FrancophonIA/ELRC3.0 huggingface dataset:
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the amount of glucose (sugar) in the blood or when the body cannot use insulin effectively.
Danish: Ved type 2-diabetes producerer bugspytkirtlen enten ikke nok insulin til at regulere blodsukkermængden, eller også kan kroppen ikke udnytte insulinet effektivt.
English: For the full list of side effects of Xigduo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Xigduo fremgår af indlægssedlen.
English: Further studies confirmed that different doses of dapagliflozin with metformin decreased HbA1c more than placebo plus comparable doses of metformin, and that dapagliflozin plus metformin was at least as effective in reducing HbA1c levels as the diabetes medicine glipizide (a type of medicine known as a sulphonylurea).
Danish: Yderligere studier bekræftede, at forskellige doser dapagliflozin med metformin nedsatte HbA1c mere end placebo plus tilsvarende doser af metformin, og at dapagliflozin plus metformin var mindst lige så effektivt til at nedsætte HbA1c som diabeteslægemidlet glipizid (et lægemiddel af typen sulfonylurinstoffer).
English: such as heart or lung failure (the heart and lungs not working as well as they should), recent heart attack or shock;
Danish: • patienter, som lider af sygdomme, der kan forårsage vævshypoksi (lavt iltniveau i kropsvæv), som f.eks. hjerte- eller lungesvigt (hvor hjertet og lungerne ikke fungerer så godt, som de bør), eller som for nyligt har haft et hjerteanfald eller været i chok
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xigduo 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 Xigduo.
English: In one main study, when dapagliflozin was used at a dose of 5 mg twice a day in addition to metformin (the same combination as in Xigduo), it decreased HbA1c levels by 0.65 percentage points after 16 weeks, compared with a reduction of 0.30 percentage points with placebo (a dummy treatment) and metformin.
Danish: I ét hovedstudie, hvor dapagliflozin blev anvendt i en dosis på 5 mg to gange dagligt som supplement til metformin (samme kombination som i Xigduo), nedsatte det HbA1c-koncentrationerne med 0,65 procentpoint efter 16 uger, sammenholdt med en reduktion på 0,30 procentpoint med placebo (en virkningsløs behandling) og metformin.
English: As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine.
Danish: Når blodet filtreres i nyrerne, forhindrer SGLT2 blodsukkeret i at blive udskilt i urinen.
English: A sixth study showed that after 24 weeks of treatment, patients taking dapagliflozin plus metformin had an average reduction in body weight of around 2 kg more than those taking placebo plus metformin.
Danish: Et sjette studie viste, at patienter, der tog dapagliflozin plus metformin, efter 24-ugers behandling i gennemsnit havde tabt sig ca. 2 kg mere end dem, der tog placebo plus metformin.
English: How is Xigduo used?
Danish: Hvordan anvendes Xigduo?
English: Two other studies showed that dapagliflozin taken with metformin and another diabetes medicine, sitagliptin or insulin, for 24 weeks, further decreased HbA1c: the dapagliflozin combination decreased HbA1c levels by 0.40 percentage points more than placebo and metformin when added to sitagliptin, and by 0.61 percentage points more than placebo and metformin when added to insulin.
Danish: To andre studier viste, at dapagliflozin, anvendt i 24 uger sammen med metformin og et andet diabeteslægemiddel, sitagliptin eller insulin, nedsatte HbA1c endnu mere: Dapagliflozin-kombinationen nedsatte HbA1c-koncentrationen 0,40 procentpoint mere end placebo og metformin som tillægsbehandling til sitagliptin, og 0,61 procentpoint mere end placebo og metformin som tillægsbehandling til insulin.
English: What benefits of Xigduo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Xigduo?
English: How does Xigduo work?
Danish: Hvordan virker Xigduo?
English: By blocking the action of SGLT2, dapagliflozin causes the kidneys to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Danish: Ved at blokere virkningen af SGLT2 får dapagliflozin nyrerne til at udskille mere blodsukker gennem urinen, så blodsukkeret falder.
English: The recommended dose is 1 tablet taken twice a day with a meal; the strength should be chosen so that in total, patients receive 10 mg of dapagliflozin each day and the same (or almost the same) dose of metformin they were taking before starting Xigduo.
Danish: Der bør vælges en styrke, så patienten i alt får 10 mg dapagliflozin dagligt og samme (eller så tæt som muligt på samme) dosis metformin, som patienten allerede fik inden behandlingen med Xigduo.
English: The Agency considered Xigduo to be effective for treating type 2 diabetes; it also leads to weight loss, which is considered beneficial in patients with diabetes.
Danish: Agenturet fandt, at Xigduo var effektivt til behandling af type 2-diabetes.
English: Severe reactions are possible.
Danish: Alvorlige reaktioner er mulige.
English: If you receive more GADOVIST than you should have received:
Danish: Hvis du får mere GADOVIST end du burde have fået:
English: Computers record the activity and translate that into images.
Danish: Computere registrerer aktiviteten og omsætter den til billeder.
English: Overdosing is unlikely.
Danish: Overdosering er usandsynlig.
English: Your doctor will decide whether the intended examination is possible or not.
Danish: Din læge vil beslutte om den påtænkte undersøgelse er mulig eller ej.
English: If it does happen, the doctor will treat any symptoms that follow.
Danish: Hvis dette sker, vil lægen behandle alle efterfølgende symptomer.
English: After the injection you will be observed for at least 30 minutes.
Danish: Efter injektionen vil du blive observeret i mindst 30 minutter.
English: In some cases he will check whether your heart and kidneys work properly.
Danish: I visse tilfælde vil han kontrollere om dit hjerte og nyrer fungerer korrekt.
English: It is not known whether these effects can also be induced by a single administration.
Danish: Det vides ikke, om disse virkninger også kan induceres af en enkelt indgift.
English: There are no adequate data from the use of gadobutrol in pregnant women.
Danish: Der findes ikke tilstrækkelig data vedrørende anvendelse af gadobutrol til gravide kvinder.
English: Athens 14122
Danish: Athen 14122
English: Within two hours more than 50% and within 12 hours more than 90% (or 92%) of the given dose is eliminated via the urine.
Danish: Inden for to timer er mere end 50 % og inden for 12 timer er mere end 90 % (eller 92 %) af den indgivne dosis udskilt via urinen.
English: Any additional instructions from the respective equipment manufacturer must also be strictly adhered to.
Danish: Alle yderligere instruktioner fra den respektive udstyrsproducent skal ligeledes omhyggeligt overholdes.
English: If this should happen to you, tell your doctor or radiologist.
Danish: Hvis dette sker for dig, skal du fortælle det til din læge eller radiolog.
English: All results are average results obtained in blinded reader studies.
Danish: Alle resultater er gennemsnitlige resultater opnået i blindstudier.
English: CNS indications:
Danish: CNS-indikationer:
English: T1 -weighted scanning sequences are particularly suitable for contrast-enhanced examinations.
Danish: T1-vægtede scanning-sekvenser er særligt egnede til kontrast-forstærkede undersøgelser.
English: The passage of Gadovist into breast milk has not been investigated in humans so far.
Danish: Passage af Gadovist til modermælken er hidtil ikke blevet undersøgt hos mennesker.
English: ATC - Code: V08C A09
Danish: ATC - kode: V08C A09
English: The usual safety requirements for magnetic resonance imaging, especially the exclusion of ferromagnetic materials, also apply when using Gadovist.
Danish: De sædvanlige sikkerhedskrav for magnetisk resonans scanning, specielt udelukkelsen af ferromagnetisk materiale, gælder også ved brug af Gadovist.
English: - Before injection
Danish: - Før injektion
English: Tell your doctor if you are pregnant or could be pregnant, since Gadovist should not be used during pregnancy unless it is considered absolutely necessary.
Danish: Fortæl det til din læge, hvis du er gravid eller kan være gravid, eftersom Gadovist ikke må anvendes under graviditet med mindre det anses for absolut nødvendigt.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF GADOBUTROL
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF GADOBUTROL
English: No metabolites are detected in plasma or urine.
Danish: Der konstateres ingen metabolitter i plasma eller urin.
English: • General information
Danish: • Generel information
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR ÆNDRINGEN AF PRODUKTRESUMEET FREMLAGT AF EMEA
English: Like all medicines, Gadovist can cause side effects, although not everybody gets them.
Danish: Gadovist kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: This is done by a complex system of magnets and radiowaves.
Danish: Dette sker ved hjælp af et komplekst system af magneter og radiobølger.
English: Gadovist should not be used in patients with uncorrected hypokalemia.
Danish: Gadovist bør ikke anvendes til patienter med ukorrigeret hypokaliæmi.
English: - Tell your doctor if you have a heart pacemaker or if there are any implants or clips containing iron in your body.
Danish: - Fortæl det til din læge, hvis du har en hjertepacemaker, eller hvis der er andre implantater eller clips indeholdende jern i din krop.
English: The potential risk of single administration for humans is unknown.
Danish: Den potentielle risiko forbundet med en enkelt indgift af stoffet hos mennesker er ikke kendt.
English: The MAH submitted its response to the CHMP List of Questions on 29 September 2006.
Danish: Indehaveren af markedsføringstilladelsen forelagde sin besvarelse af CHMP's spørgsmål den 29. september 2006.
English: - If you are younger than 18, the use of Gadovist is not recommended.
Danish: - Hvis du er under 18 år, er brugen af Gadovist ikke anbefalet.
English: After the administration, the patient should be kept under observation for at least half an hour, since experience shows that the majority of undesirable effects occur within this time.
Danish: Efter indgift bør patienten holdes under observation i mindst en halv time, da erfaringer viser, at størstedelen af bivirkningerne indtræffer inden for dette tidsrum.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: [To be completed nationally] Date of last renewal: 24.01.2005
Danish: DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: [Udfyldes nationalt] Dato for fornyelse af tilladelsen: 24.01.2005
English: Low blood pressure Allergy-like reaction
Danish: Lavt blodtryk Allergi-lignende reaktion
English: Shelf life after first opening of the container:
Danish: Opbevaringstid efter første åbning af beholderen:
English: Adverse reactions from clinical trial data (experience in more than 2900 patients)
Danish: Bivirkninger indberettet i kliniske studier (erfaringer fra mere end 2900 patienter)
English: Read all of this leaflet carefully before you are given this medicine.
Danish: Læs denne indlægsseddel grundigt, inden du får dette lægemiddel.
English: - Allergy-like reactions may occur after use of Gadovist.
Danish: - Der kan opstå allergi-lignende reaktioner efter brug af Gadovist.
English: Within the range 0.47 to 2.0 Tesla, the relaxivity displays only slight dependency on the strength of the magnetic field.
Danish: I intervallet 0,47 til 2,0 Tesla viser relaksiviteten kun ringe afhængighed af den magnetiske feltstyrke.
English: BATCH NUMBER Lot {number}
Danish: BATCHNUMMER Lotnummer {nummer}
English: These include especially medicines that change the rhythm or rate of your heartbeat.
Danish: Dette omfatter især medicin, som ændrer på rytmen eller frekvensen af dit hjerteslag.
English: Plasma protein binding is negligible.
Danish: Plasmaproteinbindingen er meget ringe.
English: Patients with an allergic disposition suffer more frequently than others from hypersensitivity reactions.
Danish: Patienter, der er disponeret for allergi, lider oftere af overfølsomhedsreaktioner end andre.
English: Chemical and physical inuse stability has been demonstrated for 24 hours at room temperature.
Danish: Der er påvist 24 timers kemisk og fysisk stabilitet under brug ved stuetemperatur.
English: No signs of intoxication from an overdose have so far been observed during clinical use.
Danish: Der er hidtil ikke observeret tegn på forgiftning fra en overdosis ved klinisk anvendelse.
English: The MAH further agreed to the proposed wording by the CHMP as follows:
Danish: Indehaveren af markedsføringstilladelsen tilsluttede sig følgende af CHMP foreslåede ordlyd:
English: Additional side effects which have been reported after the approval of Gadovist:
Danish: Yderligere bivirkninger som er blevet rapporteret efter godkendelsen af Gadovist:
English: Physico-chemical properties:
Danish: Fysisk-kemiske egenskaber:
English: Gadobutrol does not cross an intact blood-brain barrier and therefore does not accumulate in healthy brain tissue or in lesions featuring an intact blood-brain barrier.
Danish: Gadobutrol overskrider ikke en intakt blodhjernebarriere og ophobes derfor ikke i sundt hjernevæv eller i læsioner med en intakt blodhjernebarriere.
English: Vasodilatation Hypotension
Danish: Karsygdomme Vasodilatation Hypotension
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I LISTE OVER LÆGEMIDLETS NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: Gadovist 1.0 mmol/ml (INN gadobutrol) was approved for “Contrast enhancement in cranial and spinal magnetic resonance imaging” (MRI) in Germany in January 2000 and subsequently in June 2000 in the EU and Norway via the mutual recognition procedure.
Danish: Gadovist 1,0 mmol/ml (INN gadobutrol) blev godkendt til "Kontrastforstærkning ved kraniel og spinal magnetisk resonans imaging (MRI)" i Tyskland i januar 2000 og efterfølgende i juni 2000 i EU og Norge ved den gensidige anerkendelsesprocedure.
English: UK - United Kingdom
Danish: UK - Det Forenede Kongerige
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
English: No impairment of renal functions has been observed during clinical trials performed on a limited number of patients.
Danish: Der er ikke observeret nedsat nyrefunktion under kliniske studier på et begrænset antal patienter.
English: The MAH is asked to provide information on the clinical utility of this product for the requested indication (directly or indirectly), according to the Points of Consider on the evaluation of diagnostic agents (CPMP/EWP/1119/98).
Danish: Indehaveren af markedsføringstilladelsen anmodes om at forelægge oplysninger om produktets kliniske værdi til den ansøgte indikation (direkte eller indirekte) i overensstemmelse med "Points to consider on the evaluation of diagnostic agents" (CPMP/EWP/1119/98).
English: Before you receive Gadovist, tell your doctor if any of these applies to you.
Danish: Før du gives Gadovist, skal du fortælle din læge, om noget af ovenstående gælder for dig.
English: Side effects which have been observed in clinical trials before the approval of Gadovist: Uncommon
Danish: Bivirkninger, som er blevet observeret i kliniske undersøgelser før godkendelsen af Gadovist: Usædvanlig
English: Tissue enhancement generally lasts up to 45 minutes after injection of Gadovist.
Danish: Vævsforstærkningen varer normalt indtil 45 minutter efter injektion af Gadovist.
English: Gadovist is injected by a doctor via a small needle into a vein.
Danish: Gadovist indsprøjtes af en læge gennem en lille nål i en blodåre.
English: Less than 0.1% of the dose is eliminated via the faeces.
Danish: Mindre end 0,1 % af dosis udskilles via fæces.
English: The MRP procedure was finalised on Day 221 of the procedure on 09.05.2006 with approval of the proposed indication and inclusion of the liver and kidney imaging studies' results under Section 5.1.
Danish: Den gensidige anerkendelsesprocedure blev afsluttet på dag 221 af proceduren den 9. maj 2006 med godkendelse af den ansøgte indikation og medtagelse af resultater af imaging-undersøgelser af lever og nyre i afsnit 5.1.
English: Having considered the grounds for the referral, the CHMP, during its May 2006 plenary meeting, requested the MAH to address the major objection to public health and adopted a List of Questions.
Danish: Efter at have gennemgået begrundelsen for indbringelsen anmodede CHMP på sit plenarmøde i maj 2006 indehaveren af markedsføringstilladelsen om at tage stilling til hovedindvendingen vedrørende den offentlige sundhed og vedtog en række spørgsmål.
English: Contrast-enhanced MRI can commence immediately afterwards (shortly after the injection depending on the pulse sequences used and the protocol for the examination).
Danish: Kontrastforstærket MR-scanning kan påbegyndes umiddelbart derefter (kort efter injektionen afhængig af de benyttede puls-sekvenser og protokollen for undersøgelsen).
English: With high local tissue concentrations of gadobutrol the T2 effect results in a lessening of signal intensity.
Danish: Ved høje lokale vævskoncentrationer af gadobutrol medfører T2effekten en nedsat signalstyrke.
English: Pack sizes of:
Danish: Pakningsstørrelser på:
English: The actual dosage of Gadovist that is right for you will depend on your body weight and on the region of examination:
Danish: Den faktiske dosis af Gadovist, som passer til dig, afhænger af din kropsvægt og af området, der skal undersøges:
English: 1 and 10 vials 1 and 10 bottles
Danish: Pakningsstørrelser på: 1 og 10 hætteglas 1 og 10 flasker
English: Member State Marketing Authorisation Holder
Danish: Medlemsstat Indehaver af markedsføringstilladelse
English: The MAH has updated SPC sections 4.1 and 4.2 in accordance with the requests of the CHMP.
Danish: Indehaveren af markedsføringstilladelsen har ajourført produktresuméets afsnit 4.1 og 4.2 i overensstemmelse med CHMP's anmodninger.
English: The tube from the injector to the patient (patient's tube) must be changed after every examination.
Danish: Slangen fra injektoren til patienten (patientens slange) skal udskiftes efter hver undersøgelse.
English: After finalisation of the procedure the Spanish Agency for Medicines and Health Products initiated a referral for Arbitration under Article 36.1 of Directive 2001/83/EC to the CHMP.
Danish: Efter procedurens afslutning indbragte den spanske lægemiddelstyrelse sagen for CHMP med henblik på voldgift i overensstemmelse med artikel 36, stk. 1, i direktiv 2001/83/EF.
English: Intravascular administration of contrast media should, if possible, be done with the patient lying down.
Danish: Intravaskulær indgift af kontraststof bør om muligt ske, mens patienten ligger ned.
English: Data are too limited to exclude the possibility of renal toxicity or aggravation of renal impairment.
Danish: Dataene er for begrænsede til at udelukke muligheden for nyretoksicitet eller en forværring af nedsat nyrefunktion.
English: Conclusions
Danish: Konklusioner
English: Do not use GADOVIST - if you are allergic (hypersensitive) to gadobutrol or any of the other ingredients of
Danish: Brug ikke GADOVIST - hvis du er allergisk (overfølsom) over for gadobutrol eller et af de øvrige indholdsstoffer i Gadovist (se
English: In patients with an allergic disposition the decision to use Gadovist must be made after particularly careful evaluation of the risk-benefit ratio.
Danish: Hos patienter disponeret for allergi må beslutningen om at anvende Gadovist træffes efter særlig omhyggelig vurdering af risk-benefit-forholdet.
English: 1 and 5 prefilled syringes
Danish: 1 og 5 fyldte sprøjter
English: In patients with severe cardiovascular disease Gadovist should only be administered after careful risk benefit assessment because only limited data are available so far.
Danish: Hos patienter med alvorlig kardiovaskulær lidelse bør Gadovist kun anvendes efter en omhyggelig vurdering af risk-benefit-forholdet, da der indtil videre kun er begrænsede oplysninger tilgængelige.
English: The pharmacokinetics of gadobutrol in humans are dose proportional.
Danish: Gadobutrols farmakokinetiske egenskaber hos mennesker er ligefrem proportionale med dosis.
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 Der er ikke udført interaktionsundersøgelser.
English: This medicinal product should be visually inspected before use.
Danish: Dette lægemiddel bør inspiceres visuelt før anvendelsen.
English: With reference to Question 2) the MAH acknowledged that Gadovist has not been adequately studied for any of its approved indications (including the new indication “contrast-enhanced MRI of liver and kidneys”) in patients aged less than 18 years.
Danish: Vedrørende spørgsmål 2) erkendte indehaveren af markedsføringstilladelsen, at Gadovist ikke var blevet tilstrækkelig undersøgt til nogen af de godkendte indikationer (herunder den nye indikation "kontrastforstærket MRI af lever og nyrer") hos patienter under 18 år.
English: Gadovist should only be administered by physicians experienced in the field of clinical MRI practice.
Danish: Gadovist må kun indgives af læger med erfaring inden for klinisk MRI.
English: Schering Lusitana, Lda Estrada Nacional 249, km 15, P.O.
Danish: Schering Lusitana, Lda Estrada Nacional 249, km 15, P.O. Box 16
English: Additional adverse reactions from postmarketing spontaneous reporting
Danish: Yderligere bivirkninger, spontant indberettet efter markedsføringen
English: D-13342 Berlin- Mitte Germany
Danish: D-13342 Berlin- Mitte Tyskland
English: One of the requirements for a diagnostic agent to be authorised is to demonstrate relevant impact on diagnostic thinking in the clinical context in which the test is to be used, unless such impact can be shown indirectly or historically.
Danish: Et af godkendelseskravene til diagnostiske midler er eftervisning af den relevante påvirkning af den diagnostiske proces i den kliniske sammenhæng, hvori testen anvendes, medmindre sådan påvirkning kan eftervises indirekte eller ad historisk vej.
English: Since contrast medium elimination is delayed in patients with severely impaired renal function, the benefits must be weighed very carefully against the risks in such cases.
Danish: Da eliminationen af kontraststoffet hos patienter med alvorlig nedsat nyrefunktion sker langsommere, må fordelene afvejes nøje i forhold til risici i disse tilfælde.
English: After intravenous administration, gadobutrol is rapidly distributed in the extra cellular space.
Danish: Efter intravenøs indgift fordeles gadobutrol hurtigt i det extracellulære rum.
English: Do not use Gadovist after the expiry date which is stated on the label after EXP.
Danish: Brug ikke Gadovist efter den udløbsdato, der står på pakningen.