FrancophonIA/ELRC3.0 huggingface dataset:
English: • Insuman Rapid, Insuman Infusat and Insuman Implantable, which are fast-acting insulin solutions containing soluble insulin;
Danish: • Insuman Rapid, Insuman Infusat og Insuman Implantable, der er hurtigtvirkende insulinopløsninger, der indeholder opløselig insulin
English: In one of the studies, Insuman was given to patients with type 1 diabetes using an external insulin pump.
Danish: I en af undersøgelserne blev Insuman givet til patienter med type 1-diabetes ved hjælp af en ekstern insulinpumpe.
English: In another study, Insuman Comb 25 was compared with semi-synthetic human insulin in patients with type 1 and type 2 diabetes.
Danish: I en anden undersøgelse blev Insuman Comb 25 sammenlignet med semisyntetisk human insulin hos patienter med type 1- og type 2-diabetes.
English: Insuman has been studied in three trials in 780 patients with either type 1 diabetes or type 2 diabetes.
Danish: Insuman blev undersøgt i tre undersøgelser hos 780 patienter med enten type 1-diabetes eller type 2diabetes.
English: In addition, Insuman Implantable must not be used any other way than as a continuous infusion using the Medtronic MiniMed Implantable Pump.
Danish: Endvidere må Insuman Implantable ikke anvendes på nogen anden måde end som kontinuerlig infusion ved hjælp af Medtronic MiniMed Implantable Pump.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose (type 1 diabetes) or when the body is unable to use insulin effectively (type 2 diabetes).
Danish: Ved sukkersyge producerer kroppen enten ikke nok insulin til at regulere blodsukkeret (type 1diabetes), eller også er den ikke i stand til at udnytte insulinet effektivt (type 2-diabetes).
English: What is Insuman?
Danish: Hvad er Insuman?
English: The CHMP decided that Insuman's benefits are greater than its risks for the treatment of type 1 and type 2 diabetes.
Danish: CHMP besluttede, at fordelene ved Insuman opvejer risiciene ved behandling af type 1- og type 2diabetes.
English: Insuman is a range of insulin-containing solutions and suspensions for injection.
Danish: Insuman er en række forskellige opløsninger og suspensioner af insulin til injektion.
English: Insuman Implantable is given only by infusion into the abdominal cavity using a pump (Medtronic MiniMed implantable pump) that is implanted under the skin of the abdomen.
Danish: Insuman Implantable gives kun ved infusion i bughulen ved hjælp af en pumpe (Medtronic MiniMed implantable Pump), der implanteres under huden i maven.
English: • Insuman Basal, an intermediate-acting insulin suspension containing isophane insulin;
Danish: • Insuman Basal, en insulinsuspension med mellemlang virkningstid, som indeholder isophaninsulin
English: Insuman Infusat is specially prepared ready to be used as a continuous infusion under the skin using an external portable infusion pump.
Danish: Insuman Infusat er fremstillet specielt til anvendelse ved kontinuerlig infusion under huden ved hjælp af en ekstern transportabel insulinpumpe.
English: Insuman was effective for both type 1 and type 2 diabetes.
Danish: Insuman var effektivt til behandling af såvel type 1- som type 2-diabetes.
English: The Insuman range is comprised of:
Danish: Insuman-produkterne er følgende:
English: What is Insuman used for?
Danish: Hvad anvendes Insuman til?
English: How has Insuman been studied?
Danish: Hvordan blev Insuman undersøgt?
English: What benefit has Insuman shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Insuman?
English: How is Insuman used?
Danish: Hvordan anvendes Insuman?
English: How does Insuman work?
Danish: Hvordan virker Insuman?
English: It is supplied in vials, cartridges, or pre-filled disposable pens.
Danish: Insuman leveres i hætteglas, cylinderampuller og færdigfyldte injektionspenne til engangsbrug.
English: EMA Number
Danish: EMA's procedurenr.
English: 2 years.
Danish: To år.
English: Wash your hands thoroughly using soap and warm water.
Danish: Vask hænderne grundigt med sæbe og varmt vand.
English: This is particularly important if you are having major surgery.
Danish: Dette er især vigtigt, hvis du skal have udført en større operation.
English: ADVATE is indicated in all age groups.
Danish: ADVATE er indiceret til alle aldersgrupper.
English: Data show that immune tolerance may be achieved.
Danish: Data viser, at der kan opnås immuntolerance.
English: (pre- and postoperative)
Danish: (præ- og postoperativ)
English: Frequency of doses (hours)/duration of therapy (days)
Danish: Hyppighed af doser (timer)/behandlingsvarighed (dage)
English: The product dissolves rapidly (usually in less than 1 minute).
Danish: Produktet opløses hurtigt (normalt på mindre end 1 minut).
English: Tel: +44(0)1256 894 959 e-mail: medinfoEMEA@shire.com
Danish: Tlf: +44(0)1256 894 959 e-mail: medinfoEMEA@shire.com
English: Glutathione (reduced)
Danish: Glutathion (reduceret)
English: However, chemical and physical in-use stability has been demonstrated for 3 hours at 25 °C.
Danish: Imidlertid er der er påvist kemisk-fysisk stabilitet i 3 timer ved 25 °C.
English: ATC code: B02BD02.
Danish: ATC-kode: B02BD02.
English: (See Section 4 “Possible side effects”).
Danish: (se afsnit 4 ”Bivirkninger”).
English: The required dose is determined using the following formula:
Danish: Den nødvendige dosis bestemmes ud fra følgende formel:
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock bør standardbehandling af shock iværksættes.
English: The data from this study demonstrate that the two prophylactic dosing regimens are comparable in terms of reduction of bleeding rate.
Danish: Data fra dette studie påviser, at de to regimer for profylaksedosis er sammenlignelige for så vidt angår nedsat blødningshyppighed.
English: The solvent vial has a blue stripe.
Danish: Solvenshætteglasset har en blå stribe.
English: Do not inject a double dose to make up for a forgotten dose.
Danish: Du må ikke injicere en dobbeltdosis som erstatning for en glemt dosis.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette må tages i betragtning for patienter på en kontrolleret natriumdiæt.
English: C OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Do not remove the device from the package.
Danish: Fjern ikke udstyret fra pakningen.
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Danish: Hvis disse inhibitorer opstår, vil tilstanden komme til udtryk som utilstrækkeligt klinisk respons.
English: • Do not try to administer the injection unless you have received special training from your doctor or nurse.
Danish: • Forsøg ikke selv at foretage injektionen, hvis du ikke har fået speciel træning i dette af din læge eller sygehuspersonalet.
English: The product is provided in one of the following configurations:
Danish: Præparatet leveres i en af følgende sammensætninger:
English: Retrospective chart review was done for 30 paediatric subjects on ITI (in study 060703).
Danish: Retrospektiv journalgennemgang blev udført for 30 pædiatriske patienter på ITI (i studie 060703).
English: No interaction studies have been performed with ADVATE.
Danish: Der er ikke udført interaktionsstudier med ADVATE.
English: Procedural site reaction a) Calculated based on total number of patients who received ADVATE (418).
Danish: Reaktion på procedurestedet a) Beregnet på basis af det totale antal patienter, der fik ADVATE (418).
English: Usually, the replacement therapy with ADVATE is a life-long treatment.
Danish: Normalt er erstatningsbehandling med ADVATE en livslang behandling.
English: (see section 4.2 for information on paediatric use).
Danish: 4.2 for oplysninger om pædiatrisk anvendelse).
English: ADVATE should be administered via the intravenous route.
Danish: ADVATE bør indgives via intravenøs vej.
English: Rarely, inhibitors may develop after the first 100 exposure days.
Danish: Inhibitorer udvikles sjældent efter de første 100 eksponeringsdage.
English: Animal reproduction studies have not been conducted with factor VIII.
Danish: Der er ikke udført reproduktionsforsøg i dyr med faktor VIII.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Danish: Trombin omdanner derefter fibrinogen til fibrin, og et koagel kan dannes.
English: Your doctor will perform appropriate laboratory tests to make sure that you have adequate Factor VIII levels.
Danish: Din læge vil med passende mellemrum foretage nødvendige laboratorietests for at sikre, at du har tilstrækkelige faktor VIII-niveauer.
English: The pulse rate should be determined before and during administration of ADVATE.
Danish: Pulshastigheden bør måles før og under indgivelse af ADVATE.
English: Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch.
Danish: Det anbefales derfor at overvåge alle patienter nøje for udvikling af inhibitorer efter ethvert produktskift.
English: Important note:
Danish: Vigtig information:
English: ADVATE is prepared without the addition of any human- or animal-derived protein in the entire manufacturing process.
Danish: ADVATE er fremstillet uden tilsætning af protein fra mennesker eller dyr under hele fremstillingsprocessen.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: However, in some cases, especially in younger patients, more frequent injections or higher doses may be necessary.
Danish: Dog kan det i nogle tilfælde, især hos yngre patienter, være nødvendigt med et øget dosis-interval eller en højere dosis.
English: Do not draw air into the syringe.
Danish: Træk ikke luft ind i sprøjten.
English: A non-interventional prospective registry (PASS-INT-004) documented ITI in 44 paediatric and adult subjects of whom 36 completed ITI therapy.
Danish: En prospektiv ikke-interventionsregisterundersøgelse (PASS-INT-004) dokumenterede ITI hos 44 pædiatriske og voksne patienter, hvoraf 36 gennemførte ITI-behandlingen.
English: Frequency categories are defined according to the following convention: 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), not known (cannot be estimated from the available data).
Danish: Frekvensen er angivet efter følgende konvention: 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • Do not use after the expiry date stated on the labels and carton.
Danish: • Må ikke anvendes efter udløbsdatoen, der fremgår af etiket og karton.
English: Verify that the solvent transfer is complete.
Danish: Kontroller, at solvenset er fuldstændigt overført.
English: Data on Immune Tolerance Induction (ITI) in patients with inhibitors have been collected.
Danish: Data vedrørende induktion af immuntolerance (ITI) hos patienter med inhibitorer er blevet indsamlet.
English: The product contains traces of mouse and hamster proteins.
Danish: Produktet indeholder spor af muse- og hamsterproteiner.
English: Do not use if packaging is opened or damaged.
Danish: Må ikke anvendes, hvis pakningen er åbnet eller beskadiget.
English: Parameter (mean ± standard deviation)
Danish: Parameter (middel ± standardafvigelse)
English: Baxter AG Industriestrasse 67 A-1221 Vienna Austria
Danish: Baxter AG Industriestrasse 67 A-1221 Wien Østrig
English: Development of antibodies to mouse and/or hamster protein with related hypersensitivity reactions may be observed.
Danish: Udvikling af antistoffer mod muse- og/eller hamsterprotein med relaterede overfølsomhedsreaktioner kan ses.
English: The dose and frequency of administration should be adapted to the clinical response in the individual case.
Danish: Dosen samt hyppigheden for indgivelse bør tilpasses det kliniske respons i hvert enkelt tilfælde.
English: Use the product immediately once the powder is completely dissolved.
Danish: Anvend produktet straks efter fuldstændig opløsning af pulveret.
English: Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Danish: Individuelle patienter kan variere i deres respons på faktor VIII, og således opnå forskellige niveauer af in vivo bedring samt udvise forskellige halveringstider.
English: Use immediately or within 3 hours of reconstitution.
Danish: Bruges straks eller inden for 3 timer efter rekonstitution.
English: Haemostasis was maintained at all times during this period and both plasma factor VIII levels and clearance rates returned to appropriate levels by postoperative day 15.
Danish: Hæmostase blev opretholdt i hele denne periode, og både plasmafaktor VIII-niveau og clearance vendte tilbage til passende niveauer på dag 15 efter operationen.
English: Very common (PUPs)d
Danish: Meget almindelig (PUPs)d
English: Under certain circumstances (e.g. presence of a low-titre inhibitor), doses larger than those calculated using the formula may be necessary.
Danish: Under visse omstændigheder (f.eks. i tilfælde af en lav titer-inhibitor) kan det være nødvendigt at indgive større doser end dem, som beregnes ved brug af formlen.
English: b) The unexpected decrease in coagulation factor VIII levels occurred in one patient during continuous infusion of ADVATE following surgery (postoperative days 10-14).
Danish: b) Den uventede nedsættelse af koagulationsfaktor VIII-niveau forekom hos én patient under kontinuerlig infusion af ADVATE efter kirurgisk indgreb (dag 10-14 efter operation).
English: Categories of these analyses for infants (1 month to <2 years of age), children (2 to <5 years of age), older children (5 to <12 years of age), adolescents (12 to <18 years of age), and adults (18 years of age and older) were used to summarize PK parameters, where age was defined as age at time of PK infusion.
Danish: Kategorierne i disse analyser med spædbørn (1 måned til <2 år gamle), børn (2 til <5 år gamle), større børn (5 til <12 år gamle), unge (12 til <18 år gamle) og voksne (18 år og ældre) blev anvendt til at opsummere de farmakokinetiske parametre, hvor alder var defineret som alderen på tidspunktet for PK-infusionen.
English: Four of these patients reported isolated events of urticaria, pruritus, rash, and slightly elevated eosinophil counts amongst repeated exposures to the study product.
Danish: Fire af disse patienter rapporterede om isolerede tilfælde af urticaria, pruritus, udslæt og let forhøjede eosinofil-tal blandt gentagne eksponeringer for studieproduktet.
English: Factor VIII level required (% or IU/dl)
Danish: Krævet faktor VIII-niveau (% eller IE/dl)
English: Turn the package over and insert the clear plastic spike through the solvent stopper.
Danish: Vend pakningen om og indsæt den klare plastik-spike gennem proppen på solvenset.
English: ADVATE must not be mixed with other medicinal products or solvents.
Danish: ADVATE må ikke blandes med andre lægemidler eller solvenser.
English: If severe, sudden allergic reactions (anaphylactic) occur, the injection must be stopped immediately.
Danish: Hvis der opstår en alvorlig, pludselig allergisk (anafylaktisk) reaktion, skal injektionen stoppes øjeblikkeligt.
English: Baxalta Manufacturing Sàrl Route de Pierre-à-Bot 111 CH-2000 Neuchâtel Switzerland
Danish: Baxalta Manufacturing Sàrl Route de Pierre-à-Bot 111 CH-2000 Neuchâtel Schweiz
English: Factor VIII inhibitor assays performed after completion of continuous infusion and at study termination were negative.
Danish: Faktor VIII-inhibitortest udført ved afslutning af den kontinuerlige infusion og ved afslutning af studiet var negative.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the product immediately and contact their physician.
Danish: Hvis symptomer på overfølsomhed optræder, bør patienterne anbefales straks at afbryde behandling med produktet og tage kontakt til deres læge.
English: After reconstitution, from a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet anvendes straks efter rekonstitution.
English: Your doctor will calculate your dose of ADVATE (in international units or IU) depending on your condition and body weight, and on whether it is used for prevention or treatment of bleeding.
Danish: Din læge vil beregne din ADVATE-dosis (i internationale enheder eller IE) ud fra din tilstand og din vægt, og ud fra om ADVATE skal bruges til at forebygge eller stoppe blødning.
English: Children and adolescents The listed warnings and precautions apply to both adults and children (from 0 to 18 years of age).
Danish: Børn og voksne De anførte advarsler og forsigtighedsregler gælder for både voksne og børn (i alderen 0 til 18 år).
English: A central venous access device (CVAD) may become necessary to allow frequent infusions of factor VIII products.
Danish: Et centralt venekateter kan være nødvendigt for at tillade hyppige infusioner af faktor VIII-produkter.
English: Date of latest renewal: 20 December 2013
Danish: Dato for første markedsføringstilladelse: 2. marts 2004 Dato for seneste genregistrering: 20. december 2013
English: Only a clear and colourless solution should be used.
Danish: Kun en klar og farveløs opløsning må anvendes.
English: - Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: - Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: d) Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients
Danish: d) Hyppigheden er baseret på studier med alle FVIII-produkter, som omfattede patienter med svær hæmofili A. PTPs = tidligere behandlede patienter, PUPs = tidligere ubehandlede patienter.
English: Within a sub-study of PUP-study 060103, ITI-treatments in 11 PUPs were documented.
Danish: I et understudie af PUP-studie 060103 blev ITI-behandlinger dokumenteret hos 11 tidligere ubehandlede patienter.
English: Pharmacokinetic data with ADVATE on previously untreated patients are currently not available.
Danish: Der findes ikke farmakokinetiske data tilgængelige for ADVATE hos tidligere ubehandlede patienter.
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
Danish: Hvis de forventede faktor VIII-aktivitetsniveauer i plasma ikke opnås, eller hvis blødning ikke kan kontrolleres med en passende dosis, bør der testes for forekomst af faktor VIII-inhibitor.
English: The factor VIII/von Willebrand Factor complex consists of two molecules (factor VIII and von Willebrand Factor) with different physiological functions.
Danish: Faktor VIII/von Willebrand-faktor-komplekset består af to molekyler (faktor VIII og von Willebrandfaktor) med forskellige fysiologiske funktioner.
English: Inject intravenously.
Danish: Injiceres intravenøst.
English: The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay.
Danish: Potensen (internationale enheder) er bestemt ud fra Den Europæiske Farmakopes kromogene analyse.
English: If you forget to use ADVATE
Danish: Hvis du har glemt at bruge ADVATE
English: The number of units of factor VIII is expressed in International Units (IU), which are related to the WHO standard for factor VIII products.
Danish: Antallet af enheder af faktor VIII er udtrykt i internationale enheder (IE), som er relateret til WHOstandarden for faktor VIII-produkter.
English: During the course of treatment, appropriate determination of plasma factor VIII levels is advised to guide the dose to be administered and the frequency of repeated injections.
Danish: Under behandlingsforløbet tilrådes passende bestemmelse af plasma faktor VIII-niveauer som vejledning for den dosis, der skal indgives, og hyppigheden for gentagne injektioner.
English: Table 2 Frequency of adverse drug reactions (ADRs) in clinical trials and from spontaneous reports MedDRA Standard System Organ Class
Danish: Skema 2 Hyppigheden af bivirkninger (ADR) i kliniske forsøg og fra spontane rapporter MedDRA Standard Systemorganklasse
English: Post procedural complication
Danish: Komplikationer efter procedure
English: This product is for single use only.
Danish: Produktet er til engangsbrug.
English: Development of inhibitors is a known complication in the treatment of haemophilia A. If your bleeding is not controlled with ADVATE, tell your doctor immediately.
Danish: Udvikling af inhibitorer er en kendt komplikation ved behandling af hæmofili A. Hvis din blødning ikke kommer under kontrol med ADVATE, skal du straks fortælle det til lægen.
English: Clinical studies with ADVATE included 418 subjects with at least one exposure to ADVATE reporting in total 93 adverse drug reactions (ADRs).
Danish: Fra de kliniske studier med ADVATE, der omfattede 418 forsøgspersoner, som blev eksponeret for ADVATE mindst én gang, rapporteredes i alt 93 bivirkninger (ADR).
English: Powder: White to off-white friable powder.
Danish: Pulver: Hvidt til off-white sprødt pulver.
English: c) ADR explained in the section below.
Danish: c) Bivirkning forklaret i afsnit herunder.
English: Talk to your doctor before using ADVATE.
Danish: Kontakt lægen, før du bruger ADVATE.
English: • Inspect the prepared solution for particulate matter and discoloration prior to administration (the solution should be clear, colourless and free from foreign particles).
Danish: • Undersøg den tilberedte opløsning for småpartikler og misfarvning inden indgivelse (opløsningen skal være klar, farveløs og fri for fremmede partikler).
English: After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.7 to 7.3.
Danish: Efter tilberedning er opløsningen klar, farveløs, fri for fremmede partikler og har en pH på 6,7 til 7,3.
English: If you are unsure about this, ask your doctor.
Danish: Hvis du er usikker, så spørg din læge.
English: Patients developing Factor VIII inhibitors
Danish: Patienter der udvikler faktor VIII-inhibitorer
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Danish: Dosis og varighed af substitutionsbehandlingen afhænger af sværhedsgraden af manglen på faktor VIII, af placering og omfang af blødningen samt af patientens kliniske tilstand.
English: Adjusted recovery and terminal half-life (t½) was approximately 20% lower in young children (less than 6 years of age) than in adults, which may be due in part to the known higher plasma volume per kilogram body weight in younger patients.
Danish: Korrigeret bedring samt terminalhalveringstid (t½) var cirka 20 % lavere hos yngre børn (yngre end 6 år) end hos voksne, hvilket til dels skyldes den kendte, højere plasmamængde pr. kg. legemsvægt hos yngre patienter.
English: Side effects with unknown frequency (frequency cannot be estimated from the available data) potentially life-threatening reactions (anaphylaxis) and other allergic reactions (hypersensitivity), general disorders (tiredness, lack of energy).
Danish: Bivirkninger med ukendt hyppighed (hyppighed kan ikke vurderes ud fra de tilgænglige data) potentielt livstruende reaktioner (anafylaksi) og andre allergiske reaktioner (overfølsomhed), almene gener (træthed og manglende energi).