eller inden for Nogle få patienter, som har oplevet hypoglykæmiske reaktioner efter skift fra animalsk insulin, har rapporteret, at de tidlige advarselssymptomer på hypoglykæmi var mindre udtalte eller forskellige fra dem, som de havde oplevet med deres tidligere insulin.
English: The physician must therefore take possible interactions into account and should always ask their patients about any medicinal products they take.
Danish: Lægen bør derfor altid overveje mulige interaktioner samt spørge sine patienterne, om de anvender andre lægemidler Følgende lægemidler kan reducere behovet for insulin:
English: Do not use Monotard ► If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of low blood sugar).
Danish: De bør ikke anvende Monotard ► Hvis De føler en begyndende hypoglykæmi (for lavt blodsukker).
English: Hypoglycaemia Hypersensitivity to human insulin or to any of the excipients (see section 6.1 List of excipients).
Danish: Overfølsomhed over for human insulin eller et eller flere af hjælpestofferne (se afsnit 6.1, Fortegnelse over hjælpestoffer).
English: 4 What to do in an emergency
Danish: 4 Forholdsregler i nødsituationer
English: 3 Using Monotard
Danish: 3 Hvordan De anvender Monotard
English: Low or high blood sugar (hypo or hyperglycaemia).
Danish: De mest almindelige bivirkninger er lavt eller højt blodsukker (hypoglykæmi eller hyperglykæmi).
English: • Before first use and just before injecting Monotard, shake the vial up and down at least 10 times and roll the vial between your hands.
Danish: Før ibrugtagning og før injektion af denne insulin rystes hætteglasset op og ned mindst 10 gange, og det rulles mellem hænderne.
English: For precautions see section 4.4 Special warnings and special precautions for use.
Danish: 4.4, Særlige advarsler og forsigtighedsregler vedrørende brugen..
English: Mixing of Monotard with phosphate buffered insulin preparations is not recommended due to the risk of precipitation of zinc-phosphate, leading to an unpredictable timing of such insulin mixtures.
Danish: Det anbefales ikke at blande Monotard med insulinpræparater med fosfatbuffer, da zincphosphat kan udfældes og ændre insulinblandingens aktionsprofil på en uforudsigelig måde.
English: • Draw the right dose of Monotard into the syringe.
Danish: Træk den korrekte mængde Monotard ind i sprøjten.
English: • Inject straight away.
Danish: Injicér straks.
English: When you start taking insulin, water retention may cause swelling around your ankles and other joints.
Danish: Når De påbegynder insulinbehandling, kan væskeophobning forårsage hævede ankler eller andre led.
English: NAME OF THE MEDICINAL PRODUCT Monotard 40 IU/ml
Danish: LÆGEMIDLETS NAVN Monotard 40 IE/ml
English: Monotard vials that are not being used are to be stored in the fridge at 2°C - 8°C, away from the freezer compartment.
Danish: Monotard hætteglas, som ikke er i brug, skal opbevares ved 2˚C - 8˚C i køleskab, ikke for tæt på fryseelementerne.
English: Taking too much or too little Monotard may cause respectively hypo or hyperglycaemia.
Danish: Over- eller underdosering af Monotard kan forårsage henholdsvis hypoglykæmi eller hyperglykæmi.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Et antal lægemidler er kendt for at påvirke glukosemetabolismen.
English: Monotard vials are for use with insulin syringes with the corresponding unit scale.
Danish: Hætteglas med Monotard skal anvendes med insulininjektionssprøjter med tilsvarende enhedsskala.
English: • Now push the needle into the vial of Monotard.
Danish: Stik nu nålen ind i hætteglasset med Monotard.
English: 1 What Monotard is
Danish: 1 Hvad Monotard er, og hvad det anvendes til
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. INDEHAVERE AF VIRKSOMHEDSGODKENDELSE ANSVARLIGE FOR BATCHFRIGIVELSE OG FREMSTILLER AF DET BIOLOGISK AKTIVE STOF
English: Take special care with Monotard ► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands ► If you are drinking alcohol: watch for signs of a hypo ► If you are exercising more than usual or if you want to change your usual diet ► If you are ill: carry on taking your insulin ► If you are going abroad: travelling over time zones may affect your insulin needs ► If you are pregnant, or planning a pregnancy: you must be especially careful to control your blood sugar; too much or too little could harm your health and the baby's ► If you are breastfeeding: there's no risk to the baby, but you may need to adjust your insulin and your diet ► If you drive or use tools or machines: watch out for signs of a hypo.
Danish: De bør være specielt opmærksom, når De anvender Monotard ► Hvis De har problemer med nyrer, lever, binyrer, hypofyse eller skjoldbruskkirtel ► Hvis De drikker alkohol: Vær opmærksom på symptomer på hypoglykæmi (lavt blodsukker) ► Hvis De dyrker mere motion end normalt eller ønsker at ændre Deres kost ► Hvis De bliver syg, skal De fortsætte insulinbehandlingen ► Hvis De har planer om at rejse til udlandet: Tidsforskellen mellem landene kan påvirke insulinbehovet
English: Make sure there is no air left in the syringe: point the needle upwards and push the air out.
Danish: Kontrollér, at der ikke er luft i sprøjten: Vend nålen opad og skub luften ud.
English: • Draw the right dose of fast acting insulin into the syringe.
Danish: Træk den korrekte mængde hurtigtvirkende insulin ind i sprøjten.
English: Inject the insulin
Danish: Sådan injiceres insulinet
English: 5 Possible side effects
Danish: 5 Hvilke mulige bivirkninger Monotard har
English: Store at 2°C - 8°C (in a refrigerator) Do not freeze
Danish: Opbevares ved 2˚C - 8˚C (i køleskab) Må ikke nedfryses
English: • If you eat too little or miss a meal
Danish: Hvis De spiser for lidt eller springer et måltid over Hvis De dyrker mere motion end De plejer.
English: • Draw as much air into the syringe as the dose of Monotard you need.
Danish: Træk en mængde luft ind i sprøjten svarende til dosis af Monotard.
English: Store at 2°C - 8°C (in a refrigerator) not near a freezing compartment.
Danish: Opbevares ved 2˚C - 8˚C (i køleskab) og ikke nær fryseelementerne.
English: To inject Monotard on its own
Danish: Hvis Monotard anvendes alene
English: LIST OF EXCIPIENTS zinc chloride, zinc acetate, sodium chloride, methyl parahydroxybenzoate, sodium acetate, sodium hydroxide, hydrochloric acid and water for injections
Danish: LISTE OVER HJÆLPESTOFFER zinkchlorid, zinkacetat, natriumchlorid, methylparahydroxybenzoat, natriumacetat, natriumhydroxid, saltsyre og vand til injektionsvæsker
English: Very rarely, people get redness, swelling or itching around the area of the insulin injection (local allergic reactions).
Danish: Reaktioner (rødme, hævelse, kløe) på injektionsstedet kan forekomme (lokale allergiske reaktioner).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 ml
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Monotard 40 IU/ml Suspension for injection in a vial Suspension for injection in a vial.
Danish: Monotard 40 IE/ml Injektionsvæske, suspension i hætteglas
English: • Draw as much air into the syringe as the dose of fast acting insulin you need.
Danish: Træk en mængde luft ind i sprøjten svarende til dosis af hurtigtvirkende insulin.
English: Always vary the sites you inject, to avoid lumps (see 5 Possible side effects).
Danish: For at undgå hudfortykkelse bør De vælge et nyt injektionssted inden for samme område til hver injektion (se 5 Hvilke mulige bivirkninger Monotard har).
English: Monotard 100 IU/ml Suspension for injection in a vial Suspension for injection in a vial.
Danish: Monotard 100 IE/ml Injektionsvæske, suspension i hætteglas
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Monotard 100 IU/ml
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E) Monotard 100 IE/ml
English: The following substances may increase insulin requirement: Thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Danish: Thiazider, glukokortikoider, thyreoideahormoner og betasympatomimetika, væksthormon og danazol.
English: Monotard is accompanied by a package leaflet with detailed instruction for use to be followed.
Danish: Følg instruktioner for brug og håndtering i den medfølgende indlægsseddel til Monotard.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Monotard 40 IU/ml
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E) Monotard 40 IE/ml
English: • Inject the air into the vial: push the needle through the rubber stopper and press the plunger
Danish: Træk en mængde luft ind i sprøjten svarende til den mængde insulin, De vil injicere Injicér luften i hætteglasset: Stik nålen igennem gummiskiven, og tryk stemplet i bund
English: 1 ml contains 40 IU of insulin human.
Danish: 1 ml Monotard indeholder 40 IE humant insulin.
English: Monotard also contains zinc chloride, zinc acetate, sodium chloride, methyl parahydroxy benzoate, sodium actetate, sodium hydroxide, hydrochloric acid and water for injections.
Danish: 1 hætteglas indeholder 10 ml svarende til 400 IE. Monotard indeholder også zinkchlorid, zinkacetat, natriumchlorid, methylparahydroxybenzoat, natriumacetat, natriumhydroxid, saltsyre og vand til injektionsvæsker.
English: Rare side effects (up to 0.1%)
Danish: Meget sjældent rapporterede bivirkninger (mindre end 1 til 10.000) Synsproblemer.
English: • Turn the vial and syringe upside down
Danish: Vend derefter hætteglasset og sprøjten med bunden i vejret
English: Causes of a hyperglycaemia
Danish: Hyperglykæmi (højt blodsukker)
English: OUTER CARTON
Danish: Udløbsdato
English: 28 February 2011
Danish: Den 28. februar 2011
English: However, a number of them questioned the restriction.
Danish: En række af dem satte imidlertid spørgsmålstegn ved begrænsningen.
English: The European Commission issued a decision on 28 February 2011.
Danish: Europa-Kommissionen traf en afgørelse den 28. februar 2011.
English: There are no new safety concerns with the medicines.
Danish: Der er ingen nye sikkerhedsproblemer med lægemidlerne.
English: Currently, four fibrates are available in the European Union:
Danish: På nuværende tidspunkt markedsføres fire fibrater i EU:
English: Fibrates have been in use since the 1960s.
Danish: Fibrater har været anvendt siden 1960'erne.
English: This means that they activate a type of receptor called the ‘peroxisome proliferator activated receptor'.
Danish: Det vil sige, at de aktiverer receptorer af typen “peroxisom-proliferatoraktiveret receptor”.
English: The Committee recommended specific changes to the information to doctors and patients for all four fibrates.
Danish: Udvalget anbefalede konkrete ændringer af informationen til læger og patienter med alle fire fibrater.
English: It is sold in all EU Member States except Denmark and the Netherlands, as well as in Iceland and Norway;
Danish: Det markedsføres i alle EU's medlemsstater undtagen Danmark og Nederlandene, desuden i Island og Norge.
English: Fibrates are ‘PPAR agonists'.
Danish: Fibrater er “PPAR-agonister”.
English: Why were fibrates reviewed?
Danish: Hvorfor blev fibrater vurderet igen?
English: Fibrates should be used only when statins are contraindicated or not tolerated.
Danish: Fibrater bør kun anvendes, når statiner er uegnede eller ikke tåles.
English: What are fibrates?
Danish: Hvad er fibrater?
English: The conclusions of the PhVWP were transmitted to the companies that market fibrates, so that they could implement the changes recommended by the working party.
Danish: PhVWP's konklusioner blev overgivet til de virksomheder, der markedsfører fibrater, for at de kunne foretage de ændringer, som arbejdsgruppen havde anbefalet.
English: The European Medicines Agency has completed a review of the safety and effectiveness of fibrates.
Danish: Det Europæiske Lægemiddelagentur har gennemgået sikkerheden og virkningen af fibrater.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of fibrates continue to outweigh their risks within these restrictions.
Danish: Efter vurdering af de foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved fibrater inden for disse begrænsninger stadig er større end risiciene.
English: However, fibrates can be used in patients who cannot take statins (another type of medicine used to lower blood lipid levels).
Danish: Fibrater kan dog anvendes hos patienter, der ikke må få statiner (en anden type lægemidler, der sænker blodlipiderne).
English: The Committee also noted that there were new data for fenofibrate that supported a change to the PhVWP recommendations, based on the results of the add-on study.
Danish: Udvalget konstaterede desuden, at der er fremkommet nye data om fenofibrat, som støtter en ændring af PhVWP's anbefalinger baseret på resultaterne af undersøgelsen om tillægsbehandling.
English: This receptor can be found in many cells throughout the body, where it is involved in breaking down dietary fat, especially triglycerides and cholesterol.
Danish: Denne receptor findes mange steder i kroppen, hvor den deltager i nedbrydningen af kostens fedtindhold, specielt triglycerider og kolesterol.
English: As a result, the Committee also allowed the use of fenofibrate together with a statin in some circumstances for patients at risk when using a statin on its own was not enough to completely control blood lipid levels.
Danish: Derfor tillod udvalget, at fenofibrat under visse omstændigheder bruges sammen med et statin til patienter, der udsættes for risiko, når statiner alene ikke begrænser blodlipiderne tilstrækkeligt.
English: The aim of the review was to establish how fibrates should now be used, taking into account their safety, their effectiveness in lowering lipid levels and the availability of other lipid-lowering medicines that were not around when fibrates were first used.
Danish: Formålet med gennemgangen var at fastlægge, hvordan fibrater bør anvendes, når man tager hensyn til sikkerhed, lipidsænkende evne og tilgængeligheden af andre lipidsænkende lægemidler, der ikke fandtes, da man begyndte at bruge fibrater.
English: The Committee also looked at the latest data from clinical studies including a trial looking at the effect of using fenofibrate as an ‘add-on' to statins.
Danish: Udvalget gennemgik derudover de seneste data fra kliniske undersøgelser, herunder en undersøgelse af fenofibrats virkning som tillægsbehandling til statiner.
English: Fibrates are a class of medicines that can be used to lower the level of lipids, such as cholesterol and triglycerides, in the blood.
Danish: Fibrater er en klasse lægemidler, der anvendes til at sænke blodets indhold af lipider såsom kolesterol og triglycerider.
English: This means that newlydiagnosed patients with blood lipid disorders should not be treated using these medicines in the first instance, unless they have very high levels of triglycerides (a type of fat).
Danish: Det vil sige, at man ikke skal vælge disse lægemidler som førstevalg til nydiagnosticerede patienter med forstyrrelser i blodlipiderne, medmindre patienten har et meget højt niveau af triglycerider (en type fedtstoffer).
English: In 2005, the CHMP's PharmacoVigilance Working Party (PhVWP) noted that there was limited evidence of the long-term benefit of fibrates in reducing cardiovascular risk, compared with the stronger evidence for statins (another type of medicines used for lowering blood cholesterol).
Danish: CHMP's arbejdsgruppe vedrørende lægemiddelovervågning (PhVWP) bemærkede i 2005, at der kun var begrænset dokumentation for fibraters evne til at nedsætte hjerte-kar-risikoen; dette skal sammenholdes med den stærkere dokumentation for statiner (en anden type kolesterolsænkende medicin).
English: • However, patients taking a fibrate-containing medicine should arrange to see their doctor to check that the medicine is the most appropriate option to lower their blood lipid levels.
Danish: • Patienter, der er i behandling med et fibrat, bør imidlertid aftale en konsultation med lægen for at denne kan afgøre, om lægemidlet er det bedste valg til at sænke blodlipiderne.
English: The Committee endorsed the conclusions of the PhVWP that fibrates are still a safe option for lowering lipid levels, but that their use as first-line treatment is not justified.
Danish: Udvalget tilsluttede sig PhVWP's konklusioner om, at fibrater stadig er et sikkert valg til sænkning af lipidindholdet, men at de ikke er berettiget som førstevalgsbehandling.
English: • Patients who are currently taking fibrates to lower their blood lipid levels should continue to do so.
Danish: • Patienter, der er i behandling med fibrater for at sænke blodets lipidindhold, skal fortsætte med behandlingen.
English: • Ciprofibrate.
Danish: • Ciprofibrat.